Arch Intern Med
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The current Food and Drug Administration (FDA) system of regulating drug safety has serious limitations and is in need of changes. The major problems include the following: the design of initial preapproval studies lets uncommon, serious adverse events go undetected; massive underreporting of adverse events to the FDA postmarketing surveillance system reduces the ability to quantify risk accurately; manufacturers do not fulfill the majority of their postmarketing safety study commitments; the FDA lacks authority to pursue sponsors who violate regulations and ignore postmarketing safety study commitments; the public increasingly perceives the FDA as having become too close to the regulated pharmaceutical industry; the FDA's safety oversight structure is suboptimal; and the FDA's expertise and resources in drug safety and public health are limited. To address these problems, we urge Congress, which is ultimately responsible for the FDA's performance, to implement the following 5 recommendations: (1) give the FDA more direct legal authority to pursue violations, (2) authorize the adoption of a conditional drug approval policy, at least for selected drugs, (3) provide additional financial resources to support the safety operations, (4) mandate a reorganization of the agency with emphasis on strengthening the evaluation and proactive monitoring of drug safety, and (5) require broader representation of safety experts on the FDA's advisory committees.
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Multicenter Study
Time course of depression and outcome of myocardial infarction.
Depression predicts worse outcomes after myocardial infarction (MI), but whether its time course in the month following MI has prognostic importance is unknown. Our objective was to evaluate the prognostic importance of transient, new, or persistent depression on outcomes at 6 months after MI. ⋯ Depressive symptoms after MI, irrespective of whether they persist, subside, or newly develop in the first month after hospitalization, are associated with worse outcomes after MI.
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Chronic critical illness is a devastating syndrome of prolonged respiratory failure and other derangements. To our knowledge, no previous research has addressed brain dysfunction in the chronically critically ill, although this topic is important for medical decision making. ⋯ Severe, prolonged, and permanent brain dysfunction is a prominent feature of chronic critical illness. These data, together with previous reports of symptom distress and rates of mortality and institutionalization, describe burdens for chronically critically ill patients receiving continued life-prolonging treatment and for their families.
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Randomized Controlled Trial
Long-term survival in elderly patients hospitalized for heart failure: 14-year follow-up from a prospective randomized trial.
The growing heart failure epidemic imposes a substantial burden on the US health care system. The ability to accurately assess prognosis would allow clinicians to triage patients to appropriate therapy and to plan the intensity of care following hospital discharge. ⋯ Among elderly patients hospitalized with heart failure, median survival is about 2.5 years. However, there is considerable heterogeneity in survival, with 25% of patients dying within 1 year and 25% surviving for more than 5 years. A simple 7-item risk score, based on data readily available at the time of admission, provides a reliable estimate of prognosis.