[Ip-health] Drug firms' lobby tactics revealed

[Ira Glazer]

http://politics.guardian.co.uk/print/0,,329587629-110251,00.html


Documents show how companies try to get new medicines fast-tracked

Rob Evans and Sarah Boseley
Thursday September 28, 2006

Multinational drug companies have been lobbying ministers in an attempt
to subvert the independent appraisal process and get their expensive new
medicines approved for large-scale use in the NHS, the Guardian can reveal.

Over the eight months from October to May this year, senior executives
from 10 drug companies met ministers to press for favourable decisions
on their products. The executives were highly critical of the National
Institute for Clinical Excellence (Nice), an independent expert body set
up to decide which drugs are cost-effective for use in the NHS.

Documents obtained by the Guardian under Freedom of Information
legislation reveal that:

=B7 The world's biggest drug company, Pfizer, warned ministers that it
could take its business elsewhere. "Pfizer ... noted that there is
complacency in some quarters of Whitehall regarding their continued
investment in the UK," the minutes of the meeting record.

Ministers later agreed to a special meeting where six companies could
lobby for their drugs for Alzheimer's disease.

=B7 Two companies lobbied ministers for wider access by patients to their
drugs, both of which were later turned down by Nice on the grounds that
they were not effective enough and too expensive.

The pharmaceutical industry is a major contributor to the UK economy.
Its total investment in research and development was more than =A33.4bn in
2004, which, a Whitehall briefing note points out, "represents around a
quarter of the UK's total manufacturing industry expenditure".

Decisions by Nice, set up seven years ago, are crucial for the
companies. It decides whether a drug should be universally available to
patients in the NHS. Chaired by Prof Sir Michael Rawlings, Nice draws on
scientific experts and consults doctors, patients, drug companies and
the Department of Health. The government invariably accepts its final
recommendations. Although ministers say they cannot influence Nice, the
documents reveal a constant stream of high-level visitors from drug
companies.

Manufacturers, led by Pfizer, have been complaining to ministers about
Nice's position on their controversial Alzheimer's drugs. Originally
Nice decided to allow them, then it reversed its position, saying they
should be used only for a minority of patients with moderate disease.

At a meeting in October with the minister, Pfizer executives made it
clear they "were unhappy with the Nice decision ... and thought their
processes were flawed". They requested a special meeting with ministers
where all the companies making Alzheimer's drugs could put their case.

The documents prepared by civil servants for the Pfizer meeting outline
the wealth and scale of the US company, which in 2004 had revenue of
$52.5bn (=A328bn) and a net income of over $11bn.

But, Pfizer executives warn the minister, it could always take its
business elsewhere. "Pfizer ... noted that there is complacency in some
quarters of Whitehall regarding their continued investment in the UK,"
the minutes record. "Pfizer asked for more public support from the
government for a robust pharmaceutical industry in the UK and more
consultation/dialogue with the government."

The subsequent meeting with all the companies took place in December.
The minister, Jane Kennedy, was confronted by eight managing directors,
vice-presidents and senior executives from six drug companies. The
executives lobbied hard for the Nice ruling to be overturned by the
government.

A memo reports the summing-up of Johnson & Johnson's vice-president
David Brickwood: "Nice should take into account what the companies see
as the overwhelming views of patients, carers and clinicians on the
efficacy of the drugs."

In a statement, Pfizer said it "regularly meets with key stakeholders,
including government ministers, to keep them up to date with issues
relating to our business". A variety of topics were discussed, it said.

"Nice and health technology assessment remains a topical issue coupled
with the proposed ban on medicines for mild Alzheimer's disease. We
believe this is the wrong decision and have appealed along with other
manufacturers of anti-dementia medicines."

In February, Eli Lilly lobbied hard for its drug Alimta, designed to
treat the asbestos-linked cancer mesothelioma. Its executives gave a
presentation to Ms Kennedy, incorporating newspaper cuttings claiming
that cancer victims were dying for want of the drug. The minister agreed
that there should be a high-level meeting between her ministry and the
Department for Work and Pensions.

But in June, Nice said there was insufficient evidence to show that
Alimta was better than other cheaper treatments, recommending that the
NHS should not use it. A Lilly spokesman said it was legitimate for the
company to make representations to the DoH but it was not seeking to
undermine Nice. "We are fully engaged and committed to the Nice
process," he said

Pressure was brought to bear on ministers by another company, Johnson &
Johnson, over its bone cancer drug Velcade. A briefing for Ms Kennedy
before a meeting with the company's executives in November says:
"Johnson & Johnson have written to the Department of Health numerous
times over the past 12 months about Velcade." The company wanted its
drug fast-tracked for approval by Nice.

Velcade was one of the five drugs Nice was asked by ministers to handle
through its new fast-track procedure. But Nice's appraisal committee has
given a preliminary opinion that it is not suitable for use in the NHS.

A Johnson and Johnson spokesman said the company was not trying to
"unduly influence" Nice but it was legitimate to seek to persuade
ministers to speed up the appraisal of Velcade. The company did not want
to comment on its lobbying over Alzheimer's drugs.

In May, the health minister Andy Burnham met Peter Dolan, then chief
executive of Bristol-Myers Squibb and chairman of the Pharmaceutical
Research and Manufacturers of America (PhRMA), the powerful industry
body in the US, which has been highly critical of Nice.

Richard Marsh, director of external affairs at Bristol-Myers Squibb, who
also attended the meeting, told the Guardian that his company had wanted
to raise a number of issues, including Nice, with the minister.

"Companies have a legitimate interest in getting the best for their
products and getting a positive appraisal by Nice. Where they have an
opportunity to raise issues with ministers, they can do that ... It may
be that Nice has genuinely got a blind spot about something and a
legitimate point can be made to ministers. I don't think the Nice
process is necessarily undermined. It is up to the minister what they do
with that information." He added that companies wanted to invest in
countries with a "favourable environment".