This article tells one version of the story about GSK's med problem:

The New York Times
May 23, 2007 Wednesday
Late Edition - Final

SECTION: Section C; Column 2; Business/Financial Desk; Pg. 1

HEADLINE: For Drug Makers, a Downside to Full Disclosure

BYLINE: By BARRY MEIER; Stephanie Saul contributed reporting.

When GlaxoSmithKline settled a lawsuit three years ago with the

State of New York over the antidepressant medication Paxil, the company
agreed to take an unusual step: publicly disclosing the results of its clinical
trials for Paxil and other drugs.

The company, which was criticized at the time for failing to publicize all
pediatric trials of Paxil, not just the positive ones, made good on its promise.
The first posting on a new Web site was about 65 studies involving its popular
diabetes drug, Avandia.

This week, GlaxoSmithKline learned what that greater disclosure could mean.

A cardiologist at the Cleveland Clinic, Dr. Steven Nissen, stumbled onto
the Glaxo Web site while researching Avandia last April. He and a colleague
quickly analyzed the data, and on Monday, The New England Journal of&nb! sp;Medic ine
released its finding that Avandia posed a heightened cardiac risk.

''It was a treasure trove,'' Dr. Nissen said about the Web site.

GlaxoSmithKline has disputed the journal's interpretation. Officials with
the Food and Drug Administration said they were reviewing whether to take any
action on Avandia.

Whatever the drug's fate, the episode is likely to fuel efforts by some
medical experts, including Dr. Nissen, to persuade lawmakers to require makers
of drugs and medical devices to disclose study results publicly. Currently,
producers are not required to do so, but Congress is considering legislating a
requirement.

Many companies besides GlaxoSmithKline already post results from some
studies or trials on their Web sites, or one operated by the Pharmaceutical
Research and Manufacturers Association, a trade group in Washington.

Dr. Bruce M. Psaty, a cardiologist at the University of Washington, said
that having such information can play a critical role, as the case of Avandia
suggests, in spotting signals of a drug's possible dangers.

Other&n! bsp;expe rts have argued that the relative efficacy or cost of competing
drugs can be compared only when all study results, rather simply those that a
company chooses to publicize, are available.

Studies have found that the vast majority of drug and medical device
studies are never published in medical journals.

''The more information, the better,'' Dr. Psaty said.

Dr. Ronald L. Krall, chief medical officer for Glaxo, said his company
sharply disputed the methodology of Dr. Nissen's study, and a top F.D.A.
official said that the agency had previously informed doctors about Avandia's
heart risks.

Dr. Krall said his company was aware when it created its database of study
results a few years ago that it might lead to controversy. Other scientists
might look at its data or choose to analyze it differently than company
officials did, he said.

''We are committed to the principle of transparency,'' Dr. Krall added.
''But we knew that when starting this, by putting the data in the public, many
things could happen, some of which could be&! nbsp;tro uble.''

Some experts also believe that releasing the results of hundreds of studies
involving drugs or medical devices might create confusion and anxiety for
patients who are typically not well prepared to understand the studies or to put
them in context.

''I would be very concerned about wholesale posting of thousands of
clinical trials leading to mass confusion,'' said Dr. Steven Galson, the
director for the Center for Drug Evaluation and Research at the F.D.A.

Roughly a decade ago, some experts raised concerns that doctors were not
getting the full picture about a drug's risks and benefits because they tended
to hear or read about only those trials in which the medication showed a
benefit.

Companies and researchers typically did not seek publication of studies
that showed that a drug had little benefit or might even cause harm. In some
cases, trials that were started and stopped before completion were not
disclosed.

As a result, outside researchers could not learn what trials of a drug had
been performed so they could put fi! ndings&n bsp;in context or compare studies of
competing drugs.

That issue caught the public's attention after it was disclosed that Glaxo
had not publicized trials of Paxil in children in which the drug showed little,
if any, benefit. The company was subsequently sued by Eliot Spitzer, who was
then the attorney general and who is now the governor of New York. The drug
maker, as part of the lawsuit's settlement, created a public Web site for trial
results. Glaxo was by no means the only drug company that came under scrutiny.
In late 2004, a group of leading medical journals, including The New England
Journal of Medicine, said that they would no longer publish articles about study
results unless producers publicly registered the tests on Web sites like
ClinicalTrials.gov, which is run by the National Library of Medicine.

As a result, the number of drug trials registered on that site has sharply
increased, said Dr. Deborah Zarin, its director. (Currently, drug manufacturers
are required to register trials of new drugs for serious or life-threatening
conditions).

But even before&n! bsp;the& nbsp;recent Avandia episode, advocates for greater study
transparency like Dr. Nissen were pushing lawmakers to take the next step by
requiring that producers of drugs and makers of devices not only register trials
but also publicly disclose study findings.

''It is critical, but this raises the question of how many other drug
safety issues are out there,'' Dr. Nissen said. Recently, the Senate passed an
F.D.A.-related bill that would set up a process for developing a mechanism that
experts expect would result in a government-run database where companies and
others would post the results of clinical trials. The House is currently
considering a bill that has somewhat different provisions.

Dr. Alan Goldhammer, a senior executive at the Pharmaceutical Research and
Manufacturers Association, said the organization supported the disclosure
provision in the Senate bill that had passed.

He said the group, however, was concerned that some states may be trying to
get ahead of the federal government on the issue; for instance, Maine recently
passed a bill that mandates the release of study findings.

&nb sp; ''We want to make sure it is done in a reasonable way,'' Dr. Goldhammer
said.

Recently, a report issued by the Institute of Medicine, a part of the
National Academy of Sciences, recommended that the F.D.A. release all summaries
of study data it had collected in the process of approving new drugs as well as
all post-marketing studies of those products.

The F.D.A. rejected the first recommendation as overly burdensome and Dr.
Galson, the director of the F.D.A.'s drug evaluation and research, said that the
agency already released much of this information. ''It is not that we are
philosophically opposed to it, but the work would be enormous,'' he said.

Even those supporting mandatory results disclosure acknowledge that finding
uniform ways to disclose complex scientific information would prove difficult
and time-consuming. For example, Dr. Zarin of ClinicalTrials.gov said that
reviewing a study's results to make sure that it was free of any biases
interjected by researchers involved in a study or by its sponsor was a major
undertaking.

Then, ther! e i s also the question of who the audience for such information
should be -- scientists, consumers or both?

Dr. Zarin said that there had been significant discussion among experts
over the last year about that issue. Most have agreed that data is best
understood by experts, a view that might not prove popular with patients.

Dr. Krall of Glaxo agreed, saying the drug maker had considered providing
summaries of its studies for patients, but then dropped the efforts after
deciding it would require making subjective decisions about trial results.

''There is not a uniform view about how to interpret results,'' he said.
''It is quite problematic to go that next step.''

URL: http://www.nytimes.com

GRAPHIC: Photo: Dr. Steven Nissen, center, favors publicizing drug studies and
trials. (Photo by Marvin Fong/The Plain Dealer, via Associated Press)

LOAD-DATE: May 23, 2007

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Love,
Vicky