CHICAGO—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 Illinois PIRG (Public Interest Research Group).
“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 are powerful substances,” said Illinois PIRG State Director, Brian Imus. “Taken by the right person, they can improve or even save lives; taken by the wrong person, they can cripple or even kill. Doctors need complete and accurate information to make appropriate prescribing decisions. They’re not getting that from the drug marketers.”
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. These dangerous messages were conveyed in a physician-inundating 38 different types of advertising.
“Doctors are getting swamped with marketing messages about drugs,” said Imus. “They can’t escape the pitches. And now we know that a lot of those messages are dangerously misleading.”
Even worse, marketing concerns are influencing the design of clinical trials, affecting which results get published, and shaping clinical trial reports. In the letters identifying advertising as false or misleading because it contained unsupported claims, FDA highlighted at least 82 times that the advertising cited clinical trials for propositions they did not support. In some instances, the cited trials actually contradicted the claims.
“When doctors can’t rely on clinical trial reports, the very foundation of pharmaceutical medicine is destroyed,” said Imus. “Medicine, not marketing must drive clinical trial, design and reporting.”
To illustrate the problem, the report includes six case studies in deceptive marketing: Vioxx, OxyContin, Paxil, Accutane, Neurontin and Tindamax.
The report also documented that 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.
“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 Imus.
"Consumers need accurate information and better drug safety oversight," emphasized Liz Foley with Consumers Union's PrescriptionForChange.org project. "Consumers are bombarded every day with ads touting the latest prescription drugs, but we clearly can't rely on the industry to give us complete information about negative side effects.”
All of the report’s numbers, derived from the FDA letters, dramatically understate the problem, explained Imus, because the FDA’s review of marketing is relatively limited. “This report only scratches the surface. There’s just no way to monitor all the marketing.”
The report highlighted state action that would make a difference, including:
• Illinois 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.
• Illinois should create a new type of citizen lawsuit to address the problem of deceptive classic advertising, deceptive sales representative statements and deceptive doctor-to-doctor marketing.
• Illinois should educate their doctors and the public by publicizing the FDA letters and other evidence of deceptive marketing.
“Illinois can take action to protect consumers from the dangers of deceptive drug marketing,” said Imus. “There’s no need to wait on either Congress or the FDA.”
