Health Meaning

In Washington, DC, the judge said this afternoon that his decision there 2 weeks, the arrest of all funding federal for research on embryonic stem cells, will be held while the case moves forward. Chief Judge Royce Lamberth, in response to a request from the Department of Justice (DOJ) that there is a preliminary injunction, issued an order of three pages this afternoon denying the request.

"Defendants are incorrect about much of their 'parade of horrors" that is supposed to result from the preliminary court injunction, "Lamberth wrote. It refers to the concerns expressed by the DOJ that stopping the research is deeply disturbing for laboratories and delay progress in developing new treatments for a variety of diseases. The National Institutes of Health stopped all research within its walls last week, although the work already financed outside NIH can continue, for now.

Lamberth believes that its hands are tied by the Dickey Amendment, adopted 14 years ago by Congress to ban federal funding for the destruction of embryos. Lamberth interprets that to include the funding of research on human embryonic stem cells, more broadly, although the Ministry of Health and Social Services and several presidential administrations have not agreed.

"In the view of the Court, a stay [allowing funding to continue] would flout the will of Congress," Lamberth wrote. "Congress remains perfectly free to amend or revise" the Dickey-Wicker amendment. "This court is not free to do so."

The next step in the case should come by the end this week. at that time, stem cells-adult applicants researchers James Sherley and Theresa Deisher-waiting to file what is called a motion for summary judgment, which asks that the case be decided without a trial. this could solve things one way or another, and in the meantime, Lamberth said the new status quo will stick.

See our full coverage of this issue.

The National Breast Cancer Coalition (NBCC), a lobbying group to influence the disease, is known for his skeptical approach, scientific struggling against cancer. In the early 190s, the group lobbied to create a research program of the Department of Defense Breast Cancer now funded at $ 150 million per year. Earlier this month, President outspoken NBCC lawyer Fran Visco, seemed out against the approval of Avastin for breast cancer, arguing that "it does not show a clinical benefit."

So it came as a surprise when NBCC announced this week a rather scientific sounding goal: to end breast cancer in 2020.

the deadline brings to mind a plan National cancer Institute in the early 00s to eliminate suffering and death from cancer in 2015, a goal that brought ridicule to the man behind it, can NCI Director Andrew von Eschenbach. the scientists called deadline unrealistic and fear it would undermine the credibility of NCI. Visco says the newsletter based in Washington DC, Letter cancer (subscription required) that the deadline of his group is different because unlike NCI, they want to change as usual. They succeed, after 2020, "I travel in Tuscany," she told the newsletter.

Science Insider was curious how NBCC proposes to end in breast cancer, as the website notes, no one knows how to prevent the disease. a white paper is scarce on details, except for an idea vaccine against the preventive breast cancer that 2020 campaign NBCC chose as his first project. According to a report in Nature Medicine in May such an experimental vaccine has prevented breast cancer in mouse models. the vaccine targets a protein produced by nursing mothers, so it could only be given to women of childbearing age past.

The paperwork continues to accumulate in the lawsuit challenging the legality of the National Institutes of Health (NIH) guidelines stem cell, the last payments being two memories attorneys on both sides. A judge of the District Court could rule on the case underlying quickly, which could stop looking back, at least briefly.

In the United States District Court for the District of Columbia, federal lawyers explain why they think the judge Royce Lamberth chief must decide the case in their favor without a trial. Their brief explains that the NIH, with the support of Congress, correctly concluded that the prohibition of research funded by the federal government that destroys the embryos does not cover human research embryonic stem cells (hESC). NIH also argued that properly developed the guidelines on stem cells.

The memory takes a hit to the applicant James Sherley, who said that the fact that four of his recent NIH grant applications to study adult stem cells have been rejected in the first stage of the review by peer shows that hESC guidelines have made it harder for him to win funding. "The fact that requests for Sherley were unscored demonstrates that ... Sherley's peers consider them scientifically worthy enough to be considered for funding," says the brief. And the applications that "are not even eligible for financing "are not in competition with applications of hESCs, the brief said.

Meanwhile, the Court of Appeals DC Circuit US is considering the appeal of 23 August Lamberth preliminary injunction temporarily close the hESC research funded by the NIH government. in a brief filed yesterday, the plaintiffs' attorneys are asking the appellate court to reinstate the injunction, repeating its argument that the guidelines of the NIH violent law on the protection of embryos. plaintiffs challenge the University of California claim in an amicus brief that the plaintiffs lack legal status because scholarship grants NIH institutions, individual scientists. Funding for the research comes Sherley all NIH, and he receives no salary from his employer, Boston Biomedical Research Institute, said memory. And Theresa Deisher applicant, as founder and R & D director of a biotechnology company, "benefits directly from any research funding," the paper argues.

The deadline for the court call is on 4 November, when the government must answer the last short of applicants. it now scheduled court oral arguments for December 6. the panel of three judges differs from all who heard oral arguments for a stay in September. a judge George W. Bush-era named Thomas Griffith, is the same, but the two are different, Karen LeCraft Henderson (appointed by the first Bush administration) and Douglas Ginsburg, a Reagan appointee.

Some viewers expect Lamberth hold until the appeals court ruled on the preliminary injunction. But Lamberth, who should not schedule oral argument because neither side asked, could instead decide in the next days. If he sides with the plaintiffs and issues of a permanent injunction, the Court of Appeal will probably remain the ban during a call. But getting the stay may take a few days to find hESCs could be arrested again.

Only two things are certain at this stage, said plaintiffs attorney Samuel Casey of international lawyers in Fairfax, Virginia, "Lamberth The judge can rule at any time", and the Court of Appeal will hear the arguments on December 6 at 09:30

short story by F. Scott Fitzgerald, "The Curious Case of Benjamin Button," an old man becomes young with each passing day, a fantastic concept recently brought to life on film by Brad Pitt. In a laboratory in Boston, a research team used genetic engineering to accomplish something similar curious, transforming frail mouse in younger versions of themselves by stimulating the regeneration of certain tissues. The study helps explain why some organs and tissues break down with age, researchers say, provides hope that this deterioration related to age may one day be thwarted and even reversed.

As we age, many of our cells stop dividing. Our bodies are no longer able to regenerate, fail slowly. Scientists do not fully understand what triggers, but many researchers suspect the gradual shrinking of telomeres, the protective DNA caps on the ends of chromosomes. A bit of telomere is lost each time a cell divides, and telomerase, the enzyme that maintains caps, is generally not active in adult tissues. Another evidence. People with longer telomeres tend to live longer, healthier lives, while those with shorter telomeres suffer more diseases associated with age, such as diabetes, Alzheimer's and heart disease there

Several years Ronald DePinho, molecular biologist and director of the Belfer Institute Dana-Farber cancer Institute, and colleagues from Harvard Medical School in Boston mice genetically modified to miss working copy of the telomerase gene. The animals died at about 6 months to young mice, who usually live until they are about 3 years old and appeared to age prematurely. At an early age, liver and spleen faded, their brains have fallen, and they have become infertile. By adulthood, these mice exhibited a large number of diseases observed in 80 humans.

DePinho said he wondered what would happen to the aging process in these mice if they suddenly began again to telomerase. "Does [we] slow down, stabilize, or would we overthrow?" He and his colleagues genetically engineered a new batch of mice with the same disability, but this time they added a telomerase gene that became active when the mice were given a drug. The researchers kept off the gene during development and let these mice prematurely age, like previous had. But then to 6 months, the team placed on the telomerase gene.

The burst of telomerase production stimulated almost complete recovery. The rodents became fertile, their livers and spleens increased in size, and new neurons appeared in their brains, the researchers reported online yesterday in Nature .

The ability to reverse the deterioration of age in the mutant mice indicates that the cells that divide to replenish the tissues are not only not die when their telomere clock expires, said DePinho. They apparently persist in a dormant state from which they can be reactivated. "One could imagine applying this approach to man," he said, focusing therapy on specific types of tissues such as the liver, where telomerase appears to play an important role in regeneration after damage hepatitis, parasitic infection, and alcoholism.

K. Lenhard Rudolph, who studies stem cell aging at the University of Ulm in Germany, says the results are encouraging for people with diseases that cause accelerated aging, such as progeria, because the mice in this study were saved despite already suffering the effects of chronic disease. "It is a proof of principle that telomeres are at work here."

pharmaceutical companies and researchers are looking for ways to restore, protect or extend the telomeres of a person, but the jury is still out on whether such interventions can slow down the symptoms of aging, much less the reverse. Telomeres investigator Maria Blasco of the National Research Center on the Spanish cancer in Madrid warned that the experience of DePinho should not raise even just people's expectations of anti-aging therapies. "This study used genetically modified mice," she said. "It remains a very important issue in the area is that you can delay aging in a normal mouse?"

DePinho agrees with these concerns. It also warns that his approach has potential drawbacks, that increasing telomerase activity beyond its natural levels can cause cancer. However, this can not be an insurmountable problem if levels telomerase can be carefully monitored. DePinho noted that mice in the study, telomerase activity has returned to a natural level, do not develop tumors.

PHILADELPHIA, PENNSYLVANIA -Men with type 1 diabetes may someday be able to use stem cells that become sperm to replace their producing cells of the pancreas insulin. These grafts would eliminate the need for frequent daily injections of insulin to control blood sugar.

Type 1 diabetes occurs when the immune system attacks and destroys insulin-producing cells in the pancreas. Without insulin to help cells absorb blood sugar, a person can not use the energy from food. Type 1 diabetes is untreated always fatal, but insulin injections and regular monitoring of blood glucose can help patients to have a relatively normal life.

Sometimes insulin injections are not enough to keep type 1 diabetes in check, however. So in the late 190s, researchers at the University of Alberta in Canada have begun transplanting cells corpses of islets in diabetic. It is not an ideal solution, but, as a beneficiary must remain on immunosuppressive drugs for the rest of their lives to prevent transplant rejection and usually will need more insulin injections.

cell biologist G. Ian Gallicano strains of Georgetown University in Washington, DC, and colleagues believe they have found a method that would give diabetics the benefits of transplantation of islet cells without need immunosuppressive drugs. Millions of sperm cells are created every day from stem cells in the testes spermatogonial cells called stem cells (SSCs). The researchers harvested from human testicular tissue SSCs and designed to become pluripotent stem cells, which have the ability to specialize in any type of cell, a process that took 2 weeks. Next, the researchers pushed the stem cells to develop into cells of the pancreatic islets.

As they reported yesterday at the annual meeting of the American Society for Cell Biology, Gallicano and colleagues transplanted human islet cells designed in diabetic mice that do not have an immune system and therefore can not attack the inserted cells. Transplants lowered high blood mice glucose levels, a good sign that the cells would do the same in humans.

Gallicano warns, however, that the technique is not ready for people just yet. "We do not get enough insulin of each cell to cure diabetes in humans."

This is a concern shared by Sheng Ding, a biochemist at the Scripps Research Institute in San Diego, California, who was not involved in the research. Before the technology is ready for the clinic, he said, researchers need to increase the production of insulin in the transplanted cells. However, Ding said: "This is a direction to continue to finally cure for type 1 diabetes"

This is not the first attempt to treat or cure diabetes with stem cells Researchers had. already used the cells of the skin or other tissue to create a slightly different type of stem cells, called induced pluripotent stem (iPS) cell, which may then proceed to replace cells damaged islets. using cells iPS has some advantages, said Gallicano. they do not require an invasive procedure to obtain, and they work for both sexes. However, researchers need to add four genes morph cells into iPS cells. genes are not yet insert the right place, which could cause cancer or cell death, he said.

the human SSCs, though, men only, are already stem cells and do not need those four genes enabled. "We must not do anything to make them pluripotent except out of their niche" in the testicles, said Gallicano.

Researchers hope they can find a method that would benefit both diabetic women . Gallicano says he sees no reason why the precursor stem cell eggs can not be used. one major difference is that the egg stem cells have only one copy of each gene, while the CSP have two copies, like other cells in the body, making it easier to apply the SSC technique.

There is another obstacle, said Gallicano, which is whether the immune system, which already created antibodies against islet cells of the body will attack the transplanted cells as well.

The United Kingdom has developed an unnecessarily heavy bureaucracy that stifles, or readers overseas, medical research, and the country should create a new agency dedicated to streamlining the approval of biomedical studies, according to a report just published by the British Academy of medical sciences (AMS).

The review of the academy was commissioned last year in response to growing concerns that the UK is losing its position as a preeminent place to do medical research. share in the world's countries clinical trials has declined amid complaints that the necessary approvals and meet all regulations of a trial is too costly, tedious and expensive. For example, biomedical charity CancerResearchUK presented evidence to AMS that after a trial receives funding, the now averages nearly 2 years before patients are not even enrolled.

"We found compelling evidence that health research in this country is threatened by a regulatory framework and governance has become unnecessarily complex and cumbersome. In addition, we have received no evidence that this increase regulation and the burden of governance led to increased guarantees of the research participants, "says Michael Rawlins, the doctor who chaired the AMS group that produced the review, in a statement.

AMS received over 300 submissions of evidence of companies, research organizations and various government agencies UK governing medical research. "the new regulators and controls have been implemented with good intentions, but effect of the sum is a fragmented process characterized by multiple layers of bureaucracy, uncertainty in the interpretation of laws and individual counseling, a lack of confidence in the system, and duplication and overlap in responsibilities "Rawlins, who was the original chair of the National Institute for health and clinical excellence, and colleagues concluded in the report:

National health Service in the UK has supposedly trusts throughout the country who oversee medical services, and the conduct of research by doctors of the NHS, and the AMS report urges the need to obtain the approval of the study in several trusts, each with its own local interpretations regulation of clinical research, "the greatest obstacle in the UK for research in health." To address this and other problems, the AMS report calls for a new independent agency for health research (HRA) that would bring together all the approval processes study in the UK.

The new agency, which would also be responsible for ethical oversight of clinical trials could facilitate better use of patient data by researchers, the report said. "Access to patient data for research is currently hampered by a fragmented legal framework, the inconsistency in the interpretation of regulations, variable orientations and a lack of clarity between researchers, regulators, patients and the public ", he concludes.

The AMS review also examined the governance of UK research on human tissue and suggested some easing of monitoring so that the regulatory burden on working with the plasma of a person , serum, stool, urine and saliva is the same as that required for studies on hair and nails of a person. There had been fears among some that the Rawlins group called for the UK to abandon giving human embryos "special status", a legal designation that brings with it additional regulatory oversight, but the AMS report makes no recommendations on this subject .

It is unclear what influence the AMS report has given the recent changes in the political situation in Britain. The review was requested by the government of the Labour Party just before the last spring election that saw the Conservative-Liberal Democrat coalition took power. As part of its push austerity and the desire to reduce the size of government, the coalition plans to eliminate some regulatory bodies of research, such as the Human Fertilisation and Embryology Authority, so it can not embrace the creation of a new oversight body. Again, if the HRA would replace the functions of several agencies, and save money by doing so he could earn more favorably. David Willetts, science minister in the coalition government, issued a statement welcoming the recommendation of AMS report, noting:. "As the government works to balance and develop the economy, it is essential that the UK continues be an attractive environment for undertaking clinical trials This activity is an essential part of the strong life sciences industry in the UK, an important growth area. "

The following additional statements issued in response to the AMS report:

Mark Walport, Director of the Wellcome Trust:

This report and its recommendations are both welcome and timely. The UK is a world leader in medical research, with benefits for health and the economy, but is prevented from maximizing its potential because of the unnecessarily complicated and bureaucratic regulations. We must find a better balance between the protection of participants involved in the research and not unduly or unreasonably impede the progress of the research that will bring significant health benefits. There should be a symmetry in regulation - regulators should be responsible for decisions to delay or prevent the research and decisions to approve it.

Alison Murdoch, head of the Newcastle Fertility Center

The regulation of embryo research rationalization project is welcomed as it should withdraw much of the duplication of the current system. A single organization with oversight of research on the embryo and other medical research will provide a consistency of standards and ensure that the bureaucracy is appropriate to the risk, while not compromising the protection afforded by Parliament to the embryo human under the HFEAct. The "special status" of the human embryo is protected by law and the regulatory process must be reorganized.

Chris Mason, chair of regenerative medicine bioprocessing, University College London (UCL):

This is an important first step in ensuring the effective transition of science stem cells World class UK in advanced safe and effective therapeutics to patients. Without reform of the emergency regulation, the position of the UK as a world leader in research on stem cells will never be translated into routine therapies. The recommendations will undoubtedly be beneficial for NHS patients and to facilitate a major new health sector in the UK.

James Lawford Davies, IVF Legal Expert, Lawford Davies Denoon, a law firm in the life sciences:

It has been suggested that these proposals mean that "the special status of the embryo will be lost," but this does not follow from the report recommendations. Research on human embryos in the UK is governed by the licensing framework established by Parliament in 190 and amended in 08. It does not propose that this be diluted or deleted, only that the functions are transferred from one body to another. The streamlined regulatory process envisaged in the report to better reflect the multifaceted nature of some areas of research, such as research on stem cells, where the current regulation is complex and may be redundant.

Sarah Norcross, director of the Progress Educational Trust:

The review of independent bodies is regular exercise for governments looking to cut costs. In 04, the British government has proposed combining the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) in a single body, the Regulatory Authority for Fertility and Tissue (RAFT). In 06, there was a similar proposal, except this time the new body would be called the tissue Regulatory Authority and Embryology (RATE). These proposals were considered and rejected, amid concerns about whether a single body covering a vast and diverse field of practice could earn the respect of Parliament, professionals and the public. What has changed since then, for the new sustainable health research proposed agency? What makes the Academy of Medical Sciences think this latest iteration of RAFT float?

Allan Pacey, Senior Lecturer in Andrology, University of Sheffield

Given the explosion of regulation and governance research we have witnessed over the past five years, I often wonder if Steptoe and Edwards began their research today when IVF would never have been invented in the UK? Bureaucratic complexities of the same company the most basic research of today are daunting. When I started my research career there 20 years ago, the procedures involved were much simpler than they are today. I still have the necessary documents to get permission to make my first research project involving human subjects. It was quite a complex project, but the file is barely a centimeter thick and correspondence with the ethics committee and a copy of the protocol amount of 25 A4 pages. If I remember correctly, about 10 to 15 members of a local ethics committee discussed the draft and they gave their approval within weeks of filing.

Fast forward to 08, and I began to get approval to proceed with another, a much simpler project where we were just planning to ask patients to two hospitals to complete a questionnaire on their experience of being a patient. Yet the complexity of ethics and governance procedures of research in place, we had to prepare documents that filled two A4 lever arch files. In addition, it took nearly 18 months to assemble and has been reviewed by about 0 people from three different committees of ethics and governance of two research departments as well as the funding agency. Wherever responsibility is to regulate research on fertility, there should be simplified - the current system does not work for everyone - all within the same patients who would benefit most from the rapid pursuit of research.

new book by journalist Seth Mnookin Panic Virus: A True Story of Medicine, Science, and Fear , explores the public health crisis on vaccines and autism. The document 1998 The Lancet by British physician Andrew Wakefield that triggered panic has long since been debunked and retracted, and Wakefield was banned from practicing medicine and accused of fraud . But that has not stopped thousands of people to refuse to vaccinate their children for fear that they could become autistic.

Mnookin warns against serious consequences. Recent outbreaks of measles, whooping cough and other preventable infections have sickened thousands of children killed and more than a dozen in the United States. Vaccine rates are falling below the level needed to prevent an epidemic in a growing number of communities, including those with rich, educated populations.

Last week Mnookin spoke with Science Insider know why.

Q: There is a perception that the refusal of the vaccine is particularly common among wealthy, well educated, he is politically liberal parents a truth to that?

MS: It is dangerous to make generalizations about a group, but anecdotal and all data which has been collected, it seems to be people who are actively involved in all possible decisions regarding the life of their children. I think it relates to a desire to take the uncertainty of the equation. And autism is such an unknown. We still do not know what causes it and we still have good answers on how to treat it. So I think that fear really resonates.

Also, I think there is a good amount of law. Not vaccinate your child means that I deserve to rely on herd immunity that exists in a population. At the most basic level, it is said that I believe that vaccines are potentially dangerous, and I want other people to be vaccinated, so I do not have to. And for people to hide under it and say, "Oh, it's just a personal decision," it is dishonest. It is a personal decision of how drunk driving is a personal decision. It has the potential to affect everyone around you.

Q: But why the Liberals

S.M :. I think it taps into the natural organic movement in many ways.

I spoke to a responsible public health and asked what is the best way to anticipate where it could be higher than normal rates of non-compliance of vaccines, and he said take a map and put a pin where there is a Whole Foods. I kind of laugh, and he said.. "No, really, I'm not kidding" These are communities with driving Prius, composting, food organic people eat

Q: in society at large, why it continues to be so afraid of vaccines

MS: I think there are a lot of different answers to that . a very large is that the fears of the impact of non-vaccination have become notional. most people of our generation do not know that people who have had polio or unfamiliar families where a child was blinded by rubella. So when there is no concern at all about vaccines, no matter how unfounded in scientific evidence, it is like you are taking an infinitesimal risk against which almost seems like a risk.

Q: in the book you are taking the media to task for maintaining autism vaccine "controversy" alive. Why

S.M:. If there is a group that deserves the blame for this, it is the press. I understand where the parents come, both parents who believe their children were injured and parents who are worried about what might happen to their children. I do not believe that the medical community and the public health community have treated well, but it was not out of incompetence or irresponsibility. The media has done a horrible job and should have known better.

Q: How

MS: Well, for example, with the initial Lancet Wakefield paper, it should have been clear to any science journalist that there was no way to conclude he did this study. Although its data is reliable, even if none of the problems of selection bias and fraud had never arrive, drawing large conclusions from a case study of 12 people is absolutely absurd. The story in the next day's paper should have been what is thus researcher, making these public health recommendations are irresponsible and have no ground in science. To use the excuse, as the media have, that we are to present both sides of the issue is a total cop-out.

Q: Are there wider lessons here on how misinformation can become so widespread

MS: This there was a University of Michigan study a few years where subjects were given a list of 20 statements about the vaccine against influenza, of which 10 were told [were] true, of which 10 were told were false. Ten minutes later, they could identify was true with a high degree of accuracy, but descended precipitously over time. Thus, the results suggest that simply hear something, even in the context of the hearing is not true, this concept gets into your mental framework in a way that willing to give you that idea more credibility. You can see this with all kinds of urban myths.

The president's budget would give the National Institutes of Health (NIH) for a modest 2.4% increase in 2012 to 745 $ million compared to the 2010 level, bringing the total to $ 31.8 billion.

The application includes an important new program. The proposed National Centre for the Advancement of Science Translational which "rethink the pipeline for the diagnosis and therapeutic discovery and development," the budget document said would NCATS built in part of a program to support clinical research of $ 485 million to the National research resource Center. NCRR, despite protests from the research community, is scheduled to be abolished.

However, NCRR remains a post in the 2012 budget and NCATS is not there. in fact, the agency is still deciding where to place other pieces of NCRR, NIH Director Francis Collins told reporters today.

Some programs get NCATS fold increases in 2012. Cures acceleration network, a drug development program created by the health care law last year, would be funded for the first time at $ 100 million. And another program called TRND develops drugs for rare and neglected diseases would see its budget double to $ 50 million. Most of the NIH institutes, however, would receive increases of between 1.6% and 2%.

NIH also wants to give graduates and postdocs on training grants a 4% increase in their allocations this year. The agency will fund 9158 new grants for research projects, a decrease of 228 from the level of 2010. The average success rate for an application submitted dipped below 21% for the first time, to 19% this year and the next.

The increase in the proposed financing of 2.4% is below the projected inflation for biomedical research to 3% in 2012, and the agency is already losing much about it this year purchasing power if, as expected, its budget remains flat. But Collins told reporters, "this kind of tax environment ... for NIH to always be given a chance to see an increase of $ 745 million is a reflection of how strongly the president feels about science and innovation as the engine of our economy and our health in future. "

and biomedical researchers are" exhilarated, not so much by the number "but that the NIH is expected to increase, said William Talman, president of the Federation of American societies for experimental biology. the slight increase "talk [Obama's] commitment to biomedical research," said Talman.

Martin Pera of the University of Southern California (USC) has announced March 7 that it will return to Australia in June to direct stem cells Australia (SCA), a new national stem cell consortium. SCA will replace the troubled Australian Stem Cell Centre (ASCC), where Pera served as research director before coming to USC in 06. In 5 years as first director Eli and Edythe Broad Center of USC medicine regenerative and stem cells, Pera built a stem cell program covering basic research to clinical trials.

SCA will be administered by the University of Melbourne and funded at $ 20.7 million over 7 years by the Australian Research Council and $ 42.3 million from the partner organizations. The consortium members include Monash University, the University of Queensland, University of New South Wales, Chang Cardiac Research Institute Victor, Walter and Eliza Hall Institute of Medical Research, Florey Neuroscience Institutes, and CSIRO.

Q: Why did you leave ASCC in 06

MP: I'm frustrated, like many scientists, what we saw as insufficient emphasis on science. We did not realize the synergies that a national center should. The inherent problem is that the ASCC is a hybrid of a biotechnology and academic organization and it was difficult to get the balance right. In recent years, this has been corrected.

Q: Why have you decided to return to Australia

MP: When the opportunity arose to help lead a new consortium Australian research on stem cells, it was a very attractive offer. On the other hand, we had taken a step at USC. We had built a stem cell program from scratch from basic research and construction of the translation side. We Doheny Eye Institute in sustained CIRM program, Professor Mark Humayun and David Hinton plan to stem clinical trials for macular degeneration, and my colleague Michael Kahn has just initiated a Phase I clinical trial of a drug for the colorectal carcinoma that was developed by means of a stem cell-based screen.

Q: You have always loved the bench. Why did you move into management

mp.:. This was an opportunity to build something more; something that will survive my own career. I always kept my own lab will focus on understanding what pluripotent stem cells really are, and extrinsic signals that govern their self-renewal and differentiation. Back in Australia, the scientific direction of the SCA will be shared and I wish to spend most of my time in the lab.

Q: When ASCC was founded in 02, Australia had a leader in research on stem cells. Not now. How the country in competition?

mp.:. Australia still has great strengths, many of them a legacy of ASCC. I do not know too many other consortia that can integrate expertise in embryonic and tissue stem cell biology, tissue regeneration and repair, bioengineering, nanotechnology, materials science, genomics and bioinformatics. The purpose of this grant is to bring these groups together and establish a powerful framework for interdisciplinary research.

An expensive clotting drug approved to treat hemophilia has become extremely popular in hospitals to stem bleeding during cardiac surgery, cerebral hemorrhage, trauma, liver transplants, and prostate removal. Yet another massive analysis of 64 studies of such "off label" uses of the drug, recombinant factor VIIa (rFVIIa) has found no evidence that it prolongs life and, in some cases, it causes embolism dangerous. "The stakes are high here in terms of results and costs of patients," says study leader Veronica Yank, a clinician at Stanford University in Palo Alto, California, who specializes in research on prevention.

in a second paper, Yank and her colleagues have shown that in US hospitals in 08, 97% of the use of rFVIIa, which costs $ 10,000 per dose and is made by Novo Nordisk of Bagsvaerd, Denmark, was off-label. It is legal for doctors to prescribe drugs off-label, but Jerry Avorn, a clinician at Brigham and Women's hospital in Boston, who co-wrote an accompanying editorial, said hospitals have a responsibility to act on these results. and if they do not? "If I were a lawyer's responsibility, I find it interesting," says Avorn.

The Food and Drug Administration of the United States approved rFVIIa in 1999 as an "orphan drug" for use in hemophiliacs who have developed immune responses against other blood clotting factors, the most common already available. The surgeons soon began to use it in many different contexts, including combat, with little evidence of efficacy. Several studies have warned about the widespread use of the drug's label, but none was as comprehensive as the two new documents, which will be published tomorrow Annals of Internal Medicine .

As Avorn notes in his editorial, there is "reason to wonder how the use of an obscure recombinant coagulation factor marketed exclusively to hematologists became so widely used." Novo Nordisk officials denied they improperly promoted off-label use of rFVIIa, but concerns about "financial arrangements" between the company and the army of the United States led the Defense Ministry to launch an investigation January 2010 is still ongoing. company officials stressed in a conference call with stock analysts that the doctors of the uS military have used the drug at their own discretion and in February 2010 "we have not been the product marketing at the Ministry of Defence. "Avorn says he has no direct knowledge of the company's marketing practices." But I think it is useful that the question was asked how it is got to be such a popular approach, "he said.

research organization stem cell California made its first prize for a clinical trial. The recipient of the $ 25 million is Geron Corp., a biotech company in Menlo Park, California, which is already being tested cells derived from human embryonic stem cells (hESCs) to treat injuries of the spinal cord spinal.

Yesterday, the Board of the California Institute for Regenerative Medicine (CIRM) has approved funding of Geron, which is actually a loan. Chairman of the Board Robert Klein called the award "a historic step for CIRM." Phase I trial of Geron's first approved the world of the trial (in 09) for a therapy derived hESCs. (The Food and Drug Administration approved a second trial for an eye disease in November 2010). He has been in the news lately because its first patient, a young man in Georgia who was partially paralyzed in a car accident, spoke at the press about his treatment.

CIRM has funded clinical trials before, including a loan of $ 20 million to Novocell Inc., now known as ViaCyte, in San Diego, but the prices were to the pre-clinical work. the Geron loan is offset by the company's funds and contingent will be refunded if the treatment is a commercial success, according to the press release of Geron.

an external review last year CIRM urged to reach over to industry. Sometime one of the criticisms of the agency, John Simpson of Consumer Watchdog Group in Santa Monica, California, was quoted in Los Angeles Times praising the Geron loan as well subject to selection and appropriate.

The Board also approved $ 37.7 million for 27 basic biology grants, as well as a plan to create a repository of cells induced pluripotent stem cells, which are derived from adult cells. The agency is working on the project with the National Institute of Neurological Disorders and Stroke (for more, see this recent Nature story).

Chances are, people will simply call Crick.

The leaders of the British Centre for Medical Research and Innovation (UKCMRI), a gigantic biomedical laboratory facility scheduled to open in central London in 2015, apparently heard the complaints about their heavy name and acronym. They just announced in July the plant will officially become the Francis Crick Institute to honor the Nobel British laureate who co-discovered the structure of DNA. The name change coincides with a new report which approves the scientific view of the installation, but also revives a debate on its location. Published by the House of Commons Science and Technology Committee, the report questions whether the benefits of the site from the city center, such as transport networks and access to universities and hospitals, were worth and limits location added.

The Panel concluded:

In our view the case for a central London location was not overwhelming and UKCMRI could be located elsewhere.

The construction of the Centre starts now and the decision can not be reversed, but it is essential that the UKCMRI develop plans and implement measures to ensure that those outside the South East part of the project and obtain maximum benefit.

The review of the UKCMRI comes as the project is about to start construction on the building that will house over 1,000 researchers and staff. Many of them are from the famous National Institute for Medical Research (NIMR) in Mills Hill, just outside of London, which will then be closed. It was the debate on whether to move NIMR in central London or to rejuvenate its facilities which, after much acrimony, eventually led to the unusual partnership that created UKCRMI. The Medical Research Council, the Wellcome Trust, CancerResearchUK and several London universities contribute all estimates land are now over $ 1 billion in the project now.

Beyond the question of the location, the MPs found little to complain about in their review of UKCRMI. They noted that the project has "experienced management team with a proven track" and the U.K. government had given promises that UKCRMI partners, not the British taxpayer, were responsible for cost overruns.

The Department of Health and Human Services (HHS) this week gave Congress more details on the budget for a project national Institutes of Health (NIH) reorganization that would create a center for research from bench to bedside. A key budget document is still pending, however, and if Congress will approve the center in time for the launch in October remains uncertain.

The plan announced in December for a National Centre for Advancing Translational Sciences (NCATS) has raised concerns that NIH may be venturing too far into drug development. Many researchers have also been upset by the decision of the NIH Director Francis Collins to create NCATS in part by the removal of another component of the NIH, National Center for Research Resources (NCRR).

Some senators and a House of Representatives key personnel have questioned the reorganization. At a Senate hearing in April, Senator Richard Shelby (R-AL) complained that NIH has not presented details of the budget of NCAT.

HHS has now provided some of these details in a letter on June 6 in the Senate and House appropriations subcommittees. HHS Secretary Kathleen Sebelius says NCATS will "propose innovative approaches to the development pipeline, provide new approaches for the diagnosis and development of therapeutic products, stimulate new avenues for basic scientific discovery, and complement the NIH research existing private sector. "

An attached table describes how the new center will change the 2012 budget request of the president. As expected, NCATS get Price $ 480 million clinical and translational sciences NCRR; $ 50 million NIH's therapeutics program for rare and neglected diseases and Cures Acceleration Network, which has no funding now, but would get $ 100 million. NIH also wants NCATS now to house its Office of Research on Rare Diseases of $ 18 million. Including other programs, NCAT budget would be $ 722 million.

The table does not list a few scheduled NCATS program that are now part of common director of NIH funds, including the $ 100-some million Molecular Libraries. But these programs could remain part of the Common Fund, but NCATS be administered, according to an HHS official.

As for the rest of the $ 1.3 billion NCRR, the table corresponds closely to a table NIH published in February. Among other changes, a large part of the funds ($ 303 million) which includes centers of primates and other comparative medicine programs would go to the office of the NIH. The National Institute of General Medical Sciences would get the $ 231 million price IDEA and $ 97 million in biotechnology programs. the Institute of the NIH minority health would take the $ 60 million research centers in minority institutions.

The table does not give Congress what he really needs, however, a change in the official budget of the Office of the White House's budget and management. Until that document is submitted, members of the appropriations committee staff may not include the reorganization in their bills for the budget of NIH for fiscal 2012 that begins October 1. And time is running out: The House subcommittee plans to mark its bill on July 26.

National of his high-profile initiative Institutes (NIH) to diagnose diseases mystery health is a pause to catch his breath.

The Undiagnosed Diseases Program was launched in 08 to help desperate people for diagnosis and use the discovery of new diseases to learn more about human biology. But as of today, the program temporarily stop accepting new applications for the cases to be studied because of "overwhelming number of applications already received," according to the note posted on the program website .

"We were inundated for some time. This is an effort on the last chance to catch up," said the head of William Gahl program, a biochemical geneticist at the National Research Institute on the genome human. "We want to be able to devote more time to the conditions that we have seen."

undiagnosed diseases Program has received inquiries from 5400, and a complete application, with medical records the sick person, were presented to about 100, according Gahl. the program has so far accepted 450 of these candidates, but only had time to investigate about 350 cases to date, each person usually comes in about a week of study at the clinical center of Bethesda, Maryland, the NIH campus. Gahl said that applications already submitted will always be considered for such a full investigation. and he hopes the program, which released its first discovery a new genetic disease earlier this year, will resume accepting new cases of applications in a few months.

the mice with liver manmade, goats with human blood cells, and other animals that contain human genes or cells are tools undoubtedly valuable for medical research, but they can also raise sensitive ethical issues and trigger public controversy. Recognizing this reality, a report published today by the British Academy of Medical Sciences recommends that the Government U.K. establish a commission of experts to help regulate certain types of experiments involving "animals containing human material."

The report authors hope that the public debate early in potentially controversial work before it is undertaken, will help encourage wider acceptance of this research. "We try to make this issue there before anything happened," says geneticist Martin Bobrow of Cambridge University, who chaired the working group of the Academy. "If public has heard of something, they are less likely to get irritable when something makes the headlines."

The report suggests that experiments with animals containing human material (ACHM) should be divided into three categories: those that should be subject to the same supervisory and regulatory and other animal experiments, those who should undergo further evaluation before receiving approval to proceed, and some that should be completely off-limits. The areas that should be further consideration include experiences that change the brain of an animal to make it more "human-like" experiences that put human germ functional cells in animals, experiments that could make the appearance or behavior of the human animal, and experiences that add human genes or cells in non-human primates.

Three types of experiments AChM should be prohibited, the report said, because they "lack of convincing scientific justification or raise very strong ethical concerns."

First, farm animals that have or may develop human germ cells in their gonads should not be allowed. Secondly, the report recommends ban on research that attempts to transplant cells sufficiently in human neurons in a non-human primate to induce human-like behavior. Finally, scientists should not allow embryos that mix cells and non human primates humans to develop beyond 14 days. Currently banned U.K. law allowing human embryos containing animal cells to develop more than 14 days. However, the embryos that are "primarily animal", but contain human cells are not regulated in the United Kingdom. The report recommends to fill this gap.

"We have not met with scientists who want to do the three category [off-limits] experience," said Robin Lovell working member of the Badge group a press conference this morning. Lovell-Badge, a stem cell biologist at the MRC National Institute for Medical Research in London, said that several types of "category two" experiments have been proposed or are under way in Britain. For example, he said, researchers studying infertility grafted human testis and ovary cells under the skin of animals in an effort to better understand their development. And animals with human skin, he said, could help scientists better understand sunburn and its connection to skin cancer. "There are good scientific reasons it must be done," he said. "But if this is done, it should be closely monitored."

Government RU revise its monitoring of animal research to comply with a recent directive of the European Union. "We hope they will take this [report] account," Bobrow said, and to establish better cooperation between the UK Home Office, which regulates animal research, and the Ministry of Health, which oversees research involving human subjects. It is particularly important, he said, to close the loophole that allows unregulated experiments with embryos of animals containing human cells.