So what does it take to keep medical research a well-oiled enterprise that efficiently and effectively delivers cures? Lots of cooperation–or so I argue, along with co-authors Alex John London and Marina Emborg in a piece appearing in Science[a publicly accessible version of the essay is available at Science Progress]. Unfortunately, we argue, the way or system of drug development currently thinks about the ethics of clinical research does not presently place sufficient emphasis on the conditions necessary to sustain this cooperation.
Right now, oversight of clinical research is focused almost exclusively on protecting the personal interests of human subjects by obtaining valid informed consent and ensuring that risks are reasonable in relation to benefits. We suggest that this ostensibly private transaction between investigators and patient-volunteers has a public dimension in at least three ways. First, such private transactions inevitably draw on public resources. Second, such transactions have externalities- adverse events occurring on one trial have potential to disrupt collaborations elsewhere in the research system. Third, lax oversight of such private transactions creates conditions where consumers have difficulty identifying (and hence rewarding) producers of high quality goods (namely, trials that are well designed).
We suggest that, when considering whether to initiate highly innovative clinical trials that draw on such public goods, proper oversight and analysis must take into consideration factors that lie beyond the personal interests of human volunteers. (photo credit: McKillaboy, Cataglyphis velox 22, 2009)
@Manual{stream2010-65,
title = {Conditions of Collaboration: Protecting the Integrity of the Scientific Enterprise},
journal = {STREAM research},
author = {Jonathan Kimmelman},
address = {Montreal, Canada},
date = 2010,
month = may,
day = 18,
url = {http://www.translationalethics.com/2010/05/18/conditions-of-collaboration-protecting-the-integrity-of-the-scientific-enterprise/}
}
MLA
Jonathan Kimmelman. "Conditions of Collaboration: Protecting the Integrity of the Scientific Enterprise" Web blog post. STREAM research. 18 May 2010. Web. 05 Dec 2024. <http://www.translationalethics.com/2010/05/18/conditions-of-collaboration-protecting-the-integrity-of-the-scientific-enterprise/>
APA
Jonathan Kimmelman. (2010, May 18). Conditions of Collaboration: Protecting the Integrity of the Scientific Enterprise [Web log post]. Retrieved from http://www.translationalethics.com/2010/05/18/conditions-of-collaboration-protecting-the-integrity-of-the-scientific-enterprise/
Much has already been said about Filing Cabinet syndrome in medical research: the tendency of researchers to publish exciting results from clinical trials, and to stash null or negative findings safely away from public view in a filing cabinet. Nonpublication distorts the medical literature, because it prevents medical practitioners from accessing negative information about drugs. Recall that, back in 2004, attorney-general Eliot Spitzer sued Glaxo Smithkline for suppressing trial results that showed elevated risk of suicide for adolescents taking the antidepressant drug Paxil; this and several similar episodes led FDA, major medical journals, World Health Organization, World Medical Association, and others to require researchers to register clinical trials before they enroll any patients.
Yet important gaps remain. In the March 2010 issue of PLoS Biology, Emily S. Sena and coauthors provide the most detailed analysis yet of one of these gaps: nonpublication of preclinical (animal) studies. They aggregated results of 16 systematic reviews of preclinical studies involving acute ischaemic stroke, and used statistical methods to estimate the degree of publication bias, and the likely effect of publication bias on measured disease responses. Among other things, they found that 16% of animal experiments were not published, leading to a 31% overstatement of efficacy. The authors note: “we estimate that for the interventions described here, experiments involving some 3,600 animals have remained unpublished. We consider this practice to be unethical.”
The authors urge that central registries of preclinical studies be established and maintained– a call that is not likely to go heeded anytime soon by companies that have much at stake in the secrecy in preclinical research. But their proposal ought to be taken seriously by anyone committed not only to respecting animals used in medical research, but also protecting the welfare of human beings who might enroll in possibly unwarranted clinical research. (photo credit: amy allcock 2009)
@Manual{stream2010-66,
title = {Filing Cabinet Syndrome: The Effect of Nonpublication of Preclinical Research},
journal = {STREAM research},
author = {Jonathan Kimmelman},
address = {Montreal, Canada},
date = 2010,
month = may,
day = 11,
url = {http://www.translationalethics.com/2010/05/11/filing-cabinet-syndrome-the-effect-of-nonpublication-of-preclinical-research/}
}
MLA
Jonathan Kimmelman. "Filing Cabinet Syndrome: The Effect of Nonpublication of Preclinical Research" Web blog post. STREAM research. 11 May 2010. Web. 05 Dec 2024. <http://www.translationalethics.com/2010/05/11/filing-cabinet-syndrome-the-effect-of-nonpublication-of-preclinical-research/>
APA
Jonathan Kimmelman. (2010, May 11). Filing Cabinet Syndrome: The Effect of Nonpublication of Preclinical Research [Web log post]. Retrieved from http://www.translationalethics.com/2010/05/11/filing-cabinet-syndrome-the-effect-of-nonpublication-of-preclinical-research/
So what does it take to keep medical research a well-oiled enterprise that efficiently and effectively delivers cures? Lots of cooperation–or so I argue, along with co-authors Alex John London and Marina Emborg in a piece appearing in Science [a publicly accessible version of the essay is available at Science Progress]. Unfortunately, we argue, the way or system of drug development currently thinks about the ethics of clinical research does not presently place sufficient emphasis on the conditions necessary to sustain this cooperation.
