Hoffmann – LaRoche Crimes :Killing People With An ANTI Acne Treatment Part II

 

SOURCE

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

http://articles.mercola.com/sites/articles/archive/2009/02/02/here-s-your-chance-to-change-the-fda-i-need-your-help-on-this-one.aspx

Simple Ways to Stop Acne Naturally

http://articles.mercola.com//sites/articles/archive/2009/03/28/Simple-Ways-to-Stop-Acne-Naturally.aspx

Natural Acne Solutions

http://www.natural-acne-solution.com/accutane-side-effects.html

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.”

http://www.accutaneaction.com/Hearings/transcripts.htm

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.

http://www.naturalhealthlibrarian.com/

“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.”

http://www.accutaneaction.com/Studies/index.html

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

http://www.biochemj.org/bj/037/0166/0370166.pdf

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

http://www.americantherapeutics.com/pt/re/ajt/abstract.00045391-200411000-00015.htm;jsessionid=JJ7HJGPKtBtS90xJTWXtLfvtd8QRWpTYzr2Hl8vJpgXZkcnwQN1Q!-450575803!181195629!8091!-1

Hypervitaminosis A and Fractures

http://content.nejm.org/cgi/content/short/348/4/347

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.

Man’s best friend?

http://archive.student.bmj.com/issues/02/05/life/158.php

Vitamin A and Sir Douglas Mawson

http://www.pubmedcentral.nih.gov/pagerender.fcgi?artid=1602734&pageindex=1#page

Acne drug has serious side effects

http://www.cbc.ca/marketplace/pre-2007/files/health/accutane/index.html

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.”

http://www.accutaneaction.com/Hearings/transcripts.htm

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.”

http://www.house.gov/stupak/accutane/p3_21.pdf

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

http://suicideandmentalhealthassociationinternational.org/acba.html

Part 2

http://suicideandmentalhealthassociationinternational.org/acba1.html

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

http://cbs2chicago.com/local/Dr.David.Cornbleet.2.339075.html

Confessed murderer’s father talks about drug’s effects

http://abclocal.go.com/wls/story?section=local&id=5697503

Accused Killer’s Dad: Slain Doctor Partly To Blame

http://www.nbc5.com/news/14291306/detail.html

Murder suspect may have believed doctor made him impotent

http://www.beforeyoutakethatpill.com/papers/accutane.txt

Suspect in doctor’s murder to be tried on island

http://abclocal.go.com/wls/story?section=local&id=5612206

Dateline NBC: In murder case, a French disconnection

http://www.msnbc.msn.com/id/23578261/

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

http://drtompeterson.blogspot.com/

Another recent murder involving Accutane
Monroeville Man to Stand Trial in Fatal Cheerleader Stabbing

http://www.foxnews.com/story/0,2933,296873,00.html

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

http://www.lawyersandsettlements.com/articles/00299/Accutane_Profits.html

“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.”

FDA Needs To Ban Accutane

http://usa.mediamonitors.net/content/view/full/35718

http://www.lawyersandsettlements.com/articles/00334/Accutane_Ban.html

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.”

http://www.drugawareness.org/Archives/1stQtr_2003/record0025.html

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)”

http://www.accutaneaction.com and http://www.ragforum.com (this is the web address to the old forum)

Why weren’t we told about this acne drug

http://www.healthy.net/scr/article.asp?Id=3401

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.”

https://www.dermadoctor.com/pages/newsletter96.asp?WID=%7B8D162C43-114F-491A-A6F4-4E4057D8F8C3%7D

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$$$”

http://www.geocities.com/HotSprings/Spa/2738/january00.html

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

http://folk.uio.no/runeb/pdf%20filer/Vitamin%20A%20toxicity.PDF

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.”

Senator: GIs Got Brain Damage From Malaria Drug

http://www.yourlawyer.com/articles/read/8121

“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.”

Suit: Lariam drugmaker hid side effects

http://www.aaconsult.com/lariam/lariam_news_31.html

“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.”

Harmful Side Effects of Lariam

http://transcripts.cnn.com/TRANSCRIPTS/0405/26/i_ins.00.html

“’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.”

Lariam’s Legacy

http://home.att.net/~kjo/lariam2.htm

“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.”

7 servicemembers ‘likely’ ill from malaria drug

http://www.estripes.com/article.asp?section=104&article=21624&archive=true

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.”

http://www.accutaneaction.com/Frauds/roche_finc_frauds.html

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

http://www.nd.edu/~mgrecon/datafiles/articles/vitamins.html

“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.”

Firms Admit To Price Fixing

http://www.lubbockonline.com/stories/052199/bus_0521990021.shtml

“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.’

http://query.nytimes.com/gst/fullpage.html?res=9900E1DB1131F933A25753C1A96F958260&sec=health&spon=&pagewanted=all

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.”

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

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,

http://www.accutane-info.com/lawsuits.php

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

http://www.law.com/jsp/law/sfb/lawArticleSFB.jsp?id=900005554550

Jury Validates Accutane Bowel Risk

http://goliath.ecnext.com/coms2/gi_0199-6746576/Jury-validates-Accutane-bowel-risk.html

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

Accutane litigation websites

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

http://www.accutane-injuries.com/side_effects.html

http://www.levinlaw.com/PracticeAreas/accutane.asp

http://www.ennislaw.com/accutane.html

http://www.lawyersandsettlements.com/case/accutane.html?ref=article290

Los Angeles Times: Acne drug is target of new suits

http://articles.latimes.com/2007/apr/16/business/fi-accutane16

“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

http://www.yourlawyer.com/articles/read/12872

Accutane Drugmaker Roche to Pay $2.5M for Man’s Sickness

http://www.foxnews.com/story/0,2933,276175,00.html

Postponed Accutane trial set for Oct. 15 in Madison County

http://www.madisonrecord.com/news/197087-postponed-accutane-trial-set-for-oct.-15-in-madison-county

Florida man gets $7 million in lawsuit against Accutane

http://www.iht.com/articles/ap/2007/10/12/business/NA-FIN-US-Accutane-Lawsuit.php

Roche Owes $2.62 Million for Man’s Illness, Jury Says (Update4)

http://www.bloomberg.com/apps/news?pid=20601085&sid=ahzh9Bep4qcs&refer=europe

Roche Must Pay Accutane User $7 Million for Illness (Update2)

http://www.bloomberg.com/apps/news?pid=20601202&sid=amiIZKeblTlE&refer=healthcare

Accutane Victim Awarded $7 million in Florida Lawsuit

http://www.newsinferno.com/archives/1909

Roche Must Pay $7 Million In Accutane Trial

http://www.pharmalot.com/2007/10/roche-must-pay-7m-in-accutane-trial/

Appeals Court Upholds $7 Million Accutane Judgement against Roche Pharmaceuticals

http://www.lawyersandsettlements.com/articles/10014/accutane-crohns.html

Accutane Injury Results in $10.5 Million Judgment

http://www.yourlawyer.com/articles/read/14268

Jury Award 10.5 Million to Accutane Victim

http://blog.ennislaw.com/2008/04/23/accutane-case-won-105-million-verdict.aspx

Accutane: Slipping Through the Cracks Everywhere

http://www.lawyersandsettlements.com/features/accutane-cracks.html

Accutane: “It was the darkest place I’ve ever been.”

http://www.lawyersandsettlements.com/articles/01907/accutane-acne.html

Former Luvabull Takes On Drugmaker

http://www.nbc5.com/health/15218077/detail.html

Congressman Turns up the Heat on the FDA Over Accutane and Others

http://www.lawyersandsettlements.com/features/accutane-suicide.html

FDA Needs To Ban Accutane

http://www.lawyersandsettlements.com/articles/00334/Accutane_Ban.html

Roche puts Accutane profits over Lives of Consumers

http://www.lawyersandsettlements.com/articles/00299/Accutane_Profits.html

Accutane – Another Case of Too Little Too Late

http://www.lawyersandsettlements.com/articles/00163/accutane.html

Lethal Accutane still a Top Seller for Hoffmann-La Roche

http://www.lawyersandsettlements.com/articles/00290/accutane_sideeffects.html

http://www.opednews.com/articles/genera_evelyn_p_060828_lethal_accutane_stil.htm

Attorney Peter Kaufman on Accutane Litigation

http://www.lawyersandsettlements.com/articles/10501/-pharma-accutane-litigation.html

Accutane: Alleging high risks for heart and liver problems

http://www.lawyersandsettlements.com/search.html?keywords=Accutane

USA Today: Grieving father spends $1 million nest egg to investigate Accutane

http://www.usatoday.com/money/industries/health/drugs/2005-01-26-accutane-usat_x.htm

USA Today: Drugmaker rebuffed call to monitor users

http://www.usatoday.com/money/industries/health/drugs/2004-12-06-accutane-cover_x.htm

Accutane: Depression, Suicide and Degenerative Diseases

http://www.lawyersandsettlements.com/articles/01918/accutane-depression-lawsuit.html

Clear Skin with Killer Side Effects

http://members.tripod.com/~dhscribbler/acutane.pdf

“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

http://www.istockanalyst.com/article/viewiStockNews/articleid/2817847

http://www.lawyersandsettlements.com/settlements/12867/accutane-settlement-teens-awarded-12-9-million-in.html

“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.”

The Ghost Under My Pillow

http://www.accutaneaction.com/swiss_tv/061114swisstv.html

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

http://www.beforeyoutakethatpill.com/index.php/tag/accutane/

Can You Please Put Some Sugar on This Crap?

http://www.huffingtonpost.com/doug-bremner/can-you-please-put-some-s_b_125072.html

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.

http://www.seniorfitness.com/Show_Disease_and_Healing_Protocol.html?ProtID=113&Title=Pancreatic%20Cancer

“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

http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20080421/chemo_brain_080421?s_name=&no_ads

“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.”

http://www.pnas.org/content/101/14/5111.full

http://www.pnas.org/cgi/content/abstract/101/14/5111

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

http://www.chemocare.com/bio/accutane.asp

http://www.chemocare.com/bio/vesanoid.asp

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

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=34517

“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

http://www.nature.com/leu/journal/vaop/ncurrent/full/2404127a.html

“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

http://grouppekurosawa.com/blog/2006/01/vitamin-d3-vitamin-and-prevention-of.htm

“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.”

http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15520642&itool=pubmed_docsum

“A more technical discussion of this phenomenon can be found in the following paper. Click the
Acta Pharma… box to read the paper online.”

http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15842766&itool=pubmed_docsum

“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.”

http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12939463&itool=pubmed_docsum

“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?

http://learn.genetics.utah.edu/content/begin/traits/telomeres/index.html

http://learn.genetics.utah.edu/content/tech/cloning/cloningrisks/index.html

“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

http://www.lef.org/protocols/prtcl-027h.shtml

“Vitamin A offers protection against radiation induced tissue damage, down-regulates
telomerase activity, and is involved at almost every juncture of cancer control.”

Telomere.net

http://www.telomere.net/

Vitamin A and Health

http://grouppekurosawa.com/blog/2006/01/vitamin-and-health.htm

Vitamin A

http://www.sahealthinfo.org/nutrition/vitaminminerals/vitamins/vitamin_a.htm

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

http://www.nytimes.com/1990/03/20/science/biologists-identify-impresario-of-life-in-vitamin-a.html?pagewanted=all

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?”

http://www.house.gov/stupak/accutane_ipledge_080107.shtml

Warning! Don’t skip over this next section.

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.

The Sexual Effects of Accutane

http://www.erbook.net/accutane

http://www.sexualtips.net/accutane_affecting_sex.htm

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.”

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

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.

 

About irmedeaca


One response to “Hoffmann – LaRoche Crimes :Killing People With An ANTI Acne Treatment Part II

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Well Balanced Blog

Take Control of Your Own Health!

Έγκλημα και Τιμωρία/Crime and Punishment/Crime et Châtiment/Delitto e castigo/Преступление и наказание

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.

BanTheBBC Blog

A constant reminder that life would be so much better without the BBC's TV Licence Gestapo

Healthy At Any Age

Welcome to June Rousso's Blog !

iGlinavos

Thoughts of a recovering leftist

Scottish Gaelic

Word a Day

NEO INKA - ΣΕ ΠΡΟΣΤΑΤΕΥΕΙ, ΔΥΝΑΜΩΣΕ ΤΟ!!!

ΓΙΝΕ Ο ΕΠΟΜΕΝΟΣ ΚΡΙΚΟΣ ΣΤΟ ΔΙΚΤΥΟ.

Talk of the Tail

"Tails" from pets searching for their forever home.

ultimatemindsettoday

A great WordPress.com site

Are You Finished Yet?

Alea Jacta Est

Watts Up With That?

The world's most viewed site on global warming and climate change

Levi Quackenboss

Putting the boss in quack.

KXAN.com

Austin News & Weather - Austin Texas, Round Rock, TX

Unstrange Mind

Remapping My World

psychinfo.gr

ΛΙΝΑ ΨΟΥΝΗ • psouni@gmail.com • www.psychinfo.gr

Wee Ginger Dug

Biting the hand of Project Fear

QuitTrain®

Quit Smoking & Take Your Freedom Back!

%d bloggers like this: