For Some, there is Not Enough Infectious Disease in the World - So They Want to Pay You to Be Infected

Enticements are high enough to lure college students into sitting around after being intentionally infected for weeks. Gonorrhea, anyone?

This is not an April Fool's prank article.

The historical landscape of medical research is marred by egregious violations of human rights, epitomized by the Nazi-era experiments and the Tuskegee Syphilis Study. These dark chapters underscore the vital importance of upholding ethical standards in research, particularly concerning informed consent and the protection of participants from harm.

During World War II, Nazi doctors conducted a series of brutal experiments on prisoners in concentration camps, including intentional infection studies. These experiments ranged from exposing subjects to pathogens like malaria, tuberculosis, typhus, and hepatitis to studying the effects of the diseases and testing potential treatments. The victims, including Jews, Romani people, Soviet POWs, and others deemed "undesirable" by the regime, were often subjected to these experiments without their consent or understanding of the procedures. The outcomes were typically dire, with many subjects dying as a result of suffering from severe, lasting effects.

These experiments are a stark reminder of the depths of human cruelty and serve as a critical reference point in the evolution of research ethics. The Nuremberg Trials, which followed the war, led to the development of the Nuremberg Code, a set of guidelines for ethical medical research that emphasizes the necessity of voluntary consent, the requirement for experiments to yield fruitful results for the good of society, and the obligation to avoid unnecessary suffering and injury.

The Tuskegee Syphilis Study, conducted by the U.S. Public Health Service between 1932 and 1972, is another notorious instance of ethical misconduct in research. In this study, African American men in Alabama who had syphilis were deliberately left untreated, even after penicillin became the standard cure in 1947. The researchers wanted to observe the natural progression of the disease under the guise of providing free healthcare to those who could not afford it. The participants were misled about the nature of their treatment and were not informed of their right to withdraw from the study. The study continued for 40 years until public outcry following media exposure led to its termination.

The Tuskegee study's legacy is a profound breach of trust between medical researchers and the public, particularly among African American communities. It highlighted the need for clear communication, informed consent, and respect for the autonomy and rights of research participants. The study eventually led to significant ethical reforms, including the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the development of the Belmont Report, which outlined ethical principles and guidelines for the protection of human research subjects.

SIGN UP FOR MEDICAL RIGHTS, INFORMED CONSENT AND HUMAN RIGHTS

These incidents, among others, have been instrumental in shaping current ethical standards in medical research, emphasizing the protection of human subjects, the importance of informed consent, and the need for research to be conducted with a clear benefit to society. They serve as a grim reminder of what can occur when ethical considerations are sidelined for the sake of scientific inquiry or under the guise of political and racial ideologies. The lessons learned from these dark periods in research history continue to inform contemporary discussions on the ethics of medical experiments, including debates on the use of human challenge trials.

These best practices appear to have all but been forgotten by Vaccine Manufacturers and Public Health.

A recent Guardian article spotlights Australia's newest facility dedicated to human challenge trials. Human challenge trials are a type of clinical research designed to expedite the understanding of diseases and the development of vaccines and treatments by intentionally exposing consenting participants to infectious agents or pathogens in a controlled environment. Unlike traditional clinical trials, where participants are given either a treatment or placebo without being deliberately infected, human challenge trials involve direct and purposeful exposure to disease-causing organisms.

This method is touted as allowing researchers to study the infection process, immune response, and the efficacy of interventions under “closely monitored conditions”. The primary goal of these trials is to fast-track the assessment of new vaccines or treatments by obtaining quicker results than conventional research methods.

The new facility, the Doherty Clinical Trials (DCT), specializes in infecting healthy volunteers with infectious diseases to test new vaccines and treatments. Located in East Melbourne, this unit—an extension of the Peter Doherty Institute for Infection and Immunity—aims to significantly cut down the time it takes for vaccines to reach the market by providing a controlled environment for direct observation of disease progression and immune response.

The trials, which focus on a variety of diseases, from influenza to malaria and gonorrhea, involve compensating volunteers, typically young adults and travelers, for their participation. The obvious ethical concerns include enticement to consent and the potential long-term health impacts on volunteers.

The recent endeavor into human challenge trials, chronicled by The Guardian's exploration of Australia's first clinical unit (implying intention for more), casts a stark light on the precarious balancing act between advancing medical science and safeguarding human safety. This balance is made all the more tenuous by the checkered history of pharmaceutical companies, whose past missteps in risk:benefit analysis during vaccine trials have sown seeds of doubt and concern. The rapid development and approval of mRNA vaccines have only intensified these apprehensions, spotlighting the industry's fraught relationship with risk assessment in its rush to market.

Compounding these concerns is the ever-present specter of lab leaks. This risk is no longer the sole purview of speculative fiction but a scientific consensus, reflecting a troubling parallel in the management and underestimation of risks associated with human challenge trials. This confluence of factors underscores a critical juncture in medical research, where the drive for innovation must be addressed with urgency and a mandate to protect human life and dignity.

The practice of human challenge trials, wherein healthy individuals are deliberately infected with pathogens, is appalling to nearly everyone except its proponents. Originating centuries ago with experiments that now seem archaic, if not outright barbaric, these trials are being morphed into some type of modern conundrum in which the thirst for scientific knowledge is allegedly pitted against the sanctity of human well-being. The advent of such trials for studying diseases and testing vaccines, notably under the shadow of expedited mRNA vaccine development for COVID-19, deserved rigorous critical scrutiny. These controversies are not academic but touch on profound concerns over participants' long-term safety and ethical treatment, exacerbated by the pharmaceutical industry's relentless pursuit of profit over people.

Amidst the alleged potential collective benefits touted by proponents, human challenge trials reveal a disturbing readiness to compromise ethical standards and safety in the name of scientific advancement. The historical and recent undertakings in this domain, exemplified by the hurried push for mRNA COVID-19 vaccines, underscore a troubling pattern of risk management and ethical oversight failures. The Guardian article detailing Australia's foray into institutionalized human challenge trials is a stark reminder of the pharmaceutical industry's murky ethical waters, where the value of human health is weighed against the lure of scientific breakthroughs and financial gain. This critical examination demands reevaluating the ethical frameworks governing such trials, questioning whether the ends can ever justifiably sanctify the means in human challenge studies.

No Truly Informed Consent Possible Amidst Financial and Social Pressures

The notion of informed consent, a cornerstone of ethical medical research, is muddied in the waters of human challenge trials by financial incentives and social pressures. Often drawn from college student populations or financially precarious backgrounds, participants face a complex decision matrix. The allure of compensation, framed as an opportunity, masks the profound ethical quandary of making decisions under duress. The Guardian article highlights how participants are remunerated at a minimum wage for their time in these trials, a factor that cannot be divorced from the context of economic need. This compensation leverages financial vulnerability, turning informed consent into a paradox where economic circumstances constrain the freedom to choose.

Exploiting Socioeconomic Vulnerabilities to Expedite Pharmaceutical Profits

The deliberate or inadvertent exploitation of socioeconomic vulnerabilities further complicates the ethical landscape of human challenge trials. Though the enticements offered may be legal and consensual on paper, they raise profound ethical questions about exploiting economic disadvantages for the benefit of commercial advancement and pharmaceutical profits. The practice veers dangerously close to the commodification of human health, where the less economically fortunate are disproportionately represented on the front lines of experimental science, not by sheer altruism but by a coerced hand of financial necessity.

The practice will disproportionately attract individuals from economically disadvantaged and minority communities. The demographic skew of human challenge trial participants towards economically disadvantaged and minority communities is not an incidental byproduct but a glaring ethical failure. Whether intentional or through the passive mechanics of economic inequality, this targeting represents a modern echo of historical injustices in medical research. Such practices exploit these communities for high-stakes research and reinforce systemic barriers to equity in health and science. The Guardian's portrayal of the Doherty Clinical Trials facility as a milieu of casual millennial appeal belies the deeper, more disquieting reality of who bears the burden of scientific progress.

Exacerbating Existing Health Disparities Through Selective Trial Recruitment

The recruitment practices of human challenge trials risk not merely perpetuating but actively exacerbating health disparities. By leaning on populations already marginalized by the healthcare system, these trials contribute to a cycle of health inequity. The participants, drawn from the lower rungs of the socioeconomic ladder, are exposed to risks that have long-term implications for their health—risks that are magnified by their diminished access to quality healthcare. This selective recruitment, when viewed through the prism of potential long-term consequences such as pathogenic priming or unforeseen vaccine reactions, reveals an unsettling willingness to sacrifice the few for the presumed benefit of the many, further entrenching health disparities rather than ameliorating them.

This section of the debate underscores the ethical quagmires intrinsic to human challenge trials, where the noble pursuit of scientific knowledge collides with individuals' fundamental rights and dignity, especially those from vulnerable populations. The ethical considerations extend beyond the mere mechanics of consent to question the moral fabric of a society willing to gamble with the health of its most disadvantaged for pharmaceutical companies’ gains.

The Risk of Initiating New Transmission Chains Within the Community

Human challenge trials introduce a profound and potentially catastrophic risk: the creation of new transmission chains that could extend beyond the controlled confines of a laboratory setting. This risk is not merely theoretical but a tangible possibility that carries with it the potential to undermine public health efforts to control infectious diseases. When volunteers are intentionally infected with pathogens, even under the most stringent of controls, the possibility of these pathogens escaping into the wider community cannot be entirely negated. This scenario could arise from many factors, including but not limited to breaches in biosecurity, asymptomatic transmission, or even well-intentioned but misguided interactions between participants and the public. While illuminating the Doherty Clinical Trials unit's state-of-the-art facilities and safety protocols, the Guardian article inadvertently casts a shadow on this grave concern, reminding us of the precarious edge on which such studies teeter.

Risks of Generating More Virulent or Resistant Strains of Pathogens

Beyond the immediate threat of new transmission chains is the alarming potential for human challenge trials to foster the emergence of more virulent or resistant strains of pathogens. This evolutionary pressure, artificially introduced in a laboratory setting, could accelerate the natural selection process, giving rise to strains that current vaccines or treatments cannot effectively combat. The history of antibiotic resistance offers a cautionary tale of how human interventions can inadvertently select more formidable adversaries in the microbial world. In the context of human challenge trials, the pursuit of scientific knowledge and vaccine development may paradoxically push pathogens to evolve in unforeseen and potentially devastating ways, setting the stage for future outbreaks that could eclipse current challenges.

Risk of Long COVID and Other Long-term Chronic Illness

The specter of Long COVID looms large over the landscape of human challenge trials, casting a long shadow on the ethical justification for such studies. Long COVID, characterized by a constellation of persistent symptoms that can follow even mild infections, underscores the profound gap in our understanding of the long-term consequences of vaccine-induced infection. The rush to develop and deploy vaccines, while understandable in the context of a global pandemic, has necessitated the acceptance of unknown long-term risks. This acceptance, however, becomes ethically untenable when individuals are intentionally exposed to pathogens in the name of science. The Guardian's discussion of the Doherty Clinical Trials unit's objectives fails to fully grapple with this critical issue, highlighting the broader industry-wide neglect of the need for comprehensive data on the long-term impacts of such exposures.

Exposing Volunteers to the Unknown Risk of Long COVID

The decision to proceed with human challenge trials in the face of insufficient data on long-term outcomes presents an ethical dilemma of significant proportions. Volunteers, motivated by altruism or financial need, are placed in a position where they must weigh the immediate benefits of participation against the murky backdrop of potential long-term health consequences. This personal calculus is further complicated by the unknowns surrounding Long COVID, a condition that continues to elude full scientific understanding and for which treatment remains elusive. The ethical quandary here is not just about informed consent but about the moral responsibility of the scientific community to protect individuals from harm. The allure of accelerating vaccine development cannot, and should not, overshadow the imperative to first do no harm, a principle that seems perilously close to being compromised in pursuing expedited pharmaceutical gains.

Pathogenic Priming and Vaccine Safety

Pathogenic priming is the act of first exposure —intentional or unintentional—to virulent epitopes from pathogens, setting the immune system up for failure later. This is usually done by priming it for autoimmunity or inducing other alterations that harm the immune system's ability to fight off infections. This phenomenon raises significant concerns regarding vaccine development and safety, particularly concerning the unforeseen consequences of immune response manipulation.

Two trial participants' quotes exemplify their lack of awareness and naivete; the first saying that he would “absolutely” do it again, and another said, “I actually found it to be really fun.” This betrays a lack of sufficient comprehension of risks.

Repeated exposures to infection and then injection will likely cause autoimmunity. The concept of pathogenic priming underscores a critical vulnerability in the human immune system's interaction with certain vaccines. Vaccines aim to prepare the body to combat future exposures by introducing an immune response to specific pathogen epitopes. However, this process can inadvertently prime the immune system for an exaggerated or misdirected response to subsequent infections. This misdirection can lead to a range of adverse outcomes, from heightened susceptibility to the disease the vaccine intended to prevent to triggering autoimmune disorders. The relevance of this phenomenon to vaccine safety is profound, necessitating rigorous evaluation of vaccine candidates to identify and mitigate potential risks of pathogenic priming.

Historical Examples of Vaccines that Led to Disease Enhancement Upon Exposure to the Wild Virus

Historical precedents of pathogenic priming highlight its potential dangers. One notable example is the respiratory syncytial virus (RSV) vaccine trials of the 1960s, where vaccinated individuals faced more severe disease upon natural infection than those not vaccinated. Similarly, dengue vaccine development encountered challenges when vaccine recipients experienced more severe disease upon subsequent natural infection due to antibody-dependent enhancement (ADE), a related mechanism. Autoimmunity against key immune proteins is also expected when pathogens’ proteins resemble human proteins in mounting an immune response to infection. These instances provide red flags, illustrating the critical need for a comprehensive understanding and assessment of infection- and vaccine-induced immune responses before experimentation on humans.

Pathogenic Priming Proven via mRNA Vaccine Technology

The race to bring forward mRNA vaccine technology introduced specific concerns regarding pathogenic priming, warned about as early as April 2020. By their nature, mRNA vaccines program cells to produce viral proteins, aiming to elicit an immune response without causing disease. This novel approach, however, ventured into largely uncharted immunological territory, raising concerns about the long-term consequences of cellular programming and the potential for unforeseen immune system alterations. Studies have shown that the predicted expected harms manifest and that repeated exposures to unsafe epitopes - via infection or injection - should be avoided.

These Risks in Accelerated Vaccine Trials are Ignored

The rapid development and deployment of mRNA vaccines in response to the COVID-19 pandemic have magnified the challenges of adequately assessing risks associated with pathogenic priming. Accelerated vaccine trials do not afford sufficient time to evaluate long-term safety concerns fully or to observe rare but serious adverse effects.

This reckless acceleration must be reconciled with the imperative to ensure vaccine safety, requiring a delicate balance between rapid advancement and the due diligence of safety assessment. The Guardian's overview of human challenge trials and the broader context of vaccine development underscores the critical need for comprehensive, long-term safety studies to safeguard against the risks of pathogenic priming, ensuring that in our pursuit to protect against infectious diseases, we do not inadvertently cause more harm than good.

A CALL FOR A BAN HUMAN CHALLENGE TRIALS

Given the complexities and potential risks outlined in discussions of pathogenic priming, vaccine safety, and the ethical considerations surrounding human challenge trials, it becomes imperative to reassess these trials' role in our collective pursuit of scientific advancement and public health safety. The inherent risks of intentionally exposing healthy individuals to pathogens—compounded by the historical instances of vaccine-induced exacerbation of disease, the theoretical and observed concerns associated with novel vaccine technologies like mRNA, and the profound ethical dilemmas posed by informed consent and socioeconomic disparities—demand a reevaluation of these practices.

The call for a ban on human challenge trials is rooted in the principle of "first, do no harm," a cornerstone of medical ethics that must guide our approach to research and development in infectious diseases. While the intention behind human challenge trials—to accelerate the development of vaccines and treatments—is understandable, especially in the face of global health crises, the potential for unintended and irreversible consequences cannot be overlooked. The risks of pathogenic priming, the possibility of initiating new transmission chains or creating more virulent strains of pathogens, and the unknown long-term health impacts on participants, including the risk of long COVID, present a clear and present danger of mass casualty events.

Moreover, the rapid pace at which these trials are conducted, driven by the perceived urgent need for solutions to emerging health threats, often means that long-term safety considerations are sidelined. This approach is at odds with the fundamental tenets of rigorous scientific inquiry and ethical responsibility. The historical precedents of vaccines that have led to enhanced disease upon exposure to the wild virus serve as a stark reminder of the importance of comprehensive, long-term safety studies within the context of clinical trials, not via retrospective studies only.

In light of these concerns, banning human challenge trials would not signify a retreat from scientific innovation or slowing progress in combating infectious diseases. Instead, it would represent a commitment to safeguarding human dignity, ensuring the ethical integrity of medical research, and prioritizing the long-term well-being of individuals over the immediate gains of rapid vaccine development. Alternatives to human challenge trials, such as long-term randomized clinical trials with total health outcome awareness paired with prediction modeling to find risk factors for adverse events, offer far more ethically viable paths that do not compromise safety or ethics.

In conclusion, this call for a ban on human challenge trials is a call for a more cautious, ethical, and sustainable approach to medical research—one that honors the public's trust in the scientific community and upholds the highest standards of health and safety.

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