FDA Approves Genetic Test for Opioid Use Disorder
In a groundbreaking development, the FDA has given the green light to AVERT-D, the first-ever genetic test that can help determine a person's increased risk of opioid use disorder. This test utilizes a simple cheek swab to analyze genetic markers associated with addiction in the brain's reward system. With approximately six million people in the United States aged 12 and older suffering from opioid use disorder, this announcement brings hope in the fight against this major public health crisis.
Dr. Megan Ranney, an emergency room physician and the Dean of Yale's School of Public Health, expressed her excitement about the new test, but also emphasized some crucial caveats. The widespread prevalence of opioid use disorder can be traced back to the promotion of opioids by companies such as Purdue Pharmaceuticals and the Sackler family over a decade ago. Increased exposure to prescription opioids has become a significant risk factor for developing opioid use disorder. The ability to quickly identify individuals at risk of addiction or those who can safely be prescribed opioids for short-term ailments has a significant impact on pain management for patients with acute medical conditions.
However, there are limitations to this exciting development. The AVERT-D test is currently only recommended for individuals with short-term prescription opioid needs, such as those undergoing orthopedic surgeries or experiencing acute trauma. Additionally, the test is not foolproof, as it misidentifies 20% to 30% of people as either being at risk or not being at risk of addiction. Therefore, it must always be combined with a clinical assessment before making any treatment decisions.
Following FDA approval, the next steps for AVERT-D involve scaling up manufacturing, establishing pricing, and securing contracts with doctor's offices. Moreover, healthcare providers need to receive proper training on how to use the test effectively. While the approval marks a significant milestone, it may still be several months, or even up to a year, before AVERT-D is widely available to physicians, pharmacists, and patients.
Given the devastating impact of opioids in communities across the country, close monitoring by the FDA will be crucial as AVERT-D becomes more accessible. It is essential to remember that opioids still have a valid clinical purpose when used appropriately. However, with the potential for false-positive results from the genetic test, there is a risk of withholding necessary pain relief for those mistakenly identified as high risk. Untreated pain can lead to increased post-traumatic stress, chronic pain, and overall distress for patients and their caregivers.
The approval of AVERT-D offers a glimmer of hope in addressing the opioid crisis. As healthcare professionals and researchers work together to refine this new tool, it is vital to strike a balance between accurately identifying at-risk individuals and ensuring adequate pain management for those who truly need it. Only through a comprehensive approach can we combat the devastating effects of opioid use disorder in our society.
