The Implications of Vaccine Safety

Introduction

Vaccines may be effective, but many times are not safe. The claim of safety is both scientific and legal, and involves many political and social implications, each with its own ethical considerations. Scientifically, there have been many times when the established claim of vaccine safety has been contested. Legally, the claim of vaccine safety is considered true until it is found to be evidently untrue in a vaccine injury court, which has happened many times. Politically, the US government and companies have empowered themselves to make billions in profits from the enforcement of vaccines, while simultaneously shielding themselves of fiscal liability for any harm caused. To advocate for mandatory vaccination, in light of evidence that adverse reactions to vaccines have been and continue to be reported, is unethical.

My life story represents important scientific evidence that there are problems with vaccine safety. I am one of many people to have suffered a serious adverse reaction to an injection, given to me by the military. In February of 2010 I had moved from BC, Canada to the USA and joined the Washington State Army National Guard. I excelled in training and afterwards, volunteered to deploy overseas. In July of 2011 I was mobilized to a combat zone on a base in Mississippi where, as per Army Regulation 40-562(1), I was told I was being given two injections including the anthrax vaccine.

I was aware at the time that many Gulf War Veterans had problems related to the anthrax vaccine, so I asked to not be given it. The nurse told me I, “have no choice,” and gave the anthrax shot in my left shoulder. I suddenly felt very dizzy. I told her I felt as if I would pass out soon, and she hurriedly prepared and administered a second injection. I lost consciousness.

When I came to, many doctors and assistants were standing around me. My blood pressure became irregular, I puked, and had red dots all over my body. I was taken to a public hospital where my left lung was found to be nearly whited out on a chest X-Ray. A slight amount of swelling was found on the left side of my heart also. That night laying in bed, I felt I may not wake up the next day, because I felt as if my lungs were sandpaper. It hurt and was laborious to breathe. I thought I would die. Each night, the breathing became a bit easier, and by the fourth night that symptom had abated.

When an Ultrasound three days after the event found that the swelling had gone away on my heart, I was returned to duty without further investigation of the incident. This was, in spite of the massive amount of swelling on my left lung. Nobody addressed what happened. I was swept under the rug.

When I returned from overseas, I developed a cough that lasted for several months. My left arm, where I received the shot, has sustained four lasting conditions including torn tendon, stretched ligament, AC joint arthropathy and shoulder socket tendonopathy. For this and two other conditions, I was able to receive compensation from the VA for thirty percent of their disability coverage.

To legally address my grievance by my First Amendment right, I had to legitimize my claim of an adverse reaction by presenting proof of consequences to my health in the form of a chronic, continuing medical condition. I was told by a nurse from a special Gulf War Syndrome (GWS) clinic that my shoulder conditions weren’t likely associated with the vaccine. All the while my main complaint was of my near-death experience. It took so long to get out of the military, and research the way to go about seeking compensation for my experience, that I found myself ineligible for two reasons. The limit for launching a case is three years, and the D.C. court responsible does not compensate for the anthrax vaccine in the first place.

Political organizations and companies reap profits off of vaccines that measure in the millions and billions, respectively. Recent waves of propaganda for and against vaccinations have caused a surge of interest in legislation mandating compulsory vaccinations, in public schools and workplaces of certain states. Vaccines may be generally effective at safeguarding people from disease, but the safety of all human beings should be a priority when making decisions on human health policies.
It is unethical to enforce mandatory vaccines on people for many reasons. It may cause harm to those who are administered inoculations. It makes the efficacy of vaccines, and profit margins for companies, a priority over human safety. Doctors swear an oath to abstain from what is deleterious or mischievous. Politicians and lawyers do not. All three professions have no reputation for being honest. In the pursuit of an ideal, society should not place trust in untrustworthy legal, political, or even medical institutions, while ignoring valid scientific and ethical reason for restraint.

The scientific claim of vaccine safety is established by Pre-Licensure, proprietary studies done by the company that manufactures the vaccine itself, after which the claim is generally regarded as true, making it the null hypothesis(2). Post-licensure studies monitor the human population for injuries, deaths and other adverse reactions to vaccines, in an attempt to find causal mechanisms for any of dozens of conditions. While vaccines may be generally effective, my research will show that there is enough evidence available, to reject the null hypothesis of vaccine safety.

Background

A rise in incidence of adverse reactions throughout the mid-1900s, caused by vaccines, resulted in many lawsuits against the manufacturers of vaccines in the USA. In the 1950s several companies which developed the Salk vaccine were sued.

“All five companies that produced the Salk vaccine in 1955—Eli Lilly, Parke-Davis, Wyeth, Pitman-Moore, and Cutter—had difficulty completely inactivating the Polio virus. Three companies other than Cutter were sued, but the cases settled out of court.”(3).

Two years after my birth, in 1986, US Congress, concerned for the health and safety of children and people in general, decided to enact the National Childhood Vaccine Injury Act to prevent disease while preventing, “against adverse reactions to vaccines.”(4) The Act established a reporting agency called the Vaccine Adverse Event Reporting System (VAERS), to take reports of adverse reactions and form a database. It also established the Vaccine Injury Compensation Program (VICP), an agency to pay money to people who were injured by vaccines.

In 1990 the FDA had granted the US military a waiver to test New Investigational Drugs on soldiers, but the soldiers were to be informed of the dangers and granted consent. A committee was held by the FDA which concluded that waiving informed consent was unethical. The military promptly held another committee and decided otherwise. Though the safety and effectiveness of the anthrax vaccine was treated with skepticism by medical and military organizations, it was used, and the military kept little to no documents, nor did they monitor adverse reactions.(5)

In 1994 John Rockefeller informed Americans of the dangers, of the New Investigational Drugs (NIDs) tested on the Persian Gulf soldiers, which may be the cause of what became known as GWS.(6) Since then the Veteran’s Administration, which runs veteran hospitals around the USA, has taken claims related to Gulf War Syndrome.

In 1996 US Congress passed the PREP Act. The act allows authorities to declare health emergencies, during which a State may enact mandatory vaccination programs. The act also protects companies that respond to those emergencies with legal immunity for any harm caused by their products.(7)

The military has long sought to develop a branch of DoD which creates vaccines and countermeasures, for its own personnel. In 2004, academics at The National Academies of Science Engineering and Medicine urged Congress to allow the military to make their own vaccines and other biodefense countermeasures. The group stipulated that, “If DOD fails to make sufficient progress toward an effective program for developing medical countermeasures within three years, then that responsibility should be partially or completely transferred out of DOD.”(8)

By 2009 a report indicated the Military began making their own medical countermeasures at a facility in Florida. Those vaccines and other drugs were, “to produce medicines the military could not rely on HHS or others to provide,”(14) said James Petro, top aid to the Assistant Secretary of Defense, said.(9)In 2013 Japan withdrew its recommendation for GSK’s HPV vaccine, citing health risks and reports of side effects. Of 3.2 million people vaccinated, 1968 reports of side effects were issued. The Japanese government studied 46 of those cases, and failed to validate a connection between the vaccine, and the pain and numbness reported, causing a need for further studies and an investigation. The head of the investigation sought to offer information which would “make people feel more at ease.”(10)

Despite setbacks, GKS and other vaccine manufacturers have increased in profits over the years, taking in yearly revenues of over 40 billion dollars. GSK, Merk, Sanofi and Pfizer are the top four companies in the market, and they practically control the entire market between the four of them.

Graph 1- List of top 10 vaccine companys’ revenue market share by company(11)

In 2017 the military is still making its own biodefense drugs and vaccines. One they are working on is the malaria vaccine. Capt. Judith Epstein, Clinical Director, Malaria Department, NMRC, reported that, “…creating a vaccine that is 90 to 100 percent effective, Federal Drug Administration (FDA) approved, long lasting, safe and tolerable, that protects against all strains of malaria is a major challenge.”(12)

In September of 2018, National Security Advisor John Bolton explained a new plan by the Trump Administration to create a council that would steer national strategies for biodefense. The agencies that will be members of the council include the DoD, EPA, Homeland Security and Agriculture. Working with global Non-Governmental Organizations such as the Red Cross, the steering council will promote research into countering pandemics as well as responding to outbreaks or attacks.(13)
Just this year (2019) the WHO declared vaccine hesitancy as one of the top ten threats to public health. The WHO’s website completely dodges talk of safety and efficacy, calling vaccines a “cost-effective way(s) of avoiding disease.”(14)

Just this last Wednesday, February the 6th of 2019, The American Medical Association wrote an open letter to the social media companies Facebook, Twitter and Youtube, Amazon and Pinterest. The AMA urged these companies to only allow scientifically valid information to be shared on their platforms. Many companies acted already, including Pinterest, which has banned vaccine related searches. The AMA took a firm position, stating in their letter that, “The overwhelming scientific evidence shows that vaccines are among the most effective and safest interventions to both prevent individual illness and protect public health.”(15)

Arguments/Evidences/Examinations

Claim #1: The legal claim of vaccine injury is denied until it becomes sufficiently evident, because an admission that a vaccine caused an injury necessitates an immediate legal payout of money to the victim(s), which has happened many times since VICP’s creation in 1986.

Evidence #1-1: The vaccine market’s big four companies currently make over 150 billion US Dollars per year, and in the lifetime of the VICP victims of vaccine injury have been paid out ~3.6 billion.(16) Companies shielded from liability for harm caused by their products walk away with trillions of dollars. Victims of harm caused by vaccines get swept under the rug, assumed away by the society that outlives them, but court records tell the tale that might be otherwise forgotten.

Evidence #1-2: Lawyers work to prove their clients were injured by a vaccine. One well-established Vaccine Law firm from Washington DC is Maglio, Christopher and Toale. Their website highlights 611 real injury compensation cases, the conditions and vaccines involved, and the compensation received. Their firm claims to have recovered over 300 million for victims of vaccine injury.(17)

Evidence #1-3: In 2012 a lawsuit launched in 2010 was unsealed for public record. The case was launched by four ex-employees of Merk Pharmaceuticals, the USA’s top grossing vaccine company, who claimed that Merk faked it’s efficacy data for over 20 years to retain a patent. Two of the four employees claimed they were “threatened with jail were they to alert the FDA to the fraud being committed,”(18). The case against Merk has taken years to play out, and until it does, we may not know whether these allegations are going to hold water. Over incidents like these, trust in vaccine safety has not been lost. It has failed to be established in the first place.

Evidence #1-4: In 2012 GlaxoSmithKline, one of the world’s largest maker of vaccines and other pharmaceuticals, pled guilty to charges of fraud regarding its practices of reporting safety data. GSK paid out three billion dollars for unlawfully promoting certain pharmaceutical drugs, failing to report safety data and for their price reporting practices.(19) Despite cuts into their profits GSK’s net worth has increased dramatically.

Examination #1: Companies and the government make much more money selling vaccines and other drugs, than they are forced to pay out to lawsuits over the harm caused. They say that the benefits outweigh the risks and rely on the perception that adverse events are understood and very rare, but monetarily it seems to be a game of assets outweighing the liabilities. The decision to make vaccines mandatory is mainly an economic decision. With Billions of dollars being made by companies and the government, it is a win-win situation for them and a win-lose situation for the rest of us. Due to the complex way in which the system has been set up to regulate adverse events, there is no justice for many victims of vaccine injury.

Claim #2: Science reports and reviews on the safety of vaccines have identified data that represents evidence that vaccines cause harm. Scientists work tediously to disprove the claim of vaccine safety. They search the VAERS database to find reports that seem disproportionate to others. They study adverse reactions after they happen because pre-licensure studies are insufficient to determine vaccine safety.(20)

Evidence #2-1: The authors of one review conducted a systematic review of records, trials, and studies. They identify fever rates of 5-7% of children 6-35 months in various trials, but rates as high as 37.1% in studies of bioCSL vaccines. Fibril convulsions were identified at a rate of 1.1 out of 1000 vaccinated children. One study identified febrile convulsions in 2.59 per 1000 vaccinated children aged 6 to 71 months. The authors admit that further study of adjuvanted vaccines is warranted to investigate safety related to fever and febrile convulsions. (21)

Evidence #2-2: One study surveyed focused on research needed to push the goal of implementing vaccination of pregnant women, in order to reach a goal of reduced infant mortality rates compared to 1990 rates. The studies reviewed identified adverse events including congenital malformations and abnormalities, 10 of which were most frequently reported. Those 10 included miscarriage, preterm birth, stillbirth, fever of mother, pre-eclampsia, site pain, low birth weight, elective abortion, respiratory distress and small-for-gestation age. Authors admit that very few studies are done in middle to low income countries. They admit that their review has limitations, including a lack of hand-searched individual journals or gray literature.(22)

Evidence #2-3: Study overviews the history of the use of Yellow Fever vaccine, adverse events that have been reported, and the ways in which vaccine policy has been altered over time, and ways which the vaccine was changed, to fix for issues that resulted in adverse events. The authors admit that more study is needed, and that causal factors related to various adverse events are not well understood, though some are. They report that efforts are being made to develop a new, safer yellow fever vaccine, and suggest a possible candidate- using inactivated YF 17D virus. All of the authors of this study work for Bio-Manguinhos/Fiocruz, which is a non-profit, government producer of vaccines, including the yellow fever vaccine.(23)

Evidence #4: Many debate whether GWS is caused by environmental exposures, psychological disorder or drugs given by the military. Studies have shown that health issues suffered by Gulf War veterans are exposure related. One in particular attributes the illness to chemical exposures including nerve agents, pesticides and biowarfare countermeasures like pyridostigmine bromide.(24)

Evidence #5: Another concludes that, “(o)ne candidate cause of Gulf War illness is vaccination against infectious diseases including medical countermeasures against biological weapons…which it was suggested was accompanied by a chronic fatigue syndrome-like illness.”(25)

Examination #2: Evidence of adverse reactions is overwhelming. While some reports are quite rare, like one in a million, some reports are one in a thousand, and some symptoms appear at rates of over thirty-five percent. The causal mechanisms associated between vaccines and adverse events are understudied and not well understood. Since it is not known who could be harmed, anyone could be harmed.

Refutations

I reject that the efficacy of a vaccine take priority over its safety. While I concede that vaccines seem to be generally effective, there are many ways which human error can cause harm to human beings. Safety is the most important issue, especially since the aim of a vaccine program is to ensure the safety of human beings. Since many causal mechanisms of adverse events are not understood, and little study is done on reactions to vaccines, mandatory vaccination programs pose a danger to public health.

I reject that the government should have authority to enforce mandatory vaccinations due to the Nuremburg Code. The CDC admits that vaccines are an ongoing human experiment, with safety being declared in pre-trials, and studies being conducted to concurrently monitor adverse events. The Nuremburg Code is a code of ethics related to conducting experiments. It lists many requirements for an ethical experiment, including the informed consent of participants, and taking precautions so as not to cause even remotely possible injury or harm to subjects. The use of vaccines has become an unethical human experiment. People should never be denied their human right to informed consent.

Conclusion

The debate of vaccine safety involves numerous broad implications. Legally, vaccine safety is denied until sufficiently evident. Scientifically, there has been an awareness of adverse reactions to vaccines for over thirty years, resulting in congressional mandates on studies of safety and efficacy. In the years from that point until now, political organizations and companies have ignored danced around the issue of vaccine safety, unethically moving forward for the sake of profits. While many vaccines are often effective, not all are, and a vaccine’s efficacy should morally not take precedence over a vaccine’s safety.

References

1)https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/r40_562.pdf
2) https://www.historyofvaccines.org/index.php/content/articles/history-anti-vaccination-movements
3)https://en.wikipedia.org/wiki/Cutter_Laboratories#The_Cutter_incident
4)https://www.law.cornell.edu/uscode/pdf/uscode42/lii_usc_TI_42_CH_6A_SC_XIX_PA_sq1_SE_300aa-1.pdf
5)https://www.ncbi.nlm.nih.gov/pubmed/12625353
6)http://thinktwice.com/gulfwar.htm
7)https://www.federalregister.gov/documents/2018/08/07/2018-16856/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-zika-virus-vaccines
8)http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=10908
9)https://www.military.com/daily-news/2013/11/27/military-biodefense-vaccine-project-begins.html
10)https://ycharts.com/analysis/story/merck_hpv_vaccine_sales_surge_despite_concerns
11)https://www.biopharma-reporter.com/Article/2016/12/02/GSK-Sanofi-Merck-Pfizer-vaccine-oligopoly-unlikely-to-be-challenged
12)https://globalbiodefense.com/2017/01/10/military-recruiting-human-trials-two-malaria-vaccines/
13)https://dod.defense.gov/News/Article/Article/1637439/new-biodefense-strategy-combats-man-made-natural-threats/
14) https://www.who.int/emergencies/ten-threats-to-global-health-in-2019
15) https://www.businessinsider.com/doctors-warn-google-twitter-facebook-anti-vaxxers-2019-3

16)https://www.sciencemag.org/news/2017/04/vaccines-trial-us-court-separates-fact-fiction
17)https://www.mctlawyers.com/vaccine-injury/cases/
18)http://ahrp.org/former-merck-scientists-sue-merck-alleging-mmr-vaccine-efficacy-fraud/
19)https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report
20)https://onlinelibrary.wiley.com/doi/full/10.1002/pds.3966
21)https://www.eurosurveillance.org/content/10.2807/1560-7917.ES2015.20.24.21159
22) Fulton, T., Narayanan, D., Bonhoeffer, J., Ortiz, J., Lambach, P., Omer, S. (2015). A systematic review of adverse events following immunization during pregnancy and the newborn period. Vaccine, 33(47), pp. 6453-6465. From link, https://www.sciencedirect.com/science/article/pii/S0264410X15011706
23) Martins, R., Leal, M., Homma, A. (2015). Serious adverse events associated with yellow fever vaccine. Human Vaccines & Immunotherapeutics, 11(9). From link, https://www.tandfonline.com/doi/full/10.1080/21645515.2015.1022700?scroll=top&needAccess=true
24)White, R., Steele, L., O’Callaghan, J., Sullivan, K., Binns, J., …Grashow, R. (2016). Recent research on Gulf War illness and other health problems in veterans of the 1991 Gulf War: Effects of toxicant exposures during deployment. Elsevier, Cortex, 74, pp.449-475. DOI: 10.1016/j.cortex.2015.08.022
25)https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1569620/