Safety Issues Surrounding Accutane
Congressman Bart Stupak
Thank you Mr. Chairman for holding this hearing on the Safety Issues Surrounding Accutane. I would also like to thank the Members who are present for today's hearing.
Two and one half years ago, Laurie, Ken and I lost our son and brother, BJ, who took his own life. Anyone who knew BJ could not understand why a young man with such an outgoing personality and bright future would end his own life. BJ taking his own life, is contrary to everything he believed in!
As only a mother's intuition can sense, Laurie asked me to check into the prescription drug BJ was taking for his acne, Accutane. Parents know their children. Mothers know their children the best!
I remember telling Laurie, I did not know how an acne medicine could possibly affect BJ's state of mind, but I would check it out. Laurie did not wait for me, she checked on the Internet and found many disturbing facts about adverse reactions to Accutane that we were never told. The most disturbing fact she found, was the February 1998 MedWatch stating AThe FDA is advising consumers and health care providers of new safety information regarding the prescription anti-acne drug Accutane (isotretinoin) and isolated reports of depression, psychosis, and rarely suicidal thoughts and actions. The MedWatch went on to say that the AFDA and the drug manufacturer are strengthening this label warning, even though it is difficult to identify the exact cause of these problems.
If Laurie and I had any idea that Accutane could cause depression, suicide ideation or suicide our sons never would have taken the drug. The thought that an acne medication would lead to such devastating side effects never occurred to us. For our family, the risks attributed to Accutane greatly outweigh any of the benefits.
Our dermatologist said that Accutane may cause chapped lips, bloody nose and dry skin. The dermatologist did not say, at any time, that Accutane may cause depression, suicide ideation or suicide.
Our oldest son, Ken completed his treatment and appeared to tolerate the drug. The next year, the dermatologist, prescribed Accutane for our younger son, BJ, before his acne was very bad.
Once on Accutane, BJ's, triglyceride levels skyrocketed and he complained of sore joints and headaches. The dermatologist said this was a normal side effect of the drug and to make sure BJ took his Accutane with a meal. BJ's triglycerides never really did get close to being normal. BJ died on Mother's Day, May 14, 2000, at the age of 17, from a self-inflicted gunshot wound.
After we found the MedWatch, I wondered why the FDA put out this warning, 18 years after the drug was approved? What was the basis of the warning? Why were we not told about the risk of depression, suicide ideation or suicide? Why didn't BJ's patient pamphlet mention anything about possible depression, suicide ideation or suicide? More important, why weren't these warnings on BJ's Accutane package which had been revised 4 months after the MedWatch was issued?
Through the help of members of this committee, I was able to obtain the FDA's February 23, 1998 Memorandum on Isotretinoin and Depression: Spontaneous Report Data presented to the Division of Dermatologic and Dental Drug Products on 1/28/98. This Memo studied 31 cases, 19 suicide attempts and 12 completed suicides. Of the 12 suicides, 10 were males with median age 17, Afor 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.
A few days later, I showed the report to the O/I subcommittee chair and asked for an investigation into the safety of Accutane. Today, more than two years later, after hours of reviewing thousands of pages of memos, reports, email, medical and scientific literature, and meetings with grieving families, this investigation leads to one conclusion. In some cases, the acne drug, Accutane results in severe cases of depression, suicide ideation, suicide attempts and suicide.
Accutane is a powerful, dangerous drug with devastating consequences for some patients. The birth defects caused by Accutane are horrific. The FDA's response to the birth defects and psychiatric events has been inadequate, irresponsible and unacceptable. Thousands of babies, teenagers, and young adults have died prematurely. While the FDA has been aware of the birth defects since at least 1982 and the psychiatric injuries since 1985, their responsibility to protect the public has been inconsistent and without direction.
The drug manufacturer, Hoffman-LaRoche, Roche here in the United States, has continued to put profits before people. They have done everything possible to prevent the American people from learning of the psychiatric injuries and deaths associated with Accutane. Even, today, I'm sure Roche will deny any casual effect of Accutane with the abortions, deaths, and suicides caused by their product.
This hearing, I am sure will be like the Firestone tire hearings, where the manufacturer blamed the drivers for their injuries. Firestone blamed the compounding factors in the drivers for Adriving too fast, riding on under inflated tires, inexperienced drivers, reckless driving, and of course, the deaths and injuries were not significant when compared to the general population. The manufacturer's best statements were you cannot absolutely prove that our tires caused the accident. We will hear Roche make the same type of arguments today that we heard in the Firestone tire hearings.
We cannot allow the drug manufacturer and the FDA to continue to turn a blind eye to the lives lost, families devastated and dreams dashed by an acne drug. The American people, our children, are not collateral damage in the scheme of corporate profits!
When Laurie and I went public (she is here today along with the Palazzolo, Bencz, Turney, and White families) to increase public awareness of this powerful drug and the deaths it has caused. The FDA said there were approximately 47 suicides in October 2000. Today, two years later, there are 167 suicides attributable to Accutane. Last Friday, my office reported another 37 suicides to the FDA. More than 200 suicides are now associated with Accutane. FDA officials indicate that this may only be 1% of the actual number of suicides. So is the number 2,000 or 20,000 Mr. Chairman?
Mr. Chairman, this drug represents a public health concern for the American people. As members of Congress, we have a responsibility to protect the public health and safety of the American people.
Mr. Chairman, in this investigation we have found that the NIH and CDC have been investigating this drug and we should hear what they have to say about the health concerns of Accutane.
Besides the birth defects and psychiatric injuries Mr. Chairman, there are other public safety and health concerns with Accutane.
The Accutane birth defects are similar to Thalidomide, which is a tightly controlled drug in this country and is used by a group unlikely to have children. Yet, Accutane is not tightly controlled like Thalidomide and Accutane is marketed to women of child bearing years despite its horrendous record of causing birth defects.
Mr. Chairman, this committee has spent a lot of time trying to deal with the devastating effects of Oxycontin because the FDA is unable or unwilling to control its use. We have the same, even worse devastation with Accutane and the FDA is unwilling or unable to control its use.
Mr. Chairman, this committee has spent a lot of time dealing with Rohypnol pouring across our Mexican border. Like Rohypnol, Accutane pours into this country from Mexico, where it can be purchased over the counter without a prescription, causing birth defects and deaths here in this country.
Mr. Chairman, this committee has spent a lot of time trying to deal with the explosion of the sale of dangerous drugs over the Internet and the FDA claims to be powerless to do anything about it. We find Accutane is being offered on the Internet at approximately 40 web sites. How will the pregnancy prevention program and the psychiatric warnings that the FDA relies on to prevent birth defects and deaths are enforced on Internet sales?
If the FDA cannot or will not regulate Accutane and these other drugs, then it is imperative for the US Congress to act to protect the American public. The bottom line remains the safety of our citizens.