[A390]Alcohol Drug Treatment Programs

Publicity about anything that might help alcoholics is bound to get attention. What better way for a drug maker to boost sales of one of its drugs than by publishing a study that makes just such a claim? The problem is that it is misleading and even unethical to suggest that a pill can be a substitute for genuine alcohol rehab.

Just such a study, paid for by Ortho-McNeil Neurologics, a division of Johnson and Johnson, and conducted by many Ortho-McNeil consultants, was published in the Oct. 10 issue of The Journal of the American Medical Association. The study concluded that its seizure and migraine medication Topamax (topiramate) "is a promising treatment for alcohol dependence." However, treatment for alcohol dependence is more than getting a fractional reduction in heavy drinking, which is what the study accomplished with its drug. Treatment for alcoholism requires getting the alcoholic through alcohol detox, then through alcohol rehab, and then through months rebuilding one's life without an alcohol problem.

The results of the study, however, were ballyhooed in the national media, and Ortho-McNeil got new publicity that may well result in a lot of doctors prescribing Topamax for their alcoholic patients instead of getting them into a proper and effective long-term alcohol rehab program.

It is illegal for a drug company to promote the use of a drug for any other than its FDA approved use - FDA approvals for Topamax were only for migraine and seizure. However, individual physicians can legally prescribe a drug for non FDA approved "off-label" use. The problem facing any drug company is how to get doctors to prescribe their drug off label, without breaking the law by promoting that to them.

Ortho-McNeil could apply to the FDA for approval of Topamax for alcoholism "treatment" but it has been reported that the company doesn't intend to do so because their patent on Topamax will soon expire. Of course, this begs the question as to why the company would pay for a study at this point.

Meanwhile, the consumer advocate group Public Citizen has publicized a letter urging the FDA to take action against Ortho-McNeil's "illegal and dangerous promotional campaign" for off-label Topamax prescriptions. Ortho-McNeil, the letter claims, released a media kit with a Q & A sheet that says, "Since topiramate is currently FDA-approved for seizures and migraines, it is available to your doctor to prescribe it to you off-label." Public Citizen asserts that this clearly violates the prohibition of off-label promotion, since patients are being "explicitly urged/promoted to ask their doctor for topiramate to treat their serious alcohol addiction." In any event, family doctors are not addiction specialists, and should be sending alcoholic patients for professional alcohol rehab, not prescribing off-label pills.

Also, current FDA labeling for Topamax states: "You should avoid drinking alcohol while taking Topamax. Alcohol with Topamax can make side effects such as sleepiness and dizziness worse." The list of other side-effects include eye problems, kidney stones, decreased sweating leading to dangerous overheating, and tingling in the limbs. The study, says Public Citizen, found a significant increase in dizziness (doubled), injury (almost tripled), and difficulty with concentration and attention (quadrupled) in the subjects receiving Topamax, compared to subjects getting a placebo. The group also pointed out that both test groups were still "heavily drinking at the end of the study" and that more subjects taking Topamax quit the study than the placebo group. The study showed "only a modest improvement in the percentage of days of heavy drinking in people using Topamax compared with people using a placebo," the group said. Even more reasons for doctors to avoid off-label prescriptions and stick to encouraging their a
lcoholic patients to enroll in recognized alcohol rehab programs.

Drugs for alcoholism have failed to make any significant dent in the drinking habits of the 15 million or more alcoholics in this country. Fueling additional sales of a drug by promoting "off label" prescriptions, especially by physicians who are not trained in addiction treatment, is not a substitute for alcohol rehab. And who's going to manage the worrisome side-effects? Pills are not the answer to alcohol addiction. Whether someone's addiction is to drugs or alcohol, the solution is a bona fide drug or alcohol rehab program.