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From: rpautrey2 on 6 Aug 2008 13:08
Why Do We Need A Publicly Funded, Publicly Accessible Database Of
Clinical Trials?

The short answer is this: To stop the pharmaceutical and device
industries from hiding the results of clinical trials that did not
show a benefit to their products. And to stop them from withholding
findings that indicate significant harms associated with their
products.

In a perfect world, an independent group of researchers would conduct
the clinical trials designed to see whether a new drug is safer or
more effective than the drugs already available for the same
condition. A head-to-head comparison would be conducted for at least
one year. If the new drug has no advantage over the older drugs, it
wouldn't be allowed on the market.

The real world scenario, unfortunately, is far less than perfect. To
receive FDA approval, a drug company need only provide two trials that
proved its drug is better than nothing (a placebo). Most trials last
only a few months. In 2002, Washington Post reporter, Shankar
Vedantam , described a new analysis of the trials conducted by drug
companies that made drugs to treat depression, such as Prozac, Paxil,
and Zoloft. The majority of these trials found that placebos were just
as effective as the antidepressants, and in some trials, the placebos
worked better. But the public never learned about the trials that
found antidepressant were ineffective. The drug companies withheld
their existence and submitted the FDA-required two trials that did
show a benefit to their drug. The analysis described by the Washington
Post reporter also revealed that the makers of Prozac had to conduct
five trials to obtain two that were positive, and the makers of Paxil
and Zoloft had to conduct even more.

The issue of drug companies withholding negative trial results has
slowly become more acute in the last 15 years because government
funding of trials has decreased considerably. The majority of all drug
trials are now conducted by the sponsoring drug companies. And it is
becoming increasingly evident that the drug companies get the results
they want. A 2003 review published in the BMJ (British Medical
Journal) found that studies sponsored by pharmaceutical companies were
far more likely to have outcomes favoring the sponsor than were
studies with other sponsors . The problem is not limited to
pharmaceutical research. For example, in a 2003 review of all studies
that looked at total hip arthroplasty implants, 75% were commercially
sponsored, of which 93% reported positive outcomes; whereas
independently funded researchers reported good results in only 37% of
studies.

This critical issue did not begin to penetrate the public's
consciousness until June 2004, when New York State attorney general,
Eliot Spitzer, filed a lawsuit against the British-based
pharmaceutical company, GlaxoSmithKline. The pharmaceutical company,
one of the world's largest, was accused of “persistent fraud” for
failing to tell doctors that some of its studies of the antidepressant
Paxil showed that the drug didn't work in adolescents and might lead
to suicidal thoughts. The lawsuit has since been settled.

For more than a decade, a small group of medical journal editors and
researchers has periodically offered a solution that has only now
gained serious attention: All clinical trials should be registered at
the onset. And the registry must be publicly available. Only then will
doctors and the public have complete information about all the
research that has been conducted on a particular drug or device.
Predictably, there is a great deal of resistance to this idea from
industry. Congress is considering legislation, entitled Fair Access to
Clinical Trials Act, which will mandate the early registration of
clinical trials. Unfortunately, there are many problems with this
proposed legislation, not the least of which is the failure to include
more than drug trials in the mandate.

Some journal editors have taken a strong stand on this issue. Last
year, a new policy was announced by 11 editors of the world's most
prestigious journals, including the New England Journal of Medicine,
The Lancet, Canadian Medical Association Journal, and the New Zealand
Medical Journal. They will not publish results of any trial that has
not been registered in a publicly available database before the first
participant is enrolled. The policy is aimed at foiling researchers
who change the goals of a study while it is in progress and to stop
drug companies from withholding the existence of trials that show
negative results.

In May 2005, the 11 editors, now called the International Committee of
Medical Journal Editors, updated its policy about the registration of
clinical trials. The journals represented by this committee will not
publish trials that are not publicly registered by July 1, 2005. The
editors have given the drug companies until September 13, 2005 to
register ongoing trials. Other editors from other medical journals
have now joined the committee. The policy will be successful only when
all medical journals take a similar stand.

The Committee defined clinical trial this way: "Any research project
that prospectively assigns human subjects to intervention and
comparison groups to study the cause-and-effect relationship between a
medical intervention and a health outcome. By ‘medical intervention'
we mean any intervention used to modify a health outcome. This
definition includes drugs, surgical procedures, devices, behavioral
treatments, process-of-care changes, and the like.”

Consumers have a major stake in this issue. We cannot make informed
medical decisions if we cannot trust the research. And clinical trials
cannot be conducted without us. People who agree to participate in
trial do so with the hope of helping themselves or future patients. To
participate in a trial that never is made public means that people
have risked the harm of the treatment to no benefit.

The Center for Medical Consumers recommends that people refuse to take
part in any clinical trial that is not registered before recruitment.
At present, the nearest thing to a publicly available registry is
www.clinicaltrials.gov This Web site lists government-sponsored
trials; it has been criticized for having incomplete information. Some
pharmaceutical companies have begun to list their clinical trials on
their respective Web sites.

Maryann Napoli, Center for Medical Consumers © July 2005



© 2005 Center for Medical Consumers

The Center for Medical Consumers cannot respond to inquiries regarding
individual health concerns.

Our Web site is updated during the first two weeks of each month.

Please send any comments or questions to medconsumers(a)earthlink.net

http://www.medicalconsumers.org/pages/StopDrugCompaniesfromHidingNegativeResults.html
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