July 15, 2004 -- Members of a government panel, which earlier t
July 15, 2004 -- Members of a government panel, which earlier this week recommended more aggressive use of statin medications for people at the highest risk of dying from heart disease, failed to disclose financial links to the companies that make the drugs, according to a story in the publication Newsday.
In a Thursday interview with WebMD, the official that oversaw the panel promised to post the financial disclosures on the National Heart, Lung, and Blood Institute's (NHLBI) web site next week. But James Cleeman, MD, strongly denies that any attempt was made to keep the public in the dark about the panelists' financial ties.
Financial information was included when the panel published its original guidelines in 2001, Cleeman says, so it did not seem necessary to include it again in the newly updated version. Cleeman is the coordinator of the NHLBI's National Cholesterol Education Program (NCEP).
"In our minds this was a non-issue because financial disclosure is available (for everyone on the panel)," he says. "However, in the current climate we understand that it is very desirable to have things as transparent as possible. So with that in mind, we are going to put this information on the NHLBI web site."
New AHA Policy
The flap also prompted the nation's leading heart organization to change its policy on financial disclosures. The updated guidelines were published in the July 13 issue of American Heart Association (AHA) journal Circulation, which has not required financial disclosures for guidelines published by outside organizations in the past.
But in a statement released late Thursday, the group vowed to publish online financial disclosures for all future guidelines included in the journal, whether they were developed by the AHA or not.
Consumer Group Weighs In
In the story published Thursday, Newsday reported that six of the nine panelists serving on the NCEP committee, which updated the guidelines, disclosed receiving grants or consulting fees from drug companies that make cholesterol-lowering drugs in the 2001 report.
One of the panelists, H. Brian Brewer, MD, of NHLBI was singled out last week in a letter sent to the director of the National Institutes of Health by Sidney Wolfe, MD, director of the consumer health activist group Public Citizen.
Wolfe has waged a very public battle against the cholesterol drug Crestor, marketed by pharmaceutical company AstraZeneca. The group charges that at least one person has died and dozens of others have been injured by the drug since its approval last summer.
In the letter, Wolfe charged that Brewer presented "incomplete and inaccurate" information about Crestor's safety in a paper paid for by AstraZeneca and published last year.
Wolfe tells WebMD it is clear that financial disclosure information should have been included in the updated cholesterol treatment guidelines.
"You have to include financial disclosures every time you publish," he says. "But an even bigger concern is the fact that people who have serious conflicts of interest are being allowed to serve on these panels. That didn't used to happen, but now it's very common."
'Too Much Spin'
The revised guidelines reduce target low-density lipoprotein (LDL), or "bad," cholesterol levels from 100 mg/dL to 70 mg/dL for those at very high risk of dying from heart attack or stroke. And it called for people at high risk to consider initiating drug therapy at a lower threshold.
The revisions were endorsed by the AHA and the American College of Cardiology, each of which had a representative on the panel. Cleeman points out that the changes were reviewed by the NCEP coordinating committee and steering bodies of the other two organizations.
"I would say that more than 90 people were involved in this review," he says. "Nobody is quarreling with the substance of the message. I hope the public will not be diverted from the importance of taking action to lower their LDL cholesterol by this."
But Curt Furberg, MD, who is a former head of clinical trials at NHLBI, said he is concerned about the amount of paid consulting being done by researchers who are supposed to have the public's best interest in mind.
"I don't think NHLBI has a good track record of disclosing conflict of interest," he tells WebMD.
"Many of these ties to drug companies are too close for comfort. There is just too much spin these days in the interpretation of research, and the spin has financial overtones."
