Going Off-Label to Get On the Wagon

The Wall Street Journal’s Health Blog reported yesterday that Public Citizen’s Health Research Group has accused the University of Virginia of encouraging doctors to prescribe Johnson & Johnson’s anti-seizure and migraine drug Topamax “off-label” to treat alcoholism.

The University of Virginia is home to a Johnson & Johnson-funded study on Topamax’s ability to treat alcoholism. The Health Blog describes claims from the Public Citizen’s Health Research Group, which says that the University of Virginia, where the study took place with funding from J&J, put out a press packet that encouraged doctors to prescribe the medication off-label. Doctors can prescribe drugs off-label for uses not formally approved by the Food and Drug Administration, but drug makers cannot advertise or promote these alternative uses. The Health Blog also notes that the scientist who led the study at UVA, Bankole Johnson, chairman of UVA’s Department of Psychiatric Medicine, has financial ties to J&J.

In their main article on the study (subscription), The Wall Street Journal relays Dr. Johnson’s comments about how the current drugs used to treat alcoholism are only prescribed after a person stops drinking or goes through detox. According to Johnson, a drug like Topamax is a welcome development because it can be introduced while a person is still drinking.

The Wall Street Journal also reports that a spokeswoman for Ortho-McNeil Neurologics, the J&J subsidiary that produces Topamax, says they have no intention of submitting the drug for FDA approval as a treatment for alcoholism. And in an article by MedPage Today, they quote a UVA spokeswoman:

“We are not suggesting a go-ahead for doctors, but we are stating a fact,” said a spokesperson. “Doctors who are interested are allowed to prescribe it. No off-label use is being proposed, advocated, or promoted.”

Looking a bit deeper into the specifics of the scientific methodology, Mark Willenbring, doctor at the National Institute on Alcohol Abuse and Alcoholism, commented in an editorial in The Journal of the American Medical Association that accompanied Johnson & Johnson’s paper on Topamax that alcoholic subjects who volunteer for a study such as this one are self-selecting, whereas many alcoholics who undergo specialty treatment are coerced by judges or employers. This self-selecting group mostly closely resembles patients likely to be seen in primary care where pharmacotherapy would be most appropriate.

The New Scientist goes into some detail about how much the patients actually improved and how the drug works by blocking the brain-chemical (or neurotransmitter) dopamine; the piece is more optimistic than The Wall Street Journal.

A letter to Food and Drug Administration Director Andrew von Eschenbach from Sidney Wolfe, MD of the Public Citizen’s Health Research Group, emphasizes the current FDA warnings that caution against taking the drug with alcohol and calls attention to the statistically significant increase in side effects mentioned in the study such as dizziness and trouble concentrating.

Although the results of the study look promising, the side effects seem substantial and even the authors admit that there was no follow-up to determine whether the patients relapsed.

The findings aren’t necessarily hype, but Public Citizen is right to call attention to the fact that FDA approval is more than red tape. Large studies must be done on diverse populations in order to ensure safety and effectiveness and assess the overall risk-benefit relationship. That’s why Topamax remains off-label for alcoholism treatment and should remain so until the FDA approves it. Although it may be worth asking whether news coverage of the study and controversy itself may spur more patients or doctors to consider off-label use.

Tags: bioethics, drug companies, FDA, Media, methodology, pharmaceuticals, Research ethics

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