Comment on: Developing good scientific publishing practices: one pharmaceutical company’s perspective

Dear Sir,

The article written by Dr Dowsett and colleagues1 is a noble effort by one pharmaceutical company to raise their head ‘above the crowd’ at a time when few are doing so. With barbs being fired at pharma by such high profile individuals as Senator Grassley, it is a courageous company that stands up to be counted. It is ironic that in commercial healthcare research, conflict of interest is presumed until proven otherwise. Certainly pharma and academia both have potential conflicts of interest in that the research they undertake can provide financial gain and/or prestige, with the latter potentially leading to the former. Of note, however, is that both are also working to improve the collective quality of life for us all. So when did making a profit or enhancing the reputation of an institution compromise the endpoint? This certainly does not unilaterally justify the means; it merely places them into perspective, as opposed to them being de facto wrong.

The reality, which is all too often forgotten, is that all parties – academic research, private enterprise, clinical experts, and peer-reviewed journals – have a valuable, and in fact, irreplaceable role in the research, development, clinical use and monitoring of a drug. Each also has a duty to be ethical in how they carry out their part of these efforts. Those that breach this responsibility should be held accountable. But the mere presence of a potential conflict should not render the verdict inevitable. Perhaps my expectations are naive, but I know many experts who would never consider jeopardizing their own integrity or another’s well-being for the sake of profit or personal gain. While I understand it is not popular to write about this unheard majority, let’s not forget that they do exist and while I don’t have a p-value to support this, I believe they do indeed represent the majority. Ethical people are ethical people, regardless of whether they work in a university or a corporation. One’s integrity does not change based on job description or which corporate entity appears on a paycheck. While times have certainly changed, as has what is acceptable in 2010 versus a decade or two ago, individual integrity usually does not change with positions.

A key point that must be differentiated is the very different and separate issue of clinical trial data transparency, compared with the transparency of the contributor to a manuscript. They are quite different, but at times get ‘thrown into the same pot.’ The need for the complete and open disclosure of the results of a clinical trial are indisputable. Data must be made available to the author and any journal editor or reviewer who has a need to review these data.

The issue of the involvement or non-involvement of a ghostwriter in the evolution of a manuscript or other scientific communication would also seem to be quite easy to agree on as well. While in times past, the term ghostwriter was acceptable, it is no longer so. The new and more acceptable term is professional medical writer or medical writer. In fact, I believe the job title and the job responsibilities of both positions are largely the same, but with one very significant difference – the ghost part. Both assist the author in a manner that the author requests, with ultimate complete control and final approval of the piece residing with the author. The difference is transparency. Transparency ensures the medical writer’s contribution is acknowledged and made public. The role the writer plays, and for that matter, the role that anyone who has a supporting role in conducting the clinical trial and the subsequent publication of the results of that clinical trial, should be fully acknowledged by the author(s) and by the journal. At times, both have failed to do so.

Most clinical investigators are good clinicians and effective at overseeing clinical trials. However, they may not always be the best individuals to write up the results either because they have schedules and commitments that would delay the science being published in a timely manner or because at times, their scientific writing skills are not strong. Logically, the use of the best or most skilled person to get the job done, whether it be to coordinate the study analysis, gather the results, evaluate the data, or draft the paper, is of value to the timely and effective communication of information to the medical and scientific community. The key is ensuring that the author acknowledges everyone who contributed to the study and paper, and that the author takes responsibility for the interpretation of the study’s data, its clinical significance, and what is submitted for peer review by the journal’s review board.

The commitment to ethical research and publication guidelines, such as the Lilly Principles of Medical Research, are commendable. Similar standards are becoming common among many pharma companies and should also be recognized. We – meaning pharma, their medical writing agencies, authors, and journal editors – must work to enforce these guidelines. Having the policies and adhering to the policies, however, are two very different responsibilities. Without the enforcement of these policies, we leave ourselves open to front page criticisms in the popular press instead of focusing on ensuring that key medical and scientific information is being communicated in top tier peer reviewed journals. While standing up to be the first counted is courageous, associations such as the International Society for Medical Publication Professionals (ISMPP) also have a responsibility to lead the efforts and ensure member compliance to these standards. The tag line should become, ‘the views expressed here, do represent those of industry and ISMPP’.

The only issue I take with the Lilly guidelines and other’s like theirs is the unilateral exclusion of commercial staff in the development of a manuscript. While I understand that this is the politically correct thing to do, it seems to contradict the spirit of authorship guidelines such as those of the ICMJE. The role of the contributor should determine whether the person is an author or an acknowledgee, regardless of the department or job title held. There are many individuals who comprise the staff of any pharmaceutical/biotechnology company who scientifically or clinically can add value to a manuscript; as long as their credentials are real and their role is fully disclosed, does it matter what their business card reads? Suppose one of these individuals is the smartest person in the room and provides the most accurate and valuable insights concerning the data contained within the manuscript? I believe the reader of a peer-reviewed publication should determine the value of a publication, provided everyone’s contribution to the paper is made transparent to that reader. Allowing the reader to judge the merit of a paper seems more prudent. My compliments to Eli Lilly and Company; perhaps when every company’s head is held high, it will become the norm, so only those who don’t will be the odd ones out. Let’s all follow Eli Lilly and Company’s example.

Transparency

Declaration of financial/other relationships

R.A.N. has disclosed that he owns stock in Complete Healthcare Communications and a number of pharmaceutical and biotechnology companies.

The authors of the paper referred to were given an opportunity to reply but chose not to.