Scientific Corruption: Statin Panel's Industry Ties
From: Dr. Jai Maharaj (usenet_at_mantra.com)
Date: 07/15/04
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Date: Thu, 15 Jul 2004 23:36:09 GMT
Scientific Corruption: Statin Panel's Industry Ties
Forwarded message from anon@mouse.com
[ Subject: Scientific Corruption: Statin Panel's Industry Ties
[ From: anon@mouse.com
[ Date: 15 Jul 2004 13:26:05 -0500
http://www.newsday.com/news/health/ny-hschol0715,0,847235.story?coll=ny-health-headlines
Panel's ties to drugmakers not cited in new cholesterol guidelines
By Delthia Ricks and Roni Rabin
Staff Writers
Newsday
Thursday, July 15, 2004
Guidelines published by a government panel earlier this
week, calling for aggressive use of statin medications to
lower cholesterol in people at high risk of heart
attacks, failed to list panelists' links to
pharmaceutical companies, many of which manufacture
statin drugs.
Of the nine panelists, six had received grants or
consulting or speakers' fees from companies that produce
some of the most popular statin medications on the
market, according to published material from 2001. Those
drugs include Pfizer's Lipitor; Bristol-Myers Squibb's
Pravachol, Merck's Lovastatin and AstraZeneca's Crestor.
Dr. James Cleeman, coordinator of the national
Cholesterol Education Program, a division of the National
Heart, Lung and Blood Institute, called the omission of
financial disclosures an oversight. In response to
Newsday's inquiries, he said panelists' pharmaceutical
company relationships will be posted on the National
Heart, Lung and Blood Institute's Web site within the
next few days.
Such financial links to drug companies were printed in
the Journal of the American Medical Association when the
original guidelines were published three years ago. Many
of the same panelists returned to produce this week's
amendments to the rules, which were published in the
journal Circulation, a publication of the American Heart
Association."We now understand, in the current climate,
it is wise to make that information [researchers'
financial connections] as transparent as possible,"
Cleeman said. " ... There is certainly no intent to
obscure information."
Cardiologists expressed no doubts about the quality of
the research leading to the updated guidelines. But
observers say the public deserves to have as much
information as possible about panelists who are making
such sweeping regulations. The guidelines also could
serve to improve the bottom line of major corporations.
"It should have been there," said Dr. Steven Nissen, a
cardiovascular researcher at the Cleveland Clinic in
Ohio,referring to financial disclosure information. He
added that "it is hard to work in the lipid field and not
have gotten a grant from a pharmaceutical company.
"Certainly if it were me, I would have disclosed it. But
it is important to point out that these are reputable
people," Nissen said of the panelists. "They are leaders
in the field, people of integrity." Nissen's research
helped influence the new guidelines.
An estimated 36 million people in the United States are
already on statin therapy, drugs that earn pharmaceutical
companies $20 billion a year. The new rules by the
Cholesterol Education Program essentially establish a new
standard of care for people with the worst forms of
cardiovascular disease.
The National Cholesterol Education Program is entirely
government-funded, Cleeman said, and operates on a budget
of about $1 million a year. The program does not receive
any money from pharmaceutical companies, he said.
The program invites outside experts to serve as panelists
and to review scientific data that will be considered for
treatment guidelines. The information is further vetted
by 90 to 100 outside experts, including heart specialists
from the American College of Cardiology and the American
Heart Association.
"There are multiple layers of review," Cleeman said.
Dr. H. Bryan Brewer, a physician-scientist at the
National Heart, Lung and Blood Institute, was one of the
guidelines' authors. He was the subject of a letter to
the director of the National Institutes of Health last
week from a consumer watchdog, Public Citizen's Health
Research Group. The advocacy organization charged that
Brewer had failed to disclose his ties to AstraZeneca.
Brewer, according to the letter, had written a glowing
report in a medical journal about Crestor without
disclosing that he is a paid consultant and had presided
over a company-sponsored symposium.
Dr. Sidney Wolfe, director of watchdog group, said he
wrote the letter because NIH officials -- and the public
-- should be aware of potential conflicts of interest.
"The public has a right to know every amount," Wolfe said
Wednesday.
Panelist Dr. Sidney Smith of the American Heart
Association said in an interview that he has received
consulting fees from Merck. But he said he was only
peripherally involved in the enrollment of patients in a
Merck-supported clinical trial about a year ago.
"One of the problems we have is that 80 to 90 percent of
the evidence from clinical trials comes from the need of
drug companies to get new drugs to market," he said. The
Institute of Medicine -- panels convened by Congress to
investigate urgent issues in health care -- has suggested
a different approach to funding such research, he said.
Those suggestions include the allocation of "$17 billion
from the government to get evidence from treatment
studies and not have to depend on drug company money."
The failure to disclose financial information comes on
the heels of investigations by both the NIH and Food and
Drug Administration to root out any conflicts of interest
among staff scientists involved in outside consulting.
The guidelines published by the panel called for lowering
cholesterol to the lowest possible levels. For the
sickest patients, that means a low-density lipoprotein --
LDL -- of 70 mg. or below. Doctors never before have been
asked to reduce patients' cholesterol to such a level,
though the trend toward lower numbers had become evident
in scientific studies in recent years.
"The guidelines are somewhat conservative and not that
favorable to industry," Nissen said. He added that the
guidelines should not be construed as a "a pro-industry
document. There's a lot of information in the document
[calling for] lifestyle changes," too.
End of forwarded message from anon@mouse.com
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household.
- Matthew 10:34-36.
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