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Lilly's new Web site gives access to data
December 09, 2004
Eli Lilly and Co. opened a first-of-its-kind
Web site to the public Wednesday where anyone
can read results of clinical trials on Lilly
drugs.
The site, www.lillytrials.com, allows the public
easy access to results of trials where experimental
and marketed Lilly
drugs were tested on human volunteers and
patients, said Dr. Alan Breier, the drugmaker's
chief medical officer.
''Lilly wants to play a leadership role as
we move to greater accountability and transparency"
in posting drug test results, he said at a teleconference.
The Indianapolis drugmaker's registry amounts
to the most far-reaching drug company effort
to publicly post drug-testing results, industry
watchers have said.
A team of 10 Lilly employees worked almost
full time on the project since August, aided
by another two dozen people, said Lilly spokesman
Edward Sagebiel. Computer costs have run less
than $50,000 to set the site up, he said.
The registry currently contains about half
of the trial data the company has pledged to
post. The rest will be added to the site in
the next seven months, Lilly said.
The site includes summaries, ranging from five
to 38 pages, of 50 trials, mostly of Lilly's
cancer and neuroscience drugs. Trial results
for diabetes, bone and cardiovascular drugs
will be added later, as well as newly launched
and newly completed studies for all Lilly drugs.
Results of trials from 1994 on are being added.
So far the site includes only drugs for which
Lilly holds the biologic license. Studies of
drugs sold by Lilly in joint ventures won't
be included unless Lilly's partner consents,
said Sagebiel.
Cialis, a pill to treat male erectile dysfunction
that Lilly co- developed with Icos Corp., is
not in the registry because Icos hasn't yet
agreed to it, he said.
Even so, all of the primary safety and efficacy
studies on Cialis already have been published
and are available elsewhere, he said.
Breier said the site is geared to serve physicians
seeking information on Lilly drugs they might
prescribe to patients. But the site also may
be useful to "an inquisitive member of
the general public" who wants to learn
more about side
effects of Lilly drugs or study other trial
data, he said.
The site includes definitions of scientific
terms and a search function to help users find
what they are looking for.
The drug industry has come under criticism
recently for not publishing or otherwise making
available data on drug trials when the results
showed the drug didn't work or had bad side
effects.
In June, the drug trade group Pharmaceutical
Research and Manufacturers adopted voluntary
guidelines for its members calling on them to
release meaningful results of their clinical
trials whether they are positive or negative.
"I think we will begin to rebuild trust
(in drug industry studies) that has frankly
eroded over time," Breier said.
In August, the British drug firm GlaxoSmithKline
agreed as part of a lawsuit by the New York
attorney general to publicly post by December
2005 results of all of its drug studies done
since 2000.
The fraud lawsuit cited evidence that Glaxo
withheld studies on its antidepressant Paxil
that showed it wasn't effective when used by
children.
Breier said Lilly would like drugmakers to
cooperate in setting up a common registry where
all drug studies from all companies and academic
and government researchers would be posted.
Lilly plans to hire an independent auditor
to audit its site annually to make sure Lilly
is posting results of all studies of its drugs.
The auditor's report also will appear on the
site.
source:-http://www.indystar.com
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