Glaxo Begins Posting Drug Trial Results
By BARRY MEIER, NY Times

GlaxoSmithKline is expected to begin posting online today the results
of clinical trials on its drugs with the release of 65 tests about a
diabetes medication, a company executive said yesterday.

The posting of trial data about the drug, Avandia, on the Web will
begin a process that will take about a year to complete, the
executive, Dr Ronald L. Krall, senior vice president for worldwide
development, said in a phone interview.

GlaxoSmithKline has said its database will include all tests on drugs
sold by the company that were conducted since 2000, the year Glaxo
Wellcome merged with SmithKline Beecham. Dr Krall said that the
database would also contain the results of earlier tests that the
company deemed medically significantly.

The company's action was expected. It comes a week after the
settlement of a lawsuit filed by the New York State attorney general,
Eliot Spitzer.

In June, Mr Spitzer accused GlaxoSmithKline of highlighting only some
of the pediatric trials of its antidepressant Paxil while playing down
negative or equivocal results. The company, which is based in Britain,
called those accusations unfounded but agreed to post test results
from all its drugs publicly and to pay the state $2.5 million to
settle the case. The company said it had been developing the drug
database before Mr Spitzer's suit.

GlaxoSmithKline's action is another step by drug producers to get out
ahead in disclosing data from clinical trials after ignoring the issue
for years. Recently, Eli Lilly also announced that it would create a
public database of all its drug test results.

In addition, the American Medical Association, the nation's largest
group of doctors, has asked federal officials to create a national
database where drug companies would be required to post trial results.
And several leading medical journals have said that they may make
trial registration a prerequisite to publishing reports about test
results.

Dr Krall said that assembling the data on Avandia required about a
month's work by 30 people.

Each of the trials of the diabetes medication will show the purpose of
the test, as well as its primary and secondary findings, a format that
will be used for all subsequent postings of drug trials.

Dr Krall said that one of the company's chief concerns was how the
public posting of the results from recent drug trials might impair the
ability of researchers to get reports about their tests published in
medical journals.

Though researchers often disclose their results in talks at medical
meetings before publication in journals, the published articles
typically serve as the first formal reports of clinical trials.

Dr Krall said that he recently discussed the issue with the editors of
two medical journals and that he came away with the impression that
the simple disclosure of trial results through a database would not
jeopardize the publication of an article that discussed and
interpreted that data.

"If we don't confound the two, then I think we are in safe territory,"
said Dr Krall, who declined to identify the publications.

He said he thought a small group of researchers, rather than the
public in general or even most doctors, would use the company's
database as a research tool because of the mass of data that will
eventually be available on it.

Drugs whose trial results the company expects to post in the coming
months, Dr Krall said, include Avodart, a treatment for benign
prostatic hyperplasia; Advair Diskus, an asthma medication; and
Valtrex, a drug for treating herpes.

The registry will be posted on the company's Web site, http://www.gsk.com