The BMJ is not exercising double standards by refusing to publish research funded by the tobacco industry while continuing to feature heavily clinical trials sponsored by pharmaceutical companies, a deputy editor of the journal insists.
The crucial distinction, argues Trish Groves, who is also editor in chief of BMJ Open, is that the drug and tobacco industries – while both “out to make money” – have very different objectives.
“The drug industry makes and sells products aimed at improving health”, states Groves in a Head to Head debate with two high-profile industry critics: Richard Smith, former editor of the BMJ and director of the United Health Group’s chronic disease initiative; and Peter Gøtzsche, head of the Nordic Cochrane Centre in Copenhagen, Denmark.
For their part, medical journals “aim to publish research that will improve health. It’s a good fit”, Groves adds. “The tobacco industry, meanwhile, makes and sells products that harm health.”
The debate was prompted by Smith’s response to the BMJ’s announcement last October that it would no longer consider for publication any study partly or wholly funded by the tobacco industry.
At the time, Smith made the point that the two justifications for ceasing publication of industry-funded tobacco research were that “the research is corrupted and that the companies are publishing research in journals primarily to advance their commercial aims oblivious of the harm they do”.
He went on to suggest that “exactly the same is true of the pharmaceutical industry and that we probably have even more evidence on the misconduct of pharmaceutical companies than of tobacco companies … So will the editors stop publishing research funded by the pharmaceutical industry, and if not why not?”
Cause of death
Smith and Gøtzsche continue to pursue this argument in the latest edition of the BMJ.
Far from doing no harm, they contend, prescribed medicines are the third leading cause of death, and “partly because of flaws in the evidence published in journals”.
Pointing to evidence that clinical trials funded by industry are “much more likely” than publicly funded trials to generate results favourable to the company, Smith and Gøtzsche cite ways in which commercial sponsors manipulate research, such as flawed coding of adverse events or simply burying unflattering results.
In contrast to tobacco-funded research, “which is comparatively rare”, two thirds of the trials published in major journals are funded by the drug industry, the authors say. Moreover, companies “use ghost writers to promote misleading trials in scores of secondary publications and reviews in major journals”.
Pharmaceutical companies also spend “millions of dollars” buying reprints of the studies they have sponsored, using the brand of the journal to promote their drugs, Smith and Gøtzsche note, adding: “The journals make huge profits on these sales, a gigantic conflict of interest”.
For Smith and Gøtzsche, there are now “much better ways” to communicate the results of clinical trials to doctors, and without paywalls.
This model would begin with a systematic review of previous research as an integral component of trial planning, which would show whether a new study was really needed or “simply promotion dressed up as science”.
The review would be posted on the internet “for anybody to comment”, and the same would apply to the trial protocol if a need for new research were identified.
The statistical analysis plan would “not be made up late in the trial, when the sponsor might already have evaluated some of the data behind closed doors” but would be posted with the protocol.
Once the trial were completed, Smith and Gøtzsche propose, the entire anonymised dataset would be uploaded for “everyone to analyse”.
The role of journals in this process would be to publish results from the systematic reviews and contrasting analyses of the trial data by independent groups, so that “everybody would be able to see every part of the evidence”.
Stand for transparency
The response from Groves does not address these proposed alternatives directly but rather takes a stand for transparency in publishing clinical trials, both prospectively and retrospectively.
She does not shrink from criticising research funded by the pharmaceutical industry, stating: “Only about one in 10 newly approved drugs substantially benefits patients, not least because patients are too often excluded from identifying gaps in treatment and in setting research questions”.
Groves also cites the “woeful legacy of widespread non-registration, non-publication, and selective reporting of clinical trials”. Yet much of this reporting bias also applies to investigator led trials, she adds.
As such, the steps now being taken to mandate prospective trial registration, ensure all results are reported, and provide access to patient-level data on the benefits and harms of interventions (the BMJ is part of the AllTrials transparency campaign) must apply to these latter studies as much as industry-led trials, Groves insists.
New rules on transparency also need to function retrospectively, she says. As such, the BMJ is keen to publish papers from the RIAT (Restoring Invisible and Abandoned Trials) initiative, whereby academics who find previously unreported trials can write them up and publish them if the original investigators decline to do so.
The journal also welcomes ‘negative’ trials that find no evidence of benefit, “as long as their research questions are important and their methods robust”. And it is particularly interested in publishing comparative-effectiveness trials, Groves notes.
Moreover, the BMJ will only consider drug and device trials if the authors commit to making the relevant anonymised patient level data available “on reasonable request”, regardless of whether the study is funded by industry.
Until the BMJ can “rely fully on academia or governments to conduct all the important drug trials that the pharmaceutical industry won’t do (and perhaps shouldn’t do)”, it will be “happy to publish high quality, relevant studies from the industry while continuing to campaign for even greater relevance and more transparency”, Groves declares.
She denies that editors are “afraid or unable” to extend the ban on industry-funded tobacco research to pharmaceuticals because journals rely on advertising, reprint or sponsorship income from drug companies.
Groves quotes BMJ editor in chief Fiona Godlee’s response to Smith’s original challenge: “If these efforts do not soon bring about a necessary sea change in the way industry funded trials are performed, the BMJ may well decide to stop publishing them. Whether an editor would survive such a decision is a question I may have to test”.
By way of additional context, the ‘competing interests’ section at the end of the article make intriguing reading.
Groves receives a bonus (and, inevitably a salary) based in part on the financial performance of the BMJ, which in turn draws revenues from drug and device manufacturers in the form of advertising, reprint sales, and sponsorship.
On the other hand, Smith was an editor of the BMJ for 25 years, and for the last 13 of those was also chief executive of the BMJ Publishing Group – responsible for the profits of not just of the BMJ but of the whole group, which published some 25 other journals.
As Groves points out, Smith was also editor of the BMJ when it previously decided against a ban on research funded by the tobacco industry. Moreover, he receives a pension from the British Medical Association, owners of the BMJ.
This pension fund, the journal points out, “is underfunded for its commitments, and the profits from BMJ are important for the finances of the BMA. Some of those profits depend on revenue made from pharmaceutical companies”.