Health Care & Prescription Drugs News

BOSTON—Over the last five years, the federal Food and Drug Administration (FDA) sent prescription drug companies 170 enforcement letters criticizing “false” or “misleading” advertising that omitted or minimized risks, promoted unproven uses, and made other deceptive claims to both doctors and consumers. Those letters addressed the marketing of 150 different drugs, including Vioxx, Paxil, Oxycontin and Accutane, according to a new report released today by the MASSPIRG Education Fund.

“Turning Medicine Into Snake Oil, How Drug Marketers Put Patients At Risk” analyzes the FDA actions and makes numerous recommendations for state and federal policy reforms to improve drug safety.

“Prescription drugs can pose serious health risks. That is why the FDA requires basic disclosure of side effects and imposes certain marketing restrictions,” said MASSPIRG Consumer Advocate Eric Bourassa. “The lax advertising enforcement by the FDA combined with drug companies’ insatiable appetite for increasing profits can be a lethal combination.”

Analyzing five years of regulatory letters from the federal Food and Drug Administration and surveying existing literature, the report found that drug marketers are misrepresenting risks, promoting unproved uses, and making a variety of unsubstantiated claims. Even worse, marketing concerns are influencing the design of clinical trials, affecting which results get published, and shaping clinical trial reports. To illustrate the problem, the report includes six case studies in deceptive marketing of: Vioxx, OxyContin, Paxil, Accutane, Neurontin and Tindamax.

The report found:

Deceptive drug marketing is pervasive, dangerous, and primarily aimed at doctors

From 2001-2005, 85 companies received 170 notices from the FDA calling the marketing for 150 different drugs false and/or misleading.
62% of the false or misleading messages targeted doctors. 37% of those messages misrepresented drugs’ risks; 22% promoted unproven uses; and 38% made unsupported or misleading claims.

Consider these two examples from the FDA enforcement letters:

Pharmacia promoted Celebrex for use in patients at risk of serious bleeding.
Pharmacia promoted Celebrex as safe for patients taking the drug Coumadin, although the prescribing materials state that patients taking both may experience serious bleeding. The FDA explained: “minimization of this risk raises significant public health and safety concerns.” (FDA Warning Letter to Pharmacia 2-1-01)

Cubist Pharmaceuticals promoted Cubicin for off-label use as a pneumonia treatment despite data showing it is ineffective.
Cubist Pharmaceuticals used a website to promote its antibiotic Cubicin for use against the bacteria that causes community-acquired pneumonia even though Cubist knows it doesn’t work for pneumonia. The FDA’s letter noted the promotion for pneumonia “poses a significant public health risk because such practice could lead to therapeutic failure and death.” (FDA Warning Letter 8-17-04)

FDA enforcement is ineffective because recidivism is rampant.

The FDA’s letters did not deter future deceptive advertising. 28 companies—approximately 1/3 of the total receiving FDA enforcement letters —received more than one letter declaring their ads false or misleading in the five years examined. In fact, these 28 companies accounted for two-thirds of all the letters received. While some of these letters identified different types of deceptive advertising problems relating to different drugs sold by the company, nearly all of these companies received more than one letter addressing the same problem.

“You know the system is broken when the FDA identifies an ad as deceptive, tells the marketer how it is deceptive, and yet the company goes ahead and runs another ad that’s deceptive in just the same way,” said Bourassa.

Other consumer groups agree.

“This report documents the exact problem we highlighted recently with the Bitter Pill Awards,” said Alex Sugerman-Brozan, Director of the Boston-based Prescription Access Litigation Project (PAL), a coalition of consumer and health care advocates.

Each year, PAL presents “honors” to drug companies engaging in over-zealous and questionable marketing practices. Among this year’s award winners was Eli Lilly, for its distracting TV ad for an attention deficit disorder drug (Strattera). Although the FDA issued a warning letter about this ‘false and misleading’ ad, by the time the FDA issued its letter, the ad campaign had already ended.

“Examples like Strattera perfectly illustrate how ineffective and inadequate the FDA's current enforcement is,” added Sugerman-Brozan.

Solutions

In Massachusetts, state Senator Mark Montigny has filed legislation, An Act Discouraging Fraudulent Marketing Practices By the Pharmaceutical Industry SB 402, that would enhance the Attorney General’s authority to address fraudulent or misleading activities by the drug industry and require doctors and hospitals to disclose gifts received from drug company representatives.

“The pharmaceutical industry is spreading money around Washington and Boston and in the process corrupting health care policy at the expense of the taxpayer,” said state Senator Mark Montigny, sponsor of a bill to address fraudulent and misleading activities by the drug industry. “If a doctor needs a Caribbean vacation, a mug or a pen, he or she is
probably not very successful and needs to be in another business. The No. 1 thing that keeps government and corporate officials honest is transparency,” added Montigny. “There ought to be a report online that everyone can see that says doc so-and-so has taken more than most.”

Among the report’s recommendations are the following:

• States should establish a comprehensive, searchable database of clinical trials to address the scientific misconduct inherent in the suppression, manipulation or misrepresentation of clinical trial data.

• For deterrence purposes, the FDA must have, and use, punishments short of removing a drug from the market. If false advertising recidivism quickly and consistently resulted in punitively large fines, the FDA could deter drug companies from repeating the offense.

• States should educate their doctors and the public by publicizing the FDA enforcement letters and other evidence of deceptive marketing, including pharmaceutical industry gifts to doctors.