Pharma Should Publish Its Trial Results
I recently listened to a panel discussion on the future of
biomedical science. The standout participant, an urbane and
knowledgeable contributor, was the CEO of a major
pharmaceutical company. He won the audience over with his
optimistic vision for the future of drug development, his
conviction of the necessity of collaboration between academia
and industry, and his characterization of the high ethical
standards that his company and the industry in general have
met.
My interest piqued by this and by our reporters' work on
clinical trials (see Feature
| The Tribulations of Clinical Trials), I dug out the
ethical principles1 adopted by PhRMA (the
Pharmaceutical Researchers and Manufacturers of America), the
representative body of the industry. Among the provisions:
"There will be timely communication of meaningful study
results, regardless of the outcome of the study. The results
must be reported in an objective, accurate, balanced, and
complete manner, with a discussion of the limitations of the
study. Study sponsors will not suppress or veto publications."
I was thunderstruck, given that an issue muddying the
current debate about the use of antidepressants in children is
the lack of access to trial results. As reported in The
Washington Times on Jan. 29, "Makers of popular
antidepressants such as Paxil, Zoloft, and Effexor have
refused to disclose the details of most clinical trials
involving depressed children, denying doctors and parents
crucial evidence as they weigh fresh fears that such medicines
may cause some children to become suicidal."
While this situation has now been rectified, the obvious
question, namely why all clinical trial results are not
available as a matter of course, has a frustrating answer: The
results are the closely guarded property of the drug
companies. The decision on when and how to make them available
rests entirely with the companies, to the extent that US Rep.
James Greenwood (R-Pa.), chairman of the Subcommittee on
Oversight and Investigations, had to politely request
unpublished data on the antidepressant trials.2
Here are a couple of extracts, taken from the published
documents of more than one company. They do not exactly jibe
with the PhRMA principles.
"Company X recognizes that the availability of clinical
trial results is critical to the communication of important
new information for the medical profession, patients, and the
public."
Hurrah!
"Company X commits to timely communication of meaningful
results ..."
Yes?
"... of controlled clinical trials of marketed products or
investigational products that are approved for marketing,
regardless of outcome."
Well, what about the antidepressant shenanigans? And what
about data from the innumerable trials that fail? These, too,
are of vital importance.
"For investigational candidates that fail in development,
Company X will collaborate with external investigators to
publish the findings based on priorities and on the medical
and scientific importance of the data."
Whose priorities? And what are the criteria for medical and
scientific importance?
Common sense dictates that innovation by the pharmaceutical
industry must be encouraged and protected, otherwise the
current, unprecedented opportunities to create new medicines
will not be realized. But withholding clinical trial results
serves this function at the expense of a wider goal, namely
the development of medical knowledge.
Not only should trial results be made available, they
should also be done so in a standardized structure on
searchable databases, as occurs in many areas of basic biology
research. A proposal for such a database was made as long ago
as 1996,3 but it has been unable to get off the
ground.
Opening up clinical trial results to researchers would
serve Pharma as well as society. Companies could be protected
by confidentiality agreements, and reach-through rights would
help hasten the development of new medicines.
This surely would be in close accord with the admirable
principles set forth by PhRMA. It is time to implement them.
Richard Gallagher, Editor
rgallagher@the-scientist.com
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