First Drug Regimen Approved for Advanced Cervical Cancer
The first combination of drugs to treat late-stage cervical cancer received U.S. Food and Drug Administration approval Thursday.
Hycamtin (topotecan hydrochloride) -- already approved to treat cancers of the ovaries and lung -- is newly sanctioned in combination with cisplatin to treat cervical cancer that's too advanced or is unlikely to respond to treatments including surgery and radiation, the agency said.
Some 10,000 U.S. women are diagnosed annually with cervical cancer, leading to 3,700 deaths each year. In clinical trials involving 293 women, participants who used the combination survived an average of 9.4 months, versus 6.5 months among those who took cisplatin alone, the FDA said
Hycamtin, made by GlaxoSmithKline, was approved in 1996 for ovarian cancer and in 1998 for small-cell lung cancer. People who take it are at risk for neutropenia, a drop in white blood cell count that boosts a person's risk of infections. Users are also at risk for a decrease in blood platelets, which could lead to excessive bleeding and anemia, the FDA said.
Many Parents Underestimate Asthma Risk: Study
Nearly half of all parents who participated in a global survey were unaware that a child with a mild form of asthma could still die from an acute attack, European researchers say.
One in three fatal asthma attacks involves a mild form of the disease, the Associated Press reported of data released at a Vienna meeting by the European Academy of Allergology and Clinical Immunology.
A survey of nearly 5,500 parents -- primarily in Britain, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and the United States -- found that parents frequently cut back on their children's use of inhalers and other treatments when their children have side effects, the wire service reported.
This exposes these children to a host of potential problems, including worsening asthma symptoms, more frequent attacks, and the need for more trips to the doctor or emergency room, the academy warned.
Some 225,000 people died from asthma last year, according to the World Health Organization, a number that's projected to rise by almost 20 percent in the next decade, the AP reported.
Separated Twins 'Doing Great'
Conjoined twins, attached from the chest to the pelvis and who shared internal organ function, were separated in a daylong operation Wednesday by a surgical team at Childrens Hospital Los Angeles.
The twins, 10-month-old Regina and Renata Salinas Fierros, were transferred early Thursday to side-by-side beds in an intensive care unit after their surgeries were complete, hospital spokeswoman Janet Dotson told the Associated Press.
"The girls are doing great," she added.
The AP reported that the twins were finally separated as the pelvic bone was cut shortly before 6:30 p.m. PT.Wednesday night. The procedure had lasted more than 12 hours and was especially difficult, the wire service said, because doctors had to devise a way to separate the liver, bladder and genitalia so that each child could function on her own.
Investigators: NIH Worker Allegedly Profited From Tissue Samples
A senior researcher at the U.S. National Institutes of Health may have profited by at least $285,000 from the transfer of human tissue samples in what appears to be a violation of agency ethics rules, House investigators told the Associated Press.
The investigators said the transfer of the samples to the drug giant Pfizer would not have been approved had agency permission been sought by Dr. Trey Sunderland, an Alzheimer's disease expert at the National Institute of Mental Health (NIMH). The arrangement raises questions about lax oversight at the agency, the investigators told the wire service.
Sunderland, chief of the geriatric psychiatry branch at the NIMH, asserted his Fifth Amendment rights against self-incrimination Wednesday by refusing to testify at congressional hearings on the allegations.
He's been under congressional scrutiny before, the AP said. The House Energy and Commerce Committee has investigated allegations that Sunderland received $517,000 since 1999 in consulting fees or expense reimbursements from Pfizer without any record of agency approval for those payments, the wire service reported.
The latest probe centers on investigators' belief that there were "reasonable grounds" that $285,000 of the $517,000 Sunderland received from Pfizer stemmed from giving the company access to spinal fluid and plasma samples in connection with Pfizer's work on an Alzheimer's drug, the AP said.
"Federal laws and policies do not permit NIH scientists to profit personally from their jobs and their patients by providing irreplaceable government assets," Rep. Ed Whitfield (R-Ky.) told the wire service. Whitfield chairs the House Energy and Commerce Committee's oversight and investigation subcommittee.
An attorney for Sunderland, Robert Muse, said his client "didn't receive a dime for providing anything to Pfizer. He received fees for consulting as well as for lectures. These were known to NIH and they were permitted under NIH rules," Muse told the AP.
The transfer of tissue samples was done under a 1998 material transfer agreement between the NIMH and Pfizer, the AP reported. A company spokesman could not be reached for immediate comment, the wire service said.
HHS Chief Uses Emergency Jet for Meetings: Newspaper
A private jet reserved for the U.S. Centers for Disease Control and Prevention in cases of emergency has been used by Health and Human Services Secretary Mike Leavitt to attend news conferences and meetings across the country, the Atlanta Journal-Constitution reported Wednesday.
While the CDC says it has used the jet for three emergencies since January, Leavitt has used the Gulfstream III jet on 19 trips to more than 90 cities, his spokeswoman told the newspaper. Most of Leavitt's trips, at a cost to taxpayers of more than $700,000, were to promote the new Medicare prescription drug benefit for seniors, the newspaper said.
In two cases, CDC officials responding to emergencies were forced to use other planes because Leavitt was using the CDC jet, the Journal-Constitution said.
A Leavitt spokeswoman defended his use of the plane, saying the trips complied with federal guidelines. Before 2006, Leavitt typically took commercial jets, as other cabinet members say they do frequently, the newspaper reported.
Last fall, Congress authorized Leavitt to use the jet at his discretion because of the nature of his work during emergencies and "significant events," the newspaper said.
Leavitt was unavailable to respond to the newspaper's story, it said.
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