Healthy Skepticism Library item: 4612

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Turning Medicine into Snake Oil
New Jersey Public Interest Research Group (NJPIRG) 2006 May 2
http://njpirg.org/reports/TurningMedintoSnakeOil.pdf

Notes:

Ralph Faggotter’s Comments:

For anyone who is still struggling under the illusion that the pharmaceutical industry can be trusted to regulate itself, reading this compelling research will rapidly bring about a transformation in their opinion.

This analysis clearly confirms the validity of Healthy Skepticism’s position.

Full text:

http://njpirg.org/reports/TurningMedintoSnakeOil.pdf (52 pages)
TurningMedintoSnakeOil.pdf (application/pdf Object)

and http://njpirg.org/NJ.asp?id2=24025&id3=NJ&id4=HP

NJPIRG News Room

For Immediate Release:
May 2, 2006

For More Information:
Abigail Caplovitz
(609) 394-8155 ×320
(646) 245-1711

Deceptive Prescription Drug Marketing Is Widespread And Dangerous
Study Analyzes FDA Actions Against Manufacturers For Deceptive Marketing Of Vioxx, Paxil, 150 Other Drugs

TRENTON-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 NJPIRG Law and Policy Center.

“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 NJPIRG Law and Policy Center Consumer Advocate Abigail Caplovitz, the report’s author. “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.”

Analyzing five years of regulatory letters from the federal Food and Drug Administration and surveying existing literature, NJPIRG Law and Policy Center 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 Caplovitz. “They can’t escape the pitches. And now we know that a lot of those messages are dangerously misleading.”

The problem of deceptive drug marketing extends to direct to consumer ads as well. Seventeen different types of adds gave consumers deceptive messages about risks, uses and other claims.

“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.”

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.

• 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 Caplovitz. “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 an runs another ad that’s deceptive in just the same way,” said Caplovitz.

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 which NJPIRG is a member. 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.

All of the report’s numbers, derived from the FDA letters, dramatically understate the problem, explained Caplovitz, 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 FDA and Congress have failed to act to assure drug safety gets top priority and that consumers and doctors have complete safety information,” said Foley of Consumers Union’s PrescriptionForChange.org project.

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 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.

• States should educate their doctors and the public by publicizing the FDA letters and other evidence of deceptive marketing.

“States can take action now to protect consumers from the dangers of deceptive drug marketing,” said Caplovitz. “There’s no need to wait on either Congress or the FDA.”