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Pharmaceutical Fraud and corruption: STATIN RECOMMENDERS' DRUGMAKER TIES

U.S. confirms panel link


July 20, 2004

Eight of the nine members of the government panel that last week published new treatment guidelines calling for a wider use of statin drugs had ties to companies that manufacture the medications, a government Web site revealed yesterday.

Newsday reported Thursday that at least six were linked to drug companies based on information available at that time.

The ties range from single honoraria as consulting or speakers fees to major research grants. The information was posted on the Web site of the National Heart, Lung and Blood Institute, following inquiries by Newsday last week.

Posting of the list follows publication last week of the institute's National Cholesterol Education Program's update to its 2001 guidelines. The guidelines were based on five studies published since 2001, which found "lower is better" for people with high cholesterol and additional risk factors that render them vulnerable to heart attack and sudden death. The guidelines were published in the journal Circulation.

If practicing physicians follow the recommendations - and it is expected that they will - about 7 million more people in the United States may soon be taking statin drugs, which lower low-density lipoproteins in the blood by controlling their production in the liver.

In the past, disclosure information has appeared in journals that published the guidelines, Dr. Barbara Alving, acting director of the National Heart, Lung and Blood Institute said yesterday. As a result of inquiries about the absence of such information, she said the policy has now changed.

"What we are also going to do to ensure that there is disclosure is to put that information on our Web site and in our own printed material," she said of government documents involving outside panelists.

"I would say that the top people who participate in [producing the] guidelines and who are throughout the academic medical centers also work with pharmaceutical companies. And if we have individuals who have no ties to pharmaceutical companies then these individuals are probably not the experts in the field," Alving said.

Information disclosed yesterday on panelists' associations with drugmakers did not include specific dollar amounts.

Maryann Napoli, assistant director the Center for Medical Consumers in Manhattan, an advocacy group, said if the institute had not been coaxed, panelists' associations to pharmaceutical companies probably would not have been made public.

"How can we trust guidelines that are promulgated by people with such strong links to these drug companies? I am really concerned that the National Cholesterol Education Program had to be prodded into putting this information on their Web site," Napoli said.

The full list is on the Institute's Web site at: