Sunday, August 5, 2012

Clinical Notes: Uganda Sees Ebola Flare-Up - MedPage Today

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General Infectious Disease

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Ebola Hits Uganda Again

A new outbreak of Ebola virus infection was reported last week in Uganda, with a total of 20 cases reported, according to the World Health Organization.

Fourteen of the cases were fatal as of the agency's most recent update. News reports said many of the victims may have contracted the virus at a funeral for the first person to die.

Ugandan officials told citizens to avoid close personal contact, including handshakes, in an effort to contain the outbreak. Isolation centers were also set up in hospitals in the country's Kibaale region, where the outbreak occurred.

Ingestible Sensor Wins FDA Approval

A tiny biosensor that can be embedded in an oral drug tablet was cleared by the FDA, its manufacturer said.

The sensor confirms that it was ingested and also wirelessly transmits data on heart rate, body position, and activity, according to Proteus Digital Health of Redwood City, Calif. The information is recorded to a wearable patch that can then relay it to a mobile phone.

Proteus said the device will provide a novel, precisely accurate way to monitor patients' compliance with oral medication regimens. Such information would be valuable not only to individual patients and their healthcare providers, but also to pharmaceutical companies and health systems for evaluating drug-taking behaviors in groups of patients.

The FDA approved the sensor system through its so-called de novo 510(k) process for low-risk devices for which no predicate product exists.

Hospital Patients Exposed to CJD

Eleven surgical patients at a North Carolina facility were possibly exposed to Creutzfeldt-Jakob disease (CJD), the human spongiform encephalopathy caused by rogue prion proteins, officials reported.

The hospital had performed surgery on a patient who subsequently was found to have CJD, according to the Greenville News in Greenville, N.C. Instruments used in the procedure underwent normal sterilization afterwards, but since hospital staff did not know at the time that the patient had CJD, they did not perform the extra steps that would definitely remove prion proteins.

Those same instruments were then used in surgeries on 11 other patients, the newspaper said. It quoted hospital officials as saying they had contacted the patients and told them of the potential exposure. The officials characterized the risk of contracting CJD as "extremely small."

Feds Produce Food Safety Booklets

A series of consumer-level booklets on food safety have been developed by the FDA and the U.S. Department of Agriculture targeting groups at special risk for food-borne illnesses.

The six booklets deal with special susceptibilities and precautions for older adults, transplant recipients, and pregnant women, as well as people with cancer, diabetes, and HIV/AIDS.

Five of the booklets are updates of earlier editions produced in 2006. The sixth, for pregnant women, is new.

Copies have been mailed to physicians who treat patients in these categories, the agencies said. They are also available for free in a digital format at www.foodsafety.gov/poisoning/risk/index.html.

Untreated Rabies Okay?

Left untreated, rabies is nearly always fatal -- at least, that's what researchers thought until scientists found seven individuals living in the Peruvian Amazon basin who appear to have survived rabies infections without vaccination.

According to a report from the CDC, a team from the agency and the Peruvian health ministry took blood samples from 63 residents of remote Amazonian communities, some of whom reported previous bat bites. Seven of the samples yielded what appeared to be neutralizing antibodies to rabies virus.

"Our results support the idea that under very unique circumstances there may be some type of enhanced immune response in certain populations regularly exposed to the virus, which could prevent onset of clinical illness," said the CDC's Amy Gilbert, PhD, who led the study, in a press release.

But she cautioned that the best approach for individuals bitten by a rabid animal remains the standard series of vaccinations.

Novel Melanoma Drugs Submitted to FDA

GlaxoSmithKline said it had submitted new drug applications to the FDA for two investigational agents for malignant melanoma.

The drugs are dabrafenib, which blocks the BRAF kinase pathway, and a MEK inhibitor called trametinib.

Both drugs would be indicated only in patients with the V600 BRAF mutation and metastatic or unresectable disease, the company said.

The firm did not give a timeline for possible approval of the two agents.

Olympic Doping Lab Repurposed After Games

A sprawling laboratory set up in London to test Olympic athletes' clinical samples for banned substances will not be closed after the games end, as originally planned, but will instead be converted into the world's first phenome lab.

The U.K.'s Medical Research Council and the National Institute for Health Research will take over the facility for use in metabolic phenotyping research. The mass spectrometers and high performance chromatography machines now used in the doping tests are ideal for the phenomic research, the agencies said in announcing the plan.

Initially, the center will process about 25,000 samples in the first year, but throughput of 100,000 is the eventual goal.

Jeremy Nicholson, PhD, of Imperial College London will be the lab's research director.

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