Opening Statement

 Chairman Dan Burton

 Government Reform Committee Hearing

 “Accutane – Is this Acne Drug Treatment Linked to Depression and Suicide?”

December 5, 2000

1:00 pm

 2154 Rayburn House Office Building

Washington, DC

Good afternoon.  A quorum being present, the Committee on Government Reform will come to order. 

I ask unanimous consent that all Members’ and witnesses’ written opening statements be included in the record.  Without objection, so ordered. 

            I ask unanimous consent that all articles, exhibits, and extraneous or tabular material referred to be included in the record.  Without objection, so ordered.

 [CHAIRMAN’S OPENING STATEMENT]

            We are here today to talk about the acne medication Accutane and concerns that the drug is linked to depression and suicide.

 Accutane was licensed by the Food and Drug Administration (FDA) in 1982 as an oral prescription drug for the treatment of severe acne.  Current recommendations indicate that the drug should only be used when a patient has not responded to other treatments including antibiotics.  

During the course of our investigation, we were told by dermatologists that while the drug has many severe side effects, that there is no other treatment available; however, we also learned that many individuals have been prescribed this drug for less severe forms of acne.  I am attaching for the record an article outlining natural treatments for acne.[1]

 The most well known adverse effect attributed to Accutane is birth defects of the children born to women who take the drug during pregnancy, However, we will focus today’s hearing on the mental health issues.  Did the Department of Health and Human Services fulfilled its public safety obligation in making the public aware of the potential for depression and suicide related to this drug? 

A significant number of psychiatric events, mostly severe depression, have been reported through post-marketing surveillance. The FDA has received reports of sixty-six suicides and one thousand three hundred seventy three psychiatric adverse events other than suicide related to Accutane.  

According to Roche Pharmaceuticals, the manufacturer of Accutane, the number of domestic and foreign reports of serious adverse events in the post-marketing adverse events database for Accutane as of April 30 was five thousand six hundred sixty-five.  The largest percentage of these reports were psychiatric problems.  Almost nineteen percent of the adverse events reported to Roche were psychiatric. 

Also, the most recent Periodic Adverse Drug Event Report for Accutane includes, for a twelve-month period, over seven hundred fifty new psychiatric adverse event reports (foreign and domestic), including two hundred that were coded as serious events, nine reports of suicide attempts, and six reports of completed suicides.[2]

 Four questions arose during the course of this investigation:

 1.                   When did the issue of depression and suicide first arise regarding Accutane?

2.                   What actions did Roche and the FDA take to determine if there was a causal link?

3.                   When and how was the public notified? And

4.                   Was that public notification adequate?

 According to Roche, there is no evidence of increased risk ofdepression or suicide related to Accutane.  Instead, they believe that the events reflect the multiple risk factors in the population of adolescents and young adults afflicted with the disfiguring disease of acne.  

While the package insert for Accutane contains language that warns of depression and suicide, this information is not typically provided to patients by either the physician or the pharmacist.

 Extensive patient education is required regarding pregnancy prevention while on Accutane because of the risk of birth defects.   However, there is no system in place to educate patients and families about depression and suicide. 

 We learned through our investigation that reports of depression and suicide are not new.  The first report of depression in patients taking Accutane occurred in September 1982.  Two patients in a clinical trial with 523 patients reported depression. Roche received five adverse experience reports of depression in 1983.  November 1983, Roche received its first report of attempted suicide.  November 1984, Roche received its first report of suicide.  In May 1986 Roche received reports of five or six positive rechallenges in patients who experienced depression during Accutane therapy.  In these patients, the depression went away when they stopped taking Accutane and began again after starting Accutane therapy again.  Positive rechallenge is a significant indicator of a causal link between a drug and the adverse event. 

 As early as November 1984, Roche began including information on the package insert about reports of depression. Even thought French authorities required a label change to include “suicide attempt” in March 1997, the FDA did not require Roche to make a label change until February 1998.  FDA also required that Roche notify physicians who were likely to prescribe Accutane.

 In February 1998, the FDA issued a “Talk Paper” advising consumers of and health care providers of new safety information regarding Accutane.  The paper states: 

  “Although the Accutane label already included information regarding depression as a possible adverse reaction, the agency felt health care providers and others needed additional information as a result of adverse events the agency has received.  FDA and the drug manufacturer are strengthening this label warning, even though it is difficult to identify the exact cause of these problems…patients who reported depression also reported that the depression subsided when they stopped taking the drug and came back when they resumed taking it.”

 What is disturbing to me is that the FDA published an article in their own Consumer Magazine entitled, “On the Teen Scene:  Acne Agony” in July 1999.  Thirty percent of the article focuses on Accutane.  It goes into great detail about the pregnancy prevention because of birth defects, but fails to make any mention of depression and suicide.  This article appeared 16 months after FDA’s advisory.

Why did the FDA not use its own Consumer magazine to notify the public of this concern? 

 Today we will hear from three families:

 Amanda Callais was prescribed Accutane as a 14 year-old in September 1997.  By November she was seriously depressed and attempted suicide.  The psychiatrist treating her for depression was not aware of the connection between Accutane and depression and did not suspend her use of the drug after her suicide attempt.  She remained seriously depressed.  In February 1998, Amanda’s mother, Lori learned of the FDA’s warning and stopped Amanda’s treatment.  Amanda quickly made a full recovery.  Mother and daughter are here today to share their experience.

 Stacy and Mike Baumann of Mundelein Illinois lost their son Daniel to suicide in December 1999.  Daniel began Accutane treatment in July 1999.  He suffered many adverse effects - chapped lips, dry skin and itching, joint and muscle pain, headaches, nausea, loss of appetite, mood swings, and insomnia. The physician thought his depression was school-related and never mentioned the FDA warning.     

 Mr. Charles Jackson of Lubbock, Texas lost his 17 year-old son, Clay, in January 2000.  Clay had been on Accutane for about three months.  The family was provided no information by the physician regarding the FDA warning.

 Accutane is only supposed to be prescribed for severe recalcitrant nodular acne after every other treatment option has faiiled.  Dr. David Pariser of Norfolk, Virginia, will be testifying on the behalf of the American Academy of Dermatology and providing an overview of the types of acne and when Accutane is recommended.

 Dr. Douglas Jacobs, on faculty at Harvard, and a Roche consultant, will present his evaluation of the adverse drug events regarding psychosis, depression, and suicide and Accutane.

 Dr. James O'Donnel, Assistant Professor of Pharmacology, Rush Medical School   will present information regarding the connection between Accutane and other vitamin A derivatives and depression and suicide. 

Dr. Jonca Bull will testify on behalf of the Food and Drug Administration.  

I realize that this issue will be difficult for some of you to discuss. My heart goes out to each of you and to every family member dealing with the tragedy of suicide.  I hope that this hearing can help resolve some of the unanswered questions so that maybe future tragedies can be avoided. 

The hearing record will remain open until December 18. 

I now recognize the ranking minority member, Mr. Waxman, for his opening statement.