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I’ve published one issue of my newsletter since last week’s group announcement. The top stories include
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Did the FDA approve a new “gene therapy” or a “gene modification” technique for cancer treatment? Earlier today, the FDA announced its approval of the first “gene therapy” in the United States . According to the agency, this is an historic action that ushers in a new approach to the treatment of cancer and other serious and life-threatening diseases. The approval is for a specific form of cancer and can only be used in pediatric and young adult patients with a form of acute lymphoblastic leukemia. While the announcement — and Commissioner Dr. Scott Gottlieb’s prepared remarks on the approval — describe this as “gene therapy”, MIT Tech Review’s Antonio Regalado tweeted the following: “BREAKING: Novartis CAR-T treatment vs cancer approved by FDA opening era of commercial human gene modification” and “So FDA just approved CART and calls it gene therapy”. I got caught up in the confusion myself, with my original tweet unfortunately parroting the FDA’s comments.
- “Gene therapy works by restoring the function of a patient’s defective gene via the introduction of a healthy copy.” (Source: NIH)
- “CAR-T is made by harvesting patients’ white blood cells and rewiring them to home in on tumors.” (STAT News)
In a judgement against the Equal Employment Opportunity Commission (EEOC) , the U.S. District Court for the District of Columbia has ruled that employers cannot force employees to pay financial penalties if they decline to participate in so-called ‘voluntary’ workplace wellness programs. In practice, these programs have cost employees thousands of dollars when they don’t participate and, according to Judge John Bates, this is “the equivalent of several months’ worth of food for the average family, two months of child care in most states, and roughly two months’ rent”. Other issues inherent in the case revolve around the 1990 Americans with Disabilities Act (ADA) and the 2008 Genetic Information Nondiscrimination Act (GINA), both of which prohibit employers from requesting or obtaining specific health, medical, and genetic information from employees. A representative of the American Association of Retired Persons ( AARP), the organization that filed the lawsuit, stated that “The court’s opinion thoroughly dismantled the agency’s (EEOC) reasoning, and we expect the agency to have a tough time justifying this rule or a similar one while staying faithful to the purpose of the civil rights statutes.”
In a reported world’s first, a diabetes app will be able to check glucose levels without drawing a drop of blood. The system works by placing your fingertip over the camera lens on your smartphone. Images reveal information on blood flow and are analyzed remotely to determine other information like heart rate, temperature, blood pressure, respiration, and blood oxygen saturation.
Startup Athelas has launched a portable blood analyzer to test for the flu and bacterial infections. It’s also intended for oncologists to provide the device to patients so that they can avoid some lab and doctor visits. The system works by capturing images of blood samples, tagging, and counting cells. The company hopes to received FDA clearance allowing it to sell the device over the counter.
A system developed by University of Washington researchers uses a smartphone camera to screen for pancreatic cancer. It works by detecting elevated levels of bilirubin in the white part of the eye. Yellow discoloration in the eyes and on the skin can be due to this buildup and is one of the earliest symptoms of pancreatic cancer and jaundice.
LIVING AND SOCIETY
According to Prof Sophie Scott from the UCL Institute of Cognitive Neuroscience, emojis enhance human interactions. Prof Scott says that “People look at emojis or gifs and think ‘They’re stupid’, but they’re trying to address something. It’s trying to put that emotional, non-verbal information back in… stuff that would be pretty effortless if you were face to face.”
A new social network called Polygram uses facial recognition to track your facial expressions and then choose emoji that correspond to your emotional state. The app also allows users to animate their emojis, which remain animated when posted to other social media sites and apps.
Samsung has launched a free Gear VR app named Relúmĭno, which is designed to aid the visually impaired. The app can reportedly “magnify or minimize images, adjust brightness and sharpness, highlight objects with an outline, invert colors when reading text, add a color filter to the screen, enhance a user’s peripheral field if they have tunnel vision, and even assist people with scotoma by helping them see what is blocked by their blind spot in the surrounding area.”
As I point out in my keynote presentation, the digital customer interface is a key tool being leveraged by companies and organizations leading the digital health revolution. The latest variation on this theme is part of Amazon’s lowering of prices on certain foods at Whole Foods and its plans to use its Prime membership as a store rewards program. Prime members will receive additional discounts. Also, one can imagine integration with the Amazon Echo Alexa AI assistant and Dash buttons.
According to a filing with the U.S. Securities and Exchange Commission, Elon Musk’s Neuralink has obtained an additional $27 million to further its mission to a build brain computer interface (BCI). Musk has also made moves to sell up to $100 million in stock to fund the company, but is adamant that Neuralink is not seeking outside investors at this time.
Misfit — which is now owned by Fossil — is launching its ‘Misfit Vapor’ smartwatch. However, without built-in GPS or LTE (cellular connection), the $199 device may turn out to be obsolete (compared to the competition) at launch.
A new type of yarn developed by researchers at the University of Texas at Dallas and Hanyang University makes its own electricity. By twisting carbon nanotubes into yarn, mechanical energy is harvested and turned into electricity.
The NY Times ran a piece on genetic testing and the potential repercussions for families in regard to ethnicity and family trees: ” With a Simple DNA Test, Family Histories Are Rewritten“. While the article appeared to be fine, consumer protection litigator Joel Winstonquestioned the ethics of promotion on the same page (see image below) of DNA testing services that may be affiliate marketing by the NY Times: “Journalistic impropriety? @nytimes/ @wirecutter simultaneously publish re DNA kits & earn affiliate $”. In another tweet, Joel added: “and what of @nytimes newpaper prominently hyping, linking, & featuring review (w/out disclosure)?”
Chicago’s NorthShore University HealthSystem has added the option of genetic testing to its annual patient physical. According to Dr. Peter Hulick, director of the Center for Personalized Medicine at NorthShore, the health system wants to be more proactive in healthcare. The process works by asking patients prior to their physical if they would like a genetic test. Once family history is added to the EHR, an algorithm uses national guidelines to determine what genetic tests, if any, might be worthwhile. The tests include BRCA1 and BRCA2 (which can reveal additional hereditary risk for breast and ovarian cancer), cardiovascular risk, and pharmacogenomic (drug response) testing.
In response to the FDA’s request for public comment on draft guidelines addressing the design of medium risk clinical decision support software, the CDS Coalition has released their desired final guidelines. As Bradley Thompson writes, “the goal is to identify when additional software validation is required, beyond the normal baseline, because the software will be taking over certain clinical decision-making from the healthcare professional. In other words, the guidelines are intended to make sure that companies are very deliberate and thoughtful about when they cross the line to take over decision-making from the healthcare professional.”
CNS Summit 2017
Nov 16-19 in Boca Raton, FL
Digital Health World Congress 2017 (Winter Edition)
Nov 29-30 in London, UK,
XPOMET Convention 2018
March 21-23 in Leipzig, Germany
Copyright © 2017 Paul Sonnier
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