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.