Experts in epidemiology and law claim that the advertising of atorvastatin failed to disclose the absence of benefits for women who should not be entitled to compensation for their losses as a result.
Theodore Eisenberg and Martin Wells, both of Cornell University, argue that unqualified claims of protection against heart attacks for the lipid lowering drug atorvastatin (made by Pfizer and sold as Lipitor) may be misleading and that this also brings into question the way in which the Food and Drug Administration (FDA) regulates drugs. They suggest that claim that a substantial portion of the multibillion dollar market in statins may be made up of users for whom the drugs offer no benefit.
An underlying study of atorvastatin specifically reported no effect in women, which Pfizer did not disclose in its advertising of the drug - according to Eisenberg and Wells. The advertising claims a clinical benefit in reducing the incidence of heart disease with no mention of gender differences. The key clinical trial of the drug found a moderately raised risk of heart disease in women.
In a statement responding to the article Pfizer said, "Statins have been called one of the most notable triumphs in modern medicine. The statin class has extensive data supporting a reduction in CV [cardiovascular] risk burden and Lipitor's ability to reduce cardiovascular morbidity and mortality has been demonstrated in 12 CV outcomes trials.
"Cardiovascular disease is a major cause of death in women as well as men and it ultimately kills as many women as men. However, onset of disease is delayed by some 10-15 years in women compared to men; thus the National Institutes for Health (NIH) ATP III guidelines define age as a risk factor in women at age 55, compared to age 45 for men. In addition, the AHA CVD Guidelines for Women were updated in 2007 and recommend that healthcare professionals should focus on women's lifetime heart disease risk, not just short-term risk."
Atorvastatin is the world's best selling drug, with more than $12 billion in annual sales.
