Yves here. Wellie, Trump seems determined to restore the Gilded Age in the US, along with its lack of professionalized medicine and fundamental research, particularly in pharmaceuticals. If you want to permanently cement China’s leading position as a supplier of pharmaceuticals and grease their path to take leadership in drug development, this is how to do it.
Conventional wisdom is that approved contracts, and that would include NIH studies underway, will have to be paid. Having said that, I do not know if any grants are phased, as in you have to complete a first set of activities before the next tranche of funds is released. But even if so, Federal claims that the recipient had not met the requirements to receive the next money distribution amounts to a contract dispute and if push comes to shove, could be adjudicated.
And it’s not as if NIH-funded studies are an isolated case. Readers can no doubt point to other areas where even short halts in spending for outside parties will produce cascading damage and even business closures.
Even so, what happens if the Administration hangs tough? It takes time and money to gin up litigation. Oh, and where were these researchers during the >20 year campaign to gut the class action bar? “First them came for the gypsies, and I did nothing…”
By Aliasger K. Salem, Associate Vice President for Research and Professor of Pharmaceutical Sciences, University of Iowa. Originally published at The Conversation
In the early days of the second Trump administration, a directive to pause all public communication from the Department of Health and Human Services created uncertainty and anxiety among biomedical researchers in the U.S. This directive halted key operations of numerous federal agencies like the National Institutes of Health, including those critical to advancing science and medicine.
These operations included a hiring freeze, travel bans and a pause on publishing regulations, guidance documents and other communications. The directive also suspended the grant review panels that determine which research projects receive funding.
As a result of these disruptions, NIH staff has reported being unable to meet with study participants or recruit patients into clinical trials, delays submitting research findings to science journals, and rescinded job offers.
Shorter communication freezes in the first few days of a new administration aren’t uncommon. But the consequences of a freeze lasting weeks or potentially longer underscore the critical role the federal government plays in supporting biomedical research. It also brings the intricate processes through which federal research grants are evaluated and awarded into the spotlight.
I am a member of a federal research grant review panel, as well as a scientist whose own projects have undergone this review process. My experience with the NIH has shown me that these panels come to a decision on the best science to fund through rigorous review and careful vetting.
How NIH Study Sections Work
At the heart of the NIH’s mission to advance biomedical research is a careful and transparent peer review process. Key to this process are study sections – panels of scientists and subject matter experts tasked with evaluating grant applications for scientific and technical merit. Study sections are overseen by the Center for Scientific Review, the NIH’s portal for all incoming grant proposals.
A typical study section consists of dozens of reviewers selected based on their expertise in relevant fields and with careful screening for any conflicts of interest. These scientists are a mix of permanent members and temporary participants.
I have had the privilege of serving as a permanent chartered member of an NIH study section for several years. This role requires a commitment of four to six years and provides an in-depth understanding of the peer review process. Despite media reports and social media posts indicating that many other panels have been canceled, a section meeting I have scheduled in February 2025 is currently proceeding as planned.
Reviewers analyze applications using key criteria, including the significance and innovation of the research, the qualifications and training of the investigators, the feasibility and rigor of the study design, and the environment the work will be conducted in. Each criterion is scored and combined into an overall impact score. Applications with the highest scores are sent to the next stage, where reviewers meet to discuss and assign final rankings.
Because no system is perfect, the NIH is constantly reevaluating its review process for potential improvements. For example, in a change that was proposed in 2024, new submissions from Jan. 25, 2025, onward will be reviewed using an updated scoring system that does not rate the investigator and environment but takes these criteria into account in the overall impact score. This change improves the process by increasing the focus of the review on the quality and impact of the science.
From Review to Award
Following peer review, applications are passed to the NIH’s funding institutes and centers, such as the National Institute of Allergy and Infectious Diseases or the National Cancer Institute, where program officials assess the applications’ alignment with the priorities and budgets of institutes’ relevant research programs.
A second tier of review is conducted by advisory councils composed of scientists, clinicians and public representatives. In my experience, study section scores and comments typically carry the greatest weight. Public health needs, policy directives and ensuring that one type of research is not overrepresented relative to other areas are also considered in funding decisions. These factors can change with shifts in administrative priorities.
Grant awards are typically announced several months after the review process, although administrative freezes or budgetary uncertainties can extend this timeline. Last year, approximately US$40 billion was awarded for biomedical research, largely through almost 50,000 competitive grants to more than 300,000 researchers at over 2,500 universities, medical schools and other research institutions across the U.S.
Consequences of An Administrative Freeze
The Trump administration’s initial freeze paused some of the steps in the federal research grant review process. Some study section meetings have been postponed indefinitely, and program officials faced delays in processing applications. Some research groups relying on NIH funding for ongoing projects can face cash flow challenges, potentially resulting in a need to scale back research activities or temporarily reassign staff.
Because my own study section meeting is still scheduled to take place in February, I believe these pauses are temporary. This is consistent with a recent follow-up memo from acting HHS Secretary Dorothy Fink, stating that the directive would be in effect through Feb. 1.
Importantly, the pause underscores the fragility of the research funding pipeline and the cascading effects of administrative uncertainty. Early-career scientists who often rely on timely grant awards to establish their labs are particularly vulnerable, heightening concerns about workforce sustainability in biomedical research.
As the NIH and research community navigate these pauses, this chapter serves as a reminder of the critical importance of stable and predictable funding systems. Biomedical research in the U.S. has historically maintained bipartisan support. Protecting the NIH’s mission of advancing human health from political or administrative turbulence is critical to ensure that the pursuit of scientific innovation and public health remains uncompromised.
If the hypothesis is that we’re getting poor health outcomes because our medical research priorities are skewed towards novel pharmaceuticals instead of [other, non-pharmaceutical based stuff], then this abrupt halt seems like a reasonable way to get the ball rolling, given that an enormous bureaucracy is in the mix.
SteveD: this abrupt halt seems like a reasonable way to get the ball rolling
Listen up. The last thing the US has, or had, left — because its leads in aerospace, automobile, healthcare, the military, manufacturing, you name it, are all gone — was the system of innovation set up under Vannevar Bush in 1946, whereby it funded research in universities then did technological transfer to the private sector to turn that research into companies.
If that vanishes, the descent of the US will accelerate rapidly.
In the real world, clinical trials have ground to a halt. Some people in them will die in the coming weeks who would not have. Bacterial and cell cultures, not maintained, too. Longer term, some promising treatments that would have saved hundreds of thousands of lives will be aborted or will be achieved later.
Just a minute before I glanced here, I talked to one partner at a deep tech VC. He said half their companies have just been put on hold.
We both immediately said the same thing Yves said up top: if you wanted to hand China not just a lead but commanding dominance in biogenetic technologies — as it already has in manufacturing, EVs, and is gaining in computer science/AI — this is how you do it.
What do people think clinical trials are? And how often do drug companies offers to “assist” with cost involve directing people to enroll in trials and studies.
I spent years in my 20s getting free HBC pills, pills that had been on the market for years, as part of a study. I cannot fathom how many people are getting their routine meds as part of a clinical trial or study who will be cut off. Medications for kidney disease don’t have a backup. You take the pills or you’re in real trouble.
People are going to die. Children are going to die.
Cultures are going to die. Will they cut off electricity so that specimens in freezers and climate controlled storage are destroyed?
Thank you, we’ll put. Speaking from the perspective of economics perhaps the focus should be on financially remediating publicly funded research as opposed to donating it to Pfizer.
Another point I want to make concerns the review panels. The current model features no pay for over-stretched academics whose chief motivation is resume’ padding on the quest for tenure (read “job security”).
The deafening silence from the top administrators of higher education indicates their unwillingness to defend their “business models”, perhaps because they recognize that they themselves are a big part of the problem.
“Clinical trials have ground to a halt.”
Fascinating – I just had a patient get enrolled in one this morning. A trial through the NIH and the National Cancer Institute. The reason I know this is because as with all of my patients, I insist they send me the informed consent and we go over it step by step. This particular patient is in a cancer center in a distant state and we just had the zoom meeting after she had faxed me the documents.
All dated JAN 28, 2025. Signed and stamped and notarized by the IRB nurse at the facility on yesterday’s date. The patient will be starting therapy tomorrow. A research chemotherapy drug. I have spoken today with the primary investigator and an employee at the NCI. I have discussed with them today my concerns about this being a “me-too” drug in cancer therapy as so many of them are these days. I asked for and have received a batch of studies that they faxed to me today so I can educate myself about this situation and what issues my patient and I can expect. I have been strongly encouraged to contact them again immediately should I have any questions.
So, no, clinical trials are still ongoing out there in the USA. The NCI was up and going today. I had zero problems reaching the individual. I was connected to their office instantly and the call came back in about 15 minutes. The same cannot be said of the months I waited to talk to the CDC about vaccine issues 4 years ago.
I just had a patient get enrolled in one this morning. A trial through the NIH and the National Cancer Institute … All dated JAN 28, 2025.
That’s your little patch of the world and the 28th, yesterday. This morning, the 29th, the company of the VC I talked to had paused half their companies — those involved in clinical trials and grants — till they’d found what was going on and the senior partner who’d donated to Trump communicated to whomever in DC.
For whatever reasons, the Trump administration has now rescinded that order —
Live Updates: Freeze on Federal Funds Rescinded
https://www.nytimes.com/live/2025/01/29/us/trump-federal-freeze-funding-news
The White House pulled back an order on Wednesday that froze trillions of dollars in federal grants and loans and sparked mass confusion across the country ….
After seeing what years of lax standards and exposing people to risk for profit, I get very concerned when I hear the words VC and clinical research trials in the same thought.
And yes I know that we have built up entire companies and structures doing things this way – and lots of people are going to lose their jobs, etc – but I would suggest that this process is largely how we end up with COVID vaccines that do not work and GLP-1 who seem to be causing more harm by the day.
At some point, hopefully before something horrendous like species extinction happens, we will all begin to realize that this is not the way.
[1] What alternative method do you propose? After all, somebody has to put the initial serious money in, right?
[2] As for ‘hopefully before something horrendous like species extinction happens, we will all begin to realize that this is not the way,’ maybe (1) it’s the mindlessly greedy way that American elites in particular roll and (2) as a result, it won’t be species extinction, but just the end of the U.S. whereupon the rest of the world may breathe sighs of relief.
Is there any evidence, besides the writer’s belief, that the freeze will be lifted after February 1? Are there other study/review groups.still meeting?
Fortunately this freeze will not affect where the majority of money is invested by pharmaceutical companies – advertising. I too want to join a parade down main street, showing off my clear skin, even at the cost of porous intestines leading to death from sepsis. Bless them for bringing back the ’60’s when the cry heard was “Live fast, die young, and leave a good-looking corpse.” /s
This will probably be a minority opinion influenced by years of neglect of one or two diseases (ME/CFS and as a result Long Covid) but… I have little respect for, nor interest in protecting, the NIH.
Before long covid, ME/CFS funding was a paltry $6.80 per year per patient in 2017. Compare that to $75,000 per patient per year on AIDS in the 90’s. Most ME researchers at the NIH reportedly “hate” ME patients. New research is still stymied by catch-22 rules which prevent exploratory research on the grounds that it is not based on “solid science” (and what is exploratory research doing if not trying to provide that foundation?) yet prevents research into treatments on the grounds that we don’t yet understand the disease mechanisms well enough.
Since 2020 congress spent an additional $1.5 billion on long covid research, but the NIH seems to have largely wasted it, in part because they had no bench of researchers or bureaucrats who understood post viral fatigue and could build upon the experience of the ME community when it comes to study design and potential treatments.
I know this sounds like sour grapes, and it is. And my indifference to the NIH is no doubt akin to calls to defund the police–based on real, long-term institutional abuse, yet perhaps not a good overall policy. What we need is a good housecleaning, which I fear I may not see in my lifetime.
But there it is. Though I know in theory Trump may interrupt important research, though I know in theory that the systems of peer review and bureaucracy can make at least adequate funding decisions for many illnesses, my own experience has shown me only disregard, timidity, and gaslighting. So I will enjoy my schadenfreude, while knowing that when the mansion is done burning I and many others will still lack a place to live.
The “largely wasted it” link is broken. I’m hoping you will post it in this thread.
I want to point out that “cleaning house” of entrenched bureaucracy is different from killing ongoing research by freezing their funding, which might be more accurately described as “punitive”. Let’s not forget the “anti-semitism hearings” which exposed a deep animosity towards free will at our universities. That’s worth a think, no? I’m sorry to hear you suffer from long covid, but there is a lot more to this than the failings of our leaders regarding covid.
” I’m sorry to hear you suffer from long covid”
I think Sick_And_Tired was saying he/she has ME/CFS and that the lack of research funds for that over the years has led to “no bench of researchers or bureaucrats who understood post viral fatigue and could build upon the experience of the ME community when it comes to study design and potential treatments [for long covid].”
Thank you and noted. S and T, sorry for misreading your comment. I am undereducated in the ME/CFS department. Curious as to why there isn’t sufficient research here. And yes, the spending discrepancies are infuriating.
I guess if the NIH won’t fund it, researchers will hesitate to undergo the not insignificant effort to apply for grants to research it, let again form an “institution” within their university dedicated to it. I would hesitate to pin the lack of meaningful forward movement on them.
No need to apologize, I wasn’t all that clear about my own situation! But yes, I’ve had ME (myalgicencephalo myelitis, aka chronic fatigue syndrome) for some years.
The “catch-22” link–which is experiencing the same mysterious issue–can be found by searching “statnews.com NIH is thwarting research on a poorly understood yet serious condition” (without the quotation marks).
The article is actually all about why ME hasn’t been funded, which to be fair has been a mystery for all of us. The short version boils down to NIH researchers just not liking us though. The more detailed version in the article might boil down to bias, a bad theory from the 80’s that just won’t die, and a bureaucracy right out of Ikiru, every part of which seems determined to make ME someone else’s problem.
Years ago (back in the ’80s), I remember first hearing about CFS when a fellow student mentioned having it. My hairdresser at the time had it, too. I think many, many people and researchers dismissed CFS as being all in one’s head, and I think that may be playing a big part in why research is underfunded. Just a wild-*ss guess on my part!
Right on the money, imo.
About apportioning blame for the simmering abscess that is ME/CFS research… I do think that the federal bureaucracy in particular deserves some blame–though obviously politicians who were unable or unwilling to challenge or follow up with the bureaucracy, and perhaps the “invisible” quality of the illness can be pointed to as well.
But in the mid-90’s congress asked the CDC to spend $23 million studying–as it was then known–CFS. Which wasn’t a lot, but apparently it was too much, as a later inquiry found that the CDC had decided to spend probably over half of that money on other stuff because… they could, I guess. And then they tried to lie about it. https://www.washingtonpost.com/wp-srv/national/daily/may99/cdc0528.htm
So even when congress does throw us crumbs, at least on one occasion the CDC stole half the crumbs from us. Which I know makes me sound like some hapless Dickens character but my point is just that the bureaucracy itself–or possibly just some of the high-up bureaucrats–does/do deserve some portion of the blame.
“perhaps the “invisible” quality of the illness can be pointed to as well.”
I’ll bet you are spot on. It makes me think about how hard it is to get someone to understand what brain fog is or what the effects are on the person suffering with it.
Strange! I am having the same issue when I enter the address (which I just copied from the website) in my address bar. Perhaps they have an overzealous bot blocker?
The link is:
https://www.statnews.com/2023/08/09/long-covid-nih-trials/
I was able to find a link and click through successfully by entering something like “statnews.com long covid NIH trials underwhelming” in a search engine. Brave worked, at least.
And I agree with you that as satisfying as it may be for me to watch people at the NIH squirm for a day this likely won’t result in anything good. My feelings aren’t deeply logical. But as a bureaucracy trying to justify its own existence, the NIH could stand to try a bit harder, from my (possibly atypical) perspective.