Health Highlights: June 29, 2006
Liver-Damage Reports Prompt Antibiotic Label Change Lawsuit Challenges Medicaid Proof-of-Citizenship Rule Scientists Find Gene Boosts Melanoma Risk Hefty Pricetag Clouds New Eyesight Drug 1 in 5 U.S. Transplant Centers Fails Standards: Report Pentagon Revising Document on Homosexuality
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Liver-Damage Reports Prompt Antibiotic Label Change
The labeling for the antibiotic Ketek (telithromycin) will be updated to reflect the possibility of severe liver damage, manufacturer Sanofi-Aventis said Thursday.
The U.S. Food and Drug Administration has received 12 reports of acute liver failure, four of which were fatal, the Associated Press reported. FDA safety evaluators found 23 other cases of serious liver injury among Ketek users, the wire service said.
An internal FDA memo says those injury reports, in proportion to the number of prescriptions written, exceed adverse reports for similar drugs, the AP said.
The drug has been sold in the United States since 2004. Earlier this month, Sanofi stopped enrolling children in trials of Ketek, the wire service said.
The Senate Finance Committee is investigating allegations of fraud connected with the Ketek trials, the AP reported, without elaborating.
Lawsuit Challenges Medicaid Proof-of-Citizenship Rule
A class-action lawsuit filed in Chicago seeks to strike down a law requiring Medicaid beneficiaries to prove U.S. citizenship before obtaining health benefits.
The lawsuit, filed this week in federal district court, seeks to enjoin the Bush administration from implementing the law, which is set to take effect July 1. Consumer groups fear the law would cause millions of low-income citizens to become uninsured, the Associated Press reported.
Congress passed the legislation earlier this year to ensure that only citizens or qualified legal immigrants have access to Medicaid. The move was sparked by an inspector general's report showing that most states don't verify claims of U.S. citizenship.
Under the disputed law, if records such as birth certificates or passports are unavailable, states can accept sworn affidavits from two people, one of whom cannot be a relative. The witnesses would be subject to prosecution if they commit perjury, the AP said.
Scientists Find Gene Boosts Melanoma Risk
Scientists have identified a gene that increases a person's risk of developing the most common form of melanoma skin cancer.
Researchers at the U.S. National Cancer Institute said they've identified variant forms of the melanocortin-1 receptor (MC1R) gene that increase a person's risk of melanoma, even if the person has dark skin pigmentation.
Looking for an association between inherited variant forms of MC1R and the development of melanoma, the researchers studied melanomas in 85 people at the Bufalini Hospital in Cesena, Italy, and 112 patients at the Department of Dermatology at the University of California, San Francisco.
"Knowing who is at greater risk for melanoma due to heredity, and understanding the pathways leading to cancer, are important steps in addressing a disease which is expected to be diagnosed in over 62,000 Americans in 2006," said Dr. Elias A. Zerhouni, director of the U.S. National Institutes of Health.
The findings are published in the June 29 online edition of the journal Science.
Hefty Pricetag Clouds New Eyesight Drug
An expensive new eyesight drug that may prevent blindness among elderly people may only be as good as a cheaper alternative, The New York Times reported.
On the up side, Lucentis, a drug made by Genentech to treat wet macular degeneration, is expected to win federal approval this week, the newspaper said. The down side is that the drug is also expected to cost 10 to 100 times more than a similar drug that some ophthalmologists say is every bit as good, the Times reported.
Wet macular degeneration is a form of bleeding behind the retina that can lead to blindness in older people.
The question is whether insurers will pay for Lucentis, with prices as high as $10,000 a year or more, compared with another drug, Avastin, that costs $1,000 a year or less. Avastin is already FDA approved, and in its off-label use works the same way as Lucentis, the Times said.
Avastin, also made by Genentech, is used intravenously to treat colon cancer. Off-label use of Avastin has shown good results for treatment of macular degeneration, but the company said it had no interest in getting Avastin approved for macular degeneration, because that would undermine Lucentis sales, the Times reported.
1 in 5 Transplant Centers Fails Standards: Report
Dozens of heart, liver and lung transplant centers across the United States continue to operate despite failing to meet standards for patient survival and the minimum number of operations performed to receive federal funding, the Los Angeles Times reported Thursday.
Forty-eight of the 236 approved centers operating nationwide under the aegis of the U.S. Centers for Medicare and Medicaid Services continue working despite the lapses, according to the newspaper's report cited by the Associated Press.
Between 2002 and 2004, the newspaper said, the programs had 71 more patients die than expected within a year of a transplant.
"The bottom line message," said Dr. Mark Barr, a cardiothoracic transplant surgeon and president of the International Society for Heart and Lung Transplantation, "is that there are too many programs in the United States that need to be shut down," the AP reported.
Medicare funds most of the nation's transplant centers and requires that they perform a minimum number of transplants and achieve a specific survival rate to be certified for funding.
Representatives of some of the programs said they should be given more time to fix problems and said that it was impossible to judge a program based on figures from just a few years.
Pentagon Revising Document on Homosexuality
Under pressure from lawmakers and medical professionals, the Pentagon says it will revise a document that labels homosexuality a mental disorder.
"Homosexuality should not have been characterized as a mental disorder in an appendix of a procedural instruction," said Defense Department spokesman Lt. Col. Jeremy Martin, cited by the Associated Press. "A clarification will be issued over the next few days," he said.
Called a Defense Department Instruction, the document outlines retirement and discharge policies for service members with disabilities. One section lists homosexuality alongside mental retardation and personality disorders.
The American Psychiatric Association declassified homosexuality as a mental disorder more than 30 years ago, the AP said.
The Pentagon already has a "don't ask, don't tell" policy that prohibits inquiries into the sex lives of service members but does require discharge of those who openly acknowledge being gay.