Suppression_of_science_not_an_anomaly

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> Suppression_of_science_not_an_anomaly

> " GM_WATCH_daily " <info

> Thu, 22 Jul 2004 13:26:21 +0100

 

>

> GM WATCH daily

> http://www.gmwatch.org

> ------

> " 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

> ------

> 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.

> -------

> 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.

> ------

> 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=7a0afadcf92e9c25d8188515\

008a22dfc57266b8 & 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;

> bhandari

>

> 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.

> -----

> 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.