Thursday, June 29, 2006

Health Headlines - June 29

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.

EU Set to Approve MS Drug Tysabri

The European Union is ready to approve the sale of Tysabri, a highly touted drug used to suppress the effects of multiple sclerosis, U.S. and Irish makers of the drug said Thursday.

"This decision means that patients in Europe who are suffering from this chronic, debilitating disease now have an effective new treatment alternative," Kelly Martin, president and chief executive officer of Elan Corp. PLC of Ireland, told the Associated Press.

The EU's expected approval follows the U.S. Food and Drug Administration's decision June 5 to allow resumed sales of Tysabri.

Tysabri had been withdrawn from the U.S. market in February 2005, after three users in clinical trials contracted a rare brain disease. Two of them died, but U.S. regulators later permitted Tysabri's relaunch after no new cases were detected and new safeguards were put into place, the AP reported.

Year-Round Birth Control Pill Approval Withheld

The U.S. Food and Drug Administration has delayed approval of a new birth control pill that prevents users from menstruating at all, the Associated Press reported Wednesday.

The FDA had already extended the review period for Lybrel, and manufacturer Wyeth Pharmaceuticals told the wire service that it hoped the contraceptive would have been approved Tuesday.

But the FDA asked for an additional delay, saying it wanted more clinical trial data on the pill's shelf live, pregnancy rates, and trial dropout rates, the AP reported.

The pill is designed to prevent menstruation, but only if used 365 days a year without interruption. Clinical trials suggested the pill was 98 percent effective in preventing pregnancy, although some users had problems with bleeding or spotting, Wyeth told the wire service.

Two Genes Linked to Liver Cancer

Abnormalities in two genes, dubbed Yap and CIAP1, probably play a "significant role" in causing liver cancer, say scientists at the Cold Spring Harbor Laboratory in New York.

Liver cancer is the fifth most common form of cancer worldwide, yet in absence of effective treatment options, it's the third-leading cause of cancer deaths, the researchers said in a statement.

The scientists discovered the genetic link while observing how engineered liver stem cells responded after being transplanted into the livers of adult mice. The researchers performed DNA scans on mice that went on to develop liver cancer.

The findings offered hope for testing new therapies and treatments for liver cancer, the researchers said. The study is published in the June 30 issue of the journal Cell.

Novel Weight-Loss Drug to Be Launched in Britain

Britons will be the first to gain access to Sanofi-Aventis' much-anticipated diet drug Acomplia (rimonabant), but obese Americans will have to wait for the U.S. Food and Drug Administration's possible approval later this year.

The European Union on Wednesday approved the heralded pill, which in trials cut users' body weight by up to 10 percent within a year, Britain's Daily Mail reported. The drug works by curbing a person's appetite.

The pill and its hefty price tag of nearly $100 a month won't be available to the British masses just yet, the newspaper noted, because Britain's National Health Service hasn't decided whether to subsidize it.

Rollouts of rimonabant are expected soon in Denmark, Ireland, Germany, Finland, and Norway, the Daily Mail said. The U.S. FDA has asked Sanofi for additional data before considering approval, Dow Jones Newswires reported.

No comments: