Population should be forced to take experimental shots “for the greater good”

Paul Joseph Watson
http://www.infowars.com/ama-make-participation-in-vaccine-trials-ma...
Wednesday, January 18, 2012

An article published by the American Medical Association’s Virtual Mentorjournal advocates making participation in vaccine trials mandatory, arguing that people should be forced to take experimental shots in a similar vein to how jury service is compulsory.

The article, written by Oxford University’s Susanne Sheehy and Joel Meyer, is entitled Should Participation in Vaccine Clinical Trials be Mandated?

Concerned about the “distressing decline in the numbers of healthy volunteers who participate in clinical trials,” the piece argues that “Compulsory involvement in vaccine studies” should be considered for the “greater good of society.”

“Many societies already mandate that citizens undertake activities for the good of society; in several European countries registration for organ-donation has switched from “opt-in” (the current U.S. system) to “opt-out” systems (in which those who do not specifically register as nondonors are presumed to consent to donation) [10], and most societies expect citizens to undertake jury service when called upon. In these examples, the risks or inconvenience to an individual are usually limited and minor. Mandatory involvement in vaccine trials is therefore perhaps more akin to military conscription, a policy operating today in 66 countries. In both conscription and obligatory trial participation, individuals have little or no choice regarding involvement and face inherent risks over which they have no control, all for the greater good of society.”

Using the example of military conscription – the draft – to justify the idea of compulsory participation in vaccine trials, illustrates how the whole idea is completely rooted in authoritarian tendencies. The draft has its historical origins in slavery and has largely been abolished by developed nations.

And if you thought the use of the term “for the greater good of society” wasn’t downright creepy enough, the authors later propose tackling society’s reluctance to accept compulsory recruitment to vaccine trials by virtually advocating the arrival of a more deadly disease than swine flu in order to ensure “compulsory recruitment becomes a more palatable option.”

“Consider an infectious disease with a high transmission and mortality rate for which vaccine development were possible but limited by a shortage of volunteers willing to participate in clinical trials. Would mandatory participation in clinical trials then be an acceptable policy?” ask the authors, ruminating on how an “Increase (in) the severity of the disease in question,” would increase the likelihood of society accepting mandatory vaccine trials.

The authors conclude by bemoaning ethical considerations that would present a roadblock to the effort to force people to take experimental vaccines, proposing instead that a system of “mandated choice” be introduced to coerce people into agreeing to be given the shots.

Mandating that people take experimental vaccines is of course completely abhorrent, it violates the fundamental human right not to be forcibly medicated, and harks back to the dark days of eugenics, mandatory sterilizations, and episodes like the Tuskegee syphilis experiment.

The very reason why less people are willing to volunteer for vaccine trials is the fact that vaccines, whether approved or experimental, have been responsible for deaths and injuries worldwide in increasing numbers. The United States, which administers the highest number of vaccines to babies, has the highest infant mortality rate out of all developed nations, a connection that is no coincidenceaccording to a recent medical study published in a prestigious medical journal.

Indeed, earlier this month GlaxoSmithKline was fined$93,000 dollars for its role in an experimental vaccine program in Argentina that killed 14 babies between 2007 and 2008.

For this authoritarian premise to even be considered in the AMA’s ‘Journal of Ethics’ is shocking, but the increasing move towards making vaccines mandatory is a wider phenomenon.

Last year, California passed a law that allows children to be given the Gardasil shot, which has been linked with thousands of adverse reactions and dozens of deaths, without parental consent.

Parents who try to remove their children from the ever-expanding list of “required” vaccine programs for school-age kids are being targeted by law enforcement. When Rachel Garmon told her doctor that she had taken the decision not to vaccinate her healthy 2 and a half year old son, she was subsequently visitedby a Pennsylvania State Trooper who was tasked with investigating her “suspicious behavior,” despite the fact that Pennsylvania is one of the many states that allows vaccination exemptions on both religious and medical grounds.

The AMA article represents a shocking insight into the control freak tendencies of some of today’s most influential medical minds. Forcing people to take part in experimental vaccine trials that pose a serious risk to their health is totally contemptible and has no place in a free society.

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Paul Joseph Watson is the editor and writer for Prison Planet.com. He is the author of Order Out Of Chaos. Watson is also a regular fill-in host for The Alex Jones Show and Infowars Nightly News.

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Virtual Mentor. January 2012, Volume 14, Number 1: 35-38.

Policy Forum

http://virtualmentor.ama-assn.org/2012/01/pfor1-1201.html

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Should Participation in Vaccine Clinical Trials be Mandated?

Susanne Sheehy, BM BCh, MRCP, DTM&H, and Joel Meyer, BM BCh, MRCP

Few would argue with Bill Gates when he describes vaccination as “the most effective and cost effective health tool ever invented” [1]. To date vaccination has saved many lives and has the potential to save millions more, especially if vaccines are developed against the “big three”: malaria, HIV, and TB [2-5]. Vaccine development, however, comes at a price that is not only financial but societal. The lack of animal models that can reliably predict vaccine efficacy means that development still unavoidably relies on testing of novel vaccines in healthy individuals. Given the often unquantifiable risks to the recipients of vaccines in early stages of development, clinical trials have traditionally relied on informed and consenting volunteers who appreciate the potential risks but still choose to participate for altruistic reasons [6, 7]. But relying on altruism alone to facilitate clinical trials is potentially unsustainable and ethically contentious.

In recent decades there has been a distressing decline in the numbers of healthy volunteers who participate in clinical trials [7], a decline that has the potential to become a key rate-limiting factor in vaccine development. Reasons for this decline are unclear but are likely to be multifaceted. One familiar problem is the payment of volunteers [8]. To date, the relatively meagre compensation that participants often receive could be seen to belittle and undervalue the contribution of these individuals to global health. The modest financial remuneration commonly provided often means that students and the unemployed make up the bulk of volunteers [6, 8, 9]. As a result, the risks of developing a health intervention that would benefit the whole population are carried disproportionately by some of society’s most poor and vulnerable. This is a situation few would judge to be fair or ethical. However it is hard to increase volunteer payment without creating financial incentives. “Danger money” is frowned upon as an inducement that inevitably clouds an individual’s appreciation of risk, limiting the likelihood that consent is informed [6, 7]. As a result, consensus has generally dictated that payment for volunteers’ trial involvement be modest and limited to compensation for travel, time, and inconvenience only.

If progression of promising vaccines from the lab to the clinic is to remain unaffected and financial inducement is an ethically unacceptable solution to the recruitment shortage, other strategies need to be considered. Compulsory involvement in vaccine studies is one alternative solution that is not as outlandish as it might seem on first consideration. Many societies already mandate that citizens undertake activities for the good of society; in several European countries registration for organ-donation has switched from “opt-in” (the current U.S. system) to “opt-out” systems (in which those who do not specifically register as nondonors are presumed to consent to donation) [10], and most societies expect citizens to undertake jury service when called upon. In these examples, the risks or inconvenience to an individual are usually limited and minor. Mandatory involvement in vaccine trials is therefore perhaps more akin to military conscription, a policy operating today in 66 countries. In both conscription and obligatory trial participation, individuals have little or no choice regarding involvement and face inherent risks over which they have no control, all for the greater good of society.

As ever, then, the debate boils down to a consideration of the “greater good” or the “lesser evil.” A key consideration is the risk benefit ratio—risk to the individual volunteer balanced against the benefit to society. Society is unlikely to accept compulsory recruitment to a trial for a vaccine against the common cold if the vaccine causes severe complications in vaccinees. Increase the severity of the disease in question, however, and compulsory recruitment becomes a more palatable option.

In 2009, initial speculation regarding the H1N1 “swine flu” pandemic set mortality estimates high. In Mexico where the outbreak started, authorities closed public and private facilities [11], putting the interests of society above those of the individual. Although millions of people were infected worldwide, mortality rates were quickly revised downwards [12], and a successful vaccine mass-produced [13]. But consider if this had not been the case. Consider an infectious disease with a high transmission and mortality rate for which vaccine development were possible but limited by a shortage of volunteers willing to participate in clinical trials. Would mandatory participation in clinical trials then be an acceptable policy?

The fundamental principles of medical ethics—beneficence, nonmaleficence, respect for autonomy, and justice—are, as always, conflicted on this issue. Given the inherent risks and common lack of efficacy in many candidate vaccines in development, the principles of nonmaleficence and beneficence would argue against the involvement of subjects in most clinical trials. Justice would reason for the fair treatment of all, supporting mandatory enrollment to help ensure that the risks of developing an intervention that could benefit all are equally borne by all.

Respect for autonomy, on the other hand, would recognize and maintain the right of individuals to self-determination and their corresponding right to refuse a medical intervention. The Universal Declaration of Human Rights upholds the rights, dignity, and freedom of individuals and the need to protect people from “arbitrary interference” [14]—principles that would inevitably be compromised by mandatory enrollment in vaccine trials. Health services depend absolutely on the public’s confidence and trust—compromising on respect for autonomy would undermine this fundamental premise and launch us on a precarious slippery slope that may be difficult to climb back up.

A more palatable and realistic option is a policy of “mandated choice.” In this case individuals would be required by law to state in advance their willingness to participate in vaccine trials [15]. The advantage of this system is that it could identify a large cohort of willing volunteers from which participants could be recruited rapidly without jeopardizing individual autonomy. It would encourage an open, noncoercive philosophy for tackling societal challenges without compromising individual freedom or public trust in the health care system.

But perhaps most importantly, as a society we need to evaluate our perception of vaccination. Any successful vaccine program by its very nature takes a once-feared illness out of the public eye. This means that the benefits of immunization become forgotten while side effects in small numbers of individuals fill the headlines. It is all too easy for sensationalist and unfounded stories such as that claiming a link between the MMR (measles-mumps-rubella) vaccine and autism [16] to instead take root in society’s collective psyche. Ultimately such a crucial public health intervention as vaccine development may become devalued—and only revalued once a drop in vaccination rates leads to resurgence of severe disease.

Perhaps lessons can also be learned from organ donation, where apathy and ignorance may be as much to blame for low donation rates as conscientious objection. If a concerted effort were made to increase public awareness of the success of vaccination, the potential of novel vaccines to improve global health drastically, and the important contribution that individuals can make by volunteering for studies, perhaps mandatory enrollment would not even need to be considered.

References

1. Gates B. Annual letter from Bill Gates. The Bill & Melinda Gates Foundation; 2001: 9. http://www.gatesfoundation.org/annual-letter/2011/Documents/2011-an.... Accessed December 15, 2011.
2. World Health Organization. Global tuberculosis control - epidemiology, strategy, financing; 2009. http://www.who.int/tb/publications/global_report/2009/en/index.html. Accessed December 15, 2011.
3. World Health Organization. World malaria report; 2009. http://www.who.int/malaria/world_malaria_report_2009/en/index.html. Accessed December 15, 2011.
4. Francis DP. Successes and failures: worldwide vaccine development and application. Biologicals. 2010;38(5):523-528.
5. UNAIDS. Global report: UNAIDS report on the global AIDS epidemic; 2010. http://www.unaids.org/globalreport/documents/20101123_GlobalReport_.... Accessed December 15, 2011.
6. Grady C. Payment of clinical research subjects. J Clin Invest. 2005;115(7):1681-1687.
7. Permuth-Wey J, Borenstein AR. Financial remuneration for clinical and behavioral research participation: ethical and practical considerations. Ann Epidemiol. 2009;19(4):280-285.
8. Stones M, McMillan J. Payment for participation in research: a pursuit for the poor? J Med Ethics. 2010;36(1):34-36.
9. Elliott C, Abadie R. Exploiting a research underclass in phase 1 clinical trials. N Engl J Med. 2008;358(22):2316-2317.
10. Saunders B. Opt-out organ donation without presumptions. J Med Ethics. 2011. [Epub ahead of print]
11. Del Rio C, Hernandez-Avila M. Lessons from previous influenza pandemics and from the Mexican response to the current influenza pandemic. Arch Med Res. 2009;40(8):677-680.
12. Nishiura H. The virulence of pandemic influenza A (H1N1) 2009: an epidemiological perspective on the case-fatality ratio. Expert Rev Respir Med. 2010;4(3):329-338.
13. Girard MP, Tam JS, Assossou OM, Kieny MP. The 2009 A (H1N1) influenza virus pandemic: a review. Vaccine. 2010;28(31):4895-4902.
14. United Nations. The Universal Declaration of Human Rights. http://www.un.org/en/documents/udhr/. Accessed December 15, 2011.
15. Herz SE. Two steps to three choices: a new approach to mandated choice. Camb Q Healthc Ethics. 1999;8(3):340-347.
16. Godlee F, Smith J, Marcovitch H. Wakefield’s article linking MMR vaccine and autism was fraudulent. BMJ. 2011;342:c7452. http://www.bmj.com/content/342/bmj.c7452. Accessed December 15, 2011.

Susanne Sheehy, BM BCh, MRCP, DTM&H,is a clinical research fellow in malaria vaccinology at the University of Oxford’s Jenner Institute in Oxford, England, and a specialist trainee in clinical infectious diseases and microbiology.

Joel Meyer, BM BCh, MRCP,is a specialist registrar in intensive care medicine and a clinical research fellow in tuberculosis vaccinology at the University of Oxford’s Jenner Institute in Oxford, England.

Related in VM

Is Mandatory Vaccination Legal in Time of Epidemic?April 2006

Should Human Papillomavirus Vaccination Be Mandatory?December 2007