Deceptive Prescription Drug Marketing Is Widespread And Dangerous
December 21st, 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. Ramn Castellblanch, a professor of Health Education at San Francisco State University. “Medicine, not marketing, must drive clinical trial design and reporting.”
FDA enforcement is ineffective.
• 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 drug marketer goes ahead and runs another ad that’s deceptive in just the same way,” said Clayton.
All of the report’s numbers, derived from the FDA letters, dramatically understate the problem, explained Clayton, because the FDA’s review of marketing is relatively limited. “This report only scratches the surface. There’s no way to monitor all the marketing, but this limited sample doesn’t inspire faith in the accuracy of the rest of the pharmaceutical industry’s advertising.”
States Can Solve the Problem
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.
• States should educate their doctors and the public by publicizing the FDA letters and other evidence of deceptive marketing.
“The good news is that states can take action now to protect consumers from the dangers of deceptive drug marketing,” said Clayton. “California has long been a national leader when it comes to protecting consumers and this is another great opportunity to set a strong example for patient safety.”
The full report is available for download at www.calpirg.org/snakeoil.