Ned Anderson: The Digital Health Update by Paul Sonnier ⋅ May 25, 2017 ⋅ #276

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The Digital Health Update by Paul Sonnier ⋅ May 25, 2017 ⋅ #276

Dear Group,

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I’ve published two issues of The Digital Health Newsletter since last week’s group announcement. I’ve copied and pasted the text from each newsletter below for better web-search (SEO) and archival purposes.

The Digital Health Newsletter by Paul Sonnier for May 20, 2017

Will consumers be able stomach gene editing better than GMOs?

That’s the pointed question Jade Scipioni of FOX Business recently asked Dr. Robert Fraley, aka ‘the godfather of GMOs’, and chief technology officer for Monsanto. As Dr. Fraley states, “Gene editing is probably one of the most exciting new techniques in biology. It’s going to have applications for human healthcare, for agriculture, both in producing better crops and better livestock. With gene editing, we don’t have to put a new gene into the plant. What we’re able to do is precisely modify a gene that’s already existing in the plant, in the animal, or even in human healthcare applications.” As I’ve previously reported, Monsanto has obtained exclusive licensing of both CRISPR/Cas9 and CRISPR/Cpf1 gene-editing technologies for agricultural applications from the Broad Institute of MIT and Harvard.

Regarding the consumer reception of gene editing, Dr. Fraley explains that, following regulatory approvals from the USDA, EPA, and FDA, they (i.e. Monsanto and other GMO producers) successfully communicated the benefits of GMOs to farmers, but did not do the same with the public.

In contrast to Dr. Fraley’s comments, Megan Westgate, executive director of the Non-GMO Project, says that “While these new technologies are touted to be more precise than older genetic engineering technologies, it is widely accepted in the scientific community that there can be ‘off target’ effects to the genome when the technologies are utilized. GMOs, including the products of these new technologies, have not been adequately tested—no long-term feeding studies have been conducted—and people are starting to connect these experimental technologies to health concerns.”

With nearly a billion people lacking proper nutrition, a rapidly growing global population, and climate change making agriculture more challenging in many regions, food security is a pressing problem. While not often noted, digital health—genomics and gene editing in particular—can play a major part in addressing this challenge.

A new virtual reality movie ‘Across the Line’ is helping people empathize with women visiting Planned Parenthood. By using 360-degree video and computer-generated images with both real audio of people shouting, documentary footage, and scripted scenes, viewers experience a trip to a women’s health clinic along with painful encounters with protesters. Research suggests this not only cultivates empathy, but can also influence people to feel more disapproval of clinic harassment and dislike certain types of behavior, such as individuals photographing patients. Planned Parenthood is also showing the film to legislatures and law enforcement groups so that they, too, can better understand the effects of harassment.

MindMaze has received FDA clearance to market its 3D virtual environment for neurorehabilitation for stroke recovery and brain injury. The company’s mind-machine interactions are delivered via neuro-virtual technology and can be used as soon as four days after a stroke. Approximately 800,000 people in the U.S. experience a stroke each year, with a resulting economic impact of $65 billion. MindMaze’s ‘MindMotion PRO’ maps a patient’s movements onto 3D avatars to deliver customized interactive exercises based on standardized neurorehabilitation principles of upper limb rehabilitation and cognitive paradigms. This re-activates damaged neural pathways and activates new ones.

In a video interview on the BBC show ‘Click’, Adrian Aoun, CEO of Forward, a new concierge healthcare service offering a ‘medical body and health scan using AI and connected tools’ was asked by a BBC journalist about the collection of “huge amounts of very, very personal data. Where is it? Who’s looking after it?” Mr. Aoun’s response was that “We have some of the best engineers in Silicon Valley from companies like Palantir and Google and Facebook looking after your data the same way that Google looks after your Gmail information.” When asked where the data is located and “How do I know my data’s in good hands?”, he stated “We don’t comment on that.” While not asked about HIPAA and healthcare data privacy, I expected that he would mention it in his response.

Digital health app Clue now advises women what to do if they forget to take their contraceptive pill. With over 5 million users, the company’s app is used by women to track their period and ‘all things related’. A survey conducted by the company revealed that in many countries a large proportion of young women didn’t know what to do if they missed taking their contraceptive pill as scheduled. In Russia, for instance, where the pill is available without a prescription, one out of four women did not receive advice about their period. The result of not taking the pill on time means that a woman can start her cycle and potentially lead to an unwanted pregnancy. Users on the pill can track categories relevant to the type of pill they take and see empty dots for days they missed taking the pill.

Researchers have found that people with lower levels of cardiorespiratory fitness had a higher risk of developing non-cancerous polyps, which are associated with an increased cancer risk. Cardiorespiratory fitness is determined by measuring VO2 max, a measure of aerobic fitness that looks at how much oxygen the body is able to use in a given time period to power its cells. According to lead study author Dr. Vikneswaran Namasivayam, a gastroenterologist at Singapore General Hospital, “A person’s age, sex and genetics also affect his or her cardiorespiratory fitness level”.

A separate study suggested that a group of 29 genes could potentially categorize individuals into low, medium and high responders to exercise. Even so, heredity is estimated to account for only 50 percent of one’s ability to improve their fitness level and the newly identified genes only explain about 23 percent of a person’s ability to improve VO2 max. According to lead researcher Claude Bouchard, of the Pennington Biomedical Research Center, “With this we can identify, with a reasonable degree of precision, who is a low responder (to exercise), an average responder, or a high responder. We can begin to rank order people for their ability to be trained before they are trained.”

Since DNA is not always destiny, there are ways to improve VO2 max . One of the best ways involves increasing your exercise, which can improve your measured VO2 max by up to 20% within just 2-3 months. Interval training is one of the most effective means of accomplishing this. And as I’ve previously reported, interval training has been shown to be superior to other types of exercise in activating genes related to improvements in cellular aging. You can also use wearables from companies like Garmin, Polar, Jabra, Suunto, and others to monitor your VO2 max.

The Digital Health Newsletter by Paul Sonnier for May 23, 2017

According to a new survey of teens and young adults age 14-24, their use of Instagram, Facebook, Snapchat, and Twitter is increasing their feelings of inadequacy and anxiety. The poll showed additional negative impacts of the platforms include exacerbating body image worries, loneliness, depression, bullying, and sleep problems. Only YouTube had a net positive impact.

Unrelated (we assume), Ev Williams recently apologized for what he believes was Twitter’s role in the election of President Donald Trump. The Twitter co-founder stated that this was “a very bad thing” and “the Internet is broken”. What he apparently fails to realize, however, is that candidate Trump received $5.6 billion in free media coverage leading up to the presidential election . This amount exceeded the combined amount received by candidates Hillary Clinton, Bernie Sanders, Ted Cruz, Paul Ryan, and Marco Rubio. Below is a picture of the empty Trump podium CNN displayed while presidential candidate Bernie Sanders was giving a speech.

In other Twitter news, the company’s algorithm is incorrectly guessing the gender of transgender users based on their profile and activity on the platform. People who have experienced the algorithm picking their sex assigned at birth—versus their actual gender identity—report feeling invalidated, hurt, and angry.

A recent article on the Regulatory Affairs Professional Society’s website mentioned a potential new Digital Health Unit at the FDA, but was unfortunately light on details. Now there’s an authoritative and detailed piece in WIRED discussing Associate Center Director for Digital Health at FDA Bakul Patel’s plans for a new digital health regulatory paradigm at the agency.

Avid runner Kelly Huron successfully fended off an attacker in a Seattle, WA bathroom while on a break during a recent run. She subsequently posted pics of her ordeal on Instagram, including a GPS-created map of her run. This use of social media can inspire other women to both speak out and take the kind of self-defense training Kelly received just weeks before the incident.

Saying that the “issue was caused by a third-party battery”, Apple is refusing to compensate a customer whose headphones exploded and injured her. The AAA batteries are used in a discontinued model of the company’s Beats product, which caught fire during a flight from Beijing to Melbourne. No word on whether the devices will be banned on airplanes.

Issues around personal DNA/genomic data ownership and privacy can be complicated. This was highlighted in a recent Twitter conversation I was involved in after I tweeted an article by Joel Winston, a former deputy attorney general for the State of New Jersey and currently working in a legal practice focused on consumer rights litigation, information privacy, and data protection law. In his piece “Ancestry.com takes DNA ownership rights from customers and their relatives“, Winstone states that according to the company’s ‘Terms of Service and Privacy Policy’ (a legal contract that users must sign), while you still own your DNA, so does Ancestry.com. Ancestry tweeted a reply to me (shown below along with Joel’s reiteration of his point and question) and you can read the full response by the company’s Chief Privacy Officer, Eric Heath, on the company’s blog, here. I’ve also included a couple of other notable replies and conversations. In summary, it seems that while you may still own your DNA data, so does Ancestry, and they can use it (and sell it) pretty much however they want to until/unless you revoke that permission by canceling your service.

Amgen’s new osteoporosis drug to prevent fractures of the vertebrae in postmenopausal women is being delayed due to a potential 30% increase in heart attacks. In 2012, the company had acquired DeCode Genetics for $415 million in hopes that the genomic insights could “pressure test its drugs by looking at people who have genetic mutations related to the proteins the medicines target”. While the technology was successful in identifying patients with sclerostin genetic mutations, had high bone density, and were therefore very fracture-resistant, it seems that there simply were not enough patients in the study to flag the potential for increased heart attack risk.

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