PhRMA urges more disclosure
Experts applaud new guidelines, but wonder about their
effectiveness | By Paula
A new set of guidelines issued by the Pharmaceutical
Research and Manufacturers of America (PhRMA) calling for the
release of more data from clinical trials is being met with guarded
skepticism by advocates who have been clamoring for increased
The guidelines, approved by PhRMA's executive committee on June
30, say the results of clinical trials for marketed drugs should be
made public "whether they are favorable to the company sponsoring
the trial or not." They also suggest that the clinician in charge of
the trial be paid in currency, and not with stock options from the
company commissioning the trial.
The voluntary guidelines have been in development since 2002 and
mostly reflect protocols already in place, according to Alan
Goldhammer, PhRMA's associate vice president for regulatory affairs.
They have been updated in recent weeks to clarify the association's
views on conflicts of interest and the publication of negative trial
results, he added. The guidelines do not specify which studies will
be made public.
"We've made it a little more clear that a clinical trial registry
is compatible with PhRMA," Goldhammer told The Scientist.
"What's most important is to focus on what prescribing physicians
need to know."
PhRMA's release of the clarified guidelines follows a June 2 lawsuit by New York State Attorney General
Eliot Spitzer, charging that GlaxoSmithKline engaged in "repeated
and persistent fraud" by withholding negative information about
Paxil and misrepresenting data concerning Paxil's safety and
efficacy when prescribed for depression in children and adolescents.
Spitzer's office would not comment on the new guidelines.
Two weeks later, the American Medical Association House of
Delegates called for the Department of Health and Human Services
to establish a comprehensive registry for all US clinical trials. On
June 18, GlaxoSmithKline announced the creation of a register that
would provide summaries of clinical trial results on the Web. The World Health Organization would like to establish
a worldwide registry of all trials.
An American Medical Association (AMA) trustee welcomed the PhRMA
guidelines, but questioned their potential effectiveness and said
they do not go far enough. All clinical trials—not just those for
marketed drugs—should be added to a public registry, said trustee
Joseph Heyman, and institutional review boards should require
registration as a condition of allowing the study to continue. Even
trials on therapies that are later discarded provide significant
information to scientists, Heyman added. For marketed drugs, it's
important to release information on all studies, even the most
"We would agree with measures to make studies public," Heyman
told The Scientist. "But [PhRMA] does not commit to make them
available at inception. From what I'm reading, if the drug never
goes to market, nobody knows about it."
Jonathan Moreno, director of the Center for
Biomedical Ethics at the University of Virginia, said that PhRMA's
guidelines are "more interesting for what they don't say than what
they say," and labeled the effort "damage control."
The guidelines do not provide enough information to ensure
accountability, Moreno said. "This is for general consumption," he
added. "How much they are doing with their members is hard to tell.
But you don't get the sense of trying to push back the boundary of
Krimsky, Tufts University professor and author of the
forthcoming Science and the Private Interest, also questioned
the lack of detail. "These are all positive things, but one of the
problems is when you get down to the details, are they talking about
phase 3, phase 4, or are they talking about all trials, 1 to 3?"
Krimsky asked. "How are things going to be reported?"
Goldhammer said that such details needed to be worked out among
PhRMA, the Food and Drug Administration (FDA), and the AMA. "We are
all in favor of transparency," he said.
American Medical News, the AMA's weekly newspaper, reported July 5 that there are already 300 trial
registries in use. The largest is the National Institute's of Health
ClinicalTrials.gov. A November 1997 federal law
requires that companies report the results of phase 2, 3, and 4
trials for therapies treating "serious or life-threatening diseases"
on that Web site.
But Theresa Toigo, an associate commissioner of the FDA, said
that only about 48% of all cancer trials done in 2002 were reported.
Toigo's study of reporting on cancer therapies was
released last fall, and the full study results are expected later in
the year. "We think more trials should be registered than actually
are registered," Toigo told The Scientist.
Links for this article
Pharmaceutical Research and Manufacturers of America
S. Warner, "The tribulations of clinical trials," The
, 18:20, April 26, 2004.http://www.the-scientist.com/yr2004/apr/feature_040426.html
"Major pharmaceutical firm concealed drug information,"
Office of New York State Attorney General Eliot Spitzer press
release, June 2, 2004.http://www.oag.state.ny.us/press/2004/jun/jun2b_04.html
"AMA recommends that DHHS establish a registry for all
US clinical trials," American Medical Association press release,
June 15, 2004.http://www.ama-assn.org/ama/pub/article/1616-8651.html
S. Vedantam, "WHO wants to start drug trial registry,"
Washington Post, July 8, 2004.http://www.washingtonpost.com/wp-dyn/articles/A35253-2004Jul7.html
Jonathan D. Morenohttp://www.healthsystem.virginia.edu/internet/bio-ethics/morenobio.cfm
V.S. Elliott, "Drug controversies prompt call for
clinical trial registry," American Medical News,
T. Toigo, "Food and Drug Modernization Act (FDAMA)
Section 113: Status Report on Implementation," Journal of Biolaw and
Business, 7:2, 2004.http://www.biolawbusiness.com/vol7num2.asp#three