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Morning Rounds Shraddha Chakradhar

New investigation reveals FDA, NIH let clinical trial sponsors keep trial results secret

Despite a now 2-year-old law requiring clinical trial sponsors to disclose results, a new investigation from Science and former STAT reporter Charles Piller finds that many ignore the law — much as they have done in the past. Sponsors have up to a year after a trial’s completion to submit results, but the report found that of 216 trials that were due to log their results by the end of September 2019, only a third did so. The violators include regular NIH funding recipients including Boston Children’s Hospital and Baylor College of Medicine. At the same time, even though the NIH has previously said it would cut off funding for those who fail to report results as required by law, it has not done so. The FDA has also not excised its fine for violators — up to $12,103 for every day of noncompliance. 

U.S. doesn’t fully protect right to health care like other countries, report finds

The U.S. is falling behind many other high-income countries on constitutionally ensuring health and disability rights for its citizens, according to a new report from UCLA’s nonprofit WORLD Policy Analysis Center. Here’s more: 

  • Health rights: 142 countries globally provide some sort of constitutional right to health, and more than 40% countries specify a right to medical care or services, whereas the U.S. doesn’t have those certain provisions. 

  • Disability rights: Only 27% of countries worldwide have constitutions that specifically prohibit discrimination or guarantee equal treatment on the basis of disability. The U.S. Constitution guarantees equal treatment, but isn’t specific to people with disabilities. 

  • Reproductive rights: Only 6% of constitutions worldwide include pregnancy as a prohibited ground for discrimination. Only 9% of constitutions globally address reproductive health care or maternal health in some form. 

Physicians spend more than 16 minutes of each patient visit with EHRs

Electronic health records are a mainstay in doctors’ offices, and a new study finds that physicians spend, on average, more than 16 minutes of each patient visit on EHRs. Data from around 100 million patient visits by 155,000 physicians revealed that the biggest component of doctors’ time with EHRs was reviewing patient charts, followed by documenting the visit and ordering tests and medications. Gerontologists were most active on EHRs — spending more than 13 minutes per patient visit per day — followed by endocrinologists with nearly 12 minutes. More than 10% of doctors’ time with EHRs happened on weekends or after 6 p.m. The study didn’t answer, however, whether the time spent on EHRs was the appropriate amount to best help patients or if physicians should make adjustments. 

Inside STAT: Consumer genetic testing: What do you get for your money?


(Alex Hogan/STAT)

The latest installment in our video series, “The Facts, STAT!,” tackles the lucrative world of consumer genetic testing and what people can really expect to get for their money. The cheapest tests, offered by companies including 23AndMe and Ancestry.com, only look at a prespecified set of the more than 6 billion letters in the genome, in a process known as genotyping. The next step up is exome sequencing, and offers a look at “chapters” of the book that is our genome for around $300. The ultimate package is whole genome sequencing, which can be upward of $500, but the trick here is sorting through all the data to extract meaningful information about health and disease. Watch the short video from STAT’s Damian Garde and Alex Hogan to learn more. 

Adolescent safety, infectious disease top WHO’s list of health challenges for the next decade 

The WHO just released a list of 13 health care challenges it says need to be urgently addressed in the next decade. The report includes many of the usual suspects including stopping infectious disease and preparing for epidemics, but also includes some out-of-the-box challenges such as keeping adolescents safe. This, according to the WHO, is an urgent challenge because more than 1 million of those ages 10-19 die yearly of road injuries, HIV, and suicide. Also on the list: improving pay and working conditions for health care personnel, ensuring more equal access to health care, and protecting people from dangerous products such as tobacco and unhealthy foods that lead to poor health. 

Elevated risk of leukemia among 9/11 responders, study suggests

There's now evidence to suggest that responders at the World Trade Center on 9/11 may have an elevated risk of leukemia. These responders have previously been diagnosed with other cancers including mesothelioma and thyroid cancer. And the new study, which included data from nearly 29,000 responders, 999 of whom developed cancer, found that the overall incidence of leukemia was 41% higher than in the general population. In addition, they were more than twice as likely to develop thyroid cancer, and had a 25% higher rate of prostate cancer. Some of these cancers, such as thyroid, emerge long after exposure to harmful substances, and the authors suggest continued monitoring of WTC responders for cancers that may not yet have been observed in this population. 

What to read around the web today

  • Taiwan’s single-payer success story — and its lessons for America. Vox
  • Trump restrictions on fetal tissue research unsettle key studies and scientists. The Washington Post
  • Eyeing more data, Livongo will integrate continuous glucose monitor into diabetes coaching program. STAT Plus
  • Haiti’s biggest hospital still not built 10 years after quake. That’s not the worst of it. Miami Herald
  • Harvard School of Public Health faculty repeatedly weighed voting no confidence in dean. The Harvard Crimson

Thanks for reading! More tomorrow,

Shraddha

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Tuesday, January 14, 2020

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