Health Highlights: Dec. 17, 2005
U.S. Team Will Test Live-Virus Bird Flu Vaccine N.J. Man Sues Over Transplanted Bone U.S. Judge Rejects Challenge to Lipitor Patent FDA Warns Against Drinking Unpasteurized Milk Congress Approves National Cord Blood Bank
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
U.S. Team Will Test Live-Virus Bird Flu Vaccine
Researchers at the U.S. National Institutes of Health will soon recruit 30 human volunteers to test the effectiveness of a vaccine containing a live but weakened form of the H5N1 bird flu virus.
According to the Associated Press, this flu shot would differ from the standard influenza vaccines distributed each year because it contains live rather than killed virus -- potentially rendering it more powerful in inducing an immune response.
The live virus used in the upcoming trial will be genetically altered, however, so that it won't make people sick. Its hoped that the new vaccine will prime the volunteer's immune systems to recognize a more deadly strain of H5N1 if and when it appears.
Up till now, avian flu outbreaks have been mostly confined to bird populations, although experts believe 70 people have died worldwide from H5N1 infection after picking up the virus from poultry. The real fear, experts say, is that the pathogen will mutate to allow for human-to-human transmission. In that case, a pandemic could kill millions worldwide.
Thats why a potentially potent vaccine containing live virus is "a great, great idea," flu expert Dr. John Treanor of the University of Rochester told the AP. "In theory, a live-virus vaccine might actually work better [than a killed-virus shot]," he said. "We don't know that because we've never tried one before."
Tests this summer using a vaccine made with another, less dangerous strain (H9N2), showed the method might be safe and effective. Lead researcher Dr. Kanta Subbarao told the AP that the trial involving the weakened H5N1 strain is set to begin in April, pending U.S. Food and Drug Administration approval.
N.J. Man Sues Over Transplanted Bone
A New Jersey man on Friday sued a Brooklyn, N.Y., funeral home and three companies involved in the harvesting or marketing of transplant tissue, claiming that the bone he received in a 2004 operation was untested for disease and came from a corpse whose family had not given permission for its use in the transplant.
According to the Associated Press, 57-year-old Gary Pieper of Mays Landing received the bone to repair vertebrae in his neck after a construction accident.
Pieper's lawyer, Patrick D'Arcy, told the AP he has 40 other prospective clients involved in similar situations across the country. The U.S. Food and Drug Administration and, reportedly, criminal investigators in Brooklyn, are also currently investigating allegations that failures to test tissues and obtain required permissions was widespread in transplants conducted between early 2004 and September 2005.
The link connecting all these cases is Fort Lee, N.J.-based Biomedical Tissue Services, which recovers tissue from the deceased and then sells it to other firms. Those firms, in turn, sell the tissue to hospitals. Biomedical Tissue Services is one of four defendants named in the Pieper lawsuit.
Because the transplanted bone cannot be removed, Pieper said he fears it could be tainted by disease that could lead to future health problems. Tests for several diseases have so far come up negative, however.
Pieper told the AP that he also worries about the age of the bone. "I don't know the origin," he said. "The original harvesting [of] the bone came from who-knows-where."
U.S. Judge Rejects Challenge to Lipitor Patent
A U.S. federal judge on Friday rejected a challenge to Pfizer's patent for the world's best-selling drug, cholesterol-lowering Lipitor.
According to a report in the New York Times, the ruling means Pfizer retains its monopoly of the drug -- which netted the company over $12 billion this year -- until 2011. Drug prices typically drop by 90 percent once a manufacturer loses its patent monopoly.
Indian drugmaker Ranbaxy had launched the suit, claiming that one of two Lipitor patents does not cover the exact molecular form of atorvastatin (the active ingredient in Lipitor) that is found in the drug. They also claimed that a second patent that does pertain to the exact molecular form is invalid because it does not represent an advance over the first patent.
Judge Joseph J. Farnan Jr., of Federal District Court in Delaware, rejected those arguments and upheld Pfizer's patents.
A Ranbaxy official said it will pursue the case in the U.S. Court of Appeals. But Pfizer's chairman, Henry A. McKinnell, called the judge's decision "an exceptionally important victory for all those who invest in medical innovation."
FDA Warns Against Drinking Unpasteurized Milk
An outbreak of serious Escherichia coli (E. coli) illness in Washington state linked to the consumption of raw (unpasteurized) milk prompted a warning Friday from the U.S. Food and Drug Administration to avoid these products.
Eight illnesses have recently been reported, the agency said, with two children still hospitalized after drinking raw milk. The milk was traced to an unlicensed dairy which has subsequently been shut down.
Pasteurization effectively removes potentially disease-causing bacteria from milk and dairy products made from milk, such as cheese.
According to the U.S. Centers for Disease Control and Prevention, more than 300 people fell ill after eating raw milk or cheese made from raw milk in 2001, and another 200 were sickened in 2002.
Congress Approves National Cord Blood Bank
The U.S. Senate on Friday gave final approval to the establishment of a national databank for umbilical cord blood and bone marrow that would speed matches between needy transplant recipients and donated blood or tissue.
According to the Associated Press, the House had already passed the bill by a 431-1 vote back in May, but the bill had been stalled as lawmakers wrangled over a separate plan that would have lifted restrictions on stem cell research. President Bush had signaled that he would veto that plan.
The bill passed Friday earmarks $79 million to boost the number of available cord blood units to 150,000 -- enough to provide a suitable match for at least 90 percent of patients. The bill also reauthorizes the bone marrow transplant system, folding it into the same database as that for donated cord blood.
"The use of stem cells from umbilical cords represents a breakthrough of immense promise," Rep. Christopher Smith, R-N.J., who co-sponsored the bill, told the AP. "This legislation will expand the inventory of cord blood units and will streamline the process for the receipt of blood matches," he said.