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?fJ • M-D-D-I REPORTS -"T'he Gray Sheet" May 23, 1994 Noting Birtcher's efforts to make the company more lean, Cleveland said, "Our job now is to assure that the size of our operating structure matches our sales potential and to put the financing in place to regain the confidence of our suppliers and maintain the loyalty of our customers.... When we have achieved that potential, I have every confidence that Birtcher Medical and its product iines will be attractive acquisition candidates that will return value to its shareholders." AMBU CARDIOPUMP "APPEARS MORE EFFECTIVE" FOR CERTAIN CPR PATIENTS, Keith Lurie, MD, University of Minnesota, Minneapolis, et al. conclude in a study published in the May 11 Journal of the American Medical Association. According to Lurie er al., active compression-decompression cardiopulmonary resuscitation (ACD CPR) using the Cardiopump "appears to be more effective than standard CPR in a well-defined subset of victims of out-of-hospital cardiac arrests during the critical initial phases of resuscitation." ACD CPR was found to be "significantly more effective" than standard CPR in patients with down- times - the duration of time between collapse and the initiation of CPR - of less than four minutes. More than 80% of the patients had a return of spontaneous circulation (ROSC) after ACD CPR com- pared with 33% after standard CPR (p<.01), and 73% of the patients were admitted to intensive care units (ICU) after ACD CPR compared with 33% after standard CPR (p<.05), the study says. • The prospective, randomized parallel-group study involved 130 out-of-hospital arrests over a 10-month period in St. Paul, Minnesota. Patients were all normothermic victims of nontraumatic cardiac arrest older than eight years who received CPR. Seventy-seven of the patients received standard CPR and 53 received ACD CPR. The main outcome measures for the study were: ROSC, admission to ICU, return of baseline neurological function (alert and oriented to person, place and time), survival to hospital discharge, survival to hospital discharge with return of baseline neurological function, and complications. For the total patient group, a higher percentage of patients who received ACD CPR had an ROSC and were admitted to the ICU compared to standard CPR (45% vs 31%, and 40% vs 26%, respectively), "but these trends were not sta- tistically significant (p<.10 and p<.10)," Lurie et al. report. For other outcome measures, the study reveals "no statistically significant differences" between ACD CPR and standard CPR: hospital discharge rates (23% vs 17%), return to baseline neurological func- tion (19% vs 17%), and return to baseline neurological function at hospital discharge (17% vs 16%). Complication rates in patients admitted to the hospital were similar in both groups, although a "signifi- cant increase in localized hematomas" was noticed for patients receiving ACD CPR The contact point between the Cardiopump and the chest wall was "redesigned to reduce this minor problem," according to the investigators. The authors note that "evaluation of any type of CPR efficacy is dependent on the effectiveness and structure" of the entire emergency medical services system, and that response times and training of EMS personnel and the general population "may contribute to the potential benefits of ACD CPR observed in St. Paul." The likelihood of treatment assignment errors - using standard CPR instead of an additional piece of equipment - also remains "a potential problem" for any study evaluating an alternative method of CPR. Despite these variables, Lurie et al. recommend that "a larger study should be performed to evaluate the potential long-term benefits of ACD CPR." ~ > FDA halted the study in May 1993 after determining the Cardiopump was a significant risk device ~ which lacked an approved investigational device exemption. The device, which is manufactured in ~ ® F-D-C Reports, Inc., 1994. Photocopying without permission is strictly prohibited. See Page One. ~ Multiple copy rate: $315 when mailed in the same envelope with $630 subscription. GO ~

• • Msr 23, 1994 M-D-D-I REPORTS - "The Gray Sheet" - 31 - Glostrup, Denmark by Ambu International, was placed on automatic import detention on Apri129 as a Class III device without appropriate -premarket approval. The agency became aware of the Cardiopump study when Ambu submitted a 510(k) for the device in April 1993. The company planned to resubmit the 510(k) in November of that year after FDA requested study data be expanded from 250 to 500 patients ("The Gray Sheet" Nov. 29, 1993, p. 6). The 510(k) is still pending, according to Ambu. In reviewing the company's studies, FDA has identified several areas of concern. For example, the agency is troubled by the investigators' waiving informed consent of patients at the time of treatment. In addition, the agency also questions whether randomization provisions in the studies were adequate to eliminate bias and whether patients were evaluated consistently. In an editorial accompanying the JAMA study, Carin Olsen, MD, calls the issue of prospective informed consent "problematic" for research in areas such as resuscitation, severe head injury and drug overdose. He adds that FDA's criteria for exception from informed consent "prevents the application to resuscitation research comparing investigational therapy to standard care, whose relative effective- ness is unknown." Furthermore, Olsen notes that various methods clinicians have developed for dealing with informed consent difficulties - including "deferred consent, compassionate use, [and] implied consent" - are not recognized under FDA regulations. Despite the widespread use of these methods for years, the agency "noticed only recently that some mechanisms do not follow the letter of the federal code" and halted those not meeting its regulations, according to Olsen. Currently, he says the agency's Office of Device Evaluation only "is accepting research protocols in which patients consent at hospital admission." Olsen contends that "the problem is that current regulations do tiot relate to resuscitation research in humans." He recommends federal regulatory agencies "develop mechanisms" to protect patients' rights "while permitting and promoting research that is legal as well as ethical." > The Cardiopump study likely will be discussed at a House Small Business/Regulation Subcommittee hearing scheduled for May 23, according to subcommittee staffers. The subcommittee hearing, chaired by Rep. Ron Wyden (D-Ore.), will focus on informed consent in emergency room settings. HHS wit- nesses on the agenda include Gary Ellis, director of the Office for the Protection from Research Risks; FDA Deputy Commissioner Mary Pendergast; Susan Alpert, MD, PhD, acting director of FDA's Office of Device Evaluation; and Robert Temple, director of the Office of Drug Evaluation I. • .... IN BRIEF.. . . GynoPharma's Paragarct. FDA approves labeling change extending use of the intrauterine copper contraceptive from eight to ten years, GynoPharma says, making Paragard `viable for twice as many years as any other avail- able reversible contraceptive.' Other labeling changes include additional data on the risk of pelvic inflammatory disease associated with intrauterine devices.... Plexus International: Receives May 4 warning letter from FDA for promotional claims of the company's Myo- Plex6000 muscle stimulator. Statements that the Myo-Plex provides "[r]elief of pain; removal of edema; muscle relaxation; rehabilitation of injured tissues"; and other claims,'extend beyond the original intended use of a muscle stimulator,'the agency contends. Plexus also is cited for failing to submit the necessary premarket noti- fication for the device. The Houston, Texas-based company is the subject of an investigation by the ABC television show 20/20.... c F-D-C Reports, Inc., 1994. Photocopying without permission is strictly prohibited. See Page One. Multiple copy rate: $315 when mailed in the same envelope with $630 subscription.