A large study—parts of which have been published in several major journals— purported to show that a drug may reduce side effect X without acting through an important intermediate process Y. This suggests that the drug may have important advantages over similar drugs in its class, and indeed it had been marketed as such. But a critic thinks that the drug may indeed act through the intermediate process Y but that this had been disguised by the way in which the drug had been taken. This was not described in the major papers, but has now been reviewed in a comparatively minor study. The editor had tentatively agreed with the critic to consider publishing a paper that discussed the mechanism, but it had been difficult to find out information on the trial protocol. - Could the authors have deliberately misled readers by not describing the drug route? - Does this amount to deception?
- It is impossible to know from the initial information whether the authors deliberately attempted to deceive by disguising the manner in which the drug was taken. - Why had it been difficult to find out information on the trial protocol? Had the pharmaceutical company exerted pressure for this information not to be released? - The editor should publish something to the effect that the apparent benefit may arise from the manner in which the drug is taken.
Somebody—possibly a representative of a drug company or a PR acting for the company—rang an editor on behalf of study authors to say that she would guarantee to buy 1000 reprints if the journal would continue to consider for publication a study that conflicted with a policy that the journal had just introduced. “And”, she said, “I will buy you a dinner at any restaurant you choose.” The paper was rejected, but should further action be taken?
_ Generally drug companies have policies against PR companies approaching journals and if the drug company was identifiable then the editor could contact the company concerned to complain. _ The lead author of the study should be informed about the actions of individuals representing the product being discussed in the paper. _ The drug company might also want to know what the PR is doing on its behalf. One of the members relayed how in a similar circumstance he had complained to the drug company which had withdrawn its contract with the offending PR company.
The editor admitted that he could not remember the name of the person involved and was unable to trace the article, but he promised to mention the incident in the journal. He fulfilled his promise.
A randomised controlled trial raised three aspects of concern: 1. The participants’ physical characteristics at entry to the study were listed in a table. For the two groups—intervention and control—one physical characteristic was given as a mean ± the standard deviations (SDs). However, the SDs for both groups were much smaller than they should have been. 2. The inclusion criteria were unusual. These excluded half of the eligible population. 3. The intervention was more successful than the control in managing the condition. The language of the paper adopted the style of an advertisement. The company manufacturing the intervention had assisted financially in the study. An independent statistical reviewer did not believe that the over stringent selection criteria could have explained the low SDs. Does COPE feel that these concerns might indicate research misconduct?
_ Was this a simple mistake between standard error and standard deviation? _ Further meta studies should be requested. _ Further clarification from the authors should be obtained along with a request for the original data.