Gene Therapy Study Suspended
A Seattle company's gene therapy study involving people with advanced arthritis has been suspended by the U.S. Food and Drug Administration after the death of a participant, the Associated Press reported Friday.
The FDA said it was investigating to what degree, if any, gene therapy played a role in the unidentified patient's death on Tuesday. The agency also was reviewing the safety of 28 other gene-therapy studies nationwide that used the same virus, called an adeno-associated virus (AAV), the AP said.
While the FDA said it wasn't aware of any serious issues in the other studies, it was reviewing them as a precaution, the AP said.
The Seattle company involved in the suspended study, Targeted Genetics Corp., notified the FDA of the patient's death this week.
More than 100 people had been enrolled in the study. The patient who died became sick after a second gene-therapy injection into an arthritic joint, the wire service said.
A National Institutes of Health advisory committee on gene therapy was scheduled to meet in September in response to the patient's death, the AP said.
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Products Recalled for Botulism Risk Still Available
Cans of recalled chili, stew, hash, and other products are still being sold across the United States, despite the possibility they could be contaminated with deadly bacteria, the Associated Press reported Friday.
More than a week after Castleberry's Food Co. recalled more than 90 products for possible botulism contamination, thousands of cans are still being pulled from store shelves as quickly as U.S. Food and Drug Administration inspectors can find them.
The last two years' worth of inventory produced at Castleberry's Augusta, Ga., plant are now on the recall list -- which could add up to tens of millions of cans. Of more than 3,700 stores visited nationwide by the FDA at one point, roughly 250 still sold the recalled products, the wire service said.
A list of the recalled products is available from the FDA. Any consumer who has a recalled can should immediately double bag the product and throw it away, the agency advised.
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West Nile Season Off to Fast Start
If this year's early tally of West Nile virus cases is any indication, the United States is on pace to have its worst season in years, the U.S. Centers for Disease Control and Prevention said Thursday.
Nearly four times as many cases of the mosquito-borne virus have been reported nationwide as the same time last year, the Associated Press said.
Nineteen states, predominantly west of the Mississippi River, have reported 122 human cases this year, compared with 33 cases by late July 2006. This year's total includes three deaths, the AP said.
The start of the season isn't always a good indicator of how bad the entire year will be, a CDC spokesman noted.
The agency advises people to use mosquito repellant, to make sure window and door screens are working properly, and to eliminate any pools of standing water that the insects might use to breed.
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Astronauts Intoxicated Before Launch: Report
NASA astronauts on two occasions were so intoxicated before launch that agency medical experts said they posed a flight safety risk, yet they were allowed to fly anyway, Aviation Week & Space Technology reported Thursday on its Web site.
The astronaut alcohol consumption fell within the standard 12-hour "bottle to throttle" rule that prohibits such drinking, the magazine said. It cited the conclusions of a NASA panel reviewing health issues in the wake of Lisa Nowak's arrest in February on charges of allegedly stalking a woman who had been dating a fellow astronaut.
A NASA spokesman declined comment, except to say that a news conference had been scheduled for Friday afternoon, the magazine reported.
A member of the panel, convened by NASA Administrator Michael Griffin, told the magazine that the report was still being drafted and would probably be released in August.
The panel's report apparently doesn't deal directly with the Nowak case and does not identify any other astronaut by name, the magazine said. |
