new cholesterol guidelines as being tainted by the influence of major pharmaceuticals
From: JWissmille (jwissmille_at_aol.com)
Date: 07/20/04
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Date: 20 Jul 2004 03:47:11 GMT
>From The Associated Press:
Jul 17, 5:56 AM EDT
Groups Blast New Cholesterol Guidelines
By LINDA A. JOHNSON
Associated Press Writer
TRENTON, N.J. (AP) -- Most of the heart disease experts who urged more people
to take cholesterol-lowering drugs this week have made money from the
companies selling those medicines.
Consumer groups on Friday blasted the new cholesterol guidelines as being
tainted by the influence of major pharmaceuticals that make blockbusters such
as
Lipitor and Pravachol. Last year, drug makers earned $26 billion worldwide on
cholesterol-lowering medicines, the top-selling class of drugs.
The new guidelines issued Monday by the American Heart Association and the
federal government were aimed at preventing heart attacks. They were written by
nine of the country's top cholesterol experts. At least six have received
consulting or speaking fees, research money or other support from makers of the
most widely used anti-cholesterol drugs.
The new guidelines would add about 7 million more Americans to the 36 million
already encouraged to take the pills to lower their cholesterol, according to
Dr. James Cleeman, coordinator of the National Cholesterol Education Program,
which drew up the guidelines. NCEP is run by the National Heart, Lung, and
Blood Institute.
Cleeman said that regardless of connections to the drug industry, the advice
to high-risk heart patients to lower their LDL, or "bad cholesterol," is sound
science. The new guidelines were based on results of five drug studies since
2001, and about 80 experts besides the authors reviewed and endorsed them,
Cleeman said.
But consumer advocates said the failure to make the conflicts of interest
clear is inexcusable.
"It's outrageous they didn't provide disclosure of the conflicts of
interest," said Merrill Goozner, with the Center for Science in the Public
Interest.
"It doesn't mean that their research is wrong," Goozner added, but doctors
and the public need to know "that the people who are giving you this advice
have
their research funded by a party who has a self interest in the outcome of
that research."
Coincidentally, Goozner's group on Monday released a study showing that at
least 24 of 164 studies it reviewed in four medical journals did not disclose
important conflicts of their authors.
Many studies of new and existing drugs are funded by their manufacturers, and
Goozner and other experts say studies showing the drugs did poorly rarely are
published. Last month, New York Attorney General Eliot Spitzer sued drugmaker
GlaxoSmithKline PLC, saying it committed fraud by withholding information
about the dangers of its antidepressant Paxil to children.
The American Medical Association then urged creation of a comprehensive,
government-run registry for all drug study results so unfavorable ones aren't
buried. Meanwhile, Merck and Bristol-Myers Squibb are quietly seeking federal
approval to sell low-dose, non-prescription versions of older cholesterol drugs
that already have generic competition.
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The heart institute posted information on industry ties of the new
guidelines' authors on its Web site Friday. Cleeman said all the authors except
him
"have some connection with industry."
Newsday first reported on the conflicts in Thursday's editions. They said six
authors had earned money specifically from cholesterol drug makers, including
Pfizer Inc., Merck & Co., Bristol-Myers Squibb and AstraZeneca LP.
Cleeman and Dr. Rose Marie Robertson, chief science officer of the heart
association, both said they felt financial disclosure was covered because most
of
the authors also worked on the last guideline update, in 2001, and made their
connections known then. Cleeman said information on the two new authors is
available from the organizations they represent, the heart association and the
American College of Cardiology.
Dr. Sidney Wolfe, co-founder of Public Citizen's Health Research Group, said
disclosure, even in a publication, is not adequate.
"These people should be disqualified from being the principal authors of
publications that have the imprimatur of the government on it," he said. He
noted
that side effects such as possible liver and muscle damage can make the drugs
more dangerous than beneficial to people who have only a moderate risk of
heart attack.
The updated guidelines say people with the greatest risk of heart attack,
more than a 20 percent risk in the next decade, should try to get their level
of
LDL, or bad cholesterol, below 70, instead of the current recommendation of
below 100. For people at high or moderately high risk of heart attack, the goal
should be to get the level below 100, instead of the current goal of below 130.
The risk level is determined by a calculation of risk factors, such as prior
heart attack or stroke, presence of heart disease or diabetes, family history,
high blood pressure and smoking. The guidelines also urge people to adapt a
healthier lifestyle, by getting more exercise, losing weight, quitting smoking
and other steps.
--- On the Net: http://www.nhlbi.nih.gov/guidelines/cholesterol/index.htm http://www.americanheart.org/ © 2004 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed. ** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. **
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