A group of public health experts and scientists is calling on the Food and Drug Administration to rescind its controversial approval of a DNA test that promises to predict the genetic risk of opioid addiction.
In a letter sent to the agency on Thursday, 31 experts in the fields of genetics, addiction, psychiatry and medical device regulation called the approval of AvertD a mistake based on flawed science and putting patients at risk. The group sent a separate letter to the Centers for Medicare and Medicaid Services, saying: The agency that oversees government health insurance programs will deny coverage for the prescription-only test.
Subscribe to The Post Most newsletter for The Washington Post’s most important and interesting stories.
The Washington Post highlighted concerns about the results of the test last month reliability and the unintended consequences of incorrect results. A negative test could give patients a false sense of security or lead doctors to “refrain from prescribing opioids to patients who test positive, even in cases where opioids are helpful,” the letters said.
“Harmful consequences of an invalid genetic test [opioid use disorder] It is clear,” the experts wrote.
SOLVD Health, the developer of the test, said in a statement Thursday that the letters had been reviewed and that the FDA’s approval “represents a significant step forward” in helping doctors and patients discuss alternatives to opioids. “In the hands of physicians, test results can be a critical tool in the fight against opioid use disorder,” the company said.
The FDA declined to comment on the letters in a statement. But he emphasized that the agency found reasonable assurance about the safety and effectiveness of the test “given the totality of 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 had “received the letter and will respond directly to experts.”
The FDA authorized AvertD in December amid a crushing overdose crisis in the United States in which more than 100,000 people die each year, mostly from illicit synthetic opioids like fentanyl. The unprecedented public health crisis began in the late 1990s when doctors increasingly prescribed addictive pain pills aggressively marketed by pharmaceutical companies.
The testing is for patients who may be prescribed opioids before surgeries. SOLVD Health and the FDA emphasized that the test does not predict whether a person will develop opioid addiction, but instead indicates whether the person is at “high” genetic risk. They say doctors should use the test as part of a comprehensive assessment of a patient’s risk.
SOLVD Health emphasized the following in its statement: The test has been validated in a clinical trial consistent with regulatory guidelines and standards.
Questions about the safety of AvertD were made public in October 2022, when an FDA advisory committee of independent experts convened. The panel voted 11-2 against the recommendation, directing the FDA to require further analysis of the study data, add strict labeling and impose requirements to educate doctors and patients about the test’s limitations.
The letter writers echoed concerns expressed at the committee meeting about the science supporting AvertD, the first FDA-approved test based on polygenic genetic testing, which analyzes small changes in multiple genes that may affect susceptibility to a disease.
The company analyzes swabs taken from a patient’s cheek, evaluates DNA for 15 genetic markers associated with opioid use disorders, and then runs the results through an algorithm trained on genetic data from more than 7,000 people, some of whom have been diagnosed with opioid use disorders. The result is a score between zero and one; A score of 0.33 or higher is considered high genetic risk.
“This test is based on an approach that has been abandoned by mainstream genetics,” the scientists wrote in letters published Thursday on the website of Physicians for Responsible Opioid Prescribing, a group that provides education about the dangers of prescription drugs.
The sample size of the data AvertD used to estimate opioid risk was not large enough to predict opioid use disorder in a “clinically useful way,” and genetic data could potentially skew results for minority populations or those of mixed heritage, the scientists say. in different parts of the world. Controlling for ancestry means the algorithm doesn’t predict opioid addiction “better than chance.”
The letters state that the company “falls into known traps of appearing to predict genetic risk without a true measure of genetic risk.”
Related Content
Big Food and dietitians offer ‘anti-diet’ advice as obesity rises
Wes Moore predicted economic recovery. Later, the Key Bridge collapsed.
Problem with sneakers? They are made to last for a very long time.