– Should Participation in Vaccine Clinical Trials be Mandated? (American Medical Association, Jan. 2012):
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
- Gates B. Annual letter from Bill Gates. The Bill & Melinda Gates Foundation; 2001: 9. http://www.gatesfoundation.org/annual-letter/2011/Documents/2011-annual-letter.pdf. Accessed December 15, 2011.
- 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.
- World Health Organization. World malaria report; 2009. http://www.who.int/malaria/world_malaria_report_2009/en/index.html. Accessed December 15, 2011.
- Francis DP. Successes and failures: worldwide vaccine development and application. Biologicals. 2010;38(5):523-528.
- UNAIDS. Global report: UNAIDS report on the global AIDS epidemic; 2010. http://www.unaids.org/globalreport/documents/20101123_GlobalReport_full_en.pdf. Accessed December 15, 2011.
- Grady C. Payment of clinical research subjects. J Clin Invest. 2005;115(7):1681-1687.
- Permuth-Wey J, Borenstein AR. Financial remuneration for clinical and behavioral research participation: ethical and practical considerations. Ann Epidemiol. 2009;19(4):280-285.
- Stones M, McMillan J. Payment for participation in research: a pursuit for the poor? J Med Ethics. 2010;36(1):34-36.
- Elliott C, Abadie R. Exploiting a research underclass in phase 1 clinical trials. N Engl J Med. 2008;358(22):2316-2317.
- Saunders B. Opt-out organ donation without presumptions. J Med Ethics. 2011. [Epub ahead of print]
- 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.
- 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.
- Girard MP, Tam JS, Assossou OM, Kieny MP. The 2009 A (H1N1) influenza virus pandemic: a review. Vaccine. 2010;28(31):4895-4902.
- United Nations. The Universal Declaration of Human Rights. http://www.un.org/en/documents/udhr/. Accessed December 15, 2011.
- Herz SE. Two steps to three choices: a new approach to mandated choice. Camb Q Healthc Ethics. 1999;8(3):340-347.
- 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.
More information on vaccinations:
– Flu Shot Fantasies: How Influenza Vaccines Halt Flu Infections (Even When They Don’t)
– Australia: Immunize Your Children Or Lose Benefits, Parents Told (ABC News, Nov. 25, 2011)
– Australian Journalist Wins Prestigious Award For Exposing Flu Vaccine Scandal
– DARPA: Do Away With Antibiotics, Then Destroy All Pathogens
– Medical Mafia Fascism Forces Parents To Hide Their Children
– 11 Shocking Things You Now Realize To Be True (But You Never Would Have Believed Just Three Years Ago)
– Wichita Schools Ban Students Whose Vaccination Status Is Not Current
– US Government Wants To Test Anthrax Vaccine On Children
– And Now: CDC Advisory Panel Declares Young Boys Should Be Vaccinated Against HPV, Cervical Cancer
– MSM Pushes ‘Success’ Of Experimental GSK Malaria Vaccine, Ignoring Deadly Side Effects
– Canada: 52 of 98 Teens Who Caught Measles Were Fully Vaccinated
– Flu Shots Contain More Than 250 Times The EPA’s Safety Limit for Mercury
– Finland: 79 Children Develop Narcolepsy After Swine Flu Vaccine, Need Lifetime Medical Care
– CDC Vaccine Secrets Revealed (Video)
– Lethal Injection: The Story Of Vaccination (Documentary)
– GMO Gardasil DNA Contamination: EMA Steps Up To The Plate, FDA Drops The Ball
– Outrage: 100% Human Papillomavirus (HPV) DNA Contamination In GMO Gardasil Vaccine Reported To FDA
– 3 Girls Dead, Others Hospitalized After Gardasil HPV Vaccine
– 100 Compiled Studies on Vaccine Dangers
– California Bill Would Allow To Inject HPV Vaccine Into 12 Year-Olds Without Parental Consent
– Bill Gates In Global Push To Vaccinate Every Child On The Planet
– Bill Gates Says Vaccine Investment Offers Best (Depopulation) Returns
– CDC Vaccine Scientist Who Downplayed Links To Autism Indicted By DOJ In Alleged Fraud Scheme
– US Government Vaccine Compensation Payouts Prove Autism Link
– CDC Vaccine Scientist Who Downplayed Links To Autism Indicted By DOJ In Alleged Fraud Scheme
– Japan: Four Infants Die Shortly After Receiving Pfizer, Sanofi Vaccines
– More Horrific US Medical Experiments Come to Light
– US Supreme Court Shields Vaccine Makers From Lawsuits
– Flu Vaccine Failure In Western Pennsylvania
– International Medical Council on Vaccination Refutes Vaccine Propaganda With Myth-Busting Report
– The Seasonal Flu Vaccine Fairy Tale Collapses
– Man Dies of Swine Flu Despite Swine Flu Vaccine
– Two-Thirds of Whooping Cough Cases Were Vaccinated in Worst Outbreak in More Than 60 Years
– 1 in 3 Americans Already Got A Extremely Toxic Flu Shot This Year
– Vaccination Link To H3N2 Death Cluster In Japan Hospital?
– UK Government ‘Investigates’ 300 ‘Mystery’ Baby Deaths on Cyprus
– Pregnant women to be vaccinated against flu for first time: Genocide!
– India: Twins Die Minutes After Measles Vaccination
– CDC Allegedly Falsifies Reports, Ignoring Up To 3,587 Miscarriages From H1N1 Swine Flu Vaccine
– More Than $1.5 Million in First-Ever Vaccine-Autism Court Award
– 3 Babies Die Within Hours After They Were Vaccinated
– And Now: Mandatory Flu Shot Pushed For Healthcare Workers (With Unemployment As Only Alternative)
– Cervical Cancer Vaccine For Girls Aged 12 Can Be Given Without Parental Consent
– Mother Wins £90,000 MMR Vaccine Compensation After 18 Years
– First batch of untested (!) flu vaccines approved by the FDA causes seizures in children
– WHO To Tax Internet Usage To Fund Genocide Vaccines In Third-World Countries
– WHO Wants to Tax Us to Death, Plans Billions in Internet and Other Taxes
– Rotavirus Vaccines Contaminated With Pig Virus, But FDA Says No Problem
– Dr. Rima E. Laibow: The Globalist Depopulation Agenda
– Discharged IDF Soldiers Sue For Millions Over Anthrax Vaccine Experiment
– Rotarix Rotavirus Vaccine Contaminated With Pig Virus DNA
– European health officials: ‘H1N1 pandemic false alarm, inquiry to expose the truth’
– 60 Million in US Vaccinated Against Swine Flu … They Have Just Destroyed Their Health
– Police State: Student Suspended And Assaulted For Handing Out ANTI-VACCINE Flyers
– Swine Flu Pizza Party: Get a shot, get a pizza for your class!
– Virologist Adrian Gibbs Repeats H1N1 Swine Flu Lab-Escape Claim in Published Study
– Shocking H1N1 Swine Flu Vaccine Miscarriage Stories From Pregnant Women
– Dr. Roby Mitchell Retracts H1N1 Vaccine Advice After Reading Insert!
– French Woman Develops Guillain-Barre Syndrome After H1N1 Swine Flu Vaccination
– Poland: Health Minister Says No To The H1N1 Swine Flu Vaccine For The Entire Country
– 3 Dutch babies die after pneumococcal vaccine, Dutch authorities pull Pfizer’s Prevenar batch
– UK government: All schoolchildren may be vaccinated against H1N1 swine flu
– CFR admits false scarcity tactic to get people to take the H1N1 swine flu vaccine
– Twenty Reasons Why Vitamin D Is Better Than The Swine Flu Vaccine
– H1N1 Swine Flu A National Emergency? Take A Close Look At This Chart
– CDC Guesstimated H1N1 Swine Flu Cases and Refused CBS Freedom of Information Act Request
– President Obama declares H1N1 swine flu a national emergency
– Flu Vaccine Brainwashing by the U.S. Department of Health & Human Services
– Satire: How to be a swine flu vaccine zealot
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– Robert F. Kennedy Jr. – Shocking Vaccine Cover Up
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– Dr. Leonard Horowitz: The CDC’s Vaccination Genocide
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– ‘Just get your damn vaccine’ America! (The Swine Flu Conspiracy
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– Forced Swine Flu Vaccination Refused By Nurses In New York
– Long Island nurses to rally against mandatory swine flu vaccines
– Seasonal flu shot may increase H1N1 risk
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– Nanoparticles used in untested swine flu vaccines
– China: Mass Swine Flu Vaccination
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– Historical facts exposing the dangers and ineffectiveness of vaccines
– Exposed: ‘The Swine Flu Hoax’ by Andrew Bosworth, Ph.D.
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– Swine Flu: The DynCorp ‘COINCIDENCE’
– H1N1 Swine Flu Pandemic: October Surprise Prevention
– Dr. Russell Blaylock: How to reduce the toxic effects if force vaccinated
– Poll: Only a third of nurses willing to have swine flu vaccine
– Leaked Government letter to neurologists reveals concern about swine flu vaccine
– Untested swine flu vaccine could be given to your children
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– Squalene: The Swine Flu Vaccine’s Dirty Little Secret Exposed
– NVIC on swine flu and the consequences for you!
– US Military To Work With FEMA During Swine Flu Pandemic
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– Baxter Filed Swine Flu Vaccine Patent a Year Ahead of Outbreak
– UK Government Swine Flu Advisor On Vaccine Maker Payroll
– Swine flu vaccine to be cleared after five-day trial !!!
– Baxter: Product contaminated with live H5N1 avian flu virus
– Now Legal Immunity for Swine flu Vaccine Makers
– New Zealand orders 300,000 doses of untested and unapproved swine flu vaccine
– Journalist Files Charges against WHO and UN for Bioterrorism and Intent to Commit Mass Murder
– Swine Flu 1976: Reality vs. Propaganda
– Homeopathy Successfully Treated Flu Epidemic of 1918
– Epidemic Influenza And Vitamin D (Flashback)
– Dr. Russell Blaylock on 1976 Swine Flu and Current Outbreak
– Merck Plant Dumps Vaccine Waste and Chemicals Into Water Supply
– Vaccines and Medical Experiments on Children, Minorities, Woman and Inmates (1845 – 2007)
Swine Flu and the Microchip:
– Greg Evenson on Microchips and Swine Flu
– Whistleblower: Forced vaccinations – clear warning
Additional information on Tamiflu:
– Canada ignores Oxford University’s warning about Tamiflu
– Swine flu: TV presenter’s daughter almost died after taking Tamiflu
– Study: Tamiflu causes sickness and nightmares in children
– Tamiflu drug made with cocktail of chemical ingredients, linked with bizarre behavior
– Bird Flu Medicine Toxic for Teens
Susanne, You are the modern day equivalent to ‘Medusa’. Your reasoning is based completely on conjecture, bogus science, non-existent evidence to back up your claims, and which disintegrates at the most cursory analysis. You should be institutionalized and kept in maximum security until the next vaccine trials as the first one subject to the ‘manadatory’ vaccine clinical trials you propose. Why don’t you publish your funding sources…probably one or more pharmaceutical companies on the short list. Please allow me to repeat, ‘You are one sick broad’…get help!