From progress to regression: biomedical research funding

Despite great advances in health-related research and health care, major challenges remain regarding the causes and cures of many diseases; these may be overcome with further research. Our society is enthusiastic about fostering such investigations. However, available federal funds limit many such projects. Previously there have been sizable increases in the NIH budget, but because of the escalating cost of scientific investigation and the pressures of financing other much-needed governmental programs, recent growth in biomedical research funding has barely kept up with inflation. This article focuses on select attempts to sustain the record of scientific achievement enabled in the past by continued increasing investment and also suggests some solutions.     

Searching the biomedical literature: research study designs and critical appraisal.

Two essential issues to consider when assessing the validity of research studies are the strengths and weaknesses of the study design and quality of methodology. This paper reviews study designs commonly used in clinical research, including case reports, cross-sectional studies, case-control studies, cohort studies, randomized controlled trials, reviews, and meta-analyses. It concludes with an outline for assessing study quality.     

'Add women & stir'--the biomedical approach to cardiac research!

In conditions shared by women and men, the biomedical model of disease assumes that illness-symptoms and outcomes are biologically and socially 'neutral'. Consequently, up until a decade ago, white middle-aged men were the model subjects in most funded cardiac trials, with the assumption that whatever the findings, the results would also hold true for women. This 'add women and stir' approach has resulted in imbalances in cardiac care and an image of coronary artery disease, which portrays a middle-aged male as its victim. Moreover, cardiac health care has been designed with the male anatomy and male experience of illness in mind, and health promotional measures have been targeted towards men. Women have received these health promotional messages to protect the hearts of men, and have been less likely to modify their own lifestyles in a cardio-protective manner. However, the biological and social differences that exist between women and men, must surely invalidate such biased biomedical assertions, and signify a need to delve beyond the realm of biomedical reductionism for greater insights and understanding. This review examines how scientific reductionism has failed to explore the impact of coronary artery disease on the lives of women and how the gendered image of this disease has privileged the normative frame.     

Behavioral research and the double-blind placebo-controlled methodology: challenges in applying the biomedical standard to behavioral headache research

The randomized, double-blind, placebo-controlled experimental design has prevailed as the "gold standard" in biomedical research, intended to control potential bias in patient/group assignment, investigator allegiance, patient expectations, and nonspecific therapeutic effects. Properly executed, such designs ensure a study's internal validity and allow differential group outcomes to be attributed to the active treatment. These controlled trials generally yield more conservative outcomes than open trials and case reports and establish efficacy in pharmaceutical research. In meta-analytic reviews, studies are often assigned quality scores based in part on the degree to which they meet this scientific standard. Applying the biomedical research design standards for blinding and placebo control to clinical trials evaluating behavioral and other nonpharmacologic headache treatment nearly always is either infeasible or simply not possible. Only rarely is blinding meaningfully achievable in administration of behavioral or psychological therapies. Various "psychological placebo" control conditions have been forwarded in behavioral studies (eg, sham treatments, pseudomeditation), but these controls are incapable of emulating an inert control condition comparable to that of the pill placebo in pharmacologic research, and they are best reserved for studies examining the mechanisms whereby an intervention produces improvement. This article reviews the conceptual and procedural challenges in applying the standard pharmaceutical clinical trials research design to behavioral headache research as well as implications for meta-analyses across studies of various treatment modalities.