The Paradox of Transparency

Bottom Line Up Front (BLUF)

You may have wondered if the side effects of the COVID19 mRNA vaccine were fully understood before they were mandated for everone, including healthy children and adults. Apparently after we've all gotten 4 or 5 jabs, the CDC finally has been looking into it until recently terminated by the RJKjr. led HHS. On September 19, 2025, geneticist Dr. Bruce Carleton of Vancouver BC Canada presented incomplete findings from a federally-funded study on genetic risks for vaccine-induced myocarditis—a study terminated with 48 hours notice in March 2025 by the same HHS administration that advocates for vaccine safety research. His preliminary data from 50 patients identified genetic variants in four genes (LRP8, AGTR1, VKORC1, and Titin) that may predispose individuals to heart inflammation after COVID-19 vaccination, with evidence suggesting those carrying more risk variants develop symptoms faster. The cancellation—part of $500 million in terminated mRNA vaccine research grants—exemplifies how political interference disrupts the personalized medicine approaches that prostate cancer patients depend on, leaving critical questions about individual risk factors permanently unanswered. For disease advocates: diversified funding, international collaboration, and protection of research infrastructure matter more than political alignment.

SIDEBAR: Understanding mRNA Vaccines and Myocarditis Risk

What is Myocarditis? Myocarditis is inflammation of the heart muscle. It can be caused by viral infections (including COVID-19 itself), bacterial infections, certain medications, and autoimmune conditions. Symptoms include chest pain, shortness of breath, and abnormal heart rhythms.

Myocarditis and COVID-19 Vaccines: What the Data Show

According to CDC surveillance data presented at the September 2025 ACIP meeting:

Myocarditis following mRNA COVID-19 vaccination is a recognized, rare adverse event
Risk is highest in males aged 12-29, particularly after the second dose
No confirmed myocarditis cases have been identified in children under 5 years of age in either VAERS or the Vaccine Safety Datalink

Comparative Risk Context Multiple studies have found:

COVID-19 infection itself carries significantly higher myocarditis risk than vaccination
The myocarditis risk from infection is approximately 2-8 times higher than from vaccination, depending on age group
Most vaccine-associated myocarditis cases are mild and resolve with conservative treatment

The Research Gap Dr. Carleton Was Addressing Dr. Carleton's cancelled study aimed to identify which specific individuals might be at elevated genetic risk—moving from population-level statistics to personalized risk assessment. This is similar to how prostate cancer patients use genetic testing to determine individual treatment needs rather than relying solely on population averages.

Important Distinctions

COVID-19 vaccines were authorized (emergency use authorization initially, then full FDA approval for some formulations), not "mandated" at the federal level
Various institutions, employers, and some state/local jurisdictions implemented requirements
Dr. Carleton's work focused on understanding rare adverse events in a subset of vaccinated individuals, not challenging the overall benefit-risk profile

What Dr. Carleton's Research Could Have Revealed If completed, the study might have enabled:

Pre-vaccination genetic screening to identify high-risk individuals
Personalized vaccine schedules (timing, dosing, or vaccine type)
Alternative vaccines for those at elevated risk
Better informed consent based on individual genetic profiles

Deaths from Myocarditis During the ACIP meeting, workgroup presentations discussed documented deaths from both symptomatic and subclinical myocarditis following vaccination, with debate about causality and the adequacy of current monitoring systems. This remains an area of active scientific investigation and legitimate scientific debate.

Why This Matters for Prostate Cancer Patients

On September 19, 2025, geneticist Dr. Bruce Carleton stood before a dramatically reconstituted Centers for Disease Control and Prevention (CDC) advisory committee to present findings from a research program that no longer existed. Just the day before, this same committee had engaged in contentious debates over long-established vaccine recommendations for measles, mumps, rubella, and hepatitis B. Now, on the second day of meetings focused on COVID-19 vaccines, the U.S. Department of Health and Human Services (HHS)—which had terminated Carleton's multimillion-dollar grant investigating rare genetic risks associated with COVID-19 vaccines—invited him to share his incomplete results anyway.

For members of the Informed Prostate Cancer Support Group, this incident illuminates broader tensions affecting all medical research: the balance between scientific inquiry, political priorities, and patient safety.

The Tumultuous Context

The September 18-19, 2025 ACIP meeting was unlike any in the committee's history. Secretary Robert F. Kennedy Jr.'s administration had replaced the entire advisory committee just months earlier, removing experienced members who had served for years and appointing new members—many with vaccine-skeptical views—mere hours before the meeting began.

The first day saw heated debates that resulted in:

The tabling of a vote to reconsider the hepatitis B birth dose, a vaccine with a 34-year safety record
Restrictions on MMRV (measles-mumps-rubella-varicella) vaccine recommendations based on concerns about febrile seizures, despite no new safety data
Emotional testimony from liaison organizations representing pediatricians, family physicians, and infectious disease specialists expressing alarm at the abandonment of evidence-based processes

Multiple liaison representatives noted that their organizations could no longer trust ACIP recommendations and would develop independent guidance. The American Academy of Family Physicians representative stated: "Because of these changes, AFP believes ACIP's recommendations no longer address threats to public health and therefore some AFP guidelines no longer align with ACIP's."

What Actually Happened to Dr. Carleton's Research

Dr. Carleton's research program, based at BC Children's Hospital Research Institute in Vancouver, was part of the Global Vaccine Data Network—a collaborative network spanning 32 countries dedicated to vaccine safety research funded by a CDC grant. The study employed sophisticated genomic analysis to identify genetic markers that might predispose certain individuals to rare adverse events following COVID-19 vaccination, specifically vaccine-induced myocarditis (heart inflammation).

The grant was cancelled with just 48 hours notice in March 2025, part of a broader sweep. As one liaison testified: "On August 5th, HHS delivered a death blow to mRNA vaccine development by cancelling $500 million in contracts for mRNA vaccines. HHS terminated 22 grants supporting refinement and development of mRNA vaccines."

When asked during his September 19th presentation why the study was terminated, Dr. Carleton stated simply: "I don't know why the grant was canceled. I understand that HHS has said the period of performance ended on March 25th. The grant was several years long, involves international surveillance as I mentioned, the network, and that's the information I was given by the principal investigators."

The timing was particularly striking: the same administration led by a vocal advocate for vaccine safety research had cancelled research designed to identify who might be at genetic risk for vaccine adverse events.

Dr. Carleton's Preliminary Findings

Despite the incomplete nature of his work, Dr. Carleton's presentation revealed potentially significant genetic associations with vaccine-induced myocarditis:

Study Design: The research examined 50 patients ranging in age from 11 to 83 years who developed myocarditis following COVID-19 vaccination. Using exome sequencing (analyzing protein-coding regions of DNA), researchers achieved an average depth of 100x coverage, with 49 of 50 samples passing quality control.

Key Discoveries: Carleton identified 18 different genes with variants occurring in at least 50% of cases when the global allele frequency was 15% or less—meaning these genetic variants appeared far more frequently in myocarditis patients than in the general population. Seven variants across four genes had been previously identified as associated with myocarditis or cardiac inflammation.

The most significant findings involved four specific genes:

LDL Receptor-Related Protein 8 (LRP8): A variant linked to cardiovascular inflammation and immune response, particularly in coronary artery disease and myocardial infarction. Among the 49 cases: 10 patients were homozygous (both gene copies affected) and 19 heterozygous (one copy affected). This variant enhances P38 MAPK pathway activation, leading to cardiac inflammation.
Angiotensin 2 Type One Receptor (AGTR1): Genotypes previously associated with greater than 90% left anterior descending artery stenosis, MI susceptibility, and essential hypertension. Among cases: 4 patients homozygous and 24 heterozygous. This variant enhances angiotensin II effects, causing hypertension, vasoconstriction, and cardiac hypertrophy.
VKORC1: Highly expressed in the heart, well-known for its association with warfarin dosage and vitamin K signaling, also linked to arterial vascular diseases and vessel calcification. Among cases: 3 homozygous patients and 24 heterozygous. These variants disrupt the vitamin K cycle, leading to vascular calcification and atherosclerosis.
Titin Variants: The most frequent genetic causes of dilated cardiomyopathy, accounting for about 25% of familial and 18% of idiopathic cardiomyopathy. Titin variants are associated with acute myocarditis with higher variant prevalence in cases than controls. Among cases: 3 patients homozygous for all four titin variants examined, 2 homozygous for three variants, and 21 heterozygous. These variants lead to sarcomere insufficiency and dilated cardiomyopathy.

Dose-Response Relationship: Perhaps most intriguingly, Dr. Carleton found that among 30 patients with time-to-onset data, as the number of homozygous variants increased, the time to symptom onset after vaccination decreased. This suggested a potential genetic dose-response effect—those with more genetic risk factors developed symptoms more rapidly after vaccination.

Original Study Goals: Before cancellation, the ambitious goal was to collect 275 cases of each adverse event category (including myocarditis, pericarditis, thrombosis, and others) and enroll vaccinated controls without adverse events. The plan included genome-wide association studies, followed by exome sequencing, and ultimately whole genome sequencing for comprehensive coverage.

The Presentation's Reception

Dr. Carleton's presentation was part of a broader COVID-19 vaccine discussion led by Dr. Retsef Levi, chair of the COVID-19 workgroup. The workgroup had prepared extensive materials on vaccine safety concerns, immune system changes, biodistribution of mRNA components, and other issues.

The committee's response revealed the meeting's underlying tensions. Some members praised the genomics work as "fascinating" and representing exactly the kind of personalized medicine approach needed. Others expressed concern that preliminary, unvalidated findings were being presented to justify restricting vaccine access.

Dr. Grant Paulson, representing the Pediatric Infectious Diseases Society, noted: "The data presented by Dr. Carleton on myocarditis was actually fascinating. I could quite closely geek out on that and ask lots of questions on the genetics of vaccine-induced myocarditis versus that induced by COVID itself or other causes. I think further research and monitoring is certainly warranted. But with that said, the data are fairly clear [that vaccines prevent severe outcomes]... I would encourage the committee to make decisions based on the data rather than theoretical concerns that are raised."

The Broader Context for Medical Research

This situation extends beyond vaccines to illuminate challenges facing all biomedical research:

Funding Vulnerability: Medical research depends heavily on federal grants that can be terminated with changing political winds. Prostate cancer research faces similar uncertainties, with funding priorities shifting based on administrative philosophies and budget constraints. The abrupt 48-hour notice given to Dr. Carleton exemplifies how quickly years of work can be disrupted.

Personalized Medicine: Dr. Carleton's work exemplifies the genomic approach that has revolutionized prostate cancer care—identifying which patients face specific risks or would benefit from particular treatments. As he noted in his conclusion: "Genomic studies of drugs have really revolutionized drug therapy. More than 500 FDA approved drugs have genetic information annotated in the drug labels. Doing the same type of work for vaccine adverse events would serve two purposes: first, it helps us understand the biological mechanisms underlying the pathophysiology of adverse events, and second, in patients who have risk variants, we can allow for more personalized vaccine schedules."

Political Interference in Science: When research outcomes become politically charged, scientific inquiry itself becomes vulnerable. The hepatitis B birth dose debate on September 18th revealed this starkly—ACIP Chair Dr. Martin Kulldorff acknowledged the vote was being reconsidered "not because of new evidence of risk reduction or safety issues, but because of vaccine skepticism." Prostate cancer patients have experienced similar tensions in debates over PSA screening guidelines.

The Value of International Collaboration: Dr. Carleton's work was part of the Global Vaccine Data Network, which includes 32 countries and was publishing "the largest myocarditis and pericarditis COVID-19 vaccine study to date," including booster doses. The U.S. withdrawal from this collaboration leaves a gap that other nations must fill.

The Politics of "Safety Research": The deepest irony is that Secretary Kennedy, who built his public profile demanding more vaccine safety research, terminated major vaccine safety studies upon assuming office. This pattern—demanding research while defunding it—creates a perpetual state of "insufficient evidence" that can justify any policy position.

Implications for Patient Advocacy

For prostate cancer patients and advocates, several lessons emerge:

1. Research Independence: The incident highlights the importance of diversified research funding. Over-reliance on any single source—government, pharmaceutical companies, or advocacy organizations—creates vulnerability when priorities shift. International collaboration can provide some buffer against single-nation policy changes.

2. Complexity of Safety Research: Investigating rare adverse events requires substantial resources and long timelines. Dr. Carleton's study was multimillion-dollar, multi-year research requiring specialized genetic analysis and international patient recruitment—similar investment scales needed for understanding prostate cancer treatment side effects and long-term outcomes.

3. Value of Preliminary Data: Even with funding terminated and data incomplete, Dr. Carleton presented findings that may guide future research and clinical decision-making. Scientific progress often comes through accumulated incremental studies rather than definitive answers—a reality familiar to prostate cancer patients following evolving treatment guidelines.

4. Genetic Susceptibility Matters: The finding that genetic variants may predict adverse events parallels prostate cancer genomics. Just as tests like Oncotype DX, Decipher, and Prolaris predict which patients need aggressive treatment, future genetic screening might identify who faces higher risks from specific interventions—if such research is permitted to continue.

5. Political Advocacy Risks: When patient advocates align with political movements, research may become entangled with broader ideological goals. Kennedy's advocacy for vaccine safety research, when translated into governmental authority, resulted in less safety research—a cautionary tale for any disease advocacy community.

The Unanswered Questions

The incident raises several concerns relevant to all medical research:

What happens to the data already collected from 50 patients? Will it be published?
How will rare adverse event monitoring continue without this research?
Will the Global Vaccine Data Network continue this work without U.S. participation?
What criteria determined which of the 22 cancelled grants to terminate?
How can scientific research maintain independence from political cycles?
If genetic risk factors exist, how will they be identified without research?

For prostate cancer patients, similar questions arise regarding research into treatment side effects, quality of life outcomes, and comparative effectiveness studies—areas often underfunded compared to drug development.

The Scientific Community's Response

Despite the controversy, the CDC's decision to invite Dr. Carleton to present his incomplete findings demonstrated institutional commitment to scientific transparency. The presentation occurred within a broader COVID-19 workgroup report that examined multiple safety concerns, with both majority and minority opinions presented.

The September 19th meeting ultimately resulted in several votes:

Passed (12-0): Recommendation that CDC update informed consent processes to better communicate vaccine risks and uncertainties
Passed (12-0): Updated vaccination schedule based on individual decision-making for all age groups, with emphasis on those at increased risk for severe COVID-19
Failed (6-6, chair breaking tie): Requirement for prescriptions for COVID-19 vaccination
Passed (12-0): Recommendation for healthcare provider-patient discussions before vaccination

These votes reflected a committee trying to balance access, safety concerns, and informed consent—all while working within a dramatically altered institutional framework.

Moving Forward

The situation underscores the fragile ecosystem sustaining medical research. The same genomic approaches that promise personalized cancer care depend on sustained, politically insulated research programs.

For prostate cancer patients and advocates, Dr. Carleton's truncated research offers both warning and hope:

Warning: Research can be terminated abruptly for political reasons, leaving critical questions unanswered. Years of work and millions in investment can disappear with 48 hours notice.

Hope: Even incomplete research can generate valuable insights. Dr. Carleton's preliminary findings suggest that genetic screening could eventually identify individuals at higher risk for certain adverse events—the same personalized medicine approach that has transformed prostate cancer care.

As Dr. Carleton concluded: "In patients who have risk variants, we can allow for more personalized vaccine schedules. In the case of mRNA vaccines and myocarditis, switching patients to either protein or non-adenoviral vector vaccines, for example, would be one option."

This is the promise of genomic medicine—not blanket recommendations, but personalized approaches based on individual risk. Achieving that vision requires sustained research funding, international collaboration, and insulation from political interference.

The Larger Pattern

Dr. Carleton's experience fits within a larger pattern visible throughout the September 18-19 meeting. Multiple liaison representatives from major medical organizations expressed unprecedented concern:

The American Medical Association representative noted the "erosion of the committee's integrity" and warned that "data is being selectively used to justify specific conclusions rather than considering all of the available evidence."
The American Academy of Pediatrics liaison emphasized that vaccine development and safety monitoring require "methodological analyses in the evidence and recommendation framework" rather than "predetermined ideology."
The Infectious Diseases Society of America representative stressed that "discussions today are relevant and very important indeed, with many scientific questions brought up which really support the need for additional funding," while noting the irony that funding was being cut.

For the informed prostate cancer patient, the lesson is clear: scientific research infrastructure requires protection from political winds. The same systems that generate evidence for cancer treatment depend on sustained funding, peer review, and evidence-based decision-making. When those systems fail—whether for vaccines, cancer drugs, or any medical intervention—patients suffer from the resulting knowledge gaps.

The paradox remains: an administration ostensibly concerned about vaccine safety cancelled research designed to identify who might be at risk. Whether this represents coherent policy, bureaucratic error, or political messaging, the result is the same—less knowledge about how to make interventions safer for everyone, and less ability to personalize medical care based on individual genetic risk.

Sources

Centers for Disease Control and Prevention. (2025, September 18-19). Meeting of the Advisory Committee on Immunization Practices (ACIP) [Meeting transcript]. Atlanta, GA. Available from CDC public records.
Centers for Disease Control and Prevention. (2025, September 18-19). Meeting of the Advisory Committee on Immunization Practices (ACIP) [Meeting agenda]. Atlanta, GA.
Carleton, B. (2025, September 19). Genomics of Vaccine-Induced Myocarditis [Presentation]. Advisory Committee on Immunization Practices Meeting, Centers for Disease Control and Prevention, Atlanta, GA.
TrialSite Staff. (2025, October 6). The Paradox of Transparency: What CNN's Vaccine Story Reveals About Science, Power, and Perception. TrialSite News. https://www.trialsitenews.com

Note: This article was prepared based on the September 18-19, 2025 ACIP meeting transcript, official agenda, and related news coverage. Dr. Carleton's findings represent preliminary research from an incomplete study and have not undergone peer review. The genetic associations described require validation in larger populations before clinical application. IPCSG members seeking more information about research funding, transparency in medical studies, or the implications of genetic testing for treatment decisions may contact their healthcare providers or patient advocacy organizations.

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