Letters Section Editor: Stephen J. Lurie,
MD, PhD, Senior Editor.
To the Editor: Dr Als-Nielsen and colleagues1 found that trials funded by for-profit organizations
favored the active drug more commonly than placebo. The authors concluded
that this may have been due to biased interpretation of trial results. However,
an association between funding and study conclusions is not surprising.
A major reason for this, which the authors alluded to briefly, is the
"violation of the uncertainty principle," an unfortunate phrase, as it implies
error or some nefarious or underhanded activity. There really is no reason
to expect that "half of all [published] trials should favor the control intervention."
While equipoise may be present in at least some trials sponsored by nonprofit
organizations, it is unrealistic to think that there is anything like equipoise
in studies sponsored by industry. It is not the business of pharmaceutical
companies to do such studies; they are in the business of confirming efficacy.
No pharmaceutical company would perform an expensive phase 3 study if it thought
the probability of a positive outcome was only 50%. After a positive phase
2 program, one expects a considerably higher probability of success. So it
is not surprising that such studies "have a higher likelihood of favoring
the experimental drug." In addition, I believe that studies from for-profit
organizations, conducted under the watchful eyes of regulatory agencies, are
more likely to be better studies (ie, to have adequate double blinding), which
would explain the association between double blinding and recommending the
Palmer RH. Results of Clinical Trials Sponsored by For-Profit vs Nonprofit Entities—Reply. JAMA. 2003;290(23):3070. doi:10.1001/jama.290.23.3070-a