Tom Curb, R.Ph.

During the past few days, the national media has published health-related reports that will legitimately compound the American public’s questioning of the objectiveness, consistency and veracity of both private and governmental researchers, their studies, and their recommendations.

First, it was reported: "The government is looking at replacing the Food-Guide Pyramid it uses to guide Americans' eating habits..." In addition to seeking ideas from the food industry, health and consumer groups and the public, the department has hired a research firm to help develop new food guideline illustrations.

"That's a good approach", said Susan Borra, executive vice president of the International Food Information Council, a communications organization supported by the food and beverage industry. (This "food-industry kudo" alone might raise doubts about the honesty of any government recommendations. Some detractors of the current, decades-old pyramid claim that it was designed to benefit influential elements of the food industry – not consumers. These doubters’ beliefs may be justified, since Agriculture Department officials also report that, "While 80% of the nation recognizes the pyramid, two-thirds are overweight or obese," and there is an undeniable dietary-related epidemic of obesity and early-onset, type-2 diabetes in the U.S.

Concurrently, it was reported in the journal Circulation: "…federal health officials yesterday sharply reduced the desired levels of harmful cholesterol (LDL) for Americans who are at moderate to high risk for heart disease." It went on that "…according to the National Cholesterol Education Program of the National Institutes of Health (which sets federal standards for preventing cardiovascular disease), people at high risk for heart attack or stroke should explore with their doctor the option of taking higher doses of cholesterol-lowering drugs to cut their level of "bad" cholesterol below current targets."

These latest recommendations, which further lower guidelines set by the government only two and a half years ago*, now call for treatment with cholesterol-lowering drugs for millions of Americans who had thought their cholesterol levels were fine. The newer guidelines increase by millions the number of Americans who (will now) meet the criteria for therapy with the powerful cholesterol-reducing drugs called statins, and many people who are already taking the medications will be advised to increase their doses. "About 36 million people in this country should be taking statins(under the old guidelines)," said Dr. James Cleeman, coordinator of the National Cholesterol Education Program "but only about half that number do." Dr. Cleeman was further quoted as saying, "…while the Program’s (latest) advice (with respect to severe reductions of "bad cholesterol) was suggested by recent clinical trials, the term, ‘therapeutic option,’ was used because the evidence was not quite ironclad."

To accommodate this new government recommendation, many patients will require higher doses of statins such as Lipitor and Zocor - already the pharmaceutical industry's most prescribed (and most costly) class of medicines. (It goes without saying that manufacturers of statins endorse the government recommendations. In general, standard "basic" doses of statins (may) reduce LDL by 30% to 40%, but for each doubling of the dose, LDL typically goes down (only) another 6%. This means that, along with millions of "new" statin consumers that this new government recommendation will generate, existing statin-patients may require at least "double doses"- thus producing a minimum additional 45% to 75% in revenue for statin manufacturers.)

Despite the article’s claims that statins are "widely viewed as very safe", higher doses can increase the risk of such side effects as liver problems and muscle pain. In fact, high doses of one statin, Baycol, taken in an attempt to reach just the existing, higher-LDL criteria caused serious injury and death, and it was removed from the market. Combining statins with other cholesterol drugs to get even more potency or perhaps to reduce side effects from high dosages would also add to the cost of therapy. (Maybe it is just a coincidence that a pill that combines Zocor and Zetia is awaiting approval at the Food and Drug Administration. This "pill" is a product from Merck, a manufacturer that along with fellow statin producers Pfizer, Astra-Zeneca, and Bristol-Myers-Squibb is one of the largest and most politically-influential drug manufacturers.)

Then, to add to consumers’ questions about credibility of "studies", USA TODAY reported that "some leading scientific and medical journals do not always enforce their conflict of interest policies with the authors of published studies." The Center for Science in the Public Interest found that in some cases the journals did not disclose contributing authors' financial conflicts of interest… Along the same line, The Washington Post reported that "most heart disease researchers receive at least some funding from drug companies - but (the researchers) maintain that their work is not influenced by such connections."

The CSPI findings come amid growing concern over the influence that private industry has on scientific research. CSPI researchers found hidden conflicts in what were called "the margins," in which there was no direct link, but the researcher stood to benefit from the same industry. (One author of a study on heart disease, for instance, failed to reveal relationships with 20 companies that made cardiovascular drugs or devices, and nine of the ten standard-setting members of the NIH’s Cholesterol Education Program are reported as receiving money from statin producers.)

Concerns were further raised by the Wall Street Journal: "At a time when corporate influence on medical research has come under growing scrutiny, the study by the Washington, D.C., consumer group (CSPI) questions the effectiveness of such journals' efforts to require researchers to disclose relationships with pharmaceutical concerns and medical-device makers," also…

Marcia Angell, former editor in chief of the New England Journal of Medicine, said the results of the (CSPI) study "should concern all of us a lot because there is plenty of evidence now that the medical literature is seriously biased in all sorts of ways." The growing corporate funding of medical research has heightened concerns about the potential skewing of research.**