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. 

And we should be looking at what other nations with excellent health outcomes are doing. Denmark has less vaccinations on its schedule than Australia. They have a very strong record of controlling infectious disease, and do not experience the high incidence of broad spectrum neurological and immune dysfunctions Australia suffers from. There is no doubt that Denmark does very well on health issues, and yet presumably someone following the Danish vaccination schedule would be considered not compliant with the Australian schedule.

We also have to question what is actually driving the current media campaign, and whether the apparent concern over vaccination rates is justified. Associate Professor Julie Leask, and Research Fellow Hal Willaby, (School of Public Health), both from the University of Sydney, suggested in an opinion piece in 'The Conversation', that elements of the media were hystericising the issue, and trading in stereotypes. They risked polarising the community, when the reality was that vaccination rates generally remained high. They proposed a more conciliatory approach and suggested that some families who are not up to date may already be struggling with a lack of access or practical support, and penalising them will only create further disadvantage.  And is the current rate of 'Conscientious Objections' (CO) really a threat to the theory of 'herd immunity'? An opinion piece on the Australian Medical Association website states,

"First, you don't need everyone to be immune to prevent an epidemic occurring. If 90 per cent or more are immune, they create sufficient fire breaks to prevent the easy transfer of most infectious diseases. So, good levels of public health could be maintained even if the CO rate climbed substantially – which it is not likely to do in real terms." 

The Cochrane Collaboration has established a reputation for independent assessment of medical products and procedures. They have played an integral role in the establishment of the 'All Trials' initiative, and continue to hold pharmaceutical companies accountable.

A recent study from US Public Citizen found that, since 1991, there have been 239 legal settlements, totaling $30.2 billion in federal and state penalties, levied against US pharmaceutical companies. There's a real laundry list of crimes, but defrauding the government, hiding drug safety information, and hawking drugs for purposes beyond which they are approved are the main ones. Drug companies have pledged to change, signed 'corporate integrity agreements' and indicated that they want to move on, promising a better future. We can be hopeful, but we also have to be realistic. Paying huge fines for illegal activity is one thing, but will they be still playing the eminence game? Will they continue to fund their own experts and do research that goes through a selective reporting of 'the evidence'? Sadly, that's probably going to be the case so you must immunise yourself: keep asking questions and questioning answers.

In America the Centre for Disease Control has come under fire for blurring the lines between regulation and marketing. The Huffington Post alleges they massively inflated flu morbidity figures, then "….. unabashedly decided to create a mass market for the flu vaccine by enlisting the media into panicking the public. An obedient and unquestioning media obliged by hyping the numbers, and 10 years later it is obliging still". This isn't America, but we do take many of our cues from the American experience, and their multi nationals reach deep into our market. What we can learn from this is the need to insulate regulatory bodies from pharmaceutical marketing. This point is strongly underscored by an article in the 'Journal of Law, Medicine and Ethics', entitled "Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs' which alleges that the medical evidence base has been massively compromised since at least 1966. The "…..proportion of new products with clinical advantages seems to have moved from about 1 in 8 down to 1 in 12, while the proportion with serious harms has gone up from 1 in 5 towards 1 in 3 as the number of drugs given priority status increases......"  Whilst there is mounting consciousness of the extent of the problem overseas, here in Australia it seems to be business as usual for the most part.

Writing in the journal of the Association of American Physicians and Surgeons, Marilyn Singleton asked us to question whether we can always trust Evidence Based Medicine. She states that "…reporting bias is systemic in medical literature. A 2012 Cochrane independent review found that company-sponsored trials were more likely to report favorable efficacy results compared with non-industry sponsored studies. Even in academic studies positive results are more likely to be published. A 2009 analysis of 18 surveys by multiple authors found 34 percent of researchers admitted to "questionable research practices." Instead of blindly accepting that research is bone fide and regulatory bodies are vigilant and unbiased, she suggests that "government intervention in medicine can be harmful to your health. Rigid rules and restrictive drug formularies are advanced based on consensus, leaving no room for individualized treatments. We want physicians whom we can trust to be open, honest critical thinkers, not "providers" who are government puppets". Once again these are sentiments which we could afford to apply to the Australian context. It is a basic tenet of medical ethics that patients are treated individually and not according to some 'one size fits' all approach, because human physiology has huge variances, and we need healthcare professionals who support this and question the basis of their knowledge and beliefs.

Returning to the original question, does the Australian experience of vaccination adhere to global best practice, and do we have the policy and regulatory framework to ensure this? There can be no under estimating the positive contribution Western medicine has made. Part of supporting its continued viability is working tirelessly to ensure it is insulated from pharmaceutical marketing and media driven policy. Our policy makers need to support 'All Trials' as a step towards this, and the adoption of Peter Collignon's eminently sensible proposals would also be a positive development.. In the meanwhile Australian consumers might perhaps take the Cochrane Collaboration's advice – "immunise yourself: keep asking questions and questioning answers."