(U.K.) Influence of Pharmaceutical Industry on Government - Martin Walker MA

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[sSRI-Research] Influence of Pharmaceutical Industry on

Government - Martin Walker MA

 

 

 

 

The attached article was sent for distribution by the

journalist/author Martin J. Walker.

 

He has published books such as: " Dirty Medicine " and " Skewed. "

 

He can e-mailed at:

 

fraka

 

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THE GHOST LOBBY

 

New Labour and the Pharmaceutical Industry

Martin Walker MA

 

 

The House of Commons Health Committee is currently deliberating over its

Inquiry into the Influence of the Pharmaceutical Industry, but, with

pharmaceutical interests by now the warp in the governmental weft, it is

hard to see how the fabric can be unpicked. Some commentators are

suggesting

that the Inquiry might be better framed as an independent inquiry into the

influence of the pharmaceutical industry in Parliament.

 

While much of the revolving door vested interest between the

government and

the industry is transparent - the MHRA the regulatory body for

pharmaceuticals funded by the industry and the Committee on Safety of

Medicines stiff with personal and non-personal pharmaceutical interests -

much of it is more obscure. Official policy on vaccinations, for

instance,

is being driven, not as one would hope by impartial medical experts,

but by

industry involvement, layered deep within the system.

 

The involvement of pharmaceutical companies with government agencies has

allowed the industry to develop a unique system of protection for its

products, from suggested production, through licensing, and finally to its

'no fault' compensation scheme, which stops claimants from taking their

cases to court.

 

It is acknowledged that a minority of individuals will suffer adverse

reactions, not only to often live viruses, bacteria and parasites in

vaccines, but to excipients such as aluminium and mercury-derived

thimersal

- hence for the very worst affected. But now research, mainly in America

suggests that vaccines might also cause rare, dramatic and immediate

side-effects such as encephalomyelitis and death, as well as being factors

in the increase of autism, epilepsy, sudden infant death syndrome (SIDS),

asthma and diabetes, as well as many less serious conditions such as ear

infections.

 

As the government steps up its vaccination programme supporting an

increased

number of vaccines it is becoming clear that government cooperation with

industry in production, linked to the 'non fault' compensation scheme, is

for the pharmaceutical industry a Holy Grail, bringing such profits as

were

only previously dreamt of by chemical and pharmaceutical companies

 

 

A very special relationship

 

The last decade has seen the emergence of an increasingly special

relationship between the government and the drugs companies. One in which

the drug companies are being drawn into funding the modernization of the

NHS, in exchange for lucrative deals over 'mandatory' prescribed drugs,

especially vaccines.

 

The British government was the first in the world to launch a mass

immunisation programme against the virus meningitis C, in the year 2000.

Earlier, the Public Health Services Laboratory (PHSL) had approached a

number of companies, including the US drug giant Wyeth to step up research

into a vaccine. When Wyeth came up with a product, the government backed

PHSL took over the vaccines testing, conducting many of the larger trials

and the post licensing surveillance hand in hand with Wyeth.

 

After discussions with industry, and on the basis of 'a few initial

studies', the government decided to inoculate children aged 15-17, as well

as babies under one year at a cost of around £14 million. We cannot know

what the incidence of meningitis C might have been following the campaign,

but a statement later put out by the Medicines Control Agency (MCA) said

that there had been 16,527 reported adverse reactions in 7,742

patients, and

12 deaths. The Agency which was and still is funded by the pharmaceutical

industry including Wyeth, stressed that none of the deaths had been

found to

be connected with the vaccine.

 

In August and September 2000, the Observer's Martin Bright and Tracy

McVeigh

reported that four of the medical experts advising the government on the

safety of the vaccine had links with Wyeth and Chiron, major US vaccine

manufacturers. And in 2002, the last time that information on

interests was

released, among the 23-strong Joint Committee on Vaccination and

Immunisation (the body that begins the process of discussing,

selecting and

recommending vaccines as part of the policy of the Department of Health),

many had interests with a wide range of pharmaceutical companies.

Professor

Keith Cartwright for example stated his interests as being with Wyeth

Lederle and Chiron for the Committee on the Safety of Medicines (CSM),

while

Prof David Goldblatt also declared interests with Wyeth.

 

The goal of vaccine research in the developed world is to create one

super-vaccine that will contain DNA from 20-30 viruses, parasites and

bacteria. The vaccine, which would be time-released, would be given to

newborn babies. In North America and Britain, right now, researchers are

working on the development of 150 viral and bacterial vaccines.

 

 

Corporate government

 

Since the year 2000, rather than distancing themselves from the

pharmaceutical companies, and tightening the regulatory screws on conflict

of interests, the links between government agencies and pharmaceutical

companies has spread unchecked.

 

A number of issues were on the agenda for the Association of the British

Pharmaceutical Industry (ABPI) when Labour came to power. Members wanted

assurances that, in a privatised NHS, there would be guaranteed

markets for

their drugs. They wanted the support of government in dealing with the

animal liberation movement, and agreement that member companies could work

with government in the multi-million-pound assured market of vaccines

production. Finally, they wanted the government to strengthen their

monopoly

market position in Britain and Europe, and to help choke off competition

from nutritional supplements and herbal medicines.

 

In 2000, New Labour set up the Pharmaceutical Industry Competitive Task

Force (PICTF), under the co-chairmanship of then parliamentary

under-secretary of state for health, Lord Hunt of Kings Heath, and Tom

McKillop, CEO of Astra Zeneca. (Lord Hunt has since resigned as junior

health minister in protest at the Iraq war.) The government team included

Lord Sainsbury and Stephen Timms MP, then permanent secretary at the

department of health. For the pharmaceutical companies, the most senior

executives from the ABPI, Glaxo Wellcome, Novartis, Pfizer and Merck Sharp

and Dohme attended.

 

While the PICTF was sitting, with the help of the Department of Trade and

Industry (dti), Wyeth -the only pharmaceutical company so far to

partner the

government in the manufacture of vaccines with its meningitis C jab -

set up

a lobby group, Networking for Industry (NFI). In turn, NFI, which takes

declared annual funding of around £100,000 from the pharmaceutical

industry,

set up the Associate Parliamentary Group for Health (APGH).

 

The competitive task force deliberated until March 2001, then a second

group

was set up to continue the high-level discussions. Named the Ministerial

Industry Strategy Group (MISG), it, too, was chaired by Lord Hunt and Tom

McKillop. The group also included Lord Sainsbury and Margaret Hodge, Sir

Richard Sykes, and ABPI director general Trevor Jones. Leading

pharmaceutical executives were again involved, along with ministers and

officers from the Department of Health (DH) and dti. The aim was to

resolve

'key issues that affect not only the industry, but the interests of

government and patients'. That these interests might at times be

irreconcilable seems not to have occurred to anyone.

 

 

A shadowy concern

 

Networking for Industry is a subsidiary of Partnership Sourcing Ltd (PSL),

which was set up in 1990 by Margaret Thatcher's government, to bring

together the dti and the Confederation of British Industry (CBI),

Britain's

main lobby group for private industry. In the climate of

privatisation, PSL

was meant to play the matchmaker between buying government departments and

sellers in industry. Today, this large 'not for profit' organisation

has an

influential board that includes representation from the dti and around 35

members, representing government departments, large corporations and

University academic departments. PSL is now at the centre of commercial

matchmaking between New Labour and private industry. Its board consists of

industrialists, members from the dti and CBI, and an MP, Barry Sheerman,

Labour member for Huddersfield, chairman of the Commons Education Select

Committee, and founding member of NFI. He is now on the NFI board, along

with at least two executives and one ex-executive of Wyeth, Kevin James,

Bernard Dunkley and Don Barrett

 

NFI, though describing itself, like PSL, as a 'not for profit' company, is

actually a lobby organisation dominated by Wyeth. The company administers

four other lobby and 'communications' organisations, which it has set up

inside Parliament: the All-Party Group for Design and Innovation (APGDI),

the Associate Parliamentary Manufacturing Industry Group (APMIG), and, in

two of the most lucrative areas of politics and policy, the Associate

Party

Sustainable Waste Group (APSWG), and the Associate Parliamentary Group on

Health (APGH).

 

The APGH, whose members put themselves forward to be selected by their

parties in the Commons or Lords, consists of Baroness Cumberlege, Baroness

Masham of Ilton, and MPs Davis Amess - presently a member of the Health

Committees Inquiry into the influence of pharmaceutical companies, David

Drew, Sandra Gidley, Patrick Hall, Dr Howard Stoate and Dr Richard Taylor.

 

Networking for Industry provides the group with administrative assistance

(office space, computer, telephone and secretarial services). 'Associate

members' Abbott, Amgen UK, AstraZenica, BT, BUPA, Close Asset Finance

Limited, GlaxoSmithKline, Kimberly-Clark Professional, Lloyds Pharmacy,

Napp, Northgate Information Solutions, Orange, Pfizer, Sanofi-Synthelabo,

Sankyo, WCI, Wyeth, Xograph, each provide £5,000 per annum, with an

additional £15,000 from Wyeth (registered December 2003).

 

The setting up and funding of groups within parliament by commercial lobby

companies has become relatively commonplace since Labour came to

power. And

perhaps few eyebrows would be raised at the disclosure that the ABPI is

controlling a parliamentary group on health. However, in the shadow of

this

group, Wyeth and the ABPI have placed another group of advisors, who

are not

members of parliament, but who, through the APGH, have direct access to

government offices.

 

 

 

Advising New Labour on the Politics of Health

 

APGH advisors include Sir Kenneth Calman, chief medical officer to the

government from 1991 to 1998, now chancellor of Durham University and

appointed by Lord Sainsbury as a member of the new Chemistry Leadership

Council; Duncan Eaton, chief executive of the NHS Purchasing and Supply

Agency, who has spent his career in the NHS and held senior positions in a

number of health authorities; David Colin-Thorne, the national clinical

director for primary care at the DH - and Bernard Dunkley and Kevin James,

executive directors of Wyeth.

 

Dunkley is also a director of Networking for Industry and is the

coordinator

of the Advisors group and special advisor to the APGH. With 37 years'

experience in drugs marketing, he is currently the serving government

affairs director for Lederle and Wyeth Laboratories, the UK vaccine

manufacturers.

 

Kevin James is executive managing director for Wyeth UK. More importantly,

he is a member of the ABPI board of management. In 2004, James took over

chairmanship of the American Pharmaceutical (companies in England) Group

(APG), which makes him one of the highest-ranking drugs salesmen in

Britain.

Don Barrett who is on the board of NFI but not on the Advisors group is a

past Corporate Affairs Executive for Wyeth in Britain. In this role, he

worked with the NHS and voluntary organisation Women's groups,

ensuring the

marketing of HRT. In the year 2000, one year after his retirement from

Wyeth, Barrett was invited onto the organising committee of the charity

Women's Health Concerns, following 'his long involvement with the

charity'.

It is easy to see the kind of policies that Wyeth and the ABPI might

want to

influence, through NFI and through the APGH. Assured markets for

vaccines,

continued buying of HRT, a clampdown on natural health remedies all spring

to mind. Through the APGH, on behalf of Wyeth or the ABPI, they talk

regularly and 'covertly' to the offices of the PM's Policy Unit, or the

offices of the Deputy Leader.

 

Since 2002, the APGH has provided an extensive diary, advice on health

issues and agenda for MPs who are members of its password-secure website.

The secretariat, the advice group and the website have, in fact, done

everything a good civil servant would do to support MPs on health matters.

 

It has an agenda of breakfasts and meal-time meetings, seminars and talks,

in buildings adjacent to the Commons, where it introduces ministers,

NHS and

DH staff to drug company executives and private health service providers.

There can be no doubt that some of the members of the APGH have no

idea that

they are part of a manoeuvre by a lobby group. Sandra Gidley, for example,

representing the Lib Dems, clearly states as part of her personal website

manifesto that, as 'Your Member of Parliament, I will never take cash from

lobbying companies.' Dr Richard Taylor, MP for Wyre Forest, is the only

independent member of the House for the Health Concern Party.

 

Dr Howard Stoate, however, is now chair of the All Party Group on Men's

Health (APGMH), of which David Amess and Sandra Gidley are also members.

Stoate set up the APGMH on behalf of the Men's Health Forum (MHF). Despite

being a registered charity, the MFH is - like so many health charities and

patient advice and support groups - an instrument of pharmaceutical

marketing, supported by, among others, Merck Sharp & Dohme, and Roche.

 

Making The Right Connections

 

Undoubtedly, the two heavyweights of the APGH and its group of

advisors are

Baroness Cumberlege, who is both a member and an advisor, and Lord Hunt of

Kings Heath, an advisor. Despite coming from different sides of the House,

these two peers have a lot in common. They were both minister of health,

Cumberlege during the premiership of John Major from 1992 to 1997, and

Hunt

from 1999 to 2003. They are both NHS modernisers, and they both have had

dealings with pharmaceutical companies. But, perhaps most perversely, Lord

Hunt is a director of Baroness Cumberlege's NHS-integrated health

consultancy company, Cumberlege Connections.

 

When Baroness Cumberlege was elevated to the Lords, she began the long

haul

through PR and health consultancy companies, which ended in 1993 with

Cumberlege Connections, a consultancy that organises conferences and

training courses to equip people to deal with government and the NHS.

 

On her way to Cumberlege Connections, the Baroness passed through some

more

and less prestigious companies. From 1997 until 2001, she was an executive

director of MJM Healthcare Solutions, which, with its sister organisation,

Mental Health Strategies, is part of Niche Healthcare Consulting. In 2001,

she joined the board of Huntsworth plc. The company, 'a specialised

communications group with public relations at its core', is comprised of a

number of market service consultants, whose main clients are Astra Zeneca,

Pfizer, Chiron Evans vaccines, Merck, Shire, Aventis, Novartis, Roche and

Abbott Laboratories.

 

In 2001, Cumberlege apparently left Huntsworth, to team up with Anthony

Mckeever, a senior NHS executive who moved to the private sector, as

co-director of Quo Health. In January 2003, Quo Health was listed by New

Labour as one of eight private companies added to the Franchising Register

of Expertise, enabling it to submit management bids for failing NHS

hospitals.

 

Lord Hunt, while Minister of Health, as well as instigating the

Pharmaceutical Industry Competitive Task Force Report, and co-chairing the

Ministerial Industry Strategy Group, was the instigator of a member of the

G10 committee that worked on European drugs industry competitiveness.

He is

actually only a year out of the tight policy group that has steered Labour

through the modernised NHS and its compact with the pharmaceutical

cartels.

Only a year away from his statement, 'The UK has a thriving and successful

pharmaceutical industry and we want to keep it that way.' In January 2004,

he took up a $58,000-a-year appointment to chair the new Patient Safety

Agency, a post for which his meetings with pharmaceutical company

executives

eminently suits him.

 

Wyeth: Partnering Democracy

 

One result of the Ministerial Industry Strategy Group, announced in March

2002 by Lord Hunt, was an agreement between the DH and the pharmaceutical

industries, under which the government was to help pharmaceutical

companies

to fund and carry out clinical research on drugs, particularly vaccines,

manufactured in the UK. This agreement, it was said, would lead to the

faster development of new drugs.

 

The agreement was something that Wyeth, in particular, had pushed for

since

it collaborated with the PHSL over the meningitis C vaccine. It resolved a

number of issues at the centre of the 2001 report by Liam Donaldson, the

present CMO. Titled Getting Beyond the Curve, the report became new

Labour's

founding document on the reorganisation of the NHS approach to infectious

diseases. It recommends the development and licensing of more multiple

vaccines for children, in partnership between government and the

pharmaceutical industry.

 

The report also suggested the reorganisation of the PHSL, and the

launching

of a new-style Health Protection Agency, under whose auspices the

genetically-modified vaccines would be developed. Called the Health

Protection Agency, this American-style disease intelligence agency, is

going into the manufacture of vaccines in partnership with leading

pharmaceutical companies. The agency which also oversees the

production of

anthrax vaccine and is locked into Britains military defence establishment

and its counter terrorist strategies, is based at Porton Down - Britain's

germ warfare establishment.

 

The new Health Protection Agency, which brings together pharmaceutical

companies and 'government' scientists in NHS labs, and which will involved

NHS clinicians' post-licensing surveillance of new vaccines, does not even

have a policy of public disclosure of interests.

 

When Hazel Blears, minister for public health, announced the board

membership of the new HPA, in an apparent attempt at subtefuge, she

declaimed loudly about the political interests of new members but

failed to

annouce their financial or pharmceutical interests. At the agency's first

meeting of the 17-person board in 2003, the minutes record that the

chairman, Sir William Stewart, asked if anyone had any interests to

declare

that had any bearings on the subject of the meeting. Everyone said no, and

the meeting moved on. And yet, at least five board members have had,

or now

have, either research or personal links with pharmaceutical companies

which

the HPA could well be in partnership with.

 

Among these four is Sir William Stewart himself, who, in September 1998,

became non-executive chairman of Cyclacel, the cancer therapeutics

company,

and who was until two years ago a member of the Corporate Technology Board

of what used to be SmithKline Beecham.

 

When more formal structures of a centralised system break down, and

distinctions between manufacturers, regulators and sellers become blurred,

when conflict interests are obscured, so is responsibility for any damage

caused by drugs.

 

The ABPI's policy on vaccines is that, with many more being developed,

especially for use in children - in North America, some public school

children now have around 15 mandated shots - it will be more

cost-effective,

and politically less contentious, to give multiple vaccines. It has pushed

very hard for these vaccines to be developed and manufactured jointly with

government, which would clearly afford drug companies, not only an assured

market, but the security of government commitment to them and official

endorsement of their importance, efficacy and safety.

 

The problems with involving government departments such as the Health

Protection Agency with the pharmaceutical companies in the development of

vaccines, has already been made manifest. Post-licensing surveillance

of the

meningitis C vaccine after the PHLS-Wyeth collaboration, was not the

measured process it might have been, and parents' complaints about adverse

reactions appeared to be treated with scepticism and their figures not

released to those who telephoned the MCA.

 

An Iatrogenic History

 

Wyeth Pharmaceuticals is no stranger to mistakes damaging to the public -

and its own financial - health. With its partner company, Lederle, it has

been involved in vaccine manufacture since it first became a commercial

certainty. From the Fifties, Wyeth produced whole-cell pertussis (whooping

cough) vaccine. From the beginning, it was found to cause high numbers of

adverse reactions, often resulting in central nervous system damage. The

linkage was so strong that Sweden banned whole-cell pertussis vaccine

in the

Seventies. Despite an acellular vaccine being adopted in Japan, Sweden and

other countries, the US government continued to partner Wyeth with its

version. In both Britain and the USA, regulatory bodies concurred that

there

was no evidence of serious damage.

 

In 1979, in Tennessee, four infants died of Sudden Infant Death Syndrome,

apparently within 24 hours of the administration of Wyeth's DPT

(diphtheria,

pertussis, tetanus) vaccine. There were 96,105 doses given out from this

batch before it was withdrawn. Wyeth then adopted a policy of sending only

small batches to widely dispersed geographical areas, so if a batch caused

serious adverse reactions, their statistical impact would be reduced.

Cases brought against the manufacturers of DPT in the early Eighties,

led in

1986 to the National Vaccine Injuries Act and the National Vaccine

Compensation Act, which resulted in Northern America in the so-called 'no

fault' awards. Like our own Vaccine Damage Payment Act, which came into

force in 1979, its purpose was to prevent individuals or groups from

taking

civil liability actions.

 

Following lawsuits in the late Nineties, Wyeth's slimming drugs Pondimin

and Redux were found to be responsible for causing, among other

conditions,

valvular heart disease. Claims on the company, most of which are still

being

dealt with, numbered initially 111,700. Of these, 11,200 have been

processed

to completion. Wyeth's 2003 Annual Report suggests that claims will

continue

to be brought until the year 2015. The sum set aside in trust for

compensation is currently $3,750 million, although the company fully

expects

claims to exceed this amount.

 

Wyeth's Rotashield vaccine was developed against the rotavirus, under

intense competition with Merck. A monkey-based, live, oral vaccine, it was

approved by the US Food and Drug Administration (FDA) in August 1998, and

administered on a mandatory basis. Just a year after it was licensed, in

July 1999, it was withdrawn from the market after mounting reports of

severe

bowel obstruction in almost 60 vaccinated children, 29 of whom required

surgery, and one of whom - a five-month-old infant - died. A study showed

that onset of the illness was increased by 60 per cent among children

receiving the vaccine. Cases of bowel obstruction were observed during

Rotashield trials, some of which were funded by Wyeth, but

investigators had

deemed them statistically insignificant.

 

In 2003, Wyeth got its fingers slightly burnt, when it tried to persuade a

wary public to take the FluMist nasally administered vaccine to guard

against the supposed coming influenza epidemic, which they and the US

government presented as a certainty. The vaccine was produced by MedImmune

and marketed by Wyeth. It was due to be sold through Wal-Mart, the world's

largest retailer, at almost $70 a shot. The budget for persuading

people to

use it was reckoned at $25 million over a two-and-a-half-month period.

As Dr Sherry Tenpenny pointed out in her article, 'Risks of FluMist

Vaccine', which appeared in the online vaccine conference at

redflagsdaily.com, the live-virus vaccine actually gave people flu.

What is

more, the packet instructions warned that recipients should 'avoid close

contact with immune-compromised individuals for at least 21 days'. Dr

Tenpenny suggested that untold millions of Americans were

immune-compromised. When neither the take-up of FluMist nor the hyped

epidemic materialised, Wyeth dumped MedImmune and abandoned the crusade to

free the world of flu.

 

Throughout the years 200 to 2004, Wyeth who, at the height of sales

controlled 70% of the market in HRT, has come under constant criticism

after

it advertised HRT as being useful to prevent heart disease, strokes and

alzheimers disease. The NHS backed Wyeth in all these claims answering

letters from MPs with bland assurances that HRT was of no danger to women

who took it.

 

Wyeth is not a rogue company in an industry ruled by probity and

philanthropy. It is, however, the fifth-largest purveyor of prescription

drugs to the NHS and is more deeply engaged than any other pharmaceutical

company in providing services such as primary care training programmes for

nurses and practice managers. The company also sponsor, train and fund

nurses in post licensing surveillance of vaccines. In giving, on its

website, examples of partnership work with the NHS, it presents itself as

though it were a professional health care company, rather than a

producer of

patent medicines. Its literature and website abound with homilies

about the

realised need for ethical behaviour and a responsible approach to selling

drugs to the NHS, but it is quite clear what NHS entry means to Wyeth.

While many patients, consumers and citizens will inevitably be adversely

affected by 'Big Pharma's' partnership with government, it is perhaps

democracy itself that will be the ultimate loser. Most people now

understand

that new Labour has slavishly followed North American politicians into

Lobbyworld. However, many voters will be even most concerned that non

-elected industry representatives, whose companies stand to earn

billions in

sales to the government, now seem to be setting the agenda on policies for

health.

 

The Commons Health Committee has been taking powerful submissions from,

among others, the Royal College of General Practitioners, who have charged

the industry with 'disease mongering'. But is the committee actually

facing

in the right direction and might it not be more appropriate to hold a

major

independent, judge led, enquiry into the comfortable financial relations

between Big Pharma and the British Government.

 

December 2004