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Thought Leadership

​A Response to the FDA’s Proposal on Treating Alcoholism

Under a proposal by the Food and Drug Administration (FDA), drugs to treat alcoholism would not have to lead to sobriety in order to be approved, according to The Partnership for Drug-Free Kids. In order to be approved, these drugs would only have to demonstrate that patients would reduce their alcohol consumption.

According to FDA spokesman Eric Pahon, “The abstinence-based endpoints have often been considered an unattainable threshold in the clinical trial setting, and may be considered a hindrance to clinical development for drugs to treat alcoholism. While total abstinence from alcohol is desirable, reducing heavy drinking to within ‘low-risk’ daily limits presents an alternative goal in drug development so more treatments may be developed.”

We appreciate and respect the goal of the FDA to address the epidemic of alcoholism in America. However, their proposal and its rationale demonstrate a perpetual misunderstanding. It is critical to affirm that alcoholism is a chronic and progressive disease. There is no quick fix and/or middle ground. Moderation management and harm reduction treatments should be viewed with skepticism and careful consideration by clinicians and patients alike.

Because alcoholism is a disease, the optimal state of wellness is not only total abstinence from alcohol, but also an overarching philosophical change to a recovering person’s behavior and approach to life. Alcoholics have learned to turn to drinking when they are anxious, happy, depressed, celebratory, and a multitude of other emotions. The goal of treatment and recovery should be navigating life without the need for any amount or type of substance. Why promote medications and treatment modalities that appeal to every alcoholic’s utopia? Of course an alcoholic wants to keep drinking in a controlled fashion. Of course he or she will embrace this chance for improvement with a pill.

The issue is approving drugs that would reduce alcohol consumption would be akin to putting a small bandage on a gash that needs extensive stitches and follow-up monitoring. Taking a pill is not a solution because alcoholism needs to be treated comprehensively.

At Caron, we embrace the belief that the journey towards sobriety begins with an integrated treatment approach that addresses our patients’ physical, mental, emotional and spiritual issues in order to reach the core of their addiction. Alcoholics need counseling, they need to understand the disease, and they need to learn alternative coping skills through education and practice. They also need a daily program of recovery via working the 12-Steps to remain focused and committed to their recovery.

While the FDA may have good intentions, it is our belief at Caron that they should reconsider their proposal on treating alcoholism.

David Rotenberg is Executive Vice President of Treatment at Caron Treatment Centers

David Rotenberg
Featured Expert
David Rotenberg

Mr. Rotenberg is the Chief Clinical Officer for Caron Pennsylvania. He is recognized throughout the industry as an expert in treating co-occurring mental health disorders, relapse and family issues, and innovative approaches to the intervention and treatment of adolescents and young adults.

During his 20 year tenure at Caron, Mr. Rotenberg has pioneered treatment approaches and developed...

Mr. Rotenberg is the Chief Clinical Officer for Caron Pennsylvania. He is recognized throughout the industry as an expert in treating co-occurring mental health disorders, relapse and family issues, and innovative approaches to the intervention and treatment of adolescents and young adults.

During his 20 year tenure at Caron, Mr. Rotenberg has pioneered treatment approaches and developed...