GlaxoSmithKline faces US lawsuit over concealment of trial results
BMJ 2004; 328 doi: https://doi.org/10.1136/bmj.328.7453.1395 (Published 10 June 2004) Cite this as: BMJ 2004;328:1395All rapid responses
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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
Competing interests: No competing interests
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
Competing interests: No competing interests