Healthy Skepticism Library item: 3902

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: news

Wilke J, Hensley S.
Pfizer Is Named in Lawsuit Over Marketing of Lipitor
The Wall Street Journal 2006 Mar 28
http://users2.wsj.com/lmda/do/checkLogin?mg=wsj-users2&url=http%3A%2F%2Fonline.wsj.com%2Fquotes%2Fmain.html%3Ftype%3Ddjn%26symbol%3Dpfe

Keywords:
Pfizer Lipitor

Notes:

Ralph Faggotter’s Comments:

‘Selling Sickness’ is the strategy of attempting to constantly widen the ‘needs-treatment’ net to catch as large a percentage of the population as possible into life-long daily tablet taking.

The pharmaceutical industry has been pursuing this financially rewarding approach on a broad front for a long time.

Consequently, the progress of this lawsuit wil be followed with great interest by both the pharmaceutical industry and the stockmarket.

Full text:

Pfizer Is Named in Lawsuit
Over Marketing of Lipitor
By JOHN R. WILKE and SCOTT HENSLEY
March 28, 2006; Page A3

Pressure is mounting on Pfizer Inc. for its marketing of the cholesterol drug Lipitor, the world’s best-selling prescription medication.

In a lawsuit filed late yesterday, a New Jersey employee-insurance fund alleged that Pfizer defrauded state and federal Medicaid programs and private insurers by marketing the drug to a broader population of patients than permitted under federal rules.

Separately, federal prosecutors in New York are reviewing this alleged off-label marketing because of the billions of dollars spent on Lipitor every year by Medicaid and the states, according to people in the industry contacted in the course of this inquiry.

The Justice Department hasn’t issued subpoenas in the matter, and it isn’t clear whether it will pursue a case against Pfizer, these people said. A spokesman for the U.S. attorney’s office in Brooklyn, N.Y., which has been looking into Pfizer’s marketing, declined to comment.

Federal officials, however, are taking a hard line on some off-label marketing. Susan Winkler, health-care fraud chief for the U.S. attorney in Boston, said at a recent conference that there would likely be more such prosecutions, and an increasing number of the government’s civil-fraud cases against drug makers also seek to recover Medicaid funds paid for unapproved uses.

The lawsuit, filed in federal court in Newark, N.J., alleges that Pfizer illegally sought to persuade doctors to prescribe an expensive, lifelong drug regimen to patients with only low to moderate heart-disease risk, in violation of its federally approved labeling. It seeks unspecified damages on behalf of insurers and alleges civil fraud and racketeering. It was filed by a Teamsters union health-insurance fund, and could be followed by an additional half-dozen such suits, seeking to represent all employee-health insurers.

A Pfizer spokesman said the company hadn’t been able to review the complaint and couldn’t comment on it. “Physicians and their patients should work together to determine the best individual approach to lowering and maintaining their cholesterol at the appropriate level,” he said.

The case spotlights the practice of off-label marketing of drugs for uses beyond those approved by regulators. It isn’t illegal for doctors to prescribe medications in ways not approved in their labeling, but it is in most cases unlawful for drug makers to explicitly promote such uses.

The stakes are high in the case of Lipitor. The world’s largest-selling drug has helped millions of people avoid or manage coronary artery disease, including heart attacks and strokes. Pfizer reported Lipitor sales last year of $12.1 billion; since 2001, it has had sales of $46 billion.

The lawsuit filed yesterday alleges that Pfizer launched a deliberate scheme in 2001 to expand the use of Lipitor beyond what has been approved by the Food and Drug Administration, encouraging doctors to use the drug on patients with evidence of elevated cholesterol, but low 10-year probability of a heart attack. In most such moderate-risk cases, the federal guidelines call for lifestyle changes, including exercise and weight loss — not drugs.

The suit cites internal Pfizer marketing documents, Pfizer-funded studies and physician-education programs that encourage doctors to use Lipitor early in treatment, despite the risk of side effects in some patients. Pfizer says side effects with Lipitor are generally mild, such as stomach upset, but the drug has been associated in rare cases with muscle damage and liver problems.

The suit also alleges that Pfizer, facing rising competition from other cholesterol-lowering drugs, has misrepresented the drug’s potential market to Wall Street as well, claiming millions more potential patients than would be expected under the government guidelines. It says a 2004 Pfizer securities filing “blatantly promotes Lipitor’s off-label use as a business opportunity for Pfizer.”

Write to John R. Wilke at john.wilke@wsj.com and Scott Hensley at scott.hensley@wsj.com