Health Highlights: Nov. 27, 2018
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Kratom Products Have High Levels of Heavy Metals: FDA
In addition to many other health risks, kratom products can have high levels of heavy metals, U.S. Food and Drug Commissioner Dr. Scott Gottlieb says.
The FDA has issued a number of warnings about the health risks posed by the herbal supplement products, which have become increasingly popular in recent years and are used recreationally and by people trying to self-medicate for pain or to treat opioid withdrawal symptoms.
Some kratom products have been found to contain salmonella and to cause infections.
FDA scientists recently tested 26 separate kratom products and found levels of lead and nickel unsafe for human consumption.
"While the levels of the specific products we've tested so far are not likely to result in immediate acute heavy metal poisoning from a single use, some of these products included levels that, with chronic use, could cause some people to suffer from heavy metal poisoning," Gottlieb said in a statement.
"We are concerned that there may be other kratom products on the market that also contain heavy metals," he added.
The FDA is companies that market these kratom products to make them aware of the heavy metal testing results.
"Kratom is not legally marketed in the U.S. as a drug or dietary supplement. While it is important to gather more evidence, data suggest that certain substances in kratom have opioid properties and that one or more have the potential for abuse," Gottlieb said.
"For individuals seeking treatment for opioid use disorder who are being told that kratom can be an effective treatment, I urge you to seek help from a health care provider," he said.
FDA to Update Medical Device Approvals Process
A major update of the United States' system for approving medical devices was announced Monday by the Food and Drug Administration.
Experts have long criticized the decades-old process for its failure to identify problems with risky medical implants and instruments, CBS News/Associated Press reported.
The revised process will ensure that new medical devices meet safety and effectiveness standards, according to the FDA.
Currently, medical device makes are generally allowed to introduce new products based on similarities to decades-old products, without having to conduct new clinical trials in patients, CBS/AP reported.
"We believe that newer devices should be compared to the benefits and risks of more modern technology," FDA Commissioner Scott Gottlieb said in a statement.
Some of the proposed changes could take years to implement, according to CBS/AP.
The FDA's announcement came a day after the release of findings from an investigation into medical device safety worldwide that was led by the International Consortium of Investigative Journalists and included more than 50 media organizations.
It found that more than 1.7 million injuries and nearly 83,000 deaths suspected of being caused by medical devices were reported to the FDA over a 10-year period, CBS/AP reported.
CDC Confirms 116 Cases of Polio-Like Condition
There have been 116 confirmed cases of a polio-like condition called acute flaccid myelitis (AFM) in the United States so far this year, the U.S. Centers for Disease Control and Prevention says.
The cases have occurred in 31 states and most have involved children, NBC News reported Monday.
In its latest update, the CDC says it is investigating 286 cases of AFM, and still does not have a confirmed cause for the disease, which causes muscle weakness or paralysis due to spinal cord damage.
High on the list of suspects are enteroviruses, which typically cause nothing worse than the common cold, NBC News reported.
"Respiratory illnesses and fever from viral infections such as enteroviruses are common, especially in children, and most people recover. We don't know why a small number of patients develop AFM, while most others recover," the CDC said.
The agency noted that AFM cases in the United States rise and fall year to year, with 120 confirmed cases in 2014, 22 cases in 2015, 149 cases in 2016 and 33 cases in 2017, NBC News reported.
Claim About World's First Gene-Edited Babies Triggers Questions, Condemnation
A unproven claim about the creation of the world's first genetically edited babies has been met with skepticism and condemnation.
He Jiankui, Southern University of Science and Technology of China in Shenzhen, said he altered embryos for seven couples during fertility treatments, resulting in a pregnancy that led to twin girls born this month, the Associated Press reported.
The objective was to give the babies the ability to resist possible future infection with HIV, the virus that causes AIDS, according to He, who did not reveal the identity of the parents, where they live, or where the research was conducted.
The claim has not been independently confirmed and has not been published in a journal, where it would be reviewed by other experts. He revealed it Monday to one of the organizers of an international conference on gene editing scheduled to begin in Hong Kong Tuesday, and in earlier interviews with the AP.
He has two genetics companies and has applied for patents on his embryo gene editing methods.
This type of gene editing is not allowed in the United States because the DNA changes can affect future generations and there is risk of damage to other genes. A number of scientists condemned He's research, and some labeled it human experimentation.
It's "unconscionable ... an experiment on human beings that is not morally or ethically defensible," Dr. Kiran Musunuru, a University of Pennsylvania gene editing expert and editor of a genetics journal, told the AP.
"This is far too premature," said Dr. Eric Topol, heads of the Scripps Research Translational Institute in California. "We're dealing with the operating instructions of a human being. It's a big deal."
But attempting gene editing to protect against HIV is "justifiable," because it's "a major and growing public health threat," Harvard University geneticist George Church, told the AP.
Several scientists who reviewed materials that He provided to the AP said there is not enough data to determine if the gene editing was effective or safe.
They also said it appears that the gene editing was incomplete and that at least one twin seems to have a patchwork of cells with various genetic changes.
"It's almost like not editing at all" if only some of particular cells were changed, because HIV infection can still occur, Church said.