Clinicians Criticize FDA Approval of Genetic Test for Predicting Opioid Addiction Risk

Core Concepts

A group of researchers and clinicians have urged the FDA to revoke its approval of a genetic test, AdvertD, that claims to predict the risk of opioid use disorder, arguing that the test is inaccurate and could lead to harmful consequences for patients.

Abstract

The content discusses the controversy surrounding the FDA's approval of a genetic test called AdvertD, which is marketed to predict the risk of opioid use disorder (OUD). A group of researchers and clinicians, including Michael T. Abrams from Public Citizen's Health Research Group and Andrew Kolodny from Brandeis University, have sent a letter to the FDA calling for the revocation of the test's approval. The key points are: The researchers argue that the algorithm used in AdvertD "fell into known pitfalls of genetic prediction" and does not accurately measure genetic risk for OUD. They warn that false-negative results could give patients and clinicians a false sense of security about using opioids, while false-positive results could lead to clinicians refraining from prescribing needed opioids, particularly in minority populations. An independent evaluation of AdvertD by Alexander Hatoum of Washington University found that many patients may not fully understand the limitations of genetic testing in predicting complex conditions like OUD. The FDA approved the test in December 2023, stating that it had worked with the company on modifications and that the advisory committee's feedback had been considered. However, the FDA's own advisory committee had previously said the probable risks of the test likely outweighed its benefits. Physicians like Maya Hambright emphasize that genetics are just one of many factors in opioid addiction, and that comprehensive patient assessment is crucial when prescribing narcotic painkillers.

Stats

The FDA stated that AdvertD correctly identified an elevated risk for OUD in about 82.8% of cases, equating to a false-negative rate of 18.2%. The false-positive rate was 20.8%.

Quotes

"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." "But it's just not reality for most diseases."

Key Insights Distilled From

Clinicians Slam FDA Over Approval of Opioid Addiction Test

by Kerry Dooley... at www.medscape.com 04-05-2024

https://www.medscape.com/viewarticle/researchers-seek-block-use-fda-approved-oud-risk-test-2024a10006jm

Deeper Inquiries

How can the FDA ensure that genetic tests for complex conditions like OUD are thoroughly evaluated for accuracy and potential harms before approval?

The FDA can ensure the thorough evaluation of genetic tests for complex conditions like OUD by implementing stringent review processes that involve expert panels, independent research validation, and post-market surveillance. Before approval, the FDA should require comprehensive data on the test's sensitivity, specificity, false-positive and false-negative rates, as well as potential risks and benefits. Involving experts in genetics, addiction medicine, and biostatistics in the review process can help assess the test's validity and clinical utility. Additionally, post-market surveillance can monitor real-world outcomes and identify any unforeseen harms or limitations of the test.

What alternative approaches or additional factors should clinicians consider when assessing a patient's risk of opioid addiction, beyond genetic testing?

Clinicians should consider a holistic approach when assessing a patient's risk of opioid addiction, beyond relying solely on genetic testing. Factors such as personal and family history of substance use disorders, mental health conditions, social determinants of health, trauma history, and environmental influences play crucial roles in addiction risk. Conducting thorough patient assessments, including psychosocial evaluations, screening for mental health disorders, and discussing past experiences with substance use, can provide a more comprehensive understanding of the patient's risk profile. Incorporating behavioral health interventions, patient education on safe opioid use, and monitoring for signs of addiction can also help mitigate risks.

How can the medical community better educate patients on the limitations of genetic testing and the nuanced factors involved in opioid addiction to prevent misunderstandings and unintended consequences?

To better educate patients on the limitations of genetic testing and the nuanced factors of opioid addiction, the medical community can implement several strategies. Firstly, healthcare providers should engage in open and transparent discussions with patients about the complexities of genetic testing, emphasizing that it is just one piece of the puzzle in assessing addiction risk. Providing patient-friendly educational materials, such as brochures or online resources, can help clarify the role of genetics in addiction and highlight the multifactorial nature of the condition. Additionally, promoting shared decision-making between patients and providers, encouraging questions, and fostering a supportive and non-judgmental environment can enhance patient understanding and reduce misconceptions about genetic testing and opioid addiction.