Should journals stop publishing research funded by the drug industry?BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g171 (Published 14 January 2014) Cite this as: BMJ 2014;348:g171
All rapid responses
Thank you to Richard Smith for his article (1). Is this not a typical ethical issue with, on the one hand, press freedom and, on the other hand, scientific rigour. Of course, we have to choose. No other way.
But I have just a little question about "Prescribed drugs are the third leading cause of death". From where comes this figure?
(1) Richard Smith. Should journals stop publishing research funded by the drug industry? BMJ 2014;348:g171
Competing interests: No competing interests
Journals are the main source for medical practitioners to acquire the most recent and relevant results of research. Forcing drug companies to publish the studies of their results elsewhere or not at all would greatly deplete the pool of research results that medical practitioners can draw on to provide better care for patients. Although the pharmaceutical industry is a multi-billion dollar market that can and has exploited the system of publishing biased articles in journals, the contribution of these massive companies is invaluable.
In refusing to publish research from drug companies, journals devalue much of the research done by drug companies. As Smith and Gotzsche point out, drug companies have caused damage by publishing misleading information and false advertising. However, perhaps the issue lies more in the transparency of publication. This article offers one possible solution that is requiring drug companies to give the raw anonymised patient data upon request. In this way, readers and medical practitioners can evaluate the reliability of drug-company-funded studies independently. Additionally, implementing additional public funded institutions to monitor these types of trials may help in reducing the bias prevalent in these studies.
Furthermore, though national governments contribute significantly to drug production, drug companies invest billions of dollars not only into the creation and development of drugs, but also into studies testing their efficacy and into gathering side effects. The cost of getting a new drug on the market costs, at the lower-end of the range, is $350 million USD. Larger companies, with numerous simultaneous drugs being developed spend a median of $5.3 billion USD per drug approved for the market . The magnitude of funds behind drug companies allows their research to concurrently study multiple potential drugs and develop a wider range of drugs. As a result, this funding needs to persist. The results of the trials and research just need to be better regulated.
Research articles begin with an abstract that summarises the research done and provides a concise conclusion which can be simply taken as a proven fact. However, it is the responsibility of the reader to go through the accompanying method, data, results and analyses to determine whether the author’s conclusion is valid and applicable. Simply stripping journals of drug company publications devalues the importance of the reader and his/her ability to interpret the article independently.
Competing interests: No competing interests
A blanket ban on publication of drug industry-funded research has implications for surgical research. Industry collaborations in surgery involve both medications and devices, the latter of which drives technological advancement. Recent efforts in surgery have focussed on strengthening these collaborations in order to promote and encourage surgical innovation, encouraged by The Royal College of Surgeons of England (RCSEng) (1).
The model of industry funded-investigator led research focuses on clinical autonomy of trial design, and discourages industry representation on trial management committees. Surgical research is frequently investigator-initiated and led; commercial partners do not automatically gain data ownership. RCSEng and partners (including the National Institute for Health Research, Cancer Research UK and the Rosetrees Trust) (2) have established a network of surgical trial units across the UK, which hold research data securely and independently. This model could be translated to pharmaceutical research in medicine, enabling greater openness whilst maximising collaboration.
A ban on publishing industry funded research could harm surgical innovation. Disclosure of (i) the role of the funder, (ii) independence of clinician researchers in trial conduct and (iii) source of data repository should be mandatory and would overcome current concerns. Commercial partnerships in surgery may be beneficial and may even speed publication, rather than delay it.
(1)National Institute for Health Research (NIHR) Clinical Research Network (CRN). Joining up with Royal Colleges. Available at: http://www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/Networks/CCRN/Spec... [Accessed 23rd January 2014].
(2)Royal College of Surgeons of England (RCSEng). The Rosetrees and the RCS Clinical Trials Initiative. Available at: http://www.rcseng.ac.uk/surgeons/research/surgical-research/surgical-cli... [Accessed: 23rd January 2014].
Competing interests: AB sits on a trial management group that has received industry funding to conduct surgical research. Within that trial, design, management and data analysis are independent of the funder; data is held in a core funded trials unit.
The question whether medical journals should stop publishing pharmaceutical industry-sponsored research is absurd. Ever since the International Committee of Medical Journal Editors (ICMJE) called for obligatory posting of running clinical trials on an publicly accessible clinical trial register as condition for publication, the call for transparency on clinical research has increased. And rightfully so. However, more than half of all drug trials are sponsored by pharmaceutical companies. How can the industry be transparent on their trials if journals refuse to publish the results? By not making this information public, journals actually contribute significantly to a biased view on the benefits and harms of new medicines. Why would the relatively scarce academia-sponsored drug research by definition be more reliable? In fact, there is good evidence that academia-identified potential targets for drug discovery could not be replicated by industry (1).
If results from industry-sponsored clinical research on new medicines are seen to be unacceptable for publication, the whole system of regulatory approval for these drugs is also flawed. Why is the evidence good enough for regulators but not for journals? Most of the clinical trials conducted by the industry are now done after extensive consultation with regulators as the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Recently and as an example, a major breakthrough was published in drug treatment of hepatitis C (2). This is a mostly industry-driven innovation that deserves to be published for the benefit of doctors and patients. If prejudice on the quality of this research prevents the public knowledge of these type of data that are good enough for stringent regulators, we are sincerely creating a disservice for the medical community.
So, medical journals: publish all drug research, irrespective the funding source, but be very critical on the research question, the methodology and the interpretation in the discussion, as with every paper of course. The data in industry trials are collected under strict Good Clinical Practice guidelines, are inspected by regulatory authorities, and are therefore reliable enough to deserve full publication.
1. CG Begley and LM Ellis. Drug development: Raise standards for preclinical cancer research. Nature 2012; 483: 531–533
2. Sulkowski MS et al. Daclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection. New Engl J Med 2014; 370: 211-221
Competing interests: Full employee of Teva Pharmaceuticals, Amsterdam
Should journals stop publishing research ... written by ghostwriters?
The answer to this question is resounding “yes” and we don’t expect any debate about it. However, as an international group of professional medical writers (NOT ghostwriters), we do want to debate Smith and Gøtzsche’s suggestion that the pharmaceutical industry’s use of ghostwriters is (note present tense) common practice.1
Like Smith and Gøtzsche, we abhor ghostwriting and agree that this practice is scientific fraud. The fight against ghostwriting must continue, regardless of who sponsors the research (industry, government, academia etc...). Nevertheless, the BMJ readership should be aware of the initiatives that have been adopted to address ghostwriting, particularly from professional medical writers and industry sponsors. These initiatives, which continue to expand and involve, include:
1. Completion of the first large (469 respondents) survey of current industry publication practices (the Global Publication Survey). The results clearly demonstrate the progress being made against ghostwriting practices in industry. A manuscript has been submitted for publication and, in keeping with transparency efforts, the dataset will be made available for others to interrogate.
2. Completion of the first systematic review on the evidence related to the prevalence of ghostwriting.2 The results clearly show how original evidence on the frequency of ghostwriting has been misreported in subsequent publications. There is no excuse for ghostwriting, but there is also no excuse for inaccurate reporting of its frequency. A manuscript has been submitted for publication, and in keeping with transparency efforts, the dataset will be made available for others to interrogate.
3. Introduction of a credential (Certified Medical Publication Professional) for writers to help editors, peer-reviewers, readers, authors, and sponsors identify if a medical writer has knowledge of ethical publication practices. A CMPP-qualified medical writer has had to pass an exam on 150 topics related to ethical publication practices. They can guide authors and sponsors (whether from industry or not) on what is required to comply with best practices. There are now more than 800 CMPP-qualified medical writers around the world. Anyone can check if a writer is CMPP-qualified by searching the CMPP directory at http://www.ismpp.org/cmpp-directory. Clearly, there are medical writers who do follow ethical publication practices without being certified, but the CMPP program (which has required considerable financial and human resources to establish and maintain) is a very practical and tangible example of how professional medical writers are trying to combat ghostwriting.
4. Introduction of a Code of Conduct that will punish any CMPP-qualified medical writer found to have brought the medical publication profession into disrepute.
5. Development of position statements from international industry associations that explicitly ban ghostwriting (see http://clinicaltrials.ifpma.org/clinicaltrials/fileadmin/files/pdfs/2010...).
6. Development of publication policies by sponsors, as well as by professional medical writing associations and companies, that explicitly ban ghostwriting, as well as guest- and ghost-authorship (see those by the American Medical Writers Association - www.amwa.org, the European Medical Writers Association – www.emwa.org, the International Society for Medical Publication Professionals – www.ismpp.org).
7. Use of audits by sponsors and professional medical writing companies to determine how well authors and professional medical writers are adhering to these policies. Policies without audits are impotent. The Global Publication Survey will provide valuable data on audit use.
8. Publication of an anti-ghostwriting checklist3 that is freely and readily available to authors around the world to document to editors and peer-reviewers that medical writing support has been used appropriately and...(this is the kicker)...that editors can ask the authors for an audit trail that validates the ethical and legitimate use of writing support.
9. Collation of evidence on the value and ethics of professional medical writers (see www.gappteam.org). Editors have agreed that professional medical writers offer a legitimate and valuable service4 and research has now shown that manuscripts prepared with professional medical writing support are of higher quality (eg, based on adherence to CONSORT),5 are published more quickly,6 and less likely to be retracted for misconduct7 than those prepared without writing support.
In summary, we abhor ghostwriting and, as professional medical writers, we want BMJ readers to be aware of numerous initiatives that are helping to combat this unethical practice. Our experience and recent evidence indicate it is not common practice in industry.
1. Smith R, Gøtzsche PC, Groves T. Should journals stop publishing research funded by the drug industry? BMJ 2014;348:g171
2. Stretton S, McGee S. Systematic review on the prevalence of ghostwriting: misleading, misguided, and mistaken ‘evidence’. Curr Med Res Opin 2012;28(1):S9-19.
3. Gøtzsche PC, Kassirer JP, Woolley KL, et al., What should be done to tackle ghostwriting in the medical literature? PLoS Med 2009;6(2):e1000023.
4. Chipperfield L, Citrome L, Clark J, et al. Authors' Submission Toolkit: a practical guide to getting your research published. Curr Med Res Opin 2010;26(8):1967-1982.
5. Jacobs A. Adherence to the CONSORT guideline in papers written by professional medical writers. Medical Writing 2010;19:196-200.
6. Bailey M. Science editing and its effect on manuscript acceptance time. AMWA Journal 2011;26:147-152.
7. Woolley KL, Lew RA, Stretton S, et al. Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. Curr Med Res Opin 2011;27:1175-1182.
Professor Karen Woolley, Mr Art Gertel, Dr Cindy Hamilton, Dr Adam Jacobs, members of the Global Alliance of Publication Professionals (GAPP; www.gappteam.org)
Competing interests: Disclosures: All GAPP members have held, or do hold, leadership roles at associations representing professional medical writers (eg, AMWA, EMWA, DIA, ISMPP, ARCS), but do not speak on behalf of those organizations. GAPP members have or do provide professional medical writing services to not-for-profit and for-profit clients. Further details can be found at www.gappteam.org
Pharmaceutical industries should have their own research journals. Non-sponsored researchers should follow the path suggested by Smith’s and Gøtzsche’s new model. It is from the mix that problems arises for clinicians and patients.
Competing interests: No competing interests
Smith, Groves and Gøtzsche all agree that the pharmaceutical industry can mislead doctors and distort medical practice, but they disagree on how to police the problem .
One important option has been oddly neglected. The extensive research evidence documenting industry’s influence on medical practice should be a core feature of all medical school curricula, and indeed that for membership exams.
Our current model is to give trainees some pointers on basic study design, and critiquing an individual academic manuscript. This is plainly not sufficient, given what we now know on the extent of withheld trial information, misleading trial reports, manipulation of the academic literature, and the biased dissemination of evidence through marketing .
The importance of these problems should not be overlooked. After initial close supervision and training, doctors go off to practice medicine independently for several decades. During this time they are responsible for keeping their knowledge current, while medicine changes all around them. Depending on speciality, a doctor who qualified in the 1970s can easily find themselves almost exclusively using treatments that came on the market long after they left formal training. On these they will be, in some respects, self-taught: and barraged with information of variable quality, from an industry with global revenues of $900bn that is actively incentivised to keep sales of individual treatments high.
Doctors in this situation should clearly be taught about the pitfalls in claims made by industry, and the evidence on biased dissemination. This is not a radical suggestion, and it does not imply that the pharmaceutical industry – which has created many lifesaving products - is a universally malevolent influence. It is simply a pragmatic approach to improving evidence based practice, in the face of influences that seek to distort prescribing decisions.
1. Smith R, Gotzsche PC, Groves T. Should journals stop publishing research funded by the drug industry? BMJ. 2014;348(jan14 3):g171–g171. doi:10.1136/bmj.g171.
2. 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. doi:10.1371/journal.pmed.1000352.
Competing interests: I am a doctor and a patient. I receive income from speaking and writing for lay audiences on problems in science and medicine, including the influence of industry on prescribing.
If we can hardly rely on the results of the pharmaceutical industry-funded clinical trials the journals should no longer publish papers funded by drug companies. They should only publish papers carried out by independent researchers, funded by public organisms, academies, universities, government, agencies, etc. The latter usually answers questions that really matters to patients, those funded by pharma hardly does.
Gøtzsche talks about a real revolution in his book, and because the need for revealing the funding of the study and the competing interests of the authors has demonstrated to be insufficient more steps should be taken (1). And what happens with the results of meta-analyses with a considerable weight of drug-funded randomised clinical trials? Can we trust their results?, mainly related to safety aspects, when we have many examples where these data have been concealed; a clear example is the recent meta-analysis on the effectiveness of statins in primary prevention issued by the Cochrane Library (2), in which, all the trials included were funded by pharmaceutical industries. Can we rely upon the data of safety of this meta-analysis? I do not think we can.
But another point that I miss in the present article, but mentioned by Gøtzsche in his book, is the fact that having a paper published in one of these journals is easier if the trial is funded by big pharma (1). It is not only a matter of whether we can trust the results of a drug company-funded article, but it is also related to the odds of succeeding in having a paper published. And this is unacceptable. This is another reason why top journals should no longer publish papers funded by the pharmaceutical industries.
1. Gøtzsche P. Deadly medicines and organized crime: how big pharma has corrupted health care. Radcliffe, 2013.
2. Taylor F, Huffman MD, Macedo AF, Moore TH, Burke M, Davey Smith G, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev 2013;(1):CD004816.
Competing interests: I report having a grant from the Fundació Jordi Gol i Gurina for a research stage at the University of Cardiff. I also report receiving research grants from the European Commission (Sixth and Seventh Programme Frameworks), Catalan Society of Family Medicine, and Instituto de Salud Carlos III
Standard journals of long standing credibility do not need any support from any industry to maintain and promote the publication of scientific studies which meet the standard requirement of the publication policy of the journal concerned. BMJ is an institution which has created niche in the field of medical journalism.
Whether the stand taken by the chief editor will put the job at risk - I do not think so. We know pharmaceutical industries are corporate sectors that can swallow small fish and influence publication policy. Yet they are aware of the repercussions if any one of their promotional studies create a dent in the brand name of the company or the drug. There has to be a balance between the publisher and the industry. The journal can publish research funded by the drug industries with a commentary on the results of research by an independent research worker in the field. Such a type of approach with active criticism will help maintain the standard of the journal as well as help the drug industry to promote publications of research funded by them under the watchful of eye of unbiased scientific critics or analysts.
Competing interests: No competing interests
David Eddy, John Ioannidis and many others have time and again shown that industry funded research, more than 85% of the time, gives positive results, while similar studies independently funded yield only about 15% positive results. This is glaring in cancer research where 85% of the research data had been found to be suspect.
In a book Science without Sense, the author Steven Milloy PhD, shows various ways of research data doctoring and sexing up by anyone (and easily by the vested interests)using four different ways-Texas sharp shooting, Mix-master technique otherwise called called meta-analysis, data dredging and inventing data. Studies have shown that the existing peer review system miserably fails in detecting this kind of fraud.
Recently a 2013 Nobel Laureate has accused some of the "top" journals of selection bias about their publications. This serious allegation brings out the truth about the whole peer review system and selecting their articles. If this is true, which I am sure is, then the whole medical science base is built on loose sand! In a move to break free from the tyranny of top-tier science journals like Nature and Science, Nobel laureate Randy Schekman announced that his lab will be boycotting these publications.
This also brings to mind the Streptokinase Vs tpA study debate and the BMJ reporting that with the photograph of the bare feet of Professor Peter Sleight with a caption "what a feat?"
So there should be no two opinions about boycotting industry funded research. This suggestion of mine could even be labelled insane as we live in a world of the corrupt.
Competing interests: No competing interests