Theranos, The Trial of Elizabeth Holmes, ch. 10: Holmes testifies about the salad days of Theranos, setting up cognitive dissonance

November 23, 2021 | by

Setting up a defense of cognitive dissonance. Today, in a brief appearance in Federal District Court in San Jose, Elizabeth Holmes returned to the stand to testify in her defense after a start last Friday. Her attorney Kevin Downey walked her through Theranos’ salad days, when the labs were numbered 1.0, cartridges stuck together, and the drug company studies were preliminary. Returning to her deep voice according to reports, she recalled Theranos’ Completed Successes, circa 2009, as many, and the performance as “really good.”

But 2009 was before the fraud with investors really got going. The falsifying of reports from Pfizer and Schering-Plough, for instance, was later. But every single drug company approached for the preliminary studies in those early days, including AstraZeneca at London’s Royal Marsden Hospital, never followed through with Theranos for more, such as a clinical trial or advanced study. Whether Holmes knew from an employee that Constance Cullen of Schering-Plough was less than enthusiastic about Theranos and found Holmes ‘cagey’ is beside the point, when the company later forged the Schering-Plough logo on a report to make it look as if Schering found Theranos’ labs acceptable. Downey took some care with Holmes not to introduce the later forgeries. Yet she was nothing if not persistent with other companies. Holmes pursued a partnership with Pfizer as late as 2015, in conjunction with Walgreens’ Theranos locations as clinical trial sites. 

She also testified that the series 4 lab could run any test, despite testimony from her last lab director Kingshun Das, MD that the series 3 could run perhaps a dozen at best and not reliably, leading him to void all tests made in 2014 and 2015. Earlier testimony stated that the series 4 never ran tests on patients.

Holmes’ testimony will continue tomorrow. Then the courts will be in recess for the Thanksgiving holiday until the 29th, which is when the prosecution will have its turn to cross-examine.

“Trying your hardest and coming up short is not a crime,” Lance Wade, another of Holmes’ many attorneys, said during opening arguments. But Holmes has already admitted to a repeated fraudulent claim of legitimacy–having the Department of Defense as a customer where the labs were on medevacs and the battlefield. But if the defense can introduce enough reasonable doubt, also known as cognitive dissonance or plain confusion, about Holmes and her ‘long con’ in the minds of the jury–that she was an entrepreneur with a dream just ‘trying harder’ and she didn’t know or mean to defraud investors as the prosecution claims but caught up in pursuing her noble aims–and add to that mind control by Sunny Balwani, Holmes does not have to be innocent to, as they say downtown, skate. CNBC, The Verge, FT, Mercury News (paywalled)

TTA’s earlier coverage: Chapter 9, Chapter 8, Chapter 7, Chapter 6, Chapter 5, Chapter 4 (w/comment from Malcolm Fisk), Chapter 3, Chapter 2, Chapter 1

News roundup: Pfizer’s COVID-19 vaccine on horizon, CVS’ new CEO, Vodafone UK 5G health survey, Centene acquires Apixio AI, Doro’s 24/7 Response

November 14, 2020 | by

As infection rates continue to rise, Pfizer’s and German partner BioNTech SE’s COVID-19 vaccine was the top of the news this undecided post-US election week. It was found to be “more than 90 percent effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis” of the Phase 3 clinical study. They exceeded their evaluable case count (total was 94). Protection was achieved 28 days after the initiation of the 2-dose vaccination. Pfizer release. Chain and independent pharmacies have already signed on for distribution at no cost to patients, covering about 60 percent of pharmacies through the US, Puerto Rico, and the USVI. It’s expected that FDA approval will be by end of year with availability early next year. HHS release. Work on 10 other vaccines goes on. The NHS is lining up for distribution with Health Secretary Matt Hancock promising that they’ll be ready from December as coronavirus diagnoses and deaths climb up from summer levels. BBC News

CVS’ CEO Larry Merlo announces 1 Feb 2021 retirement, Aetna head Karen Lynch to take the helm. Ms. Lynch will also join the board of directors. Mr. Merlo will depart after the shareholder meeting and serve as a strategic adviser until 31 May, which is typical of CEO phased departures. He leaves CVS in excellent shape having conducted during his 10-year tenure the acquisition of Aetna in 2018 and the growth of CVS to almost 10,000 store locations, initiating 1,500 HealthHUBs, and over $199 bn in earnings through Q3 this year. Ms. Lynch joined Aetna in 2012 from Magellan Health Services, a specialty/behavioral managed health company, and Cigna. She hit a home run with vitalizing Aetna’s Medicare Advantage business to 2.5 million members from under 1 million in 2013 and became Aetna’s president in 2015. Mark Bertolini, Aetna’s CEO during the merger in 2018 (but not Federally approved till September 2019), lost his spot on the board in an apparent spat/downsizing last February.  FierceHealthcare, Healthcare Dive, Fortune

Vodafone UK’s new survey on 5G and Internet of Things (IoT) devices in UK health and social care has been issued. A key finding is the comfort level of some telehealth consults well past 50 percent, and over 60 percent in the 18-34 and 35-54 age groups. There is 60-70+ agreement with Government investment in digital technology to ‘future proof the UK healthcare sector’ and to pay for care homes’ high-quality broadband and mobile. More in Vodafone’s study here.

Healthcare payer Centene Corporation is acquiring healthcare analytics company Apixio. Apixio’s AI platform analyzes large amounts of unstructured patient data in physician notes and medical charts. It then creates algorithms to extract high-quality insights to support payers’ and providers’ administrative activities. Acquisition cost is not disclosed and close is expected by end of year. It will be an ‘operationally independent entity’ in an Enterprise group, but complement other in-house technologies such as Interpreta. A bit of catch up here as larger plans Anthem, UnitedHealth/Optum, and Humana all have either substantial in-house AI analytics or have contracted with outside vendors (e.g. Microsoft) for this capability. Release. (Disclosure: This Editor was formerly with Centene, via their WellCare Health Plans acquisition)

Doro Mobile UK and Ireland is introducing ‘Response by Doro’, a touch button service to summon help if needed. The alert button is on the back of the phone versus on the screen, which differs it from most mobile systems. The standard level connects to family and friends, with the Response Premium level connecting to a 24/7 service. For BT Mobile and EE mobile customers with a Doro mobile phone, their first month’s access to Response Premium is free. Release (PDF)

23andMe returns to direct-to-consumer genetic testing marketing

October 23, 2015 | by

Nearly two years after the FDA shut the door on 23andMe‘s direct marketing of genetic testing, it is now back in the market with FDA clearance. The new Personal Genome Service (PGS) now meets FDA standards–and is now $199 where it was previously $99. It is as before a saliva-based test that in about two months, provides that person with an online report. There are multiple types, for instance the carrier status test on 36 inherited conditions, including cystic fibrosis and sickle cell anemia. The company is also bolstered by closing a $115 million round this month and in January a partnership with Pfizer to sell the company its Research Portal aggregated, anonymized data. Earlier this year, FDA cleared in Class II their Bloom Syndrome test [TTA 20 Feb] and late last year resumed DTC test marketing in the UK. Mobihealthnews also includes a helpful timeline of 23andMe’s troubles and recovery.

23andMe’s FDA coup hazardous to personal DNA data security?

March 5, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/03/DNA-do-not-access.jpg” thumb_width=”150″ /]Genetic test developer 23andMe’s wins with the FDA [TTA 20 Feb] served to clear the path for their current Bloom Syndrome and future kits as Class II devices. It’s long been believed that the company’s real diamond mine is in selling the DNA data gained through the kits, and with consent, to major pharma and medical companies. Proof: recent collaboration announcements with Genentech and Pfizer on genetic research. But how will this data be safeguarded? It may not be a significant concern now, but “Personal DNA information will become far more critical and more important to safeguard than the details of our life circumstances”. Hackermania’s Running Wild with AnthemHealth-sized data breaches (more…)

Breaking news out of the mHealth Summit

December 12, 2014 | by

mHealth Summit this year had an abundance of digital health company news announcements, not only from the conference but also timed to coincide with the heightened interest around it. Your Editor looks over the most interesting of them, briefly. Thanks to Ashley Gold of Politico’s Morning eHealth (@ashleygold, daily reports archived here), Stephanie Baum of MedCityNews (@stephlbaum) and Anne Zieger of Healthcare Dive for their coverage and their company in the press room!

Partners HealthCare researches, Validic expands, AliveCor and Omron ally, Happtique sells out, Doctor on Demand is telemental, Orange goes dental, VA Innovation Rocks

  • Partners HealthCare/Center for Connected Health’s cHealth Compass will use panel and other research to help companies, device manufacturers, startups and investors determine what end users–consumer and provider–want out of personal health tech. Focus groups, interviews and usability testing will help to determine product design, evaluation, assess applications and feasibility as well as interim/final product testing. Partners is already organizing in Massachusetts a 2,000-patient database which rewards participants $50 on registration and $110 annually to be in a monthly survey panel. cHealth Compass website, BetaBoston (Boston Globe)
  • Health data connector/aggregator Validic demonstrates the attractiveness of Anything Big Data on with new clients including the Everyday Health consumer/professional website and the adidas Group’s sport and fitness apps. Recently they added WebMD, Pfizer, University of Pittsburgh Medical Center (UPMC), NexJ Health and MedHost to their client list. The company claims that their ‘ecosystem’–probably the most popular buzzword at this year’s conference–of healthcare companies and tech developers now reaches over 100 million people with devices such as Omron, Alere, Qardio, Telcare, Jawbone and Withings. Release
  • AliveCor accentuates the retail with Omron. AliveCor, which developed the first FDA-cleared ECG for smartphones and gained clearance for an atrial fibrillation algorithm in August, is collaborating with Japanese device manufacturer Omron on developing its retail presence. Omron’s devices are available in major drugstores such as Walgreens, RiteAid and Walmart so certainly AliveCor is due to benefit. AliveCor is also part of a revived QualcommLife (more on this in an upcoming article)  Release, Mobihealthnews (Your Editor had the pleasure of meeting at last AliveCor’s CMO and founder Dr. Dave Albert.)
  • Happtique sold to SocialWellth. Last year’s floor talk was about Happtique’s first class of certified apps and a security expert’s untimely discovery of major flaws (more…)

Bayer AG enters the healthcare accelerator game (DE)

September 9, 2014 | by

Bayer HealthCare AG’s Grants4Apps program announced its support of five startups that, in their words, will support improved outcomes or pharmaceutical processes. Unlike companies like GE or Pfizer, Bayer is outright granting a substantial amount of cash to each–€ 50,000–and offering space plus 3 1/2 months of mentoring in their Berlin HQ in return for the usual small equity stake. Of 70 applications, five were granted to European companies which will have their Demo Day on 1 December:

  • Cortrium:  their C3 device is a state-of-the-art wearable tech sensor for clinical-quality hospital wireless monitoring of health data including electrocardiogram (ECG), body surface temperature, respiratory rate, and body posture/physical activity. Blood oxygen and blood pressure to come in 2015. (Denmark, spun off from Nokia R&D)
  • PharmAssistant: self-management tool for chronic disease patients, consisting of a smart pill container and a remote cloud-based monitoring service (Portugal) (more…)

Medtronic, Covidien and what it might mean for digital health

June 17, 2014 | by

“This acquisition will allow Medtronic to reach more patients, in more ways and in more places,” Medtronic Chairman and CEO Omar Ishrak

Cover the Earth? While the healthy Medtronic offer ($42.9 billion in cash and stock) for Ireland-headquartered Covidien plc is not a ‘digital health deal’, it does point to Medtronic’s strategy which includes digital health. There is of course the obvious: growth by acquisition and integration. Acquisitions require cash, and the highly controversial change of domicile to Ireland via ‘tax inversion’ will fatten the exchequer in two ways. First is through the lower overall Irish corporate tax versus the 35 percent US tax, one of the highest in the world. Second is much more flexibility in repatriating plentiful foreign earnings at lower Irish corporate rates rather than the high US rates which Medtronic has avoided. Third is increasing dividends, which can drive up stock price and investor interest. Of interest to the latter is also that Covidien adds horizontal (and global) competitive strength to Medtronic in the clinical area–surgical, vascular, respiratory and wound care.

More Ways-More Places. Not just staples and sutures, Covidien has developed its own advanced in-hospital mobile patient monitoring in Vital Sync as well as several hospital monitoring devices in their Nellcor line. In addition to technology collaboration, the next point of integration could then be with Medtronic’s post-acute telehealth devices from Cardiocom, purchased less than one year ago. We noted at the time that it gave Medtronic entreé into the “chronic condition management continuum– not only into telehealth via Cardiocom’s devices and hubs, but also their clinical and care management systems.”

Approval will take time. Both the US and UK, through various regulatory agencies, scuppered the Pfizer-AstraZeneca deal on similar tax domiciling and competitive grounds. If it does go through, there will be a lot of reorganization. But while it digests, this Editor will be watching Medtronic for its usual pattern of making smaller ‘more ways/more places’ deals in the interim with an eye to diversifying past US-taxable medical devices. One pointer is their just-announced partnering with Sanofi to develop drug delivery-medical device combinations and care management services for diabetes patients (MedCityNews).

Related reading: Medtronic hints at more acquisitions following $43 billion Covidien deal (MedCityNews); The Medtronic, Covidien Inversion Deal Is More About Dividends Than Tax (Forbes); Medtronic agrees to buy Covidien for $42.9b in cash, stock (Boston Globe); Medtronic’s $43B Covidien deal—and Irish tax move (CNBC)

 

‘Candy Crushing’ stroke rehab

January 21, 2014 | by

A development that deserves more attention is the use of ‘gamification’ in rehab. In one program, it’s using a combination of incentives, brain stimulation and robotics. The popular Candy Crush Saga game uses a moving candy target, rewards (to higher levels) and reduced reaction times at the harder levels. The Manhasset, New York-based Feinstein Institute for Medical Research at North Shore-LIJ Health System is testing this notion with rehab for paralyzed limbs. Instead of concentrating on training other limbs to compensate for the paralyzed ones, the Non-Invasive Stroke Recovery Lab program focuses on gaining more movement in the affected limbs. Using robots to move the limb at first, then sensing when the patient is moving them on their own, they gradually train the brain to move the limb for whatever motion can be achieved. Therapists use these programs with patients to gain the “just-right” amount of challenge to maintain motivation and attention. According to their website, several programs are being tested using devices for the wrist, shoulder-elbow, hand and an anti-gravity one for the shoulder. A fifth one is in early development to improve gait post-stroke. Also in test is coupling this with trans-cranial direct current stimulation. mHealthNews. Feinstein Institute and researcher (Bruce Volpe) website.

Drug manufacturer Pfizer is also testing gamification for a different sort of rehabilitation–using Evo Challenge from Akili Interactive Labs in determining the status of and improving the abilities of those with cognitive impairments, Alzheimer’s disease (with and without amyloid in the brain) and ADHD. The game, which involves navigation around obstacles and rewards, is designed to improve the impaired processing of cognitive interference, a/k/a distractions. MedCityNews

Birmingham OwnHealth Take II – take your pick

August 17, 2013 | by

You wait for a cohort study to come along for ages, then suddenly two come along within a week of each other…of the same intervention, although with apparently different conclusions. The second paper, entitled “Analysis of the Impact of the Birmingham OwnHealth Program on Secondary Care Utilization and Cost: A Retrospective Cohort Study”, is published online in the Journal of Telemedicine and e-Health, ahead of print, with lead author Liv Solvår Nymark.  (Our post on the previously-reviewed paper, whose lead author was Adam Steventon is here).

The Steventon paper found that the OwnHealth intervention “did not lead to the expected reductions in hospital admissions or secondary care costs over 12 months, and could have led to increases” whereas the Nymark paper “found difference in costs constituted (more…)