Hoffmann – LaRoche Crimes :Selling Chemo Drugs As Acne Treatment

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.”

http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3639t2.rtf

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.”

http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3639t2.rtf

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.

http://www.druglib.com/adverse-reactions_side-effects/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.”

http://leda.law.harvard.edu/leda/data/472/Green.html

A very comprehensive but still incomplete list of Accutane’s side effects

http://accutane.poweradvocates.com/accutane_side_effects.html

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.”

Forbes.com Face of the Year: David Graham

http://www.forbes.com/2004/12/13/cx_mh_1213faceoftheyear.html

NaturalNews.com The FDA Exposed: An Interview with Dr. David Graham

http://www.naturalnews.com/011401.html

Mercola.com Secrets of the FDA Revealed by Top Insider Doctor

http://articles.mercola.com/sites/articles/archive/2005/08/13/secrets-of-the-fda-revealed-by-top-insider-doctor.aspx

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

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