Here’s our letter to the GMC, about addressing systemic failures in the medical profession

December 17th, 2013 by Ben Goldacre in badpharma, competing interests, conflict of interest, publication bias, regulating research | No Comments »

The GMC are focused mainly on the narrow issue of an individual doctor’s competence when seeing individual patients. But there are broader issues that have an equally important impact on patient care and public trust: failure to publish clinical trials, failure to participate in research, and imperfectly declared conflicts of interest, for example.

The Health Select Committee have an annual review with the GMC to discuss how they’re getting on. Here’s a letter I wrote to them, along with Iain Chalmers, Fiona Godlee and Trish Groves of the BMJ, and Ginny Barbour from PLoS. We suggest some actions the GMC could take to improve patient care on all these issues. Below that is the video of the committee raising our concerns with the GMC. Broadly speaking: the GMC said they’d have a think. This is forward movement, and there’s more to come next year, with the launch of something interesting, new, and fun (and currently a bit secret…).

Submission to Health Committee accountability hearing with the General Medical Council, December 2013.

Dr Ben Goldacre, Sir Iain Chalmers, Dr Trish Groves, Dr Fiona Godlee, Dr Virginia Barbour. 

Ben Goldacre is a medic and academic who writes for the public on misuses of scientific evidence, including a recent book about problems in medicine [1]. Iain Chalmers is co-founder of the Cochrane Collaboration, and director of the James Lind Library. Trish Groves is a medic and Deputy Editor of the British Medical Journal. Fiona Godlee is a medic and Editor in Chief of the British Medical Journal. Virginia Barbour is a medic and Editor in Chief of PLoS Medicine. All are also co-founders of AllTrials, a campaign with widespread public and professional support calling for all trial results on currently used treatments to be made publicly available [2].

We are writing to raise three areas where the assistance of the GMC would be very valuable to patients and the public, and where such intervention is timely.

1. Promoting participation in research.

The GMC guidance previously stated that doctors “must work with colleagues and patients . . . to help resolve uncertainties about the effects of treatments” (para 14f). However, in 2013 the GMC removed this clause [3]. This decision should be reversed, and the clause reinstated. Research is the only way we can identify and reduce uncertainty about which treatments work best. At present there is considerable red tape obstructing doctors who seek to conduct research. Much of this red tape is unnecessary; the incentives to participate in research do not reflect the urgency of the need for better evidence to guide clinical practice. There are many documented cases where patients have suffered and died unnecessarily, because doctors have failed to recognise uncertainty and conduct research to address it [3]. The GMC requires doctors to practice medicine based on research evidence. We cannot do so without producing this evidence, and doctors have a responsibility to all patients to help identify and reduce uncertainty in everyday clinical practice. This should be unambiguously reflected in GMC guidance, as it was until 2013.

2. A register for doctors’ conflicts of interest

There is a need for a register of doctors’ conflicts of interest, similar that for MP’s. At present, doctors may receive consultancy income, research funding, sponsorship, travel, hospitality and free educational activity sponsored by the pharmaceutical and device industries; many doctors serving on Clinical Commissioning Groups now run companies whose services are commissioned by their own CCG; many media doctors receive income from PR or medical companies; and so on.

Conflicts of interest cannot be prevented, nor would it be desirable to do so: there is much good work done by doctors collaborating with industry. These payments also do not mean that doctors are corrupt. However, there is extensive research evidence showing that doctors with financial conflicts of interest often express more favourable views on the treatments in question, when compared to doctors who have not received such payments. It is therefore important that information about these conflicts of interest is transparent. It is currently extremely hard – and in many cases impossible – for patients, colleagues, patients and the public to establish who has paid a doctor.

Industry and self-regulatory approaches to this have failed, and will most likely to continue to do so. The Ethical Standards in Health and Life Sciences Group (co-chaired by the ABPI and the Royal College of Physicians) is a particularly concerning example: they produced “guidelines” documents for doctors which contained a number of false claims, and gave false reassurance on important matters of patient safety, before disbanding in October 2013, without ever giving a clear account of their activities [4] [5] [6]. Furthermore, declarations of payments to doctors from the pharmaceutical industry (which has often been proposed, but never delivered) would be insufficient, as this sector covers only a small proportion of the many sources of payments to doctors, as described above.

The GMC requires doctors to re-register each year, and maintains a public register. It is therefore in a clear position to request a simple declaration of financial conflicts of interest from each doctor in the UK, annually, and make this information publicly available on the register.

3. Action on withheld trial results

The problem of clinical trial results being witheld, on treatments in current use, continues to undermine the evidence base for medicine. The best currently available evidence suggests that around half of all trials have their results withheld [7]. Doctors, patients, researchers and payers cannot make informed decisions about which treatments are best, when half of all trial results are unavailable. This problem has not been adequately addressed by medical and academic professional bodies, regulators, or industry. There has also been a worrying trend for some in both industry and medicine to give false reassurance, claiming that the problem has been fixed. This poses a significant threat to patient care.

The Science and Technology Select Committee called on the government to take action over this issue in September 2013 [8]. The Health Committee called on the GMC to take action on this issue in January 2013 [9]. The British Medical Association passed a motion in June 2013 [10] [11] [12] stating that:

“(i) Selective non-publication of unflattering trial data is research misconduct

“(ii) Registered medical practitioners who give grounds to believe they have been involved in such conduct should have their fitness to practice assessed by the GMC.”

It would therefore be useful if the GMC could prominently clarify their position, and strengthen the wording of their guidance, requiring that any doctor working on a trial both past and present – on all treatments currently in use – is responsible for ensuring that the trial is registered, with its results made publicly available within a year of completion; and forbidden from entering into contracts with trial sponsors that relinquish access to data and prevent dissemination of results.

While only a small proportion of doctors actively participate in conducting randomised trials, a much larger number make a valuable positive contribution by recruiting and encouraging patients to participate in others’ trials research. They too have a responsibility around missing trial results. Para 49d of Good Medical Practice says that doctors must work in partnership with patients, providing “any other information patients need if they are asked to agree to be involved in teaching or research”. This would be greatly strengthened by adding a new clause 49e “Doctors should advise patients to participate in a clinical trial only if: (1) the study protocol has been registered and made publicly available; (2) the protocol refers to systematic reviews of existing evidence showing that the trial is justified; and (3) each patient receives a written assurance that the full study results will be published and sent to all participants who indicate that they wish to receive them.” [13] [14]

The GMC do good work on misdeeds by individuals in individual studies. However, it is inadequate and inconsistent to only hold individual studies to high standards, when the biases we are seeking to exclude can re-emerge further down the chain. Even when all trials are conducted perfectly, if those whole studies with unflattering results are withheld from the public record – as we know they commonly are – then we are overall misled on the risks and benefits of treatments, as surely as if the data from the individual studies themselves were fraudulent. The GMC are in a position to police the withholding of trial results, as they police other forms of research misconduct. It is in patients’ interests that they should do so.

References.

[1] “Bad Pharma: how medicine is broken, and how we can fix it” Ben Goldacre, 4th Estate, 2013

[2] www.alltrials.net

[3] Roberts I, Chaudhry B, Chalmers I. New GMC guidance takes a major, ethically flawed, backward step. BMJ. 2013;346(jun18 2):f3879–f3879.

www.bmj.com/content/346/bmj.f3879

[4] Arie S. Doctors’ groups are criticised for endorsing pro-industry guidelines. BMJ. 2013;347(oct09 2):f6066–f6066. doi:10.1136/bmj.f6066.

[5] Arie S. How a marriage with big pharma ended in divorce. BMJ. 2013;347(oct08 5):f6062–f6062. doi:10.1136/bmj.f6062.

[6] Goldacre B, Carroll D, Hall E. Guidelines for collaboration with industry should be transparent. BMJ. 2013;347(oct09 4):f6100–f6100. doi:10.1136/bmj.f6100.

[7] Huser V, Cimino JJ. Linking ClinicalTrials.gov and PubMed to Track Results of Interventional Human Clinical Trials. PLoS ONE. 2013;8(7):e68409. doi:10.1371/journal.pone.0068409.

[8] Science and Technology Committee, Third Report, Clinical Trials, 9 September 2013.

www.parliament.uk/business/committees/committees-a-z/commons-select/science-and-technology-committee/news/130916-clinical-trials-report-published/

[9] Health Committee, Eighth Report, National Institute for Health and Clinical Excellence, 16 January 2013. www.parliament.uk/business/committees/committees-a-z/commons-select/health-committee/news/13-01-15/

[10] bma.org.uk/working-for-change/improving-and-protecting-health/clinical-trials

[11] ecancer.org/journal/news/4200-bma—–non-publication-of-trials-results-is-research-misconduct.php

[12] www.alltrials.net/2013/bma-votes-that-non-publication-of-trials-results-is-research-misconduct/

[13] Chalmers I, Glasziou P, Godlee F. All trials must be registered and the results published. BMJ 2013;346:f105

Here’s the video, the interesting bit comes at about 16:54, sorry it’s in Silverlight, that’s how Parliament issues their data…


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