Healthy Skepticism International News

September 2005

Submission from Healthy Skepticism re RACP Ethical Guidelines

Abstract:
The Royal Australasian College of Physicians (RACP) is the college for medical specialists in Australia and New Zealand. RACP is revising its Ethical Guidelines and invited Healthy Skepticism to make a submission. Peter Mansfield and Jon Jureidini wrote part 1 of our submission. Part 2 was written by medical ethicist and HS member Wendy Rogers. RACP’s May 2005 draft Ethical Guidelines are available at:
http://www.racp.edu.au/public/news_ethics.htm

Submission from Healthy Skepticism re RACP Ethical Guidelines
Peter Mansfield, Wendy Rogers and Jon Jureidini

Introduction
Thank you for inviting us to contribute to development of the “Ethical Guidelines for Relationships involving Medical Practitioners, Researchers and Industry”.

We congratulate the RACP for working on this very important and difficult issue and for the major improvements in the May 2005 draft.

This submission is in two main parts. Part 1 addresses what we regard as the main issues. Part 2 provides specific feedback on details of the May 2005 draft.

Competing interest disclosure:
The RACP, NHMRC and Healthy Skepticism are all likely to benefit if recommendations in this submission are followed.

Healthy Skepticism currently has a contract with the RACP to provide an educational module: Update on Treatment Decision Making. This will include material on adverse influences on treatment decision making including misleading drug promotion.
The authors have worked for and/or benefited from NHMRC funding and or may apply for such funding in the future.

Acknowledgement
We thank Univ Dist Prof Howard Brody, Department of Family Practice and Center for Ethics and Humanities in the Life Sciences, Michigan State University for commenting on an earlier draft.

Part 1: The case for system reforms to reduce ethical dilemmas
Peter Mansfield, Jon Jureidini

Current systems are placing individuals in bad choice vs bad choice dilemmas that can only be resolved by system reform. Consequently we urge the RACP to move widen the current focus on individual decision making to include reform of systems.

Part 1 of our submission is in 5 parts:
1.Currently, Medical Practitioners and Researchers relationships with Industry do more harm than good for Patients, the Public, Medical Practitioners and Researchers.

2.The causes of those harms are system problems

3.Recommended solutions for the system problems

4.The RACP has a dilemma

5.Recommended solutions for RACP

1. Currently, Medical Practitioners and Researchers relationships with Industry do more harm than good for Patients, the Public, Medical Practitioners and Researchers.

The evidence supporting the conclusion in this heading is available at http://www.healthyskepticism.org/library.php We would be happy to immediately provide a 2 page summary on request if there is any doubt about our conclusion.

2. The causes of those harms are system problems

When done well, drug manufacture, research and education are beneficial. When done well, it is also beneficial to have promotion to persuade medical practitioners, patients and the public to make changes including increasing use of underused therapies (including drugs) and decreasing use of overused therapies.

Those four functions (Manufacture, Research, Education and Promotion) are currently largely paid for by drug companies who in turn are paid according to achievement of higher sales of more expensive drugs. This leads to distortion of the four functions towards higher sales of more expensive drugs. The promotion function is distorted so that increased exposure of health professionals to promotion is associated with inferior practice.[1]

Currently, health professionals are locked together with drug companies in a flawed system where both groups encourage the other to do the wrong thing in a vicious cycle. If companies over-promote their drugs effectively, they are rewarded with higher drug sales. If drugs are overused, companies have more money for gifts and for promotion that reinforce health professionals’ beliefs that they are doing the right thing.

This system problem arises because people are vulnerable to being misled and companies are under selection pressure to mislead.

Drug companies are required to maximise profit or risk being taken over by more aggressive competitors. By law they are required to only invest in those activities that they judge most likely to produce the highest returns for shareholders. Current payment systems give drug companies more money if they use the techniques that work to influence human decision makers to use drugs more often. This is regardless of the impact on health.

Human decision makers are vulnerable to being misled into using drugs more often than is appropriate. (Those who believe they are not vulnerable may be more vulnerable.[2]) Consequently, drug companies have little choice but to mislead health professionals. Drug companies may mislead deliberately but it may be more common for misleading promotion to arise from drug company staff developing honestly held illusions about their products as a result of the groupthink that normally occurs within companies.[3]

Similar distortions apply to the education function so that education has become a form of promotion in disguise for more expensive drugs.[4]

Research questions, funding, practice, publication, interpretation and debate have all been distorted towards increasing sales of more expensive drugs.[5],[6],[7]

Manufacturing has also been distorted. Many useful drugs eg chlorthalidone 12.5mg are not being manufactured because they are off patent so not profitable and would compete against more expensive drugs.

3. Recommended solutions for the system problems

Healthy Skepticism’s suggestions for system reform were set out in our Memorandum for the UK House of Commons Health Committee Inquiry into The Influence of the Pharmaceutical Industry.[8]
The main components are:
a) Increase regulation of drug promotion
b) Improve medical decision making
c) Redesign the incentives for doctors
d) Redesign the incentives for drug companies

We recommend that the separate functions be paid for separately by splitting the government funds currently paid to drug companies into separate payment sources for each function: Research, Education, Promotion and Manufacturing.

Each payment source would invite organisations (including drug companies, universities, non-profit organisations and the royal colleges) to submit proposals for funding by competitive tender. The NHMRC provides an imperfect but well developed and useful model for how this recommendation would work.

Whilst revenue neutral, our recommended reforms would involve improved allocation of large amounts of money. According to US based global healthcare investment and strategy advisor Viren Mehta in May 2005 “The industry spends perhaps around 10% of its revenues on conducting clinical trials, and then another 30% promoting its products.”[9] Mehta’s estimate is accurate for Australia then there is potential for 40% of current government expenditure on pharmaceuticals to be reallocated. Government expenditure on the PBS and RPBS in the year ending June 2004 was $5.46 billion.[10] If total annual expenditure, including public hospitals is approximately $6 billion then up to $ 2.4 billion could be reallocated by reducing overpricing paid by the governments to free up about $1.6 billion to go to the NHMRC to distribute to research organisations by competitive tender and about $800 million to go to an equivalent organisation set up to fund education and health promotion organisations also by competitive tender.

Research, education and promotion tenders would be open to any organisation including drug companies, universities, non-profit organisations and the royal colleges. If the drug companies do well in the competition with then their incomes would not change but their incentives would be better aligned to improving health. If they were not competitive then significant funding would become available for organisations that are able to do those functions better. Either way the ethical dilemmas for health professionals, researchers and drug company staff would be significantly improved.

These reforms would lead to significant improvements in health care and thus improved performance of the whole economy which would lead to further increases in funding for research, health care, education and health promotion in a virtuous cycle. In the long run all would be better off including drug company staff and shareholders.

4. The RACP has a dilemma

The RACP is caught in a dilemma between the evidence of harm versus the political reality that it is likely that few RACP fellows are aware of and believe the evidence.[11] An understandable but ethically unjustified response to that dilemma would be to fudge the issue by using ambiguity and/or compromise and/or putting the onus on individuals to decide for themselves between bad choices. In the next section we will recommend some better solutions.

5. Recommended solutions for RACP

a) Include the following sentence in the RACP “Ethical Guidelines for Relationships involving Medical Practitioners, Researchers and Industry”: Pending major reforms, any type of relationship between medical practitioners or researchers with industry will be unethical because within current systems there is no known way for medical practitioners or researchers to ensure that they gain more benefit than harm for patients, the public or themselves.

b) Set a deadline (eg 5 years) to achieve either major reforms or a policy of no relationships with industry.

c) Develop education for fellows regarding the evidence about relationships with industry. (Healthy Skepticism is ready, willing and able to assist with this.)

d) Campaign for system reforms as recommended in section 3 above.

Part 2: Comments on Ethical Guidelines for Relationships involving Medical Practitioners, Researchers and Industry. RACP May 2005
Wendy Rogers

Key issues
These guidelines focus on complex procedural mechanisms to “manage” conflicts of interest rather than clear and unambiguous advice about avoiding conflicts.

There is insufficient recognition of the increasingly incontrovertible evidence about the harmful effects of industry-medical relationships such as direct harms to patients and increased costs to the community from inappropriate prescribing[12]

The unnecessarily complicated theoretical framework relies heavily upon the concept of ‘dualities’ of interest which adds little to our understanding of the issues.

There is no recognition of the obligation of medical practitioners to fund their own CPD/CME.

The advice is weak and at times ambiguous.

Text-based comments

Title
The Guidelines seem to be aimed at all medical practitioners, rather than members of the RACP. If this is the RACPs’ intention, then it is likely that these Guidelines would have more authority had they been drafted by a working party with membership from the full range of medical specialties.

Membership of Working Party
I note the absence of external members, and in particular, lack of community or patient representatives. A list of the groups and/or individuals consulted or contributing to this draft would be welcome, to support the statement that “the text also reflects the input of a wide range of contributors from the professions, consumer organisations and industry” (p ii, repeated on pages 4-5)

Executive summary
This fails to draw the reader’s attention to the major issues as it is lengthy with lists of dot points that are not ordered in significance. The lists are a mixture of conclusions and recommendations. A shorter list of key conclusions and specific guidance would be more useful.

Chapter I
I.1
This section could be strengthened by a clearer statement of the issue that the Guidelines are addressing. In addition, it would be helpful to have a full description of the consultation processes.

p5-6 “While we have relied heavily on published evidence to support our conclusions we recognise that there is no universal consensus about how to assess the influence of industry on health care and research or about the most appropriate courses of action to respond to issues arising in specific settings. Accordingly, we accept that not everyone will agree with our recommendations and that on occasions individuals and organisations will choose other courses of action.”
This statement does not do justice to the accumulated evidence that the influence of the industry about which we know the most, the pharmaceutical industry, is pursued through extremely effective and widespread methods, and causes harms to patients.[13]
This qualification, together with the third paragraph on page 6, are used to justify the limited guidance offered in these guidelines.

I.2, p8
This could be strengthened and made less ambiguous by listing the full range of promotional activities undertaken by industry, including use of key opinion leaders, sponsorship of consumer groups and advertising direct to patients. In addition, there are considerably more published accounts of the effects of promotion than are listed in the references for this section.[14]

I.4, p9-10
Again, this paragraph (last para page 9) seems unduly pessimistic about the possibility of issuing clear and unambiguous advice about avoiding conflicts of interest in relationships with industry.

I.5
This section offers the opportunity to really inform readers about the harms that can follow from relationships with industry, especially from inappropriate prescribing, both in terms of harms to individual patients and cost-related harms. Unless these are clearly spelled out, it is open to practitioners to deny knowledge of the effects of these relationships.

I.6, p10
The general principle is over long and unwieldy and may perhaps be more clearly restated as “Medical practitioners have a duty to act in the best interests of patients by providing independent, expert and unbiased advice to patients.” The sentence “This means that benefits received as a result of relationships between health professionals and industry – whether pecuniary or non-pecuniary, or in cash or kind, as gifts, hospitality or subsidies - must leave the independence of professional judgement unimpaired” is at odds with the evidence that gifts etc DO influence professional judgment and are offered for precisely that reason.[15]

I.7
Again, this section seems to deny or dilute the evidence that relationships with industry are effective in influencing medical practice, for example prescribing pharmaceuticals, in ways that are inconsistent with the best interests of patients and the principles of scientific integrity.Not only does this deny the effectiveness of some industry strategies, it is inconsistent with the claim on page 19 of the guidelines, that there is compelling evidence about the effects of gifts on doctors’ judgment.

Chapter II
II.1
This chapter draws up the concept of dualities of interest previously used in other RACP publications. However, this concept does little to assist with the definition or clarification of conflicts of interest. I suggest drawing upon the published literature in this area, and using a standard definition such as:“On the standard view, P [an individual person or corporate body] has a conflict of interest if, and only if, (1) P is in a relationship with another requiring P to exercise judgement on another’s behalf and (2) P has a (special) interest tending to interfere with the proper exercise of judgement in that relationship.”[16]
The main point is that medical practitioners have to exercise judgment about medical interventions on behalf of patients who lack the expertise to make their own judgments, and that this duty is compromised if doctors have other pecuniary and non-pecuniary interests interfering with the proper exercise of their judgment. This basic consideration is not clearly spelled out in chapter II – there is no mention of having to exercise judgment on behalf of patients. The term “dualities” adds nothing to the analysis other than to add an unnecessary layer of complication. It could be replaced with the observation that medical practitioners have multiple interests, that at time conflict. The problem is self-interest that influences judgments made on behalf of patients.

II.4
The key strategy for problematic conflicts of interest is to avoid them. This should be emphasised. The process of setting up conflicts of interests committees is cumbersome and probably unworkable, especially for small private practices. The responsibility should be on individual practitioners to recognise illegitimate conflicts (ie self-interest versus patient welfare) and avoid them. For the RACP, the responsibility is surely to foster an atmosphere in which most relationships with industry are unacceptable just because they aim to influence medical judgments in ways that are inimical to the welfare of patients and the duties of practitioners.

Chapter III
This section on implementation relies upon formation of COI committees; as mentioned, this is a potentially unwieldy solution. If established, what powers would such committees have, and to whom would they report? In addition, the effective functioning of COI committees would rely upon individual practitioners recognising that they have a conflict, but the Guidelines do not indicate mechanisms for increasing awareness about conflicts of interest amongst medical practitioners.

Chapter IV
IV.2
This section could be strengthened with more references. There is useful collection of references on the web in the Healthy Skepticism library.[17]

IV.3
The advice here is cumbersome and potentially ineffective. I feel it is unlikely that practitioners will, for example, say to patients: “I am receiving gifts from company x. It is well known that accepting gifts influences prescribing in ways that benefit the company in question and may harm you”. This is however, what the Guidelines require if they are serious about disclosure of conflicts.

IV.4, p19
I feel that it is extremely misleading to write that “Clinicians and the pharmaceutical industry share common goals in that they are engaged in the treatment of disease and the conduct of research directed towards improvements in treatment.” The pharmaceutical industry has a legal obligation to make a profit – developing and selling drugs it the way that it does this. Any sharing of goals is incidental to their primary aim of making a profit.
The list of ‘concerns’ raised by promotional activities should be expanded to include direct harms to patients, and increased costs to the community from inappropriate prescribing. As the psychological evidence suggests that promotional effects upon judgment may occur without awareness, it is unlikely that a medical practitioners will reliably be able to assess when their judgment is affected. Unfortunately, the only way to avoid bias is to avoid all gifts and promotional materials from industry sources and to keep up to date using high quality educational methods.

p20
As per the previous paragraph, there is no “safe” level of gifts, trivial or otherwise. The advice should be to reject all gifts. It would be lovely to see the RACP taking leadership here re continuing medical education (CME or CPD) and to take a strong stance on the need for high quality, relevant, up to date and unbiased information provided in a “sponsorship”-free environment (ie a dedicated teaching space rather than a restaurant). Unfortunately the profession is used to free “education” provided with meals etc. This may be a hard habit to break, but it is up to the profession to both acknowledge the need for and be prepared to pay for good ongoing education.

p21
As the guidelines acknowledge, provision of samples is a marketing exercise and should be rejected by practitioners, as should support programs.

IV.5
The comments above in relation to pharmaceutical agents apply in large part to therapeutic devices as patients are reliant upon advice from their medical practitioners about devices just as they are reliant upon advice about drugs. This advice should not be influenced by external commercial interests.

p23
It is wrong (not “inappropriate”) to obtain a benefit from the sales of medical devices to one’s own patients.

IV.6
As per the comments above, there is no legitimate role for industry in serious educational activities that are accredited for CME/CPD. Industry-sponsored meetings should be recognised as such, and not accredited.In relation to conference sponsorship, I agree that any sponsorship should be indirect, untied and fully disclosed.

p27
Sponsorship for non-active attendance at meetings should be banned. I agree that practitioners have a duty to stay up to date, but attendance at industry-sponsored meetings is not the way to do this, and uses valuable time that could be spent in more worthwhile educational activities.

p28
Sponsorship of grand rounds should be prohibited on the following grounds:

•It condones industry sponsorship of what should be a credible academic activity.

•It is an abrogation of responsibilities towards training staff including students as it promotes acceptance of commercially-sponsored “education” and implicitly denies the well-recognised harms of such arrangements.

•It has been demonstrated to be commercially effective in terms of increasing prescribing of the sponsor’s products.

•It provides industry with access to a wide range of practitioners at different stages of their careers.

•It is unnecessary as such rounds can be provided at low cost, for example through small weekly contributions from senior consultants.

•It sets a poor example for others involved in providing medical education whilst creating an artificially high standard of “entertainment” associated with educational meetings.

IV.7, p30
This section does not take account of the influence of key opinion leaders who may exert considerable influence on behalf of the companies for whom they are consultants.
The advice in paragraph three would be difficult to implement for private practitioners.
The last sentence on this page, stating that membership on advisory boards is one way that practitioners can “ensure that pharmaceutical developments satisfy communal needs” reflects a worrying level of optimism and naivety, given the track record of the industry in creating demand for life-style drugs and production of me-too drugs, rather than using criteria such as burden of disease as a mechanism for prioritising their research programs.

p31
Key point: what would count as “evidence that decisions of the advisory board have an impact upon the company”?
IV.8
This section does not mention the common practice of paying practitioners to recruit patients into trials, which creates a direct conflict of interest if the money is paid to the practitioner. Patients should be informed of recruitment payments to the practitioner and/or practice or organisation.

Chapter V
V.1
This section does not explain why or how scientific societies and industry have a mutually beneficial relationship, nor does it acknowledge the ways in which sponsorship relationships can influence the judgments of that society’s members. Once again, there is a need for medical practitioners to be willing to pay for the things that they need and/or value, and for the profession to wean itself away from a culture of entitlement. The recent paper by Kerridge et al (reference 21 in the guidelines) indicates that industry sponsorship formed a small part of the overall income of the societies and organisations that they surveyed, with the majority of income derived from membership subscriptions and training fees. If this is the general case, then it should not be a large task to decrease that contribution to zero, and thereby avoid conflicts of interest that have the potential to harm patients.

V.6, p37
As per previous comments, all CME/CPD should be independent and rigorous, and paid for by participants.

p38
The advice to use independent observers (para 2) is unwieldy – who would count as an independent observer, and what parameters should they use to assess the outcomes?
The key points are weak: there is no place for commercial interests in educational activities.

Chapter VI
Many of the issues covered here are issues of research ethics and governance, which are covered in the NHMRC’s National Statement and the AVCC’s Joint Statement. Both of these documents provide comprehensive advice on research ethics and researcher conduct and it is probably better to refer readers to these documents rather than provide a further source of guidance that lacks the authority of the existing documents.

VI.1
The introduction does not cover the full range of adverse effects that have been associated with industry funded research, such as controlling the agenda, choice of intervention, poor trial design (eg inappropriate comparators), suppression and distortion of results, and publication bias.

VI.4
The NHMRC document is the National Statement on Ethical Conduct in Research Involving Humans, not the Statement on Human Experimentation (see also p 47).

VI.7, p46
The key point mentions a “responsible ethics committee” (see also p45). The NHMRC has provided guidelines for review of research using Human Research Ethics Committees (HRECs). Properly constituted HRECs can register with the NHMRC and are subject to the guidelines in the National Statement. Any mention of ethics committees should acknowledge these existing structures and use terminology that is consistent with the current national research ethics framework.

Chapter VII
Most of the issues in this chapter have already been covered:
There is no place for commercial sponsorship in medical education.
Gifts are a mechanism for industry to influence the judgment of practitioners in ways that are not in the interests of patients, and should therefore be banned.

Appendix 1
The tools rely upon the concept of dualities which does little to clarify the issues.
Tool 1 could be omitted with no loss – the key question is the first question in tool 2 “Are personal interests in conflict with those of the community, including patients and research subjects?”
There is no mention of the primacy of medical practitioners’ obligation to provide independent unbiased advice for the benefit of patients and the community.
There is no recognition of the fact that self-interest (especially when coupled with a sense of entitlement) is very potent, and likely to skew judgment about conflicts in favour of the recipient.

Avoidance of conflicts, rather than management, is the solution of choice.

————————————————————————————————————————

[1] http://www.healthyskepticism.org/library/topics/influence.php

[2] Sagarin BJ, Cialdini RB, Rice WE, Serna SB. Dispelling the illusion of invulnerability: the motivations and mechanisms of resistance to persuasion. J Pers Soc Psychol 2002; 83: 526-541.

[3] Goleman D. Vital lies, simple truths: The psychology of self-deception. London: Bloomsbury 1997

[4] http://www.healthyskepticism.org/library/topics/sponsorship.php

[5] http://www.healthyskepticism.org/library/topics/funding.php

[6] http://www.healthyskepticism.org/library/topics/quality.php

[7] http://www.healthyskepticism.org/library/topics/publication.php

[8] http://www.healthyskepticism.org/news/issue.php?id=6

[9] Mehta V. Batten down the hatches in 2005. Scrip World Pharmaceutical News 2005; 3025: 57

[10] http://www.health.gov.au/internet/wcms/publishing.nsf/Content/health-pbs-general-pubs-pbbexp-jun04.htm/$FILE/bookp01.pdf

[11] http://www.healthyskepticism.org/library/topics/opinions.php

[12] http://www.healthyskepticism.org/library.php

[13] http://www.healthyskepticism.org/library/topics/influence.php

[14] http://www.healthyskepticism.org/library.php

[15] http://www.healthyskepticism.org/gifts.php

[16] Davis, Michael. 2001. Introduction. In Conflict of Interest in the Professions, edited by M. Davis and A. Stark. New York: Oxford University Press, page 8.

[17] http://www.healthyskepticism.org/library.php

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