FDA Urged To Rescind Approval Of Opioid Addiction Test

FDA Faces Backlash Over Genetic Test For Opioid Addiction Risk

The United States Food and Drug Administration (FDA) is facing backlash over its approval of a genetic test to detect if a person is at risk for opioid use disorder.

The test, known as AdvdertD, was approved by the administration in December of 2023 and was touted as the first DNA test to evaluate if people have an elevated risk for opioid addiction. Using a buccal swab, a sample taken from the inside of the cheek, AdvertD is meant to help guide decisions about opioid prescriptions for patients not previously treated with these drugs, such as someone undergoing a planned surgery, the FDA said.

However, the FDA’s approval of AdvertD went against advice given by its own independent advisory committee, which nearly unanimously voted against the test in 2022 over concerns the test may fail to identify potential addiction risk factors, leading to overprescribing.

Currently, the opioid crisis is responsible for over 720,000 deaths since 2000, with nearly 250,000 of those occurring in the last 5 years alone.

Scientists Voice Concerns Over AdvertD

It’s not just the FDA’s own independent advisory committee voicing concerns over the approval of AdvertD. On April 4, a group of 30 physicians and researchers led by Michael T. Abrams, MPH, PhD, senior health researcher for Public Citizen’s Health Research Group, urged the FDA to reconsider its approval.

Abrams and other signers of the letter, which included Andrew Kolodny, MD, the Medical Director for the Opioid Policy Research Collaborative at Brandeis University, said the algorithm used in creating AvertD “fell into known pitfalls of genetic prediction that give the appearance of predicting genetic risk, without being a true measure of genetic risk.”

“The harmful consequences of an invalid genetic test for OUD are clear. Patients who test negative, and their clinicians, may have a false sense of security about use of opioids,” the letter states.

The letter adds that false-positive test results may result in harmful consequences, with clinicians refraining from prescribing needed opioids, a problem that may be magnified in minority populations.

Why False Results Can Be Harmful

Along with Dr. Kolodny and Dr. Abrams, another signer of the letter is Alexander Hatoum, PhD, from Washington University, who conducted an independent analysis of AdvertD. The study, which was published back in 2021 in Drug and Alcohol Dependency, found that none of the genetic predictability tests, including AdvertD, “predict OUD better than chance when ancestry was balanced.”

Hatoum explained that most patients are not aware of the limits of genetic testing, and that the availability of an OUD test may give the impression that there are specific, identifiable genes that make someone more vulnerable.

“But it’s just not reality for most diseases,” Hatoum explained in a recent interview.

“This test will make the opioid crisis worse,” said Dr. Andrew Kolodny, medical director of opioid policy research at Brandeis University in Massachusetts and one of the those who signed the letter. “It will contribute to overprescribing, it will contribute to an increased incidence of opioid use disorder. In other words, more people [are] becoming newly addicted to opioids.”

“You’re not going to find a genetics professor in the United States or anywhere that would say using these 15 genetic markers will tell you anything,” Kolodny said.

SOLVD Health Responds To Criticism

In a recent statement by SOLVD Health, the company that manufactures AdvertD, a spokesperson said the company was “reviewing the letter,” but believes the FDA’s approval “represents a significant step forward.”

“In the hands of physicians, the test results can be a critical tool to help combat opioid use disorder,” the spokesperson said.

To date, the FDA has declined to speak on the letter. However, the agency did comment on the approval of the tests, claiming it cleared AdvertD due to “”the urgent need for medical devices that can make a positive impact on the overdose crisis.”

Currently, SOLVD is not selling AdvertD in the United states, and has yet to declare a price for the product. Hatoum, Kolodny, Abrams, and other signers of the letter urged the FDA not to use federal funds to pay for the test.

Assessing Your Risk

Genetic testing for opioids may not be where they need to be as of yet, but that doesn’t mean you can’t assess your risk through other methods. Speaking with an addiction specialist or someone versed in addiction criteria can be a great way to assess your current relationship with substances and help you get an idea of your risk level.

An addiction specialist can help guide you through an assessment utilizing criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) to gauge whether or not an opioid use disorder is present. A result of 2-3 present symptoms is classified as a “mild” OUD, while 4-5 and 6 or more are classified as “moderate” and “severe” respectively. The criteria outlined in the DSM-5 for opioid use disorder include the following:

• Opioids are often taken in larger amounts or over a longer period of time than intended.
• There is a persistent desire or unsuccessful efforts to cut down or control opioid use.
• A great deal of time is spent in activities necessary to obtain the opioid, use the opioid, or recover from its effects.
• Craving, or a strong desire to use opioids.
• Recurrent opioid use resulting in failure to fulfill major role obligations at work, school, or home.
• Continued opioid use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of opioids.
• Important social, occupational or recreational activities are given up or reduced because of opioid use.
• Recurrent opioid use in situations in which it is physically hazardous
• Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by opioids.
• Tolerance, as defined by either of the following: a need for markedly increased amounts of opioids to achieve intoxication or desired effect or markedly diminished effect with continued use of the same amount of an opioid
• Withdrawal, as manifested by either of the following: the characteristic opioid withdrawal syndrome or the same (or a closely related) substance are taken to relieve or avoid withdrawal symptoms.

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If you or someone you know is struggling with an opioid addiction, waiting to get help is never the answer. To learn more about opioid addiction treatment, contact a treatment provider today to find out what options are available to you.