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Subject:

Curbing the Influence of the Drug Industry: A British View

From:

"Kathrynne Holden, MS, RD" <[log in to unmask]>

Reply-To:

Kathrynne Holden, MS, RD

Date:

Tue, 27 Sep 2005 08:00:28 -0500

Content-Type:

text/plain

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Parts/Attachments

text/plain (358 lines)

Colleagues, the following is FYI and does not necessarily reflect my own
opinion. I have no further knowledge of the topic. If you do not wish to
receive these posts, set your email filter to filter out any messages
coming from   @[log in to unmask]    and the program will remove
anything coming from me.
---------------------------------------------------------
Volume 2 | Issue 9 | SEPTEMBER 2005
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10%2E1371%2Fjournal%2Epmed%2E0020241

	
Essay


Curbing the Influence of the Drug Industry: A British View

A recent report from politicians in Britain recommends a fundamental 
review of drug development, marketing, and prescribing practices

Richard Smith

Richard Smith is Chief Executive of UnitedHealth Europe, London, United 
Kingdom. E-mail: [log in to unmask]

Competing Interests: RS was an editor for the BMJ for 25 years. For the 
last 13 of those years, he was the editor of the BMJ and chief executive 
of the BMJ Publishing Group, responsible for the profits of not only the 
BMJ but of the whole group, which published some 25 other journals. He 
stepped down in July 2004. He is now a member of the board of the Public 
Library of Science, a position for which he is not paid. The 
UnitedHealth Group, of which UnitedHealth Europe is a part, includes a 
company that performs clinical trials for the pharmaceutical industry. 
RS has no responsibility for or influence over this company.

Published: August 2, 2005

DOI: 10.1371/journal.pmed.0020241

Copyright: © 2005 Richard Smith. This is an open-access article 
distributed under the terms of the Creative Commons Attribution License, 
which permits unrestricted use, distribution, and reproduction in any 
medium, provided the original work is properly cited.

Abbreviations: KOL, key opinion leader; NICE, National Institute of 
Health and Clinical Excellence

Citation: Smith R (2005) Curbing the Influence of the Drug Industry: A 
British View. PLoS Med 2(9): e241

Britain's House of Commons Health Committee has recently recommended a 
fundamental realignment of the relationships between the pharmaceutical 
industry and government, regulators, doctors, the health service, and 
patients [1]. The committee said that the industry has interdigitated 
itself into every aspect of health care, and that government and others, 
including doctors, have taken the easy route of assuming that the 
interests of the industry and of the health services and patients are 
the same.

The committee's report makes clear that reducing the influence of the 
industry would be good for everybody, including—paradoxically—the 
industry itself, which could concentrate on developing new drugs rather 
than on corrupting doctors, patient organisations, and others. “It is 
not in the long term interests of the industry for prescribers and the 
public to lose faith in it,” says the report. “We need an industry which 
is led by the values of its scientists not those of its marketing force.”
Select Committees: Rationality before Realpolitik

The Health Committee is one of many select committees of the House of 
Commons. The committees are comprised of members of parliament and 
politicians from all parties, and they can choose to examine any subject 
that raises matters of public importance. They receive written and oral 
evidence, including from government ministers, and produce reports and 
recommendations to which the government is required to respond.

The 11-member Health Committee chose to examine the influence of the 
drug industry because of increasing public concern that this influence 
is excessive. The committee was particularly worried by the industry's 
role in promoting “medicalisation,” the idea of a pill for every ill: 
“What has been described as the ‘medicalisation’ of society—the belief 
that every problem requires medical treatment—may also be attributed in 
part to the activities of the pharmaceutical industry” [1]. The 
committee, whose terms of reference are shown in Box 1, was also worried 
by the high prevalence of drug side effects. It heard from every 
interested party, including representatives of the drug companies, 
patients, doctors, medical journal editors, critics of the industry, and 
government ministers and officials.
Box 1. Terms of Reference for the Health Committee Enquiry

“The Health Committee is to undertake an inquiry into the influence of 
the pharmaceutical industry on health policies, health outcomes and 
future health priorities and needs. The inquiry will focus, in 
particular, on the impact of the industry on the following:

     *

       drug innovation
     *

       the conduct of medical research
     *

       the provision of drug information and promotion
     *

       professional and patient education
     *

       regulatory review of drug safety and efficacy
     *

       product evaluation, including assessments of value for money

In doing so, the Committee will examine the influence of the 
pharmaceutical industry on the NHS; National Institute for Clinical 
Excellence (NICE); regulatory authorities and advisory and consultative 
bodies; prescribers, suppliers and providers of medicines; professional, 
academic and educational institutions; the (professional and lay) press 
and other media; and patients, consumers, the general public and 
representative bodies.”

(Information taken from [1])

The government does not have to accept the recommendations from select 
committees, and it recently rebuffed recommendations from the same 
Health Committee encouraging open access to scientific research [2]. 
Usually, the committees will be much bolder than the government, which 
is heavily lobbied and pays more attention to realpolitik than to 
rational argument. Just as the publishing industry pressured the 
government to ignore recommendations on open access [3], the 
pharmaceutical industry will be doing the same now—and the industry is 
powerful; it is Britain's third most profitable economic activity (after 
tourism and finance) and employs 83,000 people.
The All-Pervasive and Persistent Influence of the Industry

Although the pharmaceutical industry is now perceived by the public as 
putting profits ahead of patients' well-being [4], it is generally, as 
the committee makes clear, a force for good. Almost all of the drugs 
that have transformed medicine in the past half century have been 
developed and manufactured by the industry. “The discovery, development 
and effective use of drugs,” says the committee, “have improved many 
people's quality of life, reduced the need for surgical intervention and 
the length of time spent in hospital and saved many lives” [1]. And 
making the industry into a scapegoat for failing to produce drugs for 
the diseases of the poor is in some ways no more sensible, I believe, 
than blaming washing machine manufacturers for poor hygiene standards in 
the developing world. The industry is part of the for-profit sector, and 
has what many philosophers might call a moral duty to maximise profits. 
Producing drugs for the poor requires imaginative public–private 
partnerships.

It's also shallow thinking to view the industry as corrupters and 
doctors as the corrupted. As a doctor myself, I think that doctors are 
in many ways to blame for the debased relationship between themselves 
and the industry. The industry is (mostly) behaving in ways that are 
“normal” within the commercial sector. It is the doctors who depart from 
their ethical base when they insist on first-class fares and lavish 
entertainment from the industry so that they can attend an international 
conference.

The fundamental problem, says the committee, is that the pharmaceutical 
industry's influence is too pervasive: “The industry affects every level 
of healthcare provision, from the drugs that are initially discovered 
and developed through clinical trials, to the promotion of drugs to the 
prescriber and the patient groups, to the prescription of medicines and 
the compilation of clinical guidelines.”
Box 2. Recommendations from the Health Committee Enquiry: Some Highlights

     *

       The process of licensing drugs, and the medicines' regulatory 
system, should both be more transparent.
     *

       There should be an independent register of clinical trials.
     *

       Clinical trials should focus on using health outcomes that are 
relevant to patients.
     *

       More research should be undertaken into the adverse effects of 
drugs and the costs of drug-induced illness.
     *

       The regulator should ensure greater restraint in medicines' 
promotion.
     *

       Tougher restriction should be placed on the prescribing 
activities of non-specialists.
     *

       Doctors should be required to declare significant sums or gifts 
they receive as hospitality.
     *

       The sponsorship of the drug industry should pass from the 
Department of Health to the Department of Trade and Industry—because the 
secretary of state for health cannot serve two masters (the public and 
the industry).
     *

       (Information taken from [1])

The committee goes into detail about each of these levels. Regulatory 
authorities, it says, are too close to the industry, meaning that they 
do not ensure that the industry works in the public interest. The 
clinical trials that are the essential evidence base for regulatory and 
clinical decisions are produced almost entirely by the industry, and the 
evidence that reaches authorities, doctors, and patients is biased. 
Guidelines for treating patients are distorted, not only because they 
must be based on biased evidence, but also because the organisations and 
people producing them are often in hock to the industry. The 
organisations may receive millions of British pounds for buildings and 
activities, while the individuals—particularly key opinion leaders 
(KOLs, as they are known in the trade)—may receive hundreds of thousands 
of pounds for consultancy, speaking fees, travel, research, and 
articles. “Drug companies are criticised for giving hospitality and 
recruiting ‘key opinion leaders’,” says the committee, “but the 
prescribers must be equally to blame for accepting the hospitality and 
some ‘key opinion leaders’ for lending their names to work they did not 
produce, often for very considerable sums.”

Next in the list of things that concerned the committee comes the 
industry's intensive marketing, which is becoming ever more important as 
the flow of drugs that offer major therapeutic advances (and so need 
much less marketing) dries up. Britain has some 8 000 drug company 
representatives, but the industry also spends millions on advertising, 
sponsorship, meetings, and increasingly, “medical education”—which often 
means a fine dinner and a lecture from a captive KOL. The report states: 
“Coupled with company-sponsored information from medical journals and 
supplements, ‘medical education’ materials, advertisements and 
sponsorship to attend conferences, workshops and other events, it is 
little wonder that prescribing practices are affected.” Medical 
journals, as I've argued in PLoS Medicine [3], are in some ways 
extensions of the marketing arm of the industry, while the free 
newspapers that overwhelm doctors in the developed world depend 100% on 
largesse from the industry.

Individual journalists are also captured, the committee heard—and 
perhaps most troublesome is the way patient organisations have become so 
dependent on the industry. The committee concluded that “Measures to 
limit the influence of industry on patient groups are needed.” 
Currently, in Britain, we see that the “patients” who are trying to 
convince the British government that it should ignore the advice of the 
London-based National Institute of Health and Clinical Excellence (NICE) 
(which says that drugs for Alzheimer's disease are not sufficiently cost 
effective) are in many ways agents of the companies that produce those 
drugs [6].

The consequences of all of these incestuous relationships, says the 
committee, are bad decisions on the regulation and prescription of 
drugs, over-reliance on drugs rather than on other interventions (such 
as dietary change, exercise, or counselling), and the “medicalisation” 
of life's problems, including baldness, shyness, unhappiness, grief, and 
sexual difficulties.
Recommendations: “Let the Sun Shine In”

The committee came up with 48 conclusions and recommendations, and I 
have listed some of the highlights in Box 2. The committee's main 
recommendation for the problems it identifies is transparency: “let the 
sun shine in.” It begins by recommending that there be a clinical trials 
register, “maintained by an independent body” and containing full 
information. Companies should be required to put the information on the 
register “at launch as a condition of the marketing licence.” The 
committee also wants regulatory authorities and ethics committees (the 
British equivalent of institutional review boards) to help with the 
design of trials to make sure that they are answering real questions. It 
didn't, however, recommend more public funding of trials. I believe that 
such funding is necessary in order to ensure that trials are addressing 
the most important questions—including head-to-head comparisons and 
trials of new drugs against older drugs and non-drug treatments. Advice 
to companies is unlikely to be effective.

There should be, says the committee, limits on the quantity of marketing 
materials, particularly in the first six months after launch, and 
stricter controls on marketing to junior doctors, nurses, and 
pharmacists. These proposals don't seem sufficiently thought through: 
it's hard to imagine how the proposals would be enforced, and they are 
patronising to junior doctors, nurses, and pharmacists—many of whom are 
much better, I suspect, at assessing evidence than burnt out, ageing, 
high-prescribing general practitioners.

Doctors might come to be seen as the villains rather than the good guys.

The Health Committee would also like to see an independent review of the 
Medicines and Healthcare Products Regulatory Agency (London, United 
Kingdom) plus a public inquiry every time a drug is withdrawn from the 
market on health grounds. It's hard to see the government implementing 
these recommendations, as inquiries are expensive and always create 
difficulties for government, but if bodies like the Medicines and 
Healthcare Products Regulatory Agency and NICE are to maintain public 
confidence they will have to distance themselves from the industry—and 
be seen to do so. Important first steps will be to make public more of 
the information they use to make their decisions and to exclude KOLs 
from their committees (which may be difficult, as KOLs include many 
prominent doctors and professors of pharmacology and therapeutics).

Doctors' organisations, says the committee, should produce publicly 
available registers of doctors' links with industry. These registers—and 
this is my recommendation and not the committee's—should also include 
information on monetary amounts. Otherwise, it will not be possible to 
separate the KOLs from the vast numbers of doctors who receive pens, 
lunches, trips, and other gifts from the pharmaceutical industry. I 
doubt very much that doctors' organisations will adopt these 
recommendations until forced to do so. In Britain, it's more 
embarrassing to ask people about money than sex. Plus, doctors might 
come to be seen as the villains rather than the good guys.

The committee also wants patients' organisations to declare their 
connections with industry and to make clear when ubiquitous “disease 
awareness” campaigns are funded by the industry, which is probably very 
common [6]. I agree with this support for transparency, and while 
recognising the penury of many patients' organisations, I think they 
would do well to resist the lure of the industry's lucre as much as they 
can.
Conclusion

In the end, this report will probably be less remembered for its 
recommendations—most of which will probably be ignored—than for having 
brought the important debate over the excessive influence of the 
pharmaceutical industry to a broader public. We all stand to benefit 
from the reduction of that influence.
References

    1. House of Commons Health Committee (2005) The influence of the 
pharmaceutical industry. Available: 
http://www.parliament.the-stationery-office.co.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf. 
Accessed 15 June 2005.
    2. House of Commons Science and Technology Committee (2005) 
Scientific publications: Free for all? Available: 
http://www.publications.parliament.uk/pa/cm200304/cmselect/cmsctech/399/399.pdf. 
Accessed 15 June 2005.
    3. Bhattacharya S (2004) UK government ‘obstructing’ open-access 
publishing. Available: http://www.newscientist.com/article.ns?id=dn6633. 
Accessed 15 June 2005.
    4. Kaufman M (2005) Drugs get good ratings, but drugmakers less so. 
Available: 
http://www.washingtonpost.com/wp-dyn/articles/A53273-2005Feb25.html. 
Accessed 15 June 2005.
    5. Smith R (2005) Medical journals are an extension of the marketing 
arm of pharmaceutical companies. PLoS Med 2: e138 DOI: 
10.1371/journal.pmed.0020138. Find this article online
    6. Hirst J (2003) Charities and patient groups should declare 
interests. BMJ 326: 1211. Find this article online
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10%2E1371%2Fjournal%2Epmed%2E0020241
-- 
Kathrynne Holden, MS, RD < [log in to unmask] >
"Ask the Parkinson Dietitian"  http://www.parkinson.org/
"Eat well, stay well with Parkinson's disease"
"Parkinson's disease: Guidelines for Medical Nutrition Therapy"
http://www.nutritionucanlivewith.com/

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