UK House of Commons Phama Inquiry (hurrah!!)

[Guest guest]

An Inquiry by the UK House of Commons Health Select Committee into the

Influence of the Pharmaceutical Industry

Margaret

28th October 2004

Given the well-known and long-term involvement with the pharmaceutical

industry of certain medical advisers prominent in the ME world, the

international ME community may be interested in this Inquiry. The House of

Commons Health Select Committee under the chairmanship of

Hinchliffe

MP is taking submissions and hearing oral evidence detailing concerns about

the power, bias and influence of the pharmaceutical industry (and flowing

from this, upon those doctors who are financially linked to it) and the

effect of such influence upon patients. There have already been two

evidence sessions and there is to be another on 11th November 2004 at

which

various Royal Colleges (including the Royal College of Psychiatrists) will

be giving evidence, with the possibility of a further evidence session in

December. The Inquiry is held in the Room at Portcullis House, just

across the road from the House of Commons. There has been great interest

in

this Inquiry, with the room being packed. The Select Committee Report is

not expected before Christmas.

The Clerk to the Committee can be contacted on 0207-219-6182. Reports of

this Select Committee, minutes of the oral evidence and press notices can be

accessed at

www.parliament.uk/parliamentary_committees/health_committee.cfm

The written submissions from many interested parties and the transcripts of

the oral evidence make lengthy and disturbing reading.

In conjunction with this Inquiry, there is to be a Conference in London on

4th November 2004 at Friends House, 173 Euston Road from 9am - 5 pm at

which

some of those who gave evidence to the Select Committee Inquiry will be

speaking. Another speaker will be the internationally renowned author and

psychologist Dr Dorothy Rowe (contact millie@a... or telephone

01992-813111). The conference will provide a forum for sharing knowledge

and

will be a rare opportunity for communication between the industry, research

analysts, health care professionals, regulators, policy makers and the

public.

On 11th September 2004 the BMJ published a piece by Ray Moynihan setting

out

the response of the pharmaceutical industry to this parliamentary Inquiry:

" The House of Commons Health Committee is investigating drug companies'

influence on medical research, the education of doctors, health information

and drug evaluation. It will specifically look at the industry's influence

on the NHS, the National Institute for Clinical Excellence (NICE) and other

regulatory authorities, universities, professional societies and the media.

For its part, the Association of the British Pharmaceutical Industry (ABPI)

strongly cautioned the committee against tougher restrictions on the

industry's communications and marketing " .

Without doubt, this is an explosive issue. Evidence given to the Health

Select Committee told of payments to medical consultants by the

pharmaceutical industry of £5,000 plus expenses for a one hour talk (with

the audience being unaware that speakers were in the pay of the industry)

and of senior doctors receiving consultancy fees from drug companies of

more

than £20,000 for a few hours' work. A senior consultant (Dr

Wilmshurst, consultant cardiologist, Royal Shrewsbury Hospital) told the

Inquiry that this was common practice, and that the sums offered to him for

a few hours work were £22,000, this being the level of payment made by drug

companies to consultants such as himself, but professors could earn

" considerably more " . The same consultant told the Inquiry he had been

offered a bribe of two years' salary not to publish research on a new drug

that was not in the interests of the drug company that produced it.

MPs were informed that the industry arranged for doctors in their pay to

receive free massage and to have their portrait painted, and that the most

important " opinion-leaders " are taken abroad by drug companies and offered

fees for consultancy work.

MPs were told that family doctors' practices can make profits of over

£50,000 per year from drug companies and that doctors are inundated with

gifts from the pharmaceutical industry. Professor Healy, Head of

Psychological Medicine, University of Cardiff, said " People like me come out

of meeting halls with our arms stuffed full of bags of free gifts " .

Explaining about such payments, Professor Healy said: " The industry is very

clever at how they organise these things. If I am working in a consultant

capacity for one of the pharmaceutical companies, I will have had media

training often. Let's say some issue blows up and the media gets told 'You

can approach Dr Healy'. I will be able to say, and the media and the

pharmaceutical company will be able to say, 'No money passed hands'. The

money comes from elsewhere; it actually comes from the trips to the

Caribbean; it comes from being asked to chair meetings which involve no

work

at all; it comes from having my papers written for me and then I am paid as

though I have written the papers. That is where the money comes from " .

The Select Committee heard of the efforts made by the industry to persuade

general practitioners to use products by arranging for the country's leading

medical experts ( " opinion leaders " in various medical disciplines) to put

their name to reports that endorse products and strategies, even though the

leading experts had not written the articles concerned. This practice,

known as " ghost-writing " , is very common. Professor Healy told MPs that

doctors maintain they are not influenced by the free gifts but are

influenced by " evidence " , and that this " evidence " now consists of articles

that have been ghost-written, so that when the industry representatives come

round, they not only dispense free gifts but also a sheaf of articles. The

problem is that such ghost-written articles (handsomely paid for by the

industry) do not represent the raw data but do influence physicians (who

believe them to be " evidence-based medicine " ).

Committee member Dr Doug Naysmith asked Professor Healy: " Are you

suggesting

that eminent clinical scientists, academics, add their names to papers that

they do not really write? " , to which Professor Healy replied: " My estimate

is that, even in journals like the BMJ, the Lancet, The New England Journal

of Medicine and JAMA, it may be worse for psychiatry than elsewhere, fifty

percent of these articles are ghost-written. It may be higher. (The) most

distinguished authors from the most prestigious universities are approached

precisely because they are the most distinguished authors from the most

prestigious universities " . Dr Naysmith's response was " This is pretty

disturbing stuff " .

The Chairman asked " Do people not see through what is going on? " , to which

Dr Wilmshurst replied " People do not always know, because people do not

always declare their conflicts of interest. Some people were earning

considerably more from individual pharmaceutical companies by talking for

them every fortnight, twice a month, than they were earning from the

university or the NHS that they work for " .

When asked about the role of the Royal Colleges in relation to the improper

publishing by the industry, Emeritus Professor Herxheimer (medical

pharmacologist) said " I think that the Royal Colleges are not really set up

in a way that would make that straightforward " , and Professor Healy said

" You are trying to force a financial camel through the eye of a scientific

needle...this comes close to fraud " .

Concerning the influence of the industry on research, Dr Wilmshurst was

explicit: " I think the pharmaceutical industry influences the research that

is published " . He went on to provide evidence of outright fraud, telling of

a drug company that had actually altered the clinical record cards detailing

side effects of a drug, which the company omitted entirely before providing

information to a regulator in The Netherlands, and that documents sent to

The Netherlands by the drug company were a forgery. Asked how

commonplace

such forgery was, Dr Wilmshurst replied: " I suspect it is as common now as

it ever was, and I think it was very common " .

On the issue of medical research, the issue of publication bias and the use

of editorial " spin " was raised by Dr Des Spence, a GP from Milngavie,

Glasgow, who questioned why the results from the industry are more likely to

show a positive outcome than those sponsored by no profit organisations.

On the issue of medical education, Dr Spence submitted that 'Promotional

hospitality masquerading as education' is the best description of the

current provision of education by the industry to the NHS. Unfortunately

this education for professionals is skewed with agenda setting by the

industry and with speakers paid directly by the industry. The written

material provided by the industry that is relied upon by many doctors lacks

a strong evidence base " .

Regarding medical education, Dr Wilmshurst gave evidence about the major

impact of the industry in this field: " There is a requirement for people to

undertake a certain number of hours of medical education, 50 hours a year,

and most of that is funded by industry, directly or indirectly. Whenever I

go to a lecture at the postgraduate institute in my hospital, the room hire

is paid by a drug company, as are the meals that you get. Next week there

is a conference at the Royal College of Physicians, at which the key speaker

is the Deputy Chief Medical Officer, and industry sponsors that meeting: it

is £2,000 a time to have your logo on the bag; £6,000 a time to sponsor part

of the cocktail reception. Presumably, the NHS is happy that industry

sponsors " (sic).

Asked what proportion of continuing professional education is typically

funded by the industry, Dr Wilmshurst replied " Ninety per cent plus " , and

Professor Healy said " There are virtually no state-funded clinical trials

here in the UK, This is probably very, very important " .

In relation to frequency of doctors' contact with the industry, Dr Spence

said it could be on a daily basis: " Often, certainly in the areas I work

in, they provide lunch on a daily basis to many of the doctors and nurses in

the area " .

Not only the common practices that pervade the pharmaceutical industry but

also the cosy relationship between it and Government are in the spotlight,

as is the failure of the regulatory body tasked with protecting the public

(the Medicines and Healthcare products Regulatory Agency -- the MHRA,

previously called the Medicines Control Agency or MCA and also the

Committee

on the Safety of Medicine or CSM).

Submissions were received which disclosed that in order to prevent

whistle-blowing, the industry relied on threats of legal action to strike

fear into civil servants working in the regulatory authorities that were

supposed to be safeguarding the public.

In his written submission, Professor Herxheimer stated " The influence of

the industry on medical practice and on the regulation of medicine is

perverse, overwhelming and relentless " .

He continued: " Close collaboration between industry, ministers and civil

servants on the principles and details of regulatory policies has continued.

During all this time the Ministry of Health and its successors, the DHSS and

the DoH have been the sponsoring Department for the pharmaceutical

industry,

whilst of course being its biggest consumer. Over the years, many personal

relationships have grown between regulatory officials and the staff of

pharmaceutical companies. Similarly comfortable contacts have existed

between many of the members of the Committee on Safety of Medicines and

the

industry, and this continues. The influence of the industry on medical

practice is enormous, but largely intangible and unseen " .

One member of the Select Committee, Dr , said: " We have had

such universal condemnation of the MHRA, the only question is, should it be

abolished? "

It was asked why there are no lawyers, or people from the Consumers'

Association (Which?) on regulatory bodies and Professor Herxheimer

provided

the answer: " the regulators are funded by industry " .

Dr Spence encapsulated the issues succinctly as being: " the current

relationship between the industry, health care professionals and government

as a whole. It is that close relationship that gives them an undue sway

over the health agenda " .

He said " I can tell you that I know hundreds of doctors and I know what the

industry is like on the ground: (it) is unbelievably vociferous and active

in promoting its own message. The amount of hospitality received by the

medical profession compared to other public services is, in my view, a

complete disgrace " .

The Inquiry was told by Dr Spence that those he represented (The No Free

Lunch Organisation) certainly believed that the industry has a major

influence over health care policy and that it has a " very clear agenda,

which is predominantly that of profit " and that this agenda is " in direct

conflict with the responsibilities of the NHS " . He informed the Inquiry

that the industry is worth £9 billion per year and said: " The pharmaceutical

industry has been the most profitable industry throughout the 1990s. They

are unbelievably profitable " .

Dr Wilmshurst said " I think there are the issues around the influence on

doctors, but there is also a more important influence, and that is the

influence on government " . Asked about this, Dr Wilmshurst said " I had a

meeting with the Chief Medical Officer two years ago and gave him other

examples of serious research misconduct. I have written to him repeatedly

since then asking what he has done about it, and I get a postcard

acknowledging my letter " .

The Inquiry also heard evidence about the deliberate creation by the

industry of so-called " lifestyle " conditions that could lead to unnecessary

use of medicines and to distorted prescribing behaviour and it heard of the

indoctrination of the public that they need drugs (such as anti-depressants)

in order to cope with their lives.

It also took evidence of the move to make ever more drugs available by

" Direct to Consumer Advertising " (DTCA), currently permitted in only two

developed countries (the US and New Zealand.

The Select Committee took evidence about the re-marketing by the industry

of

old generic drugs under new names (with the new named drugs being far

more

expensive), which are advertised by the industry as being of superior

efficacy or safety when there is no evidence of this.

One submission to the Inquiry was from a group of consultant psychiatrists

calling itself " Critical Psychiatry Network " ; it was founded in Bradford in

1999 and the submission bears the name of a Dr Philip . Whilst the

submission will raise a few hackles within the ME community (for example,

the belief of its members that " the practice of psychiatry must recognise

the primacy of social, cultural, economic and political contexts " and the

fact that members " disagree with the emphasis placed on biological research

and treatments " ), nevertheless the submission states what the ME community

knows only too well: " The problems of definition and validation of illness

in psychiatry mean that the field is more open to manipulation by commercial

interest than other areas of medicine. Psychiatry is unlike any other

branch of medicine in that patients may be compelled to take medication for

lengthy periods of time against their consent. The government is about to

introduce new legislation to replace the 1983 Mental Health Act, in which

these powers of compulsion will be extended into the community. This

change

in the law has major ethical implications. Perhaps more so than any branch

of medicine, psychiatry is open to the influence of external interests.

This can be seen in the influence that the industry has on the design,

conduct and reporting of psychiatric research. We are deeply concerned

about the influence of the pharmaceutical company representatives in

shaping

the opinions of mental health professionals. Their work represents the

triumph of the science of marketing over the marketing of science " .

The involvement of patient charities with the industry was also under

scrutiny, with the Consumers' Association submission stating: " while some

have a clear and accessible policy on their links with the industry, in

general there is a distinct lack of transparency about such relationships " .

The same submission states: " Charities, particularly smaller ones that are

less well funded, need to be protected from exploitation. We understand the

Long-term Medical Conditions Alliance is intending to revise its own

guidelines " .

In his written submission Dr Spence raised the same issue: " We are

concerned

about motivation of the pharmaceutical industry involvement with patient

advocacy groups " .

The use of public relations (PR) companies and other " creative techniques "

employed by the pharmaceutical industry was exposed to the Inquiry,

including the use in promotional campaigns of celebrities who subsequently

denied any knowledge of the lobby group.

Significantly, the written submission on behalf of The Consumers'

Association states: " We have a particular interest in consumer involvement

at all levels of decision-making: CA has researched and published reports

on the outcome of a CA inquiry into how well NICE works from the patient

perspective. Protecting the public and consumer interest must be at the

heart of any regulator's powers, decision-making and actions. Parliamentary

scrutiny is necessary, but not sufficient, to ensuring regulators are

publicly accountable " .

In his written submission, Professor Healy was blunt: " Every patient who

enters a clinical trial in the United Kingdom is putting every Member of

Parliament in a state of legal jeopardy " .

Members of the Select Committee are on record as being " horrified " by the

evidence they heard (see " Drug companies are accused of putting patients'

lives at risk " by Colin Brown, Deputy Political Editor, The Independent,

15th October 2004).

The evidence to be presented at the next session and the publication of the

Health Committee's Report on the influence of the pharmaceutical industry

are awaited with keen interest.

[Guest guest]

An Inquiry by the UK House of Commons Health Select Committee into the

Influence of the Pharmaceutical Industry

Margaret

28th October 2004

Given the well-known and long-term involvement with the pharmaceutical

industry of certain medical advisers prominent in the ME world, the

international ME community may be interested in this Inquiry. The House of

Commons Health Select Committee under the chairmanship of

Hinchliffe

MP is taking submissions and hearing oral evidence detailing concerns about

the power, bias and influence of the pharmaceutical industry (and flowing

from this, upon those doctors who are financially linked to it) and the

effect of such influence upon patients. There have already been two

evidence sessions and there is to be another on 11th November 2004 at

which

various Royal Colleges (including the Royal College of Psychiatrists) will

be giving evidence, with the possibility of a further evidence session in

December. The Inquiry is held in the Room at Portcullis House, just

across the road from the House of Commons. There has been great interest

in

this Inquiry, with the room being packed. The Select Committee Report is

not expected before Christmas.

The Clerk to the Committee can be contacted on 0207-219-6182. Reports of

this Select Committee, minutes of the oral evidence and press notices can be

accessed at

www.parliament.uk/parliamentary_committees/health_committee.cfm

The written submissions from many interested parties and the transcripts of

the oral evidence make lengthy and disturbing reading.

In conjunction with this Inquiry, there is to be a Conference in London on

4th November 2004 at Friends House, 173 Euston Road from 9am - 5 pm at

which

some of those who gave evidence to the Select Committee Inquiry will be

speaking. Another speaker will be the internationally renowned author and

psychologist Dr Dorothy Rowe (contact millie@a... or telephone

01992-813111). The conference will provide a forum for sharing knowledge

and

will be a rare opportunity for communication between the industry, research

analysts, health care professionals, regulators, policy makers and the

public.

On 11th September 2004 the BMJ published a piece by Ray Moynihan setting

out

the response of the pharmaceutical industry to this parliamentary Inquiry:

" The House of Commons Health Committee is investigating drug companies'

influence on medical research, the education of doctors, health information

and drug evaluation. It will specifically look at the industry's influence

on the NHS, the National Institute for Clinical Excellence (NICE) and other

regulatory authorities, universities, professional societies and the media.

For its part, the Association of the British Pharmaceutical Industry (ABPI)

strongly cautioned the committee against tougher restrictions on the

industry's communications and marketing " .

Without doubt, this is an explosive issue. Evidence given to the Health

Select Committee told of payments to medical consultants by the

pharmaceutical industry of £5,000 plus expenses for a one hour talk (with

the audience being unaware that speakers were in the pay of the industry)

and of senior doctors receiving consultancy fees from drug companies of

more

than £20,000 for a few hours' work. A senior consultant (Dr

Wilmshurst, consultant cardiologist, Royal Shrewsbury Hospital) told the

Inquiry that this was common practice, and that the sums offered to him for

a few hours work were £22,000, this being the level of payment made by drug

companies to consultants such as himself, but professors could earn

" considerably more " . The same consultant told the Inquiry he had been

offered a bribe of two years' salary not to publish research on a new drug

that was not in the interests of the drug company that produced it.

MPs were informed that the industry arranged for doctors in their pay to

receive free massage and to have their portrait painted, and that the most

important " opinion-leaders " are taken abroad by drug companies and offered

fees for consultancy work.

MPs were told that family doctors' practices can make profits of over

£50,000 per year from drug companies and that doctors are inundated with

gifts from the pharmaceutical industry. Professor Healy, Head of

Psychological Medicine, University of Cardiff, said " People like me come out

of meeting halls with our arms stuffed full of bags of free gifts " .

Explaining about such payments, Professor Healy said: " The industry is very

clever at how they organise these things. If I am working in a consultant

capacity for one of the pharmaceutical companies, I will have had media

training often. Let's say some issue blows up and the media gets told 'You

can approach Dr Healy'. I will be able to say, and the media and the

pharmaceutical company will be able to say, 'No money passed hands'. The

money comes from elsewhere; it actually comes from the trips to the

Caribbean; it comes from being asked to chair meetings which involve no

work

at all; it comes from having my papers written for me and then I am paid as

though I have written the papers. That is where the money comes from " .

The Select Committee heard of the efforts made by the industry to persuade

general practitioners to use products by arranging for the country's leading

medical experts ( " opinion leaders " in various medical disciplines) to put

their name to reports that endorse products and strategies, even though the

leading experts had not written the articles concerned. This practice,

known as " ghost-writing " , is very common. Professor Healy told MPs that

doctors maintain they are not influenced by the free gifts but are

influenced by " evidence " , and that this " evidence " now consists of articles

that have been ghost-written, so that when the industry representatives come

round, they not only dispense free gifts but also a sheaf of articles. The

problem is that such ghost-written articles (handsomely paid for by the

industry) do not represent the raw data but do influence physicians (who

believe them to be " evidence-based medicine " ).

Committee member Dr Doug Naysmith asked Professor Healy: " Are you

suggesting

that eminent clinical scientists, academics, add their names to papers that

they do not really write? " , to which Professor Healy replied: " My estimate

is that, even in journals like the BMJ, the Lancet, The New England Journal

of Medicine and JAMA, it may be worse for psychiatry than elsewhere, fifty

percent of these articles are ghost-written. It may be higher. (The) most

distinguished authors from the most prestigious universities are approached

precisely because they are the most distinguished authors from the most

prestigious universities " . Dr Naysmith's response was " This is pretty

disturbing stuff " .

The Chairman asked " Do people not see through what is going on? " , to which

Dr Wilmshurst replied " People do not always know, because people do not

always declare their conflicts of interest. Some people were earning

considerably more from individual pharmaceutical companies by talking for

them every fortnight, twice a month, than they were earning from the

university or the NHS that they work for " .

When asked about the role of the Royal Colleges in relation to the improper

publishing by the industry, Emeritus Professor Herxheimer (medical

pharmacologist) said " I think that the Royal Colleges are not really set up

in a way that would make that straightforward " , and Professor Healy said

" You are trying to force a financial camel through the eye of a scientific

needle...this comes close to fraud " .

Concerning the influence of the industry on research, Dr Wilmshurst was

explicit: " I think the pharmaceutical industry influences the research that

is published " . He went on to provide evidence of outright fraud, telling of

a drug company that had actually altered the clinical record cards detailing

side effects of a drug, which the company omitted entirely before providing

information to a regulator in The Netherlands, and that documents sent to

The Netherlands by the drug company were a forgery. Asked how

commonplace

such forgery was, Dr Wilmshurst replied: " I suspect it is as common now as

it ever was, and I think it was very common " .

On the issue of medical research, the issue of publication bias and the use

of editorial " spin " was raised by Dr Des Spence, a GP from Milngavie,

Glasgow, who questioned why the results from the industry are more likely to

show a positive outcome than those sponsored by no profit organisations.

On the issue of medical education, Dr Spence submitted that 'Promotional

hospitality masquerading as education' is the best description of the

current provision of education by the industry to the NHS. Unfortunately

this education for professionals is skewed with agenda setting by the

industry and with speakers paid directly by the industry. The written

material provided by the industry that is relied upon by many doctors lacks

a strong evidence base " .

Regarding medical education, Dr Wilmshurst gave evidence about the major

impact of the industry in this field: " There is a requirement for people to

undertake a certain number of hours of medical education, 50 hours a year,

and most of that is funded by industry, directly or indirectly. Whenever I

go to a lecture at the postgraduate institute in my hospital, the room hire

is paid by a drug company, as are the meals that you get. Next week there

is a conference at the Royal College of Physicians, at which the key speaker

is the Deputy Chief Medical Officer, and industry sponsors that meeting: it

is £2,000 a time to have your logo on the bag; £6,000 a time to sponsor part

of the cocktail reception. Presumably, the NHS is happy that industry

sponsors " (sic).

Asked what proportion of continuing professional education is typically

funded by the industry, Dr Wilmshurst replied " Ninety per cent plus " , and

Professor Healy said " There are virtually no state-funded clinical trials

here in the UK, This is probably very, very important " .

In relation to frequency of doctors' contact with the industry, Dr Spence

said it could be on a daily basis: " Often, certainly in the areas I work

in, they provide lunch on a daily basis to many of the doctors and nurses in

the area " .

Not only the common practices that pervade the pharmaceutical industry but

also the cosy relationship between it and Government are in the spotlight,

as is the failure of the regulatory body tasked with protecting the public

(the Medicines and Healthcare products Regulatory Agency -- the MHRA,

previously called the Medicines Control Agency or MCA and also the

Committee

on the Safety of Medicine or CSM).

Submissions were received which disclosed that in order to prevent

whistle-blowing, the industry relied on threats of legal action to strike

fear into civil servants working in the regulatory authorities that were

supposed to be safeguarding the public.

In his written submission, Professor Herxheimer stated " The influence of

the industry on medical practice and on the regulation of medicine is

perverse, overwhelming and relentless " .

He continued: " Close collaboration between industry, ministers and civil

servants on the principles and details of regulatory policies has continued.

During all this time the Ministry of Health and its successors, the DHSS and

the DoH have been the sponsoring Department for the pharmaceutical

industry,

whilst of course being its biggest consumer. Over the years, many personal

relationships have grown between regulatory officials and the staff of

pharmaceutical companies. Similarly comfortable contacts have existed

between many of the members of the Committee on Safety of Medicines and

the

industry, and this continues. The influence of the industry on medical

practice is enormous, but largely intangible and unseen " .

One member of the Select Committee, Dr , said: " We have had

such universal condemnation of the MHRA, the only question is, should it be

abolished? "

It was asked why there are no lawyers, or people from the Consumers'

Association (Which?) on regulatory bodies and Professor Herxheimer

provided

the answer: " the regulators are funded by industry " .

Dr Spence encapsulated the issues succinctly as being: " the current

relationship between the industry, health care professionals and government

as a whole. It is that close relationship that gives them an undue sway

over the health agenda " .

He said " I can tell you that I know hundreds of doctors and I know what the

industry is like on the ground: (it) is unbelievably vociferous and active

in promoting its own message. The amount of hospitality received by the

medical profession compared to other public services is, in my view, a

complete disgrace " .

The Inquiry was told by Dr Spence that those he represented (The No Free

Lunch Organisation) certainly believed that the industry has a major

influence over health care policy and that it has a " very clear agenda,

which is predominantly that of profit " and that this agenda is " in direct

conflict with the responsibilities of the NHS " . He informed the Inquiry

that the industry is worth £9 billion per year and said: " The pharmaceutical

industry has been the most profitable industry throughout the 1990s. They

are unbelievably profitable " .

Dr Wilmshurst said " I think there are the issues around the influence on

doctors, but there is also a more important influence, and that is the

influence on government " . Asked about this, Dr Wilmshurst said " I had a

meeting with the Chief Medical Officer two years ago and gave him other

examples of serious research misconduct. I have written to him repeatedly

since then asking what he has done about it, and I get a postcard

acknowledging my letter " .

The Inquiry also heard evidence about the deliberate creation by the

industry of so-called " lifestyle " conditions that could lead to unnecessary

use of medicines and to distorted prescribing behaviour and it heard of the

indoctrination of the public that they need drugs (such as anti-depressants)

in order to cope with their lives.

It also took evidence of the move to make ever more drugs available by

" Direct to Consumer Advertising " (DTCA), currently permitted in only two

developed countries (the US and New Zealand.

The Select Committee took evidence about the re-marketing by the industry

of

old generic drugs under new names (with the new named drugs being far

more

expensive), which are advertised by the industry as being of superior

efficacy or safety when there is no evidence of this.

One submission to the Inquiry was from a group of consultant psychiatrists

calling itself " Critical Psychiatry Network " ; it was founded in Bradford in

1999 and the submission bears the name of a Dr Philip . Whilst the

submission will raise a few hackles within the ME community (for example,

the belief of its members that " the practice of psychiatry must recognise

the primacy of social, cultural, economic and political contexts " and the

fact that members " disagree with the emphasis placed on biological research

and treatments " ), nevertheless the submission states what the ME community

knows only too well: " The problems of definition and validation of illness

in psychiatry mean that the field is more open to manipulation by commercial

interest than other areas of medicine. Psychiatry is unlike any other

branch of medicine in that patients may be compelled to take medication for

lengthy periods of time against their consent. The government is about to

introduce new legislation to replace the 1983 Mental Health Act, in which

these powers of compulsion will be extended into the community. This

change

in the law has major ethical implications. Perhaps more so than any branch

of medicine, psychiatry is open to the influence of external interests.

This can be seen in the influence that the industry has on the design,

conduct and reporting of psychiatric research. We are deeply concerned

about the influence of the pharmaceutical company representatives in

shaping

the opinions of mental health professionals. Their work represents the

triumph of the science of marketing over the marketing of science " .

The involvement of patient charities with the industry was also under

scrutiny, with the Consumers' Association submission stating: " while some

have a clear and accessible policy on their links with the industry, in

general there is a distinct lack of transparency about such relationships " .

The same submission states: " Charities, particularly smaller ones that are

less well funded, need to be protected from exploitation. We understand the

Long-term Medical Conditions Alliance is intending to revise its own

guidelines " .

In his written submission Dr Spence raised the same issue: " We are

concerned

about motivation of the pharmaceutical industry involvement with patient

advocacy groups " .

The use of public relations (PR) companies and other " creative techniques "

employed by the pharmaceutical industry was exposed to the Inquiry,

including the use in promotional campaigns of celebrities who subsequently

denied any knowledge of the lobby group.

Significantly, the written submission on behalf of The Consumers'

Association states: " We have a particular interest in consumer involvement

at all levels of decision-making: CA has researched and published reports

on the outcome of a CA inquiry into how well NICE works from the patient

perspective. Protecting the public and consumer interest must be at the

heart of any regulator's powers, decision-making and actions. Parliamentary

scrutiny is necessary, but not sufficient, to ensuring regulators are

publicly accountable " .

In his written submission, Professor Healy was blunt: " Every patient who

enters a clinical trial in the United Kingdom is putting every Member of

Parliament in a state of legal jeopardy " .

Members of the Select Committee are on record as being " horrified " by the

evidence they heard (see " Drug companies are accused of putting patients'

lives at risk " by Colin Brown, Deputy Political Editor, The Independent,

15th October 2004).

The evidence to be presented at the next session and the publication of the

Health Committee's Report on the influence of the pharmaceutical industry

are awaited with keen interest.

[Guest guest]

An Inquiry by the UK House of Commons Health Select Committee into the

Influence of the Pharmaceutical Industry

Margaret

28th October 2004

Given the well-known and long-term involvement with the pharmaceutical

industry of certain medical advisers prominent in the ME world, the

international ME community may be interested in this Inquiry. The House of

Commons Health Select Committee under the chairmanship of

Hinchliffe

MP is taking submissions and hearing oral evidence detailing concerns about

the power, bias and influence of the pharmaceutical industry (and flowing

from this, upon those doctors who are financially linked to it) and the

effect of such influence upon patients. There have already been two

evidence sessions and there is to be another on 11th November 2004 at

which

various Royal Colleges (including the Royal College of Psychiatrists) will

be giving evidence, with the possibility of a further evidence session in

December. The Inquiry is held in the Room at Portcullis House, just

across the road from the House of Commons. There has been great interest

in

this Inquiry, with the room being packed. The Select Committee Report is

not expected before Christmas.

The Clerk to the Committee can be contacted on 0207-219-6182. Reports of

this Select Committee, minutes of the oral evidence and press notices can be

accessed at

www.parliament.uk/parliamentary_committees/health_committee.cfm

The written submissions from many interested parties and the transcripts of

the oral evidence make lengthy and disturbing reading.

In conjunction with this Inquiry, there is to be a Conference in London on

4th November 2004 at Friends House, 173 Euston Road from 9am - 5 pm at

which

some of those who gave evidence to the Select Committee Inquiry will be

speaking. Another speaker will be the internationally renowned author and

psychologist Dr Dorothy Rowe (contact millie@a... or telephone

01992-813111). The conference will provide a forum for sharing knowledge

and

will be a rare opportunity for communication between the industry, research

analysts, health care professionals, regulators, policy makers and the

public.

On 11th September 2004 the BMJ published a piece by Ray Moynihan setting

out

the response of the pharmaceutical industry to this parliamentary Inquiry:

" The House of Commons Health Committee is investigating drug companies'

influence on medical research, the education of doctors, health information

and drug evaluation. It will specifically look at the industry's influence

on the NHS, the National Institute for Clinical Excellence (NICE) and other

regulatory authorities, universities, professional societies and the media.

For its part, the Association of the British Pharmaceutical Industry (ABPI)

strongly cautioned the committee against tougher restrictions on the

industry's communications and marketing " .

Without doubt, this is an explosive issue. Evidence given to the Health

Select Committee told of payments to medical consultants by the

pharmaceutical industry of £5,000 plus expenses for a one hour talk (with

the audience being unaware that speakers were in the pay of the industry)

and of senior doctors receiving consultancy fees from drug companies of

more

than £20,000 for a few hours' work. A senior consultant (Dr

Wilmshurst, consultant cardiologist, Royal Shrewsbury Hospital) told the

Inquiry that this was common practice, and that the sums offered to him for

a few hours work were £22,000, this being the level of payment made by drug

companies to consultants such as himself, but professors could earn

" considerably more " . The same consultant told the Inquiry he had been

offered a bribe of two years' salary not to publish research on a new drug

that was not in the interests of the drug company that produced it.

MPs were informed that the industry arranged for doctors in their pay to

receive free massage and to have their portrait painted, and that the most

important " opinion-leaders " are taken abroad by drug companies and offered

fees for consultancy work.

MPs were told that family doctors' practices can make profits of over

£50,000 per year from drug companies and that doctors are inundated with

gifts from the pharmaceutical industry. Professor Healy, Head of

Psychological Medicine, University of Cardiff, said " People like me come out

of meeting halls with our arms stuffed full of bags of free gifts " .

Explaining about such payments, Professor Healy said: " The industry is very

clever at how they organise these things. If I am working in a consultant

capacity for one of the pharmaceutical companies, I will have had media

training often. Let's say some issue blows up and the media gets told 'You

can approach Dr Healy'. I will be able to say, and the media and the

pharmaceutical company will be able to say, 'No money passed hands'. The

money comes from elsewhere; it actually comes from the trips to the

Caribbean; it comes from being asked to chair meetings which involve no

work

at all; it comes from having my papers written for me and then I am paid as

though I have written the papers. That is where the money comes from " .

The Select Committee heard of the efforts made by the industry to persuade

general practitioners to use products by arranging for the country's leading

medical experts ( " opinion leaders " in various medical disciplines) to put

their name to reports that endorse products and strategies, even though the

leading experts had not written the articles concerned. This practice,

known as " ghost-writing " , is very common. Professor Healy told MPs that

doctors maintain they are not influenced by the free gifts but are

influenced by " evidence " , and that this " evidence " now consists of articles

that have been ghost-written, so that when the industry representatives come

round, they not only dispense free gifts but also a sheaf of articles. The

problem is that such ghost-written articles (handsomely paid for by the

industry) do not represent the raw data but do influence physicians (who

believe them to be " evidence-based medicine " ).

Committee member Dr Doug Naysmith asked Professor Healy: " Are you

suggesting

that eminent clinical scientists, academics, add their names to papers that

they do not really write? " , to which Professor Healy replied: " My estimate

is that, even in journals like the BMJ, the Lancet, The New England Journal

of Medicine and JAMA, it may be worse for psychiatry than elsewhere, fifty

percent of these articles are ghost-written. It may be higher. (The) most

distinguished authors from the most prestigious universities are approached

precisely because they are the most distinguished authors from the most

prestigious universities " . Dr Naysmith's response was " This is pretty

disturbing stuff " .

The Chairman asked " Do people not see through what is going on? " , to which

Dr Wilmshurst replied " People do not always know, because people do not

always declare their conflicts of interest. Some people were earning

considerably more from individual pharmaceutical companies by talking for

them every fortnight, twice a month, than they were earning from the

university or the NHS that they work for " .

When asked about the role of the Royal Colleges in relation to the improper

publishing by the industry, Emeritus Professor Herxheimer (medical

pharmacologist) said " I think that the Royal Colleges are not really set up

in a way that would make that straightforward " , and Professor Healy said

" You are trying to force a financial camel through the eye of a scientific

needle...this comes close to fraud " .

Concerning the influence of the industry on research, Dr Wilmshurst was

explicit: " I think the pharmaceutical industry influences the research that

is published " . He went on to provide evidence of outright fraud, telling of

a drug company that had actually altered the clinical record cards detailing

side effects of a drug, which the company omitted entirely before providing

information to a regulator in The Netherlands, and that documents sent to

The Netherlands by the drug company were a forgery. Asked how

commonplace

such forgery was, Dr Wilmshurst replied: " I suspect it is as common now as

it ever was, and I think it was very common " .

On the issue of medical research, the issue of publication bias and the use

of editorial " spin " was raised by Dr Des Spence, a GP from Milngavie,

Glasgow, who questioned why the results from the industry are more likely to

show a positive outcome than those sponsored by no profit organisations.

On the issue of medical education, Dr Spence submitted that 'Promotional

hospitality masquerading as education' is the best description of the

current provision of education by the industry to the NHS. Unfortunately

this education for professionals is skewed with agenda setting by the

industry and with speakers paid directly by the industry. The written

material provided by the industry that is relied upon by many doctors lacks

a strong evidence base " .

Regarding medical education, Dr Wilmshurst gave evidence about the major

impact of the industry in this field: " There is a requirement for people to

undertake a certain number of hours of medical education, 50 hours a year,

and most of that is funded by industry, directly or indirectly. Whenever I

go to a lecture at the postgraduate institute in my hospital, the room hire

is paid by a drug company, as are the meals that you get. Next week there

is a conference at the Royal College of Physicians, at which the key speaker

is the Deputy Chief Medical Officer, and industry sponsors that meeting: it

is £2,000 a time to have your logo on the bag; £6,000 a time to sponsor part

of the cocktail reception. Presumably, the NHS is happy that industry

sponsors " (sic).

Asked what proportion of continuing professional education is typically

funded by the industry, Dr Wilmshurst replied " Ninety per cent plus " , and

Professor Healy said " There are virtually no state-funded clinical trials

here in the UK, This is probably very, very important " .

In relation to frequency of doctors' contact with the industry, Dr Spence

said it could be on a daily basis: " Often, certainly in the areas I work

in, they provide lunch on a daily basis to many of the doctors and nurses in

the area " .

Not only the common practices that pervade the pharmaceutical industry but

also the cosy relationship between it and Government are in the spotlight,

as is the failure of the regulatory body tasked with protecting the public

(the Medicines and Healthcare products Regulatory Agency -- the MHRA,

previously called the Medicines Control Agency or MCA and also the

Committee

on the Safety of Medicine or CSM).

Submissions were received which disclosed that in order to prevent

whistle-blowing, the industry relied on threats of legal action to strike

fear into civil servants working in the regulatory authorities that were

supposed to be safeguarding the public.

In his written submission, Professor Herxheimer stated " The influence of

the industry on medical practice and on the regulation of medicine is

perverse, overwhelming and relentless " .

He continued: " Close collaboration between industry, ministers and civil

servants on the principles and details of regulatory policies has continued.

During all this time the Ministry of Health and its successors, the DHSS and

the DoH have been the sponsoring Department for the pharmaceutical

industry,

whilst of course being its biggest consumer. Over the years, many personal

relationships have grown between regulatory officials and the staff of

pharmaceutical companies. Similarly comfortable contacts have existed

between many of the members of the Committee on Safety of Medicines and

the

industry, and this continues. The influence of the industry on medical

practice is enormous, but largely intangible and unseen " .

One member of the Select Committee, Dr , said: " We have had

such universal condemnation of the MHRA, the only question is, should it be

abolished? "

It was asked why there are no lawyers, or people from the Consumers'

Association (Which?) on regulatory bodies and Professor Herxheimer

provided

the answer: " the regulators are funded by industry " .

Dr Spence encapsulated the issues succinctly as being: " the current

relationship between the industry, health care professionals and government

as a whole. It is that close relationship that gives them an undue sway

over the health agenda " .

He said " I can tell you that I know hundreds of doctors and I know what the

industry is like on the ground: (it) is unbelievably vociferous and active

in promoting its own message. The amount of hospitality received by the

medical profession compared to other public services is, in my view, a

complete disgrace " .

The Inquiry was told by Dr Spence that those he represented (The No Free

Lunch Organisation) certainly believed that the industry has a major

influence over health care policy and that it has a " very clear agenda,

which is predominantly that of profit " and that this agenda is " in direct

conflict with the responsibilities of the NHS " . He informed the Inquiry

that the industry is worth £9 billion per year and said: " The pharmaceutical

industry has been the most profitable industry throughout the 1990s. They

are unbelievably profitable " .

Dr Wilmshurst said " I think there are the issues around the influence on

doctors, but there is also a more important influence, and that is the

influence on government " . Asked about this, Dr Wilmshurst said " I had a

meeting with the Chief Medical Officer two years ago and gave him other

examples of serious research misconduct. I have written to him repeatedly

since then asking what he has done about it, and I get a postcard

acknowledging my letter " .

The Inquiry also heard evidence about the deliberate creation by the

industry of so-called " lifestyle " conditions that could lead to unnecessary

use of medicines and to distorted prescribing behaviour and it heard of the

indoctrination of the public that they need drugs (such as anti-depressants)

in order to cope with their lives.

It also took evidence of the move to make ever more drugs available by

" Direct to Consumer Advertising " (DTCA), currently permitted in only two

developed countries (the US and New Zealand.

The Select Committee took evidence about the re-marketing by the industry

of

old generic drugs under new names (with the new named drugs being far

more

expensive), which are advertised by the industry as being of superior

efficacy or safety when there is no evidence of this.

One submission to the Inquiry was from a group of consultant psychiatrists

calling itself " Critical Psychiatry Network " ; it was founded in Bradford in

1999 and the submission bears the name of a Dr Philip . Whilst the

submission will raise a few hackles within the ME community (for example,

the belief of its members that " the practice of psychiatry must recognise

the primacy of social, cultural, economic and political contexts " and the

fact that members " disagree with the emphasis placed on biological research

and treatments " ), nevertheless the submission states what the ME community

knows only too well: " The problems of definition and validation of illness

in psychiatry mean that the field is more open to manipulation by commercial

interest than other areas of medicine. Psychiatry is unlike any other

branch of medicine in that patients may be compelled to take medication for

lengthy periods of time against their consent. The government is about to

introduce new legislation to replace the 1983 Mental Health Act, in which

these powers of compulsion will be extended into the community. This

change

in the law has major ethical implications. Perhaps more so than any branch

of medicine, psychiatry is open to the influence of external interests.

This can be seen in the influence that the industry has on the design,

conduct and reporting of psychiatric research. We are deeply concerned

about the influence of the pharmaceutical company representatives in

shaping

the opinions of mental health professionals. Their work represents the

triumph of the science of marketing over the marketing of science " .

The involvement of patient charities with the industry was also under

scrutiny, with the Consumers' Association submission stating: " while some

have a clear and accessible policy on their links with the industry, in

general there is a distinct lack of transparency about such relationships " .

The same submission states: " Charities, particularly smaller ones that are

less well funded, need to be protected from exploitation. We understand the

Long-term Medical Conditions Alliance is intending to revise its own

guidelines " .

In his written submission Dr Spence raised the same issue: " We are

concerned

about motivation of the pharmaceutical industry involvement with patient

advocacy groups " .

The use of public relations (PR) companies and other " creative techniques "

employed by the pharmaceutical industry was exposed to the Inquiry,

including the use in promotional campaigns of celebrities who subsequently

denied any knowledge of the lobby group.

Significantly, the written submission on behalf of The Consumers'

Association states: " We have a particular interest in consumer involvement

at all levels of decision-making: CA has researched and published reports

on the outcome of a CA inquiry into how well NICE works from the patient

perspective. Protecting the public and consumer interest must be at the

heart of any regulator's powers, decision-making and actions. Parliamentary

scrutiny is necessary, but not sufficient, to ensuring regulators are

publicly accountable " .

In his written submission, Professor Healy was blunt: " Every patient who

enters a clinical trial in the United Kingdom is putting every Member of

Parliament in a state of legal jeopardy " .

Members of the Select Committee are on record as being " horrified " by the

evidence they heard (see " Drug companies are accused of putting patients'

lives at risk " by Colin Brown, Deputy Political Editor, The Independent,

15th October 2004).

The evidence to be presented at the next session and the publication of the

Health Committee's Report on the influence of the pharmaceutical industry

are awaited with keen interest.

[Guest guest]

An Inquiry by the UK House of Commons Health Select Committee into the

Influence of the Pharmaceutical Industry

Margaret

28th October 2004

Given the well-known and long-term involvement with the pharmaceutical

industry of certain medical advisers prominent in the ME world, the

international ME community may be interested in this Inquiry. The House of

Commons Health Select Committee under the chairmanship of

Hinchliffe

MP is taking submissions and hearing oral evidence detailing concerns about

the power, bias and influence of the pharmaceutical industry (and flowing

from this, upon those doctors who are financially linked to it) and the

effect of such influence upon patients. There have already been two

evidence sessions and there is to be another on 11th November 2004 at

which

various Royal Colleges (including the Royal College of Psychiatrists) will

be giving evidence, with the possibility of a further evidence session in

December. The Inquiry is held in the Room at Portcullis House, just

across the road from the House of Commons. There has been great interest

in

this Inquiry, with the room being packed. The Select Committee Report is

not expected before Christmas.

The Clerk to the Committee can be contacted on 0207-219-6182. Reports of

this Select Committee, minutes of the oral evidence and press notices can be

accessed at

www.parliament.uk/parliamentary_committees/health_committee.cfm

The written submissions from many interested parties and the transcripts of

the oral evidence make lengthy and disturbing reading.

In conjunction with this Inquiry, there is to be a Conference in London on

4th November 2004 at Friends House, 173 Euston Road from 9am - 5 pm at

which

some of those who gave evidence to the Select Committee Inquiry will be

speaking. Another speaker will be the internationally renowned author and

psychologist Dr Dorothy Rowe (contact millie@a... or telephone

01992-813111). The conference will provide a forum for sharing knowledge

and

will be a rare opportunity for communication between the industry, research

analysts, health care professionals, regulators, policy makers and the

public.

On 11th September 2004 the BMJ published a piece by Ray Moynihan setting

out

the response of the pharmaceutical industry to this parliamentary Inquiry:

" The House of Commons Health Committee is investigating drug companies'

influence on medical research, the education of doctors, health information

and drug evaluation. It will specifically look at the industry's influence

on the NHS, the National Institute for Clinical Excellence (NICE) and other

regulatory authorities, universities, professional societies and the media.

For its part, the Association of the British Pharmaceutical Industry (ABPI)

strongly cautioned the committee against tougher restrictions on the

industry's communications and marketing " .

Without doubt, this is an explosive issue. Evidence given to the Health

Select Committee told of payments to medical consultants by the

pharmaceutical industry of £5,000 plus expenses for a one hour talk (with

the audience being unaware that speakers were in the pay of the industry)

and of senior doctors receiving consultancy fees from drug companies of

more

than £20,000 for a few hours' work. A senior consultant (Dr

Wilmshurst, consultant cardiologist, Royal Shrewsbury Hospital) told the

Inquiry that this was common practice, and that the sums offered to him for

a few hours work were £22,000, this being the level of payment made by drug

companies to consultants such as himself, but professors could earn

" considerably more " . The same consultant told the Inquiry he had been

offered a bribe of two years' salary not to publish research on a new drug

that was not in the interests of the drug company that produced it.

MPs were informed that the industry arranged for doctors in their pay to

receive free massage and to have their portrait painted, and that the most

important " opinion-leaders " are taken abroad by drug companies and offered

fees for consultancy work.

MPs were told that family doctors' practices can make profits of over

£50,000 per year from drug companies and that doctors are inundated with

gifts from the pharmaceutical industry. Professor Healy, Head of

Psychological Medicine, University of Cardiff, said " People like me come out

of meeting halls with our arms stuffed full of bags of free gifts " .

Explaining about such payments, Professor Healy said: " The industry is very

clever at how they organise these things. If I am working in a consultant

capacity for one of the pharmaceutical companies, I will have had media

training often. Let's say some issue blows up and the media gets told 'You

can approach Dr Healy'. I will be able to say, and the media and the

pharmaceutical company will be able to say, 'No money passed hands'. The

money comes from elsewhere; it actually comes from the trips to the

Caribbean; it comes from being asked to chair meetings which involve no

work

at all; it comes from having my papers written for me and then I am paid as

though I have written the papers. That is where the money comes from " .

The Select Committee heard of the efforts made by the industry to persuade

general practitioners to use products by arranging for the country's leading

medical experts ( " opinion leaders " in various medical disciplines) to put

their name to reports that endorse products and strategies, even though the

leading experts had not written the articles concerned. This practice,

known as " ghost-writing " , is very common. Professor Healy told MPs that

doctors maintain they are not influenced by the free gifts but are

influenced by " evidence " , and that this " evidence " now consists of articles

that have been ghost-written, so that when the industry representatives come

round, they not only dispense free gifts but also a sheaf of articles. The

problem is that such ghost-written articles (handsomely paid for by the

industry) do not represent the raw data but do influence physicians (who

believe them to be " evidence-based medicine " ).

Committee member Dr Doug Naysmith asked Professor Healy: " Are you

suggesting

that eminent clinical scientists, academics, add their names to papers that

they do not really write? " , to which Professor Healy replied: " My estimate

is that, even in journals like the BMJ, the Lancet, The New England Journal

of Medicine and JAMA, it may be worse for psychiatry than elsewhere, fifty

percent of these articles are ghost-written. It may be higher. (The) most

distinguished authors from the most prestigious universities are approached

precisely because they are the most distinguished authors from the most

prestigious universities " . Dr Naysmith's response was " This is pretty

disturbing stuff " .

The Chairman asked " Do people not see through what is going on? " , to which

Dr Wilmshurst replied " People do not always know, because people do not

always declare their conflicts of interest. Some people were earning

considerably more from individual pharmaceutical companies by talking for

them every fortnight, twice a month, than they were earning from the

university or the NHS that they work for " .

When asked about the role of the Royal Colleges in relation to the improper

publishing by the industry, Emeritus Professor Herxheimer (medical

pharmacologist) said " I think that the Royal Colleges are not really set up

in a way that would make that straightforward " , and Professor Healy said

" You are trying to force a financial camel through the eye of a scientific

needle...this comes close to fraud " .

Concerning the influence of the industry on research, Dr Wilmshurst was

explicit: " I think the pharmaceutical industry influences the research that

is published " . He went on to provide evidence of outright fraud, telling of

a drug company that had actually altered the clinical record cards detailing

side effects of a drug, which the company omitted entirely before providing

information to a regulator in The Netherlands, and that documents sent to

The Netherlands by the drug company were a forgery. Asked how

commonplace

such forgery was, Dr Wilmshurst replied: " I suspect it is as common now as

it ever was, and I think it was very common " .

On the issue of medical research, the issue of publication bias and the use

of editorial " spin " was raised by Dr Des Spence, a GP from Milngavie,

Glasgow, who questioned why the results from the industry are more likely to

show a positive outcome than those sponsored by no profit organisations.

On the issue of medical education, Dr Spence submitted that 'Promotional

hospitality masquerading as education' is the best description of the

current provision of education by the industry to the NHS. Unfortunately

this education for professionals is skewed with agenda setting by the

industry and with speakers paid directly by the industry. The written

material provided by the industry that is relied upon by many doctors lacks

a strong evidence base " .

Regarding medical education, Dr Wilmshurst gave evidence about the major

impact of the industry in this field: " There is a requirement for people to

undertake a certain number of hours of medical education, 50 hours a year,

and most of that is funded by industry, directly or indirectly. Whenever I

go to a lecture at the postgraduate institute in my hospital, the room hire

is paid by a drug company, as are the meals that you get. Next week there

is a conference at the Royal College of Physicians, at which the key speaker

is the Deputy Chief Medical Officer, and industry sponsors that meeting: it

is £2,000 a time to have your logo on the bag; £6,000 a time to sponsor part

of the cocktail reception. Presumably, the NHS is happy that industry

sponsors " (sic).

Asked what proportion of continuing professional education is typically

funded by the industry, Dr Wilmshurst replied " Ninety per cent plus " , and

Professor Healy said " There are virtually no state-funded clinical trials

here in the UK, This is probably very, very important " .

In relation to frequency of doctors' contact with the industry, Dr Spence

said it could be on a daily basis: " Often, certainly in the areas I work

in, they provide lunch on a daily basis to many of the doctors and nurses in

the area " .

Not only the common practices that pervade the pharmaceutical industry but

also the cosy relationship between it and Government are in the spotlight,

as is the failure of the regulatory body tasked with protecting the public

(the Medicines and Healthcare products Regulatory Agency -- the MHRA,

previously called the Medicines Control Agency or MCA and also the

Committee

on the Safety of Medicine or CSM).

Submissions were received which disclosed that in order to prevent

whistle-blowing, the industry relied on threats of legal action to strike

fear into civil servants working in the regulatory authorities that were

supposed to be safeguarding the public.

In his written submission, Professor Herxheimer stated " The influence of

the industry on medical practice and on the regulation of medicine is

perverse, overwhelming and relentless " .

He continued: " Close collaboration between industry, ministers and civil

servants on the principles and details of regulatory policies has continued.

During all this time the Ministry of Health and its successors, the DHSS and

the DoH have been the sponsoring Department for the pharmaceutical

industry,

whilst of course being its biggest consumer. Over the years, many personal

relationships have grown between regulatory officials and the staff of

pharmaceutical companies. Similarly comfortable contacts have existed

between many of the members of the Committee on Safety of Medicines and

the

industry, and this continues. The influence of the industry on medical

practice is enormous, but largely intangible and unseen " .

One member of the Select Committee, Dr , said: " We have had

such universal condemnation of the MHRA, the only question is, should it be

abolished? "

It was asked why there are no lawyers, or people from the Consumers'

Association (Which?) on regulatory bodies and Professor Herxheimer

provided

the answer: " the regulators are funded by industry " .

Dr Spence encapsulated the issues succinctly as being: " the current

relationship between the industry, health care professionals and government

as a whole. It is that close relationship that gives them an undue sway

over the health agenda " .

He said " I can tell you that I know hundreds of doctors and I know what the

industry is like on the ground: (it) is unbelievably vociferous and active

in promoting its own message. The amount of hospitality received by the

medical profession compared to other public services is, in my view, a

complete disgrace " .

The Inquiry was told by Dr Spence that those he represented (The No Free

Lunch Organisation) certainly believed that the industry has a major

influence over health care policy and that it has a " very clear agenda,

which is predominantly that of profit " and that this agenda is " in direct

conflict with the responsibilities of the NHS " . He informed the Inquiry

that the industry is worth £9 billion per year and said: " The pharmaceutical

industry has been the most profitable industry throughout the 1990s. They

are unbelievably profitable " .

Dr Wilmshurst said " I think there are the issues around the influence on

doctors, but there is also a more important influence, and that is the

influence on government " . Asked about this, Dr Wilmshurst said " I had a

meeting with the Chief Medical Officer two years ago and gave him other

examples of serious research misconduct. I have written to him repeatedly

since then asking what he has done about it, and I get a postcard

acknowledging my letter " .

The Inquiry also heard evidence about the deliberate creation by the

industry of so-called " lifestyle " conditions that could lead to unnecessary

use of medicines and to distorted prescribing behaviour and it heard of the

indoctrination of the public that they need drugs (such as anti-depressants)

in order to cope with their lives.

It also took evidence of the move to make ever more drugs available by

" Direct to Consumer Advertising " (DTCA), currently permitted in only two

developed countries (the US and New Zealand.

The Select Committee took evidence about the re-marketing by the industry

of

old generic drugs under new names (with the new named drugs being far

more

expensive), which are advertised by the industry as being of superior

efficacy or safety when there is no evidence of this.

One submission to the Inquiry was from a group of consultant psychiatrists

calling itself " Critical Psychiatry Network " ; it was founded in Bradford in

1999 and the submission bears the name of a Dr Philip . Whilst the

submission will raise a few hackles within the ME community (for example,

the belief of its members that " the practice of psychiatry must recognise

the primacy of social, cultural, economic and political contexts " and the

fact that members " disagree with the emphasis placed on biological research

and treatments " ), nevertheless the submission states what the ME community

knows only too well: " The problems of definition and validation of illness

in psychiatry mean that the field is more open to manipulation by commercial

interest than other areas of medicine. Psychiatry is unlike any other

branch of medicine in that patients may be compelled to take medication for

lengthy periods of time against their consent. The government is about to

introduce new legislation to replace the 1983 Mental Health Act, in which

these powers of compulsion will be extended into the community. This

change

in the law has major ethical implications. Perhaps more so than any branch

of medicine, psychiatry is open to the influence of external interests.

This can be seen in the influence that the industry has on the design,

conduct and reporting of psychiatric research. We are deeply concerned

about the influence of the pharmaceutical company representatives in

shaping

the opinions of mental health professionals. Their work represents the

triumph of the science of marketing over the marketing of science " .

The involvement of patient charities with the industry was also under

scrutiny, with the Consumers' Association submission stating: " while some

have a clear and accessible policy on their links with the industry, in

general there is a distinct lack of transparency about such relationships " .

The same submission states: " Charities, particularly smaller ones that are

less well funded, need to be protected from exploitation. We understand the

Long-term Medical Conditions Alliance is intending to revise its own

guidelines " .

In his written submission Dr Spence raised the same issue: " We are

concerned

about motivation of the pharmaceutical industry involvement with patient

advocacy groups " .

The use of public relations (PR) companies and other " creative techniques "

employed by the pharmaceutical industry was exposed to the Inquiry,

including the use in promotional campaigns of celebrities who subsequently

denied any knowledge of the lobby group.

Significantly, the written submission on behalf of The Consumers'

Association states: " We have a particular interest in consumer involvement

at all levels of decision-making: CA has researched and published reports

on the outcome of a CA inquiry into how well NICE works from the patient

perspective. Protecting the public and consumer interest must be at the

heart of any regulator's powers, decision-making and actions. Parliamentary

scrutiny is necessary, but not sufficient, to ensuring regulators are

publicly accountable " .

In his written submission, Professor Healy was blunt: " Every patient who

enters a clinical trial in the United Kingdom is putting every Member of

Parliament in a state of legal jeopardy " .

Members of the Select Committee are on record as being " horrified " by the

evidence they heard (see " Drug companies are accused of putting patients'

lives at risk " by Colin Brown, Deputy Political Editor, The Independent,

15th October 2004).

The evidence to be presented at the next session and the publication of the

Health Committee's Report on the influence of the pharmaceutical industry

are awaited with keen interest.