Although the statin Lipitor has been on the market since 1996, it wasn't approved for the prevention of heart attacks until 2004.
The FDA approved it for this because the ASCOT study showed that there was a reduction in heart attacks overall for the approximately 10,000 patients in that study. However, the FDA looked at this study as a whole, rather than looking at the different types of patients in the study.
In fact, the women in that study who had no prior history of heart disease who took Lipitor actually had 10% more heart attacks than the 1,000 women taking a placebo.
Despite the fact that the FDA approved Lipitor for prevention of heart attacks, there is still no reliable medical evidence that Lipitor or any other statin is effective at preventing heart attacks for women and people over 65, who have no history of heart disease.
Health Care For All, a PAL coalition member, and other plaintiffs have filed a nationwide class action lawsuit in US District Court for the District of Massachusetts against Pfizer. The suit alleges that Pfizer engaged in a massive deceptive advertising campaign to convince women and individuals over the age of 65, who do not have a prior history of heart disease or diabetes, that lowering cholesterol by using Lipitor will reduce the risk of heart disease.
The lawsuit alleges that Pfizer engaged in fraudulent and deceptive practices in its marketing of Lipitor and violated various state consumer protection statutes. The suit seeks monetary recovery for the consumers and payors described below, as well as an order enjoining Pfizer from continuing its allegedly unlawful promotion of Lipitor.
Source: Prescription Access
2 comments:
I'm director of Prescription Access Litigation, and a regular reader of Pharma Gossip. I was very pleased to see an entry about this lawsuit brought by our members. We think the tactics we allege in this lawsuit regarding Lipitor are all too typical today. Drug companies today are more interested in marketing expensive drugs of questionable worth to large groups of people who may or may not need them than in researching genuinely beneficial new drugs.
PAL also hosts the annual Bitter Pill Awards, in which we give out "awards" for the most deceptive or ridiculous pharmaceutical campaigns of the past year. This year's awards are at the end of April. Nominations are open, so visit the Awards website and nominate your favorite/least favorite drug, campaign, or company.
For more info on the Lipitor suit, go to http://www.prescriptionaccess.org/index.php?base_id=407. To learn about our many other cases challenging illegal drug industry behavior, go to prescriptionaccess.org and click on "Current Cases."
A fan! :-)Thanks for this.
I would appreciate your thoughts on the comment posted on the previous blog entry (The best clinical data money can buy).
Please email to: pharmagossip@hotmail.co.uk if you would prefer to reply in private.
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