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

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 “” “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.