Automatic External Defibrillators: Not Just for Adults Anymore
On May 4, 2001, the US Food and Drug Administration (FDA) approved the first automatic external defibrillator (AED) for use on infants and young children whose hearts stop. AEDs previously on the market were for use in adults and children older than 8 years of age.
The device, which is manufactured by Agilent Technologies, Inc, of Palo Alto, California, is designed for use on infants and children up to the age of 8 years or those who weigh ≤55 pounds. The new device has specially designed pediatric defibrillation pads that deliver an electrical shock of 50 J of energy; this is 100 fewer J than that delivered by AEDs designed for older children and adults.
In a discussion paper, the FDA said the device for infants and young children was approved on the basis of laboratory and animal testing by the manufacturer and on reports in the literature that showed AEDs can be used successfully on both adults and children. A follow-up study of 50 children worldwide will be conducted by Agilent to determine how well the device performs in actual practice.
AEDs are designed to administer an electric shock to restore normal heart rhythm when the organ begins to beat irregularly and ineffectively. An AED senses the heart rhythm and advises the person operating it whether a shock is needed. No shock can be delivered unless the AED determines that it is necessary. The machines have become an integral part of the protocol for resuscitating people who experience ventricular fibrillation or sudden death.
Drug Shortages Threaten Patients
Nationwide shortages of commonly used drugs and vaccines in recent years have forced doctors to ration limited supplies for the neediest patients, according to a May 6, 2001, story in the Los Angeles Times.
In the past, pharmaceutical firms have blamed the shortfalls on temporary manufacturing or distribution problems. However, the Times blames the shortages on another problem as well: the changing economics of the pharmaceutical industry.
In a story on its Web page (http://www.ashp.org/shortage/), the American Society of Health-System Pharmacists attributed the shortages to the adoption of just-in-time inventory systems by pharmacies, wholesalers, and manufacturers of drugs. They also said fewer companies are making products and that corporations sometimes decide not to make a drug or the ingredients that are key to its manufacture. Violations of current good manufacturing practices can also shut down an operation either temporarily or permanently, causing a shortage of the drug.
In a 1997 talk paper on the issue, the FDA said it attempts to alleviate such shortages in many ways. The FDA intervenes in the marketplace only when the drug meets a true medical necessity and the shortage threatens people’s lives and ability to live productively. The agency has a choice: it either finds ways to make the drug available quickly or identifies viable alternatives.
In some instances, when the FDA must shut down manufacturing at a particular plant because of poor manufacturing standards, it may elect to exempt the needed drug from the ban.
When a company decides to stop making a drug because it does not receive a profit for doing so, the FDA and the National Organization for Rare Disorders may seek to have other companies make the drug. If there is a delay in production, other companies may make the drug on a short-term basis at the behest of the FDA. In other instances, a manufacturer may set up an allocation plan for the drugs in short supply, sending supplies only to patients in the most desperate need. The FDA maintains a drug shortage page at http://www.fda.gov/cder/drug/shortages.
Atrial Fibrillation Will Increase 2.5 Times Over Next 50 years With Aging Population
Experts estimate that 0.95% of the US population suffers from atrial fibrillation, with the frequency varying from 0.1% in adults younger than 55 years to 9% in those aged ≥80 years. In a study led by Alan Go, MD, of the division of research of Kaiser Permanente of Northern California, experts estimated that as many as 2.3 million US adults currently have atrial fibrillation (JAMA. 2001;285:2370–2375).
Dr Go and his colleagues predicted that the prevalence of the disease will increase to as many as 6.3 million people by the year 2050 and that more than half of those affected will be ≥80 years of age. They made their estimates on the basis of a cross-sectional study of adults ≥20 years who were enrolled in a large California health maintenance organization. Men were more likely to suffer from atrial fibrillation than women; whites were more likely to have it than blacks.
The authors concluded that the healthcare system needs to prepare for the growth in the number of cases of the disease, which is associated with a host of symptoms and ischemic stroke. “Coordinated efforts by cardiologists, primary care providers, and neurologists will be needed to meet the increasing challenge of stroke prevention and rhythm management in the growing elderly population with atrial fibrillation,” they wrote.
Blacks Less Likely to Receive Heart Catheterization, Regardless of Doctor’s Race
Yale University School of Medicine physicians found that black patients who had experienced a heart attack were less likely to undergo heart catheterization than their white counterparts, a circumstance that remained the same whether the treating physician was white or black (N Engl J Med. 2001;344:1443–1449). These data indicate that well-recognized disparities in the treatment of blacks and whites could be a systemic medical problem rather than an issue of white doctors being less willing to treat black patients aggressively, the authors said.
The analysis, which appears in the May 10, 2001, issue of the New England Journal of Medicine indicates that disparities in treatment cannot be pared down to a simple issue of discrimination by the white majority against the black minority. Harlan Krumbholz, MD, associate professor of cardiology and senior author of the article, told the New York Times in its May 10, 2001, edition, “We do find disturbing differences in patterns of care, but whatever accounts for this is likely to be pervasive throughout the system.”
The authors studied patients aged ≥65 years who had experienced a heart attack in 1994 and 1995. There were 35 676 white and 4039 black patients treated by 17 550 white and 588 black physicians. In the study, the authors found that 38.4% of black patients who had white doctors underwent catheterization and 38.2% of black patients who had black doctors underwent the procedure. Of white patients who had white doctors, 45.7% underwent catheterization, whereas 49.6% of white patients who had black doctors underwent the procedure.
In an accompanying editorial, Arnold M. Epstein, MD, and John Z. Ayanian, MD, MPP, both of Harvard School of Public Health in Boston, said that “overt racial prejudice did not account for racial differences in the rates of cardiac catheterization” (N Engl J Med. 2001;344:1471). They noted, however, that “both white and black physicians may have subtle biases that are based on other social factors that influence their judgments about patients’ suitability for procedures.” Doctors may feel that it is too difficult to explain the procedures to patients of lower socioeconomic status, or physicians may have negative perceptions of less affluent patients, a group in which black patients are disproportionately represented.
The disparities found in this study suggest, “that the healthcare system is less responsive to black patients than to white patients and that systemic change will therefore be required.” Although eliminating the racial disparities in treatment will be complicated and difficult, “we should get on with it,” the doctors wrote.
- Copyright © 2001 by American Heart Association