In December 2016, Charles Piller (@cpiller), the west coast editor for Stat, reported that a genetic test to identify patients who could be prone to addiction lacked a firm scientific basis.
With an eye-opening headline, “Called ‘hogwash,’ a gene test for addiction risk exploits opioid fears,” the article raised important questions about the Proove Opioid Risk test from Proove Biosciences in Irvine, Calif. Continue reading
The placebo effect presents quite the conundrum to researchers attempting to discern whether a particular intervention truly offers clinical benefit for patients. Those most susceptible to the effect can feel so much better after a placebo that their “improvement” exceeds that of others taking a chemically active drug.
This problem may slow down the pipeline for new effective drugs, Erik Vance suggests in his recent Washington Post article, “People susceptible to the placebo effect may be keeping us from getting new drugs.” Continue reading
The nation’s clinical laboratories have pushed back hard against a proposal by U.S. Food and Drug Administration in October 2014 that would regulate laboratory developed tests. More than a year later, the disagreement became more heated when the Association of Molecular Pathology (AMP) accused the FDA of fabricating examples in a November report on LDTs.
In the report, “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies,” the agency cited 20 examples of problematic LDTs, saying, “…these products may have caused or have caused actual harm to patients.” We covered this report in a blog post earlier this month.
But that’s just the beginning of the story, as Allison Proffitt, editorial director of BioITWorld, found. Continue reading
At a conference last year, Michael Laposata, M.D., Ph.D., one of the nation’s best known pathologists, explained how clinical laboratories could deliver more value to patients, physicians, and health insurers. To do so, pathologists and laboratory scientists need to provide more detailed explanations about lab test results because even physicians who order genetic and molecular tests are often confused about the results, said Laposata, chairman of the Department of Pathology at the University of Texas Medical Branch.
When he explains test results to ordering physicians, he frequently refers to an “allele” which is one of two or more versions of a gene, he said. When he does, physicians sometimes ask, “What’s an allele?”
His anecdote is telling following President Obama’s announcement last month that he recommended spending $215 million on the precision medicine initiative. The announcement was correctly hailed as an important and needed investment in medical technology. “Precision medicine” is described by the National Institutes of Health as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.” Continue reading
The White House has announced its anticipated “Precision Medicine Initiative,” which it describes as an “emerging field of medicine that takes into account individual differences in people’s genes, microbiomes, environments, and lifestyles – making possible more effective, targeted treatments for diseases like cancer and diabetes. ”
Health Journalism 2014 featured a panel about personalized medicine and the presentations from “Getting personal: The medical and ethical challenges of using genetic information” may offer some story ideas and considerations for reporters who are explaining President Barack Obama’s proposal. Continue reading