TESTIMONIES CONNECT SUICIDE TO ACNE DRUG

WASHINGTON -- Testimony from parents of two teenagers who committed suicide
while taking a popular acne drug prompted criticism Tuesday of the Food and
Drug Administration for not ensuring that patients and their families are
informed about such risks.

Members of the House Government Reform Committee also questioned why
Hoffman-La Roche, maker of the acne drug Accutane, and the American Academy
of Dermatology based in Schaumburg, Ill., whose members write 85% of U.S.
prescriptions for the drug, have not been more aggressive in publicizing
the risk of psychiatric problems in patients.

Accutane, on the market since 1982, is a highly effective, last-resort
treatment for severe cystic acne. The drug's most known adverse effect is
serious birth defects in children born to women who took the drug while
pregnant.

The FDA has received reports of 66 suicides and 1,373 other psychiatric
adverse events in Accutane users, said Rep. Dan Burton, R-Ind., chairman of
the committee.

Rep. Henry Waxman, D-Calif., noted that reports submitted to the FDA
represent only 1%-10% of all adverse cases from the drug.

Hoffman-La Roche of Nutley, N.J., has said repeatedly that there is no
scientific proof that Accutane causes depression or suicide. A consultant
for the company, psychiatrist Douglas Jacobs, testified Tuesday that young
men with severe acne, the majority of Accutane users, are more susceptible
to depression and suicide.

In October, Rep. Bart Stupak, D-Mich., whose 17-year-old son killed himself
while taking Accutane, called for more studies to determine whether the
drug can cause suicidal thoughts.

Stupak's wife, Laurie, was in the audience Tuesday.

Accutane's package insert first mentioned a possible link between Accutane
and depression in 1986. Although French authorities required adding risk of
suicide to the package insert of the European version of Accutane in March
1997, the FDA did not require such a change in the USA until a year later.

Last May, the FDA also required that new Accutane packages include
information about depression and suicide.

Nevertheless, the parents who spoke Tuesday said they knew nothing of such
risks until after their children committed suicide.

Stacy and Michael Baumann of Mundelein, Ill., whose son, Daniel, a high
school sophomore, killed himself last December while taking Accutane,
testified that their dermatologist handed out outdated brochures and that
their pharmacist provided no counseling.

''Mistakes were made by many, and now we are suffering,'' Stacy Baumann
told the committee.

Jonca Bull, deputy director of the FDA office that reviews dermatologic
drugs, acknowledged that ''our traditional tools for conveying safety
information do not work as effectively as we would like to see them work.''

Congressman Burton replied: ''That's kind of a cop-out, isn't it?''

The FDA and Hoffman-La Roche have been revising Accutane's patient consent
form to highlight the drug's association with depression and suicide. They
also are developing a consumer-friendly ''Medication Guide'' to be
distributed by pharmacists each time they fill an Accutane prescription.

Bull said the new consent form and the guide will be out in mid-January,
and Congressman Waxman asked why the FDA didn't take such steps two years
ago, when it strengthened professional labeling.