IMMP / The Independent Safety Monitoring Board
By Barbara Sumner Burstyn
In July this year the British Medical Journal (BMJ) printed an open letter to our Minister of Health, Annette King from a group of 35 doctors from Australia, Belgium, Canada, Croatia, France, Germany, India, Italy, Japan, Netherlands, Norway, South Africa, Spain, Sri Lanka, United Kingdom and the United States. (2) They were decrying the dismantling of New Zealand’s intensive medicines monitoring programme (IMMP). Effusive in their praise, the doctors said the IMMP had contributed very valuably to the safety of medicines in New Zealand and worldwide.
“Drug regulatory agencies in other countries and professionals working on the safety of medicines have admired and envied it because it has so successfully identified previously unrecognized adverse reactions, measured risks, and identified risk factors. For example, it enabled New Zealand to lead the world in taking regulatory action over agranulocytosis due to mianserin and liver toxicity due to nefazodone.”
The letter went on to say that many drug disasters have shown that it is unsafe to rely only on spontaneous reporting of suspected adverse drug reactions. “Such systems are essential, but the data they provide mostly suffer from gross under-reporting and other biases and are usually hard to interpret.”
Despite well reasoned opposition from within both the New Zealand and international medical community and the fact that internationally the IMMP is regarded as being at the leading edge of modern pharmacovigilance the Ministry, on behalf of Minister Annette King smoothed over the criticisms with comments about the out-dated systems used by the IMMP.
The former director of the IMMP program wrote to the BMJ stating that, "The minister should feel embarrassed at the level of response provided on her behalf." One Christchurch doctor called the Ministry’s response ‘lame’. Dr Simon C Roughan said the dismantling of a proven health safety mechanism would blur future health monitoring statistics or future research. “This appears to be a way of concealing from the public any blunders that their new baby "MedSafe" or the incompetence of their new Trans Tasman Agency, is likely to make.” Roughan comments that the experimental MeNZBvaccination is a perfect example.
In place of the IMMP, which previously would have overseen the introduction of a new vaccine, the handpicked Independent Safety Monitoring Board is scrutinizing the safety of the MeNZBvaccine. This group consists of five experts. But whereas the IMMP was unaffiliated to any drug trials, their researchers or funders, at least four members of the new safety committee are linked with members of the vaccine research team or have involvement or vested interest in the development and promotion of vaccines.
One safety board member has previously published papers with MeNZBvaccine researchers and is the recent recipient of a large grant from a joint venture of the HRC and the Ministry of Health to study ways of overcoming some of the barriers that are faced by parents when immunizing their children. One board member co-authored a policy paper in 2001 recommending the development of a meningococcal B vaccine citing only material provided by the research team and Ministry of Health.
She is in the same department as a key researcher who recently contradicted himself by publicly siding with a pharmaceutical company against a public interest group, denying the results of previous research he’d completed and published.
Another member has previously worked for vaccine manufacturing companies and is now a key advocate of vaccine use. The forth member is a key government advocate of vaccination in the USA and recently published a glowing research paper regarding a vaccine.
At the same time another paper found that while the same vaccine reduced one type of infection in certain age groups, it caused bacterial cousins to flourish, filling the vacuum and resulting in more disease. The final member, a biostatistician, clearly won't have much work to analyze given that only serious adverse events associated with other vaccines have been pre-determined as being relevant to the MeNZBand are being systematically filtered out from any analysis.
The word independent in the group’s title is very misleading, says Ron Law, a medical risk analyst. “The majority has cogent conflicts of interest and well-developed reasons to protect the perceived integrity of their vaccine and those conflicts of interest throw doubt on their pronouncements of safety.”
The MeNZBmonitoring system has walked all over internationally accepted drug monitoring and classification of adverse drug reactions. It has been set up with the express purpose of protecting the integrity of the vaccine, and the vaccination program, rather than to ensure the safety of consumers.
Here’s the anomaly. The Guardian Weekly recently called publicly funded services the final frontier for transnational corporations. They pointed out that with the backing of the WTO, third world countries are being forced to strip their legislation of anything that might hinder corporate involvement. The article details how, under threat of crippling economic penalties, tax funded pools for things like public health services are being tapped by transnational corporations.
Here in New Zealand, it seems no pressure is needed. We have willingly eroded our world-class medicines monitoring programme and replaced it with one that would seem to specifically benefit a pharmaceutical company drug trial. And we have happily handed over a good portion of 200 million of public health funding to an American corporation, to test a corporate trademarked experimental vaccine for an epidemic that may not even exist. Using the Ministries own figures from their Epidemiology of Meningococcal Disease Annual Report 2002 and 2003 it appears the Ministry has overestimated the number of cases caused by MeNZB strain by up to 137%.
With anecdotal evidence coming in every day of adverse reactions to the vaccine: vomiting, swollen limbs, violent headaches, the questions that surround this vaccine cannot be assuaged by Ms King’s personal confidence or reports by the Independent Safety Monitoring Board that it has found no concerning issues.
Barbara Sumner Burstyn© October 2004