Category: Health Policy

Is getting people off weight loss medications the right move?

May 6, 2024

By RICHARD FRANK

Demand for GLP-1 medications soared last year and shows no signs of stopping in 2024. Employers and health plans are understandably anxious about how long they should expect to pay for these pricey drugs. They’re itching for an easy off-ramp.

Some solutions are cropping up to pave the way. Many of them claim they can help patients reap the benefits of GLP-1s within a short time frame, and get them off the drugs within 12 months to save costs. But the data doesn’t support that promise. In fact, studies suggest some patients may need to stay on the drugs indefinitely to sustain outcomes while other patients may be able to discontinue the drugs and at least maintain their cardiometabolic risk reduction even if they cannot maintain all of their weight loss.

A better strategy to control costs is to more accurately pinpoint those who really need the drugs—and keep those who don’t off of them from the start. Of course, there will be times when deprescribing is appropriate, and we need to clinically support patients through that process. But one-size-fits-all solutions centered on medication as a silver bullet to obesity are only setting up patients and payers for failure. Similarly, those whose sole promise is to deprescribe, don’t follow the evidence.

Prescribing GLP-1s with the goal to deprescribe is foolhardy

GLP-1s treat obesity, but they don’t cure it. GLP-1 agonists increase the body’s own insulin production and slow the movement of food from the stomach to the small intestine. The drugs help people eat less by curbing cravings and boosting satiety. Studies show that once people go off semaglutide, the cravings come back in full force—and so does much of the weight.

While GLP-1 medications produce nearly miraculous outcomes in some people, they’re no quick fix. Obesity is a complex chronic disease. Drugs alone can’t solve for genetic predisposition, behaviors, mental and emotional components, social determinants of health, and other compounding elements that contribute to obesity. In the right circumstances, drugs can give people a solid leg up in better managing those contributing factors—but they’re not for everyone.

Keto is not a sustainable replacement for GLP-1s

Highly restrictive diets like the keto diet aren’t for everyone either. Keto requires a drastic reduction in carbohydrate intake, which can be difficult to maintain long-term. Not to mention, the high-fat content of keto diets can also lead to other health issues and isn’t conducive to tapering off of GLP-1 medications. Side effects from the drugs can make a high-fat diet difficult to tolerate.

It’s good to be wary of solutions that promise an off-ramp by way of highly restrictive diets. While a keto diet may help people lose weight in the short term, studies show that weight loss is rarely sustained over the long run and may be detrimental to overhaul health. The diet is associated with many complications that often lead to hospital admissions for dehydration, electrolyte disturbances, and hypoglycemia.

Triage the right care to the right people at the right time

Obesity’s complex nature requires a personalized approach to treatment that delivers the right care to the right people at the right time. That takes a whole care team of specialized providers—like registered dietitians, health coaches, and prescribing physicians to help people at various stages of the disease. And since obesity often occurs alongside other cardiometabolic conditions like hypertension, diabetes, COPD, and more, patients need the help of specialists who understand how those different conditions interact.

What’s behind all these assessments of digital health?

Apr 29, 2024

By MATTHEW HOLT

A decent amount of time in recent weeks has been spent hashing out the conflict over data. Who can access it? Who can use it for what? What do the new AI tools and analytics capabilities allow us to do? Of course the idea is that this is all about using data to improve patient care. Anyone who is anybody, from John Halamka at the Mayo Clinic down to the two guys with a dog in a garage building clinical workflows on ChatGPT, thinks they can improve the patient experience and improve outcomes at lower cost using AI.

But if we look at the recent changes to patient care, especially those brought on by digital health companies founded over the past decade and a half, the answer isn’t so clear. Several of those companies, whether they are trying to reinvent primary care (Oak, Iora, One Medical) or change the nature of diabetes care (Livongo, Vida, Virta et al) have now had decent numbers of users, and their impact is starting to be assessed.

There’s becoming a cottage industry of organizations looking at these interventions. Of course the companies concerned have their own studies, In some cases, several years worth. Their logic always goes something like “XY% of patients used our solution, most of them like it, and after they use it hospital admissions and ER visits go down, and clinical metrics get better”. But organizations like the Validation Institute, ICER, RAND and more recently the Peterson Health Technology Institute, have declared themselves neutral arbiters, and started conducting studies or meta-analyses of their own. (FD: I was for a brief period on the advisory board of the Validation Institute). In general the answers are that digital health solutions ain’t all they’re cracked up to be.

There is of course a longer history here. Since the 1970s policy wonks have been trying to figure out if new technologies in health care were cost effective. The discipline is called health technology assessment and even has its own journal and society, at a meeting of which in 1996 I gave a keynote about the impact of the internet on health care. I finished my talk by telling them that the internet would have little impact on health care and was mostly used for downloading clips of color videos and that I was going to show them one. I think the audience was relieved when I pulled up a video of Alan Shearer scoring for England against the Netherlands in Euro 96 rather than certain other videos the Internet was used for then (and now)!

But the point is that, particularly in the US, assessment of the cost effectiveness of new tech in health care has been a sideline. So much so that when the Congressional Office of Technology Assessment was closed by Gingrich’s Republicans in 1995, barely anyone noticed. In general, we’ve done clinical trials that were supposed to show if drugs worked, but we have never really bothered figuring out if they worked any better than drugs we already had, or if they were worth the vast increase in costs that tended to come with them. That doesn’t seem to be stopping Ozempic making Denmark rich.

Likewise, new surgical procedures get introduced and trialed long before anyone figures out if systematically we should be doing them or not. My favorite tale here is of general surgeon Eddie Jo Riddick who discovered some French surgeons doing laparoscopic gallbladder removal in the 1980s, and imported it to the US. He traveled around the country charging a pretty penny to teach other surgeons how to do it (and how to bill more for it than the standard open surgery technique). It’s not like there was some big NIH funded study behind this. Instead an entrepreneurial surgeon changed an entire very common procedure in under five years. The end of the story was that Riddick made so much money teaching surgeons how to do the “lap chole” that he retired and became a country & western singer.

Similarly in his very entertaining video, Eric Bricker points out that we do more than double the amount of imaging than is common in European countries. Back in 2008 Shannon Brownlee spent a good bit of her great book Overtreated explaining how the rate of imaging skyrocketed while there was no improvement in our diagnosis or outcomes rates. Shannon by the way declared defeat and also got out of health care, although she’s a potter not a country singer.

You can look at virtually any aspect of health care and find ineffective uses of technology that don’t appear to be cost effective, and yet they are widespread and paid for.

So why are the knives out for digital health specifically?

And they are out. ICER helped kill the digital therapeutics movement by declaring several solutions for opiod use disorder ineffective, and letting several health plans use that as an excuse to not pay for them. Now Peterson, which is using a framework from ICER, has basically said the same thing about diabetes solutions and is moving on to MSK, with presumably more categories to be debunked on deck.

Harnessing Digital Innovation to Unlock Cancer Discoveries

Apr 19, 2024

By DOUG MIRSKY & BRIAN GONZALEZ

What if digital innovations could be the key to reducing the burden of cancer? CancerX was founded in 2023 as part of the Cancer Moonshot to achieve this goal. By uniting leading minds across industries such as technology, healthcare, science, and government, we are breaking down silos and leveraging digital innovation in the fight against cancer. With ambitious goals to cut the death rate from cancer by at least 50% and to improve the experience of people who are affected by cancer, digital innovation is critical.

As a public-private partnership co-hosted by Moffitt Cancer Center and the Digital Medicine Society, CancerX has created a unique ecosystem and community of public and private innovators. We are focused on fostering innovation and collaboration to accelerate the pace of digital tools to help patients across their entire cancer journey. We unite experts across industries and the government, leveraging the success of the Department for Health and Human Services’ InnovationX model; a public-private partnership approach that has driven breakthroughs in kidney care, Lyme disease and COVID-19. In collaboration with the Office of the National Coordinator for Health Information Technology (ONC) and the Office of the Assistant Secretary for Health (OASH), CancerX is in sync with the US government in our common Cancer Moonshot goals to boost government-wide engagement with industry muscle. This type of multidisciplinary partnership is necessary to change the landscape of cancer treatment and care.

At the one year anniversary of CancerX, we look back on a very fast pace in building up our three pillars of work, demonstrating the ways that digital innovation is contributing to fighting cancer:

Pre-Competitive Evidence Generation – A rolling series of multi-stakeholder initiatives to develop evidence, best practices, toolkits, and value models to drive the success of the mission.
Demonstration Projects – These implementation projects pilot novel, mission-aligned approaches to demonstrate their value and sustainability for scale to drive broad adoption.

Startup Accelerator – This program provides mentorship, education, and exposure to funding and clinical partnership opportunities to a start-up cohort aligned with the mission.

And we are already deeply underway with efforts across each of the three pillars.

And Now For Something Completely Different

Apr 16, 2024

By KIM BELLARD

The most interesting story I read in the past week doesn’t come from the more usual worlds of health and/or technology, but from sports. It’s not even really news, since it was announced last fall; it’s just that it wasn’t until last week that a U.S. publication (The New York Times) reported on it. In a nutshell, a Paris football (a.k.a. soccer) club is not charging its fans admission during the current season.

Since last week I wrote about medical debt in the U.S. healthcare system, you might guess where this is going. The club is Paris FC. Last November it announced:

For the first time in history, Paris FC is offering free tickets for all home matches at the Stade Charléty, starting from the 11 November until the end of the 2023-2024 season from its Bastia reception, in a bid to offer a new and innovative vision of football by welcoming as many people as possible.

The policy includes the men’s second division team and the woman’s first division team. The NYT article clarifies that fans supporting the visiting team might be charged a “nominal” fee, and that hospitality suites still pay market rates.

Pierre Ferracci, Chairman of Paris FC, said: “We are proud to support this ambitious and pioneering project, which goes beyond the simple framework of sport in terms of the values it conveys. We want to bring people together around our club and our teams, while committing ourselves with strength and conviction. In a context of difficult purchasing power, we are confident that a club can be an ideal tool for bringing together people of goodwill and engage with societal issues.”

Fabrice Herrault, Paris FC’s general manager told NYT: “It was a kind of marketing strategy. We have to be different to stand out in Greater Paris. It was a good opportunity to talk about Paris F.C.” The club estimates it might cost them $1 million.

It seems to be working. The NYT reports:

Months later, most metrics suggest the gambit has worked. Crowds are up by more than a third. Games held at times appealing for school-age children have been the best attended, indicating that the club is succeeding in attracting a younger demographic.

The idea is not entirely de novo; last spring Fortuna Düsseldorf, a German second division football club, announced it would offer free admission for at least three matches this season, with the intent that eventually all home matches. “We open up football for all. We will have free entry for league games in this stadium,” Alexander Jobst, the club’s chief executive, said at the time. “We call it ‘Fortuna for all’ which can and will lead us to a successful future.”

In a NYT interview last spring, Mr. Jobst added: “We think it is completely new. We were trying to think about how we could do the soccer business completely different from before.”

I’m always a sucker for efforts to think about a business completely different than before.

Fortuna has now had two of its three free matches, and Mr. Jobst told NYT last week: “Our average attendance has gone from 27,000 to 33,000. Our merchandise sales are up by 50 percent. Our sponsorship revenue is up 50 percent. We have reached a record number of club members.”

Sure sounds like a success.

If data is the new oil, there’s going to be war over it

Apr 15, 2024

By MATTHEW HOLT

I am dipping into two rumbling controversies that probably only data nerds and chronic care management nerds care about, but as ever they reveal quite a bit about who has power and how the truth can get obfuscated in American health care.

This piece is about the data nerds but hopefully will help non-nerds understand why this matters. (You’ll have to wait for the one about diabetes & chronic care).

Think about data as a precious resource that drives economies, and then you’ll understand why there’s conflict.

A little history. Back in 1996 a law was passed that was supposed to make it easy to move your health insurance from employer to employer. It was called HIPAA (the first 3 letters stand for Health Insurance Portability–you didn’t know that, did you!). And no it didn’t help make insurance portable.

The “Accountability” (the 1st A, the second one stands for “Act”) part was basically a bunch of admin simplification standards for electronic forms insurers had been asking for. A bunch of privacy legislation got jammed in there too. One part of the “privacy” idea was that you, the patient, were supposed to be able to get a copy of your health data when you asked. As Regina Holliday pointed out in her art and story (73 cents), decades later you couldn’t.

Meanwhile, over the last 30 years America’s venerable community and parochial hospitals merged into large health systems, mostly to be able to stick it to insurers and employers on price. Blake Madden put out a chart of 91 health systems with more than $1bn in revenue this week and there are about 22 with over $10bn in revenue and a bunch more above $5bn. You don’t need me to remind you that many of those systems are guilty with extreme prejudice of monopolistic price gouging, screwing over their clinicians, suing poor people, managing huge hedge funds, and paying dozens of executives like they’re playing for the soon to be ex-Oakland A’s. A few got LA Dodgers’ style money. More than 15 years since Regina picked up her paintbrush to complain about her husband Fred’s treatment and the lack of access to his records, suffice it to say that many big health systems don’t engender much in the way of trust.

Meanwhile almost all of those systems, which already get 55-65% of their revenue from the taxpayer, received additional huge public subsidies to install electronic medical records which both pissed off their physicians and made several EMR vendors rich. One vendor, Epic Systems, became so wealthy that it has an office complex modeled after a theme park, including an 11,000 seat underground theater that looks like something from a 70’s sci-fi movie. Epic has also been criticized for monopolistic practices and related behavior, in particular limiting what its ex-employees could do and what its users could publicly complain about. Fortune’s Seth Joseph has been hammering away at them, to little avail as its software now manages 45%+ of all encounters with that number still increasing. (Northwell, Intermountain & UPMC are three huge health systems that recently tossed previous vendors to get on Epic).

Meanwhile some regulations did get passed about what was required from those who got those huge public subsidies and they have actually had some effect. The money from the 2009 HITECH act was spent mostly in the 2011-14 period and by the mid teens most hospitals and doctors had EMRs. There was a lot of talk about data exchange between providers but not much action. However, there were three major national networks set up, one mostly working with Epic and its clients called Carequality. Epic meanwhile had pretty successfully set up a client to client exchange called Care Everywhere (remember that).

Then, mostly driven by Joe Biden when he was VP, in 2016 Congress passed the 21st Century Cures Act which among many other things basically said that providers had to make data available in a modern format (i.e. via API). ONC, the bit of HHS that manages this stuff, eventually came up with some regulations and by the early 2020’s data access became real across a series of national networks. However, the access was restricted to data needed for “treatment” even though the law promised several other reasons to get health data.

As you might guess, a bunch of things then happened. First a series of VC-backed tech companies got created that basically extract data from hospital APIs in part via those national networks. These are commonly called “on-ramp” companies. Second, a bunch of companies started trying to use that data for a number of purposes, most ostensibly to deliver services to patients and play with their data outside those 91 big hospital systems.

Which brings us to the last couple of weeks. It became publicly known among the health data nerd crowd that one of the onramp companies, Particle Health, had been cut off from the Carequality Network and thus couldn’t provide its clients with data.

Health Care’s Debt Problem

Apr 10, 2024

By KIM BELLARD

Among the many things that infuriate me about the U.S. healthcare system, health systems sending their patients to collections – or even suing them – is pretty high on the list (especially when they are “non-profit” and./or faith-based organizations, which we should expect to behave better).

There’s no doubt medical debt in the U.S. is a huge problem. Studies have found that more than 100 million people have medical debt, many of whom don’t think they’ll ever be able to pay it off. Kaiser Family Foundation estimates Americans owe some $220b in medical debt, with 3 million people owing more than $10,000. It’s oft cited that medical debts are the leading cause of bankruptcy, although it’s quite not clear that is actually true.

So you’d think that helping pay off that debt would be a good thing. But it turns out, it’s not that simple.

A new study from the National Bureau of Economic Research (NBER) by Raymond Kluender, et. alia, found that, whoops, paying off people’s medical debt didn’t improve their credit score or financial distress, made them less likely to pay future medical bills, and didn’t improve their mental health.

“We were disappointed,” said Professor Kluender told Sarah Kliff in The New York Times. “We don’t want to sugarcoat it.”

The researchers worked with R.I.P. Medical Debt, a non-profit that buys up medical debt “at pennies on the dollar,” to identify people with such debt, and then compared people whom R.I.P. Medical Debt had helped versus those it had not. One set of people had hospital debts that were at the point of being sold to a collection agency, and another had debts that had already been sent to collection. And, perhaps to highlight how little we understand our healthcare system, they asked experts in medical debt what their expectations for the experiment were.

Much to everyone’s surprise, having debt paid off made no difference between control and debt-relief groups. I.e.,

“We find no average effects of medical debt relief on the financial outcomes in credit bureau data in either of our experiments.
We similarly estimate economically small and statistically insignificant effects on other measures of financial distress, credit access, and credit utilization.
We find that debt relief causes a statistically significant and economically meaningful reduction in payment of existing medical bills.
We estimate statistically insignificant average effects of medical debt relief on measures of mental and physical health, healthcare utilization, and financial wellness, with “opposite-signed” point estimates for the mental health outcomes relative to our prior.”

In short:

Our findings contrast with evidence on the effects of non-medical debt relief and evidence on the benefits of upstream relief of medical bills through hospital financial assistance programs. Our results are similarly at odds with views of the experts we surveyed, pronouncements by policymakers funding medical debt relief, and self-reported assessments of recipients of medical debt relief.

Amy Finkelstein, a health economist at the MIT and a co-director of J-PAL North America, a nonprofit group that provided some funding for the study, told Ms. Kliff: “The idea that maybe we could get rid of medical debt, and it wouldn’t cost that much money but it would make a big difference, was appealing. What we learned, unfortunately, is that it doesn’t look like it has much of an impact.”

If only it was that easy.

To be clear, there were three key statistically significant effects:

“small improvements in credit access for the subset of persons whose medical debt would have otherwise been reported to the credit bureaus,
modest reduction in payments of future medical bills, and
worsened mental health outcomes, concentrated among those who had the largest amount of debt relieved and those who received phone calls to raise awareness and salience of the intervention.”

The authors admitted they had not expected the mental health results and had no good explanation, but their “preferred interpretation is that recipients of the cash payments viewed the transfers as insufficient to close the gap between their resources and needs, raising the salience of their financial distress and harming their mental health.”

As Neale Mahoney, an economist at Stanford and a co-author of the study, told Ms. Kliff: “Many of these people have lots of other financial issues. Removing one red flag just doesn’t make them suddenly turn into a good risk, from a lending perspective.”

The authors concluded:

Nonetheless, our results are sobering; they demonstrate no improvements in financial well-being or mental health from medical debt relief, reduced repayment of medical bills, and, if anything, a perverse worsening of mental health. Moreover, other than modest impacts on credit access for those whose medical debt is reported, we are unable to identify ways to target relief to subpopulations who stand to experience meaningful benefits.

On the other hand, Allison Sesso, R.I.P. Medical Debt’s executive director, told Ms. Kliff that study was at odds with what the group had regularly heard from those it had helped. “We’re hearing back from people who are thrilled,” she said.

As statisticians would say, anecdotes are not data.

————-

Removing medical debt seems like a can’t-lose idea. A number of states and local governments have passed programs to pay off medical debt (most working with R.I.P. Medical Debt) and a number of others are considering it.

Last fall the Consumer Financial Protection Bureau initiated rulemaking that would remove medical bills from credit reports. It has also, according to NPR, “penalized medical debt collectors, issued stern warnings to health care providers and lenders that target patients, and published reams of reports on how the health care system is undermining the financial security of Americans.”

Director Chopra admits: “Of course, there are broader things that we would probably want to fix about our health care system, but this is having a direct financial impact on so many Americans.”

If nothing else, the new study should remind us that our health system is best at putting band-aids on problems rather than solving them. The problems we should be addressing include: why are so many charges so high, why aren’t people better protected against them, and why don’t more Americans have enough resources to pay their bills, especially unpredictable ones like from health care services?

I’m glad R.I.P. Medical Debt is doing what it is doing, but let’s not kid ourselves that it is solving the problem.

Kim is a former emarketing exec at a major Blues plan, editor of the late & lamented Tincture.io, and now regular THCB contributor

An Urgent Call to Raise Awareness of Heart Disease in Women

Apr 5, 2024

By KELLY CARROLL

There is a dire need to raise awareness about heart disease in women. It is the number one killer of American women, and key data points reveal a lack of cognizance among doctors and women.

An assessment of primary care physicians published in 2019 revealed that only 22% felt extremely well prepared to evaluate cardiovascular disease risks in female patients. A 2019 survey of American women showed that just 44% recognized heart disease as the number one cause of death in women. Ten years earlier, in 2009, the same survey found that 65% of American women recognized heart disease as the leading cause of female death, revealing an alarming decline in awareness.

Recent evidence suggests that many adults don’t know the important health numbers that can help identify heart disease risk factors, like their blood sugar and cholesterol. A 2024 survey of American adults conducted by The Ohio State University Wexner Medical Center found that only 35% of adults knew their blood pressure and 16% of adults knew their cholesterol levels. In comparison, the study reported that 58% knew their childhood friend’s birthday.

Heart Disease Risk Factors in Women

Women have specific risk factors for heart disease that don’t pertain to men. Nanette Wenger, M.D., a cardiologist and researcher, said in an American Heart Association (AHA) statement, “For most of the last century, heart disease was considered a problem for men, and women were believed to have cardioprotective benefits from female sex hormones such as estrogen. However, emerging evidence shows that there are a substantial number of heart disease risk factors that are specific to women or predominant in women.” Some gender-specific risk factors outlined by the AHA are early onset of menstruation, early menopause, autoimmune disease, anxiety, depression, and pregnancy complications.

Bethany Barone Gibbs, Ph.D., an associate professor at West Virginia University, emphasized in an email that pregnancy is a “critical window” for women’s cardiovascular health. She said, “The cardiovascular and metabolic challenge of pregnancy may unmask risk for conditions like hypertension and diabetes, but it is also possible (though not yet clear) that experiencing an adverse pregnancy outcome may independently contribute to the development of maternal cardiovascular disease.” A history of adverse pregnancy outcomes can be associated with more than two times the risk of cardiovascular disease later in life, she explained.

Filling in knowledge gaps regarding the connections between pregnancy and long-term cardiovascular health is important to improving outcomes.

Optum: Testing Time for an Invisible Empire

Apr 2, 2024

By JEFF GOLDSMITH

Years ago, the largest living thing in the world was thought to be the blue whale. Then someone discovered that the largest living thing in the world was actually the 106 acre, 47 thousand tree Pando aspen grove in central Utah, which genetic testing revealed to be a single organism. With its enormous network of underground roots and symbiotic relationship with a vast ecosystem of fungi, that aspen grove is a great metaphor for UnitedHealth Group. United, whose revenues amount to more than 8% of the US health system, is the largest healthcare enterprise in the world. The root system of UHG is a vast and poorly understood subsidiary called Optum.

At $226 billion annual revenues, Optum is the largest healthcare business in the US that no-one knows anything about. Optum by itself has revenues that are a little less than 5% of total US healthcare spending. An ill-starred Optum subsidiary, Change Healthcare, which suffered a catastrophic $100 billion cyberattack on February 21, 2024 that put most of the US health system on life support, put its parent company Optum in the headlines.

But Change Healthcare is a tiny (less than 2%) piece of this vast new (less than twenty years old) healthcare enterprise. If it were freestanding, Optum would be the 12^th largest company in the US: identical in size to Costco and slightly larger than Microsoft. Optum’s topline revenues are almost four times larger than HCA, the nation’s largest hospital company, one third larger than the entirety of Elevance, United’s most significant health plan competitor, and more than double the size of Kaiser Permanente.

If there really were economies of scale in healthcare, they would mean that care was of demonstrably better value provided by vast enterprises like Optum/United than in more fragmented, smaller, or less integrated alternatives. It is not clear that it is. If value does not reach patients and physicians in ways that matter to them—in better, less expensive, and more responsive care, in improved health or in a less hassled and more fulfilling practice—ultimately the care system as well as United will suffer.

What is Optum?

Optum is a diversified health services, financing and business intelligence subsidiary of aptly named UnitedHealth Group. It provides health services, purchases drugs on behalf of United’s health plan, and provides consulting, logistical support (e.g. claims management and IT enablement) and business intelligence services to United’s health plan business, as well as to United’s competitors.

Of Optum’s $226 billion topline, $136.4 billion (or 60% of its total revenues) represent clinical and business services provided to United’s Health Insurance business. Corporate UnitedHealth Group, Optum included, generated $29 billion in cashflow in 23, and $118.3 billion since 2019. United channeled almost $52 billion of that cash into buying health-related businesses, nearly all of which end up housed inside Optum.

For most of the past decade, Optum has been driving force of incremental profit growth for United. Optum’s operating profits grew from $6.7 billion in 2017 (34% of UHG total) to $15.9 billion in 2023 (55% of total). However, the two most profitable pieces of Optum by operating margin—Optum Health and Optum Insight—have seen their operating margins fall by one third in just four years. The slowing of Optum’s profitability is a huge challenge for United.

Gaul Had Three Parts, So Does Optum

The largest and least profitable (by percent margin) piece of Optum is its giant Pharmacy Benefit Manager, Optum Rx, the third largest PBM in the US.

The Long and Tortured History of Alpha-Synuclein and Parkinson’s Disease

Mar 29, 2024

By STEVEN ZECOLA

This study tracks the decades-long journey to harness alpha-synuclein as a treatment for Parkinson’s disease. Steven Zecola an activist who tracks Parkinson’s research and was on THCB last month discussing it, offers three key changes needed to overcome the underlying challenges.

A Quick Start for Alpha-Synuclein R&D

In the mid-1990’s, Parkinson’s patient advocacy groups had become impatient by the absence of any major therapeutic advances in the 25 years since L-dopa had been approved for Parkinson’s disease (PD).

The Director of National Institute of Neurological Disorders and Stroke (NINDS) set up a workshop in August 1995 that featured scientists with expertise in human genetics who might open novel avenues for PD research.

One such scientist, Robert Nussbaum, made the following remarks at the workshop:

“…finding genes responsible for familial Parkinson’s should be helpful for understanding all forms of the disease. Techniques now available should allow researchers to find the genes responsible for familial Parkinson’s disease in a relatively short time.”

Two years later in 1997, Spillantini et al. showed that alpha-synuclein (A-syn) was a major contributor of abnormal clusters of proteins in the brain, not only in patients with synuclein mutations but, more importantly, in patients with sporadic Parkinson’s disease as well.

As Nussbaum had predicted, progress had occurred rapidly. President Clinton in his 1998 State of the Union address, said:

“Think about this, the entire store of human knowledge now doubles every 5 years. In the 1980’s, scientists identified the gene causing cystic fibrosis. It took 9 years. Last year scientists located the gene that causes Parkinson’s disease in only 9 days.”

The NIH is Asked to Take a Leadership Role

Shortly after President Clinton’s call to action, a Senate Committee asked the National Institutes of Health (NIH) to develop a coordinated effort to take advantage of promising opportunities in PD research.

In response, the NIH and the National Institute of Neurological Disease and Stroke (NINDS) held a major planning meeting that included all components of the PD community. The group’s recommendations formed the basis of a five-year PD Research Agenda.

The Research Agenda was codified in a comprehensive 42-page report that covered all aspects of research from better understanding the disease, to creating new research capabilities, to developing new treatments, and to enhancing the research process.

Noting the “remarkable paradigm shift in Parkinson’s disease research” from the discovery of the effects of alpha-synuclein, the report stated that:

“New insights into the role of synucleins in the pathobiology of Parkinson’s disease would accelerate discovery of more effective therapies and provide fresh research opportunities to advance our understanding of Parkinson’s disease”.

NIH invested nearly $1 billion from FY 2000 to FY 2004 to implement the PD Research Agenda. A-syn research would be funded out of the funds allocated to the categories of Genetics and Epidemiology, with both categories targeted to receive about 15% of the overall spending.

Overall, there were 19 broad categories with spending authorizations, including $32.7 million allocated to Program Management and Direction.

When the PD Research Agenda reached the end of its 5-year span, NINDS sponsored a second PD Summit which was held in June 2005. It brought together an industry-wide consortium to assess the progress over the previous five years and to develop future directions for PD research.

The participants generated more than fifty specific recommendations. NIH considered these plans and the unmet goals from previous efforts and developed a 3-year Plan.

A major focus of that Plan was to identify and intervene with the causes of PD.

Gen Z’s Mid-Life Crisis

Mar 27, 2024

By KIM BELLARD

These are not happy times in America.

Now, I’m not thinking about the increasing cultural wars, the endless political bickering, the troubles in the Med-East or Ukraine, the looming threat of climate crisis, or the omnipresent campaigning for the November 2024 elections, although all those play a part. I’m talking about quantifiable data, from the latest World Happiness Report. It found that America has slipped out of the top 20 countries for the first time, falling to 23^rd – behind countries like Slovenia and the U.A.E. and barely ahead of Mexico or Uruguay.

Even worse, the fall in U.S. scores is primarily due to those under 30. They ranked 62^nd, versus Americans over 60, who ranked 10^th. A decade ago those were reversed. Americans aged 30-44 were ranked 42nd for their age group globally, while Americans between the ages 45-59 ranked 17^th.

It’s not solely a U.S. phenomenon. Overall, young people are now the least happy, and the report comments: “This is a big change from 2006-10, when the young were happier than those in the midlife groups, and about as happy as those aged 60 and over. For the young, the happiness drop was about three-quarters of a point, and greater for females than males.”

“I have never seen such an extreme change,” John Helliwell, an economist and a co-author of the report, told The New York Times, referring to the drop in happiness among younger people. “This has all happened in the last 10 years, and it’s mainly in the English-language countries. There isn’t this drop in the world as a whole.”

Jan-Emmanuel De Neve, director of the University of Oxford’s Wellbeing Research Center and an editor of the report, said in an interview with The Washington Post that the findings are concerning “because youth well-being and mental health is highly predictive of a whole host of subjective and objective indicators of quality of life as people age and go through the course of life.”

As a result, he emphasized: “in North America, and the U.S. in particular, youth now start lower than the adults in terms of well-being. And that’s very disconcerting, because essentially it means that they’re at the level of their midlife crisis today and obviously begs the question of what’s next for them?”

Gen Z is having a mid-life crisis.