Tricks help drug makers sell prescription meds for uses not approved by FDA
At least one in five prescriptions that doctors write is for a drug to be used for purposes or in ways different from those approved by the FDA. In 2001, that added up to 150 million prescriptions. And with such a large market up for grabs, it should be no surprise that drug manufacturers are keen to find ways to work around legal restrictions against the promotion of prescription drugs for such "off-label" purposes.
A new study out today in PLoS Medicine (dated Oct. 28) details the creative ways in which drug companies conduct "stealth marketing" campaigns that encourage physicians to prescribe a medication for "off-label" use, but do so within the narrow confines of the law.
Though there's nothing illegal about a physician prescribing medications for uses that FDA has not approved as safe and effective, it is illegal for companies to tout them in advertising and public promotion. It can cost a company caught in the act big-time: Several years ago, Warner-Lambert, a subsidiary of Pfizer, was forced to pay $430 million in civil and criminal fines for marketing the anti-epilepsy drug Neurontin as a drug for psychiatric diseases.
The authors suggest that physicians are no less immune to "buzz" advertising strategies than the rest of us are. So, at professional meetings and educational seminars that physicians must attend to keep their licenses up to date, drug companies with a new drug to sell or an old drug to revive often stir interest in a drug's "off-label" uses by sponsoring the presentation of small, preliminary studies. Though the studies would likely not pass muster in a medical journal, doctors still hear of evidence that a medication they already prescribe for an approved purpose may treat other disorders too. And that evidence often comes from a researcher who has won lucrative funding -- and sometimes speakers' fees -- from the company that makes the drug in question.
In some cases, a drug company may foster wider use of a drug through this kind of stealth marketing than if it were to take the ordinary route to broad acceptance by doctors and patients -- seeking approval for the "indication" from the FDA. Asking FDA's blessing requires the performance of costly and time-consuming clinical trials, which sometimes don't yield impressive results. By comparison, creating "buzz" is inexpensive.
"Pharmaceutical marketing has distorted the discourse on off-label marketing and encouraged the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown," write authors Dr. Adriane Fugh-Berman of Georgetown University and Dr. Douglas Melnick, a preventive physician based in North Hollywood. One study has found that three-quarters of off-label prescriptions are written without a shred of scientific evidence supporting the drug's effectiveness for the purpose.
Fugh-Berman is the force behind a pharmaceutical-industry watchdog website, http://www.pharmedout.org/. Melnick worked in the pharmaceutical industry as a physician in the firm's medical affairs department, supporting marketing efforts.
The authors suggest that FDA regulators should expend more effort enforcing -- and perhaps extending -- restrictions of off-label marketing than is currently the case. They suggest that physicians, who often find themselves on the receiving end of such campaigns, could be offered rewards for reporting off-label marketing.
-- Melissa Healy
