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Fiona Godlee: Why pharma should not be allowed to fill the gap in patient information

29 Sep, 08 | by BMJ Group

Fiona Godlee There was one thing we were all agreed on – proposers and opposers alike – at the Great Oxford Debate last week: there’s a big gap in the quality and quantity of information for patients. Where we disagreed – and starkly – was whether the drug industry should be allowed to fill that gap.

Yes said Thomas Lonngren, Scott Gotlieb and Mary Baker. No said I, Des Spence, and Phil Hammond. Proposing the motion – “It’s madness that pharma can’t speak to patients” – Thomas Lonngren, head of the European Medicines Agency, talked of irrational and erroneous prescribing which could only be tackled by providing better patient information from the people who know these drugs best.

Regulation could be designed to ensure that most of this information was objective, he said. Why penalise the majority of law abiding companies with a blanket ban because a few behave badly? Scott Gotlieb, a medical journalist and former deputy commissioner at the US Food and Drug Administration, talked of professional elites and protectionism.

Why did journals, through their embargo policies and closed access, stop research results reaching the public immediately they’re available? (As it happens, the BMJ is open access and is happy to publish results of research already available on trial databases.)

Mary Baker, president of the European Parkinson’s Disease Association, talked movingly of life and death and of the responsibility of patients and the public to play an active role in drug development. She warned that by the time we reach the age of 60 we’ll have an average of three diseases each. My cheap quip in reply was that industry would surely prefer this to be six diseases, or ten, preferably ones that won’t kill us straight away but will require long years of expensive drug treatment.

We in opposition knew that swaying an audience dominated by employees and guests of industry would not be easy. Pointless to pretend that current provision of information for patients is perfect. Our point was that allowing industry to talk directly to patients would make things far worse. Experience with direct to consumer advertising in America and New Zealand suggests that it fuels drug bills, inappropriate prescribing, and medicalisation. Standard product information is one thing – of course that should be more widely available. But to make informed decisions, patients need objective, unbiased information comparing one drug with another and with non-drug treatments, information which can’t come from a sector with such an obvious and irreducible conflict of interest. We should all be concerned that the European Union is reconsidering relaxing the current ban.

Meanwhile, there is information that the drug industry is still not willing to share. A study in PLoS Medicine last week found that over half of trials of new drugs remain unpublished more than five years after FDA approval.

New medicines are not good medicines, said Des Spence, GP and BMJ columnist, reeling off example after example of new drugs that were enthusiastically prescribed only to be withdrawn because of serious, even fatal, side effects. To show what horrors may be in store if industry is allowed to target patients with its marketing techniques, Phil Hammond, media doc and self styled “ginger sex God,” marshalled an assortment of industry freebies he’d collected over his years as a GP: some juggling balls (“a useful decision-making tool”) and a Prozac branded desk paper weight with a clock inside  “conveniently facing the doctor so that after ten minutes it can flash a message saying ‘tell them to piss off and take some Prozac.’ ”

Speakers from the floor branded the opposition paternalistic, patronising, and protective of professional elites. How were doctors to be made accountable if patients were denied adequate information?  Several speakers took up Mary Baker’s cry that there has to be a two way conversation between industry and patients during the developmental stage of new drugs so that industry can properly understand patients’ needs.

But as I said in my summing up, this is entirely different to the one way promotional conversation that industry would like to be having with patients, the conversation that would be, in the words of one of the few floor speakers willing to oppose the motion, a slippery slope to a US style nightmare featuring “drugsupermarket.com” “youswitch” and “eBMJay.”

Our defeat was never in doubt, but the fact that it wasn’t a rout seemed to us a victory. The ayes to the right 98, the noes to the left 39.  I like to think we changed a few minds.

Fiona Godlee, editor, BMJ

Competing interests: The debate was organised by the Pharmaceutical Times and sponsored by Sanofi-Aventis. The BMJ paid for my travel to and from Oxford. The organisers gave me dinner and speakers were offered an honorarium, which I asked to be donated to charity.

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  • Des Spence

    This was tough gig – a stony response . When I have spoken in the past , many in the audience were cynical about corporate medicine and Big Pharma especially. So did we convince the Industry of the need to limit marketing – clearly not from the vote. But did they listen and is the industry reflective and respectful – they most certainly were. Whether the future of our health will be define by therapeutics or whether we will see a continued backlash against the medicalization of all – only time will tell. Viva the debate.

  • Jason Barton

    As someone who has worked in both Canadian and American systems, I agree with the concerns about direct-to-consumer marketing. It is not just about Pharma, but anyone with a pecuniary interest is bound to introduce biases that promote those interests, sometimes (often?) overriding interests of the public and patient, regardless of high-minded denials. Pharma also has the advantage of financial and political leverage (why was the Great Oxford Debate sponsored by the drug industry and why was the audience filled with their representatives? Curious…).
    I have found it interesting that, after returning to Canada, where there is less direct advertising, my patients here use about a third of the number of medications that my American patients did. Maybe they are just healthier, but is it the advertising?
    One last comment: who says that Pharma knows the drugs better than the physicians and pharmacists that prescribe and dispense them? Or do they know things they are not telling us…

  • Ray Armstrong

    The current groundswell of opinion that patients should be able to top up their NHS treatment by contributing their own funds can only add to the anxiety that any perceived information vacuum should not be filled by those with such an obvious conflict of interest.

  • Jaime Belmares

    A comment from the U.S. I think this is a really really really bad idea. Here we have direct company-to-consumer advertising, and it’s a major problem. Patients come asking you for specific medications, and this creates a problem as they expect newer and more expensive medications, which are not necessarily better. I have strong doubts (based on the experience here) that any information provided this way is really unbiased. If there needs to be a greater understanding of health information by patients, this gap should be filled with accredited governmental or independent bodies. The CDC here does that in some topics.

  • http://oakgroupuk.co.uk David Maltz

    There is a need for patient particpation in drug choices, but direct to consumer advertising is not the way. Most physcians in the US would wish that this type of advertising could be prohibited again, as it puts the physican in the position of counter-detailing the patient. This takes time and is often not effective.
    With the elimination or minimization of presription costs in most areas of the UK, which is desireable, the problems with direct to consumer advertising of pharmeceuticals will be magnified substanitally.

  • Charles Wilson

    Until foxes are watching the hen-house, absolutely not: this is the role of unbiased evidence based information.

  • vijayashankara

    working in india for most of my carreer, i know how the pharma companies influences the practicing general practioners and the specialists with their aggressive marketing approach. and if they are given a direct access to the patient education and awareness, one can imagine the how well it be utilised. our primary concern is how to make the doctors weaned away from the pharma company education and not give them another platform for their benefits.

  • Phil Barber

    The Pharma’s are already much too intrusive, and much more pro-active than many might think, among other things dominating and distorting research priorities, and massaging the outcomes. In my opinion they even have a hand in moulding disease nomenclature to maximise the opportunities for product licensing – look at the massive drive to heighten awareness of the extremely vague entity ‘COPD’, closely linked to mass prescribing of the latest expensive combination inhaled recipes. In accepting this approach to disease management and research, we are not only providing sub-standard care for our patients but intellectually dumbing down our approach to disease classification and research. If we let the Pharmas set the exam questions as well as marking the papers, we are heading for trouble. The last thing we need is for them now to have direct patient contact for ‘educationl purposes.
    Cui bono? – still a good test.

  • Phil Barber

    Sorry, ‘educational’ on penultimate line!

  • Bill Hart

    It’s quite simple really. If the patient pays for their care in its entirity, then it’s quite reasonable for Pharma to advertise direct to them. If someone else picks up the tab, for example government, then Pharma must be muzzled.

  • Dr Sudhir Mishra

    Is there less malpractice by pharma companies in this world that they should be allowed to provide information to patients.
    The pharma information, in India at least, if often half correct, sentences being picked out of context from journal and books, to be presented to doctors. Often doctors are fooled by them. How will public handle the (mis)information by pharma needs to be thought.

  • D S Goel

    I endorse Phil Barber’s views. At the recent World Psychiatric Congress in Prague, it was difficult to distinguish the sheriff from the hired gun.

  • Jessie Prynne

    Conversations between pharma and patients are certainly desirable in order to enhance the quality of patient information, but only if it’s not just one-way from pharma, if the patients are helped to understand the advice being offered, if it’s unbiased and balanced. Until this is a reality, it’s little surprise that many will have concerns about pharma’s motivations in wanting more direct access to patients. However, if it looks like the industry are willing to stick to their side of the bargain, then conversations should be encouraged.

  • http://www.bestplanetsneakers.com timberland boots

    Is there less malpractice by pharma companies in this world that they should be allowed to provide information to patients.
    The pharma information, in India at least, if often half correct, sentences being picked out of context from journal and books, to be presented to doctors. Often doctors are fooled by them. How will public handle the (mis)information by pharma needs to be thought.

  • http://www.pmcpa.org.uk Chris Brinsmead, President, The Association of the British Pharmaceutical Industry (ABPI)

    In case Fiona Godlee’s blog on the Great Oxford Debate gave anyone the wrong impression, the pharmaceutical industry has repeatedly said that it does not want direct-to-consumer advertising of prescription only medicines in Europe.

    What the industry would like is acceptance, on an EU basis, that the industry can contribute valuable, high quality information to patients about the products it researches, develops and manufactures. As Fiona says, to allow patients to make informed decisions, the information provided by the pharmaceutical industry must be objective and unbiased, and this is exactly what the ABPI Code of Practice requires. In addition, companies must not encourage members of the public to ask a health professional to prescribe a specific prescription only medicine.

    Clearly the quality of all information is paramount and the UK industry would be happy to see the standards in the ABPI Code apply to all information providers. Surely a comprehensive range of high quality information from a number of sources would be to everyone’s benefit?

  • http://www.bvwaghmare.blogspot.com AIDS information

    This is a great inforrmative article about patents and pharmaceutical. i am a pharmacist and its of great value for me .
    Keep it up.

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