The news is on the Bloomberg wire. Beck & Herrmann have this to say: “Despite the absence of scientific evidence, juries have repeatedly awarded millions of dollars to folks who developed IBD [inflammatory bowel disease] after taking Accutane. … If you ever need another example of the cost of litigation driving a beneficial drug off the market, add Accutane to your list.” From the Bloomberg account it appears, however, that generic versions of the powerful anti-acne medication will continue to be available — for now, at least.
More: New Jersey Lawsuit Reform Alliance (“If you are reading this and currently taking Accutane, trial lawyers owe you an apology. You just lost your drug.”); a curious 2002 Accutane lawsuit.
17 Comments
Accutane is a drug prescribed for a limited period of time for the treatment of severe acne. Irritable bowel disease is a group of non-specific GI problems that cause intestinal pain, altered digestion, and (often) diarrhea.
If the IBD bothers you more than the acne, then just stop taking Accutane. Nope, $10,000,000 lawsuit ’cause they didn’t warn about every possible side effect in the universe.
I hope Dr. T isn’t a medical doctor as he just described the symptoms of Irritable bowel syndrome. IBD is Inflammatory bowel disease not Irritable bowel syndrome.
IBD is a very serious disease, IBS not so much. (technically IBD is a more general term for a number of diseases involving inflammatory bowels…i.e. crohn’s disease, ulcerative colitis, and a few others)
That said it’s a sad day for common sense.
Nothing, I repeat nothing, can replace Accutane in controlling the worst forms of acne. The kind of cystic scarring nightmare acne that destroys lives.
This is a black day in medical history.
Years ago I did a short stint at a sleazy plaintiff’s firm that was suing Roche on behalf of a client who was taking Accutane and, despite the zillions of warnings, got pregnant. A Catholic, she refused to abort and gave birth to a severely deformed infant who died shortly thereafter. Anyway, the firm sent two associates (including me) to Roche HQ to examine the ton of documents including pre-FDA approval documents on Accutane. I came away from there thoroughly impressed by the power of Vitamin A derivatives to ameliorate numerous truly horrifying skin diseases. Ever hear of a Harlequin fetus? These drugs, including Accutane, are miracle workers. (The plaintiff lost her case.)
Why hasn’t Roche simply added a warning against IBD?
Accutane saved my life. I had SEVERE CYSTIC ACNE and Accutane stopped it. This is absolutely outrageous. Don’t people know how disabling severe cystic acne is? I basically didn’t talk to anyone during high school and was teased and beaten up daily.
Fortunately, I was mentally fit enough to survive the teasing, tormenting, pointing and staring I received before Accutane, but it’s a shame kids will have to suffer with it. When I started taking Accutane in 1983–while I was in college–the cystic acne cleared up within 6 months and I was able to get on with my life.
Hoffmann La Roche has had to be dragged into adding warnings to Accutane ever since the first major birth defects started to show up. There’s more going on here than we’re being led to believe. $33 million is not major money to a $14 billion company; by comparison, that’s about what it paid its executive committee last year. Moreover, it may well have paid considerably more than that in birth-defect lawsuits as well as the costs of the pregnancy-prevention marketing that it eventually put in place. The idea that it would fight that hard to keep the drug on the market in the face of severe birth defects and then capitulate over IBD strikes me as a stretch. The drug is off patent now and facing generic competition; presumably it just isn’t making enough money for Hoffmann La Roche to deal with the continued lawsuits.
Don’t get me wrong; accutane is an amazingly effective drug. I just think we’re not getting the full story from the company here.
ALL drugs have side effects, some mild and some serious. Peter Huber gave a lecture on “junk science” in the courtroom in the late 1980s to the American Society of Mechanical Engineers (and probably many other organizations) during which he unfolded a package insert for birth control pills which was unreadable. In mini-print, there was warning after warning after warning, each brought upon by a court case. His prediction that the mushrooming of lawsuits would sink big pharma never came true, but they still remain a thorn in the side.
The solution is simple in principle. List the worst side effects (death, liver failure, etc.) with a probability, and give the patient a truly informed consent. Physicians (and the patients) also need to know that Accutane should be prescribed only for severe cystic acne and not for a pimple here and there.
In any event, the generics will probably fill the void with Accutane.
I had moderate-to-severe acne as a teenager and was put on Accutane in the mid-90s given other medications were ineffective. I cannot argue with the power of the drug as it cleared up my skin very quickly. That said, I was diagnosed with ulcerative colitis 5 years later. The risk of depression was the only side-effect the dermatologist highlighted at when he prescribed Accutane.
If you are currently taking Accutane and found the recent news disappointing; don’t be, it’s not worth it. My ulcerative colitis has progressively gotten worse over the years. Imagine going to the bathroom 10-20x per day because of persistent diarrhea and blood in your stools. The physical and psychological effects of the disease are nothing to take lightly. The medications I am currently taking to treat the disease come with their own side effects. Furthermore, if the few treatment options I have left are not effective, I will have no choice but to have my colon removed.
I don’t object to the flaws of our judicial system; however, this is far different than say, the tobacco cases. There are many questions left unanswered about what causes Ulcerative Colitis and how the disease runs its course. In most cases, this is not negligence on behalf of the patient. Please do not marginalize the disease or oversimplify the problem.
And why in the world would you think that your ulcerative colitis was caused by a short treatment with a drug that you took FIVE YEARS previously?
It needs to remain an option for people with severe cystic acne! I’m still recovering from it, years later.
I was sick and tired of answering the “What happened to your face? Were you in a car accident” questions so I’ve had 4 separate cosmetic procedures.
My cystic acne stopped cold after 6 months of Accutane in 1983. It was life-changing. I suppose if I had some sort of psychological disorder, I’d blame every problem I’ve ever had since then on the Accutane, but I’m smarter than that.
Do you know what severe cystic acne looks like? It looks like this: http://luskiewnik.strefa.pl/akne/user/image/acne_vulgaris400.jpg
VMS: “… the generics will probably fill the void with Accutane.”
Stupid comment. It is only a matter of time before the corrupt litigation industry puts any other manufacturers of Accutane out of business.
Proof? Google “accutane” and look at all the sleazy lawyers.
“Stupid comment. It is only a matter of time before the corrupt litigation industry puts any other manufacturers of Accutane out of business.”
Not exactly. Roche is getting out because of the generic competition and liability reasons. Roche has been dealing with Accutane lawsuits for over twenty years, while the generic competition is a relatively new development. The price of Accutane has steadily been dropping and Roche has been losing market share every year for the last few years. Selling at the marginal price while taking on serious liability just isn’t appealing enough to Roche. The calculus may be different for a generic manufacturer.
Marni, re-read my comment. Nowhere in there did I blame accutane for my UC, in fact I said that there are many questions left unanswered about the disease. Neither you, nor I have any idea whether accutane is to blame for my UC. The fact that the liability of the product outweighs future economics, is telling. Time will tell who’s right…
I was over 30 when my cystic acne started to come out and I remember how painful it was – not only on the outside but also on the inside. Dealing with the people who would make comments about how my face looked and the stares from little kids who’s parents didn’t teach them that it wasn’t polite. Within a 2 year period I probably went to 2-3 different doctors and given countless medications(of which one actually damaged my esophagus and gave me an ulcer) before I found a doctor that would listen to me and actually put me on the Accutane. Within 3 months of being on it my face was already starting to get back to normal and by the time my 5 month dosage was ending I was totally cleared.
I have now been clear for 6 months and definately would do it all over again. I want to thank Roche and so do my 5 children for getting their mother back.
I took Accutane back when I was a 8th grader and into the first half of my freshman year. Yes it is true they do not know what causes UC but I was warned about depression not a condition where the only cure is to remove my colon. I had very bad acne but if I knew the chance of getting what I have now I would have dealt with it. Having a pizza face is a much easier way to live life then being stuck with 20,000 in medical bills, always going to the bathroom, and being in pain. Its a bit more embarrassing not being able to make it to a bathroom in time and having an accident on yourself than it is to have acne.
Have there been any studies showing that people who have taken Accutane (a population of 13 million) have greater odds of getting UC than the general population? I’d love to see one.