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Health Highlights: Jan. 13, 2008

British PM Backs Controversial Organ Donor Program 'Lethargic' Roundworm May Hold Key to Human Sleep NeedsFood 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 Tests

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

British PM Backs Controversial Organ Donor Program

British Prime Minister Gordon Brown is supporting a proposal that would allow doctors to remove organs shortly after a person has died unless there had been an explicit objection made by the patient before his or her death or by family members.

This innovative legal change could eventually presume that anyone in the United Kingdom who had not previously opted out of a national registry would be a posthumous organ donor, the London Sunday Telegraph reports.

Brown wrote an opinion piece in the newspaper explaining his position. "A system of this kind seems to have the potential to close the aching gap between the potential benefits of transplant surgery in the UK and the limits imposed by our current system of consent," Mr Brown wrote.

The presumption provision is not part of the initial program, the Telegraph reports. Instead, the British government will immediately begin a rating program of hospitals for the number of dying patients they "convert" into donors and for doctors who identify potential donors.

The provision has drawn strong criticism from patient rights groups. "They call it presumed consent, but it is no consent at all," the newspaper quotes Joyce Robin from the watchdog organization Patient Concern as saying. "They are relying on inertia and ignorance to get the results that they want."


'Lethargic' Roundworm May Hold Key to Human Sleep Needs

The humble roundworm C. elegans, used in thousands of laboratory experiments, may some day help humans understand and control their sleep patterns.

A team of University of Pennsylvania scientists has found that C. elegans is the perfect model to identify a gene that regulates sleep. The gene is controlled by a small molecule called cyclic GMP, according to a university press release. Cyclic GMP had not been previously thought to play a role in regulating sleep, the researchers said.

However, the findings, reported in the advanced online edition of the journal Nature, suggest that cyclic GMP may play a role in regulating human sleep and may even be used to help develop new drugs for sleep disorders.

The roundworm has a quiet state during its development called lethargus that is very much like sleep, first author Dr. David Raizen says in the news release. "Just as humans are less responsive during sleep, so is the worm during lethargus," says Raizen. "And, just as humans fall asleep faster and sleep deeper following sleep deprivation, so does the worm."

An important finding, Raizen's team reports, is that during the lethargus state, neural changes occur that allow the worm's nervous system to develop. This is the same process as found in mammals, the researchers report.


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.


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.


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.


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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