Health Highlights: July 16, 2005
U.S. Regulators Approve Brain Stimulator for Depression FDA to Rule on 'Morning-After Pill' by September FDA Investigating Pain Patch Deaths Chiron Cites Flu Vaccine Problems in Europe Indonesia Says Bird Flu Cases May Have Passed Between People
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
U.S. Regulators Approve Brain Stimulator for Depression
U.S. health officials approved on Friday an implantable electronic device designed to help treat severe depression in patients who have failed to respond to all other treatments.
Houston-based Cyberonics said the Food and Drug Administration had signed off on its Vagus Nerve Stimulation Therapy System. The pacemaker-like device sends electrical impulses to the brain, which can apparently result in improvement in those suffering from severe depression. The system was originally designed to treat epilepsy, according to MarketWatch.
The FDA approved the VNS system with the caveat that it be used with more traditional psychiatric therapies. The device costs about $15,000, MarketWatch said.
The company, which estimates that about 4 million Americans suffer from intractable depression, said the market for the device could reach $1.2 billion by the end of the decade, MarketWatch said.
The system has already been approved to treat depression by regulators in Europe and Canada.
Critics said there has been a lack of rigorous scientific research to prove the VNS system really works, according to the Associated Press.
But FDA medical device chief Dr. Daniel Schultz said he was persuaded by Cyberonics' research, despite initial skepticism within his agency. "These are patients pretty much at the end of the line in terms of what treatment options are available to them," he said.
FDA to Rule on 'Morning-After Pill' by September
The U.S. Food and Drug Administration will decide by Sept. 1 whether the controversial "morning-after" contraceptive pill can be sold without a prescription.
The announcement was contained in a letter from Department of Health and Human Services Secretary Michael Leavitt to high-ranking senators. The news led two Democratic senators, Patty Murray of Washington and Hillary Rodham Clinton of New York, to say they'd allow a vote on the confirmation of Lester Crawford as commissioner of the FDA, the Associated Press reported.
The two lawmaker had held up a vote on Crawford's nomination because of a decision delay on the pill, also known as "Plan B."
"After more than two years of waiting, American consumers and American women will finally get an answer," the two Democrats said.
In December 2003, an FDA advisory panel recommended in a 24-3 vote that the pill be approved for over-the-counter sales. But the FDA ignored that recommendation, citing concerns that the pill could lead young teens to have sex, leaving them susceptible to sexually transmitted diseases. The pill's manufacturer, Barr Laboratories, filed a second application with the agency to address those concerns, the AP said.
Supporters of over-the-counter Plan B said the pill would help women prevent unintended pregnancies and reduce the need for abortions, the news service said.
FDA Investigating Pain Patch Deaths
The U.S. Food and Drug Administration is investigating 120 deaths among users of patches that emit the painkiller fentanyl. The agency also warned patients Friday to be sure to use the potent narcotic properly to avoid accidental overdose, the Associated Press reported.
The FDA is reviewing whether any of the deaths were related to inappropriate use of the painkiller or factors related to the product's quality.
Fentanyl is a strong narcotic painkiller that could cause death from overdose if the product's directions aren't strictly followed, the agency said in issuing Friday's public health advisory. The patch is available under the brand name Duragesic, and as a generic version.
The agency said Fentanyl skin patches should be used only when chronic pain isn't controlled with shorter-acting painkillers, and should not be used to treat short-term pain, pain that isn't constant, or for post-surgical pain.
The agency also reminded users to properly dispose of used, unneeded or defective patches by folding the sticky sides together and flushing them down the toilet, to prevent possible abuse by children.
Friday's warning followed by two days the FDA's ban on sales of the narcotic painkiller Palladone, citing the potential for deadly reactions if the drug was used with alcohol.
In a separate action, a healthcare accrediting group is warning about the potential misuse of a cancer drug the could kill or permanently paralyze patients.
The drug vincristine is supposed to be injected into a vein, but on rare occasions has been added to spinal catheters used by leukemia and lymphoma patients, the Joint Commission on Accreditation of Healthcare Organizations said.
The group noted some 49 cases of vincristine mix-ups worldwide since 1968, killing about 90 percent of these patients, the Associated Press reported.
Chiron Cites Flu Vaccine Problems in Europe
Chiron Corp., the U.S. maker of flu vaccine whose quality-control problems led to widespread shortages in the United States last year, now says it is cutting supplies to Europe because of tainted vaccine produced at a German plant.
The company, citing manufacturing problems at its Marburg, Germany, facility, said it will only make 4 million of 12 million doses it had expected to produce for sale in Germany and England, the Associated Press reported.
The Marburg difficulties are reminiscent of contamination problems that led the British government to shut a Chiron plant in Liverpool last fall that was to have produced about half of the 100 million doses of flu vaccine ordered by the United States for the 2004-2005 season. That closure led to significant shortages in the United States for several months. The British plant was allowed to reopen in March.
Indonesia Says Bird Flu Cases May Have Passed Between People
An Indonesian man and his two daughters have died of suspected bird flu, and there's no evidence that they had contact with poultry, raising the possibility of person-to-person transmission, authorities told the Associated Press on Friday.
The victims are a 38-year-old man and his 9- and 1-year-old daughters, the wire service said. Residents of a Jakarta suburb, they all died within 10 days of each other, Indonesian Health Minister Siti Fadilah Supari said.
The government is awaiting tests to confirm that they all contracted the deadly H5N1 strain of avian flu, she added.
Bird flu has killed at least 51 people in Vietnam, Thailand and Cambodia over the past two years, the AP said. Most cases have involved bird-to-human transmission. But in January, HealthDay cited cases of likely person-to-person transmission between an 11-year-old girl in Thailand and her mother and aunt.
World health authorities have long warned of a scenario involving a strain of bird flu combining with a human form of the disease, sparking a global pandemic that would be resistant to human flu vaccines.