https://www.asam.org/asamw-editorial-comment/asam-weekly-editorial-comment/2019/02/25/guest-editorial-comment-end-point-in-aud-treatment

Comment; I LOVE the comparison between using Methadone to suppress the cough with active tuberculosis being similar to “cutting down” on alcohol use–neither disease is improved by such an inappropriate intervention!

by Stuart Gitlow, MD, MPH, MBA, DFAPA, DFASAM | Feb 25, 2019

Dr. Stuart Gitlow, Past-President of ASAM, serves as Guest Editor to this week’s ASAM Weekly, with a comment on a 21 February conference report in MDedge (Collins TR, “Alcohol abstinence questioned as addiction treatment goal”).  The article link is provided here, with Dr. Gitlow’s response below it.   
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According to this article, the FDA has a “fixation on abstinence or elimination of all heavy drinking” as endpoints required in pivotal clinical trials on alcohol use disorder. “Experts” are noted to think this to be shortsighted, unnecessarily discouraging people with alcohol use disorder from pursuing treatment. Raymond Anton, MD is noted to be advocating for a new endpoint recognizing the benefits of lesser reductions in alcohol intake. 

I am confused as to whether the entire discussion within the article revolves around alcohol use or whether instead it revolves around alcohol use disorder. And I worry that those advocating for a new endpoint may also have some confusion. I especially am concerned that the referenced article is based on COMBINE data, which itself was quite flawed due to the requirement of a certain volume of alcohol intake for inclusion, thereby studying only a subset of those with alcohol use disorder rather than a representative disease population. 

Alcohol use disorder does not have a severity level based upon volume or frequency of alcohol intake. Because of that, the severity of alcohol use disorder does not improve if volume or frequency of intake declines. On the other hand, morbidity secondary to alcohol use disorder may indeed be related to volume and frequency of alcohol intake. And therefore, if volume/frequency declines, morbidity would likely improve, at least for a short period of time. 

Similarly, patients with tuberculosis have a cough. The frequency and intensity of coughing is not utilized to determine the severity of TB. However, the coughing can be impairing and can be considered an aspect of morbidity from TB. So here’s the question: If we give something (methadone, perhaps) to improve the cough in TB, resulting in improved morbidity, are we treating the TB? Are we altering the long term TB disease course? 

The answer to both is no, of course we’re not. Similarly in alcohol use disorder, a decrease in alcohol intake will certainly help the patient feel better and will likely result in improvement in short term sequelae. It will not, however, impact the underlying addictive disease, nor, I fear, will it result in any improvement in the long-term disease course. And the one year study referenced here is nowhere near a long enough period to be useful in determining disease course for a lifelong chronic illness. At best, it can hint at what might be useful for that subset of the alcohol use disorder population that was originally included in the COMBINE data. 

– Stuart Gitlow MD, MPH, MBA
  Past President, ASAM

Dr. Raymond Oenbrink