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Extra scrutiny for industry funded trials

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7529.1350 (Published 08 December 2005) Cite this as: BMJ 2005;331:1350

Rapid Response:

Without new rules for industry-sponsored research, science will cease to exist

Rothman, Evans, Carlin and myself agree that there is a problem. I
totally agree with them that the problem is not one of "villains".

However, the problem is not only one of conflicts of interest. In all
scientific debates all sides always have their own biases: we have no
other way to look at data but to interpret them. However, in usual
clinical or epidemiologic research, studies are repeated by others, in
different settings and by different means, looking for biases, flaws, and
ways of remedying them, endlessly arguing whether the biases are remedied
or not. That is the essence of open scientific debate and criticism, which
is the only guarantee for progress. That is no longer possible with
pharmaceutical products because the monopoly of the pharmaceutical
industry of studies of its own products leads to persistently one-sided
studies that can no longer be questioned by studies from other sides.

Moreover, the one-sidedness cannot be seen from the public record, that is
the published papers. Without the possibility of open debate, science
simply ceases to exist. That is why this is an exception which calls for
other measures such as more overseeing for which a suitable mechanism
should be found. Next to obligatory clinical trial registration, JAMA's
proposal is a second. Rothman, Evans and Carlin's proposal to make all
data public is another: e.g., all data submitted to drug regulatory
authorities should become public because these data are different from the
published papers. Even better would be independent funds for clinical
research (1). These may lead to studies showing true equipoise in the long
run: that new therapies in need of scrutiny have a 50-50 chance of being
better than standard (2).

(1) Remuzzi G, Schieppati A, Boissel JP, Garattini S, Horton R.
Independent clinical research in Europe. Lancet. 2004;364:1723-6.

(2) Kumar A, Soares H, Wells R, Clarke M, Hozo I, et al. Children's
Oncology Group. Are experimental treatments for cancer in children
superior to established treatments? Observational study of randomised
controlled trials by the Children's Oncology Group. BMJ. 2005;331:1295-8.

Competing interests:
None declared

Competing interests: No competing interests

14 December 2005
Jan P Vandenbroucke
Professor of Clinical Epidemiology
Leiden University Medical Center, 2300 RC Leiden