Health Meaning

After months of inactivity, a lawsuit challenging the legality of the National Institutes of Health (NIH) __gVirt_NP_NN_NNPS <__ funding for human embryonic stem cells (hESC) research may soon be moving again. Today, plaintiffs' lawyers in Sherley v. Sebelius asked US District Judge Royce Lamberth to allow the two sides to meet an April 29 decision from a federal appeals court.

In a victory for NIH, this decision overturned the preliminary injunction Lamberth last August that briefly stop hESC research.

The complainants note that 2-1 opinion of the court of appeal "expressly left many questions unanswered." They want to be given until 3 June to a page file 10 (or less) additional memory, the defendants respond to 10 pages by June 24, and that claimants until July 6 to submit a response five pages. In September the two parties asked Lamberth's prompt action in the case; the latest submissions were filed in October.

Whether or not cell phones cause brain cancer is an issue that has been debated (but no answer) for years, and aujourd 'hui the World health Organization (WHO) stepped into the fray. A WHO committee that evaluates various potential carcinogens found that radiofrequency electromagnetic fields, including cell phones are "possibly carcinogenic" to people. The announcement was seized upon and published in dozens of news outlets in minutes.

The International Agency for Research on Cancer (IARC) has concluded a possible carcinogenicity after a review of eight days of the literature by 31 experts in Lyon, France. The ranking is in the middle of the hierarchy of the IARC risk, joining a group of more than 250 potential carcinogens that also includes lead, engine exhaust, and occupational exposure to dry cleaning. In a sign of how difficult it is to determine that something does not cause cancer, one of some 00 agents that IARC has evaluated, caprolactam, a component of fibers and plastics, falls into the category "probably not carcinogenic".

Regarding cell phones, "we found some evidence of son tell us how cancer can happen, but I think that there are gaps and uncertainties recognized," said Jonathan Samet , chairman of the IARC working group and a physician and public health expert at the University of Southern California in Los Angeles, at a press conference. the working group was particularly influenced by an international study called Interphone which is to examine whether exposure to electromagnetic fields from cell phones radiofrequency causes cancer. last year, the INTERPHONE study group wrote in International Journal of Epidemiology it saw "no increased risk of glioma or meningioma." He continued: "There were suggestions of an increased risk of glioma at the highest exposure levels, but biases and errors" make it is difficult to demonstrate that the phones were the cause. "The possible effects of long-term heavy use of mobile phones require further investigation," they concluded.

IARC would like more research as well. Samet noted that, at this stage, there are almost 5 billion cell phone subscriptions worldwide, and "we expect an ever larger population that is exposed for longer and longer." That said , moving the cell phone category "possible" in a final will not be easy. epidemiological studies like tend to match Intercom healthy people with those who have brain cancer and ask both to remember their cell phone use. "We know that is inherently flawed," said Samet. And because these studies take time to complete, they inevitably look older technology. animal studies looking at the risk of radio frequency electromagnetic fields were mixed, both to know if they see a danger and why this might be.

what IARC reassess the risks of cell phone, the committee said, will depend on what new research comes out.

The chairman of a committee set up to help US National Institutes of Health decide to pursue biomedical and behavioral research with chimpanzees resigned . The organizers of the committee - the Institute of Medicine (IOM) and the National Research Council, revealed in an oblique noted June 8 that President

John Stobo, who oversees health science and service the University of California system (UC), "will not be on the committee." Stobo did not respond to an inquiry about his departure.

Stobo, who chaired the first meeting of the committee on May 26, is the third scientist was "provisionally approved" to participate and then removed. ( Nature news blog first reported on the committee changes earlier today.) Although it is not known why Stobo left, a committee member who asked not to be named said Science Insider IOM said it "could be considered" as Stobo was biased for animal research because of its position UC.

The Humane Society of the United States (HSUS) complained to the President of IOM Harvey Fineberg in a letter on May 24 that the committee was "significantly unbalanced," noting alleged conflict of interest of several members. Neither UC nor Stobo was mentioned in the letter, but he made only the institutions behind the other two members who left the committee. One was Alan Leshner, executive director of the AAAS Science s editor. The Board of AAAS advocated research primates in the past. The other member of the former committee was veterinary Leticia Medina of Abbott Laboratories, which used chimpanzees in research on hepatitis C.

HSUS is a key sponsor of a bill now before the US Congress, the Great Law of the cost savings of the Ape protection and prohibiting search "invasive" captive chimpanzees.

Christine Stencel, a spokesman for the IOM, said he did not discuss details of service to members. "We have mutually determined that these people will not be on the committee," said Stencel. "The process is confidential."

Despite the Italian researchers HIV / AIDS gain a level above berth in the field, the government has no plans to continue the National Programme AIDS research, which in its heyday in the 190s, received € 25 million per year. The program, long part of the Istituto Superiore di Sanita (ISS), the equivalent of the US National Institutes of Health in 09 was transferred to the Ministry of Health and given less than € 10 million which will be available until this year. The money will be executed in 2012, and there was no new call for funding. "There is no plan to boost the AIDS research program," complains Stefano Vella, who heads the research group on HIV, hepatitis and global health to the ISS in Rome. "The time here are tough "

immunologist Guido Poli of the scientific Institute San Raffaele in Milan noted that this" very quiet funeral for public funding of research on HIV / AIDS "comes at a most damaging moment.: Rome will host the International AIDS Conference July 20 17- sponsored by the International AIDS Society. "What I find unacceptable silence and resignation that is noticeable within the research community," said Poli. He further complained that Italy is the only G8 country that has not recently contributed to the Fund global fight against AIDS, tuberculosis and malaria. Vella, representing Italy at the European Commission Directorate General for research in Brussels, says the country is inefficient with collaborations based in Europe. "the total absence of strategic and it suicidal for the country is the main cause of poor performance at the European level, "says Vella.

ISS President Enrico Garaci said the Ministry of Health "is determined to continue to support the effort" and that "the possibility to fund AIDS research through a dedicated project remains on the table actively pursues the coming years (from 2013 and beyond). "He also notes that researchers of HIV / AIDS can also be financed through other avenues in Italy and the European community . "In conclusion, the availability of a dedicated project on AIDS must be justified, but it should be felt not as replacement of a broader competition with other Italian and European scientists active in different fields," written in Garaci an e-mail.

Poli replies that "option" has been on the table for several months, and notes that HIV grants / AIDS often suffer when they compete for the general fund because of the perception that they will receive support through the National AIDS Programme. He noted that the Ministry of Health in 09 has provided HIV / AIDS projects that € 2 million on a pot of € 100 million, and one of these projects was for basic research. "research on HIV / AIDS in disadvantaged effect in the absence of a dedicated fundraiser," concludes Poli.

* This article was corrected on June 30 to reflect that the National AIDS Research Programme transferred to the Ministry of Health in 09 and given less than € 10 million, not less than 2 million €, which become available until this year.

hundreds weekend floods in Copenhagen destroyed cell lines Biobank of the Danish Cancer Society. Scientists are still working to assess the full damage, says Jørgen Olsen, head of the biobank; they were able to recover more than 1 million tissue samples, however, including a prospective study of nutrition and cancer for 20 years.

Heavy rains flooded the streets and sewers of Copenhagen on Saturday, causing considerable damage in the city. the basement of the cancer society filled with 2 meters of water in about half an hour on Saturday night, says Olsen. "This was about 20 centimeters too high for freezers," he said, which filled with water, thaw cell lines and tissue samples. The researchers are not able to reach their samples to the Sunday mid-day, when the water had partially retreated. Right now, a refrigerated truck arrived Jutland, allowing refreeze samples researchers.

The cell lines are unlikely to survive the thawing, but the tissue samples are less delicate, Olsen said. "It does not matter that they have been warmed for a few hours, as long as you freeze again," he said. Some of the lost cell lines were shared with other laboratories and can be retrieved, but Olsen believes that dozens have been permanently lost. He said the cleaning and complete assessment of the damage will take months.

The biomedical research community is excited by the decision of the Federal Court today to throw a trial that threatened to close research funded by the federal government on human embryonic stem cells (hESCs). United States District Court for the District of Columbia Chief Judge Royce Lamberth, who earlier ruled against the National Institutes of Health, this time came down on the side of the NIH in several key arguments in the case.

The plaintiffs expect to appeal, and could end up before the Supreme Court of the United States. But their chances seem slim because the 38-page opinion strongly favors NIH, say some who read it. "It was a great decision to slam dunk even if Lamberth clearly somewhat reluctantly," said Anthony Mazzaschi of the Association of American Medical Colleges in Washington, DC "They can keep uncertainty alive for another 2 to 3 years but [their suit] is on life support, "said Stanford University law professor Hank Greely.

Harvard Medical School researcher George Daley stem cells is safer." I hope we're done for now, but nothing surprises me anymore, "said Daley.

the suit, Sherley v. Sebelius , was filed in 09 by groups that included two scientists who study adult stem cells. They argued that the execution of the July NIH guidelines of an order from President Barack Obama to lift the limits on hESC research violated the Dickey Amendment , a law that prohibits federal funding for "research in which a human embryo or embryos are destroyed."

In a ruling, Lamberth concluded that the plaintiffs were likely to win. It issued a preliminary injunction in August 2010 that stopped briefly NIH funding for hESC research before an appeals court suspended the injunction. But that court, the Court of the United States call for the DC Circuit, in a 2-1 decision in April overturned the preliminary injunction, allowing research to continue until Lamberth ruled on the background of the underlying case.

And this time, Lamberth sided with the NIH. Much of its decision based on deference to the conclusion of the Court of Appeal that NIH can interpret Dickey-Wicker to allow funding for hESC research but not on their derivation because the definition of "research" the law is ambiguous. "In the absence of a compelling reason to depart from this operation, the Court has to take at this stage of the proceedings," said the notice.

However, Lamberth did not seem happy about it. Citing the dissenting appeals court judge, he wrote: "While it is true that by following the Court of Appeal's conclusion as to the ambiguity of" research ", this Court become a reluctant partner in a bout of 'linguistic jujitsu, "... such is the life of a penultimate court."

Lamberth did not buy the argument of the plaintiffs that the hESC research puts embryos at risk by creating demand for hESCs. by that reasoning, even research involving a propane tank that took place in a laboratory adjacent to a place where the embryos were stored would be contrary to law, the notice said .

Finally, Lamberth threw on the complainants' request that NIH had improperly ignored tens of thousands of comments from opponents looking hESC when he developed the guidelines. President Obama had directed NIH to loosen search limits in hESC imposed by President George W. Bush. To prohibit research on hESCs instead of changing the rules "have violated the law," Lamberth wrote.

Steven Aden of the Alliance Defense Fund in Washington, DC, one of the plaintiffs' lawyers, said in a statement they "weigh all their call options." The plaintiffs would appeal first to return to the court of appeal, where the same three-member panel would likely hear the case, says Greely. If they lose again, which seems likely, applicants can appeal to the Supreme Court. "I think they will lose [in the Supreme Court], but it is probably worth it for them to give it a shot," said Greely.

Barbara Alving, director of the National Institutes doomed of Health (NIH) National Center for Research Resources (NCRR) announced earlier this week that she resign at the end of September.

The decision Alving to resign after six years in charge of NCRR is no surprise. The center of $ 1.3 billion, which funds biomedical resources such as large instruments and animal models, is scheduled to have its programs distributed among the other NIH institutes, on 1 October under a controversial plan by the NIH Director Francis Collins to establish a National Centre for the advancement of translational sciences (NCATS). Alving was one of many scientists who opposed the reorganization, arguing that it would be more logical to extend NCRR instead of scrapping it completely.

Alving said Science Insider she's leaving now because it has completed its "major goals", including the establishment of translational and clinical science major support scholarships, grants set up 5 years ago to support -to-bedside research bench in major academic medical centers. This program, which replaced a popular clinical research program, offers lessons for how reorganizations should be performed, Alving suggests. "Many voters are not happy," she said. But "there was a lot of discussion, a lot of buy-in. ... There was a calendar, finances have been developed, we knew where the funding would come, Congress has kept its part of the agreement. "

These things" not done optimally "with the current reorganization NIH, she said. NIH "tried to get community buy-in" of stakeholders NCRR but only "after the fact."

But Alving stresses that the disappearance of NCRR is not guaranteed. The Congress should not pass a . draft 2012 spending legislation for NIH October 1 the Committee of the House of representatives that funds NIH questioned the reorganization, although Senate budgeteers are more favorable, the 2012 budget of the NIH may liquidate part of a continuing resolution, a bill that extends the funding a year earlier. legislators should carve out an exception to dissolve and create NCATS NCRR. "I actually think NCRR will continue for an indefinite period of time," says Alving.

The uncertainty left in limbo NCRR members of staff who have been told they will spend their programs to other institutions, but have not received individual assignments. farewell note Alving advises them to "keep calm and carry on."

Alving, 65, is a hematologist who served as deputy and acting director of the National Heart, Lung, and Blood Institute (NHLBI ) and also led health Initiative of the woman before she comes to NCRR, first as acting director. she now plans to explore opportunities in health and global consultation, she said.

Two days after announcing Monday Alving, Collins published an NIH notes across its appreciation for "his unconditional service" at NIH and "his dedication and commitment." NCRR Deputy Director Louise Ramm will become acting director NCRR.

The resignation of Alving adds several NIH director positions. Anthonio Scarpa, director of the Center for Scientific Review, leaves later this month. Scarpa said the NIH staff at the end of July he was leaving in part to make room for someone who will "better reflect the [NIH] vision and the director of management style." NIH is working on a statement by Collins on the starting Scarpa, the press office said NIH. And Jeremy Berg, head of the National Institute of General Medical Sciences, NIH left in June; no replacement has yet been named.

The NHLBI also lacked a permanent director since Elizabeth Nabel left at the end of 09. That's five of the 27 institutes and centers of the NIH soon be without a permanent leader. (The fifth vacancy to the Information Technology Center, the center of the IT campus of NIH.)

* This article has been updated to reflect the fact that even if Alving was the director of NCRR since 07, it began as acting director in 05, and was therefore in charge of NCRR for 6 years and not 4 years.

The Bill & Melinda Gates Foundation today announced that Trevor Mundel, who currently heads the giant development team pharmaceutical Novartis International AG, will take over as president of its global health program on 1 December. Mundell, a scientist and physician pharmaceutical, replace Tachi Yamada, who retired as chairman of the program in June.

The program, which draws from $ 36.3 billion endowment of the Gates Foundation, fundraising, development and implementation of projects to fight against diseases such as HIV / AIDS, malaria, malnutrition, polio and tuberculosis in poor countries. To date, the program has granted $ 14.7 billion in grants, including funds in efforts to understand the disease kwashiorkor malnutrition and develop potential treatments against HIV.

Several pharmaceutical companies, including Alkermes Inc., Parke-Davis, Pfizer and Novartis, Mundel brought to shake their research and development programs and streamline the translation process from basic research on new drugs. Mundell is a big proponent of the "modeling and simulation" according to a 09 article in the Bio-IT World, using complex mathematical models to optimize and accelerate all biochemical medicines mechanisms for decision making and profits.

The appointment of Mundel probably reflects the will of the Gates Foundation to apply this approach to their health plans and drug development, said Denise DeMan-Williams, founder and CEO of the biotech Bench International recruitment firm (who recruited Mundel Novartis for work). "Trevor is someone who is probably several years ahead of his time," she said. "I think he will do flawlessly."

A US based company received permission to begin the first clinical trial in Europe involving human embryonic stem cells (hES). Advanced Cell Technology (ACT), based in Marlborough, Massachusetts, today received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to begin a trial that will treat 12 patients with macular dystrophy Stargardt. The disease strikes people between the ages of 10 and 20, causing a progressive loss of vision. There is currently no treatment.

Eye surgeon James Bainbridge of Moorfields Eye Hospital and University College London will lead the UK trial. He and his colleagues will inject into patients' eyes of the cells of the pigment epithelium of the retina that ACT-derived cells hES. In animal models, the cells were able to delay or even reverse the progression of the disease. Phase I / II will primarily examine the safety of the treatment, however.

Robert Lanza, scientific director of ACT, said the trial was essentially the same design as the US trial of the company with Stargardt's patients, which was approved last year. The fact that the US Food and Drug Administration approved the trial, however, was not a shoo-in with U.K. authorities said Lanza. "I thought it was going to sail through I was wrong; .. They were very strict"

The new trial is the first using hES cells to be approved outside the United States, said Lanza. the company plans to apply for approval for a second UK trial for macular degeneration, he added, would complement its US-based assay for the same condition. They then plan to wait until that the first results are in before starting any additional tests, he said. the first two US patients received cells of the company in July-a patient with Stargardt's disease and with related macular degeneration age. the first indications are positive, Lanza said. "We are very pleased with what we see today."

Women who donate their eggs for research in the UK should be compensated for the discomfort, risk, and inconveniences they suffer, according to a report published yesterday by the Nuffield Council on Bioethics. In its report "The human body: donation for medicine and research," influential think tank recommends that the U.K. National Health Service (NHS) to pay for funerals of organ donors.

The debate about the ethics of paying egg donors was revived after the news last week that researchers in New York came a little more to use human eggs to transform cells adults in embryonic stem cells. The group paid their donor $ 8,000 each. At the same time, another set of scientists published an account of their failed attempts donor recruitment eggs in Massachusetts without pay.

Currently British regulators cap the reimbursement of sperm and egg donation £ 250 ($ 30). The amount is intended to cover the direct costs such as travel or parking. The new report recommends that donors for fertility treatments are reimbursed for lost wages as well.

Women who are willing to donate eggs for research should also receive payment for their time, inconvenience and discomfort, the report said. "We see egg donation for research purposes, really quite comparable to those who volunteer for phase I clinical trials," says Albert Weale, chairman of the Nuffield Council. The report stresses that it should be limits on the number of times a person can donate.

in its recommendations, the report said researchers should share the tissue donated by patients or the general public. " it is unacceptable for individual researchers or research groups to obstruct, inhibit or deny access to other researchers for research scientifically valid "on samples freely given, the report said.

the Board recommends that NHS conduct a pilot study to pay for the funerals of organ donors to see if such a program could increase donation rates. under the plan, the NHS should pay for funeral expenses for those who were on organ donation national registry if they have died in circumstances where their organs could be donated. It also recommends to ask the families when they authorize organ donation if they would also be willing to give other tissue for research purposes.

A group of experts today called for the creation of a massive data network that combines advanced genomic and molecular data Stroke patients with their routine medical records. Such a database would be a boon to research and help advance medical care in the era of "precision medicine," said the panel.

The National Research Council panel was formed last year at the request of the National Institutes of Health (NIH) to examine how more than 100 years, the disease classification system should be changed to take account of the molecular biology of ideas. But the committee decided that "our challenge is greater," said panel co-chair Susan Desmond-Hellmann, chancellor of the University of California, San Francisco, at a press conference today. Instead of a new classification, the nation needs a live network data on molecular tests for individuals and health records. This system will be used to develop a new taxonomy of disease and customize medical care, according to the report of 108 pages, entitled Toward Precision Medicine: Creating a Knowledge Network for Biomedical Research and a new taxonomy of the disease .

Precision drug is already emerging in the diagnosis and treatment of cancer, said the report, some patients now receive medications appropriate to a specific molecular marker in their tumor, and parents can be tested for some cancer risks. In contrast, a middle-aged man diagnosed with Type II diabetes usually receives a drug 50 who may or may not help. And no type II diabetes risk test are available for family members.

What is needed, says the report, is for patient health records to be combined with layers of genomic molecular and other measures, such as blood proteins and microbes in the gut of a patient. As GPS data used to make Google maps, this data could be connected in detail by researchers and used more superficially by others, such as doctors to treat patients, according to the report. Separate databases are combined to form a single network.

Modest efforts like this already exist. For example, the organization Kaiser Permanente health care is building a genetic database of 500,000 patients in the San Francisco area to be used for disease studies. "We want to do it on a larger scale," said panel co-chair Charles Sawyers of Memorial Sloan-Kettering Cancer Center in New York at the briefing. (Another example, he said, is a plan for the islands Faroe to sequence genomes of every 50,000 of its citizens and to use the data for research and health care.)

as a pilot project, the report recommends the sequencing of whole genomes 1 million Americans and combining data with medical history to look for genetic links to disease. This may seem expensive, although the costs of sequencing down to $ 1,000 per genome, it would cost $ 1 billion but $ 1000 is in range of costs that routine analysis of MRI, Desmond-Hellmann said. another use metabolomic profiles pilot blood from patients to help predict which patients with insulin resistance will continue to develop diabetes type II.

Creating network during the next decade or two should not require new funding, according to the report. "This is not to the Human Genome Project," Sawyers said. "It is taking advantage of things going anyway and unite and do it to the point of care." NIH needs to redirect resources and push for more long-term studies that combine research in health care, the report said. The construction of the network may also require a revision of the rules of confidentiality of patients and an "evolution" in public attitudes about enabling researchers to use their medical data.

therapeutic drugs sometimes more damage they heal. One solution to this problem is to enclose medicines in a capsule, protecting the body and the body of them until they can be released at just the right spot. There are many ways to trigger this release, including changes in temperature, acidity and exposure to magnetic fields. But triggers can come with their own risk-burns, for example. Now, researchers in California have developed what could be the most benign trigger to date :. Shine the light in the near infrared (NIR) of the encapsulated drug

The idea of ​​using light to release an encapsulated drug is not new. Researchers around the world have developed polymers and other materials begin to degrade when they absorb either ultraviolet (UV) or visible light. But fabrics also easily absorb UV and visible light, which means the drug release can be triggered near the skin, where the light can reach the capsule. NIR light largely passes through the tissues, so the researchers tried to use it as a trigger. But few compounds absorb NIR well and undergo chemical changes.

That changed last year when Adah Almutairi, a chemist at the University of California, San Diego, said she and her colleagues designed a polymer that decomposes when it absorbs the NIR light. Their NIR absorbing polymer used a group called commercially available o-nitrobenzyl (ONB). When they catch the light, the ONB groups fall the polymer, leading to its degradation. But ONB is only one NIR absorber so-so, and it could be toxic to cells when it is detached from the polymer.

So Almutairi and colleagues went back to the drawing board. On November 8 the number of macromolecules , they indicate the creation of a new material for capsules is even better. It consists of a long chain of small cyclic compounds containing said groups cresol in a chained polymer. Cresol contains reactive components that make it very unstable in its polymer form, a characteristic Almutairi and his colleagues use to their advantage. After the polymerization cresols, they cap each reactive component with a light absorbing compound Bhc called. When BHCS absorb NIR light, the reactive groups are exposed and to break the long polymer chains in two short. Bright light continues this additional ventilation, which could release drugs polymer locks. Moreover, Almutairi said Bhc is 10 times better absorb NIR than is ONB and is not toxic to cells.

Yue Zhao, a chemist at the University of Sherbrooke in Quebec, Canada, calls the new "special chemistry" approach and said he suspects other drug delivery experts will turn to the new made for their education. Almutairi says she and her colleagues plan to test whether the compound is useful for slow release of therapeutic proteins in the eye to treat macular degeneration.

people who volunteer for research funded by the federal government in both this country and abroad are well protected by the federal ethics rules, a group of senior experts has found. But there is room for improvement. The United States needs to do a better job of monitoring human studies, the panel said, and should consider the creation of a compensation system for injured volunteers.

This advice comes from a report released today by the Presidential Commission for the Study of Bioethical issues. He began a probe last year after a historian revealed that in the 1940s, US researchers deliberately exposed more than 1,300 Guatemalans with syphilis and other sexually transmitted diseases to study the effects and possible treatments. President Barack Obama has requested an investigation of the facts that the commission finished in September; he found ethical violations "unreasonable". The president also called for a review of whether the research topics today are adequately protected.

In the decades since the Guatemala study, the United States and other authorities imposed many standards and rules on the use of human subjects, the Panel finds. In the US, the 30-year-old federal Common Rule requires informed consent, an independent ethical evaluation, and minimizing risk. The common rule also applies to the growing share of funded US trials conducted abroad, where most countries now have similar rules. Consequently, "the commission is convinced that what happened in Guatemala in the 1940s could not happen today," said Chairman of the Committee Amy Gutmann, president of University of Pennsylvania, during a Wednesday press conference.

However, in his report of 104 pages (plus notes and appendices), the Commission finds shortcomings in transparency. When his staff asked 18 US agencies identified by the common rule to the list of human studies they support, many could not easily provide the information. Even the National Institutes of Health (NIH) of the base subsidies can not be easily searched only human research. And a federal database of drug trials, ClinicalTrials.gov, leaves many at an early stage (phase I) trials and social science studies and behavior, according to the report, titled "Moral Science: Protection participants in human research subjects. "

Bioethics Committee, which collected 55,000 studies funded by the federal government in 2010, said that federal agencies should be required to make public basic information online about each project, including title the investigator, the location and funding of the study.

Another problem the commission of the flags is the need to address or compensate the wounded volunteers. Most developed countries have remuneration policies but in the US it is said, efforts are "piecemeal." Patients may continue in case of injury, but the resolution can take years. Some organizations their own pay systems for in-house research, pharmaceutical companies usually have insurance the University of Washington is "a wonderful case study," said the vice president James Wagner commission, president of Emory University. : It provides up to $ 10,000 in costs out of pocket and unlimited treatment through its health care system for subjects who claim to need help the United States should consider establishing a national compensation system. for research topics, the commission concludes Although there is a pattern to it. - National it Injury compensation Program vaccines is not the only option "Usually, what works in the US are not. not a uniform centralized system, but a system whereby, for example, the federal government may recommend or require that all the institutions of a certain size to ensure they have provisions for compensation, "said Gutmann. "We want the government to get this right."

Among its 14 recommendations, the Committee is also focusing on the possibility that developers could choose to locate a study in a place for reasons of "disturbing" for example because the regulations are not strong. for this reason, the committee concludes, funding agencies should ensure that the study can be done ethically in a proposed site. at the same time, he said the United States should consider allowing the rules of a foreign country to supplant the common rule when they are equivalent.

the Committee also makes recommendations for an ongoing overhaul of the common rule, including : development of simple shapes, standard informed consent allowing multi-site studies to go through a central ethical review; and to facilitate the examination requirements for studies that present a minimal risk.

The report notes that previous bioethics panel made recommendations for-like example, in 02 the Institute of Medicine urged the institutions necessary to compensate for injured research participants. This time, the Office of the White House science and technology policy and other agencies should issue a response on why or why not the government plans to respond to the opinion of the Committee, the report said.

Last week, Guatemala issued its own report on the review of the 1940 syphilis; he found that nearly 2,100 people had been deliberately exposed to diseases, much more than what had been reported earlier, according to a press report. Guatemalan investigators drew on archived documents that the US bioethics commission has not had access to, says director Valerie Bonham Executive Board. His team is currently reviewing the report, which received Spanish. He plans to fold the findings in a study guide for students about the Guatemala study.

Correction :. This article has been amended to correct a statement suggesting that the report specifically recommends a compensation system along the lines of the National Compensation Program Vaccine Injury

Sepsis is not only one of the diseases of old people used to die before the discovery of antibiotics. It is still a major killer. Now, a new study shows that immune cells called B cells prevent sepsis in mice, a discovery that could help scientists design better treatments for the disease.

Each year, up to 1 million people in the US suffer from septicemia, a rampant infection associated with inflammation bodywide. Despite antibiotics and other treatments, approximately 25% of sepsis patients die, says the researcher of infectious diseases Steven Opal of Brown University, who was not involved in the study. "Sepsis is a huge problem that we had a lot of difficulty to solve," he said.

At first glance, the B cells do not look like part of the solution. Their most current work is pump defensive proteins called antibodies. Immunologist Filip Swirski of Harvard Medical School in Boston and colleagues found the involvement of cells in sepsis by accident. Swirski was probing the role of immune cells called macrophages in cardiovascular disease. He and his colleagues tried to identify the cells that make macrophage colony stimulating factor (GM-CSF). this protein has a great influence on white blood cells, which stimulates some of them to mature and start-up disease-fighters such as neutrophils. Swirski said researchers thought that macrophages or other non-B cells were the source of GM-CSF. However, in mice, the team found, most GM -CSF-producing cells in the spleen were B cells These cells, as innate lined researchers -B response activator cells (IRA) were unique. Their cell membrane bristling a combination of proteins not seen on other cells B. Furthermore, B cells generally detect microbes intrusion using the cell B receptor, a protein that is found only on their surface, while the IRA-B cells based on the same protein that are prevalent on macrophages and other cells of the body.

A situation where GM-CSF may be important is that sepsis studies conflict on whether it is harmful or beneficial. To measure the effects of IRA-B cells, the researchers studied mice who developed sepsis due to intestinal perforation. Mice that lacked B cells died, while 40% of control animals who had survived many cells, Swirski and his colleagues report online today in Science . The IRA-B cell "is a specialized manufacturer GM-CSF in the context of infection," says Swirski.

The study is not the first to suggest that B cells sepsis curb a published article last summer as this conclusion, but it did not identify the brand B cells offers the advantage or how they help. Swirski suggests that IRA-B cells prevent sepsis accelerating attack by neutrophils on pathogens, which therefore allows the immune system to the previous stop. IRA-B cells normally hang in the wall of the abdomen. But when they detect bacteria, they upset the spleen, where different types of immune cells mingle.

"They deliver a precise dose of GM-CSF where it is needed," says Swirski. a quick victory stimulated by the chemical may be important, he said, because "the immune system is a double-edged sword in sepsis: it is necessary to get rid of a bacterial infection, but it can cause enormous damage "for example, the inflammation caused by the immune system cells can lead to clotting. bloodshed that affects many patients with sepsis.

"It is a study quite remarkable, and quite surprising," said Opal. To move forward, he suggests, researchers must determine what range of pathogens of the IRA-B cell is working against and if they can use to fight against infections. Swirski and his colleagues have made a discovery encouraging, identifying IRA-B cells in people. In the future, the team suggests it might be possible to grow cultured cells and injecting them into patients or using drugs to stimulate replication in the body.

The Broad Institute was filled $ 32.5 million a philanthropist to take on one of the biggest challenges in biology: molecular mapping circuit inside mammalian cells. The Broad Institute in Cambridge, Massachusetts, will create what he calls an observatory of the cell that brings together biologists from the Institute and elsewhere to fight against this problem, similar to how astronomers gather in observatories telescope to collect and analyze data.

The gift announced yesterday comes from the Klarman Family Foundation, a Boston charity founded by financier Seth Klarman, who sits on the board of the Broad and his wife Beth. Broad will use the money to build on efforts by systems biologists to map how genes, RNA, proteins and other biomolecules interact in ways to operate cells in healthy people and in disease. "It is a big challenge, but it is one in which the groups around the world have made much progress in recent years," thanks in part to new tools to cut genes and analyzing interactions gene- protein, said biologist Broad calculation Aviv Regev, who will lead the observatory.

The $ 32.5 million will fund a 5 year program with three components, as Regev. One is the development of technology by improving existing tools and make them available "not only in the observatory, but to the broader community," Regev said. Another observatory will support small collaborative grants the Broad Institute and beyond

The third component has a specific goal. study "many layers of circuits as possible" in two to four types of mammalian cells to build a global model of internal operations a cell. this is a pilot project, Regev said, in order to finally be able to apply to any type of cell, she said. at this point, it could become the basis of a great effort International some use the term "Project human circuit," Regev said.

Regev said that while the National Institutes of Health (NIH) is funding studies of cell circuits, the federal agency that would support not necessarily observatory wants to do. "It is one of those cases where philanthropy can really help you to push the envelope in terms of risk," she said.

Harvard University researcher Benjamin Ebert on stem cells, which will be involved in the new company, agrees. Ebert and Regev mapped gene expression in blood stem cells as they mature into different types of blood cells. The extension of this work to the proteins encoded by these genes is "much more complicated" because it involves hundreds of interactions, says Ebert. And because this model is "exploratory enough" and not test a hypothesis, it might not do well in NIH peer review, he said. "It is extremely helpful to have funding for this stuff."

A steering committee will refine the Observatory plan over the next few months, said Regev. For now, he sets up in the space in the Broad building.

The Broad is not alone: ​​Mount Sinai School of Medicine in New York, the Allen Institute for Brain Science in Seattle, the Salk Institute in San Diego, and the University of California, San Diego, are also the big launch efforts to study the cell circuits, said UCSD calculation biologist Trey Ideker. He suggests that these groups should eventually form a "large, coordinated science project" so they can divide the task of mapping circuits in different types of cells. "This is a very big goal and in a sense the logical successor the human genome project, "said Ideker.

A long legal battle over a health study of $ 11.5 million to determine whether the diesel exhaust damage the lungs of miners suddenly expanded to take on review by scientific peers. Editors at least four research publications say they have received a letter informing them against "the publication or other distribution" of data and draft documents. The warning, including a vague statement about "consequences" that could result if the advice is ignored, signed by Henry Chajet, a lawyer at Patton Boggs law firm in Washington, DC, and a lobbyist for the group mine awareness resources, which works on behalf of the mining industry.

Chajet declined to comment, but his letter, it is clear that he seeks to persuade reviews for delay publication or distribution of documents containing the results of the Diesel Exhaust in Miners Study (DEMS) , a research project funded by the government. The letter stressed that the mining industry coalition of groups are legally entitled to examine the study data prior to publication. Other lawyers and researchers involved in the case also declined to comment because the 2-decade dispute over DEMS is now pending before the US Court of Appeals in New Orleans.

The diesel study, the planning began in 1992, is jointly managed by the National Institute for Occupational Safety and Health (NIOSH) and the National Cancer Institute (NCI). He monitored the health of more than 12,000 miners exposed to diesel exhaust in underground spaces. One of the objectives of the study (which controls for smoking) was to learn how miners developed lung cancer. NIOSH currently diesel exhaust class as a "potential human carcinogen", but new data could lead to a review of that assessment.

The timing of the publication of DEMS data is critical because two prestigious groups, the International Agency for Research on Cancer and the National Toxicology Program of the US are set to review their standards on risks to the health of diesel exhaust. Their decisions could have financial consequences for many diesel engine users, particularly in lawsuits claiming damages.

A coalition of industry, including mine awareness Resource Group, has long argued that DEMS was scientifically wrong. The first coalition took the federal government to court in the 190s, arguing that the industry should be more involved in monitoring DEMS. The case went through several hearings (details below), resulting in a court order that requires scientific DEMS deliver all data related to DEMS, including scientific articles projects on the basis of these data, the coalition of mining and House of representatives Committee on education and the workforce, which claims jurisdiction under consideration. The coalition and the Committee have the right to examine the data for 0 days before publication.

Editors at two Publications- UK labor and environmental medicine ( OEM ) and The Annals of Occupational Hygiene -Say they received the Chajet letter warning them not to publish the results DEMS or even move around the draft documents. Science obtained a copy of the letter, which said, in part, "We respectfully request that you and your Board to carefully consider any intention to publish these [DEMS] documents, as well as the impact and . the consequences of all this publication "He continues:" [W] e provide you notice of this situation in the hope that if you are considering the publication or distribution of these documents, refrain from doing so, until that orders and judicial Congress guidelines are met, or otherwise resolved. "(Read the full text of the letter.)

Dana Loomis, editor of OEM and epidemiologist at the University of Nebraska Medical Center in Omaha, said:" I was completely surprised "by the letter, especially since OEM has not and never had paper DEMS in the study." It is a vague but threatening letter, and I think his imprecision is what makes it remarkable, "said Loomis." It shows how the legal system can be used to restrict scientific communication. "Loomis said he doubts the court decisions would even apply to scientific journals, particularly those based in another country.

another recipient, the Annals of Occupational Hygiene had already published some DEMS work in October 2010-long, four-part explanation of the methodology of DEMS. (parts one, two, three, and four here. the Annals published a refutation of six scientists working for the mining group a few months later, in April 2011.)

Trevor Ogden , a retired physicist and editor of Annals , said his newspaper has accepted the four documents in February 2010 publication usually takes 7 weeks after acceptance, but the various actions delayed publication justice in this case for months. The newspaper also accepted a fifth paper in February 2011, but is still waiting for permission to run DEMS.

Ogden said: "Despite our efforts to be neutral on various controversies, this newspaper has often been accused of being on the side of employers. However, I am disgusted by the many actions taken to delay [the DEMS] publications and avoid opening them to public scrutiny. " Ogden added that the letter he received was sent to two other publishers as well, but they refused to be named.

Loomis said Journal of the National Cancer Institute already has a document outlining the main conclusions of DEMS. A spokesman declined to comment when JNCI had received a letter.

By jumping up and down through the court system, the legal case has stretched almost as long as DEMS and turned several times on bureaucratic minutiae. The first dispute involved whether DEMS should include industry representatives on scientific oversight committee. The two sides also disputed exactly who should have jurisdiction over DEMS. Finally, a court decision forced DEMS filing a charter with a US House committee. This would have had to go through the House Committee on Education and the Workforce. But the US Department of Health and Social Services (which oversees NIOSH NCI) presented falsely claims to another committee. This inevitably brought new trial, with accusations that DEMS was trying to "evade transparency." DEMS Personnel file with the appropriate committee of the Senate.

Litigation on the erroneous filing went to court Federal Lake Charles, Louisiana, where judge Richard Haik ruled in March 00 DEMS had to return all data on mining groups and the House Committee on education and the workforce. Haik indeed their granted the power to stop DEMS publish results.

Dems leaders have appealed, and the Court of appeal of the United States of New Orleans has canceled a large part of the court decision less than in May 01, saying that DEMS had the right to publish. However, he said that scientists had to return all data and drafts in the mining coalition and the House for consideration of committee and that these examiners should obtain materials at least 0 days before publication.

The legal fracas began again in 2010 and 2011, The Annals ready to publish the four methodological documents. Mining groups have accused scientists DEMS had withheld data and not put draft documents before submitting them for peer review, in violation of court orders. The case is returned to the judge Haik, which again ruled in favor of mining groups, taking the federal government in contempt and reaffirming that the DEMS scientists must return all data and projects of all documents they intend to publish. The decision also ordered the people to notify DEMS scientific journals that newspapers are not allowed to move all the projects they had already received. The case has since been appealed and argued before the Court of Appeal of New Orleans US; a decision is expected soon.

the main US professional society representing gene therapists have argued this week that the clinical trials their maturation area should no longer be required to undergo an examination by a special federal advisory committee. Although others disagree, many say it is time to take a fresh look at the role of the venerable Recombinant DNA Advisory Committee (RAC).

RAC was established in 1974 to oversee all gene splicing experiments, and later moved its primary focus on human gene therapy. In the mid-190s, then-National Institutes of Health (NIH) Director Harold Varmus asked whether the RAC was necessary, and its mission was changed to approve the protocols to offer advice. But all researchers funded by the NIH that provides gene therapy trial is even necessary to send a thick asked 21 researchers, ethicists, public representatives and other RAC members for review. The committee selects approximately 20% of 50 to 100 protocols it receives each year for discussion at public meetings. FCAC also oversees institutional biosafety committees and updates the guidelines of the NIH to work with recombinant DNA.

But now, after 20 years of experience, more than 1000 US trials, and a growing number of successful gene therapy in the clinic, some researchers say it is time to end RAC examination protocols gene therapy. A big reason, they say, is that the proposals are being examined by the US Food and Drug Administration and the institutional ethics and biosafety boards, which now have much experience with the field. "Gene therapy is over-regulated to the point where it is crippling progress," said Xandra Breakefield of Massachusetts General Hospital in Charlestown, elected president of the American Society of Gene Therapy and Cellular (ASGCT).

said ASGCT the two main concerns of safety altering the germ line DNA or by creating a new pathogen havent materialized vector for vectors that most trials are now using. in a recent letter to the RAC and Breakefield read a statement at a meeting RAC yesterday, the company said that instead of examining individual protocols RAC should instead focus on "new research areas."

This proposal got a mixed reaction from RAC members and others who submitted comments online. While many gene therapists agree, including European exchange-ASGCT some have suggested that the RAC exams are valuable to assess the safety and ethics of new therapies and can effectively review of speed other organizations. Commenters also welcomed the RAC value as a forum for public discussion that does not exist in other areas of clinical research. "It would be a mistake to underestimate the importance," said Claudia Mickelson, biosafety officer at the Massachusetts Institute of Technology in Cambridge.

The President of the RAC, Yuman Fong of Memorial Sloan Kettering Cancer Center, New York, urged caution: "To go to the examination most things to see there is a big step." He also noted that because no gene therapy treatments have been approved by the FDA, public confidence is "very important". At the same time, it is appropriate that the RAC should have a "dialogue" to whether it should "pare back" role.

Amy Patterson, NIH Associate Director for Science Policy, said the NIH has no plans to end the RAC "We still believe it is important to have this transparent forum. "But she said NIH is" happy to think of ways to simplify the process of RAC, "and is likely to welcome a broader discussion.

The US government today issued a new policy that will require federal agencies to systematically examine potential risks associated with funded studies the federal government involving 15 "high consequence" pathogens and toxins, including avian influenza H5N1. The exams are designed to reduce the risks associated with "dual use research of concern" (DURC) that could be used for good or evil.

The new Durc month policy in the making, and part a reaction to the ongoing controversy over research involving H5N1 avian influenza current virus-will expand reviews already conducted by two major funding agency for biomedical research, the National Institutes of Health (NIH) and the Centers for Disease Control . (CDC) both organizations are already discussing the proposed studies intramural by the scientific staff to the potential dual use; now they will extend these tests to extramural projects carried out by scientists at universities and other institutions. the new rules would also apply to any other biological research funding unclassified federal agencies such as the US Department of Agriculture and the Ministry of Defence.

The new policy requires all agencies to review the two proposed projects and those already financed. If a review identifies potential DURC, the funding agency, the institution and the principal investigator are supposed to develop a "risk mitigation plan." This could include efforts to change the way research is done, the move to a safer lab, and communicate to the public and other scientists responsibly. for particularly problematic studies, agencies will determine whether to seek "voluntary redaction of research publications or communications" or to display results .

the policy, which seems to take effect immediately, requires agencies to report to the White House within 60 days on the proposed number or current studies focus on 15 targeted agents, and within 0 days on how many projects Durc comments identified.

continues to dog the controversial one Advisory Board will be National children study (NCS), an ambitious federal plan to track the health of 100,000 children from birth up 'at age 21. next Tuesday to consider reducing cost alternatives to the design of the original study. But some researchers involved in the study believe that the National Institutes of Health (NIH) has already made a decision.

Study planners at NIH wanted originally to recruit pregnant women and their babies for $ 3 billion NCS provided by knocking on doors of households in a random sample of 105 US counties. When pilot studies begun in 09 found that it is too expensive, the NIH began testing alternatives, such as finding women through the offices of health care providers in counties. Then in February, the NIH announced a reduction of 15% of the $ 193 million annual budget of the NCS which could mean replacing sampling County with pregnant women recruited by providers who are part of health care organizations .

This caused an uproar (and two resignations adviser): Many researchers involved with NCS said that only a sample of the geographic base would yield results applicable to all American children, including the poor. And abandon the 105 counties would waste years of work on strengthening the support of the community, they said. National Institute of Child Health and Development Director Alan Guttmacher, whose institute runs NCS, said no final decision was taken.

Indeed, next week, the advisory committee will examine the NCS new sampling plans described in this white paper. Some providers even sample geographically; others would recruit women through interested health care providers; a third set would use hybrid designs.

Nigel Paneth of Michigan State University in East Lansing, who heads one of 40 NCS "vanguard" pilot sites, he and others have found ways to cut costs in 105 counties for example, collecting placentas but not cord blood at birth. Paneth expects many researchers Site pioneering sign a proposal that they will present to the Advisory Committee next week.

But Paneth also concerned that the spirit of NIH is already established. In a document dated April 13 said that Paneth ready NIH to inform members of Senator Thad Cochran (R-MS) staff, the agency wrote: "Thus, the main study used ... HMO and other networks health care providers that the main source of recruitment "He goes on to say." the main study will not be building a "national probability sample '."

"This is an illustration rather overwhelming the way they are [NCS leaders] not being honest with us, "Paneth.

NCS leaders deny that any decision was taken. in a statement, Director NCS Steven Hirschfeld said the three information pages of documents of the Senate was "only part of the more verbal briefing, which ... provided more detailed information." He says that "the design of the main study is still being finalizing "with the participation of the Advisory Committee and other stakeholders. Hirschfeld added that NCS has already cut some costs by making changes such as the use of non-proprietary software and a central ethics committee.

Community members in 105 counties are also angry about the NCS changes. Last month, the Community Advisory Board for the University of Mississippi-run NCS pilot site in Hinds County Hirschfeld wrote "to express our confusion, deep exasperation, and the major concern."

"We feel deceived," said the letter. The possibility that the 105 study sites will be removed from the main study "is a parody" and is especially troubling for a condition that gets worse and pregnancy the birth of the results of the nation and the significant health disparities, the letter said. "the Mississippi delta is the closest thing our nation needs a third world country," says the letter, and the abandonment of NCS sites in the state "seriously undermines the validity of the NCS."

The National Institutes of Health (NIH) today announced a new plan to stimulate drug development: It has an agreement with three large pharmaceutical companies to share abandoned experimental drugs with academic researchers so they can find new uses. NIH puts up $ 20 million for grants to study medicine.

"The goal is simple: to see if we can teach old drugs new tricks," said Health and Human Services Secretary Kathleen Sebelius at a press conference today that included representatives of Pfizer, AstraZeneca and Eli Lilly. These companies will give researchers access to two dozen compounds that have gone through safety studies, but has not done beyond clinical mid-stage trials. They stowed the drugs, either because they do not know enough about the disease for which they worked were developed or because a business decision the sidelined.

Often tens of millions of dollars and years of research have been devoted to these compounds, so they are already well along the drug development pipeline. The government program will allow the university to "Crowdsource" ways to use them, said director Francis Collins NIH. The idea for the refurbishment of the compounds is not new, he noted and others, the drug AZT AIDS, for example, began as a failed treatment of cancer.

NIH first started talking with companies on a drug rescue efforts at a workshop in April 2011. Uses The result Discovering New Therapeutic Molecules for existing program is "the first initiative signature "4-month-old NIH National Center for the advancement of translational sciences (NCATS), Collins said. NCATS plans to put $ 20 million of its $ 575 million budget request for 2013 in the new program.

researchers will be able to browse the basic information about online drugs. If they see one that interests them and successfully apply for a grant, they will have access to compounds and detailed data on safety , pharmacokinetics and administration. If the drug meets milestones in tests on animal models, they can receive funds to take in early clinical trials. NCATS Acting Deputy Director Kathy Hudson said NIH plans to possibly be eight to 10 cooperation agreements which will run up to 3 years.

The pilot program also includes a "model" legal agreement with the companies. The company retains ownership of the compound, but researchers will receive a new intellectual property they discover. The researchers are free to publish their results, although the company gets to review the manuscript to protect confidential information.

If a promising compound, NIH hopes that the original company (which has the first option to license him) or another company will take through clinical trials for advanced stage. Collins said NIH hopes the program will benefit research areas such as neurological diseases that businesses stepped back because of delays and uncertainty of long-term development success.

The new NIH program is similar to an agreement with AstraZeneca in December with the Medical Research Council U.K. share 22 compounds; it has already attracted more than 100 proposals, said Donald Frail, vice president of the unit of innovative medical science and new business opportunities.

Pfizer is interested in the NIH program because it already has a drug repurposing collaboration with Washington University in St. Louis and realized he needed a larger effort, said Rod MacKenzie, senior Vice President group, responsible for research and development pharmatheraupetics. "It gives us a chance to access a large scale ... the wonderful minds that we have in the university community," said McKenzie.

Although 24 compounds in addition to only a small fraction of the medications on shelves-MacKenzie companies said that Pfizer has "dozens" -NIH hope that more companies will participate. "I think people were waiting to see what this [program] like," said Sebelius.

NIH issued a request for information on the program today and expects to issue a request for pre-applications later this month.

* Correction, May 4: An earlier version of this article incorrectly stated that companies can not impose restrictions on the publication of results. The state of research agreements (ie Sec. 11 in agreement Pfizer) that the company has the right to examine and revise manuscripts to protect confidential information. The Company may also request the submission to be delayed for 30 days so that it can apply for a patent.

Responding to accusations of improper procedures, $ 3 billion research fund cancer Texas agreed to re -consider marketing a controversial $ 20 million award made in March for two institutions Houston. But it is unclear whether the plan will satisfy the critics, who ask a rigorous scientific review.

Meanwhile, according to emails obtained by a newspaper in Texas, a Nobel scientist who resigned in part to its price on concerns about the grant was forced to leave after he complained that the exams had become politicized.

The grant of the Institute of Prevention and Cancer Research of Texas (CPRIT) provides $ 20 million in one year to be split between Rice University and the University of Texas MD Anderson Cancer Center, who split-up of the lion to $ 18 million of his Institute of applied science Cancer (IACS). CPRIT Scientific Director, Alfred Gilman, announced earlier this month that he resign in part because he believes IACS, which plans to discover and develop drugs, is a research program "disguise [d]" the marketing to avoid scientific scrutiny. Scientific Review Board CPRIT shared these concerns.

Other questions about the allocation process have since come: Some members of the review of the marketing of CPRIT Council, which approved the granting of the incubator, have links with the rice or MD Anderson, for example. And from MD Anderson does not go through the office of the Provost of the University, which looks at potential conflicts of interest and have identified one in this case, because the lead researcher Lynda Chin is married to MD Anderson President Ronald DePinho. Critics allege that CPRIT and MD Anderson bypassed normal procedures.

Yesterday DePinho CPRIT sent a letter calling the allegations "inaccurate" and "false," but said it is "understandable" why scientists would be involved "in the absence of all the facts." The letter says MD Anderson is ready to submit its proposal for a "reconsideration." But the letter denies that the grant must go through the provost MD Anderson. Because it is a business plan, the proposal will be considered by "business affairs" department of MD Anderson, said the letter.

CPRIT Executive Director William Gimson wrote back the same day DePinho that CPRIT accepts the offer to re-examine the IACS part of the proposal of the incubator. (He refused the offer of MD Anderson to delay funding for a year, because it would be incompatible with CPRIT policies.) The letter also indicates that, in accordance with the incubator Request for Applications (RFA) has approved the last year by the Board CPRIT, the proposal will be considered by the review of the marketing CPRIT board. At the same time, Gimson wrote, "the incubator RFA is designed for commercial and any proposal must comply with this criterion."

What is not clear is whether the marketing examiners see the IACS project in the same way the scientific critics. They argue that because IACS objectives such as the study of "target biology" and did not identify the products or business, it is about marketing, not on science. Depending on how soon MD Anderson resubmits its proposal, the board exam marketing could make a decision before the next meeting of CPRIT board in July.

The Gilman concerns about the review process CPRIT led to pressure from, according to an online report today The Dallas Morning News . The article cites April 1 Gilman email to colleagues in which he said Gimson told him to resign because the board CPRIT "has no faith in your ability to do your job." Gilman wrote that he replied that "I will not resign, they would need to fire me."

More from the article:

The resignation request by Bill Gimson, executive director of the Institute of Prevention and Cancer Research of Texas, or CPRIT is came after Gilman wrote four pages letter in which he warned that "political considerations" should not be held to decide how public dollars should CPRIT award.

E-mail and letters Gilman were among hundreds of pages of documents published by CPRIT in response to a public records request by The Dallas Morning News. Reached for comment this morning, Gilman declined to answer questions.

Dozens of emails focus on Gilman position that the system of CPRIT "peer review" in which out-of-state scientific review applications to avoid potential conflicts of interest, is attacked by enemies, including some members of the monitoring committee agency that Gilman called "people really badly."

The researchers reacted with mixed feelings to the National Institutes of Health (NIH) plans to reorganize its great clinical prices to fit the mission its new center of translational science.

The program translational scientific and clinical Price (CSTC), a budget of $ 461 million in 2012, grant funds of several million dollars that support clinical research in 60 major academic medical centers. NIH has created a lot of anxiety in the CSTC community when he decided in late 2010 to move this flagship program of another center proposed at the National Center for the Advancement of Translational Sciences (NCATS), which aims to eliminate bottlenecks, throttling drug development.

A big concern was that the new supervisors to NCATS have no interest in continuing the CSEC support for community engagement and other aspects of medicine that do not concern the therapeutic development. They are not reassured when NCATS Acting Director Thomas Insel said that the centers would "evolve".

Anxious got some relief Friday when NIH issued a Request for Applications (RFA) for CTSAs renewal. search categories such as research and community epidemiology are still listed as potential activities CSEC. "The full spectrum of translational research is clearly included," says Lloyd Michener, who heads a community research center that is part of the CSTC from Duke University in Durham, North Carolina. At the same time, the proposals should not include as much specific activities as before, suggesting that this CTSAs person can focus on their strengths, said Henry Ginsberg, director of CSTC Columbia University and co-Chair of the Executive Committee CTSA Consortium.

in another indication that the agency does not grow drastically change NIH says it will seek the advice of a report from the Institute of medicine requested by Congress, due out next summer .

However, the FRG has budgetary implications: He says that the awards will now be adjusted to correspond to 3% of the overall NIH funding of an institution It will probably mean reductions for some and larger budgets. for the others. (Minimum $ 4 million A budget should protect small institutions have eviscerated programs.) NIH plans to withhold funds for a later competition, which will support the roles of CTSAs in a national network. "We do not know if all NCATS wants to achieve can be accomplished in the same total budget of the bottom line we have now," says Ginsberg.

Letters of Intent for the RFA are due on 10 December.

A seemingly small mistake in an article The New England Journal of Medicine ( NEJM ) landed a Danish physician and researcher in hot water last month after a German company threatened to sue for potential losses that could run into the millions of dollars. The exchange prompted consternation media in Denmark about whether academic freedom was censored, but the researcher Anders Perner of Copenhagen University Hospital has corrected the error, which occurred in the publication of a study of a drug widely used to prevent shock and avoided a lawsuit. Still, the episode has shone a light on a therapy that some researchers say may do more harm than good, despite its widespread use.

The question is hydroxyethyl starch (HES), a synthetic derivative of ordinary starch that has been used worldwide for decades to avoid shock in patients who have lost large amounts of blood. It is also used to treat patients with sepsis, the blood leaking out of their hair. "HES binds liquid, and the idea is that it continues the volume of blood," says Tobias Welte, a pulmonologist at the Hannover Medical School in Germany, who studied the compound.

27 June Perner
published a randomized clinical trial in NEJM who compared HES effects was in septic patients to treatment with an alternative called acetate Ringer. the results are not good for HES: After 0 days, 201 of the 398 patients in the HES group were dead, against 172 of the 400 patients in the group treated with acetate Ringer patients treated with HES were also more likely to need therapy. renal replacement and suffer a severe hemorrhage. the study was "well designed and well conducted," said Greg Martin, an expert in critical care medicine at Emory University school of medicine in Atlanta. = "# t = articletop">

On July 9, however, Perner received an email from the German pharmaceutical company Fresenius Kabi, one of the largest manufacturers of HES, saying that in NEJM article he had misidentified the compound used in the study. Perner had used Tetraspan, produced by B. Braun Melsungen, Germany, and often described as HES 130 / 0.42. (The first number gives the molecular weight of the chemical, the second is an indication of the number of hydroxyethyl starch in.) While section names methods of society and drugs, it is called HES 130 / 0.4 in the original article and its title. These are the specifications of the product HES Fresenius, Voluven.

The e-mail, Perner says, included a threat by Fresenius to take legal action to recover the financial losses of the company would suffer because of misinformation. In a market worth billions which could be a lot of money, says Welte. Perner says Fresenius also demanded an explicit declaration that the first version of the document was incorrect.

Perner and NEJM changed the online version accordingly and Fresenius said it's the end of the story. "Our goal was to have the scientific misinformation in the title and text of the article in NEJM corrected," wrote a company spokesperson in an email. "This is . happened if we see no need for action "

Fresenius said his product is different from that used Perner not only in the report hydroxyethyl, but in other ways as well; for example, contrasted with the test compound in the test, it was not produced using potato starch.

But Perner maintains it was not a error, claiming that the differences are inconsequential, and the data of the study are likely to apply to Voluven well. the change is minimal compared hydroxyethyl and unlikely to affect the drug action he argued. "We rounded up to 0.4 because the product lines HES is less relevant details," he said, stressing that the hydroxyethyl ratio is 0.4 to 0.44 in Tetraspan and 0.38 to 0.45 Voluven. "Paper is more accurate now," he admits, "but from a scientific point of view, I think it makes no difference." Welte agrees. "For all practical purposes, these compounds are identical. If you do a test with aspirin, you should not write if you used the drug produced by Bayer or anyone else either," he said.

The debate on security and the effectiveness of various forms of HES has been ongoing for some time. Welte was involved in a 08 study, also published in NEJM , which concluded that HES solutions should be avoided "until the end of the long-term studies with a sufficient number of patients show that HES solution is particularly safe in critically ill patients. "this study unused another compound (HES 0 / 0.5)," but you can take the data from the new study on top of ours and they are almost identical, "says Welte.

HES compounds were first developed by Fresenius in 1974, and others soon followed. Although the compounds have received regulatory approval in the United States and throughout Europe, Perner argues that their safety has not been assessed adequately by modern standards. "When side effects occurred, companies have made new smaller molecules, but launched on the back of products older, "he said. Others share his concern. "For me, there is sufficient evidence of adverse effects with starch solutions in sepsis to restrict the use of all starches until additional safety and efficacy data are available" said Martin. regulators ignored evidence of potential side effects and failed to act, says Welte.

Although there has been concern about the compounds since 01, benefit analysis risk years remained positive, the regulatory body of the German BfArM medicine said in a statement to science Insider. the new study results from Perner are being evaluated, a spokesman the agency said, but no decision will likely be made until the results of another clinical trial, expected in August, are presented. the study, led by John Myburgh at the George Institute for global Health in Sydney in Australia, the compound of Fresenius

Most experimental cancer drugs never make it to market because they do not contribute enough people in early clinical trials. But even in the "failure" of drug trials, researchers may find that some patients saw their tumors shrink dramatically. As it is not known why some react, but most do not, researchers generally shake head and move on. But researchers now report that by sequencing the entire genome of the tumor of a patient outliers, they learned why her cancer disappeared when she took an experimental drug that did not help others. This drug has a new lease on life with this cancer, and these tests can help revive other drugs against cancer that have shown promise in laboratory studies, but first failed in clinical trials.

Researchers at Memorial Sloan Kettering Cancer Center (MSKCC) in New York have been intrigued by the case of a woman with metastatic bladder cancer whose tumors disappeared after she received a drug, called everolimus, which targets a protein involved in cell growth known as the mTORC1. Most patients in the trial are not helped by drugs and it was abandoned as a single agent for bladder cancer. But this patient has been cancer-free for 2.5 years, a "result quite unprecedented" for this cancer that is resistant to chemotherapy, says doctor-researcher David Solit of MSKCC and Weill Cornell Medical College in New York.

The group Solit tested the women's tumors for mutations in a few genes in the mTORC1 pathway that could explain the sensitivity of the tumor, but found nothing. So, in collaboration with bioinformatics Barry Taylor's lab at the University of California, San Francisco, the group Solit sent a sample of the woman's tumor to a commercial laboratory for whole genome sequencing.

By comparing the genome of the tumor to normal DNA of women, the researchers found mutations in two genes, NF2 and TSC1 , the laboratory studies have also suggested are in the path of mTORC1. Mutations in TSC1 but not NF2 , also turned in several other samples of bladder cancer. Although TSC1 ( tuberous sclerosis 1 ) has not been on the radar of scientists, it was logical that this gene could be involved: People born with TSC1 mutation later develop benign tumors. The researchers then looked TSC1 mutations in 13 other patients in the same drug trials failed. Four whose tumors had shrunk mutations in TSC1 , but only one of the nine who did not respond had the change, the researchers report online today in Science .

Solit and others plan to screen patients with bladder cancer who have TSC1 mutation in their tumors so they can continue the trial everolimus and other mTORC1 drugs targeted in these patients. "Now we have a clear path forward," said Solit. And he thinks that the same approach can be used in other clinical trials. "This will change the way we view these outliers" said Solit . While researchers already knew that some drugs against cancer work only on patients with specific mutations in their tumors, whole genome sequencing could help identify more such genetic changes, he said.

"This is a great story," says cancer researcher José Baselga from the Massachusetts General Hospital in Boston. Baselga, who conducted a clinical trial of everolimus in breast cancer, now expected to test for patients TSC1 mutations to see if they explain why some responded better than others. the study also shows that the search for gene sensitivity to drugs will require more than testing for a tumor only a few candidates, Baselga said. "We probably go further" and sequence whole genomes, he said.

The discovery that the cell development is not a one way street won the Nobel Prize this year in physiology or medicine. John B. Gurdon, a developmental biologist at the Wellcome Trust / Cancer Research UK Gurdon Institute at the University of Cambridge in the UK and Shinya Yamanaka, a researcher on stem cells at Kyoto University in Japan and the Gladstone Institute at the University of California, San Francisco, won the prize for their discovery that mature cells can be reprogrammed to resemble versatile cells of a very early embryo. These so-called pluripotent cells have the ability to become any of the body's tissues. The work of the pair that connects two eras of modern biology, "revolutionized our understanding of how cells and organisms develop," the Nobel Committee in its announcement attribution.

The ability to reprogram adult cells allowed the researchers to study certain diseases in new ways and raises the possibility of one day becoming replacement tissue or even organs in the laboratory. "I think everyone who works on developmental biology and on the understanding of disease mechanisms will applaud these excellent choices and clear to the Nobel Prize," said John Hardy, a neuroscientist at University College London. "The work countless laboratories build on the breakthroughs they have pioneered. "

In normal development, the mature cells their pluripotent state in various specialized cell type-a neuron, muscle cell or a skin cell, for example. For many years, development biologists thought that the cellular maturation process was irreversible. In 1962, however, John Gurdon, working at Oxford University, has shown that under the right conditions, an adult cell nucleus could become young again development. He replaced the nucleus of a frog's egg with a nucleus taken from a cell in the intestine of a tadpole. In some cases, the egg cell was able to "reprogram" the DNA in the nucleus and the tadpole egg cell developed into an adult frog the first animal cloned from mature cells ^* . Other researchers built on the findings of Gurdon, the most famous of the team that cloned Dolly the sheep using a similar feat of nuclear transplantation. This breakthrough has shown that mammalian cells may undergo the same transformation of immature to mature.

More than four decades later, Shinya Yamanaka showed that an egg cell is not necessary to reprogram the DNA of a cell pluripotency. Working with mouse cells, Yamanaka and his colleagues found that adding extra copies of four genes to skin cells growing in a lab dish, they could induce the cells to act like embryonic stem (ES ) cells, pluripotent cells from early embryos. A few years later, Yamanaka and other teams have shown that a similar technique could work on human cells. This allowed scientists to establish stable growth of cell populations from patients with diseases such as amyotrophic lateral sclerosis (ALS). Researchers can study these cells, called induced pluripotent stem (iPS), for an overview of the disease. In the case of ALS, they can encourage them to become muscle and nerve cells that mimic the problems seen in people with the condition. Yamanaka, who originally trained as an orthopedic surgeon, welcomed the Nobel honor with a note of caution about the speed, it could provide medical benefits. "I feel a great joy, but at the same time a great responsibility. The iPS technology is new and actually we have not been able to apply these findings to develop new therapies or medication. I think we need further research to make a contribution to society as soon as possible. "

Yamanaka was also welcomed because it gives researchers a potential alternative to human ES cells, which were ethically and politically controversial given their source. scientists are still working to understand exactly how the reprogrammed cells by adding genes differ from pluripotent cells found in embryos, and how these differences may affect how cells . can be used

Gurdon issued a statement outlining how the research of two scientists had left the basic science in medicine: "I am extremely honored to have achieved this spectacular recognition, and very happy to be due to receive with Shinya Yamanaka, whose work has brought the whole field within the realistic expectation of therapeutic benefits. ... It is particularly nice to see how pure basic research, originally aimed at testing the genetic identity of different cell types in the body, found have clear human health prospects. "

At the press conference at Kyoto University today, Yamanaka said he could not have accomplished his work without the financial support it received from the country." I really feel that Japan is receiving the award. "in 09, he and Gurdon shared the prize Albert Lasker Basic Medical Research

More background information of Science and science :. Now

• Rewrite the cells their own destiny (one of science [1945024InsightsdelaDécenniedel'])
• Yamanaka initial meeting announcement in 06, covered by science NOW
• First publications in 07 describing ways to create induced pluripotent stem cells using mouse cells, as covered by science NOW profile
• 08 science Yamanaka
• First demonstration that induced pluripotent stem cells can be created using human cells, as covered by science NOW
• science [1945024s'] 08 Breakthrough of the year: reprogramming cells
• (Related video Discovery of the year and reference web links associated with the reprogramming of cells)
• 2010 article on how reprogrammed cells help researchers study various diseases ( science podcast on the same subject)