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Fair Warning: There Won’t Be Fair Warnings

By KIM BELLARD

Perhaps you are the kind of person who acts as though that the food in the grocery store somehow magically appears, with no supply chain vulnerabilities along the way. You trust that the water that you drink and the air you breathe are just fine, with no worries about what might have gotten into them before getting to you. You figure that the odds of a tornado or a hurricane hitting your location are low, so there’s no need for any early warning systems. You believe that you are healthy and don’t have to worry about any pesky outbreaks or outright epidemics.

Well, I worry about all those, and more. Say what you will about the federal government – and there’s plenty of things it doesn’t do well – it has, historically, served as the monitoring and warning system for these and other potential calamities. Now, under DOGE and the Trump Administration, many of those have been gutted or at least are at risk.

But, at the end of the day, the thing at risk is us.

Here is a not exhaustive list of examples:

FDA: Although HHS Secretary Kennedy has vowed he will keep the thousands of inspectors who oversee food and drug safety, it has already suspended a quality control program for its food testing laboratories, and has cut support staff that, among other things, make arrangements for those inspectors to, you know, go inspect.  Even before recent cuts, a 2024 GAO report warned that the FDA was already critically short on inspectors.

The FDA has already laid off key personnel responsible for tracking bird flu, including virtually all of the leadership team in the Center for Veterinary Medicine’s office of the director. Plus: “The food compliance officers and animal drug reviewers survived, but they have no one at the comms office to put out a safety alert, no admin staff to pay external labs to test products,” one FDA official, who was not authorized to speak publicly, told CBS News.

Even worse, drafts of the Trump budget proposal would further slash FDA budget, in part by moving “routine” food inspections to states.  

CDC: Oh, gosh, where to start? Cuts have shut down the labs that help track things like outbreaks of hepatis and antibiotic-resistant gonorrhea. We’re having a hard time tracking the current measles outbreak that started in Texas and has now spread to over half the states.

The White House wants to encourage more people to have babies, but has cut back on a national surveillance program that collects detailed information about maternal behaviors and experiences to help states improve outcomes for mothers and babies. It helped, among other things, compare IVF clinics. “We’ve been tracking this information for 38 years, and it’s improved mothers’ health and understanding of mothers’ experiences,” one of the statisticians let go told The Washington Post.

The Office on Smoking and Health was effectively shuttered, in what one expert called “the greatest gift to the tobacco industry in the last half century.”  CDC cuts will force the Consumer Product Safety Commission (CPSC) to stop collecting data on injuries that result from motor vehicle crashes, alcohol, adverse drug effects, aircraft incidents and work-related injuries.

And if you’re thinking of taking a cruise, you should know that the CDC’s cruise ship inspections have all been laid off – even though those positions are paid for by the cruise ship companies, not the federal government.

EPA: Even though EPA head Lee Zeldin “absolutely” guarantees Trump cuts won’t hurt either people or the environment, the EPA has already announced it will stop collecting data on greenhouse gas emissions, is shutting down all environmental justice offices and is ending related initiatives, “a move that will impact how waste and recycling industries measure and track their environmental impact on neighboring communities.”

The EPA has proposed rolling back 31 key regulations, including ones that limit limiting harmful air pollution from cars and power plants; restrictions on the emission of mercury, a neurotoxin; and clean water protections for rivers and streams. Mr. Zeldin called it the “greatest day of deregulation our nation has seen” and declared it a “dagger straight into the heart of the climate change religion.”  But, sure, it won’t hurt anything.

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Shocking: Trump Builds a Wall Between Basic and Applied Research

By MIKE MAGEE

The leaders of America’s scientific community seem genuinely surprised by the actions of the past three weeks. They expected to be spared the wrath of Trump because they believed that “Americans of all political persuasions have respect for science and celebrate its breakthroughs.”

Maybe so. But that is an inadequate defense against a multi-pronged attack which includes purposefully selecting unqualified hostiles to key management positions; restricting scientists travel and communications; censuring scientific discourse; and clawing back promised funding for research projects already underway. This “knee-capping” has extended beyond our geographic boundaries with Trump’s vengeful withdrawal from the WHO and the Musk inspired elimination of USAID.

“This too will pass,” whisper Republicans behind closed doors. But even so, the nature of scientific discovery and implementation is a complex rebuild. This is because the path from innovation to invention to implementation is interdisciplinary and requires collaborative interfaces and multi-year problem solving. Not the least of the challenges is gaining access, trust, and cooperation from the general public which requires funding, public education, and community planning.

Take for example a life saving device that is increasingly ubiquitous–found everywhere these days from rural high school cafeterias to the International Space Station and everywhere in between-– the Automated External Defibrillator or AED.

It is estimated that AED’s have the potential to save 1,700 American lives a year. Experts estimate that over 18,000 Americans have a life threatening cardiac arrest outside of a hospital with a shockable rhythm disturbance each year. But 90% don’t survive because access to an AED is delayed or not available. Without a correction in about ten minutes, you are likely to die. This means that the 6 pound AED has be where the patient is, the bystander has to know what to do with it, and there can be no delay.

Creating the modern day AED was a century long affair according to the  “Institute of Electrical and Electronics Engineers” or IEEE .

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Goodbye, American Science

By KIM BELLARD

Many people don’t realize it, but a hundred years ago America was something of a scientific backwater. Oh, sure, we had the occasional Nobel laureate, but the center of science was in Europe, particularly Germany. Then in the early 1930’s the Nazis decided that “purity” – of political ideas, of blood – was more important than truth, making life uncomfortable at best and deadly at worst for their scientists. So hundreds of them fled, many of them ending up in the U.S. And – voila! – American science came of age and hasn’t looked back.

Until now. Now, I fear we’re going to suffer what Germany did, a brain drain that will bode well for some other country’s scientific fortunes.

Once of the first chilling announcements from the Trump Administration was that it was freezing NIH grants in order to ensure they were in compliance with Trump’s executive order banning DEI-related efforts. That froze some $1.5b in grant funding.

Piling on, the Administration announced that NIH grants would limit indirect costs to 15%. Sounds reasonable, you might say, but the vast machinery of U.S. biomedical research uses these “indirect” costs to fund the infrastructure that makes the research possible. Numerous state Attorney Generals immediately filed a lawsuit to block the cuts, claiming:

This research funding covers expenses that facilitate critical components of biomedical research, such as lab, faculty, infrastructure and utility costs. Without it, lifesaving and life-extending research, including clinical trials, would be significantly compromised. These cuts would have a devastating impact on universities around the country, many of which are at the forefront of groundbreaking research efforts – while also training future generations of researchers and innovators.

Oh, and on top of all this, as many as 1,500 NIH employees are in line to be laid-off.  

Katie Witkiewitz, a professor at the University of New Mexico, lamented to The New York Times: “The N.I.H. just seems to be frozen. The people on the ground doing the work of the science are going to be the first to go, and that devastation may happen with just a delay of funding.”

Universities are similarly frozen, not sure when or how much money they can expect. The University of Pittsburgh has paused all Ph.D. admission, until it can better understand its funding future. One has to suspect it won’t be the only such program to do so, and we may never know how many would-be Ph.D. students will simply decide a future in U.S. science is too bleak to risk.

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The Next Steps in Parkinson’s Disease Research

By STEVEN ZECOLA

Steven Zercola is back with his latest insights into research in Parkinson’s disease. You can say previous part of this series here

In its latest report, the National Institute of Health (NIH) references 508 active Parkinson’s disease (PD) projects as the recipients of $243M in grants.

A few caveats are warranted about these numbers:

  1. The information is not as precise as it seems.  The NIH report states that: “NIH does not expressly budget by category”. Rather, it “categorizes diseases, conditions, and other research based on a computerized process that it uses at the end of each fiscal year”.
  2. NIH alludes to $74 million of the overall budget as indirect costs without an explanation of this distinction.
  3. Only about half of the aforementioned research grants are available to review. The NIH report specifies that “{t}he minimum reporting threshold for a specific disease/condition is $500,000”.
  4. NIH isn’t the only federal government agency providing grants for PD research.  For example, the Department of Defense also maintains a budget for PD research, albeit much smaller.

Generally speaking, one can categorize basic research into having exploratory, explanatory or diagnostic objectives.  Given that basic research for PD has gained some important insights over the past several decades, I have added some PD-specific categories to the more general categories of research, as shown in the chart below.

Once these additional categories were identified, I assigned each of the reported studies and associated costs to the corresponding categories as follows:

CategoryNumberCosts ($000)
Explanatory5018,162
Exploratory3213,178
Diagnostic2111,499
Tools74,444
Biomarkers93,541
DBS133,598
Alpha-synuclein3816,642
Physical therapies1718,119
Indirect2718,975
Total214$108,158

As you can see from the activity on explanatory and exploratory research, NIH is still very much in a discovery mode when it comes to PD research.  From my perspective as a patient, only about 25% of these identified grants are in a position to produce game-changing results within the 10-year window of the legislation (namely, tools, biomarkers and alpha-synuclein).

In terms of clinical research, clinicaltrials.gov provides a listing of all trials, broken down into phases, including those that are completed, recruiting or terminated.  However, the inputs are not reviewed by an independent party, and the overall numbers are not reliable and do not reflect the funding status of the trials.

Nevertheless, there are a series of individual trials that show promise.

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A Health Economist to lead the NIH

By SAURABH JHA

Early on in the COVID-19 pandemic a seroprevalence study from Santa Clara indicated that the viral spread was far greater than was believed. The study suggested that the infection fatality rate (IFR) was much lower than the case fatality rate and perhaps even lower than the suspected IFR. The researchers estimated that 2.8% of the county had been infected by April 2020. The virus was contagious and, most importantly, caused many asymptomatic infections.  

The study, released as a preprint within a month of the lockdown, should have been published by the NEJM or Lancet. The specificity of the immunoassay was a whopping 99.5% and could not have been lower than 98.5%. Instead, it was roundly criticized by born-again methodological purists. Noted statistician, Andrew Gelman, known expert at dealing with (very) imperfect statistical methods, wanted an apology from the researchers for wasting everyone’s time by making “avoidable screw ups.”

Around the same time, a similar study published in JAMA came to similar conclusions. Researchers found that the seroprevalence COVID-19 antibodies in LA county was 4.65%, 367 000 adults had SARS-CoV-2 antibodies, substantially greater than the 8430 confirmed infections. They concluded that “contact tracing methods to limit the spread of infection will face considerable challenges.” No one asked the researchers for an apology, presumably because the study had passed anonymous peer review and had escaped the wrath of the medical commentariat.

A few months later, a German study suggested that many infected with COVID-19 had myocarditis. This meant that the asymptomatic were not just reservoirs of viral transmission, but walking tombs of cardiac doom. By many, the researchers, who used cardiac MRI to look for myocarditis, put a figure at nearly 80%. That’s a lot. No virus had ever done that. That number itself should have invited scrutiny. The animated, born-again empiricists, who has been energized by the Santa Clara study into becoming methodological sleuths, went into hibernation after the German myocarditis study. The study was swallowed uncritically by many and was covered by the NY Times.

If the rigor demanded of the Santa Clara study was that of a Pythagorean proof, the German myocarditis study received the scrutiny of a cult prophet. The burden of proof in them days was like shifting sand, which shifted depending on the implications of the research. The Santa Clara study suggested the test – isolate strategy was forlorn, as controlling the viral spread was akin to chasing one’s tail. The German myocarditis study was cautionary, emphasizing that that the virus should not be under estimated, as even asymptomatic infections could be deadly. The Santa Clara study challenged lockdowns, the German study supported lockdowns.

The senior author of the Santa Clara study, Jay Bhattacharya, has been nominated by President Trump to be the next NIH director. His nomination has surprised a few, upset a few, irritated a few, shocked a few and, as befits a polarized country, pleased many. Bhattacharya may well have won the popular vote, though I’m uncertain he will win the institutional vote.

Bhattacharya’s anti-lockdown views rapidly made him a persona non grata in academic circles.

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The Healthcare Industry Needs a Course Correction

By STEVEN ZECOLA

The United States healthcare system has failed by any measure.

First, costs are out of control. For example, 17% of the country’s GDP is spent on healthcare. This percentage was less than half that amount in 1980. It is expected to continue growing to 20% by 2032. Seventy-five percent of these costs are attributable to chronic diseases.

Second, notwithstanding the highest percentage of GDP spent on healthcare of the top ten high-income countries, the US has the worst performance outcomes whether measured on life expectancy, preventable mortality through disease management, and even access to care through insurance coverage or other means.

Third, the agency overseeing the healthcare industry is the Department of Health and Human Services. HHS is organized by functions such as Clinical Health Services and Behavioral Health Services rather than organized by disease management. The five strategic imperatives of its 4-year strategic plan do not contain benchmarks for improving the health status of the population, nor concrete steps to achieve the benchmarks. There is no mention of costs.

Fourth, the industry is huge and has many different components from healthcare providers to equipment manufacturers, to researchers, to pharmaceutical companies, to genetic companies, to insurance companies and so on. Over 16 million people are employed in the industry, with 60,000 in HHS alone. At this level of aggregation, leadership and management prowess becomes watered down and there can be no driving force for across-the-board improvements in disease management.

Fifth, the industry spends about $100 billion per year on R&D in pursuit of FDA approvals. The cost of this development translates into more than $2 billion per approved drug. Once approved, the drug effectively gains a barrier against unfettered competition. Independent analysts have estimated the costs of this regulatory scheme vastly exceed the benefits. Yet the FDA holds firm in its approach, given that its primary objective is safety.

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Long COVID cardiac studies: More questions than answers.

BY ANISH KOKA

The NIH recently announced $1.2 billion dollars in funding for research on Long COVID. This is in part because of a faction of scientists that have mined electronic health record databases to find evidence that the long term impacts of COVID on a variety of different organ systems is significant.

I have some concerns when it comes to the cardiac complications discussed related to Long COVID.

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ARPHA-H Needs to Think Bigger

BY KIM BELLARD

Everyone loves DARPA, the Defense Advanced Research Projects Agency that is credited with such hits as the internet and GPS, but is also responsible for things like the Boston Dynamics back-flipping robots and even Siri.  DARPA’s mission is to make “pivotal investments in breakthrough technologies for national security,” but, as the previous examples illustrate, we can’t always tell how those breakthrough technologies are going to get used.  

Healthcare is, at long last, getting its own DARPA, with ARPA-H (Advanced Research Project Agency for Health).  It’s been discussed for years, but just last week was finally funded; a billion dollars over three years.  But I fear it is already off on the wrong foot, even ignoring the fact that President Biden had requested $6.5b.  

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Crowd-Funding for Research Dollars: A Cure for Science’s Ills?

By Jai Ranganathan

Science in crisis

Scientists – and science generally – are in a moment of crisis on multiple fronts. The gap between science and society has grown to a chasm, with disastrous consequences for issue after issue. For example, just last month, Tennessee passed legislation permitting creation “science” into classrooms. On another front, the concern of Americans about global warming has dramatically declined over the past decade, despite the scientific consensus on the clear and present danger caused by climate change.

But science illiteracy in the general public isn’t the only crisis in science. Funding for research is becoming increasingly unattainable, with funding rates at their lowest levels in a decade at the National Science Foundation (NSF) and the National Institutes of Health (NIH), the two most important American science agencies (see here and here for details). The situation in many other nations is no better. In Spain, for example, science spending by the central government has fallen by 20% since 2009. Even worse, research funding from traditional sources will likely be even harder to come by in the years to come due to ongoing economic instability around the world.

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Creative Minds: Building a Better Electronic Health Record

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By Dr. FRANCIS COLLINS

Is 5 too few and 40 too many? That’s one of many questions that researcher David Chan is asking about the clinical reminders embedded into those electronic health record (EHR) systems increasingly used at your doctor’s office or local hospital. Electronic reminders, which are similar to the popups that appear when installing software on your computer, flag items for healthcare professionals to consider when they are seeing patients. Depending on the type of reminder used in the EHR—and there are many types—these timely messages may range from a simple prompt to write a prescription to complex recommendations for follow-up testing and specialist referrals.

Chan became interested in this topic when he was a resident at Brigham and Women’s Hospital in Boston, where he experienced the challenges of seeing many patients and keeping up with a deluge of health information in a primary-care setting. He had to write prescriptions, schedule lab tests, manage chronic conditions, and follow up on suggested lifestyle changes, such as weight loss and smoking cessation. In many instances, he says electronic reminders eased his burden and facilitated his efforts to provide high quality care to patients.

Still, Chan was troubled by the lack of quantitative evidence Continue reading…