Genetics have little to do with disease. But that doesn’t stop some people from pretending they do, and the hype continues. First it was the physician, Francis Collins at the NIH. So determined was Francis that he and his lab faked 5 studies to prove his point. He was promising that knowing a person’s genetic code would predict the person’s disease status, and that people would carry a genomics card in their wallet to present to physicians for treatment purposes. Apparently god told him these were the facts. That was bogus, just like his data. Now another physician, Keri Donaldson, MD, is the CEO of a company that’s had a genetic test approved by the FDA to predict opioid addiction. That too is bogus.
The FDA approved AvertD in December 2023. The prescription-only genetic test from SOLVD Health is expected to be on the market soon. AvertD detects the presence of 15 single nucleotide polymorphisms (SNPs) to help identify people who may have an increased risk of opioid addiction. It’s intended to be used in combination with clinical evaluations and patient assessments when prescription opioids are being considered to treat acute pain.
The major risks associated with AvertD are false-negative and false-positive results. Before the FDA approved it, an FDA advisory committee voted strongly against an earlier version of AvertD, with false-negative and false-positive test results being a primary concern.
Apparently the FDA thought that the test wasn’t a very good test, but that it’s better than nothing. However, the problem isn’t that the test has weak specificity and sensitivity, the problem is that it doesn’t work.
The AvertD test will only cause harm. Patients who test negative, and their clinicians, will be left with a false sense of security, which can result in overuse of opioids and addiction. Patients who test positive will be falsely branded as prone to a highly stigmatized condition. These patients may become fearful of taking opioids, even in situations where use is beneficial.
Stem Cells, Health, Technology 