On the morning of Sept. 2, 2009, another Pfizer unit, Pharmacia & Upjohn, agreed to plead guilty to the same crime. This time, Pfizer executives had been instructing more than 100 salespeople to promote Bextra — a drug approved only for the relief of arthritis and menstrual discomfort — for treatment of acute pain of all kinds.
For this new felony, Pfizer paid the largest criminal fine in U.S. history: $1.19 billion. On the same day, it paid $1 billion to settle civil cases involving the off-label promotion of Bextra and three other drugs with the United States and 49 states.
“At the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct in 2004, Pfizer was itself in its other operations violating those very same laws,” Loucks, 54, says. “They’ve repeatedly marketed drugs for things they knew they couldn’t demonstrate efficacy for. That’s clearly criminal.”
The penalties Pfizer paid for promoting Bextra off-label were the latest chapter in the drug’s benighted history. The FDA found Bextra to be so dangerous that Pfizer took it off the market for all uses in 2005.
Across the United States, pharmaceutical companies have pleaded guilty to criminal charges or paid penalties in civil cases when the Justice Department finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of chest infections, heart attacks, suicidal impulses or death.
It used to be legal for companies to promote drugs in the United States for any use. Congress banned the practice in 1962, requiring pharmaceutical companies to first prove their drugs were safe and effective for specific uses.
If the law is clear, why do drug companies keep breaking it? The answer lies in economics. Pharmaceutical companies spend about $1 billion to develop and test a new drug. To recoup their investment, the companies want doctors to prescribe their drugs as widely as possible.
Since May 2004, Pfizer, Eli Lilly, Bristol-Myers Squibb and four other drug companies have paid a total of $7 billion in fines and penalties. Six of the companies admitted in court that they marketed medicines for unapproved uses. In September 2007, New York-based Bristol-Myers paid $515 million — without admitting or denying wrongdoing — to federal and state governments in a civil lawsuit brought by the Justice Department. The six other companies pleaded guilty in criminal cases.
In January 2009, Indianapolis-based Lilly, the largest U.S. psychiatric drugmaker, pleaded guilty and paid $1.42 billion in fines and penalties to settle charges that it had for at least four years illegally marketed Zyprexa, a drug approved for the treatment of schizophrenia, as a remedy for dementia in elderly patients.
In five company-sponsored clinical trials, 31 people out of 1,184 participants died after taking the drug for dementia — twice the death rate for those taking a placebo, according to an article in the Journal of the American Medical Association.
“Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law,” says Jerry Avorn, a professor at Harvard Medical School. “The Pfizer and Lilly cases involved the illegal promotion of drugs that have been shown to cause substantial harm and death to patients.”
The widespread off-label promotion of drugs is yet another manifestation of a health-care system that has become dysfunctional.
“It’s an unbearable cost to a system that’s going broke,” Avorn says. “We can’t even afford to pay for effective, safe therapies.”
About 15 percent of all U.S. drug sales are for unapproved uses without adequate evidence the medicines work, according to a study by Randall Stafford, a medical professor at Stanford University.
As large as the penalties are for drug companies caught breaking the off-label law, the fines are tiny compared with the firms’ annual revenue.
The $2.3 billion in fines and penalties Pfizer paid for marketing Bextra and three other drugs cited in the Sept. 2 plea agreement for off-label uses amount to just 14 percent of its $16.8 billion in revenue from selling those medicines from 2001 to 2008.
The total of $2.75 billion Pfizer has paid in off-label penalties since 2004 is a little more than 1 percent of the company’s revenue of $245 billion from 2004 to 2008.
Lilly already had a criminal conviction for misbranding a drug when it broke the law again in promoting schizophrenia drug Zyprexa for off-label uses beginning in 1999. The medication provided Lilly with $36 billion in revenue from 2000 to 2008. That’s more than 25 times as much as the total penalties Lilly paid in January.
Companies regard the risk of multimillion-dollar penalties as just another cost of doing business, says Lon Schneider, a professor at the University of Southern California’s Keck School of Medicine in Los Angeles. In 2006, he led a study for the National Institute of Mental Health of off-label use of drugs, including Zyprexa.
“There’s an unwritten business plan,” he says. “They’re drivers that knowingly speed. If stopped, they pay the fine, and then they do it again.”
Paying the doctors
In pushing off-label use of drugs, companies find ready and willing partners in physicians. Under the fragmented system of U.S. medical regulation, it’s legal for doctors to prescribe FDA-approved drugs for any use. The FDA has no authority over doctors, only over drug companies, regarding off-label practices. It’s up to the states to oversee physicians.
“I think the physician community has to take some ownership responsibility and do their own due diligence beyond the sales and marketing person,” says Boston’s former U.S. Attorney Michael Sullivan.
Doctors generally don’t tell people they’re prescribing drugs pitched to them by pharmaceutical salespeople for unapproved treatments, says Peter Lurie, former deputy medical director of Public Citizen, a Washington-based public interest group. Most doctors don’t keep track of FDA-approved uses of drugs, he says.
“The great majority of doctors have no idea; they don’t even understand the distinction between on- and off-labeling,” he says.
Pfizer’s marketing program offered doctors up to $1,000 a day to allow a Pfizer salesperson to spend time with the physician and his patients, according to a whistle-blower lawsuit filed by John Kopchinski, who worked as a salesman at Pfizer from 1992 to 2003.
“By ‘pairing up’ with a physician, the sales representative was able to promote over a period of many hours, without the usual problems of gaining access to prescribing physicians,” Kopchinski says. “In essence, this amounted to Pfizer buying access to physicians.”
Pfizer spokesman Chris Loder says the company stopped what it calls “mentorships” in 2005. He says Pfizer paid doctors $250 a visit. The goal was clear: Get doctors to prescribe a new drug as widely as possible.
Pfizer’s Neurontin is a case in point. The FDA approved the drug as a supplemental medication to treat epilepsy in 1993. Pfizer took in $2.27 billion from sales of Neurontin in 2002. A full 94 percent — $2.12 billion — of that revenue came from off-label use, according to the prosecutors’ 2004 Pfizer sentencing memo.
Since 2004, companies that are now Pfizer divisions have pleaded guilty to off-label marketing of two drugs. Pfizer continued off-label promotions for these medications after buying the firms, according to documents.
Pfizer first stepped into an off-label scheme in 1999, when it offered to buy Warner-Lambert, based in New Jersey. Prosecutors charged that Warner-Lambert marketed Neurontin off-label between 1995 and 1999.
Warner-Lambert admitted doing so for one year in a May 2004 guilty plea for which Pfizer paid $430 million in fines and penalties.
When the FDA approved Neurontin in 1993 to be used only along with other epilepsy drugs, the agency wrote that as a side effect, the drug can induce depression and suicidal thoughts in patients.
The whistle-blower
Much of what prosecutors learned about Warner-Lambert’s marketing of Neurontin comes from a former employee, David Franklin, who holds a Ph.D. in microbiology.
Franklin, 48, whose title at Warner-Lambert was medical liaison, says his job involved more salesmanship than science. He told doctors that Neurontin was the best drug for a dozen off-label uses, including pain relief, bipolar disease and depression.
“Technically, I had responsibility for answering physician questions about all of Parke-Davis’s drugs,” Franklin says. “In practice, my real job was to promote Neurontin for off-label indications heavily — to the exclusion of just about everything else.”
Franklin says he knew such uses of the drug had no scientific support for effectiveness and safety.
“I was actually undermining their ability to fulfill the Hippocratic oath,” Franklin says, referring to a physician’s pledge to “First, do no harm.”
After working for Warner-Lambert for three months, Franklin quit and filed a whistle-blower lawsuit on behalf of taxpayers to recover money the government paid for illegally promoted drugs. He stood to collect as much as 30 percent of any settlement the company made with the government.
Franklin had to wait four years — until 2000 — before the Justice Department began a criminal investigation. In November 1999, Pfizer made its public offer to buy Warner-Lambert. In January 2000, a federal grand jury in Boston issued subpoenas to Warner-Lambert employees to testify about the marketing of Neurontin.
That March, Warner-Lambert’s annual report disclosed that prosecutors were building a criminal case. Undeterred, Pfizer bought Warner-Lambert in June for $87 billion — the third-largest merger in U.S. history.
More sales than Viagra
A year after the acquisition, the FDA discovered that Neurontin was still being marketed off-label. In a June, 2001 letter to the company, the agency wrote that Pfizer’s promotion of the drug “is misleading and in violation of the Federal Food, Drug and Cosmetics Act.”
Pfizer marketed Neurontin off-label after receiving that letter, agency records show. For 2001, Pfizer reported revenue of $1.75 billion from Neurontin sales, making it the company’s fourth-largest-selling drug that year, ahead of impotence pill Viagra, which Neurontin topped for four years.
As Neurontin sales soared to $2.27 billion in 2002, the FDA found that Pfizer was improperly claiming that the drug was useful for a broader range of brain disorders than scientific evidence had established.
The agency sent a letter dated July 1, 2002, that said the company’s marketing practices were in violation of FDA rules. It asked Pfizer to stop using misleading promotions. Pfizer reported $2.7 billion in revenue from Neurontin in 2003. Overall, the drug has provided Pfizer with $12 billion in revenue.
Pfizer spokesman Chris Loder says, “Regarding the 2001 and 2002 FDA letters, we do not believe that they were suggestive of any continuing off-label promotion.”
For blowing the whistle on his employer, Franklin collected $24.6 million under the False Claims Act.
Prosecutors Loucks and Sullivan got involved in the case after Franklin filed his suit, relying on information from Franklin and their own investigation. Before 2004, prosecutions for off-label marketing were rare.
“Until a couple of these cases became public, companies were probably saying, ‘Everybody does it this way,’ ” Sullivan says.
Loucks had a track record in off-label prosecutions. In 1994, he negotiated a $61 million settlement with C.R. Bard of New Jersey, which pleaded guilty to promoting off-label use of a heart catheter that led to patient deaths.
The off-label campaign
In the January 2004 settlement negotiations with Loucks, Sullivan and two other prosecutors, Pfizer’s lawyers assured the U.S. Attorney’s Office that the company wouldn’t market drugs off-label.
“They asserted that the company understood the rules and had taken steps to assure corporate compliance with the law,” Loucks says. “We remember those promises.”
What Pfizer’s lawyers didn’t tell the prosecutors was that Pfizer was at that moment running an off-label marketing promotion using more than 100 salespeople who were pitching Bextra, according to a Pfizer sales manager who pleaded guilty to misbranding a drug in March 2009.
Pharmacia & Upjohn developed Bextra, which was approved by the FDA in 2001 for only the treatment of arthritis and menstrual discomfort.
P&U and Pfizer had by then crafted a joint marketing agreement to sell the drug. In November 2001, Mary Holloway, a Pfizer Northeast regional manager, began illegally training and directing her sales team to market Bextra for the relief of acute pain, Holloway admitted in the plea.
On Dec. 4, 2001, Pfizer executives sent Holloway a copy of a nonpublic FDA letter to the company. The agency had denied Pfizer’s application to market Bextra for acute pain. Clinical trials had shown Bextra could cause heart damage and death.
Pfizer bought Pharmacia & Upjohn in April 2003. From 2001 through 2003, P&U, first as an independent company and then as a unit of Pfizer, paid doctors more than $5 million in cash to lure them to resorts, where salespeople illegally pitched off-label uses for Bextra, P&U admitted.
In her guilty plea, Holloway said her team had solicited hospitals to create protocols to buy Bextra for the unapproved purpose of acute pain relief. Her representatives didn’t mention the increased risk of heart attacks in their marketing.
They told doctors that side effects were no worse than those of a sugar pill, Holloway said.
In 2003, Holloway reported her unit’s off-label promotions of Bextra up the corporate ladder at Pfizer, according to a presentencing memo to the judge written by Robert Ullmann, Holloway’s attorney. Top managers didn’t attempt to halt the illegal conduct, the memo said.
By late 2004, Bextra reached blockbuster status, with annual sales of $1.29 billion. Holloway promoted Bextra until the FDA asked Pfizer in April 2005 to pull it from the market for all uses.
The agency concluded that the drug increased the risk of heart attacks, chest infections and strokes in cardiac surgery patients. In June 2009, Holloway, 47, was sentenced to two years on probation and fined $75,000. She didn’t return phone calls seeking comment.
‘We regret . . . ‘
By 2007, the criminal and civil cases against Pfizer, its employees and its subsidiaries had begun to mount. The tally of drugs cited by federal prosecutors for off-label promotion reached six by 2009. In April 2007, P&U pleaded guilty to a felony charge of offering a $12 million kickback to a pharmacy benefit manager. Pfizer paid a criminal fine of $19.7 million. In September 2009, Pfizer agreed to pay $2.2 billion in fines and penalties. P&U pleaded guilty to a felony charge of misbranding Bextra with the intent to defraud. After the settlement, Pfizer general counsel Amy Schulman said the company had learned its lesson.
“We regret certain actions we’ve taken in the past,” she said. “Corporate integrity is an absolute priority for Pfizer.”
One reason drug companies keep breaking the law may be because prosecutors and judges have been unwilling to use the ultimate sanction — a felony conviction that would exclude a company from selling its drugs for reimbursement by state health programs and federal Medicare.
At Pfizer’s Pharmacia sentencing in October, U.S. District Court Judge Douglas Woodlock said companies don’t appear to take the law seriously. “It has become something of a cost of doing business for some of these corporations, to shed their skin like certain animals and leave the skin and move on,” he said.
As prosecutors continue to uncover patterns of deceit in off-label marketing, millions of patients across the nation remain in the dark. Doctors often choose the medications based on dishonest marketing by drug company salesmen.
Loucks says that putting an end to the criminal off-label schemes will be difficult. As drugmakers repeatedly plead guilty, they’ve shown they’re willing to pay hundreds of millions of dollars in fines as a cost of generating billions in revenue.
The best hope, Loucks says, is that drug companies actually honor the promises they keep making — and keep breaking — to obey the law of the land.
As much as $100 million for health-care fraud enforcement is tied up in the stalled reform legislation, according to Loucks.
“It will be increasingly hard for the threat of exclusion to seem credible and thus serve as a deterrent to bad corporate behavior,” he says, “unless Congress supports health-care fraud prosecutions with more money.”
A version of this story originally appeared in Bloomberg Markets Magazine. It was awarded a 2010 Society of American Business Editors and Writers award for enterprise reporting and general excellence.
Why don’t we know why Tb is so hard to treat and why is there no vaccine for it?
Because MYCObacteria tuberculosis is a fungal type infection, bearing the same antigens as LYMErix (TLR2 agonists), which did not prevent Lyme, but gave people an immuno suppression – like AIDS – outcome, just like Lyme.
Yale and UConn lied about the definition of Lyme and they lied about the outcome of LYMErix. (And now they have been defunded by the NIH.)
See more about how Yale and UConn lost all their funding, but the university that employs the man who discovered all mechanisms/outcomes of Lyme and LYMErix (arthritis to enhancing opportunistics like Epstein-Barr and CMV) was given a 65 million dollar grant to “translate” this research,… further down on this homepage.
We’d like to thank the Wall Street Journal for bringing this fiasco to the world’s attention.
Why don’t we know why infections like MRSA, Tb, and Lyme are so tough to treat?
What are the mechanisms of the reactivation of latent viruses?
Why is there no HIV, Tuberculosis or “Lyme” (real name, Relapsing Fever) vaccine?
Why did all the vaccines for these – Tb, Lyme, and HIV – all fail?
What happens to the immune system with chronic exposure to fungal antigens like the chronic shedding of Osps by Borreliae (known as blebs) in their typical Relapsing Fever-like mechanisms of relapse?
Why did all those vaccines end up to be the same thing and no one knew they all were the same thing and especially that they all failed in the same way?
[Because Yale and UConn lied about the outcome of LYMErix and the definition of Lyme to the FDA in 1994 and again in 1998. And they are lying still.]
But why does everyone at the CDC, NIH, Yale and IDSociety.org still say they don’t know what OspA is?
Maybe they refuse to admit what OspA is because that info betrays the mechanisms of vaccines-induced brain damage.
The reasons there are no Lyme, HIV, and TB fungal “vaccines” are the same reasons childhood immunizations fail and end up giving children the very viruses the vaccines were intended to prevent.
The CDC staff has recently been detected going around to the colleges recruiting from the chemistry and biochemistry undergraduates.
It’s too late. Because of this crime, USA has no competitive technoglobal edge. The whole world looks at this crime. Brazilian scientists flat out make fun of Americans and “Lyme Disease.”
The Tuberculosis global fiasco is a headline article in the Wall Street Journal – not a rag usually associated with moral issues. Clue. USA lost its technoglobal edge. American biotech and Pharma companies are sucking global wind.
THE FOLLOWING IS A LETTER OF COMPLAINT ABOUT THE INCOMPETENCE OF IDSA AND THE NIH, (See more at 101016.htm, or the Immunology of Epstein-OspA-Borreliosis).
This is evidence that it is known why children acquire the brain damage we call Autism and the mechanisms by which that damage occurs is similar to Lyme- and LYMErix-Disease:
2) Measles, Mumps, and Rubella — Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps: Recommendations of the Advisory Committee on Immunization Practices (ACIP) http://www.cdc.gov/mmwr/preview/mmwrhtml/00053391.htm
“Updated information on adverse events and contraindications, particularly for persons with severe HIV infection, persons with a history of egg allergy or gelatin allergy, persons with a history of thrombocytopenia, and persons receiving steroid therapy [are immunosuppressed- KMD].”
An ^^^ immunosuppressed pregnant cow was given a Brucella (LYMErix-like) “live attenuated” vaccine and the baby cow ended up with the disease, which then was transferred to the humans handling the cow and her dead baby. This parallels what is happening to children who are vaccinated while immunosuppressed, or who receive mycoplasmally (LYMErix-like) contaminated vaccines.
4) in the case of pandemic MRSA, as we have seen, the vaccine didn’t work because TLR2 agonists (lipoproteins) suppress the immune system. We also learned from the MRSA vaccine patent, that:
“Several established vaccines consist of live attenuated organisms where ***the risk of reversion to the virulent wild-type strain exists. In particular in immunocompromised hosts this can be a live threatening scenario.*** Alternatively, vaccines are administered as a combination of pathogen-derived antigens together with compounds that induce or enhance immune responses against these antigens (these compounds are commonly termed adjuvant), since these subunit vaccines on their own are generally not effective.” http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7,771,728.PN.&OS=PN/7,771,728&RS=PN/7,771,728
Do not ^^ cause immunosuppression/stress as
it causes increased mortality from existing
infections and especially do not cause stress to
humans by treating them to *ABUSE* instead
of medicine when they don’t the special “controversial”
disease that fits the commercial (unknown) vaccine model: http://www.ncbi.nlm.nih.gov/pubmed/20466055
Because ^^ that – the abuse – activates Epstein-Barr.
———————————
RULE: Don’t give immunosuppressed mammals live attenuated vaccines, and especially don’t give them vaccines that contain fungal or mycoplasmal antigens like LYMErix or OspA.
What do you say? Do you like that rule?
Especially if we added the OspA/MS/Roland Martin
“Immunosuppression>> MS Outcome of Lyme” data
to that data set?
What about if we added the 1918 Spanish
Flu data to the rule: “People with strong
(Steere-HLA-like, Dearborn definition-like)
immune responses are likelier to choke to death
on the pneumonia (fungal) that follows the influenza,
whereas immunosuppressed people won’t produce a
hyperinflammatory response and thereby survive the
pandemic.”
We haven’t had any new Rules in a while.
All we ever hear is that “Lyme causes nothing”
and “no disease outcomes happen from Lyme”
and “nothing causes anything” and “Lyme victims
are looney” and “Lyme victims have paranoid
delusional wannabee diseases” and the latest:
“Lyme victims are terrorists !!!”: http://www.ncbi.nlm.nih.gov/pubmed/21867956
“But get the mysterious unknown OspA vaccine.”
– – – – – – –
??
What do you think?
How about that for a rule?
You might have to find out what OspA is, first.
No hurry. It was ordered removed by the FDA
in Feb, 2002 for producing “chronic Lyme-like”
illness (clue).
And that was the last time Uncle Sam said
anything *TRUE* about “Lyme Disease.”
10 years….
Kathleen M. Dickson
former Pfizer Analytical Methods Development
and VALIDATION chemist
SOURCE
Rather than admit that one of their silver bullets, Accutane (isotretinoin), which was a “goose laying the golden egg” for F. Hoffmann-La Roche Pharmaceuticals (and their various “Roche” associates world-wide) to the tune of a billion dollars a year, could make kids kill themselves or cause grotesque birth defects in the kids of over half of women exposed when pregnant, dermatologists have sung themselves a lullaby that their magic pills don’t make kids depressed, they actually make them better, by clearing up those ugly zits that drive them to despair. In what can only be described as a tragic collusion of conflicts of interest (COI) amongst their Key Opinion Leaders (KOLs) and willful denial amongst the lowly rank and file, they have decided to say “What? Me Worry?”
When the heat got turned up on Roche Pharmaceuticals after the son of Congressman Bart Stupak’s (D-Mich) son Bart Jr. died of suicide while on Accutane in 2000, they got busy and called a “Scientific Advisory Board” meeting at the Ritz Carlton in Alexandria, Virginia, to opine on the topic of the relationship between Accutane treatment and depression. This meeting included figures from psychiatry like Kathleen Merikangas, PhD, Stuart Montgomery, PhD, and David Nutt, MD, Chair of Dermatology David Bickers MD, and psychiatrist Douglas Jacobs, MD. Between the lot of them I think they have written about one paper total in the literature on the subject. But they did get paid a nice consulting fee for their efforts, of course.
Accutane and depression
Their conclusion? No relationship, of course.
I wasn’t aware you were an Accutane expert, Kathleen!
I challenge them all to a debate. I’ll fight them with one hand behind my back!
Fact is Accutane’s efficacy for acne was discovered a decade before Roche put a patent on it, in a paper in the New England Journal of Medicine.
I have communicated with two of the authors, both dermatologists, Frank Yoder MDand Gary Peck, MD.
Both of them agreed with my opinion that Accutane can cause depression in some individuals.
What is really sad about this whole sordid tale is how degenerated the so-called dermatology “literature” has become on the topic.
For example, the most commonly cited study to support the statement that acne is associated with depression, a study that has been cited several hundred times by dermatologists writing in the literature, involved only ten patients with acne and no comparison subjects (Gupta et al., 1990). No statistics were performed (obviously since there was no comparison group). Scores on the questionnaires for anxiety and depression were not related to severity of acne.
And the fact is that the rest of the literature isn’t any better. Objective measures of acne do not correlate with severity of anxiety or depression. Acne does not cause major depression. It is simple as that.
Sure, kids worry about their zits and feel better when they go away, but the studies do not support the conclusion that acne causes major depression, and that treatment of acne cures depression.
In spite of this the manufacturer of Accutane, Hoffmann-LaRoche, has consistently downplayed the risks of suicide and depression and has denied a causal association (McCoy, 2004). The dermatology community has joined with the manufacturer in praising the merits of this medication for the treatment of acne which they describe as the “penicillin of dermatology”. It took only 10 months for the FDA to approve Accutane for the treatment of cystic and nodular acne in May of 1982, however controversy has followed it from the time of its initial launch. In January of 1983 one of the authors of the first paper to describe the use of isotretinoin for the treatment of acne in 1977, Dr. Frank Yoder, wrote about the potential dangers of Accutane (Yoder, 1983). In 1990 Dr. David Graham of the FDA highlighted the inability of the Dermatological Medications Advisory Committee to the FDA to be impartial since it was made up entirely of dermatologists (Green & Hutt, 2002). At that time he stated that Accutane should be taken off of the market, mainly because of the risk of birth defects. Indeed its use has always been curtailed or highly restricted in European countries, unlike the US where it is often prescribed for minor blemishes. Strong feelings about the utility of isotretinoin for the treatment of acne in the dermatology community, and forceful marketing by the manufacturer in the US, have caused a delay in awareness of the potential risks in the US. In 1998, the year that the FDA first approached Hoffmann-LaRoche about adding a warning related to suicide with Accutane to its label, the manufacturer ran an ad that stated, “Effective treatment of severe recalcitrant nodular acne minimizes progressive physical scarring, as well as negative psychosocial effects such as depression and poor self image” (Green & Hutt, 2002). This was in spite of the fact that less than half of patients prescribed the medication actually had nodular acne. The FDA required that Hoffman-LaRoche pull the ad.
In 2000 Congressman Bart Stupak’s son, Bart Jr., committed suicide while on Accutane. Congressman Stupak called for congressional hearings on the safety of the drug and in September of that year the FDA called a Dermatologic Advisory Committee meeting on the topic. In November of 2001 an educational grant from Roche funded a supplement of the Journal of the American Academy of Dermatology on isotretinoin which followed the Scientific Advisory Board Meeting in Alexandria VA they held on the topic. The basic science-related articles focused on retinoids and the skin, essentially ignoring the large extant literature on retinoids and the central nervous system. Psychiatric side effects merited literally two sentences, and one article, written by one of Roche’s hired guns, stated that there was no evidence for any association (Jacobs et al., 2001), ignoring the reported challenge-rechallenge cases which have been cited in the pharmacoepidemiology literature as adequate in and of themselves to establish causality (Strom, 2005). This led members of the FDA to write a letter of response, “in the interest of public health,” admonishing the authors of these articles for the short shrift they paid to the issue of Accutane and psychiatric side effects (O’Connell, Wilkin, Pitts, 2002).
The degree to which dermatologists have thrown science and logic out of the window in order to protect their magic bullet is simply remarkable. For instance in a 2004 article entitled “Myths of Isotretinoin Therapy” (Alcalay, 2004) “isotretinoin causes depression and suicide attempts” was listed as a “myth”. The article went on to state that any risk needed to be “weighed against the increasing prevalence of depression among adolescents and young adults and the psychological impact of acne.” [In fact, depression is not increasing amongst teenagers and acne has not been associated with clinical depression, rather only changes in self esteem].
Here are some authentic mythic figures for you, Dr. Alcalay! And they don’t have any pharmaceutical industry COIs!
Mythic figures
Aktan, S., Ozmen, E., Sanli, B. (2000). Anxiety, depression, and nature of acne vulgaris in adolescents. International Journal of Dermatology, 39, 354-357.
Alcalay, J. (2004). Myths of isotretinoin therapy in patients with acne: A personal opinion. Journal of Drugs in Dermatology, 3(2), 179-182.
Green, J., Hutt, P. (2002). Babies, blemishes, and FDA: A history of Accutane regulation in the United States., Leda. Cambridge, MA.
Gupta, M. A., Gupta, A. K., Schork, N. J., Ellis, C. N., Voorhees, J. J. (1990). Psychiatric aspects of the treatment of mild to moderate facial acne: Some preliminary observations. International Journal of Dermatology, 29(10), 719-721.
Jacobs, D. G., Deutsch, N., Brewer, M. (2001). Suicide, depression, and isotretinoin: Is there a causal link? Journal of the American Academy of Dermatology, 45, S168.
Kellett, S. C., Gawkrodger, D. J. (1999). The psychological and emotional impact of acne and the effect of treatment with isotretinoin. British Journal of Dermatology, 273-282.
McCoy, K. (2004, December 7, 2004). Drug Maker rebuffed call to monitor users. USA Today, pp. 1-2.
O’Connell, K. A., Wilkin, J. K., Pitts, M. (2002). Isotretinoin (Accutane) and serious psychiatric adverse events. Journal of the American Academy of Dermatology, 48(2), 306-307.
Shuster, S., Fisher, G. H., Harris, E., Binnel, D. (1978). The effect of skin disease on self-image. British Journal of Dermatology, 99(Suppl 16), 18-19.
Smithard, A., Glazebrook, C., Williams, H. C. (2001). Acne prevalence, knowledge about acne and psychological morbidity in mid-adolescence: a community-based study. British Journal of Dermatology, 145, 274-279.
Strom, B. L. (Ed.). (2005). Pharmacoepidemiology (4 ed.). New York: Wiley.
Van der Meeren, H. L. M., van der Schaar, W. W., van den Hurk, C. M. A. M. (1985). The psychological impact of severe acne. Cutis, 36(1), 84-86.
Wu, S. F., Kinder, B. N., Trunnell, T. N., Fulton, J. E. (1988). Role of anxiety and anger in acne patients: Relationship with the severity of the disorder. Journal of the American Academy of Dermatology, 18, 325-333.
Yoder, F. W. (1983). Isotretinoin: A word of caution. Journal of the American Medical Association, 249(3), 350-351.
The only Accutane side effects that have ever received any substantial media attention are the
birth defects and psychiatric side effects, and even then, the media has completely missed the
boat and downplayed their seriousness. But this is likely to change in the near future now that
hundreds of new lawsuits are getting into the spotlight.
The pharmaceutical industry is the most powerful and profitable industry in the world,
leveraging their influence with the FDA, the FTC, Capitol Hill, lobbyists, and other entities in
government to ensure that nothing threatens their monopoly over the treatment of disease in
America. Yet again, modern medicine’s conventional old-school obsolete attitude is to have
acne occur and then treat it after the fact, rather than prevent it in the first place. As is the case
with many other health conditions, several alternative natural remedies and dietary modification
programs exist that are highly effective against acne, but the problem is nobody knows about
them to take advantage of their availability because they are not being promoted to the masses,
because they are not a patentable, profitable, pharmaceutical drug like Accutane. The current
FDA regulating system states that it is illegal to make medical claims about a remedy being
effective for a disease unless it has been evaluated and approved as a drug by the FDA. You
read that right. The FDA has set as law that only a drug can cure, prevent or treat a disease,
absolutely nothing else can. For example, if you say that an orange cures the disease of scurvy,
technically you’ve broken the law and could be thrown in prison. There is no incentive to spend
the huge amount of money needed to get a natural remedy approved because natural remedies
cannot be patented. So, according to this logic and these rules, technically it would be illegal for
a dermatologist to recommend diet modification or a safe alternative natural remedy for their
patient’s acne instead of the toxic chemotherapy drug Accutane or antibiotics, which is
incredibly insane. Therefore a lot of people mistakenly believed that Accutane was their only
available option because the dermatologist had erroneously told them that nothing else worked.
Also, why would dermatologists recommend a safe natural remedy when Roche has been giving
them many incentives to prescribe Accutane “off-label” to many patients with mild to moderate
acne. On a side note, doctor’s often claim they don’t have time to read the latest Physician’s
Desk Reference sections on the drugs they prescribe, which would keep them up-to-date on all
the side effects. This is preposterous. I’m not a doctor (last time I checked) and it only took me
25 minutes to read the entire 7 page section on Accutane in the PDR.
The future of medicine does not involve foolishly bombarding the body with toxic drugs like
Accutane. The real progress that is being made in health care comes from physicians who are
thinking outside the box and providing a type of care that takes the entire person into account,
searches for the root underlying cause, devises specific individualized treatment plans, and often
doesn’t require drug therapy of any kind. Proper nutrition, clean air/water, and stress reduction
techniques always go a long way in helping people become healthier. Yes there are definitely
important truly “safe and effective” drugs out there, but they are few and far between and
probably not more than 200 of them are actually needed. Improvements toward this new vision
of health care have been occurring gradually over last few years, more and more physicians are
beginning to gravitate away from the conventional paradigms by becoming more progressive and
open-minded, but before significant change can take place, modern medicine needs to start
viewing the human body as a dynamic entity instead of a collection of isolated parts.
Great article by Dr. Joseph Mercola that includes a petition to sign to help reform the FDA
Vitamins are essential compounds for life to occur and to maintain healthy function of all of the
metabolic reactions in a living organism, which is why they are called vitamins. The word
vitamin originated from the term “vitamine” which was coined in 1911 by the Polish scientist
Cashmir Funk to define a group of compounds that are considered vital for life. Vitamin A
(Retinol) plays a vital role in vision, skin health, gene expression, reproduction, fetal
development, growth, bone metabolism, immune response, and the cellular formation of tissue.
In the complete absence of vitamin A for an extended period of time, people go blind, hence it is
extremely important to consume some vitamin A on an ongoing basis. Normal RDA
(recommended daily allowance) doses of natural vitamin A in the vicinity of 5000 IU are
completely harmless and greatly beneficial to our health. But like many other things in the body
and in the field of endocrinology, maintaining the correct balance is the key, and severe
consequences can result when this balance is thrown off. This is especially true with vitamin A
and the retinoids. When vitamin A is consumed in the diet, it is then converted by the body into
biologically active retinoids that influence the expression of genes, also known as protein
transcription, the biological process of building structures that are the essence of life and that
sustain life. Humans and mammals cannot utilize any dietary protein without the presence of
vitamin A, therefore retinoids are vitally important in the mechanism of protein transcription. In
fact, retinoic acid is considered to be the great “impresario” orchestrator of life. Being the chief
regulator of protein transcription and cell division, it is arguably the body’s most important
master molecule. Beta-carotene (non-toxic precursor pro-vitamin A), a healthy beneficial
antioxidant found in several fruits and vegetables, is converted into vitamin A in the liver on an
as needed basis in a tightly regulated process, which illustrates one of the safety mechanisms set
up within the body to prevent vitamin A toxicity, because vitamin A performs the crucial
function of regulating the gene expression and protein transcription. Accutane is downstream at
end of the retinoic acid metabolic pathway so it bypasses these biological safety check points.
The problem with Accutane is that it gives all the other vitamins a bad rap. As a general rule,
vitamins and nutritional supplements are all very safe health enhancing compounds, but there are
a few exceptions and vitamin A is one of them, because it has by far the worst toxicity profile out
of all the vitamins. A high degree of individual variability exists with vitamin A toxicity. Some
very sensitive individuals experience signs of toxicity at only 50,000 IU per day, but most people
don’t experience toxicity until doses above 300,000 IU per day are achieved, which is roughly
equivalent to taking one dose of Accutane. Even a low dosage of Accutane (10 mg to 20 mg) is
still a hefty amount of vitamin A. To avoid birth defects, pregnant women should never
consume more than 10,000 IU of vitamin A per day in their diet or supplements. It’s ok to
incorporate natural vitamin A into an acne treatment program, just make sure to stay below a
daily dose of 30,000 IU. If for any reason you do decide to exceed this threshold and something
weird happens to your body, don’t come back and say that I didn’t sufficiently warn you.
Vitamin A toxicity resulting from dietary factors like excessive consumption of animal liver or
excessive intake of nutritional supplemental vitamin A is very rare because all supplement
manufacturers set their dosages at or near the 5,000-10,000 IU upper limit. Therefore someone
would seriously have to go out of their way to intentionally poison themselves with supplemental
vitamin A. But the horrible toxicity of vitamin A has been experienced by millions acne patients
around the world as a result of dermatologists irresponsibly and carelessly handing out Accutane
prescriptions “off-label” to many many people with mild to moderate acne, not severe cystic
acne, which is the only medical condition Accutane is approved to treat. Roche has exploited the
one vitamin with the worst toxicity profile, creating a potent, dangerous drug out of it. Accutane
induces a severe form of vitamin A toxicity, which is how it reduces acne, reduces cell division
and severely dries out the entire body by effectively slamming shut all of the sebaceous (oil)
glands in the skin and degrading the glycosaminoglycan water-holding protein molecules
collagen, hyaluronic acid, elastin, and chondroitin sulfate in connective tissue everywhere,
leaving the person in a chronically dehydrated hung-over state because the terrain throughout
their whole body has been literally turned into a desert, they are unable to retain moisture
between their cells. Severe systemic dryness is the hallmark sign of vitamin A toxicity. The
more toxic dose of Accutane or vitamin A consumed, the more severely dried out the entire body
becomes, especially the skin, eyes, and mucous membranes. The chronic life-long latent effect
of extreme dryness doesn’t happen to everybody, but it does happen (with varying degrees) to
everybody while they are taking Accutane. Depending on the severity of Accutane’s original
assault on the person’s DNA protein transcription mechanisms, some people recover from their
side effects with time, others aren’t so lucky. And from what I can tell, there’s no way of
knowing in advance which group somebody will fall into. If you’ve taken Accutane in the past
(a lot of people have) and your body currently feels normal, healthy, and without any severe
dryness, consider yourself extremely lucky and don’t ever take this drug again. Vitamin A
toxicity is very real, and more common and deadly than people realize, all because of Accutane.
Here’s an extremely important question for all the current prospective Accutane users to ponder
over. Do you think it is better to have extra oily supple skin or chronic life-long dry skin, the
latter being a potential outcome of using Accutane. Don’t know? I’ll help you out with another
hint. Take a look around, how many people do you see in their 50’s to 70’s with oily skin or
acne? Having acne prone oily supple skin is a sign of youth because as the body ages the skin
gradually and inevitably dries out. If somebody were to design the perfect drug to accelerate the
aging process by prematurely drying out the entire body, that drug would be Accutane. Roche
doesn’t disclose this fact in their product information on Accutane because their primary motive
is profits not patient safety and they know that teenagers don’t ever think this far ahead when the
prospect of clear skin is on the line. This drug permanently shrinks the oil glands everywhere
and damages the ability to regenerate water-holding molecules, like the glycosaminoglycan
hyaluronan AKA hyaluronic acid, which holds water hundreds of times its own weight in the
skin and other areas of connective tissue. These specialized molecules in connective tissue are
extremely important because they are the scaffolding that holds the body together, they facilitate
cellular waste removal, and they are the Internet of the body, performing the crucial role of
facilitating cell-to-cell communication. Imagine the body as a giant brick building with the cells
being the bricks and hyaluronan being the network of white mortar connecting them. People
erroneously believe that if Accutane dehydrates and dries them out too much, they can just drink
more water. But it doesn’t exactly work that way, because Accutane damages the ability to
regenerate the water-holding molecules that enable tissues to retain the water and fluids that the
person is drinking (in some cases, drinking lots of water can help alleviate the severe dryness but
it’s not a complete solution to the problem). Just like many other cells that are rapidly dividing
and constantly turning themselves over, the hyaluronan water-holding matrix also turns itself
over often. An interesting fact about hyaluronic acid is that the average 70-kg man has roughly
15 grams of it in his entire body, and about one-third of this is turned over (degraded and
synthesized) every day. The body has other natural biological strategies for retaining water. Dr.
Susan Lark, a respected and renowned anti-aging doctor states, “remember when you were
younger and your skin just glowed naturally? Well the reason for that glow was the natural oil in
your skin. Scientists call it sebum. And it helps prevent “trans-epidermal water loss” – which is
a fancy term for losing all the moisture in your skin.” It’s no wonder that a common testimonial
given by young people taking Accutane is that they feel like an 80 year old person in a 23 year
old body. Dermatologists are supposed to be in favor of anti-aging, but for the past 25 years,
they’ve been passing out a drug that acts to accelerate the aging process by severely drying out
the entire body. Aging is a side effect of being alive, but in the case of Accutane, it’s appearing
more and more likely that aging is the predominant side effect.
The FDA refuses to acknowledge aging as a disease, and for them, everything that is not
acknowledged is prohibited, this includes any company that attempts to promote the evidence in
scientific literature of the life extending properties of vitamins and other nutrients. Several high
quality nutritional wellness products exist on the market today that do indeed have research
validated life extending properties. But vitamin A is the major exception to the life extending
properties of wellness nutrition, because even though some vitamin A is essential for health and
longevity, too much vitamin A is dangerous and will actually elicit the opposite effect by causing
tissue function changes that mimic accelerated aging. Nutritional supplement makers always list
their vitamin A dosage recommendations in the safe range because they value people’s safety.
Roche on the other hand has no problem with promoting their potent dangerous pharmaceutical
vitamin A derivative (Accutane) to large numbers of acne patients, while not telling them what it
is or how it works. Meanwhile the FDA sits back and does nothing. Even though the evidence
is overwhelming that taking Accutane accelerates the aging process (by reducing stem cell
proliferation and causing severe dryness), the FDA doesn’t care, because in their view, aging is
not classified as a disease.
People have absolutely no idea what they are getting themselves into when they take Accutane.
They take it and hope for the best. Patients starting out on this drug never imagine they might
end up with over a dozen side effects after they finish taking it. Chronic dry eye, dry skin, dry
nasal passage, eczema, diffuse hair loss, peeling skin, erectile dysfunction, cheilitis, diabetes,
sjogren’s syndrome, ibs, joint pain, muscle weakness, mental changes, insomnia, dizziness,
fatigue, etc, all together is pretty much impossible for somebody in their early 20’s to experience,
unless they’ve been exposed to Accutane that is. Of course most of the doctors these patients
visit deny that all their problems could be from Accutane. This is the same repeating story I’ve
encountered over and over, but in some ways you have to cut these doctors some slack. This
situation has never happened before with any medication and no one seems to get it. People
often don’t associate problems with Accutane because of the latency of them. Some have their
worst side effects start months after their course, many five years after and others even up to 10 –
15 years after. Some last longer before the side effects kick in and to some it happens right away
while they’re on the drug.
Standard operating procedure at Hoffmann-La Roche has always been to blame the patients for
their psychiatric side effects, despite the fact that vitamin A toxicity has been linked to mental
illness for hundreds of years ever since the European explorer Gerrit de Veer and the Arctic
explorer Elisha Kane and his crew experienced psychotic reactions and other severe health
problems after they consumed polar bear liver, which was later found out to contain lethal
concentrations of vitamin A. In the past and even up to the present, many nutritional health
experts and doctors have not reported or publicized the information about the potentially severe
side effects of vitamin A toxicity as much as they should. As a result people think that all
vitamins are safe and non-toxic in high dosages, and when they go to the dermatologist and the
derm tells them that taking Accutane is like taking high amounts of vitamin A, they
automatically think to themselves, “oh it’s just a vitamin, it’s harmless.” These people are
definitely in for a big surprise. Anybody who wants to observe the nasty and horrible effects that
occur with severe vitamin A toxicity needs to look no further than the side effect profile of
Accutane. Pharmacologist Dr. James O’Donnell gave a remarkably informative presentation
outlining the similar toxicology of Accutane and vitamin A during the first Accutane
Congressional Hearing held on December 15th, 2000. Here are the most significant highlights.
“I am an Assistant Professor of Pharmacology at the Rush Medical College in Chicago, and I am
also a licensed pharmacist. I do not hold any federal grants, although I have testified as an expert
witness in matters against Roche. I would like to project my one slide, and leave it projected for
the course of my comments. My review has included the basic pharmacology and toxicology of
vitamin A, and if we can focus just on the top three chemical formulas there, from the audience
you won’t be able to see that, but please take my word that the three molecules of retinol (vitamin
A), tretinoin (Retin-A), and isotretinoin (Accutane), are practically identical. As a chemist and a
pharmacologist, looking at these three chemicals, not knowing anything different, you would
predict the same actions, including the same toxicities.”
“Vitamin A is an essential factor in physiological growth, visual function, epithelial cell
differentiation and reproduction and is believed to exert its influences at the DNA level where it
plays an important role in regulating transcription of a number of genes.”
“An intake of retinoids greatly in excess of requirement results in a toxic syndrome know as
hypervitaminosis A. Some or all of the symptoms of hypervitaminosis A also are the major toxic
effects that are manifest during the therapeutic use of natural and synthetic retinoids in the
treatment of skin disorders. Accutane, being an analog of vitamin A, shares many of the side
effects experienced with vitamin A.”
“Accutane is associated with a long list of side-effects which are frequent, varied and at times
severe. The most commonly occurring adverse reactions are those involving the skin and
mucous membranes, which occur in all patients treated with Accutane. Other side effects
reported include skin fragility, pyogenic granuloma-like lesions, epidermal blistering,
gastrointestinal intolerance and alopecia.”
“Blepharitis and conjunctivitis associated with Accutane use were recognized well before its
marketing. Corneal opacities and acute myopia have been reported in government publications
and in the ophthalmologic literature. Other ocular reactions include optic neuritis, cataracts,
decreased night vision, blurred vision and photosensitivity. Pseudotumor cerebri (PTC) and
headaches are also associated with the drug.”
“There are two types of hypervitaminosis A, acute and chronic. Acute hypervitaminosis A
results from ingestion of a very high dose of vitamin A over a short period of time. Signs and
symptoms include drowsiness, irritability, irresistible desire to sleep, severe headache due to
increased intracranial pressure, dizziness, blurred vision, vomiting, papilledema, and, after 24
hours, widespread peeling of the skin. Chronic hypervitaminosis A is more common than the
acute form and results from continued ingestion of high doses of vitamin A for months or even
years. Symptoms include anorexia, dry itchy skin, dry eyes, alopecia, increased intracranial
pressure, fatigue, irritability, somnolence, skin desquamation, fissuring of the lips, pain in the
legs and forearms, hepatomegaly, neurologic disturbances and lethargy. Elevated blood lipids
are also common. This reads just like the Accutane package insert.”
“I referred to earlier, describe patients who are psychotic, who have schizophrenic like
symptoms, and suicides have been associated with vitamin A toxicity. The condition of vitamin
A toxicity causes a change in the brain chemistry. The condition that brings vitamin A toxic
patients to the hospital is a swelling of the brain.”
“We have a long history of psychiatric toxicity associated with Vitamin A. It’s not surprising
that we have similar reports of similar psychiatric toxicity associated with Accutane.”
“An FDA memo of February 1998 stated that for a majority of the evaluable cases of suicide,
suicide attempt or suicide ideation associated with Accutane, for the majority, there was no
antecedent history of depression, and the patients were not noted or known to be depressed in the
time period prior to their suicide. As a result of underreporting, the actual number of suicides
could be 10 times greater than the number of reports.”
“The numbers are alarming. The price is death and destruction of our children and young
adults.”
“We don’t need absolute scientific proof in order to recognize a signal and act on it.”
“Indeed, the mechanism of action of Accutane in treating acne is unknown! In fact, the FDA
rarely has more than signal before significant warning changes and sometimes drug withdrawal
occurs.”
“In my opinion, we have sufficient evidence to be very concerned and take some corrective
steps. The link between vitamin A toxicity, including central nervous system toxicity, and
Accutane is indisputable.”
Investigative health journalist Bill Sardi published a compelling and insightful report on
Accutane and its long-term side effects titled Accutane: a modern horror story. This report came
out five years ago, so some of the statistics might be outdated, but it is very thorough and well
referenced. One important topic he covers is how oral hyaluronic acid supplementation might
improve the extreme dryness of tissues caused by Accutane. Former Accutane users suffering
the chronic latent effects of severe systemic dryness of their skin, eyes, lips, mouth, and nasal
passage should consider taking oral hyaluronic acid supplements. Hyaluronic acid is the
scaffolding that holds the human body together. It cushions joints and nerves, dilutes toxins and
serves as a barrier against the spread of disease.
“The medical community and a drug company are in a state of denial regarding side effects
caused by Accutane. Nutritional supplements should be taken during Accutane therapy to ward
off potential side effects. Dietary supplements may also remedy chronic side effects experienced
by former Accutane users. Urgency is required to search for safer alternatives than Accutane for
the treatment of acne.”
“Mathew Hamilton’s story is a case in point. At the age of 15, and with a mild case of acne at
best, his dermatologist in Cape Town, South Africa, prescribed Accutane (Roaccutane outside
the USA). Matthew only experienced the common symptoms of dry skin and chapped lips while
taking the medication. Otherwise, things were uneventful. Then four months after finishing
treatment, Matthew had a suicidal episode, a latent side effect of the drug produced by shutting
off the production of serotonin, a mood-controlling brain chemical.”
“A year later, Matthew was still struggling with suicidal attacks for no apparent reason. Around
this time his hair began to fall out and his scalp became itchy. Backaches and clicking sounds in
all of his joints appeared. Instead of graduating as the top student in his high school, as
anticipated by his previous school record, Matthew was struggling with the side effects of
Accutane. Muscle weakness ensued. Then hair loss spread to his eyebrows, eyelashes, and other
body hair. His eyes were always dry and floaters, what appear as cobwebs or black globs in the
visual field appeared. Nightmares and bouts of depression were common.”
“Matthew began his own investigation. While literature provided by Roche, the manufacturer of
Accutane, states that side effects magically go away after ceasing use of the drug, he began to
make contact with people who had taken the drug when it first became available in 1982 and
were still suffering with side effects 21 years later.”
“Then Matthew found another important link to his other side effects. Accutane, also switches
off the production of hyaluronic acid, the water-holding molecule in the connective tissue
between living cells in the body. Hyaluronic acid is concentrated in the joints, skin, scalp, and
eyes, exactly where all of Matthew’s symptoms were concentrated. Scientific studies appear to
confirm Hamilton’s suspicions regarding hyaluronic acid. The destruction of hyaluronic acid
would explain the universal symptoms of dryness associated with Accutane use, the dry eyes,
hair, skin, and joints.”
“Just as Accutane causes the drying up of secretions from the sebaceous glands, it also inhibits
the secretion from other glands as well. Accutane is not specific to the oil glands in the skin. It
dries out the whole body.”
“One of the common statements heard from young Accutane victims is: I feel like a 23 year old
grandmother or grandfather. It’s not surprising that these people feel old before their time.
Progeria is known as a disease of premature aging. Progeria children develop premature
wrinkled skin, hair loss, cataracts, and other signs of advanced aging. Progeria is universally
diagnosed by an elevated losss of hyaluronic acid in the urine. Progeria children excrete up to 17
times more hyaluronic acid than healthy children. Were these Accutane side effect sufferers
simply mimicking symptoms similar to progeria?”
“Oral hyaluronic acid (HA) supplements are relatively new. They offer hope for restoration of
tissues adversely affected by Accutane. Just 1000 milligrams can hold or gel 6 liters of water in
the body. Oral hyaluronic acid supplements have been reported to lessen or eradicate joint pain
in cases of osteoarthritis, eliminate back pain caused by swollen vertebral discs, refill skin tissues
to the point of reduction of wrinkles, cause floaters in the eyes to disappear, and improve
thickness and luster of hair. The production of hyaluronic acid may be impaired in Accutane
users. Supplementation may be beneficial.”
“Accutane kills by the hand of its users. They swallow the Accutane pills and they commit
suicide. It’s a perfect cop out for the pharmaceutical companies. The drug company’s
fingerprints are all over the lethal weapon, but they escape responsibility by having Accutane
users sign a consent form.”
“There are a number of reports of side effects associated with Accutane that are not generally
listed or highlighted by the manufacturer.”
“A seeming paradox exists with Accutane. Why does it induce night blindness when vitamin A
is required for rhodopsin, the night vision chemical? For decades it has been known that a
shortage of vitamin A produces night blindness. By 1986 the first cases of poor night vision
were being documented among Accutane users. [Archives Ophthal 104:831-37,1986] Night
blindness has been reported to occur within two weeks of starting Accutane (20 mg daily dose).
[Australia J Derm 40:208-10, 1999] The occurrence of night blindness with Accutane suggests
this drug in some way interferes with vitamin A metabolism. A similar paradox exists for
Accutane and dry eyes. Vitamin A is a treatment for dry eyes. Vitamin A is required for the
production of mucin by the goblet cells.”
“One thing is clearly established. The side effects of Accutane don’t wear off for everyone. For
example, an 18-year Accutane sufferer (1985-2003) started with low back pain and fatigue about
6 months following Accutane treatment. Then later inflammatory bowel disease occurred.
Arthritis in other joints and mental depression became part of the syndrome. In 1992 Sidney
Lerman reported that Accutane therapy produced irreversible cases of dry eye two years
following cessation of therapy and also some cases of cataracts in relatively young patients
(teens to 40’s), which demonstrates that some of the ocular side effects caused by this drug ‘are
not reversible when the drug is stopped.’ [Lens Eye Toxicology Res 9: 429-38, 1992]”
“Acne patients need to seek safer alternative treatments. Dermatologists are not likely to aid
patients in the quest for alternative therapies. With some guidance, many acne patients are likely
to find safer remedies outside the dermatologist’s office. Doctors will argue there isn’t sufficient
evidence to prove that alternative therapies are more effective than Accutane. However, the
evidence for alternatives is lacking by the very reluctance of the medical community to explore
their use.”
To understand how Accutane causes dry, irritated eyes, do this experiment. Fill two small bowls
with water and place them side by side. Next, pour any type of oil into one bowl but not the
other. Now wait a really long time and then observe what happened to the bowl without any oil.
There is less water in this bowl due to evaporation, but none of the water in the other bowl has
evaporated because the oil formed a barrier layer on the surface. This analogy illustrates what
happens when Accutane causes the meibomian gland (a specialized sebaceous gland) in the
eyelids to secrete less oil. The specific function of the meibomain gland in the eyelids is to
secrete a protective oil layer into the tear film, which prevents tears and the eyeball surface
mucosal layer from evaporating. The problem with Accutane is that it does not know the
difference between the sebaceous glands all over the skin and the sebaceous (meibomian) glands
inside the eyelids. Therefore when Accutane partially or completely destroys the meibomian
glands, decreasing oil and lubrication, tears evaporate much quicker, the mucosal layer becomes
degraded, and potentially permanent, severe, irritating dry eye syndrome is the result, causing
eyes to drag around in their sockets.
This is why people are NOT supposed to use eye drops while they are taking Accutane
(dermatologists don’t usually tell their patients this), because if their eyes are getting dry to the
point that they constantly need to use eye drops, it means that they must reduce their Accutane
dosage immediately, unless they want Accutane to give them a permanent case of dry eye
syndrome where they’ll have to use eye drops, won’t be able to wear contact lenses, and have
constant eye irritation/pain for the rest of their life, and be much more susceptible to
conjunctivitis, eye infections and cataracts as they get older.
Pseudotumor Cerebri otherwise known as intracranial hypertension or swelling of the brain is
one of several serious side effects of both vitamin A toxicity and Accutane. The drug brochure
provided by Roche way back in the 1970’s states that adverse reactions to Accutane “are
essentially those of hypervitaminosis A.” At an FDA meeting in 1983, Dr. Del Vecchio
described Accutane’s side effects and said that “just about everything that happens with
Accutane may happen with vitamin A overdosage.”
Most of the Accutane side effects resemble acute or chronic hypervitaminosis A, but
paradoxically, a few of Accutane’s side effects like permanent night blindness, resemble vitamin
A deficiency or hypovitaminosis A.
Evidence about Accutane’s propensity to cause psychiatric problems had been building up all
throughout the 80’s and 90’s, but nobody, not even the dermatologists were talking about it or
acknowledging that it was happening. Despite all of the accumulating evidence, dermatologists
announced to everyone that there was absolutely no link between Accutane and psychiatric side
effects. A shocking report appeared in The Journal of the American Academy of Dermatology
back in 1987 that was titled “Hypervitaminosis A syndrome: a paradigm of retinoid side effects.”
(J Am Acad Dermatol 1987;16: 1027-39) I guess none of the dermatologists bothered to read
their own journal because this report should have raised some serious red flags about the
connection between retinoids and psychiatric toxicity. In this report it says that physicians
utilizing retinoids should be aware that in the past few decades patients have been committed to
psychiatric hospitals for severe depression and schizophrenia when mental changes were due to
hypervitaminosis A. The report also says that investigative trials of new retinoids have shown
how important it is to become familiar with hypervitaminosis A syndrome because so many side
effects associated with new retinoids (such as Accutane) have previously been encountered in
patients with chronic hypervitaminosis A.
Hoffmann-La Roche has always continued to deny that Accutane can cause psychiatric side
effects like depression and suicide, but they do not acknowledge the fact that vitamin A toxicity
has been consistently linked to mental illness for centuries. In 1597, European explorer Gerrit de
Veer spent the winter in Nova Zembla. His diary of the experience revealed how he and the rest
of his men became “gravely ill and feared for their lives” after eating polar-bear liver.
250 years later, in 1856, the Arctic explorer Elisha Kane and his crew experienced extreme
fatigue, drowsiness, irritability, headache, bone pain, peeling skin, vertigo, and psychosis after
they consumed polar-bear liver, which was later determined to be poisonous because it contains
lethal amounts of vitamin A. A one-half pound serving of polar bear liver will deliver about
9,000,000 IU of vitamin A to your diet, an extremely lethal dose that will make all your skin peel
off before you die. Fatal cases typically end with full-body skin loss, liver damage, delirium,
hemorrhage, and coma. This danger of toxicity resulting from the ingestion of bear liver has
long been known by indigenous Inuit people of the Arctic regions, but many Western explorers
and hunters had no knowledge and ended up learning the hard way. A common practice among
the Inuit is to bury polar bear livers deep under the ice or toss them into the sea in order to
prevent their sled dogs from chowing down their last meal. Polar-bear liver contains about 1
million IU of vitamin A per ounce (the RDA for adult humans is only 5000 IU), which is why if
you decide to snack on it, the top layer of skin on your hands and other places all over your body
will come off in giant sheets. Not surprisingly, peeling of the skin on the palms and soles and
skin coming off on various places of the body is also a potential side effect of Accutane. An
article titled “The Vitamin A Content and Toxicity of Bear and Seal Liver” dated 1943 described
what happened to these explorers after they ingested polar bear liver. The side effects of eating
polar bear liver are very similar to the side effects of Accutane.
The Vitamin A Content and Toxicity of Bear and Seal Liver
The abstract of Dr. James O’Donnell’s article titled “Polar Hysteria: An Expression of
Hypervitaminosis A” states,
“Isotretinoin (Accutane) is a drug closely related to the chemical structure of Vitamin A. The
pharmacology and toxicology of these two retinoids is similar enough to warrant comparison.
Accutane is a powerful drug which its manufacturer, Roche, indicates is limited for severe
recalcitrant nodular acne. This potency is also reflected in Accutane’s well-known ability to
produce severe birth defects if taken during pregnancy. Less well-known is the risk of this lipid
soluble chemical to affect the Central Nervous System. Reports of intracranial hypertension,
depression, and suicidal ideation with Accutane use have prompted an examination of this
serious and life threatening potential. Though Roche has added a warning to its product label for
signs of depression and suicidal ideation, this product is being overprescribed for all forms of
acne, including mild cases and moderate acne that have not been treated with alternative
medications, which have a lesser risk of depression and suicide. There is no contesting that this
drug is effective at clearing up the most severe forms of acne, but the public must be informed of
its proper, limited indication for use; depression and suicide can follow in patients with no prior
history of psychiatric symptoms or suicide attempts.”
Polar Hysteria: An Expression of Hypervitaminosis A
Most animal liver is safe to eat (for people who have never taken Accutane), but it should be
noted that bear, seal, and husky livers are not safe for anybody. In 1913, the Swiss explorer and
skiing champion Xavier Mertz embarked on an Antarctic expedition with the Australian Sir
Douglas Mawson and Lieutenant Edward Ninnis. While attempting to cross the Ninnis Glacier,
Ninnis fell into a crevasse, along with six dogs, the tent and most of the supplies. With only a
few days worth of rations left and 315 miles from the main base, Mertz and Mawson now faced
the impossible challenge of getting back to safety without sufficient food. They began to eat the
livers of their husky sled dogs and over a few weeks’ duration both were poisoned, experiencing
dryness of the nose, mouth, eyes, cracked lips, hair loss, irritability, fatigue, and loss of all skin
on their legs, hands, feet, genitals, “skin coming off whole body” according to Mawson’s diary.
Even the thick skin on the soles of their feet came off, leaving areas of the underlying tissue
bloody and exposed. Mertz consumed more liver and eventually became fatally poisoned after
developing severe stomach pains, diarrhea, and going insane. The dreadful details of Mertz and
Mawson’s ordeal can be read in the British Medical Journal articles “Man’s best friend?” and
“Vitamin A and Sir Douglas Mawson.” Several parallels to the side effects of Accutane are
exceedingly apparent.
Here’s a quote from the above article describing the controversy over the psychiatric side effects,
“Hoffmann-La Roche says there is no causal relationship between Accutane and depression or
suicide. Experts point out that no one factor causes suicide and that a high percentage of
Accutane users -teens and young adults- are already more likely to get depressed. But some
doctors say there’s plenty of evidence to support a link between Accutane and depression and
suicide. And they argue that evidence of the link dates back to Arctic explorers of the 19th
century. Diaries tell of how some sailors suffered polar madness. Experts today say it was from
eating polar bear liver, which is full of vitamin A. In large doses Vitamin A can cause brain
toxicity, seizures, and behavioral changes. Accutane is a derivative of vitamin A.”
The following transcript from the first Accutane Congressional Hearing held on December 15th,
2000 illustrates the wide-spread lack of knowledge about the severe consequences of vitamin A
toxicity, even among dermatologists. Chairman Burton expressed his own concern and urgency
by taking the initiative himself to inform all the dermatologists in the nation about Accutane’s
psychiatric side effects, because as expected, the people from Roche and the American Academy
of Dermatology were reluctant to do it.
CHAIRMAN BURTON: Then why don’t you just go ahead and send a fax out to all the
dermatologists in the country, saying this is a risk, and many dermatologists evidently don’t
know about it. There was testimony before the Congress of the United States by people who
have lost children, who knew nothing about it, even though it had been publicized on the
Internet, and so we want to make sure you know about it. Why don’t you do that?
DR. PARISER: I’ll check into it.
CHAIRMAN BURTON: Would you do that?
DR. PARISER: All right.
CHAIRMAN BURTON: And if you don’t, do me a favor. Give me a list of all your members,
and I’ll send the dammed thing out. Because I don’t want to have other people coming before our
Committee with their kids being dead because possibly Accutane caused it. Now, let me ask you
a question, Dr. O’Donnell. You said that the people who ate polar bear livers in the middle 1880′s
that were on polar expeditions.
DR. O’DONNELL: That’s right.
CHAIRMAN BURTON: And they had psychotic events because of the large amounts of
Vitamin A they were consuming in the livers of polar bears; is that correct?
DR. O’DONNELL: Yes, sir.
CHAIRMAN BURTON: And was this just an isolated incident, or was this something that
happened more than once?
DR. O’DONNELL: There were several reports. Not many were published, but it was common
knowledge that people had to avoid excessive use. Similar reports since then have published
neurotoxicity, toxic psychosis, but the first report that I referred to was a polar expedition in
1856.
CHAIRMAN BURTON: So Vitamin A in large quantities definitely causes the kinds of
problems you’re talking about, and that is what Accutane, in main part, is made up of?
DR. O’DONNELL: Yes, sir.
CHAIRMAN BURTON: One of the things that bothers me, the question that was just asked by
Mr. Waxman, you kind of just, we aren’t really geared up to get that kind of information out to
the American people. That’s kind of a cop out, I think, isn’t it? I mean, the Food & Drug
Administration is supposed to be the person or the group that guarantees the safety and the
efficacy of pharmaceuticals and drugs for the people of this country, and if something is going
awry, you’re saying, oh, it takes so much time to get the information out, and I mean, 19,000
dermatologists, you could send letters out tomorrow to all of them, in big bold print, to all the
pharmacists in the country, and you don’t send, put it on the email. You know, there’s all kinds
of ways to communicate in this age, and I think it’s a real cop out for the FDA to say, oh, we
can’t do that. The other thing I want to ask you is this: In 1850 something, polar bear livers were
causing psychiatric problems on people that were eating them, because of large amounts of
Vitamin A. This pharmaceutical expert, or pharmacologist
MR. O’DONNELL: Both.
CHAIRMAN BURTON: Both. Indicated that the brain swells up when you have too much
Vitamin A in it, which causes severe problems. When the testing was done, back in the 1980′s,
before Accutane was put on the market, did anybody check mice brains? Did they give them
large amounts, or any kind of animals large amounts of Vitamin A, to check to see if it caused
any side effects? Did anybody check that out?
DR. HUENE: I would add that the label does address a condition known as psuedotumor cerebri,
which is I think the brain swelling that you referenced, that was known to be related to
hypervitaminosis A.
CHAIRMAN BURTON: When we hear of people whose children who have committed suicide,
or who have had adverse events occur because of Accutane, and they didn’t even know anything
about this, were never warned by their dermatologist, were never warned by their pharmacist.
They had no knowledge. They went home, started giving their child the pills, and those side
effects occurred. My gosh, what a mistake. What a tragedy. In any event, we would like to have
that information submitted for the record, and I would like to have a list, if you don’t have it, of
all the dermatologists in the country, and if your association won’t contact them, then I’ll figure
out a way to do it myself, and the Committee will. And I think that we ought to put on our email
to all pharmacists in the country the warning that Roche is now putting on their label so that they
will all be aware of it as well.
Also at this Congressional Hearing, many individuals and their families testified about their
experiences with Accutane.
“As Amanda’s depression worsened despite the therapy and medication, the only thing we could
visibly see working was the Accutane. Her lips dried out, cracked and bled; her joints ached, and
she was always thirsty. But the dermatologist told us that that was just the effect of Accutane,
nothing to be worried about, just don’t get pregnant.”
“Stacy and Mike Baumann of Mundelein Illinois lost their son Daniel to suicide in December
1999. Daniel began Accutane treatment in July 1999. He suffered many adverse effects;
chapped lips, dry skin and itching, joint and muscle pain, headaches, nausea, loss of appetite,
mood swings, and insomnia. The physician thought his depression was school-related and never
mentioned the FDA warning.”
“I met a friend from high school not long ago and it turns out she was on her way to pick up a
prescription for her son of Accutane. When I asked if she was aware of the potential risk, she
looked at me like I was crazy. I asked her if she was counseled by her dermatologist, who was
different from ours, and she said she was not. I asked her if this drug was prescribed when other
remedies had failed, and found that it had been prescribed first, before any other remedies had
been tried.”
“Our children are dying because a drug company makes lots of money from this drug. This is the
same company, cited for once advertising that Accutane helped depression, this just one month
after the FDA required the warning about suicide. We would never allow our children to play
Russian roulette with a gun, but we allow that to happen every time a prescription for Accutane
is given.”
Michigan Congressman Bart Stupak has been working relentlessly to create more awareness
about the dangers of Accutane and its psychiatric side effects ever since his family tragedy back
on May 14th, 2000, when his son Bart Jr. fatally shot himself near the end of his course of
Accutane. During the second Accutane Congressional Hearing held on December 15th, 2000,
Stupak blasted the FDA, Hoffmann-La Roche and dermatologists for failing to protect young
people from the side effects of Accutane.
“We cannot allow the drug manufacturer and the FDA to continue to turn a blind eye to the lives
lost, families devastated and dreams dashed by an acne drug. The American people, our children,
are not collateral damage in the scheme of corporate profits!”
“The drug manufacturer, Hoffmann-La Roche, Roche here in the United States, has continued to
put profits before people. They have done everything possible to prevent the American people
from learning of the psychiatric injuries and deaths associated with Accutane. Even, today, I’m
sure Roche will deny any casual effect of Accutane with the abortions, deaths, and suicides
caused by their product.”
“Accutane is a powerful, dangerous drug with devastating consequences for some patients. The
birth defects caused by Accutane are horrific. The FDA’s response to the birth defects and
psychiatric events has been inadequate, irresponsible and unacceptable. Thousands of babies,
teenagers, and young adults have died prematurely. While the FDA has been aware of the birth
defects since at least 1982 and the psychiatric injuries since 1985, their responsibility to protect
the public has been inconsistent and without direction.”
“The Accutane birth defects are similar to Thalidomide, which is a tightly controlled drug in this
country and is used by a group unlikely to have children. Yet, Accutane is not tightly controlled
like Thalidomide and Accutane is marketed to women of child bearing years despite its
horrendous record of causing birth defects.”
“If the FDA cannot or will not regulate Accutane, then it is imperative for the US Congress to act
to protect the American public. The bottom line remains the safety of our citizens.”
“The scope and depth of Accutane’s serious adverse event reports compiled by the FDA are only
a fraction of the actual number of deaths, birth defects and devastation caused by this drug. The
true number of Accutane victims and their families are real, and once again the FDA has let us
down!”
During this Congressional Hearing, the President and Chief Executive Officer of Hoffmann-La
Roche, George B. Abercrombie, testified before the Committee. After giving various statements
under oath about studies, marketing, clinical trials, and Roche’s connections with entities down
in Mexico, two members of the committee told Mr. Abercrombie that they did not believe his
testimony, and that he had given the testimony in front everyone with a “straight face.” Florida
Congressman Peter Deutsch stated to Mr. Abercrombie during his questioning that “what you
just said is not a truthful statement, you’re beyond the straight face test, I’m sorry.” Not a single
member of the Congressional committee spoke in support of Hoffmann-La Roche. Also at this
hearing, confidential papers were revealed showing that after the first Accutane Congressional
Hearing held on December 15th, 2000, Roche employees were celebrating and shaking each
other’s hands because they were able to delay and prevent the authorities from implementing a
registry for Accutane’s psychiatric side effects.
In another Congressional statement titled Supplemental Review of Accutane Safety Issues Stupak
talks about how, for decades, Roche has continually suppressed critical information about
Accutane’s mechanism of action and the biological mechanisms of vitamin A and retinoids. In
the several quotes from his statement I’ve provided below, HLR stands for Hoffmann-La Roche,
“During a time when it took years to receive a new drug approval, in 1982 the FDA approved
Accutane within 9 months. The FDA has reviewed the original application for Accutane and has
told committee members and staff that Accutane would never be approved by today’s drug
regulatory standards. The original new drug application trials showed that of the 523 people
given Accutane in test studies only 89 were children and only 6 had a diagnosis of acne. The
Accutane labeling is misleading ‘in stating that efficacy for severe nodular acne was established
in clinical trials, given the extremely small sample size.’ Because Accutane has significant
adverse effects associated with its use, it is to be prescribed only to patients with severe
recalcitrant cystic acne. It is unknown whether these 6 children had severe cystic acne. Exhibits
#1,2, and 3.”
“The FDA’s safety focus has been on the birth defects and not the psychiatric injuries caused by
Accutane. In 1985, the first suicide attributed to Accutane was reported to the FDA. Dr. Huene,
FDA Medical Officer, requested a review of the number of CNS [central nervous system] effects
reported in patients on Accutane. These have included severe headaches, seizures, tremors,
disorientation, numbness and parethesias, blurred vision, memory loss and behavioral changes
other than depression. Exhibit #5.”
“In 1987, Dr. Huene requested assistance with the ‘difficulty of reviewing the adverse reaction
reports associated with Accutane therapy……well over 3,000 adverse reaction reports…..(the
number is probably approaching 4,000 by now)….. we find it impossible to deal with this
volume of information coherently….’ Without an additional full-time reviewer to
‘…..adequately collate, review and make recommendations’ regarding all the adverse reaction
reports associated with Accutane. Exhibit #5.”
“In regard to psychiatric injuries, HLR’s efforts have been to suppress adverse events reports and
medical/scientific evidence. HLR withheld its own studies that shed light on Accutane’s effect
on the central nervous system. Further, HLR failed to submit safety precautions employed by
other countries, provided ‘junk science,’ and denied any biological causation between Accutane
and psychiatric injuries. The only consistent explanation of these psychiatric injuries put forth
by HLR is to blame the patients for their psychiatric problems. Throughout the history of
Accutane, HLR claims it does not know how Accutane works. Therefore, HLR cannot claim
that Accutane does not cause psychiatric injuries. HLR cannot have it both ways. It is obvious
HLR is more interested in protecting its profits than in finding the cause of psychiatric injuries in
Accutane therapy. Exhibit #77, 78, and 79”
“HLR cannot claim that it was not aware of the requirement to inform the FDA of recent
scientific and medical studies showing that Accutane, vitamin A, retinoids or retinoic acid affect
the central nervous system. As part of its annual report to the FDA, HLR submits a list of
medical studies and scientific research on Accutane therapy, vitamin A, retinoids, and retinoic
acid. Some of these studies and research demonstrate a cause-effect relationship between
Accutane therapy and psychiatric injuries. For example, some of these studies and research from
as early as 1980 raise the concern of vitamin A toxicity from retinoid use affecting the central
nervous system. Exhibit #51, 52, and 53”
“HLR will put out information they know is wrong and very little is done to correct it. For
example, when Charles Bishop flew his airplane into the bank in Tampa and Accutane was
mentioned as a possible cause in Bishop’s behavior, HLR cranked up its PR machine. The
thought was planted that we would have to wait until the autopsy report to see if Accutane was
present in Bishop’s body. HLR knows full well that standard autopsies do not test for the
presence of Accutane. As the FDA pointed out in an email, ‘Given the bad news about the poor
kid in Florida, it is even MORE urgent that we get the letter out to JAAD (Journal of the
American Academy of Dermatology)…….The derms are being poisoned with absolute nonsense
and it is downright dangerous in my book……I know we can’t compete with the Roche machine
for their attention, but we have to try anyway!’ Exhibit #101 and 102.”
“In 1999, the FDA was so concerned about HLR’s reporting and ‘soft coding’ of Accutane
psychiatric injuries that they did a ‘surprise’ inspection of HLR’s plant and its adverse events
database. The inspection resulted in a Warning Letter from the FDA for not timely submitting
adverse event reports for several years and failing to disclose over 2,000 more Accutane adverse
event reports. Exhibit #91,92, and 93.”
“As the June 25th, 2002 FDA states, “So….even if you make a VERY conservative guess at the
number of waived cases, adding this up for just this ONE year exceeds the numbers derms have
available on their radar since the drug was approved in 1982……As it stands right now, we do
not even know how many such reports fall under each Body System. I am very concerned that
someone ‘outside’ is going to get their hands on, and publish, the real numbers of psych reports
obtained during the legal discovery processes no doubt going on……FDA is going to look pretty
sad if someone else points out there are thousands more than we acknowledge publicly!!”
Exhibit #42.”
“At our December 11th, 2002 hearing, our colleague Ted Strickland picked up on the deadly
spontaneous action caused by Accutane in young people when he asked, ‘Is it possible that this
medication has an effect, an action that results in spontaneous, impulsive, self-destructive
behavior that is different from that which occurs from a clinical depression?’”
“The ‘spontaneous action’ mentioned by Congressman Strickland and testified to by the Turney
and Benz family members at our December 11th, 2002 hearing separates Accutane caused
psychiatric injuries from clinical depression. Even the dermatologist at the hearing testified that
she could not predict when spontaneous events may occur in Accutane patients.”
“In the case of Matthew Turney, age 16, he was alone for 10 minutes when he came home from
school and shot himself. Matthew and his parents were watching for any signs of depression as
they were aware that Accutane may cause psychosis, suicidal ideation, suicide attempts, and
suicides. Yet his parents never saw signs of depression and are asking how do parents protect
their children when there are no clues as to when the fatal 10 minutes can occur!” Exhibit #60”
“Micheal Benz was a 31 year old fire fighter who never had acne but was prescribed Accutane.
A tri-athlete, Michael cried out for help from his physician and was told to come back on
Monday. Micheal Benz drowned himself by weighting his body down with weight lifting
plates. The investigation into his death showed that he had logged onto an Accutane website the
weekend he died. As a fire fighter and an EMT, Michael Benz must have had some idea what
was happening to him. Still, he could not resist the sudden urge to take his own life. Exhibit #61”
“A review of the suicide adverse event reports describes young people with no history of
psychiatric problems taking their lives. There are reports of young people talking to their parents
one minute and then hanging themselves the next minute. There are reports of young people
who have fender bender accidents and when law enforcement arrives to discuss the accident with
them, they leave to get their driver’s license and instead grab a gun and shoot themselves.
Exhibit #62.”
“This aggressive behavior referred to as OIB or SIB (self-inflicted bodily harm) was referenced
in a 1999 email where the Accutane Medical Review Officer remarked that “I gave up trying to
track all psychiatric reports and just have the self-injurious behavior cases…..sorted into my
‘SIB” stack, which is sadly growing tall.” Exhibit # 63, 64, and 65.”
“This aggressive behavior seen in Accutane patients manifested itself not only in self-inflicted
injuries but also in four murders and reported murderous ideation amongst Accutane patients.
Exhibit #66.”
“Of course, HLR denied any causation between aggressive behavior and Accutane therapy.
Finally, on October 30th, 2002 the FDA added ‘aggressive/violent behavior to the list of events
that Accutane may cause.’ Exhibit #68.”
“As the FDA noted in its August 31st, 2000 email, ‘The population for whom Accutane is
prescribed is overwhelmingly young and healthy. Accutane has been associated with many
adverse events affecting nearly every organ system, and is a potent teratogen. Some of these
adverse events are serious/life-threatening and the current labeling include a Black Box Warning,
11 additional Warnings, and 18 Precautions.’ Even with this growing list of Accutane
warnings/precautions, patients and their families are never told of its hidden dangers. Exhibit
#68.”
During a January 2003 interview with Jamie Kosar about the psychiatric side effects of
Accutane, Bart Stupak had this to say when Kosar asked if there had been other types of brain
damage or psychiatric injury such as anxiety and panic attacks associated with Accutane,
“Yes. It’s there. It’s all there. They’re changing their labeling you know. And it wasn’t clear
yesterday and maybe we didn’t do a good job on this part. They’ve had to change their label. The
new label talks about ‘aggressive, violent behavior.’”
“The ‘depression’ that you see with this, if you want to use that word, is not your garden type
depression that we all see. It’s not that kind at all. It comes on [snaps fingers] like that. And it’s
a violent outburst. We didn’t get into it yesterday because I had so many areas I could go. They
talked about SIB’s throughout the whole thing. ‘Self-inflicted bodily harm.’ These kids, there’s
one kid who set himself on fire and jumped off a cliff. He lived. He can’t tell you today why he
did it. An Accutane kid. He left a note that doesn’t make any sense whatsoever. There’s a service
man that was taking Accutane. Came home. He was probably about twenty years old. He was in
boot camp. He knew his parents would be gone. They would be home on Sunday. He came home
and ransacked the house looking for a gun to shoot himself. Couldn’t find one, so instead, he
took a big knife and started stabbing himself. And his buddies happened to come through the
kitchen door and found him on the kitchen floor full of blood all over the place. And to this day
he doesn’t know why he did it. If he could’ve found a gun that day he would’ve killed himself.”
At the end of this interview when Stupak was asked if there was anything he’d like to tell a
parent or any young adult or teenager who was considering Accutane for their acne, he
responded with,
“Don’t do it. It’s not worth the consequences. What is the benefit you’re receiving clean skin.
But, you may have a child who is forever scarred mentally, physically. We talked about the
strokes yesterday. Young people dying of strokes. We talked about the heart attacks. We talked
about the lymphoma. We talked about the acute pancreatitis. Even if you don’t die from
pancreatitis it’s very painful. We talked about the hearing loss. There’s vision problems. There
are eighteen different warnings with this drug. Read them. And if you still think it’s worth it,
that’s your decision. It’s just not worth it.”
The full interview can be found at the following links. Stupak gives an in-depth discussion about
the disturbing patterns that are seen in Accutane’s psychiatric side effects and how Roche has
suppressed and twisted around the evidence.
“The implications are clear. Accutane is a very powerful drug that has been linked to suicides,
birth defects and severe psychiatric/brain injuries. Either the FDA takes a more aggressive
stance in managing and controlling ALL the risks associated with Accutane, or every day in this
country our friends and loved ones will suffer severe consequences. Many of those
consequences, some have argued (ie. brain injuries, severe birth defects), may even be a fate far
worse than death.”
Did Accutane Have a Role In the Death of Bart Stupak, Jr.?
Part 1
Stupak weighed in on the FDA’s reluctance to take action in 2004.
“FDA must ensure that all health prescribers and patients receive education about all the effects
of this drug, including psychiatric. The current voluntary informed consent forms must be made
mandatory.”
“The agency cannot continue to claim this drug is safe, while at the same time say Accutane may
cause serious psychiatric events, including suicide. In fact, the FDA has evidence – animal
studies and a new PET human brain scan study – which demonstrate that Accutane affects the
brains of young people.”
“This past month, I have spoken with three more families who have lost their sons to Accutane,
yet the FDA and the manufacturers of Accutane ignore this fact.”
On October 24th, 2006, former patient Hans Peterson walked into the office of Chicago
dermatologist Dr. David Cornbleet and stabbed him to death because the Accutane Cornbleet
prescribed Hans caused him many permanent side effects including impotence. A year after the
murder, Chicago police were tipped that Hans had fled the United States and obtained French
citizenship down on the island of St. Martin located in the Caribbean. This is where he
eventually turned himself in to French authorities and confessed to the crime, which under
French Law, protected him from being sent back to the US to face trial. Here are a few articles
about this story.
Man Surrenders In Murder Of Downtown Dermatologist, Suspect Allegedly Admitted To
Revenge Killing
According to one of his final blogs on the Ro/Accutane Action Group forum, before turning
himself in, Hans wrote,
“Justice will not be found through the legal system. Would taking some of their money even be
justice? Their lives would go on, just with a little less money. Our lives will never be the same.”
The Cornbleet family has set up a website to create more awareness about this case and to
generate a following for the extradition of Hans Peterson back to the United States. http://drdavidcornbleet.blogspot.com/ In his thesis titled “A Tragedy with Multiple Victims
and Multiple Villains” Hans Peterson’s father, Dr. Thomas Peterson writes,
“Hans believed that it was Accutane that caused him so much pain and anguish. Since the
murder, many, many blogs that Hans wrote about how Accutane ruined his life have been
discovered. Reading the blogs is like reading the secret diary of a young man who is going mad.
In fact, the Accutane had caused Hans to become psychotic, a permanent condition that
developed in the first two weeks after ingesting the drug. The effects do not go away, there is no
antidote, and Hans, an exceptionally intelligent man, knew that his life was over. He blamed Dr.
Cornbleet and eventually decided that vigilante justice was the only justice possible.”
“The FDA has allowed Roche to continue to market this drug by putting more responsibility on
the prescribing doctor. Unfortunately, not all doctors are responsible.”
“In 1997, Liam Grant from Ireland committed suicide while taking Accutane. His father (Liam
Grant Sr.) was wealthy and funded research on the physical effects of Accutane on the brain. J.
Douglas Bremner, Professor of Psychiatry and Radiology and Director of the Emory University
Medical School Clinical Neuroscience Research Unit has done this research [Am J Psychiatry
2005; 162:983-991] and it is showing damage to the emotional part of the brain from Accutane
through PET scans. He asked Roche to provide him with Accutane to help with further research.
They refused. They do not want any research to show that Accutane damages the brain because
that would be detrimental to their future legal cases. Their defense is that there is no scientific
evidence of any damage, and they dismiss these cases of psychosis and suicide as people who
were going to go insane anyway.”
“In his book, The Lucifer Effect, renowned social psychologist Phillip Zimbardo explores the
“process of transformation at work when good or ordinary people do bad or evil things.
Professor Zimbardo discusses the power of the System, (the ‘big picture…big power’) to create a
situation in which evil triumphs over good. He calls this phenomenon, ‘The Lucifer Effect.’
America’s health care system is now so corrupted by the millions of dollars being fed into it by
big pharmaceutical companies that, arguably, the system is creating unknown numbers of
situations ripe for the Lucifer Effect to prevail. Accutane is just one of an unknown number of
drugs still on the market because Big Pharma is putting millions of dollars into Congress, the
overseers of our Health Care System.”
“When Roche’s company’s own safety experts recommended in 1997 changing the U.S. label
on Accutane to reflect the evidence that the drug ‘probably caused’ depression and other
psychiatric illnesses in some patients, the marketing department warned that such a warning
would impact the marketing strategy and profits (estimated at over $700 million).”
“Accutane is Roche’s number one selling product. Roche refuses to supply information on the
adverse reaction reports they receive.”
“The FDA has implemented programs; including writing letters warning prescribing physicians
to have patients sign an ‘Informed Consent’ form. Roche negotiated to make this a voluntary,
rather than a mandatory, form.”
“According to Professor Zimbardo, ‘Powerful Systems Exert Pervasive Top-Down Dominance’
Big Pharmaceutical’s million of dollars are at the top of the United States Health Care System. It
is this system that has created ‘Multiple Victims and Multiple Villians.’ There is plenty of blame
to go around in the Peterson/Cornbleet tragedy.”
A Tragedy with Multiple Victims and Multiple Villains
In her article titled “Roche puts Accutane profits over Lives of Consumers” journalist Evelyn
Pringle writes,
“In 1985, Accutane’s package insert directed at doctors first mentioned reports of depression in
patients taking the acne drug, which means that more than 20 years ago, Hoffmann-La Roche at
least suspected there might be a risk of depression and suicide by persons taking the drug.
However, Roche’s financial records show that the company is not about to let a little thing like
the death of its customers get in the way of corporate profits, because the drug is still a best seller
and young people with no history of depression who take it are still killing themselves.”
“And once again, according to BBC News, ‘Roche insists there is no proven relationship
between the drug and depression.’ Roche’s comments to the BBC are clearly dishonest
considering that in 1986, doctors were notified that Accutane users who became depressed saw
their depression lift when they stopped taking the drug but return when they were placed back on
the medication. Doctors were also informed that simply stopping Accutane therapy might not be
sufficient to treat the depression and that follow up on the depression might be necessary.”
“Public health officials had been voicing concerns about patients committing suicide while on
Accutane for well over a decade. For instance, a 1998 memo from the FDA’s medical officer in
charge of Accutane states: ‘Given all the pieces of evidence available, it is difficult to avoid the
conclusion that Accutane can adversely affect the adult human brain in clinically significant
ways and that Accutane use is associated with severe psychiatric disease in some patients.’ The
memo recommends ‘active consideration of removal of Accutane from the market.’ But instead
of removing the drug from the market, on February 25th, 1998, the FDA required Roche to add
the following bold-face warning to drug’s physician package insert: ‘WARNINGS – Psychiatric
Disorders: Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide
attempts and suicide. Discontinuation of Accutane therapy may be insufficient; further
evaluation may be necessary. No mechanism of action has been established for these events. Of
the patients reporting depression, some reported that the depression subsided with
discontinuation of therapy and recurred with reinstitution of therapy.’”
“In perverse twist of logic, in the same year, Roche began actively marketing Accutane as a
treatment for depression, under the theory that it could help people who were suffering from
depression due to poor self-image as a result of acne. On March 5th, 1998, Roche received a
letter from the FDA stating that such promotion was false and misleading, and that Accutane had
never been approved for the treatment of depression, and that in fact, just the opposite was true.
The letter stated in relevant part: ‘Roche … has not systematically studied the ability of Accutane
to modify or prevent such illnesses as depression and has presented no basis for asserting that
Accutane is effective in improving the psychosocial and emotional well-being of such patients.
This claim is particularly troublesome in light of information recently presented in a Dear Doctor
letter, that Accutane may cause depression, psychosis, and rarely, suicidal ideation, suicide
attempts and suicide.’”
“In July of 1998, the FDA becomes aware that French authorities had already required the
addition of an Accutane ‘suicide attempt’ warning in 1997, of the 1992-94 French study
associating Accutane with depression, and of Roche’s failure to disclose this information to the
agency.”
Roche puts Accutane profits over Lives of Consumers
“Unfortunately hundreds of parents already know that Accutane can cause some teenagers to
commit suicide, but new evidence of a link between the acne drug and depression in the journal,
Neuropsychopharmacology, will hopefully put an end to the years of claims by Hoffmann-La
Roche that its drug is not responsible for the suicides. The drug maker’s explanation for the
sudden unexpected suicides among teens on Accutane has always been to say that teens were
likely to be depressed due to their acne.”
“For years, Roche has denied that Accutane causes depression and suicide and internal FDA
documents show the agency was aware of these risks almost since the drug came on the market.”
“The new scientific evidence will hopefully put to rest the ridiculous claim that teens on
Accutane commit suicide because they have acne. However, the news is not likely to offer much
solace to all the grieving parents. According to the Guardian article, last year in the UK, Jason
Spiller, 16, killed himself after starting the drug in April 2005. The previous year, David
Roberts, a 20-year-old, killed himself, and in 1997, Seumas Todd, 20, son of the actor Richard
Todd, killed himself while taking the drug.”
“Documents introduced at a December 11th, 2002, Congressional hearing by the House
Oversight and Investigation Subcommittee, revealed a 1998 letter to the FDA from an official at
the CDC, that compares Accutane to the infamous cancer and leprosy drug Thalidomide, a well
known cause of birth defects, stating, ‘we simply need to remove the drug from the market.’
The committee also discussed the unnecessary health problems caused by the high rate of ‘off-
label’ use of Accutane by individuals who did not have severe cystic acne, the only condition the
drug is FDA approved to treat. Dr Janet Woodcock, director of the FDA’s Center for Drug
Evaluation and Research, testified that, ‘A proportion of people treated with this drug in the last
decade had mild acne and should’ve been treated with other drugs.’ In fact at the time, the off-
label use of Accutane was so prevalent, that some experts estimated that the improper use was
close to 90% among women.”
“To date, other serious side effects associated with Accutane include problems with the pancreas,
liver, stomach, bones, muscles, hearing, vision, allergic reactions, blood sugar, or red and white
blood cells. According to the iPLEDGE web site, the most common side effects include dry skin,
chapped lips, dry eyes, and dry nose that may lead to nosebleeds.”
“The FDA needs to yank this drug off the market once and for all. Weighed against its endless
list of serious side effects, there is no justifiable reason to keep it on the market. Let the drug
companies develop a new drug to treat acne.”
During the past two decades many Accutane patient support groups and activist groups have
emerged all around the world. In 2001, Andrew Hart from Sydney, Australia created the
Australian Roaccutane Survivors Group (Roaccutane is Accutane outside the USA). On their
website, Hart describes Accutane’s resemblance to vitamin A toxicity, and the many chronic
latent symptoms experienced by former Accutane users,
“It is the belief of the Australian Roaccutane Survivors Group (ARSG) that many Australians are
suffering adversely both in the short- and long-term from the acne drug Roaccutane. Doctors are
still failing to adequately warn patients of the currently known short-term risks. More
concerning, many patients are complaining about long-term side effects that may appear years
after finishing therapy and which may last for up to 15 years post-therapy. These side effects are
not being related to a patient’s previous ingestion of Roaccutane, especially since the patient is
unlikely to consult the same dermatologist for such complaints and despite the fact that in many
cases, the patients’ skin/eyes/hair are still very dry and continue to exhibit a sensitivity to vitamin
A ingestion. Even worse, the majority of patients who receive Roaccutane have mild acne which
means the majority of Roaccutane is prescribed outside of the strict licensing limitations which
restrict it to the most severe disfiguring cases of acne. The ARSG believes that most doctors and
health authorities are yet to appreciate the gravity of this situation.
The side effects reported by people in the years post -therapy include those characteristic of
hypervitaminosis A; (vitamin A toxicity) and include:
1.Neurological Toxicity: chronic fatigue, visual disturbances, headaches, weakness, changes in
coordination, vertigo, chronic neuropathic pain, nausea, psychiatric disturbances (psychosis,
schizophrenia, depression, suicide), confusion, irritability, lack of concentration, memory
difficulties, depressed libido, male impotence, insomnia, tinnitus.
2. Musculoskeletal Problems: joint pain, back pain, bone pain and tenderness, muscle aches and
pains, stiffness, decreased flexibility and range of motion, bone spurs.
3. Mucocutaneous Toxicity: dry and peeling skin/eyes/hair/lips/nose, hair loss, hair thinning,
hair changes, rashes, dermatitis, eczema, chronic skin/eye/lip infections.
4. Ocular Problems: dry eyes, conjunctivitis, cataracts, blurred vision, double vision, optic
neuritis, papilledema, changes in night vision.
5. Gastrointestinal Problems: loss of appetite, weight loss, irritable bowel syndrome, Crohn’s
disease, Ulcerative colitis, pancreatitis, nausea, non-specific gastrointestinal changes and
inflammatory bowel diseases.
6. Hormonal and Sexual Dysfunction: abnormal menstruation (women), impotence (men),
painful intercourse.
These side effects are now accepted as short-term risks of Roaccutane therapy. Patients are not
being warned however, that many of these symptoms may persist up to 15 years or more post-
therapy.”
David Chow, chairman of the Ro/Accutane Action Group in the UK, has suffered for several
years from “a multiplicity of long-term side effects” and a constantly painful lip condition called
exfoliative cheilitis. His full story can be found at the Ro/Accutane Action Group Forum. http://ragforum.freeforums.org/index.php I’ve included a brief summary of his story below,
“In 1994, at the age of 17, I took a course of isotretinoin (Roaccutane) for mild acne, a decision I
have regretted ever since. In my case, the side-effect of dry lips has progressed to persistent
exfoliative cheilitis. My lips are constantly painful, fissured, swollen and prone to recurrent
infections, making everyday activities such as eating, drinking and even smiling (though I don’t
have much to smile about these days) a daily ordeal. My ability to speak for any length of time
is so severely impaired that I am unable to work. I have also developed central nervous system
problems similar to those associated with Roaccutane. As a result of a report submitted by me to
the UK’s Medicines Control Agency, cheilitis now appears as a side-effect on all prescribing
information sheets. However, this possible side-effect has been known and listed for some 20
years in the US. Such omissions are not uncommon. Another long-known side-effect I have –
blepharitis (inflammation of the eyelids) – is mentioned nowhere in the documentation. It makes
me wonder what the MCA is for. More pertinently, Roaccutane is being prescribed outside of its
licence, as it was originally intended for only those who had the most severe, recalcitrant forms
of cystic nodular acne. Studies have shown that the extent of off-label prescribing may be as high
as 80 percent. You may be familiar with the association between isotretinoin therapy and
suicide, consistently denied by Roche, the manufacturer of Roaccutane, and the medical
dermatological establishment. I can’t help but wonder about the volume of adverse reaction
reports they seem to be ignoring. Since attending a meeting last December in London, organized
by Mr. Liam Grant, whose son committed suicide after a course of Roaccutane, I have become
aware of many others whose lives have been damaged by isotretinoin therapy. I am seeking a
dermatologist who would be prepared to review my case as well as others in the hope that we
might be able to seek some redress from Roche for our years of pain and impaired prospects.
David Chow, Chairman of the Accutane/ Roaccutane Action Group (UK)”
Roche has known since the 1970’s that Accutane causes side effects in 100 % of everyone who
takes it. Everybody gets dry/cracked/fissuring lips while on it, which is a definitive sign of
vitamin A toxicity. Dermatologists tell their patients that they need to endure the most common
side effects of Accutane (dry skin, dry lips, photosensitivity, dry eyes) in order to gain a
therapeutic acne reducing effect. Do these patients realize that these specific symptoms they’re
experiencing are due to the vitamin A toxicity syndrome caused by the Accutane pills they are
taking? Dermatologists usually don’t disclose to their patients that they are basically poisoning
their body with vitamin A in order to reduce their acne, but a few dermatologists really do tell it
how it is by saying that Accutane causes “controlled vitamin A poisoning” as illustrated by the
following quote from a dermatologist’s website about Accutane,
“I’ve always tried to explain it as controlled vitamin A poisoning, as the potential side effects are
similar to those that would occur if you took far too much oral vitamin A.”
It has been estimated that up to 90 % of all Accutane prescriptions are going to people with mild
to moderate acne. All you have to do is look at the sales of Accutane, compare it to the small
percentage of people with severe cystic acne, and it becomes obvious. Making matters worse,
the dermatologists are getting all of their information from Roche drug sales reps and are not
conducting any due-diligence of their own, which is why some of the blame has to be placed on
them. These doctors are using a powerful drug that can inflict chronic latent severe side effects
upon teenagers and young adults who have their entire lives ahead of them.
Initially, Accutane was only meant to be prescribed for severe cystic acne, but it is still debatable
whether or not the drug should even be used for this type of severe acne because the patient
might end up with side effects that are far worse than severe cystic acne. By prescribing
Accutane for “off-label” uses such as mild and moderate cases of acne, dermatologists have
radically deviated from its strict prescribing guidelines. This is definitely good for business
because it increases the sales of the drug over 2000 percent, but not so good for the health of
millions of innocent and naive teenagers who have been exposed. It is clear that the first dictum
of the practice of medicine, to “first do no harm,” is being ignored. One thing becomes very
obvious when you examine the whole Accutane situation. Dermatologists only care about clear
skin, your health and bodily functions mean absolutely nothing to them.
We’re talking about an acne medication. Most people rightfully think that acne medications are
all safe because acne itself is a benign non-life-threatening condition. This is logically how it’s
supposed to be, but Roche, the FDA, and even some dermatologists have done an excellent job
of deceiving everybody. A few dermatologists are much more ethical when it comes to
prescribing Accutane and recognizing its dangers. In 1983, Dr. Frank Yoder, one of the two
doctors who originally discovered Accutane to be an effective acne medication, wrote a letter to
the American Medical Association stating,
“I wish to express my concern and anxiety over the potential tragedy that might arise from abuse
and misuse of Accutane…the potential toxicity of this drug has been seriously under-
emphasized.” [Isoretinoin: A Word of Caution 249 JAMA 350 (1983)]
The risks of taking Accutane are so great that the FDA has taken the remarkable step of requiring
each prescription to come with a medication guide that explains the side effects in non-technical
language. But the Accutane Medication Guide didn’t come out until 2001, which was two
decades too late for thousands of people who had been inflicted with severe side effects. Even
though the medication guide was released in 2001, not all dermatologists and pharmacists have
been handing it out to everybody. It contains a laundry list of warnings such as,
“Stomach area (abdomen) problems. Certain symptoms may mean that your internal organs are
being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus
(connection between mouth and stomach). If your organs are damaged, they may not get better
even after you stop taking Accutane. Stop taking Accutane and call your doctor if you get:
-severe stomach, chest or bowel pain
-trouble swallowing or painful swallowing
-new or worsening heartburn
-diarrhea
-rectal bleeding
-yellowing of your skin or eyes
-dark urine”
“Vision problems. Accutane may affect your ability to see in the dark. This condition usually
clears up after you stop taking Accutane, but it may be permanent. Other serious eye effects can
occur. Stop taking Accutane and call your doctor right away if you have any problems with your
vision or dryness of the eyes that is painful or constant.”
“Hearing Problems. Some people taking isotretinoin have developed hearing problems. It is
possible that hearing loss can be permanent. Stop using Isotretinoin and call your prescriber if
your hearing gets worse or if you have ringing in your ears.”
“Spontaneous reports of osteoporosis, osteopenia, bone fractures, delayed healing of bone
fractures, muscle weakness, and calcifications of tendons and ligaments have been seen in the
Accutane population. There are reports that some patients had stunted growth after taking
Accutane for acne as directed.”
Contrary to popular belief, the human body doesn’t completely stop growing until the age of 21,
sometimes later. It was known decades before Accutane was released onto the market that
vitamin A toxicity can cause premature growth plate closure in children and adolescents, which
is why nobody should be allowed to take Accutane if they’re under the age of 21, but
dermatologists still routinely prescribe it to teenagers as young as 13, so the derms have
apparently never gotten wind of this side effect because they tend to get their information from
Roche and don’t ever think for themselves. The testimonial I’ve quoted below illustrates how a
family discovered the growth plate closure problem the hard way. It was posted on a Yahoo
Geocities Accutane message board way back on December 12th, 1999.
“It troubles me greatly to see that young growing teenagers are being given this drug. I have two
boys that had their growth plates rapidly closed by this drug. Roche lists as its first side effect in
their South African package insert: premature epiphyseal plate closure. Medline has a pediatric
precaution stating that Accutane is absolutely contraindicated in ages 0-16 due to premature
epiphyseal plate closure. The side effects are much more powerful in a growing body. My boys
bones never finished spreading and maturing. They also have premature arthritis. This drug
robbed them of all their dreams as we are a very tall family and they were never told it would
stop their growth. We finally got the charts from the doctor and he wrote that he old us of
growth retardation. My boys would have never taken this drug if they had been told the truth.
They did not have anything but pimples. Unfortunately for us, we believed the doctor. Even in
the US package insert it only says that premature epiphyseal closure is suggestive. How can it be
known in one country and suggestive in another. Someone is not telling the truth. Most kids
don’t even realize that this drug stopped them from growing. We had been tracking our sons
height and have x-rays before, during and after on our 14 year old. His bones were completely
sealed shut. My boys are now 17 & 19 and they are still the same size as they were at 14 & 15.
Why aren’t the doctors telling the truth$$$”
The research document titled “Health risks related to high intake of performed retinol in the
Nordic countries” contains an abundance of information about retinol toxicity (AKA vitamin A
toxicity or hypervitaminosis A) and its deleterious effects of the musculoskeletal system. Below,
I’ve listed a few important quotes.
“Synthetic retinoids are widely used in the treatment of skin diseases and some cancers. Their
toxic effects mimic those of hypervitaminosis A and include musculoskeletal symptoms. The
patients may complain of bone and joint pain, stiffness, and/or impairment of function. Cortical
hyperostoses and ligamentous calcification are the most frequently reported skeletal changes
(DiGiovanna et al., 1986; Pittsley and Yoder, 1983). In children, premature epiphyseal closure
has been described following high dose retinoid therapy (Milstone et al., 1982). Of higher
importance is the concern that long-term therapy with synthetic retinoids might induce
osteoporosis. Animal studies have predicted development of osteoporosis as a dose-dependent
toxic effect (reviewed in Teelmann 1989). In man, synthetic retinoids have been shown to alter
bone turnover (Decensi et al., 1999; Kindmark et al., 1998). Decreased bone mineral density has
been found in retinoid treated patients compared to age- matched controls (DiGiovanna et al.,
1995; Leachman et al., 1999; Okada et al., 1994). The risk of undesirable skeletal effects is of
course dependent on the choice of drug, dosage, and duration of treatment, but it nevertheless
clearly exists, which the clinical guidelines advising caution and careful monitoring of bone
symptoms during long-term therapy witness (Glover et al., 1987; Nesher and Zuckner, 1995).”
“As described in chapter 5, the symptoms of retinol toxicity include hypercalcaemia, bone and
joint pain, as well as skeletal abnormalities, clearly indicating that high doses of retinol interferes
with calcium and bone metabolism. The mechanisms of these effects are not well understood,
but as will be discussed below are likely to be complex. However, although these toxic effects
have been known for decades, the effect of physiological ranges of retinol intake on skeletal
integrity has not received much attention.”
“Bone, along with the skin and the developing embryo, are some of the targets for retinol activity
and these tissues appear to be more susceptible to deleterious effects than others (Teelmann,
1989)”
“A large body of evidence documents that large doses of retinol have undesirable effects on the
skeleton. It is generally accepted that toxicity is associated with consumption of retinol, whereas
carotenoids in foods are not known to be toxic in healthy persons.”
“Bone alterations are the most prominent and well-described effect in toxicology studies in
animal models. A striking feature is the consistent occurrence of spontaneous fractures. In a
recent review, Binkley and Krueger (2000) note that searching Medline, they found no other
compounds reported to produce spontaneous fractures. Other manifestations include severe
osteoporosis, thinning of the bone, retardation of growth, exostosis, and premature growth-plate
closure (Carroll et al., 1997; Niemann and Obbink, 1954; Tang et al., 1985).”
“As described in chapter 5, chronic hypervitaminosis A produces a broad spectrum of symptoms
from a variety of organ systems. The clinical picture may be quite diversified and non-specific.
In many cases, the correct diagnosis is difficult and may not be made for months or even years.
Skeletal symptoms are a major feature of chronic retinol intoxication and they have been
described in a number of case reports. They include general muscular and skeletal discomfort,
severe bone pain, especially in the long tubular bones, tender swellings, disability and limitation
of motion (Caffey, 1950; Frame et al., 1974; Romero et al., 1996). Common clinical findings are
hypercalcaemia, hyperostosis and ligamentous calcification (Ragavan et al., 1982). Other extra-
skeletal calcifications, like nephrocalcinosis, have been described (Frame et al., 1974). At a later
stage, demineralisation of bones or osteoporosis may be seen (Bartolozzi et al., 1967; Frame et
al., 1974; Gerber et al., 1954). In children, growth retardation and premature epiphyseal closure
may occur (Pease, 1962). In bone biopsies taken from subjects intoxicated with retinol, an
increase in extent of the bone resorbing surfaces was seen, while the formation surfaces were on
the low side of the normal range (Jowsey and Riggs, 1968). The presence of enlarged osteocyte
lacunae, so-called ‘osteolysis,’ is another characteristic of retinol intoxication, that has been
described in both humans (Jowsey and Riggs, 1968) and animals (Belanger and Clark, 1967).
These alterations are compatible with loss of bone tissue.”
Health risks related to high intake of performed retinol in the Nordic countries
Roche’s track record for creating dangerous drugs extends beyond Accutane. Take Lariam for
example, which is used to prevent Malaria. Just like Accutane, Lariam has been linked to several
cases of permanent brain damage, severe psychiatric side effects, suicides, and murders. Roche
is also responsible for developing the date-rape drug Rohypnol, and the dangerously addictive
tranquilizer Valium. With all this in mind, it becomes clear that creating deadly drugs with
mind-altering side effects is their forte.
“service members have been diagnosed with permanent brainstem and vestibular damage from
being given this drug despite the fact that alternative drugs might have been chosen to prevent
infection.”
“A San Antonio couple has filed suit in New Jersey state court charging drug giant Hoffmann-La
Roche with ‘knowingly withholding or misrepresenting information’ about side effects of its
anti-malaria drug called Lariam.”
“Lariam also made news this summer, after three Fort Bragg Special Forces soldiers given the
drug during deployment in Afghanistan returned home and allegedly killed their wives. Two
also committed suicide.”
“Manofsky is a decorated serviceman, a weapons targeting specialist, a naval aviator who has
also boated, skied and dived. Now he can’t do any of those things. Manofsky’s problems began
when he was sent to Kuwait in the run-up to the war in Iraq. Like thousands of others, he was
given a drug called Lariam to prevent malaria. He got sick. He couldn’t sleep and he started
having psychological problems. ‘I lost it. I literally went nuts. I was talking to myself. I was
talking to myself in the chow. I was waking up mad. I would go to bed mad. Using my hands
to talk to myself.’ The panic attacks became so acute we had to rush him to the emergency
hospital five different times. He also went into seizures where his whole body was convulsing.”
“’I’ve chased bad guys all around the world; been beat up, shot at; developed dengue fever and
encephalitis’ says Jim Prietsch, who has worked as a Washington, D.C., police officer and
protected U.S. and foreign leaders for the State Department and the World Bank. Nothing, he
adds, was as bad as what happened two years ago on back-to-back trips to Indonesia and Africa.
‘I started to have panic attacks, nightmares, hallucinations, by the time I got to Africa, I thought I
was going crazy. Problems got worse and worse. Finally, I had seizures like someone was
reaching inside my brain and flipping it upside down. I had no idea what was going on.’ Not
until a colleague from Europe saw the white pill Prietsch took once a week ‘He told me, ‘That’s
your problem – that stuff is poison.’’ An infectious-disease specialist later confirmed that the
cause of Prietsch’s problems was most likely the pills he’d been taking: mefloquine.”
“Seven U.S. servicemembers have been diagnosed with inner ear damage ‘most likely’ caused
by use of the anti-malaria drug Lariam, said a Navy surgeon treating them. Use of the drug is the
only factor the seven members have in common, he said.”
“’Lariam studies have indicated that Lariam can damage the vessels and nerves of the brain, and
the inner ear is subject to that same damage because it is part of the brain,’ said Hoffer, an ear,
nose and throat surgeon who has practiced in the field for 10 years.”
Hoffmann-La Roche is part of a leading international health care company called “The Roche
Group” with its principal businesses in pharmaceuticals, diagnostics and vitamins. This group is
made up of many subsidiaries, they are the seventh largest pharmaceutical company in the world
and are active in more than 150 countries. The Roche Group is well known all throughout the
legal system because of their long-standing track record with regards to both civil and criminal
activity. In 1999 Hoffmann-La Roche was named the top corporate criminal by the publication,
Multinational Monitor, after they pleaded guilty and paid the largest criminal fine in history,
$500 million to the American Department of Justice, $462 million to the EU, fines in several
other countries, plus a 10 billion dollar settlement to creditors and suppliers they had defrauded
in the US, EU and most other countries where they were selling vitamins. This happened after
they were caught perpetuating a vitamin conspiracy/cartel where they collaborated to artificially
inflate the price of food fortifying vitamins in the United States and all over the world for over a
decade. FBI and EU documentation on this fraud showed an extraordinary level of corruption,
lies, and misrepresentations made by Roche personnel at all levels of the organization, from its
senior board of directors in Basal, Switzerland, through the separate Roche board of directors in
each of the countries where Roche was conducting and perpetuating the fraud. Several of
Roche’s corporate executives were sentenced to prison for their roles in the vitamin cartel.
United States Attorney General Janet Reno stated about the vitamin cartel,
“On a daily bases for the past 10 years, every American consumer paid to eat and drink or use a
product whose price was artificially inflated. Day by day, consumers took a hit in their wallet so
that these co-conspirators could reap hundreds of millions of dollars in additional revenue.”
She went on to state that,
“This cartel was truly extraordinary. It lasted almost a decade and involved a highly
sophisticated and elaborate conspiracy to control everything about the sale of these products.
These companies fixed the price; they allocated sales volumes; they allocated customers; and in
the United States they even rigged bids to make absolutely sure the cartel would work. The
conspirators actually held “annual meetings” to fix prices and to carve up world markets, as well
as frequent follow-up meetings to ensure compliance with their illegal scheme. The enormous
effort that went into maintaining this conspiracy reflects the magnitude of the illegal revenues it
generated as well as the harm it inflicted on the American economy.”
“…Indeed, the members of the vitamin cartel, including Hoffmann-La Roche, continued to meet
and carry out their global agreement even while Hoffmann-La Roche was being investigated,
prosecuted, and fined $14m in March 1997 for participating in the citric acid cartel.”
“The vitamin cartel was led by the top management at some of the world’s largest corporations,
including one company, F. Hoffmann-La Roche – which continued to engage in the vitamin
conspiracy even as it was pleading guilty and paying a fine for its participation in the citric acid
conspiracy….some senior executives of this mult-national firm knew about the firm’s
participation in international cartels in two industries. When the firm’s illegal activities were
uncovered in one industry, and the firm had to plead guilty and pay millions of dollars in fines,
those executives could have and should have terminated the firm’s cartel activities in the second
(and larger) industry. Instead, those executives orchestrated false statements to enforcement
authorities, took steps to further conceal the firm’s illegal activities, and continued to lead the
world’s other producers in a global cartel.”
The Ro/Accutane Action Group states on their website,
“The vitamin cartel was described by the US Attorney General as the most pervasive and
harmful criminal antitrust conspiracy ever uncovered, and Roche agreed to pay the largest fine in
criminal history because it was caught flagrantly violating the law.”
U.S. Outlines How Makers of Vitamins Fixed Global Prices
“Investigators were said to have been particularly angry at the executive, Kuno Sommer, because
he had lied about the existence of the vitamin cartel and his role following Roche’s guilty plea in
another price-fixing case two years ago. In that case, involving citric acid, Roche paid a $14
million fine and promised to cooperate with investigators. Dr. Sommer, who had previously
lived in New Jersey when he served as North American regional manager for Roche, denied in a
1997 interview with investigators that there was a vitamin cartel and said he was not aware of
any meetings or conversations involving price-fixing in that market, according to court papers
filed by the Government Thursday that are part of his plea agreement. In fact, at that time he
was still playing an important role in setting vitamin prices and allocating market share,
according to a plea agreement filed on his behalf Thursday in Federal court in Dallas. While
Justice Department officials said Dr. Sommer was not the highest-level executive who knew
about the conspiracy and cover-up, they did not say who might be prosecuted next. Among the
executives who did not receive immunity in the deal reached with Roche were Roland
Bronnimann, president of the Vitamins and Fine Chemicals division, and Andreas Hauri, a
former executive vice president and head of global marketing.”
“At a news conference here to announce the initial results of the investigation, Attorney General
Reno and other senior officials described a global conspiracy to fix vitamin prices. They said one
Swiss executive had agreed to return to the United States to serve a jail sentence, although he
was not the highest-ranking official involved in the scheme. At least seven other executives
remained under investigation.”
“Two giant foreign companies agreed Thursday to pay $725 million in fines for plotting to raise
and fix the prices of vitamins used in virtually every American home and added to bread, milk
and breakfast cereal. The $500 million fine to be paid by F. Hoffmann-La Roche Ltd., a Swiss
pharmaceutical company, is the largest federal criminal fine ever imposed in any type of case,
Attorney General Janet Reno told a news conference. A German firm, BASF AG, agreed to pay
a $225 million fine for its role in the conspiracy to increase vitamin prices in the United States
and around the world. Both companies pleaded guilty in U.S. District Court in Dallas.”
The New York Times: Tearing Down The Facade of ‘Vitamins Inc.’
In his book titled Why Animals Don’t Get Hearth Attacks – But People Do, Dr. Matthias Rath,
M.D. described Roche’s vitamin cartel.
“By the turn of the century, the world’s largest pharmaceutical and nutritional companies,
including Hoffmann-La Roche, BASF, Rhone-Poulenc, Archer Daniels Midland (ADM), Takeda
and other multinational corporations, had admitted to forming a so-called “vitamin cartel” to
conduct criminal price-fixing for vitamin raw materials. Hundreds of millions of people
worldwide were defrauded for almost a decade and had to pay artificially high prices for
vitamins and certain other essential nutrients. The U.S. Justice Department declared that this
vitamin cartel was the largest cartel ever discovered and named it an ‘economic conspiracy.’”
“Hoffmann-La Roche apparently invited BASF, Rhone-Poulenc, Takeda and other
manufacturers of vitamin raw materials to engage in criminal price-fixing on a global level. The
fraudulent profits these companies made from their criminal practices may have reached
hundreds of billions of dollars over the past 10 years. Compared to that, the fines these
companies had to pay were insignificant.”
“Not only should governments have sued these companies for the damage they had done, but
above all, consumers world-wide should have filed class action lawsuits against them. These
companies have harmed millions of people twice: First, they knowingly refused to promote and
disseminate lifesaving information about the use of vitamins for the prevention of heart disease,
thereby causing millions of heart disease patients to die unnecessarily over the past 10 years.
Second, they caused financial damage to hundreds of millions of people – literally every vitamin
consumer on earth.”
“My correspondence with Hoffmann-La Roche executives also proves the statements they and
others made that the corporate executives did not know about these criminal activities were lies.
The opposite is true: These corporate executives not only knew about these crimes, they were
the organizers. The executives responsible for these crimes should be prosecuted and held
responsible for their actions.”
“While that may take time, one benefit is already here today. All these companies have pleaded
guilty to criminal activities. Thus, everyone can describe these companies and their executives
for what they are – criminals who distinguish themselves from a street robber only by the
magnitude of their crimes.”
Scribd.com Why Animals Don’t Get Hearth Attacks – But People Do
Over the past 10 years, several anti-Accutane forums and posts have been closed down as a
result of legal threats against the servers by you know who. But today the evidence of all the
dangerous side effects is so overwhelming and indisputable Roche can’t get away with launching
these types of legal threats anymore. Throughout the 80’s and 90’s, Roche settled a countless
number of severe side effects cases out of court and out of the public eye with gagging clauses.
Under the terms of the settlement, the victims could not come forward to tell their story or share
it with anyone. This is one of the tactics used by Roche to keep the most horrible Accutane side
effects and evidence continuously suppressed over a long period of time. In “Babies, Blemishes
and FDA: A History of Accutane Regulation in the United States” Julia Green from Harvard
Law School writes,
“Out of the spotlight, Hoffmann-La Roche continued to grapple with the repercussions of
Accutane related birth defects. By the mid 1990’s, Accutane had earned the company a
significant list of enemies, many of whom were looking to draw blood. Frank Yoder, in some
ways a patron Saint of Hoffmann-La Roche—after all, his 1976 discovery had resulted in a
tremendous money maker for the company—had spent the past fifteen years insulting Roche in
the Washington Post. A subset of the plaintiff’s bar called the Accutane Litigation Group had
also been chipping away at Hoffmann-La Roche. The company had settled a number of
expensive lawsuits. But each time documents were sealed, which meant new plaintiffs would
have to start from scratch. The plaintiff’s bar had become convinced that Hoffmann-La Roche
had acted recklessly—something which might entitle clients to steep punitive damages.”
Roche has never disclosed the total amount of money they’ve spent settling Accutane litigation
cases. In 1995, a medical student launched a legal campaign to sue Roche for over $10 million.
The lawsuit was later settled privately out of court, the details of this story can be read at the
following link,
Attorney Michael Hook of the law firm Hook Bolton Mitchell Kirkland & McGhee in Pensacola,
Florida, has put together a consortium of law firms to take on Hoffmann-La Roche in the courts.
Hook has spent the last 20 years of his legal career mainly defending doctors, hospitals and
insurance companies, but he described that his life changed dramatically in 2001 when he
decided to take up the challenge of suing a major drug company because in his words one must
commit “every waking moment and all of your resources to take them on.”
Consortium of Firms Working on Accutane Litigation
In the article above, Hook said that Hoffmann-La Roche “knew what it was doing and made
billions in profits but did nothing to assess its drug, did not do tests even though scads and scads
of people were reporting inflammatory bowel disease……..Some of my clients don’t have
intestines, don’t have colons–it’s horrible what they have to live with, it got to the point where I
decided if I don’t do this, who’s going to? I knew it would require me to give up the rest of my
practice and really work on it continuously. But how long has this been going on, and no one
has gone after the company?”
Hook believes that the plaintiffs are on “solid ground with discovery evidence and experts.” Dr.
David B. Sachar is the plaintiffs lead expert. Sachar is the director emeritus of gastroenterology
at Mount Sinai School of Medicine in New York and until last month served as chair of the FDA
advisory committee on gastrointestinal drugs.
“Early on, [Sachar] said, ‘I believe Accutane is causing inflammatory bowel disease,’ His experts
have reviewed discovery materials and testified that the manufacturer withheld documents about
IBD and other key plaintiff issues.”
The first four trials have already been decided in favor of the plaintiffs, and Roche has been
ordered to pay Andrew McCarrell, Adam Mason, Kamie Kendall, and Jordan Speisman millions
of dollars because Accutane caused their inflammatory bowel disease leading to surgical removal
of their colons.
A short video from the Levin-Papantonio law firm in Pensacola, Florida
Accutane’s history and its connection with severe gastrointestinal disorders
Accutane Documentary on Youtube: The Ghost Under My Pillow
“Tim Robbins is like millions of Americans, most of them teenagers and young adults, who have
taken the powerful drug Accutane and watched their embarrassing acne disappear within weeks.
Robbins is also one of nearly 500 individuals who say they paid a terrible price as a result and
are suing drug maker Hoffmann-La Roche Inc. The first trial opens today in Illinois. At issue is
whether the company downplayed the risk that the medication could cause serious
gastrointestinal diseases. But pharmaceutical giant Roche, which is based in Nutley, N.J., flatly
denies it and maintains that there is no reliable evidence that Accutane causes inflammatory
bowel disease. Many of the plaintiffs who contend that the treatment led to their conditions —
ulcerative colitis or Crohn’s disease — say they can be treated with drugs or suffer only
occasional but debilitating flare- ups. The conditions are characterized by abdominal pain,
diarrhea and weight loss. The problem was much more severe for Robbins, 28, a former
construction worker in Oak Ridge, Tenn. He had his colon removed and permanently lives with a
colostomy bag. ‘There are days when I wonder, why did this have to happen to me?’ he said.
Robbins’ trial is expected to start this summer.”
“Mike Papantonio, senior counsel at Levin, Papantonio, Thomas, Mitchell, Echsner & Proctor of
Pensacola, Fla., one of five law firms representing the Accutane plaintiffs. Papantonio said
lawyers would present documents in court that showed that the company long ago knew not only
that the drugs could cause gastrointestinal diseases but also that they were more common than
any other side effects listed on the drug’s label. In addition, he said, there are more than half a
dozen instances in which internal company documents show that the company describes the drug
as a possible cause of the disease.”
Accutane Maker Roche AG Ordered to Pay $2.62 Million to Patient Who Developed
Inflammatory Bowel Syndrome After Using Drug
“The lawyers and staff of Ennis & Ennis P.A. would like to congratulate attorney Mike Hook
and his staff for their tremendous verdict in the amount of $10.5 million for a 24 year old Utah
woman who was diagnosed with ulcerative colitis after taking Accutane. This has been a well
kept dirty secret by the manufacturer Hoffmann-La Roche for many years. We are glad to see
these cases come to light and hopefully the word will spread to teenagers and young adults who
are still on the drug or are thinking of taking the drug. We have been working with Mike and his
staff since 2003 on these cases and it has been a long hard fight. The manufacturer has
stonewalled the litigants time and again and it is good to see these cases finally get to trial and let
the truth come out. Mike and his team have won 3 straight trials in New Jersey state court in the
amount of $2.5 million, $7.5 million and yesterdays verdict of $10.5 million. We are convinced,
based on our research, that there are many more victims out there who have not correlated their
illness to the drug accutane. Accutane has received much publicity for side effects including
depression, suicide and birth defects. The real dark secrets lie in the correlation between accutane
and IBD (Inflammatory Bowel Disease), Ulcerative Colitis, Crohn’s, Liver and Kidney damage.”
“(OPENPRESS) May 31st, 2007 — Ennis & Ennis P.A. announced that it has been retained by
almost 100 clients who have been diagnosed and treated for Inflammatory Bowel Disease (IBD),
Crohns Disease, Ulcerative Colitis, Kidney and Liver Transplants. Today’s $2,600,000 verdict
against Hoffmann-La Roche validates our client’s claims nationwide and in Canada. ‘We have
been working with trial team lawyer Michael Hook since 2003 on Accutane cases and we would
like to congratulate Michael Hook, David Buchanan and all the dedicated professionals who did
the behind the scenes work’ said Attorney David F. Ennis. Attorney David Ennis is quoted as
saying ‘It is a great day in America when a citizen of Alabama can hire a lawyer in Florida and
bring a claim in the great state of New Jersey against a Swiss manufacturer, (Hoffmann-La
Roche one of the biggest and most profitable pharmaceutical companies in the world) and a jury
of their peers over a three week time period can come to a reasonable verdict on liability and
damages.’ It renews your faith in the jury system and you hope American citizens realize that if
they ever give up their right of trial by jury they will lose all power and leverage against major
Corporations.”
New Jersey Jury Awards $12.9 Million to Three Patients Whose Use of Roche Acne Medication
Accutane Found to Cause Severe Bowel Illness
“The three plaintiffs are all Florida residents – Kelly Mace, 25, of Pensacola, along with Jordan
Speisman, 27, of Gainesville, and Lance Sager, 28, of Ft. Lauderdale. All were first prescribed
Accutane nearly a decade ago while still in their teens to relieve adolescent acne. All three
succumbed to various forms of IBD, including ulcerative colitis and Crohn’s disease, while
taking Accutane or shortly thereafter.”
“Roche first advised physicians about a possible association between Accutane and
inflammatory bowel disease in 1984. In the ensuing years, the evidence accumulated by Roche
and outside scientists demonstrated that, far from a coincidence, Accutane was in fact inducing
inflammatory bowel disease in Accutane patients. Nonetheless, Roche failed to strengthen its
warnings either to patients or prescribing physicians. The jury saw evidence of Roche studies,
never published for the scientific and medical community, that Accutane’s by-products damage
the gastrointestinal tract and lead to degeneration and erosion of the intestinal lining — a trigger
for IBD. Significantly, those studies, which were performed in animal models specifically to
test the gastrointestinal safety of the drug, tested exposures that were lower than those seen in
patients taking Accutane. Also in Roche’s files but not shared with the medical community, were
hundreds of patient reports of IBD in connection with Accutane use. Notably, in numerous of
the reports, the symptoms of IBD appeared with Accutane use, subsided when Accutane use was
terminated, but then recurred following re-introduction of the drug. Roche repeatedly
determined internally that Accutane was the best and only explanation for these IBD reports.”
“This is an important outcome and consistent with the recognition by the medical community
that Accutane is a trigger for IBD,” said David Buchanan, a partner with Seeger Weiss in New
York who served as co-counsel to the plaintiffs at trial.
“We applaud the jury’s diligence and hope their verdict will finally break down the arrogance and
stonewalling by Roche in denying Accutane’s role in the prolonged illness of so many patients
who took the drug unaware of the extreme, prolonged effects it would have on their intestinal
tract,” he added. He noted that Roche faces as many as 600 Accutane cases around the country.
Michael Hook served as lead counsel in the case. He stated, “It is unconscionable that faced with
so much scientific proof that Roche has continued to deny its culpability in these cases. Since
first acknowledging in 1984 that Accutane may be associated with IBD, the company has
collected a mountain of evidence showing that Accutane in fact induces, causes, and aggravates
IBD. Yet, Roche never shared that information with prescribing doctors or patients. Shockingly,
Roche had internally contraindicated Accutane for IBD, another fact not shared with the medical
community. As a result, the labeled warnings on IBD haven’t changed to reflect the likely link,
which most certainly would have caused most doctors to rethink prescribing Accutane and led
patients to reconsider their potential for acquiring this horrific and debilitating disease.”
Very few people know this but Accutane is not technically an acne medication, it was originally
developed to be a chemotherapy drug back in the 1970’s and is still used as chemotherapy today
for leukemia, pancreatic cancer, brain tumors, and other types of cancers. It has powerful
systemic cell division reducing effects throughout the entire body, and acne reducing skin
dryness happens to be one of its side effects. Cancer chemotherapy drugs by their very nature
are some of the most powerful and toxic pharmaceuticals used in conventional medicine. During
clinical trials in the late 1970’s, researchers discovered that some of their cancer patients had
their acne cleared up during their chemotherapy. This was when drug regulatory authorities all
around the world tossed their logic and common sense out the window and Accutane slowly
became known as a popular treatment for acne. Roche accomplished this by paying off several
different doctors (Dr. William Cunliffe, Dr. Douglas Jacobs, Dr. Susan Jick) to promote
Accutane as a safe and effective drug for acne. United States attorney Mike Papantonio has
fought and won in some of the most significant litigations against the pharmaceutical industry for
product liability. Today he is working on Accutane. During a television documentary broadcast
in Switzerland last year created by investigative journalist Serena Tinari, Papantonio said,
“The interesting thing about this drug it’s that it was never intended for something like clearing
up pimples. This was a drug that was intended for chemotherapy. Roche could not make enough
money with it just with chemotherapy, so they said: Let’s expand it. Let’s sell it to more people.
And they ended up selling it to people with acne.”
“If you, today, were to ask Roche: Explain to me what is the mechanism, the bio mechanism of
this drug. You know what? They wouldn’t be able to tell you. They don’t know. This drug has
been on the market since 1982 and they have not spent one dime, not one single dime, trying to
figure out how it works, how it goes about causing these side effects.”
“You have 152, about 152 side effects. People would never make the choice to use this drug.
Never. Once they understand how dangerous it is, there’s no logic, there’s no reasoning person
that would say: I’m going to take Accutane to clear up pimples.”
Congressman Bart Stupak was interviewed at the beginning, he said,
“My son went on Accutane in December 1999 and on May 14th, about 5 and a half months later
he shot himself while on Accutane. This was completely out of characteristic of my son. He
was a young man who loved life. He’d light up this room if he walked in right now. So after
some time my wife just thought that maybe there could be some relation between Accutane and
his suicide. I found that hard to believe: why would an acne medicine lead to disturbed thoughts
or depression. We found that the FDA, the Food and Drug Administration here, in the United
States, filed a warning in 1998. We had no knowledge of that. My first question was: why don’t
people know about this? Secondly, why would the FDA in 1998 put a warning note, but not tell
people? And what led to the warning. Why the warning?”
Later in the program, Dr. Douglas Bremner, Professor of Psychiatry and Director of the Emory
University Medical School Clinical Neuroscience Research, explained his research he’d
conducted with Accutane and brain scans,
“We looked at a group of 13 individuals who were treated with isotretinoin, which is Accutane in
the United States, and compared it to 15 individuals who were treated with antibiotics. And we
looked at brain function before and after treatment, with antibiotic or isotretinoin. And we found
a 21 % decrease in brain function over the frontal cortex, which is the brain region involved in
emotion and mood, in the patients treated with isotretinoin, but not in the patients treated with
antibiotic.”
“I asked if they’d (Roche) be interested in providing medication or other support for the study
and they weren’t interested. Well, often times companies will give, provide free medication.
I’ve done that all the time. They may not fund a study, but if you request, they’ll provide free
medication. So, I was surprised that they were not interested in providing even the medication.
You can calculate that it takes 800 patients in order to have an adequate trial. And, you know,
I’ve asked the FDA if they would request Roche to just provide the medication for a trial like
that. And they told me that they don’t have the power to do that. I mean, if they don’t have the
power to do that, then who does!”
“The effect is through protein transcription, that would imply that the effects would take longer
to come on, but also would take longer to go away. Because, once you’ve started affecting
protein transcription, you’re basically talking about changing the structure of the brain. It could
take weeks to refer back to normal. It’s possible that some individuals would just stay that way.
There will continue to be cases of suicide and depression. You know, Roche may continue to
argue that they’re not related, that suicide is common or that there’s other extenuating
circumstances. However, the science won’t stop. There’s even a new study that came out, it
increases oxidative stress and causes DNA damage. So, I don’t think that…..I think that most
people would think twice about taking a drug that causes DNA damage. I mean, I certainly
would.”
Roche orchestrated an elaborate smear campaign in their attempt to discredit Dr. Douglas
Bremner and his research work. Click the following link to read the full story on Dr. Bremner’s
blog.
“Well I thank Hoffmann-La Roche Pharmaceuticals and my dispute with them about whether
their acne drug Accutane can cause depression for: 1) deposing me 16 times; 2) calling me a
liar); 3) attacking my professional reputation; 4) suing my university; 5) trying to get me fired
from my university; 6) trying to get my paper on the effects of Accutane on the brain retracted;
7) accusing me of fraud to the Editor (yes, Robert Freedman MD) of the journal where the paper
was published, which led to, more inquiries at my university.”
“What is really sad about this whole sordid tale is how degenerated the so-called dermatology
literature has become on the topic. For example, the most commonly cited study to support the
statement that acne is associated with depression, a study that has been cited several hundred
times by dermatologists writing in the literature, involved only ten patients with acne and no
comparison subjects (Gupta et al., 1990). No statistics were performed (obviously since there
was no comparison group). Scores on the questionnaires for anxiety and depression were not
related to severity of acne.”
“And the fact is that the rest of the literature isn’t any better. Objective measures of acne do not
correlate with severity of anxiety or depression. Acne does not cause major depression. It is
simple as that.”
“Sure, kids worry about their zits and feel better when they go away, but the studies do not
support the conclusion that acne causes major depression, and that treatment of acne cures
depression.”
Are Dermatologists Dips**ts? The Depressing Accutane Tale
Here’s a question for all the dermatologists and everyone else that doesn’t believe Accutane
affects brain function, and therefore had nothing to do with all of the reported psychiatric
injuries, suicides, and murders. If Accutane supposedly only affects the skin, then why do
oncologists use it for pancreatic cancer, leukemia, brain tumors and other certain types of
cancers? To corroborate, here’s a quote from a website devoted to pancreatic cancer therapies.
“Accutane: Based on the need to inhibit pancreatic cancer cell division at different stages of its
growth and induce apoptosis (programmed cell death) of cancer cells, multiple therapeutic
modalities are often recommended. One successful treatment modality is to combine the
differentiating-inducing drug Accutane (13-cis-retinoic acid) with other chemotherapy drugs,
such as 5-FU. Both Accutane and 5-FU are toxic drugs that must be carefully administered by a
medical oncologist. A combination of 13-cis-retinoic acid (Accutane) and interferon-alpha was
tested in a Phase II trial of 22 patients with pancreatic cancer. One patient experienced partial
remission and 14 patients demonstrated stable disease for about 5 months (Brembeck et al.
1998).”
‘Chemo brain’ real for many cancer patients: study
“The research concludes that a common chemotherapy drug, known as 5-fluorouracil (5-FU),
causes stem cells in the central nervous system to die off well after treatment has ended. The
resulting side effects are often referred to as “chemo brain.”
“Because of our growing knowledge of stem cells and their biology, we can now begin to
understand and define the molecular mechanisms behind the cognitive difficulties that linger and
worsen in a significant number of cancer patients,”
“The 5-FU chemotherapy drug treats cancer by halting cell division, and has been used for more
than 40 years. It is often given in combination with other chemotherapy drugs, and is commonly
used to treat breast, ovarian, stomach, colon, pancreatic and other types of cancer.”
Joseph Mercola, D.O. states on his website “Chemotherapy, which has been one of the principal
treatment methods for the past 50 years, works by killing all cells – throughout your body – that
multiply and divide rapidly. This would include cancer cells, but also other rapidly multiplying
and dividing cells, such as: Bone marrow (which produces blood), Digestive system,
Reproductive system, Hair follicles.” http://www.mercola.com/
Since Accutane is fat (lipid) soluble, it is one of the few drugs that is able to cross the blood-
brain barrier and get into the central nervous system. This fact alone explains how it can elicit
devastating psychiatric side effects, and why it is often used as chemotherapy for brain tumors.
Accutane has been on the market for the past 25 years and during that entire time Hoffmann-La
Roche has specifically declared in the Physician’s Desk Reference that its exact mechanism of
action is unknown. In my opinion, this has basically been their way of sidestepping issues
regarding all the many harmful side effects Accutane causes to the human body, and also to
distract people from gaining insight about how this drug does what it does. They neglect to
mention that Accutane is a systemic chemotherapy agent that reduces cellular proliferation of the
sebaceous glands in the skin all over the body (which is why it’s so effective against acne), and
also does the same thing to the cells lining the digestive tract, areas of the brain, eyes, and
mucous membranes (causing a lot of dryness). To corroborate my previous statement, take a
look at what scientist James Crandall says in this scientific study which can be found on
PubMed. He is stating point blank this is how Accutane works and this is what’s causing the
side effects.
“Retinoic acid (active form of Accutane) induces differentiation and reduces proliferation of
stem and progenitor cells. It works on acne by inducing similar events in basal sebocytes. These
same actions also lead to 13-cis-retinoic’s (Accutane’s) side effects, and these are directed
towards proliferating cells in the adult such as in the skin, gut and bone.”
“A wide ranging effect of retinoic acid is to inhibit proliferation in dividing cells, and this
accounts for its frequent consideration as an anti-cancer agent.”
This study was published in 2004, here is its abstract.
“The active component of the acne drug Accutane is 13-cis-retinoic acid (RA), and it is highly
teratogenic for the developing central nervous system. Very little is known, however, regarding
the effect of this drug on the adult brain. Regions of the brain that may be susceptible to RA are
those that continue to generate new neurons. In the adult mouse, neurogenesis is maintained in
the hippocampus and subventricular zone. This report demonstrates that a clinical dose (1
mg/kg/day) of 13-cis-RA in mice significantly reduces cell proliferation in the hippocampus and
the subventricular zone, suppresses hippocampal neurogenesis, and severely disrupts capacity to
learn a spatial radial maze task. The results demonstrate that the regions of the adult brain where
cell proliferation is ongoing are highly sensitive to disruption by a clinical dose of 13-cis-RA.”
In the quotes above, Crandall hints at Accutane’s mechanism of action but he doesn’t
specifically say the actual mechanism because he doesn’t know about the telomere (pronounced
TEE-LA-MEER) research that I have discovered. Recently I have discovered research showing
that all-trans retinoic acid (abbreviated ATRA which is the final biologically active metabolite
that Accutane turns into) down-regulates the telomerase enzyme (pronounced TEE-LA-MER-
AZE) and induces telomere shortening and cell death. This I believe is the mechanism of
action. Accutane causes telomere shortening leading to permanently arrested cell division /
proliferation.
So why are short telomeres a bad thing to have? Here’s a quick rundown of telomere biology.
Cells all over the body are replaced by means of cell division, and there is a limit on the number
of times that they may successfully divide. This is known as the Hayflick Limit. Most cells in
the body divide about 50 times before they stop dividing and die a natural death. The
mechanism that controls this cell division lies within the telomere / telomerase, which is a cap
like structure on the end of all the different twenty three pairs of chromosomes. Chromosomes
are the helical structures of DNA that are found inside the nucleus of all cells in our body which
carry our genetic code. The telomere chain and its length can be thought of as a string of beads
(repeating code at the end of every DNA strand), with one bead falling off the string each time a
cell divides. Therefore, the telomere shortens up a little bit every time a cell divides, and again
this places a limit on the number of times a cell can replicate itself, known as the Hayflick Limit.
Once these beads run out and disappear, the cell stops dividing and undergoes programmed cell
death (AKA apoptosis). The constant process of telomeres getting shorter eventually leads to the
death of the cell and over time this cumulative cell death leads to one of the major components of
the aging process. However, there exists a specialized enzyme called telomerase which acts to
repair damage to the telomere, maintain its stability, and extend the length of the telomere beads,
thereby overcoming the Hayflick Limit. Germ line cells and cancerous cells continually express
telomerase in such a way that they never run out of telomere beads and therefore remain
immortal. Telomerase is naturally expressed more in cells in the body that are the most rapidly
dividing: the immune system, skin, bone, digestive tract, mucous membranes, etc. because these
cells undergo much more cell division (more turnover) throughout a person’s lifetime and
therefore need to have their string of beads repaired and relengthened more often. Right now
I’m going to include a relevant quote from Dr. Aubrey De Grey’s new book titled Ending Aging,
which can be found at Amazon.com or any major bookstore. Dr. De Grey is a world famous
Biogerontologist, which in a nutshell means he studies the underlying causes of the aging
process.
“If it weren’t for telomerase, this gradual shortening would eventually lead to the complete loss
of the telomeres in cells that replicate frequently during the lifespan, and thus the gradual erosion
of the genes themselves. Telomerase periodically relengthens the telomere before it becomes
critically short.” (De Grey, 294)
10% of cancer cells use an alternative process to continue their cell division known as alternative
lengthening of telomeres, but 90 % of cancer cells activate the telomerase enzyme in such a way
that it continually rebuilds the telomere chain so that these cells never run out of cell divisions
and therefore become immortal. This is one of the major defining hallmark characteristics of
cancer. Cells divide and grow out of control and don’t die off like they are supposed to. The
telomere Hayflick Limit can be thought of as a cellular countdown clock mechanism that is in
place to specifically protect us from renegade cells growing wildly out of control (AKA cancer).
The following quote from Dr. Aubrey De Grey’s Ending Aging explains what would happen if
cancerous cells were deprived of telomerase or alternative lengthening of telomeres.
“Either way, without a way to renew their telomeres, the single-minded multiplication of
potential cancer cells rapidly grinds to a halt as it reaches the end of its telomere “rope,” and we
wind up with a tiny (and generally short-lived) lump in our bodies instead of a life-threatening,
malignant condition.” (De Grey, 295)
From what I’ve observed, I believe the people who suffer the chronic latent side effects of
Accutane have the opposite problem that people with cancer have. With cancer patients, there’s
too much uncontrolled disorderly rapid cell division going on, but with Accutane patients,
there’s too little normal necessary bodily cell division or sometimes none at all because the
Accutane has caused critical telomere shortening, inducing growth arrest and cell death in
various areas of the body where cell proliferation is supposed to be ongoing.
What’s bad about Accutane is that there’s a huge amount of individual variability when it comes
to the side effects. For some people, it takes multiple courses of Accutane to induce permanent
side effects, but for others all it takes is one round to put their bodies past the point of no return.
Different people get different combinations of side effects and they are very unpredictable,
because through influencing DNA transcription (which is what all retinoid/vitamin A drugs do),
it causes random groups of cells all over the body to differentiate and shut-down when they are
not supposed to. This is why it is used in chemotherapy. Chemotherapy drugs kill rapidly
dividing/proliferating cancerous cells, but they also kill the healthy rapidly dividing/proliferating
native cells of the body along with the cancer. Accutane binds to the vitamin A (retinoid)
nuclear receptors RAR and RXR on the surface of the nucleus inside every cell in the entire body
and changes the way that the cells read their genes (protein transcription). This is why Accutane
has an extremely long list of side effects involving every tissue and every organ in the human
body. The cells that are the most vulnerable to this effect are the ones that need to divide and
proliferate (undergo mitosis) more often.
The severity of Accutane long-term side effects all depends on how far the course of Accutane
down-regulated the telomerase enzyme and shortened the telomere length. Here’s another quote
from Dr. De Grey’s book where he explains what would happen if telomerase was completely
down-regulated.
“Deleting telomere elongation capacity throughout the body would also be life-threatening,
because it would mean that our regular, proliferating cells (like those in the skin or the lining of
the gut) would suddenly have iron limits on their ability to reproduce themselves and thus
replenish tissue. From the moment that we denuded our cells of telomerase, a clock would be
ticking. With each division the telomere would shorten by a notch from whatever it had been
when we took telomerase out. We would be under the specter of a rather horrible death, as our
stem cells went offline one by one under replicative senescence (see Chapter 10): with each
failure of a stem cell responsible for supplying key functions, the tissue would fail to be renewed
and would slowly degenerate.” (De Grey, 297)
Accutane and ATRA (all-trans retinoic acid or Vesanoid) are very similar drugs, they are both
retinoids, they have very similar side effect profiles and pharmacokinetics and they are almost
chemically identical. Interestingly, Roche states a 14% incidence of depression for 10 mg of
Vesanoid, with the knowledge that this is exactly what 40 mg of Accutane interconverts into.
Two of ATRA’s side effects are dry eyes and dry skin, so it would work against acne, but Roche
hasn’t studied it against acne because they’ve been too busy making a killing (pardon the pun)
selling Accutane. If you read over ATRA’s side effect profile in the link I’ve put below, you’ll
notice how it’s very similar to Accutane (they both cause retinoid toxicity AKA vitamin A
toxicity). To clarify, here are the brand names and chemical names for these two drugs that are
both manufactured by Hoffmann-La Roche.
Accutane (used for Acne)
Isotretinoin
13-cis retinoic acid
Vesanoid (used for Leukemia)
Tretinoin
All-trans retinoic acid (ATRA) or retinoic acid
Accutane and Vesanoid information on Chemocare.com
Since a certain percentage of Accutane metabolizes into ATRA (about 30%), and since the
ATRA metabolite is how Accutane exerts its pharmacological actions on the body, there’s no
doubt that if ATRA causes telomere shortening then Accutane also causes telomere shortening.
If Accutane truly does cause telomere shortening and down regulation of the telomerase enzyme,
this could mean huge significant implications for maintaining adequate cell proliferation all over
the body for the rest of a former Accutane patient’s lifetime. In other words, Accutane, being a
potent chemotherapy drug, attacks and damages the cells in the body that are supposed to remain
dividing and proliferating for a person’s entire lifetime. If cells have shorter telomere lengths
(shorter telomeres), they get closer to the Hayflick Limit and can’t divide/proliferate as much or
they go on to experience growth arrest and cell death (apoptosis). This is how Accutane reduces
acne, and why in some cases, the acne doesn’t come back, and the patient is left with permanent
dry skin, dry mucous membranes, digestive problems, hair loss, and other various permanent
side effects. During the course of treatment and after, Accutane has increased the cell division /
turnover rate so drastically (new cells are born and die at a faster rate), that these cells run out of
cell divisions and are driven into their Hayflick Limit. This can be illustrated by observing what
happens when somebody eats polar bear liver (contains extremely toxic levels of vitamin A
similar to Accutane) and their skin starts to peel off all over their body in thick giant sheets from
the increased cellular turnover rate, also a potential side effect of Accutane. The cell division
rate (beads falling off the string) has been increased so fast and telomerase has been down-
regulated so much that it cannot repair the telomere chain (the beads on the string) before the
cells lose all of their cell divisions (beads) and enter growth arrest (Hayflick limit). Here’s an
excellent definition of the Hayflick Limit.
“Dr. Leonard Hayflick discovered that mammalian cells divide only a fixed number of times.
This “Hayflick Limit” was later proven to be caused by telomeres on the ends of chromosomes
that shorten with each cell division. When the telomeres are gone, the DNA can no longer be
copied, cell division ceases, and cells enter replicative senescence or old age.”
Conduct some research online and through Wikipedia on cell division (mitosis), telomerase,
telomere shortening, and the Hayflick Limit, and how they have long been considered to play a
role as one of the major components of the aging process. Another observation that would be
worthwhile to consider is that people with the premature aging disorder Progeria have shortened
telomeres. So there is enough evidence to predict a possible backlash that is going to occur when
this information gets fully verified, that Hoffmann-La Roche and the American Academy of
Dermatology have given a drug that causes a form of premature aging to millions of teenagers
and young adults with acne. Specialized tests are available that can assess telomere shortening,
validating the damage caused by Accutane. One of them is called the Terminal Restriction
Fragment southern blot TTAGGG telomere length assay.
It’s imperative to understand that stopping Accutane doesn’t necessarily mean that the user is in
the clear. There are several reports by people who claim that some of their side effects,
particularly the worst kinds, didn’t emerge until years after they stopped Accutane. This drug is
proving to have a chronic latent effect on people’s bodies, which is also how it permanently
cures their acne, with lots of collateral damage of course. If people investigated further into their
own use, there could very well be a massive backlash when this information gets out, even with
people who took a low dosage and got good results from their course of Accutane and so far
haven’t developed any complications or chronic health problems. My impression, after
conducting many hours of research, is that there are thousands of people out there with really
bizarre and unusual chronic health problems as a result of their exposure to Accutane, but they
just haven’t investigated and made the connection yet.
I always knew that Accutane’s mechanism of action would reveal itself by examining the way
that retinoids are used in chemotherapy. When retinoids are used for chemotherapy, at least they
make an attempt to tell patients how the stuff works and warn them about the side effects. This
study below, published back in 2001, is the smoking gun for Accutane’s mechanism of action,
because ATRA (all-trans retinoic acid or Vesanoid) is the active metabolite that 13-cis retinoic
acid (Accutane) turns into. Nobody besides me has made this connection yet. Nobody has
posted any information about retinoids and how they cause telomere shortening on the
Ro/Accutane Action Group forum. Here’s a quote from the abstract of a study which can be
found at the following link.
Retinoids down-regulate telomerase and telomere length in a pathway distinct from leukemia cell
differentiation
“A second pathway of hTERT regulation, identified in the RAR-responsive, maturation-resistant
NB4-R1 cell line, results in a down-regulation of telomerase that develops slowly during two
weeks of all-trans retinoic acid (ATRA) treatment. This pathway leads to telomere shortening,
growth arrest, and cell death, all events that are overcome by ectopic expression of hTERT.”
Here’s another interesting quote from the scientific abstract of a more recent study published in
2006, I’ve provided the link to this study below.
Telomerase targeting by retinoids in cells from patients with myeloid leukemias of various
subtypes, not only APL
“These results support the idea that, by hTERT targeting, retinoids can induce telomere
shortening and cell death and their integration in therapy protocols for myeloid leukemias
refractory to maturation should be considered.”
So to sum all of this up, these research studies I listed above show that long-term treatment with
ATRA (all-trans retinoic acid), which is almost chemically identical to Accutane, causes
“telomere shortening, growth arrest, and cell death.” The cells that the researchers tested were
cancerous cell lines, but if ATRA causes these effects in cancerous cell lines, then it is highly
likely that it will do the same thing to our body’s own rapidly dividing/proliferating cells such as
the cells in the bone, skin, digestive tract, and even the hippocampus and subventricular zone in
the brain.
Another significant observation which can be gleaned from this research is that if ATRA causes
telomere shortening, and this is also the mechanism of action for how vitamin A toxicity causes
many side effects and reduces cell division, then telomere shortening could explain why lots of
people have reported that consuming high amounts of vitamin A or foods rich in vitamin A after
their course of Accutane worsens their side effects, especially the problems related to dryness.
In other words, it explains why for some people, the side effects become much worse after they
stop Accutane, because the dietary vitamin A they need to stay alive might be slowly killing
them because Accutane has shortened their telomeres too far. A search on the Internet reveals an
abundance of information about vitamin A and retinoid compounds being inhibitors of
telomerase.
Vitamin D3, Vitamin A and The Prevention of Tumor Cell Immortality
“This subject is complicated so forgive me if my explanation is not completely understandable.
Telomeres exist at the ends of chromosomes. As chromosomes replicate during cell division, the
telomeres protect the chromosomes from damage and cell death. Yet telomere function declines
as cells continue to divide, and the ends of chromosomes become progressively shorter. After a
prescribed number of cell divisions, the cell dies. This is referred to as the limited lifespan of
somatic cells. As cells grow, the ends of their chromosomes progressively shorten until they
die…but NOT in cancer cells.”
“Telomerase is the enzyme that corrects the shortening of the chromosomes as they continue to
divide. This enzyme is not active in normal cells, but it is very active in at least 90% of all
cancers and leukemias. This means that telomerase expressing cells can continue to divide over
and over without fear of dying of old age. Cancer cells that possess active telomerase activity
can survive, while non-active varients will die. This is dogma and it is carved in stone. It
doesn’t make ANY difference if the cancer cells are activated by oncogenes, such as RAS, or if
the cancer cells are of a particular genetic makeup, the chromosomes in these cells will shorten,
causing the death of these cells, unless telomerase activity is activated.”
“There is no shortage of biotech companies out there who would give anything if they could only
develop telomerase inhibitors. They should stop trying. Vitamin D3 and vitamin A, combined,
inhibit the SYNTHESIS of the catalytic unit of telomerase. This means that these two hormones
will not allow cancer cells to divide indefinitely. And that ain’t bad. The following study was
conducted in prostate cancer cells, but the principle applies to ALL cells.”
“ONLY the heterodimer of vitamin D3 and vitamin A receptors can inactivate the telomerase
gene. So get these supplements integrated into your daily routine. Stay tuned…”
Learn Genetics: Are Telomeres The Key To Aging And Cancer?
“Yet, each time a cell divides, the telomeres get shorter. When they get too short, the cell no
longer can divide and becomes inactive or “senescent” or dies. This process is associated with
aging, cancer and a higher risk of death. So telomeres also have been compared with a bomb
fuse.”
“Without telomeres, the main part of the chromosome – the part containing genes essential for
life – would get shorter each time a cell divides. So telomeres allow cells to divide without
losing genes. Cell division is needed so we can grow new skin, blood, bone and other cells when
needed.”
“An enzyme named telomerase adds bases to the ends of telomeres. In young cells, telomerase
keeps telomeres from wearing down too much. But as cells divide repeatedly, there is not
enough telomerase, so the telomeres grow shorter and the cells age.”
“Geneticist Richard Cawthon and colleagues at the University of Utah found shorter telomeres
are associated with shorter lives. Among people older than 60, those with shorter telomeres were
three times more likely to die from heart disease and eight times more likely to die from
infectious disease.”
Vitamin A Cancer Adjuvant Therapy from the Life Extension Foundation
“Vitamin A offers protection against radiation induced tissue damage, down-regulates
telomerase activity, and is involved at almost every juncture of cancer control.”
In my opinion Roche stating that “the exact mechanism of action is unknown” for the past 25
years is just a ruse to distract people from learning the information that the systemic cell division
reducing effect of retinoic acid is specifically what’s responsible for making their acne go away
and causing many of the side effects. James Crandall’s statement “A wide ranging effect of
retinoic acid is to inhibit proliferation in dividing cells, and this accounts for its frequent
consideration as an anti-cancer agent” is good enough for me as an explanation for the
mechanism of action. But I’ve gone one step further and identified the mechanism. Being a
systemic chemotherapy agent, Accutane does not know the difference between cancer and your
body’s own rapidly dividing cells. With the knowledge that many parts of the human body, such
as the skin, nasal passage, immune system, areas of the brain, digestive tract, bones, lungs,
mucous membranes, bladder, urinary tract, sexual organs etc. rely on rapid cell
division/proliferation to sustain their proper function throughout a person’s lifetime, this
information about retinoic acid having a “chemotherapy like” cell division reducing effect
becomes extremely important. Because it means that if you take too much Accutane for too long
of a period of time, you are essentially slowing down or stopping cell division in areas of your
body where cells are supposed to remain dividing for your entire lifetime. In my opinion this is
what’s causing most of the chronic long-term side effects, these people basically have the
opposite problem that people with cancer have. As I’ve discussed in depth, the explanation for
the mechanism of action likely involves human telomerase reverse transcriptase (hTERT), the
chief regulator of cell division in our rapidly dividing cells. It has already been shown that
retinoic acid down-regulates hTERT in cancerous cells, which is more than enough evidence to
call for an investigation of its effects on hTERT in the human leukocytes, enterocytes,
keratinocytes, sebocytes, endothelial progenitor cells and other various progenitor cells. Specific
tissue biopsies and blood tests before and after a course Accutane will identify the extent to
which cell division has been reduced.
As a result of Accutane, cells in many different areas of the body have a decreased ability to
divide and proliferate, which is why the mucous membranes, the nasal passage, eyes, lips
become very dry, and this also happens to various areas of the digestive tract, decreasing the
integrity of the mucosal barrier that protects the gut wall, which is then more vulnerable to
sustaining damage and developing into inflammatory bowel disease. The digestive tract can be
thought of as a tube (your body is hollow) that is technically outside of the body because the
mucosal layer is what protects us from pathogens and the harsh substances of digestive
metabolism. Just like the skin, the lining of the digestive tract is a fortress that separates our
bodies from the outside world. This protective barrier becomes dysfunctional and gets
diminished after Accutane because the cells can’t divide as much. One reported side effect is
cracking and severe dryness of the region around the anus, leading to rectal bleeding. This isn’t
surprising because a very common side effect is severe cracking and dryness of the lips
(exfoliative cheilitis), which is another mucous membrane.
For all the people out there who like to use topical retinoids like Retin-A on their skin, be careful
not to use it too often (not more than once per week) or else you might induce too many cell
divisions (peeling skin) which could lead to the cells hitting their Hayflick Limit (skin cells can’t
turn themselves over anymore). Many misinformed people have been lead to believe that the
Hayflick Limit is an urban myth when it comes to topical retinoids and agents used for facial
exfoliation. Well, listen up because I’ve got the straight dope right here. Topical Retin-A works
by burning off a layer of skin to try to create a better one. It is tretinoin, a retinoid also known as
all-trans retinoic acid or ATRA, and one of the scientific studies I’ve referenced and discussed
in-depth above shows that long-term treatment with ATRA targets human telomerase reverse
transcriptase and induces telomere shortening, growth arrest and cell death (Hayflick Limit).
Therefore, in light of this new information, what do you think could happen if you undergo too
many facial exfoliations or apply topical Retin-A on your face too often?
Does anyone remember the drug Thalidomide, an anti-nausea medication prescribed to pregnant
women in Europe back in the late 1950’s and early 1960’s? This drug caused approximately
10,000 babies to be born with severe debilitating or deadly birth defects. The scope of the
Thalidomide tragedy was so awful and incomprehensible that governments around the world,
including the United States, proclaimed that they needed to learn a lesson from this tragedy and
that such a catastrophe must never be allowed to happen again. Well, guess what, it has
happened again, just in a more out of the spotlight, clandestine manner. Accutane is
Thalidomide Jr. and the devastation caused by Thalidomide is dwarfed by the devastation caused
by Accutane. It has been estimated that in upwards of 50,000 infants have been exposed to the
horrific teratogenic (birth defect causing) effects of Accutane during the quarter of a century that
it has been on the market. The only reason Accutane is still on the market today is because of
abortion, because without abortion, it would’ve been impossible to cover everything up for so
long. In the past, if you were a woman on Accutane and you became pregnant, the
dermatologists would recommend that you get an abortion. But hold on just one minute. Should
having to get an abortion be allowed because of a side effect of taking an acne medication? By
not giving out Accutane to so many people in the first place, this problem would be solved.
Abortion and patient confidentiality are the methods used by Hoffmann-La Roche and the
American Academy of Dermatology to suppress the shocking evidence about the real number of
infants severely affected by Accutane. Investigative health journalist Bill Sardi sums up this
situation by saying,
“Pimpled people have been poisoned with a vitamin/drug. Unlike Thalidomide, a drug that
medical doctors were unaware caused birth defects, it was well known that Accutane, a synthetic
form of vitamin A, caused malformed babies before it was placed on the market. Elisabeth
Robert, MD, PhD, at the European Institute of Genomutations in France, says Accutane is not
well-known for its link to birth defects whereas Thalidomide is. So one drug, Thalidomide, has
been removed from the marketplace, while a similar drug, Accutane, experiences robust sales”
(Accutane: A modern horror story, http://www.knowledgeofhealth.com )
In 1990, an internal FDA memo by Dr. David Graham (the same FDA drug safety scientist who
later blew the whistle on Vioxx in 2004) said that Accutane was an “imminent hazard” to public
health and needed to be taken off the market immediately. Graham stated in the memo,
“As our data on drug use and contraceptive failure show, there probably have been between
15,000 and 18,000 pregnancy exposures to Accutane since its appearance on the market in 1982.
The magnitude to fetal injury and death has been great and permanent, with 11,000 to 13,000
Accutane-related abortions, and 900 to 1,100 Accutane related birth defects…….Accutane poses
an imminent hazard to public health, and as such should be withdrawn immediately from the
market.”
More recently it was revealed that,
“An FDA official at the February 2004 advisory committee acknowledged that there are
probably 3,500 Accutane exposed babies each year in the United States, most are aborted!
Hoffmann-La Roche claims that they do not have to report the abortions because, to use their
words, a fetus is not a human being and it does not have to be reported under the FDA reporting
system.”
Human Teratology: Isotretinoin and Vitamin A
Presentation by Dr. Edward Lammer MD
The New York Times: Biologists Identify ‘Impresario’ of Life In Vitamin A
The recently implemented IPLEDGE program (designed to eliminate Accutane pregnancies) has
turned out to be a failure because despite its implementation many women have still became
pregnant while on Accutane, and those are only the cases that have been reported. Congressman
Bart Stupak says there have been instances of people getting pregnant, hushing it up with their
dermatologist, getting an abortion, and not reporting it to anybody. In his recent statement to the
FDA Advisory Committee Hearing on iPLEDGE, held on August 1st, 2007, Stupak also talks
about how the FDA defeated the proposal for a mandatory registry of birth defects and
psychiatric side effects,
“It is difficult to understand how the FDA can knowingly allow hundreds of birth defects to
occur per year and remain silent. The FDA’s attempt to say nothing about Accutane birth defects
is summed up in this email, ‘As for the ‘needle, I think you and a lot of other non-dermatologists
are in for a major shock IF the truth is ever exposed. I know that I am going to say is anecdote,
but I personally know several derms whose patients have become pregnant on Accutane and
NOT A SINGLE one reported it (except to their lawyer). And I don’t even know that many
derms, as I am not into the local derm scene!! [……….] Roche and the AAD [American
Academy of Dermatologists] are so adamantly opposed to collecting the real number of exposed
fetuses for a reason and I personally do not believe them when they say it is concern for patients’
privacy (we do NOT have to compromise that in any way to collect the data). I think it is a
concern about the public outcry/outrage that will ensue if the truth comes out.’”
“As we know, the FDA dropped the mandatory patient registry and certification of practitioners
whose prescribe Accutane to prevent birth defects and psychiatric injuries. Once again, the FDA
succumbed to Roche’s pressure and the registry and certification was abandoned. Each time the
Advisory Committee made recommendations to limit the distribution and use of Accutane,
Roche pressured the FDA to protect and increase its sales of Accutane. In fact, the latest defeat
of the mandatory registry and certification will benefit Roche by approximately $450 million.
After all the devastation this drug has caused teens!!!! What special powers or charm does
Roche have with the FDA? Many are starting to ask that question.” It is time for this committee
on behalf of the American people to “start asking that question” what is the special power or
charm that has allowed Roche to market Accutane which has caused death and devastation
among our young people?”
For some people Accutane has caused them permanent severe sexual side effects like painful
intercourse in men and women, erectile dysfunction, genital hypersensitivity, urinary
discomfort/pain (interstitial cystitis), and severe dryness of the vaginal lining and penis. These
side effects are most likely due to Accutane causing excessive thinning of the skin on their
genitalia, with even the possibility of it sloughing off the entire top layer of skin, and degrading /
drying out the mucosal barrier lining the bladder and urethra. Other cases exist where people
can’t kiss anymore because Accutane induced a severe lip condition called exfoliative cheilitis,
which causes their lips to feel extreme hypersensitive pain if anything touches them. To this day
these side effects are not included among Accutane’s incredibly long list of warnings in its
package insert. There’s an M.D. on the Internet named Dr. Kevin Pezzi who discusses Roche’s
cover-up of Accutane’s permanent sexual side effects in his book titled The Science of Sex and
here at his website http://www.erbook.net/accutane initially posting this information 6 years ago.
Many stories can be found on the Internet written by individuals with various sexual side effects
from Accutane. Here’s an example from the Ro/Accutane Action Group Forum.
“This is beyond personal, but I am at my wit’s end, and I’m desperate for any solutions out there.
This post is regarding a mature subject matter, and it’s not pretty, so read on at your own risk.
I finished a course of accutane about 6 months ago. Since that time, the skin on my penis has
progressively deteriorated. Strange pinkish/reddish patches have cropped up on the glans. The
glans has become permanently red in some places and dark brown in others and has become very
rough and irritated. Some of the skin surrounding the meatus has peeled away and refuses to
heal. One side of my urethra has become red and occasionally will tear, bleed slightly, and then
scab over. The skin on the entire shaft has become so incredibly thin that all the veins are visible
and painful to the touch. The entire area is incredibly sore, and brushing up against anything
(including clothing) is unbearable.
No doctor can figure out the problem. I have been tested for every STD on the books (herpes,
HIV, syphilis, gonorrhea, chlamydia), and they have all come back clean. I’ve been given
prescription oral antifungal medicine and used topicals, but they were useless. I’ve also been
given medium strength steroids and protopic from one doctor who believed it could be psoriasis –
but no luck in fixing the problem.
At this point, I’m pretty much certain accutane caused my condition. My symptoms do not
match up with any skin/genital disease on the books, and the temporal proximity in taking the
medicine and the onset of symptoms, while possibly coincidence, is more likely indicative of an
adverse reaction to the medicine. The reason I am posting is not to wage a war against Roche
(though I certainly respect that others want compensation for their pain). My purpose is to see if
anyone else out there has had this problem as a result of taking accutane, and if so, whether they
have found any way to make it go away, or at the very least, more bearable.
Has anyone found that their problems have improved with time?
I am really struggling here. I used to have such a nice life, and I would do anything in the world
to have it back. Any help is much appreciated.
Thanks.”
Comment from a Medical Doctor
“I have used Accutane myself years ago, and I have regretted doing so ever since. A few weeks
after I began using it, my libido decreased dramatically. Even worse, my ability to experience
sexual pleasure was greatly diminished as well. While I can feel some pleasure, it’s much less
than before. Quantitating such a subjective thing is obviously difficult, but I’d estimate that it is
90 percent less than what it once was. Even though I am a physician, I have discussed this
problem with other doctors (urologists, a neurologist, and internists) and no one had any idea
what to do about this problem. I’ve researched it myself, and I don’t know what–if anything–can
be done to reverse it. The manufacturer claimed to have never heard of this reaction before, but
they could simply be saying that to avoid legal consequences. I HAVE heard others say they’ve
had similar problems after using Accutane, and I think that many people may have had the
problem yet never felt comfortable discussing it with anyone. (Consequently, the true incidence
may be far greater than what anyone suspects.) In my case, it took years before I had the
courage to mention this to anyone except my girlfriend — it’s not an easy thing to discuss. While
Accutane achieves a long-term control of acne in SOME people, I think its potential
complications outweigh its utility in that regard. There are numerous other drawbacks to this
drug in addition to the one that I discussed above, so I’m not kidding when I say that I’d rather
play Russian roulette than to take Accutane.”
These side effects have been acknowledged in other countries (In a 1994 study, the UK’s Dr.
William Cunliffe wrote about Accutane causing severe dryness of the penis, using the medical
term Balanitis) and they’ve been reported to the FDA and other regulating bodies for the past 20
years (read through the list of ADRs on Congressman Bart Stupak’s website). But the Feds and
Roche (remember the pharmaceutical companies basically own the FDA) have done nothing to
warn patients because this is the one side effect that would tend to strongly dissuade people from
taking Accutane for their acne, plus Roche would lose hard on their bottom line. Roche even
created a small study to give male acne patients reassurance that Accutane had not been found to
cause problems with male reproduction, despite the fact that an abundance of adverse drug
reaction reports related to sexual side effects had been coming into them and the FDA for many
years. The results of this small and meaningless and probably fraudulent study was inserted into
a pamphlet titled “What young men/women need to know about acne” and handed out by
dermatologists to all patients receiving Accutane. It says,
“One thing you should know about Accutane is that clinical studies have shown that Accutane
does not cause any negative effects on the ability to produce normal sperm or on male
reproduction……Although you may see special instructions to female patients on the package of
Accutane, and on other materials your doctor may give you about Accutane (isotretinoin), these
instructions about avoiding pregnancy do not apply to young men. Young men may rest assured
that the special instructions for young women to avoid pregnancy do not apply to them.”
Liam Grant, chairman of the Ro/Accutane Action Group, gave an excellent detailed presentation
at the FDA Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee held on
September 19th, 2000. Here are several quotes from his presentation.
“Good afternoon, ladies and gentlemen. My name is Liam Grant. I’m chairperson of an
organization called the Ro/Accutane Action Group. Our group was set up in 1997 to provide
support for Accutane victims, to investigate all aspects of Accutane from the initial pretrial
studies to review the literature, ADR reports, physician guidelines and so on in each country
throughout the world where the drug is sold, also to fund and coordinate a series of scientific
studies on Accutane to determine the mechanism by which Accutane causes so many severe
physical and psychiatric side effects.”
“The principal side effects of Accutane based on adverse reaction reports and published studies
include general side effects such as photophobia, muscle and joint pain, insomnia, lethargy,
central nervous system side effects such as pseudotumor cerebri, which is described as a serious
condition involving swelling of the brain, visual disturbances, hearing deficiencies, malaise,
drowsiness, amnesia, hallucinations, and psychiatric disorders, which include behavioral
disorders, seizures, psychosis, schizophrenia, depression, suicide ideation, suicide thoughts and
actions, and also as we all know, it’s a teratogen.”
“What do scientific literature reports say about Accutane? Well, there are a substantial number
of published studies linking the ingestion of Accutane to the emergence of psychiatric disorders
as far back as 1983, less than one year after the drug was released onto the market. I’ve only
time to briefly refer to three of these studies.”
“The American Academy of Dermatology published a study in 1983 where the authors reported
that 5.5 percent of patients experienced depressive symptoms while on Accutane. In the case of
one 21-year-old man in that study, the symptoms of depression and forgetfulness were severe
enough to cause withdrawal of the drug. So, within a few months of Accutane being introduced,
the first independent study showed that 5.5 percent of patients experienced symptoms within 2 to
3 weeks of starting on Accutane.”
“Another published study in 1990 in the same dermatological magazine set out details of serious
psychiatric disorders suffered by 7 patients where treatment had to be discontinued because of
the severity of the side effects, and they were listed, including manic depression, suicidal
thoughts, fear of going insane, et cetera. And remember, that was 1990.”
“Another study showed that adverse drug reaction reports for Accutane in the United States in
the period from October 1982 to June 1985 represented the highest number of adverse drug
reaction reports received by any agency for any prescription drug. It also stated that 22 percent
of adverse drug reactions for Accutane relate to central nervous system disorders, such as
headache, insomnia, depression, dizziness, personality disorder, and pseudotumor cerebri. Now,
that’s 1985.”
“Sales of Accutane from 1982 to 1985 were very small in the United States because of publicity
on the number and serious nature of birth defects caused by Accutane at that time. Accutane at
that time had been likened to Thalidomide. So, Accutane with small sales at that time was
attracting more adverse drug reactions than any other prescription medicine, despite the fact that
some of these other prescription medicines were being sold to not just tens but hundreds of
millions of people.”
“How many adverse drug reaction reports are there for Accutane? Well, in May 1998 Roche
issued a letter to the Irish Medicines Board, which disclosed that there were 40,000 adverse drug
reactions on the Roche database in respect of Roaccutane. A review of all ADR data recorded
since that time suggests that there may well now be 50,000 to 55,000 such ADR reports for
Accutane on the Roche worldwide database.”
“Studies show that only 1 in 10 serious ADRs are ever reported. In some countries, it may be
only 1 in a 100. If we apply a factor of 10 to the number of adverse reactions recorded for
Accutane, we get a figure of 500,000 or more, more than half a million people, which I think
gives some idea of the number of people and the scale of suffering caused by this drug.”
“Roche have not provided a full list of all ADRs held in the Roche database for Accutane. The
FDA and other national agencies have not received this full and detailed list of all ADRs, which I
cannot understand. Dermatologists who prescribe this drug on a daily basis have not got the full
list of adverse drug reactions worldwide in respect to this drug. Therefore, as I speak, I don’t
know and I doubt if anyone in this room, apart from the Roche people, knows the total number of
suicides worldwide, suicide attempt, and suicide ideations recorded for the drug and also the
number, up to tens of thousands, of psychiatric disorders recorded for the drug worldwide.”
“I’m just going to briefly mention Norway in reference to a group of 32 very courageous people
in Norway who, in 1988, set up an Accutane support group and went to the media to highlight
the terrible side effects caused by Accutane. We have the copy of the newspaper reports which
are now 12 years out-of-date. They sought from the medical professional to devise proper
medical treatment for people who had suffered this severe physical and psychiatric side effects
which are listed in those publications in 1988. As a result of this, the Norwegian Health
Authority commissioned a study in 1992. The study was financed by Roche. The final report
submitted to the Norwegian Health Authority in 1993 made no reference whatsoever to the
scientific publications at that time linking the ingestion of Accutane and the emergence of
psychiatric disorders and other items. They did not disclose the number or the nature of adverse
drug reactions held on the Roche database at that time.”
“Following the increased label warnings introduced by the FDA in February 1998, Roche placed
advertisements in the media indicating that Accutane could alleviate depression. That was their
reaction. On the 8th of March 1998, the FDA sent warning letters to Roche ordering them to
withdraw the promotional material stating that they were false and misleading and promote
Accutane for an unapproved use. Roche used similar procedures or maybe tactics in the United
Kingdom, but time does not permit me to just deal with those in detail at the moment. Also,
Roche used similar advertising tactics in Ireland after the increased label warnings were applied
and a feature on that is by Drs. Bickers and Jacobs. And when we looked who were Drs. Bickers
and Jacobs, we found that they had been employed by Roche in 1997 in order to try and persuade
the FDA not to bring in increased label warnings.”
“It came to our attention that Accutane was for sale on the Internet. Now, as far as we can
determine — and we’ve been monitoring the Internet for many years – the drug was not sold on
the Internet prior to the increased label warnings, featuring psychiatric illness and suicide. To
investigate the ease with which Accutane could be obtained online, we placed orders under the
names of boys and girls in their teens. Within 10 days, we were supplied with the drug from
South Africa with a prescription from a doctor with a South African address. Despite the
restrictions for the prescribing of Accutane, such as blood tests, pregnancy tests, it is possible to
get Accutane without a medical consultation. All you need is a credit card. No medical
consultation. No meeting between patient and a doctor. No blood tests. No birth control
safeguards. No monitoring of patients.”
“Now, Roche profits from sale of Accutane via the Internet could be in tens of millions and
perhaps even hundreds of millions of dollars.”
“The license for Accutane states that it should only be used for severe recalcitrant cystic acne as
a treatment of last resort when all other treatments have failed. And that’s the position in most of
the countries, if not all of the countries. We believe that more than 80 percent of patients
prescribed Accutane have mild or moderate acne, which is in violation of the license.
Prescribing doctors should be required to certify that patient’s acne is within the license
guidelines.”
“I’ll just mention. There was a survey on several hundred dermatologists, conducted by a
professor well-known to this side of the house, which showed that 74 percent of patients were
prescribed Accutane for mild or moderate acne. We have other studies in France, and if anybody
wants to have a look at them, we would provide them — showing that between 70 and 80 percent
of people prescribed Accutane have mild or moderate acne. Of course, Roche knows that.
Everybody knows that. It’s produced for severe nodular cystic acne. Unfortunately, the FDA
and other national agencies say that they really can’t do anything about it. It’s the prerogative of
the doctor.”
“Studies need to be undertaken by Roche or dermatologists to elucidate the mechanisms by
which Accutane interacts with the central nervous system and other systems in the body. This
will give us an insight into the causes of the specific side effects and hopefully leading to
developing proper medical treatment for the tens of thousands, if not hundreds of thousands, of
people who have suffered and continue to suffer severe side effects from this drug.”
“Patients should have all the proper tests, blood tests, pregnancy tests, and so on which should be
properly monitored.”
“Sale of Accutane on the Internet should be immediately prohibited.”
“Independent studies urgently need to be carried out to establish exactly the mechanism by
which this drug causes so many side effects.”
“An appropriate medical treatment — this is probably the most important — must be
devised to counteract the side effects and to provide treatment for the many tens and
hundreds of thousands of people who have suffered severe side effects from this drug.”
There you have it. Even though my report is the most comprehensive and well-documented
dossier on Accutane that I know of to date, I’m convinced other studies and information exists
out there but they’ve been suppressed. Independent studies must be immediately carried out in
order to confirm and verify Accutane’s mechanism of action, that is driving cells toward their
Hayflick Limit which I have discussed in-depth in this report, and research also needs to be
carried out on the dysfunctional vitamin A and retinoic acid metabolism in former Accutane
patients with chronic long-term side effects. People have a right to know how this drug has
altered their body down at the cellular level. I don’t know if an antidote or a medical treatment
exists that can counteract all of the permanent side effects caused by Accutane. There are some
treatments that can help certain specific side effects. But if the chronic side effects are indeed a
result of telomere shortening induced by Accutane, then these side effects will be permanent
unless somebody figures out a way to fix this one major component of the aging process. The
everlasting damage caused by Accutane is identifiable with current medical technology, and I’ve
provided some giant clues here in my report to point the scientists in the right direction. For
example, has anybody ever bothered to the check the chromosomes (including telomeres and
telomerase) before and after a course of Accutane? An enormous amount of research has been
devoted to studying vitamin D, another fat-soluble vitamin, which has turned out to be a very
safe and effective health enhancing supplement. Now the research ball definitely needs to get
rolling with Accutane and vitamin A but this research must not be carried out by Roche, because
as Congressman Bart Stupak has said many times and as their criminal history has demonstrated
over and over again, they cannot be trusted. A question that arises is what needs to happen to the
Roche executives and all the others who are mainly responsible for keeping this toxic crap on the
market all these years and handing it out to so many people. I have the answer and it’s simple.
Find them and throw their asses in jail. This should be a no-brainer because what they’ve done
with Accutane is 100 times worse than any financial crime ever committed by a corporate
executive. This is very serious business because we’re talking about people’s health and their
lives, not their retirement portfolio and personal financial assets. It’s time for Roche to be
criminally investigated for their unbelievable negligence and outrageous “off-label” promotion
of Accutane to millions of people with mild to moderate acne, the evidence is not that hard to
find. They are directly responsible for poisoning millions of acne patients with a powerful
chemotherapy drug, hiding the evidence of its life-altering dangers, not conducting any research
on its mechanism of action, and causing death and permanent injury to thousands of babies,
teenagers and young adults all over the world. Everybody is a victim of misinformation because
of them, which is why they deserve to be in jail, period. Or better yet, give them this choice.
They must choose one of two options. Option number one, they themselves take a 5 month
course of Accutane at 80 mg per day. Option number two, they spend the rest of their lives in
prison. If they think that Accutane is such a safe nonchalant simple drug that can be handed out
to perfectly healthy young people with only a few acne spots on their face or body, then they
should have no problem with picking option number one. But I can guarantee that unless they
are completely ignorant and oblivious to reality, every single one of them will steer clear of
option number one and take the prison time instead, because by having access to all the adverse
drug reaction reports, they know for a fact how incredibly devastating the permanent side effects
of Accutane can be and this is something they will avoid at all costs.
By: Nathan C. Carr SOURCE
Submitted To: Attorney Michael Hook, The Accutane Litigation Group
Date: June 2009
“Those who cannot remember the past are condemned to repeat it”
-George Santayana The Life of Reason
“Chronic cellular dehydration painfully and prematurely kills”
-F. Batmanghelidj, M.D. Your body’s Many Cries For Water
“We cannot allow the drug manufacturer and the FDA to continue to turn a blind eye to the lives
lost, families devastated and dreams dashed by an acne drug. The American people, our
children, are not collateral damage in the scheme of corporate profits! Accutane is a powerful
drug that can cause serious physical harm and death. With a drug like this on the market, it
needs to be carefully tracked and monitored to reduce the exposures to the drug’s harmful side
effects. Unfortunately, we can’t seem to rely on the FDA and the drug’s manufacturer to do the
right thing and implement such a plan.”
-Michigan Congressman Bart Stupak
“An ongoing human horror story surrounds Accutane, the vitamin A drug used to treat acne. An
untold number of Accutane users face life-long chronic side effects, and doctors offer no
solutions to these problems. But there is hope. Effective natural remedies for acne would
eliminate the appalling side effects of Accutane.”
– Bill Sardi, investigative health journalist
“I’ve always tried to explain it as controlled vitamin A poisoning, as the potential side effects are
similar to those that would occur if you took far too much oral vitamin A.”
-Dermadoctor.com
“Skin coming off whole body”
-Arctic explorer Sir Douglas Mawson, January, 1913
“We simply assume, that the doctors have personal responsibility. They are specialists, who
have the information either in their head or they know where to find it.”
-Andres Schneider, Swissmedic
“Micheal Benz was a 31 year old fire fighter who never had acne but was prescribed Accutane.
A tri-athlete, Michael cried out for help from his physician and was told to come back on
Monday. Micheal Benz drowned himself by weighting his body down with weight lifting plates.
The investigation into his death showed that he had logged onto an Accutane website the
weekend he died. As a fire fighter and an EMT, Michael Benz must have had some idea what
was happening to him. Still, he could not resist the sudden urge to take his own life.”
-United States Congress, Supplemental Review of Accutane Safety Issues
“The interesting thing about this drug it’s that it was never intended for something like clearing
up pimples. This was a drug that was intended for chemotherapy. Roche could not make enough
money with it just with chemotherapy, so they said: Let’s expand it. Let’s sell it to more people.
And they ended up selling it to people with acne. If you, today, were to ask Roche: Explain to
me what is the mechanism, the bio mechanism of this drug. You know what? They wouldn’t be
able to tell you. They don’t know. This drug has been on the market since 1982 and they have
not spent one dime, not one single dime, trying to figure out how it works, how it goes about
causing these side effects. You have 152, about 152 side effects. People would never make the
choice to use this drug. Never. Once they understand how dangerous it is, there’s no logic,
there’s no reasoning person that would say: I’m going to take Accutane to clear up pimples.”
-Mike Papantonio, pharmaceutical litigation attorney
“Sale of Accutane on the Internet should be immediately prohibited. Independent studies
urgently need to be carried out to establish exactly the mechanism by which this drug causes so
many side effects. An appropriate medical treatment, this is probably the most important, must
be devised to counteract the side effects and to provide treatment for the tens of thousands, if not
hundreds of thousands, of people who have suffered severe side effects from this drug.”
-Liam Grant, Ro/Accutane Action Group chairman
“Retinoic acid (active form of Accutane) induces differentiation and reduces proliferation of
stem and progenitor cells. It works on acne by inducing similar events in basal sebocytes. These
same actions also lead to 13-cis-retinoic’s (Accutane’s) side effects, and these are directed
towards proliferating cells in the adult such as in the skin, gut and bone. A wide ranging effect
of retinoic acid is to inhibit proliferation in dividing cells, and this accounts for its frequent
consideration as an anti-cancer agent.”
-James Crandall, Ph.D. UMASS Medical School Neuroscientist
“I believe I have discovered the elusive mechanism of action, which is down-regulation of the
telomerase enzyme leading to telomere shortening, growth arrest and cell death. In other words
the more Accutane you take, the more it increases your cellular turnover rate, driving the rapidly
multiplying cells in your body toward their Hayflick Limit.”
-Nathan Carr
“While there are many drugs that interfere with one or more aspects of sexuality while the user is
taking them, with one exception all of these problems resolve once the drug is discontinued. The
only drug that can permanently affect libido and sexual pleasure in some people is Accutane.”
-Kevin Pezzi, M.D. The Science of Sex
“After years of denials, Roche will at last be forced to accept responsibility for its actions and the
horrible illness its drug has burdened me with. While I am pleased with the jury’s verdict, it’s too
bad that Roche can’t give me my life back.”
-Jordan Speisman
If you were to ask random people what they know about Hoffmann-La Roche’s acne drug
Accutane, 80 % of them will have never heard of it, and the other 20 % will probably say “yeah
isn’t that the acne medication that causes birth defects and psychiatric side effects?” These
dangers are significant, but there’s definitely much more to Accutane’s rap sheet than just the
birth defects and psychiatric side effects. A quick glance over the Physician’s Desk Reference,
some websites, and its recent medication guide reveals that Accutane owns one of the most
extensive and hazardous side effect profiles of any drug ever approved by the FDA. This drug is
not being used by a limited number of patients with a life-threatening medical condition. After
25 years it’s still being handed out to thousands of healthy teenagers and young adults with a
benign harmless condition almost everybody acquires at some point early in their lives, mild to
moderate acne. Evidence has accumulated that Roche knew about many severe side effects
before Accutane was released onto the market in 1982, but it is only recently (2001) that the
FDA has forced them to create warning labels that accurately list these side effects. These
disclosures arrived too late for thousands of former Accutane users who are only now
discovering that the drug they trusted to help them overcome acne was affecting them in
dangerous ways. Very recently, some doctors are still withholding crucial information by not
giving their patients the medication guide or having them sign the informed consent forms, but
even these documents don’t list everything.
Since the information has managed to be suppressed so effectively, nobody knows the full story
behind this unique drug and what is currently happening with it, so I’ve created this
comprehensive report to blow the whistle because the time is now and long overdue. Accutane
is a toxic drug that has proven to be a massive public health threat. I believe I have discovered
Accutane’s mechanism of action and later I will lay my evidence on the table for everyone to
see. I’ve provided scientific studies to validate my hypothesis and I’ve used analogies and clear-
cut language to make the complex biology easy to understand. Reputable physicians have told
me that it sounds extremely promising as an explanation for the mechanism of action. Unless
somebody comes along and stops them, history reveals that Roche and certain dermatology
organizations will continue doing everything in their power to ensure Accutane stays on the
market and continue to needlessly poison the health of many teenagers and young adults with
mild to moderate acne. But I’ve put together the pieces of the puzzle and it is highly unlikely
Roche will be able to keep Accutane on the market after my report gets widely distributed out
into the open and the truth is finally brought to the surface. Many misinformed people, including
some dermatologists, make statements about Accutane that have absolutely no validity
whatsoever and they talk about it like it’s over-the-counter cough syrup. It’s not. It’s a very
dangerous and powerful chemotherapy drug that causes a long list of unpredictable serious side
effects and is only supposed to be prescribed to the small minority of individuals with severe
cystic acne all over their face and body. Somebody needed cut through all the BS that’s
constantly being promoted about Accutane being a safe miracle wonder drug, by presenting the
facts, and that somebody turned out to be me. If you are a teenager with any type of persistent
acne problem, don’t let your vanity cloud your rationality. There’s a trap waiting for you in the
dermatologist’s office. Let’s learn more about it.
Today, anybody that is scientifically savvy and abreast about Accutane knows it decreases
cellular proliferation everywhere across the board in the entire body; the skin, bone, digestive
system, mucous membranes, areas of the brain, and cancer, which is why it is used in
chemotherapy, but up until now, no one supposedly knows exactly how it causes reduced cell
division. All throughout the history of Accutane, Hoffmann-La Roche Pharmaceuticals has
continued to use the lame excuse in the Physician’s Desk Reference that “the exact mechanism
of action is unknown” which is their way of copping out by stating that they don’t understand
how the drug works to reduce acne or how it causes side effects. Liam Grant, the chairperson of
the Ro/Accutane Action Group, http://www.accutaneaction.com located overseas in the UK and
Ireland, explained Roche’s deceptive tactics very well at the FDA Meeting of the Dermatologic
and Ophthalmic Drugs Advisory Committee held on September 19th, 2000.
“Roche have stated publicly for the past 17 years in every country — because we followed the PR
statements from Roche and they’re all the same, and they haven’t changed, by the way, since
1983 — we do not know the mechanism by which this drug works. Therefore, there’s no proof
that Accutane causes depression or psychiatric disorders. And they have no shortage of medical
people and others who will go up with this statement. So, here we have a product. We know it
causes the side effects, but why do they cause them? Well, that’s not our problem. We don’t
know how it works. Therefore, don’t ask me about the psychiatric side effects and don’t ask me
about all the many, many, many physical side effects. The Ro/Accutane Action Group as an
organization now have to go out and are now spending our money because we know, of course,
that the mechanism can be determined.”
As Liam Grant just said, the mechanism of action can be determined. Roche has possessed this
technological capability for quite a long time, and it is entirely possible they already know the
mechanism but they just aren’t telling anybody because doing so would incriminate them. A few
organizations besides Roche have the technology needed to decipher Accutane’s mechanism of
action such as the Life Extension Foundation in Ft. Lauderdale, FL and the Linus Pauling
Institute at Oregon State University. But their expertise might not be needed because I believe I
have already discovered the mechanism of action. The smoking gun was published way back in
2001, and then buried away in the chemotherapy research archives, which is where I found it six
years later and connected the dots. But we’re talking about an acne medication, so why was I
searching through chemotherapy research for clues on how Accutane works? Because Accutane
is not technically an acne medication. Very few people know this. It was originally developed
to be a chemotherapy drug and is still used as chemotherapy today for various types of cancers.
It has powerful cellular proliferation reducing effects throughout the entire body, and acne
reducing skin dryness happens to be one of its side effects. While clinical trials were being
conducted in the 1970’s, the researchers noticed that their cancer patients were having their acne
cleared up during their chemotherapy. To make a long story short, this is when all logic and
common sense got thrown out the window and Accutane slowly became known as a popular
treatment for acne, not chemotherapy. At least the oncologists know what they’re dealing with
and counsel their patients thoroughly about the severe side effects when prescribing Accutane
and other retinoid drugs for cancer. The American Academy of Dermatology on the other hand
took the reckless approach when they decided that we don’t know how this toxic chemotherapy
drug works to reduce acne but we’ll go ahead and dish it out to millions of healthy young people
anyway.
During my in-depth investigation to expose the truth about Accutane, I was hard pressed to find
any genuine good news associated with it. The only two benefits of this drug are that it fights the
growth of cancer and it’s effective at clearing up the most severe forms of cystic acne, the kind
of acne so severe it leaves pot holes in the skin all across the body. For these people who
represent a small percentage of everyone with acne, Accutane can work well and produce a
favorable outcome when it’s used properly in low dosages. But on the other end of the spectrum
in terms of mild to moderate acne, which 90% of all Accutane prescriptions are given for, it’s
difficult to applaud the positive acne clearing aspects of Accutane when the drug is in actuality
just plain pure poison that causes side effects in 100 % of everyone who takes it. Everybody gets
dry/chapped/fissuring lips while on it which is a clear sign of vitamin A toxicity.
To all the teenagers and young adults reading this, remember that a little imperfection is just a
part of being human. If you have a few acne spots on your body, who cares? This sort of thing
tends to happen to the majority of everyone around this age because hormones are raging and
cells are extremely sensitive to testosterone and insulin. Don’t get all obsessive and let your
acne become a negative symbol of your body-image and self-esteem. If any of your friends are
offended by a few small acne spots, do yourself a favor and kick their shallow superficial asses
to the curb or show them this report to set them straight, I guarantee that their paradigm on acne
and skin health is completely misguided. For 25 years Hoffmann-La Roche has been taking
advantage of desperate, vulnerable and naïve teenagers such as yourself who just want to have
their acne gone once and for all. Don’t take Accutane and play pharmaceutical Russian roulette
with your life and long-term health because of measly mild to moderate acne. I know that it’s
tempting to give in when the almighty acne cure is being dangled in front of your face by the
dermatologist, while he or she is simultaneously telling you how great Accutane is based solely
on the information they’ve received from Roche. But it’s imperative for you to understand that
this s**t alters your DNA/gene expression and reduces stem cell proliferation throughout your
whole body (later on I will explain how it does this). Use safe alternative acne treatments
instead. There are several out there that work. Take the initiative, do your own research and
discover them for yourself. You don’t need to take Accutane for your mild to moderate acne,
because that would be like using rocket grenades to hunt birds perched on the roof of your house.
Before I launch into my explanation to deconstruct Accutane’s mechanism of action, I’m going
to provide detailed background information about the history, science, pharmacology and politics
of Accutane, vitamin A, and retinoids, including various relevant quotations from experts on this
topic as I go along. Accutane is a member of a family of compounds known as retinoids which
are related to vitamin A (Retinol). Manufactured by the Swiss pharmaceutical company
Hoffmann-La Roche, Accutane, also known as isotretinoin or 13-cis retinoic acid, is a synthetic
derivative of vitamin A with a chemical structure that is very similar to vitamin A. It works
against the millions of sebaceous glands all over the body, shrinking them and diminishing their
output. Because Accutane is one of the biologically active retinoids and is readily converted into
all-trans retinoic acid (the metabolic end stage retinoid), Accutane is estimated to be 100 times
more potent than dietary vitamin A, which is why the side effects of Accutane closely resemble
hypervitaminosis A or vitamin A toxicity. To corroborate, here’s another quote by Liam Grant
from his statement at the FDA Meeting of the Dermatologic and Ophthalmic Drugs Advisory
Committee held on September 19th, 2000.
“What is Accutane? Accutane is an analog of vitamin A. It’s likened to an overdose of vitamin
A. There are many published studies showing that excess vitamin A causes a condition known
as hypervitaminosis A. The study I mention here is a 1972 study, and it showed that the
ingestion of large amounts of vitamin A is known to cause depression and psychiatric illness. In
fact, we have also reports in the 1800’s and the early 1900’s of groups of people with high intake
of vitamin A in their diet which caused major depression and psychiatric illness. Therefore, the
manufacturers of Accutane, Roche, would have been able to predict with reasonable certainty the
main side effects caused by Accutane, including psychiatric side effects and teratogenicity
(causes birth defects). And that prediction could have been made with certainty prior to the drug
ever being launched here in the United States or in other countries.”
In case anyone hasn’t already noticed, the pharmaceutical companies are following directly in
the footsteps of the tobacco companies and the story behind Accutane is hands down the most
striking example of the unholy alliance between the pharmaceutical industry and their servant the
FDA. Nothing else like it has ever happened before, in fiction or in reality and some say the
drug has achieved the distinction of being the most dangerous product on the market for the last
25 years. Anybody who says that the introduction of Accutane into the marketplace “was a great
step forward in the treatment of acne” is extremely ignorant and has no idea what they are
talking about. Since this drug was approved by the FDA in 1982, its warning label has been
changed more than 50 times because of adverse reactions. The list of side effects and warnings
takes up 7 pages in the newly updated Physician’s Desk Reference. It’s among the top four
drugs that attract the most reported adverse drug reactions on the FDA’s database. Due to the
incidence of underreporting, the FDA estimates only about 1 to 10 percent of all side effects ever
get reported to the agency. Based on this info, one can only imagine how many serious side
effects have occurred because of Accutane that have never been reported to anyone. Even Roche
has admitted several years ago that there are over 40,000 Accutane adverse drug reaction reports
on the database at their headquarters in Basel, Switzerland. As of today 266 cases of suicide
have been reported to be caused by Accutane here in the United States, over 5000 psychiatric
adverse drug reactions have been reported to the FDA and remember these probably represent
only 1 to 10 percent of the actual number that have occurred. Since 1982, hundreds of deaths
other than suicide (strokes, heart attacks, Crohn’s disease, and several other causes) have been
recorded in the FDA’s adverse event reporting system. In the year 2007 alone, 430 cases of
inflammatory bowel disease and 22 deaths were reported in connection with Accutane.
According to the Ro/Accutane Action Group, http://www.accutaneaction.com (Roaccutane is
Accutane outside the United States) in August of 1997 the FDA issued a warning letter to
Roche for failing to submit serious adverse event and death reports in a timely manner. Roche
claimed that its computer systems were responsible for delays of up to eight years in complying
with the law. Despite all of the shocking adverse drug reaction reports, patients today are still
not being adequately warned by dermatologists about more than 150 different side effects this
drug can cause and about the possibility that some of these side effects might emerge years or
even decades after someone finishes a course of Accutane when it is too late to change their
mind. To put it bluntly, the FDA has never really done anything other than a slap on the hand to
punish Hoffmann-La Roche for their blatantly outrageous and murderous criminal behavior. For
over two decades they’ve followed their usual game plan of sticking their heads in the sand when
the s**t hits the fan and pretending like it never existed. In her report titled “Babies, Blemishes
and FDA: A History of Accutane Regulation in the United States” Julia Green from Harvard
Law School writes,
“In September 1983, the advocacy organization Public Citizen petitioned FDA to further adjust
the Accutane label. Public Citizen’s Health Research Group claimed that the drug’s warnings
were inadequate and consequently Accutane had been over-prescribed. The group demanded a
boxed warning describing the possibility of birth defects, spontaneous abortions, Crohn’s disease
and several other serious health problems. In addition, Public Citizen asked FDA to require
patient package inserts explaining the possible side-effects in non-technical language. FDA
declined Public Citizen’s requests.”
The greatest kept secret in all of journalism is that journalists are told by their bosses what they
can and can’t say. Nobody is telling me what I can and can’t say in this report, which is why
you’re able to read my unique perspective on Accutane that you won’t find anywhere else.
One of the major reasons why the evidence about its side effects has managed to be suppressed
for so long is because the mainstream broadcasting networks receive two thirds of their
advertising revenue directly from the pharmaceutical industry. And the fox has been guarding
the henhouse for a lot longer than people realize. In 1992, under pressure to get drugs passed
through the review pipeline quicker, with virtually no debate at all, Congress passed PDUFA (the
Prescription Drug User Fee Act) which basically made it so that the pharmaceutical companies
now pay the FDA “user fees” to review and approve their drugs, and these “user fees” account
for about 50 % of the FDA’s budget, a blatant and ridiculous conflict of interest.
FDA drug safety scientists like Dr. David Graham have recommended many times that Accutane
be removed from the market, but they are not the ones who call the final shots at the FDA
because they are not that high up in the chain of command. “You don’t get rewards for doing the
work that gets a drug taken off the market” Graham stated before a Senate committee on
November 18th, 2004. “I could have given a very mealy-mouthed statement, but then I would
have been part of the problem.”
“The FDA as currently configured is incapable of protecting America from unsafe drugs.”
Youtube.com Money Talks: Profits Before Patient Safety
“This 50-minute documentary was created to give an in-depth, academic perspective on the
questionable marketing tactics of the pharmaceutical industry, and features the commentary of
investigative journalists and medical professionals including Dr. John Abramson, author of
Overdosed America, and Prescription Access Litigation Project Director, Alex Sugerman-
Brozan. Other notable interviewees include Dr. Bob Goodman of Columbia University, founder
of the ‘No Free Lunch’ program, and Dr. Jerome Hoffmann of UCLA Medical School.”
Side Effects: Directed by Kathleen Slattery-Moschkau
BOSTON — A Boston University engineering professor has been found dead in a school lab.
A BU spokesman says the body of 62-year-old Franco Cerrina was found Monday morning in a fifth-floor lab at the Photonics Center, where the science and engineering of light are studied. The cause of death hasn’t been determined.
Investigators don’t suspect foul play. They’ve ruled out homicide.
Cerrina was a native of Italy. He joined the BU faculty in 2008 as chairman of the Electrical and Computer Engineering Department after spending 24 years at the University of Wisconsin-Madison. He held 16 patents and was described as a leading scholar in optics, lithography and nanotechnology.
BU spokesman Colin Riley calls the death a terrible loss for the university.
The Occupational Safety and Health Administration is investigating.
Linked In??
Read the Article of Natural News,Interesting Huh?
Natural News Bombshell: 2 Merck Insiders (Virologist Expert Scientists!) Say MERCK has been faking vaccine data for over a decade, spiking test samples with animal antibodies, and selling vaccines that cause the infection they are supposed to prevent. Doctor Wakefield, you can rest now.
Posted on June 28, 2012
MMR BOMBSHELL TO CLEAR NAME OF WAKEFIELD — Gardasil Next? SunBurn Syndrome Victims Suffer Terrible Pain!
Merck vaccine fraud exposed by two Merck virologists; company faked mumps vaccine efficacy results for over a decade, says lawsuit
Mike Adams
Natural News
June 28, 2012
Breaking news: According to two Merck scientists who filed a False Claims Act complaint in 2010 — a complaint which has just now been unsealed — vaccine manufacturer Merck knowingly falsified its mumps vaccine test data, spiked blood samples with animal antibodies, sold a vaccine that actually promoted mumps and measles outbreaks, and ripped off governments and consumers who bought the vaccine thinking it was “95% effective.”
According to Stephen Krahling and Joan Wlochowski, both former Merck virologists, the Merck company engaged in all the following behavior:
• Merck knowingly falsified its mumps vaccine test results to fabricate a “95% efficacy rate.”
• In order to do this, Merck spiked the blood test with animal antibodies in order to artificially inflate the appearance of immune system antibodies. As reported in CourthouseNews.com:
Merck also added animal antibodies to blood samples to achieve more favorable test results, though it knew that the human immune system would never produce such antibodies, and that the antibodies created a laboratory testing scenario that “did not in any way correspond to, correlate with, or represent real life … virus neutralization in vaccinated people,” according to the complaint. (http://www.courthousenews.com/2012/06/27/47851.htm)
• Merck then used the falsified trial results to swindle the U.S. government out of “hundreds of millions of dollars for a vaccine that does not provide adequate immunization.”
• Merck’s vaccine fraud has actually contributed to the continuation of mumps across America, causing more children to become infected with mumps. (Gee, really? This is what NaturalNews has been reporting for years… vaccines are actually formulated to keep the outbreaks going because it’s great for repeat business!)
• Merck used its false claims of “95 percent effectiveness” to monopolize the vaccine market and eliminate possible competitors.
• The Merck vaccine fraud has been going on since the late 1990′s, say the Merck virologists.
• Testing of Merck’s vaccine was never done against “real-world” mumps viruses in the wild. Instead, test results were simply falsified to achieve the desired outcome.
• This entire fraud took place “with the knowledge, authority and approval of Merck’s senior management.”
• Merck scientists “witnessed firsthand the improper testing and data falsification in which Merck engaged to artificially inflate the vaccine’s efficacy findings,” according to court documents (see below).
US government chose to ignore the 2010 False Claims Act!
Rather than taking action on this false claims act, the U.S. government simply ignored it, thereby protecting Merck’s market monopoly instead of properly serving justice. This demonstrates the conspiracy of fraud between the U.S. government, FDA regulators and the vaccine industry.
Chatom Primary Care sues Merck for Sherman Act monopolization, breach of warranty, violation of consumer protection laws
[Merck engaged in] …a decade-long scheme to falsify and misrepresent the true efficacy of its vaccine.
Merck fraudulently represented and continues to falsely represent in its labeling and elsewhere that its Mumps Vaccine has an efficacy rate of 95 percent of higher.
In reality, Merck knows and has taken affirmative steps to conceal — by using improper testing techniques and falsifying test data — that its Mumps Vaccine is, and has been since at least 1999, far less than 95 percent effective.
Merck designed a testing methodology that evaluated its vaccine against a less virulent strain of the mumps virus. After the results failed to yield Merck’s desired efficacy, Merck abandoned the methodology and concealed the study’s findings.
…incorporating the use of animal antibodies to artificially inflate the results…
…destroying evidence of the falsified data and then lying to an FDA investigator…
…threatened a virologist in Merck’s vaccine division with jail if he reported the fraud to the FDA…
…the ultimate victims here are the millions of children who every year are being injected with a mumps vaccine that is not providing them with an adequate level of protection. And while this is a disease that, according to the Centers for Disease Control (‘CDC’), was supposed to be eradicated by now, the failure in Merck’s vaccine has allowed this disease to linger, with significant outbreaks continuing to occur.
Chatom Primary Care also alleges that the fraudulent Merck vaccine contributed to the 2006 mumps outbreak in the Midwest, and a 2009 outbreak elsewhere. It says, “there has remained a significant risk of a resurgence of mumps outbreaks…”
This investigation is only beginning
NaturalNews has only begun to investigate this incredible breaking news about Merck and the vaccine industry. We are pouring through the court documents to identify additional information that may be relevant to this case, and we plan to bring you that information soon.
For the record, Merck denies all allegations. Is anyone surprised?
1. ADHD and Drugs for Pediatric ‘Psychopathologies’
Thanks to Pharma’s “diagnose early” and screening campaigns, millions of children are treated with stimulants for ADHD and antipsychotics for bipolar disorder and assorted conduct, oppositional defiant, development disorders and “spectrums” today. No wonder Michael Bandick, brand manager for Eli Lilly’s popular antipsychotic Zyprexa, called it ” the molecule that keeps on giving ” at a national sales meeting.
But giving kids daily drugs creates two problems. First, parents will never know if their kids would have outgrown their conditions, and second, it’s unlikely they’ll ever get “clean.” In fact, Pharma marketers worry about the revenue threat of kids going off their meds when they leave home and even run an ad campaigns in college newspapers to keep them on. One ad shows the lead singer of Maroon 5, declaring, “I remember being the kid with ADHD. Truth is, I still have it.”
The ad’s tag line reads, “It’s Your ADHD. Own It.”
2. Hormone Replacement Therapy
When the popular HRT pill Prempro was launched by Wyeth, now Pfizer, in the 1980s, then-CEO Bob Essner told sales associates, “We can make real the full promise of HRT to create in the near future a world where the majority of women will start HRT at menopause and continue on it for the rest of their lives,” reports Philadelphia magazine. The scheme of treating estrogen “deficiency” for 30 or 40 years worked until 2002 when HRT was found to cause breast cancer, heart attacks, strokes, blood clots and dementia. They were some of the conditions it was supposed to prevent. Oops. But Pharma has not abandoned the billion-dollar franchise and news about estrogen benefits is creeping back into the news, predicated on the public’s short memory. People don’t lose hormones because they age; they age because they lose hormones, say Pharma hormone sellers. Even men now “suffer from” testosterone deficiencies or Low T.
3. Happy Pills
Pharma’s success in convincing people with anxiety or the “blues” that they need an antidepressant was a Wall Street coup. Instead of taking the occasional Xanax, people agreed to alter their entire body chemistry with a drug they took for months, years or decades.
But as antidepressants fall in popularity, because of their many side effects, including alarming “discontinuation symptoms” when people try to stop, WebMD is conducting damage control to keep people on them. Don’t believe that antidepressants turn “you into a zombie,” make you gain weight, ruin your sex life, make you “forget your problems rather than dealing with them” or cost too much, says the huge pro-pill Web site in one article. Depression is linked to heart disease, obesity, diabetes, Alzheimer’s and cancer says a second WebMD article . Stay on your meds.
4. Proton Pump Inhibitors (PPIs)
Some say gastroesophageal reflux disease (GERD) is just lowly “heartburn” whipped up by Pharma into a profitable disease. But over 110 million prescriptions were written for proton pump inhibitors (PPIs) like Nexium and Prevacid in 2009, making it the third most prescribed class of drugs. Long-term use of PPIs increases the risk of hip, wrist and spine fractures, the FDA warns and the drugs can cause potentially lethal C. difficile-caused diarrhea and community-acquired pneumonia says national health advocacy group, Public Citizen. But Pharma has a different message. GERD can lead to esophageal inflammation , scar tissue and cancer, if untreated, it tells patients and symptoms won’t go away on their own. No wonder doctors call PPIs “Purple Crack.”
5. Statins
The best-selling statin drugs like Lipitor and Crestor that lower their cholesterol risks are pretty much the definition of “lifer medications,” taken in perpetuity. Who would dare to go off of them and risk cardiovascular events?
One patient on a cholesterol drug site writes that despite feeling “miserable” on statins, “What do you do? Go off the statins and let your arteries clog up?” But medical professionals say it is not safe to stay on statins indefinitely. Patients are at risk of liver dysfunction, acute kidney failure, cataracts and muscle damage known as myopathy, reports British Medical Journal . And statins can also cause memory loss and increase the risk of developing of Type 2 diabetes and muscle damage, FDA warns .
Still the appeal of a drug that lowers the risk of cardiovascular events without a change in diet or lifestyle made Lipitor the top-selling drug in the world, until recently, when its patent expired. Statins are now prescribed for kids, for the same reason.
6. Asthma-Control Medicines
Like ADHD and “pediatric psychopathology” drugs, Pharma conducts aggressive early treatment campaigns for asthma drugs, recommending that children as young as one year be treated when “symptoms” first emerge. (“Before they go away,” says one cynical doctor.)
It has also marketed daily asthma “control” medicines like Advair and Symbicort so aggressively (prescription drugs added onto patients’ regular asthma medicine — ka-ching) that nearly two-thirds of the nation’s millions of asthma sufferers take them. Despite the expense of adding an additional drug to rescue inhalers or inhaled corticosteroids when asthma is a lifelong disease, there are no clinical benefits to the upsell, says the research institute of Medco, the nation’s largest pharmacy benefit manager. Neither trips to the ER or hospitalizations are reduced with control drugs. And there’s another mark against the daily drugs that don’t work: they may make asthma worse says some published reports. Source
Here’s a report on the FDA that could only come from outside the United States. I’m reading to you from The Independent, a British newspaper, that says, “Vital data on prescription medication found in millions of British homes has been suppressed by the powerful U.S. drug regulators, even though the information could potentially save lives.” An investigation by The Independent states that, under pressure from the pharmaceutical industry, the American Food and Drug Administration routinely conceals information it considers commercially sensitive, leaving medical specialists unable to assess the true risks.
This no surprise to those who are regular readers of this site, but to a lot of consumers in the United States, it is a big surprise. They can’t believe that the Food and Drug Administration would censor and suppress drug safety information. They think the FDA is looking out to protect them. The heroic FDA, protecting American consumers from greedy drug companies selling dangerous drugs, putting public safety first and corporate profits last. Of course, that’s all a myth.
The real FDA: Profits first, safety last
Here’s the real FDA, in my view: Colluding with drug companies, suppressing clinical trial data, covering up the truth about dangerous prescription drugs, refusing to pull drugs off the market even though they are literally killing hundreds of thousands of Americans. The FDA: Censoring its own drug safety scientists to make sure they don’t go public with their information about how dangerous these drugs are. The FDA: Under the table deals with drug companies? Maybe. Lots of political influence with the leaders of drug companies? Probably. Covering up facts about the dangers of prescription drugs? Most definitely. Absolutely. Without question.
This is the FDA that we have here in the United States, running the drug industry. Running it! The FDA that tries to create a monopoly drug market in this country by banning the import of generic prescription drugs from elsewhere around the world. This is an agency that has attempted again and again to discredit Chinese medicine, nutritional supplements, herbal medicine and anything that would compete with prescription drugs. It has sought to outlaw these natural substances and herbs that have been proven healers for literally 2,000 years in the history of medicine. This is the FDA that has put drug profits first, and public safety last, time and time again.
This is the agency that rigs its own safety panels. “Oh, is there a dangerous drug out there? Let’s have a panel and a hearing. Let’s rig the hearing with decision makers who are paid by pharmaceutical companies. They’re the ones who will get to vote.” Wow, what a big surprise. They all voted to make the drug legal again. That’s what happened with Vioxx. Oh, it only killed 50,000 or 60,000 people. “Ahh, that’s just a side effect,” they said, and the panel voted to put it back on the market. “It’s safe enough for us. We’re the FDA.” Apparently, a drug has to kill more than 60,000 people to be considered dangerous.
Does it have to kill half a million people to be pulled by the FDA? How many Americans have to die before the FDA says, “This is a dangerous drug. Maybe it shouldn’t be on the market?” How many children have to be doped up on antidepressants, committing suicide and shooting each other in public schools before the FDA says, “Well, maybe children shouldn’t be on these dangerous drugs that alter brain chemistry?” Think about this.
How many senior citizens have to die of gastrointestinal bleeding from the consumption of nonsteroidal anti-inflammatory drugs (NSAIDs) before the FDA will say, “Gee, maybe they should have a warning on them?” How many people have to die in this country before the FDA will stand up and do its job? When will the American people start listening?
You know, everywhere else around the world, the FDA is a complete joke. Here’s The Independent in the U.K., doing a report on the FDA that you probably would never see in the United States. Why not? Because the mass media apologizes for the drug industry, and most of the media outlets in this country are funded by drug money. Look at any magazine, newspaper, or cable news program, and what do you see? Drug ads. Those ads are paying the salaries of the very people who decide what’s news and what isn’t.
Drugs, drugs everywhere
Have you picked up a magazine lately? Have you picked up any of those news magazines on the newsstands? Have you picked up a medical journal? Did you notice that they’re 50 percent drug ads? There’s hardly any news in the news magazines at all. The news that you find is highly censored and edited. Much of the bad news about drugs is suppressed.
Have you looked around your local community lately? Did you notice how many pharmacies are being constructed? There’s a drug store on every corner, it seems. Even grocery stores are building pharmacies like mad. Everyone wants to get in the drug business all of a sudden. It’s like we have a country of drug pushers, drug runners, drug retailers, drug manufacturers and drug apologizers. And who’s the Al Capone running the drug racket? The FDA, of course.
And then we have this “War on drugs,” which does really important things like outlawing hemp. Oh yes, hemp is so dangerous. My God, you can make paper with it! It’s so dangerous, this hemp. You can make a pair of jeans out of hemp. You can make sails for ships out of hemp, as some history buffs know. You can make car bumpers out of hemp and recyclable car parts. You can make biodiesel out of hemp. Oh, you can make a lot of things out of hemp, including highly nutritious hemp seeds, loaded with omega-3 fatty acids, outstanding for health and human nutrition. The one thing you can’t do with hemp is get high from smoking it. The THC content is so low in industrial hemp that you’d have to smoke a hundred pounds of hemp just to feel anything resembling a buzz. And yet we have to outlaw hemp in this country because we’re fighting “the war on drugs!” Meanwhile, the real drug threat is prescription drugs. They’re the 4th leading cause of death in this country. And they remain perfectly legal. Hmmm… are the politicians smoking crack?
America is a drug nation
The FDA: The Fraud and Drug Administration. Making sure everyone in America has the right to keep on buying, selling and consuming drugs. I remember we used to have a society in which Nancy Regan would teach children to say, “Just say no to drugs.” We used to have signs in front of our schools that said, “This is a drug-free zone.” In fact, we still have some of these signs, but if you walk past these signs and walk into the school, you find out that as many as 30 to 40 percent of these children are on drugs. They’re on powerful narcotics that have been prescribed to them by doctors, psychiatrists and school counselors, and pushed onto them by school administrators and parents who are cowering in fear over what might happen if their little Johnny doesn’t stop being so hyper. We’ve got to put them on drugs! It’s a drug nation; a pharmaceutical factory. We have so many kids on drugs that they’ve actually made it illegal not to put your kids on drugs!
There’s a family that fought child protective services authorities because they didn’t want to put their daughter on chemotherapy drugs. They wanted to treat their daughter naturally, with their own method of healing. But the state said, “No, you can’t do that. We’re going to force your child to be poisoned with chemotherapeutic agents that generate profits for prescription drug companies… chemical agents that don’t have any sort of documented benefit for enhancing the lifespan of kids or adult patients, and yet are used by every oncologist in the country. We’re going to force these drugs into the body and bloodstream of your daughter. We’re going to take your daughter away from you.” And they did. That’s how drugged up we are in this nation. We’ve made drugs mandatory.
We’re drugging each other, and when we refuse to be drugged, we invoke the law and steal children from parents and put people in jail; yet, you still can’t grow hemp. Oh no, hemp’s dangerous. Oh boy, what would happen if everyone grew hemp? Gee, let’s see, you’d have a huge multi-billion dollar industry for American farmers. Wouldn’t that be terrible? Let’s see, you’d have a renewable energy source, you’d have a crop that’s good for the environment, a crop that doesn’t need to be grown with pesticides or herbicides. Wouldn’t that be terrible? To re-invigorate the whole farming industry in this country? Gotta outlaw hemp, but keep those drugs pumping.
Keep that drug economy pumping!
Keep that drug industry legal. Keep on poisoning the hearts, minds, bodies and nervous systems of all the people in this country. You’ve got to keep them on drugs. Why? Well, drugs are profitable. We’re all invested in the drug companies. Gee, if the drug companies weren’t making money, people wouldn’t have their retirement portfolios, so you sure don’t want to do anything that would harm the drug companies. You gotta keep everything moving along. That’s what the Fraud and Drug Administration helps do: Keep it all pumping right along and keep those drugs coursing through the veins of our people.
How many drugs? So many that you can now find traces of these drugs in the public water supplies. If you put a little drug sensor at the end of the Mississippi river where it empties into the Gulf of Mexico, you can find drugs – prescription drugs – just coming right on down the river. Here they come! We could bottle these up and sell them back to the same people who took them once already. These drugs are, of course, killing the oceans, the coral reefs and the ocean life in the Gulf of Mexico. The Gulf of Mexico is half dead now, which is better than the American population, which is half brain dead. We’re all on statin and antidepressant drugs and other kinds of prescription drugs that basically sap our cognitive ability, sap our lucidity and take away our ability to think clearly about issues like health.
Information suppression and other tricks of the FDA’s trade
Now, getting back to the report by The Independent, one team of investigators found that 28 pages of data had been removed from the FDA files on a new family of painkillers because of what? Confidentiality. It’s a trade secret. That’s how the FDA covers up negative information. “Gee, did the study show that 10 percent of the people died from heart attacks? Don’t worry. We can just call it a trade secret. Then we’ll take it out of the official report. No one will know.”
Information about cox-2 inhibitors has been suppressed. One of the Swiss investigators, Dr. Peter Juni, who helped expose the risks of these drugs, claims the FDA obstructed his efforts. We all know about the suppression of Dr. David Graham’s testimony by the FDA, and how he had been threatened in a variety of ways to make sure that he wouldn’t go public with his information. Finally, he was able to testify before Congress, something the FDA certainly did not like. And this is a guy who works there.
There is another guy, Dr. Andrew Mosholder, an expert at the FDA’s Office of Drug Safety, who presented an analysis of 22 different studies on more than 4,000 children, covering nine antidepressants. He found that the risk of suicide-related events was twice that of children given a placebo. For those who can’t do the math, that’s a 200 percent increase, or twice the chance. That’s a tremendous increase in the risk of suicide-related events for taking these drugs.
The FDA is committing crimes against humanity
Keep on dosing these children. That’s right, call it a brain chemistry imbalance and put those kids on drugs. It’s not like children need to do things like play outdoors. It’s not like they need physical exercise and sunshine. It’s not like they need healthy school lunches or good nutrition. It’s not like they need any of that. What they need is drugs. Clearly. The evidence shows it; this is medical science here, and this is clinically proven stuff. This is rational medicine; this is scientifically based.
Oh yeah, we have a bunch of people with a bunch of initials after their names (also known as “psychiatrists”), and they say, “Give the kids more drugs.” That’s what’s happening in the country today. There doesn’t seem to be any end in sight. Now, all of this just confirms what I’ve been saying about the FDA all along. While some people are out there talking about, “Let’s reform the FDA,” my view continues to be, “Let’s arrest the FDA.” Let’s make some arrests. Let’s get some criminal convictions of these people, because in my view they are committing crimes against humanity.
That’s what’s really going on here. Crimes against humanity. These are not small violations of local law. This is not some guy at WorldCom fixing the numbers to move a couple of billion dollars into his private bank account. These are bureaucrats, decision makers, even politicians, who have been given the responsibility of protecting the public and who have sold out that responsibility. They have sold their souls in exchange for whatever money or power they’re receiving from the drug industry. They have sold out.
The drugging of our children is a chemical holocaust
Do you know who’s paying the price? Our children — the health and the minds of our children. And the rest of the population too, you name it: Adults, senior citizens, expectant mothers – forty percent of our nation is now on prescription drugs. It is unprecedented in the history of the world. The level of corruption and the number of criminals now running our health care system is unprecedented in the history of the world. These are criminals who need to be arrested. Someone in a position of authority – someone like the Attorney General – needs to run in there and make some arrests.
Set an example that says, “Hey, you know what? You cannot conduct this kind of chemical holocaust on the children of our nation and get away with it. You can’t do this in America.” America is the land of the free, the home of the brave and a country where we’re supposed to understand what justice is all about and where we fought for freedom, they say. Freedom of what? Freedom to keep dosing our children on prescription drugs? No! I say we have the freedom to know the truth about the drug companies.
The only freedoms we’re really fighting for are freedoms like the one I’m exercising here, freedom of speech. This is the one freedom that is the most powerful of all, because it is the freedom that can protect all the other freedoms, and, ultimately, our children. It can protect us from the criminals running our nation. Criminals like those at the FDA.
Legalize hemp and make long-term prescription drug use illegal
Now, if we had honest leaders in this country, prescription drugs would be illegal, at least for long-term use, and hemp would be legal. We could grow hemp for industrial use. Create new revenues streams for farmers. Grow our own biodiesel and reduce our need to import foreign oil.
At the same time, we need to outlaw many prescription drugs, especially for long-term use. We need to outlaw, for one thing, the use of these drugs in children. Instead of doing the responsible thing of addressing children’s nutritional habits, of taking junk foods out of schools, banning the advertising of soft drinks, junk foods and sugar cereals to children, instead of giving them some recess time, what do we do? We drug them. We say, “Oh, well, they just have some brain chemistry imbalance,” and we dose them full of drugs.
That is not an answer to the problems of our nation. We need to ban these drugs; we need to outlaw them. And we need to arrest these criminals at the FDA and the criminals at the top of these drug companies who are allowing this to happen; in fact, they’re pushing for it. They’re devising new ways to drug more and more people with more and more prescription drugs as the years go by. They’re actually fabricating new diseases and finding ways to convince people they are “afflicted” with completely fictitious disorders like “Social Anxiety Disorder” or “Premenstrual Dysphoric Disorder.”
Drug companies can’t wait for the coming wave of Alzheimer’s patients. They just drool over the diabetes numbers, because more and more American citizens are gong to be diabetic in the years ahead. That has them patting themselves on the back, rubbing their hands in greed, “Oh, can’t wait for those diabetes people. They’re going to need a lot of drugs for that.”
The medical destruction of the USA
Something has got to change around here. And it may be too late. It really may be, because our nation is destroying itself. It’s drugging itself into oblivion, and, all the while, spending more money than it has available. We’re spending ourselves into medical bankruptcy – all the while hiding behind this illusion of so-called science-based medicine.
We are missing out on a huge opportunity to do something productive; something like teaching expectant mothers how to have healthy babies through nutrition or teaching superlearning strategies all children that involve new learning technologies. We are missing the opportunity to combine that with outstanding nutrition and the mass consumption of essential fatty acids that are absolutely crucial for healthy brain development development.
Our medical system had a great opportunity, a golden opportunity to do something really helpful for humanity, and they flushed it away out of a quest for profits. The Fraud and Drug Administration stands at the top of this pyramid of control, pulling the strings and making sure the Drug Empire continues to tighten its iron grip. And it has happened. More people are taking drugs. Drugs are more and more profitable, dangerous drugs are not removed from the market and Americans have few alternative choices. That’s what’s happening today, and if you aren’t outraged by it, then you are not aware of what’s going on.
America has been conned by the FDA
If you think all these drugs are medically justified, you’ve been conned. If you think doctors have been trained on how to help people be healthy, then you’ve been fooled. These drugs haven’t been proven safe, and the FDA is not looking out for the public safety. Just like every other American out there, you’ve been conned. And the whole world is laughing at us; that is, when we’re not bombing them.
So, I just have one question from all of this: for how long will the American people allow this to continue? I’m really curious because I want to know. Will the people continue to allow their children and their senior citizens to be drugged? Will they continue to allow drug companies to extract more and more dollars from their pockets and leave them in financial ruin? Is this what people are going to allow to continue happening in this country?
Because maybe the answer is they’ll allow it forever. Maybe they’ll never be the wiser. Keep on eating those processed foods, those junk foods, those restaurant foods, all those unhealthy, toxic, disease-causing ingredients. Keep on buying those personal care products, coating your hair in cancer-causing ingredients, coloring your hair with cancer-causing solvents. That’s right. Keep on drinking all that alcohol, smoking all those cigarettes, watching that prime-time television sitcom to distract yourself from the crumbling of our nation that’s happening all around you this very minute. We’ve got to keep people distracted. Maybe they won’t notice.
Keep them drugged up. They’ll just keep on working, because somebody’s got to pay for all this, right? Somebody’s got to foot the bill. And the person footing the bill is, of course, Joe Public. Nearly every American consumer out there is writing a check to the drug companies right now, and saying, “Keep on drugging me, my children and my parents in the nursing home. I’m going to keep writing you checks until I have no more money left. I’m going to keep on writing them anyway after that, and put myself in medical bankruptcy, just to stay addicted to these prescription and over-the-counter drugs.” That’s what Americans are saying right now.
And the FDA must be standing back watching, laughing its head off, thinking, “Wow, it worked.” It’s what they must be thinking right now. “I can’t believe we pulled this off! They bought it. Can you believe it? These people are suckers, they bought it!”
And by the way, there’s another new disease out there that’s very dangerous to your health. It’s called “Conventional Medicine Belief Disorder” (CMBD) and its primary symptom is an irrational belief in a system of medicine that has nothing to do with promoting health. The cure for CMBD isn’t a drug, it’s an ANTI-drug. What is the ANTI-drug? That will be revealed in a later article. But here’s a hint: you don’t need a prescription to get it. Thanks for tuning in to this commentary.
Is someone you know or love, dying… because the FDA won’t let them have the CURE???
The answer is probably yes!
The FDA and Big Pharma are Killing Us!
It’s happening! See from Forbes Magazine…
“Approve a medication that has an unintended side effect and congressional headline-seekers will be giving officials the third degree. Better to let people die by depriving them of new medicines than to be excoriated by congress“.
* Should Americans die because FDA officials don’t want to be embarrassed?
* Should people die because the FDA has made it so expensive to get FDA approval, that if a cure is not guaranteed to make BILLIONS, it will never make it to market? No matter the benefit, because of the FDA, we can’t have it! Does this make any sense?
The situation is so bad that one doctor that has actually cured many cancers (the FDA even acknowledged it), was prosecuted, for doing so!
The situation is crazy! But it can’t and won’t change unless the public is made aware!
FOR THE SAKE OF THE PEOPLE YOU LOVE, for the your future health and that of your loved ones… SHARE THIS!
This insanity must be stoppled! There are cures that are in existence that we can’t have. Even if you or you children don’t neeed them today…someday they will! If we want them to be availble when we need them, we better start doing something about it, Right Now! It has to start somewhere… why not us?… why not today? Share This!
The following videos are just a couple of exaples of what is being denied to the public.
MORE MEDICINAL OPTIONS? How the FDA Kills Us!
The FDA in conjunction with big pharma has a stranglehold on research and future drug patents. The profit motive combined with the total cowding out of competition guarantess corporate profits and fewer cures!
If you are not big Pharma, you can’t even get to clinical trial.
Big pharma suggested and FDA agreed to require fees just to apply for a trial. It provides the FDA with almost $600 million a year, about half of it’s budget. This puts the FDA on the payroll of the industry it regulates. The FDA now operates as if the customers are the Drug companies, rather than the consumer. What a great way to keep out competition and influence the decisions of the FDA.
Trials often last 5 to 10 years or more and cost upwards of Five Hundred Million to complete. If you don’t have $500 million, let alone have the ability to risk $500 million, no matter how great the medication, you won’t get to trial… UNLESS, you partner up with Big Pharma (another way they control the industry).
Natural Remedies- You can’t patent a nutrient or vitamin and you can’t advertise anything as a cure (even if it is), for anything without FDA approval, which you can’t get for under $500 million. Then, once you get the approval, you can’t profit from it because it is an unpatentable natural product. The result is that if it’s not a drug that can be patented, it will NEVER get FDA approval and therefore, it will never be allowed to be advertised and used for a cure… even if it works!
Whether by design or accident, no cures can be offered to the consumer unless it’s controlled by big pharma through the FDA.. Is this killing us?
It Can’t Be That Bad?
If you came up with a therapy or even CURE for cancer that was head and shoulders more effective than any other approved therapy, you’d get rich right? The world would sing your praises, buildings and towns would be named after you… right?
WRONG!
see the cure for cancer…
specifically 39 minutes into the film.
It happened. A dramatic improvement in treatment (for many, an outright cure that most still have not heard about), was discovered that resulted in complete remission in MANY patients, a much higher remission and cure rate than with any FDA approved treatments… and there were absolutely no side affects. So what did the FDA do in conjunction with the National Cancer Institute? What did our government do? Focus on this fabulous life saving breakthrough, right? Not exactly. They fought it all the way. Put up road blocks, prosecuted the Doctor that made the discovery, tried to destroy him, embroiled him in specious legal battles while surreptitiously partnering with a dishonest associate of the inventing doctor. They, started a “new” company and attempted to steal the patents on it.
FDA Mandates Death?
Assume you are dying, there is no FDA approved cure but there is a new treatment, unapproved but with promising results. If you take it, you might live. You also might die. If you don’t take it, you die. PERIOD.
Thousands, if not, millions face this heart wrenching choice every year. Take the experimental drug and possibly live or maybe die… or DON’T take that chance face an inevitable death because nothing else has a chance.
Most any sane person would choose to take the gamble. Nothing to lose a new life to gain. The problem is, They don’t have that choice. Without FDA approval, even if you want to take that chance, you can’t. If the doctor or practitioner gives you the treatment, they will be put in prison. So your only choice is to die!
Isn’t it your body? Isn’t that what we always hear? Our body, our choice, except when it comes to an incurable disease? Then our only choice is to die??? What are they afraid of? If you don’t take it, you WILL die, If you DO take it you might die but might live?
Cancer and Statins comprise a huge medical industry.
Just as with all other things, when big money is involved, ethics go out the window… people re dying because of it.
[Video]
In the Video you will listen that the USA government and the FDA allowed Bayer to dump the infected vaccines in Spain,France & rest of Europe,South America & Japan
Bayer Sells AIDS-Infected Drug Banned in U.S. in Europe, Asia – Unearthed documents show that the drug company Bayer sold millions of dollars worth of an injectable blood-clotting medicine — Factor VIII concentrate, intended for hemophiliacs — to Asian, Latin American, and some European countries in the mid-1980s, although they knew that it was tainted with AIDS. Bayer knew about the fact that the drug was tainted and told the FDA to keep things under wraps while they made a profit off of a drug that infected its patients. If these allegations are true, then both Bayer and the FDA are at fault for this catastrophe. FDA regulators helped to keep the continued sales hidden, asking the company that the problem be ”quietly solved without alerting the Congress, the medical community and the public,” according to the minutes of a 1985 meeting
CRIME DOES NOT PAY... PLUS, THE BUTLER DID IT! AND REMEMBER: WHAT DOESN'T KILL YOU, WILL -MOST LIKELY- TRY AGAIN... AND DON'T FORGET: TODAY IS A GOOD DAY FOR SOMEONE ELSE TO DIE.
1rex22
Insomniacs II 