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1Hoffmann-La Roche’s Cover-up of Accutane
2
3By: Nathan C. Carr
4Contact Email: theinsidr27@yahoo.com
5Submitted To: Attorney Michael Hook, The Accutane Litigation Group
6Date: June 2009
7“Those who cannot remember the past are condemned to repeat it”
8-George Santayana The Life of Reason
9“Chronic cellular dehydration painfully and prematurely kills”
10-F. Batmanghelidj, M.D. Your body’s Many Cries For Water
11"We cannot allow the drug manufacturer and the FDA to continue to turn a blind eye to the lives
12lost, families devastated and dreams dashed by an acne drug. The American people, our
13children, are not collateral damage in the scheme of corporate profits! Accutane is a powerful
14drug that can cause serious physical harm and death. With a drug like this on the market, it
15needs to be carefully tracked and monitored to reduce the exposures to the drug's harmful side
16effects. Unfortunately, we can't seem to rely on the FDA and the drug's manufacturer to do the
17right thing and implement such a plan."
18-Michigan Congressman Bart Stupak
19“An ongoing human horror story surrounds Accutane, the vitamin A drug used to treat acne. An
20untold number of Accutane users face life-long chronic side effects, and doctors offer no
21solutions to these problems. But there is hope. Effective natural remedies for acne would
22eliminate the appalling side effects of Accutane.”
23- Bill Sardi, investigative health journalist
24“I’ve always tried to explain it as controlled vitamin A poisoning, as the potential side effects are
25similar to those that would occur if you took far too much oral vitamin A.”
26-Dermadoctor.com
27“Skin coming off whole body”
28-Arctic explorer Sir Douglas Mawson, January, 1913
29“We simply assume, that the doctors have personal responsibility. They are specialists, who
30have the information either in their head or they know where to find it.”
31-Andres Schneider, Swissmedic
32“Micheal Benz was a 31 year old fire fighter who never had acne but was prescribed Accutane.
33A tri-athlete, Michael cried out for help from his physician and was told to come back on
34Monday. Micheal Benz drowned himself by weighting his body down with weight lifting plates.
35The investigation into his death showed that he had logged onto an Accutane website the
36
37weekend he died. As a fire fighter and an EMT, Michael Benz must have had some idea what
38was happening to him. Still, he could not resist the sudden urge to take his own life.”
39-United States Congress, Supplemental Review of Accutane Safety Issues
40“The interesting thing about this drug it’s that it was never intended for something like clearing
41up pimples. This was a drug that was intended for chemotherapy. Roche could not make enough
42money with it just with chemotherapy, so they said: Let’s expand it. Let’s sell it to more people.
43And they ended up selling it to people with acne. If you, today, were to ask Roche: Explain to
44me what is the mechanism, the bio mechanism of this drug. You know what? They wouldn’t be
45able to tell you. They don’t know. This drug has been on the market since 1982 and they have
46not spent one dime, not one single dime, trying to figure out how it works, how it goes about
47causing these side effects. You have 152, about 152 side effects. People would never make the
48choice to use this drug. Never. Once they understand how dangerous it is, there’s no logic,
49there’s no reasoning person that would say: I’m going to take Accutane to clear up pimples.”
50-Mike Papantonio, pharmaceutical litigation attorney
51“Sale of Accutane on the Internet should be immediately prohibited. Independent studies
52urgently need to be carried out to establish exactly the mechanism by which this drug causes so
53many side effects. An appropriate medical treatment, this is probably the most important, must
54be devised to counteract the side effects and to provide treatment for the tens of thousands, if not
55hundreds of thousands, of people who have suffered severe side effects from this drug.”
56-Liam Grant, Ro/Accutane Action Group chairman
57"Retinoic acid (active form of Accutane) induces differentiation and reduces proliferation of
58stem and progenitor cells. It works on acne by inducing similar events in basal sebocytes. These
59same actions also lead to 13-cis-retinoic's (Accutane’s) side effects, and these are directed
60towards proliferating cells in the adult such as in the skin, gut and bone. A wide ranging effect
61of retinoic acid is to inhibit proliferation in dividing cells, and this accounts for its frequent
62consideration as an anti-cancer agent."
63-James Crandall, Ph.D. UMASS Medical School Neuroscientist
64“I believe I have discovered the elusive mechanism of action, which is down-regulation of the
65telomerase enzyme leading to telomere shortening, growth arrest and cell death. In other words
66the more Accutane you take, the more it increases your cellular turnover rate, driving the rapidly
67multiplying cells in your body toward their Hayflick Limit.”
68-Nathan Carr
69“While there are many drugs that interfere with one or more aspects of sexuality while the user is
70taking them, with one exception all of these problems resolve once the drug is discontinued. The
71only drug that can permanently affect libido and sexual pleasure in some people is Accutane.”
72-Kevin Pezzi, M.D. The Science of Sex
73"After years of denials, Roche will at last be forced to accept responsibility for its actions and the
74horrible illness its drug has burdened me with. While I am pleased with the jury's verdict, it's too
75bad that Roche can't give me my life back.”
76-Jordan Speisman
77
78If you were to ask random people what they know about Hoffmann-La Roche’s acne drug
79Accutane, 80 % of them will have never heard of it, and the other 20 % will probably say “yeah
80isn’t that the acne medication that causes birth defects and psychiatric side effects?” These
81dangers are significant, but there’s definitely much more to Accutane’s rap sheet than just the
82birth defects and psychiatric side effects. A quick glance over the Physician’s Desk Reference,
83some websites, and its recent medication guide reveals that Accutane owns one of the most
84extensive and hazardous side effect profiles of any drug ever approved by the FDA. This drug is
85not being used by a limited number of patients with a life-threatening medical condition. After
8625 years it’s still being handed out to thousands of healthy teenagers and young adults with a
87benign harmless condition almost everybody acquires at some point early in their lives, mild to
88moderate acne. Evidence has accumulated that Roche knew about many severe side effects
89before Accutane was released onto the market in 1982, but it is only recently (2001) that the
90FDA has forced them to create warning labels that accurately list these side effects. These
91disclosures arrived too late for thousands of former Accutane users who are only now
92discovering that the drug they trusted to help them overcome acne was affecting them in
93dangerous ways. Very recently, some doctors are still withholding crucial information by not
94giving their patients the medication guide or having them sign the informed consent forms, but
95even these documents don’t list everything.
96Since the information has managed to be suppressed so effectively, nobody knows the full story
97behind this unique drug and what is currently happening with it, so I’ve created this
98comprehensive report to blow the whistle because the time is now and long overdue. Accutane
99is a toxic drug that has proven to be a massive public health threat. I believe I have discovered
100Accutane’s mechanism of action and later I will lay my evidence on the table for everyone to
101see. I’ve provided scientific studies to validate my hypothesis and I’ve used analogies and clearcut language to make the complex biology easy to understand. Reputable physicians have told
102me that it sounds extremely promising as an explanation for the mechanism of action. Unless
103somebody comes along and stops them, history reveals that Roche and certain dermatology
104organizations will continue doing everything in their power to ensure Accutane stays on the
105market and continue to needlessly poison the health of many teenagers and young adults with
106mild to moderate acne. But I’ve put together the pieces of the puzzle and it is highly unlikely
107Roche will be able to keep Accutane on the market after my report gets widely distributed out
108into the open and the truth is finally brought to the surface. Many misinformed people, including
109some dermatologists, make statements about Accutane that have absolutely no validity
110whatsoever and they talk about it like it’s over-the-counter cough syrup. It’s not. It’s a very
111dangerous and powerful chemotherapy drug that causes a long list of unpredictable serious side
112effects and is only supposed to be prescribed to the small minority of individuals with severe
113cystic acne all over their face and body. Somebody needed cut through all the BS that’s
114constantly being promoted about Accutane being a safe miracle wonder drug, by presenting the
115facts, and that somebody turned out to be me. If you are a teenager with any type of persistent
116acne problem, don’t let your vanity cloud your rationality. There’s a trap waiting for you in the
117dermatologist’s office. Let’s learn more about it.
118Today, anybody that is scientifically savvy and abreast about Accutane knows it decreases
119cellular proliferation everywhere across the board in the entire body; the skin, bone, digestive
120
121system, mucous membranes, areas of the brain, and cancer, which is why it is used in
122chemotherapy, but up until now, no one supposedly knows exactly how it causes reduced cell
123division. All throughout the history of Accutane, Hoffmann-La Roche Pharmaceuticals has
124continued to use the lame excuse in the Physician’s Desk Reference that “the exact mechanism
125of action is unknown” which is their way of copping out by stating that they don’t understand
126how the drug works to reduce acne or how it causes side effects. Liam Grant, the chairperson of
127the Ro/Accutane Action Group, www.accutaneaction.com located overseas in the UK and
128Ireland, explained Roche’s deceptive tactics very well at the FDA Meeting of the Dermatologic
129and Ophthalmic Drugs Advisory Committee held on September 19th, 2000.
130“Roche have stated publicly for the past 17 years in every country -- because we followed the PR
131statements from Roche and they're all the same, and they haven't changed, by the way, since
1321983 -- we do not know the mechanism by which this drug works. Therefore, there's no proof
133that Accutane causes depression or psychiatric disorders. And they have no shortage of medical
134people and others who will go up with this statement. So, here we have a product. We know it
135causes the side effects, but why do they cause them? Well, that's not our problem. We don't
136know how it works. Therefore, don't ask me about the psychiatric side effects and don't ask me
137about all the many, many, many physical side effects. The Ro/Accutane Action Group as an
138organization now have to go out and are now spending our money because we know, of course,
139that the mechanism can be determined.”
140http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3639t2.rtf
141As Liam Grant just said, the mechanism of action can be determined. Roche has possessed this
142technological capability for quite a long time, and it is entirely possible they already know the
143mechanism but they just aren’t telling anybody because doing so would incriminate them. A few
144organizations besides Roche have the technology needed to decipher Accutane’s mechanism of
145action such as the Life Extension Foundation in Ft. Lauderdale, FL and the Linus Pauling
146Institute at Oregon State University. But their expertise might not be needed because I believe I
147have already discovered the mechanism of action. The smoking gun was published way back in
1482001, and then buried away in the chemotherapy research archives, which is where I found it six
149years later and connected the dots. But we’re talking about an acne medication, so why was I
150searching through chemotherapy research for clues on how Accutane works? Because Accutane
151is not technically an acne medication. Very few people know this. It was originally developed
152to be a chemotherapy drug and is still used as chemotherapy today for various types of cancers.
153It has powerful cellular proliferation reducing effects throughout the entire body, and acne
154reducing skin dryness happens to be one of its side effects. While clinical trials were being
155conducted in the 1970’s, the researchers noticed that their cancer patients were having their acne
156cleared up during their chemotherapy. To make a long story short, this is when all logic and
157common sense got thrown out the window and Accutane slowly became known as a popular
158treatment for acne, not chemotherapy. At least the oncologists know what they’re dealing with
159and counsel their patients thoroughly about the severe side effects when prescribing Accutane
160and other retinoid drugs for cancer. The American Academy of Dermatology on the other hand
161took the reckless approach when they decided that we don’t know how this toxic chemotherapy
162drug works to reduce acne but we’ll go ahead and dish it out to millions of healthy young people
163anyway.
164
165During my in-depth investigation to expose the truth about Accutane, I was hard pressed to find
166any genuine good news associated with it. The only two benefits of this drug are that it fights the
167growth of cancer and it’s effective at clearing up the most severe forms of cystic acne, the kind
168of acne so severe it leaves pot holes in the skin all across the body. For these people who
169represent a small percentage of everyone with acne, Accutane can work well and produce a
170favorable outcome when it’s used properly in low dosages. But on the other end of the spectrum
171in terms of mild to moderate acne, which 90% of all Accutane prescriptions are given for, it’s
172difficult to applaud the positive acne clearing aspects of Accutane when the drug is in actuality
173just plain pure poison that causes side effects in 100 % of everyone who takes it. Everybody gets
174dry/chapped/fissuring lips while on it which is a clear sign of vitamin A toxicity.
175To all the teenagers and young adults reading this, remember that a little imperfection is just a
176part of being human. If you have a few acne spots on your body, who cares? This sort of thing
177tends to happen to the majority of everyone around this age because hormones are raging and
178cells are extremely sensitive to testosterone and insulin. Don’t get all obsessive and let your
179acne become a negative symbol of your body-image and self-esteem. If any of your friends are
180offended by a few small acne spots, do yourself a favor and kick their shallow superficial asses
181to the curb or show them this report to set them straight, I guarantee that their paradigm on acne
182and skin health is completely misguided. For 25 years Hoffmann-La Roche has been taking
183advantage of desperate, vulnerable and naïve teenagers such as yourself who just want to have
184their acne gone once and for all. Don’t take Accutane and play pharmaceutical Russian roulette
185with your life and long-term health because of measly mild to moderate acne. I know that it’s
186tempting to give in when the almighty acne cure is being dangled in front of your face by the
187dermatologist, while he or she is simultaneously telling you how great Accutane is based solely
188on the information they’ve received from Roche. But it’s imperative for you to understand that
189this s**t alters your DNA/gene expression and reduces stem cell proliferation throughout your
190whole body (later on I will explain how it does this). Use safe alternative acne treatments
191instead. There are several out there that work. Take the initiative, do your own research and
192discover them for yourself. You don’t need to take Accutane for your mild to moderate acne,
193because that would be like using rocket grenades to hunt birds perched on the roof of your house.
194Before I launch into my explanation to deconstruct Accutane’s mechanism of action, I’m going
195to provide detailed background information about the history, science, pharmacology and politics
196of Accutane, vitamin A, and retinoids, including various relevant quotations from experts on this
197topic as I go along. Accutane is a member of a family of compounds known as retinoids which
198are related to vitamin A (Retinol). Manufactured by the Swiss pharmaceutical company
199Hoffmann-La Roche, Accutane, also known as isotretinoin or 13-cis retinoic acid, is a synthetic
200derivative of vitamin A with a chemical structure that is very similar to vitamin A. It works
201against the millions of sebaceous glands all over the body, shrinking them and diminishing their
202output. Because Accutane is one of the biologically active retinoids and is readily converted into
203all-trans retinoic acid (the metabolic end stage retinoid), Accutane is estimated to be 100 times
204more potent than dietary vitamin A, which is why the side effects of Accutane closely resemble
205hypervitaminosis A or vitamin A toxicity. To corroborate, here’s another quote by Liam Grant
206from his statement at the FDA Meeting of the Dermatologic and Ophthalmic Drugs Advisory
207Committee held on September 19th, 2000.
208
209“What is Accutane? Accutane is an analog of vitamin A. It's likened to an overdose of vitamin
210A. There are many published studies showing that excess vitamin A causes a condition known
211as hypervitaminosis A. The study I mention here is a 1972 study, and it showed that the
212ingestion of large amounts of vitamin A is known to cause depression and psychiatric illness. In
213fact, we have also reports in the 1800’s and the early 1900’s of groups of people with high intake
214of vitamin A in their diet which caused major depression and psychiatric illness. Therefore, the
215manufacturers of Accutane, Roche, would have been able to predict with reasonable certainty the
216main side effects caused by Accutane, including psychiatric side effects and teratogenicity
217(causes birth defects). And that prediction could have been made with certainty prior to the drug
218ever being launched here in the United States or in other countries.”
219http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3639t2.rtf
220In case anyone hasn’t already noticed, the pharmaceutical companies are following directly in
221the footsteps of the tobacco companies and the story behind Accutane is hands down the most
222striking example of the unholy alliance between the pharmaceutical industry and their servant the
223FDA. Nothing else like it has ever happened before, in fiction or in reality and some say the
224drug has achieved the distinction of being the most dangerous product on the market for the last
22525 years. Anybody who says that the introduction of Accutane into the marketplace “was a great
226step forward in the treatment of acne” is extremely ignorant and has no idea what they are
227talking about. Since this drug was approved by the FDA in 1982, its warning label has been
228changed more than 50 times because of adverse reactions. The list of side effects and warnings
229takes up 7 pages in the newly updated Physician’s Desk Reference. It’s among the top four
230drugs that attract the most reported adverse drug reactions on the FDA’s database. Due to the
231incidence of underreporting, the FDA estimates only about 1 to 10 percent of all side effects ever
232get reported to the agency. Based on this info, one can only imagine how many serious side
233effects have occurred because of Accutane that have never been reported to anyone. Even Roche
234has admitted several years ago that there are over 40,000 Accutane adverse drug reaction reports
235on the database at their headquarters in Basel, Switzerland. As of today 266 cases of suicide
236have been reported to be caused by Accutane here in the United States, over 5000 psychiatric
237adverse drug reactions have been reported to the FDA and remember these probably represent
238only 1 to 10 percent of the actual number that have occurred. Since 1982, hundreds of deaths
239other than suicide (strokes, heart attacks, Crohn’s disease, and several other causes) have been
240recorded in the FDA’s adverse event reporting system. In the year 2007 alone, 430 cases of
241inflammatory bowel disease and 22 deaths were reported in connection with Accutane.
242http://www.druglib.com/adverse-reactions_side-effects/accutane/
243According to the Ro/Accutane Action Group, www.accutaneaction.com (Roaccutane is
244Accutane outside the United States) in August of 1997 the FDA issued a warning letter to
245Roche for failing to submit serious adverse event and death reports in a timely manner. Roche
246claimed that its computer systems were responsible for delays of up to eight years in complying
247with the law. Despite all of the shocking adverse drug reaction reports, patients today are still
248not being adequately warned by dermatologists about more than 150 different side effects this
249drug can cause and about the possibility that some of these side effects might emerge years or
250
251even decades after someone finishes a course of Accutane when it is too late to change their
252mind. To put it bluntly, the FDA has never really done anything other than a slap on the hand to
253punish Hoffmann-La Roche for their blatantly outrageous and murderous criminal behavior. For
254over two decades they’ve followed their usual game plan of sticking their heads in the sand when
255the s**t hits the fan and pretending like it never existed. In her report titled “Babies, Blemishes
256and FDA: A History of Accutane Regulation in the United States” Julia Green from Harvard
257Law School writes,
258“In September 1983, the advocacy organization Public Citizen petitioned FDA to further adjust
259the Accutane label. Public Citizen’s Health Research Group claimed that the drug’s warnings
260were inadequate and consequently Accutane had been over-prescribed. The group demanded a
261boxed warning describing the possibility of birth defects, spontaneous abortions, Crohn’s disease
262and several other serious health problems. In addition, Public Citizen asked FDA to require
263patient package inserts explaining the possible side-effects in non-technical language. FDA
264declined Public Citizen’s requests.”
265http://leda.law.harvard.edu/leda/data/472/Green.html
266A very comprehensive but still incomplete list of Accutane’s side effects
267http://accutane.poweradvocates.com/accutane_side_effects.html
268The greatest kept secret in all of journalism is that journalists are told by their bosses what they
269can and can’t say. Nobody is telling me what I can and can’t say in this report, which is why
270you’re able to read my unique perspective on Accutane that you won’t find anywhere else.
271One of the major reasons why the evidence about its side effects has managed to be suppressed
272for so long is because the mainstream broadcasting networks receive two thirds of their
273advertising revenue directly from the pharmaceutical industry. And the fox has been guarding
274the henhouse for a lot longer than people realize. In 1992, under pressure to get drugs passed
275through the review pipeline quicker, with virtually no debate at all, Congress passed PDUFA (the
276Prescription Drug User Fee Act) which basically made it so that the pharmaceutical companies
277now pay the FDA "user fees" to review and approve their drugs, and these "user fees" account
278for about 50 % of the FDA's budget, a blatant and ridiculous conflict of interest.
279FDA drug safety scientists like Dr. David Graham have recommended many times that Accutane
280be removed from the market, but they are not the ones who call the final shots at the FDA
281because they are not that high up in the chain of command. “You don’t get rewards for doing the
282work that gets a drug taken off the market” Graham stated before a Senate committee on
283November 18th, 2004. “I could have given a very mealy-mouthed statement, but then I would
284have been part of the problem.”
285“The FDA as currently configured is incapable of protecting America from unsafe drugs.”
286Forbes.com Face of the Year: David Graham
287http://www.forbes.com/2004/12/13/cx_mh_1213faceoftheyear.html
288NaturalNews.com The FDA Exposed: An Interview with Dr. David Graham
289
290http://www.naturalnews.com/011401.html
291Mercola.com Secrets of the FDA Revealed by Top Insider Doctor
292http://articles.mercola.com/sites/articles/archive/2005/08/13/secrets-of-the-fda-revealed-by-topinsider-doctor.aspx
293Youtube.com Money Talks: Profits Before Patient Safety
294http://www.youtube.com/watch?v=tmp2n-vFdwk
295“This 50-minute documentary was created to give an in-depth, academic perspective on the
296questionable marketing tactics of the pharmaceutical industry, and features the commentary of
297investigative journalists and medical professionals including Dr. John Abramson, author of
298Overdosed America, and Prescription Access Litigation Project Director, Alex SugermanBrozan. Other notable interviewees include Dr. Bob Goodman of Columbia University, founder
299of the 'No Free Lunch' program, and Dr. Jerome Hoffmann of UCLA Medical School.”
300Side Effects: Directed by Kathleen Slattery-Moschkau
301http://www.youtube.com/watch?v=oqgtXTRWykc
302http://www.youtube.com/watch?v=m-08sIjcyi4
303The only Accutane side effects that have ever received any substantial media attention are the
304birth defects and psychiatric side effects, and even then, the media has completely missed the
305boat and downplayed their seriousness. But this is likely to change in the near future now that
306hundreds of new lawsuits are getting into the spotlight.
307The pharmaceutical industry is the most powerful and profitable industry in the world,
308leveraging their influence with the FDA, the FTC, Capitol Hill, lobbyists, and other entities in
309government to ensure that nothing threatens their monopoly over the treatment of disease in
310America. Yet again, modern medicine’s conventional old-school obsolete attitude is to have
311acne occur and then treat it after the fact, rather than prevent it in the first place. As is the case
312with many other health conditions, several alternative natural remedies and dietary modification
313programs exist that are highly effective against acne, but the problem is nobody knows about
314them to take advantage of their availability because they are not being promoted to the masses,
315because they are not a patentable, profitable, pharmaceutical drug like Accutane. The current
316FDA regulating system states that it is illegal to make medical claims about a remedy being
317effective for a disease unless it has been evaluated and approved as a drug by the FDA. You
318read that right. The FDA has set as law that only a drug can cure, prevent or treat a disease,
319absolutely nothing else can. For example, if you say that an orange cures the disease of scurvy,
320technically you’ve broken the law and could be thrown in prison. There is no incentive to spend
321the huge amount of money needed to get a natural remedy approved because natural remedies
322cannot be patented. So, according to this logic and these rules, technically it would be illegal for
323a dermatologist to recommend diet modification or a safe alternative natural remedy for their
324patient’s acne instead of the toxic chemotherapy drug Accutane or antibiotics, which is
325incredibly insane. Therefore a lot of people mistakenly believed that Accutane was their only
326available option because the dermatologist had erroneously told them that nothing else worked.
327Also, why would dermatologists recommend a safe natural remedy when Roche has been giving
328
329them many incentives to prescribe Accutane “off-label” to many patients with mild to moderate
330acne. On a side note, doctor’s often claim they don’t have time to read the latest Physician’s
331Desk Reference sections on the drugs they prescribe, which would keep them up-to-date on all
332the side effects. This is preposterous. I’m not a doctor (last time I checked) and it only took me
33325 minutes to read the entire 7 page section on Accutane in the PDR.
334The future of medicine does not involve foolishly bombarding the body with toxic drugs like
335Accutane. The real progress that is being made in health care comes from physicians who are
336thinking outside the box and providing a type of care that takes the entire person into account,
337searches for the root underlying cause, devises specific individualized treatment plans, and often
338doesn’t require drug therapy of any kind. Proper nutrition, clean air/water, and stress reduction
339techniques always go a long way in helping people become healthier. Yes there are definitely
340important truly “safe and effective” drugs out there, but they are few and far between and
341probably not more than 200 of them are actually needed. Improvements toward this new vision
342of health care have been occurring gradually over last few years, more and more physicians are
343beginning to gravitate away from the conventional paradigms by becoming more progressive and
344open-minded, but before significant change can take place, modern medicine needs to start
345viewing the human body as a dynamic entity instead of a collection of isolated parts.
346Great article by Dr. Joseph Mercola that includes a petition to sign to help reform the FDA
347http://articles.mercola.com/sites/articles/archive/2009/02/02/here-s-your-chance-to-change-thefda-i-need-your-help-on-this-one.aspx
348Simple Ways to Stop Acne Naturally
349http://articles.mercola.com//sites/articles/archive/2009/03/28/Simple-Ways-to-Stop-AcneNaturally.aspx
350Natural Acne Solutions
351http://www.natural-acne-solution.com/accutane-side-effects.html
352Vitamins are essential compounds for life to occur and to maintain healthy function of all of the
353metabolic reactions in a living organism, which is why they are called vitamins. The word
354vitamin originated from the term “vitamine” which was coined in 1911 by the Polish scientist
355Cashmir Funk to define a group of compounds that are considered vital for life. Vitamin A
356(Retinol) plays a vital role in vision, skin health, gene expression, reproduction, fetal
357development, growth, bone metabolism, immune response, and the cellular formation of tissue.
358In the complete absence of vitamin A for an extended period of time, people go blind, hence it is
359extremely important to consume some vitamin A on an ongoing basis. Normal RDA
360(recommended daily allowance) doses of natural vitamin A in the vicinity of 5000 IU are
361completely harmless and greatly beneficial to our health. But like many other things in the body
362and in the field of endocrinology, maintaining the correct balance is the key, and severe
363consequences can result when this balance is thrown off. This is especially true with vitamin A
364and the retinoids. When vitamin A is consumed in the diet, it is then converted by the body into
365biologically active retinoids that influence the expression of genes, also known as protein
366transcription, the biological process of building structures that are the essence of life and that
367sustain life. Humans and mammals cannot utilize any dietary protein without the presence of
368
369vitamin A, therefore retinoids are vitally important in the mechanism of protein transcription. In
370fact, retinoic acid is considered to be the great “impresario” orchestrator of life. Being the chief
371regulator of protein transcription and cell division, it is arguably the body’s most important
372master molecule. Beta-carotene (non-toxic precursor pro-vitamin A), a healthy beneficial
373antioxidant found in several fruits and vegetables, is converted into vitamin A in the liver on an
374as needed basis in a tightly regulated process, which illustrates one of the safety mechanisms set
375up within the body to prevent vitamin A toxicity, because vitamin A performs the crucial
376function of regulating the gene expression and protein transcription. Accutane is downstream at
377end of the retinoic acid metabolic pathway so it bypasses these biological safety check points.
378The problem with Accutane is that it gives all the other vitamins a bad rap. As a general rule,
379vitamins and nutritional supplements are all very safe health enhancing compounds, but there are
380a few exceptions and vitamin A is one of them, because it has by far the worst toxicity profile out
381of all the vitamins. A high degree of individual variability exists with vitamin A toxicity. Some
382very sensitive individuals experience signs of toxicity at only 50,000 IU per day, but most people
383don’t experience toxicity until doses above 300,000 IU per day are achieved, which is roughly
384equivalent to taking one dose of Accutane. Even a low dosage of Accutane (10 mg to 20 mg) is
385still a hefty amount of vitamin A. To avoid birth defects, pregnant women should never
386consume more than 10,000 IU of vitamin A per day in their diet or supplements. It’s ok to
387incorporate natural vitamin A into an acne treatment program, just make sure to stay below a
388daily dose of 30,000 IU. If for any reason you do decide to exceed this threshold and something
389weird happens to your body, don’t come back and say that I didn’t sufficiently warn you.
390Vitamin A toxicity resulting from dietary factors like excessive consumption of animal liver or
391excessive intake of nutritional supplemental vitamin A is very rare because all supplement
392manufacturers set their dosages at or near the 5,000-10,000 IU upper limit. Therefore someone
393would seriously have to go out of their way to intentionally poison themselves with supplemental
394vitamin A. But the horrible toxicity of vitamin A has been experienced by millions acne patients
395around the world as a result of dermatologists irresponsibly and carelessly handing out Accutane
396prescriptions “off-label” to many many people with mild to moderate acne, not severe cystic
397acne, which is the only medical condition Accutane is approved to treat. Roche has exploited the
398one vitamin with the worst toxicity profile, creating a potent, dangerous drug out of it. Accutane
399induces a severe form of vitamin A toxicity, which is how it reduces acne, reduces cell division
400and severely dries out the entire body by effectively slamming shut all of the sebaceous (oil)
401glands in the skin and degrading the glycosaminoglycan water-holding protein molecules
402collagen, hyaluronic acid, elastin, and chondroitin sulfate in connective tissue everywhere,
403leaving the person in a chronically dehydrated hung-over state because the terrain throughout
404their whole body has been literally turned into a desert, they are unable to retain moisture
405between their cells. Severe systemic dryness is the hallmark sign of vitamin A toxicity. The
406more toxic dose of Accutane or vitamin A consumed, the more severely dried out the entire body
407becomes, especially the skin, eyes, and mucous membranes. The chronic life-long latent effect
408of extreme dryness doesn’t happen to everybody, but it does happen (with varying degrees) to
409everybody while they are taking Accutane. Depending on the severity of Accutane’s original
410assault on the person’s DNA protein transcription mechanisms, some people recover from their
411side effects with time, others aren’t so lucky. And from what I can tell, there’s no way of
412knowing in advance which group somebody will fall into. If you’ve taken Accutane in the past
413(a lot of people have) and your body currently feels normal, healthy, and without any severe
414
415dryness, consider yourself extremely lucky and don’t ever take this drug again. Vitamin A
416toxicity is very real, and more common and deadly than people realize, all because of Accutane.
417Here’s an extremely important question for all the current prospective Accutane users to ponder
418over. Do you think it is better to have extra oily supple skin or chronic life-long dry skin, the
419latter being a potential outcome of using Accutane. Don’t know? I’ll help you out with another
420hint. Take a look around, how many people do you see in their 50’s to 70’s with oily skin or
421acne? Having acne prone oily supple skin is a sign of youth because as the body ages the skin
422gradually and inevitably dries out. If somebody were to design the perfect drug to accelerate the
423aging process by prematurely drying out the entire body, that drug would be Accutane. Roche
424doesn’t disclose this fact in their product information on Accutane because their primary motive
425is profits not patient safety and they know that teenagers don’t ever think this far ahead when the
426prospect of clear skin is on the line. This drug permanently shrinks the oil glands everywhere
427and damages the ability to regenerate water-holding molecules, like the glycosaminoglycan
428hyaluronan AKA hyaluronic acid, which holds water hundreds of times its own weight in the
429skin and other areas of connective tissue. These specialized molecules in connective tissue are
430extremely important because they are the scaffolding that holds the body together, they facilitate
431cellular waste removal, and they are the Internet of the body, performing the crucial role of
432facilitating cell-to-cell communication. Imagine the body as a giant brick building with the cells
433being the bricks and hyaluronan being the network of white mortar connecting them. People
434erroneously believe that if Accutane dehydrates and dries them out too much, they can just drink
435more water. But it doesn’t exactly work that way, because Accutane damages the ability to
436regenerate the water-holding molecules that enable tissues to retain the water and fluids that the
437person is drinking (in some cases, drinking lots of water can help alleviate the severe dryness but
438it’s not a complete solution to the problem). Just like many other cells that are rapidly dividing
439and constantly turning themselves over, the hyaluronan water-holding matrix also turns itself
440over often. An interesting fact about hyaluronic acid is that the average 70-kg man has roughly
44115 grams of it in his entire body, and about one-third of this is turned over (degraded and
442synthesized) every day. The body has other natural biological strategies for retaining water. Dr.
443Susan Lark, a respected and renowned anti-aging doctor states, “remember when you were
444younger and your skin just glowed naturally? Well the reason for that glow was the natural oil in
445your skin. Scientists call it sebum. And it helps prevent “trans-epidermal water loss” – which is
446a fancy term for losing all the moisture in your skin.” It’s no wonder that a common testimonial
447given by young people taking Accutane is that they feel like an 80 year old person in a 23 year
448old body. Dermatologists are supposed to be in favor of anti-aging, but for the past 25 years,
449they've been passing out a drug that acts to accelerate the aging process by severely drying out
450the entire body. Aging is a side effect of being alive, but in the case of Accutane, it’s appearing
451more and more likely that aging is the predominant side effect.
452The FDA refuses to acknowledge aging as a disease, and for them, everything that is not
453acknowledged is prohibited, this includes any company that attempts to promote the evidence in
454scientific literature of the life extending properties of vitamins and other nutrients. Several high
455quality nutritional wellness products exist on the market today that do indeed have research
456validated life extending properties. But vitamin A is the major exception to the life extending
457properties of wellness nutrition, because even though some vitamin A is essential for health and
458longevity, too much vitamin A is dangerous and will actually elicit the opposite effect by causing
459
460tissue function changes that mimic accelerated aging. Nutritional supplement makers always list
461their vitamin A dosage recommendations in the safe range because they value people’s safety.
462Roche on the other hand has no problem with promoting their potent dangerous pharmaceutical
463vitamin A derivative (Accutane) to large numbers of acne patients, while not telling them what it
464is or how it works. Meanwhile the FDA sits back and does nothing. Even though the evidence
465is overwhelming that taking Accutane accelerates the aging process (by reducing stem cell
466proliferation and causing severe dryness), the FDA doesn’t care, because in their view, aging is
467not classified as a disease.
468People have absolutely no idea what they are getting themselves into when they take Accutane.
469They take it and hope for the best. Patients starting out on this drug never imagine they might
470end up with over a dozen side effects after they finish taking it. Chronic dry eye, dry skin, dry
471nasal passage, eczema, diffuse hair loss, peeling skin, erectile dysfunction, cheilitis, diabetes,
472sjogren’s syndrome, ibs, joint pain, muscle weakness, mental changes, insomnia, dizziness,
473fatigue, etc, all together is pretty much impossible for somebody in their early 20’s to experience,
474unless they’ve been exposed to Accutane that is. Of course most of the doctors these patients
475visit deny that all their problems could be from Accutane. This is the same repeating story I’ve
476encountered over and over, but in some ways you have to cut these doctors some slack. This
477situation has never happened before with any medication and no one seems to get it. People
478often don't associate problems with Accutane because of the latency of them. Some have their
479worst 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
480while they’re on the drug.
481Standard operating procedure at Hoffmann-La Roche has always been to blame the patients for
482their psychiatric side effects, despite the fact that vitamin A toxicity has been linked to mental
483illness for hundreds of years ever since the European explorer Gerrit de Veer and the Arctic
484explorer Elisha Kane and his crew experienced psychotic reactions and other severe health
485problems after they consumed polar bear liver, which was later found out to contain lethal
486concentrations of vitamin A. In the past and even up to the present, many nutritional health
487experts and doctors have not reported or publicized the information about the potentially severe
488side effects of vitamin A toxicity as much as they should. As a result people think that all
489vitamins are safe and non-toxic in high dosages, and when they go to the dermatologist and the
490derm tells them that taking Accutane is like taking high amounts of vitamin A, they
491automatically think to themselves, "oh it’s just a vitamin, it’s harmless." These people are
492definitely in for a big surprise. Anybody who wants to observe the nasty and horrible effects that
493occur with severe vitamin A toxicity needs to look no further than the side effect profile of
494Accutane. Pharmacologist Dr. James O’Donnell gave a remarkably informative presentation
495outlining the similar toxicology of Accutane and vitamin A during the first Accutane
496Congressional Hearing held on December 15th, 2000. Here are the most significant highlights.
497“I am an Assistant Professor of Pharmacology at the Rush Medical College in Chicago, and I am
498also a licensed pharmacist. I do not hold any federal grants, although I have testified as an expert
499witness in matters against Roche. I would like to project my one slide, and leave it projected for
500the course of my comments. My review has included the basic pharmacology and toxicology of
501vitamin A, and if we can focus just on the top three chemical formulas there, from the audience
502
503you won't be able to see that, but please take my word that the three molecules of retinol (vitamin
504A), tretinoin (Retin-A), and isotretinoin (Accutane), are practically identical. As a chemist and a
505pharmacologist, looking at these three chemicals, not knowing anything different, you would
506predict the same actions, including the same toxicities.”
507“Vitamin A is an essential factor in physiological growth, visual function, epithelial cell
508differentiation and reproduction and is believed to exert its influences at the DNA level where it
509plays an important role in regulating transcription of a number of genes.”
510“An intake of retinoids greatly in excess of requirement results in a toxic syndrome know as
511hypervitaminosis A. Some or all of the symptoms of hypervitaminosis A also are the major toxic
512effects that are manifest during the therapeutic use of natural and synthetic retinoids in the
513treatment of skin disorders. Accutane, being an analog of vitamin A, shares many of the side
514effects experienced with vitamin A.”
515"Accutane is associated with a long list of side-effects which are frequent, varied and at times
516severe. The most commonly occurring adverse reactions are those involving the skin and
517mucous membranes, which occur in all patients treated with Accutane. Other side effects
518reported include skin fragility, pyogenic granuloma-like lesions, epidermal blistering,
519gastrointestinal intolerance and alopecia.”
520“Blepharitis and conjunctivitis associated with Accutane use were recognized well before its
521marketing. Corneal opacities and acute myopia have been reported in government publications
522and in the ophthalmologic literature. Other ocular reactions include optic neuritis, cataracts,
523decreased night vision, blurred vision and photosensitivity. Pseudotumor cerebri (PTC) and
524headaches are also associated with the drug.”
525“There are two types of hypervitaminosis A, acute and chronic. Acute hypervitaminosis A
526results from ingestion of a very high dose of vitamin A over a short period of time. Signs and
527symptoms include drowsiness, irritability, irresistible desire to sleep, severe headache due to
528increased intracranial pressure, dizziness, blurred vision, vomiting, papilledema, and, after 24
529hours, widespread peeling of the skin. Chronic hypervitaminosis A is more common than the
530acute form and results from continued ingestion of high doses of vitamin A for months or even
531years. Symptoms include anorexia, dry itchy skin, dry eyes, alopecia, increased intracranial
532pressure, fatigue, irritability, somnolence, skin desquamation, fissuring of the lips, pain in the
533legs and forearms, hepatomegaly, neurologic disturbances and lethargy. Elevated blood lipids
534are also common. This reads just like the Accutane package insert.”
535“I referred to earlier, describe patients who are psychotic, who have schizophrenic like
536symptoms, and suicides have been associated with vitamin A toxicity. The condition of vitamin
537A toxicity causes a change in the brain chemistry. The condition that brings vitamin A toxic
538patients to the hospital is a swelling of the brain.”
539“We have a long history of psychiatric toxicity associated with Vitamin A. It's not surprising
540that we have similar reports of similar psychiatric toxicity associated with Accutane.”
541
542“An FDA memo of February 1998 stated that for a majority of the evaluable cases of suicide,
543suicide attempt or suicide ideation associated with Accutane, for the majority, there was no
544antecedent history of depression, and the patients were not noted or known to be depressed in the
545time period prior to their suicide. As a result of underreporting, the actual number of suicides
546could be 10 times greater than the number of reports.”
547“The numbers are alarming. The price is death and destruction of our children and young
548adults.”
549“We don’t need absolute scientific proof in order to recognize a signal and act on it.”
550“Indeed, the mechanism of action of Accutane in treating acne is unknown! In fact, the FDA
551rarely has more than signal before significant warning changes and sometimes drug withdrawal
552occurs.”
553“In my opinion, we have sufficient evidence to be very concerned and take some corrective
554steps. The link between vitamin A toxicity, including central nervous system toxicity, and
555Accutane is indisputable.”
556http://www.accutaneaction.com/Hearings/transcripts.htm
557Investigative health journalist Bill Sardi published a compelling and insightful report on
558Accutane and its long-term side effects titled Accutane: a modern horror story. This report came
559out five years ago, so some of the statistics might be outdated, but it is very thorough and well
560referenced. One important topic he covers is how oral hyaluronic acid supplementation might
561improve the extreme dryness of tissues caused by Accutane. Former Accutane users suffering
562the chronic latent effects of severe systemic dryness of their skin, eyes, lips, mouth, and nasal
563passage should consider taking oral hyaluronic acid supplements. Hyaluronic acid is the
564scaffolding that holds the human body together. It cushions joints and nerves, dilutes toxins and
565serves as a barrier against the spread of disease.
566http://www.naturalhealthlibrarian.com/
567“The medical community and a drug company are in a state of denial regarding side effects
568caused by Accutane. Nutritional supplements should be taken during Accutane therapy to ward
569off potential side effects. Dietary supplements may also remedy chronic side effects experienced
570by former Accutane users. Urgency is required to search for safer alternatives than Accutane for
571the treatment of acne.”
572“Mathew Hamilton’s story is a case in point. At the age of 15, and with a mild case of acne at
573best, his dermatologist in Cape Town, South Africa, prescribed Accutane (Roaccutane outside
574the USA). Matthew only experienced the common symptoms of dry skin and chapped lips while
575taking the medication. Otherwise, things were uneventful. Then four months after finishing
576treatment, Matthew had a suicidal episode, a latent side effect of the drug produced by shutting
577off the production of serotonin, a mood-controlling brain chemical.”
578
579“A year later, Matthew was still struggling with suicidal attacks for no apparent reason. Around
580this time his hair began to fall out and his scalp became itchy. Backaches and clicking sounds in
581all of his joints appeared. Instead of graduating as the top student in his high school, as
582anticipated by his previous school record, Matthew was struggling with the side effects of
583Accutane. Muscle weakness ensued. Then hair loss spread to his eyebrows, eyelashes, and other
584body hair. His eyes were always dry and floaters, what appear as cobwebs or black globs in the
585visual field appeared. Nightmares and bouts of depression were common.”
586“Matthew began his own investigation. While literature provided by Roche, the manufacturer of
587Accutane, states that side effects magically go away after ceasing use of the drug, he began to
588make contact with people who had taken the drug when it first became available in 1982 and
589were still suffering with side effects 21 years later.”
590“Then Matthew found another important link to his other side effects. Accutane, also switches
591off the production of hyaluronic acid, the water-holding molecule in the connective tissue
592between living cells in the body. Hyaluronic acid is concentrated in the joints, skin, scalp, and
593eyes, exactly where all of Matthew’s symptoms were concentrated. Scientific studies appear to
594confirm Hamilton’s suspicions regarding hyaluronic acid. The destruction of hyaluronic acid
595would explain the universal symptoms of dryness associated with Accutane use, the dry eyes,
596hair, skin, and joints.”
597“Just as Accutane causes the drying up of secretions from the sebaceous glands, it also inhibits
598the secretion from other glands as well. Accutane is not specific to the oil glands in the skin. It
599dries out the whole body.”
600“One of the common statements heard from young Accutane victims is: I feel like a 23 year old
601grandmother or grandfather. It’s not surprising that these people feel old before their time.
602Progeria is known as a disease of premature aging. Progeria children develop premature
603wrinkled skin, hair loss, cataracts, and other signs of advanced aging. Progeria is universally
604diagnosed by an elevated losss of hyaluronic acid in the urine. Progeria children excrete up to 17
605times more hyaluronic acid than healthy children. Were these Accutane side effect sufferers
606simply mimicking symptoms similar to progeria?”
607“Oral hyaluronic acid (HA) supplements are relatively new. They offer hope for restoration of
608tissues adversely affected by Accutane. Just 1000 milligrams can hold or gel 6 liters of water in
609the body. Oral hyaluronic acid supplements have been reported to lessen or eradicate joint pain
610in cases of osteoarthritis, eliminate back pain caused by swollen vertebral discs, refill skin tissues
611to the point of reduction of wrinkles, cause floaters in the eyes to disappear, and improve
612thickness and luster of hair. The production of hyaluronic acid may be impaired in Accutane
613users. Supplementation may be beneficial.”
614“Accutane kills by the hand of its users. They swallow the Accutane pills and they commit
615suicide. It’s a perfect cop out for the pharmaceutical companies. The drug company’s
616fingerprints are all over the lethal weapon, but they escape responsibility by having Accutane
617users sign a consent form.”
618
619“There are a number of reports of side effects associated with Accutane that are not generally
620listed or highlighted by the manufacturer.”
621“A seeming paradox exists with Accutane. Why does it induce night blindness when vitamin A
622is required for rhodopsin, the night vision chemical? For decades it has been known that a
623shortage of vitamin A produces night blindness. By 1986 the first cases of poor night vision
624were being documented among Accutane users. [Archives Ophthal 104:831-37,1986] Night
625blindness has been reported to occur within two weeks of starting Accutane (20 mg daily dose).
626[Australia J Derm 40:208-10, 1999] The occurrence of night blindness with Accutane suggests
627this drug in some way interferes with vitamin A metabolism. A similar paradox exists for
628Accutane and dry eyes. Vitamin A is a treatment for dry eyes. Vitamin A is required for the
629production of mucin by the goblet cells.”
630“One thing is clearly established. The side effects of Accutane don’t wear off for everyone. For
631example, an 18-year Accutane sufferer (1985-2003) started with low back pain and fatigue about
6326 months following Accutane treatment. Then later inflammatory bowel disease occurred.
633Arthritis in other joints and mental depression became part of the syndrome. In 1992 Sidney
634Lerman reported that Accutane therapy produced irreversible cases of dry eye two years
635following cessation of therapy and also some cases of cataracts in relatively young patients
636(teens to 40’s), which demonstrates that some of the ocular side effects caused by this drug ‘are
637not reversible when the drug is stopped.’ [Lens Eye Toxicology Res 9: 429-38, 1992]”
638“Acne patients need to seek safer alternative treatments. Dermatologists are not likely to aid
639patients in the quest for alternative therapies. With some guidance, many acne patients are likely
640to find safer remedies outside the dermatologist’s office. Doctors will argue there isn’t sufficient
641evidence to prove that alternative therapies are more effective than Accutane. However, the
642evidence for alternatives is lacking by the very reluctance of the medical community to explore
643their use.”
644To understand how Accutane causes dry, irritated eyes, do this experiment. Fill two small bowls
645with water and place them side by side. Next, pour any type of oil into one bowl but not the
646other. Now wait a really long time and then observe what happened to the bowl without any oil.
647There is less water in this bowl due to evaporation, but none of the water in the other bowl has
648evaporated because the oil formed a barrier layer on the surface. This analogy illustrates what
649happens when Accutane causes the meibomian gland (a specialized sebaceous gland) in the
650eyelids to secrete less oil. The specific function of the meibomain gland in the eyelids is to
651secrete a protective oil layer into the tear film, which prevents tears and the eyeball surface
652mucosal layer from evaporating. The problem with Accutane is that it does not know the
653difference between the sebaceous glands all over the skin and the sebaceous (meibomian) glands
654inside the eyelids. Therefore when Accutane partially or completely destroys the meibomian
655glands, decreasing oil and lubrication, tears evaporate much quicker, the mucosal layer becomes
656degraded, and potentially permanent, severe, irritating dry eye syndrome is the result, causing
657eyes to drag around in their sockets.
658This is why people are NOT supposed to use eye drops while they are taking Accutane
659(dermatologists don't usually tell their patients this), because if their eyes are getting dry to the
660
661point that they constantly need to use eye drops, it means that they must reduce their Accutane
662dosage immediately, unless they want Accutane to give them a permanent case of dry eye
663syndrome where they'll have to use eye drops, won't be able to wear contact lenses, and have
664constant eye irritation/pain for the rest of their life, and be much more susceptible to
665conjunctivitis, eye infections and cataracts as they get older.
666Pseudotumor Cerebri otherwise known as intracranial hypertension or swelling of the brain is
667one of several serious side effects of both vitamin A toxicity and Accutane. The drug brochure
668provided by Roche way back in the 1970’s states that adverse reactions to Accutane “are
669essentially those of hypervitaminosis A.” At an FDA meeting in 1983, Dr. Del Vecchio
670described Accutane’s side effects and said that "just about everything that happens with
671Accutane may happen with vitamin A overdosage."
672http://www.accutaneaction.com/Studies/index.html
673Most of the Accutane side effects resemble acute or chronic hypervitaminosis A, but
674paradoxically, a few of Accutane’s side effects like permanent night blindness, resemble vitamin
675A deficiency or hypovitaminosis A.
676Evidence about Accutane’s propensity to cause psychiatric problems had been building up all
677throughout the 80’s and 90’s, but nobody, not even the dermatologists were talking about it or
678acknowledging that it was happening. Despite all of the accumulating evidence, dermatologists
679announced to everyone that there was absolutely no link between Accutane and psychiatric side
680effects. A shocking report appeared in The Journal of the American Academy of Dermatology
681back in 1987 that was titled “Hypervitaminosis A syndrome: a paradigm of retinoid side effects.”
682(J Am Acad Dermatol 1987;16: 1027-39) I guess none of the dermatologists bothered to read
683their own journal because this report should have raised some serious red flags about the
684connection between retinoids and psychiatric toxicity. In this report it says that physicians
685utilizing retinoids should be aware that in the past few decades patients have been committed to
686psychiatric hospitals for severe depression and schizophrenia when mental changes were due to
687hypervitaminosis A. The report also says that investigative trials of new retinoids have shown
688how important it is to become familiar with hypervitaminosis A syndrome because so many side
689effects associated with new retinoids (such as Accutane) have previously been encountered in
690patients with chronic hypervitaminosis A.
691Hoffmann-La Roche has always continued to deny that Accutane can cause psychiatric side
692effects like depression and suicide, but they do not acknowledge the fact that vitamin A toxicity
693has been consistently linked to mental illness for centuries. In 1597, European explorer Gerrit de
694Veer spent the winter in Nova Zembla. His diary of the experience revealed how he and the rest
695of his men became “gravely ill and feared for their lives” after eating polar-bear liver.
696250 years later, in 1856, the Arctic explorer Elisha Kane and his crew experienced extreme
697fatigue, drowsiness, irritability, headache, bone pain, peeling skin, vertigo, and psychosis after
698they consumed polar-bear liver, which was later determined to be poisonous because it contains
699lethal amounts of vitamin A. A one-half pound serving of polar bear liver will deliver about
7009,000,000 IU of vitamin A to your diet, an extremely lethal dose that will make all your skin peel
701off before you die. Fatal cases typically end with full-body skin loss, liver damage, delirium,
702
703hemorrhage, and coma. This danger of toxicity resulting from the ingestion of bear liver has
704long been known by indigenous Inuit people of the Arctic regions, but many Western explorers
705and hunters had no knowledge and ended up learning the hard way. A common practice among
706the Inuit is to bury polar bear livers deep under the ice or toss them into the sea in order to
707prevent their sled dogs from chowing down their last meal. Polar-bear liver contains about 1
708million IU of vitamin A per ounce (the RDA for adult humans is only 5000 IU), which is why if
709you decide to snack on it, the top layer of skin on your hands and other places all over your body
710will come off in giant sheets. Not surprisingly, peeling of the skin on the palms and soles and
711skin coming off on various places of the body is also a potential side effect of Accutane. An
712article titled “The Vitamin A Content and Toxicity of Bear and Seal Liver” dated 1943 described
713what happened to these explorers after they ingested polar bear liver. The side effects of eating
714polar bear liver are very similar to the side effects of Accutane.
715The Vitamin A Content and Toxicity of Bear and Seal Liver
716http://www.biochemj.org/bj/037/0166/0370166.pdf
717The abstract of Dr. James O’Donnell’s article titled “Polar Hysteria: An Expression of
718Hypervitaminosis A” states,
719“Isotretinoin (Accutane) is a drug closely related to the chemical structure of Vitamin A. The
720pharmacology and toxicology of these two retinoids is similar enough to warrant comparison.
721Accutane is a powerful drug which its manufacturer, Roche, indicates is limited for severe
722recalcitrant nodular acne. This potency is also reflected in Accutane's well-known ability to
723produce severe birth defects if taken during pregnancy. Less well-known is the risk of this lipid
724soluble chemical to affect the Central Nervous System. Reports of intracranial hypertension,
725depression, and suicidal ideation with Accutane use have prompted an examination of this
726serious and life threatening potential. Though Roche has added a warning to its product label for
727signs of depression and suicidal ideation, this product is being overprescribed for all forms of
728acne, including mild cases and moderate acne that have not been treated with alternative
729medications, which have a lesser risk of depression and suicide. There is no contesting that this
730drug is effective at clearing up the most severe forms of acne, but the public must be informed of
731its proper, limited indication for use; depression and suicide can follow in patients with no prior
732history of psychiatric symptoms or suicide attempts.”
733Polar Hysteria: An Expression of Hypervitaminosis A
734http://www.americantherapeutics.com/pt/re/ajt/abstract.00045391-20041100000015.htm;jsessionid=JJ7HJGPKtBtS90xJTWXtLfvtd8QRWpTYzr2Hl8vJpgXZkcnwQN1Q!450575803!181195629!8091!-1
735Hypervitaminosis A and Fractures
736http://content.nejm.org/cgi/content/short/348/4/347
737Most animal liver is safe to eat (for people who have never taken Accutane), but it should be
738noted that bear, seal, and husky livers are not safe for anybody. In 1913, the Swiss explorer and
739skiing champion Xavier Mertz embarked on an Antarctic expedition with the Australian Sir
740Douglas Mawson and Lieutenant Edward Ninnis. While attempting to cross the Ninnis Glacier,
741
742Ninnis fell into a crevasse, along with six dogs, the tent and most of the supplies. With only a
743few days worth of rations left and 315 miles from the main base, Mertz and Mawson now faced
744the impossible challenge of getting back to safety without sufficient food. They began to eat the
745livers of their husky sled dogs and over a few weeks’ duration both were poisoned, experiencing
746dryness of the nose, mouth, eyes, cracked lips, hair loss, irritability, fatigue, and loss of all skin
747on their legs, hands, feet, genitals, “skin coming off whole body” according to Mawson’s diary.
748Even the thick skin on the soles of their feet came off, leaving areas of the underlying tissue
749bloody and exposed. Mertz consumed more liver and eventually became fatally poisoned after
750developing severe stomach pains, diarrhea, and going insane. The dreadful details of Mertz and
751Mawson’s ordeal can be read in the British Medical Journal articles “Man’s best friend?” and
752“Vitamin A and Sir Douglas Mawson.” Several parallels to the side effects of Accutane are
753exceedingly apparent.
754Man’s best friend?
755http://archive.student.bmj.com/issues/02/05/life/158.php
756Vitamin A and Sir Douglas Mawson
757http://www.pubmedcentral.nih.gov/pagerender.fcgi?artid=1602734&pageindex=1#page
758Acne drug has serious side effects
759http://www.cbc.ca/marketplace/pre-2007/files/health/accutane/index.html
760Here's a quote from the above article describing the controversy over the psychiatric side effects,
761"Hoffmann-La Roche says there is no causal relationship between Accutane and depression or
762suicide. Experts point out that no one factor causes suicide and that a high percentage of
763Accutane users -teens and young adults- are already more likely to get depressed. But some
764doctors say there's plenty of evidence to support a link between Accutane and depression and
765suicide. And they argue that evidence of the link dates back to Arctic explorers of the 19th
766century. Diaries tell of how some sailors suffered polar madness. Experts today say it was from
767eating polar bear liver, which is full of vitamin A. In large doses Vitamin A can cause brain
768toxicity, seizures, and behavioral changes. Accutane is a derivative of vitamin A."
769The following transcript from the first Accutane Congressional Hearing held on December 15th,
7702000 illustrates the wide-spread lack of knowledge about the severe consequences of vitamin A
771toxicity, even among dermatologists. Chairman Burton expressed his own concern and urgency
772by taking the initiative himself to inform all the dermatologists in the nation about Accutane’s
773psychiatric side effects, because as expected, the people from Roche and the American Academy
774of Dermatology were reluctant to do it.
775CHAIRMAN BURTON: Then why don't you just go ahead and send a fax out to all the
776dermatologists in the country, saying this is a risk, and many dermatologists evidently don't
777know about it. There was testimony before the Congress of the United States by people who
778have lost children, who knew nothing about it, even though it had been publicized on the
779Internet, and so we want to make sure you know about it. Why don't you do that?
780DR. PARISER: I'll check into it.
781
782CHAIRMAN BURTON: Would you do that?
783DR. PARISER: All right.
784CHAIRMAN BURTON: And if you don't, do me a favor. Give me a list of all your members,
785and I'll send the dammed thing out. Because I don't want to have other people coming before our
786Committee with their kids being dead because possibly Accutane caused it. Now, let me ask you
787a question, Dr. O'Donnell. You said that the people who ate polar bear livers in the middle 1880's
788that were on polar expeditions.
789DR. O'DONNELL: That's right.
790CHAIRMAN BURTON: And they had psychotic events because of the large amounts of
791Vitamin A they were consuming in the livers of polar bears; is that correct?
792DR. O'DONNELL: Yes, sir.
793CHAIRMAN BURTON: And was this just an isolated incident, or was this something that
794happened more than once?
795DR. O'DONNELL: There were several reports. Not many were published, but it was common
796knowledge that people had to avoid excessive use. Similar reports since then have published
797neurotoxicity, toxic psychosis, but the first report that I referred to was a polar expedition in
7981856.
799CHAIRMAN BURTON: So Vitamin A in large quantities definitely causes the kinds of
800problems you're talking about, and that is what Accutane, in main part, is made up of?
801DR. O'DONNELL: Yes, sir.
802CHAIRMAN BURTON: One of the things that bothers me, the question that was just asked by
803Mr. Waxman, you kind of just, we aren't really geared up to get that kind of information out to
804the American people. That's kind of a cop out, I think, isn't it? I mean, the Food & Drug
805Administration is supposed to be the person or the group that guarantees the safety and the
806efficacy of pharmaceuticals and drugs for the people of this country, and if something is going
807awry, you're saying, oh, it takes so much time to get the information out, and I mean, 19,000
808dermatologists, you could send letters out tomorrow to all of them, in big bold print, to all the
809pharmacists in the country, and you don't send, put it on the email. You know, there's all kinds
810of ways to communicate in this age, and I think it's a real cop out for the FDA to say, oh, we
811can't do that. The other thing I want to ask you is this: In 1850 something, polar bear livers were
812causing psychiatric problems on people that were eating them, because of large amounts of
813Vitamin A. This pharmaceutical expert, or pharmacologist
814MR. O'DONNELL: Both.
815CHAIRMAN BURTON: Both. Indicated that the brain swells up when you have too much
816Vitamin A in it, which causes severe problems. When the testing was done, back in the 1980's,
817before Accutane was put on the market, did anybody check mice brains? Did they give them
818large amounts, or any kind of animals large amounts of Vitamin A, to check to see if it caused
819any side effects? Did anybody check that out?
820DR. HUENE: I would add that the label does address a condition known as psuedotumor cerebri,
821which is I think the brain swelling that you referenced, that was known to be related to
822hypervitaminosis A.
823CHAIRMAN BURTON: When we hear of people whose children who have committed suicide,
824or who have had adverse events occur because of Accutane, and they didn't even know anything
825about this, were never warned by their dermatologist, were never warned by their pharmacist.
826They had no knowledge. They went home, started giving their child the pills, and those side
827effects occurred. My gosh, what a mistake. What a tragedy. In any event, we would like to have
828
829that information submitted for the record, and I would like to have a list, if you don't have it, of
830all the dermatologists in the country, and if your association won't contact them, then I'll figure
831out a way to do it myself, and the Committee will. And I think that we ought to put on our email
832to all pharmacists in the country the warning that Roche is now putting on their label so that they
833will all be aware of it as well.
834Also at this Congressional Hearing, many individuals and their families testified about their
835experiences with Accutane.
836“As Amanda's depression worsened despite the therapy and medication, the only thing we could
837visibly see working was the Accutane. Her lips dried out, cracked and bled; her joints ached, and
838she was always thirsty. But the dermatologist told us that that was just the effect of Accutane,
839nothing to be worried about, just don't get pregnant.”
840“Stacy and Mike Baumann of Mundelein Illinois lost their son Daniel to suicide in December
8411999. Daniel began Accutane treatment in July 1999. He suffered many adverse effects;
842chapped lips, dry skin and itching, joint and muscle pain, headaches, nausea, loss of appetite,
843mood swings, and insomnia. The physician thought his depression was school-related and never
844mentioned the FDA warning.”
845“I met a friend from high school not long ago and it turns out she was on her way to pick up a
846prescription for her son of Accutane. When I asked if she was aware of the potential risk, she
847looked at me like I was crazy. I asked her if she was counseled by her dermatologist, who was
848different from ours, and she said she was not. I asked her if this drug was prescribed when other
849remedies had failed, and found that it had been prescribed first, before any other remedies had
850been tried.”
851“Our children are dying because a drug company makes lots of money from this drug. This is the
852same company, cited for once advertising that Accutane helped depression, this just one month
853after the FDA required the warning about suicide. We would never allow our children to play
854Russian roulette with a gun, but we allow that to happen every time a prescription for Accutane
855is given.”
856http://www.accutaneaction.com/Hearings/transcripts.htm
857Michigan Congressman Bart Stupak has been working relentlessly to create more awareness
858about the dangers of Accutane and its psychiatric side effects ever since his family tragedy back
859on May 14th, 2000, when his son Bart Jr. fatally shot himself near the end of his course of
860Accutane. During the second Accutane Congressional Hearing held on December 15th, 2000,
861Stupak blasted the FDA, Hoffmann-La Roche and dermatologists for failing to protect young
862people from the side effects of Accutane.
863"We cannot allow the drug manufacturer and the FDA to continue to turn a blind eye to the lives
864lost, families devastated and dreams dashed by an acne drug. The American people, our children,
865are not collateral damage in the scheme of corporate profits!"
866
867"The drug manufacturer, Hoffmann-La Roche, Roche here in the United States, has continued to
868put profits before people. They have done everything possible to prevent the American people
869from learning of the psychiatric injuries and deaths associated with Accutane. Even, today, I'm
870sure Roche will deny any casual effect of Accutane with the abortions, deaths, and suicides
871caused by their product."
872"Accutane is a powerful, dangerous drug with devastating consequences for some patients. The
873birth defects caused by Accutane are horrific. The FDA's response to the birth defects and
874psychiatric events has been inadequate, irresponsible and unacceptable. Thousands of babies,
875teenagers, and young adults have died prematurely. While the FDA has been aware of the birth
876defects since at least 1982 and the psychiatric injuries since 1985, their responsibility to protect
877the public has been inconsistent and without direction."
878"The Accutane birth defects are similar to Thalidomide, which is a tightly controlled drug in this
879country and is used by a group unlikely to have children. Yet, Accutane is not tightly controlled
880like Thalidomide and Accutane is marketed to women of child bearing years despite its
881horrendous record of causing birth defects."
882"If the FDA cannot or will not regulate Accutane, then it is imperative for the US Congress to act
883to protect the American public. The bottom line remains the safety of our citizens."
884"The scope and depth of Accutane's serious adverse event reports compiled by the FDA are only
885a fraction of the actual number of deaths, birth defects and devastation caused by this drug. The
886true number of Accutane victims and their families are real, and once again the FDA has let us
887down!"
888During this Congressional Hearing, the President and Chief Executive Officer of Hoffmann-La
889Roche, George B. Abercrombie, testified before the Committee. After giving various statements
890under oath about studies, marketing, clinical trials, and Roche’s connections with entities down
891in Mexico, two members of the committee told Mr. Abercrombie that they did not believe his
892testimony, and that he had given the testimony in front everyone with a “straight face.” Florida
893Congressman Peter Deutsch stated to Mr. Abercrombie during his questioning that “what you
894just said is not a truthful statement, you’re beyond the straight face test, I’m sorry.” Not a single
895member of the Congressional committee spoke in support of Hoffmann-La Roche. Also at this
896hearing, confidential papers were revealed showing that after the first Accutane Congressional
897Hearing held on December 15th, 2000, Roche employees were celebrating and shaking each
898other’s hands because they were able to delay and prevent the authorities from implementing a
899registry for Accutane’s psychiatric side effects.
900In another Congressional statement titled Supplemental Review of Accutane Safety Issues Stupak
901talks about how, for decades, Roche has continually suppressed critical information about
902Accutane’s mechanism of action and the biological mechanisms of vitamin A and retinoids. In
903the several quotes from his statement I’ve provided below, HLR stands for Hoffmann-La Roche,
904“During a time when it took years to receive a new drug approval, in 1982 the FDA approved
905Accutane within 9 months. The FDA has reviewed the original application for Accutane and has
906
907told committee members and staff that Accutane would never be approved by today’s drug
908regulatory standards. The original new drug application trials showed that of the 523 people
909given Accutane in test studies only 89 were children and only 6 had a diagnosis of acne. The
910Accutane labeling is misleading ‘in stating that efficacy for severe nodular acne was established
911in clinical trials, given the extremely small sample size.’ Because Accutane has significant
912adverse effects associated with its use, it is to be prescribed only to patients with severe
913recalcitrant cystic acne. It is unknown whether these 6 children had severe cystic acne. Exhibits
914#1,2, and 3.”
915“The FDA’s safety focus has been on the birth defects and not the psychiatric injuries caused by
916Accutane. In 1985, the first suicide attributed to Accutane was reported to the FDA. Dr. Huene,
917FDA Medical Officer, requested a review of the number of CNS [central nervous system] effects
918reported in patients on Accutane. These have included severe headaches, seizures, tremors,
919disorientation, numbness and parethesias, blurred vision, memory loss and behavioral changes
920other than depression. Exhibit #5.”
921“In 1987, Dr. Huene requested assistance with the ‘difficulty of reviewing the adverse reaction
922reports associated with Accutane therapy……well over 3,000 adverse reaction reports…..(the
923number is probably approaching 4,000 by now)….. we find it impossible to deal with this
924volume of information coherently….’ Without an additional full-time reviewer to
925‘…..adequately collate, review and make recommendations’ regarding all the adverse reaction
926reports associated with Accutane. Exhibit #5.”
927“In regard to psychiatric injuries, HLR’s efforts have been to suppress adverse events reports and
928medical/scientific evidence. HLR withheld its own studies that shed light on Accutane’s effect
929on the central nervous system. Further, HLR failed to submit safety precautions employed by
930other countries, provided ‘junk science,’ and denied any biological causation between Accutane
931and psychiatric injuries. The only consistent explanation of these psychiatric injuries put forth
932by HLR is to blame the patients for their psychiatric problems. Throughout the history of
933Accutane, HLR claims it does not know how Accutane works. Therefore, HLR cannot claim
934that Accutane does not cause psychiatric injuries. HLR cannot have it both ways. It is obvious
935HLR is more interested in protecting its profits than in finding the cause of psychiatric injuries in
936Accutane therapy. Exhibit #77, 78, and 79”
937“HLR cannot claim that it was not aware of the requirement to inform the FDA of recent
938scientific and medical studies showing that Accutane, vitamin A, retinoids or retinoic acid affect
939the central nervous system. As part of its annual report to the FDA, HLR submits a list of
940medical studies and scientific research on Accutane therapy, vitamin A, retinoids, and retinoic
941acid. Some of these studies and research demonstrate a cause-effect relationship between
942Accutane therapy and psychiatric injuries. For example, some of these studies and research from
943as early as 1980 raise the concern of vitamin A toxicity from retinoid use affecting the central
944nervous system. Exhibit #51, 52, and 53”
945“HLR will put out information they know is wrong and very little is done to correct it. For
946example, when Charles Bishop flew his airplane into the bank in Tampa and Accutane was
947mentioned as a possible cause in Bishop’s behavior, HLR cranked up its PR machine. The
948
949thought was planted that we would have to wait until the autopsy report to see if Accutane was
950present in Bishop’s body. HLR knows full well that standard autopsies do not test for the
951presence of Accutane. As the FDA pointed out in an email, ‘Given the bad news about the poor
952kid in Florida, it is even MORE urgent that we get the letter out to JAAD (Journal of the
953American Academy of Dermatology)…....The derms are being poisoned with absolute nonsense
954and it is downright dangerous in my book…...I know we can’t compete with the Roche machine
955for their attention, but we have to try anyway!’ Exhibit #101 and 102.”
956“In 1999, the FDA was so concerned about HLR’s reporting and ‘soft coding’ of Accutane
957psychiatric injuries that they did a ‘surprise’ inspection of HLR’s plant and its adverse events
958database. The inspection resulted in a Warning Letter from the FDA for not timely submitting
959adverse event reports for several years and failing to disclose over 2,000 more Accutane adverse
960event reports. Exhibit #91,92, and 93.”
961“As the June 25th, 2002 FDA states, “So….even if you make a VERY conservative guess at the
962number of waived cases, adding this up for just this ONE year exceeds the numbers derms have
963available on their radar since the drug was approved in 1982……As it stands right now, we do
964not even know how many such reports fall under each Body System. I am very concerned that
965someone ‘outside’ is going to get their hands on, and publish, the real numbers of psych reports
966obtained during the legal discovery processes no doubt going on……FDA is going to look pretty
967sad if someone else points out there are thousands more than we acknowledge publicly!!”
968Exhibit #42.”
969“At our December 11th, 2002 hearing, our colleague Ted Strickland picked up on the deadly
970spontaneous action caused by Accutane in young people when he asked, ‘Is it possible that this
971medication has an effect, an action that results in spontaneous, impulsive, self-destructive
972behavior that is different from that which occurs from a clinical depression?’”
973“The ‘spontaneous action’ mentioned by Congressman Strickland and testified to by the Turney
974and Benz family members at our December 11th, 2002 hearing separates Accutane caused
975psychiatric injuries from clinical depression. Even the dermatologist at the hearing testified that
976she could not predict when spontaneous events may occur in Accutane patients.”
977“In the case of Matthew Turney, age 16, he was alone for 10 minutes when he came home from
978school and shot himself. Matthew and his parents were watching for any signs of depression as
979they were aware that Accutane may cause psychosis, suicidal ideation, suicide attempts, and
980suicides. Yet his parents never saw signs of depression and are asking how do parents protect
981their children when there are no clues as to when the fatal 10 minutes can occur!” Exhibit #60”
982“Micheal Benz was a 31 year old fire fighter who never had acne but was prescribed Accutane.
983A tri-athlete, Michael cried out for help from his physician and was told to come back on
984Monday. Micheal Benz drowned himself by weighting his body down with weight lifting
985plates. The investigation into his death showed that he had logged onto an Accutane website the
986weekend he died. As a fire fighter and an EMT, Michael Benz must have had some idea what
987was happening to him. Still, he could not resist the sudden urge to take his own life. Exhibit #61”
988
989“A review of the suicide adverse event reports describes young people with no history of
990psychiatric problems taking their lives. There are reports of young people talking to their parents
991one minute and then hanging themselves the next minute. There are reports of young people
992who have fender bender accidents and when law enforcement arrives to discuss the accident with
993them, they leave to get their driver’s license and instead grab a gun and shoot themselves.
994Exhibit #62.”
995“This aggressive behavior referred to as OIB or SIB (self-inflicted bodily harm) was referenced
996in a 1999 email where the Accutane Medical Review Officer remarked that “I gave up trying to
997track all psychiatric reports and just have the self-injurious behavior cases…..sorted into my
998‘SIB” stack, which is sadly growing tall.” Exhibit # 63, 64, and 65.”
999“This aggressive behavior seen in Accutane patients manifested itself not only in self-inflicted
1000injuries but also in four murders and reported murderous ideation amongst Accutane patients.
1001Exhibit #66.”
1002“Of course, HLR denied any causation between aggressive behavior and Accutane therapy.
1003Finally, on October 30th, 2002 the FDA added ‘aggressive/violent behavior to the list of events
1004that Accutane may cause.’ Exhibit #68.”
1005“As the FDA noted in its August 31st, 2000 email, ‘The population for whom Accutane is
1006prescribed is overwhelmingly young and healthy. Accutane has been associated with many
1007adverse events affecting nearly every organ system, and is a potent teratogen. Some of these
1008adverse events are serious/life-threatening and the current labeling include a Black Box Warning,
100911 additional Warnings, and 18 Precautions.’ Even with this growing list of Accutane
1010warnings/precautions, patients and their families are never told of its hidden dangers. Exhibit
1011#68.”
1012http://www.house.gov/stupak/accutane/p3_21.pdf
1013During a January 2003 interview with Jamie Kosar about the psychiatric side effects of
1014Accutane, Bart Stupak had this to say when Kosar asked if there had been other types of brain
1015damage or psychiatric injury such as anxiety and panic attacks associated with Accutane,
1016"Yes. It's there. It's all there. They're changing their labeling you know. And it wasn't clear
1017yesterday and maybe we didn't do a good job on this part. They've had to change their label. The
1018new label talks about ‘aggressive, violent behavior.’”
1019“The ‘depression’ that you see with this, if you want to use that word, is not your garden type
1020depression that we all see. It's not that kind at all. It comes on [snaps fingers] like that. And it's
1021a violent outburst. We didn't get into it yesterday because I had so many areas I could go. They
1022talked about SIB's throughout the whole thing. ‘Self-inflicted bodily harm.’ These kids, there's
1023one kid who set himself on fire and jumped off a cliff. He lived. He can't tell you today why he
1024did it. An Accutane kid. He left a note that doesn't make any sense whatsoever. There's a service
1025man that was taking Accutane. Came home. He was probably about twenty years old. He was in
1026boot camp. He knew his parents would be gone. They would be home on Sunday. He came home
1027
1028and ransacked the house looking for a gun to shoot himself. Couldn't find one, so instead, he
1029took a big knife and started stabbing himself. And his buddies happened to come through the
1030kitchen door and found him on the kitchen floor full of blood all over the place. And to this day
1031he doesn't know why he did it. If he could've found a gun that day he would've killed himself."
1032At the end of this interview when Stupak was asked if there was anything he'd like to tell a
1033parent or any young adult or teenager who was considering Accutane for their acne, he
1034responded with,
1035"Don't do it. It's not worth the consequences. What is the benefit you're receiving clean skin.
1036But, you may have a child who is forever scarred mentally, physically. We talked about the
1037strokes yesterday. Young people dying of strokes. We talked about the heart attacks. We talked
1038about the lymphoma. We talked about the acute pancreatitis. Even if you don't die from
1039pancreatitis it's very painful. We talked about the hearing loss. There's vision problems. There
1040are eighteen different warnings with this drug. Read them. And if you still think it's worth it,
1041that's your decision. It's just not worth it."
1042The full interview can be found at the following links. Stupak gives an in-depth discussion about
1043the disturbing patterns that are seen in Accutane’s psychiatric side effects and how Roche has
1044suppressed and twisted around the evidence.
1045“The implications are clear. Accutane is a very powerful drug that has been linked to suicides,
1046birth defects and severe psychiatric/brain injuries. Either the FDA takes a more aggressive
1047stance in managing and controlling ALL the risks associated with Accutane, or every day in this
1048country our friends and loved ones will suffer severe consequences. Many of those
1049consequences, some have argued (ie. brain injuries, severe birth defects), may even be a fate far
1050worse than death.”
1051Did Accutane Have a Role In the Death of Bart Stupak, Jr.?
1052Part 1
1053http://suicideandmentalhealthassociationinternational.org/acba.html
1054Part 2
1055http://suicideandmentalhealthassociationinternational.org/acba1.html
1056Stupak weighed in on the FDA’s reluctance to take action in 2004.
1057“FDA must ensure that all health prescribers and patients receive education about all the effects
1058of this drug, including psychiatric. The current voluntary informed consent forms must be made
1059mandatory.”
1060“The agency cannot continue to claim this drug is safe, while at the same time say Accutane may
1061cause serious psychiatric events, including suicide. In fact, the FDA has evidence - animal
1062studies and a new PET human brain scan study - which demonstrate that Accutane affects the
1063brains of young people.”
1064"This past month, I have spoken with three more families who have lost their sons to Accutane,
1065
1066yet the FDA and the manufacturers of Accutane ignore this fact."
1067On October 24th, 2006, former patient Hans Peterson walked into the office of Chicago
1068dermatologist Dr. David Cornbleet and stabbed him to death because the Accutane Cornbleet
1069prescribed Hans caused him many permanent side effects including impotence. A year after the
1070murder, Chicago police were tipped that Hans had fled the United States and obtained French
1071citizenship down on the island of St. Martin located in the Caribbean. This is where he
1072eventually turned himself in to French authorities and confessed to the crime, which under
1073French Law, protected him from being sent back to the US to face trial. Here are a few articles
1074about this story.
1075Man Surrenders In Murder Of Downtown Dermatologist, Suspect Allegedly Admitted To
1076Revenge Killing
1077http://cbs2chicago.com/local/Dr.David.Cornbleet.2.339075.html
1078Confessed murderer's father talks about drug's effects
1079http://abclocal.go.com/wls/story?section=local&id=5697503
1080Accused Killer's Dad: Slain Doctor Partly To Blame
1081http://www.nbc5.com/news/14291306/detail.html
1082Murder suspect may have believed doctor made him impotent
1083http://www.beforeyoutakethatpill.com/papers/accutane.txt
1084Suspect in doctor's murder to be tried on island
1085http://abclocal.go.com/wls/story?section=local&id=5612206
1086Dateline NBC: In murder case, a French disconnection
1087http://www.msnbc.msn.com/id/23578261/
1088According to one of his final blogs on the Ro/Accutane Action Group forum, before turning
1089himself in, Hans wrote,
1090“Justice will not be found through the legal system. Would taking some of their money even be
1091justice? Their lives would go on, just with a little less money. Our lives will never be the same.”
1092The Cornbleet family has set up a website to create more awareness about this case and to
1093generate a following for the extradition of Hans Peterson back to the United States.
1094http://drdavidcornbleet.blogspot.com/ In his thesis titled “A Tragedy with Multiple Victims
1095and Multiple Villains” Hans Peterson’s father, Dr. Thomas Peterson writes,
1096“Hans believed that it was Accutane that caused him so much pain and anguish. Since the
1097murder, many, many blogs that Hans wrote about how Accutane ruined his life have been
1098discovered. Reading the blogs is like reading the secret diary of a young man who is going mad.
1099In fact, the Accutane had caused Hans to become psychotic, a permanent condition that
1100developed in the first two weeks after ingesting the drug. The effects do not go away, there is no
1101
1102antidote, and Hans, an exceptionally intelligent man, knew that his life was over. He blamed Dr.
1103Cornbleet and eventually decided that vigilante justice was the only justice possible.”
1104“The FDA has allowed Roche to continue to market this drug by putting more responsibility on
1105the prescribing doctor. Unfortunately, not all doctors are responsible.”
1106“In 1997, Liam Grant from Ireland committed suicide while taking Accutane. His father (Liam
1107Grant Sr.) was wealthy and funded research on the physical effects of Accutane on the brain. J.
1108Douglas Bremner, Professor of Psychiatry and Radiology and Director of the Emory University
1109Medical School Clinical Neuroscience Research Unit has done this research [Am J Psychiatry
11102005; 162:983-991] and it is showing damage to the emotional part of the brain from Accutane
1111through PET scans. He asked Roche to provide him with Accutane to help with further research.
1112They refused. They do not want any research to show that Accutane damages the brain because
1113that would be detrimental to their future legal cases. Their defense is that there is no scientific
1114evidence of any damage, and they dismiss these cases of psychosis and suicide as people who
1115were going to go insane anyway.”
1116“In his book, The Lucifer Effect, renowned social psychologist Phillip Zimbardo explores the
1117“process of transformation at work when good or ordinary people do bad or evil things.
1118Professor Zimbardo discusses the power of the System, (the ‘big picture…big power’) to create a
1119situation in which evil triumphs over good. He calls this phenomenon, ‘The Lucifer Effect.’
1120America’s health care system is now so corrupted by the millions of dollars being fed into it by
1121big pharmaceutical companies that, arguably, the system is creating unknown numbers of
1122situations ripe for the Lucifer Effect to prevail. Accutane is just one of an unknown number of
1123drugs still on the market because Big Pharma is putting millions of dollars into Congress, the
1124overseers of our Health Care System.”
1125“When Roche’s company’s own safety experts recommended in 1997 changing the U.S. label
1126on Accutane to reflect the evidence that the drug ‘probably caused’ depression and other
1127psychiatric illnesses in some patients, the marketing department warned that such a warning
1128would impact the marketing strategy and profits (estimated at over $700 million).”
1129“Accutane is Roche’s number one selling product. Roche refuses to supply information on the
1130adverse reaction reports they receive.”
1131“The FDA has implemented programs; including writing letters warning prescribing physicians
1132to have patients sign an ‘Informed Consent’ form. Roche negotiated to make this a voluntary,
1133rather than a mandatory, form.”
1134“According to Professor Zimbardo, ‘Powerful Systems Exert Pervasive Top-Down Dominance’
1135Big Pharmaceutical’s million of dollars are at the top of the United States Health Care System. It
1136is this system that has created ‘Multiple Victims and Multiple Villians.’ There is plenty of blame
1137to go around in the Peterson/Cornbleet tragedy.”
1138A Tragedy with Multiple Victims and Multiple Villains
1139http://drtompeterson.blogspot.com/
1140
1141Another recent murder involving Accutane
1142Monroeville Man to Stand Trial in Fatal Cheerleader Stabbing
1143http://www.foxnews.com/story/0,2933,296873,00.html
1144In her article titled “Roche puts Accutane profits over Lives of Consumers” journalist Evelyn
1145Pringle writes,
1146“In 1985, Accutane's package insert directed at doctors first mentioned reports of depression in
1147patients taking the acne drug, which means that more than 20 years ago, Hoffmann-La Roche at
1148least suspected there might be a risk of depression and suicide by persons taking the drug.
1149However, Roche's financial records show that the company is not about to let a little thing like
1150the death of its customers get in the way of corporate profits, because the drug is still a best seller
1151and young people with no history of depression who take it are still killing themselves.”
1152“And once again, according to BBC News, ‘Roche insists there is no proven relationship
1153between the drug and depression.’ Roche's comments to the BBC are clearly dishonest
1154considering that in 1986, doctors were notified that Accutane users who became depressed saw
1155their depression lift when they stopped taking the drug but return when they were placed back on
1156the medication. Doctors were also informed that simply stopping Accutane therapy might not be
1157sufficient to treat the depression and that follow up on the depression might be necessary.”
1158“Public health officials had been voicing concerns about patients committing suicide while on
1159Accutane for well over a decade. For instance, a 1998 memo from the FDA's medical officer in
1160charge of Accutane states: ‘Given all the pieces of evidence available, it is difficult to avoid the
1161conclusion that Accutane can adversely affect the adult human brain in clinically significant
1162ways and that Accutane use is associated with severe psychiatric disease in some patients.’ The
1163memo recommends ‘active consideration of removal of Accutane from the market.’ But instead
1164of removing the drug from the market, on February 25th, 1998, the FDA required Roche to add
1165the following bold-face warning to drug's physician package insert: ‘WARNINGS - Psychiatric
1166Disorders: Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide
1167attempts and suicide. Discontinuation of Accutane therapy may be insufficient; further
1168evaluation may be necessary. No mechanism of action has been established for these events. Of
1169the patients reporting depression, some reported that the depression subsided with
1170discontinuation of therapy and recurred with reinstitution of therapy.’"
1171“In perverse twist of logic, in the same year, Roche began actively marketing Accutane as a
1172treatment for depression, under the theory that it could help people who were suffering from
1173depression due to poor self-image as a result of acne. On March 5th, 1998, Roche received a
1174letter from the FDA stating that such promotion was false and misleading, and that Accutane had
1175never been approved for the treatment of depression, and that in fact, just the opposite was true.
1176The letter stated in relevant part: ‘Roche ... has not systematically studied the ability of Accutane
1177to modify or prevent such illnesses as depression and has presented no basis for asserting that
1178Accutane is effective in improving the psychosocial and emotional well-being of such patients.
1179This claim is particularly troublesome in light of information recently presented in a Dear Doctor
1180letter, that Accutane may cause depression, psychosis, and rarely, suicidal ideation, suicide
1181
1182attempts and suicide.’"
1183“In July of 1998, the FDA becomes aware that French authorities had already required the
1184addition of an Accutane ‘suicide attempt’ warning in 1997, of the 1992-94 French study
1185associating Accutane with depression, and of Roche's failure to disclose this information to the
1186agency.”
1187Roche puts Accutane profits over Lives of Consumers
1188http://www.lawyersandsettlements.com/articles/00299/Accutane_Profits.html
1189“Unfortunately hundreds of parents already know that Accutane can cause some teenagers to
1190commit suicide, but new evidence of a link between the acne drug and depression in the journal,
1191Neuropsychopharmacology, will hopefully put an end to the years of claims by Hoffmann-La
1192Roche that its drug is not responsible for the suicides. The drug maker's explanation for the
1193sudden unexpected suicides among teens on Accutane has always been to say that teens were
1194likely to be depressed due to their acne.”
1195“For years, Roche has denied that Accutane causes depression and suicide and internal FDA
1196documents show the agency was aware of these risks almost since the drug came on the market.”
1197“The new scientific evidence will hopefully put to rest the ridiculous claim that teens on
1198Accutane commit suicide because they have acne. However, the news is not likely to offer much
1199solace to all the grieving parents. According to the Guardian article, last year in the UK, Jason
1200Spiller, 16, killed himself after starting the drug in April 2005. The previous year, David
1201Roberts, a 20-year-old, killed himself, and in 1997, Seumas Todd, 20, son of the actor Richard
1202Todd, killed himself while taking the drug.”
1203“Documents introduced at a December 11th, 2002, Congressional hearing by the House
1204Oversight and Investigation Subcommittee, revealed a 1998 letter to the FDA from an official at
1205the CDC, that compares Accutane to the infamous cancer and leprosy drug Thalidomide, a well
1206known cause of birth defects, stating, ‘we simply need to remove the drug from the market.’
1207The committee also discussed the unnecessary health problems caused by the high rate of ‘offlabel’ use of Accutane by individuals who did not have severe cystic acne, the only condition the
1208drug is FDA approved to treat. Dr Janet Woodcock, director of the FDA's Center for Drug
1209Evaluation and Research, testified that, ‘A proportion of people treated with this drug in the last
1210decade had mild acne and should've been treated with other drugs.’ In fact at the time, the offlabel use of Accutane was so prevalent, that some experts estimated that the improper use was
1211close to 90% among women.”
1212“To date, other serious side effects associated with Accutane include problems with the pancreas,
1213liver, stomach, bones, muscles, hearing, vision, allergic reactions, blood sugar, or red and white
1214blood cells. According to the iPLEDGE web site, the most common side effects include dry skin,
1215chapped lips, dry eyes, and dry nose that may lead to nosebleeds.”
1216
1217“The FDA needs to yank this drug off the market once and for all. Weighed against its endless
1218list of serious side effects, there is no justifiable reason to keep it on the market. Let the drug
1219companies develop a new drug to treat acne.”
1220FDA Needs To Ban Accutane
1221http://usa.mediamonitors.net/content/view/full/35718
1222http://www.lawyersandsettlements.com/articles/00334/Accutane_Ban.html
1223
1224During the past two decades many Accutane patient support groups and activist groups have
1225emerged all around the world. In 2001, Andrew Hart from Sydney, Australia created the
1226Australian Roaccutane Survivors Group (Roaccutane is Accutane outside the USA). On their
1227website, Hart describes Accutane’s resemblance to vitamin A toxicity, and the many chronic
1228latent symptoms experienced by former Accutane users,
1229"It is the belief of the Australian Roaccutane Survivors Group (ARSG) that many Australians are
1230suffering adversely both in the short- and long-term from the acne drug Roaccutane. Doctors are
1231still failing to adequately warn patients of the currently known short-term risks. More
1232concerning, many patients are complaining about long-term side effects that may appear years
1233after finishing therapy and which may last for up to 15 years post-therapy. These side effects are
1234not being related to a patient's previous ingestion of Roaccutane, especially since the patient is
1235unlikely to consult the same dermatologist for such complaints and despite the fact that in many
1236cases, the patients’ skin/eyes/hair are still very dry and continue to exhibit a sensitivity to vitamin
1237A ingestion. Even worse, the majority of patients who receive Roaccutane have mild acne which
1238means the majority of Roaccutane is prescribed outside of the strict licensing limitations which
1239restrict it to the most severe disfiguring cases of acne. The ARSG believes that most doctors and
1240health authorities are yet to appreciate the gravity of this situation.
1241The side effects reported by people in the years post -therapy include those characteristic of
1242hypervitaminosis A; (vitamin A toxicity) and include:
12431.Neurological Toxicity: chronic fatigue, visual disturbances, headaches, weakness, changes in
1244coordination, vertigo, chronic neuropathic pain, nausea, psychiatric disturbances (psychosis,
1245schizophrenia, depression, suicide), confusion, irritability, lack of concentration, memory
1246difficulties, depressed libido, male impotence, insomnia, tinnitus.
12472. Musculoskeletal Problems: joint pain, back pain, bone pain and tenderness, muscle aches and
1248pains, stiffness, decreased flexibility and range of motion, bone spurs.
12493. Mucocutaneous Toxicity: dry and peeling skin/eyes/hair/lips/nose, hair loss, hair thinning,
1250hair changes, rashes, dermatitis, eczema, chronic skin/eye/lip infections.
12514. Ocular Problems: dry eyes, conjunctivitis, cataracts, blurred vision, double vision, optic
1252neuritis, papilledema, changes in night vision.
12535. Gastrointestinal Problems: loss of appetite, weight loss, irritable bowel syndrome, Crohn's
1254disease, Ulcerative colitis, pancreatitis, nausea, non-specific gastrointestinal changes and
1255inflammatory bowel diseases.
1256
12576. Hormonal and Sexual Dysfunction: abnormal menstruation (women), impotence (men),
1258painful intercourse.
1259These side effects are now accepted as short-term risks of Roaccutane therapy. Patients are not
1260being warned however, that many of these symptoms may persist up to 15 years or more posttherapy."
1261http://www.drugawareness.org/Archives/1stQtr_2003/record0025.html
1262David Chow, chairman of the Ro/Accutane Action Group in the UK, has suffered for several
1263years from “a multiplicity of long-term side effects” and a constantly painful lip condition called
1264exfoliative cheilitis. His full story can be found at the Ro/Accutane Action Group Forum.
1265http://ragforum.freeforums.org/index.php I’ve included a brief summary of his story below,
1266“In 1994, at the age of 17, I took a course of isotretinoin (Roaccutane) for mild acne, a decision I
1267have regretted ever since. In my case, the side-effect of dry lips has progressed to persistent
1268exfoliative cheilitis. My lips are constantly painful, fissured, swollen and prone to recurrent
1269infections, making everyday activities such as eating, drinking and even smiling (though I don’t
1270have much to smile about these days) a daily ordeal. My ability to speak for any length of time
1271is so severely impaired that I am unable to work. I have also developed central nervous system
1272problems similar to those associated with Roaccutane. As a result of a report submitted by me to
1273the UK’s Medicines Control Agency, cheilitis now appears as a side-effect on all prescribing
1274information sheets. However, this possible side-effect has been known and listed for some 20
1275years 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
1276me wonder what the MCA is for. More pertinently, Roaccutane is being prescribed outside of its
1277licence, as it was originally intended for only those who had the most severe, recalcitrant forms
1278of cystic nodular acne. Studies have shown that the extent of off-label prescribing may be as high
1279as 80 percent. You may be familiar with the association between isotretinoin therapy and
1280suicide, consistently denied by Roche, the manufacturer of Roaccutane, and the medical
1281dermatological establishment. I can’t help but wonder about the volume of adverse reaction
1282reports they seem to be ignoring. Since attending a meeting last December in London, organized
1283by Mr. Liam Grant, whose son committed suicide after a course of Roaccutane, I have become
1284aware of many others whose lives have been damaged by isotretinoin therapy. I am seeking a
1285dermatologist who would be prepared to review my case as well as others in the hope that we
1286might be able to seek some redress from Roche for our years of pain and impaired prospects.
1287David Chow, Chairman of the Accutane/ Roaccutane Action Group (UK)”
1288www.accutaneaction.com and www.ragforum.com (this is the web address to the old forum)
1289Why weren’t we told about this acne drug
1290http://www.healthy.net/scr/article.asp?Id=3401
1291Roche has known since the 1970’s that Accutane causes side effects in 100 % of everyone who
1292takes it. Everybody gets dry/cracked/fissuring lips while on it, which is a definitive sign of
1293vitamin A toxicity. Dermatologists tell their patients that they need to endure the most common
1294side effects of Accutane (dry skin, dry lips, photosensitivity, dry eyes) in order to gain a
1295
1296therapeutic acne reducing effect. Do these patients realize that these specific symptoms they're
1297experiencing are due to the vitamin A toxicity syndrome caused by the Accutane pills they are
1298taking? Dermatologists usually don't disclose to their patients that they are basically poisoning
1299their body with vitamin A in order to reduce their acne, but a few dermatologists really do tell it
1300how it is by saying that Accutane causes "controlled vitamin A poisoning” as illustrated by the
1301following quote from a dermatologist’s website about Accutane,
1302“I’ve always tried to explain it as controlled vitamin A poisoning, as the potential side effects are
1303similar to those that would occur if you took far too much oral vitamin A.”
1304https://www.dermadoctor.com/pages/newsletter96.asp?WID=%7B8D162C43-114F-491AA6F4-4E4057D8F8C3%7D
1305It has been estimated that up to 90 % of all Accutane prescriptions are going to people with mild
1306to moderate acne. All you have to do is look at the sales of Accutane, compare it to the small
1307percentage of people with severe cystic acne, and it becomes obvious. Making matters worse,
1308the dermatologists are getting all of their information from Roche drug sales reps and are not
1309conducting any due-diligence of their own, which is why some of the blame has to be placed on
1310them. These doctors are using a powerful drug that can inflict chronic latent severe side effects
1311upon teenagers and young adults who have their entire lives ahead of them.
1312Initially, Accutane was only meant to be prescribed for severe cystic acne, but it is still debatable
1313whether or not the drug should even be used for this type of severe acne because the patient
1314might end up with side effects that are far worse than severe cystic acne. By prescribing
1315Accutane for “off-label” uses such as mild and moderate cases of acne, dermatologists have
1316radically deviated from its strict prescribing guidelines. This is definitely good for business
1317because it increases the sales of the drug over 2000 percent, but not so good for the health of
1318millions of innocent and naive teenagers who have been exposed. It is clear that the first dictum
1319of the practice of medicine, to “first do no harm,” is being ignored. One thing becomes very
1320obvious when you examine the whole Accutane situation. Dermatologists only care about clear
1321skin, your health and bodily functions mean absolutely nothing to them.
1322We're talking about an acne medication. Most people rightfully think that acne medications are
1323all safe because acne itself is a benign non-life-threatening condition. This is logically how it's
1324supposed to be, but Roche, the FDA, and even some dermatologists have done an excellent job
1325of deceiving everybody. A few dermatologists are much more ethical when it comes to
1326prescribing Accutane and recognizing its dangers. In 1983, Dr. Frank Yoder, one of the two
1327doctors who originally discovered Accutane to be an effective acne medication, wrote a letter to
1328the American Medical Association stating,
1329“I wish to express my concern and anxiety over the potential tragedy that might arise from abuse
1330and misuse of Accutane…the potential toxicity of this drug has been seriously underemphasized.” [Isoretinoin: A Word of Caution 249 JAMA 350 (1983)]
1331The risks of taking Accutane are so great that the FDA has taken the remarkable step of requiring
1332each prescription to come with a medication guide that explains the side effects in non-technical
1333
1334language. But the Accutane Medication Guide didn’t come out until 2001, which was two
1335decades too late for thousands of people who had been inflicted with severe side effects. Even
1336though the medication guide was released in 2001, not all dermatologists and pharmacists have
1337been handing it out to everybody. It contains a laundry list of warnings such as,
1338“Stomach area (abdomen) problems. Certain symptoms may mean that your internal organs are
1339being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus
1340(connection between mouth and stomach). If your organs are damaged, they may not get better
1341even after you stop taking Accutane. Stop taking Accutane and call your doctor if you get:
1342-severe stomach, chest or bowel pain
1343-trouble swallowing or painful swallowing
1344-new or worsening heartburn
1345-diarrhea
1346-rectal bleeding
1347-yellowing of your skin or eyes
1348-dark urine”
1349“Vision problems. Accutane may affect your ability to see in the dark. This condition usually
1350clears up after you stop taking Accutane, but it may be permanent. Other serious eye effects can
1351occur. Stop taking Accutane and call your doctor right away if you have any problems with your
1352vision or dryness of the eyes that is painful or constant.”
1353“Hearing Problems. Some people taking isotretinoin have developed hearing problems. It is
1354possible that hearing loss can be permanent. Stop using Isotretinoin and call your prescriber if
1355your hearing gets worse or if you have ringing in your ears.”
1356“Spontaneous reports of osteoporosis, osteopenia, bone fractures, delayed healing of bone
1357fractures, muscle weakness, and calcifications of tendons and ligaments have been seen in the
1358Accutane population. There are reports that some patients had stunted growth after taking
1359Accutane for acne as directed.”
1360Contrary to popular belief, the human body doesn’t completely stop growing until the age of 21,
1361sometimes later. It was known decades before Accutane was released onto the market that
1362vitamin A toxicity can cause premature growth plate closure in children and adolescents, which
1363is why nobody should be allowed to take Accutane if they're under the age of 21, but
1364dermatologists still routinely prescribe it to teenagers as young as 13, so the derms have
1365apparently never gotten wind of this side effect because they tend to get their information from
1366Roche and don’t ever think for themselves. The testimonial I’ve quoted below illustrates how a
1367family discovered the growth plate closure problem the hard way. It was posted on a Yahoo
1368Geocities Accutane message board way back on December 12th, 1999.
1369“It troubles me greatly to see that young growing teenagers are being given this drug. I have two
1370boys that had their growth plates rapidly closed by this drug. Roche lists as its first side effect in
1371their South African package insert: premature epiphyseal plate closure. Medline has a pediatric
1372precaution stating that Accutane is absolutely contraindicated in ages 0-16 due to premature
1373epiphyseal plate closure. The side effects are much more powerful in a growing body. My boys
1374
1375bones never finished spreading and maturing. They also have premature arthritis. This drug
1376robbed them of all their dreams as we are a very tall family and they were never told it would
1377stop their growth. We finally got the charts from the doctor and he wrote that he old us of
1378growth retardation. My boys would have never taken this drug if they had been told the truth.
1379They did not have anything but pimples. Unfortunately for us, we believed the doctor. Even in
1380the US package insert it only says that premature epiphyseal closure is suggestive. How can it be
1381known in one country and suggestive in another. Someone is not telling the truth. Most kids
1382don't even realize that this drug stopped them from growing. We had been tracking our sons
1383height and have x-rays before, during and after on our 14 year old. His bones were completely
1384sealed shut. My boys are now 17 & 19 and they are still the same size as they were at 14 & 15.
1385Why aren't the doctors telling the truth$$$”
1386http://www.geocities.com/HotSprings/Spa/2738/january00.html
1387The research document titled “Health risks related to high intake of performed retinol in the
1388Nordic countries” contains an abundance of information about retinol toxicity (AKA vitamin A
1389toxicity or hypervitaminosis A) and its deleterious effects of the musculoskeletal system. Below,
1390I’ve listed a few important quotes.
1391“Synthetic retinoids are widely used in the treatment of skin diseases and some cancers. Their
1392toxic effects mimic those of hypervitaminosis A and include musculoskeletal symptoms. The
1393patients may complain of bone and joint pain, stiffness, and/or impairment of function. Cortical
1394hyperostoses and ligamentous calcification are the most frequently reported skeletal changes
1395(DiGiovanna et al., 1986; Pittsley and Yoder, 1983). In children, premature epiphyseal closure
1396has been described following high dose retinoid therapy (Milstone et al., 1982). Of higher
1397importance is the concern that long-term therapy with synthetic retinoids might induce
1398osteoporosis. Animal studies have predicted development of osteoporosis as a dose-dependent
1399toxic effect (reviewed in Teelmann 1989). In man, synthetic retinoids have been shown to alter
1400bone turnover (Decensi et al., 1999; Kindmark et al., 1998). Decreased bone mineral density has
1401been found in retinoid treated patients compared to age- matched controls (DiGiovanna et al.,
14021995; Leachman et al., 1999; Okada et al., 1994). The risk of undesirable skeletal effects is of
1403course dependent on the choice of drug, dosage, and duration of treatment, but it nevertheless
1404clearly exists, which the clinical guidelines advising caution and careful monitoring of bone
1405symptoms during long-term therapy witness (Glover et al., 1987; Nesher and Zuckner, 1995).”
1406“As described in chapter 5, the symptoms of retinol toxicity include hypercalcaemia, bone and
1407joint pain, as well as skeletal abnormalities, clearly indicating that high doses of retinol interferes
1408with calcium and bone metabolism. The mechanisms of these effects are not well understood,
1409but as will be discussed below are likely to be complex. However, although these toxic effects
1410have been known for decades, the effect of physiological ranges of retinol intake on skeletal
1411integrity has not received much attention.”
1412“Bone, along with the skin and the developing embryo, are some of the targets for retinol activity
1413and these tissues appear to be more susceptible to deleterious effects than others (Teelmann,
14141989)”
1415
1416“A large body of evidence documents that large doses of retinol have undesirable effects on the
1417skeleton. It is generally accepted that toxicity is associated with consumption of retinol, whereas
1418carotenoids in foods are not known to be toxic in healthy persons.”
1419“Bone alterations are the most prominent and well-described effect in toxicology studies in
1420animal models. A striking feature is the consistent occurrence of spontaneous fractures. In a
1421recent review, Binkley and Krueger (2000) note that searching Medline, they found no other
1422compounds reported to produce spontaneous fractures. Other manifestations include severe
1423osteoporosis, thinning of the bone, retardation of growth, exostosis, and premature growth-plate
1424closure (Carroll et al., 1997; Niemann and Obbink, 1954; Tang et al., 1985).”
1425“As described in chapter 5, chronic hypervitaminosis A produces a broad spectrum of symptoms
1426from a variety of organ systems. The clinical picture may be quite diversified and non-specific.
1427In many cases, the correct diagnosis is difficult and may not be made for months or even years.
1428Skeletal symptoms are a major feature of chronic retinol intoxication and they have been
1429described in a number of case reports. They include general muscular and skeletal discomfort,
1430severe bone pain, especially in the long tubular bones, tender swellings, disability and limitation
1431of motion (Caffey, 1950; Frame et al., 1974; Romero et al., 1996). Common clinical findings are
1432hypercalcaemia, hyperostosis and ligamentous calcification (Ragavan et al., 1982). Other extraskeletal calcifications, like nephrocalcinosis, have been described (Frame et al., 1974). At a later
1433stage, demineralisation of bones or osteoporosis may be seen (Bartolozzi et al., 1967; Frame et
1434al., 1974; Gerber et al., 1954). In children, growth retardation and premature epiphyseal closure
1435may occur (Pease, 1962). In bone biopsies taken from subjects intoxicated with retinol, an
1436increase in extent of the bone resorbing surfaces was seen, while the formation surfaces were on
1437the low side of the normal range (Jowsey and Riggs, 1968). The presence of enlarged osteocyte
1438lacunae, so-called ‘osteolysis,’ is another characteristic of retinol intoxication, that has been
1439described in both humans (Jowsey and Riggs, 1968) and animals (Belanger and Clark, 1967).
1440These alterations are compatible with loss of bone tissue.”
1441Health risks related to high intake of performed retinol in the Nordic countries
1442http://folk.uio.no/runeb/pdf%20filer/Vitamin%20A%20toxicity.PDF
1443Roche’s track record for creating dangerous drugs extends beyond Accutane. Take Lariam for
1444example, which is used to prevent Malaria. Just like Accutane, Lariam has been linked to several
1445cases of permanent brain damage, severe psychiatric side effects, suicides, and murders. Roche
1446is also responsible for developing the date-rape drug Rohypnol, and the dangerously addictive
1447tranquilizer Valium. With all this in mind, it becomes clear that creating deadly drugs with
1448mind-altering side effects is their forte.
1449"service members have been diagnosed with permanent brainstem and vestibular damage from
1450being given this drug despite the fact that alternative drugs might have been chosen to prevent
1451infection."
1452Senator: GIs Got Brain Damage From Malaria Drug
1453http://www.yourlawyer.com/articles/read/8121
1454
1455“A San Antonio couple has filed suit in New Jersey state court charging drug giant Hoffmann-La
1456Roche with ‘knowingly withholding or misrepresenting information’ about side effects of its
1457anti-malaria drug called Lariam.”
1458“Lariam also made news this summer, after three Fort Bragg Special Forces soldiers given the
1459drug during deployment in Afghanistan returned home and allegedly killed their wives. Two
1460also committed suicide.”
1461Suit: Lariam drugmaker hid side effects
1462http://www.aaconsult.com/lariam/lariam_news_31.html
1463“Manofsky is a decorated serviceman, a weapons targeting specialist, a naval aviator who has
1464also boated, skied and dived. Now he can't do any of those things. Manofsky's problems began
1465when he was sent to Kuwait in the run-up to the war in Iraq. Like thousands of others, he was
1466given a drug called Lariam to prevent malaria. He got sick. He couldn't sleep and he started
1467having psychological problems. ‘I lost it. I literally went nuts. I was talking to myself. I was
1468talking to myself in the chow. I was waking up mad. I would go to bed mad. Using my hands
1469to talk to myself.’ The panic attacks became so acute we had to rush him to the emergency
1470hospital five different times. He also went into seizures where his whole body was convulsing.”
1471Harmful Side Effects of Lariam
1472http://transcripts.cnn.com/TRANSCRIPTS/0405/26/i_ins.00.html
1473“’I've chased bad guys all around the world; been beat up, shot at; developed dengue fever and
1474encephalitis’ says Jim Prietsch, who has worked as a Washington, D.C., police officer and
1475protected U.S. and foreign leaders for the State Department and the World Bank. Nothing, he
1476adds, was as bad as what happened two years ago on back-to-back trips to Indonesia and Africa.
1477‘I started to have panic attacks, nightmares, hallucinations, by the time I got to Africa, I thought I
1478was going crazy. Problems got worse and worse. Finally, I had seizures like someone was
1479reaching inside my brain and flipping it upside down. I had no idea what was going on.’ Not
1480until a colleague from Europe saw the white pill Prietsch took once a week ‘He told me, 'That's
1481your problem - that stuff is poison.’’ An infectious-disease specialist later confirmed that the
1482cause of Prietsch's problems was most likely the pills he'd been taking: mefloquine.”
1483Lariam’s Legacy
1484http://home.att.net/~kjo/lariam2.htm
1485“Seven U.S. servicemembers have been diagnosed with inner ear damage ‘most likely’ caused
1486by use of the anti-malaria drug Lariam, said a Navy surgeon treating them. Use of the drug is the
1487only factor the seven members have in common, he said.”
1488“’Lariam studies have indicated that Lariam can damage the vessels and nerves of the brain, and
1489the inner ear is subject to that same damage because it is part of the brain,’ said Hoffer, an ear,
1490nose and throat surgeon who has practiced in the field for 10 years.”
14917 servicemembers ‘likely’ ill from malaria drug
1492
1493http://www.estripes.com/article.asp?section=104&article=21624&archive=true
1494Hoffmann-La Roche is part of a leading international health care company called "The Roche
1495Group" with its principal businesses in pharmaceuticals, diagnostics and vitamins. This group is
1496made up of many subsidiaries, they are the seventh largest pharmaceutical company in the world
1497and are active in more than 150 countries. The Roche Group is well known all throughout the
1498legal system because of their long-standing track record with regards to both civil and criminal
1499activity. In 1999 Hoffmann-La Roche was named the top corporate criminal by the publication,
1500Multinational Monitor, after they pleaded guilty and paid the largest criminal fine in history,
1501$500 million to the American Department of Justice, $462 million to the EU, fines in several
1502other countries, plus a 10 billion dollar settlement to creditors and suppliers they had defrauded
1503in the US, EU and most other countries where they were selling vitamins. This happened after
1504they were caught perpetuating a vitamin conspiracy/cartel where they collaborated to artificially
1505inflate the price of food fortifying vitamins in the United States and all over the world for over a
1506decade. FBI and EU documentation on this fraud showed an extraordinary level of corruption,
1507lies, and misrepresentations made by Roche personnel at all levels of the organization, from its
1508senior board of directors in Basal, Switzerland, through the separate Roche board of directors in
1509each of the countries where Roche was conducting and perpetuating the fraud. Several of
1510Roche’s corporate executives were sentenced to prison for their roles in the vitamin cartel.
1511United States Attorney General Janet Reno stated about the vitamin cartel,
1512“On a daily bases for the past 10 years, every American consumer paid to eat and drink or use a
1513product whose price was artificially inflated. Day by day, consumers took a hit in their wallet so
1514that these co-conspirators could reap hundreds of millions of dollars in additional revenue.”
1515She went on to state that,
1516“This cartel was truly extraordinary. It lasted almost a decade and involved a highly
1517sophisticated and elaborate conspiracy to control everything about the sale of these products.
1518These companies fixed the price; they allocated sales volumes; they allocated customers; and in
1519the United States they even rigged bids to make absolutely sure the cartel would work. The
1520conspirators actually held “annual meetings” to fix prices and to carve up world markets, as well
1521as frequent follow-up meetings to ensure compliance with their illegal scheme. The enormous
1522effort that went into maintaining this conspiracy reflects the magnitude of the illegal revenues it
1523generated as well as the harm it inflicted on the American economy.”
1524"…Indeed, the members of the vitamin cartel, including Hoffmann-La Roche, continued to meet
1525and carry out their global agreement even while Hoffmann-La Roche was being investigated,
1526prosecuted, and fined $14m in March 1997 for participating in the citric acid cartel."
1527"The vitamin cartel was led by the top management at some of the world's largest corporations,
1528including one company, F. Hoffmann-La Roche - which continued to engage in the vitamin
1529conspiracy even as it was pleading guilty and paying a fine for its participation in the citric acid
1530conspiracy….some senior executives of this mult-national firm knew about the firm's
1531participation in international cartels in two industries. When the firm's illegal activities were
1532uncovered in one industry, and the firm had to plead guilty and pay millions of dollars in fines,
1533
1534those executives could have and should have terminated the firm's cartel activities in the second
1535(and larger) industry. Instead, those executives orchestrated false statements to enforcement
1536authorities, took steps to further conceal the firm's illegal activities, and continued to lead the
1537world's other producers in a global cartel."
1538http://www.accutaneaction.com/Frauds/roche_finc_frauds.html
1539The Ro/Accutane Action Group states on their website,
1540“The vitamin cartel was described by the US Attorney General as the most pervasive and
1541harmful criminal antitrust conspiracy ever uncovered, and Roche agreed to pay the largest fine in
1542criminal history because it was caught flagrantly violating the law.”
1543U.S. Outlines How Makers of Vitamins Fixed Global Prices
1544http://www.nd.edu/~mgrecon/datafiles/articles/vitamins.html
1545“Investigators were said to have been particularly angry at the executive, Kuno Sommer, because
1546he had lied about the existence of the vitamin cartel and his role following Roche's guilty plea in
1547another price-fixing case two years ago. In that case, involving citric acid, Roche paid a $14
1548million fine and promised to cooperate with investigators. Dr. Sommer, who had previously
1549lived in New Jersey when he served as North American regional manager for Roche, denied in a
15501997 interview with investigators that there was a vitamin cartel and said he was not aware of
1551any meetings or conversations involving price-fixing in that market, according to court papers
1552filed by the Government Thursday that are part of his plea agreement. In fact, at that time he
1553was still playing an important role in setting vitamin prices and allocating market share,
1554according to a plea agreement filed on his behalf Thursday in Federal court in Dallas. While
1555Justice Department officials said Dr. Sommer was not the highest-level executive who knew
1556about the conspiracy and cover-up, they did not say who might be prosecuted next. Among the
1557executives who did not receive immunity in the deal reached with Roche were Roland
1558Bronnimann, president of the Vitamins and Fine Chemicals division, and Andreas Hauri, a
1559former executive vice president and head of global marketing.”
1560“At a news conference here to announce the initial results of the investigation, Attorney General
1561Reno and other senior officials described a global conspiracy to fix vitamin prices. They said one
1562Swiss executive had agreed to return to the United States to serve a jail sentence, although he
1563was not the highest-ranking official involved in the scheme. At least seven other executives
1564remained under investigation.”
1565Firms Admit To Price Fixing
1566http://www.lubbockonline.com/stories/052199/bus_0521990021.shtml
1567“Two giant foreign companies agreed Thursday to pay $725 million in fines for plotting to raise
1568and fix the prices of vitamins used in virtually every American home and added to bread, milk
1569and breakfast cereal. The $500 million fine to be paid by F. Hoffmann-La Roche Ltd., a Swiss
1570pharmaceutical company, is the largest federal criminal fine ever imposed in any type of case,
1571Attorney General Janet Reno told a news conference. A German firm, BASF AG, agreed to pay
1572
1573a $225 million fine for its role in the conspiracy to increase vitamin prices in the United States
1574and around the world. Both companies pleaded guilty in U.S. District Court in Dallas.”
1575The New York Times: Tearing Down The Facade of 'Vitamins Inc.'
1576http://query.nytimes.com/gst/fullpage.html?res=9900E1DB1131F933A25753C1A96F958260&s
1577ec=health&spon=&pagewanted=all
1578In his book titled Why Animals Don’t Get Hearth Attacks - But People Do, Dr. Matthias Rath,
1579M.D. described Roche’s vitamin cartel.
1580“By the turn of the century, the world’s largest pharmaceutical and nutritional companies,
1581including Hoffmann-La Roche, BASF, Rhone-Poulenc, Archer Daniels Midland (ADM), Takeda
1582and other multinational corporations, had admitted to forming a so-called “vitamin cartel” to
1583conduct criminal price-fixing for vitamin raw materials. Hundreds of millions of people
1584worldwide were defrauded for almost a decade and had to pay artificially high prices for
1585vitamins and certain other essential nutrients. The U.S. Justice Department declared that this
1586vitamin cartel was the largest cartel ever discovered and named it an ‘economic conspiracy.’”
1587“Hoffmann-La Roche apparently invited BASF, Rhone-Poulenc, Takeda and other
1588manufacturers of vitamin raw materials to engage in criminal price-fixing on a global level. The
1589fraudulent profits these companies made from their criminal practices may have reached
1590hundreds of billions of dollars over the past 10 years. Compared to that, the fines these
1591companies had to pay were insignificant.”
1592“Not only should governments have sued these companies for the damage they had done, but
1593above all, consumers world-wide should have filed class action lawsuits against them. These
1594companies have harmed millions of people twice: First, they knowingly refused to promote and
1595disseminate lifesaving information about the use of vitamins for the prevention of heart disease,
1596thereby causing millions of heart disease patients to die unnecessarily over the past 10 years.
1597Second, they caused financial damage to hundreds of millions of people – literally every vitamin
1598consumer on earth.”
1599“My correspondence with Hoffmann-La Roche executives also proves the statements they and
1600others made that the corporate executives did not know about these criminal activities were lies.
1601The opposite is true: These corporate executives not only knew about these crimes, they were
1602the organizers. The executives responsible for these crimes should be prosecuted and held
1603responsible for their actions.”
1604“While that may take time, one benefit is already here today. All these companies have pleaded
1605guilty to criminal activities. Thus, everyone can describe these companies and their executives
1606for what they are – criminals who distinguish themselves from a street robber only by the
1607magnitude of their crimes.”
1608Scribd.com Why Animals Don’t Get Hearth Attacks - But People Do
1609http://www.scribd.com/doc/3859811/Why-Animals-Dont-Get-Heart-Attacks-but-People-Do
1610
1611Over the past 10 years, several anti-Accutane forums and posts have been closed down as a
1612result of legal threats against the servers by you know who. But today the evidence of all the
1613dangerous side effects is so overwhelming and indisputable Roche can't get away with launching
1614these types of legal threats anymore. Throughout the 80’s and 90’s, Roche settled a countless
1615number of severe side effects cases out of court and out of the public eye with gagging clauses.
1616Under the terms of the settlement, the victims could not come forward to tell their story or share
1617it with anyone. This is one of the tactics used by Roche to keep the most horrible Accutane side
1618effects and evidence continuously suppressed over a long period of time. In “Babies, Blemishes
1619and FDA: A History of Accutane Regulation in the United States” Julia Green from Harvard
1620Law School writes,
1621“Out of the spotlight, Hoffmann-La Roche continued to grapple with the repercussions of
1622Accutane related birth defects. By the mid 1990’s, Accutane had earned the company a
1623significant list of enemies, many of whom were looking to draw blood. Frank Yoder, in some
1624ways a patron Saint of Hoffmann-La Roche—after all, his 1976 discovery had resulted in a
1625tremendous money maker for the company—had spent the past fifteen years insulting Roche in
1626the Washington Post. A subset of the plaintiff’s bar called the Accutane Litigation Group had
1627also been chipping away at Hoffmann-La Roche. The company had settled a number of
1628expensive lawsuits. But each time documents were sealed, which meant new plaintiffs would
1629have to start from scratch. The plaintiff’s bar had become convinced that Hoffmann-La Roche
1630had acted recklessly—something which might entitle clients to steep punitive damages.”
1631http://leda.law.harvard.edu/leda/data/472/Green.html
1632Roche has never disclosed the total amount of money they've spent settling Accutane litigation
1633cases. In 1995, a medical student launched a legal campaign to sue Roche for over $10 million.
1634The lawsuit was later settled privately out of court, the details of this story can be read at the
1635following link,
1636http://www.accutane-info.com/lawsuits.php
1637Attorney Michael Hook of the law firm Hook Bolton Mitchell Kirkland & McGhee in Pensacola,
1638Florida, has put together a consortium of law firms to take on Hoffmann-La Roche in the courts.
1639Hook has spent the last 20 years of his legal career mainly defending doctors, hospitals and
1640insurance companies, but he described that his life changed dramatically in 2001 when he
1641decided to take up the challenge of suing a major drug company because in his words one must
1642commit "every waking moment and all of your resources to take them on."
1643Consortium of Firms Working on Accutane Litigation
1644http://www.law.com/jsp/law/sfb/lawArticleSFB.jsp?id=900005554550
1645Jury Validates Accutane Bowel Risk
1646http://goliath.ecnext.com/coms2/gi_0199-6746576/Jury-validates-Accutane-bowel-risk.html
1647In the article above, Hook said that Hoffmann-La Roche "knew what it was doing and made
1648billions in profits but did nothing to assess its drug, did not do tests even though scads and scads
1649
1650of people were reporting inflammatory bowel disease……..Some of my clients don't have
1651intestines, don't have colons--it's horrible what they have to live with, it got to the point where I
1652decided if I don't do this, who's going to? I knew it would require me to give up the rest of my
1653practice and really work on it continuously. But how long has this been going on, and no one
1654has gone after the company?"
1655Hook believes that the plaintiffs are on “solid ground with discovery evidence and experts.” Dr.
1656David B. Sachar is the plaintiffs lead expert. Sachar is the director emeritus of gastroenterology
1657at Mount Sinai School of Medicine in New York and until last month served as chair of the FDA
1658advisory committee on gastrointestinal drugs.
1659“Early on, [Sachar] said, 'I believe Accutane is causing inflammatory bowel disease,' His experts
1660have reviewed discovery materials and testified that the manufacturer withheld documents about
1661IBD and other key plaintiff issues.”
1662The first four trials have already been decided in favor of the plaintiffs, and Roche has been
1663ordered to pay Andrew McCarrell, Adam Mason, Kamie Kendall, and Jordan Speisman millions
1664of dollars because Accutane caused their inflammatory bowel disease leading to surgical removal
1665of their colons.
1666A short video from the Levin-Papantonio law firm in Pensacola, Florida
1667Accutane’s history and its connection with severe gastrointestinal disorders
1668http://video.google.com/videoplay?docid=-8081722726487714383&hl=en
1669Accutane Documentary on Youtube: The Ghost Under My Pillow
1670http://www.youtube.com/watch?v=RGzK448fKyw
1671Accutane litigation websites
1672http://accutane.poweradvocates.com/accutane_side_effects.html
1673http://www.accutane-injuries.com/side_effects.html
1674http://www.levinlaw.com/PracticeAreas/accutane.asp
1675http://www.ennislaw.com/accutane.html
1676http://www.lawyersandsettlements.com/case/accutane.html?ref=article290
1677Los Angeles Times: Acne drug is target of new suits
1678http://articles.latimes.com/2007/apr/16/business/fi-accutane16
1679“Tim Robbins is like millions of Americans, most of them teenagers and young adults, who have
1680taken the powerful drug Accutane and watched their embarrassing acne disappear within weeks.
1681Robbins is also one of nearly 500 individuals who say they paid a terrible price as a result and
1682are suing drug maker Hoffmann-La Roche Inc. The first trial opens today in Illinois. At issue is
1683whether the company downplayed the risk that the medication could cause serious
1684gastrointestinal diseases. But pharmaceutical giant Roche, which is based in Nutley, N.J., flatly
1685denies it and maintains that there is no reliable evidence that Accutane causes inflammatory
1686bowel disease. Many of the plaintiffs who contend that the treatment led to their conditions —
1687ulcerative colitis or Crohn's disease — say they can be treated with drugs or suffer only
1688
1689occasional but debilitating flare- ups. The conditions are characterized by abdominal pain,
1690diarrhea and weight loss. The problem was much more severe for Robbins, 28, a former
1691construction worker in Oak Ridge, Tenn. He had his colon removed and permanently lives with a
1692colostomy bag. ‘There are days when I wonder, why did this have to happen to me?' he said.
1693Robbins' trial is expected to start this summer.”
1694“Mike Papantonio, senior counsel at Levin, Papantonio, Thomas, Mitchell, Echsner & Proctor of
1695Pensacola, Fla., one of five law firms representing the Accutane plaintiffs. Papantonio said
1696lawyers would present documents in court that showed that the company long ago knew not only
1697that the drugs could cause gastrointestinal diseases but also that they were more common than
1698any other side effects listed on the drug's label. In addition, he said, there are more than half a
1699dozen instances in which internal company documents show that the company describes the drug
1700as a possible cause of the disease.”
1701Accutane Maker Roche AG Ordered to Pay $2.62 Million to Patient Who Developed
1702Inflammatory Bowel Syndrome After Using Drug
1703http://www.yourlawyer.com/articles/read/12872
1704Accutane Drugmaker Roche to Pay $2.5M for Man's Sickness
1705http://www.foxnews.com/story/0,2933,276175,00.html
1706Postponed Accutane trial set for Oct. 15 in Madison County
1707http://www.madisonrecord.com/news/197087-postponed-accutane-trial-set-for-oct.-15-inmadison-county
1708Florida man gets $7 million in lawsuit against Accutane
1709http://www.iht.com/articles/ap/2007/10/12/business/NA-FIN-US-Accutane-Lawsuit.php
1710Roche Owes $2.62 Million for Man's Illness, Jury Says (Update4)
1711http://www.bloomberg.com/apps/news?pid=20601085&sid=ahzh9Bep4qcs&refer=europe
1712Roche Must Pay Accutane User $7 Million for Illness (Update2)
1713http://www.bloomberg.com/apps/news?pid=20601202&sid=amiIZKeblTlE&refer=healthcare
1714Accutane Victim Awarded $7 million in Florida Lawsuit
1715http://www.newsinferno.com/archives/1909
1716Roche Must Pay $7 Million In Accutane Trial
1717http://www.pharmalot.com/2007/10/roche-must-pay-7m-in-accutane-trial/
1718Appeals Court Upholds $7 Million Accutane Judgement against Roche Pharmaceuticals
1719http://www.lawyersandsettlements.com/articles/10014/accutane-crohns.html
1720Accutane Injury Results in $10.5 Million Judgment
1721http://www.yourlawyer.com/articles/read/14268
1722
1723Jury Award 10.5 Million to Accutane Victim
1724http://blog.ennislaw.com/2008/04/23/accutane-case-won-105-million-verdict.aspx
1725Accutane: Slipping Through the Cracks Everywhere
1726http://www.lawyersandsettlements.com/features/accutane-cracks.html
1727Accutane: “It was the darkest place I’ve ever been.”
1728http://www.lawyersandsettlements.com/articles/01907/accutane-acne.html
1729Former Luvabull Takes On Drugmaker
1730http://www.nbc5.com/health/15218077/detail.html
1731Congressman Turns up the Heat on the FDA Over Accutane and Others
1732http://www.lawyersandsettlements.com/features/accutane-suicide.html
1733FDA Needs To Ban Accutane
1734http://www.lawyersandsettlements.com/articles/00334/Accutane_Ban.html
1735Roche puts Accutane profits over Lives of Consumers
1736http://www.lawyersandsettlements.com/articles/00299/Accutane_Profits.html
1737Accutane - Another Case of Too Little Too Late
1738http://www.lawyersandsettlements.com/articles/00163/accutane.html
1739Lethal Accutane still a Top Seller for Hoffmann-La Roche
1740http://www.lawyersandsettlements.com/articles/00290/accutane_sideeffects.html
1741http://www.opednews.com/articles/genera_evelyn_p_060828_lethal_accutane_stil.htm
1742Attorney Peter Kaufman on Accutane Litigation
1743http://www.lawyersandsettlements.com/articles/10501/-pharma-accutane-litigation.html
1744Accutane: Alleging high risks for heart and liver problems
1745http://www.lawyersandsettlements.com/search.html?keywords=Accutane
1746USA Today: Grieving father spends $1 million nest egg to investigate Accutane
1747http://www.usatoday.com/money/industries/health/drugs/2005-01-26-accutane-usat_x.htm
1748USA Today: Drugmaker rebuffed call to monitor users
1749http://www.usatoday.com/money/industries/health/drugs/2004-12-06-accutane-cover_x.htm
1750Accutane: Depression, Suicide and Degenerative Diseases
1751http://www.lawyersandsettlements.com/articles/01918/accutane-depression-lawsuit.html
1752Clear Skin with Killer Side Effects
1753http://members.tripod.com/~dhscribbler/acutane.pdf
1754
1755“The lawyers and staff of Ennis & Ennis P.A. would like to congratulate attorney Mike Hook
1756and his staff for their tremendous verdict in the amount of $10.5 million for a 24 year old Utah
1757woman who was diagnosed with ulcerative colitis after taking Accutane. This has been a well
1758kept dirty secret by the manufacturer Hoffmann-La Roche for many years. We are glad to see
1759these cases come to light and hopefully the word will spread to teenagers and young adults who
1760are still on the drug or are thinking of taking the drug. We have been working with Mike and his
1761staff since 2003 on these cases and it has been a long hard fight. The manufacturer has
1762stonewalled the litigants time and again and it is good to see these cases finally get to trial and let
1763the truth come out. Mike and his team have won 3 straight trials in New Jersey state court in the
1764amount of $2.5 million, $7.5 million and yesterdays verdict of $10.5 million. We are convinced,
1765based on our research, that there are many more victims out there who have not correlated their
1766illness to the drug accutane. Accutane has received much publicity for side effects including
1767depression, suicide and birth defects. The real dark secrets lie in the correlation between accutane
1768and IBD (Inflammatory Bowel Disease), Ulcerative Colitis, Crohn's, Liver and Kidney damage.”
1769“(OPENPRESS) May 31st, 2007 -- Ennis & Ennis P.A. announced that it has been retained by
1770almost 100 clients who have been diagnosed and treated for Inflammatory Bowel Disease (IBD),
1771Crohns Disease, Ulcerative Colitis, Kidney and Liver Transplants. Today's $2,600,000 verdict
1772against Hoffmann-La Roche validates our client's claims nationwide and in Canada. ‘We have
1773been working with trial team lawyer Michael Hook since 2003 on Accutane cases and we would
1774like to congratulate Michael Hook, David Buchanan and all the dedicated professionals who did
1775the behind the scenes work’ said Attorney David F. Ennis. Attorney David Ennis is quoted as
1776saying ‘It is a great day in America when a citizen of Alabama can hire a lawyer in Florida and
1777bring a claim in the great state of New Jersey against a Swiss manufacturer, (Hoffmann-La
1778Roche one of the biggest and most profitable pharmaceutical companies in the world) and a jury
1779of their peers over a three week time period can come to a reasonable verdict on liability and
1780damages.’ It renews your faith in the jury system and you hope American citizens realize that if
1781they ever give up their right of trial by jury they will lose all power and leverage against major
1782Corporations.”
1783New Jersey Jury Awards $12.9 Million to Three Patients Whose Use of Roche Acne Medication
1784Accutane Found to Cause Severe Bowel Illness
1785http://www.istockanalyst.com/article/viewiStockNews/articleid/2817847
1786http://www.lawyersandsettlements.com/settlements/12867/accutane-settlement-teens-awarded12-9-million-in.html
1787“The three plaintiffs are all Florida residents - Kelly Mace, 25, of Pensacola, along with Jordan
1788Speisman, 27, of Gainesville, and Lance Sager, 28, of Ft. Lauderdale. All were first prescribed
1789Accutane nearly a decade ago while still in their teens to relieve adolescent acne. All three
1790succumbed to various forms of IBD, including ulcerative colitis and Crohn's disease, while
1791taking Accutane or shortly thereafter.”
1792“Roche first advised physicians about a possible association between Accutane and
1793inflammatory bowel disease in 1984. In the ensuing years, the evidence accumulated by Roche
1794and outside scientists demonstrated that, far from a coincidence, Accutane was in fact inducing
1795inflammatory bowel disease in Accutane patients. Nonetheless, Roche failed to strengthen its
1796
1797warnings either to patients or prescribing physicians. The jury saw evidence of Roche studies,
1798never published for the scientific and medical community, that Accutane's by-products damage
1799the gastrointestinal tract and lead to degeneration and erosion of the intestinal lining -- a trigger
1800for IBD. Significantly, those studies, which were performed in animal models specifically to
1801test the gastrointestinal safety of the drug, tested exposures that were lower than those seen in
1802patients taking Accutane. Also in Roche's files but not shared with the medical community, were
1803hundreds of patient reports of IBD in connection with Accutane use. Notably, in numerous of
1804the reports, the symptoms of IBD appeared with Accutane use, subsided when Accutane use was
1805terminated, but then recurred following re-introduction of the drug. Roche repeatedly
1806determined internally that Accutane was the best and only explanation for these IBD reports.”
1807"This is an important outcome and consistent with the recognition by the medical community
1808that Accutane is a trigger for IBD," said David Buchanan, a partner with Seeger Weiss in New
1809York who served as co-counsel to the plaintiffs at trial.
1810"We applaud the jury's diligence and hope their verdict will finally break down the arrogance and
1811stonewalling by Roche in denying Accutane's role in the prolonged illness of so many patients
1812who took the drug unaware of the extreme, prolonged effects it would have on their intestinal
1813tract," he added. He noted that Roche faces as many as 600 Accutane cases around the country.
1814Michael Hook served as lead counsel in the case. He stated, "It is unconscionable that faced with
1815so much scientific proof that Roche has continued to deny its culpability in these cases. Since
1816first acknowledging in 1984 that Accutane may be associated with IBD, the company has
1817collected a mountain of evidence showing that Accutane in fact induces, causes, and aggravates
1818IBD. Yet, Roche never shared that information with prescribing doctors or patients. Shockingly,
1819Roche had internally contraindicated Accutane for IBD, another fact not shared with the medical
1820community. As a result, the labeled warnings on IBD haven't changed to reflect the likely link,
1821which most certainly would have caused most doctors to rethink prescribing Accutane and led
1822patients to reconsider their potential for acquiring this horrific and debilitating disease."
1823Very few people know this but Accutane is not technically an acne medication, it was originally
1824developed to be a chemotherapy drug back in the 1970’s and is still used as chemotherapy today
1825for leukemia, pancreatic cancer, brain tumors, and other types of cancers. It has powerful
1826systemic cell division reducing effects throughout the entire body, and acne reducing skin
1827dryness happens to be one of its side effects. Cancer chemotherapy drugs by their very nature
1828are some of the most powerful and toxic pharmaceuticals used in conventional medicine. During
1829clinical trials in the late 1970’s, researchers discovered that some of their cancer patients had
1830their acne cleared up during their chemotherapy. This was when drug regulatory authorities all
1831around the world tossed their logic and common sense out the window and Accutane slowly
1832became known as a popular treatment for acne. Roche accomplished this by paying off several
1833different doctors (Dr. William Cunliffe, Dr. Douglas Jacobs, Dr. Susan Jick) to promote
1834Accutane as a safe and effective drug for acne. United States attorney Mike Papantonio has
1835fought and won in some of the most significant litigations against the pharmaceutical industry for
1836product liability. Today he is working on Accutane. During a television documentary broadcast
1837in Switzerland last year created by investigative journalist Serena Tinari, Papantonio said,
1838
1839“The interesting thing about this drug it’s that it was never intended for something like clearing
1840up pimples. This was a drug that was intended for chemotherapy. Roche could not make enough
1841money with it just with chemotherapy, so they said: Let’s expand it. Let’s sell it to more people.
1842And they ended up selling it to people with acne.”
1843“If you, today, were to ask Roche: Explain to me what is the mechanism, the bio mechanism of
1844this drug. You know what? They wouldn’t be able to tell you. They don’t know. This drug has
1845been on the market since 1982 and they have not spent one dime, not one single dime, trying to
1846figure out how it works, how it goes about causing these side effects.”
1847“You have 152, about 152 side effects. People would never make the choice to use this drug.
1848Never. Once they understand how dangerous it is, there’s no logic, there’s no reasoning person
1849that would say: I’m going to take Accutane to clear up pimples.”
1850Congressman Bart Stupak was interviewed at the beginning, he said,
1851“My son went on Accutane in December 1999 and on May 14th, about 5 and a half months later
1852he shot himself while on Accutane. This was completely out of characteristic of my son. He
1853was a young man who loved life. He’d light up this room if he walked in right now. So after
1854some time my wife just thought that maybe there could be some relation between Accutane and
1855his suicide. I found that hard to believe: why would an acne medicine lead to disturbed thoughts
1856or depression. We found that the FDA, the Food and Drug Administration here, in the United
1857States, filed a warning in 1998. We had no knowledge of that. My first question was: why don’t
1858people know about this? Secondly, why would the FDA in 1998 put a warning note, but not tell
1859people? And what led to the warning. Why the warning?”
1860Later in the program, Dr. Douglas Bremner, Professor of Psychiatry and Director of the Emory
1861University Medical School Clinical Neuroscience Research, explained his research he’d
1862conducted with Accutane and brain scans,
1863“We looked at a group of 13 individuals who were treated with isotretinoin, which is Accutane in
1864the United States, and compared it to 15 individuals who were treated with antibiotics. And we
1865looked at brain function before and after treatment, with antibiotic or isotretinoin. And we found
1866a 21 % decrease in brain function over the frontal cortex, which is the brain region involved in
1867emotion and mood, in the patients treated with isotretinoin, but not in the patients treated with
1868antibiotic.”
1869“I asked if they’d (Roche) be interested in providing medication or other support for the study
1870and they weren’t interested. Well, often times companies will give, provide free medication.
1871I’ve done that all the time. They may not fund a study, but if you request, they’ll provide free
1872medication. So, I was surprised that they were not interested in providing even the medication.
1873You can calculate that it takes 800 patients in order to have an adequate trial. And, you know,
1874I’ve asked the FDA if they would request Roche to just provide the medication for a trial like
1875that. And they told me that they don’t have the power to do that. I mean, if they don’t have the
1876power to do that, then who does!”
1877
1878“The effect is through protein transcription, that would imply that the effects would take longer
1879to come on, but also would take longer to go away. Because, once you’ve started affecting
1880protein transcription, you’re basically talking about changing the structure of the brain. It could
1881take weeks to refer back to normal. It’s possible that some individuals would just stay that way.
1882There will continue to be cases of suicide and depression. You know, Roche may continue to
1883argue that they’re not related, that suicide is common or that there’s other extenuating
1884circumstances. However, the science won’t stop. There’s even a new study that came out, it
1885increases oxidative stress and causes DNA damage. So, I don’t think that…..I think that most
1886people would think twice about taking a drug that causes DNA damage. I mean, I certainly
1887would.”
1888The Ghost Under My Pillow
1889http://www.accutaneaction.com/swiss_tv/061114swisstv.html
1890http://www.youtube.com/watch?v=RGzK448fKyw
1891Roche orchestrated an elaborate smear campaign in their attempt to discredit Dr. Douglas
1892Bremner and his research work. Click the following link to read the full story on Dr. Bremner’s
1893blog.
1894“Well I thank Hoffmann-La Roche Pharmaceuticals and my dispute with them about whether
1895their acne drug Accutane can cause depression for: 1) deposing me 16 times; 2) calling me a
1896liar); 3) attacking my professional reputation; 4) suing my university; 5) trying to get me fired
1897from my university; 6) trying to get my paper on the effects of Accutane on the brain retracted;
18987) accusing me of fraud to the Editor (yes, Robert Freedman MD) of the journal where the paper
1899was published, which led to, more inquiries at my university.”
1900“What is really sad about this whole sordid tale is how degenerated the so-called dermatology
1901literature has become on the topic. For example, the most commonly cited study to support the
1902statement that acne is associated with depression, a study that has been cited several hundred
1903times by dermatologists writing in the literature, involved only ten patients with acne and no
1904comparison subjects (Gupta et al., 1990). No statistics were performed (obviously since there
1905was no comparison group). Scores on the questionnaires for anxiety and depression were not
1906related to severity of acne.”
1907“And the fact is that the rest of the literature isn’t any better. Objective measures of acne do not
1908correlate with severity of anxiety or depression. Acne does not cause major depression. It is
1909simple as that.”
1910“Sure, kids worry about their zits and feel better when they go away, but the studies do not
1911support the conclusion that acne causes major depression, and that treatment of acne cures
1912depression.”
1913Are Dermatologists Dips**ts? The Depressing Accutane Tale
1914http://www.beforeyoutakethatpill.com/index.php/tag/accutane/
1915Can You Please Put Some Sugar on This Crap?
1916
1917http://www.huffingtonpost.com/doug-bremner/can-you-please-put-some-s_b_125072.html
1918Here’s a question for all the dermatologists and everyone else that doesn’t believe Accutane
1919affects brain function, and therefore had nothing to do with all of the reported psychiatric
1920injuries, suicides, and murders. If Accutane supposedly only affects the skin, then why do
1921oncologists use it for pancreatic cancer, leukemia, brain tumors and other certain types of
1922cancers? To corroborate, here’s a quote from a website devoted to pancreatic cancer therapies.
1923http://www.seniorfitness.com/Show_Disease_and_Healing_Protocol.html?ProtID=113&Title=P
1924ancreatic%20Cancer
1925“Accutane: Based on the need to inhibit pancreatic cancer cell division at different stages of its
1926growth and induce apoptosis (programmed cell death) of cancer cells, multiple therapeutic
1927modalities are often recommended. One successful treatment modality is to combine the
1928differentiating-inducing drug Accutane (13-cis-retinoic acid) with other chemotherapy drugs,
1929such as 5-FU. Both Accutane and 5-FU are toxic drugs that must be carefully administered by a
1930medical oncologist. A combination of 13-cis-retinoic acid (Accutane) and interferon-alpha was
1931tested in a Phase II trial of 22 patients with pancreatic cancer. One patient experienced partial
1932remission and 14 patients demonstrated stable disease for about 5 months (Brembeck et al.
19331998).”
1934‘Chemo brain’ real for many cancer patients: study
1935http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20080421/chemo_brain_080421?s_nam
1936e=&no_ads
1937“The research concludes that a common chemotherapy drug, known as 5-fluorouracil (5-FU),
1938causes stem cells in the central nervous system to die off well after treatment has ended. The
1939resulting side effects are often referred to as "chemo brain."
1940"Because of our growing knowledge of stem cells and their biology, we can now begin to
1941understand and define the molecular mechanisms behind the cognitive difficulties that linger and
1942worsen in a significant number of cancer patients,"
1943“The 5-FU chemotherapy drug treats cancer by halting cell division, and has been used for more
1944than 40 years. It is often given in combination with other chemotherapy drugs, and is commonly
1945used to treat breast, ovarian, stomach, colon, pancreatic and other types of cancer.”
1946Joseph Mercola, D.O. states on his website “Chemotherapy, which has been one of the principal
1947treatment methods for the past 50 years, works by killing all cells - throughout your body - that
1948multiply and divide rapidly. This would include cancer cells, but also other rapidly multiplying
1949and dividing cells, such as: Bone marrow (which produces blood), Digestive system,
1950Reproductive system, Hair follicles.” http://www.mercola.com/
1951Since Accutane is fat (lipid) soluble, it is one of the few drugs that is able to cross the bloodbrain barrier and get into the central nervous system. This fact alone explains how it can elicit
1952devastating psychiatric side effects, and why it is often used as chemotherapy for brain tumors.
1953
1954Accutane has been on the market for the past 25 years and during that entire time Hoffmann-La
1955Roche has specifically declared in the Physician’s Desk Reference that its exact mechanism of
1956action is unknown. In my opinion, this has basically been their way of sidestepping issues
1957regarding all the many harmful side effects Accutane causes to the human body, and also to
1958distract people from gaining insight about how this drug does what it does. They neglect to
1959mention that Accutane is a systemic chemotherapy agent that reduces cellular proliferation of the
1960sebaceous glands in the skin all over the body (which is why it’s so effective against acne), and
1961also does the same thing to the cells lining the digestive tract, areas of the brain, eyes, and
1962mucous membranes (causing a lot of dryness). To corroborate my previous statement, take a
1963look at what scientist James Crandall says in this scientific study which can be found on
1964PubMed. He is stating point blank this is how Accutane works and this is what’s causing the
1965side effects.
1966"Retinoic acid (active form of Accutane) induces differentiation and reduces proliferation of
1967stem and progenitor cells. It works on acne by inducing similar events in basal sebocytes. These
1968same actions also lead to 13-cis-retinoic's (Accutane’s) side effects, and these are directed
1969towards proliferating cells in the adult such as in the skin, gut and bone."
1970"A wide ranging effect of retinoic acid is to inhibit proliferation in dividing cells, and this
1971accounts for its frequent consideration as an anti-cancer agent."
1972This study was published in 2004, here is its abstract.
1973“The active component of the acne drug Accutane is 13-cis-retinoic acid (RA), and it is highly
1974teratogenic for the developing central nervous system. Very little is known, however, regarding
1975the effect of this drug on the adult brain. Regions of the brain that may be susceptible to RA are
1976those that continue to generate new neurons. In the adult mouse, neurogenesis is maintained in
1977the hippocampus and subventricular zone. This report demonstrates that a clinical dose (1
1978mg/kg/day) of 13-cis-RA in mice significantly reduces cell proliferation in the hippocampus and
1979the subventricular zone, suppresses hippocampal neurogenesis, and severely disrupts capacity to
1980learn a spatial radial maze task. The results demonstrate that the regions of the adult brain where
1981cell proliferation is ongoing are highly sensitive to disruption by a clinical dose of 13-cis-RA.”
1982http://www.pnas.org/content/101/14/5111.full
1983http://www.pnas.org/cgi/content/abstract/101/14/5111
1984In the quotes above, Crandall hints at Accutane’s mechanism of action but he doesn’t
1985specifically say the actual mechanism because he doesn’t know about the telomere (pronounced
1986TEE-LA-MEER) research that I have discovered. Recently I have discovered research showing
1987that all-trans retinoic acid (abbreviated ATRA which is the final biologically active metabolite
1988that Accutane turns into) down-regulates the telomerase enzyme (pronounced TEE-LA-MERAZE) and induces telomere shortening and cell death. This I believe is the mechanism of
1989action. Accutane causes telomere shortening leading to permanently arrested cell division /
1990proliferation.
1991
1992So why are short telomeres a bad thing to have? Here’s a quick rundown of telomere biology.
1993Cells all over the body are replaced by means of cell division, and there is a limit on the number
1994of times that they may successfully divide. This is known as the Hayflick Limit. Most cells in
1995the body divide about 50 times before they stop dividing and die a natural death. The
1996mechanism that controls this cell division lies within the telomere / telomerase, which is a cap
1997like structure on the end of all the different twenty three pairs of chromosomes. Chromosomes
1998are the helical structures of DNA that are found inside the nucleus of all cells in our body which
1999carry our genetic code. The telomere chain and its length can be thought of as a string of beads
2000(repeating code at the end of every DNA strand), with one bead falling off the string each time a
2001cell divides. Therefore, the telomere shortens up a little bit every time a cell divides, and again
2002this places a limit on the number of times a cell can replicate itself, known as the Hayflick Limit.
2003Once these beads run out and disappear, the cell stops dividing and undergoes programmed cell
2004death (AKA apoptosis). The constant process of telomeres getting shorter eventually leads to the
2005death of the cell and over time this cumulative cell death leads to one of the major components of
2006the aging process. However, there exists a specialized enzyme called telomerase which acts to
2007repair damage to the telomere, maintain its stability, and extend the length of the telomere beads,
2008thereby overcoming the Hayflick Limit. Germ line cells and cancerous cells continually express
2009telomerase in such a way that they never run out of telomere beads and therefore remain
2010immortal. Telomerase is naturally expressed more in cells in the body that are the most rapidly
2011dividing: the immune system, skin, bone, digestive tract, mucous membranes, etc. because these
2012cells undergo much more cell division (more turnover) throughout a person’s lifetime and
2013therefore need to have their string of beads repaired and relengthened more often. Right now
2014I’m going to include a relevant quote from Dr. Aubrey De Grey’s new book titled Ending Aging,
2015which can be found at Amazon.com or any major bookstore. Dr. De Grey is a world famous
2016Biogerontologist, which in a nutshell means he studies the underlying causes of the aging
2017process.
2018“If it weren’t for telomerase, this gradual shortening would eventually lead to the complete loss
2019of the telomeres in cells that replicate frequently during the lifespan, and thus the gradual erosion
2020of the genes themselves. Telomerase periodically relengthens the telomere before it becomes
2021critically short.” (De Grey, 294)
202210% of cancer cells use an alternative process to continue their cell division known as alternative
2023lengthening of telomeres, but 90 % of cancer cells activate the telomerase enzyme in such a way
2024that it continually rebuilds the telomere chain so that these cells never run out of cell divisions
2025and therefore become immortal. This is one of the major defining hallmark characteristics of
2026cancer. Cells divide and grow out of control and don’t die off like they are supposed to. The
2027telomere Hayflick Limit can be thought of as a cellular countdown clock mechanism that is in
2028place to specifically protect us from renegade cells growing wildly out of control (AKA cancer).
2029The following quote from Dr. Aubrey De Grey’s Ending Aging explains what would happen if
2030cancerous cells were deprived of telomerase or alternative lengthening of telomeres.
2031“Either way, without a way to renew their telomeres, the single-minded multiplication of
2032potential cancer cells rapidly grinds to a halt as it reaches the end of its telomere “rope,” and we
2033wind up with a tiny (and generally short-lived) lump in our bodies instead of a life-threatening,
2034malignant condition.” (De Grey, 295)
2035
2036From what I’ve observed, I believe the people who suffer the chronic latent side effects of
2037Accutane have the opposite problem that people with cancer have. With cancer patients, there’s
2038too much uncontrolled disorderly rapid cell division going on, but with Accutane patients,
2039there’s too little normal necessary bodily cell division or sometimes none at all because the
2040Accutane has caused critical telomere shortening, inducing growth arrest and cell death in
2041various areas of the body where cell proliferation is supposed to be ongoing.
2042What’s bad about Accutane is that there's a huge amount of individual variability when it comes
2043to the side effects. For some people, it takes multiple courses of Accutane to induce permanent
2044side effects, but for others all it takes is one round to put their bodies past the point of no return.
2045Different people get different combinations of side effects and they are very unpredictable,
2046because through influencing DNA transcription (which is what all retinoid/vitamin A drugs do),
2047it causes random groups of cells all over the body to differentiate and shut-down when they are
2048not supposed to. This is why it is used in chemotherapy. Chemotherapy drugs kill rapidly
2049dividing/proliferating cancerous cells, but they also kill the healthy rapidly dividing/proliferating
2050native cells of the body along with the cancer. Accutane binds to the vitamin A (retinoid)
2051nuclear receptors RAR and RXR on the surface of the nucleus inside every cell in the entire body
2052and changes the way that the cells read their genes (protein transcription). This is why Accutane
2053has an extremely long list of side effects involving every tissue and every organ in the human
2054body. The cells that are the most vulnerable to this effect are the ones that need to divide and
2055proliferate (undergo mitosis) more often.
2056The severity of Accutane long-term side effects all depends on how far the course of Accutane
2057down-regulated the telomerase enzyme and shortened the telomere length. Here’s another quote
2058from Dr. De Grey’s book where he explains what would happen if telomerase was completely
2059down-regulated.
2060“Deleting telomere elongation capacity throughout the body would also be life-threatening,
2061because it would mean that our regular, proliferating cells (like those in the skin or the lining of
2062the gut) would suddenly have iron limits on their ability to reproduce themselves and thus
2063replenish tissue. From the moment that we denuded our cells of telomerase, a clock would be
2064ticking. With each division the telomere would shorten by a notch from whatever it had been
2065when we took telomerase out. We would be under the specter of a rather horrible death, as our
2066stem cells went offline one by one under replicative senescence (see Chapter 10): with each
2067failure of a stem cell responsible for supplying key functions, the tissue would fail to be renewed
2068and would slowly degenerate.” (De Grey, 297)
2069Accutane and ATRA (all-trans retinoic acid or Vesanoid) are very similar drugs, they are both
2070retinoids, they have very similar side effect profiles and pharmacokinetics and they are almost
2071chemically identical. Interestingly, Roche states a 14% incidence of depression for 10 mg of
2072Vesanoid, with the knowledge that this is exactly what 40 mg of Accutane interconverts into.
2073Two of ATRA's side effects are dry eyes and dry skin, so it would work against acne, but Roche
2074hasn't studied it against acne because they've been too busy making a killing (pardon the pun)
2075selling Accutane. If you read over ATRA’s side effect profile in the link I've put below, you’ll
2076notice how it’s very similar to Accutane (they both cause retinoid toxicity AKA vitamin A
2077
2078toxicity). To clarify, here are the brand names and chemical names for these two drugs that are
2079both manufactured by Hoffmann-La Roche.
2080Accutane (used for Acne)
2081Isotretinoin
208213-cis retinoic acid
2083Vesanoid (used for Leukemia)
2084Tretinoin
2085All-trans retinoic acid (ATRA) or retinoic acid
2086Accutane and Vesanoid information on Chemocare.com
2087http://www.chemocare.com/bio/accutane.asp
2088http://www.chemocare.com/bio/vesanoid.asp
2089Since a certain percentage of Accutane metabolizes into ATRA (about 30%), and since the
2090ATRA metabolite is how Accutane exerts its pharmacological actions on the body, there’s no
2091doubt that if ATRA causes telomere shortening then Accutane also causes telomere shortening.
2092If Accutane truly does cause telomere shortening and down regulation of the telomerase enzyme,
2093this could mean huge significant implications for maintaining adequate cell proliferation all over
2094the body for the rest of a former Accutane patient’s lifetime. In other words, Accutane, being a
2095potent chemotherapy drug, attacks and damages the cells in the body that are supposed to remain
2096dividing and proliferating for a person’s entire lifetime. If cells have shorter telomere lengths
2097(shorter telomeres), they get closer to the Hayflick Limit and can’t divide/proliferate as much or
2098they go on to experience growth arrest and cell death (apoptosis). This is how Accutane reduces
2099acne, and why in some cases, the acne doesn’t come back, and the patient is left with permanent
2100dry skin, dry mucous membranes, digestive problems, hair loss, and other various permanent
2101side effects. During the course of treatment and after, Accutane has increased the cell division /
2102turnover rate so drastically (new cells are born and die at a faster rate), that these cells run out of
2103cell divisions and are driven into their Hayflick Limit. This can be illustrated by observing what
2104happens when somebody eats polar bear liver (contains extremely toxic levels of vitamin A
2105similar to Accutane) and their skin starts to peel off all over their body in thick giant sheets from
2106the increased cellular turnover rate, also a potential side effect of Accutane. The cell division
2107rate (beads falling off the string) has been increased so fast and telomerase has been downregulated so much that it cannot repair the telomere chain (the beads on the string) before the
2108cells lose all of their cell divisions (beads) and enter growth arrest (Hayflick limit). Here’s an
2109excellent definition of the Hayflick Limit.
2110“Dr. Leonard Hayflick discovered that mammalian cells divide only a fixed number of times.
2111This "Hayflick Limit" was later proven to be caused by telomeres on the ends of chromosomes
2112that shorten with each cell division. When the telomeres are gone, the DNA can no longer be
2113copied, cell division ceases, and cells enter replicative senescence or old age.”
2114Conduct some research online and through Wikipedia on cell division (mitosis), telomerase,
2115telomere shortening, and the Hayflick Limit, and how they have long been considered to play a
2116role as one of the major components of the aging process. Another observation that would be
2117worthwhile to consider is that people with the premature aging disorder Progeria have shortened
2118
2119telomeres. So there is enough evidence to predict a possible backlash that is going to occur when
2120this information gets fully verified, that Hoffmann-La Roche and the American Academy of
2121Dermatology have given a drug that causes a form of premature aging to millions of teenagers
2122and young adults with acne. Specialized tests are available that can assess telomere shortening,
2123validating the damage caused by Accutane. One of them is called the Terminal Restriction
2124Fragment southern blot TTAGGG telomere length assay.
2125It’s imperative to understand that stopping Accutane doesn’t necessarily mean that the user is in
2126the clear. There are several reports by people who claim that some of their side effects,
2127particularly the worst kinds, didn’t emerge until years after they stopped Accutane. This drug is
2128proving to have a chronic latent effect on people’s bodies, which is also how it permanently
2129cures their acne, with lots of collateral damage of course. If people investigated further into their
2130own use, there could very well be a massive backlash when this information gets out, even with
2131people who took a low dosage and got good results from their course of Accutane and so far
2132haven’t developed any complications or chronic health problems. My impression, after
2133conducting many hours of research, is that there are thousands of people out there with really
2134bizarre and unusual chronic health problems as a result of their exposure to Accutane, but they
2135just haven’t investigated and made the connection yet.
2136I always knew that Accutane’s mechanism of action would reveal itself by examining the way
2137that retinoids are used in chemotherapy. When retinoids are used for chemotherapy, at least they
2138make an attempt to tell patients how the stuff works and warn them about the side effects. This
2139study below, published back in 2001, is the smoking gun for Accutane's mechanism of action,
2140because ATRA (all-trans retinoic acid or Vesanoid) is the active metabolite that 13-cis retinoic
2141acid (Accutane) turns into. Nobody besides me has made this connection yet. Nobody has
2142posted any information about retinoids and how they cause telomere shortening on the
2143Ro/Accutane Action Group forum. Here's a quote from the abstract of a study which can be
2144found at the following link.
2145Retinoids down-regulate telomerase and telomere length in a pathway distinct from leukemia cell
2146differentiation
2147http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=34517
2148"A second pathway of hTERT regulation, identified in the RAR-responsive, maturation-resistant
2149NB4-R1 cell line, results in a down-regulation of telomerase that develops slowly during two
2150weeks of all-trans retinoic acid (ATRA) treatment. This pathway leads to telomere shortening,
2151growth arrest, and cell death, all events that are overcome by ectopic expression of hTERT.”
2152Here's another interesting quote from the scientific abstract of a more recent study published in
21532006, I’ve provided the link to this study below.
2154Telomerase targeting by retinoids in cells from patients with myeloid leukemias of various
2155subtypes, not only APL
2156http://www.nature.com/leu/journal/vaop/ncurrent/full/2404127a.html
2157"These results support the idea that, by hTERT targeting, retinoids can induce telomere
2158
2159shortening and cell death and their integration in therapy protocols for myeloid leukemias
2160refractory to maturation should be considered."
2161So to sum all of this up, these research studies I listed above show that long-term treatment with
2162ATRA (all-trans retinoic acid), which is almost chemically identical to Accutane, causes
2163“telomere shortening, growth arrest, and cell death.” The cells that the researchers tested were
2164cancerous cell lines, but if ATRA causes these effects in cancerous cell lines, then it is highly
2165likely that it will do the same thing to our body’s own rapidly dividing/proliferating cells such as
2166the cells in the bone, skin, digestive tract, and even the hippocampus and subventricular zone in
2167the brain.
2168Another significant observation which can be gleaned from this research is that if ATRA causes
2169telomere shortening, and this is also the mechanism of action for how vitamin A toxicity causes
2170many side effects and reduces cell division, then telomere shortening could explain why lots of
2171people have reported that consuming high amounts of vitamin A or foods rich in vitamin A after
2172their course of Accutane worsens their side effects, especially the problems related to dryness.
2173In other words, it explains why for some people, the side effects become much worse after they
2174stop Accutane, because the dietary vitamin A they need to stay alive might be slowly killing
2175them because Accutane has shortened their telomeres too far. A search on the Internet reveals an
2176abundance of information about vitamin A and retinoid compounds being inhibitors of
2177telomerase.
2178Vitamin D3, Vitamin A and The Prevention of Tumor Cell Immortality
2179http://grouppekurosawa.com/blog/2006/01/vitamin-d3-vitamin-and-prevention-of.htm
2180“This subject is complicated so forgive me if my explanation is not completely understandable.
2181Telomeres exist at the ends of chromosomes. As chromosomes replicate during cell division, the
2182telomeres protect the chromosomes from damage and cell death. Yet telomere function declines
2183as cells continue to divide, and the ends of chromosomes become progressively shorter. After a
2184prescribed number of cell divisions, the cell dies. This is referred to as the limited lifespan of
2185somatic cells. As cells grow, the ends of their chromosomes progressively shorten until they
2186die...but NOT in cancer cells.”
2187http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=pubmed&
2188dopt=Abstract&list_uids=15520642&itool=pubmed_docsum
2189“A more technical discussion of this phenomenon can be found in the following paper. Click the
2190Acta Pharma... box to read the paper online.”
2191http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=pubmed&
2192dopt=Abstract&list_uids=15842766&itool=pubmed_docsum
2193“Telomerase is the enzyme that corrects the shortening of the chromosomes as they continue to
2194divide. This enzyme is not active in normal cells, but it is very active in at least 90% of all
2195cancers and leukemias. This means that telomerase expressing cells can continue to divide over
2196and over without fear of dying of old age. Cancer cells that possess active telomerase activity
2197
2198can survive, while non-active varients will die. This is dogma and it is carved in stone. It
2199doesn't make ANY difference if the cancer cells are activated by oncogenes, such as RAS, or if
2200the cancer cells are of a particular genetic makeup, the chromosomes in these cells will shorten,
2201causing the death of these cells, unless telomerase activity is activated.”
2202“There is no shortage of biotech companies out there who would give anything if they could only
2203develop telomerase inhibitors. They should stop trying. Vitamin D3 and vitamin A, combined,
2204inhibit the SYNTHESIS of the catalytic unit of telomerase. This means that these two hormones
2205will not allow cancer cells to divide indefinitely. And that ain't bad. The following study was
2206conducted in prostate cancer cells, but the principle applies to ALL cells.”
2207http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=pubmed&
2208dopt=Abstract&list_uids=12939463&itool=pubmed_docsum
2209“ONLY the heterodimer of vitamin D3 and vitamin A receptors can inactivate the telomerase
2210gene. So get these supplements integrated into your daily routine. Stay tuned...”
2211Learn Genetics: Are Telomeres The Key To Aging And Cancer?
2212http://learn.genetics.utah.edu/content/begin/traits/telomeres/index.html
2213http://learn.genetics.utah.edu/content/tech/cloning/cloningrisks/index.html
2214“Yet, each time a cell divides, the telomeres get shorter. When they get too short, the cell no
2215longer can divide and becomes inactive or "senescent" or dies. This process is associated with
2216aging, cancer and a higher risk of death. So telomeres also have been compared with a bomb
2217fuse.”
2218“Without telomeres, the main part of the chromosome - the part containing genes essential for
2219life - would get shorter each time a cell divides. So telomeres allow cells to divide without
2220losing genes. Cell division is needed so we can grow new skin, blood, bone and other cells when
2221needed.”
2222“An enzyme named telomerase adds bases to the ends of telomeres. In young cells, telomerase
2223keeps telomeres from wearing down too much. But as cells divide repeatedly, there is not
2224enough telomerase, so the telomeres grow shorter and the cells age.”
2225“Geneticist Richard Cawthon and colleagues at the University of Utah found shorter telomeres
2226are associated with shorter lives. Among people older than 60, those with shorter telomeres were
2227three times more likely to die from heart disease and eight times more likely to die from
2228infectious disease.”
2229Vitamin A Cancer Adjuvant Therapy from the Life Extension Foundation
2230http://www.lef.org/protocols/prtcl-027h.shtml
2231“Vitamin A offers protection against radiation induced tissue damage, down-regulates
2232telomerase activity, and is involved at almost every juncture of cancer control.”
2233
2234Telomere.net
2235http://www.telomere.net/
2236Vitamin A and Health
2237http://grouppekurosawa.com/blog/2006/01/vitamin-and-health.htm
2238Vitamin A
2239http://www.sahealthinfo.org/nutrition/vitaminminerals/vitamins/vitamin_a.htm
2240In my opinion Roche stating that “the exact mechanism of action is unknown” for the past 25
2241years is just a ruse to distract people from learning the information that the systemic cell division
2242reducing effect of retinoic acid is specifically what’s responsible for making their acne go away
2243and causing many of the side effects. James Crandall’s statement “A wide ranging effect of
2244retinoic acid is to inhibit proliferation in dividing cells, and this accounts for its frequent
2245consideration as an anti-cancer agent” is good enough for me as an explanation for the
2246mechanism of action. But I’ve gone one step further and identified the mechanism. Being a
2247systemic chemotherapy agent, Accutane does not know the difference between cancer and your
2248body’s own rapidly dividing cells. With the knowledge that many parts of the human body, such
2249as the skin, nasal passage, immune system, areas of the brain, digestive tract, bones, lungs,
2250mucous membranes, bladder, urinary tract, sexual organs etc. rely on rapid cell
2251division/proliferation to sustain their proper function throughout a person’s lifetime, this
2252information about retinoic acid having a “chemotherapy like” cell division reducing effect
2253becomes extremely important. Because it means that if you take too much Accutane for too long
2254of a period of time, you are essentially slowing down or stopping cell division in areas of your
2255body where cells are supposed to remain dividing for your entire lifetime. In my opinion this is
2256what’s causing most of the chronic long-term side effects, these people basically have the
2257opposite problem that people with cancer have. As I’ve discussed in depth, the explanation for
2258the mechanism of action likely involves human telomerase reverse transcriptase (hTERT), the
2259chief regulator of cell division in our rapidly dividing cells. It has already been shown that
2260retinoic acid down-regulates hTERT in cancerous cells, which is more than enough evidence to
2261call for an investigation of its effects on hTERT in the human leukocytes, enterocytes,
2262keratinocytes, sebocytes, endothelial progenitor cells and other various progenitor cells. Specific
2263tissue biopsies and blood tests before and after a course Accutane will identify the extent to
2264which cell division has been reduced.
2265As a result of Accutane, cells in many different areas of the body have a decreased ability to
2266divide and proliferate, which is why the mucous membranes, the nasal passage, eyes, lips
2267become very dry, and this also happens to various areas of the digestive tract, decreasing the
2268integrity of the mucosal barrier that protects the gut wall, which is then more vulnerable to
2269sustaining damage and developing into inflammatory bowel disease. The digestive tract can be
2270thought of as a tube (your body is hollow) that is technically outside of the body because the
2271mucosal layer is what protects us from pathogens and the harsh substances of digestive
2272metabolism. Just like the skin, the lining of the digestive tract is a fortress that separates our
2273bodies from the outside world. This protective barrier becomes dysfunctional and gets
2274diminished after Accutane because the cells can’t divide as much. One reported side effect is
2275cracking and severe dryness of the region around the anus, leading to rectal bleeding. This isn’t
2276
2277surprising because a very common side effect is severe cracking and dryness of the lips
2278(exfoliative cheilitis), which is another mucous membrane.
2279For all the people out there who like to use topical retinoids like Retin-A on their skin, be careful
2280not to use it too often (not more than once per week) or else you might induce too many cell
2281divisions (peeling skin) which could lead to the cells hitting their Hayflick Limit (skin cells can’t
2282turn themselves over anymore). Many misinformed people have been lead to believe that the
2283Hayflick Limit is an urban myth when it comes to topical retinoids and agents used for facial
2284exfoliation. Well, listen up because I’ve got the straight dope right here. Topical Retin-A works
2285by burning off a layer of skin to try to create a better one. It is tretinoin, a retinoid also known as
2286all-trans retinoic acid or ATRA, and one of the scientific studies I’ve referenced and discussed
2287in-depth above shows that long-term treatment with ATRA targets human telomerase reverse
2288transcriptase and induces telomere shortening, growth arrest and cell death (Hayflick Limit).
2289Therefore, in light of this new information, what do you think could happen if you undergo too
2290many facial exfoliations or apply topical Retin-A on your face too often?
2291Does anyone remember the drug Thalidomide, an anti-nausea medication prescribed to pregnant
2292women in Europe back in the late 1950’s and early 1960’s? This drug caused approximately
229310,000 babies to be born with severe debilitating or deadly birth defects. The scope of the
2294Thalidomide tragedy was so awful and incomprehensible that governments around the world,
2295including the United States, proclaimed that they needed to learn a lesson from this tragedy and
2296that such a catastrophe must never be allowed to happen again. Well, guess what, it has
2297happened again, just in a more out of the spotlight, clandestine manner. Accutane is
2298Thalidomide Jr. and the devastation caused by Thalidomide is dwarfed by the devastation caused
2299by Accutane. It has been estimated that in upwards of 50,000 infants have been exposed to the
2300horrific teratogenic (birth defect causing) effects of Accutane during the quarter of a century that
2301it has been on the market. The only reason Accutane is still on the market today is because of
2302abortion, because without abortion, it would’ve been impossible to cover everything up for so
2303long. In the past, if you were a woman on Accutane and you became pregnant, the
2304dermatologists would recommend that you get an abortion. But hold on just one minute. Should
2305having to get an abortion be allowed because of a side effect of taking an acne medication? By
2306not giving out Accutane to so many people in the first place, this problem would be solved.
2307Abortion and patient confidentiality are the methods used by Hoffmann-La Roche and the
2308American Academy of Dermatology to suppress the shocking evidence about the real number of
2309infants severely affected by Accutane. Investigative health journalist Bill Sardi sums up this
2310situation by saying,
2311“Pimpled people have been poisoned with a vitamin/drug. Unlike Thalidomide, a drug that
2312medical doctors were unaware caused birth defects, it was well known that Accutane, a synthetic
2313form of vitamin A, caused malformed babies before it was placed on the market. Elisabeth
2314Robert, MD, PhD, at the European Institute of Genomutations in France, says Accutane is not
2315well-known for its link to birth defects whereas Thalidomide is. So one drug, Thalidomide, has
2316been removed from the marketplace, while a similar drug, Accutane, experiences robust sales”
2317(Accutane: A modern horror story, www.knowledgeofhealth.com )
2318In 1990, an internal FDA memo by Dr. David Graham (the same FDA drug safety scientist who
2319
2320later blew the whistle on Vioxx in 2004) said that Accutane was an “imminent hazard” to public
2321health and needed to be taken off the market immediately. Graham stated in the memo,
2322“As our data on drug use and contraceptive failure show, there probably have been between
232315,000 and 18,000 pregnancy exposures to Accutane since its appearance on the market in 1982.
2324The magnitude to fetal injury and death has been great and permanent, with 11,000 to 13,000
2325Accutane-related abortions, and 900 to 1,100 Accutane related birth defects…….Accutane poses
2326an imminent hazard to public health, and as such should be withdrawn immediately from the
2327market.”
2328More recently it was revealed that,
2329"An FDA official at the February 2004 advisory committee acknowledged that there are
2330probably 3,500 Accutane exposed babies each year in the United States, most are aborted!
2331Hoffmann-La Roche claims that they do not have to report the abortions because, to use their
2332words, a fetus is not a human being and it does not have to be reported under the FDA reporting
2333system."
2334Human Teratology: Isotretinoin and Vitamin A
2335Presentation by Dr. Edward Lammer MD
2336http://www.youtube.com/watch?v=ACUZZzW3I4w
2337The New York Times: Biologists Identify ‘Impresario’ of Life In Vitamin A
2338http://www.nytimes.com/1990/03/20/science/biologists-identify-impresario-of-life-in-vitamina.html?pagewanted=all
2339The recently implemented IPLEDGE program (designed to eliminate Accutane pregnancies) has
2340turned out to be a failure because despite its implementation many women have still became
2341pregnant while on Accutane, and those are only the cases that have been reported. Congressman
2342Bart Stupak says there have been instances of people getting pregnant, hushing it up with their
2343dermatologist, getting an abortion, and not reporting it to anybody. In his recent statement to the
2344FDA Advisory Committee Hearing on iPLEDGE, held on August 1st, 2007, Stupak also talks
2345about how the FDA defeated the proposal for a mandatory registry of birth defects and
2346psychiatric side effects,
2347“It is difficult to understand how the FDA can knowingly allow hundreds of birth defects to
2348occur per year and remain silent. The FDA’s attempt to say nothing about Accutane birth defects
2349is summed up in this email, ‘As for the ‘needle, I think you and a lot of other non-dermatologists
2350are in for a major shock IF the truth is ever exposed. I know that I am going to say is anecdote,
2351but I personally know several derms whose patients have become pregnant on Accutane and
2352NOT A SINGLE one reported it (except to their lawyer). And I don’t even know that many
2353derms, as I am not into the local derm scene!! [……….] Roche and the AAD [American
2354Academy of Dermatologists] are so adamantly opposed to collecting the real number of exposed
2355fetuses for a reason and I personally do not believe them when they say it is concern for patients’
2356privacy (we do NOT have to compromise that in any way to collect the data). I think it is a
2357concern about the public outcry/outrage that will ensue if the truth comes out.’”
2358
2359“As we know, the FDA dropped the mandatory patient registry and certification of practitioners
2360whose prescribe Accutane to prevent birth defects and psychiatric injuries. Once again, the FDA
2361succumbed to Roche’s pressure and the registry and certification was abandoned. Each time the
2362Advisory Committee made recommendations to limit the distribution and use of Accutane,
2363Roche pressured the FDA to protect and increase its sales of Accutane. In fact, the latest defeat
2364of the mandatory registry and certification will benefit Roche by approximately $450 million.
2365After all the devastation this drug has caused teens!!!! What special powers or charm does
2366Roche have with the FDA? Many are starting to ask that question.” It is time for this committee
2367on behalf of the American people to “start asking that question” what is the special power or
2368charm that has allowed Roche to market Accutane which has caused death and devastation
2369among our young people?”
2370http://www.house.gov/stupak/accutane_ipledge_080107.shtml
2371Warning! Don’t skip over this next section.
2372For some people Accutane has caused them permanent severe sexual side effects like painful
2373intercourse in men and women, erectile dysfunction, genital hypersensitivity, urinary
2374discomfort/pain (interstitial cystitis), and severe dryness of the vaginal lining and penis. These
2375side effects are most likely due to Accutane causing excessive thinning of the skin on their
2376genitalia, with even the possibility of it sloughing off the entire top layer of skin, and degrading /
2377drying out the mucosal barrier lining the bladder and urethra. Other cases exist where people
2378can’t kiss anymore because Accutane induced a severe lip condition called exfoliative cheilitis,
2379which causes their lips to feel extreme hypersensitive pain if anything touches them. To this day
2380these side effects are not included among Accutane’s incredibly long list of warnings in its
2381package insert. There's an M.D. on the Internet named Dr. Kevin Pezzi who discusses Roche’s
2382cover-up of Accutane’s permanent sexual side effects in his book titled The Science of Sex and
2383here at his website www.erbook.net/accutane initially posting this information 6 years ago.
2384The Sexual Effects of Accutane
2385http://www.erbook.net/accutane
2386http://www.sexualtips.net/accutane_affecting_sex.htm
2387Many stories can be found on the Internet written by individuals with various sexual side effects
2388from Accutane. Here’s an example from the Ro/Accutane Action Group Forum.
2389“This is beyond personal, but I am at my wit's end, and I'm desperate for any solutions out there.
2390This post is regarding a mature subject matter, and it's not pretty, so read on at your own risk.
2391I finished a course of accutane about 6 months ago. Since that time, the skin on my penis has
2392progressively deteriorated. Strange pinkish/reddish patches have cropped up on the glans. The
2393glans has become permanently red in some places and dark brown in others and has become very
2394rough and irritated. Some of the skin surrounding the meatus has peeled away and refuses to
2395heal. One side of my urethra has become red and occasionally will tear, bleed slightly, and then
2396scab over. The skin on the entire shaft has become so incredibly thin that all the veins are visible
2397and painful to the touch. The entire area is incredibly sore, and brushing up against anything
2398
2399(including clothing) is unbearable.
2400No doctor can figure out the problem. I have been tested for every STD on the books (herpes,
2401HIV, syphilis, gonorrhea, chlamydia), and they have all come back clean. I've been given
2402prescription oral antifungal medicine and used topicals, but they were useless. I've also been
2403given medium strength steroids and protopic from one doctor who believed it could be psoriasis but no luck in fixing the problem.
2404At this point, I'm pretty much certain accutane caused my condition. My symptoms do not
2405match up with any skin/genital disease on the books, and the temporal proximity in taking the
2406medicine and the onset of symptoms, while possibly coincidence, is more likely indicative of an
2407adverse reaction to the medicine. The reason I am posting is not to wage a war against Roche
2408(though I certainly respect that others want compensation for their pain). My purpose is to see if
2409anyone else out there has had this problem as a result of taking accutane, and if so, whether they
2410have found any way to make it go away, or at the very least, more bearable.
2411Has anyone found that their problems have improved with time?
2412I am really struggling here. I used to have such a nice life, and I would do anything in the world
2413to have it back. Any help is much appreciated.
2414Thanks.”
2415Comment from a Medical Doctor
2416“I have used Accutane myself years ago, and I have regretted doing so ever since. A few weeks
2417after I began using it, my libido decreased dramatically. Even worse, my ability to experience
2418sexual pleasure was greatly diminished as well. While I can feel some pleasure, it's much less
2419than before. Quantitating such a subjective thing is obviously difficult, but I'd estimate that it is
242090 percent less than what it once was. Even though I am a physician, I have discussed this
2421problem with other doctors (urologists, a neurologist, and internists) and no one had any idea
2422what to do about this problem. I've researched it myself, and I don't know what--if anything--can
2423be done to reverse it. The manufacturer claimed to have never heard of this reaction before, but
2424they could simply be saying that to avoid legal consequences. I HAVE heard others say they've
2425had similar problems after using Accutane, and I think that many people may have had the
2426problem yet never felt comfortable discussing it with anyone. (Consequently, the true incidence
2427may be far greater than what anyone suspects.) In my case, it took years before I had the
2428courage to mention this to anyone except my girlfriend -- it's not an easy thing to discuss. While
2429Accutane achieves a long-term control of acne in SOME people, I think its potential
2430complications outweigh its utility in that regard. There are numerous other drawbacks to this
2431drug in addition to the one that I discussed above, so I'm not kidding when I say that I'd rather
2432play Russian roulette than to take Accutane.”
2433These side effects have been acknowledged in other countries (In a 1994 study, the UK's Dr.
2434William Cunliffe wrote about Accutane causing severe dryness of the penis, using the medical
2435term Balanitis) and they've been reported to the FDA and other regulating bodies for the past 20
2436
2437years (read through the list of ADRs on Congressman Bart Stupak’s website). But the Feds and
2438Roche (remember the pharmaceutical companies basically own the FDA) have done nothing to
2439warn patients because this is the one side effect that would tend to strongly dissuade people from
2440taking Accutane for their acne, plus Roche would lose hard on their bottom line. Roche even
2441created a small study to give male acne patients reassurance that Accutane had not been found to
2442cause problems with male reproduction, despite the fact that an abundance of adverse drug
2443reaction reports related to sexual side effects had been coming into them and the FDA for many
2444years. The results of this small and meaningless and probably fraudulent study was inserted into
2445a pamphlet titled “What young men/women need to know about acne” and handed out by
2446dermatologists to all patients receiving Accutane. It says,
2447"One thing you should know about Accutane is that clinical studies have shown that Accutane
2448does not cause any negative effects on the ability to produce normal sperm or on male
2449reproduction……Although you may see special instructions to female patients on the package of
2450Accutane, and on other materials your doctor may give you about Accutane (isotretinoin), these
2451instructions about avoiding pregnancy do not apply to young men. Young men may rest assured
2452that the special instructions for young women to avoid pregnancy do not apply to them.”
2453Liam Grant, chairman of the Ro/Accutane Action Group, gave an excellent detailed presentation
2454at the FDA Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee held on
2455September 19th, 2000. Here are several quotes from his presentation.
2456“Good afternoon, ladies and gentlemen. My name is Liam Grant. I'm chairperson of an
2457organization called the Ro/Accutane Action Group. Our group was set up in 1997 to provide
2458support for Accutane victims, to investigate all aspects of Accutane from the initial pretrial
2459studies to review the literature, ADR reports, physician guidelines and so on in each country
2460throughout the world where the drug is sold, also to fund and coordinate a series of scientific
2461studies on Accutane to determine the mechanism by which Accutane causes so many severe
2462physical and psychiatric side effects.”
2463“The principal side effects of Accutane based on adverse reaction reports and published studies
2464include general side effects such as photophobia, muscle and joint pain, insomnia, lethargy,
2465central nervous system side effects such as pseudotumor cerebri, which is described as a serious
2466condition involving swelling of the brain, visual disturbances, hearing deficiencies, malaise,
2467drowsiness, amnesia, hallucinations, and psychiatric disorders, which include behavioral
2468disorders, seizures, psychosis, schizophrenia, depression, suicide ideation, suicide thoughts and
2469actions, and also as we all know, it's a teratogen.”
2470“What do scientific literature reports say about Accutane? Well, there are a substantial number
2471of published studies linking the ingestion of Accutane to the emergence of psychiatric disorders
2472as far back as 1983, less than one year after the drug was released onto the market. I've only
2473time to briefly refer to three of these studies.”
2474“The American Academy of Dermatology published a study in 1983 where the authors reported
2475that 5.5 percent of patients experienced depressive symptoms while on Accutane. In the case of
2476one 21-year-old man in that study, the symptoms of depression and forgetfulness were severe
2477enough to cause withdrawal of the drug. So, within a few months of Accutane being introduced,
2478
2479the first independent study showed that 5.5 percent of patients experienced symptoms within 2 to
24803 weeks of starting on Accutane.”
2481“Another published study in 1990 in the same dermatological magazine set out details of serious
2482psychiatric disorders suffered by 7 patients where treatment had to be discontinued because of
2483the severity of the side effects, and they were listed, including manic depression, suicidal
2484thoughts, fear of going insane, et cetera. And remember, that was 1990.”
2485“Another study showed that adverse drug reaction reports for Accutane in the United States in
2486the period from October 1982 to June 1985 represented the highest number of adverse drug
2487reaction reports received by any agency for any prescription drug. It also stated that 22 percent
2488of adverse drug reactions for Accutane relate to central nervous system disorders, such as
2489headache, insomnia, depression, dizziness, personality disorder, and pseudotumor cerebri. Now,
2490that's 1985.”
2491“Sales of Accutane from 1982 to 1985 were very small in the United States because of publicity
2492on the number and serious nature of birth defects caused by Accutane at that time. Accutane at
2493that time had been likened to Thalidomide. So, Accutane with small sales at that time was
2494attracting more adverse drug reactions than any other prescription medicine, despite the fact that
2495some of these other prescription medicines were being sold to not just tens but hundreds of
2496millions of people.”
2497“How many adverse drug reaction reports are there for Accutane? Well, in May 1998 Roche
2498issued a letter to the Irish Medicines Board, which disclosed that there were 40,000 adverse drug
2499reactions on the Roche database in respect of Roaccutane. A review of all ADR data recorded
2500since that time suggests that there may well now be 50,000 to 55,000 such ADR reports for
2501Accutane on the Roche worldwide database.”
2502“Studies show that only 1 in 10 serious ADRs are ever reported. In some countries, it may be
2503only 1 in a 100. If we apply a factor of 10 to the number of adverse reactions recorded for
2504Accutane, we get a figure of 500,000 or more, more than half a million people, which I think
2505gives some idea of the number of people and the scale of suffering caused by this drug.”
2506“Roche have not provided a full list of all ADRs held in the Roche database for Accutane. The
2507FDA and other national agencies have not received this full and detailed list of all ADRs, which I
2508cannot understand. Dermatologists who prescribe this drug on a daily basis have not got the full
2509list of adverse drug reactions worldwide in respect to this drug. Therefore, as I speak, I don't
2510know and I doubt if anyone in this room, apart from the Roche people, knows the total number of
2511suicides worldwide, suicide attempt, and suicide ideations recorded for the drug and also the
2512number, up to tens of thousands, of psychiatric disorders recorded for the drug worldwide.”
2513“I'm just going to briefly mention Norway in reference to a group of 32 very courageous people
2514in Norway who, in 1988, set up an Accutane support group and went to the media to highlight
2515the terrible side effects caused by Accutane. We have the copy of the newspaper reports which
2516are now 12 years out-of-date. They sought from the medical professional to devise proper
2517medical treatment for people who had suffered this severe physical and psychiatric side effects
2518
2519which are listed in those publications in 1988. As a result of this, the Norwegian Health
2520Authority commissioned a study in 1992. The study was financed by Roche. The final report
2521submitted to the Norwegian Health Authority in 1993 made no reference whatsoever to the
2522scientific publications at that time linking the ingestion of Accutane and the emergence of
2523psychiatric disorders and other items. They did not disclose the number or the nature of adverse
2524drug reactions held on the Roche database at that time.”
2525“Following the increased label warnings introduced by the FDA in February 1998, Roche placed
2526advertisements in the media indicating that Accutane could alleviate depression. That was their
2527reaction. On the 8th of March 1998, the FDA sent warning letters to Roche ordering them to
2528withdraw the promotional material stating that they were false and misleading and promote
2529Accutane for an unapproved use. Roche used similar procedures or maybe tactics in the United
2530Kingdom, but time does not permit me to just deal with those in detail at the moment. Also,
2531Roche used similar advertising tactics in Ireland after the increased label warnings were applied
2532and a feature on that is by Drs. Bickers and Jacobs. And when we looked who were Drs. Bickers
2533and Jacobs, we found that they had been employed by Roche in 1997 in order to try and persuade
2534the FDA not to bring in increased label warnings.”
2535“It came to our attention that Accutane was for sale on the Internet. Now, as far as we can
2536determine -- and we've been monitoring the Internet for many years - the drug was not sold on
2537the Internet prior to the increased label warnings, featuring psychiatric illness and suicide. To
2538investigate the ease with which Accutane could be obtained online, we placed orders under the
2539names of boys and girls in their teens. Within 10 days, we were supplied with the drug from
2540South Africa with a prescription from a doctor with a South African address. Despite the
2541restrictions for the prescribing of Accutane, such as blood tests, pregnancy tests, it is possible to
2542get Accutane without a medical consultation. All you need is a credit card. No medical
2543consultation. No meeting between patient and a doctor. No blood tests. No birth control
2544safeguards. No monitoring of patients.”
2545“Now, Roche profits from sale of Accutane via the Internet could be in tens of millions and
2546perhaps even hundreds of millions of dollars.”
2547“The license for Accutane states that it should only be used for severe recalcitrant cystic acne as
2548a treatment of last resort when all other treatments have failed. And that's the position in most of
2549the countries, if not all of the countries. We believe that more than 80 percent of patients
2550prescribed Accutane have mild or moderate acne, which is in violation of the license.
2551Prescribing doctors should be required to certify that patient's acne is within the license
2552guidelines.”
2553“I'll just mention. There was a survey on several hundred dermatologists, conducted by a
2554professor well-known to this side of the house, which showed that 74 percent of patients were
2555prescribed Accutane for mild or moderate acne. We have other studies in France, and if anybody
2556wants to have a look at them, we would provide them -- showing that between 70 and 80 percent
2557of people prescribed Accutane have mild or moderate acne. Of course, Roche knows that.
2558Everybody knows that. It's produced for severe nodular cystic acne. Unfortunately, the FDA
2559and other national agencies say that they really can't do anything about it. It's the prerogative of
2560the doctor.”
2561
2562“Studies need to be undertaken by Roche or dermatologists to elucidate the mechanisms by
2563which Accutane interacts with the central nervous system and other systems in the body. This
2564will give us an insight into the causes of the specific side effects and hopefully leading to
2565developing proper medical treatment for the tens of thousands, if not hundreds of thousands, of
2566people who have suffered and continue to suffer severe side effects from this drug.”
2567“Patients should have all the proper tests, blood tests, pregnancy tests, and so on which should be
2568properly monitored.”
2569“Sale of Accutane on the Internet should be immediately prohibited.”
2570“Independent studies urgently need to be carried out to establish exactly the mechanism by
2571which this drug causes so many side effects.”
2572“An appropriate medical treatment -- this is probably the most important -- must be
2573devised to counteract the side effects and to provide treatment for the many tens and
2574hundreds of thousands of people who have suffered severe side effects from this drug.”
2575http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3639t2.rtf
2576There you have it. Even though my report is the most comprehensive and well-documented
2577dossier on Accutane that I know of to date, I’m convinced other studies and information exists
2578out there but they’ve been suppressed. Independent studies must be immediately carried out in
2579order to confirm and verify Accutane’s mechanism of action, that is driving cells toward their
2580Hayflick Limit which I have discussed in-depth in this report, and research also needs to be
2581carried out on the dysfunctional vitamin A and retinoic acid metabolism in former Accutane
2582patients with chronic long-term side effects. People have a right to know how this drug has
2583altered their body down at the cellular level. I don’t know if an antidote or a medical treatment
2584exists that can counteract all of the permanent side effects caused by Accutane. There are some
2585treatments that can help certain specific side effects. But if the chronic side effects are indeed a
2586result of telomere shortening induced by Accutane, then these side effects will be permanent
2587unless somebody figures out a way to fix this one major component of the aging process. The
2588everlasting damage caused by Accutane is identifiable with current medical technology, and I’ve
2589provided some giant clues here in my report to point the scientists in the right direction. For
2590example, has anybody ever bothered to the check the chromosomes (including telomeres and
2591telomerase) before and after a course of Accutane? An enormous amount of research has been
2592devoted to studying vitamin D, another fat-soluble vitamin, which has turned out to be a very
2593safe and effective health enhancing supplement. Now the research ball definitely needs to get
2594rolling with Accutane and vitamin A but this research must not be carried out by Roche, because
2595as Congressman Bart Stupak has said many times and as their criminal history has demonstrated
2596over and over again, they cannot be trusted. A question that arises is what needs to happen to the
2597Roche executives and all the others who are mainly responsible for keeping this toxic crap on the
2598market all these years and handing it out to so many people. I have the answer and it’s simple.
2599Find them and throw their asses in jail. This should be a no-brainer because what they've done
2600with Accutane is 100 times worse than any financial crime ever committed by a corporate
2601executive. This is very serious business because we're talking about people's health and their
2602
2603lives, not their retirement portfolio and personal financial assets. It’s time for Roche to be
2604criminally investigated for their unbelievable negligence and outrageous “off-label” promotion
2605of Accutane to millions of people with mild to moderate acne, the evidence is not that hard to
2606find. They are directly responsible for poisoning millions of acne patients with a powerful
2607chemotherapy drug, hiding the evidence of its life-altering dangers, not conducting any research
2608on its mechanism of action, and causing death and permanent injury to thousands of babies,
2609teenagers and young adults all over the world. Everybody is a victim of misinformation because
2610of them, which is why they deserve to be in jail, period. Or better yet, give them this choice.
2611They must choose one of two options. Option number one, they themselves take a 5 month
2612course of Accutane at 80 mg per day. Option number two, they spend the rest of their lives in
2613prison. If they think that Accutane is such a safe nonchalant simple drug that can be handed out
2614to perfectly healthy young people with only a few acne spots on their face or body, then they
2615should have no problem with picking option number one. But I can guarantee that unless they
2616are completely ignorant and oblivious to reality, every single one of them will steer clear of
2617option number one and take the prison time instead, because by having access to all the adverse
2618drug reaction reports, they know for a fact how incredibly devastating the permanent side effects
2619of Accutane can be and this is something they will avoid at all costs.
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