http://www.observer.co.uk/uk_news/story/0,6903,363705,00.html

Meningitis advisers funded by drug firms

Fresh controversy surrounding Britain's Meningitis C vaccination programme

Martin Bright and Tracy McVeigh
Sunday September 3, 2000
The Observer

Four of the medical experts advising the Government on whether the new meningitis C vaccine is safe have links to one or more of the drug companies that produce it, The Observer has discovered. The revelations, following last week's report of a cover-up of suspected adverse reactions to the drug, has prompted concern among parents and MPs about conflicts of interest in the medical profession.

The Department of Health last night confirmed that Professor Janet Darbyshire, a member of the Government's Committee on Safety of Medicines, had received support for academic research from US firms Wyeth and Chiron, who produce the two main meningitis products being used on children in Britain: Meningitec and Meninjugate. Darbyshire is professor of epidemiology at London University and director of the Medical Research Council.

DoH officials also confirmed that three members of the Joint Committee on Vaccination and Immunisation had declared interests in vaccine manufacturers.

One of them, Dr David Goldblatt of the Institute of Child Health, has served on an expert advisory panel for Wyeth and received research grants from Wyeth and North American Vaccines, which produces a third meningitis C drug to be introduced this year. Another, Professor Keith Cartwright of the University of Bristol, received funding from the drug industry to 'evaluate candidate meningicoccal vaccines'.

Exposure of the links between the advisers and drugs firms came as the Government's Chief Medical Officer reacted strongly to last week's Observer story of how information on possible adverse reactions to the vaccine was kept from parents. In a letter to The Observer, published today, Professor Liam Donaldson insists information on reactions to vaccinations is sent, on request, to members of the public, health professionals or MPs by the Medicines Con trol Agency. 'There is not, and never has been, a "cover-up" over releasing information about reported deaths or suspected adverse reactions following meningitis C vaccine,' he said.

This week every GP in the country will receive a statement from the chairs of the two committees, assuring them of the safety of the meningitis C vaccine. The statement, from Professor Alasdair Breckenridge of the Committee on Safety of Medi cines, and Professor Michael Langman of the Joint Committee on Vaccination and Immunisation, updates information made public by The Observer last weekend about bad reactions to the new vaccine reported by GPs and nurses. It says there have been 16,527 reported adverse reactions from 7,742 patients, and 12 deaths. It reiterates that none of the deaths reported by GPs was found to be connected to the vaccine.

The statement ends: 'The balance of risk and benefit is overwhelmingly favourable. There is no suggestion that this vaccine has led to any deaths. We strongly recommend that those due for vaccination should receive meningitis C vaccine.'

Latest figures show that more than 15 million doses of the meningitis C vaccine have been give to children and teenagers in the past 10 months.

Statistics from the Public Health Laboratory Service show that, in the 15-to-17-year-old group, in the last 12 weeks only six cases of meningitis were reported, compared with 26 in the same period last year. And in children under one year old, there was only one case reported in this period, compared with 19 in 1999.

Incidences of meningitis continue to rise in those who have not been vaccinated.

Despite assurances that information on possible adverse reactions to the vaccine is freely available, parents calling the Medicines Control Agency told The Observer they were still being refused the data.

In north Somerset, one mother of a 13-year-old was told 'it wasn't necessary' for her to have that information.

'My son is about to have his vaccination and, after reading last week's Observer that figures on adverse reactions existed, I wanted to see them. I believe I have a right as a mother to have all the information to hand when I make a decision,' she said. She said the agency employee had told her: 'Stories like this should really be taken cum grano salis - that's a pinch of salt in English, madam.'

Another caller was told that the MCA did not have the information and referred her to her doctor. A third caller eventually managed to get a copy of the letter sent to GPs.

The figures collated by the agency are based on the 'yellow card reporting scheme'. This seeks reports of suspected adverse reactions to drugs from health professionals. They are requested to submit reports of reactions whether or not it is clear that a drug or vaccine caused it. The 12 deaths reported under this scheme may be an underestimation, since only around 15 per cent of GPs and healthcare professionals use the yellow card scheme. The Department of Health believes that the reporting rate is higher where a new drug is involved.

The Liberal Democrat consumer affairs spokesman, Norman Baker, has tabled parliamentary questions about the financial interests of members of Department of Health advisory committees. He said last night: 'This is a question of propriety. There must be enough independent people around to give advice without turning to those who clearly have a conflict of interests. I am not questioning their academic credentials, but with the best will in the world their judgments must be looked at in that context.'

Tory Health spokesman Liam Fox, a GP, said the Government must reassure the public.

The Secretary of State authorised the licence for the Wyeth vaccine, Meningitec, when the mass immunisation programme began last November, on advice from the Committee on Safety of Medicines. The Joint Committee on Vaccination and Immunisation also recommended the vaccine.

Wyeth spokesman Don Barrett said the amount of money paid to the academic departments of government committee members was confidential. Chiron, whose vaccine was introduced in April, stands to make $200 million from the NHS deal.

Last night the National Meningitis Trust, sponsored by Wyeth, was drawn into the controversy when it refused to disclose how much money it received from the giant drug company. In a statement, Chief Executive Philip Kirby said: 'We would refute in the strongest possible terms the suggestion that any information we provide is anything other than totally objective and the best available.'

This week Posh Spice Victoria Beckham revealed she had viral meningitis, a less serious type of the disease. After doctors ordered her to rest, she cancelled several appearances and flew home from Germany. Viral meningitis is an inflammation of the lining of the brain and usually clears up within a week or two without treatment.

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.