FDA Catches On: Drug Companies Mislead Doctors
Doctors rely on drug company representatives for information about a drug's risks and benefits. The information that the drug company provides to the doctors is supposed to be accurate and truthful. Unfortunately, as I wrote here, the representatives sometimes understate a drug’s risks, overstate its benefits, and promote the drug for uses for which it has not been approved, all in an attempt to increase sales and boost profits. The bad information leads doctors to prescribe drugs to their patients when they really shouldn't. As a result, consumers are needlessly injured.
Now the FDA is catching on. On May 11 the FDA announced that it is asking doctors to turn in drug company representatives who provide misleading information about the drugs they are promoting. The FDA is asking doctors to be on the lookout for -- an anonymously report -- the following types of drug company violations:
Example of Omission of Risk
You attend a speaker program which features a slide show that presents efficacy information about Drug X, but no risk information.
This presentation would be misleading because it fails to include a fair balance of benefit and risk information for Drug X.
Example of Unapproved Use
You are in a commercial exhibit hall and a company representative tells you that a drug is effective for a use that is not in the FDA-approved product labeling.
This presentation would be illegal because it promotes an off-label use.
Example of Overstating the Effectiveness
“Doctor Smith, Drug X delivers rapid results in as little as 3 days.”
This presentation is misleading because the majority of patients studied in the clinical trials for Drug X showed results at 12 weeks, with only very few showing results in 3 days.
Why is the FDA asking doctors to help? Isn't it the FDA's job to police the drug companies? According to the FDA website:
[Our] traditional surveillance activities have been somewhat limited by [our] inability to monitor drug promotion in settings such as physician offices, local dinner programs, and promotional speaker training sessions. By raising awareness about misleading promotion and providing an easy process for reporting it, FDA can gain the valuable assistance of health care professionals in helping to decrease the number of misleading promotional messages about prescription drugs.
It's good to see that the FDA is finally catching on. But there's an obvious problem with the program. The doctors rely on the drug company representatives for information about the drugs. How can they be expected to know when the information the drug company gives them is false or misleading?
