Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study
BMJ 2017; 356 doi: https://doi.org/10.1136/bmj.i6770 (Published 17 January 2017) Cite this as: BMJ 2017;356:i6770
All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
“So what is the way around? Until a more independent and honest way of reporting scientific results is agreed please keep the ordinary doctors like me informed and hopefully alert”.
YY Ivanov
Having spent the last few years of my retirement reading medical papers (particularly open access) and also as a patient reviewer for the BMJ (my thanks to Dr Godlee for this brilliant initiative), I have repeatedly found that within the reports of many studies, data that could answer a specific question is missing though it patently must exist.
I believe that if the results are published in the public domain, the data on which those results are based should also be in the public domain. The absent data (under the guise of confidentiality) imply to me that they are NEGATIVE. Were they positive, they would have been published.
I also believe that the reviewers should be totally independent from the sponsor. Unfortunately I suspect that this is often not the case. Furthermore, I have noted cases where lead authors claim “independence” because they receive funding “indirectly”.
In short the pharmaceutical industry is too involved in the detail of the research on their product. Back decades in my experience, this was not the case. Yes they provided money, comments and even advice but it was left to the researchers to report as they saw fit. Now because of cost and PROFIT the reverse is true. Prof. Gotszche in his book “Deadly Medicines and Corporate Crime” has explained the problem in some detail: a book that should be in every doctor's reading list.
Competing interests: No competing interests
The hypothesis of principal investigators financial ties to become associated with industry in producing positive study outcomes is worth reviewing. The authors (Rosa Ahn et al.BMJ 2017;356: i6770) limited their study to a sample of 250 out of 1109 potentially relevant studies. Maximum possible no. of studies should have been considered for better evidence in their cross sectional study. However, the evidence gathered was important such as
i. High prevalence of financial ties in Phase II and III
ii. High prevalence of financial ties in large sized samples
iii. High prevalence of financial ties in industry funding
iv. High prevalence of financial ties in non inferior trials
v. High prevalence of financial ties in North America and Europe.
However, financial ties in Asia showed very low prevalence. Financial self reported or held ties were observed to be significantly associated statistically with study outcomes as also indicated in the literature.
Another clear message from this cross sectional study is that non-industry funded studies are not significantly associated with study outcome. There is definitely a take home message. The known association of industry financial involvement with positive study outcome has possible explanations as stated by the authors and is important. In order to reduce the influence of industry on outcome, IRBs related conflicts of interest must be more strictly dealt with. Such a possibility should lie with the individual institutions that clear the projects of scientists. Another possibility is at screening at clinical trial registries. It is known that the benefits that industry gets for positive study outcomes are much higher than those for Principal Investigators who receive academic benefits.
Dr Satyanarayana Labani, Dr Smita A, Ms. Swati M
Scientist G,
Division of Epidemiology & Bio-statistics
National Institute of Cancer Prevention & Research, ICMR,
Noida (UP), India - 201301
Competing interests: No competing interests
Dear Editor in Chief,
Thank you for the challenging paper.
As I grow older (34 years' service as a pulmonary physician), I have less and less doubt about the influence pharmacy companies exert upon the reporting of scientific data. And this paper piles on more doubts.
The question is - Is reporting disclosures by authors and still intentionally presenting results thus favoring the sponsor enough? I do not think so!
So what is the way around? Until a more independent and honest way of reporting scientific results is agreed please keep the ordinary doctors like me informed and hopefully alert.
Kind regards,
Dr. Yavor Ivanov
Clinic of pneumonology and phthisiatry
Pleven, Bulgaria
Competing interests: No competing interests
The article is important and timely. An additional area of inquiry should be diagnostic and therapeutic methods that are promoted by clinicians whose practices, rather than their patients, benefit from these procedures.
Competing interests: No competing interests
This is most welcome research, with an outcome that would not surprise many. A thread that is woven within much of 'sponsored' or 'supported' clinical trial activity incorporates a profound sense of gratitude on behalf of not only the investigators but the large institutions that employ them.
That is because we all develop lasting memories of people, the professionals involved in clinical research, very commonly the research team from the company and/or team supporting the study, but most particularly the research staff employed through incorporated funding to 'perform' the study.
Those highly skilled professionals, often research nurses or physicians of various kinds, thus soften some of the unmet needs that academic and healthcare institutions have with regard to clinical staffing. The profound impact that has cannot be underestimated and could be a consistently influencing bias towards favourable leanings in the direction of the investigational product or process.
We should and must learn from this study, and harness its impact towards a hope for ensuring greater objectivity in clinical research.
Competing interests: No competing interests
Investigators can minimize commercial bias if they want to
This article adds important evidence that corporate payments to investigators are powerful enough to independently bias the reported outcomes of even randomized clinical trials.
The authors conclude that these influences are so extensive that restricting involvement of people with financial ties is not plausible. However, researchers at the Mario Negri Institute and its dozens of labs employ rules and procedures described in the book, Good Pharma: the Public Health Model of the Mario Negri Institute, to ensure that their research is independent of commercial influence and all trial results are published. The Mario Negri uses RCT designs to test for clinical superiority. Costs are a fraction of commercial trials and paid up so there is no investment to recover. If a country or the EU wanted to oversee manufacturing, drug prices could be a fraction of government-protected patent prices that now burden their budgets.
Competing interests: No competing interests