Seizure Drug May Treat Alcoholism

Topiramate has been used to treat alcoholism for a little while now and was featured in the HBO Addiction series. This story has been very widely reported over the last few days. It may become a useful tool for a small number of alcoholics, but I find the results reported in this article pretty underwhelming:

Compared with placebo treatment, treatment with Topamax was associated with an 8 percent greater reduction in the percentage of heavy drinking days during the trial, the researchers reported.

Researcher Bankole Johnson, MD, tells WebMD that alcoholics in the trial who took Topamax went from the equivalent of drinking a bottle and a half of wine a day to about 3 1/2 glasses of wine.

"I think that is a big difference," he says. "Most people can manage that amount of alcohol without getting into too much trouble."

The researchers reported that Topamax users had a greater rate of achieving 28 or more days of continuous nonheavy drinking during the study and 28 days of continuous abstinence.

The manufacturer has also been accused of promoting off-label use:

But in a letter to the FDA, the consumer interest group Public Citizen accused the company of illegally promoting use of the drug for this purpose.

While doctors can legally prescribe FDA-approved drugs for nonapproved conditions, it is illegal for the companies that market the drugs to promote these so-called "off label" uses.

The Public Citizen complaint involved a question-and-answer sheet distributed to the media before publication of the study, which specifically discussed the drug's potential "off label" use for alcohol dependence.

Kara Russell of Ortho-McNeill tells WebMD that the company knew nothing about the question-and-answer sheet until the Public Citizen letter became public."

Ortho-McNeil Neurologics does not support any reference to off label use of its products and only promotes the use of Topamax in the approved indication of migraine and epilepsy treatment," Russell says.

I'm not surprised. I've wondered what arrangement led to the prominent placement of topiramate in the HBO series. It was practically an infomercial and led the lay people I know to grossly overestimate the effectiveness of the drug.




Technorati Tags: topiramate, addiction, alcoholism, treatment, research, medication

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Tobacco, tobacco tobacco

Three recent articles on tobacco. First, The Boston Globe reports on the effectiveness of pharmacological treatments for nicotine addiction. The article presents a pretty pharmacological treatments as an essential part of a smoking cessation plan.

Philip Quartier, a 64-year-old stockbroker from Mission Hill, had been smoking a pack of cigarettes a day for 45 years when he quit for the first time. After five clean years, an impulse led him to pick up another cigarette eight months ago, and the biking enthusiast, who has lung disease, was frustrated to be back to his old habit.

Determined to quit for good, he dug out the subliminal motivation tapes he'd used the first time around, went back on the nicotine patch, bought a self-help book, and joined a counseling group, but several months into the process, he was getting nowhere. So in November, he got a prescription for Chantix (varenicline), a six-month-old drug that is the first new quit-smoking treatment in a decade.

The pills don't work for everyone but quickly diminished Quartier's cravings. "By the eighth day I was absolutely ready" to give cigarettes up again, he said.

Though most smokers try to quit without help, nicotine-free treatments including Chantix and longtime staples like nicotine gum and patches are more effective than trying to quit "cold turkey," according to experts and research.

Next, Dr. Wes questions the federal push toward pharmacological treatments and provides some compelling arguments:

Well it seems that nicotine patches are now part of the federal guidelines regarding smoking cessation issued by the Public Health Service, a division of the Department of Health and Human Services. But an interesting twist to these guidelines was revealed yesterday (WSJ, subscription):

(Doctor) Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit-smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies. ... Dr. Fiore, a University of Wisconsin professor of medicine, headed the 18-member panel that created those guidelines. He and at least eight others on it had ties to the makers of stop-smoking products.

Those opposed to urging medication on most quitters note that cold turkey is the method used by the vast majority of former smokers. They fear the federal government's campaign could discourage potential quitters who don't want to spend money on quitting aids or don't like the idea of treating their nicotine addiction with more nicotine.

"To imply that medications are the only way is inappropriate," says Lois Biener, a senior research fellow at the University of Massachusetts at Boston who has surveyed former smokers in her state. "Most people don't want them. Most of the people who do quit successfully do so without them."

What is interesting is the way the government makes these recommendations: based on clinical trials. And who is better equipped to perform clinical trials than drug companies? (Bias 1). Further, all of the individuals in clinical trials must sign consent, and therefore have to be willing to take a drug (Bias 2). So these "clinical trials" are, by their very nature, skewed toward those willing to take a drug.

But in the interest of revealing effectiveness of these smoking cessation drugs in the real world, another type of study, an observational population trial that looks at all comers to the smoking cessation party, found this:

Studies of quitters outside clinical trials have shown no consistent advantage for medicine over cold turkey, the pharmaceutical industry's primary competitor. An unpublished National Cancer Institute survey of 8,200 people who tried quitting found that at three months, users of the nicotine patch and users of bupropion (Wellbutrin) remained abstinent at higher rates than did users of no medication. But at nine months, the no-medication group held an advantage over every category of stop-smoking medicine. The study was presented at a world tobacco conference last summer.

Finally, a recent Biological Psychiatry commentary addresses the links between alcohol and nicotine addiction, including the genetic links, shared neurobiological mechanisms, shared behaviors and treatment.

Epidemiologic data confirm that: (1) heavy drinking may stimulate smoking; (2) cessation of smoking may enhance abstinence from alcohol; and (3) combined treatment for dual addiction may achieve the most beneficial treatment outcome.

Psychiatric disorders and substance misuse

Last night I posted an article about gender and substance misuse. I didn't realize that the Psychiatric Times had a special report section on psychiatric disorders and substance misuse. I haven't had time to read the whole thing yet. What I did read seemed okay other than a sky high prevalence estimate for borderline personality disorder in people with substance use disorders:

Nearly one third of those with a lifetime SUD diagnosis also have BPD (median, 27%; range, 5.2% to 74.0%).^16,20 BPD appears to be less prevalent in persons with alcohol use disorders (median, 16%; range, 3.2% to 27.4%) than in those with drug use disorders, especially cocaine and opioid abuse.^17,20 For example, Ross and colleagues¹⁷ found that almost half (47%) of individuals using heroin who entered treatment for SUD also had BPD.

Here's a list of all the articles:

• The Link Between Psychotic Disorders and Substance Use By Emma Barkus, PhD
• Safe Treatment of Pain in the Patient With a Substance Use Disorder By Penelope P. Ziegler, MD
• Schizophrenia and Substance Abuse: Is There a Role for Atypical Antipsychotics? By Giovanni Caracci, MD
• Implications for Treatment and Prognosis of Borderline and Substance Use DisordersBy Ulrike Feske, PhD, Paul H. Soloff, MD, and Ralph E. Tarter, PhD
• Substance Abuse in Women: Does Gender Matter?By Sudie E. Back, PhD, Regana Contini, MD, and Kathleen T. Brady, MD, PhD

What a Long Strange Trip It's Been

Mentions of ecstasy as a therapeutic tool have popped up here and there for some time. Looks like we may be hearing more about it in the coming year:

This year, the drug MDMA, otherwise known as ecstasy, could take a step toward medical respectability. Researchers in South Carolina have begun experimenting with MDMA for patients with post-traumatic stress disorder. At Harvard, a long-awaited pilot study will begin on whether the drug can help relieve anxiety and pain in terminal cancer patients in connection with psychotherapy. And studies will also start in Switzerland and Israel, where a former chief psychiatrist of the Israel Defense Forces will oversee work with people whose PTSD stems from terrorism or war.

Ketamine relieves depression within hours

Ketamine may provide insight into new mechanisms for medication development for depression:

A drug used as a general anaesthetic may also work as a remarkably rapid antidepressant, according to a preliminary study.

The drug’s hallucinogenic side effects mean it is unlikely to be prescribed to patients, but it could pave the way to new faster-acting antidepressants, the researchers suggest.

Ketamine is used as an animal tranquiliser, but is perhaps better known as an illicit street drug, sometimes called “special K”. Now researchers have found the drug can relieve depression in some patients within just 2 hours – and continue to do so for a week.

Narcotic Meds for Back Pain Questioned

This caught my attention and has some practical application, for physicians treating back pain--they should engage in pretty tight follow-up of they are prescribing opiates on long term basis for back pain. What I found more interesting is that this figure of 24% matches previous "capture rate" data pretty closely.

While the pain may be relieved to some extent over the short-term (3 months), the risk of addiction and long-term effectiveness may override any temporary benefits.

Researchers from the Yale School of Medicine found use of opiods for short-term relief of chronic back pain lead to behaviors of opiod abuse in 24 percent of the cases reviewed.

My Adventures in Psychopharmacology

A 23 year old women tells of her nightmarish experience with the psychiatric and addiction treatment system. She was prescribed 15 different drugs over a period of 5 years and, surprise, surprise, when treatment failed, she was blamed. The story ends with her being presumably correctly diagnosed and treated, but it's hard not to wonder if she has a chronic mentally illness at all.

Aside from the iatrogenic harm that professional hubris can cause, this story illustrates the hazards of a system that encourages rapid diagnosis.

Facts on the new smoking cessation medication

A new fact sheet on Varenicline (the generic name for Chantix), the newly approved smoking cessation drug. It's the first drug to target nicotine receptors.