MEDICAL ETHICS
CLINICAL TRIALS:
NOW ON TRIAL
7th June 2000
By Fintan Dunne
AidsMyth Dissident
News
The growing stench of corruption from the medical establishment has forced
US Government agencies to respond to public concern. The OPRR research oversight
body is to be scrapped, other moves are afoot to tighten controls on clinical
trials, and even fines for errant researchers are being mooted.
Meanwhile the normally staid New England Journal of Medicine is embroiled
in the controversy - replacing an editor whose parting shot was to slam ethical
standards in medical research. Then the new editor - who has close ties to
industry, was discovered to have been the 1999 target of FDA allegations about
his misleading statements on athsma drugs.
All this is encouraging for AIDS dissidents - long convinced of dubious medical
practices. But is there really the political will to do more than just cut
the top off the iceberg of commercially driven medical research? Perhaps not.
The US government Tuesday 6th June announced the creation of a new Office
for Human Research Protections (OHRP) responsible for ensuring that clinical
research meets national safety requirements. The office will develop stronger
patient protection policies to apply to all research funded or regulated by
HHS. The agency will also ``provide leadership''
to all 17 federal agencies that carry out research involving human subjects,
according to HHS.
Branding medical research as "exploding with opportunity,''
HHS Secretary Donna Shalala said ``to achieve the benefits
of that research we need a solid foundation of thoughtfully-designed and thoroughly-executed
research patient protections.'' OHRP will replace the existing Office
for Protection from Research Risks (OPRR), which was part of the National
Institutes of Health (NIH).
The new agency will implement programs announced by Shalala last month, including
a requirement that researchers undertake special training in ethics, and a
rule that researchers requesting NIH funding for early stage clinical trials
must first submit plans for monitoring safety. The first director of the new
office will be Dr. Edward Greg Koski, a researcher from Harvard Medical School.
He is promised a substantial funding increase in reported comments by the
Surgeon General's Office.
MISLEADING STATEMENTS BY NEJ EDITOR
Meanwhile, back at the NEJ. It emerged recently that the FDA, in March 1999,
accused the new editor-in-chief of The New England Journal of Medicine, Dr.
Jeffrey M. Drazen, of misleading statements about asthma drug, Xopenex in
a press release issued last year. Drazen, professor of medicine at Harvard
Medical School, will take over as editor-in-chief of the journal on July 1.
Frank Fortin of Journal's publishers Massachusetts Medical Society, unaware
of the FDA allegations, said even if the selection committee had known, "it
would not have affected their decision.'' Fortin said, "the
FDA letter will not have any bearing" on the decision by the society
to name Drazen as editor-in-chief.
According to the FDA, Drazen in a March 1999 news release described Xopenex
as "the first real advance in rescue asthma therapy
in over 20 years.'' The FDA determined the statement misleading because
it "overstates the safety and efficacy of the product.''
Drazen's own ties to industry came under scrutiny recently the journal disclosed
that it had published 19 articles on drug treatments without disclosing the
authors' industry links. One of the authors was Drazen, who had accepted grants
or an advisory role at eight companies.
JOURNAL EDITOR'S PARTING SHOTS
Dr. Marcia Angell, is leaving the New England Journal of Medicine with some
panache - biting the hand that has fed her, as she goes. The June 1st issue
of the Journal reported that news items may not include details of ``financial
ties between study groups or experts and pharmaceutical manufacturers.''
The investigators found that only 47% of news stories mentioned potential
harm, and just 39% of stories disclosed potential conflicts of interest. Of
207 randomly selected newspaper and television reports, 40% did not quantify
in any way the benefits of the drug.
To illustrate, the study discussed how evening news broadcasts reported the
osteoporosis drug Alendronate reduced hip fractures by 50%. But only 2% of
untreated osteoporosis patients sustained hip fractures, so the new drug would
reduce hip fractures from 2% to 1% among these people. None of the stories
disclosed that the investigator had received funding for the study from the
drug manufacturer.
In the previous May 2000 issue, departing editor Angell called for stronger
restrictions on stock ownership and other financial incentives for researchers,
saying conflicts of interest are tainting science: "When
the boundaries between industry and academic medicine become as blurred as
they are now, the business goals of industry influence the mission of medical
schools in multiple ways."
She said, medical schools have struck a "Faustian bargain"
with the industry, industry reps are lavishing giveaway products, other gifts
and trips on doctors, and consulting fees are swaying researchers toward more
favorable findings on products. She also noted in an editorial that "the
costs of the industry-sponsored trips, meals, gifts, conferences, and symposiums
and the honorariums, consulting fees, and research grants are simply added
to the prices of drugs and devices."
MANIPULATING CLINICAL TRIALS RESULTS
Also in the May 2000 issue, Dr. Thomas Bodenheimer of the University of California
at San Francisco said 70 per cent of money for clinical tests of drugs and
devices now comes from industry, not government. Drug companies that pay for
research and clinical tests of new medicines have been suppressing or manipulating
the results - especially when for-profit SMO companies set up specifically
to test drugs conduct the trials, he reported.
Six of the 12 investigators Bodenheimer interviewed “cited
cases of articles whose publication was stopped or whose content was altered
by the funding company. One drug company delayed publication of a study’s
results by requesting changes to the manuscript to make the product look better.
“During the delay, the company secretly wrote a competing
article on the same topic, which was favorable to the company’s viewpoint,”
said Bodenheimer.
When another researcher found that a drug he was studying caused adverse reactions.
He sent his manuscript to the sponsoring company for review. The company vowed
never to fund his work again and published a competing article with scant
mention of the adverse effects.
In another case where the drug did not work, the company delayed publication
until the investigator lost interest. Bodenheimer also warned that drug companies
“design studies likely to favor their product...”
Bodenheimer spotlighted the growing use of professional medical writers ("ghostwriters")
employed by drug companys."Ghostwriters typically receive a packet of materials
from which they write the article; they may be instructed to insert a key
paragraph favorable to the company's product."
Yet despite all this evidence, Harvard Medical School professor Dr. Barry
Eisenstein, told Reuters, “There has always been conflict
of interest. Harvard is reviewing its conflict of interest policies that now
bar researchers from having more than $20,000 worth of stock in the companies
whose products they are studying".
Journal editor Angell noted this "softening...to prevent
the loss of star faculty members to other schools" in her editorial,
describing it as "exactly the wrong thing for Harvard
Medical School to do." “There is now considerable
evidence that researchers with ties to drug companies are indeed more likely
to report results that are favorable to the products of those companies,”
Angell said.
GENE THERAPY CONCERNS PROMPT FINES PROPOSAL
Proposed fines for errant researchers and their universities - recently announced
by Health and Human Services Secretary Donna Shalala, may be some way off
implementation. Congress must pass legislation and is unlikely to address
the issue this year. Growing criticism of poor oversight of gene therapy experiments
prompted the move, including one that killed an Arizona teen-ager last fall.
FDA investigators said scientists involved in that death broke numerous federal
safety rules. Other FDA investigations shut down gene therapy trials. But
the FDA cautioned that once medical experiments begin, there is little independent
monitoring by overburdened review bodies. NIH will now require early-stage
clinical trials to undergo more intensive patient monitoring.
At least one AIDS dissident activist known to AidsMyth is convinced that his
HIV diagnosis arose from participation in clinical research into AIDS vaccines.
There is a considerable marketing effort in place to convince the public of
the efficacy of various AIDS vaccines.
The Thinktwice Global Vaccine Institute told AidsMyth Dissident news: "In
our frank opinion, you would have to be an idiot to participate in an HIV/AIDS
vaccine trial. Some trials have already taken place and the results showed
that the onset of AIDS was accelerated. We believe that an AIDS vaccine will
compromise health and create additional epidemics of the disease (and other
similar autoimmune diseases as well)."
ELECTION FEVER
Meanwhile the Justice Department is accusing drug companies of a price-fixing
"conspiracy" on a range of medications and of colluding with doctors
to maximize profits. But much of the current backlash against drug companies
is related to the fact that the USA is in an election year. In the longer
term, as long as the heavy marketing costs of drugs are paid for eventually
by consumers, the pharmaceutical behemoth is likely to thunder on regardless
of concerns of malpractice. Unless, of course, a major scandal like the spurious
AIDS "epidemic" was to be publicly revealed. Watch this space....
State
your opinion in the
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NEJ: Is Medicine for Sale?
http://www.nejm.org/content/2000/0342/0020/1516.asp
NEJ: Uneasy Alliance --
Clinical Investigators and the Pharmaceutical Industry http://www.nejm.org/content/2000/0342/0020/1539.asp
Thinktwice Global Vaccine institute
http://thinktwice.com/global.htm
AidsMyth Dissident News
http://www.aidsmyth.com/
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