Deceptive Prescription Drug Marketing Is Widespread And Dangerous
March 14th, 2007 Posted by: Dr. Cox
New Study Analyzes FDA Actions Against Manufacturers For Deceptive Marketing Of Vioxx, Paxil, 150 Other Drugs
SAN FRANCISCO—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 doctors and consumers about 150 different drugs including Vioxx, Paxil, Oxycontin and Accutane, according to a new report released today by the CALPIRG 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 are powerful substances,” said CALPIRG Education Fund Health Care Advocate Emily Clayton. “Taken by the right person, they can improve or even save lives; taken by the wrong person, they can cripple or kill. Doctors need complete and accurate information to make appropriate prescribing decisions. They’re not getting that from the drug marketers.”
Analyzing five years of regulatory letters from the federal Food and Drug Administration and surveying existing literature, CALPIRG Education Fund 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: 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. These dangerous messages were conveyed in a physician-inundating 38 different types of advertising.
“Doctors are getting swamped with marketing messages about drugs,” said Clayton. “They can’t escape the pitches, and now we know that a lot of those messages are dangerously misleading.”
Deceptive marketing includes clinical trials.
• 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 made by manufacturers.
• Drug marketers turn clinical trials into marketing tools by suppressing unfavorable reports and using PR firms to write favorable ones (the PR firm does not appear as an author of the report, instead a doctor is retained to be the named author); by misrepresenting unfavorable data that is published; and, most subtly, by designing studies to get only the results they want.
“When doctors can’t rely on clinical trial reports, the very foundation of pharmaceutical medicine is destroyed,” said Dr. Ram