COVID-19’s negative impact on clinical trials–can remote patient monitoring and telehealth companies help?

September 30, 2020 | by

We’ve previously noted the interest of large drug clinical trials companies in remote patient monitoring–example the acquisition of the much-passed-along Care Innovations by PRA Health Sciences [TTA 8 Apr]. Logically, these clinical trials have been hampered by the COVID-19 pandemic, affecting recruitment, data sharing, preservation of data, and how trials can be conducted.

TMF Futures: Keeping Data Alive has just been published by Arkivum, a University of Southampton (UK) spin-out which specializes in the digital preservation of valuable data for the life sciences industry and global scientific institutions through the Arkivum Trust. This initial survey was conducted in July 2020 by Arkivum, Phlexglobal, the Ethical Medicines Industry Group (EMIG), and Survey Goo. The 206 senior representatives surveyed all have responsibility for/knowledge of clinical trials, with senior and director-level positions in general and senior management; regulatory; quality assurance; clinical; operations.

TMF refers to the trial master file that is required by FDA and EMA. Paper TMFs have largely converted to electronic form (eTMF). Life science organizations have also largely transferred data to eClinical applications. Despite that, the survey found that 45% of clinical research organizations (CROs) struggle to manage, locate and report data, while 50% are unable to convert documents from multiple software applications in order to make them usable. 

Topline findings of the survey:

  • 74% of respondents say that COVID-19 will continue to compromise their ability to deliver on clinical trial objectives for the next six to 12 months;
  • 70% say that COVID-19 has triggered a change in the way clinical trials will be conducted;
  • Interoperability between eClinical applications used in trials remains a major challenge – for example, 39% of all respondents and 50% of contract research organizations are unable to convert documents from multiple eClinical applications;
  • Current archiving of clinical trial data is not always fit for purpose – for example, 65% of compliance, legal, and regulatory professionals describe their ability to access data as ‘extremely inadequate’ or ‘very inadequate’.

Of interest to our Readers is page 11 of the survey, which found that 56% of respondents believe that there will be increased remote patient monitoring in post-COVID clinical trials, and that 22% believe that new technology will be developed to shorten clinical trial duration and reduce cost. In addition, recruitment has to come from more diverse areas and to mitigate the difficulty of finding people to be in clinical trials.

For telehealth developers, providers, and software developers who have the systems, data, and access to patients/users, clinical trials and CROs may be a strong future market. We may also have profitable insights into interoperability and data sharing.

To obtain a free copy of the survey, fill out the short form here. Arkivum press release. Hat tip to Penny Lukats of SENSO Communications (UK).

Doro adds Spain’s Victrix SocSan to its growing brand portfolio for £1.28 million plus shares

September 30, 2020 | by

Sweden’s Doro has a new addition to its portfolio, and it’s an interesting one. Victrix SocSan, headquartered in Madrid, coordinates health and social care primarily through data analysis blending different health and social care sources “to provide low-cost yet highly effective proactive interventions for chronic disease management, elder care, and wellbeing.” It concentrates on care workflow and information exchange, according to their website. Unlike previous Doro acquisitions such as ElderCare UK [TTA 11 Aug], Invicta Telecare, parent of Centra Pulse and Connect [TTA 19 Sept 19], and Welbeing [7 June 18], it’s about the technology and not the territory or system. “A strong technical platform and knowledge is an important component in our strategy. The Victrix Care Platform gives us new opportunities to develop and offer coordinated and proactive care services, both in individual and assisted living, ” according to Doro Group President and CEO Carl-Johan Zetterberg Boudrie. 

The acquisition cost is modest compared to some of the US blockbuster deals we’ve seen lately. Cash upfront is SEK 14.8 million (UK£1.28 million, US$1.65 million, €1.41 million). The 232,744 shares in Doro AB closed today at SEK47.50 which is about SEK11.05 million (UK£956 thousand, US$1.2 million, €1.1 million). There are other payouts noted in the press release. Their results will be consolidated into Doro’s from 30 September. According to the release, the Victrix team will be joining Doro. Their CEO and founder, Joe Killen, is a familiar figure in the UK from his nearly 20 years at Tunstall Spain and Southern Europe. Hat tip to one of our UK Readers who wishes to stay anonymous.

News roundup: Amwell’s socko IPO raises $742M, Walmart and the Clinic Wars, Taskforce on Telehealth Policy report released, Israel’s Essence releases fall detection sensor system

September 18, 2020 | by

Telehealth bullishness shows no sign of diminishing. On Wednesday, Amwell‘s (the former American Well) IPO stunned markets by not only debuting at $18 per share (a price only large investors received) but also opening at $25.51 on the NYSE (AMWL) and floating more than 41 million shares for a raise of $742 million. If underwriters exercise all their options, the raise could exceed $850 million. Only last week, the SEC filing projected a sale of 35 million shares at $14 to $16 a share. Back in August, the raise was estimated to be only about $100 million. (One could consider this a prime example of ‘sandbagging’.) Friday closed at $23.02 in a week where Mr. Market had a lot of IPOs and hammered traditional tech stocks. As reported earlier, Amwell is backed by Google via a private placement and also Teva Pharmaceutical.

Smaller and lower profile than Teladoc, Amwell provides services for 55 health plans, 36,000 employers, and in 150 of the nation’s largest health systems, with an estimated 80 million covered lives. Like Teladoc, Amwell has yet to be profitable, with 2019 losses of $88 million and $52 million in 2018. FierceHealthcare, Marketwatch. Meanwhile, the Teladoc acquisition of Livongo has gone quiet, as is usual.

The Clinic Wars continue. Another front in the consumer health wars (and repurposing retail) is more, bigger, better clinics onsite. CVS drew first blood early this year with the expansion of MinuteClinics into fuller-service HealthHUBs, with a goal of 1,500 by end of 2021. Walgreens flanked them with 500 to 700 Village Medical full-service offices [TTA 9 July]. In this context, the expansion of Walmart Health locations looks limp, with their goal of 22 locations in Georgia, Florida, Arkansas, and Chicago metro by end of 2021. Another concern is with scale and modularizing the Walmart Health locations’ construction via constructor BLOX,  One wonders with recently reported layoffs of 1,000 at corporate and the replacement of industry innovation veteran Sean Slovenski with Lori Flees, whether there’s some radical rethinking of their clinic business investment as not mass but targeted to underserved areas that avoid CVS and Walgreens. FierceHealthcare, Walmart blog  CVS also announced the doubling of their drive-thru COVID-19 testing sites to 4,000 by mid-October. FierceHealthcare

More Weekend Reading. Here in the US, the Taskforce on Telehealth Policy, a joint effort between the National Committee for Quality Assurance (NCQA), the Alliance for Connected Care, and the American Telemedicine Association, has issued a report that focuses on maintaining quality care, fitting telehealth into value-based care models, enforcing HIPAA for patient privacy, and ensuring widespread and equitable access to broadband and technology. The involvement of the NCQA is a major step forward in advancing policy in this area. Press release/summary, Report page, Powerpoint slides, and webinar recording  Hat tip to Gina Cella for the ATA.

New entrant in passive fall detection. Israel’s Essence SmartCare is launching MDsense, a multi-dimensional fall detection solution for the residential market. It is sensor-based, using wall mounted intelligent sensors rather than wearable devices that statistically are not worn about half of the time and have their own well-documented performance concerns. The release also mentions it can differentiate between multiple persons and pets, which this veteran of QuietCare would like to see. MDSense is part of Essence’s Care@Home system which uses AI and machine learning to continuously collect actionable data to respond to fall events and manage care better towards improved outcomes.

Public Policy Projects, Tunstall UK release joint TECS study finding growth during pandemic, recommendations

September 18, 2020 | by

Weekend reading. Public Policy Projects and Tunstall Healthcare UK & Ireland have released a joint study finding, unsurprisingly but encouragingly, that the usage of technology-enabled care services (TECS) has accelerated during the COVID-19 pandemic. The nine-part, 62-page study electronically available here examines TECS through case studies in England, Scotland, and Wales as well as in France, Sweden, and especially Spain. There is a worthwhile examination of the types of TECS currently existing, a look back at the Whole System Demonstrator (WSD), barriers to adoption, and recommendations for policy going forward. ECHAlliance/Tunstall release.

Tunstall UK also won the ‘Leading Innovators in Assisted Living Technology 2020’ award at the Healthcare & Pharmaceutical Awards 2020, and the ‘Best Non-Clinical Equipment, Product or Service Supplier’ for their nurse call system, Tunstall Carecom, in the Care Home Awards 2020. ECHAlliance release

The Theranos Story, ch. 65: Elizabeth Holmes’ “mental disease or defect” defense revealed

September 18, 2020 | by

Going the ‘Twinkie Defense’ one better? While this Editor was enjoying a much-needed break from the Insanity of the World, hurtling across the wires was the revelation that Elizabeth Holmes’ pricey defense attorneys have prepared a defense for her that includes evidence “relating to a mental disease or defect or any other mental condition of the defendant bearing on the issue of guilt.” Interpreted, her mental state may have affected her intent and judgment in her business dealings. 

According to the filing, the defense is introducing testimony from Mindy Mechanic, Ph.D., a clinical psychologist and professor at California State University at Fullerton. According to her bio, her “work focuses on the psychosocial consequences of violence, trauma, and victimization with an emphasis on violence against women and other forms of interpersonal violence. Her work has addressed the mental health consequences of violence, such as Post-Traumatic Stress Disorder and depression as well as other important physical and social health outcomes.” 

The defense attempted to introduce this evidence without further examination by the Federal prosecution. Unfortunately, US District Judge Edward Davila did not agree. Ms. Holmes will be examined by two experts for the prosecution: Daniel Martell, Ph.D., a forensic neuropsychologist for the forensic litigation consulting firm Park Dietz & Associates, and University of California San Francisco psychiatrist Renee Binder, MD. Over the objections of the defense, the examination will be videotaped. The trial will commence with jury selection on 9 March 2021 [TTA 27 Aug].

Most of our Readers who care about this will be wondering, after they’ve picked themselves off the floor laughing at the above notion, that any person with a mental defect of this type could have fooled the savviest Sand Road VCs, Stanford/Hoover Institution luminaries, an admiral, a Marine general later Secretary of Defense, and Rupert Murdoch for years, to the tune of nearly $1 bn. That they should be gulled and fooled is disturbing enough. What is equally disturbing is the desperation of the defense to attempt an ‘insanity defense lite’ that sources and justifies Ms. Holmes’ inability to discern right from wrong.

This then proceeds to exactly what was the ‘interpersonal violence’ or post-traumatic stress that caused her judgment to warp quite this way. Was it her upbringing, which apparently was a bit upper-middle-class flaky–the ‘it’s not High Anxiety, it’s parents!’ reason? Was it a head trauma (the Howard Hughes defense), drugs, or surgery gone wrong? Did Sunny get Blue (in more than one way) on her? Stock up on the popcorn–la scandale Theranos has just gotten even more interesting. CBS Bay Area, Bloomberg News, Forbes, MedCityNews

A historical footnote. The term ‘Twinkie Defense’ came into usage in 1978 during the defense of the murderer of San Francisco mayor George Moscone and the better-known supervisor Harvey Milk. While not used per se by the defense team, the testimony of a psychiatrist for the defense that the murderer excessively consumed junk food, including Twinkies, as an indicator of depression and a sign of diminished capacity was hyped by the press as the ‘Twinkie Defense’. The term has passed into the vernacular. Ironically, both trials are occurring in the Bay Area.  Hat tip to The Crime Report.

The book of ‘Thank and Praise’ with a selection of their 1,000 messages (UK)

September 18, 2020 | by

James McLoughlin of the UK organization Thank and Praise has reached out once again to this Editor with an update on their social thanking of the ‘unsung heroes’ in healthcare during the depths of the COVID-19 pandemic. TAP has compiled a free e-book of a selection (64 pages) of their over 1,000 messages–print and video (page 65)–posted on their thanking walls. The messages thank healthcare workers, teachers, shop workers, church staff, food deliverers, social workers, homeless outreach, and many others who helped others. The illustrations were contributed by children and young adults. The book is also being sent to the organizations mentioned in the book. Reach out to James if TAP can help your organization. Our previous coverage: TTA 10 Apr, 12 June   Press release

Tunstall funding by M&G, Barings passes European Commission ‘concentration’ review

September 2, 2020 | by

The European Commission, in a brief filing on EUR-Lex, has stated their ‘non-opposition’ to the ‘concentration’ in Tunstall Group Holdings’ additional funding obtained by M&G Investment Management and Baring Asset Management via share purchase. Tunstall announced this funding in April [TTA 10 April] and filed with the European Commission on 3 June (prior notification).

The definition of ‘concentration’ in the EU is the legal combination of two or more firms by merger or acquisition. The prior notification from the Commission considers that this concentration may fall within the scope of the Merger Regulations but reserved a decision on this.

Charterhouse Capital Partners, the prior controlling investor, is not mentioned in the prior notification. Revealed in the notification is that Baring is actually controlled by MassMutual in the US, a surprise to this Editor. Hat tip to a Reader in the UK industry who wishes to remain anonymous.

Anthem-Cigna merger lawsuit finally wraps with ‘No damages for you! Or you!’

September 2, 2020 | by

Not with a bang, but a whimper and a large bill. The long, drawn-out (May 2017!) lawsuit and countersuit in Delaware Chancery Court between payers Anthem and Cigna ended with the decision by Vice Chancellor J. Travis Laster to refuse to award damages to either party in the litigation.

Cigna, which was seeking nearly $15 bn from Anthem, seemed to receive the worst of his judgment. In his decision (PDF), VC Laster stated that Cigna was unable to prove that Anthem breached the Efforts Covenants and in fact, Cigna sought to derail the deal by pulling back on integration efforts, thus itself breaching the covenants. Thus, Cigna was not entitled to the $1.85 bn breakup fee or additional damages. Anthem proved that they sought to complete the merger and Cigna did not, thus seeking $20 bn in damages. In counterpoint, Cigna was able to prove that the deal would have been blocked regardless of their actions to demo the deal.

VC Laster’s conclusion, “In this corporate soap opera, the members of executive teams at Anthem and Cigna played themselves. Their battle for power spanned multiple acts….Each party must bear the losses it suffered as a result of their star-crossed venture.” The testimony revealed the deep divisions and battle lines between both companies during the merger preliminaries, until the Federal courts and DOJ put paid to it.

Yet the denouement of this Merger Made In Hell may not be fini. Anthem said in a statement to Fierce Healthcare that it feels “this decision is in the best interests of Anthem and our stakeholders.” But a Cigna spokesperson said they are not finished and considering a potential appeal. “We are pleased that the Court agreed with us that Cigna did not cause the merger to fail. We continue to strongly believe in the merits of our case, and we are evaluating our options with respect to appeal.” Certainly not the peaceful-in-public parting after the Federal denial of their merger by Aetna (acquired by CVS) and Humana (still in play).

The chief beneficiaries of this three-year drama? The law firms listed on page 1 of the opinion. Also Wall Street Journal (paywalled in part).

As practices reopen, telemedicine visits continue to plunge from 69% to 21%: Epic (US)

September 2, 2020 | by

The extreme high tide has receded–but still way up than before the pandemic.  The Epic Health Research Network (yes, that Epic EHR), updated its earlier study through 8 May [TTA 22 July] to compare in-office to telehealth visits through 12 July. The trend that EHRN spotted (as well as Commonwealth Fund/Phreesia/Harvard) continued with telemedicine visits declining as practices reopened. As of mid-July, telehealth visits, as a  percentage of national ambulatory visits, declined to 21.2 percent compared to 78.8 percent in-office. 

The new EHRN study used a broader sampling than previously. They surveyed healthcare providers of data: 37 healthcare organizations representing 203 hospitals and 3,513 clinics in 50 states. The decline in telehealth visits noted in early May continued, with May finishing with a national 50/50 split.

But in context, telehealth visits immediately before the COVID-19 pandemic were a whopping .01 percent. 

Regionally, the Northeast leads in July telehealth visits with 25 percent. The South has the least adoption of telehealth with only 13 percent. In terms of total office visits, neither the South nor West have rebounded to pre-pandemic levels, whereas the Northeast and Midwest have.

The key to the future of the telehealth bubble bath is if telehealth usage versus in-person stabilizes for several months. But there’s another factor which has come about through higher telehealth usage. Noted in our July article was speculation on the reasons why the sudden decline, other than practices reopening, most of which pointed to practice training, reimbursement, and older/sicker patients falling into the smartphone/digital divide. The STAT article has statements from telehealth providers which are quite bubbly and quotable, with the CEO of MDLive stating that new bookings are up 300 percent and mental health hasn’t declined. But a problem now surfacing is providing patients with the right care at the right time–and fitting it into the office schedule. What visits can best be handled as telehealth and which require an in-person visit? This Editor recalls that Zipnosis, a white-labeled telehealth system we haven’t heard from in a while, incorporated for health system applications a triage intake which would direct the patient to the right level of care. Can this be rolled out in a similar way to the practice level?