TheU.S. health care system is concerned about opioid use disorder statistics, which reach about 6 million people per year. Opioids are the most effective and powerful analgesics prescribed to patients with chronic pain, cancer, after complex surgical interventions, PTSD, chronic insomnia, depression, etc.
However, despite their therapeutic effects, opioids can cause addiction, cardiovascular disease, liver problems, psychiatric disorders, lead to overdose and death. Given the opioid crisis in the health care system, the FDA has approved the first ever genetic test to assess risk for opioid use disorder.
First step taken: How will the AvertD test impact the opioid crisis?
The AutoGenomics AvertD genetic test is designed for patients who are considering a short course of oral opioid painkillers, such as after elective surgery. The new tool is only recommended for people who have not previously used opioids.
Patients must give consent before the test is administered. It is not intended for those being treated for chronic pain, FDA experts note.
"The opioid crisis is one of the most serious public health problems in the United States, requiring innovative measures to prevent, diagnose, and treat opioid use disorders," notes Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health.
Approval of the new genetic test is another step forward in preventing new cases of opioid use disorder, supporting treatment for people, and reducing the abuse of opioid analgesics," Shuren adds.
Is a survey more effective than a test? Skeptics' arguments
Despite the innovativeness of the new test, some experts are skeptical about its use in clinical practice. There are also those who believe that AutoGenomics AvertD could have dangerous unintended consequences. To perform the test, health care providers must take a swab sample from the cheek to analyze 15 genetic markers associated with addiction.
"Genetics is a 'complex profession.' It's not just about the heritability of one mutated gene that leads to opioid use disorder. Many other genes contribute to this effect," notes Andrew Saxon, professor of psychiatry and behavioral sciences at the University of Washington School of Medicine.
Risk factors for opioid addiction may manifest themselves to varying degrees based on differences in demographic groups. This can make them difficult to identify in population samples, said Kathryn Case, a professor at Columbia University School of Public Health and a psychiatrist.
"The likelihood that a commercially developed genetic test to assess opioid addiction would have the kind of validity that would be needed for real-world clinical practice seems exaggerated," Dr. Case argues.
The psychiatrist adds: "If you just ask people, "Do you have a history of addiction in your family?" I hypothesize that would be a better risk classifier than this genetic test." Dr. Saxon also believes that even interviewing a patient about a history of substance use, especially tobacco, can be more informative than a test.
Skeptical experts point out: if one relies too much on the result of a genetic test, a false negative result can give patients a sense of security about developing disorders, and a false positive result can limit access to needed medications.
Will the test be helpful in making an informed decision?
The new FDA approval requires AutoGenomics to educate healthcare providers on the proper use of the test, as well as conduct a large study based on regular reports from healthcare providers. Information from the test can help patients concerned about opioid treatment for acute pain make more informed decisions, FDA experts believe.
"This information should be used as part of a complete clinical and risk assessment. It should not be used in isolation to make treatment decisions," Shuren notes.
Drug overdose deaths have skyrocketed in recent years, with about three-quarters of the cases involving opioids. According to the U.S. Centers for Disease Control and Prevention, more than 83,000 people died from opioid overdoses last year.
Most experts agree that not only addiction, but also opioid therapy is one of the biggest factors in the development of disorders. Whether a genetic test will help to change the situation, further research will show.