Lipitor Ads and Women: Grounds For A Lawsuit
9 CommentsBy Ed Silverman // September 22nd, 2008 // 10:24 am
A review of existing studies of statins was unable to find clinical evidence indicating the drugs - and in particular, Pfizer’s Lipitor - reduced the risk of heart attacks for women, even though huge sums are spent each year to lower cholesterol in women, according to the meta-analysis published in the Journal of Empirical Legal Studies.
Moreover, the review found Lipitor ads fail to report clinical trials were statistically significant for men, and results were inconclusive for women - even though such info appears in product labeling. The FDA, therefore, failed to properly regulate Pfizer promotions, according to the authors, who say the misleading ads are a persuasive argument in favor of allowing state-court lawsuits against the drugmaker.
In short, Cornell Law School’s Ted Eisenberg and Marty Wells of Cornell University maintain the findings undermine the recent push by drugmakers and the FDA to support preemption - the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. The US Supreme Court reviews a case in November (here is background with many links).
“When studies consistently reveal uncertain efficacy for a group as large as women, a system that imposes no duty to further test, but allows continued marketing to millions of women, is insufficient. In the drug arena, as in other areas of tort law, it is too hopeful to expect ready detection of efforts to conceal or spin health information. Even an extremely well-functioning FDA would likely miss concerted efforts to hide or shade results. The actual functioning of the FDA may unintentionally promote concealment and spin,” write the authors, who were expert witnesses in Vioxx litigation.
“Beyond drug safety, state law causes of action also can contribute to proper incentives with respect to studies of drug efficacy…It is shameful that, while accumulating billions of dollars in profits from statins, no drug company has yet published a study adequately powered to test the efficacy of statins with respect to primary prevention of women’s cardiovascular outcomes.
“That the FDA felt powerless to require such studies, or felt that such studies were not needed, establishes that it should not be the sole force shaping this aspect of health-care policy. The economic costs of the questionable efficacy claims for statins may exceed the economic cost of their adverse side effects,” they conclude. “The flexibility of the common law and consumer protection laws can contribute to creating appropriate incentives for socially and economically beneficial behavior.”
We await a reply from Pfizer. A Pfizer spokeswoman writes us with this comment: “Pfizer has conducted several long-term CV outcomes studies to evaluate the impact of Lipitor. Although these studies evaluated a broad range of patient populations, they were not designed to specifically study women. Statistical analyses of the primary CV endpoint in each of these studies have demonstrated the treatment effect with Lipitor produced similar reductions in CV risk in women compared to men.
“Based primarily on the results of the ASCOT-LLA clinical trial, Lipitor is indicated to: Reduce the risk of heart attack, stroke, certain types of heart surgery and chest pain ‘in adult patients without clinically evident coronary heart disease (CHD), but with multiple risk factors for CHD such as age, smoking, hypertension, low HDL-C, or a family history of early CHD.’ This FDA-approved primary prevention indication is for ‘adult patients’ regardless of sex and without restrictions based on gender.
“Long-term Lipitor CV outcomes studies included primary CHD prevention studies (ASCOT LLA, CARDS, and SPARCL) and secondary CHD prevention studies (ALLIANCE, TNT, IDEAL, and PROVE-IT).”
Justice in MI
I have only read the abstract of the original study.
But it also includes this rather ominous sentence: “The legal analysis raises the quesstion of whether Lipitor’s advertisements, which omit that Lipitor’s clinical trial found slight _increased_ [emphasis in original] risk for women, is consistent with the FDCA and related FDA regulations.”
Comments?
Marilyn Mann
I don’t know what clinical trial they are referring to.
Meg
I read enough alternative publications on the danger of statins that I bailed out, after many years. Now I take vitamin C. I wouldn’t take statins if you paid me, and have made sure to tell all my friends, giving them the best articles to read.
Jaynesday
Quoting - Cornell Law School’s Ted Eisenberg and Marty Wells of Cornell University report -
“When studies consistently reveal uncertain efficacy for a group as large as women, a system that imposes no duty to further test, but allows continued marketing to millions of women, is insufficient. In the drug arena, as in other areas of tort law, it is too hopeful to expect ready detection of efforts to conceal or spin health information. Even an extremely well-functioning FDA would likely miss concerted efforts to hide or shade results. The actual functioning of the FDA may unintentionally promote concealment and spin,”
Pfizer’s reply –
Summarized - We did the studies and the drug is safe for everyone and by the way….
“This FDA-approved primary prevention indication is for ‘adult patients’ regardless of sex and without restrictions based on gender.”
Note the boldly played trump card.
laurie
“they were not designed to specifically study women.”
“these studies have demonstrated the treatment effect with Lipitor produced similar reductions in CV risk in women compared to men”
How does one reconcile these two statements?? They haven’t studied the specific gender group, but can say that the drug is effective for that specific gender group?
Theodore Eisenberg
The comment reported to have been made on this website by a Pfizer spokeswoman refers to three primary prevention Lipitor studies, ASCOT, CARDS, and SPARCL. In CARDS, all of the patients studied were, according to an article in Lancet, suffering from type 2 diabetes.
In SPARCL, all of the patients studied were, according to a New England Journal of Medicine article, victims of prior stroke or transient ischemic attack.
Only ASCOT included many subjects lacking prior history of diabetes or stroke-like events. And, in ASCOT, the risk of the primary endpoint for women was increased (albeit insignificantly), not decreased. This is not revealed in the Lipitor advertising I have seen. The absence of evidence of benefit in ASCOT is consistent with Pfizer’s CASHMERE trial, which found no significant effect on arterial thickening for postmenopausal women on Lipitor vs. placebo. CASHMERE, like ASCOT, and unlike CARDS and SPARCL, was not limited to subjects with serious prior cardiovascular problems. To my knowledge, the CASHMERE researchers have not published their results in an article, though the study was completed in July 2006. Results are available at clinicaltrials.gov.
For women with elevated cholesterol and no prior history of diabetes, stroke or TIA, the Lipitor primary prevention studies cited by the spokeswoman provide no evidence of a protective effect against the heart-related endpoint. To date, the ASCOT and CASHMERE studies provide a consistent picture of no beneficial effect on heart/artery endpoints.
The ASCOT and CASHMERE results are consistent with another Lipitor trial, BELLES. That study, of postmenopausal women, found no significant reduction in calcium volume score for women on high-dose Lipitor compared to a lower dose of another statin, though the absence of placebo precludes conclusions about the absolute effect of Lipitor in that study.
Ed Silverman
Dear Mr. Eisenberg,
Thanks much for joining the conversation and providing further insight into the Pfizer comments. Such input and dialogue is very much appreciated, especially when discussing newly published studies.
Regards,
ed s
Scott Lawrence
Are these professional or DTC ads?
Dianne
“In short, Cornell Law School’s Ted Eisenberg and Marty Wells of Cornell University maintain the findings undermine the recent push by drugmakers and the FDA to support preemption…”
Like “The Blob,” The FDA Preemption Monster is Coming!!!
Did you know
that there is a November 3 Supreme Court case, Levine v Wyeth, that will decide if you get to keep your right of “due proces of law” if you or a loved one are harmed or die from the use of a FDA-approved drug?
Welcome to the world of FDA Preemption,
Already available in Michigan and
Coming Soon to Your State!
Think about the devastating effects of Vioxx - Trasylol - Paxil - Rezulin - Baycol - Bextra - Zelnorm - Redux (Fen-Phen), etc, etc, etc … under this new law, there is no recourse, even though the manufacturer was aware of the dangers…
Contact your US Reps. and Sens. Today. Let them know you are Against FDA Preemption.
House: @ https://forms.house.gov/wyr/welcome.shtml.
Senate @ U.S. Senate: Senators Home
And, Please Sign this Petition http://www.ipetitions.com/petition/fdapreemptionbadmedicine/
More Information: http://www.pharmaccountability.org