Lawmakers’ Proposal Would Turn Patients Into Guinea Pigs

Statement of Dr. Michael Carome, Director of Public Citizen’s Health Research Group

Note: U.S. Reps. Fred Upton (R-Mich.) and Joseph Pitts (R-Pa.) on Thursday sent a letter (PDF) to Sylvia Burwell, secretary of the U.S. Department of Health and Human Services, complaining that the agency has been blocking the U.S. Food and Drug Administration (FDA) from loosening patient safety rules that limit companies’ ability to market their products for unapproved uses. The lawmakers attached a draft bill that would enable the companies to engage in extensive promotion of prescriptions and devices for unapproved uses.

The letter from Representatives Upton and Pitts shows a lack of appreciation for the role of the FDA in protecting patient health and a naive view of industry marketing practices.

The threat to patient health posed by the draft bill attached to their letter is tremendous. FDA approval of a product for one use (say, to treat cancer) tells us nothing about whether it is safe and effective for another use (say, to treat migraines). Yet this bill would allow drug and medical device manufacturers to advertise and promote their products – both to doctors and directly to consumers – for uses never approved by the FDA.

The only limit: The unapproved use touted in an ad or promotional material would have to be supported by some “scientific or medical evidence” – apparently even if the evidence is contradicted by other studies, is far too preliminary to be reliable, or otherwise falls short of what would be needed to establish the safety and effectiveness of the product for the touted use.

Moreover, most studies are performed or paid for by the industry itself, and time and again we have seen pharamaceutical companies skew study results or suppress negative results to create a false view of a product’s safety and effectiveness for a particular use.

The bill would create a significant risk that, once the FDA approved a product for a single use, patients would become guinea pigs for the drug and device industries. In short, the members’ proposal would be a giant step backward to the time of 19th century snake oil salesmen.