FDA Issues Warning Letter Over Alcohol Dependency Drug
For anyone whose life has been ruined by alcoholism, the chance to turn everything around with a shot in the arm must be appealing. Get an injection from your doctor and instantly repair every personal relationship that was destroyed by the disease. The appeal of such easy redemption is obvious, but it is also obviously a fantasy. The FDA has told one drug company that it cannot advertise that fantasy. Earlier this month, the Food and Drug Administration sent a warning letter to Alkermes, Inc., the makers of the alcohol-dependency drug Vivitrol. The drug is designed to decrease cravings for alcohol, but Alkermes has been advertising that it can do much more. The letter advised Alkermes that it had to stop distributing a DVD shown to potential Vivitrol users and a patient brochure because of exaggerated claims of efficacy. The DVD featured testimonials in which Vivitrol users said things such as this, from “Tina S.”:
“The money was going towards alcohol and not the kids. . . . With the drinking, DSS got involved. . . . Julie at the clinic, she suggested Vivitrol. . . . Since I’ve been on the shot. . . . I feel better about myself now that I’m sober. I’ve got a little bit more respect from the kids and that I feel like a mother now. Physically I’m in better shape than I was. . . . Couldn’t even crawl out of bed and now I’m back to work. . . . My life has changed so much in the past year. I’ve gotten remarried. We’re working on the house and everything’s going pretty good.”
The patient brochure featured similar statements, and a list of ten reasons to quit, including:
2. You will have a better relationship with your family.
3. You will have a better relationship with your friends.
7. You will accomplish more of the things you want to get done.
10. You will experience personal and spiritual growth.
The FDA said all of this went too far. “These claims misleadingly overstate the efficacy of Vivitrol by implying that the usual outcome of treatment with Vivitrol is a positive effect on a patient’s interpersonal relationships, emotional functioning, work productivity, productivity in general, and overall quality of life. FDA is not aware of substantial evidence or substantial clinical experience to support such effects of Vivitrol treatment.” It also faulted Alkermes for burying warnings about risks after the testimonials where they were not likely to attract any attention from viewers.
Some have suggested that Alkermes executives need to find a better way to present accurate information to vulnerable clients. It certainly seems like a cheap way to sell a drug, exploiting the desperation of people who have hit rock bottom. The drug may very well help people stay sober, and that is undoubtedly an important step in putting a life back together. But anyone considering taking Vivitrol should keep in mind that the drug is only designed to help them fight the urge to drink. The rest they have to figure out on their own.
