|2||General Discussions / General Chat / Re: A Trip Down Memory Lane|
|Justice will not be found through the legal system. There is no way to objectively verify Accutane-induced permanent neurological problems. Even if there were, it would be near impossible to legally prove causation. Even then, statutes of limitation would have run... If and when the **** ever does hit the fan they will just point out how strenuously they claimed their ignorance about permanent problems.
Would legal justice even be justice, anyway? The people who have profitted from Roche's deception won't be personally brought to justice -- they will be shielded from personal liability... Roche's stock might drop, that's about it, it still would have been rational for those ***holes to deceive regarding Accutane in the first place: its profits over the years have been more than enough. The corrupt FDA, as a gov't institution, can't be held liable....
There is no foreseeable retributive action in the legal system which would make their fraud regarding Accutane a mistake. Their decisions were economically rational and they know it. Would taking some of their money even be justice? Their lives would go on, just with a little less money. Our lives will never be the same.
If you seek real justice, it will not come through the legal system -- they know this, that's why they continue to deceive and play ignorant. It is the financially rational thing to do...
|3||Announcements & Member Introduction Boards ( New Members Read First) / The Meeting Place / Video on where the world is headed.|
Thought provoking video - though, for many of us, our trust in the FDA, and, by extension, other government agencies has already vanished.
|4||General Discussions / Your Experience after taking Accutane/Roaccutane / Re: Please help, I need advice...|
|My experience is similar to yours. Sadly, I must say that it is possible to experience major long term problems from only two days worth of pills.
I took a two doses (a 40 mg dose and an 80 mg undivided dose) in a period of two days over five years ago. My problems are different from yours: tinnitus, total loss of sexual sensation, depression, anxiety, loss of craving for food, and some other neurological/mental problems. Over time I have gotten used to most of them, but they are still there. (they also mirror yours in that over the course of five to seven days they fluctuated and got worse). I do not mean to say that yours are permanent, as everyone is different, and a few problems I experienced initially, such as insomnia, have resolved. Luckily you took a small dose, so... your problems may not be severe, and they may not even be long-term at all.
|5||General Discussions / General Chat / Re: Magnitude of Potential Toxicity|
on January 18th, 2007, 8:00pm, jrempire2 wrote:
I can't speak for all of the symptoms, but at least some of them, in at least some cases are not related to excess stored levels of retinoic acid in the body.
I was deceived by my doctor almost 5 years ago into taking this drug (no consent form, no med guide, no warnings whatsoever). I took a rather high dose for two days. TWO DAYS!!! (albeit an 80 mg undivided dose) Life altering, presumably neurological, problems which I never experienced before have plagued me ever since.
I will never know again what it is like to pleasure a woman because I no longer have any sexual sensation - I will never again experience what silence is due to the constant ringing in my ears - I will never know who I would have become because of what this motherf**king drug has done to my mind. A drug which I should have never been prescribed.
I seriously doubt less than 200mg TOTAL of isotretinoin or its metabolites have remained stored in my body over the years creating these problems. In at least some cases, such as mine, this drug just does its damage when its taken, or shortly thereafter, and that's it. No real hope of recovery, doctors are useless, the damage is done.
Doubt my problems and their connection to Accutane all you want - I know I wouldn't believe a word of it if I had never taken the drug and someone told me the story I have told above. The truth is, I'm a rational non-hypochondriac who still can't believe how his life has been changed by this drug.
|6||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Re: How to compensate for accutane-symptoms|
|For those of you that are really desperate for a cure, this might be worth a shot, assuming Max's theory about lost dopamine receptors is true: (synopsis: a drug similar to the bolded drugs below has stimulated regrowth of some nerve cells in rats).
Dopamine Drug Leads to New Neurons and Recovery of Function in Rat Model of Parkinson's Disease
For release: Tuesday, July 04, 2006
Overview In preliminary results, researchers have shown that a drug which mimics the effects of the nerve-signaling chemical dopamine causes new neurons to develop in the part of the brain where cells are lost in Parkinson's disease (PD). The drug also led to long-lasting recovery of function in an animal model of PD. The findings may lead to new ways of treating PD and other neurodegenerative diseases.
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In preliminary results, researchers have shown that a drug which mimics the effects of the nerve-signaling chemical dopamine causes new neurons to develop in the part of the brain where cells are lost in Parkinson's disease (PD). The drug also led to long-lasting recovery of function in an animal model of PD. The findings may lead to new ways of treating PD and other neurodegenerative diseases. The study was funded in part by the NIH's National Institute of Neurological Disorders and Stroke (NINDS).
The study suggests that drugs that affect dopamine D3 receptors might trigger new neurons to grow in humans with the disease. Some of these drugs are commonly used to treat PD. The finding also suggests a way to develop new treatments for PD. The results appear in the July 5, 2006, issue of The Journal of Neuroscience.
Parkinson's disease, a progressive neurodegenerative disorder that causes tremors, stiffness, slow movements, and impaired balance and coordination, results from the loss of dopamine-producing neurons in part of the brain called the substantia nigra. While many drugs are available to treat these symptoms during the early stages of the disease, the treatments become less effective with time. There are no treatments proven to slow or halt the course of PD. However, many researchers have been trying to find ways of replacing the lost neurons. One possible way to do this would be to transplant new neurons that are grown from embryonic stem cells or neural progenitor cells. However, this type of treatment is very difficult for technical reasons.
The new study, conducted by Christopher Eckman, Ph.D., and Jackalina Van Kampen, Ph.D., at the Mayo Clinic College of Medicine in Jacksonville, Florida, focused on a second possible way to restore function â€“ prompting stem cells that normally remain dormant in the adult brain to develop into neurons. While most researchers previously believed the adult brain could not develop new neurons, recent studies have shown that the brain contains stem cells and that new neurons can develop in some regions. Studies by Dr. Van Kampen and others also have shown that drugs which affect dopamine D3 receptors can trigger development of new neurons (a process called neurogenesis) in the brains of adult rats. Until now, however, no one had shown that the newly developed neurons could connect with other parts of the brain and restore function.
"This is the first study to show that endogenous neurogenesis [development of new neurons from cells already in the brain] can lead to recovery of function in an animal model of Parkinson's disease," says Dr. Eckman.
The researchers gave either 2-, 4-, or 8-week continuous infusions of a drug called 7-OH-DPAT, which increases the activity of dopamine D3 receptors, into the brain ventricles of adult rats with neuron loss in the substantia nigra and symptoms similar to human PD on one side of the body. 7-OH-DPAT is not used in humans, but its effects on dopamine receptors are similar to the drugs pramipexole and ropinirole, which are approved to treat PD. The rats also received injections of a chemical called bromodeoxyuridine (BrdU), which marks proliferating cells, and infusions of a substance that fluorescently "traces" how neurons connect. The animals were tested before and 3 days after receiving the treatment to see how well they could walk and reach to retrieve food pellets with their paws. A subset of the rats was tested again 2 and 4 months following the treatment.
Rats treated with 7-OH-DPAT had more than twice as many proliferating cells in the substantia nigra as rats that were treated with saline, the researchers found. Many of the newly generated cells appeared to develop into mature neurons, and approximately 28 percent of them appeared to be dopamine neurons by 8 weeks after treatment. Animals treated for 8 weeks also developed almost 75 percent of the normal number of neuronal connections with other parts of the brain and showed an approximately 80 percent improvement in their movements and a significantly improved ability to retrieve food pellets. These effects lasted for at least 4 months after the treatment ended.
"There was a profound behavioral effect of the treatment, even after it 'washed out' of the system," Dr. Eckman notes. "This shows that the treatment affects the underlying pathology."
Several previous studies have pointed to the possibility that drugs like pramipexole and ropinirole might modify the course of PD, but this effect is difficult to test and has never been proven, says Dr. Eckman. While these drugs are useful in treating the symptoms of PD, they have not been designed to prompt development of new neurons, he adds. Altering how the current drugs work or developing new compounds to enhance neurogenesis could provide an entirely new avenue for treating this disease.
â€śThese findings are very exciting for several reasons. Being able to stimulate endogenous stem cells in patients would alleviate the need for transplantation of engineered cells, and as a drug therapy, it would be also easy to administer to patients. Moreover, given that similar drugs exist, medicinal chemistry to maximize this effect could be achieved quickly,â€? says Diane Murphy, Ph.D., the NINDS program director for the grant that funded this research.
Dr. Eckman and Dr. Van Kampen are now looking at how different doses of pramipexole and similar drugs affect neurogenesis. Once they identify the most effective doses in animals, researchers might be able to test comparable doses in humans. They are also carrying out experiments to learn if using drugs that act on other kinds of receptors might stimulate neurogenesis in Alzheimer's disease and other neurodegenerative diseases.
The NINDS is a component of the National Institutes of Health (NIH) within the Department of Health and Human Services and is the nationâ€™s primary supporter of biomedical research on the brain and nervous system. The NINDS mission is to reduce the burden of neurological disease. Go to http://www.ninds.nih.gov/ for more information.
The National Institutes of Health (NIH) â€” The Nation's Medical Research Agency â€” includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
Van Kampen JM and Eckman CB. "Dopamine D3 Receptor Agonist Delivery to a Model of Parkinson's Disease Restores the Nigrostriatal Pathway and Improves Locomotor Behavior." The Journal of Neuroscience, July 5, 2006, Vol. 26, No. 27, pp. 7272-7280.
Reporters: for more information, contact Natalie Frazin or Paul Girolami, ph: 301-496-5924.
Date Last Modified: Tuesday, July 04, 2006
|7||General Discussions / General Chat / haven't seen these posted yet....|
-- depression study
-- canadian (?) accutane commercial
|8||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Has anyone else tried an MAOB inhibitor?|
|Max reported limited success with an MAOB inhibitor (such as eldepryl - selegiline). What's your conclusion regarding MAOB inhibitors, Max? Has anyone else tried them?|
|9||General Discussions / General Chat / Lariam (Different Roche Drug) Brain Damage Link|
|Lariam (anti-malaria drug manufactured by Hoffman LaRoche has been linked to brain damage/inner ear damage).
|10||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Re: Potential Cure: Cigarettes|
|I'd be willing to die somewhat prematurely from emphysema, if I'd get 30 years of freedom from Accutane toxicity. (But, in all honesty, I'm rather skeptical that tobacco actually would offer substantial relief from Accutane toxicity.)|
|11||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Re: Science: Dopamine discussion|
|And, about the comparison with Parkinson's Disease: Isn't it the Dopamine producing cells that are damaged in Parkinson's Disease, and not the Dopamine receptors? If so, this analogy may not be that strong.|
|12||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Re: Science: Dopamine discussion|
on June 3rd, 2004, 3:13pm, Accurate wrote:
Where do you see this? All that I have found is that it has been used on mice and rats with qualfied success. (High incidence of tumors, and other problems)
|13||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Potential Cure: Cigarettes|
|I'm not even joking. If Max's hypothesis about MAOB inhibition is correct, than smoking may actually help:
|14||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Re: How to compensate for accutane-symptoms|
|Max - A few questions:
Do you still take an MAOB inhibitor? If so, does it still work?
What Accutane-induced problems were you experiencing? Were you experiencing loss of sexual sensation?
Why do you say that it is the D3 and D4 receptors, specifically, that are damaged by Accutane?
|15||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Re: Att, Max from Patti|
|Correct me if I'm wrong, Max, but, as I understand it, it's an MAOB inhibitor. Searches on the internet indicate that one MAOB inhibitor is known as selegiline, and is sold under the trade names eldepryl and carbex in the United States. I don't know much about any of this - this is just the best understanding that I have come to - so take everything I say with a grain of salt. You might be able to buy it from some online pharmacies if you can't get it from a doctor, i guess. I might try it out.|
|16||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Re: Science: How to compensate for accutane-sympto|
|Are you certain it was an MAO-B inhibitor (like selegiline), not MAOI, or MAOA, or anything?|
|17||General Discussions / General Chat / Re: Our purpose is soley for vindication?|
Yes they can, Accutane generates around 1.2 billion in revenue annually. 5 million is nothing. I think this is part of the problem: The expected litigation costs are minimal relative to revenue generated. (Proving causation regarding Accutane can be very difficult. Even proving damages regarding some side effects, neurological, for instance, can be very difficult. Factor in the number of people that are injured and don't sue, and the high market price of Accutane, and it should be easy to see that Accutane won't be pulled off of the market for financial reasons anytime soon.)
Cloud: I agree that for a very small number of people, Accutane's benefits MIGHT outweigh its risks. However, an extremely limited Accutane distribution scheme is definitely not a current reality, and may be virtually impossible to implement. It would require a number of things, including adequate dissemination of information regarding side effects (this isn't done because no hint at the frequency of side effects is given - hell, the approximate frequency isn't even known. Also, some side effects aren't even mentioned). And regulation of physicians, which the FDA has no power to do.
I can't say that I support Accutane remaining on the market if someone, such as myself, can be permanently and seriously damaged, without warning, simply because he chose the wrong doctor to treat his mild acne. (All that I wanted was some skin cream).
|18||General Discussions / General Chat / Re: first day went pretty bad|
on May 20th, 2004, 7:36am, Elessar wrote:
I notice that you didn't respond to any of my questions... evidently you have no basis for making these statements, and, as I said, you are just pulling them out of your ass.
Derren Brown? Never heard of him. I would need to see his show to comment adequately on him. But, I don't see how the fact that someone has "psychological illusion skills" demonstrates that what I am experiencing is somehow psychosomatic.
|19||General Discussions / General Chat / Re: first day went pretty bad|
You try to act analytical and skeptical regarding Accutane side effects, and then jump to conclusions when it suits your interests: How do you know what the man was dreaming about? How do you know there was any connection between a dream and an injury? You can't. I can handle some skepticism about Accutane side effects, but you need to at least be consistent.
Do you have any basis for this, or are you just pulling it out of your ass?
Once again: Why does the fact that you had some pain that is no longer there mean that it was "all psychological"? If you had pain, and then it went away, how does that bring you to the conclusion that it wasn't real?
|20||General Discussions / General Chat / Re: Our purpose is soley for vindication?|
|Don't you feel vindicated when you do that? (I'm not saying it's the only thing that you feel.)|
|21||General Discussions / General Chat / Re: Question.... Please respond|
|*Tinnitus (ringing in the ears) - it's always there, accompanied by minor hearing loss.
*Complete loss of sexual sensation along with a near complete loss of libido.
*Undiagnosed bowel problems - I haven't had a normal bowel movement in over two years.
*Central nervous system problems - Primarily that my mind is completely different than it was before. I realize that this is nebulous and hard to explain, and may give rise to skepticism, but I'm not the same person that I was before: I can't focus on anything, I enjoy nothing, I have absolutely no appetite, and I'm in a perpetual state of anxiety. Some would diagnose this as "depression" - but, that label doesn't do it justice. This is something more. I experienced "depression" before Accutane - this isn't the same thing. This is a drastic change in your mind that I am unable to adequately explain at the moment.
*Variety of minor side effects such as slight hairloss and floaters.
I can live with most of this stuff. It's what it has done to my mind, and my complete inability to enjoy sex, that really bothers me.
|22||General Discussions / General Chat / Re: Question.... Please respond|
on May 17th, 2004, 9:28am, Elessar wrote:
I would gladly have a leg or an arm amputed, or lose all of my hearing, or lose anything you'd be willing to lose in the above quote, if all of my side effects would completely go away. I realize this may sound ridiculous to you, but I've thought this out thoroughly - I would trade a lot for relief from this. I don't doubt that acne is a serious problem for you, but don't take the potential side effects lightly, either. They can be permanent.
|23||General Discussions / Your Experience after taking Accutane/Roaccutane / Re: Why don't we try to get on shows|
|The holocaust analogy:
Just like virtually any other analogy, it's far from perfect. Informing a skeptic about the dangers of Accutane by drawing an analogy to the holocaust would, in all probability, backfire. The skeptic would most likely discredit everything else that is said, and consider you a raving lunatic. In order to inform people about the dangers of Accutane, credibility is needed - holocaust analogies are not the way to go about it.
Obviously, the scope of the holocaust far exceeds anything that has resulted from Accutane - comparing Accutane with the holocaust seems ludicrous on many levels. That being said, the analogy is not completely baseless. Before the concentration camps were discovered, many doubted their existence, and felt that nothing like that could ever happen. After their horrific discovery, the world has gone to great lengths to ensure that nothing like it ever happens again. Perhaps what we are attempting to do is similar to this. People doubt the existence of serious, permanent side effects associated with Accutane. People feel that there is no way that anything that is on the market could possibly be so dangerous. If, in the future, the horrific nature of Accutane becomes fully known, perhaps the world will go to great lengths to ensure that nothing similar to it happens again. (For instance - removing it from the market, changing drug approval procedures; changing adverse event reporting mechanisms; punishing Roche in a way that would somehow make it clear that it would be unprofitable for companies to do similar things in the future; putting effort into explaining and/or treating the adverse events, etc.)
|24||General Discussions / General Chat / Re: side effect knowledge|
|I'm not totally unsympathetic to what you're saying - Cloud9. I'm generally in favor of consumer choice, and I feel that assumption of risk should bar recovery *IF* the consumer is adequately informed of the risks involved in choosing a medical treatment. The problem is, with Accutane, that is a very big if, for a variety of reasons, including:
1) Not all patients receive the medication guide, or the consent forms. I received neither, and I was prescribed Accutane in 2002 when fairly tight restrictions were in place. Physicians are not required by law to show the patient the consent form. And, although the FDA does require distribution of the medication guide with Accutane prescriptions, it is often not given out (due to forgetfulness, incompetence, or who knows what). I must admit that the writing on the Accutane box itself does contain some warnings. However, they are arguably not stated clearly, and minimized.
2) Many people assume that because a particular product is on the market, it meets some minimum safety requirements. (For instance, that it doesn't cause serious and permanent side effects in a significant portion of its users.) Virtually any drug on the market has a long list of side effects associated with it. How is the consumer supposed to know that Accutane poses a significantly greater risk than other drugs?
3) You can't assume that all physicians that prescribe Accutane will adequately inform patients about its risks. Some of them don't know, and may not even want to know, how dangerous Accutane can be. Also, in extremely rare cases, such as mine, a physician may not want to fully inform his patient about the risks of Accutane, due to a conflict of interest.
Primarily due to #2, above, I don't think Accutane should be on the market. People assume that because something is approved by the FDA, it can't be THAT bad. Unfortunately, in the case of Accutane, it is.
|25||General Discussions / General Chat / Re: Side effects years after treatment|
|You seem to be under the impression that those of us who attribute our physical problems to Accutane ingestion have arrived at this conclusion solely by virtue of the fact that we took Accutane in the past and later experienced physical problems. I can't speak for others, but that is not the case with me.
Prior to ingesting Accutane in April of 2002, I had never experienced any sexual dysfunction or persistent tinnitus. Within five days of the first pill that I ingested, I experienced a number of physical problems, including a total loss of sexual sensation and tinnitus (ringing in the ears). These problems have persisted, unchanged, to this day. Due to 1) the timing of the onset of these problems, 2) my compete lack of similar problems prior to ingesting Accutane, and 3) anecdotal evidence that indicates that others have had such problems that they attribute to Accutane ingestion, I don't feel that it is unreasonable for me to conclude that I am experiencing these problems because of Accutane.
I obviously agree that attributing every single physical problem that one experiences in life to prior Accutane ingestion is absurd - But, I feel that dismissing any possibility of a causal relationship between Accutane ingestion and physical problems, merely because these problems are experienced in some form by a substantial portion of the population is equally absurd.
|26||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Re: Erectile dysfunction?|
|I really can't say what the cause could be - no one knows anything about this, it seems. Hormonal imbalance? Neurological damage? It would be great if it were the former, because it would probably be treatable. If there were a drug that could treat this, I would have no problem taking it for the rest of my life.
How am I coping with it? Not particularly well. You take a drug in order to increase your chances of getting laid, and end up not being able to enjoy getting laid. (Getting an erection isn't that big of a problem - it's the near complete loss of sensation.) I guess you could try to enjoy pleasing the other person, and all that crap. But, still, this side effect is horrible...
|27||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Re: Erectile dysfunction?|
|I have the exact same thing. You're doomed, as far as I know. Two years and counting for me - no improvement.|
|28||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Re: Loss of Sexual Sensation|
|I doubt I'll get any definitive answers on this - but, any idea if this is neurological? or glandular? or something else? Has anyone who has experienced loss of sexual sensation post-Accutane experienced even a partial recovery? I'm not very optimistic myself considering the length of time that it has been gone and the lack of improvement.|
|29||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Re: Loss of Sexual Sensation|
|Also, this website appears to have some information:
|30||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Loss of Sexual Sensation|
|Just trying to get some information from anyone who has experienced persistent loss of sexual sensation after using Accutane. (I took a high dose for only a couple of days, and have not had any sexual sensation since - it's been a over a year and a half.) I found the following anecdotes on google newsgroups:
|31||General Discussions / General Chat / Re: Is 1 20mg pill of Roaccutane likely to do dama|
|I listed them on a thread a little over a year ago. I felt really sick after the 80 mg dose, most of the problems came on over the next 4 or 5 days: tinnitus, loss of sexual sensation and libido, difficulty concentrating/depression have all persisted and appear to be permanent (it's been about a year and a half). I had really bad insomnia and headaches for about 2 or 3 months, but that has passed.|
|32||General Discussions / General Chat / Re: Is 1 20mg pill of Roaccutane likely to do dama|
|I'd be surprised if you did, that isn't much Accutane - but who knows, I have persistent side effects after taking a total of 120 mg over the course of two days. (single 40 mg dose on day one, single 80 mg dose on day two)|
|33||General Discussions / General Chat / Re: FDA statistics|
|You say that the information is available, but this site does not indicate where it is available - if it is available in the transcript of a government hearing, or in 'non-sensitive communications' between health agencies and Roche, or any other form, there should be some way that it can be verified outside of this website. (A link to the communication/hearing etc., or some form of citation that can be used by people to find this information.) I'm not saying that claims need to literally be published in some form, just that there has to be some way of verifying them.|
|34||General Discussions / General Chat / Re: FDA statistics|
Is there anyone that can tell me where this information is actually published?
I admire the effort of the people that run this site, but you should really provide some adequate form of citation, so we know that these figures aren't just pulled out of the air.
This is not limited to the quotation above. The statements below are made on the RAG website, but they are simply stated without citation. I don't doubt the truth of these statements, but in order for this website to be taken seriously, there needs to be some way of verifying the claims that are made on it.
|35||General Discussions / General Chat / Re: FDA statistics|
|any information that would help me find where these statistics are published? was it in a journal or some other publication?|
|36||General Discussions / General Chat / FDA statistics|
|I am required to write a 'publishable note' on a legal issue as a member of a journal at my law school. At this point, I'm planning on writing about the use of strict liability instead of negligence as the standard in Accutane product liability actions. It has been mentioned that, according to the FDA, Accutane ranks fifth(?) among all drugs in terms of the number of adverse events associated with its use, and that the Accutane adverse event to prescription ratio is alarmingly high. Can anyone tell me where to find this information? or other information which clearly and objectively demonstrates the high incidence of serious and permanent side effects associated with Accutane?|
|37||General Discussions / General Chat / Re: Law review article Accutane|
[FN116]. The 1982 label warned:
Because birth defects have been shown in experimental animals, you should not take Accutane if you are pregnant or intend to become pregnant while undergoing treatment. If you are of child-bearing potential, be sure to use an effective form of contraception. Should you become pregnant, be sure to tell your doctor.
The June 2001 Accutane7 package insert features an icon of a pregnant woman with a superimposed circle and line drawn diametrically through the bulging abdomen, and the words "Avoid Pregnancy." It declares:
Accutane must not be used by females who are pregnant or who may become pregnant while undergoing treatment. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extremely high risk that a deformed infant can result if pregnancy occurs while taking Accutane in any amount even for short periods of time....Accutane is contraindicated in females of childbearing potential unless the patient meets all of the following conditions:
• Must have severe disfiguring nodular acne that is recalcitrant to standard therapies.
• Must be reliable in understanding and carrying out instructions.
• Must be capable of complying with the mandatory contraceptive measures required for Accutane therapy and understand behaviors associated with an increased risk of pregnancy.
The package insert goes on to require oral and written warnings, two negative pregnancy tests, agreement to use two forms of contraceptive, and the viewing of an instructional video. It details the kinds of "documented fetal abnormalities"--including cerebral abnormalities, cerebellar malformation, hydrocephalus, ear, eye, and cardiovascular abnormalities, low IQ scores, premature births, and an increased risk of spontaneous abortions.
The package insert concludes:
Accutane should be prescribed only by prescribers who have special competence in the diagnosis and treatment of severe recalcitrant nodular acne, are experienced in the use of systemic retinoids, and understand the risk of teratogenicity if Accutane is used during pregnancy.
A detailed consent form requires initials by the patient and a parent or guardian (if the patient is a minor under eighteen) for each of fifteen items, and must be counter-signed by the prescriber, who must affirm:
I have fully explained to the patient __________, the nature and purpose of the treatment described above and the risks to females of childbearing potential. I have asked the patient if she has any questions regarding her treatment with Accutane and have answered those questions to the best of my ability.
[FN117]. See Food & Drug Admin., Appendix II (Sept. 18-19, 2000), at http:// www.fda.gov/ohrms/dockets/ac/00/backgrd/3639b1e_03.pdf.
[FN119]. See id.
[FN120]. See Food & Drug Admin., Briefing Information 1 (Sept. 18-19, 2000), at www.fda.gov/ohrms/dockets/ac/00/backgrd/3639b1.htm.
[FN121]. See Food & Drug Admin., supra note 117.
[FN122]. The date has been extended to "after 2002," pursuant to the Patent Term Restoration Act, 35 U.S.C. §156(c) (1994), which states "[t]he term of a patent eligible for extension...shall be extended by the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued...." Id.; see also Correspondence with William Epstein, supra note 104.
[FN123]. Food & Drug Admin., supra note 120, at 1.
[FN124]. Micronizing is a reduction of particle size, which Roche reports improved absorption of isotretinoin. Absorption of Accutane is 30 percent greater when taken with food than without. See Food & Drug Admin., supra note 120, at 13.
[FN125]. Food & Drug Admin., supra note 120, at 1.
[FN126]. Food & Drug Admin., FDA 6 (Aug. 9, 2000), at http:// www.fda.gov/ohrms/dockets/ac/00/backgrd/3639b1.htm.
[FN127]. Id. (emphasis added).
[FN128]. The agency review noted that because of changes in the forms of contraception now sold, including "implantable" and "low dose" and "tri-cyclic" options, the level of assurance provided by old studies that showed that Accutane does not interfere with the effectiveness of contraception must be reevaluated. Id. at 10.
[FN129]. Id. at 12.
[FN130]. Id. at 14.
[FN132]. See Margaret A. Berger, Eliminating General Causation: Notes Towards a New Theory of Justice and Toxic Torts, 97 Colum. L. Rev. 2117 (1997) (proposing a new model for toxic tort cases that would impose liability without proof that the defendant's product caused the plaintiff's illness; instead, liability would rest on proving that the defendant failed to develop and disclose information that is needed to assess serious latent risks).
[FN133]. See Wendy E. Wagner, Choosing Ignorance in the Manufacture of Toxic Products, 82 Cornell L. Rev. 773 (1997).
[FN134]. See James v. Bessemer Processing, Inc., 155 N.J. 279, 300 (199 ("Legal scholars have long struggled with the problem of adapting traditional legal doctrines of causation to the difficulties of proving medical causation in the toxic-tort context, but courts have been resistant to novel models of causation."); see also David M. Benjamin, Elements of Causation in Toxic Tort Litigation: Science and Law Must Agree, 14 J. Legal Med. 153 (1993); Berger, supra note 132; Christopher L. Callahan, Establishment of Causation in Toxic Tort Litigation, 23 Ariz. St. L.J. 605 (1991); Ora Fred Harris, Jr., Toxic Tort Litigation and the Causation Element: Is There Any Hope of Reconciliation?, 40 Sw. L.J. 909 (1986); Susan R. Poulter, Science and Toxic Torts: Is There a Rational Solution to the Problem of Causation?, 7 High Tech. L.J. 189 (1992); L. Grant Foster, Comment, A Case Study in Toxic Tort Causation: Scientific and Legal Standards Work Against Recovery for Victims, 19 Envtl. L. 141 (198; Paul K. Sidorenko, Comment, Evidentiary Dilemmas in Establishing Causation: Are Courts Capable of Adjudicating Toxic Torts?, 7 Cooley L. Rev. 441 (1990).
[FN135]. Wagner, supra note 133, at 815.
[FN136]. See id.
|38||General Discussions / General Chat / Re: Law review article Accutane|
[FN99]. A teratogen causes congenital abnormalities.
[FN100]. Isotretinoin was approved by the FDA in 10 mg and 40 mg oral capsule form on May 7, 1982, and in 20 mg oral capsule form on March 28, 1993. See Food & Drug Admin., FDA Application No. 018662, available at http:// www.accessdata.fda.gov/scripts/cder/ob/docs/tempnodet.cfm?Appl_ No=018662&Table1=Rx (last visited Jan. 27, 2002).
[FN101]. U.S. Patent No. 4,464,394 (issued Aug. 7, 1984) (emphases added) (claiming "[c]ompositions and methods for using 13-cis vitamin A acid compounds"). The patent had an unextended expiration date of August 7, 2001. See Food & Drug Admin., Electronic Orange Book, available at http:// www.accessdata.fda.gov/scripts/cder/ob/docs/patexcl.cfm?Appl_No=018662&Product_ No=002&table1=Rx (last visited Jan. 27, 2002).
[FN102]. See 35 U.S.C §154(a)(1)(1994):
Contents.-Every patent shall contain a short title of the invention and a grant to the patentee, his heirs or assigns, of the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States, and, if the invention is a process, of the right to exclude others from using, offering for sale or selling...products made by that process, referring to the specification for the particulars thereof.
Id. The right is broadly construed. A patentee is entitled to all uses and benefits of her invention, whether or not she contemplated them, or knew of them.
[FN103]. During the term of years fixed by a patent, no one may make, use, or sell the patented product without the patentee's authority. The grant of patent is a grant of a statutory monopoly. See Sears, Roebuck & Co. v. Stiffel Co., 376 U.S. 225 (1964). The patentee has the exclusive right to manufacture, use, and sell its invention. The heart of the legal monopoly is the right to invoke the state's power to prevent others from utilizing the discovery without consent. But the patentee may not use the power of a patent to levy a charge for making, using, or selling products not within the reach of the monopoly granted by the government. See Zenith Radio Corp. v. Hazeltine Research, Inc., 395 U.S. 100 (1969). The right is limited by the legislative doctrine of patent misuse. See 35 U.S.C. §271(d) (1994). Nor may the holder use the patent for purposes which violate antitrust law. See In re Recombinant DNA Tech. Patent & Contract Litig., 850 F. Supp. 769 (S.D. Ind. 1994); see also Marina Lao, Unilateral Refusals to Sell or License Intellectual Property and the Antitrust Duty to Deal, 9 Cornell J.L. & Pub. Pol'y 193 (1999).
[FN104]. See Correspondence with William Epstein, Esq., Patent Law Dep't, Hoffman-LaRoche, Inc., Nutley, N.J. (on file with author). The entire record in the case is sealed, according to William Epstein, who was attorney of record for the '394 patent.
[FN105]. See Henderson, supra note 74, at 481.
[FN106]. See 35 U.S.C. §283 (1994) (injunction), §284 (1994) (damages-- subject to trebling), §285 (1994) (attorney fees in exceptional cases), §289 (1994) (restitution of total profit of infringer).
[FN107]. U.S. Patent No. 4,464,394 (issued Aug. 7, 1984) (assigning patent to Hoffman-LaRoche, Inc.).
[FN108]. See U.S. Patent No. 5,698,593 (issued Dec. 16, 1997) (assigning patent to the United States):
According to the present invention, acne can be treated by administering to a patient having mild cystic acne or with scarring non-cystic acne a compound selected from the group consisting of 13-cis-retinoic acid and its derivatives, in an amount of approximately 1.5 to 3 mg/kg/day for a period of from about two to about four weeks. The treatment is then stopped, despite any persistent acne. The patients are then observed for three to four months to determine the need for additional treatment. If minimal acne remains, the short course of treatment may be repeated. If moderate or severe acne is present, then the current recommended method of 1 mg/kg/day for five months may be added.
The method of the present invention substantially reduces the number of patients who must receive the full five-month course of treatment with 13- cis-retinoic acid or its derivatives, and thus reduces the total dose administered to patients. This, of course, reduces the duration of acute toxicity, the risk of teratogenicity, the risk of chronic radiologic toxicity, and the number of laboratory tests and physicians' office visits required to monitor the therapy. This has the beneficial effect of also reducing the expense and inconvenience to the patient.
Id.; s ee also U.S. Patent No. 4,322,438, (issued Mar. 30, 1982) (stating a claim by the same researcher for another, safer method of dosing severe acne patients).
[FN109]. Products Liability Restatement §6(d) states:
(d) A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:
(1) prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or
(2) the patient when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.
Restatement (Third), supra note 4, §6(d)(1)-2.
[FN110]. Henderson & Twerski, supra note 2, at 175.
[FN111]. See Restatement (Third), supra note 4, Reporter's Note to cmt. f.
[FN112]. See Freeman v. Hoffman-LaRoche, Inc., 618 N.W.2d 827, 834-35, 840 (Neb. 2000). The Nebraska court ruled on the pleadings which alleged a defect in consumer expectation terms. It did not go beyond the conclusory allegations to address the merits of the drug or any postulated alternative. The court appears to have been unaware of the Roche New Drug Application discussed below, and the issue was not briefed by either party. See id.
[FN113]. Following the practice of the FDA Advisory Committee, Accutane7 refers to the old formulation and NF to the new.
[FN114]. See Ctr. for Drug Evaluation & Research, Accutane (Isotretinoin), at http://www.fda.gov/cder/drug/infopage/accutane/default.htm (last modified Nov. 15, 2001).
[FN115]. See Gilhooley, supra note 68 (discussing possible regulatory requirement that some drugs be prescribed only by physicians with special training and FDA approval of drugs only for certain uses); infra note 116.
|39||General Discussions / General Chat / Re: Law review article Accutane|
One may marvel at the business acumen of the Roche strategists who appear to be on the verge of replacing an old monopoly with a new one by means of a safer product. But it is possible at the same time to conclude that the social cost of the tardy development of the new product provides the basis for a finding of liability in favor of the deformed children of mothers who took Accutane (the old formula) when Roche could have brought the new formulation to market earlier instead of waiting for the end of the old product's patent monopoly period. The Accutane/Accutane NF scenario represents a potentially common situation. It demonstrates an avenue of liability for which my approach allows and the reporters' does not--even in an egregious case of warehousing an alternative safer design for deployment when the patent term expires.
*770 A jury might reasonably conclude that the manufacturer's timetable for development of the new, low-dose, more controllable product was dictated too much by market considerations and too little by concern for the safety and health of those who consumed the product, those who were aborted, or those born with grave deformities that might have been avoided if the dosing pattern had been lowered and the new formulation had been deployed earlier. Liability might reasonably be found in favor of those injured before the new formulation was approved.
In such a case--when the manufacturer has effectively occupied the field by means of its patent monopoly--the reporters' comparison with other FDA-approved drugs test has little meaning. The facts suggest that Roche was motivated to advance its research into a new design by concern over its impending loss of its patent monopoly, rather than by safety concerns. This supports a conclusion the reporters have rejected--that drug manufacturers (and medical device manufacturers) should not be able to employ as a categorical defense to a drug design defect claim that there is no other, safer, FDA-approved product on the market.
In the case of Accutane, a plaintiff would now have the benefit of Roche's belated, self-interested research and development. However, there will not always be such dramatic evidence, supplied by the defendants, of an alternative safer design. In such cases the argument of Professor Margaret Berger grows stronger--that the causal relation burden on the plaintiff should be relaxed when study of dangers and possible solutions has clearly been neglected. [FN132] Berger's approach would help to address the problem of encouraging ignorance, a problem Wendy Wagner has lucidly described. [FN133] But courts have been reluctant to make such changes in the causal relationship burden plaintiffs must meet. [FN134]
*771 Professor Wagner argues that a conventional causation rule provides a negligent manufacturer who deliberately fails to conduct toxicity tests with higher odds of escaping liability than a manufacturer who does conduct safety testing. [FN135] This results both in wrongful, harmful activity and in uncompensated victims. Wagner suggests that requiring plaintiffs to prove causation in toxic tort cases clearly adversely affects safety research and contributes to the tort system's failure to deliver on its essential compensatory function. [FN136] Wagner's argument suggests a postmarketing duty to engage in reasonable testing and development of alternatives. If a company has nothing to show in the case of substantial observed risk of harm, the plaintiff would be entitled to a presumption that the insufficiently tested product caused her harm. I would suggest that failure to do such development-- particularly in a patent-constrained market--should lead to a similarly relaxed burden on the nature of the alternative safer design evidence that a plaintiff must mount.
The Accutane example demonstrates that the institutional competence problems with the section 2(b) alternative safer design test, which the reporters assert should bar design testing of drugs as a category, are not so formidable as they might appear at first blush. The alternative safer design test works well in a case such as that presented by Accutane, in which small changes yielded significant safety gains but were neglected until approaching loss of a broad patent monopoly threatened the manufacturer-designer with loss of market control.
UCLA Law Review
*737 THE TRUE TEST: ALTERNATIVE SAFER DESIGNS FOR DRUGS AND MEDICAL DEVICES
IN A PATENT-CONSTRAINED MARKET
George W. Conk [FNa1]
Copyright © 2002 Regents of the University of California; George W. Conk
|40||General Discussions / General Chat / Re: Law review article Accutane|
This defeatist image of juridical helplessness in the face of technology and bureaucracy is deployed to undergird their categorical rule of exclusion of drugs and devices from the section 2(b) alternative safer design test. They would have done better to adopt the unsurprising, fact-sensitive, case-by-case approach that the reporter's note recognizes as the trend among common law courts. [FN111] But the history of the drug Accutane (which by chance was the product before the first court to confront, and reject, section 6(c) [FN112]) shows that comparative assessment of the reasonableness and feasibility of an alternative design may present no problems that challenge the limits of courts' ability to assess the reasonableness of technological and marketing decisions.
As the twenty-year term for the Accutane patent drew to a close, Hoffman-LaRoche acted to preserve its exclusive market position. The company sought FDA approval for Accutane NF (new formulation). Roche seeks not only approval for its new formula but also withdrawal of FDA approval for its existing product, Accutane. [FN113] The issues were debated in a series of papers prepared for the September 2000 meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA's Center for Drug *766 Evaluation and Research (CDER)--the entity that approves new drugs and monitors postmarket performance. [FN114]
The powerful teratogenicity of Accutane presented a substantial concern regarding this product, the female users of which are almost exclusively of childbearing age. The risk management objectives were that no one should begin Accutane therapy while pregnant, that no one should become pregnant while using Accutane, and that a monitoring program should be implemented to accomplish those goals. The manufacturer now instructs prescribers and patients that the drug should be prescribed only by persons with special expertise in treating recalcitrant, disfiguring nodular acne. [FN115]
Despite increasingly rigorous warnings and awareness of the dangers, [FN116] the epidemiology submitted by Roche showed that from 1989 to 2000 there *767 were 958 identified Accutane-exposed pregnancies. [FN117] Of those, 834 were terminated. Only 164 were spontaneous. Twenty-six pregnancies were ectopic. There were 111 live births. Sixty of those children were examined or their records reviewed. Of these, 13 percent showed "major malformations." [FN118] The Roche safety database from 1982 to 2000 showed 1995 pregnancies, 1446 terminations, 383 live births, 166 unknowns, and found that 42 percent of identified live births produced children with congenital abnormalities. [FN119] The conclusion was that pregnancy exposures reported to Roche and the FDA were not declining. The concern heightened because use of Accutane was escalating. Despite the manufacturer's efforts to communicate the drug's teratogenic potential there was still limited compliance with pregnancy testing before and during exposure, in addition to incomplete use of contraceptives. [FN120]
The FDA analysts concluded that only 40 percent of female Accutane users participated in Roche's "pregnancy protection program" and that there has been "substantial non-compliance with critical elements of the program." Twenty- five percent of female users did not have pregnancy tests before beginning treatment and 33 percent did not postpone treatment until receiving their test results. Both Roche (which estimated that 996 out of 1000 women avoid pregnancy while on Accutane therapy) and the FDA concur that the numbers of pregnancies and fetal exposures to Accutane must be reduced. [FN121]
Roche explained in its briefing materials for the New Drug Application, submitted in October 1999 (two years before the '394 patent's original August 2001 expiration date): [FN122]
A new formulation of isotretinoin, Accutane NF, was developed and submitted as a New Drug Application (NDA 21-177) in October 1999. *768 This micronized formulation has pharmacokinetic advantages over the current marketed Accutane, namely administration independent of food consumption and reduced variability in exposure. Thus, taking Accutane NF with or without food produces comparable exposures. In contrast, taking the current marketed Accutane with or without food markedly alters exposure levels (by a factor of 2) . . . . Accutane is prescribed for administration twice per day in divided doses and must be administered with food. [FN123]
The result of micronizing [FN124] the chemically identical product is a clinically equivalent drug with safety advantages. Roche explains:
A large clinical trial (602 patients randomized to treatment) showed that Accutane NF has efficacy equivalent to Accutane with clinically relevant safety and tolerability advantages. . . . The new formulation . . . will be dosed once per day at 0.4 mg/kg with or without food . . . . [T]he results clearly indicate that the new formulation of isotretinoin . . . will provide appropriate exposure to isotretinoin to produce clinically equivalent efficacy with safety advantages, when compared with Accutane administered with food. [FN125]
The new formulation allows a 60 percent reduction in the dose administered to the patient of the highly dose-responsive toxin. An FDA staff study reports that the current dosage range of Accutane is 0.5 to 2.0 mg/kg/day to be taken with food in two divided doses. FDA analysis of the Roche application studies showed that "it is likely that patients who received [Accutane] in the therapeutic study had approximately 240% higher exposure to isotretinoin than the subject is who received [Accutane] NF." [FN126] Because the study showed therapeutic equivalence in the total trial population, the FDA staffers concluded that
the currently recommended dosing range for Accutane® may be too high. This is of considerable clinical importance because many of the side effects of isotretinoin are dose-dependent. . . . Available dose-ranging studies for Accutane® do not definitively establish that even the lower end of the currently labeled dosage is the minimum effective dose. [FN127]
The clinical study showed that 95 percent of users of Accutane experienced some adverse effect, while approximately 35 percent of patients in both *769 groups experienced "severe" side effects. The FDA staff analysis called for more study of whether isotretinoin contributes to psychiatric disease or reduces the effectiveness of newly developed hormonal contraceptives. [FN128] But they nonetheless hailed Roche's new formulation and the lower and more consistently administered doses it helps make possible. While noting that the "safety database for a new drug at the time of approval is almost always 'inconclusive' in that the database is too small to detect all relevant signals" [FN129] the FDA staffers favored approval of the new drug formulation, stating:
The food effect is so large with Accutane®, that even adequate dose- ranging would not eliminate "over-dosage" and "under-dosage" due to the realities of compliance with food instructions . . . . Under-dosing, which would likely result if patients took a minimum effective dose of current Accutane without food, has significant public health importance because . . . [it might lead to r]etreatment with Accutane [that] exposes patients to many more weeks of potentially serious adverse effects, increases the risks of fetal exposure, and delays resolutions of nodulocystic lesions that can lead to permanent disfiguring scars. [FN130]
Therefore, the staff study concludes:
We believe that the relative food independence of the new formulation is an important advantage over the currently marketed formulation because of reduced pharmacokinetic variability, independent of "convenience." There does not appear, however, to be any apparent public health advantage to marketing both formulations. [FN131]
|41||General Discussions / General Chat / Law review article re: Accutane|
|Here's an excerpt from an article that discusses Accutane and Accutane NF:
IV. Accutane and the Patent Monopoly Driven Development Process
A. Market Failure
One problem a generic competitor might confront is that a patent holder might reformulate a soon-to-be-off-patent drug and then seek FDA approval *762 for the new, improved product (and the withdrawal of market approval for the old). With development and design choices driven by high- stakes financial gambits, patient safety can obviously take a back seat to market strategies. Such is the case with the effective (and powerfully teratogenic [FN99]) acne drug Accutane, approved by the FDA as an oral capsule in 1982. [FN100] The drug is a generic composition of the long- known Vitamin A derivative called isotretinoin. Hoffman-LaRoche, Inc. was granted a patent in 1984 (the '394 patent), which claims as its invention a
method of prophylaxis against the development of epithelial carcinomas of the skin, gastrointestinal tract, respiratory tract or genito-urinary tract which comprises enterally administering to persons susceptible to such carcinomas a composition comprising a medicinally inert, pharmaceutically acceptable carrier material and 13-cis vitamin A acid or a pharmaceutically acceptable salt thereof, said composition being administered in an amount sufficient to provide from about 0.05 mg to about 3.0 mg of 13-cis vitamin A acid or its pharmaceutically acceptable salt per kg of body weight per day. [FN101]
Although the patent was issued to Roche based on the method's demonstrated utility as a skin cancer prophylactic, patent law grants the monopoly for all uses--including those not foreseen or claimed at the time of application. [FN102] The essence of a patent monopoly is to exclude others from competing. [FN103] *763 This broad "method patent," which covers a wide range of dosages claimed to be effective, was effectively deployed by Roche against Ortho Pharmaceuticals, which introduced a competing product and withdrew it from the market, agreeing to entry of a consent order after Roche asserted infringement. [FN104]
Such a patent-constrained market environment can create a type of market failure that impedes the availability of alternative, safer compositions or methods of manufacture, or alternative safer dosing methods. As Professor Henderson has acknowledged, market failure may justify a design defect claim that effectively drives up the cost or deprives some people of products they could safely use, because the product poses unreasonable risks for other less careful (or more susceptible) users. [FN105] Competitors who confront the patent monopoly face costly litigation, the risk of losing their research investment, the risk of compensatory damages (trebled in the case of willful infringement), and equitable relief including injunctions, destruction of the infringing product, and attorneys' fees awards. [FN106]
B. Unreasonable Failure to Adopt Better Instructions for Safe Use.
Accutane is covered by a broad method patent which deters competitors. A competitor who wants to sell the generic composition (which is in the public domain) and recommend to users a safer method of administration can be blocked by Roche, which possesses the right to bar anyone else's use of its patented method of "enterally" administering a wide range of effective doses. [FN107]
A government-funded researcher, Gary L. Peck, M.D., claimed, in a patent owned by the United States, that a different dosing pattern can reduce the total dose ingested and thereby decrease the risk of birth defects caused *764 by the medication. [FN108] Hoffman-LaRoche did not adopt the method, and no competitor could market the composition within the '394 patent's dosing range without Roche's permission during the patent term. The evidence of a safer method of use might subject Hoffman-LaRoche to a negligence-based claim for failure to adequately test Peck's method and give better instructions for safe use. Such claims, and their negligence base, are acceptable under section 6(d) of the Products Liability Restatement, section 6(d). The Restatement does not suggest that in a warning case the plaintiff must prove the FDA would approve the method or the instructions for use. Good grounds to believe there is a safer method that was unreasonably rejected is sufficient to impose liability on prescription drug manufacturers for failure to warn. [FN109]
C. Design Defect Liability for Accutane
Better instructions on safe use do not discharge the duty of the manufacturer and designer of a drug. Making the product itself safer reduces the risks of patient noncompliance and of physicians' ignorance, among other foreseeable dangers. In an ordinary market, a factfinder may place great *765 weight on the conformity of a manufacturer's conduct to industry practice. In a patent- constrained market there is usually no competitor to whom the designer's work may be compared. The reporters' proposed restriction of design defect liability to comparison with products on the market therefore effectively grants "blanket immunity" to prescription drug and medical device designers who hold a patent that is the basis for the medicine or the medical device.
The reporters argue that even if
[i]n the emerging new world of genetic engineering . . . [it becomes] possible to rearrange molecular structures to create safer drugs that courts can compare relatively easily with existing drugs. But as long as marketing of such safer drugs requires FDA approval, in-court replication of the formal approval process will continue to exceed the limits of adjudication. [FN110]
|42||General Discussions / General Chat / Re: Permit Roche to view medical records?|
|If you were to actually file a suit against Roche, they would have to be given access to your medical records before the trial in order to set up their defense. I don't see how giving them your records earlier would hurt your case, but there could be something that I am unaware of. So, I don't know, ask a lawyer.|
|43||General Discussions / General Chat / Re: Accutane and ringing in the ears?|
|I've been experiencing ringing in my ears since taking Accutane for a very short period of time about a year ago. (I only took it for a couple of days, evidently I'm very sensitive to it... 80 mg per day taken in one dose) The ringing has been constant, though it only really bothers me when I try to sleep. I went to the American Tinnitus Association clinic in Portland, OR to evaluate it. They didn't give me a definite prognosis, but stated that since it had lasted for more than six months, it was unlikely to go away. (They didn't have any specific knowledge of Accutane as a cause of tinnitus, but speculated that because Accutane, unlike most drugs, goes directly through the blood-brain barrier, it may be more likely to damage the inner ear than most other drugs.)|
|44||General Discussions / General Chat / Re: To everyone (especially the haters)|
|I was not saying that the side effects are any more debilitating for those that only had mild acne in the first place, or that those with mild acne are any more likely to suffer side effects than those who had severe cystic acne. I am saying that it is more obvious that Accutane's risks outweigh its benefits when the person who was prescribed Accutane only had mild acne to begin with. Personally, knowing the potential side effects of Accutane, I would not have risked it even if I did have severe acne. The choice of whether or not to take Accutane should be up to each person, but it should be an adequately informed choice. That's really all that I meant, that people in general are not adequately informed of the risks of Accutane, and that those risks must be weighed against Accutane's potential benefits (its potential benefits being small in the case of someone with mild acne, and thus making the decision to take Accutane for mild acne irrational)
As far as me thinking there should be a place for it at all- I think that if it is in the market, it should be very restricted. There may be extreme cases of truly severe acne for which Accutane may be justified. I don't know what it would be like to be someone with such a condition, so I don't feel I am in the position to tell them that Accutane is not worth the risk (however high that risk may be). I just feel that they should be fully aware of the risk (as most people who take Accutane now are not).
Then again, in some ways I do feel like retracting my opinion that Accutane should be on the market for extreme cases. In practice, I don't see how these risks would be adequately conveyed to the person who would go on Accutane. I made the mistake of assuming that because a product was on the market, it met some basic safety requirements. Perhaps the potential Accutane user would make such an assumption as well and disregard the warnings.
|45||General Discussions / General Chat / Re: To everyone (especially the haters)|
|In my case, and probably the case of many others who took accutane as something other than a last resort treatment for severe acne, there was not an adequate disclosure of the risk of long term side effects. At no point prior to my ingestion of Accutane was I led to believe that Accutane posed a risk that was substantially greater than the risk posed by most prescription drugs. I agree that Accutane's permanent withdrawal from the market would not be the ideal solution . For a very small percentage of people, Accutane's benefits may outweigh its risks. However, given the apparently substantial number of people who are experiencing permanent side effects due to their ingestion of Accutane, (Many of whom were not adequately aware of the high risks of Accutane and took Accutane for a condition that did not warrant the prescription of Accutane), it seems that a withdrawal from the market would be proper until some method of adequately conveying the extreme risks of this drug could be put into place. I am shocked by the way that Accutane is currently dispensed. I still can't believe that I'm suffering serious permanent side effects from taking a drug for only mild acne. Until the way that Accutane is dispensed is drastically changed, I think it should not be on the market.|
|46||General Discussions / Your Experience after taking Accutane/Roaccutane / Re: Side effects possible from accutane-use of 2 d|
|I took Accutane for two days nine months ago. Since then I have been experiencing problems which I attribute to my very brief usage of Accutane. These problems include tinnitus, mental problems, loss of sexual sensation, and bowel problems. I understand why you feel that it is improbable/impossible to experience long-term side effects from using Accutane for two days. However, due to the timing of the onset of these problems, and the fact that many others have experienced similar problems after using Accutane, I feel that there is a causal relationship between my physical problems and my usage of Accutane.
|47||General Discussions / Your Experience after taking Accutane/Roaccutane / Re: Anxiety or panic disorder???|
|I'm also experiencing persistent tinnitus and psychological problems nine months after discontinuing Accutane. I took it for a very short period of time (only a couple of days) but at a relatively high dose. I have just begun law school, and tasks like paying attention or concentrating are not as easy as they were before I took Accutane. Perhaps I can use whatever legal knowledge I gain to take my revenge... I have nothing else to live for.|
|48||General Discussions / General Chat / Re: When will people listen? When will doctors?|
You describe your use of Accutane as a gamble. A rational gambler typically knows the expected payoff and loss, as well as the probablities of winning and losing. In the case of your Accutane usage, you have some idea of the potential gains and losses involved, however I don't feel that you are aware of the likelihood of experiencing positive or negative consequences from your accutane usage. By taking Accutane, you appear to be making assumptions about the likelihood of experiencing permanent side effects.
I do not know what percentage of people who take Accutane experience permanent side effects, and I doubt anyone has a good idea of what that percentage is.
From what little information there is, such as sites like this, I would SPECULATE that the likelihood of experiencing permanent side effects from Accutane use is considerably higher than doctors/the public believe it to be.
I have absolutely no way of verifying this, and I do concede that it is possible that the people experiencing Accutane side effects are members of a very small minority.
I do not agree with your assertion that EVERYONE who takes Accutane will develop side effects sooner or later. How can you make this claim? Because you and a number of other people you have talked to have experienced permanent side effects from accutane? Perhaps only some people react to the drug in such a negative manner. I agree with some of what you say. I just do not see how you can make this claim.
|49||General Discussions / General Chat / Re: Been 4 days now|
|maripr: So, your pharmaceutical job is not low-level? I find that doubtful.|
|50||General Discussions / General Chat / Re: Been 4 days now|
|Thank you for your meaningless opinion maripr. You seem to have too much confidence in your knowledge of prescription drugs due to your low level job at a pharmaceutical company.|
|51||General Discussions / General Chat / Re: Been 4 days now|
|It's in another thread.
Brief accutane treatment, or something like that:
|52||General Discussions / General Chat / Re: Been 4 days now|
You do not develop permanent side effects overnight. -maripr
I did, over two nights.
|53||General Discussions / Your Experience whilst on Accutane/Roaccutane / Re: IMPOTENCE + LOSS OF LIBIDO|
|I'm going through the same thing. I would describe my condition as a loss of libido and pleasurable sexual sensation. I don't know if this is related, but my testicles are always very descended now after accutane.
Unfortunately, it hasn't gotten better for me. The loss of sexual sensation probably pisses me off more than the other side effects. I'm on zoloft now (the sexual side effects began before zoloft). My only hope for recovery is that the zoloft (which has sexual side effects) is masking any recovery that may have taken place.
|54||General Discussions / General Chat / Congressional Hearing|
|Anyone else see the congressional hearing on Accutane? What struck me was how most of the FDA people defended Accutane. The personal stories and Roche representatives offered no real surprises, just a lot of predictable, canned responses from the latter.
Listening Dr. Woodthingy (FDA) was almost exactly like listening to Abercrombie (Roche). She repeatedly referred to the lack of scientific evidence of a link when questioned about the link between Accutane and depression. She refused to say anything negative about Roche or Accutane.
I would have liked one of the congressmen to ask Abercrombie what he means by scientific evidence, and continue the questioning down that path.
|55||General Discussions / Your Experience whilst on Accutane/Roaccutane / Re: Jack's Progress|
I did not say that giving support to those who have suffered accutane side effects was the ONLY purpose of this board. I was responding to your claim that it would be more productive for this board to devote itself to coming up with alternatives to accutane, rather than discussing Accutane side effects.
|56||General Discussions / Your Experience whilst on Accutane/Roaccutane / Re: Jack's Progress|
One thing that you don't seem to understand is that to many people on this board, including me, our acne is of little or no importance to us in relation to the persistent side effects that we are experiencing. You state that "ACNE is the WORST side effect I could have for the next 10 years." How would you know? Personally, I would rather have a truly horrible case of cystic acne for the rest of my life than the side effects that I am currently experiencing. So, I disagree with your statement that "[this board] would be much more productive if you drive your research to ways of being cured of acne 'al natural'." The purpose of this board is to serve those suffering from Accutane side effects, not acne.
I also don't think you are qualified to say that it is impossible for side effects to develop years after taking the drug. I don't know how this drug works, and I don't think you know how this drug works. The only people that might know how Accutane works, and how it might produce side effects is Roche. And they're not going to talk about it.
|57||General Discussions / General Chat / Re: working out? and a few other questions..|
|banner: I was unable to decipher your post. What are you trying trying to say? That my problems are psychological?|
|58||General Discussions / General Chat / Re: working out? and a few other questions..|
|Since taking a relatively high dose of accutane for a very short period of time 7 months ago, I have been experiencing persistent sexual problems. I would describe it as a loss of libido and sexual sensation. I have lost virtually all interest in sex. When I do engage in sex or masturbation, the act is no longer pleasurable. I can get an erection and otherwise function normally. The pleasurable sensation is just gone.|
|59||Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Treating and Coping with Long-term side-effects after taking Accutane/Roaccutane. / Re: Hearing Impairment and Accutane|
|For those of you are experiencing tinnitus after taking accutane:
If you ever get your hearing test try to get tested for Oto Acoustic Emissions. My hearing tested normally in all other respects, but the audiologist felt that my OAEs were abnormal. (In this test, the audiologist put a device which made a variety of sounds against my ear. If the hair follicles are healthy, they will respond by returning a sound. If they are not, they won't. Mine did not respond at higher frequencies.) I am under the impression that many hearing test centers do not test for OAEs.
So, if are experiencing accutane induced tinnitus, and are getting your hearing tested, you might want to make sure they test for OAEs. I would be interested in hearing the results.
|60||General Discussions / General Chat / Update-almost 6 months after BRIEF accutane use|
|A few months ago I wrote about my experience with accutane. I think the thread is titled "BRIEF accutane treatment".
My experience is:
About 6 months ago, I saw an unethical dermatologist for my mild, but persistent acne. As many of you know, accutane is only approved for severe, recalcitrant, nodular acne. My acne did not fit any of these criteria.
Anyway, he said that it was an extremely safe and popular drug with no side effects. He said it had been around for a long time, millions of people have been on it, and no one has ever had any problems with it. He was also supposed to give me the blood tests, and make me sign the frightening consent form, neither of which he did. On top of all of this, he started me off on 80 mg a day, and told me I could take it all at once. (In retrospect, I can see that the reason he pushed accutane on me, and hid its serious side effects, was that he was desperate for patients, and, if I were to go on accutane, I would have to see him every two weeks for a check up. (He's a weird guy; no secretary; he lives in his office)) The pharmacist for got to give me the medication guide as well.
I only took this f**king drug for two days before I developed a headache. I did a little research around this time and found out how nasty this drug was. I stopped taking it, and thought that I would be fine because I took it for such a short period of time. However, while taking Accutane, and for a few days afterward, I developed a variety of side effects. They included depression, ringing in the ears, bowel problems, insomnia, loss of appetite, impotence, hair loss, and an inability to focus my mind.
Six months later, some of these side effects have improved, but most have not. The insomnia has totally stopped. I sleep like a baby. The depression has improved a little, with the help of zoloft, but I am still far from normal in this respect. The tinnitus, sexual problems, loss of appetite, and hair loss are all as bad as ever. (The hair loss has stopped, but has not yet grown back.) The bowel problems are currently my biggest concern. I haven't taken a normal dump since accutane. And now, for the past couple of days, there has been blood on my toilet paper.
I guess I hold some hope for recovery. However, if I really was going to make a near complete recovery, I would think that all of my symptoms would have shown some signs of improvement. This has not been the case, so I currently think that such a recovery is rather unlikely.
This forum and websites similar to it are really my only tools for determining my prospects for recovery as I have gotten absolutely no help from doctors to date. As best I can tell, from the information in this forum, it seems that of those who experience accutane induced side effects, a number get better within a few weeks of stopping accutane, and the others never do seem to get better. Correct me if I'm wrong, but it seems that there are no examples here of successful recoveries that take a long time to occur (many months, or years).
Anyway, it appears that my life has been ruined from taking an absurdly potent drug that I had no business taking in the first place. Some precautions were in place to warn me, but none of them were followed in my case. The process of informing patients of the possible adverse effects of this drug needs to be drastically reformed. I strongly believe that private doctors should not be allowed to prescribe this drug, in order to avoid situations like mine involving an unethical physician. (only doctors affiliated with hospitals should be allowed to prescribe it, in my opinion.) Well, I hope that I get better, but it really doesn't look like that is going to happen at this point. I would like to think positively, however, I have yet to find any examples of long-term recovery to base a positive outlook on.
|61||General Discussions / General Chat / Re: Abortions and Birth Defects|
|Abstinence is not sufficient contraception?|
|62||General Discussions / General Chat / Re: BRIEF accutane treatment|
|63||General Discussions / General Chat / Re: BRIEF accutane treatment|
|Judging by the posts that I have read, it appears that there may not be much hope for recovery. These problems appear to be neurological, does that mean that they are irreversible? Am I rendered virtually impotent for life because I took this stupid acne drug for 2 days? Can anything be done about my problems? I guess some cortisone in the first couple of days might have made a difference, but can anything be done now? All that I wanted was some skin cream. I'm taking zoloft and that helps a little, but I'm not really getting better.
Are there any stories of recovery from the neurological side effects of accutane?
|64||General Discussions / General Chat / BRIEF accutane treatment|
|In late April, I went to see a dermatologist for my very mild, but persistent acne. He was an unethical old man who suggested accutane. He said that it was a very safe and popular drug with no serious side effects. I was never given a blood test. He never showed me the consent forms that he is required by law to make me sign. I was started on 80 mg per day. (I weigh around 190) He said that I could take the entire day's dose at once. When I picked up my prescription, the pharmacist conveniently forgot to give me the FDA required medication guide. When I picked up the medication, I was under the impression that accutane was an extremely safe drug.
I took it for 2 days. Then I got a bad headache and read about the side effects. I stopped right away. I thought that I was safe having only taken a few pills. However, about 5 days later, I got really depressed and couldn't sleep. My ears started to ring around this time, and a lot of hair around my hairline began to fall out. (The roots of these follicles were black, normally they're white.) My appetite went away around this time as well. A couple of days after this, my libido vanished and I lost virtually all sexual sensation. Since then, I have gotten an audiogram, on the OAE section of the audiogram it was discovered that my cochlear hair follicles are unresponsive at high frequencies. Apparently, they never grow back. This would commonly result in tinnitus. It has been over a month and a half since my very brief experience with accutane and most of these effects have not improved at all. (I sleep a little better as I am starting to get used to the ear ringing, but that is about it.)
Am I permanently affected from taking an acne medicine for 2 days?
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