New Test for Pneumonia Antigen
The U.S. Food and Drug Administration has approved a first-of-a-kind urine test for Streptococcus pneumoniae, a leading cause of pneumonia. The test should be used in conjunction with review of a patient's symptoms to rule out other causes of pneumonia. Test results are available within 15 minutes.
A swab is dipped into a urine specimen, removed and inserted into the test device. A positive result indicates that the patient most likely has pneumococcal pneumonia. A culture should be performed to confirm the test results.
In clinical trials, the test was found to be 93 percent accurate in detecting S. pneumoniae when it was performed on urine samples from 373 patients known to have pneumococcal pneumonia.
Temozolomide for Brain Cancer
Temozolomide (Temodar) has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with refractory anaplastic astrocytoma (a form of brain cancer) who have relapsed following chemotherapy that includes a nitrosourea drug and procarbazine. It is the first new chemotherapy agent for this type of brain tumor to be approved in the United States in 20 years. Accelerated approval is a regulatory mechanism that allows early approval for a product intended to treat serious or life-threatening conditions for which no acceptable alternative treatments exist or that provides a meaningful therapeutic benefit over existing treatments.
In a single-arm, multi-center study, 162 patients who had anaplastic astrocytoma received temozolomide at first relapse. Fifty-four patients had disease progression on prior therapy with a nitrosourea and procarbazine and their malignancy was considered refractory to chemotherapy. The overall tumor response rate in these 54 patients was 22 percent, and the complete response rate was 9 percent.
The FDA reports that the most common side effects were nausea, vomiting, headache, fatigue, low blood counts and constipation. Severe vomiting may require antiemetic therapy before or during treatment.
Drug for Radiation-Induced Nausea and Vomiting
Granisetron (Kytril), a 5-HT3 receptor antagonist, has been approved by the U.S. Food and Drug Administration for the prevention of nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. Granisetron is currently approved for the prevention of nausea and vomiting associated with emetogenic cancer therapies, including high-dose cisplatin.
In clinical trials of patients undergoing total body irradiation for bone marrow transplantation, 22 percent of those who received granisetron did not experience vomiting or receive rescue antiemetics, compared with zero percent in a historical negative control group. In addition, patients who received granisetron also had fewer emetic episodes during the first day of radiation and over the four-day treatment period, compared with patients in the control group. Adverse events included headache, diarrhea and asthenia.
In another trial of patients receiving fractionated upper abdominal radiation for cancer, granisetron provided significantly greater protection from nausea and vomiting than placebo. Adverse events in this trial included diarrhea, asthenia and constipation.
The rotavirus vaccine (RotaShield) was voluntarily pulled off the market by the manufacturer in October after at least 99 cases of intussusception linked to the vaccine were reported. Any physicians who still have doses of the vaccine have been asked to return them to the manufacturer immediately.
The vaccine was approved in 1998 to protect children against rotavirus, the leading cause of childhood diarrhea. In July, the U.S. Food and Drug Administration advised physicians to temporarily stop vaccinating infants against rotavirus after 20 infants developed intussusception soon after receiving the vaccine. An estimated 1 million infants in the United States had received the rotavirus vaccine. Available data do not indicate an ongoing risk to children given the vaccine in the past. Intussusception thought to be associated with the vaccine occurred within the first two weeks after vaccination.
Physicians and patients may call 877-768-2543 with any questions about the rotavirus vaccine.
National Rural Health Association Paper Addresses Uninsured in Rural and Frontier Areas
Rural America has a 20 percent higher rate of uninsured persons than urban areas, according to a new issue paper from the National Rural Health Association (NRHA) that discusses the impact of no insurance on rural and frontier residents. The paper also looks at the impact of managed care, Medicare and Medicaid and discusses specific policy issues relating to the rural uninsured. Four recommendations are made by the NRHA to improve access to health insurance for this population.
The complete text of this and other NRHA policy issue papers is available in the advocacy section of the NRHA Web site at http://www.NRHArural.org. Copies may also be obtained by contacting the Communications Department in the NRHA office at 816-756-3140.
Results of National Drug Abuse Survey
Findings of the 1998 National Household Survey on Drug Abuse (NHSDA), released by Secretary Donna E. Shalala of the U.S. Department of Health and Human Services (HHS), show that illicit drug use declined among young people 12 to 17 years of age from 1997 to 1998, while illicit drug use among the overall population remained flat.
Among children 12 to 17 years of age, an estimated 9.9 percent reported current use of illicit drugs in 1998, which means that they used an illicit drug at least once in the 30 days before the survey interview. The percentage of users was down significantly from the estimate of 11.4 percent in 1997. Inhalant use by teenagers also decreased significantly, from 2.0 percent in 1997 to 1.1 percent in 1998. According to the survey, the rate of teenagers who reported trying marijuana for the first time declined significantly, and the average age of first-time use increased.
“For the past two years we have been cautiously optimistic as a series of encouraging reports seemed to indicate a leveling off and even a possible decline in drug use among teens after years of dramatic increases,” said Secretary Shalala. “While it looks like we have turned the corner with today's report, we must not rest. Too many young people are still using drugs, and we must continue to build on our promising efforts to push the rate of drug use down even further.”
In the fall of 2000, the Substance Abuse and Mental Health Services Administration (SAMHSA) of the HHS will expand the NHSDA to provide information on substance abuse at the state level. A summary of the 1998 NHSDA survey is available on the SAMHSA Web site at http://www.samhsa.gov.
HTAC Report on Automatic External Defibrillators
The Health Technology Advisory Committee (HTAC) has published a report on automatic external defibrillators (AEDs). HTAC was established in 1992 by the Minnesota State Legislature. It is an independent, non-partisan advisory body that evaluates new and emerging health care technologies based on existing scientific research and technology assessments.
In the United States, sudden cardiac arrest strikes 350,000 persons per year, making it the most common event leading to death. Most events of sudden cardiac arrest are caused by arrhythmias, the most common of which is ventricular fibrillation. Fortunately, the use of AEDs can potentially improve the survival rate of persons with ventricular fibrillation. AEDs automatically perform an analysis of the heart, determine if defibrillation is required and deliver electrical shocks to the heart. There is a growing trend toward the placement of AEDs in public and private settings. The HTAC report is intended to assist persons who are considering buying and installing AEDs or making them a part of their first response team.
The report lists the five main parts of a successful AED program. They include an evaluation to determine appropriate placement of the device, a plan for implementing personnel training and retraining, medical oversight, data collection protocols and follow-up of outcomes. It also emphasizes the importance of having cardiopulmonary resuscitation and AEDs associated with an effective first response dispatch system and recommends that widespread public use of AEDs should not proceed until data are collected on the effectiveness of these devices in medical settings.
For more information on this report, call HTAC at 651-282-6374 or write to: HTAC, 121 E. Seventh Pl., Ste. 400, St. Paul, MN 55101. All HTAC reports are also available on the Internet at http://www.health.state.mn.us/htac/index.htm.
Synercid for Vancomycin-Resistant Infections
The U.S. Food and Drug Administration (FDA) recently approved a combination of quinupristin and dalfopristin (Synercid), the first antibacterial drug to treat infections associated with vancomycin-resistant Enterococccus faecium (VREF) bacteremia when no alternative treatment is available.
According to the FDA, infections related to E. faecium occur in persons who are hospitalized or immunocompromised. E. faecium is resistant to multiple antibiotics. For many years, vancomycin (Vancocin) has been the last resort for treatment of this infection. In 1989, the first case of VREF was reported in the United States; since that time, the incidence of VREF has rapidly increased.
Synercid is the first drug in the streptogramin class of antibiotics to be approved for use in humans in the United States. Because Synercid was able to remove VREF infection from the bloodstream, it was given accelerated approval, a regulatory mechanism that allows early approval for products intended to treat serious or life-threatening conditions when they provide meaningful therapeutic benefit over existing treatments.
In four noncomparative studies, 1,222 patients were given Synercid to treat VREF infections. Based on study criteria, Synercid was found to be 52 percent effective in the patients who were well enough to be evaluated. The sources of infection in these patients included intra-abdominal sites, skin, soft tissue and the urinary tract. Also, 330 of the enrolled VREF patients had bacteremia of unknown origin. Of these patients, 90 percent experienced clearance of VREF in the first 48 to 72 hours of initial therapy.
The most frequently reported side effects of Synercid included muscle and joint pain, nausea, diarrhea, vomiting and rash. When the drug was administered through a peripheral vein, many patients also experienced local reactions to the injection, including pain and inflammation at the site of the injection.
Booklet About Clinical Trials for Cancer Prevention
The National Cancer Institute (NCI) has published a booklet titled “Taking Part in Clinical Trials: Cancer Prevention Studies” for people who may be interested in participating in a cancer prevention trial. The booklet explains clinical trials, discusses issues that are relevant to participants in cancer prevention clinical trials and identifies potential benefits and drawbacks to participation.
The booklet is divided into a question and answer format. Some of the questions include: What is cancer? What are cancer risk factors? What is a cancer prevention clinical trial? How do researchers design cancer prevention clinical trials? How do review groups protect participants? What happens in a phase 2 cancer prevention clinical trial? Should I take part in a cancer prevention clinical trial? The booklet also lists NCI information resources.
Free copies of the booklet (NIH Publication No. 98-4250) may be obtained by calling the NCI's Cancer Information Service at 800-4-CANCER or on the NCI Web site (http://www.nci.nih.gov/).