Health Meaning

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.