Collaboration with drug industry won’t affect clinical decisions, says new guide

BMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e2489 (Published 2 April 2012)
Cite this as: BMJ 2012;344:e2489

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The pharmaceutical companies invest a huge amount of money into creating the prefect marketing strategy to communicate and influence people to make a profit. Healthcare professionals work to improve health and quality of life to a budget. To ignore this conflict is like crossing a road and not taking into account the large metal objectives hurtling towards you! We all need to look and explore the evidence to make a judgement call.

Of course, healthcare professionals and the pharmaceutical industry should work together to secure future worthy drug development and medical research, to transfer accurate information and to guide the production of useful policies. Pretending we do not have different expertise, agendas and roles will not help us accomplice this.

Competing interests: None declared

Nancy Isaac, Unemployed

n/a, n/a

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A short article in the BMJ reported a document apparently agreed by the BMA, the RCP, DOH and the RCGP among other signatories. It is called “Guidance on collaboration between health care professionals and the pharmaceutical industry". We have waited before commenting to see if any of the signatories are prepared to comment on this document but no response appears to be forth-coming. This is an extremely flawed document containing a number of assertions not backed up by evidence. These include:- “Healthcare and industry professionals are able to manage their relationships with each other without compromising clinical decision making" There is a considerable body of evidence shows the more contact a clinician with drug reps the less evidence based their prescribing1,2. "Industry plays a valid and important role in the provision of medical education", This directly contradicts the recent RCP report on medical education and is also in conflict with the 2005 House of Commons report on the relationship between the pharmaceutical industry and medical education3. “Information about industry-sponsored trials is publically available” There have been numerous cases over recent years where this had patently not been the case, eg rosiglitazoneand tamiflu4. We call on those who have signed this document, in particular the BMA, RCP, DOH and RCGP to explain their reasons for endorsing this document and to disassociate themselves from it. 1.Spurling GK, Mansfield PR, Montgomery BD, Lexchin J, Doust J, Othman N, Vitry AI. Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review. PLoS Med 2010; 7(10): e1000352. 2. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003; 326(7400): 1167-70. 3. "The Influence of the Pharmaceutical Industry". Report of the House of Commons Health Committee. 5 April 2005 4. Rosiglitazone: What went wrong. 2010, BMJ, 341, pp530-4.

Competing interests: JM and MK and founding members of Healthy Skepticism UK.

Jennifer McAughey, GP

Merav Kliner

Health Skepticism UK, Belfast

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I agree with Cattaneo et al [1]. In 2005 Fiona Godlee responded to the seminal House of Commons Health Committee report on the influence of the pharmaceutical industry [2,3]:

"The power of drug companies to buy influence over every key group in health care—doctors, charities, patient groups, journalists, politicians—has clearly shocked a UK parliamentary committee...It should shock us all. Can we console ourselves that companies' lavish spending on research and marketing, which far outstrips spending on independent research and drug information, leads to truly innovative treatments? No, says the committee's report. Can we rely on regulatory bodies to keep the industry in check? No, again."

And yet today there is not so much at the bat of an eyelid from BMJ over BMA's endorsement of this remarkable new document. What we seem to have is complete and utter capitulation before the industry, and a new won naievety about their intent.

Meanwhile, I note that Dr Cattaneo writes on behalf of the Italian equivalent of No Free Lunch [1] and there has been no statement weeks on from the British body. Its spokesman, Des Spence [4], has been a weekly BMJ columnist now for more than five years. And if you go to their news page it tells you to look at BMJ [5]. The dog has steadfastly not barked.

[1] Cattaneo et al 'Re: Collaboration with drug industry will affect clinical decisionsns, says new guide' BMJ Rapid Responses 22 April 2012 http://www.bmj.com/content/344/bmj.e2489/rr/580514

[2] House of Commons Health Committee 'The Influence of the Pharmaceutical Industry' Fourth Report of Session 2004-5 http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/4...

[3] Fiona Godlee 'Say know to the free lunch' BMJ 14 April 2005 http://www.bmj.com/content/330/7496/0.8?page=1&tab=responses

[4] About No Free Lunch http://www.nofreelunch-uk.org/about.shtml

[5] No Free Lunch Newsroom http://www.nofreelunch-uk.org/newsroom.shtml

Competing interests: I do not benefit from industry largesse in any way.

John Stone, UK Editor

AgeofAutism.com, London N22

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Dear Editor,
Like our Australian colleagues, we were puzzled by the “neutral” reporting on the Ethical Standards in Health and Life Sciences Group’s “Guidance on collaboration between healthcare professionals and the pharmaceutical industry” by the BMJ.1 This was a very unexpected uncritical report by the journal we all associate with the “Who pays for the pizza?” and “How to dance with porcupines” articles and covers.2-4 Possible explanations:
• The wind is blowing in favour of the industry, as shown by other episodes of the same kind under the current UK government?5
• The same neoliberal wind shakes the WHO flag, and apparently finds little resistance; why should it not hit the BMJ?6
• That’s the way things are going even at the United Nations?7
• The Guidance carries the BMA logo, and it’s difficult to be critical towards one’s own mother?
We have no answer, but would expect one from the BMJ, not necessarily one of those listed above. Meanwhile, we agree with the arguments put forward by our Australian colleagues.

Adriano Cattaneo, on behalf of No Grazie Pago Io (www.nograziepagoio.it), the Italian equivalent of No Free Lunch
Maria Font, on behalf of Dialogo sui Farmaci*
Daniela Zanfi, on behalf of Informazioni sui Farmaci*
Nicola Magrini, on behalf of Pacchetti Informativi sui Farmaci*
* Italian drug bulletins belonging to the International Society of Drug Bulletins (ISDB)

1. Dyer C. Collaboration with drug industry won’t affect clinical decisions, says new guide. BMJ 2012;344:e2489
2. Moynihan R. Who pays for the pizza? Redefining the relationships between doctors and drug companies. 1: entanglement. BMJ 2003;326:1189-92
3. Moynihan R. Who pays for the pizza? Redefining the relationships between doctors and drug companies. 2: disentanglement. BMJ 2003;326:1193-6
4. Wager E. How to dance with porcupines: rules and guidelines on doctors' relations with drug companies. BMJ 2003;326:1196-8
5. Mayor S. Specialists condemn government’s obesity plan as too simplistic. BMJ 2011;343:d6688
6. Richter J. WHO Reform and Public Interest Safeguards: An Historical Perspective. Social Med 2012;6:141-50
7. Heath I. Seeming virtuous on chronic diseases. BMJ 2011;343:d4239

Competing interests: The authors of this letter are members of associations that promote a progressive disentanglement of health professionals from industry, or members of the editorial committees of independent Drug Bulletins

Adriano Cattaneo, Epidemiologist

Maria Font, Daniela Zanfi, Nicola Magrini

Institute for Maternal and Child Health IRCCS Burlo Garofolo, Via dell'Istria 65/1, 34137 Trieste, Italy

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You state in this article that the Ethical Standards in Health and Life Sciences Group "points out that the industry was responsible for 92% of drug research and development in 2009 and that it takes 10-15 years and typically costs £550m (€660m; $880m) to develop a new drug." I would be interested to know where these figures came from. They look suspiciously like those that Marcia Angell dealt with a few years ago.1
Have none of them read Marcia Angell's dismantling of this claim? Her analysis reveals how these figures are grossly inflated, how most new drugs are 'me-too' derivatives, how very few innovative drugs are produced now and that most of these come from academic institutions. I can't see that much has changed
Is the former editor of the New England Journal of Medicine someone who can be ignored? Or is all that in the past and the likes of Vioxx forgotten?

1.Marcia Angell. The Truth about Drug Companies. 2005 Random House

Competing interests: None declared

Richard Stenning, Patient

none, n/a

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It is disappointing to see [1] so many reputable organisations join the Association of the British Pharmaceutical Industry in endorsing such a damaging and ill conceived document [2]. Unreferenced statements such as 'Healthcare and industry professionals are able to manage their relationships with each other without compromising clinical decision making' [2], at odds with a growing body of evidence [3], are unhelpful.

We would like to suggest an alternative set of principles for consideration:

1) Despite its flaws [4], we are probably stuck with the current model of pharmaceutical R&D, at least in the short to medium term.

2) If industry wish to make information on their products available, they can publish in a peer reviewed journals like the rest of us. Clinicians should treat this data with caution, as funding source is strongly associated with reported outcome in published trials [5].

3) It is difficult to assess how others' conflicts of interest might affect their account of the evidence base. For this reason, we should demand review articles and medical education be delivered, in almost all cases, by people with no industry links [6]. The presence of people with significant industry links on guideline committees [7] is totally unacceptable.

4) Industry codes of conduct usually have limited impact – the ABPI code is a good example of this [8].

5) Patients would be shocked if they realised the extent to which our profession is dependent on industry. Blanket bans on contact with industry reps, of the kind imposed in several American medical schools [9], are a step in the right direction.

1. Dyer C. Collaboration with drug industry won’t affect clinical decisions, says new guide. BMJ 2012; 344: e2489.
2. Ethical Standards in Health & Life Sciences Group. Guidance on collaboration between healthcare professionals and the pharmaceutical industry. Available from http://www.abpi.org.uk/our-work/library/guidelines/Documents/Guidance%20... (accessed 18 April 2012).
3. Spurling GK, Mansfield PR, Montgomery BD, Lexchin J, Doust J, Othman N, Vitry AI. Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review. PLoS Med 2010; 7(10): e1000352.
4. Trouiller P, Olliaro P, Torreele E, Orbinski J, Laing R, Ford N. Drug development for neglected diseases: a deficient market and a public-health policy failure. Lancet 2002; 359(9324): 2188-94.
5. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003; 326(7400): 1167-70.
6. See http://www.conflictfreeconferences.com (accessed 18 April 2012).
7. Neuman J, Korenstein D, Ross JS, Keyhani S. Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. BMJ 2011; 343: d5621.
8. Herxheimer A, Collier J. Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation. BMJ 1990; 300: 307-11.
9. For an up to date summary of regulations, see http://www.amsascorecard.org (accessed 18 April 2012).

Competing interests: TAY and CJR recently set up a scheme (see www.conflictfreeconferences.com) to accredit medical education which is independent of industry. We are have no financial conflict of interest. In 2009, TAY assisted with a study which used point of care HIV tests provided free of charge by Pasante. In 2010-11, TAY worked as a research fellow on a study part funded by GSK.

Tom A Yates, MRC Advanced Course Masters Student in Epidemiology (a)

Carl J Reynolds, CT1 in Acute Medicine (b)

a) London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT b) Chelsea and Westminster Hospital

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Whose interests lie behind new ‘consensus’?

The new guidance on collaboration between health professionals and big Pharma urges doctors not to be “tempted to accept the negative myths about cooperating with industry”(1). Some ‘myths’ are specifically mentioned: industry influence impairs clinical decision-making and may be perceived negatively by peers. Other myths are clearly implied: industry provision of medical education is flawed; contact with drug reps does more harm than good (2). Given evidence (3) that these are anything but ‘myths’, we assumed that the BMJ, having drawn attention to such problems in a celebrated cover issue (31 May 2003), was again doing so as an April Fool’s spoof. Our amusement was short-lived, however, when we noticed endorsements by an impressive array of UK bodies including the Welsh and Scottish Governments, the BMA, the Lancet, many Royal Colleges, and the Department of Health (2).

How did these diverse bodies with missions quite distinct from for-profit industry (4) come to endorse a document that reads like spin from a commercially-funded PR firm?

This Guidance whitewashes industry’s unethical behaviour (5) and, particularly with these endorsements, risks further undue influence over doctors’ decision-making. Big Pharma has an inevitable commercial agenda that can and must be kept separate from medical education.

1 Dyer C. Collaboration with drug industry won’t affect clinical decisions, says new guide. BMJ 2012;344:e2489
2 Association of the British Pharmaceutical Industry. Guidance on collaboration between healthcare professionals and the pharmaceutical industry. 29 March 2012
http://www.abpi.org.uk/our-work/library/guidelines/Pages/collaboration-g...
3 Menkes DB. New Zealand doctors and the pharmaceutical industry—time to cut the cord? NZ Med J 2011;124:6-8.
4 Lo B. Serving Two Masters — Conflicts of Interest in Academic Medicine. N Engl J Med 2010; 362:669-671
5 Braillon A. Drug industry is now biggest defrauder of US government. BMJ 2012;344:d8219

Competing interests: None declared

David B Menkes, Member

Peter Mansfield, Jörg Schaaber, Tim Reed, Joel Lexchin

Healthy Skepticism, Private Bag 3200, Hamilton 3240, New Zealand

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18 April 2012

Rogers et al [1] are right, this is indeed disappointing, and equally it is disappointing that the only comment so far is from a group of Australian academics: no thunderous editorial from the BMJ despite its avowed commitment to academic independence and journal ethics. And, moreover, it all comes endorsed by the BMJ's parent organisation the BMA. It also reminds me of the initiative undertaken by the editor the Lancet at the beginning of 2008 [2], and I seem to remember that that did not fare well. However, that was an initiative to consult the medical profession, whereas this seems to be an attempt to change culture from the top. Why bother to ask after all: you might have to listen to well reasoned answers?

Not only is this very unwise but with barely a word being said it has now become official ideology, and we can only expect as a result a further excess of grief. It will be ordinary citizens who will pay both from their pockets and with their lives. As JK Galbraith warned in 1999 [3]:

"Take the common outcry about corporate welfare. Here the private firm, as it is called, receives a public subsidy for its product or service. But what is called corporate welfare is a minor detail. Far more important is the full-fledged takeover by private industry of public decision-making and government spending."

In 13 years we ought to have learnt many lessons, but instead we seem to have surrendered any kind of scepticism whatsoever. And, of course, what we have is not a fee market but a captive one.

[1] Rogers et al 'Re: Collaboration with drug industry won’t affect clinical decisions, says new guide'BMJ Rapid Responses 16 April 2012 http://www.bmj.com/content/344/bmj.e2489?tab=responses

[2] Annabel Ferriman 'Royal college sets up working party to improve relations between doctors and drug industry'BMJ2008;336doi: 10.1136/bmj.39428.617431.DB(Published 3 January 2008)

[3] JK Galbraith 'Free Market Fraud', The Progressive, January 1999 http://www.progressive.org/mag_galbraith0199

Competing interests: None declared

John Stone, UK Editor

AgeofAutism.com, London N22

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I would like to endorse the views of Wendy Rogers, Tamara Zutlevics, Melissa Raven, and Jon Jureidini on the 'new guide to promote collaboration between healthcare organisations and the drug industry.'(1) I share their conclusion that 'this Guidance refuses to take seriously the challenging issue of conflicts of interest and does nothing to improve ethics or transparency. It is deeply disappointing.'

My own experience has been that education and marketing remain entangled and that 'transparency' is often claimed but is less often a reality.(2)

(1) BMJ Rapid Response: Re: Collaboration with drug industry won’t affect clinical decisions, says new guide. Wendy Rogers, Tamara Zutlevics, Melissa Raven, and Jon Jureidini

(2) BMJ 2011;343:d7375 System for disclosing hospitality should be transparent. 15 Nov 2011

Competing interests: None declared

Peter J. Gordon, Old Age Psychiatrist

NHS, Forth Valley

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BMJ April Fool’s news regarding collaboration with the drug industry

Clare Dyer reported on a new guideline to promote collaboration between doctors and the pharmaceutical industry, urging doctors not to be “tempted to accept the negative myths about cooperating with industry”.(1) It is backed by a huge number of major UK bodies: the BMA, the Department of Health, the NHS Confederation, the Academy of Medical Royal Colleges and the the Royal College of Nursing amongst others, despite containing misleading assertions.(2) For example, “4. Industry plays a valid and important role in the provision of medical education … “ and “6. Medical representatives can be a useful resource for healthcare professionals …”
We can only assume that the BMJ published this on the 2nd as April Fool’s Day fell on a Sunday this year. We are worried that BMJ readers might have missed the joke, or will find that the joke will be on patients.
Doctors should not be tempted to accept the positive myths about the industry. Those who seek to defend its important role should not disremember that too many companies still exhibit poor records of ethics. GlaxoSmithKline recently agreed to pay $3bn to settle civil and criminal investigations into its sales practices for numerous drugs, its fourth such case since April 2008, surpassing the previous record of $2.3bn by Pfizer in 2009.(3)
Cuddly collaboration with persisting recidivists would be taking forgiveness and ‘second chances’ too far, once again.(4)

References
1 Dyer C. Collaboration with drug industry won’t affect clinical decisions, says new guide. BMJ 2012;344:e2489 (2 April 2012)
2 Association of the British Pharmaceutical Industry. Guidance on collaboration between healthcare professionals and the pharmaceutical industry. 29 March 2012 Available at http://www.abpi.org.uk/our-work/library/guidelines/Pages/collaboration-g...
3 Braillon A. Drug industry is now biggest defrauder of US government. BMJ 2012;344:d8219
4 Mulholland H. David Cameron: Andy Coulson deserves to be given a second chance. The Guardian 17 January 2011. Available at http://www.guardian.co.uk/politics/2011/jan/17/david-cameron-andy-coulso... Accessed 14 April 2012

Competing interests: SB is a committee member of Healthwatch, a charity ‘for treatments that work’”

Alain Braillon, Public Health

Susan Bewley(b), Andrew Herxheimer(c), Liliya E. Ziganshina(e) (b) Professor of complex obstetrics, King’s College London, London SE1 7EH, UK (c) Emeritus fellow, UK Cochrane Centre (e) Head of Basic and Clinical Pharmacology Department, Kazan Federal University, Kazan 420008, Russian Federation

none, 80000 Amiens. France

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