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Sarah Sorscher, Azza AbuDagga, Sammy Almashat, Michael A Carome, Sidney M Wolfe Health Research Group, Public Citizen, Washington, DC, USA Purpose: The Food and Drug Administration (FDA) permits investigators to withhold active interventions from human subjects randomly assigned to control groups in clinical trials. The scope of this practice in trials for life-threatening diseases is unknown. We assessed the frequency and characteristics of trials providing control group subjects with active interventions versus those providing only placebos to control group subjects in trials supporting FDA approvals of new drugs for nine life-threatening diseases. Materials and methods: We reviewed the FDA’s database of approved drug products and identified all new approvals from 2006 to 2011 for drugs or biological products indicated for asthma, bipolar disorder, chronic obstructive pulmonary disease (COPD), diabetes mellitus, hypertension, osteoporosis, Parkinson’s disease, partial seizures, and schizophrenia. Then, we identified all trials described in FDA medical review documents for these approvals and abstracted information on trial characteristics and the interventions provided to control group subjects. Results: Of 508 included trials, 201 (39.6%) were placebo-only-controlled, meaning subjects in at least one control group did not receive an active intervention, and 307 (60.4%) were active-controlled, meaning subjects in all control groups received an active intervention. The total recorded enrollments in control groups provided with placebos only and in control groups provided with active interventions were 19,361 and 93,093 subjects, respectively. The proportion of placebo-only-controlled trials varied across diseases (P

Context: Hemoglobin-based blood substitutes (HBBSs) are infusible oxygen-carrying liquids that have long shelf lives, have no need for refrigeration or cross-matching, and are ideal for treating hemorrhagic shock in remote settings. Some trials of HBBSs during the last decade have reported increased risks without clinical benefit.Objective: To assess the safety of HBBSs in surgical, stroke, and trauma patients.Data Sources: PubMed, EMBASE, and Cochrane Library searches for articles using hemoglobin and blood substitutes from 1980 through March 25, 2008; reviews of Food and Drug Administration (FDA) advisory committee meeting materials; and Internet searches for company press releases.Study Selection: Randomized controlled trials including patients aged 19 years and older receiving HBBSs therapeutically. The database searches yielded 70 trials of which 13 met these criteria; in addition, data from 2 other trials were reported in 2 press releases, and additional data were included in 1 relevant FDA review.Data Extraction: Data on death and myocardial infarction (MI) as outcome variables.Results: Sixteen trials involving 5 different products and 3711 patients in varied patient populations were identified. A test for heterogeneity of the results of these trials was not significant for either mortality or MI (for both, I2 = 0%, P > or = .60), and data were combined using a fixed-effects model. Overall, there was a statistically significant increase in the risk of death (164 deaths in the HBBS-treated groups and 123 deaths in the control groups; relative risk [RR], 1.30; 95% confidence interval [CI], 1.05-1.61) and risk of MI (59 MIs in the HBBS-treated groups and 16 MIs in the control groups; RR, 2.71; 95% CI, 1.67-4.40) with these HBBSs. Subgroup analysis of these trials indicated the increased risk was not restricted to a particular HBBS or clinical indication.Conclusion: Based on the available data, use of HBBSs is associated with a significantly increased risk of death and MI. [ABSTRACT FROM AUTHOR]

Many U.S. military veterans lack health insurance and are ineligible for care in Veterans Administration health care facilities. Using two recently released national government surveys--the 2004 Current Population Survey and the 2002 National Health Interview Survey--the authors examined how many veterans are uninsured (lacking health insurance coverage and not receiving care from the VA) and whether uninsured veterans have problems in access to care. In 2003, 1.69 million military veterans neither had health insurance nor received ongoing care at Veterans Health Administration (VHA) hospitals or clinics; the number of uninsured veterans increased by 235,159 since 2000. The proportion of nonelderly veterans who were uninsured rose from 9.9 percent in 2000 to 11.9 percent in 2003. An additional 3.90 million members of veterans' households were also uninsured and ineligible for VHA care. Medicare covered virtually all Korean War and World War II veterans, but 681,808 Vietnam-era veterans were uninsured (8.7 percent of the 7.85 million Vietnam-era vets). Among the 8.27 million veterans who served during 'other eras' (including the Persian Gulf War), 12.1 percent (999,548) lacked health coverage. A disturbingly high number of veterans reported problems in obtaining needed medical care. By almost any measure, uninsured veterans had as much trouble getting medical care as other uninsured persons. Thus millions of U.S. veterans and their family members are uninsured and face grave difficulties in gaining access to even the most basic medical care. [ABSTRACT FROM AUTHOR]

THE NUMBER OF nurse-midwife-attended births in U.S. hospitals has jumped tenfold in the last 20 years, rising from just 19,686 in 1975 to 196,977 in 1994. Certified nurse-midwives (CNMs) focus on childbirth as a normal event, emphasizing the educational and psychosocial aspects of care and the judicious use of technological interventions. CNM care appears particularly well suited to help solve two difficult problems in U.S. obstetric care-our country's slow progress in improving the health status of newborns and the excessive use of medical interventions during childbirth. Despite the fact that CNM care has been found to be safe and cost-effective, only a small fraction of those pregnant women who could benefit from CNM care use midwifery services. Lack of consumer awareness is part of the problem, but barriers also exist to accessing CNM services. Sixty-four percent of CNM practices responding to a survey reported practice restrictions, most commonly due to state laws, hospital policies, and inappropriately restrictive physician back-up. One state, Florida, is aggressively promoting the use of CNM care as the standard of practice for healthy pregnant women. [ABSTRACT FROM AUTHOR]