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The Open Data Movement Runs Aground on FOURIER

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BY ANISH KOKA

Reanalysis of a trial used to approve a commonly used injectable cholesterol-lowering drug confirms the original analysis by accident.

The open-data movement seeks to liberate the massive amount of data generated in running clinical trials from the grasp of the academic medical-pharmaceutical industrial complex that mostly runs the most important trials responsible for bringing novel therapeutics to market.

There are only a few elite academic trialist groups capable of running large trials and there’s ample reason to be suspicious about the nexus that has developed between academia and the pharmaceutical companies that shower them with cash to hopefully get a positive study result and pay off the pharmaceutical research investment manifold. The FDA is the major regulator of the whole process, but the expertise required for regulation means that the FDA is frequently comprised of ex-pharma employees or ex-academics.

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At CES, A Tractor And A Patient Stethoscope Point To Digital Health Future

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By MICHAEL MILLENSON

A Deere tractor developed in Moline, Illinois and a stethoscope-for-patients from Singapore pointed to the future of digital health at CES 2023, the Consumer Technology Association gathering that’s become a global innovation hub.

The tractor appeared on a large video screen during the opening keynote by Deere & Company chief executive officer John May. The industrial company exec clearly relished the chance to trumpet the way Deere had turned tractors into high-tech tools to optimize farmers’ outcomes ­– an accomplishment inspiring envy among medical information mavens hoping to similarly transform patients’ outcomes.

“The John Deere presentation was one of the best technological presentations I have ever seen,” enthused ResMed chief medical officer Dr. Carlos Nunez at a later panel. Nunez pointedly noted that “you think health care would be difficult,” yet here Deere had revolutionized a centuries-old, rural, agrarian, manual profession.

Deere’s “smart machines” incorporate computer vision, soil moisture sensing, GPS with precise signal correction, machine learning and cloud computing, all of which enable farmers to plant corn, cotton and other crops “with precision beyond human capacity.” Farmers can track the tractor’s data collection with their smartphone and make real-time adjustments. In health care terms, that all adds up to personalized, evidence-based farming.

The technology gap between physicians and farmers is actually wider than May let on.

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The Danger of Stroking a Tiger

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By MIKE MAGEE

On the evening of December 29, 1940, with election to his 3rd term as President secured, FDR delivered these words as part of his sixteenth “Fireside Chat”: “There can no appeasement with ruthlessness…No man can tame a tiger into a kitten by stroking it.”

Millions of Americans, and millions of Britons were tuned in that evening, as President Roosevelt made clear where he stood while carefully avoiding over-stepping his authority in a nation still in the grips of a combative and isolationist opposition party.

The Germans were listening as well and sent a different type of message as the Luftwaffe, in concert with the address, launched their largest yet raid on the financial district of London. Their “fire starter” group, KGr 100, initiated the attack with incendiary bombs that triggered fifteen hundred fires that began a conflagration ending in what some labeled the “Second Great Fire of London.”

There was nothing happenstance about the timing or methods of the attack. The night was moonless, keeping RAF fighters lacking air-to-air radar grounded. There were high winds to fan the flames that night. High explosive bombs were used to target water mains to hamper fire fighters, and the Thames was at low tide making accessing it for a water supply neigh impossible.

Combined with Roosevelt’s words, the actions of December 29, 1940, now 82 years later, highlight two truisms when confronting evil orchestrated at the hands of racist, autocratic leaders.

First, appeasement does not work. It expands the vulnerability of a majority suffering the “tyranny of the minority.”

Second, the radicalized minority will utilize any weapon available, without constraint, to maintain and expand their power.

The battle to save democracy in these modern times has not been won. As was FDR at the time of his address, we are in the early years of this deadly serious conflict, and still in catch-up mode, awakened from a self-induced slumber on January 6, 2020.

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We’re Disrupting Disruption

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By KIM BELLARD

The Sunday Times featured an op-ed by Mark Britnell, a professor at the UCL Global Business School for Health, with the headline Our creaking NHS can’t beat its admin chaos without a tech revolution. Substitute “U.S. healthcare system” for “NHS” and the headline still would work, as would most of the content.   

I wouldn’t hold my breath about that tech revolution. In fact, if you’re waiting for disruptive innovation in healthcare, or more generally, you may be in for a long wait.

A new study in Nature argues that science is becoming less disruptive. That seems counterintuitive; it often feels like we’re living in a golden age of scientific discoveries and technological innovations. But the authors are firm in their finding: “we report a marked decline in disruptive science and technology over time.” 

The authors looked at data from 45 million scientific papers and 3.9 million patents, going back six decades. Their primary method of analysis is something called a CD Index, which looks at how papers influence subsequent citations. Essentially, the more disruptive, the more the paper itself is cited, rather than previous work.       

The results are surprising, and disturbing. “Across fields, we find that science and technology are becoming less disruptive,” the authors found, “…relative to earlier eras, recent papers and patents do less to push science and technology in new directions.” The declines appeared in all the fields studied (life sciences and biomedicine, physical sciences, technology, and social sciences), although rates of decline varied slightly.  

The authors also looked at how language changed, such as introduction of new words and use of words that connote creation or discovery versus words like  “improve” or “enhance.” The results were consistent with the CD Index results.

“Overall,” they say, “our results suggest that slowing rates of disruption may reflect a fundamental shift in the nature of science and technology.”

“The data suggest something is changing,” co-author Russell Funk, a sociologist at the University of Minnesota in Minneapolis, told Nature. “You don’t have quite the same intensity of breakthrough discoveries you once had.”

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Expanding Real World Datasets

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How are you working to advance research and improve patient outcomes? Are you precisely matching records across disparate datasets? Find out at a Webinar on Feb 1st 1pm ET Sponsored by LexisNexis Risk Solutions Health Care

Healthcare’s fragmented data silos and strict but necessary privacy restrictions make it difficult to link real-world datasets. Legacy tokenization technology has helped link records across disparate data sources, but it lacks the accuracy required to uncover actionable insights that can truly improve patient outcomes. Next-generation tokenization technology leveraging a Referential Data Layer is needed to match de-identified records with precision. Hear from Solis Mammography’s CMO on how they are leveraging referential tokenization technology to link their longitudinal imaging data with complementary clinical and genomics data, enabling in-depth breast cancer research to champion women’s long-term health and wellness.

If you care about healthcare improvement, and want to continue to make an impact, join us to learn more about:
• What is referential tokenization and why it matters in healthcare
• Challenges and limitations of legacy tokenization technology
• The power of linking real-world data sets through a network of curated partners
• How Solis Mammography is leveraging referential tokenization to advance women’s health
• Actionable use cases demonstrating referential tokenization further empowering your organization to improve patient outcomes.

Join Us | February 1 @ 1pm ET/10am PT | Register Today

Speakers are: Camille Cook, MPH, Sr. Director, Healthcare Strategy, RWD @LexisNexis® Risk Solutions

Camille has 15 years of experience in healthcare with a focus on leveraging big-data to improve clinical care outcomes. Throughout her career, Camille successfully implemented innovative practices for healthcare IT, healthcare organizations, and life sciences companies utilizing health informatics, big-data, epidemiology, and human behavior patterns to create actionable insights that guide healthcare policy and meaningful use practices. Camille has spent the last 7 years evaluating syndromic infectious disease trends, healthcare operations, health economic outcomes research, and social determinants of health.

Matt Veatch, Real World Data Consultant, Founder and Managing Director @Revesight Consulting

Leveraging over 25 years of experience in biopharmaceutical product and medical device development, Matt advises life science companies on global RWD access and RWE strategic planning, execution, and M&A investments. Prior to establishing Revesight Consulting in 2017, Matt served in various corporate leadership positions, most recently as Vice-president of Strategic Operations at Syneos Health, leading initiatives in RWD access and decentralized study management. Prior to Syneos, Matt rose through various levels to become the Global Head of RWD-Driven Research for Quintiles, founding and leading the landscape-changing strategic collaboration with IMS Health in 2015, directly seeding the $19 billion merger of the firms in 2016 to form IQVIA. Additionally, Matt is a Founding Board Member of the Decentralized Trials & Research Alliance.

Chirag Parghi, MD, MBA, Chief Medical Officer @Solis Mammography

Dr. Chirag Parghi is a board-certified radiologist with fellowship (subspecialty) training in breast imaging and the Chief Medical Officer of Solis Mammography where he oversees clinical quality across more than 100 breast centers. As CMO, he also leads the clinical research endeavors where he is the principal investigator on several trials and manages relationships with the various radiologist practices.  Dr Parghi is still a practicing radiologist with an academic appointment at Albert Einstein medical center in Philadelphia.  Dr. Parghi’s clinical interests are rooted in the use of emerging technologies (including AI) to facilitate the early diagnosis, individualized risk modeling, and treatment of breast cancer.

My family’s disastrous experience with a growth-driven long-term care company

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by “E-PATIENT” DAVE DEBRONKART

Continuing THCB’s occasional series on actual experiences with the health care system. This is the secondin a short series about a patient and family experience from one of America’s leading ePatients.

I’ve been blogging recently about what happens in American healthcare when predatory investor-driven companies start moving into care industries because of, as Pro Publica puts it, “easy money and a lack of regulation.”  The first two posts were about recent articles in The New Yorker on companies that are more interested in sales and growth than caring.

My mother died in October. What we haven’t disclosed until now is that it happened in horror story #3: she passed after a single week of “respite care” provided by the local outlet of a growing chain of assisted living facilities.

Our mom, a 93 year old cardiac patient, had been in the hospital for ten days, and was discharged to go “home with assistance” because she was steadily improving. The respite facility’s director, an RN, evaluated Mom in the hospital, declared her appropriate for their respite care service, and took payment in full (in advance) for two weeks.

Mom’s primary caregivers were, as usual, the family’s daughters (my sisters), who had been with her throughout the hospitalization (and for countless hours every year). Mom and they discussed the discharge plans at length. Believing that a good respite care facility was an excellent bridge for continued progress between hospital and returning home, they purchased a two week stay after discharge. An important part of the decision was the website’s promise of “Strengthening during physical therapy.”

We soon found out that the facilities and understaffing were so precarious and stress-inducing, and so many things went wrong, that we didn’t dare leave her alone. To the contrary, after just one week, our mom said she was so stressed that she wanted to get out of there, and two days later she passed away.

Mom loved to sit in this gazebo, along a tributary of the Chesapeake. Photo by my sister.

Our complaint letter and management’s response

Much has been written in healthcare and other industries about how to document and report a service problem and how management should respond.

My sisters carefully composed a detailed seven page letter to management, listing everything that went wrong, from a wrong-height toilet seat, to a shower chair with missing handrail (perfect for assisted living, not!), to the Bluetooth room key that kept failing, to staff that couldn’t recognize the on/off switch on her oxygen, to stress-inducing fire alarms with nobody coming to help. That’s only a few items; their entire letter was published yesterday on The Health Care Blog (thank you THCB!).

And the facility’s response? After walking through the whole letter with my sisters on a call, their emailed bottom line was, verbatim:

“The services listed for respite program were available to your mother.”

Well, their marketing people need to talk to their facility managers.

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One family’s disastrous experience with a growth-driven long-term care company

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by “E-PATIENT” DAVE DEBRONKART

Continuing THCB’s occasional series on actual experiences with the health care system. This is the first in a short series about a patient and family experience from one of America’s leading ePatients.

I’ve been blogging recently about what happens in American healthcare when predatory investor-driven companies start moving into care industries because the money’s good and enforcement is lax. The first two posts were about recent articles in The New Yorker on companies that are more interested in sales and growth than caring. I now have permission to share the details of one family’s disastrous encounter with such a company’s “respite care” service.

The National Institute of Health says respite care “provides short term relief for primary caregivers.” It’s not medical care or memory care or assisted living; it’s not paid for by health insurance and it’s not regulated by the Federal government. It just replaces, for a while, the ordinary duties provided by family caregivers, so they can get a break.

The family’s mother was discharged from hospital to home. The primary caregivers were, as usual, the family’s daughters, who had been with their mother throughout the hospitalization. Believing that a good respite care facility was an excellent bridge for continued progress between hospital and returning home, they purchased a two week stay before taking their mother home.

It did not go well: ten days later their mother was dead.

The memorial tree planted by the family at their mother’s favorite park. Photo by Sarah.

The company’s website and lobby are gorgeous, of course. The reality was not. Media coverage talks about management’s desire to climb the rankings of biggest companies in the industry, as they acquire some facilities and build new ones. I believe the public needs to be alerted to such companies, in which management’s attention and achievements are much more on further growth than on delivering what they’ve already sold.

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THCB Quickbite: Ashish Shah, CEO, Dina

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Dina is a tech company that helps coordinates care in the home. CEO Ashish Shah explains that their platform is used by care coordinators, social workers and others to make sure the DME, the skilled nursing, meals and everything else actually arrives at the home. At the moment they support Medicare Advantage plans, large provider systems and also aggregators that manage care at home.

THCB Quickbite: Zak Holdsworth, CEO, Hint Health

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Zak Holdsworth has been delivering tech and services support for the growing Direct Primary Care (DPC) movement for 8 years. His company Hint Health supplies all the back office and now an EMR for those primary care doctors who are opting out of the insurance system and charging $1,000 a year (give or take) to manage all the care for their patients. It’s a niche but an interesting niche that is growing at 30-40% a year, and Zak’s company is helping their customers as they both start in DPC and move that care management downstream, including building out a care services cash market for their patients.–Matthew Holt

THCB Quickbite: Rami Karjian CEO & Pippa Shulman CMO, Medically Home

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Another quickbite from the end of last year. I caught up with Rami Karjian CEO & Pippa Shulman CMO, Medically Home. The company has grown a lot since its early days growing out of Atrius Medical Group in Boston. Now they are delivering hospital at home tools and services in 19 states and have had huge investments from Mayo, Kaiser and others. Covid, as you can imagine, helped a bit! Costs are down, outcomes are up, and 20-30% of hospital care could be heading to the home. This one looks real–Matthew Holt

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