New Labour and the Pharmaceutical Industry

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New Labour and the Pharmaceutical Industry

Thu, 23 Dec 2004 00:47:23 -0000

 

The Ghost Lobby - New Labour and the Pharmaceutical Industry

Health Freedom

 

 

By Martin Walker

 

" 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. . . .

 

. . . 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. . .

 

. . . 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 National Health

Service, 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. . .

 

. . . 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. . .

 

. . .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. "

 

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 Britain's 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 subterfuge, she

declaimed loudly about the political interests of new members but

failed to announce their financial or pharmaceutical 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 2000 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?

 

Posted on Tuesday, December 21, 2004 at 06:03 PM

 

Updated on Wednesday, December 22, 2004 at 10:27 AM

 

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