Thursday, July 15, 2004

Panel's ties to drugmakers not cited in new cholesterol guidelines


July 15, 2004

Guidelines published by a government panel earlier this week, calling for aggressive use of statin medications to lower cholesterol in people at high risk of heart attacks, failed to list panelists' links to pharmaceutical companies, many of which manufacture statin drugs.

Of the nine panelists, six had received grants or consulting or speakers' fees from companies that produce some of the most popular statin medications on the market, according to published material from 2001. Those drugs include Pfizer's Lipitor; Bristol-Myers Squibb's Pravachol, Merck's Lovastatin and AstraZeneca's Crestor.

Dr. James Cleeman, coordinator of the national Cholesterol Education Program, a division of the National Heart, Lung and Blood Institute, called the omission of financial disclosures an oversight. In response to Newsday's inquiries, he said panelists' pharmaceutical company relationships will be posted on the National Heart, Lung and Blood Institute's Web site within the next few days.

Such financial links to drug companies were printed in the Journal of the American Medical Association when the original guidelines were published three years ago. Many of the same panelists returned to produce this week's amendments to the rules, which were published in the journal Circulation, a publication of the American Heart Association."We now understand, in the current climate, it is wise to make that information [researchers' financial connections] as transparent as possible," Cleeman said. " ... There is certainly no intent to obscure information."

Cardiologists expressed no doubts about the quality of the research leading to the updated guidelines. But observers say the public deserves to have as much information as possible about panelists who are making such sweeping regulations. The guidelines also could serve to improve the bottom line of major corporations.

"It should have been there," said Dr. Steven Nissen, a cardiovascular researcher at the Cleveland Clinic in Ohio,referring to financial disclosure information. He added that "it is hard to work in the lipid field and not have gotten a grant from a pharmaceutical company.

"Certainly if it were me, I would have disclosed it. But it is important to point out that these are reputable people," Nissen said of the panelists. "They are leaders in the field, people of integrity." Nissen's research helped influence the new guidelines.

An estimated 36 million people in the United States are already on statin therapy, drugs that earn pharmaceutical companies $20 billion a year. The new rules by the Cholesterol Education Program essentially establish a new standard of care for people with the worst forms of cardiovascular disease.

The National Cholesterol Education Program is entirely government-funded, Cleeman said, and operates on a budget of about $1 million a year. The program does not receive any money from pharmaceutical companies, he said.

The program invites outside experts to serve as panelists and to review scientific data that will be considered for treatment guidelines. The information is further vetted by 90 to 100 outside experts, including heart specialists from the American College of Cardiology and the American Heart Association.

"There are multiple layers of review," Cleeman said.

Dr. H. Bryan Brewer, a physician-scientist at the National Heart, Lung and Blood Institute, was one of the guidelines' authors. He was the subject of a letter to the director of the National Institutes of Health last week from a consumer watchdog, Public Citizen's Health Research Group. The advocacy organization charged that Brewer had failed to disclose his ties to AstraZeneca. Brewer, according to the letter, had written a glowing report in a medical journal about Crestor without disclosing that he is a paid consultant and had presided over a company-sponsored symposium.

Dr. Sidney Wolfe, director of watchdog group, said he wrote the letter because NIH officials -- and the public -- should be aware of potential conflicts of interest.

"The public has a right to know every amount," Wolfe said Wednesday.

Panelist Dr. Sidney Smith of the American Heart Association said in an interview that he has received consulting fees from Merck. But he said he was only peripherally involved in the enrollment of patients in a Merck-supported clinical trial about a year ago.

"One of the problems we have is that 80 to 90 percent of the evidence from clinical trials comes from the need of drug companies to get new drugs to market," he said. The Institute of Medicine -- panels convened by Congress to investigate urgent issues in health care -- has suggested a different approach to funding such research, he said. Those suggestions include the allocation of "$17 billion from the government to get evidence from treatment studies and not have to depend on drug company money."

The failure to disclose financial information comes on the heels of investigations by both the NIH and Food and Drug Administration to root out any conflicts of interest among staff scientists involved in outside consulting.

The guidelines published by the panel called for lowering cholesterol to the lowest possible levels. For the sickest patients, that means a low-density lipoprotein -- LDL -- of 70 mg. or below. Doctors never before have been asked to reduce patients' cholesterol to such a level, though the trend toward lower numbers had become evident in scientific studies in recent years.

"The guidelines are somewhat conservative and not that favorable to industry," Nissen said. He added that the guidelines should not be construed as a "a pro-industry document. There's a lot of information in the document [calling for] lifestyle changes," too.

July 14, 2004

"If John Kerry wins the presidency, his household will be the richest ever to occupy the White House. Kerry's wife, Teresa Heinz Kerry, controls a vast fortune estimated by a Los Angeles Times study to fall somewhere between $900 million to $3.2 billion. Through a series of entirely legal maneuvers, Kerry is attempting to conceal from American voters the full extent of his wife's wealth and her corporate holdings -- and the fact that she apparently manages to pay a remarkably small amount of taxes.

Such evidence as one is able to assemble from publicly available information raises deeply disturbing questions. The Kerry campaign has disclosed Mrs. Kerry's 2003 income as $5,115,000. Using a conservative estimate of her wealth at $1 billion -- at the low end of the Los Angeles Times' estimates -- then we can easily see that her investments yielded only a miniscule one half of one percent last year.

In 2003 even Treasury bills yielded twice that much. Dividends on the S&P 500 yielded three times that much. Long-term Treasury bonds yielded eight times that much. If Mrs. Kerry's investment income really was only one half of one percent, then she is perhaps the world's worst investor. Or if her income is in fact greater, and she has found some way to minimize it for tax purposes, then Mrs. Kerry may be the world's greatest cheat.

Let's put this in terms that people of less extreme wealth can relate to. If you had $100,000 invested last year and your investment income was only $500 -- the same percentage as Mrs. Kerry's income -- then something would be very much out of whack.

Perhaps much of Mrs. Kerry's wealth is held in various types of trusts, the income of which is not reported on her personal tax returns. But if that's "

Tuesday, July 06, 2004

Madeleine Brindley, The Western Mail
July 5 2004

THE health of people in Wales is being put at risk by official policies which discourage sunbathing and promotes the use of sun block, a report today claims.
The Health Research Forum report has said that Government policy on sunlight is based on a major error, mistaken assumptions and wishful thinking.
It claims that the cost of disease caused by insufficient exposure to sunlight and a deficiency in vitamin D is estimated to be billions of pounds a year in Britain.
A lack of vitamin D is thought to be associated with, or a cause of a number of chronic diseases, 16 different types of cancer and several nervous system disorders, the report said.
And it claims the Government advice to cover up, keep in the shade and use sun tan lotion with a sun protection factor of 15 or above, is based on outdated information, mistaken interpretation of evidence and guesswork.
It appears to contradict current thinking about sun exposure and the summer sun campaigns which encourage people to limit their time in the sun and to avoid the risk of burning.
The report, Sunlight Robbery, written by Oliver Gillie, a former Sunday Times medical correspondent and the ex-medical editor of the Independent, claims that the major error in Government policy is the notion that short periods outdoors produce sufficient levels of vitamin D in the body.
The report says these claims by the National Radiological Protection Board (NRPB) are based on the observations of only nine patients in England over one summer - seven of whom did"

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