The Political Economy of the Regulation of Vaccines

Chapter 9 pages 263-272  The political economy of the regulation of vaccines  By Toby Rogers

Link to book found here: https://ses.library.usyd.edu.au/bitstream/handle/2123/20198/Rogers_T_thesis.pdf?sequence=2&isAllowed=y 

Introduction to the vaccines and autism debate.  One of the things that makes vaccines different from every other possible environmental trigger described thus far is the presence of thousands of parents who claim that they personally witnessed autistic regression — their child was healthy, the child was vaccinated pursuant to the U.S. schedule at a ‘well baby’ visit, and within hours, minutes, days, or weeks the child lost speech, motor coordination, eye contact, and/or developed a host of other symptoms associated with autism. With the other toxicants on the list, the possible damage is invisible — cells and systems are harmed during critical developmental periods in utero or slowly over time and this damage is only flagged later when the child misses key developmental milestones. With vaccines there are parents who say that they witnessed with their own eyes what happened to their previously healthy child. Recent scholarship suggests that autistic regression may be the rule rather than the exception (Ozonoff et al., 2018). 

The debate over vaccines is the most contentious facet of the autism debate and it is one of the most polarised debates in American society today. As a result, I devote more pages to the research in connection with vaccines than any other facet of the autism debate. The vaccines and autism debate is also one of the strangest debates I have ever seen in political economy so I want to foreground the discussion in this chapter by highlighting some of the internal contradictions and paradoxes that swirl around this topic: 

 1. All parties to the debate acknowledge that the current vaccine schedule could not exist in the absence of liability protection. Vaccines, according to their producers, cannot compete in the normal capitalist marketplace because class action lawsuits from those injured by their products would drive them out of business. Many state governments then require citizens to have this product injected into their bodies as a condition of entry to school, day care, and some jobs. So there is a paradox at the heart of this debate which is that this product is required in the name of public safety, even while its producers acknowledge that the product does not meet the usual product liability norms of the capitalist marketplace. 

 2. We know that vaccines cause injury sometimes — there is an entire separate branch of the U.S. Court of Federal Claims to compensate those injured by vaccines and the U.S. Supreme Court, in Bruesewitz v. Wyeth (2011), ruled that vaccines are ‘unavoidably unsafe’. So the question is not do vaccines sometimes cause harm but rather, what is the rate of harm? However, the official government position is that to measure the likely rate of harm, via a comparison with an unvaccinated control group, would be unethical (see #5 below). 

 3. We know that the Vaccine Adverse Event Reporting System (VAERS), because it is voluntary, undercounts the actual number of vaccine injuries. The former FDA commissioner David Kessler (1993) stated that adverse events in connection with pharmaceutical products are underreported by a factor of 100. So the question is not whether VAERS undercounts, but the degree of undercounting.  

 4. Many of the ingredients in vaccines — in particular ethylmercury and aluminium — are known neurotoxins (Grandjean & Landrigan, 2014). Defenders of the current paradigm argue that ‘the dose makes the poison’ (see Offit & Jew, 2003), but that idea has been challenged in recent years as toxicologists have discovered non-linear dose response curves and concluded that some substances, such as lead, have no safe dose (Grandjean & Landrigan, 2014, p. 331). The debate is not over whether ethylmercury and aluminium are neurotoxins, the debate is over their dose response curves which are not well understood. 

 5. All parties to the debate admit that there are no studies with an unvaccinated control group that show that the national vaccine schedule is safe. Defenders of the status quo admit this as a point of pride, arguing that a proper double blind RCT would be unethical because they already know (based on experience) that vaccines are safe. But at the same time they argue that RCTs are the gold standard and should guide all other decisions in medicine. It creates an unusual spectacle whereby autism advocacy groups are demanding double blind RCTs while mainstream figures in science and medicine are violating their own preferred epistemology by blocking the sorts of studies that could resolve this debate. 

 6. Even though the facts mentioned here are not in dispute, if one publicly points out these troubling contradictions and paradoxes in connection with the national vaccine program, one is risking one’s career and one will likely be ostracised by colleagues, friends, and family and labelled crazy and a conspiracy theorist (see: Martin, 2018). If one responds to the uncertainty created by undone science by refusing to vaccinate one’s children, most states then mandate that they cannot go to publicly funded day care or school. Even more troubling, doctors ‘may report the parent to Child Protective 266 Services’ for ‘medical negligence’ if the parent refuses to vaccinate his/her child (Rosenberg, 2012, p. 242). 

 The debate regarding vaccines and autism is fraught. Yet, this is a conversation one must have if one is to understand the political economy of autism. This chapter has two main sections — the regulatory history of vaccines in the U.S. (9.1.0) and the scientific debate about vaccines and autism (9.2.0). Each section has numerous subsections that I will introduce at the start of each section. In this chapter I will attempt to show that capitalism shapes every aspect of the national vaccine schedule. Policies, procedures, bureaucratic infrastructure, and regulatory decisions are focused narrowly on the product and getting the product approved and into the marketplace without ever assessing the health of the whole system. 

 9.1.0 Introduction to the political economy of vaccines In this section I will provide an overview of the size of the vaccine market (9.1.1); document the growth in the U.S. vaccine schedule (9.1.2); review the vaccine approval process (9.1.3); argue that clinical trials as part of the FDA licensure process are too short, too small, and use toxic placebos (9.1.4); discuss COI at the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), the CDC’s Advisory Committee on Immunization Practices (ACIP), and the National Vaccine Advisory Committee (NVAC) (9.1.5); show that post-market surveillance of vaccine adverse events is inadequate (9.1.6); document the revolving door between CDC and vaccine makers (9.1.7); discuss the lobbying at the state level to make vaccines compulsory 267 (9.1.8); and show COI in science and medical journals associated with vaccines (9.1.9). 

 9.1.1 The size of the vaccine market Vaccine manufacturers reported $28.3 billion in global sales in 2015 (Transparency Market Research, 2016). The vaccine market is characterised by oligopoly as just four firms — GSK, Merck, Pfizer, and Sanofi — generated 86% of total global vaccine revenue in 2015 (EvaluatePharma, 2016). Several market research companies project robust growth in vaccine sales over the coming years: Markets to Markets projects the global vaccine market to reach $48 billion by 2021; Zion Market Research projects the vaccine market to reach $59.2 billion by 2020; and Mordor Intelligence projects a global vaccine market of $55 billion by 2021 (La Vigne, 2016). Just over one-third of global sales are projected to come from North America by 2024 ($28 billion out of $72.5 billion in vaccine sales in 2024) (Transparency Market Research, 2016). 

 Paediatric vaccines currently account for 57.5% of the vaccine market but adult vaccines sales are expected to outpace paediatric vaccines sales in the coming years (Transparency Market Research, 2016). Johnson (2009) writing in the Wall Street Journal observes that the 1986 NCVIA and the Vaccine Injury Compensation Program ‘is an important reason why the vaccine business has been transformed from a risky, low-profit venture in the 1970s to one of the pharmaceutical industry’s most attractive product lines today’ (para. 2). More recently, ‘Old vaccines have been reformulated with higher costs. New ones have entered the market at once-unthinkable prices. Together, since 1986, they have pushed 268 up the average cost to fully vaccinate a child with private insurance to the age of 18 to $2,192 from $100, according to data from the Centers for Disease Control and Prevention’ (Rosenthal, 2014, para. 4). ‘The federal government... buys half of all vaccines’ administered to children, and even with bulk discounts, its costs have increased 15-fold since 1986 (Rosenthal, 2014, para. 5). 

Just as there are billion dollar drugs, there are now billion dollar vaccines. So for example, Prevnar ‘is priced at $136 [per shot], and most states require children to get four doses before entering day care or school’ (Rosenthal, 2014, para. 6). ‘Pfizer, the sole manufacturer, had revenues of nearly $4 billion from its Prevnar vaccine line last year, about double what it made from high-profit drugs like Lipitor and Viagra, which now face generic competitors’ (Rosenthal, 2014, para. 6). With liability protection, a guaranteed market of 4 million new children born into the U.S. each year, and guarantors in the form of the federal government footing half of the bill and insurance companies also picking up a large share, vaccines are a product unlike any other in the marketplace. The profits that one can earn from this unique product are largely dependent upon a pharmaceutical company’s ability to get additional vaccines added to the schedule. Yet as an indicator of just how vast the pharmaceutical industry is at this point, ‘even though the dollar figure is large and growing, vaccines still only account for 3 percent of the market share within the global pharmaceutical industry’ (La Vigne, 2016). 

 9.1.2 The growth in the U.S. vaccine schedule In 1983, the official U.S. vaccine schedule could be explained in half a page and consisted of the following vaccines: DTP (diphtheria, tetanus, and pertussis) (2 months), OPV (oral polio vaccine) (2 months), DTP (4 months), OPV (4 months), DTP (6 269 months), MMR (measles, mumps, and rubella) (15 months), DTP (18 months), OPV (18 months), DTP (4 years), OPV (4 years), and Td (tetanus and diphtheria without pertussis) (15 years) (CDC, 1983). So, counting each component of the conjugate vaccines separately, the schedule contained 24 doses total consisting of 7 injected vaccines and 4 oral vaccines. In 1985 the autism rate in the U.S. was calculated at 1 in 2,500 (Autism Speaks, 2010). The current vaccine schedule (CDC, 2017) takes eight pages to explain and consists of the following:

Centers for Disease Control and Prevention Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, United States (2017)

 Influenza (pregnancy) 

 Tdap (pregnancy)

 DTaP (18 months) 

 Influenza (18 months) 

 Hep B (birth) 

 Hep B (2 months) 

 Hep A (18 months) 

 Influenza (30 months) 

 rotavirus (2 months) 

 DTaP (2 months) 

 Influenza (42 months) 

 DTaP (4 years) 

 Hib (2 months) 

 PCV (2 months) 

 IPV (4 years) 

 MMR (4 years) 

 IPV (2 months) 

 rotavirus (4 months) 

 Varicella (4 years) 

 Influenza (5 years) 

 DTaP (4 months) 

 Hib (4 months) 

 Influenza (5 years) 

 Influenza (6 years) 

 PCV (4 months) 

 IPV (4 months) 

 Influenza (7 years) 

 Influenza (8 years) 

 Hep B (6 months) 

 rotavirus (6 months) 

 Influenza (9 years) 

 HPV (11 years) 

 DTaP (6 months) 

 Hib (6 months) 

 Tdap (12 years) 

 Influenza (12 years) 

 PCV (6 months) 

 IPV (6 months) 

 Meningococcal (12 years) 

 Influenza (13 years) 

 Influenza (6 months) 

 Influenza (7 months) 

 Influenza (14 years), 

 Influenza (15 years) 

 Hib (12 months) 

PCV (12 months) 

 Influenza (16 years) 

 Meningococcal (16 years) 

MMR (12 months) 

 Varicella (12 months) 

 Influenza (17 years) 

 Influenza (18 years) 

Hep A ( 12 months) 

 DTaP (diphtheria, tetanus, and acellular pertussis); 

Hib (haemophilus influenzae type b); 

HPV (human papillomavirus); 

IPV (inactivated poliovirus); 

MMR (measles, mumps, rubella); 

PCV (pneumococcal conjugate vaccine); 

Tdap (tetanus, diphtheria, and acellular pertussis) — which is different than DTaP. 

As one can see the schedule is heavily front-loaded into the first two years of life with as many as seven injections at the six month paediatric ‘well baby’ visit. In total, counting each component of the conjugate vaccines separately, the current schedule has 74 doses of 53 injected vaccines and three oral vaccines. Presently the autism rate is estimated at 1 in 36 (Zablotsky et al., 2017). This simply shows temporal association, but the association is troubling and that is one of the cases to answer here.  

9.1.3 The vaccine approval process in the U.S. 

 Vaccine development goes through four clinical stages (Pickering & Orenstein, 2002). ‘Phase 1 trials in humans include the smallest number of volunteers and are primarily designed to identify problems of acute safety’ (Pickering & Orenstein, 2002, p. 148). As I will show below (9.1.4) there are concerns that this phase may be too short and too small to detect iatrogenic events such as autism. Phase 2 looks at ‘dose range and immunogenicity’ and involves 100–1,000 human participants (Pickering & Orenstein, 2002, p. 148). Phase 3 looks at ‘vaccine efficacy’ and involves 500 to 20,000 participants (Pickering & Orenstein, 2002, p. 148). Phase 4 trials happen after the vaccine is already on the market and may involve 10,000 to 100,000 participants; postmarketing surveillance ostensibly includes millions of participations (Pickering & Orenstein, 2002, p. 148).   

The vaccine approval process in the U.S. is unusual because no less than 4 committees of political appointees sit above the FDA licensure process. The charter for each of these committees is focused first and foremost on the product, vaccines, rather than on health or wellness per se. The federal government uses a stakeholder model of decision 272 making where all of the relevant parties, including the vaccine maker, are usually at the table. The stakeholder model stands in contrast to Mertonian norms of science that emphasise disinterestedness and organised scepticism as well as the literature on the funding effect that shows that COI change research outcomes.

 The Vaccines and Related Biological Products Advisory Committee (VRBPAC) consists of 15 members appointed by the FDA commissioner (FDA, 2017b). The charter states that the VRBPAC ‘advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective vaccines and related biological products for human use...’ (FDA, 2017b). In 2017, Leonard Friedland, Vice President of GlaxoSmithKline (GSK) and David Greenberg, Associate Vice President of Sanofi Pasteur both sat on the VRBPAC (FDA, 2017a). The VRBPAC often offers their recommendations regarding a new vaccine before FDA staff have made a determination whether the vaccine is safe and effective (Pickering & Orenstein, 2002, p. 149). Putting the political (stakeholder) process ahead of the scientific review process raises troubling questions about the objectivity of the FDA. 

Go to document on line here: https://ses.library.usyd.edu.au/bitstream/handle/2123/20198/Rogers_T_thesis.pdf?sequence=2&isAllowed=y