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Owen Dyer
GlaxoSmithKline faces US lawsuit over concealment of trial results
BMJ 2004; 328: 1395 [Full text]
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[Read Rapid Response] Mea Culpa ...Educational Medicine et al
Sam I Sussman   (16 June 2004)
[Read Rapid Response] Publication Bias
J A C Delaney   (17 June 2004)

Mea Culpa ...Educational Medicine et al 16 June 2004
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Sam I Sussman,
Assistant Professor Psychiatry
Physicians Canada.1532 Hillside Drive, London, Ontario, Canada, N6G4M4

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Re: Mea Culpa ...Educational Medicine et al

When will we ever learn ! Over ten years ago in a letter to the BMJ(BMJ, May 1994; 308: 1301)I had stated that the barrage of the latest offerings of pharmaceuticals in medical journals posed a threat to medical practice and that another mechanism must be adopted to fund medical journals. Should we be surprised that financial interests are the predominant modus operandi of drug houses? Should we be wagging the finger at drug houses and decrying their base materialism and corresponding dishonesty and damage created? Is not the whole infrastructure of medical education from journals to medical practice a party to this charade? Drug research is funded by those who have the gold. While their golden calf is not worshipped by medical practitioners, physicians are not blameless as long as there are really no real competing alternate sources of funding drug research. The pharmaceutical industry is expert in purveying their truths. We must not fall prey by default. Safeguards have proven to be weak, too late and ineffective. Litigation occurs after the fact, is not terribly therapeutic and more often than not considered as in many multi- national enterprises the cost of doing business. Must we wait another decade to find solutions to this dilemma? Have we adopted the persona of false consciousness not to recognize that we are very much part of this problem? If not now then when?

Competing interests: None declared

Publication Bias 17 June 2004
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J A C Delaney,
Statistician
Clinical Epidemiology, Royal Victoria Hospital, Montreal, QC, Canada, R 4.36, 687 Pine Ave W,H3A1A1

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Re: Publication Bias

GlaxoSmithKline's recent legal troubles resulting from not publishing negative results of clincial trials involving the anti-depressant 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 postive trials and industry sponsorship (3).

But these cases, while they are alarming, should not blind us to the general problem of negetative results not being reported. Proper analysis of new medical therapies requires properly weighing the evidence for the new therapy (4). The proper solution to the under-reporting of negetive 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

1.Dyer O. GlaxoSmithKline faces US lawsuit over concealment of trial results.BMJ. 2004 ;328(7453):1395.

2. Felson DT and Glantz L.A surplus of positive trials: weighing biases and reconsidering equipoise. Arthritis Res Ther. 2004;6(3):117-9.

3. Bhandari M, Busse JW, Jackowski D, Montori VM, Schunemann H, Sprague S, Mears D, Schemitsch EH, Heels-Ansdell D and Devereaux PJ. Association between industry funding and statistically significant pro- industry findings in medical and surgical randomized trials. CMAJ. 2004;170(4):477-80.

4. Kleijnen J and Knipschild P. Review articles and publication bias. Arzneimittelforschung. 1992;42(5):587-91.

Competing interests: None declared