CURE Trial Shows Benefit in Patients With Acute Coronary Syndrome
Patients who received the anti-clotting drug clopidogrel along with aspirin when exhibiting the symptoms of acute coronary syndromes without ST-segment elevation were less likely to die, have a nonfatal heart attack, or stroke. However, use of the drug was associated with a higher risk of bleeding, said the Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) trial Investigators in a report that appeared in the August 16, 2001 issue of the New England Journal of Medicine (2001;345:494-502).
The investigators randomly assigned 12 562 patients who arrived at the hospital within 24 hours of symptom onset to receive clopidogrel immediately or placebo in addition to aspirin for 3 to 12 months. The treatment group received 300 mg of clopidogrel immediately, followed by 75 mg once daily.
In the treatment group, 9.3% of patients died, experienced a nonfatal heart attack, or a stroke compared with 11.4 % in the placebo group. The relative risk with clopidogrel compared with placebo was 0.80. Patients in the clopidogrel group were significantly less likely to suffer from severe or refractory ischemia or heart failure or to need revascularization procedures.
However, the investigators warned that 3.7% patients in the clopidogrel group suffered major bleeding compared with 2.7% in the placebo group. However, the number of life-threatening bleeding episodes in the 2 groups did not differ significantly.
The authors concluded that treatment with clopidogrel and aspirin had benefits for patients with acute coronary syndromes without ST-segment elevation.
Research Leaders Sound Alarm About Status of Clinical Research in Academic Health Centers
A survey of department chairs and senior research administrators in United States medical schools revealed that many felt that clinical research programs were less healthy, of poorer quality, and facing greater challenges than basic research at their institutions, wrote 4 researchers from the Institute for Health Policy, Department of Medicine and Department of Health Care Policy at Massachusetts General Hospital and Harvard Medical School, and the Association of American Medical Colleges, Washington, DC, in the August 15, 2001, issue of the Journal of the American Medical Association (2001;286:800–806).
In discussing their rationale for the survey, Eric G. Campbell, PhD, Joel S. Weissman, PhD, Ernest Moy, MD, MPH, and David Blumenthal, MD, MPP, noted that the current healthcare environment is usually blamed for reductions in clinical research. Insurers have been less willing to pay for the higher costs of patient care in academic health centers and may limit their patients’ ability to participate in research by sending them to lower-cost providers or refusing to pay the additional costs associated with clinical research. Young faculty may be encouraged to spend more time seeing patients to cover their salaries and generate revenue for the institution than in participating in clinical research projects. “As a result, insufficient numbers of trained clinical researchers are currently available to meet the need,” the authors wrote. In addition, academic health centers are being challenged by nonacademic contract research organizations for the opportunity to do the clinical research.
In their survey, the researchers sent one questionnaire to senior research administrators and one to department chairs. Of 712 subjects who received the questionnaires, 478 completed them. More than half (52%) of all those who responded rated the health and robustness of their clinical research as excellent, whereas 63% rated their basic science research as excellent.
The authors noted that those who answered the questionnaire felt an “overall sense of urgency with respect to the challenges facing clinical research,” with some feeling that a crisis has been reached and other saying that delays in facing the challenges of such research would be costly to the overall clinical enterprise.
However, the authors noted that some subjective notions could affect the answers on the questionnaires. “Our respondents, especially senior research administrators, believe that considerable amounts of clinical research do not meet their standards. One potential explanation of this finding is that less than two-thirds of senior research administrators had conducted clinical research and thus may be less likely to consider such research as high quality. It may also be that the expectations of respondents regarding clinical research are unrealistically high given that clinical research as a discipline is younger than many of the basic science disciplines.”
Inspector General Report Calls Medicare Complaint System (Peer Review Organizations) Ineffective
The system of complaint review designed to safeguard millions of Medicare beneficiaries is seriously flawed and rarely results in any action taken against hospitals or physicians, according to an August 13, 2001 report issued by the Inspector General of the US Department of Health and Human Services. The specific target of the criticism is the system of Medicare Peer Review Organizations (PROs) that has reviewed quality of care complaints from elderly or disabled beneficiaries since 1987. The report, “The Medicare Beneficiary Complaint Process: A Rusty Safety Valve,” follows up on a 1995 investigation that found similar flaws in the process.
The current report finds that little has improved in the intervening 6 years. Between August 1997 and July 1999, PROs in the various states found that there were quality problems involved in 13% of complaints. However, PROs called for corrective action in only 6 of the 66 complaints in which the organizations had identified quality concerns.
In addition, the Inspector General found that reaching PROs would be difficult for beneficiaries because telephones were often busy and were answered only by recordings at some. The report agreed with the PROs themselves, who said that beneficiaries do not understand the complaint process.
The Inspector General charged that the complaint process involving the PROs is treated as a minor activity by the Centers for Medicare and Medicaid Services (formerly the Health Care Financing Administration). The report noted that PROs “tend to be more oriented toward the medical community than to the beneficiary community.” The report is available online at http://www.hhs.gov/oig/oei/reports/a535.pdf.