I made this announcement to 54,053 members of the Digital Health group on LinkedIn. If you’re on LinkedIn, please do join the group, which allows you to opt in to receiving these announcements in addition to connecting with thousands of other global stakeholders in digital health. Note that I will continue to update this announcement up until sending out the final version via LinkedIn.
It was a huge week in genomics, particularly with the gene editing technology known as CRISPR. First, in the legal dispute between UC Berkeley and the Broad Institute (affiliated with Harvard and MIT) over who owns the invention of CRISPR, the U.S. Patent Office has decided in favor of the Broad Institute, saying that it can retain its patents for the use of the technology, primarily in plant, animal, and human cells. In other words, the most valuable application areas.
And in other major gene editing news, in a new consensus study entitled “Human Genome Editing: Science, Ethics, and Governance“, the National Academy of Sciences has endorsed CRISPR germline gene editing modification of humans (namely changing human embryos, sperm, or eggs), but only when it is used to prevent the birth of children with serious diseases. As Antonio Regalado reports in MIT Tech Review, the recommendations come “freighted with moral and technical caveats” and it may be many years before this is safe enough to consider. The panel suggested that there should be stringent oversight and that enhancements—like attempting to alter genes to make people more intelligent—should not be pursued at this time. Antonio adds that “the panel’s endorsement of GM humans could prove politically explosive, and puts the academy’s experts in conflict with existing legislation in Europe and the U.S. as well as with swaths of the public who oppose the idea of modifying the human genome from birth out of religious conviction or for other reasons.” To give you an idea of how big even this limited application can be, at the recent annual meeting of the American Association for the Advancement of Science (AAAS), geneticist George Church argued that CRISPR gene-edited sperm could have a role in 6% of births.
And by borrowing tactics used in DTC marketing of nutraceuticals, some consumer genomics firms are potentially giving a bad name to the field. In a piece by Kristen Brown, The Next Pseudoscience Health Craze Is All About Genetics, Dr. Eric Topol points out that “Millions of people have had genotyping done, but few people have had their whole genome sequenced. We need billions of people to get their genome sequenced to be able to give people information like what kind of diet to follow.”
There are hiccups in the efforts of China’s big tech players to grow and profit from medical-focused digital health in the country. In a Bloomberg piece “China’s Tech Tycoons’ Healthcare Dreams Aren’t Coming True“, it’s reported that after 2014’s banner year of investment in “Internet health” totaling $1.4B, investments are down precipitously. Digital health efforts by the likes of billionaires Robin Li (search engine Baidu), Jack Ma (Alibaba), and Tencent Holdings are struggling to make money. With millions of Chinese developing chronic diseases like diabetes and willing to pay for health management solutions, the market opportunity is certainly strong. But just like in the United States, digital health companies can be stymied or outright blocked by policymakers and establishment healthcare players who drive policy that cripples cost-cutting innovation. For example, Ali Health built an online consultation and e-pharmacy platform, but regulators ended pilot programs allowing websites to sell over-the-counter drugs. To compound matters, not only is there a dearth of medical data to feed AI systems like Li’s but, according to Unicorn Studio’s Roger Liu, “China’s entire healthcare database hasn’t been brought online. For places that have data, they won’t share it with you. Without data, how can you talk about online health care.” Sounds eerily familiar to the United States.
Apropos the situation in China, in a piece entitled “Orthodoxy vs. innovation in medicine“, Robert Graboyes—senior research fellow with the Mercatus Center at George Mason University—points out that “The medical field has spent a century cultivating an infrastructure of credentials and orthodoxy. In an era of rapid technological development, an inescapable question is whether that infrastructure is actually an enemy of innovation.” Robert points to how the American Medical Association’s “Flexner Report”—a critique of America’s medical schools released in 1910—put into place a homogeneity throughout healthcare that discouraged experimentation in practice. He contrasts this with how “Toyota methods” have shown great results in some hospitals outside the United States. While he emphasizes medical education, I think he could have added that healthcare processes could also benefit from applying concepts and tools of the Toyota Production System, a system which is steeped in the philosophy of “the complete elimination of all waste imbuing all aspects of production in pursuit of the most efficient methods”. Lindsey Dunn wrote a piece on this in a 2009 article in Becker’s Hospital Review: “5 Key Principles for Hospitals From Toyota’s Lean Production System“. Graboyes does suggest that while “Digital Era technologies are penetrating health care worldwide: genomics, telemedicine, wearable and implantable telemetry, big data, artificial intelligence, and 3D printing”, they—digital health—are being met with resistance from providers, regulators and lawmakers. “Encouraging adoption”, he says, “means allowing greater risk (by providers and patients), and it’s difficult to reform one institution without reforming the others simultaneously.”
The group discussion started by Sarah Kohl, MD, FAAP is located here.
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