Medicine Man

Ghana will receive $1.7 million from UNICEF to increase the distribution of insecticide-treated nets among children younger than age five in the country's campaign against malaria, UNICEF Executive Director Ann Veneman said Wednesday at the Third High Level Forum on Aid Effectiveness in Accra, Ghana, GNA/My Joy Onlinereports.

Veneman expressed concern over statistics indicating that the number of children younger than age five in Ghana who sleep under ITNs is less than the number of ITNs distributed in the country. She added that ITNs prevent approximately 80% of malaria cases in Africa by protecting the user from insect bites and killing mosquitoes. "Thousands of children under the age of five die from malaria each year in Ghana," Veneman said, adding that "it is unacceptable that this preventable disease still claims the lives of so many" (GNA/My Joy Online, 9/3).

During the forum, which took place from Sept. 2 to Sept. 4, government and civil society delegates discussed ways to increase effective use of development aid and create partnerships between donors and recipients (Mannak, Inter Press Service, 9/2). Veneman noted that with "less than eight years left" to achieve the United Nations Millennium Development Goals -- which include reversing the spread of malaria by 2015 -- the "international community must work together to achieve sustainable results on the ground" (UNICEF release, 9/3).

Teenagers, minorities and single women in New Jersey all have a higher risk of poor birth outcomes and also are less likely than others to receive early prenatal care, according to a report released on Wednesday by state Health Commissioner Heather Howard, the Newark Star-Ledger reports.

In February, Howard appointed the Prenatal Care Task Force to recommend ways to improve access to early prenatal care and examine the racial and ethnic disparities in the state.

The task force report, based on data from 1990 to 2004, found that across all racial and ethnic groups, uninsured women had the lowest rate of trimester prenatal care at 73% and that women with private insurance had the highest rate at 96%. The overall average for prenatal care was 89%.

The task force recommended increased preconception health awareness, promotion of equity in birth outcomes and assurance of availability of early prenatal services for women living in areas with hospital closures or reductions in obstetrical services.

Howard will present the findings on Thursday at the University of Medicine and Dentistry of New Jersey's Ninth Annual Perinatal Health Disparities Conference (Stewart, Newark Star-Ledger, 9/3).

The report is available online (.pdf).

Black women who undergo a lumpectomy surgery to treat early-stage breast cancer are less likely than their white counterparts to receive the recommended follow-up radiation therapy treatments, according to study released on Wednesday, Reuters/Boston Globe reports. Standard care after a lumpectomy includes a series of radiation treatments to ensure that all cancerous cells have been treated.

The study, led by Grace Li Smith, a postdoctoral fellow in radiation oncology at the University of Texas M.D. Anderson Cancer Center, looked at 37,305 women ages 65 and older who had undergone lumpectomy surgery to remove cancerous tumors from their breasts. Of the women, 34,024 were white and 2,305 were black. Researchers found that 65% of black women received radiation therapy after the surgery, compared with 74% of white women. The disparities were more prevalent on the West Coast, in the South and the Northeast, while certain regions -- including the West and Midwest -- showed no racial disparities, according to the study (Dunham, Reuters/Boston Globe, 9/3).

The study did not look at the reasons for the findings, but Smith noted that possible reasons black women are not receiving follow-up treatment include doctors not offering them the treatment, black women declining the treatment or being unable to complete the entire treatment series because of other health problems. The study looked at Medicare beneficiaries, of whom all had insurance coverage for lumpectomy and radiation, so access to care was not a significant factor, the Chronicle reports.

David Wetter, chair of M.D. Anderson's Health Disparities Research department, said, "Physicians have a lot of unconscious biases about who's likely to comply with or accept treatment, and some patient populations are more likely to be suspicious of radiation's effectiveness or side effects."

Eric Winer, a Harvard University professor of medicine and director of the Dana-Farber Cancer Institute's Breast Oncology Center, said, "When women have the two-step treatment of lumpectomy and radiation, it's possible for some to fall through the cracks," but "there's absolutely no reason it should be happening more frequently to black women." Wetter added, "It's clear that there's a whole lot going on in clinical encounters that needs to be examined more."

The study will be presented on Friday at the Second Annual American Society of Clinical Oncology Breast Cancer Symposium (Ackerman, Houston Chronicle, 9/3).

The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

The four drugs, known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system, are approved to treat a variety of conditions which may include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease.

FDA today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 to require manufacturers of TNF inhibitors to make safety-related changes to prescribing information, or labeling.

"Under the FDA's new authorities, we can require safety label changes and a risk evaluation and mitigation strategy, known as REMS, when the agency becomes aware of new safety information," said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products, Center for Drug Evaluation and Research. "Requiring the risks to be highlighted will help health care professionals be more vigilant in watching for these adverse events, and is necessary to ensure that the benefits of these drugs outweigh their risks."

Since the initial approval of the four TNF blockers, the prescribing information for these drugs has included information about the risk of serious infections, including fungal infections. However, based on reports reviewed by FDA, health care professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment.

Patients taking TNF blockers should be aware that they are more susceptible to serious fungal infections. Those who develop a persistent fever, cough, shortness of breath, and fatigue should promptly seek medical attention. To assist in the diagnosis, those being treated with TNF blockers should tell their health care professionals where they live and what areas they have recently visited. Patients who develop a fungal infection may be advised to stop the TNF blocker until they recover.

FDA has reviewed 240 reports of histoplasmosis, an infection caused by the fungusHistoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. The majority of the reports involved people in the Ohio River and Mississippi River valleys (the fungus is commonly found in those areas). In at least 21 of the reports, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.

The FDA reviewed one reported case of histoplasmosis in a patient taking Cimzia. The FDA also has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF blockers.

TNF blocker manufacturers are required to submit safety labeling changes, including strengthened warnings and revisions to the Medication Guides to the FDA within 30 days or to provide a reason why they do not believe labeling changes are necessary.

If they do not submit new language, or if the FDA disagrees with the new language the company proposes, the Food and Drug Administration Amendments Act of 2007 provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information.

Medication Guides will become part of a REMS for Humira and Remicade and are already part of a REMS for Enbrel and Cimzia. The manufacturers for all four of these drugs will also be required to educate prescribers about the risks.

For more information: http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm

http://www.fda.gov

The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.

The COBAS TaqMan HBV Test extracts and then amplifies sections of viral DNA from human plasma or serum. The viral DNA sections are measured to establish a baseline level before beginning treatment, and then used again during treatment to assess an individual's response to therapy. (The baseline level of hepatitis B virus should decrease with successful treatment.) The test is used with other clinical findings, such as results from biochemical and serological testing.

"Measuring a patient's HBV viral load is an important aspect of managing chronic hepatitis B infections," said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "The COBAS TaqMan test gives health care providers a new and sensitive tool for this process."

HBV is the most serious type of viral hepatitis, infecting about two billion people worldwide each year, according to the World Health Organization. A vaccine for HBV has been available in the United States since 1982. However, according to the Centers for Disease Control and Prevention, about 1.25 million people in the United States have chronic hepatitis B. Another 60,000 become infected each year and some 5,000 die from hepatitis B-related complications.

HBV is spread through sexual exposure, use of infected needles, and transmitted from infected mother to child during birth. Symptoms occur in about 70 percent of patients, and include abdominal pain, jaundice, fatigue, loss of appetite, nausea, and vomiting.

COBAS TaqMan HBV Test is manufactured by Roche Diagnostic Division, Basel, Switzerland.

http://www.fda.gov