Tag Archive for 'Stem cell controversy'

Congress can codify sensible National Institutes of Health research rules

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THE SWIRL of controversy that greeted President Obama’s executive order lifting the ban on federal funding of stem cell research in March didn’t make a significant return when the final rules were released over the summer. That’s because the National Institutes of Health successfully navigated a minefield of ethical and moral questions. To protect those regulations from politics and changes by another administration, Rep. Diana DeGette (D-Colo.) soon will introduce the Stem Cell Research Enhancement Act of 2009. The legislation would codify Mr. Obama’s executive order permitting federal funding of such research within guidelines established by the NIH and would require that they be reviewed periodically (…)

Mr. Obama’s executive order overturned one issued by President George W. Bush in 2001 that allowed federal funding only for those stem cell lines already developed. Scientists ultimately found the number of approved lines too few and the utility of those lines limited.

For facilities with stem cell lines developed on or before July 7, the NIH will establish a committee of scientists, ethicists and advocates to examine on a case-by-case basis the procedures and paperwork to determine whether the lines were derived with voluntary informed consent from donors and in a manner consistent with the new rules. This panel would also make the same evaluation of stem cell lines originating outside the United States. There are an estimated 700 stem cell lines already in existence.

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California Stem-cell Institute Makes First Development Grants

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Five years after the passage of Proposition 71, the California Institute of Regenerative Medicine is awarding grants for stem-cell research targeted at clinical applications. In what both the San Diego Union-Tribune and Knight Science Journalism Tracker are calling an “irony,” ten of the 14 grants are going to researchers working with adult stem-cells.

On Thursday, October 29, the New York Times reported: “In a tacit acknowledgment that the promise of human embryonic stem cells is still far in the future, California’s stem cell research program on Wednesday awarded grants intended to develop therapies using mainly other, less controversial cells.

“The $230 million in grants awarded Wednesday to California universities and companies represent a big step toward moving stem cells from basic research toward application in treating diseases like cancer and AIDS. Grant recipients are supposed to have a therapy ready for initial human testing in four years.

“But only four of the 14 projects involve embryonic stem cells. The others will use so-called adult stem cells or conventional drugs intended to kill cancer stem cells, which are thought to give rise to tumors.

“The grants thus represent a departure from the program’s original mission. California voters approved the 10-year, $3 billion effort in 2004 largely to get around restrictions on embryonic stem cell research imposed by the administration of President George W. Bush.”

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Safety call over stem cell trips

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A clampdown on unproven and potentially unsafe stem cell research is being called for by an expert group.
Bionet, a group of expert Chinese and European doctors, lawyers and bioethicists, says countries throughout the world must develop more effective regulation for this emerging science (…)

They had provided a wealth of anecdotal evidence about their concerns that stem cell research was being moved too rapidly into clinical practice without proper study.
He said: “The key is informed consent. Doctors should be able to tell the patient about the short-term and long-term prognosis and the things we don’t know about the risks.”

Bionet is recommending that the safety and efficiency of stem cell treatments is investigated through state-of-the-art clinical trials before they are offered to patients (…)

And there should be quality standards for stem cells used in clinical practice.
These should include the bacterial and viral contamination applied during the production of the stem cells.

China introduced new regulations in May calling for clinical trials before stem cell treatments were offered to patients.
Professor Qui Renzong, vice-president of the ethics committee at the Chinese Ministry of Health, said: “In China there are about 150 institutions now providing stem cell therapy for diabetes through to spinal injuries.” (…)

“When stem cell ‘treatments’ are based overseas, regulatory oversight and jurisdiction is particularly problematic.
We take this very seriously and strongly encourage anyone considering participating in overseas stem cell ‘research trials’ or buying internet treatments to talk to their doctor and follow health guidelines.”

from http://news.bbc.co.uk/2/hi/health/8234206.stm

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SOUTH KOREA – Seoul lifts ban on stem cell research

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The South Korean bioethics committee has lifted a ban on human stem cell research. The decision will now allow for work on human embryonic stem cells to resume after being interrupted three years ago following the scandal involving Hwang Woo-suk, the false “pioneer of human cloning”. The veterinarian, a national hero at the time, fell from grace after the international scientific community and the University of Seoul uncovered that results from his research on embryonic stem cells were falsified in the laboratory to give the impression that his group was successful in cloning healthy cells from cells affected by incurable diseases.

The lifting of the research ban, explained the bioethics committee, involves a hospital in Seoul (Cha General Hospital), which will resume research under four conditions: written approval from women donating eggs (only those from aborted fetuses will be used); the use of laboratory animals to reduce the use of these eggs to a minimum; instituting a surveillance committee to avoid abuses; the names of the studies must not refer to words or meanings that could “feed false hopes”, including mentioning “cure for Parkinson’s”. The decision to lift the ban must receive authorization from the Health Ministry, and in all likelihood, it will not be rejected.

South Korea seems to be following the policy decisions regarding bioethics of the American administration. Among the steps taken by US President Barack Obama, is also the decision to resume financing for human stem cell research with an initial allocation of one billion dollars. “The decision will restart research,” said Chung Hyung-Min, who pointed out that such studies “have been performed by English scientists and other countries” but until now “there have not scored any successes”.

Embryonic stem cell research has sparked a heated worldwide debate involving ethics, science, and the right to life. The position of the Catholic Church has always been that it considers embryos as human lives. In May of 2008, bishops confirmed strongly condemned the revisions of the law on bioethics approved by Parliament, which allow for those who accept to participate in cloning experiments to be eligible for “reimbursements of their expenses”.

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ITALY – Study: Italy furthest behind in the world for stem cell research

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Research in Italy, in the coming years, will suffer much more compared to research in other countries, because, explained a study on the future of biomedical research in Italy described yesterday in Siena by Stefano Palumbo, “the national debate on bioethical issues will continue to be affected by pre-established ideological positions, and often, will be aimed at imposing limits on scientific research”.

Due to the overwhelming “majority of Catholic members in the National Bioethics Committee, Italy will be,” according to the study, “the most conservative country in the world regarding stem cells,” which will result in great delays in finding treatments for serious diseases like “diabetes, Parkinson’s, cancer, Huntington’s, and Alzheimer’s”.

Between 2009 and 2015, Italian research will be affected by the economic crisis, and, according to the study, which was financed by the MPS Foundation and Siena Biotech, “will also be affected by the crisis in the pharmaceutical sector, resulting from the expiration of patents and the inability to replace products whose patents have expired with new products”. According to the experts, Italian research groups will be increasingly dependent on international financing.

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SPAIN – Stem cells obtained without destroying embryo

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A new technique has shown that allowing embryonic stem cell research and having laws that regulate and monitor this type of research does not prevent the development of less ethically controversial techniques, rather, it creates incentives for them. In Valencia, at the same clinic where the first Spanish embryonic stem cell lines were obtained, the same researcher who developed the lines has obtained embryonic stem cells without destroying the embryo.

The announcement was made by Carlos Simòn, making the Centro de Investigaciòn Prìncipe Felipe (CSPF) the third laboratory in the world to succeed with the technique. The first researcher successfully perform this technique was Robert Lanza from Advanced Cell Technology in Boston in 2007 and at the University of California in San Francisco one month later the technique was performed again. The technique used is similar to prenatal diagnosis, which removes a single cell from the embryo. Health Advisor, Manuel Cervera, while presenting these stem cell lines announced the need for this type of work and the willingness to obtain stem cells using this technique.

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