(STAT News) – A wearable device claiming to block the pain of opioid withdrawal has been cleared by the Food and Drug Administration under an expedited review process for medical devices. However, patient safety advocates note that the device has limited evidence for its effectiveness. The NSS-2 Bridge is a device that attaches to the ear and transmits small electrical pulses through four cranial nerves. It’s marketed by Indiana-based Innovative Health Solutions, and was cleared to treat chronic and acute pain in 2014. IHS can now market the device as one that reduces symptoms of opioid withdrawal including nausea, anxiety, and aches.
(New Scientist) – GENE editing is entering the mainstream. CRISPR, a cheap and easy technique for making precise changes to DNA, has got researchers around the world racing to trial its use in treating a host of human diseases. But this race is not confined to the lab. Last month, Josiah Zayner, a biochemist who once worked for NASA, became the first person known to have edited his own genes with CRISPR.
(Quartz) – But Madeux’s life might be about to change. He is the first patient to receive an experimental gene therapy as part of a clinical trial. Earlier this week, Sangamo Therapeutics injected Madeux with viruses containing a package of gene-editing material, according to the AP. The hope is that these viruses will enter Madeux’s cells, specifically liver cells, inject the missing gene at the right place in his DNA. Only about 1% of the liver’s cells need to be fixed, and give his liver the ability to produce the enzyme he has been missing all his life.
(Wired) – We’re not living in the golden age of AI, but we are living in the golden age of AI-enhanced productivity. Call it the First Pass Era. AI is now powerful enough to make a solid first attempt at countless complex tasks, but it’s not so powerful that it seems threatening. For more thought-intensive, subjective work, we still need humans.
(Quartz) – A.J. has now survived long enough that he can receive a kidney transplant, something that would allow him a healthy and normal childhood unmarked by the trials of constant dialysis. His father Anthony Dickerson is an excellent match and eager to donate, but the hospital has said no. The reason why reveals a troubling strain of paternalism in how our transplant field treats living organ donors. Anthony’s donation was scheduled for Oct. 3, but on Sep. 28 he was jailed for a parole violation. The authorities released him in time for surgery, but that’s when the transplant center balked, requiring that Dickerson “demonstrate good behavior” for three months before he would be reconsidered as a donor candidate.
(New York Times) – The hard data have been rolling in now at a steady pace. A recent study in the Annals of Family Medicine used the E.M.R. to examine the work of 142 family medicine physicians over three years. These doctors spent more than half of their time — six hours of their average 11-hour day — on the E.M.R., of which nearly an hour and a half took place after the clinic closed. Another study, in Health Affairs, tracked the activities of 471 primary care doctors over a three-year period, and also found that E.M.R. time edged out face-to-face time with patients.
FDA Issues Strong Warning against Kratom, an Herbal Supplement Used to Treat Pain and Other Conditions
(STAT News) – The Food and Drug Administration on Tuesday issued a public health advisory about the potential risks of an herbal supplement called kratom, warning that people who use it to treat pain in place of opioids or to wean themselves off opioids are exposing themselves to an unregulated product that has not been proven safe or effective. The announcement from FDA Commissioner Scott Gottlieb is sure to rile devoted kratom users, who contend the supplement has provided them with a way to manage pain, anxiety, and a range of other conditions.
(Spectrum) – Several research teams are using so-called induced pluripotent stem cells to study autism. These cells are derived from skin cells and have the same genetic makeup as the donor. A cocktail of chemicals and growth factors transforms the cells into immature brain cells called neural progenitor cells, and eventually into neurons. In the new work, researchers generated neural progenitor cells from two people with deletions of 16p11.2, a chromosomal region tied to autism, and two people with ‘idiopathic’ autism, meaning the condition’s cause is unknown.
(Quartz) – The health-care community lit up in conversation after news broke that the US Food and Drug Administration (FDA) has approved the world’s first digital drug. It’s a pill that contains a minuscule chip—made of magnesium, silicon, and copper—that can send information from inside the body to an adhesive patch that’s placed on a patient’s torso. The patch can send data to a doctor’s office, as well as to a special smartphone app for those who wish to monitor themselves, until the chip is naturally digested.
(NPR) – Does a California law violate the Constitution by requiring anti-abortion pregnancy centers to inform clients about free or low-cost abortion and contraception services? That’s the question the Supreme Court is taking on, in a new case it accepted on Monday. California’s Reproductive FACT Act became law in October of 2015. It requires licensed and covered facilities to give all their clients notice that the state “has public programs that provide immediate free or low-cost access to comprehensive family planning services, prenatal care, and abortion, for eligible women.”
(The Scientist) – Engineering an immune cell to recognize and kill a cancer cell is the key to chimeric antigen receptor (CAR) T-cell therapy, but modified immune cells also have the potential to cause problems for patients. One such complication, cytokine release syndrome, is an overreaction of the immune system that can cause symptoms as mild as a fever and as serious as organ dysfunction and death. In a study published today (November 13) in Nature Chemical Biology, researchers have generated nonimmune cells with the ability to kill cancer cells on contact.
(New York Times) – The full genetic sequences of Ms. Michelson, Mr. Harris and Ms. Morano are among some three dozen genomes of North American, Caribbean and European supercentenarians being made available this week by a nonprofit called Betterhumans to any researcher who wants to dive in. A few additional genomes come from people who died at 107, 108 or 109. If unusual patterns in their three billion pairs of A’s, C’s, G’s and T’s — the nucleobases that make up all genomes — can be shown to have prolonged their lives and protected their health, the logic goes, it is conceivable that a drug or gene therapy could be devised to replicate the effects in the rest of us.
(News-Medical) – Patients who had lost their sight to an inherited retinal disease could see well enough to navigate a maze after being treated with a new gene therapy, according to research presented today at AAO 2017, the 121st Annual Meeting of the American Academy of Ophthalmology. Patients in the study had a condition called Leber congenital amaurosis (LCA), which begins in infancy and progresses slowly, eventually causing complete blindness. This new, first-of-its-kind gene therapy is currently under review by the U.S. Food and Drug Administration for potential approval this year. There are currently no treatments available for inherited retinal diseases.
Parents Reach Settlement with IVF Clinic after Sons Were Born with Genetic Condition Fragile X Syndrome
(Sydney Morning Herald) – Before she had her two sons, Leighee Eastbury was told she wasn’t a carrier for Fragile X syndrome, a genetic condition that her boys will now live with for the rest of their lives. It wasn’t until her oldest son Hayden was a toddler that Ms Eastbury learned that she was in fact a carrier and both her boys were affected by the condition which causes intellectual disability. “I was devastated, absolutely devastated, it was something I had a test for … you base all your family planning and everything off that test,” she told reporters on Monday in Sydney.