Groups blast new cholesterol guidelines over conflict of interest
LINDA A. JOHNSON, Associated Press Writer
Friday, July 16, 2004
(07-16) 17:17 PDT 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. All but one 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, said Cleeman, who was the only author without financial ties.
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.
According to information posted Friday on the heart institute's Web site, eight of the nine authors have received money from cholesterol drug makers, including Pfizer Inc., Merck & Co., Bristol-Myers Squibb and AstraZeneca LP.
Newsday first reported on the financial ties Thursday.
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.