The drugs industry and its watchdog: a relationship too close for comfort?

[Guest guest]

This is mirrored in most government agencies and the industry they are

supposed to be regulating. The agencies for safe foods, safe water,

safe air, safe health care, civil liberties, etc seem each day to be doing more

the bidding of the people who they are supposed to be regulating. We have the

best politicians and government that (corporate) money can buy. F.

 

 

SSRI-Research@

Mon, 4 Oct 2004 20:41:55 -0400

The drugs industry and its watchdog: a relationship too close

for comfort?

 

 

 

http://www.guardian.co.uk/print/0,3858,5030704-103690,00.html

 

The drugs industry and its watchdog: a relationship too close for comfort?

 

Rob Evans and Sarah Boseley

Monday October 4, 2004

The Guardian

 

It would appear to be a happy and satisfying relationship. " Our

priorities are aligned, " says one document. There have been " notable

successes " says another, citing " another example " of where the two

sides " cooperated well " . In business partners, this would seem to

indicate a harmony of views. The documents obtained by the Guardian,

however, relate to meetings between the drug industry and the watchdog

body set up by government to police it. Critics say the drug regulator

and the industry are too close. Their proceedings have long been

shrouded in secrecy because of the drug companies' insistence on the

commercial sensitivity of information relating to their products.

Today, documents obtained by the Guardian under the open government

code reveal the reality of relations between the Medicines and

Healthcare products Regulatory Agency (MHRA) and the trade association

of the industry it regulates. The documents show that: · the regulator

and the industry have been engaged in a joint lobbying campaign in

Europe; · the industry privately drew up its own detailed blueprint of

how the MHRA should be run; · the industry has been pushing for higher

level representation at the MHRA against ministers' wishes.

 

Since 1989, when the then prime minister, Margaret Thatcher, took drug

regulation out of the hands of the Department of Health, the MHRA has

been 100% funded by the pharmaceutical companies. The MHRA's chief

executive, Kent Woods, appointed in January, has no drug company

background, but critics say the agency continues in the unquestioning

belief that the regulator and the industry are working together in the

mutual interests of public health. John Abraham, professor of

sociology at Sussex University, who is well respected for his books on

drug regulation, says that in 1989 there was a reconstruction of the

regulators' mission alongside the new fees relationship. The MHRA came

to believe the interests of public health are coherent with the

promotion of the industry. " The criticism of the old Department of

Health medicines department in the 70s was that it didn't have any

teeth. Not only does it now not have any teeth, but it is not

motivated to bite, " he said. The MHRA told the Commons health select

committee inquiry into the influence of the industry that it does not

consider the fee relationship to be a problem. " I would suggest to a

lay person there is a big problem with the concept of independence

from industry of a body that is fully funded by industry, " said

Professor Abraham. The UK's regulatory agency competes with those of

other countries to approve drugs for the whole of Europe.

 

But Professor Woods says that neither industry funding nor close

liaison is a problem. " It is important that the regulator understands

the regulated industry. " I have to say that our areas of overlapping

interests are not 100%. There are some things where we have common

cause but our prime responsibility is to ensure we protect public

health. These are aims which the industry shares. I don't think there

is a necessary antipathy between what the ABPI [The Association of the

British Pharmaceutical Industry] is trying to achieve and what we are

trying to achieve. But there are other areas in which we can't agree. "

Richard Ley, spokesman for the ABPI, denied that the ABPI had the MHRA

" in its pocket " . " The objective of the MHRA is to ensure that

medicines are assessed to be effective and as safe as possible. Those

are also our aims. We have an absolute desire to have good quality

medicines. " The documents record the regular meetings and dinners

between the MHRA and the ABPI over the past year.

 

Among the " notable successes " of its close collaboration with the

industry, the MHRA paper cited how it " cooperated well " with the trade

association to lobby other European governments and the European

commission on a review of legislation governing drug companies. It

was, according to the briefing paper, " another example where the

Association of the British Pharmaceutical Industry and the MHRA worked

closely together " . Minutes of a meeting between the ABPI and senior

MHRA officials in April record that the " ABPI thought there was a

remarkable concordance between MHRA and their priorities... " At their

meeting with the MHRA top officials in June, the ABPI presented an

eight-page blueprint detailing how it thinks the MHRA should be run to

" build upon the excellent working relationship " between the industry

and the regulator. According to this document, " our priorities are

aligned [ABPI/MHRA] " . Following this meeting, Nicky Lilliott, the

ABPI's head of regulatory affairs, wrote to Professor Woods, to

confirm that, as agreed, the ABPI would develop an action plan to

discuss a wide range of issues for the future of the agency. " I would

propose that over the summer the ABPI drafts an action plan and this

is then circulated to yourself and colleagues for comments, with the

intention to agree the action plan at our meeting in September. " " The

action plan would need assigned topic leaders, joint ABPI/MHRA, in

order to achieve the agreed objectives/milestones. The main driver for

the actions and timelines for these issues will be the implementation

(of) the new pharmaceutical legislation by October 2005 " . Professor

Woods said the action plan related to establishing a framework for

bilateral meetings. The documents show the ABPI is unhappy at proposed

changes to the structure of the MHRA. It used to have three people on

the ministerial advisory board and two on the Medicines Commission,

the drug licensing appeal body.

 

Pressure

 

In a letter to Professor Sir Alistair Breckenridge in January, Dr John

Patterson, the ABPI president, wrote: " We remain concerned at the lack

of representation of the pharmaceutical industry at board level within

the MHRA ... As the only regulatory agency that is fully

industry-funded, we believe it is essential that we have a say on a

variety of issues, not least financial matters relating to fees and

service levels. " After more pressure, MHRA officials discussed

alternative arrangements. Roy Alder, a senior MHRA official, suggested

in March that " there could be scope for industry to make a similar

input to MHRA business and operational policy " through other ways. He

wrote: " Ministers are clear that the MHRA board should have no current

industry people. There seems no option on this issue. " He suggested

someone recently retired from the industry could possibly be put on

the board, " but ministers may want to avoid any perception of industry

interests at board level. " The Committee on the Safety of Medicines

(CSM), made up of independent experts, advises the MHRA on which drugs

to license after studying clinical trial data on safety and efficacy.

 

Its members are supposed to declare any sponsorship or payments they

receive for lectures or advice from industry. The last complete

declaration of interests of CSM members, for 2001, shows 17 out of 36

members had personal financial links to the industry, while others

have declared non-personal interests such as research grants. The

documents show that industry has been agitated about ministers'

" unrealistic " plans to tighten the rules on conflicts of interests.

The ABPI complained ministers were " being too restrictive in the

requirement for experts to not hold any personal interests in the

pharmaceutical industry. " Professor Abraham claims there is too much

of the " revolving door " syndrome at the MHRA. Not only do CSM members

take fees from industry, but many agency officials used to work for

drug companies, such as the former head of worldwide drug safety at

GlaxoSmithKline, who is now the MHRA's head of licensing. · Tomorrow:

How drug companies pay to persuade doctors to prescribe their products

 

Guardian Unlimited © Guardian Newspapers Limited 2004