House of Commons - Health - Written Evidence

Select Committee on Health Written Evidence

APPENDIX 19

Memorandum by Dr Peter R Mansefield on behalf of Healthy Skepticism Inc (PI 50)

HEALTHY SKEPTICISM ABOUT DRUG PROMOTION

INTRODUCTION

This memorandum will focus on the provision of drug information and promotion but will provide brief comments relevant to all the other terms of reference for the inquiry.

We are currently working on a detailed policy discussion paper for Australia titled: "Pharmaceutical policy: Proposals for getting better value for money." The current draft is available on request. To keep this memorandum short and relevant to the UK the focus here will be on key concepts rather than details. We understand that there are plans for the inquiry to visit Australia. Members of Healthy Skepticism Inc. including myself would be happy to discuss our suggestions in more detail then.

This memorandum includes:

— Introduction to Healthy Skepticism Inc

— Introduction to the author

— The provision of drug information and promotion

— Understanding the problems

— Possible solutions

— Professional and patient education

— Drug innovation and the conduct of medical research

— Regulatory review of drug safety and efficacy

— Product evaluation, including assessment of value for money

INTRODUCTION TO HEALTHY SKEPTICISM INC

Healthy Skepticism is an international non-profit organisation for health professionals and everyone with an interest in improving health. Most members are doctors or pharmacists. Our main aim is to improve health by reducing harm from misleading drug promotion. Our strategy includes three approaches: research, education and advocacy. One of our activities that brings all three approaches together is Healthy Skepticism AdWatch.

AdWatch is a monthly webpage designed to help doctors, pharmacists and the public defend ourselves from misleading drug promotion. AdWatch illuminates the logical, psychological and pharmacological techniques used in drug advertisements. AdWatch also provides practical recommendations for optimal medical care. Everyone is invited to participate by providing feedback to the AdWatch team and to the companies responsible for the advertisement.

We are based in Australia but have many supporters in the UK. We have published many articles in the BMJ (British Medical Journal) and The Lancet. One of these articles is a review of the evidence about antidepressant drugs for children published in the BMJ in April 2004. We concluded that the magnitude of benefit from antidepressant drugs for children is unlikely to be sufficient to justify the risks of harm. We also reported that "authors of all of the four larger studies have exaggerated the benefits, downplayed the harms, or both." Our article received extensive coverage in newspapers around the world.

A second opinion about Healthy Skepticism Inc:

"A small group known as Healthy Skepticism . . . has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontie"res and Health Action International] are small, but they are capable; they bear malice towards no one, and they are honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them."—Graham Dukes (Professor of Drug Policy Studies, University of Oslo, Norway)

INTRODUCTION TO THE AUTHOR

The author of this Memorandum is Dr Peter R Mansfield, General Practitioner, Director of Healthy Skepticism Inc. and Research Fellow, Department of General Practice, University of Adelaide. Peter's research is supported by (Australian) National Health and Medical Research Council Public Health Postgraduate Scholarship 250465. In 2004 Peter was awarded Flinders University's highest award for graduates: The Convocation Medal "for outstanding leadership in the advancement of professional practice and service to the community in the safe use of pharmaceutical drugs."

THE PROVISION OF DRUG INFORMATION AND PROMOTION

UNDERSTANDING THE PROBLEMS

1. Currently drug promotion does more harm than good

All of the studies, that we are aware of, that measure the impact of exposure to and attitudes towards drug company information on the quality of medicines use support the same conclusion. The more doctors depend on drug company information, the more medically inappropriate and expensive their prescribing.[36][37][38][39][40][41][42][43][44][45][46][47]

It is likely that drug promotion can be beneficial when the following conditions are met:

— the information used is reliable, balanced and relevant without significant omissions.

— that drug has a superior ratio of benefits over harms and costs compared to current treatments for a specific indication.

— the drug is currently under used for that specific indication.

— the promotion is targeted at increasing the use of a drug for the specific indication to appropriate levels and not beyond.

However, those conditions are rarely met. The percentage of new drugs that have any medical advantage over older cheaper drugs has been assessed as only 23% during 1989-2000 in the USA and only 10.5% during 1980-2003 in France.[48][49],48

A major economic study of drug promotion in The Netherlands concluded that the "average effect of [drug] marketing on price elasticities is unambiguously welfare-negative. This is because the effect we see is an effect after correcting for quality differences and this allows us to interpret the lower sensitivity to prices as brand loyalty not supported by product characteristics. This is socially undesirable."[50]

We conclude that drug promotion is an effective tool that can be used for good or ill. However, currently drug promotion does more harm than good.

2. Doctors are susceptible to influence

Doctors have mostly been trained to memorise and apply medical information but few have much expertise in critical appraisal of scientific evidence[51] or in the psychology and informal logic of decision making.[52] Doctors are intelligent but nevertheless are often vulnerable to being influenced by the same advertising methods that influence many other people.[53] For example, even small gifts lead to unintended bias.[54] Many doctors are aware that other doctors are influenced by drug promotion but deny that they are influenced themselves.[55] That "illusion of unique invulnerability" makes people more vulnerable.[56]

We conclude that doctors are more vulnerable to misleading drug promotion than they think. This probably also applies to everyone else.

3. Drug companies seek profits

Drug companies do what they are paid to do. Regardless of the level of good intentions, companies have little choice but to do what works to maximise profit. Otherwise they risk being overtaken or taken over by more aggressive competitors. If the probability and magnitude of gains from misleading promotion exceed the risk of penalties then misleading promotion should be expected. Drug company staff may be genuinely misled by their own propaganda because of groupthink[57] or they may comply with what works because of "golden handcuffs" (the fear of losing jobs that pay more than they could get elsewhere).

Current systems, in all the countries that we know about, pay drug companies most for doing what works to increase the price and sales of new patent monopoly protected drugs regardless of the impact on health. Drug companies know a great deal about what works for influencing doctors and have huge resources for promotion.[58]

We conclude that drug companies currently use misleading drug promotion because it is profitable. If they could make more profit using reliable promotion, they would.

4. We have a system problem

Currently doctors and drug companies are locked together 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, doctors reward them via higher drug sales. If doctors over-prescribe drugs, companies have more money for gifts and for promotion reinforcing doctors' beliefs that they are doing the right thing.

We conclude that, because doctors are vulnerable to misleading promotion, the system currently rewards drug companies for promotion that is distorted towards increasing sales regardless of the impact on health.

POSSIBLE SOLUTIONS

There are four main approaches that if used in combination could unlock the system problem described above:

1. Increased regulation of drug promotion.

2. Improve medical decision making.

3. Redesign the incentives for doctors.

4. Redesign the incentives for drug companies.

1. Increased regulation of drug promotion

Because drug promotion currently does more harm than good, ideally it should be completely banned. We understand that this recommendation may seem extreme but it does follow logically. If banning drug promotion is not achievable then the more it can be limited the more health care is likely to be improved. Whatever promotion is allowed should be regulated up to the point of diminishing returns.

Evaluation of drug promotion requires skills in many fields including: clinical pharmacology and pharmaco-epidemiology, health economics, marketing, psychology, semiotics and informal logic. Healthy Skepticism Inc. has a track record in medical education and training for organisations such as the Australian Health Insurance Commission. We would be willing and able to develop training in evaluation of drug promotion for regulators.

We recommend using a regulatory pyramid approach as elucidated by Ayres and Braithwaite (1994).[59] This involves developing the capacity to use a wide range of sanctions with the understanding that if problems are not resolved with easy sanctions then the regulator will move to using progressively more onerous sanctions.

Easy sanctions should include appeals to social responsibility. Healthy Skepticism Inc. has over 20 years of experience with such appeals, sometimes with significant success.[60]

Medium level sanctions should include appeals to the desire for profit. The probability and magnitude of fines need to be greater than the probability and magnitude of profit from misleading promotion.

Ideally regulatory pyramids should include removal from the market as an achievable final sanction. This is because some companies don't respond appropriately to lower level sanctions. It is accepted in most countries that regulation of health professionals should include the capacity to remove them from the market. However removing a large pharmaceutical company from the market would cause significant harm if it is a monopoly supplier of essential drugs. Consequently, it is important to develop other incapacitating sanctions. One option is to have the capacity to revoke licences to promote specific drugs for specified periods. Another option is to develop professional regulation systems for individual staff of pharmaceutical companies so that individuals can be removed from the market. However it is important to remember that the cause of the problems is at the system level so blaming individuals alone will not solve the problem. If the system is not changed the staff who replace those who have been removed are like to behave in similar ways to their predecessors.

Developing regulatory capacity is not enough without appropriate implementation. Implementation is often undermined by the normal process known as regulatory capture. Ayres and Braithwaite (1994) have made a detailed argument for avoiding regulatory capture by using a combination of (a) regulation by government staff with (b) industry self regulation and (c) delegation of regulatory powers to non-profit public interest groups. We agree with their conclusions. Healthy Skepticism Inc. would consider serving in the way Ayres and Braithwaite suggest if the opportunity arose.

Without the capacity to remove whole companies from the market, regulation alone will not be enough to solve all the problems so regulation should be combined with the other approaches below.

2. Improve medical decision making

Medical decision making can best be improved via education for doctors, pharmacists and consumers so that all are empowered to play their part better. Healthy Skepticism Inc. has expertise in education for medical decision making particularly via the AdWatch section of our website. We are willing and able to share our expertise.

If doctors were helped to become better decision makers then prescribing could improve. Such improvement could occur in part via reduced vulnerability to misleading drug promotion. Drug companies could reduce that improvement by using more subtle misleading techniques, but it is also possible that they might adapt to improved decision making by providing more reliable information.[61] The fact that doctors have human vulnerabilities limits the extent of improvement that can be achieved by improving medical decision making alone. However worthwhile improvements may be achieved if improved decision making capacity is supported by incentives as is discussed below.

3. Redesign the incentives for doctors

Ideally doctors should be prohibited from receiving any incentives from drug companies because even small gifts lead to unintended bias.[62] [63] This may seem an extreme position but the available evidence suggests that no other policy would be effective for reducing adverse influence. If prohibiting gifts is not achievable, another option would be to make all gifts taxable. As an example, if doctors were invited to a meeting and served a meal then the drug company would be obliged to issue them with a form giving the value of the meal. At tax time doctors would have to declare, and pay tax, on all gifts that they received from drug companies.

We are aware that the UK is about to experiment with expanded direct incentives for achieving performance targets.[64] Such incentives may be beneficial in their own right and may have a beneficial side effect of motivating doctors to be more wary of drug promotion that conflicts with the achievement of quality targets. This hope is supported somewhat by experience in New Zealand where giving GPs a period of budget management responsibly is thought to have led to a significant increase in the level of scepticism about drug promotion.[65]

We conclude that removing incentives for bad practice and increasing incentives for good practice will contribute to reducing the adverse influence of drug promotion. We use the concept of direct incentives for achieving performance targets as a model for part of our proposals of redesigning incentives for drug companies below.

4. Redesign the incentives for drug companies

Drug companies are currently paid according to drug sales volumes at prices that are much higher than manufacturing costs. They use the surplus for multiple functions including research, education and promotion. We recommend that these 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 etc. Each payment source would invite organisations (including drug companies) to submit proposals for funding by competitive tender.

For example, the promotion payment source could put out to tender contracts for promotion of activities given priority according to health need. These priority activities could include pharmaceutical issues (eg increasing the use of underused drugs or decreasing the use of overused drugs) and also non-pharmaceutical issues (eg increasing physical activity levels). These contracts could include direct incentives for achieving performance targets. Drug company marketing departments could compete against, or form consortia with, other organisations (eg universities and non-government organisations) to win these contracts.

Such tendering could produce significant improvements with minimal disruption to pharmaceutical companies because they already subcontract many of these activities to other organisations, eg advertising agencies, university researchers and medical education providers.

Total payments from government to drug companies could be kept the same. The separate payments for promotion would be funded from savings achieved by lowering drug prices towards manufacturing costs without the large surpluses that are currently used to pay for other functions such as research, education and promotion etc. These functions would be paid for separately. The lower prices would reduce the funds available for misleading promotion and reduce the profits to be gained from it.

Another proposal that is compatible with our first proposal is to pay for drug sales with a blended combination of the traditional payments per sales volume (but at lower prices) supplemented with bonus payments for achieving performance targets. These targets could include measurers of appropriate utilization across postcodes in proportion to need and measures of appropriate prescribing by doctors. Such direct incentives for achieving performance targets would reward appropriate promotion.

A third proposal that is compatible with our other proposals is to use price volume agreements and risk sharing agreements as have been used in Australia[66] or capped annual contracts as have been used in New Zealand.[67] Under price volume agreements the price payed per drug pack gradually decreases as the sales volume increases so that the incentive to over-promote is reduced. By contrast fixed prices reward over-promotion because of economies of scale over fixed costs lead to higher marginal profits at higher sales volumes. Capped annual contracts are similar except that once a pre-specified sales target (calculated to match national needs) has been reached then the price paid for additional sales drops to zero. This gives drug companies an incentive to de-promote their drug if it is being overuse so as to maximise their profit by maintaining sales volumes at the target.

Political achievability of these proposals would be enhanced by ensuring that drug companies continued to receive good returns on investment as long as they were efficient and effective at achieving the new performance targets. The main difference would be a shift from paying drug companies to do the wrong thing (over-promoting drugs) to paying them more according to their contributions to improving health. In the long run giving drug companies a more valuable role plus economic gains from improved health would enable and justify countries to pay drug companies more money than otherwise. Drug company staff who are unhappy about the status quo may be more productive if enabled to work more for the common good than currently.

PROFESSIONAL AND PATIENT EDUCATION

Similar tendering systems as suggested above for promotion could be used as a better way to fund continuing education for health professionals, patients and the wider public.

Last week the BMJ accepted a commissioned editorial written by Peter Mansfield and experts in Canada and New Zealand about the conflicting pressures on policy about direct to consumer promotion of prescription drugs that. We concluded that "the potential awareness raising benefits of direct to consumer advertising could be better targeted and sustained at lower cost with less harm through publicly funded and accountable drug information services and health campaigns."

DRUG INNOVATION AND THE CONDUCT OF MEDICAL RESEARCH

Rather than aiming at greatest medical need, current systems for paying drug companies reward research and development of "me too drugs" for chronic conditions of people who have the greatest capacity to pay. The industry is spending increasing amounts on that type of research with diminishing returns.[68] The large pharmaceutical companies are increasingly outsourcing research and development to smaller organisations that are more innovative and efficient.[69]

Drug company funding of medical research is associated with systematic bias.,[70] ,[71] [72]

Similar tendering systems as suggested above for promotion could be used as a better way to fund drug research and also development of drugs that currently would not be developed by drug companies because they are judged unlikely to be very profitable.

REGULATORY REVIEW OF DRUG SAFETY AND EFFICACY

Our comments above about the problem of regulatory capture in relation to regulation of promotion also apply to regulation of safety and efficacy, so we will repeat them here:

Developing regulatory capacity alone is not enough. Regulators must use their capacities appropriately. This is often undermined by the normal process know as regulatory capture. Ayres and Braithwaite (1994) have made a detailed argument for avoiding regulatory capture by using a combination of (a) regulation by government staff with (b) industry self regulation and (c) delegation of regulatory powers to non-profit public interest groups.[73] We agree with their conclusions. Healthy Skepticism Inc. would consider serving in the way Ayres and Braithwaite suggest if the opportunity arose.

PRODUCT EVALUATION, INCLUDING ASSESSMENT OF VALUE FOR MONEY

Evaluation of drugs includes evaluation of the claims that drug companies make about their drugs. This requires similar skills to those required for evaluation of drug promotion including: clinical pharmacology and pharmaco-epidemiology, health economics, marketing, psychology, semiotics and informal logic. Healthy Skepticism Inc. has a track record in medical education and training for organisations such as the Australian Health Insurance Commission. We would be willing and able to develop training in evaluation of claims about drugs for drug evaluators.

ACKNOWLEDGEMENTS

I thank A/Prof Joel Lexchin of the School of Health Policy and Management at York University, Canada, Ms Melissa Raven of the Department of Public Health, Flinders University, Australia, Prof David Menkes of the Psychological Medicine Academic Unit, University of Wales, UK and Dr Staffan Svensson of the Department of Clinical Pharmacology, Sahlgren's University Hospital, Gothenburg, Sweden for helpful comments.

35 Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4. Back

36 Becker MH, Stolley PD, Lasagna L, McEvilla JD, Sloane LM. Differential education concerning therapeutics and resultant physician prescribing patterns. J Med Educ 1972;47:118-27. Back

37 Linn LS, Davis MS. Physicians' orientation toward the legitimacy of drug use and their preferred source of new drug information. Soc Sci Med 1972;6:199-203. Back

38 Mapes R. Aspects of British general practitioners' prescribing. Med Care 1977;15:371-81 Back

39 Haayer F. Rational prescribing and sources of information. Soc Sci Med 1982;16:2017-23. Back

40 Ferry ME, Lamy PP, Becker LA. Physicians' knowledge of prescribing for the elderly: a study of primary care physicians in Pennsylvania. J Am Geriatr Soc 1985; 33:616-21. Back

41 Bower AD, Burkett GL. Family physicians and generic drugs: a study of recognition, information sources, prescribing attitudes, and practices. J Fam Pract 1987;24:612-6. Back

42 Cormack MA, Howells E. Factors linked to the prescribing of benzodiazepines by general practice principals and trainees. Family Practice 1992;9:466-71. Back

43 Berings D, Blondeel L, Habraken H. The effect of industry-independent drug information on the prescribing of benzodiazepines in general practice. Eur J Clin Pharmacol 1994;46:501-505. Back

44 Caudill TS, Johnson MS, Rich EC, McKinney WP. Physicians, pharmaceutical sales representatives, and the cost of prescribing. Arch Fam Med 1996;5:201-6. Back

45 Mansfield PR, Lexchin J Scepticism and beliefs about new drugs. Healthy Skepticism International News 2001;19:1/6 www.healthyskepticism.org/editions/2001/IN0106.htm Back

46 Caamano, F; Figueiras, A, and Gestal-Otero, JJ Influence of commercial information on prescription quantity in primary care. Eur J Public Health. 2002 Sep; 12(3):187-91. Back