By MARK BLAXILL and BARBARA LOE FISHER
Editor's Note: Age of Autism is publishing this "white paper" on vaccine safety and children's health at a time when the issue has never been more important -- witness the mandate for flu shots just ordered in New Jersey. It was written in response to a blue-ribbon panel's unsatisfactory review of vaccine safety at the CDC -- a panel on which Blaxill and Fisher both served. In this installment -- titled From Safety Last to a Quest for Zero Vaccine Adverse Events -- they call for a Zero Defects approach to vaccine safety in the face of the thousands of adverse events reported every year, a number they point out is far lower than the actual total.
Members of our organizations (SafeMinds and the National Vaccine Information Center) recall private conversations during which National Immunization Program officials revealed their underlying utilitarian philosophy: parents of vaccine injured children, calling for reform of the vaccination system, were described as "selfish"; adverse events were described as "acceptable losses"; while adverse events resulting in injuries and death were dismissed as either coincidences or the inevitable by-products of the pursuit of the "greater good." Dr. Robert Chen, the man most responsible for setting the tone and direction of NIP safety practices for over a decade, described the end result of a utilitarianism mindset on safety management at NIP in 1999:
"[W]e have been relatively slow in appreciating the importance the public now places on vaccines safety. In fact, much of our resource allocations still unfortunately reflect safety last rather than safety first…Furthermore…we have not been as interested in preventing vaccine-induced illnesses as we are with vaccine-preventable diseases."
The fact that Chen would make this concession in print suggests strongly that not only does this "safety last" mindset exist, but that it is more severe and pervasive than he and others acknowledge. Indeed, it affects all aspects of safety management in the childhood immunization program. A partial list of "safety last" examples would include the following.
• The CDC has long acknowledged the central problem with the Vaccine Adverse Event Reporting Systems (VAERS): that the reporting of vaccine adverse events will necessarily be reduced under a passive reporting system. Estimates of the underreporting vary (a common estimate is that only 5-10% of adverse events are reported), yet there are only limited efforts in place to promote and encourage the reporting of these events as mandated by Congress (under PL 99-5500).
• When observed, adverse events are routinely dismissed by pediatricians as unrelated to vaccination, with the tacit support and encouragement of NIP officials. Adverse event reports are frequently met with the assertion that the timing of onset of seizure disorders, sudden infant death syndrome, hospitalizations and other vaccine injuries are only coincidentally related to vaccination.
• When faced with adverse event claims, families of vaccine injured children in the Vaccine Injury Compensation Program (VICP) often find themselves the target of active suppression of those claims, as even straightforward events are routinely opposed in an adversarial process. Expert witnesses for the CDC called to testify in VICP award proceedings routinely deny the very existence of vaccine adverse events.
• More broadly, the Vaccine Injury Compensation Program, originally conceived as a means for rapid compensation for families suffering from vaccine injury, has approached the management of compensation with a stubborn reluctance to grant awards. The result of this reluctance is that only a fraction of the hundreds of millions of dollars set aside in the vaccine injury trust fund has ever been paid out.
• In the meantime, vaccine manufacturers have received widespread protection from product liability claims, an exemption that substantially reduces the normal marketplace incentives on manufacturers to ensure the safety of their products.
• This unusual liability exemption stands in stark contrast to disturbing examples of longstanding product contamination, including the recent discoveries of connections between contaminated polio vaccines and highly carcinogenic simian virus (SV40) detected in many human cancers.
• More complex safety concerns have faced even greater neglect, as safety testing of the new expanded-program strategies, e.g., comparing exposed populations to zero exposure populations, has never been attempted.
• When high profile safety investigations have taken place, these investigations have been carried out by interested parties. In the case of three thimerosal studies in Denmark, for example, the primary authors for all of them were directly employed by a vaccine manufacturer (or its affiliates) that held direct profit interests in the products involved
These problems have all been compounded as the safety management agenda has shifted from evaluating narrowly defined events, such as a seizure response to a dose of whole cell pertussis in DPT vaccines, to assessing adverse effects rooted in cumulative exposures to vaccine elements ( e.g., thimerosal exposure from three separate childhood vaccines in combination with prenatal mercury exposures from maternal dental amalgams or seafood ingestion) or the interactive effects of multiple antigen vaccines and/or multiple vaccines given in close succession. Co-factors, which could also play a role in vaccine adverse events suffered by an individual, such as coinciding viral or bacterial infection at the time of vaccination; simultaneous exposure to environmental toxins, such as pesticides or toxic mold; or predisposing genetic factors due to biodiversity in an ethnically diverse population, are never factored in. Vaccine safety administrators are ill prepared even to acknowledge the possibility of such effects, let alone evaluate them.
One consequence of combining mandatory vaccination policies with exempting manufacturers from product liability has been the absence of free market competitive pressures to raise quality performance. As the quality revolution in management swept through the business world in the latter part of the 20th century, most competitive industries have embraced quality disciplines that have not yet penetrated the NIP. One of the leading quality management experts, Philip Crosby, in his influential book, Quality is Free (1980), succinctly described one of the core lessons of quality management.
"The first step is to examine and adopt the attitude of defect prevention. This attitude is called symbolically, Zero Defects. Zero Defects is…a standard that management can convey to employees to help them decide to do the job right the first time…Most people talk about an AQL, an acceptable quality level. An AQL really means a commitment before the job to produce imperfect material…Consider the AQL you would accept on the products you buy. Would you accept in advance an automobile that you knew in advance was 15% defective?…How about the nurses that care for newborn babies? Would an AQL of 3% on mishandling be too rigid?…The only proper performance standard is Zero Defects. Why settle for less? People accept the performance standards you give them."
The pursuit of zero defects in vaccine safety would demand a performance standard of zero adverse reactions. Such a goal need not be immediately attainable, but the relentless focus on continuous improvement toward that goal would mean that no disabling injuries or deaths would be viewed as acceptable. Instead, every adverse reaction would be managed as an opportunity for analysis of the root causes of vaccine failures. Instead of encouraging reclassification of adverse events as coincidental events, severe reactions would be treated with respect, compassion and curiosity. And instead of fighting injured families as greedy opportunists, compensation programs would be restored to their original role, as an occasion to provide justice and deserved financial support. But as Philip Crosby describes it, embracing Zero Defects (Zero Adverse Reactions in this context) requires adopting a new attitude, one that several panel participants noted would require sweeping cultural changes in all aspects of vaccine safety management. Culture change can only come from the top. This brings us to the conditions and context for leadership on vaccine programs and safety, in other words, vaccine governance.
Next: Part 7
Mark Blaxill is Editor at Large for Age of Autism. Barbara Loe Fisher is co-founder of the National Vaccine Information Center.