Confessions of a Quackbuster

This blog deals with healthcare consumer protection, and is therefore about quackery, healthfraud, chiropractic, and other forms of so-Called "Alternative" Medicine (sCAM).

Tuesday, June 28, 2005

Health Ministry rejects claims vaccine data 'falsified'

Health Ministry rejects claims vaccine data 'falsified'
28 June 2005

The Health Ministry has rejected claims by anti-immunisation lobbyists that it "falsified data" to make health professionals believe meningococcal disease is on the rise.

The ministry says the data being questioned was a mistake that was picked up in a report before it was even published.

The $200 million meningococcal B vaccination campaign to vaccinate all 1.1 million New Zealanders aged under 20 began in South Auckland last July.

New Zealand has been in the grip of a meningococcal disease epidemic since 1991, which has infected 5700 victims, resulting in 227 deaths, most of them children.

Self-styled risk and policy analyst Ron Law and writer/researcher Barbara Sumner Burstyn, who have accused the ministry of running "a state-funded medical experiment", said in a statement documents sent to healthcare workers contained a "falsified graph suggesting that meningococcal disease was on the increase".

One graph in a draft of the 2004 annual meningococcal disease report prepared by Environmental Science and Research (ESR) showing the number of meningococcal bacteria isolated from patients included 70 additional cases in the 2004 data.

"This strongly suggests that the message being conveyed to the ministry by the public about the need for and efficacy of the experimental MeNZB(tm) vaccine is being falsified," Mr Law said.

AdvertisementAdvertisementHowever, the director of the Meningococcal Immunisation Programme, Dr Jane O'Hallahan, said the information in the 2004 report was accurate.

"An incorrect graph was circulated to health professionals before this report was finalised and we caught the error and corrected it before ESR and the Ministry of Health published the report," she said.

Stakeholders who received the incorrect graph have had their attention drawn to the correct version in the report, which is publicly available on the ministry's website.

Ms Sumner Burstyn had also accused the report's author, Dr Stewart Reid of "a conflict of interest" because he was clinical investigator for one of vaccine-maker Chiron's clinical trials, as well as a member of the Medicines Assessment Advisory Committee, which gave the go-ahead to the MeNZB(tm) vaccine.

"When the qualifications of reporters investigating the development and release of an experimental medicine are called into question, it is ironic that the qualifications of the one of the most senior players in the MeNZB(tm) saga have been withheld from the public," she said.

However, the ministry said there was no substance to the allegations: a panel independent of the ministry chose the preferred provider of the vaccine from tenders submitted by four manufacturers.

The principal investigator of the trials was not a Chiron employee.

The Independent Safety Monitoring Board was set up by the Health Research Council to independently monitor the roll out of the meningococcal B immunisation programme.

The ISMB has five members from New Zealand and overseas with extensive expertise covering statistics, vaccine trials, public health epidemiology, clinical paediatrics and meningococcal disease.

Last week Health Director-General Karen Poutasi took the unprecedented step of writing an open letter to New Zealanders replying to mounting criticisms of the campaign, which was published in metropolitan and regional daily papers.

Dr Poutasi said the ministry had to correct "some of the misinformation that has circulated".

It was pointless to focus on narrow timeframes with meningococcal epidemics, which went through "peaks and troughs", she said.

In the first five months of last year, there had been two deaths, while this year there had been five by May.

The epidemic was likely to run for another 6-10 years if the ministry took a "do nothing" approach, she said.

The immunisation programme was not just about preventing deaths, but also brain damage, amputation, deafness, massive scarring, learning disabilities and other things caused by meningococcal disease.

For every 100 cases of meningococcal disease, approximately 4 will die and 20 will be permanently maimed or disfigured, while 76 will be treated and make a full recovery.