Soapbox: Big Genomics and DNA testing–why we need a Genomic Data Bill of Rights

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/03/DNA-do-not-access.jpg” thumb_width=”150″ /]This week, consumer genomics testing company 23andMe announced that outside app developers would no longer have access to raw genomic data, as they have had since 2012. They will continue to have access to data through reports generated by the company. 23andMe cited privacy concerns–wisely, in this Editor’s opinion, to safeguard this burgeoning area of digital health. Seeking Alpha

TimiHealth is an affected firm that seeks to move customer data, with consent, to an allegedly more secure blockchain platform, TimiDNA, citing 23andMe’s monetization of their data and CMS’ Blue Button initiative, a recent meeting in which 23andMe participated as a developer. Blasting away, TimiHealth stated that “It flies in the face of the mission of CMS, and the MyHealthEData initiative and the goal of putting patients first.” Release

However, the consumer marketing of DNA testers such as 23andMe, Ancestry.com, and smaller competitor Helix, has already led to multiple privacy questions on how the data of millions are being used and sold. 

This Editor would feel safe in assuming that most customers do not know nor particularly care that GlaxoSmithKline (GSK) as of July owns 50 percent of 23andMe via a $300 million investment. Both have announced a four-year partnership to use the 23andMe genetic database for drug research. For instance, the LRRK2 gene has been linked to some forms of Parkinson’s disease. GSK needs about 100 for a trial sample of one, but 23andMe has already provided 250 Parkinson’s patients who have agreed to be re-contacted for GlaxoSmithKline’s clinical trials. Scientific American

While most data is de-identified, you can agree to be contacted for further use in clinical trials, which is fine–but most users do not know how to opt out. It’s a surprisingly tricky process, as outlined in this useful Business Insider article, and you may not be able to withdraw all your data or have your saliva sample destroyed.

Data can be hacked and reprocessed. Three years ago, TTA explored reports on exactly how de-identified genomic data could be made identifiable through the ‘nefarious use’ of genomic data sets available through research networks [TTA 31 Oct 15].

Despite the trite, simplistic, and condescending commercials by Ancestry.com on how someone found they had ethnic or national roots they never dreamed of, or were related to royalty, both giving meaning to their presumably mundane life, genetic info has value beyond the feel-good. It’s long past time for a plain language Genomic Data Bill of Rights.

  • Individuals should know how their personal genomic data is being used and how it is being protected
  • They should be able to opt out of use, identified and de-identified, easily–and not have to jump through hoops
  • Reporting/interpretation should also have integrity, consideration, and respect that it may upset a person or that it may not be interpreted correctly, which is a fundamental problem 
  • A more radical view is that the same individuals should be compensated when their data is used

This Editor will settle for the first two bullets, for now. 

Can Big Pharmas hiring of digital execs actually ‘reimagine medicine’?

Reimagination or hallucination? In recent weeks, both Glaxo Smith Kline and now Novartis have hired digital analytics and marketing executives out of non-healthcare businesses to lead their digital transformation. For GSK, Karenann Terrell joined in the new position of chief digital and technology officer from six years as chief information officer for Walmart and CIO for pharma Baxter International. From Sainsbury’s Argos, Bertrand Bodson will be assuming the chief digital officer title at Novartis without any previous healthcare experience.

Both are expected to be transformative, disruptive, and ‘reimagine medicine’. Ms. Terrell’s experience and accomplishments appear to be the closest fit to her GSK’s job expectations of integrating digital, data, and analytics strategy with enhancing clinical trials and drug discovery, as well as improving professional and consumer interactions. Novartis’ mission for Mr. Bodson aims even higher. In addition to these, he will be ‘transforming our business model using digital technologies’, ‘reimagine (sic) medicine by leveraging digital on behalf of millions of patients and practitioners’, and ‘leading cultural change’.

Both companies have good starts in advanced technologies–GSK in AI, sensor technologies for managing COPD, and a medical device mobile app; Novartis with ‘smart pill’ Proteus, a pilot with heart medication Entresto tied to monitoring and coaching, and through its Alcon subsidiary with Google, a wired-up contact lens that detects blood glucose [TTA 17 July 14]. However, this last appears to be stalled in trials and Alcon on the block. According to the FT, Novartis is feeling the pressure to develop more digital partnerships, such as Novo Nordisk’s teaming with Glooko and Sanofi with Verily Life, all in diabetic management. Acquisitions may also be the way forward.

A significant impediment to all this integration is consumer and professional trust. If too closely tied to a pharmaceutical company or appearing to be too self-serving, remote monitoring and counseling may not be trusted to be in the patient’s (or doctor’s) best interest or objective as to better approaches. The overuse of analytics, for instance in counseling or patient direction, may be perceived as violating patient privacy–creeping out the patient isn’t helpful. The bottom line: will these digital technologies serve the patient and maintain medical best practices–or best serve the pharmaceutical company’s interests?

This Editor doesn’t question these individuals’ ability, but the organizations’ capability for change. But count this Editor as a skeptic on whether one or two digital execs can marshal the bandwidth and the internal credibility to transform these lumbering, complex, regulated, and long cycle businesses. Big Retail is fast moving by comparison. PMLive 31 July (GSK), 13 Sept (Novartis)  Hat tip to TTA alumna Toni Bunting

Diabetes management: the Next Big Health Tech Thing?

Big Data? Passé. Health IT security and hacking? At a peak. So what’s the Next Big Thing? If you’re tracking where the money’s going, it’s diabetes management. This week saw the joint venture Onduo formed by the controversial [TTA 6 Apr] life sciences-focused Verily (Google Alphabet) and Big Pharma Sanofi with a nest egg of $500 million. Onduo will be combining devices with services to help Type II diabetics. Based upon CEO Joshua Riff’s statements to MedCityNews, their platforms are yet to be developed, but “will be a digital platform that will involve software, hardware, and very importantly service” to change patient behaviors. Partnerships with Sutter Health in Northern California and Allegheny Health Network of western Pennsylvania will test their approaches in a clinical setting. Xconomy, Reuters

Verily’s other diabetes project include the £540 million bioelectronics partnership announced in August with UK-based GSK in Galvani Electronics [TTA 3 Aug] with a focus on inflammatory, metabolic and endocrine disorders, including Type II diabetes. With Dexcom, Verily is also building an inexpensive, smaller next-gen continuous glucose monitoring sensor; Mr Riff was coy about whether this sensor would be used but allowed that sensors might be used in Onduo’s approaches. Verily is also developing the well-known glucose-reading contact lens with Novartis [TTA 1 Sep 15].

Also this week, Glooko and Sweden’s Diasend announced their merger (more…)

Google’s Verily joint ventures with GSK into bioelectronics (UK/US)

Verily, the Alphabet (Google) life sciences research group, and GlaxoSmithKline are partnering in a joint venture that may replace drugs for disease with micro-electronic implantable devices. GSK will own 55 percent of Galvani Bioelectronics, with Verily owning 45 percent. They have pledged an investment of £540 million in the new UK-based business over 7 years, as well as contributing intellectual property rights to Galvani. Most of the staff will be at GSK in Stevenage with some at Verily’s HQ in South San Francisco, and led by Kris Famm, formerly GSK’s vice president of bioelectronics R&D. The deal is expected to close by end of year.

According to Business Insider UK, GSK has been involved with bioelectronics for four years. It’s defined as “a relatively new scientific field that aims to tackle a wide range of chronic diseases using miniaturised, implantable devices that can modify electrical signals that pass along nerves in the body, including irregular or altered impulses that occur in many illnesses.” The diseases that are being targeted are inflammatory, metabolic and endocrine disorders, including type 2 diabetes. According to the MedCityNews interview of Verily’s CTO Brian Otis, the systems will be closed loop where the devices listen to the nerve signals, do real-time signal processing and send the optimized signal back to the nerve to restore healthy function. GSK has the diagnostic and biologic expertise, Verily has the device smarts. Also Mobihealthnews, Recode