Healthy Skepticism Library item: 874

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Publication type: news

Cohen R.
Regulators deny they covered up suicide info: FDA says antidepressant findings needed scrutiny
STAR-LEDGER 2004 Sep 24

Full text:

The Food and Drug Administration yesterday disputed congressional charges it failed to protect the public by withholding important information about the risk of suicide for children and teenagers who take antidepressant drugs.

Robert Temple, director of the FDA’s office of medical policy, said the agency prevented its own expert, Andrew Mosholder, from presenting his negative conclusions about antidepressants last February because of the belief more study was needed.

“We didn’t think the information was wrong. We just didn’t think it was ripe yet. We thought the cases needed to be looked at before a conclusion was reached,” Temple told the House Energy and Commerce investigations subcommittee.
“A premature conclusion … would be a disservice to the public health, given the serious and potentially life-threatening nature of severe depression,” Temple said.

At the same time, Temple said the agency would soon issue regulations requiring antidepressants to carry strong warnings. A final decision could come within a few days, he said.

The explanation did not sit well with members of the congressional panel, who expressed anger and frustration that FDA data on the dangers and effectiveness of antidepressants first developed a year ago were not officially made available until just this month. In March, however, the agency issued a public health advisory telling doctors to monitor younger patients for suicidal behavior or thoughts.

Rep. Peter Deutsch (D-Fla.) said the FDA handled the question of the safety and efficacy of these drugs in adolescents in “an unscrupulous manner,” and he accused the agency of a “cover-up” and moving too slowly to protect the public.

When the findings about the dangers of the drugs leaked to the press, he said, the FDA conducted a “witch hunt” to find the source and to keep other information away from congressional committees instead of seeking to inform the public of the risk.

Rep. Joe Barton (R-Tex.) said Mosholder was “muzzled” by “higher-ups who disagreed with him,” while Rep. Bart Stupak (D- Mich.) said he was “appalled … by the systematic efforts of the FDA to suppress information that could have prevented senseless deaths of too many children.”

New Jersey Rep. Mike Ferguson (R-7th Dist.) told Temple and other FDA witnesses he was “mystified” that such important safety data on children and teens was withheld. “You tried to control the information the advisory committee was getting,” said Ferguson. “They didn’t hear Dr. Mosholder’s side.”

While Mosholder’s findings were developed last September, it was disclosed at the hearing yesterday that warning signs of suicidal tendencies in pediatric clinical trials for antidepressants first arose in 1996 and 1997 but were not aggressively pursued by the FDA. It has been previously reported that drug companies withheld negative data about antidepressants for years.

Mosholder’s findings have been backed up by an independent analysis of 15 clinical trials. The data were finally presented this month to an advisory panel, showing use of antidepressants by children and adolescents is twice as likely as a placebo to cause suicidal thoughts or behavior.

The advisory panel recommended the FDA issue the most severe type of warning to doctors and patients that antidepressants not only cause some children and teenagers to become suicidal, but most have also failed to cure their depression.

Temple told the congressional panel the FDA will make a decision soon, but is still debating exactly how the new warnings should be handled.

Mosholder, also testifying before the subcommittee, was careful not to criticize his superiors. He said there was “a lack of confidence in his data and the meaning of the data” by some of his managers.

The controversy over the antidepressants, which generated more than $11 billion in retail sales in 2003 and include well-known names such as Zoloft, Paxil and Effexor, has been escalating for more than a year. The issue was triggered by regulators in the United Kingdom who warned doctors not to prescribe the medicines to children.

Only one antidepressant, Prozac, is approved for use by people under age 18, but doctors are free to prescribe whatever drugs they want, a controversial practice known as off-label use. As a result, antidepressant prescriptions to youngsters accounted for nearly 8 percent of the total written during the first six months of 2004, according to IMS Health, a market-research firm.