Most Results Of Drug Studies Never Published
- From: rpautrey2 <rpautrey2@xxxxxxxxx>
- Date: Tue, 30 Sep 2008 09:36:35 -0700 (PDT)
Most Results of Drug Studies Never Published
By Maggie Mahar, Health Beat
Posted on September 29, 2008, Printed on September 30, 2008
http://www.alternet.org/story/100789/
Last week, the Guardian UK published a story that should be shocking
-- but isn't: "More than Half of U.S. Drug Studies Never See the Light
of Day." This serves as further proof -- if we needed it -- that
pharmaceutical companies should not be allowed to control what doctors
and patients know, and don't know, about new drugs.
More than half of US drug safety studies never see the light of day
Only 43 percent of the evidence of safety and efficacy that the US
Food and Drug Administration uses to approve drugs is published in
scientific journals. The authors of the survey say this amounts to
"scientific misconduct."
James Randerson, guardian.co.uk,Tuesday September 23 2008 10:46 BST
The results of more than half of all clinical trials that demonstrate
the safety and effectiveness of new drugs are not published within
five years of the drug going on the market, according to an analysis
of 90 drugs approved by US regulators between 1998 and 2000.
The researchers, who traced the publication or otherwise of 909
separate clinical trials in the scientific literature, wrote that the
failure of drug companies to publish the evidence relating to new
medicines amounted to "scientific misconduct". They said it "harms the
public good" by preventing informed decisions by doctors and patients
about new medicines and by hampering future scientific work.
Sir Iain Chalmers, who is director of the James Lind Library in Oxford
and a founder of the Cochrane Collaboration, a respected organization
that reviews medical evidence, said that it was vital that all data on
new medicines be made public.
"Patients may otherwise suffer or die unnecessarily," said Chalmers,
who was not involved in the work. "The people who participate in a
trial have a right to expect that their participation and their data
will be made available publicly so that people can take whatever
decisions seem appropriate in the light of that information."
The US researchers who carried out the study searched the academic
literature for publication of the trials that drug companies relied on
to convince the US Food and Drug Administration that their new
products were safe and effective and so worthy of market approval.
Information that is used to convince the regulators is not necessarily
subsequently published for public and scientific scrutiny, but the
scale of the missing information was found to be vast.
Five years after each of the 90 drugs was first available for
patients, only 43 percent of the studies supporting the drugs' use had
been published, with most publication happening in the first one or
two years. In the case of one product -- an antibiotic -- the
researchers could not find a single supporting trial in the scientific
literature, while five trials were published twice and one was
published three times.
The team also found evidence for a "publication bias." Trials with
statistically significant results were more likely to be published
than those with non-significant results, as were those with larger
sample sizes.
"In the years immediately following FDA approval that are most
relevant to public health, there exists incomplete and selective
publication of trials supporting approved new drugs," Prof Ida Sim and
her colleagues at the University of California, San Francisco, wrote
in the journal PLoS Medicine.
One possible explanation for the scientific data not being published
is that drug companies hold back publication of the results that are
least flattering to their new drugs. Another possibility is that
academic journal editors are less inclined to publish papers on trials
that have negative or ambiguous results.
"Regardless of the cause, publication bias harms the public good by
impairing the ability of clinicians and patients to make informed
clinical decisions, and the ability of scientists to design safer and
more efficient trials based on past findings," the authors wrote.
"Publication bias can thus be considered a form of scientific
misconduct."
The reporting of clinical trial results should have improved since the
period analysed by the researchers, because the 2007 FDA Amendments
Act mandated basic results reporting for all trials supporting FDA-
approved drugs and devices. However, the researchers said it remained
to be seen whether clinical reporting would improve.
The new law could even have the opposite effect. "Might sponsors feel
less compelled to publish equivocal trials because the basic results
will already be in the public domain?" they speculated.
Liked this story? Find more health news at Health Beat.
Maggie Mahar is a fellow at the Century Foundation and the author of
Money-Driven Medicine: The Real Reason Health Care Costs So Much
(Harper/Collins 2006).
© 2008 Health Beat
http://www.alternet.org/healthwellness/100789/
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