Opioid Addiction Test Controversy: FDA Approval Reconsidered

A group of specialists urged the commissioner to cancel the agency’s approval of the test in a letter, claiming it is ineffective.

TFD – Explore the ongoing controversy surrounding the FDA’s approval of a genetic test by SOLVD Health meant to identify susceptibility to opioid addiction. A group of specialists has raised concerns about its efficacy, leading to discussions about the risks and benefits of genetic marker testing for opioid use disorder. Stay updated on this critical healthcare debate.

Reactions to the Food and Drug Administration’s approval of a genetic test meant to identify those who are more susceptible to opioid addiction are being felt.

The FDA authorized the test, known as AvertD, in December. It finds a few genetic markers linked to opioid use disorder, according to the maker, SOLVD Health, based in California. It is intended to be used prior to the first time an opioid prescription is given; for instance, prior to surgery, when a doctor would recommend a brief course of opioids for recuperation.

In theory, this is a promising test: for certain individuals, even a brief prescription for an opioid medication might lead to addiction.

Over the past 20 years, the opioid problem in the US has been linked to about 645,000 deaths. In 2022, the Substance Abuse and Mental Health Services Administration estimated that 6.1 million Americans suffered from an opioid use disorder.

The agency disregarded the opinion of its own independent advisory group, which overwhelmingly voted against approval of AvertD in 2022 due to worries that the test might not be able to detect individuals who are at risk for opioid use disorder, which could result in overprescribing. Nevertheless, the government still cleared AvertD.

A group of medical professionals and researchers urged the FDA to withdraw the clearance of the test in a letter dated Thursday that was written to FDA Commissioner Robert Califf. They claimed the test did not predict opioid use disorder “any better than chance.”

Among those who signed the petition was Dr. Andrew Kolodny, medical director of opioid policy studies at Brandeis University in Massachusetts, who stated, “This test will make the opioid crisis worse.” “It will lead to an increase in the incidence of opioid use disorder and overprescribing.” To put it another way, more people are developing new opioid addictions.

The consequences of making a mistake

The letter’s writers specifically criticize SOLVD Health’s assertion that its test, which uses 15 genetic markers, can reliably predict a person’s likelihood of developing an opioid addiction.

Making a mistake has repercussions: According to the authors, a test that is unable to identify a patient who is at risk could mislead both the patient and the physician on opioid usage. However, falsely classifying a patient as at risk may cause a physician to refuse to provide the patient with the necessary opioid prescriptions, burdening them with a highly stigmatized medical condition in the process.

A representative for SOLVD Health issued a statement stating that while the business is examining the letter, it still feels that the approval “represents a significant step forward.”

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

Regarding the letter, the FDA declined to comment.

The clearance of the test was attributed, according to an agency representative, to “the urgent need for medical devices that can make a positive impact on the overdose crisis.” Before approval, the FDA has addressed the advisory committee’s concerns in collaboration with SOLVD Health.

“The FDA determined that there is reasonable assurance of AvertD’s safety and effectiveness,” stated a spokesman.

Dr. Katherine Keyes, an epidemiology professor at Columbia University Mailman School of Public Health in New York, stated that many in the scientific community, however, are extremely sceptical that a person’s risk of opioid use disorder can be predicted based on only a few genetic markers.

She described addiction as a “complex trait” that encompasses many variables outside heredity, such as a person’s socioeconomic background and level of substance use.

Using the acronym for opioid use disorders, Keyes stated, “We know the risk of OUD increases with the dose and duration of an opioid prescription.” “One of the strongest risk factors for the development of opioid use disorder is still having a prescription for opioids.”

According to Kolodny, a test can also unjustly single out individuals who might be more predisposed to having these genetic markers.

Kolodny declared, “There isn’t a single genetics professor in the United States or anywhere else who would tell you that using these 15 genetic markers will tell you anything.”

On the FDA advisory panel in 2022, Dr. Adam Gordon, a professor of medicine and psychiatry at the University of Utah School of Medicine, voted against the approval of AvertD. He said that the risk of using such a test has been acknowledged even by the FDA.

FDA staff stated in briefing materials released before to the advisory committee meeting that genetic risk “may not be the biggest factor” in opioid use disorder.

Additionally, the FDA stated in a release announcing AvertD’s approval that false positives and false negatives are the test’s primary risk.

Using metrics called sensitivity and specificity, SOLVD Health evaluated the test’s efficacy in separating out false positives and false negatives in its application for approval.

According to Dr. Andrew Saxon, a professor of psychiatry and behavioral sciences at the University of Washington School of Medicine, a highly specific test accurately rules out people without the condition, minimizing false positives, while a highly sensitive test accurately identifies people with the condition, minimizing false negatives.

“A quarter of the individuals you identify in the test as potentially having this disorder did not have this disorder, if your specificity was 75%,” he explained.

According to SOLVD Health’s application, AvertD showed a sensitivity of roughly 82% and a specificity of roughly 79%.

According to those figures, about 1 in 5 findings would be erroneous positives and about 1 in 5 false negatives.

Gordon stated, “I believe the product has the potential to cause harm.”

In order to guarantee that the test is being administered correctly, SOLVD Health must train healthcare professionals as part of AvertD’s clearance process. The business must also conduct a comprehensive study to further evaluate the test’s efficacy.

The FDA has a track record of approving goods notwithstanding the advisory committees’ claims that there is insufficient data to support their efficacy or safety.

For instance, in 2021, the FDA authorized Biogen’s Aduhelm, an Alzheimer’s medication, even though its advisory committee had rejected it, citing insufficient proof of the medication’s efficacy.

The medication was taken off the market by the business earlier this year.