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
Sometime this year, the U.S. Food and Drug Administration is expected to issue guidance to clinical laboratories that produce lab-developed tests (LDTs). Clinical labs that offer LDTs, and associations that represent these labs, have criticized the FDA’s oversight proposal and are challenging the agency’s authority to regulate these tests.
Many of us will be writing about LDTs, their value to patients and the need for a review of how these tests are produced, whether the results are clinically valid, and whether their marketing claims are accurate. Continue reading
Baltimore Sun reporter Andrea McDaniels was surprised to learn about an off-label treatment for tooth decay that some dentists are using.
In the fight against decay-causing bacteria, some researchers call the agent, silver diamine fluoride, a “silver-fluoride bullet.”
They point to evidence suggesting that SDF is not only effective in halting the decay process but in preventing the development of new caries. The material is cheap and can be easily painted onto the affected tooth.
In this Q&A, McDaniels tells us more about her work on the story, and offers some insights into how she manages her busy health and medical beat at the Sun.
Photo: Lydia Polimeni, National Institutes of Health via Flickr
A Stat investigation has found that “prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments.”
The violations have left gaping holes in a federal database used by millions of patients, their relatives, and medical professionals, often to compare the effectiveness and side effects of treatments for deadly diseases such as advanced breast cancer.
Many American consumers may not realize this, but only New Zealand and the United States are the only countries with strong pharmaceutical regulations in which direct-to-consumer advertising from pharma companies is allowed.
All those TV commercials and double-spread ads for prescription drugs – whether it’s for erectile dysfunction drugs or mental disorders or high blood pressure or some chronic condition – are missing from the media in most of the world.
The way such ads look and sound (including the usual mind-numbing text block tucked into a print ad detailing risks and potential side effects, or a hastily spoken voice-over toward the end of a commercial), may soon change. The U.S. Food and Drug Administration is revising regulations governing how companies communicate risk to consumers. Continue reading