Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
NIH Panel Will No Longer Review Gene Therapy Experiments
A U.S. National Institutes of Health oversight panel will no longer review all applications for gene therapy experiments, U.S. health officials say.
Instead, the panel will assume an advisory role, while the U.S. Food and Drug Administration will assess gene therapy experiments and products as it does with other treatments and drugs, the Associated Press reported.
When the NIH panel of independent experts was created, there were numerous safety concerns and scientific unknowns about gene therapy. But it is now an established field of medical care with no extraordinary risks, health officials said.
It’s time for the FDA to review gene therapy proposals on its own without duplication of regulatory oversight, NIH Director Dr. Francis Collins and FDA chief Dr. Scott Gottlieb wrote Wednesday in the New England Journal of Medicine.
The proposed change will take effect after a public comment period, the AP reported.
There are more than 700 proposals for gene therapy in the pipeline, and “it seems reasonable to envision a day when gene therapy will be a mainstay of treatment for many diseases,” Collins and Gottlieb wrote. “The tools we use to address other areas of science are now well suited to gene therapy.”
Some bioethics experts agreed with the change.
“This is something the FDA has the tools to handle. I don’t think this is somehow a massive deregulation,” Leigh Turner, from the University of Minnesota Center for Bioethics, told the AP. “We never want to become blase or cavalier about gene therapy clinical trials. Careful scrutiny, whether by one body or two, is as important as ever.”
The change is consistent with recommendations made several years ago by the Institute of Medicine, according to Jeffrey Kahn, director of the Bioethics Institute at Johns Hopkins University.
“We have mechanisms in place to protect patients,” he told the AP.
But another bioethics expert has concerns.
With gene editing and other new techniques on the horizon, “this is not the right time to be making any moves based on the idea that we know what the risks are,” Stanford bioethicist Mildred Cho told the AP.
Gene therapies are biologically complex treatments, and “we really don’t understand how they work,” in many cases, Cho said. “There are miraculous recoveries and remissions that we haven’t seen before, but there also are very spectacular failures.”
U.S. Overdose Deaths Reach Record High
A record 72,300 Americans died of drug overdoses in 2017, a 10 percent increase from the previous year, new preliminary government estimates show.
The figures, from the U.S. Centers for Disease Control and Prevention, indicate a spike in overdose deaths from synthetic opioids and a decline in deaths from heroin, prescription opioid pills and methadone.
The death toll is higher than the peak yearly death totals from HIV, car crashes or gun deaths, according to The New York Times reported Wednesday.
“Because it’s a drug epidemic, as opposed to an infectious disease epidemic like Zika, the response is slower,” Dan Ciccarone, a professor of family and community medicine at the University of California, San Francisco, told The Times.
“Because of the forces of stigma, the population is reluctant to seek care. I wouldn’t expect a rapid downturn; I would expect a slow, smooth downturn,” said Ciccarone, who studies heroin markets.
A 2016 federal government phone survey suggested that around 2.1 million Americans had opioid use disorders. However, not all drug users have telephones and some respondents may not mention their drug use. The actual number could be as high as 4 million, Ciccarone said.
The number of opioid users has been rising “in most places, but not at this exponential rate,” Brandon Marshall, an associate professor of epidemiology at Brown University School of Public Health, told the newspaper. “The dominant factor is the changing drug supply.”
Doctors Remove Contact Lens Embedded in Woman’s Eyelid for Years
Doctors recently removed a contact lens that was embedded in a woman’s eyelid for nearly three decades after she was hit in the eye while playing badminton.
The woman was 14 at the time and thought she had lost the contact lens. At age 42, she visited an ophthalmologist because her left eyelid had been swollen and drooping for about six months, Fox News reported.
Doctors determined she had a cyst. When they removed it, the cyst broke open and revealed a hard contact lens, according to a paper published recently in the journal BMJ Case Reports.
The woman couldn’t recall how the contact lens got there or how long it was there, but her mother remembered that she had been hit in the eye with a shuttlecock during a game of badminton 28 years ago, Fox News reported.
It’s not clear why the contact lens only started to cause problems nearly three decades later, the doctors wrote.
Posted: August 2018
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