Healthy Skepticism Library item: 17242

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Edwards J
Pfizer's Pyramid of Doom, Or How the Drugmaker Oversold the Market for Cholesterol Drugs by 28 Million Americans
BNet 2010 Feb 16
http://industry.bnet.com/pharma/10006721/pfizers-pyramid-of-doom-how-the-drugmaker-overstated-the-market-for-cholesterol-drugs-by-28-million-americans/

Notes:

See BNet site for diagrams and charts.

Full text:

This, according to a whistleblower lawsuit, is Pfizer’s Pyramid of Cholesterol Doom: a diagram that allegedly shows the company believed 64 million Americans could use treatment with the company’s cholesterol drug, Lipitor:

The problem? According to guidelines from the National Cholesterol Education Program, only about 36.6 million people actually need a cholesterol drug. The rest should change simply their diets and exercise more, the suit claims. The diagram, which is not part of the complaint, was leaked to BNET by a source.

Pfizer presented this diagram to analysts on June 17, 2003, the suit claims, along with this text:

Pfizer estimates that while 64 million Americans have elevated cholesterol, only around one third are treated. Lipitor’s established and growing safety and efficacy record make it a first choice for new patient treatment.

The suit, filed by a former Pfizer executive who claims the drug was promoted unlawfully, alleges that the only way Pfizer could believe that 64 million Americans would be eligible candidates for Lipitor is if it also knew that the drug was going to be promoted for unapproved, “off-label” use to patients who would not normally qualify under the approved uses for the drug.

Pfizer has opposed the suit and had the case dismissed at least once. Lipitor is the best-selling drug on the planet with annual revenues of more than $12 billion.

The suit gives this description of the NCEP guidelines, which, it alleges, form the basis of government diagnostic policy for cholesterol drugs:

According to NCEP, there are 101.8 million adults who could benefit from therapeutic lifestyle changes alone or combined lifestyle changes and drug therapy.
Of that number, 36.6 million require drug treatment because their LDL levels exceed the Guideline cutpoints for commencing statin therapy.
The remaining 65.2 million Americans need TLC, not drug therapy.
There are 17.4 million Americans in the Moderate Risk category. Of that group, 14.6 million people (84 percent) need only therapeutic lifestyle changes.
Drug therapy and therapeutic lifestyle changes are recommended for the remaining 2.8 million.
Pfizer once went along with this, the suit claims:

Pfizer’s own Operating Plan for 2002, discussed infra, stated unequivocally that only 36 million Americans are “Eligible for a Cholesterol-lowering Drug.”

The gap of 28 million Americans (the difference between the 64 million to whom Pfizer unlawfully markets and the 36 million Pfizer believes are eligible for statin use) represents a pool of patients who do not meet either Lipitor’s label or the Guidelines, and toward whom marketing of Lipitor would be off-label and unlawful.

But in the 2003 meeting, Karen Katen, Pfizer’s former president, allegedly showed the “Platform for Growth” slide, showing 64 million Americans as targets. The suit says:

Ms. Katen stated that Pfizer would take advantage of this opportunity for growth through a combination of educational and promotional activity. …

The gap of 28 million Americans (the difference between the 64 million to whom Pfizer unlawfully markets and the 36 million Pfizer believes are eligible for statin use) represents a pool of patients who do not meet either Lipitor’s label or the Guidelines, and toward whom marketing of Lipitor would be off-label and unlawful.