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Healthy Skepticism Library item: 12281

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: Journal Article

Main ML, Goldman JH, Grayburn PA.
Thinking outside the 'box' - the ultrasound controversy
J Am Coll Cardiol 2007 Dec 18; 50:(25):2434-7


On October 10, 2007, the U.S. Food and Drug Administration (FDA) announced a new “black box” warning for the perflutren-containing ultrasound contrast agents, contraindicating their use in patients with acute coronary syndromes, acute myocardial infarction, and worsening or clinically unstable heart failure. These warnings ignore the proven efficacy of ultrasound contrast agents, the previously established safety of these compounds, the potential risks of alternative procedures, and the likely confounding effect of pseudocomplication. We suggest that the FDA Medical Imaging Division convene a panel of cardiologists experienced in a variety of imaging modalities to fully assess the adverse events that have been attributed to these agents and that any future FDA warnings acknowledge the possible influence of pseudocomplication, the proven efficacy of the modality in question for early and accurate diagnosis of cardiovascular disease, and the known and theoretical risks of alternative testing that may be necessary.

Acute Coronary Syndrome/mortality Acute Coronary Syndrome/ultrasonography* Adult Aged Cause of Death Contrast Media/administration & dosage Contrast Media/contraindications* Contrast Media/toxicity Drug Labeling* Echocardiography*/mortality Female Fluorocarbons/administration & dosage Fluorocarbons/contraindications* Fluorocarbons/diagnostic use Fluorocarbons/toxicity Heart Failure/mortality Heart Failure/ultrasonography* Humans Male Microbubbles Myocardial Infarction/mortality Myocardial Infarction/ultrasonography* Risk Factors United States United States Food and Drug Administration* Ventricular Dysfunction, Left/mortality Ventricular Dysfunction, Left/ultrasonography


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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909