Do we need to reboot the Australian experience of vaccination policy?

Last year Greens Senator Richard Di Natale used parliament to chastise the Australian Vaccination Network, a community based group that takes an anti vaccination stance. He accused them of promoting misleading information that he believed was hostile to good health outcomes. He stated that as a man who adhered to Evidence Based Medicine there was no legitimate contrarian position on the vaccination issue. Di Natale drew upon experiences derived in Third World countries to validate his position that vaccination is vital for combating infectious diseases.

Di Natale is well within his rights to take the AVN to task. The AVN has often posted material on their Facebook page which is non academic in nature, and speculative or emotive in content. People should not be making such important decisions based upon information that may be unreliable. But this should surely apply even more strongly to our policy makers. Rather than entering into the absolutist dualism of 'for' or 'against' positions, which seem to rapidly descend into dogma, policy via proclamation and hysteria, let's frame the issue in common sense terms, bearing in mind that there are many different possibilities such as being pro-vaccination, yet critical of a certain product, ingredient, or aspects of policy.

Let's ask a simple question:

Does the Australian experience of vaccination conform with world best practice, and do we have a regulatory and policy framework in place that would ensure this?

In a previous article I explored the impact of pharmaceutical marketing upon the medical evidence base. The 'All Trials' campaign which began in Britain in January 2013 arose as a direct result of the all pervasive problems of what psychiatrist Dr Peter Parry termed 'Marketing Based Medicine'. Writing as editor of The Lancet in 2002 Richard Horton stated that around 90% of clinical trial guidelines were being written by people with financial links to pharmaceutical companies. The current state of play is that these companies are not obliged to release all of their clinical data for independent assessment, and worse still it has become clear that articles appearing in medical journals are being 'ghost written' by people with financial links to pharmaceutical companies, and this is being hidden by non disclosure agreements. It is a shocking state of affairs that has been decades in the making, and may take decades to unravel. There is little doubt that massive fraud is involved.

Against this backdrop it is difficult to see how Di Natale can state that Evidence Based Medicine unequivocally supports his position. It would be a positive development if he chose to support 'All Trials' and he would be in the company of the entire British medical establishment. What the 'All Trials' initiative may reveal is yet to be determined, but as a subset of pharmaceutical products, vaccines are unlikely to be exempt from the overwhelming influence of pharmaceutical marketing on the medical evidence base. And although there isn't space here to dwell on this, there certainly isn't consensus in the international scientific community on the safety and efficacy of all vaccines. An example is Israel's Professor Yehuda Shoenfeld who visited these shores awhile back and talked about Autoimmune Syndrome Induced by Adjuvant (ASIA). He is certainly not anti-vaccination, but his contention was that for some people with a genetic pre-disposition, aluminium adjuvants can trigger a catastrophic immune dysfunction. And the senior post doctoral researchers in vaccine safety at the University of British Columbia, Professor Chris Shaw and Dr Lucija Tomijanovic, also problemise aluminium adjuvants, contending that their effect upon paediatric populations requires urgent investigation.

"Because infants and children represent those who may be most at risk for complications following vaccination, a more rigorous evaluation of potential vaccine-related adverse health impacts in pediatric populations than what has been provided to date is urgently needed". They state that "in spite of the widespread agreement that vaccinesare largely safe and serious adverse complications are extremely rare, a close scrutiny of the scientific literature does not support this view". There are many more examples.

Given that the evidence base is in turmoil, and there certainly isn't medical consensus on safety and efficacy issues, a renewed call for coercive measures to ensure compliance with the Australian schedule, such as withholding family payments, is ethically fraught. But what is particularly problematic is the fact that Australia has no vaccine injury compensation scheme. This stands at odds with virtually every other first world country. The World Health Organisation acknowledges that injuries, and even death, can result in some instances from vaccination and consider it ethically vital that nations that can afford to do so have such a scheme in place. In the United States the 'Vaccine Court' makes hundreds of awards every year. Although it is a 'no fault' system it does place a strong onus upon the complainant. Despite being a wealthy country Australia has no such compensation system, and parents of children damaged by vaccination have to fend for themselves or undertake privately funded legal action.

A World Health Organisation document on compensation schemes discusses this and cites ethicist Michelle Mello. It "…..argues that solidarity means members of a community do not bear the risks of vaccination alone. Vaccine injuries can be severe and complex, and are often suffered by children who require a lifetime of care and may not qualify for other benefits under accident insurance schemes. In a vaccination program, the injured and uninjured pay unequal shares………Mello argues that, in line with principles of fairness and solidarity, mechanisms are needed to prevent the uninjured (unintentionally) "free-riding" on the injured.) 

The absence of a compensation scheme alone should be considered a scandalous lapse in policy. Is it ethically acceptable to pressure people who are healthy to take a risk, and have no 'safety net' in place?

Most vaccination proponents will argue that serious adverse reactions are rare, but if you are affected by one this is not only cold comfort but a life changing challenge, made much worse by having no recourse to compensation. But another big problem is that we do not have accurate, agreed upon figures. During the height of the flu vaccine adverse reactions in 2010 Peter Collignon, a professor of infectious diseases from the Australian National University was interviewed by ABC news. He felt the number of adverse reactions was probably under estimated, given that authorities don't have a congruent and approachable system to monitor peoples' reactions. He believed that an effective surveillance system should monitor a sample group of thousands for one or two weeks before a new vaccine is rolled out for the entire population. "We need a better system than voluntary notification to the TGA (Therapeutic Goods Administration) that there's a problem," he said. "Because whenever you do that you really underestimate how much of a problem there is. This is a position he reiterates today. When I interviewed families who claimed to have experienced an adverse reaction there was a common thread – medical professionals were unwilling to countenance the possibility, even when the symptoms were extreme and immediate, and their cases were never referred to the TGA.

If we don't have statistics on adverse reactions, both those supported by medical staff and 'possibles', how can we reasonably expect people to make informed decisions, or support a schedule where this remains an unknown? And how can problems with a product be identified in a timely fashion so harm can be minimised? Collignon's proposal, namely that before a new vaccine is released, it could be tested on a sample group, and these people could be closely and independently monitored, would go a long way towards ensuring that products are safe and effective. And whilst people might accept some risk in combating highly infectious diseases with a high morbidity rate, vaccines meant to prevent diseases that have a very low morbidity rate in robust individuals need to be unequivocally safe. The adverse reactions that followed an iteration of the flu vaccine in 2010 have had a dramatic impact upon families who thought they were using a safe and effective product.