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Thursday, August 4, 2016

Morning Rounds by Megan Thielking

Good morning, folks! Here's what you need to know to get on top of the day's big stories in health. 

Half of pediatric clinical trials don't make it to publication

Nearly half of all pediatric clinical trials are discontinued early or never published, finds a new analysis of 559 pediatric trials registered on ClinicalTrials.gov. Despite a federal push to boost research on childhood illness, and laws requiring clinical trial reporting, 19 percent of trials end early and another 30 percent of finished trials aren’t published. The analysis found that while industry-sponsored trials were more likely to be completed than academia-backed trials, they were less likely to be published. That’s a trend seen in adult clinical trials, too. The paper’s authors say that there needs to be better accountability to make sure that pediatric participation in clinical trials doesn’t go to waste.

Device reps in the OR buddy up to surgeons, for better and for worse

Medical device reps don’t just sell surgeons tools anymore — they’re also on-hand during surgeries to assist with the devices. Researchers conducted anonymous interviews with both surgeons and device reps to delve into the potential ethical dilemmas of the situation. Some of the highlights:

  • “When I worked as a sales rep, I wasn't paid a salary. It was all commission... And doctors kind of know that... They understand that the rep is just trying to earn a living. They feel somewhat obligated to use the most expensive device because they obviously called you in for it.” (Device rep)

  • “Nowadays, a [device] rep is in the OR for every case that you’re using his or her stuff.” (Orthopedic surgeon)

  • “There are some things that are good about having a rep around in the OR if you need a part and if you don’t know what it is or where it is. They can help with that kind of stuff, but if they ever try to tell me how to do something — done.” (Ear, nose, and throat surgeon)

Burwell to Congress: We're running out of Zika funds

Republicans in Congress aren't all convinced that the Obama administration is actually hard up for Zika funds, so HHS secretary Sylvia Burwell spelled it out for them in a letter Wednesday. The CDC, she said, has $222 million to spend and has already used more than $120 million of it, and the rest will be gone by the end of September. The NIH will have used up all of its $47 million by the end of this month, and the Biomedical Advanced Research and Development Authority's $85 million will run out around the same time, according to the letter. 

"I am evaluating all options in order to avoid delaying the development of a Zika vaccine" because of the NIH and BARDA cash shortages, Burwell wrote. The catch, though, is that most Republicans are still blaming Democrats for holding up the Zika bill in the Senate, and haven't changed their tune even as Zika spreads in the Miami area. Democrats say it would be easier to pass if Republicans would drop the anti-Planned Parenthood language and other riders.

Inside STAT: The key role Chinese hamsters play in biotech

Molly Ferguson for STAT

The Chinese hamster may have had a humble beginning as a pesky rodent in the fields, but nearly a dozen biotech drugs are now being made using the ovary cells of the tiny critters. Those drugs generated a whopping $57 billion in sales just in 2013. In the newest episode of our podcast Signal, Luke Timmerman and Meg Tirrell explore the crucial role that those Chinese hamsters played in the birth of biotech — listen here.

Lab Chat: A tiny, batteryless sensor could monitor muscles and nerves

The minuscule sensor gets a dose of ultrasound gel. (University of California, Berkeley)

Horton may have heard a Who, but at the University of California, Berkeley, it's the speck of dust that hears you. Scientists have created a minuscule wireless sensor that monitors nerves, muscles, and organs in the body in real time. For the growing field of “electroceuticals” — electronic devices used in the body for therapeutic effects — a platform that could monitor nerves and also zap them into action is an exciting idea. Here’s what researcher Dongjin Seo told me about the findings, published in Neuron.

How does the sensor work?

It’s about as large as a grain of sand. It essentially consists of three different components. One is the actual recording electrode on the implant, which is measuring the electrical signal going on in the nervous system. The second component is the custom chip that we made that can encode that information wirelessly out. The third and final component is the transducer, which harvests the energy from the outside world. So we ping this implant with ultrasound to give this the power to operate. It doesn’t have any battery or energy storage.

And how do you see it being used one day?

We are proposing that this ultimately could be a platform. It’s a mechanism to power super tiny devices buried super deep in the body, and a patch over the site could ping and wake up the sensor to work. In this particular paper, we were looking at the peripheral nervous system. For that, we’re considering future applications that could use the platform for bladder control or appetite suppression.

Having one sickle cell mutation doesn't carry the same risk as having two

It’s long been assumed that sickle cell genetic variants increase a person’s risk of death — whether that person carries one or two copies of the variant — but new research finds that’s not the case. Sickle cell variants occur in about 1 in 13 African-Americans. People who have two copies of the variant are diagnosed with sickle cell disease, and their lifespan is on average 40 to 60 years. People with just one copy are said to have sickle cell trait. In an analysis of health records of nearly 50,000 Army soldiers, researchers found that patients with sickle cell trait don’t on average die any sooner than those without the condition.

FDA committees consider new drug application for harder-to-abuse opioid

Today, two FDA committees will meet to discuss a new drug application for a painkiller that’s intended to deter users from abusing the drug. It’s an extended release morphine tablet for use in patients who need round-the-clock opioid treatment for a long period of time. Such abuse-deterrent formulations, or ADFs, make it more difficult for people to abuse the drugs, whether that’s through extending the release of a drug over time, making it difficult to crush or grind the tablets, or building in a mechanism that burns or irritates the nose if the pill is crushed up and snorted. The FDA has already approved a handful of such drugs in the past few years, and is now considering whether the data on the new drug is strong enough to warrant labeling it as an ADF.

What to read around the web today

  • Making sure ecstasy is ecstasy: Volunteers test drugs at UK music fests. NPR
  • How Toradol became the NFL's favorite painkiller. SB Nation
  • This scientist's death was a mystery for 150 years, until his own skeleton closed the case. Washington Post

More reads from STAT

Thanks for reading! More tomorrow,

Megan

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