End Fatigue

Studies Funded by Drug Companies are Severely Biased

As discussed in my article Healing the Health Care System—Part 2, research published in JAMA (the AMA journal) finds that studies funded by drug companies are (obscenely) likely to misrepresent the data. This study showed that if the drug company pays for the study, it is 3 to 20 times more likely to report a positive result—given the same data. In head on studies of medications, the drug made by the company paying for the study was 20 times as likely to beat its competitor. From a scientific point of view, this says clearly that studies paid for by the drug companies are simply NOT VALID. This simple truth is ignored by "scientific" medical journals. Hard to blame them though—most of their money comes from drug company ads, and the "experts" are largely on the drug company payroll. Unfortunately, the cost of ignoring this scientific fact is over 200,000 medication deaths a year and a poorly effective health care system on the verge of bankruptcy. (See Healing the Health Care System—Part 1.)

Association of Funding and Conclusions in Randomized Drug Trials

A Reflection of Treatment Effect or Adverse Events?

Bodil Als-Nielsen, MD; Wendong Chen, MD; Christian Gluud, MD, DMSc; Lise L. Kjaergard, MD
JAMA. 2003;290:921-928.

Context: Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions.

Objective: To explore whether the association between funding and conclusions in randomized drug trials reflects treatment effects or adverse events.

Design: Observational study of 370 randomized drug trials included in meta-analyses from Cochrane reviews selected from the Cochrane Library, May 2001. From a random sample of 167 Cochrane reviews, 25 contained eligible meta-analyses (assessed a binary outcome; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment). The primary binary outcome from each meta-analysis was considered the primary outcome for all trials included in each meta-analysis. The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect, adverse events, and additional confounding factors (methodological quality, control intervention, sample size, publication year, and place of publication).

Main Outcome Measure: Conclusions in trials, classified into whether the experimental drug was recommended as the treatment of choice or not.

Results: The experimental drug was recommended as treatment of choice in 16% of trials funded by nonprofit organizations, 30% of trials not reporting funding, 35% of trials funded by both nonprofit and for-profit organizations, and 51% of trials funded by for-profit organizations (P<.001; X² test). Logistic regression analyses indicated that funding, treatment effect, and double blinding were the only significant predictors of conclusions. Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice (odds ratio, 5.3; 95% confidence interval, 2.0-14.4) compared with trials funded by nonprofit organizations. This association did not appear to reflect treatment effect or adverse events.

Conclusions: Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results. Readers should carefully evaluate whether conclusions in randomized trials are supported by data.