FDA Is Under Fire for Approving a Genetic Test for Risk of Opiate Addiction

(NewsReady.com) – The opioid crisis has taken hundreds of thousands of lives over the last 20 years. It’s also created a problem for chronically ill patients who need powerful pain medications to function. The Food and Drug Administration (FDA) is now taking heat for approving a genetic test for opioid addiction risk.

In December, the FDA approved a test called AvertD. The company that makes the test, SOLVD Health, claims it detects several genetic markers associated with opioid addiction. The company calls for doctors to use the test before they prescribe a patient opioids for the first time.

On April 4, a group of experts sent a letter to FDA Commissioner Dr. Robert Califf and urged him to revoke the test’s approval. Genetic scientists, addiction specialists, psychiatrists, and others signed off on the letter. They stated that there’s not enough scientific evidence about opioid addiction and genetics to prove the test can actually predict a person’s risk of becoming addicted to the medication.

According to the letter, AvertD detects 15 gene markers, but the experts argue this is a method that most mainstream geneticists have abandoned. Further, the group states that studies show that even testing a “full genome’s worth of markers (roughly 6,000,0000)” doesn’t provide enough information to determine whether someone is predisposed to addiction.

Most alarmingly, the experts pointed out that a peer-reviewed study was conducted using the same methodology as AvertD and found the test “did not predict the risk of [opioid addiction] any better than chance.”

In other words, the scientists and other experts allegedly discovered the test does not work. They warned it could lead to a situation where patients who have tested negative “have a false sense of security about the use of opioids.” Or doctors might not prescribe medication to patients who need it just because the test results claimed they were predisposed to opioid addiction. They go on to say that it could disproportionately impact minorities because of the methodology used.

A spokesperson for the FDA told NBC News that the agency approved the test because there’s a need for devices that could have an impact on the overdose crisis. The spokesperson did not explain how a device that’s allegedly useless would help.

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