The Food and Drug Administration (FDA) has just issued guidelines to the pharmaceutical industry in an attempt to encourage them to bring novel drugs to market to assist opioid addicts in their quest for recovery. Whether or not this is good news for any family seeking to save a loved one’s life depends on what result they want for their family member. Do they want that person to recover their health and self-determinism because they have broken free from addiction? Or is it enough that they are not risking overdose or exposure to Hepatitis C or HIV with every injection? A discussion of the desired outcome of addiction treatment is at the heart of these new guidelines.
The result of treatment for addiction is now being referred to as an “endpoint.” And given the urgent need to prevent overdoses and save lives, the FDA is encouraging pharmaceutical corporations to look at many different “alternative endpoints” that could justify approval for their products.
The FDA materials state: We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission.
The FDA goes on to advise pharmaceutical companies interested in throwing their hats into the ring on how to work with these other measures:
Sponsors and other stakeholders often mistakenly believe that using a change in drug use patterns as the endpoint always requires complete abstinence. However, the sponsor could employ drug use patterns other than abstinence as thresholds to define response to OUD treatment. In proposing other drug use patterns as response-defining thresholds, the sponsor should specify how the change in drug use pattern will be measured. Certain changes in drug use patterns, such as “fewer occasions of use per day” or “reduced amount of use per occasion,” may prove impractical to measure. In addition, to support a drug use pattern as a response-defining threshold, the sponsor should evaluate and submit evidence from clinical trials, longitudinal observational studies, or other sources of information to show that such reduction in drug use predicts clinical benefit (i.e., better health outcomes or psychosocial function). Sponsors should discuss with the [FDA] division approaches to measure change in drug use patterns and how evidence of clinical benefit could be generated. [Emphasis added.]
This discussion of the endpoint being sought is extremely important. The FDA is talking here about how a pharmaceutical company can validate their new medication. In this passage, the FDA is essentially stating that “harm reduction is good enough.” Abstinence—meaning freedom from the abuse of prescription or illicit drugs—is not required to be “good enough.”
Is it good enough? Isn’t harm reduction a completely different activity from addiction treatment? Harm reduction measures include handing out clean syringes, teaching people how to prevent overdoses as they inject heroin and providing safe, medically-supervised injecting facilities. If the American medical industry settles on harm reduction as the acceptable endpoint of medication-assisted treatment, are they really doing their job for addicted Americans?
Is MAT Even Being Administered Properly?
One of the FDA documents that discuses endpoints makes an important and relevant comment on how buprenorphine products used in MAT should be administered. That comment follows the passage quoted above which we include again here for clarity:
We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission… Treatments that can impact these aspects of addiction can be important parts of a comprehensive approach to the treatment of opioid use disorder. [Emphasis added.]
At the moment, according to the website of the Substance Abuse and Mental Health Services Administration (SAMHSA), there are more than 45,000 practitioners approved to dispense buprenorphine products to those struggling with addiction. The requirement for approval to bring in addicted patients and prescribe buprenorphine consists of being licensed to prescribe medications (doctor, nurse, etc.), completing an eight-hour online course and making an application for approval to the Drug Enforcement Administration.
These requirements in no way require a prescriber to establish a comprehensive program of addiction treatment. But according to SAMHSA: Medications such as buprenorphine, in combination with counseling and behavioral therapies, provide a whole-patient approach to the treatment of opioid dependency.
Where is the verification that patients are getting more than just pills or tiny sheets of film to tuck into their cheeks? Is there a regulatory body collecting information from these 45,000 practitioners and ensuring that patients have a complete approach to their recovery?
One wonders if opening the door to novel treatment drugs is premature, if there is a lack of verification that the existing drugs are being properly used. If they are not being used in comprehensive recovery programs, why would novel drugs being brought to market make our situation any better?