The Center for Science in the Public Interest and a cohort of researchers are calling for an independent re-evaluation of the scientific data used by NIH's National Cholesterol Education Program to justify lowering the threshold for statin therapy.

A point-by-point analysis of why NCEP's recent recommendations are flawed is set forth in a Sept. 23 petition submitted to NIH, the National Heart, Lung & Blood Institute and NCEP leadership. Copies of the letter also were sent to the American Heart Association, the American College of Cardiology and several members of Congress.

NCEP's update to its 2001 Adult Treatment Panel (ATP) III report was published in Circulation in July. The report recommends that moderately high-risk patients use drug therapy to achieve LDL cholesterol levels of under 100 mg/dL, as opposed to the 130 mg/dL threshold advised in the group's 2001 report (¹ Also see "Mevacor OTC Study Shows High-Risk Users Will “Upstream,” Merck Says" - Pink Sheet, 19 July, 2004., p. 5).

To reach the new conclusion, NCEP's nine panel members reviewed five major clinical trials on statin therapy that have been published since 2001.

CSPI and 34 researchers from various institutions nationwide ask NCEP "to create an independent review panel free of conflicts of interest to review all the data in the five studies that led to this recent update." The new panel "should also review the studies that led to the original guidelines. If warranted, it should issue revised conclusions," the petition states.

An independent panel is needed in part because of the NCEP panel's ties to the drug industry, according to CSPI et al. The initial report "failed to disclose that eight of its nine authors have financial relationships with drug companies...[that] certainly could affect authors' judgment and undermine public confidence in the report," the petitioners claim.

In a Sept. 24 release, CSPI identifies Pfizer, Merck, Bristol-Myers Squibb and AstraZeneca as companies to which some panel members have relationships.

In addition to questioning financial ties to the studies, the letter points to weaknesses in the research cited in both the 2004 update and original 2001 report, maintaining that several studies do not support expanding the population size of statin users.

Addressing the 2001 report's assertion that statins reduce the risk of heart disease in moderately high-risk women under the age of 65, the petitioners contend that "not one" of the six studies cited at the time "provide significant evidence" in support of the claim.

Further, "among the five new studies, only ASCOT specifically addresses the benefit of statin therapy in women with multiple risk factors and no history of heart disease," the authors assert.

In ASCOT, "the women treated with atorvastatin [Pfizer's Lipitor ] developed 10% more heart disease (not significant) than the women in the control group," the petition notes. Thus, "there is still no significant evidence from the 'gold standard' of medical research, large randomized clinical trials, showing that women who do not already have heart disease benefit from taking a statin drug."

CSPI et al. also point to the drawbacks of the ALLHAT study, which placed about three times as many patients on statin therapy as in the control group.

"The results show that tripling the number of people taking statins (virtually in accord with the 2001 NCEP recommendations) provides no additional benefit," the petitioners say. "The only group that derived any significant benefit from more statins was African-Americans, who had fewer episodes of heart disease, but not fewer deaths."

ALLHAT "suggests that treating an additional 25-30 million Americans with statins as suggested by the 2001 and latest NCEP recommendations will provide little, if any, benefit," CSPI et al. say. "This evidence certainly does not justify adding tens of billions of dollars to our annual health care expenditures."

Finally, the consumer group maintains that evidence showing statins can be helpful for primary prevention of heart disease in diabetics is "mixed."

The updated NCEP report cites the Heart Protection Study's finding that statins significantly reduced the risk of heart disease in diabetic patients. However, "this ignores the three other studies under review that found that statins did not provide significant benefit to people with diabetes," CSPI et al. maintain.

NCEP Statin Recommendations Challenged By CSPI, Researchers

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