Did Daniel’s acne medication kill him?
High school student’s suicide illuminates risks in drugs approved by the Food and Drug Administration

April 4, 2007
BY JIM RITTER jritter@suntimes.com
Daniel Baumann did not leave a suicide note before he sneaked out of the house early one Saturday and jumped in front of a train.

But his mother believes she knows why the Mundelein High School sophomore took his life.

For five months, Daniel had been taking the acne drug Accutane. It was only after he died that the Food and Drug Administration warned the drug could lead to suicide.
Daniel’s death is a tragic example of how drugs may not be safe, even though they have been approved by the FDA, consumer advocates say.

Serious safety problems often don’t become apparent until long after a drug goes on sale. Twelve years after the heart surgery drug Trasylol was approved, a major study found it increased the risk of kidney failure, heart attack and stroke. The study found that two less-costly generic drugs are safer.

You could fill a medicine cabinet with similar problem drugs:

• Sporanox, a toenail fungus drug, can cause heart failure.

• The painkiller Vioxx caused heart attacks and strokes before it was pulled from the market.

• The anti-depressant Paxil can increase suicidal behavior in children and teens.

• Rezulin, a diabetes drug, was pulled in 2000 after it was linked to deadly liver failure.

Fed up with such horror stories, Congress is considering a bill that would give the FDA more muscle to regulate drugs after they’ve gone on the market.

The FDA sometimes will approve a drug even if there are lingering safety concerns, provided the manufacturer promises additional studies. But the FDA recently reported that companies have failed to complete 71 percent of the 1,259 post-market studies they’ve promised.

Drugmakers say they are committed to finishing the studies, but sometimes have trouble finding volunteers.

Before drugs are approved, they typically are tested on a few thousand patients. This number may not be large enough to reveal rare but serious side effects. Also, the studies may be as short as six months, and include patients who are younger and healthier than the population that will use the drug.

Bill would provide database
Most drug studies are funded by drug companies. Results are reported to the FDA, but not necessarily to the public. Drug companies often trumpet positive results, while burying negative studies.
The Senate is considering a bill that would require companies to post results of all studies, good or bad, in a database available to doctors and patients.

The bill would give the FDA more teeth in requiring companies to finish promised studies. The FDA also could force companies to detail safety problems in warning labels and patient medication guides. And the agency could ban, for two years, ads for new drugs that might pose safety problems.

The legislation is sponsored by liberal Ted Kennedy (D-Mass.) and conservative Mike Enzi (R-Wyo.)

‘I just feel weird’
However, Pharmaceutical Research and Manufacturers of America said the United States already sets the “worldwide gold standard” for drug safety. The trade group said fewer than 3 percent of prescription drugs have been withdrawn the past 20 years.
The group also said that restricting drug ads “could have the perverse and unintended effect of chilling the communication of truthful, accurate and useful information.”

Consumers Union has recruited Baumann and other advocates to lobby for the Kennedy-Enzi bill.

Baumann said her music-loving son initially had no mental health problems. But after Daniel began taking Accutane in 1999, he sometimes would break into tears for no reason. When his mother once asked why he was crying, Daniel answered, “I just feel weird.”

In 2001 — 19 years after Accutane went on the market — the label was updated to include a suicide warning.

If that warning had been in place in 1999, Baumann said, “We would never had taken the drug.”

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