Accutane
Statement of Rep. Bart Stupak
October 5, 2000
I want to thank you all for coming here today. This is one press conference Laurie, Ken and I, and the other families who have joined me, wish we never had to attend. The information on my website and the press packet you have received relate to my concern about the potential risks of Accutane. I want to explain to you today the reasons for my family's concern about Accutane, manufactured by Roche Laboratories. After everyone has had an opportunity to comment, we will take questions.
To begin with, I would like to give you some background on how this all came about. My son BJ died in May of this past year. His death, like the death of any child, is a parent's greatest heartache and we were devastated. Our son BJ loved life. He was involved in sports, many school activities, Treasurer of the student body and President-elect of the student council at Menominee High School in Menominee, Michigan. BJ had many friends. He was a happy teenager who had great potential for life. He showed no signs of depression or loss of enthusiasm for life.
BJ committed suicide. As Laurie removed BJ's personal items and was in the process of disposing of the few Accutane pills that were left from his prescription, she questioned whether Accutane was related to BJ's death. Laurie went on the Internet and typed in the word Accutane. She came across the MedWatch alert that had been issued by the FDA in February of 1998, and it raised questions that require answers on the use of this prescription medication and its relation to the death of children.
The MedWatch stated that due to the adverse event reports the FDA had received on Accutane, the FDA felt there was sufficient cause to strengthen the warning on the Accutane label to include the risk of psychosis and suicidal thoughts and actions.
The FDA in February of 1998 stated in a Memorandum the adverse events that had been reported from the use of Accutane. The Memorandum showed that there were 31 cases of suicide, suicide attempt or suicide ideation that were associated with the use of Accutane. Of that number, 12 were suicides, 9 of them male, 2 female, and 1 unknown, and the median age was 17. The average onset of the event was 88 days after the patient had started on the prescribed use of Accutane. As the FDA Memorandum stated: "(f)or the majority, there was no antecedent history of depression and the patients were not noted or known to be depressed in the time period prior to their suicide."
I also found that Roche had received a warning letter in March 1998 from the FDA because Roche was marketing the drug as a treatment for depression, under the theory that it could help people who were suffering from depression and poor self-image as a result of their acne. The FDA warning letter to Roche stated that this promotion was false and misleading, and that Accutane had never been approved for treatment of depression. In fact, quite the opposite was true, as you will read in the warning letter which is enclosed in the press packet. In pertinent part, the FDA states:
Roche, however, has not systematically studied the ability of Accutane to modify or prevent such illnesses as depression and has presented no basis for asserting that Accutane is effective in improving the psychosocial and emotional well-being of such patients. This claim is particularly troublesome in light of information recently presented in a Dear Doctor letter, that Accutane may cause depression, psychosis, and rarely, suicidal ideation, suicide attempts and suicide.
As parents, Laurie and I took the information we had found very seriously. As I said earlier, BJ had not shown signs of depression, and if we had known that this drug could cause depression, suicide ideation, or suicide, BJ would never have come into contact with Accutane. The warnings on BJ's Accutane package contained none of these risks. The only warnings contained on the package were for the side effects of : headaches, nausea, vomiting, blurred vision, changes in mood, severe stomach pain, diarrhea, rectal bleeding, persistent feeling of dryness of the eyes, and yellowing of the skin or eyes and/or dark urine. Nothing about depression, suicide ideation or suicide.
All Accutane package labeling currently state that before a woman takes Accutane she must read, understand, and sign a consent form.
As a parent, I would have wanted to know of the risk of depression, suicide ideation and suicide, before allowing my child to take this drug. As a legislator, I believe that the public has a right to know of all risks associated with prescription drugs. There needs to be a thorough study implemented to determine the connection between Accutane, depression, suicide ideation and suicide. The study should be conducted by an independent third party, not by the FDA or Roche.
I am speaking out now because of my concern raised by the information I discovered. I believe the public needs to make its own informed decision about the risks associated with Accutane.
I can say that what Laurie and I turned up on our own caused us concern that there appeared to be a link. The MedWatch in 1998 indicates that the FDA had enough concern regarding a link to advise the inclusion of an additional warning. In mid-September the FDA provided an Advisory Panel with a figure of 37 suicides attributed to the use of Accutane since 1983. The FDA raised their figure to 44 suicides over the same period after Roche corrected the FDA's number. My staff and I have painstakingly gone through the FDA's Adverse Event Reports connected with Accutane, and we found 54 suicides since 1998, the same year the FDA issued its MedWatch. Another 30 deaths that are most probably suicides occurred between 1983-1997, a time where the record-keeping was a little less precise. A total of 84 suicides and BJ's is not part of the adverse event reports. The compilation of statistics that we put together, and an explanation of our methodology to minimize inaccuracies is in the press packet as well.
As you can tell, our numbers, the FDA's numbers, and Roche's numbers are different and vary greatly- the FDA's numbers show an average of 2 suicides a year, our numbers show that in the last two and half years, there have been almost 2 suicides a month associated with the use of Accutane. I know that none of these numbers are complete, because there was no report on BJ. In fact, the FDA has indicated that the actual number of suicides as a result of Accutane could be as much as ten times higher than the reported numbers.
I believe that the statistics I mentioned previously are alarming enough to inform the public of the risk that may be associated with the use of Accutane and the recommendations contained in the press packet you received calling for an independent study and a uniform and immediate warning and notification system. The copies of the package labeling in the press packet that were received from Roche show that they still do not uniformly warn of the risks and the adverse side effects identified as depression, suicide ideation and suicide. BJ's package labeling never included any warning as to the risk of depression, suicide ideation and suicide. There is a concern here of a potential risk to the health and safety of our children.
I have given you our recommendations and they are posted on my website. Thank you for your concern.
