Secrecy does not serve us wellBMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f3819 (Published 12 June 2013) Cite this as: BMJ 2013;346:f3819
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INFRINGEMENT OF 'CODE' CRITERIA FOR EDITORS OF SCIENTIFIC JOURNSALS
Some Iranian research manuscripts are being refused attention because of the Office of Foreign Assets Control (OFAC) guidelines or more importantly misinterpretation of them (1-4). The Committee on Publication Ethics (COPE) code of conduct for Editors demands behaviour of the highest integrity including championing freedom of expression and that rejection of a paper should be based only on the paper's importance, originality and clarity(5).
Is CODE aware of the Journals’ misinterpretation of OFAC restrictions on editorial freedom and if so what has it done about this. If the restrictions are not universally enacted, which publishers are refusing to accept manuscripts and why?
Considering the fact that in Iran, all universities and all medical schools and their affiliated hospitals, except Azad university, are linked to government, misinterpretation of OFAC’s regulation, will affect the academic activity of the vast majority of Iranian academic staff. Some editors do not follow the COPE Code of Conduct.
The failure of Journal editors abroad to stand up and fight this unjustified decision is a disgrace. The very people, the editors, who should be our leaders in setting standards are failing in their duty.
Does COPE itself have a role here? It is highly expected that its management board make a public statement on independence of academic publishing from political issues in any country at any time.
Qaboosnameh is a book written by Amir Onsorolmaly Kaykavous (an Iranian scientist and prince)in more than 900 years ago . It is a compilation of advice that he has written for his son in 44 chapters. He describes in every chapter the “DO’s” and “DON’Ts” of many careers and situations in his era. In fact, it can be regarded as a book of professionalism in various careers. In one section he writes: “ It is very awful that the policeman needs a policeman to watch and check their actions in order not to do wrong!” (6). Now in some ways, one feels that the awful era that Amir Kaykavous had foreseen has happened. In the other chapter, he mentions: “If you want others follow to your words in action, at first you should act to what you say.”(7).
Journal publishers who expect their authors to comply with ethical standards do not follow the same ethical standards in some instances. We have to bear in mind that Ethics and ethical leadership deal with actions not words.
In summary, imposed sanctions by OFAC has caused misinterpretation of editors of some journals in other countries. Therefore they do not publish some Iranian manuscripts for purely political reasons .It seems that editors and publishers have not adequately stood up for their principles publicly, principles which they have publicly laid down. A call for a position statement by the Board of Directors of COPE, emphasizing the unconditional and permanent independence of academic publishing from political arguments is invited.
1-http://www.ecfr.gov/cgi-bin/text- idx?c=ecfr&SID=713e99aa63301afc51201ab323c9b624&rgn=div5&view=text&node=31:3.1.1. 1.20&idno=31#31:22.214.171.124.126.96.36.199 (accessed 26 May 2013)
2-http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0e7344e962b7ccadc067a551... (accessed 26 May 2013)
3-http://news.sciencemag.org/scienceinsider/2013/05/scientific-journals-ad...(accessed 26 May 2013)
4- Lankarani KB, Haghdoost A, Smith P. Embargo on publication of scientific papers by Iranian authors. Lancet. 2012 Aug 18; 380(9842):648-9.
6- Yousefi G,Chapter 8:Revisiting the advice of Anooshirvan. In Ghaboosnameh edited by Yousefi G, Elmi-Farhangi Publications,Tehran, , 2007, page 51-55.
7- Yousefi G,Chapter 40: and The Attitudes of a Minister, In Ghaboosnameh edited by Yousefi G, Elmi-Farhangi Publications, Tehran, 2007, page 216-222.
Competing interests: No competing interests
Many thanks for your question.
The BMJ is against academic boycotts and has no restrictions on publishing articles from authors in Iran. We have noted the UK's restrictions on trading with Iran and are also aware of the new US restrictions. These may have implications for whether we can levy an author fee from an author in Iran. We will decide this on a case by case basis.
Competing interests: FG is the editor of the BMJ and responsible for all it contains.
Dear Dr Godlee,
I am writing to you regarding the recent articles published in the BMJ in relation to the safety profile of GLP-1s. As a company with a 90-year history dedicated to diabetes care, research and education, Novo Nordisk has always put patients first. We would like to take this opportunity to respond and set out our position on the recent articles and related commentary.
Firstly, regarding the safety profile of Victoza® (liraglutide):
o Based on an overall assessment of safety data from all available sources, including one of the largest clinical trial programmes within diabetes, and the clinical experience since its initial launch in Europe in 2009, there is no indication that Victoza® (liraglutide) increases the risk of pancreatic cancer.
o No cause and effect relationship has been established between pancreatitis and the use of Victoza® (liraglutide) based on the available pre-clinical studies(1), clinical trials(2) and post-marketing surveillance data(3).
o All cases of acute pancreatitis within the Victoza® (liraglutide) clinical trial programme have been reported and published(2). The number of cases of pancreatitis in Victoza® (liraglutide) treated patients is low and is consistent with what would be expected in an average population of people with type 2 diabetes(4) which already carries a higher risk of acute pancreatitis compared to people without diabetes(5).
o Current labelling for Victoza® (liraglutide), in keeping with other incretin-based therapies, includes a precautionary warning that clearly describes the symptoms of pancreatitis.
o On 13 June 2013 at an independent scientific workshop Novo Nordisk presented interim data from an on-going prospective, matched cohort epidemiological study comparing Victoza® (liraglutide) with four other widely used anti-diabetic drug classes. The study comprised more than 100,000 patient years of treatment across all cohorts, and was presented as part of a complete overview of available Victoza® (liraglutide) safety data, including non-clinical and clinical data as well as data from post-marketing commitments. Together the data reconfirmed the pancreatic safety profile of Victoza® (liraglutide)(3).
Secondly, regarding Professor Butler’s recent study of pancreata from organ donors(6): Victoza® (liraglutide) was not investigated in this study of patients having been treated with a DPP-4 inhibitor (sitagliptin) or a GLP-1 receptor agonist (exenatide). We note that several limitations in terms of generalising the findings of this study have been identified and published by independent researchers(7,8).
Finally, regarding the allegation that pharmaceutical companies withhold important data:Novo Nordisk strongly objects to the accusation that it withheld data and takes this matter extremely seriously. All available data held by Novo Nordisk on pancreatic effects of Victoza® (liraglutide) have been shared with the regulatory agencies and are publicly available.
1.Nyborg et al, Evidence for the absence of structural pancreatic changes in three species, diabetes, 2013
2.Jensen et al Pancreas 2012:41(8):1370-1
3.Novo Nordisk, post marketing data on file. June 2013
4.Parks M, Rosebraugh C. Weighing risks and benefits of liraglutide--the FDA's review of a new antidiabetic therapy. N Engl J Med. 2010 Mar 4;362(9):774-7
5.Noel RA, Braun DK, Patterson RE, Bloomgren GL 2009 Increased risk of acute pancreatitis and biliary disease observed in patients with type 2 diabetes: a retrospective cohort study. Diabetes Care 32:834–838; Diabetes ObesMetab 12:766–771
6.Butler AE, Campbell-Thompson M, Gurlo T, Dawson DW, Atkinson M, Butler PC. Marked Expansion of Exocrine and Endocrine Pancreas with Incretin Therapy in Humans with increased Exocrine Pancreas Dysplasia and the potential for Glucagon-producing Neuroendocrine Tumors. Diabetes 2013 Mar 22.
7.Kahn SE. Incretin Therapy and Islet Pathology - A Time for Caution. Diabetes 2013 Apr
8.Nauck MA. A Critical Analysis of the Clinical Use of Incretin-Based Therapies: The benefits by far outweigh the potential risks. Diabetes Care 2013 May 6.
Competing interests: No competing interests
Last week’s BMJ and Channel 4 Dispatches programme “Diet, Drugs and Diabetes” focussed on possible dangers of incretin based therapies and alleged that the pharmaceutical industry is hiding important safety data, putting patient safety at risk (1-3). While drug safety and transparency by all stakeholders are paramount, it is important to remember that no drug is completely safe. Even widely used and well established diabetes treatments, such as metformin and sulphonylureas, may cause lactic acidosis and significant disabling hypoglycaemia respectively. Both clinicians and those with diabetes need to make a balanced decision about the risks and benefits of any treatment and this requires a non-judgemental appraisal of the data. The Dispatches programme and accompanying articles in the BMJ failed in this regard.
We have seen the damage to patient well-being caused by irresponsible reporting in the case of the MMR scare and autism, albeit based on fraudulent research. Such ‘health scares’, when not supported by adequate peer reviewed research, lead to much anxiety with many patients stopping treatment and much healthcare professional time is needed to reassure people about their treatment.
The BMJ articles allege that the issue of pancreatitis and carcinoma of the pancreas was hidden yet these potential side effects have been widely discussed at a variety of specialist forums and in both the general and specialist peer reviewed literature (4-6) and listed as a side effect in such publications as the latest edition of the British National Formula. The current data about the risks of pancreatitis and carcinoma of the pancreas remain inconclusive and at present do not provide a cogent case to stop using the treatments. On the other hand, there are many reasons to continue using incretin based therapies. The commonest cause of death and morbidity in people with type 2 diabetes is cardiovascular disease and two recent meta-analyses have indicated that treatment with DPP-4 inhibitors or GLP-1 receptor agonists during randomised controlled trials are associated with a reduction in cardiovascular events (7;8), a point edited out of my Dispatches interview with Dr Cohen. For many people with diabetes, the risk benefit ratio remains in favour of treatment.
Publishing a highly selective one-sided set of reports not only damages the reputation of the BMJ but does precisely what the BMJ is accusing the pharmaceutical companies of doing. This approach lets down the academic and clinical community as well as people with diabetes who deserve an open and honest discussion about the strengths and weaknesses of these, and all other, diabetes treatments.
Richard IG Holt
(1) Cohen D. Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed? BMJ 2013;346:f3680.
(2) Gale E. Incretin therapy: should adverse consequences have been anticipated? BMJ 2013;346:f3617.
(3) Montori VM. Helping patients make sense of the risks of taking GLP-1 agonists. BMJ 2013;346:f3692.
(4) Butler PC, Elashoff M, Elashoff R, Gale EA. A Critical Analysis of the Clinical Use of Incretin-Based Therapies: Are the GLP-1 therapies safe? Diabetes Care 2013 May 6.
(5) Nauck MA. A Critical Analysis of the Clinical Use of Incretin-Based Therapies: The benefits by far outweigh the potential risks. Diabetes Care 2013 May 6.
(6) Gier B, Butler PC. Glucagonlike Peptide 1-based drugs and pancreatitis: clarity at last, but what about pancreatic cancer? JAMA Intern Med 2013 Apr 8;173(7):539-41.
(7) Patil HR, Al Badarin FJ, Al Shami HA, Bhatti SK, Lavie CJ, Bell DS, et al. Meta-analysis of effect of dipeptidyl peptidase-4 inhibitors on cardiovascular risk in type 2 diabetes mellitus. Am J Cardiol 2012 Sep 15;110(6):826-33.
(8) Monami M, Cremasco F, Lamanna C, Colombi C, Desideri CM, Iacomelli I, et al. Glucagon-like peptide-1 receptor agonists and cardiovascular events: a meta-analysis of randomized clinical trials. Exp Diabetes Res 2011;2011:215764.
Competing interests: RIGH has acted as an advisory board member and speaker for Novo Nordisk, and as a speaker for Sanofi-Aventis, Eli Lilly, Boehringer-Ingelheim, Otsuka, GlaxoSmithKline, AstraZeneca, Merck Sharpe and Dohme and Bristol-Myers Squibb. He has received grants in support of investigator trials from Novo Nordisk.
Fiona Godlee states that 'science thrives on open challenge and objective debate'. Can Dr Godlee let us know what the BMJ Publishing Group's policy is on manuscripts that include an author from Iran? Recently, another major scientific publisher, Elsevier, has stated that its US editors and US reviewers must not handle articles that include an author employed by the government of Iran.  Do similar restrictions apply on the staff employed by the BMJ Publishing Group in the USA and on its US reviewers?
1. Marshall E. Scientific Journals Adapt to New U.S. Trade Sanctions on Iran. http://goo.gl/tAeIF
2. Seeley M. Trade sanctions against Iran affect publishers. http://goo.gl/HYLQl
Competing interests: No competing interests