FDA cracks down on body parts companies
Tue, 12 Jun 2007 16:13:40 GMTBy SETH BORENSTEIN and MARILYNN MARCHIONE, Associated Press Writers
WASHINGTON - Federal regulators say they have dramatically boosted inspections of companies that harvest cadaver body parts for transplant, acknowledging weaknesses in government oversight of the multibillion-dollar human tissue industry that last year was rocked by scandal.
The U.S. http://www.fda.gov/cber/tissue/httf07report.htm
Children with autism get day in court
Tue, 12 Jun 2007 00:40:14 GMTBy ANDREW BRIDGES, Associated Press Writer
WASHINGTON - In excruciating detail, an Arizona mother on Monday described severe autism and devastating health problems that plague her 12-year-old daughter and asked a court to find common childhood vaccines were the cause.
The test case is being closely watched by nearly 5,000 families of autistic children who have lodged similar claims for compensation from a federal fund.
The case of Michelle Cedillo, of Yuma, Ariz., is the first alleging a vaccine-autism link to be heard in the U.S. Court of Federal Claims. It and eight other test cases are important because they will guide the handling of the other pending claims. Most contend that a mercury-rich preservative called thimerosal is to blame for the impaired social interaction typical of the disorder.
Should they prevail, the families will be eligible for compensation from a federal vaccine injury fund established by Congress to ensure an adequate supply of vaccines by shielding manufacturers from lawsuits. No autism claim has been paid from the fund thus far.
Large scientific studies have found no association between autism and vaccines containing thimerosal.
Government attorney Vincent Matanoski dismissed much of what the plaintiffs are expected to present during the three-week hearing as conjecture or speculation.
"You'll find their hypotheses untested or, when tested, have been found false," Matanoski said.
Theresa Cedillo said her daughter suffered five days of fever, her temperature often spiking to 105 degrees, after receiving a measles, mumps and rubella vaccination at age 15 months. Michelle was a happy, robust, responsive and loving child — in short, normal — but hasn't been the same since, her mother told the court.
Wearing noise-canceling headphones, Michelle was brought into the courtroom in a wheelchair at the start of the proceedings. She stayed only a short time, moaning audibly several times. Besides autism, Michelle suffers from inflammatory bowel disease, glaucoma and epilepsy. In addition, her bones, weakened by years of malnourishment, are prone to breaks, Theresa Cedillo said. Everything she eats is pumped in through a feeding tube, except for crackers and water.
"Clearly the story of Michelle's life is a tragic one," Special Master George Hastings Jr. said in thanking the family for allowing theirs to be the first test case. Hastings pledged he and two other special masters would listen carefully to all evidence.
Theresa Cedillo and husband Michael allege thimerosal-containing vaccines weakened their daughter's immune system and prevented her body from clearing the measles virus after she was immunized. That theory is one of three alleged by the thousands of plaintiffs. The others claim either thimerosal or the measles vaccine alone caused their children's autism.
"We hope to find out what happened and hopefully get the help she needs," said Theresa Cedillo, who takes care of her daughter full time at home.
The burden of proof is easier than in a traditional court. Plaintiffs only have to prove that a link between autism and the shots is more likely than not, based on a preponderance of evidence. But many parents say their children's symptoms did not show up until after their children received the vaccines, required by many states for admission to school.
"These are families who followed the rules. These are families who brought children in for vaccines. These are families who immunized their children," Cedillo attorney Thomas Powers said. Later, outside court, he cast aside any suggestion his clients were anti-vaccine.
Autism is characterized by impaired social interaction. Those affected often have trouble communicating, and they exhibit unusual or severely limited activities and interests.
In 1999, the U.S. government asked vaccine manufacturers to eliminate or reduce the use of thimerosal in childhood vaccines to limit infant exposure to mercury. Today, the preservative is no longer found in routine childhood vaccines but is used in some flu shots.
The nine test cases will be heard consecutively over the next year. A ruling in the Cedillo case could take months or longer, attorneys said.
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On the Net:
U.S. Court of Federal Claims: http://www.uscfc.uscourts.gov
Rice engineered to carry cholera vaccine
Mon, 11 Jun 2007 23:15:15 GMTBy RANDOLPH E. SCHMID, AP Science Writer
WASHINGTON - A team of Japanese researchers has developed a type of rice that can carry a vaccine for cholera, a step that could one day ease delivery of vaccines in developing countries.
While it's only the latest of several plants being tested as potential means of producing vaccines, the development is potentially important in medically underserved countries that lack refrigeration to store regular vaccines.
But the work is preliminary, having been tested only in mice.
The team, led by Hiroshi Kiyono of the division of mucosal immunology at the University of Tokyo, reports the development of the new vaccine in Tuesday's issue of Proceedings of the http://www.pnas.org
Buffalo food fest orders healthier items
Mon, 11 Jun 2007 21:27:25 GMTBy CAROLYN THOMPSON, Associated Press Writer
BUFFALO, N.Y. - For the first time in its 23-year history, the Taste of Buffalo, a foodie free-for-all attracting tens of thousands, is ordering restaurants to offer healthier options.
At least one item on each vendor's menu must meet standards on fat, salt and cholesterol.
That means diners at the July 7-8 event will see mango sorbet and smoked chicken sandwiches among the hot fudge sundaes and bleu cheese burgers, a low-fat cookie there with the cheesecake.
But will they bite?
"It'll be interesting to see," said Ania Gurnari, whose family-owned bakery, E.M. Chrusciki, has offered its sugar-coated "angel wings" and other pastries at the festival for more than 20 years.
Her father came up with a chewy spice cookie to meet the new healthy mandate, using applesauce to make it moist and sweet.
"We're going to be serving New York-style cheesecake, there's nothing fat-free about that," Gurnari laughed. "So having that side by side, we'll see what choices people make."
The idea is not to force tasters to shun their favorites, organizers say, but to give them a chance to try healthy dishes that might be just as good.
"What a great opportunity ... to recognize that a lot of people currently have a perception that healthy food has to taste bad," said Dr. Michael Cropp, president and chief executive of Independent Health. The health insurance company's community outreach foundation worked with festival organizers to develop the new rules.
"We thought, as a first step, if we can have all these restaurants demonstrate how they can provide a healthy option that tastes great, we're going to change people's perceptions," Cropp said.
No one even noticed when Rita Sabharwal altered her chicken curry and rice dish two years ago to make it healthier, substituting more tomatoes for some of the oil.
"We sold out anyway," said Sabharwal of Tandoori's Royal Indian Cuisine. This year, Sabharwal has created a vegetarian dish of chickpeas and spinach, keeping an eye on oil content.
Each restaurant had to submit a healthy recipe that was analyzed by a computer program. No more than 30 percent of calories could come from fat and less than 10 percent from saturated fat. There were also sodium and cholesterol restrictions.
While some, like Tandoori's, created brand new dishes, others tweaked existing ones. Louie's Hot Dogs simply switched out the crushed tomatoes from its Sloppy Louie Burger with a lower-salt version to meet the guidelines.
Among other offerings will be a vegetable croissant, baked spring rolls and Cajun boiled crawfish.
Even at Chrusciki's bakery, customers are looking for less guilty pleasures.
"People ask for fat-free, sugar-free everything these days," Gurnari said. "Sometimes we look at them like, `OK, wrong place.' But now, at least we can say we have this healthy choice item."
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On the Net:
Taste of Buffalo: http://www.tasteofbuffalo.com
Independent Health Foundation: http://www.independenthealth.com
Expert panel says to call kids obese
Tue, 12 Jun 2007 20:10:03 GMTBy LINDSEY TANNER, AP Medical Writer
CHICAGO - Doctors ought to quit using fuzzy terms to define children's weight problems and instead refer to truly fat kids as overweight or obese, a committee of medical experts recommended.
Less blunt terms used by the government and many doctors diplomatically avoid the term "obese." Instead, they refer to children many would consider too fat as being "at risk for overweight," and "overweight" for those others would consider obese.
Those categories don't adequately define the hefty problem, according to the group, which was convened by the American Medical Association and funded by federal health officials including the Centers for Disease Control and Prevention.
The nonbinding recommendations are designed as guidelines for pediatricians and other medical professionals who work with children. The http://www.ama-assn.org
CDC: http://www.cdc.org
