Wouldn’t it be nice to know if you or your loved one were at risk for addiction, before the doctor wrote your prescription?
Proove Biosciences claims their genetic testing can do just that. They have designed a test that combines a patient questionnaire with DNA examination to determine if the patient will become addicted to opioids. Proove’s website states this test is 93 percent accurate.
Where’s the Proof?
Not everyone believes these claims. Many experts are questioning Proove’s methods and the lack of science behind their testing.
Eduardo Butelman, PhD, of Rockefeller University, points out that there are no data on the tests’ predictive value. Proove uses 12 genetic variants, including those in opioid receptors, to determine genetic risk. Butelman notes, “There are no data on how you can build a risk score by combining all of those [SNPs] together. And no one has shown mathematically how you can combine that genetic information with environmental information. It seems a little premature to use it for actual diagnostic purposes.”
“We are nowhere near having any diagnostic genetic test for a disease as complex as a psychiatric disorder,” notes Zena Samaan, PhD, McMaster University, who studies the genetics of addiction. “We don’t have a single group of genes to say this is the culprit, that this is what’s causing addiction.”
Dawei Li, PhD, of the University of Vermont, is concerned about the lack of replicable evidence for the test. “Many of the positive genetic association reports were eventually not able to be replicated in other populations or within the same population but just by another research lab,” Li said.
The testing falls under “laboratory-developed tests,” meaning FDA guidelines are loose to non-existent. Basically, companies like Proove have no oversight “on whether or not their products work as advertised.”
“The FDA should have strict guidance on these diagnostic tests because these are exploratory and might be overemphasizing an outcome that’s just not there yet,” Samaan said. “There should be better oversight. Science should advance quickly, but not at the expense of patients.”
Sceptics also point out conflict-of-interest issues. Those involved in approval of the tests directly benefit financially from its use. Plus, testing involves payments to doctors whose patients participate.
True or False?
The danger of inaccurate testing is the potential effects it has on patient care. If the test tells a doctor that their patient is at risk, the physician might not prescribe opioid painkillers. If the test is wrong, they’re potentially denying surgery and cancer patients who are in severe pain the drugs they need to help them.
Even if the test is accurate, it may have negative results. Once a patient undergoes this testing, the results are in their medical file. This could cause denial of prescriptions, not only to them, but their relatives. Children of an at-risk patient could be viewed as at-risk too, due to their genetic relationship.
Workers compensation claims could also be affected. Payment for prescriptions might be denied “in the best interests of the injured worker.”
On the other hand, if the testing works, it could help slow the growing number of opioid addictions across the country.
So, the question remains – does it really work? Proove says yes. Many scientists say “hogwash.”
Additional Reading: 5 Ways You Are Physiologically Predisposed for Addiction
Image Source: iStock