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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.

Ami Parekh, Included Health

Mar 28, 2024

Ami Parekh is the Chief Health Officer of Included Health. It provides navigation services & expert medical opinions (the original Grand Rounds) and virtual care (the old Doctors on Demand) and it then bought a smaller company called Included Health. Ami explains why navigation exists (clue: health plans have been terrible at it) and how it works, and what money it saves on trend (about 2%). They’re also reaching out asking about people’s “Healthy days” and are tracking that metric, and giving people more healthy days–Matthew Holt

WEBINAR: The How-To of Healthcare Analytics: Implementation to Activation

Mar 28, 2024

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.

Disability Activist: Take Great Care When Seeing Bias Toward Disabled Citizens

Mar 20, 2024

By RANDY SOUDERS

During the years I served as Chairman of the Board for Jean Kennedy Smith’s Arts and Disability program, Very Special Arts (VSA at the Kennedy Center), I had there opportunity to meet a wide range of remarkable and courageous disabled Americans. Among the lasting friendships is a painter and visual artist, Randy Souders, who was rendered quadriplegic at the age of 17 in a 1972 accident. His concerns of late have been heightened by Trump and MAGA Republicans. I share his communication with his permission here in the hope that tech designers and others will be alert to the fact that great care is required at this point, lest history repeat. — Mike Magee MD

When I was injured at the age of 17 the world was still quite closed for people like me. That was a year before passage of HR 504 of the Rehabilitation Act of 1973. As I recall that law was the first to mandate access to public places that received federal funds. A year later Jean Kennedy Smith founded VSA (Very Special Arts) which has provided important arts opportunities to literally millions of people with disabilities around the globe. It was a very different world back then and artistic achievement was an important way people such as myself could prove their worth to a society that still saw little evidence of it.

It’s unbelievable to think there are serious threats to roll back many of those hard won gains in the name of deregulation and profitability. Disability is costly and people with disabilities are still woefully underemployed. So when a billionaire presidential candidate repeatedly mocks people with disabilities, how long till the “useless/ unworthy” excuses rise again? The old term describing a person with a disability as an “invalid” has another meaning. The adjective use is defined as “Not valid; not true, correct, acceptable or appropriate.”

Few today are aware that the first victims of the Holocaust were the mentally, physically and neurologically disabled people. They were systematically murdered by several Nazi programs specifically targeting them. The Nazi regime was aided in their crimes by perverted “medical doctors and other experts” who were often seen wearing white lab coats in order to visually reinforce their propaganda.

Branded as “useless eaters” and existing as “lives not worthy of life,” people with disabilities were declared an unbearable burden both to German society and the state. As Holocaust historians have documented, “From 1939 to 1941 the Nazis carried out a campaign of euthanasia known as the T4 program (an abbreviation of Tiergartenstrasse 4 which itself was a shortened version of Zentral Dienststelle-T4: Central Office T4) the address from which the program was coordinated.”

These most vulnerable of humans were reportedly the first victims of mass extermination by poison gas and cheaper CO2 from automobile exhaust fumes. But first “a panel of medical experts were required to give their approval for the euthanasia/ ‘mercy-killing’ of each person.”

In the end an estimated quarter million people with disabilities were killed in gas chambers disguised as shower rooms. This model for killing disabled people was later applied to the industrialized murder within Nazi concentration and death camps such as Auschwitz-Birkenau.”

Much has been written on this topic but few seem to know the chronology and diabolical history of how these “beneficial cleansings” of undesirables often start. The Nazi’s enlisted medical doctors to provide them with a veneer of moral justification for their atrocities.

Throughout history, authoritarian political despots have also worked diligently to silence dissent and co-opt religion in order to assist in their mutual quests for total control and dominance of others.

Microplastics, Major Problem

Mar 19, 2024

By KIM BELLARD

It’s been almost four years since I first wrote about microplastics; long story short, they’re everywhere. In the ground, in the oceans (even at the very bottom), in the atmosphere. More to the point, they’re in the air you breathe and in the food you eat. They’re in you, and no one thinks that is a good thing. But we’re only starting to understand the harm they cause.

The Washington Post recently reported:

Scientists have found microplastics — or their tinier cousins, nanoplastics — embedded in the human placenta, in blood, in the heart and in the liver and bowels. In one recent study, microplastics were found in every single one of 62 placentas studied; in another, they were found in every artery studied.

One 2019 study estimated “annual microplastics consumption ranges from 39,000 to 52,000 particles depending on age and sex. These estimates increase to 74,000 and 121,000 when inhalation is considered.” A more recent study estimated that a single liter of bottled water may include 370,000 nanoplastic particles. “It’s sobering at the very least, if not very concerning,” Pankaj Pasricha, MD, MBBS, chair of the department of medicine at the Mayo Clinic, who was not involved with the new research, told Health.

But we still don’t have a good sense of exactly what harm they cause. “I hate to say it, but we’re still at the beginning,” Phoebe Stapleton,a professor of pharmacology and toxicology at Rutgers University, told WaPo.

A new study sheds some light – and it is not good. It found that people with microplastics in their heart were at higher risk of heart attack, stroke, and death. The researchers looked at the carotid plaque from patients who were having it removed and found 60% of them had microplastics and/or nanoplastics. They followed patients for three years to determine the impacts on patients’ health and found higher morbidity/mortality.

“We are reasonably sure that the problem comes from a frailty of the plaque itself,” says Giuseppe Paolisso, a professor of internal medicine and geriatrics at the University of Campania Luigi Vanvitelli in Naples, Italy, and one of the study’s authors. “We suppose due to the fact that the plaques with microplastics and nanoplastics have a higher degree of inflammation, this kind of plaque can be broken more easily; and once they are broken, they can go into the blood streams.”

“This is pivotal,” Philip Landrigan, an epidemiologist and professor of biology at Boston College, who was not involved in the study, wrote in an accompanying opinion piece. “For so long, people have been saying these things are in our bodies, but we don’t know what they do.” He went on to add: “If they can get into the heart, why not into the brain, the nervous system? What about the impacts on dementia or other chronic neurological diseases?”

Scary stuff.

If that isn’t scary enough, an article last year in PNAS found: “Indeed, it turns out that a host of potentially infectious disease agents can live on microplastics, including parasites, bacteria, fungi, and viruses.” Even worse: “Beyond their potential for direct delivery of infectious agents, there’s also growing evidence that microplastics can alter the conditions for disease transmission. That could mean exacerbating existing threats by fostering resistant pathogens and modifying immune responses to leave hosts more susceptible.”

However much you’re worrying about microplastics, it’s not enough.

The Latest AI Craze: Ambient Scribing

Mar 18, 2024

By MATTHEW HOLT

Okay, I can’t do it any longer. As much as I tried to resist, it is time to write about ambient scribing. But I’m going to do it in a slightly odd way

If you have met me, you know that I have a strange English-American accent, and I speak in a garbled manner. Yet I’m using the inbuilt voice recognition that Google supplies to write this story now.

Side note: I dictated this whole thing on my phone while watching my kids water polo game, which has a fair amount of background noise. And I think you’ll be modestly amused about how terrible the original transcript was. But then I put that entire mess of a text into ChatGPT and told it to fix the mistakes. it did an incredible job and the output required surprisingly little editing.

Now, it’s not perfect, but it’s a lot better than it used to be, and that is due to a couple of things. One is the vast improvement in acoustic recording, and the second is the combination of Natural Language Processing and artificial intelligence.

Which brings us to ambient listening now. It’s very common in all the applications we use in business, like Zoom and others like transcript creation from videos on Youtube. Of course, we have had something similar in the medical business for many years, particularly in terms of radiology and voice recognition. It has only been in the last few years that transcribing the toughest job of all–the clinical encounter–has gotten easier.

The problem is that doctors and other professionals are forced to write up the notes and history of all that has happened with their patients. The introduction of electronic medical records made this a major pain point. Doctors used to take notes mostly in shorthand, leaving the abstraction of these notes for coding and billing purposes to be done by some poor sap in the basement of the hospital.

Alternatively in the past, doctors used to dictate and then send tapes or voice files off to parts unknown, but then would have to get those notes back and put them into the record. Since the 2010s, when most American health care moved towards using electronic records, most clinicians have had to type their notes. And this was a big problem for many of them. It has led to a lot of grumpy doctors not only typing in the exam room and ignoring their patients, but also having to type up their notes later in the day. And of course, that’s a major contributor to burnout.

To some extent, the issue of having to type has been mitigated by medical scribes–actual human beings wandering around behind doctors pushing a laptop on wheels and typing up everything that was said by doctors and their patients. And there have been other experiments. Augmedix started off using Google Glass, allowing scribes in remote locations like Bangladesh to listen and type directly into the EMR.

But the real breakthrough has been in the last few years. Companies like Suki, Abridge, and the late Robin started to promise doctors that they could capture the ambient conversation and turn it into proper SOAP notes. The biggest splash was made by the biggest dictation company, Nuance, which in the middle of this transformation got bought by one of the tech titans, Microsoft. Six years ago, they had a demonstration at HIMSS showing that ambient scribing technology was viable. I attended it, and I’m pretty sure that it was faked. Five years ago, I also used Abridge’s tool to try to capture a conversation I had with my doctor — at that time, they were offering a consumer-facing tool – and it was pretty dreadful.

Fast forward to today, and there are a bunch of companies with what seem to be really very good products.

What could we do if GLP-1 weight loss drugs were free? Would our obesity epidemic be solved for good?

Mar 13, 2024

By CECI CONNOLY and SAMI INKINEN

Unless you have been living under a rock, you likely have heard the names Ozempic, Wegovy or Mounjaro. Or perhaps been humming the jingle. Rarely has a class of drugs (in this case, GLP-1s) achieved such widespread attention in popular culture and the media, which has people clamoring for them in every doctor’s office in the nation.

And for good reason. What we know is that the efficacy and safety profile of these medications is substantially better than any weight loss drug in the past, while our obesity epidemic has only ballooned. As organizations committed to sound science and holistic patient care, we are encouraged by the benefits of these new therapies for diabetes. The clinical evidence shows that GLP-1s are highly effective for controlling blood glucose levels among patients living with Type 2 diabetes and certain co-morbidities. GLP-1s may even improve heart health for high-risk patients.

To date, the biggest worry with these weight loss therapeutics has been the hefty price tag, ranging from $800 to $1700 per person, per month. Conservatively, these weekly injections could cost the nation more than $100 billion dollars annually. Already, state Medicaid budgets are sagging under the financial burden. In North Carolina, for example, officials dropped coverage of GLP-1s for obesity, noting that two drugs alone would cost about $1 billion over 6 years, and that’s with a nice discount.

As troubling as the cost is, what we don’t know is what should really worry us. Amidst the excitement over patients rapidly shedding up to 15% of their body mass, fundamental questions remain about who should be taking GLP-1s, at what dosages and what the long-term health and economic consequences will be for patients and society. Ultimately, the price paid to people’s long-term health may be more concerning than the price paid out-of-pocket.

With the recent release of the SELECT trial data highlighting limitations of existing published studies of GLP-1s, it is now even clearer that the public isn’t getting the full picture.

Wait Till Health Care Tries Dynamic Pricing

Mar 12, 2024

By KIM BELLARD

Nice try, Wendy’s. During an earnings call last month, President and CEO Kirk Tanner outlined the company’s plan to try a new form of pricing: “Beginning as early as 2025, we will begin testing more enhanced features like dynamic pricing and day-part offerings along with AI-enabled menu changes and suggestive selling.”

None of the analysts on the call questioned the statement, but the backlash from the public was immediate — and quite negative. As Reuters described it: “the burger chain was scorched on social media sites.”

Less than two weeks later Wendy’s backtracked – err, “clarified” – the statement. “This was misconstrued in some media reports as an intent to raise prices when demand is highest at our restaurants,” a company blog post explained. “We have no plans to do that and would not raise prices when our customers are visiting us most.”

The company was even firmer in an email to CNN: “Wendy’s will not implement surge pricing, which is the practice of raising prices when demand is highest. This was not a change in plans. It was never our plan to raise prices when customers are visiting us the most.”

OK, then. Apology accepted.

At this point it is worth explaining a distinction between dynamic pricing and the more familiar surge pricing. As Omar H. Fares writes in The Conversation: “Although surge pricing and dynamic pricing are often used interchangeably, they have slightly different definitions. Dynamic pricing refers to any pricing model that allows prices to fluctuate, while surge pricing refers to prices that are adjusted upward.”

Uber and other ride sharing services are well known for their surge pricing, whereas airlines’ pricing is more dynamic, figuring out prices by seat by when purchased by who is purchasing, among other factors.

Wendy’s wouldn’t be the first company to use dynamic pricing and it won’t be the last. Drew Patterson, co-founder of restaurant dynamic pricing provider Juicer, told The Wall Street Journal that dozens of restaurant brands used his company’s software. The company’s website doesn’t publicize those brands, of course. Still, he emphasized: “You need to make it clear that prices go up and they go down.”

Dave & Busters is public about its pricing strategy. “We’re going to have a dynamic pricing model, so we have the right price at the right time to match the peak demand,” Dave & Buster’s CEO Chris Morris said during an investor presentation last year. On the other hand, Dine Brands (Applebee’s/IHOP) Chief Executive John Peyton said. “We don’t think it’s an appropriate tool to use for our guests at this time.”

The potential revenue benefits are obvious, but there are risks, as Wendy’s quickly found out. Mr. Fares says: “One of the biggest risks associated with dynamic pricing is the potential negative impact on customer perception and trust. If customers feel that prices are unfair or unpredictable, they may lose trust in the brand.”

What Wendy’s tried to announce is not ground-breaking. Catherine Rampell pointed this out in a Washington Post op-ed:

In other words, things will be cheaper when demand is low to draw in more customers when there’s otherwise idle capacity. Lots of restaurants do this, including other burger chains. It’s usually called “happy hour.” Or the “early-bird special.” Non-restaurants do it, too. Think the weekday matinee deals at your local movie theater or cheaper airfares on low-traffic travel days.

Indeed, The Wall Street Journal reported: “An estimated 61% of adults support variable pricing where a restaurant lowers or raises prices based on business, with younger consumers more in favor of the approach than older ones, according to an online survey of 1,000 people by the National Restaurant Association trade group.”

I wonder what the support would have been if the question had been about healthcare instead of restaurants.

Roy Schoenberg, CEO, AmWell

Mar 11, 2024

AmWell is a now veteran telehealth platform. It used its IPO money to re-architect its entire platform and add companies like Conversa AI chat service and mental health service Silvercloud, as well as integrating deeply with EMRs & more. That change hit its earnings….so can they recover? Roy Schoenberg, CEO, tells you why this is good for AmWell and what happens next.–-Matthew Holt