listener
GlaxoSmithKline to Post Trial Results
NEW YORK (AP) -- GlaxoSmithKline PLC, which was sued by the
New York attorney general for fraud for withholding critical
clinical information, said Friday it will post the results
of all of its drug trials on the Web.
The move comes amid mounting pressure on drug companies to
make all trial results more widely available. Doctors
receive much of their information on clinical trials at
medical meetings, by reading journals and through drug
company marketing, but there has long been concern that
negative information is largely absent from those channels.
Glaxo was sued over the issue two weeks ago, and the
American Medical Association passed a resolution this
week calling for a comprehensive, government-run registry
for all drug study results so that unfavorable results
aren't buried.
Meanwhile, international medical journals are considering
not publishing studies conducted by drug companies unless
the trials are listed in a public registry.
Doctors were largely unimpressed with Glaxo's announcement,
saying they need one central place to get information rather
than having to scour multiple sites. They also criticized
Glaxo's decision not to disclose when it is starting a trial
- because then it won't have to account for what happened in
the study if the results are negative.
Glaxo couldn't say when the information would be posted but
said it shouldn't take longer than six months.
"I think this is the right thing to do. We think more
transparency is better," said chairman and chief executive
Jean-Pierre Garnier, who added he supported a
comprehensive registry. "We don't want to be accused of
anything about the way we deal with trials. I think it too
important a subject."
Garnier said the company had been considering the Web site
for months and the decision to announce it was a reaction
to the AMA resolution, not the lawsuit. Still, he said he
hoped it would persuade Attorney General Eliot Spitzer to
drop the lawsuit.
Glaxo already has posted on its Web site the studies Spitzer
accused it of hiding, along with what Garnier said was proof
that the trial results had been made public.
The lawsuit, filed in New York State Supreme Court, said
Glaxo suppressed four studies of its anti-depressant Paxil
that failed to demonstrate the drug was effective in
treating children and adolescents and that suggested a
possible increase in suicidal thinking and behavior.
It also said an internal 1999 Glaxo document showed that the
company intended to "manage the dissemination of data in
order to minimize any potential negative commercial impact."
A Spitzer spokeswoman said officials were examining Glaxo's
proposal and the information about the Paxil trials posted
on the Web to see if they would affect the lawsuit.
The controversy over prescribing antidepressants to children
has magnified the issue of whether there is adequate
disclosure of clinical trial information.
Garnier said both the Web site and any future public
registry present problems not only for drug companies, but
for doctors and patients.
"Some studies need to be seen in the entire context of all
the research," Garnier said. "There is always a risk of junk
science through isolating just one trial."
He said the part of the problem is that journals don't
publish negative news.
"They have difficulty getting excited about negative news.
They favor the positive," he said.
Medical editors say that is because they receive more
favorable studies than unfavorable ones. "We can only
publish what we get, and we get far more positive than
negative," said Dr. Catherine DeAngelis, editor in chief of
the Journal of the American Medical Association.
Editors also want complete news. New England Journal of
Medicine Editor in Chief Dr. Jeffrey Drazen said when a
company started eight trials but only talks about three, it
signals that something may be amiss. "We want to give your
readers complete information," he said.
Drug companies have made similar announcements in the past,
but they haven't improved disclosure. In 1998, Glaxo
Wellcome started a registry that listed the purpose and
parameters of its trials with links to publications carrying
the results. It hasn't been updated since the company merged
with Smith Kline Beecham in 2000.
"I've congratulated companies before and their efforts
haven't been worth anything," said Dr. Drummond Rennie, a
deputy editor at JAMA.
There are several public and private clinical trials
registries, but doctors say they are not standardized
or complete.
One of the largest is ClinicalTrials.gov, which was started
in 2000 by the National Library of Medicine. It lists about
10,000 studies.
Federal law requires that companies that have conducted
studies for serious or life-threatening treatments post them
there. The FDA is investigating whether the companies are
doing so, said Alexa McCray, the library's director for
biomedical communications.
Merck & Co. said it supports expanding that site to add more
trials and information - but spokeswoman Janet Skidmore
could not say whether Merck would list of all its trial
results on the Web.
"If Zee continues to post all those links, well, we may
have no choice but to make this information available,"
said Skidmore.
(ok, that last paragraph was added.....I couldn't resist!)
L.
NEW YORK (AP) -- GlaxoSmithKline PLC, which was sued by the
New York attorney general for fraud for withholding critical
clinical information, said Friday it will post the results
of all of its drug trials on the Web.
The move comes amid mounting pressure on drug companies to
make all trial results more widely available. Doctors
receive much of their information on clinical trials at
medical meetings, by reading journals and through drug
company marketing, but there has long been concern that
negative information is largely absent from those channels.
Glaxo was sued over the issue two weeks ago, and the
American Medical Association passed a resolution this
week calling for a comprehensive, government-run registry
for all drug study results so that unfavorable results
aren't buried.
Meanwhile, international medical journals are considering
not publishing studies conducted by drug companies unless
the trials are listed in a public registry.
Doctors were largely unimpressed with Glaxo's announcement,
saying they need one central place to get information rather
than having to scour multiple sites. They also criticized
Glaxo's decision not to disclose when it is starting a trial
- because then it won't have to account for what happened in
the study if the results are negative.
Glaxo couldn't say when the information would be posted but
said it shouldn't take longer than six months.
"I think this is the right thing to do. We think more
transparency is better," said chairman and chief executive
Jean-Pierre Garnier, who added he supported a
comprehensive registry. "We don't want to be accused of
anything about the way we deal with trials. I think it too
important a subject."
Garnier said the company had been considering the Web site
for months and the decision to announce it was a reaction
to the AMA resolution, not the lawsuit. Still, he said he
hoped it would persuade Attorney General Eliot Spitzer to
drop the lawsuit.
Glaxo already has posted on its Web site the studies Spitzer
accused it of hiding, along with what Garnier said was proof
that the trial results had been made public.
The lawsuit, filed in New York State Supreme Court, said
Glaxo suppressed four studies of its anti-depressant Paxil
that failed to demonstrate the drug was effective in
treating children and adolescents and that suggested a
possible increase in suicidal thinking and behavior.
It also said an internal 1999 Glaxo document showed that the
company intended to "manage the dissemination of data in
order to minimize any potential negative commercial impact."
A Spitzer spokeswoman said officials were examining Glaxo's
proposal and the information about the Paxil trials posted
on the Web to see if they would affect the lawsuit.
The controversy over prescribing antidepressants to children
has magnified the issue of whether there is adequate
disclosure of clinical trial information.
Garnier said both the Web site and any future public
registry present problems not only for drug companies, but
for doctors and patients.
"Some studies need to be seen in the entire context of all
the research," Garnier said. "There is always a risk of junk
science through isolating just one trial."
He said the part of the problem is that journals don't
publish negative news.
"They have difficulty getting excited about negative news.
They favor the positive," he said.
Medical editors say that is because they receive more
favorable studies than unfavorable ones. "We can only
publish what we get, and we get far more positive than
negative," said Dr. Catherine DeAngelis, editor in chief of
the Journal of the American Medical Association.
Editors also want complete news. New England Journal of
Medicine Editor in Chief Dr. Jeffrey Drazen said when a
company started eight trials but only talks about three, it
signals that something may be amiss. "We want to give your
readers complete information," he said.
Drug companies have made similar announcements in the past,
but they haven't improved disclosure. In 1998, Glaxo
Wellcome started a registry that listed the purpose and
parameters of its trials with links to publications carrying
the results. It hasn't been updated since the company merged
with Smith Kline Beecham in 2000.
"I've congratulated companies before and their efforts
haven't been worth anything," said Dr. Drummond Rennie, a
deputy editor at JAMA.
There are several public and private clinical trials
registries, but doctors say they are not standardized
or complete.
One of the largest is ClinicalTrials.gov, which was started
in 2000 by the National Library of Medicine. It lists about
10,000 studies.
Federal law requires that companies that have conducted
studies for serious or life-threatening treatments post them
there. The FDA is investigating whether the companies are
doing so, said Alexa McCray, the library's director for
biomedical communications.
Merck & Co. said it supports expanding that site to add more
trials and information - but spokeswoman Janet Skidmore
could not say whether Merck would list of all its trial
results on the Web.
"If Zee continues to post all those links, well, we may
have no choice but to make this information available,"
said Skidmore.
(ok, that last paragraph was added.....I couldn't resist!)
L.
