This article highlights a different approach for the treatment of alcoholism, namely a monthly injection of an opioid antagonist in conjunction with counseling or group therapy. The allure of this drug is that the oral medication performs well among those who take it. This may be a welcome treatment regimen for individuals seeking help for their alcoholism. Perhaps because of side-effects or for other reasons, compliance with the pill is not great, so this once-a-month treatment is attractive on the face of it. Unfortunatelly, this story provides little information about the efficacy of this treatment. Trials of the drug showed that about 15% of patients stopped taking the drug during the 6 month trial because of side effects, but the story didn’t mention this. The story also didn’t mention that the trials showed high rates of anorexia, nausea and fatigue among the actively treated subjects.
In fact, no details on the clinical trials or the views of experts in the field were provided. The story only included quotes from drug company spokesmen. Finally, while this was an article highlighting a new option for the treatment of alcoholism, no mention was made of established programs for treating alcoholism.
The article may have been a bit naive on the pricing issue. While saying that a drug company executive said the drug’s price wouldn’t be decided until its U.S. launch in late June, did the reporter even push for an estimate? Were drug analysts consulted? In addition, the drug needs to be given as monthly injections in a doctor’s office. The story didn’t include that factor in its too-brief discussion of costs.
No mention of the percentage of individuals who could be expected to benefit from this treatment was provided.
The potential for liver damage was mentioned, acknowledging that Vivitrol will carry a black-box warning about this. But the trials of the drug showed that about 15% of patients stopped taking the drug during the 6 month trial because of side effects. The story didn’t mention that the trials showed high rates of anorexia, nausea and fatigue among the actively treated subjects.
No mention was made of the recently-concluded phase III clinical trials studying the efficacy of this treatment. This randomized controlled trial can be found in the April 6, 2005 issue of JAMA. While the treatment was shown to result in a statistically significant decrease in heavy drinking in men, there was no reduction in the number of days without any alcohol consumption for either men or women.
This piece does not appear to disease-monger. A prevalence for alcohol dependence in the US is placed at 9 million with an estimated 2.2 million who are seeking treatment for alcoholism.
The story didn’t include any comment from any independent expert not connected with the drug or its maker.
The article mentions other medications for the treatment of alcoholism such as oral naltrexone and antabuse while failing to mention acamprosate. The benefit of this new, injectable treatment for alcoholism, which is to be administered monthly, is that it eliminates the challenge presented by the need for daily adherence to treatment. However, there was no mention of Alcoholic’s Anonymous or other treatment programs .
It was reported that this drug will be sold beginning in late June which concurs with the information in the company press release.
Reported as new treatment for alcoholism; according to the FDA, there is no therapeutic equivalent for Vivitrol. So we’ll give this a satisfactory score. But the story could have asked questions such as “Is this truly novel? Is an injectable treatment that different from a pill?”
As much of the material in the article is consistent with the Alkermes, Inc. (drug company) press release of April 13 on the FDA approval of Vivitrol, it would appear that the press release was a main source of information for this story. There is no evidence of information from any other source.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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