Introduction: The intersection of politics and science is increasingly fraught with tension, especially in the realm of health and medicine. Recent developments regarding the investigation into autism treatments highlight this friction, showcasing the impact of political influence on scientific integrity. This article explores various cases, including the controversial use of leucovorin for autism, the implications of personnel cuts within vital health agencies, and concerning trends around climate change and governance. Each section delves into the critical dynamics at play, revealing the ongoing struggle for scientific truth amid external pressures.
Part the First: Politics and Science. It probably comes as no surprise that autism has emerged in recent discussions, particularly in light of political pressures within health agencies: Inside FDA, career staffers describe how political pressure is influencing their work.
The inquiry began in August and caught scientists at the Food and Drug Administration (FDA) off guard. The head of the agency’s medicine regulation division sought their opinions on leucovorin, a generic medication typically used to mitigate the side effects of cancer treatments. He had observed some promising studies and believed the FDA could fast-track its approval as a treatment for autism.
Insights from the leucovorin research referenced earlier indicate:
The leucovorin case is relatively straightforward: several studies suggest that this medication may enhance the performance of individuals with autism on standardized verbal ability tests. However, these studies are limited in scale.
For instance, one study, published in the European Journal of Pediatrics, followed 80 patients aged 2 to 10 who were randomly assigned to receive either leucovorin or a placebo. The treating families and physicians were unaware of which children received the treatment. After 24 weeks, the children given leucovorin scored 1.2 points higher on a 60-point scale measuring autism severity compared to the placebo group.
Although this result is statistically significant, smaller studies often run the risk of false positives. Generally, researchers would expand upon such findings with a large-scale randomized controlled trial to confirm efficacy and safety—typically involving hundreds or thousands of participants.
A correlation that is statistically significant must be carefully scrutinized; statistical significance does not equate to clinical significance unless supported by more robust evidence than that derived from a mere 80 subjects—a sample far too small to draw conclusions about a complex condition like autism. The work of Bradford Hill and Richard Doll is particularly noteworthy; their research linked smoking to lung cancer, demonstrating that while not every smoker developed cancer, a significant majority of lung cancer patients were smokers. Furthermore, the higher the consumption of cigarettes, the greater the chances of diagnosis and mortality.
The combination of statistical data and dose-response relationships solidified this link. Bradford Hill’s Criteria for Causation should not be dismissed when conclusions predetermine the analysis. Although over forty years passed, the “molecular archaeology” of lung cancers and many other types is now well understood. Modern clinical and radiation oncology has improved treatment outcomes, for which I personally express gratitude.
So, what exactly is leucovorin? Known as folinic acid, it bears similarities to methotrexate (MTX), a pioneering cancer chemotherapy developed in 1947. MTX works by inhibiting an enzyme vital for DNA replication, allowing it to typically destroy cancer cells more rapidly than normal cells. Leucovorin is used to counteract the unwanted effects of MTX. However, it remains uncertain how leucovorin could alleviate autism symptoms. While repurposed medications can indeed prove beneficial, the rationale for using leucovorin in autism treatment appears tenuous at best. Addressing this, Dr. Marty Makary, formerly of Johns Hopkins University and current Commissioner of the FDA, stated:
“Today, the FDA is filing a federal register notice to change the label on an exciting treatment called prescription leucovorin, making it available for children with autism,” he said. “Leucovorin holds promise for hundreds of thousands of kids with autism.” (Here is the tweet.)
Reshma Ramachandran, a health services researcher and clinician at Yale School of Medicine, commented that this sequence of events contradicts the FDA’s proper functioning.
“What we’re witnessing is a belief system driving the search for supportive evidence,” said Ramachandran. “That approach is fundamentally flawed for a scientific agency like the FDA.”
The disconnect highlights the rising tension between career scientists and political figures as Kennedy pursues his agenda. STAT conducted interviews with over twenty current and former agency officials and legal experts about the political influences at the FDA. Most sought anonymity to avoid potential personal and professional repercussions.
Seeking anonymity is understandable; the looming risk of repercussions deeply influences this environment. Political maneuvering often ignores the necessary caution expected of scientists. Such caution is an obligation for citizens while political leaders operate under different rules. It is crucial to note that the FDA, CDC, and NIH, while not flawless, are essential for public health and the advancement of biomedical sciences. The early detection of AIDS by field scientists from the CDC in June 1981 exemplifies their value, just as the NIH has supported nearly every American recipient of the Nobel Prize in Physiology or Medicine since World War II.
Another medical field, particularly concerned with uncovering its mysteries, is Alzheimer’s disease, which has sought a definitive breakthrough for over four decades. The amyloid hypothesis may not be a dead end, but skepticism is warranted.
Part the Second: Just Because You Stop Looking Does Not Mean the Problem has Gone Away. Once again, we turn to STAT for reliable reporting, albeit occasionally favoring the biomedical sector. In an important piece, a piece discusses the cuts affecting a CDC team managing a central health and nutrition survey. The NHANES program has gathered data on dietary habits, diabetes, and other prevalent health issues for decades.
According to the National Library of Medicine, NHANES is the primary source of health and nutritional status data for community-dwelling individuals. It effectively combines rigorous data analysis with survey responses.
Located in Hyattsville, Maryland, this statistics center has provided significant insights on prevalent diseases and behaviors via representative surveys for 60 years, where contractors assess the Americans’ health and nutrition through surveys, health examinations, and laboratory tests. Recently, around 100 positions were cut across various divisions of NCHS (data analysis, informatics, operations, and planning), impacting all eight remaining members of the planning branch after earlier job losses on February 14 and April 1, which resulted in retirements.
“The capacity to monitor emerging outbreaks will also be compromised,” commented Denys Lau, a former division head tracking national health care provision, who is now editor-in-chief of the American Journal of Public Health.
Like Lau, Tom Frieden, the president and CEO of Resolve to Save Lives and former CDC director, perceives inconsistency in the administration’s stated priorities and actions. “NHANES helped spotlight the perilous overconsumption of ultra-processed foods among Americans, an issue Secretary Kennedy frequently emphasizes as a significant health risk.”
Muddled priorities? Perhaps not. It appears the current administration aims to validate assorted preconceived health notions—essentially, a departure from traditional scientific methods practiced up until recently. NHANES has served as a counterbalance to the interests of Big Food and Big Agriculture. Although the latter stalwarts may not ultimately triumph, their defeat necessitates sustained effort and patience.
Part the Third: Completion of Yet Another Hat Trick. The circumstances surrounding the National Institutes of Health (NIH) have raised concerns: the disbanding of committees advising federal health agencies on the ethics and implications of scientific research:
A panel of scientific experts, clinicians, and patient advocates had spent two years devising strategies to bolster community engagement in NIH-funded research. When they presented their plan to NIH Director Jay Bhattacharya, he commended it for addressing a crucial objective: restoring public trust in clinical research. Hence, it befuddled the assembled members when they learned this meeting would mark their final gathering.
The advisory committee, NExTRAC, was established in 2019 to succeed the storied Recombinant DNA Advisory Committee (RAC). Initially created in the mid-‘70s, the RAC oversaw pioneering genetic engineering technologies and played a significant role in the rollout of synthetic insulin and early gene therapy clinical trials. This laid the foundation for modern success in these fields. Recent innovations in biosafety and ethical considerations, including CRISPR gene drives and new frameworks for personal health data, were the focus of NExTRAC’s work in recent years. Yet, in May, committee members received emails informing them of the committee’s closure, a move attributed to enhancing NIH’s operational efficiency.
The disbanding raises questions about how NIH intends to continue fostering open discussions about ethical issues surrounding groundbreaking biotechnologies. The termination of NExTRAC follows a broader trend of diminishing scientific expertise within governmental frameworks under the guise of streamlining operations. Since January, nearly four dozen committees offering advice to various entities within the Department of Health and Human Services have been dissolved, as noted in a federal database.
Previous reports by STAT and other outlets have covered some of these terminations, including those affecting committees focused on improving infection control and tackling systemic health care barriers for marginalized populations. Additionally, committees were disbanded that made recommendations for studying long Covid and addressing ethical dilemmas in human health research, as well as programs designed to screen newborns for genetic conditions. The ramifications of these disbandments, including those pertaining to NExTRAC and groups involved in Alzheimer’s research and NIH grant evaluations, are only beginning to surface.
During NExTRAC’s final meeting on September 29, Bhattacharya stated that the decision “does not reflect a reduced commitment from me to seek advice that challenges existing models.” He insisted that public discourses on these issues would proceed through “alternative channels.” The committee concluded its activities by endorsing recommendations put forth by its public engagement working group.
Many within the scientific community are perplexed, especially considering Bhattacharya’s established stance that indicates Covid would have been a minor issue if we allowed widespread infection. Recent panels I’ve participated in have included members from the community, a decision that has enlightened many experts, who often overlook straightforward questions. Therefore, while this approach may seem reasonable from the administration’s perspective, it raises the important rhetorical question: Who will guard the guardians? Without scrutiny over decision-makers, there is the potential for unchecked actions that could jeopardize public interests.
Indeed, the NIH has historically been a challenging entity for those of us who rely on it for our scientific careers. While never perfect, its impact based on Vannevar Bush’s vision has exceeded expectations. However, with research funding manipulated by those with vested interests, outcomes risk becoming predetermined, drawing parallels to the alarming trend of image manipulation in scientific publications—an unsettling thought. And let’s not forget, the MMR vaccine has never been linked to autism, nor has acetaminophen.
Part the Fourth: Coral Catastrophe. As the saying goes, concerns about our oceans have been “preyin’ on my mind,” especially as ocean temperatures reach alarming levels: Coral die-off marks Earth’s first climate ‘tipping point’:
Rising global temperatures have forced coral reef ecosystems into widespread decline, marking the first climate-related ‘tipping point’ as announced by researchers today.
They further indicate that without prompt measures to reduce greenhouse gas emissions, other Earth systems may also reach critical tipping points, leading to irreversible changes.
“We can no longer discuss tipping points as a future concern,” says Steve Smith, a social scientist at the University of Exeter and lead author of a recent report on the proximity of Earth to approximately 20 planetary tipping points. “This is our current reality.”
Led by Smith and fellow researchers, the report evaluates the dangers associated with breaching tipping points such as ice-sheet collapse, rising sea levels, and the degradation of the Amazon rainforest. Additionally, it examines positive tipping points aimed at engendering social and economic transformations, including clean energy adoption.
In their initial assessment released less than two years ago, scientists raised alarms without officially declaring any climate tipping points had been achieved. Since then, however, global temperatures have surged, leading to heightened worries that climate change is accelerating, potentially resulting in more sweeping consequences in the coming decades.
The repercussions for coral reefs have been notably dire over the past two years, bringing these ecosystems to their tipping point. Warm waters have triggered a bleaching event, which occurs when corals expel the symbiotic algae that provide them with essential nutrients and vibrant colors. The fourth global bleaching event in recent decades began in January 2023, and it is estimated that over 84% of the planet’s coral ecosystems have been affected.
Corals, among the oldest multicellular organisms on Earth, exhibit remarkable biological processes. Bleaching occurs due to environmental stress, primarily warmed waters, prompting corals (Subphylum Anthozoa) to expel their photosynthetic dinoflagellate partners (often misidentified as algae). Under healthy conditions, zooxanthellae coexist within coral polyps—providing carbon dioxide and receiving nutrients through photosynthesis, a mutually beneficial relationship.
Several significant bleaching events have occurred in the past two decades, with many corals successfully recovering. However, bleached corals are not dead but critically ill. Eventually, there may come a time when recovery becomes impossible, converting once-thriving ecosystems into barren underwater landscapes. Yet, as former politician Newt Gingrich remarked, “So what, extinction happens all the time” (paraphrase). While this statement holds some validity, the lessons from the extinction of the dodo and the passenger pigeon must not be overlooked in this current Sixth Great Extinction, driven predominantly by human greed and folly according to reasonable scientific assessments.
Part the Fifth: The Nervous Breakdown of the Professional Managerial Class Continues. The ongoing political landscape is further elaborated in Corey Robin’s Mamdani’s New Birth of Freedom. Although it’s evident that the political elite will resist change, their ability to maintain the status quo appears tenuous. Amidst swirling political rivalries, the rise of Zohran Mamdani presents an intriguing contrast as he runs against Andrew Cuomo:
In this political landscape, Mamdani takes on Andrew Cuomo, once embroiled in scandal, who appears to have been buoyed by the influence of Donald Trump. Trump’s own scandals aside, he has been involved in a range of dubious activities. Amid pressures from various interests, Cuomo’s political survival has relied heavily on an unwarranted alliance with Trump.
In contrast, Mamdani boasts an unblemished record and a commitment to progressive policies. Untainted by corruption, he embodies integrity in a political landscape increasingly defined by deceit.
Interestingly, this emphasis on steadfast legality and principles arises from a democratic socialist platform—advocating for rent control, free public transport, universal childcare, and making life affordable in New York.
This emerging narrative challenges the very foundation of American policy; ensuring affordable living conditions and supporting public amenities like healthcare and education may pave the way for a society benefiting all citizens. What will become of figures such as Billy Ackman and Donald Trump? While these individuals may retain their wealth, a shift toward one-person, one-vote governance, as opposed to current practices equating dollars with votes, holds promise for redefining power dynamics. Moreover, it presents an opportunity for individuals to pursue fulfilling careers and contribute positively to society.
Part the Sixth: Update on the New ICE Age. An instance from the local scene illustrates the ongoing realities in our current climate: ICE raids leave lingering impacts across Coastal Georgia communities. Whether the initiatives taken within Georgia will ultimately prove successful remains uncertain, mirroring the complexities of development agreements. Similarly, a significant stretch of farmland near Atlanta was developed for Rivian, finally witnessing actual construction activity after extensive delays; whatever rationale prompted the ICE raid in this vicinity, it appears Hyundai benefited from unwritten agreements with federal authorities.
