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The Food and Drug Administration (FDA) is facing criticism following its approval of a genetic test called AvertD, designed to assess the risk of opioid addiction.
The test, developed SOLVD Health, aims to identify individuals at heightened risk for opioid use disorder detecting specific genetic markers. Despite its December approval, concerns have emerged regarding the test’s efficacy and potential impact on opioid prescribing practices.
Experts Share Concerns About Opioid Genetic Test
AvertD operates on the premise that genetic predispositions play a significant role in addiction susceptibility. However, experts argue that addiction is a multifaceted issue influenced various factors beyond genetics, such as socioeconomic status and environmental exposure.
Dr. Katherine Keyes of Columbia University stresses the complexity of addiction, suggesting that relying solely on genetic markers may oversimplify the risk assessment process.
“We know the risk of [opioid use disorders] increases with the dose and duration of an opioid prescription,” Keyes told NBC News. “Receiving an opioid prescription remains one of the strongest risk factors for the development of opioid use disorder.”
Additionally, the FDA’s decision to greenlight AvertD contradicted the recommendations of its independent advisory committee, which expressed reservations about the test’s accuracy and its potential to exacerbate overprescribing.
Critics fear that false positives and negatives could lead to inappropriate opioid prescribing practices, putting patients at risk of addiction or depriving them of necessary pain management.
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(Photo : DON EMMERT/AFP via Getty Images)
A Drug Enforcement Administration (DEA) chemist checks confiscated powder containing fentanyl at the DEA Northeast Regional Laboratory on October 8, 2019 in New York. According to US government data, about 32,000 Americans died from opioid overdoses in 2018. That accounts for 46 percent of all fatal overdoses. Fentanyl, a powerful painkiller approved the US Food and Drug Administration for a range of conditions, has been central to the American opioid crisis which began in the late 1990s.
Worsening US Opioid Crisis
Dr. Andrew Kolodny, a prominent voice in opioid policy research, warns that AvertD could worsen the ongoing opioid crisis contributing to increased addiction rates. Despite SOLVD Health’s claim of AvertD’s ability to accurately predict addiction risk using 15 genetic markers, skepticism remains prevalent within the scientific community.
Dr. Adam Gordon, who voted against AvertD’s approval on the FDA advisory panel, highlights the agency’s acknowledgment of the test’s inherent risks.
Meanwhile, political tensions surround the issue as House Republicans propose budget cuts affecting crucial funding for states’ responses to the opioid epidemic, the White House said in a recent briefing. President Biden emphasizes the importance of bipartisan efforts to combat the crisis, advocating for increased access to treatment and stricter border security measures to curb fentanyl trafficking.
The State Opioid Response grant program, targeted for cuts House Republicans, has played a vital role in expanding access to addiction treatment and overdose reversal medications. Since 2018, the program has facilitated treatment for over 1.2 million individuals and reversed more than 550,000 overdoses nationwide.
In light of the controversy surrounding AvertD, SOLVD Health is mandated to provide training to healthcare professionals on the test’s appropriate usage. Additionally, the company is required to conduct a large-scale study to further evaluate the test’s effectiveness.
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