An article was published in Journal A, investigating the efficacy and safety of generic medicine A. The authors did not declare any conflicts of interest. Generic medicine A is manufactured by company A.
Before publication in journal A, the same authors published another study in journal B as a preliminary report. No conflicts of interest were declared.
In a recently published article in journal C, from the same authors, with collaboration of other authors in a multicentric study investigating the same drug, the authors declared conflicts of interest, stating clearly that they had been involved in manufacturing medicine A as the stockholders of company B.
The editor-in-chief of journal A, asked the first and corresponding authors to publish a corrigendum declaring the conflicts of interest. They responded that they did not include the conflicts of interest in their publication in journal A because at the time of submission the generic drug A was manufactured by company A. Given the medicine was the intellectual property of company B, the journal felt that the response of the authors regarding the issue with conflicts of interest was an inappropriately undisclosed conflict of interest.
Furthermore, some of the authors of the paper have editorial positions in journal B which should be investigated in terms of publication misconduct. The editor-in-chief of journal B has no relationship with company B.
Some of the authors of the three articles are stockholders of company B, which holds the intellectual property of the generic medicine A. Author A was the CEO of pharmaceutical company B at the start of the project and had a key role in study design, data collection and analysis. It is unclear when they left the company. Author A has also held office in related government departments and is the current director of medical association A. While there were five manufacturers of generic medicine A, medical association A published a guideline in journal B including the name of generic medicine A as the sole treatment without mentioning any conflict of interest. The government committee on ethics in biomedical research is directed by author A.
The American College of Physicians has updated its approach for declaring conflicts of interest in clinical guidelines and in some cases it proposes exclusion of authors from authorship or voting in such guidelines. Both of the US Preventive Services Taskforce and the UK National Institute for Health and Care Excellence also have moved beyond a simple declaration of interest in these guidelines on managing conflicts of interest .
Questions for COPE Council
- What is the advice from COPE regarding the undisclosed conflict of interest in journal A, and what action should be taken?
- Are stockholders of a pharmaceutical industry allowed to perform research and publish it as a research paper even if they declare their conflicts of interest in the paper?
- In this case, the issue involves the director of the government committee on ethics in biomedical research, so how and where should the issue be investigated?
Advice on this case is from a small number of COPE Council Members. Most cases on the COPE website are presented to the COPE Forum where advice is offered by a wider group of COPE Members and COPE Council Members. Advice on individual cases is not formal COPE guidance.
Generally, authors need to declare conflicts of interest (potential or actual) at the time of publication at the latest (and when submitting at the earliest). Once an article is published, disclosure of arising conflicts is not necessary unless the conflicts were 'potential' in the sense that they could be perceived as influencing the article in question (eg, a favorable product review that supports the author's application for employment at a related company). An obvious rule of thumb is: is there a link between the author and the paper such that the author may potentially receive a benefit beyond mere publication of the paper. In this case the answer must be yes because although the variant of the drug was from company A, it is equivalent to that sold by company B, for which there are several commercial links. Therefore, the findings in journal A on drug A may have commercial implications for company B. .
Regarding a stockholder of a company being able to perform research related to products of that company, the answer must be yes, so long as there is appropriate disclosure; otherwise, employees of a company (who have an even more direct interest) would be precluded from publishing anything related to products from their employers. In the medical field, Pharma is involved in lots of research evaluating the efficacy and safety of new drugs, but the transparency of Pharma’s (or the sponsor’s) role in the design of a study, data collection, and writing must be clearly disclosed.
Regarding journal B, simply holding an editorial position is not evidence of misconduct—this has to be established based on the content of the article in that journal versus the other publication (journal A).
In answer to the final question, probably the only avenue is to contact the head of the Ministry of Health or perhaps the Minister of Health.
Ultimately, perhaps this journal's author guidelines need to be strengthened regarding conflict of interest disclosures. Do the instructions include clear information about conflict of interests and/or state which style guide it follows? Many biomedical journals follow the AMA Manual of Style which includes the following in section 5.5 of the current 10th edition: 'Financial interests may include but are not limited to employment, consultancies, stock ownership, honoraria, expert testimony, royalties, patents (filed, pending, or registered), grants, and material or financial support from industry, government, or private agencies. Nonfinancial interests include personal or professional relationships, affiliations, knowledge, or beliefs that might affect objectivity.'