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Health Highlights: Jan. 12, 2008

Food From Cloned Animals OK for Humans, European Agency SaysInformed Consent Knowledge Tested for Clinical Trials Participants Canned Beans Recalled Over Botulism Concerns FDA OKs Blood-Typing TestsHigh Lead Levels Prompt Recall of Tinker Bell Lamps New Method of Creating Embryonic Stem Cells Devised

Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

Food From Cloned Animals OK for Humans, European Agency Says

While the U.S. Food and Drug Administration has yet to issue an opinion as to whether certain foods from cloned animals are safe to consume, the agency that regulates food in Europe has issued a preliminary report saying that the food is probably safe.

According to the Associated Press, the European Union's Food Safety Authority issued a 47-page report, concluding that while meat and milk from cloned animals is probably safe, there was "only limited data available" on the whole issue of cloning animals. Further consultation with scientists was urged by the safety agency.

The FDA is expected to give its ruling on cloned foods sometime this month, and preliminary information from the agency indicates it, too, will approve their sale. But a 2006 nationwide poll found that more than 64 percent of Americans were not comfortable with the whole issue of animal cloning, the A.P. reports.

"Based on current knowledge, there is no expectation that clones or their progeny would introduce any new food safety risks compared with conventionally bred animals," the wire service quotes the European Union preliminary report as saying.

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Informed Consent Knowledge Tested for Clinical Trials Participants

Medical and scientific field testing for topics other than medical research can be just as effective in drawing conclusions and developing new methods, according to a Johns Hopkins study.

"Many clinical researchers believe that the informed consent process and documents need to be better and that people often consent without understanding that the research is not intended to benefit them personally," says Dr. Jeremy Sugarman, professor of bioethics and medicine at the Berman Institute of Bioethics at The Johns Hopkins University.

Actually, it was the development of something that didn't work that allowed the research team to identify ways to improve the informed consent process. The scientists had created a questionnaire for U.S. military veterans being treated for a variety of ailments.

But when the researchers examined results of the questionnaire answers, they found that that the questionnaire did nothing to improve informed consent.

A significant number of patients did not fully understand the purpose of the research, according to a Johns Hopkins news release, and many of them didn't understand that agreeing to take part in a clinical trial was voluntary.

The researchers will develop new informed consent methods based on the original research. "This study shows that we can do rigorous clinical testing of informed consent, just like we can do rigorous testing of drugs in clinical trials," Sugarman says in the news release.

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Canned Beans Recalled Over Botulism Concerns

New Era Canning Co. of New Era, Mich. is recalling cans of Mexican style chili beans, green beans, and dark red kidney beans that may not have been adequately cooked and have the potential for growth of Clostridium botulinum, which can cause botulism, the U.S. Food and Drug Administration said.

The recall covers the following products:

  • GFS brand Fancy Mexican Style Chili Beans in 6 lb. 12 oz. cans with lot number 00249 5AJ6LC with a 4-digit time stamp number ranging from 2113 through 2235 printed on the end of the can after the lot number.
  • Kitchen brand Blue Lake Mixed Cut Green Beans in 6 lb. 6 oz. cans with lot number 00249 6FG5GA printed on the end of the cans. They were not sold at retail stores, but were distributed to a Michigan restaurant.
  • Great Value brand Dark Red Kidney Beans in 15.5 oz cans with lot number 00249 CKJ6LD printed on the end of the can. They were sold at Wal-Mart stores in Arizona, Colorado, Idaho, Montana, Nevada, Utah and Wyoming.

The company and the FDA are not aware of any illnesses related to these products. Botulism, a potentially deadly form of food poisoning, may have symptoms such as: general weakness, dizziness, double-vision, trouble speaking or swallowing, difficulty breathing, abdominal distention and constipation.

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FDA Approves New Blood-Typing Tests

The U.S. Food and Drug Administration said it's approved 14 new tests for determining a person's blood type, a process that's essential to a safe blood supply and safe transfusions.

Mismatched transfused blood can cause serious, potentially fatal reactions.

"These 14 new tests will provide blood establishments and transfusion services with additional choices to help assure safe, well-matched transfusions," Dr. Jesse L. Goodman, director of the FDA's Center for Biologics Evaluation and Research, said in a prepared statement. "The tests offer a broader diversity of reliable blood-typing tests and will help protect against product shortages."

The Olympus PK System Blood Group and Phenotyping Reagents use monoclonal antibodies to test for the A, B, O and Rh factors, as well as for other factors that signify rarer blood types.

The tests are manufactured by a French company, DIAGAST.

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High Lead Levels Prompt Recall of Tinker Bell Lamps

About 60,000 children's novelty lamps have been recalled because surface paint on the lamps contains excessive amounts of lead, the U.S. Consumer Product Safety Commission said Friday.

The Tinker Bell lamps, made in Hong Kong and distributed by Kash N' Gold Ltd. of Deer Park, N.Y., include a sculpted Tinker Bell figure in a flower garden. An animation of Tinker Bell swaying back and forth while music plays is begun when the light switch or demo button is pressed.

The lamps were sold at electronics and appliance stores across the United States from January 2007 through October 2007 for about $40. Consumers with these lamps should stop using them and return them to the place of purchase for a refund.

lamp_recall

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New Method of Creating Embryonic Stem Cells Devised

U.S. scientists say they've created a number of colonies of human embryonic stem cells without harming embryos from which cells were taken, the Washington Post reported.

The scientists extracted a single cell from the embryo (which in-vitro fertilization clinics do when they test for genetic defects) and introduced a molecule called laminin to keep it in a stem cell state.

The research, published in the journal Cell Stem Cell, is the latest in series of advances that may hasten development of stem cell therapies for a number of diseases, the Post reported.

Since this new method doesn't harm the embryo, it should be eligible for U.S. government funding, said study leader Robert Lanza, chief scientific officer at Advance Cell Technology in Massachusetts.

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