Health Highlights: Nov. 15, 2017
FDA Approves Device to Treat Opioid Withdrawal Symptoms Drug for Rare Genetic Enzyme Disorder Approved by FDA Senate Tax Bill Includes Repeal of Affordable Care Act's Mandated Coverage Scientists Make First Attempt at DNA Editing Inside the Body
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Approves Device to Treat Opioid Withdrawal Symptoms
A prescription device to help treat symptoms of opioid withdrawal has been approved by the U.S. Food and Drug Administration.
There are three approved drugs to treat opioid addiction, but this is the first device available to help patients.
The NSS-2 Bridge device is placed behind the ear and emits electrical pulses to stimulate branches of certain cranial nerves in order to provide relief from opioid withdrawal symptoms such as sweating, gastrointestinal upset, agitation, insomnia and joint pain, according to the FDA.
Patients can use the device for up to five days during the initial physical withdrawal phase.
In 2014, the FDA approved the device for use in acupuncture. The agency's approval of the device to treat opioid withdrawal symptoms is based on a clinical study of 73 patients. All of them had a reduction in symptoms within 30 minutes of using the device, the FDA said.
Drug for Rare Genetic Enzyme Disorder Approved by FDA
A drug to treat an extremely rare genetic enzyme disorder has been approved by the U.S. Food and Drug Administration.
Mepsevii (vestronidase alfa-vjbk) was approved to treat children and adults with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. It is a progressive condition that affects most tissues and organs.
Until now, patients with the condition had no approved treatment options, the FDA said.
Less than 150 people worldwide have MPS VII, which can cause skeletal abnormalities, heart liver and spleen problems, and narrowed airways that can lead to lung infection and trouble breathing.
Depending on the severity of their symptoms, some patients die in infancy while others live into their teens or adulthood.
Approval of the new drug was based on positive results among 23 patients, ages 5 months to 25 years, the FDA said.
Senate Tax Bill Includes Repeal of Affordable Care Act's Mandated Coverage
A repeal of the Affordable Care Act's requirement that most people have health insurance is included in a Senate Republican tax bill.
Repealing the so-called individual mandate would pay for tax cuts, according to Senator Tom Cotton, Republican of Arkansas, one of those who pushed for including the repeal in the tax bill, The New York Times reported.
Eliminating the mandate would free up more than $300 billion over a decade that could go toward tax cuts, according to the Congressional Budget Office.
Repealing the mandate would reduce the number of people with health coverage, so the government would spend less on subsidized health plans, The Times reported.
Scientists Make First Attempt at DNA Editing Inside the Body
In a world-first trial, scientists in California edited DNA inside the body in at attempt to cure a genetic disease.
The patient is 44-year-old Brian Madeux, who has a metabolic disease called Hunter syndrome. During a three-hour IV infusion on Monday, he received billions of copies of a corrective gene and a genetic tool to cut his DNA in an exact location, the Associated Press reported.
Indications of whether the procedure is working may become apparent in a month, and tests will provide a definitive answer in three months.
Until now, scientists have edited people's DNA by altering cells in the lab and then returning them to patients. There are also other types of gene therapies that don't involve editing DNA, the AP reported.
If successful, this new approach could be a major advance for the emerging field of gene therapy.
"We cut your DNA, open it up, insert a gene, stitch it back up. Invisible mending," Dr. Sandy Macrae, president of California-based Sangamo Therapeutics, told the AP. "It becomes part of your DNA and is there for the rest of your life."
The company is testing this method for two metabolic diseases and hemophilia.
There is no way to reverse mistakes that might occur while editing DNA within the body.
"You're really toying with Mother Nature" and there are unknown risks, independent expert Dr. Eric Topol of the Scripps Translational Science Institute in San Diego, told the AP. But these studies should continue because they target incurable diseases, he added.
Animal tests were very promising and protections are in place to help ensure safety, according to Dr. Howard Kaufman, a scientist on the National Institutes of Health panel that approved the studies.
The promise of this type of gene editing is too great to ignore, he told the AP.
"So far there's been no evidence that this is going to be dangerous," Kaufman said. "Now is not the time to get scared."
People with Hunter syndrome lack a gene that makes an enzyme that breaks down certain carbohydrates, leading them to accumulate in cells and cause a range of issues, including frequent colds and ear infections, hearing loss, heart and breathing trouble, skin and eye problems, bone and joint afflictions, bowel concerns, and brain and thinking problems, the AP reported.