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FDA expands investigation into tainted heart drugs

The FDA is expanding its investigation into valsartan heart drugs after finding out an ingredient used to make the widely prescribed medicines contained a substance tied to cancer. Last month, generic valsartan blood pressure pills were found to be tainted with NDMA, a chemical that the EPA considers a possible carcinogen. The finding sparked widespread product recalls, and regulators have been scrambling to nail down how the substance turned up in the drug. Because the FDA isn't completely certain about the cause of the contamination, the agency says it will now test all medications in the relevant class of drugs, known as angiotensin II receptor blockers.

Biohackers gather to talk experiments and ethics

Biohackers are convening in California this weekend to talk about everything from the future of human implants to the promise of artificial intelligence. The do-it-yourself scientists typically run experiments outside of traditional university labs and often advocate for open access to science. One talk at the conference, in particular, caught my eye: the bioethics of self-experimentation. A handful of biohackers have infamously experimented on themselves — including publicly injecting themselves with untested treatments — which has spurred debate about the safety and ethics of self-experimentation.

The FDA did surprise inspections at vape shops. Here's what they found

The FDA just published its findings from surprise inspections at dozens of vape shops that make liquid nicotine and related products, the first report of its kind since the FDA started regulating e-cigarettes in 2016. Here’s the rundown:

  • The testing: Among the 28 shops that manufacture products, only one reported testing the finished products to ensure the products contained the concentration of nicotine listed on the label. Six of the stores said they request testing records from the manufacturers of outside tobacco products they sell.

  • The training: None of the shops had quality assurance programs, standardized job training, or standard operating procedures, the FDA says — instead, workers received on-the-job training. 

  • The takeaway: Those findings suggest "that consumers might not receive complete information regarding product contents or purchase products of consistent quality,” the agency says.

Inside STAT: This doctor wants to change how her peers perceive their patients


Shekinah Elmore was not yet a physician when she gave her own second opinion. (hyacinth empinado / stat)

Having worn both a hospital gown and white coat, Shekinah Elmore looks at her work through two lenses. After a year of cancer treatment — including lung surgery, chemotherapy, and a double mastectomy — she was determined to start medical school. Her doctors tried to dissuade her and suggested she take more time to recover from her third stint of cancer. But two weeks after finishing treatment, Elmore took an oath to do no harm. Now, as a fourth-year resident in the Harvard Radiation Oncology Program, she wants to help bridge the gaps between doctors and patients. STAT’s Orly Nadell Farber has a profile of Elmore here.

Many drug industry payments aren't reported in oncology studies

A significant share of pharmaceutical payments to authors of oncology clinical trials published in leading journals aren’t disclosed in those papers, according to a new analysis published in JAMA Oncology. Past studies have identified undisclosed financial conflicts, but the new study looked specifically at clinical trials associated with oncology drugs approved in 2016 and 2017. Researchers tallied industry payments to oncologists who published in six high-impact journals, then checked to see whether the physicians properly disclosed that funding. The finding: Nearly one-third of the authors didn’t fully disclose their payments.

Lab Chat: Regenerating nerve fibers in rats

New research in mice and rats suggests using a series of growth factors and other substances might help severed nerve fibers regenerate after a spinal cord injury. Here’s what study author Mark Anderson of EPFL told me about the findings, published in Nature.

What did you set out to study?

We wanted to figure out a way to cause severed nerve fibers to grow past the sites of spinal cord injury. We found that the growth capacity of these neurons is really high during development. But once matured, that capacity is turned off and never comes back. We wanted to replicate developmental axon growth in the injured adult spinal cord.

How did you do that?

We delivered a sequence of substances to facilitate growth. When these three things are given sequentially, axons grow past the injury site. When any one is absent, regeneration fails. But the rats still couldn't walk. We’re now seeing whether combining this regenerative process with rehabilitation will allow these axons to function.

What to read around the web today

  • As Hurricane Harvey raged, his wife was dying. 911 couldn't help. New York Times
  • Watch: Can virtual reality transform physical therapy? STAT
  • The $109,000 heart attack bill is down to $332. What about other surprise bills? Kaiser Health News
  • CRISPR fixed Duchenne muscular dystrophy in beagles. Will this technique overtake an older gene therapy? STAT Plus
  • NIH tries to turn billions in new funding into treatment for Alzheimer's. Science

Thanks so much for reading! Have a wonderful long weekend,


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Friday, August 31, 2018


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