Tobacco Documents Online

Wa11 St. Jnl Washington, DC MAY 111994 • . FDA Halts Test on Device That Shows Promise for Victims of Cardiac Arrest By Rov WtYs[.ow Staff RCPorLCr of TIIF: WAI.I. STRF.k:T JUURNAL Researchers said a device patterned after a household plunger appears to offer the first chance in 30 years to improve on generally poor results in reviving victims of cardiac arrest. But the Food And Drug Administration halted an experiment in which the device was being tested because patients, who were unconscious, couldn't consent to its use. The agency said the company that makes the device also failed to obtain approval to use it in a trial. Results of the partially completed study, along with an editorial on the FDA's action appear in today's Journal of the American Medical Association. The epi- sode underscores the complexity of is- sues involved in the regulation of medical experiments performed on humans and it is certain to provoke more controversy for the FDA, which is already under fire for its procedures in evaluating new medical products. More than 400,000 Americans collapse from sudden cardiac arrest outside of a hospital each year, and the standard initial emergency treatment is cardiopulmonary resuscitation. But success in reviving such victims ranges from 1% to about 20% in a handful of cities with effective emergency medical systems, said Joseph P. Ornato, a cardiologist at the Medical College of Vir- ginia. The new pumping device, manufac- tured by Ambu International Inc., Copen- hangen, enables an emergency worker or other user to both compress and decom- press the chest during CPR, said Keith G. Lurie, a cardiologist at University of Min- nesota and lead author of the study. That appears to increase the flow of oxy- gen and blood through the body better than does traditional CPR, he said. Dr. Lurie helped develop the pump after he was on call the day a patient was admitted to San Francisco General Hospi- tal after having been revived for the third ' time by family members who used a household toilet plunger on his chest. After initial studies on animals and on small numbers of people, Dr. Lurie, who has since moved to Minneapolis, and his colleagues began a clinical trial at the St. Paul-Ramsay Medical Center, St. Paul, with the help of 400 city emergency workers who were trained to use the pump. In a random trial that lasted 10 months before the FDA ordered it halted, 77 pa- tients who collapsed of cardiac arrest outside the hospital were treated with standard CPR while 53 were treated with the pump. Researchers said 26%o who re- ceived standard care were revived enough to be admitted to an intensive-care unit. compared with 40% treated with the pump. But the number of patients involved was too small for the results to be considered statistically significant. When the researchers looked at pa- tients who were. treated in less than 10 minutes of their collapse - a crucial factor in survival no matter what treatment is administered, 38% treated with the pump survived to be discharged from the hospi- tal, compared with 20% with standard CPR. Those results weren't statistically significant either. Dr. Lurie said that in any event, the results reflected a strong , emergency medical system with trained workers who can arrive quickly at the side of a victim. Researchers were hoping to enroll 260 patients in the study, but the FDA says it stopped the experiment because Ambu hadn't obtained the approval required to use an experimental device in a research project. Mary Pendergast, a senior adviser to David Kessler, the commissioner of the FDA, also said the company submitted plans for a "poorly designed" trial, and one in which the issue of obtaining in- formed consent from participants wasn't adequately adaressed. Ms. Pendergast suggested a better ap- proach for the company would be to test the device first on patients in a hospital who might be at risk for cardiac arrest and could give consent in advance. In an editorial accompanying the study, Carin M. Olson, a contributing editor of the Journal, noted that obtaining consent from patients in cardiac arrest "is problematic." Dr. Olson said regulations that prohibit "necessary research" and force a halt to experiments and a loss of potentially important findings "must be rewritten." Dr. Lurie said the device is on the market in most countries, including Can- ada, Britain and France, where regulators approved it after a six-week•evaluation. In Austria, ambulances are required to carry it, he said.