Comments on: Lipitor Ads and Women: Grounds For A Lawsuit

By: Ben Evenson

Ben Evenson — Fri, 24 Apr 2009 15:55:31 +0000

This is for my mother, Dorothy A Evenson she is 80 years young, and I am her care giver. Thank You for any help. Ben Evenson

By: Dianne

Dianne — Tue, 23 Sep 2008 13:54:54 +0000

“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

By: Scott Lawrence

Scott Lawrence — Tue, 23 Sep 2008 13:11:45 +0000

Are these professional or DTC ads?

By: Ed Silverman

Ed Silverman — Tue, 23 Sep 2008 12:58:36 +0000

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

By: Theodore Eisenberg

Theodore Eisenberg — Tue, 23 Sep 2008 12:39:54 +0000

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.

By: laurie

laurie — Tue, 23 Sep 2008 11:33:02 +0000

“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?

By: Jaynesday

Jaynesday — Tue, 23 Sep 2008 01:28:11 +0000

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.

By: Meg

Meg — Mon, 22 Sep 2008 20:25:48 +0000

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.

By: Marilyn Mann

Marilyn Mann — Mon, 22 Sep 2008 17:09:55 +0000

I don’t know what clinical trial they are referring to.

By: Justice in MI

Justice in MI — Mon, 22 Sep 2008 14:41:51 +0000

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?