The U.S. Food and Drug Administration on Tuesday approved a new tool that uses genetic testing to help assess whether certain people are at risk for developing opioid use disorder.
The AutoGenomics EvertD trial is for adults who are considering a short-term course of oral opioid pain medications, such as after a planned surgical procedure. It can only be prescribed to people who have not used opioids before, and patients must consent to the trial. It is not for people who are being treated for chronic pain.
The opioid crisis, one of the most serious public health issues facing the United States, requires innovative measures to prevent, diagnose, and treat opioid use disorder, including assessing the risk of developing the disorder. said Dr. Jeff Shuren, FDA director. The Center for Devices and Radiological Health said in a statement. This approval marks another step forward in the FDA’s efforts to prevent new cases of OUD, support the treatment of people with the disorder, and reduce the misuse of opioid analgesics.
However, some experts are skeptical of its use in clinical practice and warn that some of its limitations may have dangerous unintended consequences.
The AvertD test uses a sample from a cheek swab to analyze 15 genetic markers that are involved in the brain’s reward pathways and linked to addiction.
But Dr. Andrew Saxon, professor of psychiatry and behavioral sciences at the University of Washington School of Medicine, said genetics is a complicated business. It’s not a simple Mendelian inheritance where there’s a mutation in one gene and that gives you opioid use disorder. It has a plethora of different genes, all of which contribute to this effect.
and there is evidence that these factors may appear to varying degrees across demographic groups, making them difficult to identify in population samples, said Dr. Katherine Keyes, a professor at the Columbia University Mailman School of Public Health, whose research focuses on the epidemiology of psychiatric and substance abuse.
So the likelihood that a commercially developed genetic test for OUD would have the kind of validity that you would need to actually drive clinical practice based on the extensive scientific literature seems like a stretch, he said. Said. If you just ask people, is there a history of drug addiction in your family? I would guess that this would be a better risk classifier than genetic testing.
Even asking a patient about their history of substance use, especially tobacco use, can be equally insightful, Saxon said.
If genetic testing is relied upon too heavily, a false negative result on the test may give patients and their providers a sense of security about their risk of developing opioid use disorder, and a false positive result may limit the patient’s access to useful medications. May limit access.
This risk-benefit analysis was at the center of the discussion about the trial at an FDA advisory committee meeting in October 2022, and the independent panel ultimately recommended against it in an 11-2 vote.
The FDA later worked with AutoGenomics as it modified the test. The terms of the new approval require the company to provide training to health care providers on the appropriate use of the test and conduct a larger study assessing post-market performance with regular progress reports.
Shuren said information from the trial could help make better decisions for patients who are concerned about being treated with opioids for acute pain. This information should be used as part of a thorough clinical assessment and risk assessment; It should not be used alone to make treatment decisions.
According to recent survey data from the US Department of Health and Human Services, nearly 6 million people ages 12 and older in the US are expected to have opioid use disorder in 2022. And drug overdose deaths have increased in recent years, involving opioids nearly three-quarters of the time. More than 83,000 people died from opioid overdoses last year, according to data from the US Centers for Disease Control and Prevention.
Keyes said, I still think that prescribed opioids remain a major risk factor for developing opioid use disorder. I would encourage physicians to look at the literature and make sure they are comfortable with the level of safety of the product.
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