Suit Charges Pfizer Misled Seniors About Lipitor

February 25, 2008

http://www.consumeraffairs.com/news04/2005/lipitor_suit.html

September 29, 2005 A lawsuit against Pfizer claims the world's largest drug company misled consumers into using its anti-cholesterol drug Lipitor despite the absence of evidence from clinical trials that these drugs are of any benefit to large segments of the population.

Pfizer promoted Lipitor by claiming it prevents heart disease in women and the elderly, where no clinical test has established such a benefit, the suit charges.

In fact, according to the complaint, women without heart disease taking Lipitor actually developed 10 percent more heart attacks than women treated with a placebo.

The lawsuit alleges that Pfizer engaged in a massive campaign to convince both doctors and patients that Lipitor is a beneficial treatment for nearly everyone with elevated cholesterol, even though no studies have shown it to be effective for women and those over 65 years of age who do not already have heart disease or diabetes.

Normally, drugs become widely used as treatments for patients only when a well-designed clinical trial finds that the drug is safe and effective for patients of the same type and age. No such trial has shown that Lipitor helps the elderly or females without prior heart disease.

"We believe Pfizer intentionally ignored the scientific evidence -- and lack thereof -- and launched a multi-million dollar ad campaign designed to push the drug to anyone they could convince to buy it," said Steve Berman, the lead attorney for the proposed class.

"We intend to prove that Pfizer pocketed billions in sales to those who do not benefit from Lipitor."

Lipitor is in the class of cholesterol-lowering drugs called statins and it is the best-selling drug in the world, with sales in 2004 of more than $10 billion.

According to John Abramson, MD, clinical instructor of ambulatory care at Harvard Medical School and author of Overdosed America: The Broken Promise of American Medicine, the scientific picture is clear.

"The idea that lowering cholesterol always reduces the risk of heart disease has become the conventional wisdom, which drug companies like Pfizer have taken great pains to promote. But for women under 65 and people over 65 with no history of heart disease or diabetes, the evidence just isn't there," Abramson said.

"Millions of women and seniors are spending huge sums to take Lipitor every day despite a lack of proof that it's doing anything beneficial for them, and may actually be harming the elderly."

Alex Sugerman-Brozan, director of the Prescription Access Litigation Project, added, "We believe that the evidence will shine light on the ways that drug companies like Pfizer work to manipulate most of what we know about prescription drugs, from the research to the guidelines that doctors follow."

One of the organizations suing Pfizer, Health Care For All, is a member of the Prescription Access Litigation Project.

The suit claims that Pfizer's promotional campaign has resulted in billions of dollars in unnecessary drug spending among these two groups of patients at a time when drug and general healthcare costs are spiraling out of control.

Nancy Yost, one of the plaintiffs in the lawsuit, is a 73-year-old woman with no history of heart disease who has been taking Lipitor for several years.

"With the high cost of prescription drugs today, no seniors I know can afford to pay for a drug that doesn't do what it promises," Ms. Yost said. "I'm disappointed that Pfizer is spending millions to convince seniors to pay top dollar for a drug without full disclosure of its effectiveness. It shows that the drug industry's priorities are skewed when they spend twice as much on marketing as they do on research."

Health Care For All noted the high economic cost to taxpayers. "We all pay the price for the over-prescription of drugs, like Lipitor, because we have to foot much of the bill for state pharmacy programs for seniors and soon for the Medicare drug benefit," said Melissa Shannon, Consumer Health Policy Coordinator of Health Care For All.

"We can't allow drug companies to trick seniors into taking expensive, unnecessary drugs that will drive up the already-high costs that Medicare will be paying for seniors' drugs."

The proposed class action seeks to represent women who have taken Lipitor and who have no history of heart disease or diabetes; people aged 65 and over who have taken Lipitor and who have no history of heart disease or diabetes; and third-party payers such as insurance companies, union health and welfare funds, self-insured employers and others, who paid for Lipitor for patients in either of these two groups.

The lawsuit alleges that Pfizer violated state consumer protection laws against deceptive advertising and seeks reimbursement for women and seniors and third-party payers who bought Lipitor unnecessarily as a result of Pfizer's marketing and promotional campaign.

"We intend to prove in this case that Pfizer's false advertising created an enormous artificial demand for Lipitor, much of which would not exist if Pfizer had fully and fairly disclosed the truth about the drug," said Berman.

The lawsuit was filed in the U.S. District Court in Boston on behalf of several individuals, Health Care For All, and the Teamsters.