How dishonesty in the medical field affects vaccine attitudes

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Introduction

I posted previously about how to change patients’ attitudes about vaccination. However, it is also important to address the medical community’s history with unethical experimentation and dishonest reporting.

I maintain that vaccines and modern medicine are essential, but I think it is important to address poor conduct that erodes the public’s opinion of science and the medical establishment; this lack of trust is what allows these dangerous ideas to gain traction.

Historical Misconduct

The United States has an unpleasant history of medical experimentation without consent. One particularly notable example is the Tuskegee Syphilis Experiment. This experiment ran for 40 years, intentionally withholding medical treatment from black Americans, infecting others with syphilis, and allowing children to be born with syphilis infections (CDC, 2017). Additional syphilis experimentation was carried out in Guatemala from 1946-1948, wherein doctors infected soldiers, prisoners, prostitutes, and the mentally ill with syphilis (BBC, 2011).

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Experiments where patients were exposed to radioactive iodine and other radioactive substances were common with the United States Atomic Energy Commission in the 1950s and 1970s (Longworth, 1999; Goliszek, 2003). These experiments involved injections and internal consumption of radioactive materials, including children, infants, and pregnant women.

Modern Controversies

Thanks to news media, we are able to learn about medical malpractice as it happens. Recently, two shocking ethics breaches occurred in the field of vaccine science. One United States researched named William Halford conducted herpes vaccination tests on Americans in St. Kitts and Nevis, two West Indies islands. In brief, Halford recruited Americans to participate in a study on the efficacy of a herpes vaccine, but conducted the tests offshore with no oversight from the FDA, and even without a medical license (Taylor, 2017). Since the tests were conducted offshore, and the testing was not registered, there is not a whole lot that can be done for the patients, some of whom are suffering from side effects. The Office of Human Research Protections (OHRP) defers to the FDA in cases of non-federally funded research, so it is unlikely that any consequences will come of this huge research misconduct (Halford’s recent death notwithstanding) (Taylor, 2017).

Another vaccine that is receiving a lot of backlash in terms of how it was tested is the infamous Gardasil vaccine. Merck’s methods in testing the vaccine’s safety do not hold up to other researchers’ standards (Joelving, 2017). The most serious issue with the testing was the procedure for reporting adverse effects. Patients presenting with symptoms, including five women who reported extreme fatigue (eventually being diagnosed with Chronic Fatigue Syndrome (CFS)), often had these new symptoms logged in new medical history, and did not have equivalent entries in the potential adverse effects log (Joelving, 2017). Adverse effects were only logged within 14 days of the last dose of the vaccine, which doesn’t give most patients enough time to realize that there is a problem, get a diagnosis, and report the issue to study coordinators. The idea that Gardasil can cause autoimmune diseases/CFS has been around since about 2015 (Feiring, 2017) and the realization that the pharmaceutical companies we hold responsible for manufacturing safe medications were cutting corners absolutely fans those fires.

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DISCLAIMER

This is not to say that Gardasil causes Chronic Fatigue Syndrome. A study done by Feiring et. al studying the same cohort of Scandinavians followed study subjects for a period of two years after receiving the Gardasil vaccine found no connection or increase of chronic fatigue syndrome diagnoses amongst six birth cohorts, totalling 176,453 children (Feiring, 2017). Anyone that can get this vaccine absolutely still should.

It is important for the public to be made aware of research and medical misconduct, especially considering our history of medical testing on the vulnerable and disadvantaged. However, with this knowledge comes increasing distrust towards the medical industry, especially amongst those who are influenced by anti-vaccine propaganda and misinformation.

In order to restore trust, we need to prevent these incidents from happening.

How to Restore Trust?

To prevent further attacks on vaccine and medical integrity, we need to start enforcing the rules in place for medical trials. A report published by a health consortium, including Transparency International Pharmaceuticals & Healthcare, TranspariMED, Cochrane, and the Collaboration for Research Integrity and Transparency at Yale University laid out a series of guidelines in plain language that will allow the public better transparency in evaluating medical trials (Cohen, 2017).

Below are the guidelines recommended:

• Trial registration
• Publication of summary results within 12 months
• Proactive disclosure of full trial reports
• Publication of trial results in academic journals (or free access through appropriate trial registries or databases)
• Frameworks that enable effective, vigilant, individual participant data sharing
  (Bruckner, 2017)

In addition, the United States federal government needs to take a stronger stance on research and medical misconduct. The FDA and OHRP need the backing and funding to be able to go after people who put the public perception of the medical establishment at risk. This includes bans on funding, fines, and legal action in circumstances that put human lives directly at risk. All clinical trials should be registered, with proper channels (including routes independent of study organizers) study participants can go through if they feel their wellbeing is at risk. Results from all clinical studies should be made public, either in journals or in preprint servers, so that less resources are wasted, and so that the public can remain informed on the state of medical research.

It will be a very long, uphill battle to restore faith in medicine, and I am well aware that there will always be people that will prefer more “natural” methods, but fight begins on an individual level. If we, as researchers, follow these guidelines and encourage our colleagues to do the same, we can begin a new era of research transparency.

Love always,
T

References

References
BBC News. (2011). Guatemala STD study 'unethical'. [online] Available at: http://www.bbc.com/news/world-latin-america-14712089 [Accessed 5 Jan. 2018].
Cdc.gov. (2017). Tuskegee Study - Timeline - CDC - NCHHSTP. [online] Available at: https://www.cdc.gov/tuskegee/timeline.htm [Accessed 5 Jan. 2018].
Cohen, D. (2017). Rules on reporting trials must be better enforced, say health integrity groups. BMJ, p.j5786.
Feiring, B., Laake, I., Bakken, I., Greve-Isdahl, M., Wyller, V., Håberg, S., Magnus, P. and Trogstad, L. (2017). HPV vaccination and risk of chronic fatigue syndrome/myalgic encephalomyelitis: A nationwide register-based study from Norway. Vaccine, 35(33), pp.4203-4212.
Goliszek, A. (2003). In the name of science. New York: St. Martin's Press, pp.132-134.
Joelving, F. (2017). What the Gardasil Testing May Have Missed. [online] Slate Magazine. Available at: https://slate.com/health-and-science/2017/12/flaws-in-the-clinical-trials-for-gardasil-made-it-harder-to-properly-assess-safety.html [Accessed 5 Jan. 2018].
Longworth, R. (1999). Injected!. Bulletin of the Atomic Scientists, 55(6), pp.58-61.
Taylor, M. (2017). Unregulated herpes experiments expose ‘black hole’ of accountability. [online] STAT. Available at: https://www.statnews.com/2017/12/21/herpes-experiments-accountability/ [Accessed 5 Jan. 2018].
Transparency International UK (2017). Clinical Trial Transparency - A Guide for Policy Makers. [online] Available at: http://www.transparency.org.uk/publications/clinical-trial-transparency/#.Wk_SW1WnHcs [Accessed 5 Jan. 2018].