An August 20, 2013 Journal of Clinical Oncology article by Nguyen et al entitled "Public Availability of Results of Trials Assessing Cancer Drugs in the United States" analyzed to what extent the results of completed studies of oncology drugs performed in the United States were publicly available, as required by the Food and Drug Administration Amendments Act (FDAAA), at clinicaltrials.gov or were published in medical journals. This paper was accompanied by an editorial by Prasad et al entitled "Finishing the Picture: Problems With Public Reporting of Clinical Trials", which reviewed the paper in detail. A close reading of these articles by a libertarian reveals an interesting statist bias.
Intriguing findings of the Nguyen et al study were as follows: (1) "Compliance with the FDAAA was higher for trials funded by industry only than those with mixed or academic funding … (20% v 11% and 6%; p < .001 …"; (2) "On multivariate analysis, industry funding only was associated with compliance with the FDAAA compared with academic funding only (adjusted odds ratio, 3.6; 95% CI, 1.8 to 6.9; p < .001) …"; and (3) "The source of funding was independently associated with compliance: trials having industry primary funding were more compliant than those with academic primary funding."
How does the editorial present these results? "Contrary to the notion that the pharmaceutical industry might have the most to lose from clinical studies which did report negative results, compliance with the FDAAA legislation was highest in trials with industry primary funding. This parallels the unexpected finding reported previously; namely, that pharmocoeconomic findings reported in pharmaceutical industry-funded reports were of higher quality than those findings reported by researchers who lacked pharmaceutical industry support. … It is not known if the selective incomplete reporting reflected differentials in studies with statistically nonsignificant primary or secondary outcomes or if the delayed studies were those where US Food and Drug Administration registration was being pursued and corporate interests mitigated against early dissemination." It is difficult to interpret the editorial commentary in any other way than as a pro-State, anti-market bias.
Of course, libertarian readers recognize that the giant American pharmaceutical corporations are anything but "free market" entitles. Rather, they are fascist organizations. Their superior compliance with FDAAA regulations, as compared to non-commercial academic researchers, is no surprise when one considers the fact that such fascist corporations have a greater incentive (survival based on profit vs. loss) than purely State-funded academic organizations, which survive regardless of how much money they lose.
The article and editorial authors predictably recommend increased American Imperial State regulation of clinical trials reporting. Sigh. A libertarian's work is never done.
Intriguing findings of the Nguyen et al study were as follows: (1) "Compliance with the FDAAA was higher for trials funded by industry only than those with mixed or academic funding … (20% v 11% and 6%; p < .001 …"; (2) "On multivariate analysis, industry funding only was associated with compliance with the FDAAA compared with academic funding only (adjusted odds ratio, 3.6; 95% CI, 1.8 to 6.9; p < .001) …"; and (3) "The source of funding was independently associated with compliance: trials having industry primary funding were more compliant than those with academic primary funding."
How does the editorial present these results? "Contrary to the notion that the pharmaceutical industry might have the most to lose from clinical studies which did report negative results, compliance with the FDAAA legislation was highest in trials with industry primary funding. This parallels the unexpected finding reported previously; namely, that pharmocoeconomic findings reported in pharmaceutical industry-funded reports were of higher quality than those findings reported by researchers who lacked pharmaceutical industry support. … It is not known if the selective incomplete reporting reflected differentials in studies with statistically nonsignificant primary or secondary outcomes or if the delayed studies were those where US Food and Drug Administration registration was being pursued and corporate interests mitigated against early dissemination." It is difficult to interpret the editorial commentary in any other way than as a pro-State, anti-market bias.
Of course, libertarian readers recognize that the giant American pharmaceutical corporations are anything but "free market" entitles. Rather, they are fascist organizations. Their superior compliance with FDAAA regulations, as compared to non-commercial academic researchers, is no surprise when one considers the fact that such fascist corporations have a greater incentive (survival based on profit vs. loss) than purely State-funded academic organizations, which survive regardless of how much money they lose.
The article and editorial authors predictably recommend increased American Imperial State regulation of clinical trials reporting. Sigh. A libertarian's work is never done.
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