Devastation of NIH-funded clinical trials: The price of Lysenkoism 2.0

In the wake of the resounding repudiation by American voterrs of the current administration delivered through last week’s midterm elections, I came across a commentary written by Rafael Dal-Re, Barbara Bierer, and bioethicist Arthur Caplan, entitled The premature termination of clinical trials: Reasons and poor justifications. Although the particular issue discussed in this article was likely not one that was anywhere near the top of voter concerns last week, it is one that very much concerns biomedical researchers and clinical trialists; specifically, the clinical trials prematurely terminated by this administration’s taking an axe to the NIH budget in the name of savings and forcing scientific research to “align with administration priorities.” So I thought that now would be as good a time as any to review just what horrors this administration’s obsession with invoking Soviet agricultural scientist and geneticist Trofim Lysenko to produce an American Lysenkoism that I like to refer to as Lysenkoism 2.0 have produced in terms of the final step in any translational biomedical research program that hopes to translate basic science into treatments, clinical trials. Conveniently, Prof. Caplan and his colleagues provided me the pretext and outline.

Of course, any time I discuss American Lysenkoism 2.0, I feel it necessary to briefly recap just who Trofim Lysenko was, what Lysenkoism is, and why what we’re seeing now is actually worse than Lysenkoism during the Soviet era in the mid-20th century. As most SBM readers know, Trofim Lysenko was a Soviet-era agricultural scientist whose ideas—which included the denial of Mendelian genetics and Darwinian evolution by natural selection in favor of a version of Lamarckism—Stalin loved not because of how scientific they were, but rather because they aligned with his understanding of Soviet Communist ideology. Unfortunately, when put into practice, Lysenko’s ideas were utterly disastrous for Soviet agriculture for decades (and, in one instance, Chinese agriculture), resulting in crop yields plummeting, turbocharging periodic famines from the 1930s through the early 1960s, when he was finally removed from power after his influence had been slowly waning in the decade after Stalin’s death. Yet, because his ideas were ideologically in sync with the regime, particularly under Josef Stalin, Lysenko yielded ruthless power over Soviet agricultural science for over three decades, and scientists who dissented in favor of good science risked penalties that ranged from being ostracized to being fired to being imprisoned, and in some cases even to being executed by the Soviet state. This history is why the term “Lysenkoism” is now commonly used to refer to the domination of science by a pseudoscientific ideology, rather than evidence, experimentation, and data. History also shows that it took Soviet agricultural science decades to recover after Lysenko had finally been deposed.

I’ve been arguing since early 2025 that what we’re seeing now is, in a way, much worse than the original Lysenkoism. True, scientists are not being executed for contradicting our Secretary of Health and Human Services, the longtime antivax activist Robert F. Kennedy, Jr., or any of his lieutenants and the useful idiots implementing his and Office of Management and Budget (OMB) Director Russell Vought’s plans, but in 2026 American Lysenkoism has demonstrated itself to be far more broad-based then the original Lysenkoism. In just biomedical science alone, examples abound, including injecting antivax (wording intended) pseudoscience into NIH research programs, attempts to alter NIH peer review processes to make it easier to disguise ideological meddling in grant funding decisions, explicitly wanting to turn the NIH into the “research arm of MAHA,” placing political operatives in charge of grant funding decisions while that all federal science grants “align with administration priorities.” Again, Trofim Lysenko ruled Soviet agriculture and genetics. In 2026, American Lysenkoism is a much more broad-based assault on all federally-funded science., not just one major area of science. Indeed, this assault involves even space science, as evidenced (in part) by news of a top American astrophysicist bolting the US for Denmark because of the current administration’s assault on science.

With that background in mind, let’s take a look at the commentary, as well as some recent evidence regarding the premature termination of clinical trials, thanks to this administration’s unprecedented premature termination of large numbers of NIH grants for nonscientific—indeed, explicitly ideological—reasons. Understand, too, that nothing like this has ever been done before; no prior administration, even conservative Republican administrations, has mass-canceled large numbers of scientific grants funded by the NIH for any reason, much less explicitly ideological reasons. The activities of the current administration make attempts by, for instance, President George W. Bush, to ban embryonic stem cell research look quaint by comparison. This is why I scoff so hard at scientists who constantly relitigate their perceived “cancellation” because of their views during the pandemic while utterly ignoring the real threat to US science.

Clinical trial ethics vs non-ideological reasons for canceling grants funding clinical trials

In fairness, it must be noted that there are a number of reasons why clinical trials are sometimes stopped sooner than the design requires, and it is therefore appropriate that the commentary begins by citing the document that currently governs medical ethics as applied to human subjects research, the Helsinki Declaration thusly:

A foundational ethical principle guiding termination of trials since the 1975 revision of the Declaration of Helsinki, is that the rights and interests of clinical trial participants must take precedence over all other considerations.

The early termination of trials can be due to scientific motives. When termination is contemplated for scientific reasons, investigators ought to have prospectively established stopping rules that are reviewed and approved by the relevant institutional review board/research ethics committee. Fulfillment of these rules is the only acceptable basis for terminating a trial before completing its planned sample size or follow-up. The role of a trial’s Data and Safety Monitoring Board is critical when the conditions for trial discontinuation are met—i.e., when scientific grounds are invoked. When the scientific rationale for termination is rigorously justified, transparently communicated, and accompanied by appropriate plans for participant care and data stewardship, the decision is generally accepted by both the scientific and bioethical communities.

Anytime human subjects are being experimented upon, as they are in clinical trials, ethics must take precedence over scientific rigor. Indeed, one of the tendencies among the cranks and denialists among “COVID contrarian” scientists and physicians that most irritated me was their “methodolatry,” defined as the obscene worship of the randomized clinical trial as the only valid method of clinical scientific investigation. Part of that methodolatry was the implied rejection of medical ethics when it came to randomized controlled clinical trials, specifically the “no saline placebo” gambit in which they claim that RCTs of vaccines are invalid if the placebo control receives something other than just normal saline. Another part was the rejection of RCT evidence that wasn’t “perfect,” but only for RCTs that found something other than what the contrarian believed.

In any event, what must be understood by lay people is that all clinical trials testing one intervention against another have built in provisional stopping points before the total planned number of human subjects is accrued. Interim analyses are baked into the design of clinical trials, where, at certain preplanned points, the data are analyzed and the clinical trial stopped if it is found that one group is definitely doing worse than another group. Sometimes the group that does better is the experimental group receiving the experimental treatment being tested, implying that the treatment being tested is actually efficacious. Sometimes it’s the placebo or standard-of-care group, implying that the experimental treatment is either causing harm (in studies comparing it to placebo) or is not as efficacious as the standard-of-care treatment. In either case, medical ethics demands that accrual to the clinical trial be stopped, because the key ethical principle governing randomized clinical trials is equipoise, defined as a genuine scientific uncertainty over which group in a trial will do better. If an interim analysis clearly shows one group doing better, there is no longer equipoise, and the trial cannot continue.

Scientifically, this is also reasonable, because if an interim analysis shows one group clearly doing better than another, then the investigators have enough data to make a conclusion about the medical intervention that they have been testing. Moreover, in the case where the experimental treatment is shown in an interim analysis to work better than placebo or standard-of-care, the subjects in those groups must immediately be offered the experimental treatment, in order to try to mitigate any harm that might have come to them.

It must be emphasized, as the authors do in their commentary, that the only ethical reason to prematurely terminate a clinical trial is the case when an interim analysis clearly demonstrates better outcomes in one research arm compared to the other(s). Unfortunately, that is not the only reason why clinical trials are sometimes prematurely terminated:

A second rationale for early termination of trials is commercial. Trials are discontinued for business reasons including corporate mergers or acquisition, loss of investment capital, strategic reprioritization of development programs, or the success of a competitor product. Although exceptions may exist, premature termination of trials for purely commercial reasons is almost always unethical. Such decisions may undermine the expectations on which participants based their consent, violate the risk-benefit relationship on which consent was based, jeopardize the participant-investigator relationship, and ignores the social duty and moral responsibility of medical research.

The discontinuation of trials for business reasons is not uncommon.^2,3 A comprehensive review of 3,145 prematurely terminated phases 2 and 3 industry-sponsored trials between 2013 and 2023 revealed that they rose from 11% (n=209) of all completed trials in 2013 to 23% (n=435) in 2023, showing virtually constant year-over-year growth.³ Among the reasons cited, commercial (“strategic” or “business-related”) reasons accounted for 36.1% of all premature terminations, making them the most common cause ahead of a lack of efficacy (23.9%) and safety issues (5.3%).³

Clearly, premature cessation of a clinical trial for purely financial reasons cannot be anything other than unethical, and, even if the financial reason is that “the money ran out sooner than expected,” such terminations are dubious at best. Here’s where the NIH comes in. The above unethical reason for stopping a clinical trial prematurely only applies to industry-sponsored trials that are (usually) intended to provide evidence that a company can use to win FDA approval of their product. Indeed, the NIH funds a relatively small percentage of drug trials, the vast majority of which are funded by industry, specifically the companies seeking FDA licensure to market their drugs. However, that does not mean that NIH funding of clinical trials is insignificant. Besides funding trials of candidate drugs that industry won’t fund and also of behavioral trials and trials of natural products that can’t easily be patented. This brings us to the third reason for premature termination of clinical trials, namely Lysenkoism 2.0:

A new rationale is emerging for ending trials which is deeply concerning: ideological reasons. In early 2025, the Trump administration implemented substantial reductions in federal support for scientific research based on stated policy priorities and on project reviews triggered by specific terms and research topics. This decision has had and contin- ues to have serious impact on the conduct of clinical trials. The NIH and other agencies were seriously affected. USAID was almost dismantled, thousands of multi-year contracts in developing countries were eliminated, and trials involving diseases including cancer, diarrhea, malaria and HIV infection were stopped.⁴ Research objectives in trials that do not align with the administration’s NIH “value priorities” emerged as the main reason for grant cuts and the early termination of trials. Ideological, political or policy-based motives constitute a third reason for premature termination of trials.

The authors argue that canceling a clinical trial for ideological reasons is also unethical, and I couldn’t agree more. For instance, the reference cited above (#4) is to a Science news article on clinical trials in underdeveloped countries that were canceled by USAID cuts. These trials included tests of two experimental HIV vaccines, trials of interventions to prevent and treat malaria, and a test of whether appropriate interventions of hydration could prevent chronic kidney disease in impoverished workers. Granted, these were not NIH-funded trials, but trials funded by USAID; however, the toll on NIH-funded clinical research has also been grim, and the authors cite a study from late last year that documented the carnage:

Patel et al.⁵ assessed the impact of funding cancellations on NIH-supported clinical trials active between February 28, 2025, and August 15, 2025. Among 11,008 NIH-funded trials, 383 (3.5%) lost grant funding. At the time funding was withdrawn, there were 74,311 trial participants that were in the “active, not recruiting” phase (i.e., participants were receiving interventions or were in the follow-up period). Most affected trials dealt with cancer (31%), infectious diseases (25%), or reproductive health (13%). Behavioral (46%), drugs (25%) and devices (4%) were the most common interventions assessed.⁵

The magnitude of ideologically based disruption deserves attention. The care of 74,311 trial participants enrolled was interrupted. This number appears exceptionally large by contemporary clinical trial standards. For example, pivotal trials supporting regulatory approval of medical devices often enroll hundreds, not thousands, of participants, with enrollment varying by device class and regulatory pathway.^6,7

Here’s a table summarizing the disease areas affected:

Interestingly, the NIH did not like this study at all, to the point where it actually responded in a letter by Matthew Memoli, an ally of OMB Director Russell Vought and a person that some (including myself) view as the real power behind Podcast Jay Bhattacharya, who appears to be NIH Director in name only, albeit nearly six months after the study’s publication. In the letter, Memoli claimed that the NIH had redone the analysis and updated it, finding only 28 trials remaining “associated with terminated grants” and only fourteen actively enrolling. Let’s just say that the wording sounded pretty fishy to me—and quite deliberate. “Remain associated” sounds a lot like it’s a snapshot of the later status of these trials months later, compared to Patel et al, which, counted trials whose grants were terminated during the study’s specified time window. Of note, the NIH response fails to provide anywhere near enough methodological detail to determine exactly how it allegedly reproduced or updated the study, to explain why its count was so much lower than that found in the study, or to state whether the 14 actively enrolling trials were a subset comparable to the paper’s 134 recruiting trials at termination. Let’s just put it this way. Memoli’s letter is one page long, and it is really short on methodology. I do not trust it.

Let’s move on. Raw number of trials aside, the clinical area most affected proportionally was infectious disease research, for which 14.4% of NIH-funded clinical trials were terminated prematurely. An earlier analysis by the Association of American Medical Colleges (AAMC) published in May 2025 found that, of all the grants terminated up to that point:

• 56% involved HIV/AIDS-related research.
• 40% focused on mental or behavioral health.
• 18% focused on cancer.
• 16% focused on COVID-19.
• 60% mentioned LGBTQ+ populations.
• 57% mentioned racial or ethnic subpopulations.
• 35% mentioned women.
• 22% mentioned low-income populations.

You can see a pattern here, right? Certainly, I can.

As the authors of the commentary note, this number of patients affected represents far more patients than estimated to be affected by premature clinical trial terminations motivated by financial considerations. Let’s look at the study cited (Patel et al). The first thing to note is that this study was published in November 2025 and only examined NIH-funded clinical trials supported by active grants that were terminated between February 28, 2025 (described as the date that the first clinical trial terminations were reported) and August 15, 2025. The authors note that one limitation of their study is that they couldn’t easily compare the number of terminations in this less-than-6 month period to historical data “due to lack of comprehensive historical grant termination data.” However, they do note that we know that premature termination of NIH grants was “rare” prior to 2025, which jibes with my experience and observations throughout my career dating back to the 1990s, also noting that, because “trials require sustained financial support to ensure operations and participant safety, unanticipated funding disruptions raise concerns about avoidable waste, data quality, and compromised ethical obligations to participants.”

No kidding. It’s the stupidest, most short-sighted way to deal with clinical trials ever, as premature termination often renders clinical trials, at best, less rigorous and reliable because it compromises clinical trial accrual, treatment, and/or followup, or, at worst, renders the data from the trial utterly unusable, meaning that what had been spent on the trial before termination was utterly wasted. Then there’s another issue. Once a grant is canceled, it’s often difficult or impossible to restart the research even if the cancellation is reversed. Without the grant, universities and other organizations doing the research can’t afford to pay the personnel doing the work, and so these personnel are let go and forced to move on. Institutional knowledge degrades. Also, anyone who has ever worked with a large clinical database knows that such databases require constant maintenance and updating to remain useful. Loss of funding can lead to loss of database maintenance and updating, and even reinstatement of funding doesn’t necessarily mean that the database will be updated properly, as data entry, once stopped, usually falls hopelessly behind.

It turns out that the effect of the administration’s termination of NIH grants funding clinical trials might well be much worse than Patel et al found a year ago. There is a website, Trials Tracker, a site developed by Rob Wagner and Amy Knopf Associate Professor of Nursing, Indiana University. They state that they “created the site to help scientists, academics, journalists, legislators and the public seeking information about clinical trials jeopardized by the National Institutes of Health (NIH) award terminations and funding freezes and delays.” Trials Tracker lists thousands of grants impacted by cancellations and hundreds of clinical trials with a total enrollment in the hundreds of thousands. Personally, I treat the data on this site with a bit of skepticism for the following reasons. Its data combine award information from Grant Witness and trial records from ClinicalTrials.gov, and it should be emphasized that its enrollment figures are not counts of people known to have been harmed or left without care. The site’s creators also note that clinical trials records do not distinguish between currently enrolled human subjects and total planned enrollment, which means that one cannot conclude how many patients have been harmed using the data on the site. Even so, however, I find the site useful as an estimate of the upper bound of how horrific the carnage on federally-funded clinical trials has been under this administration.

The consequences of Lysenkoism 2.0 unleashed on NIH-funded clinical trials

As an editorial accompanying Patel et al notes, there are many adverse consequences to yanking grant funding for clinical trials. Even leaving aside the most important issue, namely that canceling clinical trials for ideological reasons is unethical and harms patients, the editors noted:

The termination of clinical trial grants for reasons other than safety or efficacy is wasteful in terms of time and energy, scientific opportunity, and federal tax dollars. Clinical trial participation often requires individuals to travel and attend dedicated study visits and undergo additional testing and procedures. Trial funding terminations thus squander participants’ and investigators’ valuable time, effort, and resources. Further, the termination of clinical trial grants stifles scientific discovery and innovation, leaving investigators with incomplete data and unanswered research questions. Because many of these trials were underway, with substantive sunk costs, their cancellation is an inefficient and profligate use of federal tax dollars that the administration purportedly aims to save.⁴

And, then, just to emphasize it yet again, add to that the horrific betrayal of clinical trial subjects enrolled in the canceled studies:

There is a more direct and sobering impact of premature and scientifically unjustifiable trial terminations: the violation of foundational ethical principles of human participant research.⁶ First and foremost, it is betrayal of the fundamental principles of informed consent for research. Participants have agreed to give of their time and effort and expose themselves to potential risks for the sake of advancing knowledge. A termination of a study or trial violates this important principle. Moreover, participants who have been exposed to an intervention in the context of a trial may be harmed by its premature withdrawal or inadequate follow-up and monitoring for adverse effects. For some participants, enrolling in a trial was a source of hope, in situations when other treatment options were inadequate. For some, participating in the study was a part of their legacy, a way they hoped to contribute to humankind, which will now be denied.

Exactly. Of course, this administration doesn’t care about the science. It doesn’t care about the ethics. It doesn’t care about the people who willingly subjected themselves to potential risk in order to advance science and, yes, out of hope. It doesn’t even care about the money, not really, given that premature grant termination leads to huge waste in the form of sunken costs, less data (or more unreliable data) than completion of the clinical trials funded by the grants would have produced, and basically a major waste of resources.

As I’ve said time and time again, the NIH is the crown jewel of US federal science. For eight decades, it has enjoyed bipartisan support and insulation, at least as much as is possible for an organization whose funding is determined by politicians in Congress, from political interference. the result has been eight decades of great accomplishments, both at the NIH itself and by non-NIH scientists and physicians whose research was funded by the NIH. As with the US vaccine program, in under two years this administration and this HHS Secretary have inflicted a generational catastrophe on NIH-funded science through their relentless attempts to bring grant funding decisions completely under the control of political appointees and thereby turn the NIH into an instrument to fund nothing other than “administration priorities.” Worse, as I’ve discussed time and time again, this administration appears to view science funding as nothing more than yet another form of patronage that it can use to reward loyalty and punish disloyalty, while advancing its ideological agenda.

As I said, the result of this administration’s mass slashing of scientifically valid NIH grants that its ideology tells it not to like will be catastrophic, and not just for science. As Dal-Re et al point out, in a post-Trump clinical trial environment, it will now be incumbent upon researchers to include the risk of premature clinical trial termination in the informed consent:

The clinical trials ecosystem has been shaken by the premature termination of trials for ideological reasons. Since the possibility that trials could again be terminated for ideological decisions in the USA or elsewhere cannot be ruled out, trial stakeholders, commentators and researchers conducting analyses should not overlook these motives as a third potential category of premature trial termination. In all trials, regardless of the interventions assessed, consent processes should acknowledge that trial discontinuation is a meaningful risk of participation and should clearly explain the circumstances under which a study might be terminated, the procedures that will follow such a decision, and how participants’ clinical care and research data will be managed thereafter.11 Recognition of this risk, however, does not eliminate the underlying ethical concern. Even when the possibility of termination is disclosed during informed consent, the interests of the funder, whether companies or governments, should not be permitted to prevail and supersede the rights and interests of trial participants.

In other words, if your trial is funded by the NIH, from here on out you probably have to include a passage in your informed consent document that there is a risk that an administration politically opposed to your research might decide to cancel funding before the trial is completed. I’m sure that will do wonders for clinical trial recruitment, but it might not matter that much given how much damage is being done to federally funded science as a result of this administration’s desire to inflict Lysenkoism 2.0 on the nation. Sadly, given my age, I doubt that I will live long enough to see the damage reversed; that is, if it is ever reversed at all. An institution that took 80 years to build to where it was before this administration only took less than two years to degrade to the point where I doubt that it will ever be as strong as it was.