Five-Year Study Shows ‘Healthy Worker Effect’ At US Paducah Plant
A five-year study into the causes of deaths of workers at
the Paducah Gaseous Diffusion Plant (PGDP) in the US state of Kentucky
shows significantly lower death rates from all causes and cancer in general
when compared to the overall US population.
However, death from lymphatic and bone marrow cancers such as leukemia or
multiple myeloma were slightly above national rates.This result is similar to those reported earlier.
The University of Louisville’s School of Public
Health and Information Sciences, the University of Cincinnati and the
University of Kentucky conducted the study.
Researchers compiled data from employees’ work history, demographic
records and records from the US Social Security Administration, the
National Death Index and individual state departments. They found complete
data for 6,759 of the 6,820 employees who worked at the plant for at least
30 days between September 1952 and December 2009.
Out of those 6,759 people, the researchers identified 1,638 deaths. This
is fewer than the 2,253 deaths that would have been expected in the general
public.
They also found that 461 of the deaths were attributed to cancer, much less than 592, to be expected from comparable sized group in the general public.
Researchers concluded that overall mortality and cancer rates were lower
than the reference population, reflecting a “strong healthy worker effect”.
This effect is well known by epidemiologists. Regular medical check-ups and
better early care for health problems among workers in industries such as
nuclear result in generally better health for these workers compared to the
average population.
PGDP is the only gas-diffusion enrichment facility still operating in the
US. Two other plants existed at Oak Ridge, Tennessee and Piketon, Ohio.
Studies had been conducted for these plants, but none had yet been
conducted for PGDP.
David Tollerud, professor of environmental and occupational health
sciences at the University of Louisville’s School of Public Health and
Information Sciences, said the study addressed lingering concerns about the
health of workers at the plant.
He said: “It is important for occupational health and public health
research to attempt to answer pressing concerns of impacted populations,
and we were able to report that we didn't find unexpectedly high rates of
disease in this workforce.”
Security workers had higher overall death rates than other employees,
while chemical operators had higher death rates from leukemia and multiple
myeloma than the rest of the workers.
The increased number of lymphatic and bone marrow cancer deaths is
consistent with what researchers expected, Mr Tollerud said. “Based on
other studies, these forms of cancer have been linked to low levels of
radiation exposure.”
The Paducah plant was commissioned in 1952 as part of a US government
programme to produce enriched uranium to fuel military reactors and nuclear
weapons.
The plant’s mission changed in the 1960s from enriching uranium for
nuclear weapons to enriching uranium for use in commercial nuclear reactors
to generate electricity. It is owned by the US. Department of Energy and is
leased and operated by the United States Enrichment Corporation, a
subsidiary of USEC Inc.
The study, titled ‘Mortality among PGDP workers,’ was published in the
July 2010 edition of the Journal of Occupational and Environmental Medicine
(www.joem.org).
>
Wednesday, August 11, 2010
Monday, August 9, 2010
FDA Gives Green Light to First Embryonic Stem Cell Trial in Humans
On July 30, 2010, Geron Corporation , a company developing biopharmaceuticals to treat cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes announced that the U.S. Food and Drug Administration (FDA) has notified them that the clinical hold placed on its Investigational New Drug (IND) application has been lifted and the company's Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may proceed.
It is the first embryonic stem cell clinical trial approved by the FDA.
The Phase I multi-center trial may hopefully establish the safety of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) Impairment Scale grade A sub-acute thoracic spinal cord injuries.
"We are pleased with the FDA's decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed," said Thomas B. Okarma, Ph.D., M.D., Geron's president and CEO. "Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged - to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord. Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer's, multiple sclerosis and Canavan disease."
FDA placed a hold on the trial following results from a single preclinical animal study in which Geron observed a higher frequency of small cysts within the injury site in the spinal cord of animals injected with GRNOPC1 than had previously been noted in numerous foregoing studies.
In response to those results, Geron developed new markers and assays as additional release specifications for GRNOPC1. The company completed an additional confirmatory preclinical animal study to test the new markers and assays, and subsequently submitted a request to the FDA for the clinical hold to be lifted.
GRNOPC1, Geron's lead hESC-based therapeutic candidate, contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury (Journal of Neuroscience, Vol. 25, 2005).
"The neurosurgical community is ready to begin the clinical testing of this new approach to treating devastating spinal cord injury," said Richard Fessler, M.D., Ph.D., professor of neurological surgery at the Feinberg School of Medicine at Northwestern University. "We know that demyelination is central to the pathology of the injury, and its reversal by means of injecting oligodendrocyte progenitor cells would be revolutionary for the field. If found to be safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."
The GRNOPC1 Clinical Program
Patients eligible for the Phase I trial must have documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T10 spinal segments and agree to have GRNOPC1 injected into the lesion sites between seven and 14 days after injury.
Although the primary endpoint of the trial is safety, the protocol includes secondary endpoints to assess efficacy, such as improved neuromuscular control or sensation in the trunk or lower extremities. Once safety in this patient population has been established, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1, enroll subjects with complete cervical injuries and expand the trial to include patients with severe incomplete (ASIA Impairment Scale grade B or C) injuries to enable access to the therapy for as broad a population of severe spinal cord-injured patients as is medically appropriate.
Geron has selected up to seven U.S. medical centers as candidates to participate in this study and in planned protocol extensions. The sites will be identified as they come online and are ready to enroll subjects into the study.
Other Potential Neurological Indications for GRNOPC1
Geron claimed that in addition to spinal cord injury, GRNOPC1 may have therapeutic utility for other central nervous system indications. It has established many collaborations with academic groups to test GRNOPC1 in selected animal models of human disease for which there is a strong rationale for the approach.
The company listed other areas of work in which it is actively involved.
Alzheimer's Disease: Alzheimer's disease is a progressive, fatal, degenerative disorder that attacks the neurons in the brain, resulting in loss of memory, cognitive function such as reasoning and language, and behavioral changes. According to the Alzheimer's Association an estimated five million people in the United States have Alzheimer's disease. GRNOPC1 is being evaluated in animal models of Alzheimer's disease in collaboration with Professor Frank M. LaFerla, Director of the Institute for Memory Impairments and Neurological Disorders (UCI MIND) at the University of California, Irvine.
Multiple Sclerosis (MS): MS is an autoimmune disease that causes demyelination of nerve axons in the brain and spinal cord often progressing to physical and cognitive disability. There is currently no known cure for the disease. According to the National Multiple Sclerosis Society there are about 400,000 people in the United States with MS. GRNOPC1 is being tested in a non-human primate model of MS in collaboration with Professor Jeffery D. Kocsis of the Departments of Neurology and Neurobiology at Yale University School of Medicine and the Department of Veterans Affairs.
Canavan Disease: Canavan disease is a fatal neurological disorder that belongs to a group of genetic disorders called leukodystrophies, characterized by the abnormal development or degeneration of myelin. Symptoms of Canavan disease present in the first six months of life and death usually occurs at 3 - 10 years of age. GRNOPC1 is being tested in a rodent model of Canavan disease in collaboration with Dr. Paola Leone, Director of the Cell and Gene Therapy Center, at the University of Medicine and Dentistry of New Jersey.
It is the first embryonic stem cell clinical trial approved by the FDA.
The Phase I multi-center trial may hopefully establish the safety of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) Impairment Scale grade A sub-acute thoracic spinal cord injuries.
"We are pleased with the FDA's decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed," said Thomas B. Okarma, Ph.D., M.D., Geron's president and CEO. "Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged - to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord. Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer's, multiple sclerosis and Canavan disease."
FDA placed a hold on the trial following results from a single preclinical animal study in which Geron observed a higher frequency of small cysts within the injury site in the spinal cord of animals injected with GRNOPC1 than had previously been noted in numerous foregoing studies.
In response to those results, Geron developed new markers and assays as additional release specifications for GRNOPC1. The company completed an additional confirmatory preclinical animal study to test the new markers and assays, and subsequently submitted a request to the FDA for the clinical hold to be lifted.
GRNOPC1, Geron's lead hESC-based therapeutic candidate, contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury (Journal of Neuroscience, Vol. 25, 2005).
"The neurosurgical community is ready to begin the clinical testing of this new approach to treating devastating spinal cord injury," said Richard Fessler, M.D., Ph.D., professor of neurological surgery at the Feinberg School of Medicine at Northwestern University. "We know that demyelination is central to the pathology of the injury, and its reversal by means of injecting oligodendrocyte progenitor cells would be revolutionary for the field. If found to be safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."
The GRNOPC1 Clinical Program
Patients eligible for the Phase I trial must have documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T10 spinal segments and agree to have GRNOPC1 injected into the lesion sites between seven and 14 days after injury.
Although the primary endpoint of the trial is safety, the protocol includes secondary endpoints to assess efficacy, such as improved neuromuscular control or sensation in the trunk or lower extremities. Once safety in this patient population has been established, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1, enroll subjects with complete cervical injuries and expand the trial to include patients with severe incomplete (ASIA Impairment Scale grade B or C) injuries to enable access to the therapy for as broad a population of severe spinal cord-injured patients as is medically appropriate.
Geron has selected up to seven U.S. medical centers as candidates to participate in this study and in planned protocol extensions. The sites will be identified as they come online and are ready to enroll subjects into the study.
Other Potential Neurological Indications for GRNOPC1
Geron claimed that in addition to spinal cord injury, GRNOPC1 may have therapeutic utility for other central nervous system indications. It has established many collaborations with academic groups to test GRNOPC1 in selected animal models of human disease for which there is a strong rationale for the approach.
The company listed other areas of work in which it is actively involved.
Alzheimer's Disease: Alzheimer's disease is a progressive, fatal, degenerative disorder that attacks the neurons in the brain, resulting in loss of memory, cognitive function such as reasoning and language, and behavioral changes. According to the Alzheimer's Association an estimated five million people in the United States have Alzheimer's disease. GRNOPC1 is being evaluated in animal models of Alzheimer's disease in collaboration with Professor Frank M. LaFerla, Director of the Institute for Memory Impairments and Neurological Disorders (UCI MIND) at the University of California, Irvine.
Multiple Sclerosis (MS): MS is an autoimmune disease that causes demyelination of nerve axons in the brain and spinal cord often progressing to physical and cognitive disability. There is currently no known cure for the disease. According to the National Multiple Sclerosis Society there are about 400,000 people in the United States with MS. GRNOPC1 is being tested in a non-human primate model of MS in collaboration with Professor Jeffery D. Kocsis of the Departments of Neurology and Neurobiology at Yale University School of Medicine and the Department of Veterans Affairs.
Canavan Disease: Canavan disease is a fatal neurological disorder that belongs to a group of genetic disorders called leukodystrophies, characterized by the abnormal development or degeneration of myelin. Symptoms of Canavan disease present in the first six months of life and death usually occurs at 3 - 10 years of age. GRNOPC1 is being tested in a rodent model of Canavan disease in collaboration with Dr. Paola Leone, Director of the Cell and Gene Therapy Center, at the University of Medicine and Dentistry of New Jersey.
Saturday, August 7, 2010
Genes from sweet pepper can fortify African banana against devastating wilt disease
Genes from sweet pepper can fortify African banana against devastating wilt disease
The BXW or Banana Xanthomonas Wilt is the tongue twisting name of a disease which wipes out banana in vast areas in the Great lake region of Africa. It costs about half a billion dollars worth of damage every year across East and Central Africa. The leaves of affected crops turn yellow and then wilt, and the fruit ripens unevenly and prematurely. Eventually the entire plant withers and rots.
Crop scientists announced today the successful transfer of green pepper genes to bananas, conferring on the popular fruit the means to resist the disease.
Dr. Leena Tripathi, a biotechnologist with International Institute of Tropical Agriculture (IITA) and lead author of the paper, said there is still a long way to go before the transgenic bananas find their way onto farmers' fields, but she called the breakthrough "a significant step in the fight against the deadly banana disease."
The transformed bananas, newly-infused with one of two proteins from the green pepper, have shown strong resistance to Xanthomonas wilt in the laboratory and in screen houses. The researchers are poised to begin confined field trials in Uganda soon.
Some of the findings on the protective impact of the two proteins—plant ferredoxin-like amphipathic protein (Pflp) and hypersensitive response-assisting protein (Hrap)—were published recently in the journal Molecular Plant Pathology.
"The Hrap and Pflp genes work by rapidly killing the cells that come into contact with the disease-spreading bacteria, essentially blocking it from spreading any further," Tripathi said. "Hopefully, this will boost the arsenal available to fight BXW and help save millions of farmers' livelihoods in the Great Lakes region."
The novel green pepper proteins that give crops enhanced resistance against deadly pathogens can also provide effective control against other BXW-like bacterial diseases in other parts of the world. Tripathi adds that the mechanism known as Hypersensitivity Response also activates the defenses of surrounding and even distant uninfected banana plants leading to a systemic acquired resistance.
Scientists from the IITA and the National Agricultural Research Organisation (NARO) of Uganda, in partnership with African Agricultural Technology Foundation (AATF), will soon begin evaluating these promising new banana lines under confined field trials. The Ugandan National Biosafety Committee recently approved the tests, which can now move forward.
The genes used in this research were acquired under an agreement from the Academia Sinica in Taiwan.
The highly destructive BXW affects all varieties, including the East African Highland bananas and exotic dessert, roasting, and beer bananas. The crop is also under threat from another deadly disease, the banana bunchy top.
Dr. Tripathi says that there are presently no commercial chemicals, biocontrol agents or resistant varieties that can control the spread of BXW. "Even if a source of resistance is identified today," Tripathi said, "developing a truly resistant banana through conventional breeding would be extremely difficult and would take years, even decades, given the crop's sterility and its long gestation period."
BXW was first reported in Ethiopia 40 years ago on Ensete, a crop relative of banana, before it moved on to bananas. Outside of Ethiopia, it was first reported in Uganda in 2001, then rapidly spread to the Democratic Republic of Congo, Rwanda, Kenya, Tanzania, and Burundi, leaving behind a trail of destruction in Africa's largest banana producing and consuming region.
BXW can be managed by de-budding the banana plant (removing the male bud as soon as the last hand of the female bunch is revealed) and sterilizing farm implements used. However, the adoption of these practices has been inconsistent at best as farmers believe that de-budding affects the quality of the fruit and sterilizing farm tools is a tedious task.
The research to fortify bananas against BXW using genes from sweet pepper was initiated in 2007.
The BXW or Banana Xanthomonas Wilt is the tongue twisting name of a disease which wipes out banana in vast areas in the Great lake region of Africa. It costs about half a billion dollars worth of damage every year across East and Central Africa. The leaves of affected crops turn yellow and then wilt, and the fruit ripens unevenly and prematurely. Eventually the entire plant withers and rots.
Crop scientists announced today the successful transfer of green pepper genes to bananas, conferring on the popular fruit the means to resist the disease.
Dr. Leena Tripathi, a biotechnologist with International Institute of Tropical Agriculture (IITA) and lead author of the paper, said there is still a long way to go before the transgenic bananas find their way onto farmers' fields, but she called the breakthrough "a significant step in the fight against the deadly banana disease."
The transformed bananas, newly-infused with one of two proteins from the green pepper, have shown strong resistance to Xanthomonas wilt in the laboratory and in screen houses. The researchers are poised to begin confined field trials in Uganda soon.
Some of the findings on the protective impact of the two proteins—plant ferredoxin-like amphipathic protein (Pflp) and hypersensitive response-assisting protein (Hrap)—were published recently in the journal Molecular Plant Pathology.
"The Hrap and Pflp genes work by rapidly killing the cells that come into contact with the disease-spreading bacteria, essentially blocking it from spreading any further," Tripathi said. "Hopefully, this will boost the arsenal available to fight BXW and help save millions of farmers' livelihoods in the Great Lakes region."
The novel green pepper proteins that give crops enhanced resistance against deadly pathogens can also provide effective control against other BXW-like bacterial diseases in other parts of the world. Tripathi adds that the mechanism known as Hypersensitivity Response also activates the defenses of surrounding and even distant uninfected banana plants leading to a systemic acquired resistance.
Scientists from the IITA and the National Agricultural Research Organisation (NARO) of Uganda, in partnership with African Agricultural Technology Foundation (AATF), will soon begin evaluating these promising new banana lines under confined field trials. The Ugandan National Biosafety Committee recently approved the tests, which can now move forward.
The genes used in this research were acquired under an agreement from the Academia Sinica in Taiwan.
The highly destructive BXW affects all varieties, including the East African Highland bananas and exotic dessert, roasting, and beer bananas. The crop is also under threat from another deadly disease, the banana bunchy top.
Dr. Tripathi says that there are presently no commercial chemicals, biocontrol agents or resistant varieties that can control the spread of BXW. "Even if a source of resistance is identified today," Tripathi said, "developing a truly resistant banana through conventional breeding would be extremely difficult and would take years, even decades, given the crop's sterility and its long gestation period."
BXW was first reported in Ethiopia 40 years ago on Ensete, a crop relative of banana, before it moved on to bananas. Outside of Ethiopia, it was first reported in Uganda in 2001, then rapidly spread to the Democratic Republic of Congo, Rwanda, Kenya, Tanzania, and Burundi, leaving behind a trail of destruction in Africa's largest banana producing and consuming region.
BXW can be managed by de-budding the banana plant (removing the male bud as soon as the last hand of the female bunch is revealed) and sterilizing farm implements used. However, the adoption of these practices has been inconsistent at best as farmers believe that de-budding affects the quality of the fruit and sterilizing farm tools is a tedious task.
The research to fortify bananas against BXW using genes from sweet pepper was initiated in 2007.
Sunday, July 25, 2010
Why MRC did not fund IVF research that led to Louise Brown, the first test tube baby?
Why MRC didn't fund IVF research that led to the birth of the world's first test tube baby
Louise Brown, the first “test tube baby” was born on July 25, 1978. Since then, an estimated 4.3 million babies have been born worldwide with the help of a range of fertility treatments.
The UK Medical Research Council refused to fund the research on In Vitro Fertilization which led to the breakthrough. Finally, the project funds came from a private trust
For the first time, the reasons for MRC’s denial for funding, was disclosed in a paper published in Europe's leading reproductive medicine journal Human Reproduction.
The authors of the new research, led by Martin Johnson, Professor of Reproductive Sciences at the University of Cambridge, and funded by the Wellcome Trust, write: "The failure of Edwards' and Steptoe's application for long-term support was not simply due to widespread establishment hostility to IVF. It failed, we argue for more complex reasons".
They listed the following reasons:
• A strategic error by Edwards and Steptoe when they declined an invitation from the MRC to join a new, directly funded Clinical Research Centre at Northwick Park Hospital, Harrow. They preferred to ask for long-term grant support at the University of Cambridge, but this meant they had to compete for funding with all the other research projects bidding for MRC support. This was also difficult for Cambridge, which lacked the back-up of an academic Department of Obstetrics and Gynaecology at that time.
• Most of the MRC referees who were consulted on the proposal considered, in line with government policy, that it was more important to limit fertility and the growth of Britain's population than to treat infertility. Treating infertility was seen as experimental research rather than as therapeutic.
• Concerns about embryo quality (would babies be born with severe abnormalities?) and patient safety made the referees doubt the wisdom of funding embryo transfer without conducting studies in primates first.
• Edwards' and Steptoe's high profile in the media antagonised the referees who strongly disapproved of this method of public discussion of the science and ethics of treating infertility.
Additionally, MRC saw Edwards and Steptoe as not being part of the "medical establishment". "Steptoe came from a minor northern hospital, while Edwards, though from Cambridge, was neither medically qualified nor yet a professor." Prof Johnson and his colleagues clarified..
Edwards had a PhD in developmental genetics from the Institute of Animal Genetics at the University of Edinburgh, then the leading UK centre in the field.
According to Professor Johnson the MRC's negative decision on funding of IVF, and their public defence of this decision, had major consequences for Edwards and Steptoe and set MRC policy on IVF research funding for the next eight years.
MRC reversed their decision after the birth of two healthy babies from seven IVF pregnancies. The MRC announced a change of policy in its 1978/79 Annual Report. Thereafter, MRC became a strong and major supporter of research on human IVF and human embryos; although not on follow-up of IVF pregnancies.
Prof Johnson and his colleagues, Sarah Franklin, Matthew Cottingham and Nick Hopwood, spent three years studying the MRC records at the National Archives at Kew in Surrey, and also documents from the Royal College of Obstetricians and Gynaecologists, Addenbrooke's Hospital, Cambridgeshire County Council and Cambridge University Library.
Bob Edwards' wife, Ruth, gave them access to his private papers, and the researchers also interviewed many of the key players involved in the MRC's decision in 1971 not to fund the research.
In an accompanying editorial, Professor John Biggers from Harvard Medical School (USA), writes: "By taking us back 40 years, the authors have demonstrated the importance of understanding a decision in light of the culture and circumstances at the time the decision was made. Although the grant was rejected, Edwards' and Steptoe's visions and persistence have benefited an enormous number of infertile people, both male and female."
The researchers observations are very interesting. According to Prof Johnson the story of the MRC's non-funding of IVF belies the cliché that science 'races ahead' of society. Similarly, the standard view, that ethical consideration of bioscience and biomedicine can only ever be reactive, is contradicted by the evidence of extensive ethical debate surrounding the prehistory of clinical IVF – most of it actively stimulated by Edwards himself.
The developments preceding the great breakthrough revealed a few other facts. Although attitudes to medical scientists in the media have changed significantly since the 1970s, scientists and clinicians engaged in high-profile work still face a dilemma. If they encourage public discussion of their work – which they may see as both necessary to securing support and desirable to ensure full ethical debate – must they inevitably weaken their standing among their peers?
The researchers claimed that their case study questions the myth of two courageous mavericks pitted against a conservative establishment. “This myth does capture important elements of truth: Edwards and Steptoe were outsiders and did pioneer—against prevailing wisdom—new ideas, therapies, values, public discourses and ethical thinking. But the process of decision-making was more complex than the myth allows. Our research provides a fuller understanding of what happened at the birth of the IVF revolution." They noted
Prof Johnson believes that today the decision-making processes involved in awarding funding for projects are more open and transparent, with discussion in the wider community and in the media actively welcomed, as was the case with the two Human Fertilisation and Embryology Acts in 1990 and 2008.
"A continuing problem, however, is more to do with the fact that there are some very fashionable topics that can create a buzz and attract huge research interest and funding, sometimes in disproportionate amounts; then it was fertility limitation, more recently genome sequencing would be an example. This can leave other Cinderella topics languishing in the ashes, with little financial support, even though they might well play an equally, if not more, important role in patient welfare."
Louise Brown, the first “test tube baby” was born on July 25, 1978. Since then, an estimated 4.3 million babies have been born worldwide with the help of a range of fertility treatments.
The UK Medical Research Council refused to fund the research on In Vitro Fertilization which led to the breakthrough. Finally, the project funds came from a private trust
For the first time, the reasons for MRC’s denial for funding, was disclosed in a paper published in Europe's leading reproductive medicine journal Human Reproduction.
The authors of the new research, led by Martin Johnson, Professor of Reproductive Sciences at the University of Cambridge, and funded by the Wellcome Trust, write: "The failure of Edwards' and Steptoe's application for long-term support was not simply due to widespread establishment hostility to IVF. It failed, we argue for more complex reasons".
They listed the following reasons:
• A strategic error by Edwards and Steptoe when they declined an invitation from the MRC to join a new, directly funded Clinical Research Centre at Northwick Park Hospital, Harrow. They preferred to ask for long-term grant support at the University of Cambridge, but this meant they had to compete for funding with all the other research projects bidding for MRC support. This was also difficult for Cambridge, which lacked the back-up of an academic Department of Obstetrics and Gynaecology at that time.
• Most of the MRC referees who were consulted on the proposal considered, in line with government policy, that it was more important to limit fertility and the growth of Britain's population than to treat infertility. Treating infertility was seen as experimental research rather than as therapeutic.
• Concerns about embryo quality (would babies be born with severe abnormalities?) and patient safety made the referees doubt the wisdom of funding embryo transfer without conducting studies in primates first.
• Edwards' and Steptoe's high profile in the media antagonised the referees who strongly disapproved of this method of public discussion of the science and ethics of treating infertility.
Additionally, MRC saw Edwards and Steptoe as not being part of the "medical establishment". "Steptoe came from a minor northern hospital, while Edwards, though from Cambridge, was neither medically qualified nor yet a professor." Prof Johnson and his colleagues clarified..
Edwards had a PhD in developmental genetics from the Institute of Animal Genetics at the University of Edinburgh, then the leading UK centre in the field.
According to Professor Johnson the MRC's negative decision on funding of IVF, and their public defence of this decision, had major consequences for Edwards and Steptoe and set MRC policy on IVF research funding for the next eight years.
MRC reversed their decision after the birth of two healthy babies from seven IVF pregnancies. The MRC announced a change of policy in its 1978/79 Annual Report. Thereafter, MRC became a strong and major supporter of research on human IVF and human embryos; although not on follow-up of IVF pregnancies.
Prof Johnson and his colleagues, Sarah Franklin, Matthew Cottingham and Nick Hopwood, spent three years studying the MRC records at the National Archives at Kew in Surrey, and also documents from the Royal College of Obstetricians and Gynaecologists, Addenbrooke's Hospital, Cambridgeshire County Council and Cambridge University Library.
Bob Edwards' wife, Ruth, gave them access to his private papers, and the researchers also interviewed many of the key players involved in the MRC's decision in 1971 not to fund the research.
In an accompanying editorial, Professor John Biggers from Harvard Medical School (USA), writes: "By taking us back 40 years, the authors have demonstrated the importance of understanding a decision in light of the culture and circumstances at the time the decision was made. Although the grant was rejected, Edwards' and Steptoe's visions and persistence have benefited an enormous number of infertile people, both male and female."
The researchers observations are very interesting. According to Prof Johnson the story of the MRC's non-funding of IVF belies the cliché that science 'races ahead' of society. Similarly, the standard view, that ethical consideration of bioscience and biomedicine can only ever be reactive, is contradicted by the evidence of extensive ethical debate surrounding the prehistory of clinical IVF – most of it actively stimulated by Edwards himself.
The developments preceding the great breakthrough revealed a few other facts. Although attitudes to medical scientists in the media have changed significantly since the 1970s, scientists and clinicians engaged in high-profile work still face a dilemma. If they encourage public discussion of their work – which they may see as both necessary to securing support and desirable to ensure full ethical debate – must they inevitably weaken their standing among their peers?
The researchers claimed that their case study questions the myth of two courageous mavericks pitted against a conservative establishment. “This myth does capture important elements of truth: Edwards and Steptoe were outsiders and did pioneer—against prevailing wisdom—new ideas, therapies, values, public discourses and ethical thinking. But the process of decision-making was more complex than the myth allows. Our research provides a fuller understanding of what happened at the birth of the IVF revolution." They noted
Prof Johnson believes that today the decision-making processes involved in awarding funding for projects are more open and transparent, with discussion in the wider community and in the media actively welcomed, as was the case with the two Human Fertilisation and Embryology Acts in 1990 and 2008.
"A continuing problem, however, is more to do with the fact that there are some very fashionable topics that can create a buzz and attract huge research interest and funding, sometimes in disproportionate amounts; then it was fertility limitation, more recently genome sequencing would be an example. This can leave other Cinderella topics languishing in the ashes, with little financial support, even though they might well play an equally, if not more, important role in patient welfare."
Monday, July 5, 2010
WSU researchers use super-high pressures to create super battery
Public release date: 4-Jul-2010
Contact: Choong-Shik Yoo
csyoo@wsu.edu
925-640-7549
Washington State University
WSU researchers use super-high pressures to create super battery
'Most condensed form of energy storage outside of nuclear energy'
PULLMAN, Wash.—The world's biggest Roman candle has got nothing on this.
Using super-high pressures similar to those found deep in the Earth or on a giant planet, Washington State University researchers have created a compact, never-before-seen material capable of storing vast amounts of energy.
"If you think about it, it is the most condensed form of energy storage outside of nuclear energy," says Choong-Shik Yoo, a WSU chemistry professor and lead author of results published in the journal Nature Chemistry.
The research is basic science, but Yoo says it shows it is possible to store mechanical energy into the chemical energy of a material with such strong chemical bonds. Possible future applications include creating a new class of energetic materials or fuels, an energy storage device, super-oxidizing materials for destroying chemical and biological agents, and high-temperature superconductors.
The researchers created the material on the Pullman campus in a diamond anvil cell, a small, two-inch by three-inch-diameter device capable of producing extremely high pressures in a small space. The cell contained xenon difluoride (XeF2), a white crystal used to etch silicon conductors, squeezed between two small diamond anvils.
At normal atmospheric pressure, the material's molecules stay relatively far apart from each other. But as researchers increased the pressure inside the chamber, the material became a two-dimensional graphite-like semiconductor. The researchers eventually increased the pressure to more than a million atmospheres, comparable to what would be found halfway to the center of the earth. All this "squeezing," as Yoo calls it, forced the molecules to make tightly bound three-dimensional metallic "network structures." In the process, the huge amount of mechanical energy of compression was stored as chemical energy in the molecules' bonds.
###
Financial support for the research came from the U.S. Department of Defense's Defense Threat Reduction Agency and the National Science Foundation.
Contact: Choong-Shik Yoo
csyoo@wsu.edu
925-640-7549
Washington State University
WSU researchers use super-high pressures to create super battery
'Most condensed form of energy storage outside of nuclear energy'
PULLMAN, Wash.—The world's biggest Roman candle has got nothing on this.
Using super-high pressures similar to those found deep in the Earth or on a giant planet, Washington State University researchers have created a compact, never-before-seen material capable of storing vast amounts of energy.
"If you think about it, it is the most condensed form of energy storage outside of nuclear energy," says Choong-Shik Yoo, a WSU chemistry professor and lead author of results published in the journal Nature Chemistry.
The research is basic science, but Yoo says it shows it is possible to store mechanical energy into the chemical energy of a material with such strong chemical bonds. Possible future applications include creating a new class of energetic materials or fuels, an energy storage device, super-oxidizing materials for destroying chemical and biological agents, and high-temperature superconductors.
The researchers created the material on the Pullman campus in a diamond anvil cell, a small, two-inch by three-inch-diameter device capable of producing extremely high pressures in a small space. The cell contained xenon difluoride (XeF2), a white crystal used to etch silicon conductors, squeezed between two small diamond anvils.
At normal atmospheric pressure, the material's molecules stay relatively far apart from each other. But as researchers increased the pressure inside the chamber, the material became a two-dimensional graphite-like semiconductor. The researchers eventually increased the pressure to more than a million atmospheres, comparable to what would be found halfway to the center of the earth. All this "squeezing," as Yoo calls it, forced the molecules to make tightly bound three-dimensional metallic "network structures." In the process, the huge amount of mechanical energy of compression was stored as chemical energy in the molecules' bonds.
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Financial support for the research came from the U.S. Department of Defense's Defense Threat Reduction Agency and the National Science Foundation.
Monday, June 21, 2010
Using carbon nanotubes in lithium batteries can dramatically improve energy capacity
Public release date: 20-Jun-2010
Contact: Jennifer Hirsch
jfhirsch@mit.edu
617-253-1682
Massachusetts Institute of Technology
Using carbon nanotubes in lithium batteries can dramatically improve energy capacity
New method produced up to ten fold increase in power
CAMBRIDGE, Mass. -- Batteries might gain a boost in power capacity as a result of a new finding from researchers at MIT. They found that using carbon nanotubes for one of the battery's electrodes produced a significant increase — up to tenfold — in the amount of power it could deliver from a given weight of material, compared to a conventional lithium-ion battery. Such electrodes might find applications in small portable devices, and with further research might also lead to improved batteries for larger, more power-hungry applications.
To produce the powerful new electrode material, the team used a layer-by-layer fabrication method, in which a base material is alternately dipped in solutions containing carbon nanotubes that have been treated with simple organic compounds that give them either a positive or negative net charge. When these layers are alternated on a surface, they bond tightly together because of the complementary charges, making a stable and durable film.
The findings, by a team led by Associate Professor of Mechanical Engineering and Materials Science and Engineering Yang Shao-Horn, in collaboration with Bayer Chair Professor of Chemical Engineering Paula Hammond, are reported in a paper published June 20 in the journal Nature Nanotechnology. The lead authors are chemical engineering student Seung Woo Lee PhD '10 and postdoctoral researcher Naoaki Yabuuchi.
Batteries, such as the lithium-ion batteries widely used in portable electronics, are made up of three basic components: two electrodes (called the anode, or negative electrode, and the cathode, or positive electrode) separated by an electrolyte, an electrically conductive material through which charged particles, or ions, can move easily. When these batteries are in use, positively charged lithium ions travel across the electrolyte to the cathode, producing an electric current; when they are recharged, an external current causes these ions to move the opposite way, so they become embedded in the spaces in the porous material of the anode.
In the new battery electrode, carbon nanotubes — a form of pure carbon in which sheets of carbon atoms are rolled up into tiny tubes — "self-assemble" into a tightly bound structure that is porous at the nanometer scale (billionths of a meter). In addition, the carbon nanotubes have many oxygen groups on their surfaces, which can store a large number of lithium ions; this enables carbon nanotubes for the first time to serve as the positive electrode in lithium batteries, instead of just the negative electrode.
This "electrostatic self-assembly" process is important, Hammond explains, because ordinarily carbon nanotubes on a surface tend to clump together in bundles, leaving fewer exposed surfaces to undergo reactions. By incorporating organic molecules on the nanotubes, they assemble in a way that "has a high degree of porosity while having a great number of nanotubes present," she says.
Lithium batteries with the new material demonstrate some of the advantages of both capacitors, which can produce very high power outputs in short bursts, and lithium batteries, which can provide lower power steadily for long periods, Lee says. The energy output for a given weight of this new electrode material was shown to be five times greater than for conventional capacitors, and the total power delivery rate was 10 times that of lithium-ion batteries, the team says. This performance can be attributed to good conduction of ions and electrons in the electrode, and efficient lithium storage on the surface of the nanotubes.
In addition to their high power output, the carbon nanotube electrodes showed very good stability over time. After 1,000 cycles of charging and discharging a test battery, there was no detectable change in the material's performance.
The electrodes the team produced had thicknesses up to a few microns, and the improvements in energy delivery only were seen at high-power output levels. In future work, the team aims to produce thicker electrodes and extend the improved performance to low-power outputs as well, they say. In its present form, the material might have applications for small, portable electronic devices, says Shao-Horn, but if the reported high power capability were demonstrated in a much thicker form — with thicknesses of hundreds of microns rather than just a few — it might eventually be suitable for other applications such as hybrid cars.
While the electrode material was produced by alternately dipping a substrate into two different solutions — a relatively time-consuming process — Hammond suggests that the process could be modified by instead spraying the alternate layers onto a moving ribbon of material, a technique now being developed in her lab. This could eventually open the possibility of a continuous manufacturing process that could be scaled up to high volumes for commercial production, and could also be used to produce thicker electrodes with a greater power capacity. "There isn't a real limit" on the potential thickness, Hammond says. "The only limit is the time it takes to make the layers," and the spraying technique can be up to 100 times faster than dipping, she says.
Lee says that while carbon nanotubes have been produced in limited quantities so far, a number of companies are currently gearing up for mass production of the material, which could help to make it a viable material for large-scale battery manufacturing.
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Source: "High-power lithium batteries from functionalized carbon nanotube electrodes." Seung Woo Lee, Naoaki Yabuuchi, Betar M. Gallant, Shuo Chen, Byeong-Su Kim, Paula T. Hammond, & Yang Shao-Horn. Nature Nanotechnology. 19 June 2010.
Contact: Jennifer Hirsch
jfhirsch@mit.edu
617-253-1682
Massachusetts Institute of Technology
Using carbon nanotubes in lithium batteries can dramatically improve energy capacity
New method produced up to ten fold increase in power
CAMBRIDGE, Mass. -- Batteries might gain a boost in power capacity as a result of a new finding from researchers at MIT. They found that using carbon nanotubes for one of the battery's electrodes produced a significant increase — up to tenfold — in the amount of power it could deliver from a given weight of material, compared to a conventional lithium-ion battery. Such electrodes might find applications in small portable devices, and with further research might also lead to improved batteries for larger, more power-hungry applications.
To produce the powerful new electrode material, the team used a layer-by-layer fabrication method, in which a base material is alternately dipped in solutions containing carbon nanotubes that have been treated with simple organic compounds that give them either a positive or negative net charge. When these layers are alternated on a surface, they bond tightly together because of the complementary charges, making a stable and durable film.
The findings, by a team led by Associate Professor of Mechanical Engineering and Materials Science and Engineering Yang Shao-Horn, in collaboration with Bayer Chair Professor of Chemical Engineering Paula Hammond, are reported in a paper published June 20 in the journal Nature Nanotechnology. The lead authors are chemical engineering student Seung Woo Lee PhD '10 and postdoctoral researcher Naoaki Yabuuchi.
Batteries, such as the lithium-ion batteries widely used in portable electronics, are made up of three basic components: two electrodes (called the anode, or negative electrode, and the cathode, or positive electrode) separated by an electrolyte, an electrically conductive material through which charged particles, or ions, can move easily. When these batteries are in use, positively charged lithium ions travel across the electrolyte to the cathode, producing an electric current; when they are recharged, an external current causes these ions to move the opposite way, so they become embedded in the spaces in the porous material of the anode.
In the new battery electrode, carbon nanotubes — a form of pure carbon in which sheets of carbon atoms are rolled up into tiny tubes — "self-assemble" into a tightly bound structure that is porous at the nanometer scale (billionths of a meter). In addition, the carbon nanotubes have many oxygen groups on their surfaces, which can store a large number of lithium ions; this enables carbon nanotubes for the first time to serve as the positive electrode in lithium batteries, instead of just the negative electrode.
This "electrostatic self-assembly" process is important, Hammond explains, because ordinarily carbon nanotubes on a surface tend to clump together in bundles, leaving fewer exposed surfaces to undergo reactions. By incorporating organic molecules on the nanotubes, they assemble in a way that "has a high degree of porosity while having a great number of nanotubes present," she says.
Lithium batteries with the new material demonstrate some of the advantages of both capacitors, which can produce very high power outputs in short bursts, and lithium batteries, which can provide lower power steadily for long periods, Lee says. The energy output for a given weight of this new electrode material was shown to be five times greater than for conventional capacitors, and the total power delivery rate was 10 times that of lithium-ion batteries, the team says. This performance can be attributed to good conduction of ions and electrons in the electrode, and efficient lithium storage on the surface of the nanotubes.
In addition to their high power output, the carbon nanotube electrodes showed very good stability over time. After 1,000 cycles of charging and discharging a test battery, there was no detectable change in the material's performance.
The electrodes the team produced had thicknesses up to a few microns, and the improvements in energy delivery only were seen at high-power output levels. In future work, the team aims to produce thicker electrodes and extend the improved performance to low-power outputs as well, they say. In its present form, the material might have applications for small, portable electronic devices, says Shao-Horn, but if the reported high power capability were demonstrated in a much thicker form — with thicknesses of hundreds of microns rather than just a few — it might eventually be suitable for other applications such as hybrid cars.
While the electrode material was produced by alternately dipping a substrate into two different solutions — a relatively time-consuming process — Hammond suggests that the process could be modified by instead spraying the alternate layers onto a moving ribbon of material, a technique now being developed in her lab. This could eventually open the possibility of a continuous manufacturing process that could be scaled up to high volumes for commercial production, and could also be used to produce thicker electrodes with a greater power capacity. "There isn't a real limit" on the potential thickness, Hammond says. "The only limit is the time it takes to make the layers," and the spraying technique can be up to 100 times faster than dipping, she says.
Lee says that while carbon nanotubes have been produced in limited quantities so far, a number of companies are currently gearing up for mass production of the material, which could help to make it a viable material for large-scale battery manufacturing.
###
Source: "High-power lithium batteries from functionalized carbon nanotube electrodes." Seung Woo Lee, Naoaki Yabuuchi, Betar M. Gallant, Shuo Chen, Byeong-Su Kim, Paula T. Hammond, & Yang Shao-Horn. Nature Nanotechnology. 19 June 2010.
Saturday, June 19, 2010
Stem cell charlatans
In the latest British Medical Journal, Bob Roehr quoted Irving Weissman, the Stanford University researcher and president of the International Society for Stem Cell Research society as saying that the society launched a patient education website "to smoke out the charlatans" who prey upon desperately ill people and their families(BMJ 2010;340:c3271. This is a step in the right direction.
Dr Weissman, clarified that probably no other society has ever done this before. He was addressing the opening of their annual meeting on 16 June, in San Francisco.
Deveoloping countries are the preferred havens for the charlatans to prey on the gullible patients.
Bob Roehr argued that the problem is large and growing. He revealed that a recent web search identified more than 200 practitioners or clinics making claims for stem cell cures;, they thrive in developing countries obviously because regulatory oversight is weak in such countries. It is unbelievable that a clinic in China claimed to have treated over 8000 people, generating over $200m (£137m; 165m) in revenue.
It is difficult to arrest these activities. The scoiety felt that basic education about stem cells may help.The society’s new website, www.closerlookatstemcells.org, offers such material. According to the website a reputable clinical trial will have a body of scientific literature behind it; will be scrutinised by an independent review board; and will have the approval of the relevant national regulatory authorities. And it will not charge for participating in the trial.
The website allows a person to submit the name of a clinic for review. The society will then ask the clinic for documentation on ethical and regulatory review of the proposed treatment. That information will form a publicly available online database. It is not clear why a crook who is cashing on the misery of a victim should cooperate for such a review.
Bob Roehr quotes the case of a farmer who spent $80,000 for a stem cell "cure" for multiple sclerosis. An instance Dr Weissman found out while he gave a lecture in his home town, Great Falls, Montana, his hometown with a population of a little over 50 000. It is a pity that people mortgage their homes desperately seeking a cure where there is none.
The service offered by the society is laudable.Jeanne F Loring from the Scripps Research Institute a speker at th emeeting highlighted other issues. She pointed ouyt that patient testimonials are a hallmark of these operations. You will not see is any scientific evidence. There will be no guarantee that you will be helped by that treatment. Lastly,there are no guarantees that you won’t be harmed.
Clinics may use inappropriate treatment. According to the researcher, these clinics often use cord blood or placental cells, which may not be appropriate for the intended use. They may use cells derived from animals, or inject cell solutions that are tainted with other products.
Dr Loring suggested that if patients could procure a sample of the cells that are going to be injected, freeze them, and send them to her, she will analyse it for free and tell you what those stem cells are. This is indeed a generous offer.She can be contacted at jloring@scripps.edu
Regrettably, reporters of some popular newspapers in India unwittingly publicize the magic cures. They do not know the damage they are doing. They must resist the temptation; publish only those cures only if they appear in peer reviewed literature.
Dr Weissman, clarified that probably no other society has ever done this before. He was addressing the opening of their annual meeting on 16 June, in San Francisco.
Deveoloping countries are the preferred havens for the charlatans to prey on the gullible patients.
Bob Roehr argued that the problem is large and growing. He revealed that a recent web search identified more than 200 practitioners or clinics making claims for stem cell cures;, they thrive in developing countries obviously because regulatory oversight is weak in such countries. It is unbelievable that a clinic in China claimed to have treated over 8000 people, generating over $200m (£137m; 165m) in revenue.
It is difficult to arrest these activities. The scoiety felt that basic education about stem cells may help.The society’s new website, www.closerlookatstemcells.org, offers such material. According to the website a reputable clinical trial will have a body of scientific literature behind it; will be scrutinised by an independent review board; and will have the approval of the relevant national regulatory authorities. And it will not charge for participating in the trial.
The website allows a person to submit the name of a clinic for review. The society will then ask the clinic for documentation on ethical and regulatory review of the proposed treatment. That information will form a publicly available online database. It is not clear why a crook who is cashing on the misery of a victim should cooperate for such a review.
Bob Roehr quotes the case of a farmer who spent $80,000 for a stem cell "cure" for multiple sclerosis. An instance Dr Weissman found out while he gave a lecture in his home town, Great Falls, Montana, his hometown with a population of a little over 50 000. It is a pity that people mortgage their homes desperately seeking a cure where there is none.
The service offered by the society is laudable.Jeanne F Loring from the Scripps Research Institute a speker at th emeeting highlighted other issues. She pointed ouyt that patient testimonials are a hallmark of these operations. You will not see is any scientific evidence. There will be no guarantee that you will be helped by that treatment. Lastly,there are no guarantees that you won’t be harmed.
Clinics may use inappropriate treatment. According to the researcher, these clinics often use cord blood or placental cells, which may not be appropriate for the intended use. They may use cells derived from animals, or inject cell solutions that are tainted with other products.
Dr Loring suggested that if patients could procure a sample of the cells that are going to be injected, freeze them, and send them to her, she will analyse it for free and tell you what those stem cells are. This is indeed a generous offer.She can be contacted at jloring@scripps.edu
Regrettably, reporters of some popular newspapers in India unwittingly publicize the magic cures. They do not know the damage they are doing. They must resist the temptation; publish only those cures only if they appear in peer reviewed literature.
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