Baclomania: The Cult Of A Cure For Alcoholism
Could a cure for one of the most destructive addictions have been lying dormant on the shelves of the FDA?
In searching for a potential cure or treatment for alcoholism, clinical researchers have thrown almost every drug they can think of at the condition. Precious few of them stick, but one of them appears to work, and it’s a U.S. Food and Drug Administration (FDA) approved muscle relaxant called baclofen.
Baclofen and its link to alcoholism and other addictions has been hotly debated since 2002. Media coverage has been fickle and despite a number of vocal experts speaking out in favor of the drug, it remains to be definitively proven to eradicate cravings.
“We need to change the addiction treatment system to one of science rather than ideology,” he says, adding that the “time is ripe” for such a change.
One theory links alcoholism to an acid called GHB, which is a relaxant and naturally produced by the body. When an individual is deficient in GHB, other relaxants such as alcohol pick up the slack, meaning that people can become gradually dependent. Baclofen, also a relaxant, acts on the same brain receptors as GHB, making you feel relaxed without having to reach for the bottle. That’s the theory anyway.
This sets the drug apart from other drugs on the market that aim to treat alcohol abuse. Antabuse, often prescribed to alcoholics doesn’t stop the craving—just punishes it. If a patient drinks while taking antabuse, a negative reaction such as vomiting is induced. Scientific and clinical research with an aim to find a pill to treat alcoholism is rarer than narcotic dependence.
Now though, the uncertainty surrounding baclofen’s credibility might be about to change one way or the other. The French government has granted funding to the tune of $920,000 to back a placebo based clinical trial by Dr. Philippe Jaury of the Paris Descartes University, which is currently underway and nearing completion.
For many people, alcoholism sufferers and experts alike, knowing how it works would be nice but for the time being they are content to be excited, they say, simply knowing that it does work.
The French government is now convinced enough to sanction the prescription of the drug for alcoholics. The ANSM, the French equivalent to the FDA, recently gave Baclofen the green light, but American alcoholics still have find a physician willing to prescribe the drug off label.
“I knew within half an hour that it was going to work,” says Beth Fields—a former alcoholic and a self-proclaimed baclofen believer from Oklahoma—as she remembers her cravings slipping away after the first pill.
But the science doesn’t necessarily agree with Field’s anecdote.
A 2007 U.S. based trial, which looked at baclofen’s potential to reduce drinking, found no significant evidence that the drug actually helps participants anymore than a placebo does. Despite that, Dr. James Garbutt who led the study says that he still believes baclofen could be a credible alcoholism treatment. He speculates that the 30 mg per day dose that he used may have been too low.
There have been a couple of previous clinical trials in Italy, which contradict Garbutt’s findings to come out in favor of a positive link between baclofen and abstinence. However, these studies had a small number of participants (82) and a running time of just 12 weeks.
The French study will follow 320 participants for 12 months, and as such it carries the promise and potential of more meaningful and conclusive evidence.
If the French trial turns out to bolster baclofen’s abstinence credentials, the results from the trial could theoretically be submitted to the FDA to request a label change for baclofen to be formally acknowledged as a treatment for alcoholism. “The FDA pays attention to other regulatory boards—they don’t make decisions in a vacuum,” says Dr. Eliot Gardner, head of Neuropsychopharmacology at the National Institutes of Health (NIH). A spokesperson from the FDA also confirmed that foreign studies may be submitted as evidence.
A sponsor is required to table such a request to the FDA, which would usually be a pharmaceutical company, but in theory it could also be a private individual. Dr. Willenbring, a Minnesota physician and founder of a specialist addiction clinic called ALLTYR, says that it is unlikely that a drug company will ever sponsor a label change for baclofen. “Since the drug is a generic there’s no way to make the investment back,” he says.
It also seems unlikely that a private citizen would act as a sponsor. The only people who are really interested in doing so are the researchers and doctors prescribing baclofen, i.e. those who want to see baclofen succeed as an alcoholism treatment. But, as Gardner says, “as a medical research scientist, I have no clue about how to raise money for such an endeavor.”
The cost of tabling a serious application that stands a chance of succeeding is estimated to be in the millions of dollars. This is because a typical application for the FDA relies on the evidence of several clinical trials, which don’t come cheap. Although an application could technically be submitted based solely on the evidence of the French study, the chances of success are greatly increased with more studies.
When asked whether they have considered raising the money to act as a sponsor, all researchers responded similarly to Gardner. Only the Franco-American Dr. Olivier Ameisen confessed to having entertained the thought, “I have considered fund raising,” he says, “but I am not sure how to do it because I am not a business man.”
Some experts remain cautious. Dr. Benjamin Rolland of the Université Lille Nord in France, where off label baclofen prescription is much more common, calls the situation a “French craze.”
Rolland believes baclofen might have potential in the fight against alcohol addiction; he’s just baffled that the drug hasn’t so far followed the normal approval protocol. Although he does actually prescribe baclofen to some of his patients, by and large he thinks that the medical community should wait for proof from the placebo trial before doctors casually prescribe baclofen. “We work on evidence, not belief and we must remember that,” he says.
“The whole story revolves around one man and we must remember that one man is only one man,” says Rolland. He’s referring to Ameisen, who became the first human to take baclofen to treat his own alcoholism when he wrote himself a prescription in the spring of 2002 and has subsequently written books about his experience.