Compensation Plan Rebuffed

A Feb 15, 2011 Canadian Medical Association (CMAJ) news article informs us that “Canada and Russia are the only G8 nations without national no-fault compensation programs for people injured from vaccines, and according to Canadian vaccine experts, it is high time Canada made its exit from that short but inglorious list.” CMAJ refers to a new report from U of Toronto’s Munk School of Global Affairs, ‘Designing a No-Fault Vaccine-Injury Compensation Programme for Canada: Lessons Learned from an International Analysis of Programmes’, by Jennifer Keelan, PhD of Dalla Lana School of Public Health, U of Toronto and Kumanan Wilson, MSc, FRCP(C), Ottawa Hospital Research Institute, U of Ottawa.

It’s not a coincidence that this report has been published just one month after the British Medical Journal lost credibility by publishing a malevolent tale (see ‘In Defense of Dr Wakefield’ at which supposedly gave credence to the crowing that “MMR vaccine doesn’t cause autism; vaccines don’t cause autism.” We’d like to think there’s a slim possibility this report may signal a genuine interest in negotiating a long-overdue plan but regret that its proposal is based on questionable assumptions. One of these is that “Universal immunization is a public good” and that, “When vaccination rates hit a particular threshold and are sustained, the transmission of the pathogen from person to person is disrupted and the incidence of the disease falls accordingly.” This, of course, describes ‘herd immunity’, a term which originated not in association with vaccination but with infectious disease.

It’s precisely the desire to emulate the elusive benefits of natural herd immunity which drives the frenetic adulation and promotion of vaccinations. As Keelan and Wilson admit, “The importance of herd immunity has influenced vaccination policy. Vaccinations are not strictly compulsory under federal or provincial laws…yet research suggests that current policies to promote vaccination can be viewed as coercive (compelled by force, intimidation, or authority). Increasingly, vaccination is a requirement for participation in public programmes (day-care, camps) and for employment.” The authors also note that, “While exemptions can be obtained for medical, philosophical or religious reasons, the availability of this option is not well publicized.” Obviously, this coercion makes it especially unethical to ignore the plight of the vaccine-injured.

The other highly questionable assumption of Keelan and Wilson is that vaccines are “amongst the safest pharmaceutical therapies available.” and that serious vaccine injuries are “rare” (“rare” being no more than 1 per 40,000 doses). This blind-eyed statement reflects a discrepancy between what they call “good scientific evidence” and “popular biological theories of harm”. But whereas the “biological theories” have not been definitively proven, the “scientific evidence” has often been influenced by conflicts of interest. Even though vaccines have been widely used for several decades and exponentially increased in the last two, we still don’t know the extent of vaccine risk.

In order to assess this, as a first step, all possible vaccine adverse events must be reported, recorded and the raw data from the records made easily available to the public. By doing this, subsequent vetting of the records by those with vested interests in maintaining high vaccination rates will be open to analysis. A second, equally important step in discovering the extent of vaccine risk is to conduct research into the long term results of vaccination. Vaccine adverse events can arise months or years after injection. And rather than a search for specific afflictions, in order to avoid possible inaccuracies due to confounding factors, comparisons of the overall health of the vaccinated with that of the totally unvaccinated must be made.

Reading the Keelan/Wilson report, one gets the impression that the main reason it’s been written is to assist in a process which could help bolster vaccine uptake. The authors note three types of “key issues arising from international experiences with no-fault programmes”. First they relate the concern that compensation eligibility which is too restrictive “can drive claimants back into the tort system (civil litigation). This, in turn, increases the profile of vaccine injuries and the potential for public controversy over vaccine safety.” Second, they relate the concern about compensation eligibility which is too generous “leading to overcompensation of claims which in turn can undermine the public’s perception of safety of vaccines.” Third, there are “Concerns that the eligibility requirements or administrative processes are onerous or too complex creating unnecessary barriers to access compensation.” It’s surprising the authors don’t remark that this third concern could have the same effect as the first.

Keelan and Wilson state: “While the ethical case to implement such a programme is clear, there are several other policy priorities related to immunization that have both a national scale and significance. Consultation with experts suggests that bolstering and increasing the capacity and funding for the National Immunization Strategy including the creation of a vaccine registry, implementing a national barcode system, ensuring continued access to new vaccines, and other issues related to barriers to licensing of novel vaccine technologies, especially new adjuvants, would all trump the formation of a coherent national policy to redress vaccine injuries. However, many experts see a no-fault compensation programme as a necessary feature of a comprehensive national vaccine safety strategy (Health Canada, 2001).”

The report compares compensation schemes in USA, the UK, New Zealand and the province of Quebec. Criteria for determining compensation and assessment of cases varies somewhat among these jurisdictions. USA’s program was initiated in 1988 at which time it based compensation on a table of known injuries, their case definitions and time from vaccination within which a committee of “experts” had decided a causal relationship was likely. As well, cases where injuries may have been due to vaccines but the injuries weren’t included in the table were allowed reviews to determine whether or not compensation was due. But later, as the table of injuries was made more restrictive and the review process resulted in fewer successful claims, proof of causation was subsequently made easier by “moving away from both scientific understandings of probable causation and traditional tort based standards of causation…An assessment of these changes was captured by Gary Golkiewicz, then Chief special Master of the programme, who argued that ‘…we now operate under a table that is very stringent and a causation and fact standard that is far more lenient (Golkiewicz 2008).’” To illustrate this, the percentage of successful claims (excluding autism cases) before 1998 was approximately 50% and after 1998 rose to approximately 74% in 2009 (Golkiewicz 2009).” (No doubt Keelan and Wilson’s “scientific understandings of probable causation” are that autism cases are much too far disassociated from vaccines to be included in this comparison.)

The UK’s compensation program is the most restrictive of all four, only allowing cases where vaccines are considered likely to have been solely responsible for 60% or more of a disability. New Zealand’s program, initiated in 2005, is the most lenient although its time limitation for filing a claim is the shortest: only one year compared to two to three years for USA and Quebec, six years for the UK. New Zealand’s program is a very small part of a much larger compensation program which covers all types of personal accidental injury. Unlike the other three jurisdictions, it receives claims for all types of vaccine injury, whether serious or not. Consequently, it awards many claimants and usually the payouts are relatively small. Another of its unique features is that it will reimburse for fees of private health providers even if the treatment provided would have been covered under the public system. In Quebec, only 109 cases have been evaluated (with only 27 successful) in the twenty three years it’s been operating. According to the authors, one of the reasons for this is that unlike New Zealanders, “Few Quebeckers are likely aware of the programme”. This, they imply, is not altogether a bad thing since, “thus, it is unlikely that the programme has had any direct impact, either positive or negative, on attitudes toward immunization or compliance to recommended immunizations.” Since the inceptions of their programs, the average number of awards per year per million population for Quebec, the UK, USA and New Zealand (in that order) have been: 0.2, 0.05, 0.3 and 11.

One of the core objectives of the USA system is to limit civil litigation against vaccine manufacturers. And although “Claimants settlements and awards are paid out of a trust fund which is funded by a special vaccine excise tax of seventy-five cents on every antigen.”, no doubt that amount is added onto the price US taxpayers pay for their vaccines. In New Zealand’s system, civil litigation is illegal; the UK and Quebec place no restrictions on it.

Mulling over the options for a Canadian national compensation plan, Keelan and Wilson suggest, “a list of disallowances could be developed to process popular claims where there is a substantial body of evidence to dispute a causal association between vaccines and specific injuries, as in the recent purported vaccine-related autism cases.” (Of course, the “substantial body of evidence” would come from liberally-funded government endorsed research and/or research conducted by vaccine manufacturers, not the meagerly-funded independent research that’s likely to show a possible causal link between vaccines and injury.)

The authors continue, “The establishment of a no-fault compensation programme will require expertise from, and collaboration with, existing national and scientific advisory committees and professional organizations representing both the medical profession and disabled citizens.” All of these entities, including “professional organizations representing…disabled citizens” would most likely have security of vaccination regimes as their prioriy. In fact, all four jurisdictions previously discussed use an assessment/adjudication process weighted in favour of disallowing claims.

Keelan and Wilson’s report ends with a conclusion that:

  • “Canada should implement a national no-fault compensation programme for vaccine-related injuries.”
  • “The programme’s chief objective should be to compensate those who have likely been injured by immunization.”
  • “A reasonable statute of limitations for filing claims of up to 3 years after immunization or onset of symptoms would be implemented…”
  • “…however a process of appeal would be reserved for extraordinary circumstances.”
  • “An ideal programme would have at its core a Table of Injuries designed to address the majority of claims filed. The Table injuries should be based on the most up-to-date scientific research and should provide compensation in cases where evidence supports that it was at least scientifically and clinically possible that the injury was caused by immunization and there are no other more probable causes for the injury presented in the medical records.”
  • “Petitioners should also have recourse to an individual hearing or case review overseen by a special master.”
  • “Compensation should be provided based on the principle that all uninsured expenses resulting from the injury would be included in a settlement. A lump sum should be paid in the event of the death of the injured party.”
  • “The Programme Director should…be tasked with overseeing a communication strategy for the programme and coordinating activities of the National Immunization Strategy, and the F/T/P scientific advisory committees and vaccine safety research agencies.”
  • “A standing expert advisory committee to oversee the table of injuries. The core committee membership should include experts in vaccinology, immunology, neurology, pediatrics, public health ethics, health law, and public health policy.”

These points would seem reasonably fair to anyone not having read the preamble of the report or knowing that conflict of interest is a frequent problem where health professionals, health institutions and governments are involved. The lack of input from members of the vaccine injured into either the design of the plan or its subsequent administration would be an abomination. It could reduce its effectiveness to a result that was merely cosmetic but just enough to maintain adherence to vaccination schedules.

In strong contrast to the recommendations of Keelan and Wilson, a report on vaccine injury compensation published in 2000 by the Manitoba Law Reform Commission (MLRC) argued for a (provincial) plan which was more likely to provide justice to the vaccine injured. One of its thirteen recommendations was that the plan should be “modeled insofar as is appropriate on the manner in which no-fault compensation claims are handled under The Victims’ Rights Act. The Act incorporates a three stage adjudication process, allowing for appeals to decisions made by a Director (who, for vaccine injury, could be “an employee of Manitoba Health with appropriate medical expertise”); if, on appeal, the Director still rejects a claim, a further appeal can be directed to the Compensation Appeal Board (which, for vaccine injury, would be “an independent administrative tribunal known as the Childhood Vaccination Injury Compensation Appeal Board.”) A most important part of this recommendation is that “The membership of the Board would include persons with expertise in immunology, lawyers and lay persons.”

A second recommendation from the MLRC concerned the amount of time allowed for a claim to be made. The Commission noted that, “There may be a great deal of medical and scientific debate as to whether a disability is a vaccine injury and care must be taken not to rule out latent damage which may become apparent some considerable time after the vaccination. …Time may run from the date of the vaccination, the onset of symptoms or the date of diagnosis of an injury or illness. The most generous rule (which, they say, “is warranted by possible medical uncertainty as to the cause of the death or injury.”) is the date of diagnosis.” Except for retroactive claims, the MLRC recommended a time limitation “within six years of death or the diagnosis of the injury or illness complained of.” Regarding retroactive claims, they stated: “Fairness and justice suggest that all persons in the province who suffered vaccine-related injuries in childhood should be compensated. …On the other hand, the older the claim the more difficult it is to process. Records may be lost and witnesses unavailable. Furthermore, unlimited access to the fund for historic claims may pose too great a burden for government to contemplate.” They recommended that retroactive claims be “brought within six years of the coming into force of the [vaccine injury compensation] Act.”

Reasoning that, “The continuing threat of tort liability may contribute to some degree to the quality of the product and the quality of the services of those administering it.”, the MLRC recommended that tort rights be maintained. They stated, “If a tort action is successful, the moneys received should be applied first to the plaintiff’s cost of the litigation, then to reimburse the no-fault fund in respect of benefits that have been paid to the successful plaintiff and then to the advantage of the plaintiff. …Where a claimant refuses to press a tort claim, an action may be commenced by and in the name of the Director.”

Finally, the MLRC distinguished itself as a body truly concerned with ethics by recommending, “That all persons involved in the system of childhood immunization provide to parents full and accurate information of the risks and benefits of each vaccine and the risks of the disease it is intended to prevent.” and, “That Manitoba Health and the professional associations involved in the administration of vaccines take all necessary steps to promote full and complete reporting of all adverse events temporally related to vaccines.”

If a compensation plan such as the one proposed by the MLRC became too onerous for taxpayers once the full extent of vaccine injury was discovered (eg if new research yielded definitive evidence that vaccines can cause autism), it would be obvious that the benefits of vaccines don’t “far outweigh the risks”. To be fiscally responsible, the vaccination programs would have to be trimmed or dropped altogether. Eventually, vaccines might be developed and administered just as other drugs – by prescription only, for a specific individual, for a specific reason, at a specific time and only with the fully informed and freely given consent of the patient.