FDA Could Get 30-Day Mandate To Tackle Opening Hearing Aid Access

Stat: Warren, Grassley Threaten To Slap FDA With A 30-Day Deadline For OTC Hearing Aid Rules
A bipartisan duo of senators is done waiting for the Food and Drug Administration to finalize a regulation that will finally let companies sell hearing aids over the counter. Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) introduced a bill Friday that would mandate that the Biden administration release the FDA’s long-stalled hearing aid regulation within 30 days. The new bill is the latest sign of frustration in Washington over the FDA’s work on hearing aid access; Grassley and Warren’s passed legislation to pave the way for cheaper, over-the-counter devices five years ago, in 2017. (Florko, 4/8)

In other news about medical devices —

KHN: Refurbished Walkers And Wheelchairs Fill Gaps Created By Supply Chain Problems
Michele Lujan needed a wheelchair for her 52-year-old husband who had been hospitalized with covid-19. But she had lost her job, and money was tight. Insurance wouldn’t cover the cost, and she didn’t see the use in buying something to meet a temporary need. So she turned to a loan closet not far from her home in the Denver suburb of Highlands Ranch. At South Metro Medical Equipment Loan Closet, crutches hung from the walls, knee scooters lined the floor, and shower seats and toilet risers overflowed from the shelves. She found a wheelchair she could borrow for free. (Ruder, 4/11)

In pharmaceutical industry news —

USA Today: Revolutionary Leukemia Treatment Offers 'A Hopeful Moment' In Fight Against Solid Tumors
On Wednesday, 5-year-old Mary Stegmueller will reach a major milestone. She will have outlived her predicted life expectancy. Twice. At age 4, Mary, a rambunctious animal lover from Northglenn, Colorado, was given nine  months to live. A devastating brain tumor was spreading its tentacles through her brain stem, the area that controls breathing, heartbeat and other essential functions. The tumor, called a diffuse intrinsic pontine glioma strikes 300-400 Americans each year, mostly children, and several thousand more worldwide. (Weintraub, 4/10)

Stat: MRNA Vaccine Boost May Help CAR T-Therapy Treat Solid Cancers 
While CAR T-therapy has cured some people with blood cancers, this form of immunotherapy has so far produced lackluster results for solid tumors like lung or kidney cancer. But a new early-phase clinical trial presented on Sunday at the American Association of Cancer Research (AACR) conference suggests that CAR T-cells may be able to shrink some solid tumors — as long as it gets a boost from an mRNA vaccine from BioNTech. (Chen, 4/10)

NPR: CDC Weighs New Opioid Prescribing Guidelines Amid Controversy Over Old Ones
Doctors will soon have new guidelines from the Centers for Disease Control and Prevention on how and when to prescribe opioids for pain. Those guidelines – currently under review as a draft – will serve as an update to the agency's previous advice on opioids, issued in 2016. That advice is widely blamed for leading to harmful consequences for patients with chronic pain. Federal officials have acknowledged their original guidance was often misapplied; it was supposed to serve as a roadmap for clinicians navigating tricky decisions around opioids and pain — not as a rigid set of rules. (Stone, 4/9)

Stat: Aduhelm Coverage Restrictions Could Shape Future Of Accelerated Approva
Whither accelerated approval? Amid the hubbub over new Medicare coverage restrictions for Alzheimer’s treatments, a key issue may not be fully appreciated: There is now bona fide pushback against accelerated approval, a controversial strategy used by regulators and companies to get new drugs to market faster than usual. On its face, this suggests potentially wider — and sobering — implications for the pharmaceutical industry and patients, because they may one day have to wait longer for new medicines to get out the proverbial door. (Silverman, 4/9)

KHN: Journalists Discuss Insulin Costs And Ethical Questions Surrounding A North Carolina Rehab Program
KHN Midwest correspondent Bram Sable-Smith discussed insulin costs on NBC’s LX on April 6. ... KHN correspondent Aneri Pattani, joined by North Carolina Health News’ Taylor Knopf, discussed some of the ethical questions raised by TROSA — a substance misuse recovery organization in North Carolina that provides free room and board for those in recovery in exchange for free work — on WUNC’s “WUNC Politics” podcast on April 6. (4/9)

Also —

Houston Chronicle: Doctor Completes First TULSA Procedure Performed At A Houston Hospital
History was made Friday as a local doctor carried out a procedure that had never been performed in a Houston hospital. The advanced prostate cancer treatment called transurethral ultrasound ablation is now being offered at Houston Methodist Willowbrook, the hospital announced this week. “This is the first time the TULSA procedure has been performed in a hospital setting in the Houston area, giving patients with prostate cancer or an enlarged prostate a significant opportunity to maintain their lifestyle,” Steven Sukin, MD, said in the announcement. (Feuk, 4/8)

AP: Can Cancer Blood Tests Live Up To Promise Of Saving Lives?
Joyce Ares had just turned 74 and was feeling fine when she agreed to give a blood sample for research. So she was surprised when the screening test came back positive for signs of cancer. After a repeat blood test, a PET scan and a needle biopsy, she was diagnosed with Hodgkin lymphoma. “I cried,” the retired real estate broker said. “Just a couple of tears and thought, ‘OK, now what do we do?’” The Canby, Oregon, resident had volunteered to take a blood test that is being billed as a new frontier in cancer screening for healthy people. It looks for cancer by checking for DNA fragments shed by tumor cells. (Johnson, 4/11)

Stat: Lighting Up Cancer Cells With PH-Activated Nanoparticles 
On a screen at the American Association of Cancer Research (AACR) conference here on Saturday, one of Jinming Gao’s graduate students squirted an acid into a test tube in their lab at the University of Texas Southwestern Medical Center. Almost immediately, fluid at the end of the tube began to glow as a white star under infrared light, visible on a surgical monitor. When the student squirted it with a base, the light winked out. Inside the tube is a nanomaterial that, on the molecular level, looks like a cluster of strings — polymers — organized into a sphere. Gao, a biomedical engineer working in cancer applications and a member of the Harold C. Simmons Comprehensive Cancer Center, calls it a micelle, and it has several unique properties that experts say other labs have struggled to achieve. In particular, micelles can carry a therapeutic payload and deliver it only at the precise acidity of a cancer tumor. (Chen, 4/10)

Stat: Seeing Benefits Of New, Fully Sequenced Genome Could Take Years 
Genomics has made significant inroads into mainstream medicine — DNA data are now routinely used to tailor cancer treatments, for example. But the reference genome created by the Human Genome Project, which has underlain so many of the scientific and clinical advances of the last 20 years, was never really finished. Technology at the time couldn’t resolve the last 8% — vast gaps spread across the genome that together add up to the equivalent of missing an entire chromosome. If you imagine a world map, that’s about the size of Africa. That means doctors have always been flying with a sizable blindspot. If a patient has a disease-causing mutation in any of those portions of the reference genome that are missing or contain errors, there’s no way to test for it. Which is why there was so much excitement last summer when a team of almost 100 scientists announced it had deciphered those pesky, previously unmappable regions and unveiled the first ever, truly complete human genome. (Molteni, 4/8)