FDA Urged Withholding Data on
Antidepressantswashingtonpost.com - September 10, 2004
The Food and Drug Administration has repeatedly urged
antidepressant manufacturers not to disclose to physicians and the
public that some clinical trials of the medications in children
found the drugs were no better than sugar pills, according to
documents and testimony released at a congressional hearing
Regulators suppressed the negative information on the grounds
that it might scare families and physicians away from the drugs,
according to testimony by drug company executives. For at least
three medications, they said, the FDA blocked the companies' plans
to reveal the negative studies, and in one case the agency reversed
a manufacturer's decision to disclose that its drug was associated
in studies with increased hostility and suicidal thinking among
"Why would FDA require a company to remove stronger labeling?"
demanded an incredulous Rep. Greg Walden (R-Ore.) yesterday, at a
hearing of the House Energy and Commerce subcommittee on oversight
and investigations. "FDA should want to encourage a company to do
that kind of thing."
Janet Woodcock, FDA's deputy commissioner for operations,
responded that regulators believe the jury is still out on the
drugs. The negative trials, she said, did not mean the medications
Several representatives noted that the study results were
obtained at tremendous cost to the American public because Congress
granted companies profitable patent extensions as an incentive to
conduct the trials.
Rep. Henry A. Waxman (D-Calif.), a member of the subcommittee,
said it was absurd to give companies profitable patent extensions on
their drugs to encourage the trials and then limit dissemination of
the results. He said his staff had estimated that a patent extension
given to Pfizer Inc. was worth $1 billion dollars. Wyeth
Pharmaceuticals, he said, made $500 million.
The hearing was prompted by widespread complaints that crucial
information about the safety and effectiveness of antidepressant
medications had not been communicated to physicians and the public.
More than two-thirds of all studies of antidepressant use among
depressed children have failed to show the drugs are effective.
Prozac is the only medicine to be specifically approved to treat
children's depression, but a number of other drugs are widely
Most physicians have not had access to the negative data and are
prescribing the drugs to millions of American children largely
because the drugs have proven effective among adults. Two internal
FDA analyses recently concluded that the class of medications is
associated with an increased risk of suicidal behavior among
At the hearing, Pfizer Vice President Cathryn M. Clary testified
that FDA had told the company that existing language in the label
for Zoloft, which suggested "that efficacy has not been established"
for depressed children, was sufficient. Pfizer had planned to add
that two studies of Zoloft found the medication was no better than
"We do not feel it would be useful to describe these negative
trials in labeling," FDA officials wrote in a letter to the company,
"since these may be misinterpreted as evidence that Zoloft does not
FDA's Woodcock said agency officials had told Wyeth to scale back
a label change that warned that the drug Effexor had been linked to
suicidal thoughts, hostility and self-harm.
"It was not very understandable," Woodcock said in an interview
when asked why the FDA had found the Wyeth label objectionable.
Wyeth and other companies were instead asked to insert a general
caution that physicians should carefully monitor the risk of suicide
among all patients with depression. Agency officials said at the
time that the caution was a reiteration of good clinical practice.
Joseph S. Camardo, senior vice president at Wyeth
Pharmaceuticals, said company scientists had disagreed with the FDA
on how to interpret the data in its labeling.
"We thought our proposal was reasonable, so it was a bit of a
surprise," he said of the FDA ruling that substituted a less pointed
In the agency's most recent internal review of the antidepressant
studies, FDA scientist Tarek Hammad concluded in August that
children taking Effexor had 8.84 times the risk of suicidal behavior
or thinking compared with children taking sugar pills.
British authorities warned physicians last year not to prescribe
a range of antidepressants to children. The FDA has called for a
more cautious interpretation of the data, which an agency advisory
committee is expected to discuss at a meeting next week.
Yesterday's hearings, which included testimony from officials
from seven pharmaceutical companies, grappled with ways to make
negative study results about drugs more accessible to the public.
Recent proposals by manufacturers, medical journal editors and
members of Congress have called for various schemes for publicly
registering all drug trials and, in some cases, disclosing the
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