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Tuesday, April 10, 2018
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Good morning, folks! Don't forget to join us for a free online chat about cancer treatment at 1 p.m. ET today — sign up
here.
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FDA slaps sales restrictions on contraception implant
The FDA is restricting sales of Essure, a permanent contraception device that’s been linked to serious safety issues, from severe pain to uterine perforation.
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The requirement: The agency will only allow women who read and
sign a brochure that runs through the risks of Essure to receive the implant.
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The background: In November 2016, the agency required the device’s
maker, Bayer, to add a boxed warning on Essure. But the agency says some women still aren't being adequately informed of Essure's risks. "This is simply unacceptable," FDA Commissioner Scott Gottlieb said in a statement.
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Disagreement remains: Critics have called on the FDA to recall
the device for years, but the agency is allowing Essure to remain on the market.
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Trump names new leader of government's malaria work
President Trump has picked a former medical device company exec to lead the government’s efforts to combat malaria worldwide. The president plans to appoint Dr. Kenneth William Staley, who is currently a
consultant at McKinsey, to oversee the President's Malaria Initiative, which was launched in 2005. At McKinsey, Staley has helped with the public health responses to both Ebola and MERS outbreaks, according to the White House. Staley was also an exec at Medtronic
and served as the Director of Biodefense Policy under former President George W. Bush.
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The push to get more pregnant women in clinical trials
The FDA has released a new draft guidance outlining how to safely — and ethically — include
pregnant women in trials for new therapies. Nearly four million women in the U.S. give birth each year, but few drugs have been approved as safe and effective to use during pregnancy. The new guidance aims to help drug
companies narrow that knowledge gap “through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk.”
Experts say it’s a sign of progress on an issue that’s long plagued pregnant women and their physicians. “It’s really exciting to see the FDA articulating support for and justification for research with
pregnant women,” bioethicist Dr. Anne Lyerly tells me. I have more details for STAT Plus subscribers
here.
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Inside STAT: The search for better overdose reversal drugs
(alex hogan / stat)
Naloxone is the only opioid overdose reversal drug that’s widely available across the country. But there have been a growing number of anecdotal reports about its limitations when it comes to treating overdoses
due to synthetic opioids. In some cases, health officials have heard that it can take multiple doses of naloxone to revive some overdose victims. Dr. Nora Volkow, the director of the National Institute on Drug Abuse, says there's a need to develop alternatives
to naloxone. STAT contributor Max Blau took a look at what potential alternatives are on the horizon — read
here.
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Be careful if you eat the world's hottest chili pepper
Doctors are warning about the dangers of downing super-hot chili peppers. In a new
case report, physicians say they treated a young man who ended up in the ER with painful, episodic headaches after eating the world’s hottest chili pepper, known as a Carolina Reaper. After eating the pepper, the man developed
recurring, severe neck pain and “crushingly painful” headaches that lasted for a few seconds at a time. After a CT scan, doctors diagnosed him with a syndrome marked by temporary narrowing of arteries in the brain. It’s the first time the condition, known
as RCVS, has been linked to hot peppers.
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A new tool to compare health disparities by state
If you, like me, like digging around health data, the CDC has a new tool for you. The agency just updated its “Stats of the states” maps to include health data from 2016, the most recent year available.
The tool lets you pick different health data sets — like cancer mortality or deaths due to firearm injuries — and then compare rates between states. It also stretches back a few years, so you can see how health trends have changed. Check it out
here.
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Salmonella outbreak linked to kratom continues to spread
The number of people sickened in a salmonella outbreak linked to the herbal supplement kratom continues to climb. The CDC says 132 people have now fallen ill in the outbreak, up from 87 in mid-March. Of
those cases, there have been 38 hospitalizations but no reported deaths. There are several different strains of salmonella involved in the outbreak, which spans 38 states. Health officials haven’t been able to pinpoint a specific source, though there have
been a string of kratom recalls in recent weeks. Just yesterday, the company Club 13 recalled several different kinds of kratom powder because of the risk of salmonella contamination.
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What to read around the web today
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FDA worried this drug was risky; now reports of deaths spark concern.
CNN
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A tale of two CT scanners — one richer, one poorer.
Kaiser Health News
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Doctors urge elite academy to expel a member over charges of plagiarism.
New York Times
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More reads from STAT
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Gene therapy's promising start came
crashing to a halt. Will CRISPR meet the same fate?
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Mass. governor defends
Vertex drug pricing, saying ‘innovation is expensive.'
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The latest from STAT Plus
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Chinese patients get these cancers at an alarming rate. Now drug makers
see an opportunity.
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With positive Keytruda data, Merck
scrambles the market for lung cancer immunotherapies.
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Thanks for reading! More tomorrow,
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