The Food and Drug Administration (FDA) is under scrutiny for its recent approval of a genetic test designed to predict an individual's susceptibility to opioid addiction. The test, known as AvertD, received FDA clearance in December. It identifies several genetic markers that the manufacturer, SOLVD Health based in California, claims are linked to opioid use disorder. Intended for use before an individual is prescribed opioids for the first time, such as prior to a surgery, the test aims to help identify those at risk.
However, concerns have been raised regarding its efficacy and potential for overprescription.
The United States has been grappling with an opioid crisis that has resulted in nearly 645,000 deaths over the last two decades. In 2022, approximately 6.1 million people in the U.S. were reported to have an opioid use disorder, as per the Substance Abuse and Mental Health Services Administration. Despite these alarming figures, the FDA's decision to approve AvertD contradicted the advice of its independent advisory committee, which had recommended against approval in 2022 due to doubts about the test's ability to accurately identify individuals at risk for opioid use disorder.
In a letter to FDA Commissioner Robert Califf dated Thursday, a group of doctors and researchers urged the agency to revoke its approval of AvertD, asserting that the test is no better at predicting opioid use disorder than chance.
Dr. Andrew Kolodny, the medical director of opioid policy research at Brandeis University in Massachusetts and a signatory of the letter, stated, "This test will exacerbate the opioid crisis. It will lead to overprescription and an increase in opioid use disorder, resulting in more individuals becoming newly addicted to opioids."
One of the primary concerns raised by the letter's authors is SOLVD Health's claim that AvertD can accurately predict an individual's risk for opioid addiction based on 15 genetic markers.
However, many experts remain skeptical, arguing that addiction is a multifaceted issue influenced by various factors beyond genetics, such as socioeconomic status and substance exposure.
Dr. Katherine Keyes, a professor of epidemiology at the Columbia University Mailman School of Public Health in New York, emphasized the complexity of addiction, stating that receiving an opioid prescription remains one of the most significant risk factors for developing opioid use disorder. She noted that while genetic markers may play a role, they are not the sole determinants of addiction risk.
Dr. Adam Gordon, a professor of medicine and psychiatry at the University of Utah School of Medicine, who voted against AvertD's approval on the FDA's advisory panel in 2022, expressed concerns about the test's potential to do harm.
He cited the FDA's acknowledgment of the risk associated with the test, as outlined in briefing documents ahead of the advisory committee meeting, which stated that genetic risk "may not be the biggest factor" for opioid use disorder.
Despite these concerns, the FDA defended its decision to approve AvertD, stating that innovative measures are necessary to address the opioid crisis.
The agency also noted that it collaborated with SOLVD Health to address the advisory committee's concerns.
However, skepticism persists within the scientific community regarding the test's ability to accurately predict opioid use disorder based on a limited number of genetic markers.
SOLVD Health claimed in its application for approval that AvertD demonstrated a sensitivity of approximately 82% and a specificity of about 79%. While these figures suggest relatively high accuracy, critics argue that the potential for false positives and false negatives could lead to harmful outcomes.
As part of AvertD's approval, SOLVD Health is required to provide training to healthcare workers to ensure appropriate use of the test and conduct further studies to assess its effectiveness.
The controversy surrounding AvertD highlights broader concerns about the FDA's regulatory process for approving tests and treatments, particularly in cases where there is limited evidence of their safety and effectiveness.
Critics argue that the FDA's approval of AvertD, despite the concerns raised by its advisory committee and the scientific community, raises questions about the agency's ability to safeguard public health in the face of complex public health challenges like the opioid crisis.