Pharma Should Publish Its Trial Results

[Guest guest]

The Scientist

April 26, 2004

Pharma Should Publish Its Trial Results

by Gallagher

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. 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and Investigations, had to politely request unpublished data on the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.

Gallagher, Editor

rgallagher@...

References

1. www.phrma.org/mediaroom/press/releases/20.06.2002.427.cfm

2. energycommerce.house.gov/108/Letters/02022004_1208.htm

3. smi-web.stanford.edu/pubs/SMI_Reports/SMI-95-0576.pdf

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org