Health Official Urged Halt of Kids' Antibiotic Trial
A U.S. Food and Drug Administration official last month called for a halt in clinical trials of an antibiotic for children because the drug could be deadly, according to internal memorandums from the agency.
The drug, Ketek, made by Sanofi-Aventis, is currently approved only for use in adults as a treatment for sinusitis, bronchitis and pneumonia. The company is testing the drug as treatment for ear infections and tonsillitis in almost 4,000 infants and children in more than a dozen countries, including the United States, The New York Times reported Thursday.
According to a recent review by FDA safety officials, there is growing evidence that Ketek is unusually toxic -- 12 adult patients in the United States have suffered liver failure, including four who died; 23 others suffered serious liver injury. Other antibiotics cause liver failure, but Ketek seems to do so almost four times as often, the officials concluded in the review, the newspaper reported.
"How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" Dr. Rosemary Johann-Liang, an official in the FDA's Office of Drug Safety at the agency, wrote in one of the memorandums obtained by the Times. Other safety officials wrote in their review that the agency should consider forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects, the paper said.
FDA spokeswoman, Susan Bro, asked about the Johann-Liang memorandum, said that it was "a preliminary, raw assessment" and that "the final decision will be made by experts who have the full benefit of a large section of opinion and scientific fact."
Melissa Feltmann, a spokeswoman for Sanofi-Aventis, said the company was in discussions with the FDA about the drug.
Informed Consent Takes Back Seat in Public Crisis: FDA
Victims of a future terrorist attack or public health emergency would no longer have to give permission before experimental tests could be run to determine why they're sick, under a federal rule published Wednesday. Privacy experts immediately condemned the ruling as unnecessary and ripe for abuse.
The rule, issued by the U.S. Food and Drug Administration, would allow health care workers to run experimental tests on blood and other samples taken from people who have fallen sick as a result of a bioterrorist attack, bird flu outbreak, detonation of a dirty bomb or any other life-threatening public health emergency, the Associated Press reported. In all other cases, the use of an experimental test still requires the informed consent of a patient, as well as the review and approval of an outside panel.
Dr. Deborah Peel, chairwoman of the Patient Privacy Rights Foundation, a watchdog group, told AP, "This sounds like they're taking for themselves the right to test individuals every time they declare a public health emergency. There is no way getting consent would delay testing."
The rule is subject to public comment until Aug. 7. The FDA said it published the rule without first seeking comments because it would hinder the response to an outbreak of bird flu or other public health emergency. The agency said the lack of such an exemption impeded the public health response to the SARS epidemic of 2003, AP reported.
Guidant Considered Warning Docs on Heart-Device Defects: Report
Guidant Corporation, which last year defended its decision not to tell physicians about significant heart-device defects, had drafted a "Dear Doctor" letter to disclose the hazards but decided not to send it, The New York Times reported Wednesday.
The proposed letter and other company records, released this week by a Texas state judge, may have significant legal and financial consequences. Since last fall, the U.S. Department of Justice and the Food and Drug Administration have been conducting an inquiry into Guidant's handling of safety issues affecting several now-recalled defibrillators.
A spokeswoman for the United States attorney's office in Minneapolis that's heading the federal inquiry declined to comment on the investigation, according to the paper's report.
At least seven patients are known to have died in episodes in which Guidant defibrillators failed to work because of an electrical defect. But many experts believe that the number is probably higher because implanted heart devices are rarely examined after a patient's death to see if they were working properly, the newspaper said.
A defibrillator is an implanted device that senses potentially fatal heart rhythms and corrects them with a timed electrical shock to restore a normal heartbeat.
FDA Stands Behind Fish Advisory
The U.S. Food and Drug Administration is reassuring consumers that its 2004 advisory about what Americans need to know about eating fish remains current, despite fears of mercury contamination in the catch.
In a prepared statement, the agency repeated its advisory recommendations that "fish and shellfish are an important part of a healthy diet and can contribute to heart health and children's proper growth and development. Because of their many healthy benefits we recommend that women and young children include them as a regular part of their diet. However, nearly all fish and shellfish contain traces of mercury."
The agency also repeated that five of the most commonly eaten fish -- shrimp, canned light tuna, salmon, pollock and catfish -- have low levels of mercury.
Consumer Reports on Tuesday had warned that pregnant women should not eat canned tuna, because a small percentage contains levels of methyl mercury as high as fish that the FDA said pregnant women should never eat -- shark, swordfish, King Mackerel, or tilefish., according to a report in USA Today.
The FDA said that although some canned tuna may contain higher mercury levels, others are lower, and that scientists took averages into account in the recommendations.
Health experts agree that eating fish is good for most people. But there are concerns that mercury and other pollutants can offset the benefits.
Angolan Cholera Death Toll Tops 1,500
A cholera outbreak in Angola has claimed 1,576 lives since February, the World Health Organization said Wednesday, with 250-300 infections still being reported daily.
The African country, whose health and public infrastructure was torn apart in a 20-year civil war that ended in 2002, reported a total of 41,475 cases in 13 of its 18 provinces as of May 31, according to the Associated Press.
The overall fatality rate stood at 3.8 percent -- above the 1 percent the WHO considers average, the report said. It's estimated that a quarter of the 4 million Angolans in the capital of Luanda live in shantytowns.
Cholera, which can be treated easily but is a major killer in developing countries, is transmitted through contaminated water. It is linked to poor hygiene, overcrowding and inadequate sanitation.