Supreme Court Won't Review Drug Ruling on Terminally Ill Patients
The U.S. Supreme Court said Monday that it will not review a ruling that terminally ill patients don't have a constitutional right to be treated with experimental drugs, the Associated Press reported.
Last year, a federal appeals court supported Food and Drug Administration policy by ruling that the U.S. government may deny access to drugs that haven't been rigorously tested and approved by the FDA, a process that can take years.
In 2003, the FDA was sued by the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation. The groups launched the legal action in an attempt to force the FDA to allow terminally ill patients access to drugs that have undergone preliminary safety testing but haven't been approved by the FDA.
The Abigail Alliance said it was seeking the "right for terminally ill patients with no remaining treatment options to fight for their own lives."
In its decision Monday, the Supreme Court did not explain its decision to reject a review of the appeals court ruling, the AP reported.
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Officials Testing for Possible Bird Flu Outbreak in India
Health officials in India are concerned there may be a possible major bird-flu outbreak after nearly 20,000 chickens died in the past week, Agence France-Presse reported.
Samples from the dead birds have been sent to a laboratory to determine if the H5N1 bird flu virus killed the chickens at the farms in an eastern district of West Bengal state.
"The dead birds showed the flu symptoms," said S.K. Bhowmic, the chief medical officer in the affected district.
West Bengal animal resources development minister Anisur Rehman said preliminary test results suggest bird flu caused the chicken deaths. A final report on test results is expected to be released later on Monday, AFP reported.
In August 2006, India declared itself free of bird flu. But there was an outbreak of bird flu among poultry in India in July 2007.
Since it first appeared in 2003, the H5N1 virus has killed more than 200 people worldwide. Health experts are worried that the virus could mutate, making it easier to transmit among humans, leading to a possible pandemic.
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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 reported.
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," he wrote.
The presumption provision is not part of the initial program, the Telegraph reported. 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 quoted Joyce Robin from the watchdog organization Patient Concern as saying. "They are relying on inertia and ignorance to get the results that they want."
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'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 study author Dr. David Raizen said in the news release. "Just as humans are less responsive during sleep, so is the worm during lethargus," Raizen said. "And, just as humans fall asleep faster and sleep deeper following sleep deprivation, so does the worm."
An important finding, Raizen's team reported, 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 reported.
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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 AP reported.
"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 quoted 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," said 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 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 said in the news release.
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