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Home > Archive > Lyme Disease > December 2005 > SmithKline has the worst overall record
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SmithKline has the worst overall record
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| kathleen 2005-12-28, 5:55 pm |
| We knew that.
==
courant.com
http://www.courant.com/news/nationw...ation-headlines
Drug Firms Make More Study Results Public
By MARILYNN MARCHIONE
AP Medical Writer
December 28 2005, 5:31 PM EST
Drug companies are making public more information about medical studies
they are conducting, but some still withhold key details, a new
analysis of a federal registry finds.
Merck & Co., stung by allegations that it hid information on Vioxx's
dangers, gets somewhat better marks in the new analysis than it did in
an earlier one. However, Pfizer Inc., GlaxoSmithKline PLC and Novartis
are lagging, according to the report in Thursday's New England Journal
of Medicine.
In May, the journal's editor-in-chief accused Merck, Pfizer and Glaxo
of making a mockery of efforts to increase the transparency of such
experiments, called clinical trials.
The new report shows some progress, said its chief author, Dr. Deborah
Zarin of the National Library of Medicine, which runs the registry.
"We're getting a lot of trials being registered," including many that
American drug companies are doing in foreign countries, she said.
The registry, http://www.clinicaltrials.gov, was created in 2000 as
part of an overhaul of Food and Drug Administration monitoring. It
requires certain types of studies to be listed, such as late-stage
experiments involving life-threatening illnesses like cancer.
But it didn't get wide participation from industry or many voluntary
listings until September 2004, when editors of leading medical journals
said they would no longer publish results of any studies that were not
first listed in a public registry.
The idea was to make it easier for scientists, regulators and the
public to cross-check what studies were being done on a drug and get
the big picture of risks and benefits. The registry includes studies by
universities, governments and industry, but concerns about openness
center on industry.
The analysis covers May 20 to Oct. 11. Entries rose from 13,153 to
22,714 in that time, spiking around Sept. 13 when the medical journals'
new policy took effect.
Zarin focused on whether company listings revealed two things: the name
of the drug or device being tested and the main outcome being measured,
such as death or cancer recurrence within five years.
Pfizer was worst on giving names; 14 of its 224 new listings lacked
this information. Glaxo named the drug in all but one of its 128 new
listings but has the worst overall record: 21 percent of its total
registry entries lack specific drug names.
Merck used to be the worst but amended its entries over the summer and
now has the best record, listing the drug 99 percent of the time.
However, it did very poorly on the second measure in the analysis,
listing what outcome was being measured only 20 percent of the time.
Novartis was even worse. It registered more studies than any other
company in the analysis -- 239 -- but gave the outcome measure for a
mere 3 percent.
Glaxo spokesman Rick Koenig said his company supports disclosure.
Besides listing on the registry studies it is launching, Glaxo also
gives detailed results of ones it has completed at http://www.gsk.com.
"We are unaware that any corporate, academic, or governmental
institution is making a more comprehensive, more widely accessible
report of the results of its clinical work," he said.
A Merck spokeswoman said the company was happy the journal acknowledged
its progress toward listing names. But she said Merck considers
information about the precise outcome it is testing to be private
information that would damage its competitive position in most
early-stage studies, which it lists voluntarily in the registry.
Efforts to reach representatives of Pfizer and Novartis were
unsuccessful.
In an editorial, journal editor-in-chief Dr. Jeffrey Drazen and Dr.
Alastair J.J. Wood, a Vanderbilt university drug expert who has served
on many FDA advisory panels, call for complete compliance with the
registry, saying it "makes moral sense."
"When patients put themselves at risk to participate in clinical
trials, they do so with the tacit understanding that their risk is part
of the public record, not merely the secret record of the sponsor,"
they wrote.
They also urged scientists and patients to refuse to participate unless
studies are fully registered.
* __
On the Net:
New England Journal: http://www.nejm.org
Registry of studies: http://www.clinicaltrials.gov
Copyright 2005 Associated Press
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| In an editorial, journal editor-in-chief Dr. Jeffrey Drazen and Dr.
Alastair J.J. Wood, a Vanderbilt university drug expert who has served
on many FDA advisory panels, call for complete compliance with the
registry, saying it "makes moral sense."
"When patients put themselves at risk to participate in clinical
trials, they do so with the tacit understanding that their risk is part
of the public record, not merely the secret record of the sponsor,"
they wrote.
They also urged scientists and patients to refuse to participate unless
studies are fully registered.
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boo yaa !!!
transparancy is everything.
enjoyable post.
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