Vaccine safety is a controversial topic, almost as controversial as politics or religion. In polite company, it is best not to bring up the subject, lest an all-out shouting match ensue. On the one side, we have the pro-vaccine camp, who believes wholeheartedly that every vaccine is necessary and safe – ‘why else would they be on the market?’ is a common refrain. On the other, the anti-vaccine crowd, who for various reasons, are against vaccines. Some among the anti-vaxers are fundamentally against all vaccines as a matter of religious or libertarian principle. In their eyes, vaccination represents the worst of big government subjugation. It is an attack on their very freedom. Others in the anti-vax crowd come to their views experientially, through injury or tragedy. Somewhere in the middle, the rest of us, parents, scientists, doctors and health advocates who are neither for nor against vaccines in principle, but who just want our kids to be safe and healthy.
Beyond For or Against
Much like the polarization of politics, the polarization of the vaccine safety and efficacy, all but nullifies reasoned concerns. One is either for or against vaccines. There is no grey area. This is fantastic for vaccine manufacturers because every concern, every injury can be written off by simply de-legitimizing the claimant – placing them in the nutty anti-vax camp, while correspondingly and overwhelming flooding the media with pro-vaccine marketing. Money does indeed buy power and power protects profits. With virtually all vaccines licensed manufactured by just five companies and revenues exceeding $25 billion annually and growing, the money and power are highly concentrated.
Stepping back though, away from the money and marketing, why anyone with a brain would believe that any vaccine or medication was universally safe and effective defies logic, not to mention the inherent variability of human physiology. To be entirely and ardently pro-vaccine as many are, one has to choose to ignore that basic fact – that for some people, some vaccines and medications either will not work or worse, will cause great injury. To ignore that fact, especially when there are no direct financial incentives to do so, one has to invalidate the tragedies that are in front of them; to convince oneself that the injured person before them is either lying to gain attention or simply is not credible and therefore not to be taken seriously. Either way, the net result of de-legitimizing injury, is to shutter the possibility of additional research, research that might find a connection. It’s quite a deft bit of cognitive dissonance, more so as the evidence of injury mounts.
De-legitimizing a claim of vaccine injury is easy; attack the person, not the claim, label the mom (because it is almost always moms making these claims) as irrational (hysterical), ignorant, and best of all, as anti-science; as if science is infallible and all-knowing rather than dynamic and changing. Ironically, bolstering the certitude of science, especially that which comes from organizations whose fiduciary or political obligations demand results remain in their favor, does more to reduce the credibility of the scientific endeavor and the public trust than simply admitting that sometimes the science is wrong or not nearly as clear as we once had believed. Polarization is more than just annoying and inconvenient. It is dangerous.
Skewed Development and Evaluation Process
As with the drug industry, especially after the recent Supreme Court decisions, the entire infrastructure of the vaccine industry is skewed in favor of finding vaccines safe and effective. There is very little space or motivation to find a vaccine dangerous. According to a recent report on Conflicts of Interest in Vaccine Safety Research:
- Industry pays for the research from bench through clinicals.
- Industry pays fees to submit to FDA, which in turn fund the operations of the FDA –the agency tasked with reviewing the drug applications.
- Industry funds the medical societies, medical journals, sponsors conferences and medical education. Negative research risks billions in funding for these organizations.
- Expert and advisory panels that review safety claims are often linked to industry, paid by industry. What few conflict of interest guidelines existed were lifted by Congress in 2012.
- Post approval surveillance is paid for by industry; studies are designed, reviewed and approved by industry sponsors, an example.
- The data for all phases of research, from clinical trials through post approval surveillance are closed and unavailable for review by any agency, including the FDA and CDC. (There is push to open these up for all. See: YODA, European Medicines Agency, PLOS, and BMJ).
- Only positive studies are submitted to FDA for approval. (Could have 99 negative, but only the one positive is used, here, here).
- Only positive studies are published. (Both by inherent publication bias and for fear of losing industry funds).
- A fair number of articles, published in medical journals, signed by experts are ghostwritten by industry, no more than mere marketing documents.
- Once a vaccine is approved, the government via the CDC mandate and promotes vaccines and vaccination programs. A large part of the CDC mission is to promote vaccines.
- Vaccine injury claims are registered with CDC and FDA sponsored organizations, VAERS and the National Vaccine Injury Compensation Program
- Per the National Childhood Vaccine Injury Act of 1986, the government must pay vaccine injury claims through a .75 cent excise tax on the vaccines themselves.
- Review of injury is done by the same agencies that approved and then promoted and mandated the vaccine.
- Those same experts, supported by industry, that approved the vaccine, review the claims.
- Findings of injury would open liability for remuneration from the same agencies that approved, promoted and mandated the vaccine – not to mention the loss of credibility.
- Should a claim make it through these hurdles, legal recourse for injury is limited by favorable precedent.
- Once service in government agencies is complete, it is often rewarded with lucrative roles within the same companies the agencies are responsible for regulating – within a year of leaving the government.
- Industry spends billions annually on lobbyists, to keep these favorable regulations – 3 lobbyist per congressperson.
Fixing the Vaccine System – The Long Game
There is no easy or quick fix. The systems and barriers to vaccine, and indeed, drug safety are deeply entrenched in organizational and legal frameworks. The pendulum has swung so far away from consumer safety in favor of corporate protections that efforts to fix these problems must be viewed in terms of a long game; one that recognizes institutional and policy change has to take place over the next 10-20 years. The first step, however, is to recognize there is a problem and that vaccine injuries are likely within a system where there is little transparency and even less accountability for injuries.
The second and more difficult phase includes the major policy and infrastructure changes.
Those are a mess. Many are discussed in the piece Conflicts of Interest in Vaccine Safety Research. Many more need to be added. I will be writing a piece on this topic over the coming weeks. If you would like to contribute your thoughts on removing conflicts of interest from the vaccine safety and indeed, the entire drug development and review process, send me a note. In the mean time, we’re doing our part to understand Gardasil and Cervarix, vaccine safety and injury.
Help Find the Answers – Participate in Research
Hormones MatterTM is conducting research on the side-effects and adverse events associated with the HPV vaccines Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.