clinical trials
Even NIH-funded clinical trials often aren't diverse enough
Clinical trials that the National Institutes of Health funds often enroll fewer Black patients and other underrepresented racial groups than they plan to, according to a study of 30 NIH-funded trials sampled by the HHS Office of Inspector General.
The OIG findings are in line with other studies from outside the government, according to William Fitzsimmons, a founder of the CARER Group, which is pushing to improve trial diversity. However, those studies looked at clinical trials funded by drug and medical device companies.
"One would assume that the academic NIH studies may perform better on diversity, but that doesn't appear to be the case," Fitzsimmons said.
FDA policy
FDA overwhelmingly urged to ban electric shock devices
With a deadline for public comment this week, the FDA received hundreds of responses to its proposal to bar the use of electric stimulation devices on people with behavioral issues. Many called the proposed ban an "overdue" move on a "horrific" practice and pointed to one place in particular — Judge Rotenberg Educational Center in Massachusetts — that still using the devices.
Electric shock had just a handful of supporters among nearly 800 comments. One was Ilana Slaff-Galatan, a doctor and president of the Rotenberg Center's parents' association. Slaff-Galatan argued that other treatments — such as pharmaceuticals — aren't as effective. But the vast majority of behavioral experts disagree.
Because JRC is the only behavioral treatment center in the country still believed to be using this method, a Massachusetts lawmaker brought it up in an FDA budget hearing last month. "I do know that the Geneva Convention regards these devices as torture. But I also have a group of families in my district who… have children and loved ones who are undergoing these treatments, and they claim that those treatments help," Rep. Stephen Lynch (D-Mass.) told FDA Commissioner Robert Califf before urging him to meet with the families. Califf encouraged families to submit comments to the docket.
For more on the long history of the electric shock debate and where it goes from here, keep an eye on my colleague Timmy Broderick's byline or reach out to them.
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