Studies Often Omit Ethics Guidelines
Doctors Frequently Don't Get All the Data From Studies
By Sid Kirchheimer
Oct. 23, 2002 -- Your doctor may not be getting all the facts about
research on new drugs and procedures needed to make safe and effective
treatment choices for you.
That's because guidelines established to ensure that scientists can
conduct unbiased research for publication in leading medical journals --
the primary sources of information for many doctors -- are often left
out of agreements made between academic institutions and the companies
that sponsor these trials.
That's the conclusion of a startling new study by Duke University
investigators, who found that medical schools rarely get provisions to
protect the independence of their researchers when signing contracts to
conduct industry-paid clinical trials.
These provisions are the basis
for guidelines used by more than 500 medical journals as the standard
for researchers submitting papers for publication.
The guidelines were
revised last year by the International Committee for Medical Journal
"From a consumer perspective, the question is if their doctors are
really being informed about all the information -- both positive and
negative -- that will impact the benefits of therapies," lead researcher
Kevin Schulman, MD, tells WebMD. "Are there really benefits to these
therapies, or are they are less than anticipated?"
Medical schools frequently conduct research sponsored by pharmaceutical
and other companies because it can generate millions of dollars for the
schools. But the Duke study suggests that it's the companies paying for
these trials that dictate what and how the research is published, which
is later read by many of the world's treating doctors.
"Based on the responses we got, the medical centers generally feel
powerless in their negotiations with the industry sponsors," Schulman
says. "If they say, 'I'm going to raise the bar in terms of the
requirements for my institution,' the sponsors will just go elsewhere to
do the trials."
Schulman and his colleagues at Duke's Medical Center and School of Law
surveyed 108 member institutions of the Association of American Medical
Colleges for their study, which appears in the Oct. 24 issue of The New
England Journal of Medicine.
The survey shows that the majority of
contracts rarely contained the recommended guidelines: that authors have
full access to all data, that data be published regardless of the
results, and that an independent committee evaluate the data and safety
The bottom line to you: The information your doctor uses from the
studies in medical journals may be tainted, the study suggests.
"For instance, there was a paper published two years ago in The Journal
of the American Medical Association on the six-month effectiveness of
Cox-2 inhibitors [drugs such as Vioxx and Celebrex used for arthritis
pain]," Schulman tells WebMD. "But it was a one-year trial. The
six-month outcomes that were published proved favorable, but the
one-year outcomes in that trial were not. And there have been a series
of such questions."
The Duke finding is not surprising to one researcher, who learned
firsthand just how career damaging it can be to publish unflattering
research. After Nancy Olivieri, MD, discovered that a drug she was
researching caused unexpected risks, drug manufacturer Apotex abruptly
ended the trial and threatened a lawsuit if she discussed or published
her findings. The University of Toronto researcher had signed a
confidentially agreement, and her school declined her legal support.
"I'm delighted that (the Duke researchers) have looked at this, but I'm
not delighted by their findings -- or surprised," Olivieri tells WebMD.
"The saddest indictment is that medical schools are prepared to
surrender their integrity because the next medical school one state over
is prepared to surrender its integrity," she says.
"We need to know that the legal frameworks are in place so that all the
data is out there in the public domain," says Schulman. "As physicians
and consumers, all we know is what is being published. But we don't know
what is not published.
What a sponsor has found in its own data may
never be shared with the public."
Thanks to WebMd.com
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