Deceptive marketing for prescription drugs is widespread, pervasive and primarily aimed at doctors, claims the New Jersey Public Interest Research Group’s Law and Policy Center, in a new report.
However, the Pharmaceutical Research and Manufacturers of America has attacked these conclusions as “irresponsible” and “exaggerated.” The industry association also told Pharma Times World News that the report “grossly misleads the public about the safety of America’s drug system and the goals, practices and results of prescription pharmaceutical marketing and advertising” and that, in many cases, it relies on outdated information and rehashes old, unsubstantiated allegations.
The NJPIRG report states that, during 2001-5, the US Food and Drug Administration sent 170 enforcement letters to 85 companies about false and/or misleading marketing for 150 drugs. 62% of these messages targeted doctors, and were expressed by 38 different types of advertising. 17 different types of false or misleading ads were aimed at the public.
FDA letters concerning unsupported claims highlighted at least 82 times that the advertising cited clinical trials for propositions they did not support; in some instances, they actually contradicted the claims, it adds.
“When doctors can’t rely on clinical trial reports, the very foundation of pharmaceutical medicine is destroyed,” said the study’s author, Abigail Caplovitz, consumer advocate at the NJPIRG Law and Policy Center.
28 firms (around a third receiving enforcement letters) were sent more than one in the period, and they accounted for two-thirds of all letters, the report adds.
“You know the system is broken when the FDA identifies an ad as deceptive, tells the marketer how it is deceptive, and yet the drug marketer goes ahead and runs another ad that’s deceptive in just the same way,” said Caplovitz. The report dramatically understates the problem, because FDA review of marketing is relatively limited, she added.
However, PhRMA senior vice president Ken Johnson criticized the Group for not carrying out a comprehensive review but simply tallying the number of notices sent to companies by the FDA and neglecting to incorporate any response actions taken by firms. “Clearly, this is evidence that the FDA’s system of drug-marketing enforcement is working, not failing,” said Mr Johnson.
He also pointed out that FDA officials and others have indicated in public statements that ads which have aired since the PhRMA’s voluntary Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines took effect in January have been more educational, and have reported that companies are submitting ads to the agency for advance review.
The NJPIRG study also claims that sales representative statements accounted for 30 of the 869 deceptive messages in the FDA letters, which it says is an “enormous” amount, given the very small percentage chance that the FDA will detect such statements. Other research suggests that as much as 11% of sales representative statements are false and favourable to the product they pitch, it adds.
However, says Johnson: “America's pharmaceutical research companies and their representatives - many of whom are health care professionals themselves - have the most information about new treatments that can help patients.” All representatives must comply with strict FDA regulations, they are well-trained technically and are prepared to answer doctors' questions about benefits, side effects and proper use of drugs, he added.
In its recommendations for change, the study urges US states not to wait for action by Congress or the FDA but to take steps now to: establish a comprehensive, searchable database of clinical trials; create a new type of citizen lawsuit; and publicise the FDA letters and other evidence of deceptive marketing.
It also calls for more power and resources for the FDA and improved prescriber education and information resources. However, Mr Johnson points out that experts regard the FDA’s review of prescription medicines as the world’s standard. “Fewer than 3% of approved prescription medicines have been withdrawn from the market over the last 20 years,” he says, adding: “this remarkable record is indicative of the FDA’s exhaustive approval process; it takes on average 10-15 years for just one new drug to be approved, and that includes up to 7.5 years of clinical trials with thousands of volunteer patients.”
To read the report: Turning Medicine Into Snake Oil: How Drug Marketers Put Patients at Risk, visit njpirg.org.
- Meantime, the Baltimore Sun reported May 7 that pharmaceutical companies have paid $3.5 billion in fines since 2001 for violations of the federal False Claims Act (under which whistle-blowers are eligible for 15%-30% of penalties against a company) with 16 cases settled and another 150 pending. Drugmakers’ lawyers have not challenged the Act because companies “risk losing lucrative government reimbursement for their drugs,” it says.