Category: Uncategorized

A Rosa Parks Moment is Coming in Phase 1 Cancer Trials

Sep 14, 2018

By DAVID C. NORRIS, MD

I want to tell you about the most exciting discovery I’ve made in 2+ years of research on dose individualization methods for phase 1 cancer trials. This discovery has nothing to do with any of the technical problems I’ve confronted and solved along the way. It involves no gigantic equation, no table of simulations results, and no colorful plot. Rather, it’s a discovery about sources of power to innovate in drug development.

In general, how would you describe the balance of power between Big Pharma and the individual patient? The question seems ludicrous—maybe even offensive—in light of ongoing scandals with price-hikes and shortages for critical drugs. But in the special area of trial methodology, I’ve got a real surprise for you…

One result from my DTAT research has been a clear demonstration that 1-size-fits-all dose finding in phase 1 cancer trials can cut the value of a drug in half, or even drop it to zero by setting the drug up for failure in phase 2 or 3. Although this economic argument has never been made quite so explicit and rigorous, I am certain the underlying principle comes as no surprise to anyone. (I note hardly anyone bats an eye when I detail the math.) Continue reading…

The White House chooses Paxlovid over science

Sep 14, 2018

BY ANISH KOKA

Yesterday, the White house COVID czar surprisingly doubled down on Paxlovid as the silver bullet for COVID.

I was curious because most impartial observers don’t believe the totality of evidence supports Paxlovid as some type of COVID-slayer. The problem is that Paxlovid showed great benefit in unvaccinated patients in preventing progression to severe disease, but much less benefit in vaccinated/prior infected individuals.

Dr. Jha cites a study in the New England Journal of Medicine to note Paxlovid is a home run for those over 65, and despite negative results for the under 65 group in this study, cites 3 other studies that support its use in the 50-64 age group. He goes onto thread together some other studies to support his views.

It’s a really interesting thread that says a lot more about the politics of COVID than the science of COVID because it rests heavily on flawed retrospective studies of Paxlovid that show benefit, and ignores the much stronger randomized controlled trials that suggest otherwise.

Health in 2 Point 00, Episode 49

Sep 11, 2018• 1

Jessica DaMassa asks me about what I saw at Techcrunch Distrupt, Clarify Health Solutions’s $57m round, what Wellth will do with its $5m & a whole lot about next weeks Health 2.0 Conference–Matthew Holt

Does Free Medical School Decrease Social Justice?

Sep 9, 2018• 5

BY ANISH KOKA, MD

The hottest medical school in the country right now is the New York University School of Medicine thanks to the gift of a generous benefactor that promises to make medical school free for all current and future medical students. The news was met with elation from the medical community of physicians that groans frequently about student debt loads routinely north of $200,000 upon matriculation. Not surprisingly, the technocrat class of public health experts and economists did not share in the jubilation. The smarter-than-the-rest-of-us empiricists are, after all, trained to think in terms of social justice and net benefits to society. The needs of medical students are far down the list of priorities when forming this social justice utopia.

Contemporary arguments for social justice in some form or the other trace their roots to the philosopher John Rawls and his 1971 magnum opus – “A Theory of Justice”. In words that would infuse liberal thought for a generation, Rawls laid out a blueprint for a just society by proposing a thought experiment called “the original position”. This was a hypothetical scenario where a group of people are asked to form the rules of a society which they will then occupy. The catch is that the people making the decision do so behind a ‘veil of ignorance’ not knowing the disadvantages conferred by any number of attributes (age, sex, gender, intelligence, beauty, etc. ) they may be reincarnated with. Rawls posited that under conditions in which there was a possibility of being born as a disadvantaged member of society, social and economic inequalities would be arranged to be of greatest benefit to the least advantaged members of society.

At first glance, it would seem that the objections to tuition-free medical school rest on a social justice framework that does not seem to comport with gifts to the soon-to-be-wealthy. After all, the $200,000 investment for medical school pales in comparison to the lifetime earnings of the average physician who is assured at least a six-figure income in seeming perpetuity. But it is not entirely clear that one has to even combat Rawlsian ideals to rebut the social justice do-gooders with strong opinions on how other people should spend their money. A Rawlsian framework never intended that everyone in society would be able to achieve the same outcome regardless of starting position. Rawls actually went out of his way to argue that inequalities were justified in society as long as the operating rules served to raise the position of those worst off in society. A rising tide should lift all boats – the rich may become richer, as long as the poor become richer as well.

A conversation with Dr. Nicole Saphier

Sep 8, 2018

By, SAURABH JHA

I have a wide ranging conversation with Dr. Nicole Saphier for JACR’s Firing Line Podcast. Dr. Saphier is a radiologist specializing in women’s imaging. We discuss screening mammograms and the breast density law. Dr. Saphier, a frequent contributor to multiple major media outlets, tells us what it means for a radiologist to opine on health policy in the national media.

About the author:

Saurabh Jha is a contributing editor to THCB. He’s the host of JACR’s Firing Line Podcast. He can be reached on Twitter @RogueRad

Physician Well-Being: Lessons From Positive Psychology

Sep 7, 2018• 2

By SANJ KATYAL

The absence of burnout does not equal wellness. While the focus on physician burnout as an epidemic is finally gaining more attention, we may be missing a larger issue. Most physicians are not burned out. We are able to function. We get through our days, make it to some of our kids’ activities and even manage to go out to dinner on the weekends. We survive the work week as we look forward to our next vacation. We do this because that is what we have always done. We put our heads down and do our work. We often project ourselves past the next exam or to the next stage of our lives to help us get through the stress. We become masters of delayed gratification. We develop the mindset of “I’ll be happy when…” I get into medical school or match into a good residency spot or make partner or have enough money to retire etc…Along the way, we may have some bright spots – falling in love, having kids, taking great vacations. We may even reward ourselves for our hard work with a new car or nicer house. We deserve it. But deep inside, “something is missing”. We have achieved most, if not all of the goals we have set for ourselves. Yet despite our hard work, many of us remain unfulfilled with our careers and often with our lives. What is it that we need? A better job with more money? A different car? A different title? Better vacations?

I have struggled with these questions and many more. How do I stop wanting what I don’t have and start wanting what I do have? How can I fully enjoy the present while also preparing for a better future? How can I spend quality time with my kids while they are still around? How can I have a career that uses all of my potentials? Of all the questions that I’ve asked myself, the most important one was this – How can I learn to flourish and not just function?

Fortunately, I found answers in the relatively new field of Positive Psychology which is the scientific study of human flourishing. Unlike traditional psychology which alleviates distress and moves a patient from a -8 to a 0 or +1 (if they are lucky), positive psychology focuses on a patient that is functioning at a +1 and tries to move them to a +8 on the flourishing scale. We need both areas of focus. There are many people that are functioning well by most standards but are nowhere near their potential level of fulfillment.

Health in 2 Point 00, Episode 48

Sep 6, 2018

Jessica DaMassa asks me about Cricket Health’s $24m raise for kidney disease services, Rx.Health from Mount Sinai and a whole bunch of big money in little China. All in 2 minutes–Matthew Holt

Is Universal Health Care Socialism?

Sep 5, 2018• 7

By ETIENNE DEFFARGES

The November midterms elections are approaching, and one of the major topics is health care. Democrats are campaigning on retaining Obamacare, in many cases advocating that we move towards universal health care.

That would be pure socialism, retort Republicans, who would rather repeal the Affordable Care Act as they attempted in 2017, even if this leads to 20 million Americans losing coverage.

Is Universal Health Care Socialism?

Only if we believe that every other developed market-based economy in the world is socialist since the U.S. is the only one without universal coverage. We spend almost $10,000 per year per capita on health care, about twice as much as most developed countries. However, in terms of major health outcomes, such as infant mortality or life expectancy, we are laggards. In a recent OECD survey, we ranked 27th out of 35 countries in life expectancy. Japan spends about $4,000 per year per capita in health care, yet the average Japanese has a life expectancy of 84 years, versus 79 for the average American. Why?

Every developed country other than the U.S. has had universal care for decades. While Prussia’s “Iron Chancellor” Otto Von Bismarck implemented the first universal care system…in 1883, our health care history is a patchwork of partial reforms, an inefficient collage of private and public institutions. We first tied health insurance to employment in 1946, because business and conservative opposition would not allow universal coverage; then added Medicare in 1965 so that our seniors would have coverage after they retired; then Medicaid, a different one for each one of our fifty states; Continue reading…

Health in 2 Point 00, Episode 47

Sep 5, 2018

Jessica DaMassa asks me about Patrick Soon-Shiong and his Verity hospital chain going bankrupt, whether Peerfit can justify its $8m raise, and who I’m going to see at TechCrunch Disrupt this week–Matthew Holt

Can CMS’ Proposed ACO Changes Really Help Medicare Beneficiaries?

Sep 4, 2018• 3

By REBECCA FOGG

Earlier this month, the Centers for Medicare and Medicaid Services Administrator Seema Verma proposed bold changes to Medicare’s Accountable Care Organizations (ACOs), with the goal of accelerating America’s progress toward a value-based healthcare system—that is, one in which providers are paid for the quality and cost-effectiveness of care delivered, rather than volume delivered.

CMS has created a number of ACO programs over the last six years in an effort to improve care quality and reduce care costs across its Fee-for-Service Medicare population. In a Medicare ACO, hospital systems, physician practices and other voluntarily band together and assume responsibility for the quality and cost of care for beneficiaries assigned to them by Medicare. All ACOs meeting quality targets at the end of a given year receive a share of any savings generated relative to a predetermined cost benchmark; and depending on the type of ACO, some incur a financial penalty if they exceed the benchmark.

According to CMS’ recent analyses, ACOs that take on higher financial risk are more successful in improving quality and reducing costs over time. So one important objective of CMS’ proposed changes is to increase the rate at which ACOs assume financial risk for their beneficiaries’ care.