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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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