Margaret McCartney: Forever indebted to pharma—doctors must take control of our own educationBMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h1965 (Published 13 April 2015) Cite this as: BMJ 2015;350:h1965
All rapid responses
I welcome Dr Spurling into the discussion
Most readers (myself included) will agree, as Dr Spurling states, that "everyone selectively quotes research articles when they argue a position", but usually the quotations reflects what the authors found in their studies. It is therefore unusual to find any authors who tolerated their findings being reported so selectively (and with such bias) such that it does not accurately reflect the actual results of the study at all.
Dr Spurling does not appear to be bothered by such misleading reporting by various other authors and lobbyists.
To illustrate what is actually happening, let me give an example of what had happened in these reporting, removing the emotional and subjective elements out of the equation:
The authors reported that their meta-analysis of have found association of conditions related to the activity X, or no significant association. We have found no evidence of better outcome from activity X but cannot exclude the possibility that good can come out of this black activity X. Any conclusions about good or bad outcomes are speculative because none of the studies that the authors found examined clinical outcomes."
I would find it hard to accept any readers and authors to just quote "The authors reported that their meta-analysis of have found association of conditions related to the activity X" as the finding, particularly when "or no significant association" should be given the same weight as the presence of association.
This is only a few steps away from selective quoting an author who wrote "There is no association between A and B", as "There is association between A and B" and leaving out the "no"!
Dr Spurling defends his (and his co-authors') precautionary recommendation is evidence-based, and suggests that because "the pharmaceutical industry has not presented convincing research evidence that their information to doctors is beneficial", this is further proof of support.
I beg to differ.
Dr Spurling and co-authors made their recommendation in 2010, thus their burden of proof for their statement should be at the time of publication, and should not rely on future supporting evidence (or the lack of it) to support their recommendation. I would have accept it if Dr Spurling have asserted their recommendation is a "safe" measure based on rationalisation and subjective value system.
But Spurling et al actually states " In the absence of evidence of net improvement in prescribing from exposure to promotional information, we recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies unless evidence of net benefit emerges.", ie there is no net evidence for (or in my view against) promotional information, I cannot see how Dr Spurling seek to misrepresent his case as evidence-based through the lack of it.
Dr Spurling suggest that I seek to be paid more, that because other professionals has continuing education without sponsorship, the public has no stomach for orthopaedic surgeons to be paid more to meet professional obligations.
I had actually wrote that
"our professional time as doctors is not "free" and if there is any suggestion that we as doctors should pay for our education with our own time and money, then perhaps we should call for better renumeration for our work when we call to remove commercial sponsorship to CME activities."
and I do feel that my surgical colleagues are unfairly singled out by Dr Spurling when my intent is clearly for the medical fraternity as a whole. As for "sponsorship-free" continuing education, depending on the country, practicing solicitors generally requires 20 hours or less Mandatory Continuing Legal Education annually of which a significant proportion can be done in-house or without specialised setup or equipment. The general cost of attaining those points is a mere fraction of that of a doctor.
If you work in Australia, it is almost certain a doctor would have to incur travelling costs in order to maintain their CME (continuing medical education), and when courses and national meetings (of Colleges and Associations) costing at least $1000 in Australia, I will not be surprised if the cost of CME for a doctor with recognised speciality (including GP) is at least $20000 annually; this of course does not include loss of income from taking time out to attend these CME. I also point out some (if not most) of these courses and meetings are already partially or indirectly sponsored so the real cost to doctors would have been even higher. And I very doubt the time spent by doctors on CME is less than 20 hours a year.
Dr Spurling states that "The onus is on those who don’t agree with the precautionary conclusion of our review to provide evidence showing the benefit of information from pharmaceutical companies.".
I suggest that he is seriously mistaken. Taking the cue from his fellow GPs in Australia (some 43,400 in 2011 Australian Bureau of Statistics), I believe the reverse is true.
Dr Spurling is a member of the group who launched No Advertising Please campaign in October 2014 the RACGP (Royal Australian College of General Practitioners) annual conference to much media support and fanfare. More than 6 months down the track, there is less than 350 signatories who pledge to not see visiting pharmaceutical representatives (drug reps) at their practice for one year; if international signatories are removed, less than 300 Australian are involved (and not all of them are GPs)
Of course Dr Spurling is welcomed to use his value-system and rationalisation process and suggest that the less than 1% written support from his GP colleague does not mean that those who did not sign the pledge are opposed to the idea, but alas I hold a very different (and commonly accepted) view: that those who did not write, did not happen.
Perhaps other readers may agree with me that the onus is on Dr Spurling to convince his immediate colleagues first, who are more likely to have drug reps going into their rooms than my surgical colleagues.
At the risk of repeating myself, I would like to stress my main reason to join this discussion, (some would say my 'bone to pick' - pun intended) was the selective quoting of findings which misleads readers about the article results.
It would now appear that both authors and readers can be guilty of this.
Beware ye of the leaven of the Pharisees
1. Spurling GK, Mansfield PR, Montgomery BD, et al. Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review. PLOS Med 2010; 7: e1000352.
Competing interests: No competing interests
Of course, everyone selectively quotes research articles when they argue a position. Otherwise, academic articles would be somewhat unwieldy collections of whole research papers. Responses to our review follow a common pattern. People who have a tendency to agree with the precautionary message of our review, like Dr McCartney, focus on the associations of pharmaceutical information and prescribing harms. People, like Dr Goh, who tend to disagree with the precautionary message frequently present a longer version of the conclusion including all the inherent doubt associated with a systematic review of heterogenous, largely observational studies, and then dismiss the conclusion.
Dr Goh argues that our precautionary conclusion is not evidence based, but I would disagree. One of the strengths of a systematic review is that it looks at all the available literature on a subject. One of the frequent claims of the pharmaceutical industry and doctors who attend their meetings is that their information is beneficial. For me, the most surprising finding of our review was that we could not find evidence to support this argument.1 The evidence for prescribing harm is mixed and observational but it seems unlikely that a randomized controlled trial of pharmaceutical promotion to doctors will be conducted even though the industry clearly has the means, expertise and resources to conduct such a trial. Since our review has been published, the pharmaceutical industry has not presented convincing research evidence that their information to doctors is beneficial. In the absence of benefit and with some evidence of harm, we considered the precautionary principle to be a reasonable and careful conclusion to the evidence we reviewed. Pointing out the limitations of our review, something all diligent academics should do, does not invalidate our conclusions which were that doctors should avoid pharmaceutical information unless evidence of benefit emerges.1
Dr Goh reassures us that he takes a healthily skeptical/ cynical approach to meetings involving commercial information. However, there is no evidence that this is a defence against industry influence. Doctors have been shown to have a higher opinion of their own ability to resist pharmaceutical influence than their peers.2 Dr Goh also suggests that in return for not attending commercially sponsored meetings he should be paid more. I am not sure that other highly educated professions, such as lawyers who fund their own continuing education, and the general public would be sympathetic to the proposal that orthopaedic surgeons be paid more to meet their professional development responsibilities, but that sentiment does illustrate the challenges facing those promoting independent medical education.
The onus is on those who don’t agree with the precautionary conclusion of our review to provide evidence showing the benefit of information from pharmaceutical companies. In the meantime, I would recommend supporting Dr McCartney’s call for independent medical education.3
1. Spurling GK, Mansfield PR, Montgomery BD, et al. Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review. PLoS Med 2010;7(10):e1000352.
2. Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical industry promotions. Am J Med 2001;110(7):551-557.
3. McCartney M. Margaret McCartney: Forever indebted to pharma--doctors must take control of our own education. BMJ 2015;350:h1965.
Competing interests: No competing interests
I am writing in response to Dr McCartney's reply to my rapid response, including her justification.
Lamenting the lack of good studies supporting one's own views does not justify selective quoting that misleads.
To put it simply, albeit bluntly: in partially and selectively quoting findings is inadvertently misleading, however unintentionally, Dr McCartney and others cannot expect to claim the moral high ground, when the end result of misrepresentation of facts is no better than what the big pharmas are exactly being accused of (by Dr McCartney and others) in their promotional activities.
Competing interests: While I am not a supporter of big pharma lobbying, I support their right to promote their wares as part of any commercial entity, just as any individual or group of people can promote their own views using whatever means to access your attention and time.
Dear Dr Goh
Many thanks, you are quite right, I should have said that associations were found between pharma sponsored education and higher prescribing frequency, higher cost, or lower prescribing quality, but also that associations were also not found. We have no good RCTs of the effect of sponsorship on guideline writing or sponsorship; but in the absence of safety data we have allowed this potential bias to take root underneath our feet without safety studies. There is other evidence that should be taken into consideration; namely that such effort and money goes into marketing to doctors. Or then there is the quality of the leaflets that still manage to get into my practice (much like the invitations to Hogwarts via owl to Harry Potter). The pharmaceutical claims are frequently based on surrogate outcomes, small study sizes, and are of poor quality, eg http://www.biomedcentral.com/1471-2296/7/13 or http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3157133/. There are many biases in medical practice that are hard to avoid. But there are others which are. So why not seek sources of information which are as unbiased as possible?
Competing interests: I wrote the article, DOI is here http://www.whopaysthisdoctor.org/doctor/6
It is difficult to disagree with McCartney's view that doctors need to wean themselves off industry sponsorship for educational events. The negative effects of being dependent on industry money for educational events have been noted for some time. (1) But other educational mediums also require independence. Guideline committees and medical journals are two additional information/educational mediums that can be biased because of financial conflicts of interest. The point is not new and has been made before. (2) (3) But it bears repeating given how much influence these mediums have on educational content. Indeed, economies of influence can permeate a medical discipline and shape educational content from the ground up.(4) Scandals involving tainted medical information resulting in the loss of human life underscore the seriousness of the situation.(3) Until medicine regains its professional independence, concerns over tainted information in medical education will likely persist - and for good reason.
1. Jerome Kassirer. On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health. Oxford University Press, 2004
2. Jeanne Lenzer; Why we can't trust clinical guidelines: BMJ 2013;346:f3830
3. Richard Smith: Lapses at the New England Journal of Medicine; J R Soc Med. 2006 Aug; 99(8): 380–382.
4.Robert Whitaker, Lisa Cosgrove; Psychiatry Under The Influence; Palgave Macmillan, 2015
Competing interests: No competing interests
Education is a paradox. It informs and conforms us with facts, but it also immerses and rehearses us with minutiae. Enlightened but benighted, and filled with the helium of higher education, our head is in the sky, and our feet barely touch the ground. What should we do? We should treat this heady intoxication with brevity, simplicity, clarity, and humility, since education is not pontification, fabrication, or polysyllabification, but public communication for and with all people - past, present, and future.
Competing interests: No competing interests
Heath Action International (HAI) is a global network of medicines policy expertise, working to increase access to essential medicines and ensure their rational use.
We were delighted to see McCartney's comment on the influence of the pharmaceutical industry on prescribing from early in a doctor's career. Readers may be interested in the WHO/HAI Manual 'Understanding and Responding to Pharmaceutical Promotion: A Practical Guide', available as a free download in English, French, Spanish and Russian from the HAI website (www.haiweb.org). and also available as hard copy.
We continue to teach from the manual, particularly in low and middle-income countries, where the influence of the pharmaceutical industry on prescribing and dispensing continues unabated. Most recently, two 'training the trainers' workshops in the Philippines, introduced the manual to over 90 Pharmacy School faculty, culminating in declarations from participants to commit to teaching students ethical behaviour when confronted with promotional activity, in all its forms. The delegates included teaching faculty and eight Deans of pharmacy schools.
Of particular note was that for the first time, the courses in Manila and Cebu were accredited with CME points, and curriculum acceptance is not far away. It is a shame that faculty in Europe and North America are less enthusiastic about teaching the dangers of pharmaceutical promotion to students. But then, many medical and pharmacy schools are already bought-out in one way or another by the pharmaceutical industry, so maybe we should not be surprised.
Competing interests: No competing interests
“Paying our own way would enable doctors to regain control.” I agree with Dr McCartney's article. That doctors' independence in the area of pharmaceutical drugs is paramount so that patients can continue to trust the advice given and drugs prescribed. As an unpaid Carer I would also appreciate the reassurance that the doctors who support the family members I care for are free from conflicts of interest and that their attentions are firstly and firmly focused on the patient.
I would like to draw attention to the transparency work of consultant psychiatrist Dr Peter J Gordon in this respect, his ongoing Petition to Scottish Parliament urging the Scottish Government to introduce a Sunshine Act for Scotland. Creating a searchable record of all payments (including payments in kind) to NHS Scotland healthcare workers from Industry and Commerce. (1)
Dr Gordon is a writer and film maker who, through the medium of his Hole Ousia website and Omphalos videos, highlights a range of topics and issues in his profession, including sponsored medical education, conflicts of interest between pharmaceutical companies and doctors, and the underpinning ethics of the therapeutic relationship.
Up to this point Dr Gordon’s Sunshine Act petition has been heard and debated in Scottish Parliament on 4 occasions, the first of which was the initial giving of evidence by the petitioner and subsequent considerations by the Public Petitions Committee. Most recently on 31 March 2015 (2) when there were discussions by MSPs about statutory legislation and it was agreed to keep the petition open while also writing to Scottish Government regarding further action. Requesting a review of their directive, NHS Circular HDL (2003) 62, instructing health boards to set up Registers of Interest so that staff can declare payments from pharmaceutical companies (3). The health boards in Scotland have not been complying with this government directive, in relation to transparency.
As an unpaid carer and now in receipt of a state pension I am encouraged by the transparency work of Dr McCartney, Dr Gordon and others, who are leading by example and advocating for people like us, customers of the health service.
1 PE01493: A Sunshine Act for Scotland, Petitioner Peter John Gordon, Scottish Parliament website:
2 A Sunshine Act for Scotland (parliamentary update), Hole Ousia website:
3 NHS Circular HDL (2003) 62, Scottish Government:
Competing interests: No competing interests
Thank you, Dr McCartney, for acknowledging that the sweet temptations gifted with education by the pharmaceutical companies are never ‘free’.
I work in a tertiary teaching hospital, in psychiatry. The pathology of disease and mechanism of actions of many medicines in psychiatry are still unknown. This can further inflate the wonders of new medicines.
An example I would like to share is the recent addition of Aripiprazole Long-Acting Injection (ALAI) (Abilify Maintana®) to our Pharmaceutical Benefits Scheme (PBS) in Australia. A pharmaceutical company representative (rep) was given an opportunity to educate the prescribers on this medicine at the weekly medical meeting at my hospital. The rep was kind enough to provide lunch.
Her opening statement of ‘I’m not here to sell anything, I am just here to present the facts’ led into a presentation of specifically chosen pieces of data, whilst omitting to complete the picture, which would help prescribers be guided by evidence to understand ALAI place in therapy.
Her key points (as the drug rep) were:
• That aripiprazole has been available for years as the oral form and is ‘unique’
• Side-effects which antipsychotics commonly cause but ALAI did not, such ALAI being weight-neutral (suggesting no weight gain) and ‘no-effect’ on QTc intervals which can precipitate cardiac events.
• And suggestion that failure to respond to ALAI is likely to be due to a sub-therapeutic oral coverage during initiation.
The director of psychiatry allowed me to have 5 minutes at the end of the presentation to clarify the evidence-based for ALAI place in therapy and local implications. I tried to ensure the ‘take home’ messages for the prescribers in my area, were not negative but a balanced informed view of ALAI, mindful of the drug rep being present to listen to my advice.
My key points (as a clinical pharmacist):
• Currently no head-to-head trials to compare ALAI to other antipsychotic long acting injection. Hence, suggestions regarding the use of one long-acting injection over another cannot be readily made.1
• Although aripiprazole has a different side-effect profile, it is not immune to side effects and is still considered a second generation antipsychotic. The main reported side-effects from the clinical trials have been akathesia/restlessness and insomnia2. These are important to note particularly in unwell patients, prescribers often expect sedation to occur with the initiation of an antipsychotic. With the use of aripiprazole this will not be the case and may lead to a prescribing cascade to facilitate sleep. Changes to QTc can occur and has with the oral form as a Treatment Emergent Adverse Event and is listed within the product information (PI)3, metabolic monitoring (which includes weight changes and cardiac) needs to be a priority for all patients treated with antipsychotics to ensure we are not causing harm.
• Aripiprazole is only listed on the PBS for schizophrenia. As antipsychotics can be indicated for other psychiatric conditions, such as bipolar, if it is not approved for those indications on the PBS it will have a large financial impact to our patients increasing cost of treatment from $6.90 per month (if they are a concession card holder) to $399.95 plus dispensing fees.4
• Within Australia the PI recommends that treatment with oral aripiprazole, or other oral antipsychotics, should be continued for 14 consecutive days to maintain therapeutic antipsychotic levels during initiation.3 Other countries where ALAI is licenced have specified aripiprazole oral to be used which clinically ensures patients are showing a response, but also prevents the use of multiple antipsychotics, especially if the oral is also being used for its sedating properties. The main studies showing non-inferiority data are for patients stabilised first on oral aripiprazole, meaning they have responded to the therapeutic agent prior to trialling the Long-acting form.5
• ALAI is currently not on our hospital formulary, this means that it has not yet gone through our local drugs and therapeutics committee which is again a chance for independent review and also addressing the cost: benefit for our patients. It also means that ALAI is not currently stocked at the hospital and therefore a delay may be expected in treatment until it is sourced, this leads to increasing costs of prolonged admissions.
The pharmaceutical rep added her input throughout my summary as a ‘right of reply’ such as ‘there is a head to head trial against another antipsychotic’ and that ‘another hospital in Australia is also awaiting formulary approval but they have been keeping a “stash of stock” so there is no delay when it is required.’ Again blurring the lines for prescribers and when questioned about the head to head trial, we discovered it has not yet been published, leading to questions of the quality, the results and if the research had been peer reviewed. Disregarding the drugs and therapeutics committee’s process encourages prescribers to work around our hospital policies and prohibits the quality use of medicines principles.
The constant denial by prescribers of being influenced by pharmaceutical reps and their ability to ‘see-through’ the biased information has been held under a magnifying glass in my organisation. Exactly one week after the reps presentation the psychiatric ward which currently has 25 admitted patients, had 10 patients prescribed oral aripiprazole. 7 of these have transitioned to the long-acting injection form. Of the remaining 15 patients 7 were admitted for mood disorders (such as suicidal ideation) and therefore ariprazole is not indicated.
I am not anti-aripiprazole by any means and it is good to have another option for our patients, however I do have a duty of care as a pharmacist to help promote quality use of medicines and evidence based practices. The change needs to occur from doctors, such as Dr McCartney, promoting the importance of independent information. Above all the change needs to be by the policy makers. The government needs to support education such as the National Prescribing Service, and allow time for clinical pharmacists to do what they do best, help prescribers and patients make informed decisions about medicines.
1. Aripiprazole modified release (Abilify Maintena) for the treatment of Schizophrenia. NPS RADAR April 2015. NPS Limited.
2. Motiwala et al. Review of depot aripiprazole for schizophrenia. Patient Preference and Adherence 2013:7 1181–1187.
3. Lundbeck Australia Pty Ltd. Abilify Maintena Product Information. 25 July 2014.
4. Australian Government Department of Health, Pharmaceutical Benefits Scheme, 2014. http://www.pbs.gov.au/pbs/home (accessed 24 Sept 2014).
5. Fleischhacker WW, Sanchez R, Perry PP, Jin N, et al. Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study. Br J Psychiatry. 2014 Jun 12. pii: bjp.bp.113.134213.
Competing interests: No competing interests
Being cynical about the self interest of big pharma..... and governments/ doctors do not live in a vacuum; learning about the latest fad without endorsing it
I thank Dr Claudina A MICHAL-TEITELBAUM for her second response to my rapid responses.
I agree that to a casual observer, the use of the word cynicism may be a rather strong word but Dr MICHAL-TEITELBAUM may be interested to know that the word according to the Oxford Dictionaries is defined as:
1.an inclination to believe that people are motivated purely by self-interest; scepticism:
2.a school of ancient Greek philosophers, the Cynics.
I am unfamiliar with the state of the national healthcare in France, but having being a doctor across the millenia in Australia, I often felt certain aspects of the national healthcare scheme (known as Medicare here) are treated like political footballs by different governments of the day. I suspect many UK doctors felt the same way about the NHS.
Just like commercial companies whose primary activity is about profit generation for its shareholders, some changes enacted by various government (in UK and Australia) seemed to be more about vote-winning rather than actually addressing the problem.
This is why there is always a healthy dose of cynicism in me (with eyes rolling) whenever I find out there is an announcement of introduction or change to a Medicare program. Of course I do not take that approach when dealing with patients!
With reference to the rest of Dr MICHAL-TEITELBAUM's reply, regardless of the reasons behind Spurling et al's findings, you are absolutely correct to suggest that big pharma will manipulate information available to the doctors and the patients at large. There is also no doubt that the the driving force for any commercial company in their activities is to promote their products, be it openly or surreptitiously.
However, medical education is not simply about learning about or confirming ideas already known and taught: it is also about challenging conventional thinking and finding applicability to individual patients in front of you.
Should one rely solely on "evidence-based medicine" in the form of peer-reviewed level 1 articles and guidelines, the medical practitioner will be at least 5 years behind the times in term of awareness of medical advancements available.
That is not to say doctors should be practising at the cutting edge of modern medicine (afterall we have all seen fads come and go), but at least there is an expectation that doctors should have some familiarity with the current popular ideas and devices.
Information about these topical issues is rarely available from journal articles upon inception; most information/propaganda about new ideas/ devices are usually from individuals or companies promoting them.
To quote the late Prof T.K. Shanmugasundaram, past-president of the Indian Orthopaedic Association: 'If you want to be a cutting-edge surgeon, stay with the times. But your patient may suffer often. But if you want to be a safe surgeon, be five years behind the times'.
In my career, I have seen orthopaedic fads involving Minimally Invasive Surgery, Metal-on-metal hip arthroplasty, hip arthroscopy, Patient-specific cutting guides for knee replacement etc just to name a few; none of them is discredited but certainly initial enthusiastic fanfare associated with their widespread introduction distilled with time into well defined indications for their application. So I am well aware of the pitfalls associated with commercial-led promotion of ideas/devices.
Neither am I suggesting doctors should actively pursue benefits from commercial sponsorship or endorsement (no doubt when that happens, the professional integrity is compromised). I have no doubt about that.
However, I would advocate that our professional time as doctors is not "free" and if there is any suggestion that we as doctors should pay for our education with our own time and money, then perhaps we should call for better renumeration for our work when we call to remove commercial sponsorship to CME activities.
Competing interests: I am guilty of attending many lunches sponsored by drug companies, hospital administration, governments, my parents and lastly (and most frequently) myself