Cholesterol Recommendations Questioned


CSPI, Doctors Want Independent Review of Research on Statins

September 23, 2004

In July, the National Institute of Health’s National Cholesterol Education Program (NCEP) urged millions more Americans to consider taking statin drugs to reduce their risk of heart disease. But after reviewing the five studies behind the new recommendations, more than three dozen physicians, epidemiologists, and other scientists, together with the Center for Science in the Public Interest (CSPI), today raised serious questions about whether the guidelines are supported by the scientific evidence. The researchers are urging the National Institute of Health (NIH) to seek an independent panel to re-review the studies.

The new, lower thresholds for considering cholesterol-lowering drugs apply to people with LDL (or “bad”) cholesterol levels between 100 and 129. People who already have heart disease but have relatively low LDL levels between 70 and 100 should similarly consider taking statins, according to the NCEP. Lower thresholds were also proposed for millions of women and elderly people at moderately high risk of heart disease, as well as for diabetics.

But in a letter to the heads of the National Institutes of Health, the National Heart, Lung, and Blood Institute and the NCEP, the physicians and scientists urge an independent review of the scientific studies behind the new recommendations. “There is strong evidence to suggest that an objective, independent re-evaluation of the scientific evidence from the five new studies of statin therapy would lead to different conclusions than those presented by the current NCEP,” the scientists wrote.

“The studies cited do not demonstrate that statins benefit women of any age or men over 70 who do not already have heart disease,” said John Abramson, a clinical instructor in primary care at the Harvard Medical School. “Furthermore, we are concerned about the findings from one of the five cited studies showing that statin therapy significantly increases the risk of cancer in the elderly.”

Eight of the nine authors of the July recommendations have financial ties to statin manufacturers, including Pfizer, Merck, Bristol-Myers Squibb, and AstraZeneca—a fact that was not disclosed when the recommendations were first published in the journal Circulation. Merrill Goozner, director of the Integrity in Science project at CSPI, says that those conflicts of interest alone are enough to warrant skepticism of the NCEP findings.

“When researchers have financial relationships with drug companies, that raises red flags. When those relationships are concealed, alarm bells start going off,” said Goozner. “Drug companies want to sell more drugs and they fund studies to further that goal. That’s why it is critical that scientists who review industry-funded studies and write clinical practice guidelines on behalf of the government be completely free of conflicts of interest.”

The petition to NIH states that the authors of the July NCEP report ignored aspects of the studies that suggested that the new guidelines should not be applied to all segments of the public. For instance:

  • None of the new studies provided significant evidence that women without heart disease benefitted from statins at the new levels;
  • The one study that looked at elderly patients over 70 did not show a significant reduction in heart disease deaths, but it did show a statistically significant increase in cancer deaths. The authors of the NCEP report dismissed the finding by combining the cancer data with data from other studies that included much younger patients;
  • Three of the four studies of diabetics showed no significant benefit from increased statin use. In making its recommendations for diabetics, the new report made no effort to compare the results of these statin studies to the far greater reductions in heart disease that could be achieved through changing diabetics’ lifestyles.

The scientists in their letter to NIH pointed out the great benefits of lifestyle changes on health—something that only received passing reference in the NCEP report. According to CSPI, media coverage of the report largely ignored the lifestyle and diet recommendations or placed them near the ends of their stories.

“The sad fact is that these lifestyle recommendations are being largely ignored, partly because the ‘experts,’ many of whom have conflicts of interest through their relationships with statin manufacturers, focus ever more attention on lowering cholesterol with expensive drugs,” the letter stated. “The vast majority of heart disease can be prevented by adopting healthy habits. The American people are poorly served when government-sanctioned clinical recommendations, uncritically amplified by the media, misdirect attention and resources to expensive medical therapies that may not be scientifically justified.”

Among the signatories on the CSPI letter are R. James Barnard, Ph.D., from the University of California, Los Angeles; cardiologist David L. Brown, MD from Albert Einstein College of Medicine and the Beth Israel Medical Center; Christopher Gardner, Ph.D., from Stanford University; and Philip R. Lee, MD, from Stanford University.

 

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