"Suppression of science is not an anomaly but is typical of and produced by, the current economic, political, and social situation, and that is - money talks. It is the system; it is not just a few bad apples" (item 2)
1.Tracking system for studies should be in place
2.Stronger sanctions needed against companies that suppress data
3.Industry-funded trials are more likely to be associated with statistically significant pro-industry findings
4.Impact of conflicts of interest on scientific judgements
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1.Tracking system for studies should be in place
British Medical J ournal 2004;329:173 (17 July), doi:10.1136/bmj.329.7458.173-b
http://bmj.bmjjournals.com/cgi/content/full/329/7458/173-b
EDITOR—GlaxoSmithKline's recent legal troubles resulting from not publishing negative results of clinical trials on the antidepressant paroxetine are just part of a larger problem of publication bias in modern research.1
There has been evidence that the literature that is published is more likely to be positive than chance alone might predict.2 There have even been links shown between positive trials and industry sponsorship.3 But these cases, although they are alarming, should not blind us to the general problem of negative results not being reported. Proper analysis of new medical treatments requires properly weighing the evidence for the new treatment.4
The proper solution to the under-reporting of negative results is to track all clinical trials so that we can ensure that the results of such trials are properly reported. It is important for both journals and investigators to work together to ensure that this occurs. Had such a system been in place, it would have been much more difficult for GlaxoSmithKline to conceal these results.
J A C Delaney, statistician, clinical epidemiology
Royal Victoria Hospital, R 4.36, 687 Pine Avenue W, Montreal, QC, Canada H3A 1A1 chris.delaney{at}clinepi.mcgill.ca
Competing interests: None declared.
References
[links to papers an be found at:
http://bmj.bmjjournals.com/cgi/content/full/329/7458/173-b - see also item 3 below]
1.Dyer O. GlaxoSmithKline faces US lawsuit over concealment of trial results. BMJ 2004;328: 1395. (12 June.)[Free Full Text]
2.Felson DT, Glantz L. A surplus of positive trials: weighing biases and reconsidering equipoise. Arthritis Res Ther 2004;6: 117-9.[CrossRef][Medline]
3.Bhandari M, Busse JW, Jackowski D, Montori VM, Schunemann H, Sprague S, et al. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ 2004;170: 477-80.
[see item 3 below]
4.Kleijnen J, Knipschild P. Review articles and publication bias. Arzneimittelforschung 1992;42: 587-91.
Other related articles in BMJ:
GlaxoSmithKline faces US lawsuit over concealment of trial results. Owen Dyer
BMJ 2004 328: 1395.
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2.Stronger sanctions needed against companies that suppress data
Bob Roehr
British Medical Journal, 2004;329:132 (17 July), doi:10.1136/bmj.329.7458.132
http://bmj.bmjjournals.com/cgi/content/full/329/7458/173-b
"Suppression of science is not an anomaly but is typical of and produced by, the current economic, political, and social situation, and that is - money talks. It is the system; it is not just a few bad apples," Dr David Egilman, a professor of medicine at Brown University, Providence, Rhode Island, told a conference this week.
Although money was important, there were also other forces at work, he said. "It is broader than money, it's ideology and power. Ideology is a much larger bias than money much harder to ferret out and think through," he added.
His words found a ready audience among those attending the one day conference Conflicted $cience: Corporate and Political Influence on Science-based Policymaking, held in Washington, DC, this week. It was sponsored by the Center for Science in the Public Interest, a US consumer advocacy organisation for health and nutrition.
Dr Egilman said ethical companies could not compete with the unethical ones because "the penalties for getting caught never approach the cost advantages of increased profit, and there rarely are criminal penalties."
He believes that part of the reform package must be to press criminal charges against industry leaders who suppress data that results in death. "And even if they get off, a trial or two will really clean the act up."
Dr Arnold Relman, emeritus editor of the New England Journal of Medicine, lamented that the dominant role that academic research institutions played in conducting clinical trials, as recently as the 1970s, had "largely been coopted by the pharmaceutical industry."
"The rhetoric from the academy [academic community] claims that their collaboration with the industry really serves the public interest because it favours the rapid transfer of basic science into the marketplace. But they do not acknowledge that scientific collaboration does not have to include financial arrangement that compromise the integrity and independence [of those institutions]," he said.
Keynote speaker Brian Baird, a Democratic Congressman from Washington state, criticised the Bush administration and Republican leadership in Congress, charging that they are conducting a "full assault on scientific integrity that is a danger not only to the enterprise of science, but ultimately to the value of inquiry, debate, and decision making that underlie the democratic process."
Mr Baird, who was first elected in 1999, is also a licensed clinical psychologist and former academic researcher. He chastised the scientific community as well, saying that its response had been "pathetic, self serving, and by and large craven."
Far too often researchers using government appropriations do not stop to think that it is someone else's hard earned money. Too often that research is "esoteric, largely unmeasurable, with no clear benefits to society, yet concludes with the obligatory sentence, 'further research is necessary.'" He challenged the audience to seriously examine their own actions.
"The scientific community has been politically asleep for too long," he said. He urged them to defend the integrity of the scientific process and also to get involved in politics at the grassroots level.
Although critics of "cheque-book science" were well represented at the conference, fewer participants offered detailed remedies.
One common theme at the conference was the need for greater transparency of information in everything from the financial interests of investigators and funding sources, to a registry of all clinical trials, to comparative rather than placebo controlled trials, to publication of negative data.
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3.Industry-funded trials are more likely to be associated with statistically significant pro-industry findings
Cited-reference access courtesy of Canadian Medical Association Journal
CMAJ • February 17, 2004; 170 (4)
http://www.cmaj.ca/cgi/content/abstract/170/4/477?ijkey=7a0afadcf92e9c25d8188515008a22dfc57266b8&keytype2=tf_ipsecsha
Association between industry funding and
statistically significant pro-industry findings in
medical and surgical randomized trials
Mohit Bhandari, Jason W. Busse, Dianne Jackowski,
Victor M. Montori, Holger Schünemann, Sheila Sprague, Derek Mears, Emil H. Schemitsch, Dianne Heels-Ansdell and P.J. Devereaux
From the Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ont. (Bhandari, Busse, Jackowski, Montori, Schünemann, Sprague, Mears, Heels-Ansdell, Devereaux);
and the Department of Surgery, University of Toronto, Toronto, Ont. (Schemitsch).
Correspondence to: Dr. Mohit Bhandari, Department of Clinical Epidemiology and Biostatistics, McMaster University Medical Centre, 1200 Main St. W, Rm. 2C3, Hamilton ON L8N 3Z5; fax 905 524-3841; [email protected]
Background: Conflicting reports exist in the medical literature regarding the association between industry funding and published research findings.
In this study, we examine the association between industry funding and the statistical significance of results in recently published medical and
surgical trials.
Methods: We examined a consecutive series of 332 randomized trials published between January 1999 and June 2001 in 8 leading surgical journals and 5 medical journals. Each eligible study was independently reviewed for methodological quality using a 21-point index with 5 domains:
randomization, outcomes, eligibility criteria, interventions and statistical issues. Our primary analysis included studies that explicitly identified the primary outcome and reported it as statistically significant. For studies that did not explicitly identify a primary outcome, we defined a "positive" study as one with at least 1 statistically significant outcome measure. We used multivariable regression analysis to determine whether there was an association between reported industry funding and trial results, while controlling for study quality and sample size.
Results: Among the 332 randomized trials, there were 158 drug trials, 87 surgical trials and 87 trials of other therapies. In 122 (37%) of the trials, authors declared industry funding. An unadjusted analysis of this sample of trials revealed that industry funding was associated with a statistically significant result in favour of the new industry product (odds ratio [OR] 1.9, 95% confidence interval [CI] 1.3–3.5). The association remained significant after adjustment for study quality and sample size (adjusted OR 1.8, 95% CI 1.1–3.0). There was a nonsignificant difference between surgical trials (OR 8.0, 95% CI 1.1–53.2) and drug trials (OR 1.6, 95% CI 1.1–2.8), both of which were likely to have a pro-industry result (relative OR 5.0, 95% CI 0.7–37.5, p = 0.14).
Interpretation: Industry-funded trials are more likely to be associated with statistically significant pro-industry findings, both in medical trials and surgical interventions.
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4.The ground breaking study done on the impact of conflicts of interest on scientific judgements:
The New England Journal of Medicine -- January 8, 1998 -- Vol. 338, No.2
Conflict of Interest in the Debate over Calcium-Channel Antagonists
Henry Thomas Stelfox, Grace Chua, Keith O'Rourke, Allan S. Detsky
Abstract available at http://www.nejm.org/content/1998/0338/0002/0101.asp
or via contents page at http://www.nejm.org/content/1998/0338/0002/TOC.asp
The study's conclusion is that a strong association is demonstrated between authors' published positions on product safety (in this case calcium-channel antagonists) and their financial relationships with the relevant industry.
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