Groups Blast New Cholesterol Guidelines

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Groups Blast New Cholesterol Guidelines

Provided by Associated Press on 7/16/2004

by LINDA A. JOHNSON Associated Press Writer

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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.

 

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