On Episode 57 of Health in 2 Point 00, Jess and I report from Exponential Medicine. In this episode, Jess and I talk about digital surgery and how Shafi Ahmed and Stefano Bini are transforming surgical training. She also asks me about my favorite session, one by Anita Ravi on health care for those who have been sex trafficked. Other highlights include ePatient Dave’s talk about access to data for patients and letting patients help, and Leerom Segal’s overview of why voice matters- Matthew Holt
Above the Fold
The IPCC Confirms Life As We Know It Will Soon Cease to Exist
By DAVID INTROCASO PhD
THCB readers may recall last year in early June when the Trump administration announced it would withdraw from the 2015 Paris climate accord and earlier this January when the World Economic Forum met to discuss its global risk report that included the chapter, “Our Planet on the Brink,” I discussed in part (here and here) the health care industry’s indifference to global warming (See also my related 3 Quarks Daily essay.) Now comes the United Nation’s Intergovernmental Panel on Climate and Change’s (IPCC’s ) latest report. Once again overwhelming scientific evidence that confirms life as we know it on this planet will soon cease to exist is received with apathetic insouciance.
Created in 1988 the IPCC is considered the world’s definitive scientific body on climate change and co-winner with Al Gore of the 2007 Nobel Peace Prize, finalized in early October its report, “Global Warming of 1.5°C.” The 2015 Paris accord called for the report. It was prepared by nearly one hundred scientists who analyzed thousands of the most recent scientific evidence. The report’s summary was accepted by over 180 countries including the American and Saudi Arabia delegation during the IPCC’s meeting recently concluded in South Korea.
What is newsworthy about the IPCC report is its conclusion that keeping or holding temperature increases below 2°C, the goal of the Paris agreement, would not avoid the catastrophic effects of global warming. At 1.5°C life on this planet would suffer serious or dire harm, at 2°C catastrophic harm. Specifically, the report compared the impact between a 1.5°C (2.7°F) increase in temperature with a 2°C (3.6°F) increase (The earth has already warmed by 1°C since the pre-industrial era). Among numerous other findings, should temperatures increase to 1.5°C, the report found of 105,000 species studied, four percent of vertebrates (that include us), eight percent of plants and six percent of insects would lose half of their climatically-determined geographic range. At 2°C, the percents double to triple. Global crop yields will decline significantly. At 1.5°C we will lose 70 to 90 percent of coral reefs, at 2°C there will be a 99 percent loss. At 1.5°C Marine fishery losses or the global annual catch loss would be 1.5 million tons, at 2°C they double.
2018 Midterms: The Year of the Female Physician
By NIRAN AL-AGBA MD 
While women make up more than half of the U.S. population, an imbalance remains between who we are as a nation and who represents us in Congress. The gender disparity is no different for physicians: more than one third of doctors in the U.S. are women, yet 100 percent of physicians in Congress are men. To date, there have only been two female physicians elected to Congress.
However, in the coming midterm election, there are six races with a chance at making history. It’s these battles which could make 2018 “The Year of the Female Physician.”
I remember being a first-time voter in 1992, labeled at the time “The Year of the Woman.” I was a sophomore at Michigan State University and turned 18 just three days before the election. Following the contentious Supreme Court hearings involving Clarence Thomas and Anita Hill, an unprecedented number of female candidates were vying for office that election year.
President George H. W. Bush was vilified for an appalling answer to the question of when his party might nominate a woman for President. “This is supposed to be the year of the women in the Senate,” he quipped. “Let’s see how they do. I hope a lot of them lose.” Frustrated about the state of gender inequality in politics, a little-known “mom in tennis shoes,” Patty Murray, decided to run for the U.S. Senate to represent Washington. She won, paving the way for an unprecedented number of women to enter national politics over the next 30 years. Still, very few of them have come with a background in medicine.
The Case for Open Innovation in Health | Sara Holoubek of Luminary Labs
“Most large healthcare companies will have numerous teams – innovation teams, maybe a venture fund, business units – all doing different things,” says Sara Holoubek, CEO of Luminary Labs, a consultancy known in healthcare for its expertise staging open innovation challenges. “How much more powerful would it be if everyone agreed on a common investment thesis? ‘We know our business model is changing and, therefore, where is our big bet?’”
The ‘big bet’ is not always easy for stakeholders in healthcare companies to agree on. Hence, Sara’s advocacy for open innovation, a methodology built for collaboration both internal and external to the organization. She’s been masterminding challenges, hackathons, participatory design sessions, and the like in healthcare for years, helping pharma companies, health plans, health systems and government organizations gain access to new ideas from external problem solvers and startups.
Open innovation not only brings much-needed agility to the way these big companies develop products, build partnerships, or pivot into new markets, but it also helps clarify which business problems the organization is actually trying to solve.
Large organization or small, how do you know when it’s time to take your innovation efforts outside? How do you make sure that your open innovation attempt is truly a ‘challenge’ and not just a splashy brainstorming session or hackathon to nothing?
A few weeks back, Luminary Labs published ‘The State of Open Innovation Report’ in effort to help benchmark the practice and build its business case as a worthwhile methodology for business innovation. Seeds of the report can be found in this interview. Listen in as Sara defines the practice and shares her tips and best practices.
Get a glimpse of the future of healthcare by meeting the people who are going to change it. Find more WTF Health interviews here or check out www.wtf.health.
Exponential Medicine
By MATTHEW HOLT
After only maybe 5 years when I’ve been away running a conflicting conference in some other part of the world I finally get to go to Exponential Medicine the next 4 days. I met Daniel Kraft way back before he was famous, and his conference grew from being a week long academic session in an airline hangar in Mountain View to being a mega 4 day bash at the Hotel Del Coronado in San Diego (partly aided by TEDMED abandoning the venue and heading off in its own strange direction post billionaire buyout–well done Mark Hodash despite the lawsuit and yes I am jealous!).
Anyway, it’s going to be lots of fun. There’s plenty of people from my Health 2.0 world presenting. Lonnie Rae Kurlander, ePatient Dave, heck even John Halamka has been tempted off the farm — although I suspect Dave will have him in a headlock about access to his BIDMC data pretty quick).
Then there’s the surgeons and the weirdos. I leave Shafi Ahmed & Stefano Bini to decide which category they’re in, although whatever John Brownstein says I do owe him a nice bottle of scotch. Anyway, check out the program and if you haven’t bought yourself a ticket or bribed your way in, don’t worry it’s all being live streamed and Jessica DaMassa from WTF Health will as ever be interviewing anyone who doesn’t get out of the way quick enough.
So if you’re there I’ll be milling around not doing much, so say hi. And otherwise follow along here and @boltyboy
Health in 2 Point 00 Episode 56
On Episode 56 of Health in 2 Point 00, Jess and I report from Livongo’s new office in San Francisco. In this episode, Jess asks me about Carrot Health’s $25 million raise for their digital smoking cessation program and 98point6’s $50 million raise for their on-demand primary care app. We also have our special guest star Dr. Jennifer Schneider here to tell us about how Livongo is working to Silence Noisy Healthcare with Applied Health Signals- Matthew Holt
The Rule of Thirds
When I was a medical student, I did a lot of rotations at the Boston VA in JP. I loved my patients there — they were patient and kind and stoic. One of the best rotations I did was Hematology, where Lou Fiore was my preceptor. Lou was not only an excellent teacher, but also a terrific doctor and a good human being all around. He used to start our days together by saying, “I’m gonna teach you one thing today.” And teach us he did, at least one thing per day. Now I teach. And on occasion I have used the Lou Fiore “I’m gonna teach you one thing today” promise. Well, today is one of those days: I’m gonna teach you one thing.
And here is that thing. I am sure I am not the first one to notice this, but I still think of it as the “Zilberberg rule of thirds.” The gist of it is that, for clinical research purposes, one can think of patient populations crudely in thirds: there is one third who are too sick to benefit from any of our interventions, there is one third who are too healthy, so that no matter how we try to tweak, their outcomes will not change, and the middle third, which comprises the “sweet spot” for intervention. So it is a fool’s errand to pursue proof of concept studies in either of the bracketing thirds, since it is only the middle third that is likely to show a signal.
Pharmaceutical manufacturers do not always appreciate this trichotomy. Look at Vioxx, for example: when used in patients who were essentially healthy, an unacceptable safety signal arose that drove the drug off the market. Same for SSRIs, where the ill-conceived enthusiasm for treating marginal depression cases seems to be debunking the entire serotonin hypothesis. The flip side is sepsis research: septic shock patients are so far gone that it is difficult for any single therapy to alter their outcomes. Just look at the Xigris story, as well as myriad other therapies that tried and failed. This is the rule of thirds at its most pronounced.
In HEOR the rule of thirds holds as well. To prove cost effectiveness the following questions need to be asked:
1. Is the disease in question prevalent?
2. Is the economic impact of the disease known and substantial?
3. Does the diagnostic/therapy in question alter the course of the disease in such a way as to be significant?
If the answer to any of the questions above is “no,” you really need to think carefully about the value proposition.
Some of you will bring up the inter-individual differences, the heterogeneous treatment effect, etc. And yes, these are supremely important. However, though the framework I propose here is simplistic, we have to start somewhere. To be sure, there is a more nuanced approach to this beast, but generally, one will not go wrong by asking these questions before committing huge resources to a project, particularly if the answer to question 2 or 3 is a resounding “no.” So, even in health economics it behooves one to know the Zilberberg rule of thirds: choose the right population where the diagnostic/therapeutic advance and its costs can be justified by a substantial gain in the outcomes.
And that is your one thing for today.
Marya Zilberberg, MD, MPH, is a physician health services researcher with a specific interest in healthcare-associated complications and a broad interest in the state of our healthcare system. She is the Founder and President of EviMed Research Group, LLC, a consultancy specializing in epidemiology, health services and outcomes research. She is also a professor of Epidemiology at the University of Massachusetts, Amherst. Dr. Zilberberg blogs at Healthcare, etc.
The Road Not Taken: The Unrecognized Harm of Excessive Regulation
The difficulty of creating new and better medicines has been the subject of extensive – at times excessive – soul searching, a process that’s intensified as high-profile patents expire, along with their associated revenue streams, traditionally relied upon to support future R&D. As a result, both biopharma companies and patients awaiting new treatments find themselves struggling for viable solutions.
Predictably, industry (where I obviously reside) attributes excessive regulation, regulators say “don’t blame us,” and considered reporters and observers typically try to split the difference – maybe everyone is a little bit at fault.
The problem with this resolution is that it’s a cop-out; while there is clearly a measure of shared responsibility, it’s willful blindness not to recognize the extent to which a deliberate and very conscious regulatory policy is putting a damper on what has traditionally been the world’s most vibrant drug development ecosystem.
It’s not that other factors (such as the complexity of science) aren’t important – in fact, it’s precisely because developing new drugs is challenging, so inherently difficult, that’s it’s crucial to do everything within our control to work together and create an environment, an ecosystem, that stimulates and enables meaningful innovation.
The most significant – and potentially, most correctable (which is why it’s especially frustrating – it’s explicitly of our own making) problem – is that regulators, as others have astutely observed, seem to have misapplied the “precautionary principle,” colloquially understood as “first, do no harm.” The problem isn’t so much the sentiment as the way it’s reduced to practice.
Racing to Nowhere
I had dinner over the weekend with a close friend who is a breast cancer survivor (her word) and a former avid participant in the annual marathons sponsored by the Susan B. Komen Foundation. Her status as a former activist was new. “Is this what we were racing for?” she said. She is skeptical by nature, and the brouhaha over Komen’s back-and-forth over funding Planned Parenthood last week didn’t make her angry. It merely flipped the switch that changes skepticism into cynicism. To paraphrase the old Phil Ochs song, she ain’t a marchin’ anymore.
I try to avoid bringing my knowledge about medical issues into private discussions (I’m not a doctor, and I take that caveat seriously. But as readers of this blog know, I’ve written extensively about recent controversies in breast cancer research, including the dust-ups over the U.S. Preventive Services Task Force recommendation that women under 50 can eschew mammography, and the Food and Drug Administration’s decision to withdraw Avastin’s approval for breast cancer). Yet my friend asked me pointedly about what I thought about Komen and why they did what they did. She knew nothing about the organization she had been supporting for many years, and now wanted answers.
Fraudulent Cancer Research: An Exception or the Tip of the Iceberg
Yesterday, 60 Minutes reported on Dr. Anil Potti, researcher at Duke University. Dr. Potti supposedly offered cancer patients improved cancer treatments. These recommendations, however, were based on falsified data.
“Five years ago, Duke University announced it had found the holy grail of cancer research. They’d discovered how to match a patient’s tumor to the best chemotherapy drug. It was a breakthrough because every person’s DNA is unique, so every tumor is different. A drug that kills a tumor in one person, for example, might not work in another. The research was published in the most prestigious medical journals. And more than a hundred desperately ill people invested their last hopes in Duke’s innovation.
In 2010, we learned that the new method was a failure. But what isn’t widely known, until tonight, is that the discovery wasn’t just a failure, it may end up being one of the biggest medical research frauds ever – one that deceived dying patients, the best medical journals and a great university.”
When the National Cancer Institute found they could not replicate Potti’s results, Duke suspended the enrollment of patients in the Potti study and asked outside review committee to analyze Dr. Potti’s discovery. After three months, however, the review committee concluded that Dr. Potti was right.
Why did no one find out earlier. Were researchers blinded by money?
