by A group of public health experts and scientists is asking the Food and Drug Administration to approve a controversial DNA test that promises to predict genetic risk of opioid addiction.
In a letter sent to the agency on Thursday, 31 experts in genetics, addiction, psychiatry and medical device regulation called for the approval of AvertD to be a mistake that relied on flawed science and put patients at risk. The group sent a separate letter to the Centers for Medicare and Medicaid Services urging the agency, which oversees government health insurance programs, to deny coverage for the prescription-only test.
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The Washington Post last month highlighted concerns about the tests reliability and unintended consequences of false results. The letters said that a negative test could give patients a false sense of security, or that doctors “may prescribe cessation of opioids for patients who test positive, even in cases where opioids are beneficial.”
“Adverse consequences of invalid genetic testing for [opioid use disorder] clear,” the experts wrote.
The test’s developer, SOLVD Health, said in a statement Thursday that it was reviewing the letters and that the FDA’s approval was “a significant step forward” in helping doctors and patients discuss alternatives to opioids. “In the hands of physicians, the test results can be a critical tool to help fight opioid use disorder,” the company said.
The FDA, in a statement, declined to comment on the letters. But she emphasized that the agency received a reasonable guarantee regarding the safety and effectiveness of the test “in light of the totality of the available evidence and the urgent need for medical devices that can have a positive impact on the overdose crisis.”
CMS said, in a statement, that it has “received the letter and will respond directly to the experts.”
The FDA authorized AvertD in December against the backdrop of a crushing overdose crisis that kills more than 100,000 people in the United States each year, mostly from illicit synthetic opioids such as fentanyl. The unprecedented public health crisis began in the late 1990s when doctors increasingly prescribed addictive pain pills heavily marketed by pharmaceutical companies.
The test is aimed at patients who may be prescribed opioids before surgeries. SOLVD Health and the FDA have said the test does not predict whether a person will develop opioid addiction but instead indicates whether a person is at “high” genetic risk. They say doctors should use the test as part of a comprehensive patient risk assessment.
SOLVD Health, in its statement, emphasized that fact a clinical trial conducted the test consistent with regulatory guidelines and standards.
Questions about the reliability of AvertD were raised publicly in October 2022 when an FDA advisory committee made up of independent experts met. The panel voted 11-2 against recommending approval, prompting the FDA to require more analysis of study data, add strict labeling and impose requirements to educate doctors and patients about the test’s limitations.
The letter writers expressed concerns raised at that committee meeting about the science behind AvertD, the first FDA-approved test that relies on polygenic genetic testing, which analyzes small variations in the abundance of genes that may affect susceptibility to disease.
The company analyzes swab samples from the inside of a patient’s cheek, assessing DNA for 15 genetic markers associated with opioid use disorders, then runs the results through a trained algorithm on genetic data from more than 7,000 people, some of whom have been diagnosed with opioid use disorder. The result is a score between zero and one, and an elevated genetic risk of 0.33 or higher is considered.
“This test is based on an approach that has been abandoned by mainstream genetics,” the scientists wrote in the letters, which were posted Thursday on the website of Physicians for Responsible Opioid Prescribing, a group that educates about the dangers of the medications. on prescription.
The scientists say the sample size of the data used by AvertD to predict opioid risk is not large enough to predict opioid use disorder in a “clinically useful way,” and that the genetic data may skew results for minority populations or those of mixed heritage. to shale from different parts of the world. Controlling for ancestry means the algorithm does not predict opioid addiction “better than chance,” they wrote.
The company “fell into well-known traps … that give the appearance of predicting genetic risk, without being a true measure of genetic risk,” the letters state.
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