n a settlement that the New York State attorney
general said would transform the drug industry, GlaxoSmithKline
agreed today to post on its Web site the results of all clinical
trials involving its drugs.
"This settlement is transformational in that it will provide
doctors and patients access to the clinical testing data necessary
to make informed judgments," the attorney general, Eliot Spitzer,
said.
While the case involves only GlaxoSmithKline, the British drug
maker, Mr. Spitzer predicted other companies would soon follow its
lead by posting the results of their own studies online. Eli Lilly,
for example, has said it will create a Web site on which it will
list the results of clinical tests of approved drugs, including
trials of those drugs for new uses. Several other companies,
including Johnson
& Johnson and Merck,
have said they support the concept of a publicly available database
that would list trial results.
If the drug makers do not take action, Mr. Spitzer threatened
more lawsuits. "We have ongoing inquiries," he said.
And in comments reminiscent of his battles with the Securities
and Exchange Commission and its former chairman, Harvey Pitt, Mr.
Spitzer sharply criticized the Food and Drug Administration for
failing to require such disclosures years ago.
"Just like with the S.E.C.," Mr. Spitzer said, "we're asking
where has the F.D.A. been all these years when clinical data has
been hidden from public scrutiny? They have simply failed to
confront the problem."
Mr. Spitzer filed suit in June against GlaxoSmithKline,
contending that it committed fraud by publicizing the results of
only one of five trials studying the effect of its huge-selling
antidepressant, Paxil, in children. That single study showed mixed
results. The others not only failed to show any benefit for the drug
in children but demonstrated that children taking Paxil were more
likely to become suicidal than those taking a placebo.
Mr. Spitzer said that GlaxoSmithKline's selective disclosures,
which have long been common in the drug industry, constituted a form
of consumer fraud. But it is unclear whether posting clinical trial
results on a Web site will entirely solve the problem.
In the case of Paxil, for instance, GlaxoSmithKline's original
analysis of its trials simply found an increased level of what the
company termed "emotional lability" among children given the drug.
Only after a reviewer at the F.D.A. asked the company to offer more
information about this category did it become clear that the
children and teen-agers given Paxil were more suicidal than those
given placebos.
Mr. Spitzer acknowledged that postings of clinical trial results
online was not a cure-all.
"Nobody should believe that we think this is a panacea and that
there will be perfect understanding of testing and clinical
variables," Mr. Spitzer said. But he said such postings would allow
academics and doctors to ask the right questions about drugs.
Spokeswomen for GlaxoSmithKline and the F.D.A. did not
immediately return phone messages.
.gif){kind=spacer}
