WASHINGTON — Drug manufacturers acknowledge that they face a
crisis of credibility that they hope to remedy by releasing
information about their clinical trials in multiple locations.
But at a contentious congressional hearing Thursday,
representatives of the companies said they also are concerned that
releasing all of the information will be so unwieldy that it could
confuse doctors and patients.
John R. Hayes, product team leader at Eli Lilly and Co., said a
single report about a drug can number more than 400,000 pages.
Flooding a Web site with 120,000 clinical trials may dilute the
usefulness of the information, said David Wheadon, senior vice
president of regulatory affairs for GlaxoSmithKline. “We always want
to make sure we're serving the good, the right purpose.”
The two testified at a House subcommittee hearing designed to
give seven drug companies an opportunity to explain how they did —
or did not — disclose studies that suggested links between
antidepressant use and suicidal thoughts in children.
Controversy first flared last summer with the disclosure that
unpublished studies made that link.
Federal health officials are preparing stronger warnings for some
antidepressants used in children. But exactly what those warnings
will say, and which drugs will be affected, hasn't been settled. A
Food and Drug Administration advisory committee will consider the
issue next week.
“While there remains a signal of risk ... for some drugs in some
trials, it is important to note that the data are not
black-and-white in providing a clear and definitive answer,” FDA
psychiatric drugs chief Thomas Laughren wrote the advisory panel
At the House subcommittee on oversight and investigations hearing
Thursday, tempers flared, tears flowed, and a major drug company,
Wyeth Pharmaceuticals, found itself pitted against the FDA.
As early as 2002, Wyeth attempted to add warning labels to its
antidepressant Effexor, but ran into FDA opposition. The ultimate
label changes mandated by the FDA dropped references to increased
hostility seen with Effexor, Wyeth acknowledged under