Health Meaning

In a statement released today on the websites of Nature and science a group of 39 influenza researchers announced a moratorium of two months on studies that avian H5N1 strain of the flu more transmissible between mammals. The moratorium is to allow time for an international debate on such research, some people say has the potential to help bioterrorism.

Science Insider spoke to Ron Fouchier of Erasmus MC in Rotterdam, the Netherlands, who made one of two studies that triggered international debate. (The document is currently in review Science .) The responses of Fouchier were translated from Dutch and edited for clarity and brevity.

Q: Who took the initiative of this ad

RF: The initiative came from Adolfo García-Sastre [an influenza researcher at Mount Sinai Medical Center in New York City who has a grant from the National Institute of Allergy and Infectious Diseases (NIAID) that funded Fouchier's study] Yoshihiro Kawaoka [dontleH5N1étudedanslapresseà Nature , was also considered by the National Advisory Council of the US science for biosecurity (NSABB)] and myself. We discussed with a group of about 10 scientists doing similar studies them; so we asked for another 30 or flu researchers who do not work on these studies, but could do if they wanted to sign. They all agreed wholeheartedly. It is therefore not a Fouchier show. It is an initiative that is supported very broadly.

Q: Why did you take this step now

RF: We have been informed by various organizations, and of course we have followed the press coverage and political debates. We had the impression, based partly on the advice of others, it would be reasonable to announce a moratorium.

Q: Which third party

R.F :. The agencies that fund our research, but also governments that we are talking to. As happens when it makes sense to pause, to give the infectious diseases field time to think about and talk about how to handle this type of research in the future. This research offers opportunities and challenges, and governments and organizations need time to react.

Q: Did you do this because if you do not do that, governments could move to stop the search

RF: The debate is so controversial that we can not rule that out. We prefer to have everyone take a break to think carefully about how to handle this.

Q: But have you received clear signals that there could be a ban of some sort

RF: We don ' have no clear signals that something will happen, but you get the signals in the press, experts and consultants, and these signals reach both governments. We see articles in Michael Osterholm [director of the Center for Infectious Disease Research and Policy at the University of Minnesota, and an influenza expert], and people like Laurie Garrett, Pulitzer Prize [and a Senior Fellow for Global Health at the Council on Foreign Relations]. And then there are the biosafety experts at the University of Pittsburgh, as Thomas Inglesby. ... And [smallpox eradication leader] D. A. Henderson was very vocal. All these people can have a strong impact on the White House and elsewhere.

Q: How do you feel about the moratorium you

R.F:. It is a pity that it should get there. I would have preferred if it has not caused so much controversy, but it has happened and we can not change that. So I think it is the right step to make. It is comparable to what happened in 1975 at the Asilomar Conference. But I think this has been driven more by the scientists themselves; this time is mostly public controversies that animate.

Q: Do you have ideas on how the debate on these studies should be organized and who should participate

RF: I think it should be a series of debates. A couple is already on track. As we said in our statement, a meeting will be organized in the next two weeks, I hope, will include the participation of the World Health Organization (WHO) and the US government. The [American Society for Microbiology] held a plenary meeting at its biodefense meeting next month. The New York Academy of Sciences meeting. People need to talk, and infectious disease specialists need to take the microphone and explain why this research is important and how you can do it safely.

Q: Does the extent of the controversy that has surprised you? If you planned this when you talked about the study at a meeting in Malta in September

RF: When we presented this, of course we expected there would be some agitation, and we would have to explain to the public and the press why we do this and how you can do it safely.

I think we did very well in the Netherlands. We were very proactive; before we submitted the paper for publication, we informed all competent authorities, so they knew what was going on and had time to prepare, and when the story began to tour in uS media, we spent three days talking to newspapers, TV, and radio. And pinched the debate in the bud. In the US, this has not occurred. And the people who are most vocal in the press are experts in biosafety. It is a pity that so few people in the field of flu jumped in front of cameras, particularly in the US

Q: Does the NSABB recommendations take you by surprise

RF: Absolutely. It was something that was unprecedented and something I did not count at all.

NSABB said the risks outweigh the benefits, and now many people say: In this case, you should not do this research at all. This is a very logical answer. But the infectious disease community does not agree with NSABB about it. NSABB that should better explain what the risks are exactly. How bioterrorism have we seen in the past? What are the chances that bioterrorist will recreate these viruses? And is it true that the publication of this research would bioterrorist or rogue nations an advantage? That's what I like to hear the NSABB.

Q: You think he does not give them an advantage

RF: No, because bioterrorist can not make this virus, it is too complex, it takes a lot of expertise. And rogue nations that have the ability to do it, do not need our information. So I do not think they will benefit from this information at all. Meanwhile, NSABB gives very little credit to the benefits of public health, while the community of the whole flu crying how important this is. For them, the balance of risks and benefits is very different from the NSABB.

Q: But NSABB several researchers of infectious diseases among its members, including Osterholm, a flu expert himself. And they hired Robert Webster, a flu researcher at St. Jude Children's Hospital in Memphis, as a special adviser.

R.F :. The question is whether it was enough or if they would have had to ask several influenza experts. If they had asked someone like Peter Palese of the Mount Sinai School of Medicine, you would have had a very different answer. If you read his piece in Nature -I think he was quite right.

Osterholm, in his article [published yesterday with Henderson] in Science has a very fatalistic attitude. He says countries in Asia, Africa and the Middle East are unable to do surveillance, so they do not need data from our paper. It's too fatalistic. It would be better to say: How can we help these countries to develop a decent surveillance system? Osterholm also said the data make no difference to the development of vaccines. Which is really based on anything. So if this is the specialist of influenza within NSABB, I would like to see someone with a more positive attitude.

Q: How moratorium affect search to your own laboratory

RF: Of course we were working to confirm which mutations cause the virus become transmissible by aerosol. This will stop now; we're almost done with this, but not quite. We worked to find out what biological properties of the virus are associated with mutations that we found. The biological properties of the virus are far more important than the changes themselves.

Q: What are the biological properties tell you

RF: In an article Current Opinion in Virology we said that we thought there were a number of things that could make a virus transmissible bird flu among mammals. At the time, that was purely hypothetical. We said the virus probably has to do better in the upper respiratory tract that deep inside the lungs; it must bind to certain receptors in mammals; it must reproduce in large quantities, to increase the chances of transmission; it must be stable in the small droplets, and so on.

Now that we have these mutations, we can examine each of these steps to see if they occur. And you will see that for each step, there are several options, the most possible mutations that only those we have found so far. So this is very important.

Something else that needs to happen is to assess existing vaccines and antiviral drugs. So far we have only looked at in vitro if the characteristics of these viruses represent existing vaccine strains, and if the virus is susceptible to antiviral drugs. We have not tried in our animal model.

Q: You also want to repeat the experiments with more H5N1 strains

R.F :. Yes. We did it with a genetic lineage of H5N1. The question is whether all the lines can become aerosol-transmissible. If they can not, if it is just that line, maybe you can focus on the region where it comes and try to stop H5N1 outbreaks there to prevent a pandemic. If this can happen anywhere, you have to work everywhere.

Q: Would you also do similar studies in other strains of avian influenza, including H7N7?

R.F :. This is certainly something we would like to do in the long term. But it has a much lower priority because we do not see the H7N7 outbreak at the moment, and we're certainly not going to do it soon; I do not think that would be wise.

Q: Have you had requests from other laboratories to share the virus that you created

R.F :. Not explicitly. Everyone understands that this is not the right time to ask.

Q: But if they ask, what would you

RF: I have an agreement with our lender, NIAID, if such requests were made, I'll discuss it with them. So I can not decide myself.

Q: Andrew Pekosz recently said Science a moratorium would be especially harmful to young scientists who do the work of actual laboratory. Do you see that as a problem?

R.F :. I think this is a small problem compared with other issues. I have a postdoc here Sander Herfst, who worked hard on this for 4 years and for which a tremendous breakthrough in his career is on hold. But these are individual cases. I think the impact of NSABB recommendations for life sciences are much more important. If we get tough new guidelines for the screening of proposals, I think that could hinder the life sciences for years.

Q: In a policy forum that you co-wrote and which was published yesterday on Science Web site of the, you say you can not promise always keep the key details of your paper secret. Under what circumstances you decide to reveal them?

R.F :. Well, Science and we said that we will try to follow the recommendations of the NSABB. The US government is now looking for a mechanism to share key information with people who have a legitimate need to see, but it is far from easy; there are all sorts of legal questions. So that this mechanism will look like and that this information can be shared with is very clear.

Meanwhile, the WHO said: This research is super important, but it is equally important that the data is shared, or it could mean the end of Pandemic preparation influenza framework . And rightly so, because this part is very important for the monitoring systems. Suppose fall if, for any reason this manuscript could not be shared with certain people. Then we have to discuss with the government of the United States and WHO. This could occur. Again, you need to weigh the benefits and risks.

Moreover, as researchers, we work very closely with people in Indonesia. It would be very unwise for us not to share our results with our close collaborators.

Q: So if researchers are not approved for use of the sharing mechanism ...

RF: I do not know who will be driving this mechanism and what arguments would be to deny access to certain people. But if the result is that I can not share the details with my staff, I have a problem. This kind of situation can occur. So we will give the US government and the NSABB the chance to put a mechanism in place, and we expect that they come with. But we can not say now that we will never share this information.

Q: When do you think you will know more about this mechanism and the publication of your article

RF: The previous deadline was the end of January, but from what I heard, the US government has requested an extension of 4 weeks. So I think it will be the end of February.

Q: Are you in contact with Yoshihiro Kawaoka

R.F :. on a daily basis.

Q: You've been all over the news while remaining completely silent. Would not you have preferred to make the case for these studies together?

R.F :. We both made a conscious choice to do what we did. I feel the responsibility to defend my point of view and respond to these media calls. And of course, I made that decision when I decided to go to Malta. He did not talk about his work at a meeting, so what he did is still under wraps in this paper Nature . And I can understand his decision; he has two laboratories to perform, one in Japan and one in the US Frankly, the last 3 months, I only politics, the press, and things like that fact. I have more time to my knowledge.

The Whittemore Peterson Institute for Neuro-Immune Disease (WPI), well known to a study published by the retracted science in 09 that linked a mouse retrovirus to chronic fatigue syndrome (CFS), will continue to receive US government funding for one, 5-year grant of $ 1.5 million to study the disease .

WPI, based in Reno, Nevada, has lost the grant from the National Institute of Allergy and Infectious Diseases (NIAID), because in September he shot Judy Mikovits, the principal investigator of the grant. WPI then filed a complaint against Mikovits for goods that have been hijacked, and it has also become the subject of a related criminal case which led to his arrest and brief incarceration. Mikovits maintained his innocence and both cases are still before the courts. Harvey Whittemore and his wife, Annette, who founded WPI, are defendants in a lawsuit filed against them by his former business partners who claim that the couple improperly used funds of a holding company he co-ownership for support their institute. They denied the charges.

members NIAID staff visited WPI 15 December and assessed the qualifications of the researcher Vincent Lombardi, a co-author of the paper retracted who still works at the institute. NIAID formally approved Lombardi as the new principal investigator yesterday, noting that he had the "technical know-how and experience directly applicable to studies of Goal 2 of the grant," which focuses on the genetic susceptibility to disease and dysregulation of the immune system. Objective 1 was to identify and confirm the new virus related to CFS.

the National Institutes of Health, the parent organization of NIAID in 2010 spent about 6 $ million on research for the CFS, an amount patient advocates argue is insufficient for a disease that affects about 1 million to 4 million Americans alone. relatively scarce subsidy completed the WPI initiative to study CFS began in September 09, the month before the controversial Science report was issued, and ends in August 2014.

Craig Thompson, chair of the Cancer Center Memorial Sloan-Kettering in New York yesterday, was hit with a second lawsuit alleging that it made a bad business deal to exploit research on the metabolism of cancer cells.

The University of Pennsylvania has filed a lawsuit in US federal court in Manhattan accusing Thompson-old Penn employee failed to share intellectual property of its findings with the university as it was required to do so. Instead, the Penn claims, Thompson released the results of its group of cancer variant cellular enzymes in Nature and Cancer Cell while helping a private company seeking patents on discoveries. This repeats certain costs of a complaint in December, when Thompson was sued by Leonard and Madlyn Abramson Family Institute, part of a research university on the transaction related cancer Thompson previously directed. He was accused of sharing intellectual property with bad company he helped launch, Agios Pharmaceuticals of Cambridge, Massachusetts. Penn and the Abramson center Agios both included as a defendant.

In her complaint, Penn alleges that Thompson violated the rules on the university's patents and "breached its fiduciary duty to the university" by "failing to disclose to the research and discoveries academics. "instead, she claims, he shared the results with Agios, which filed patents, and disclosed his work in international journals," at the expense of the university. "

Agios, with $ in outside support 150 million, hopes to develop new therapies based on this research

in response, Thompson said. "I believe that the allegations in the complaint Penn is unfounded, both in fact and law. I am very disappointed that Penn chose to file its lawsuit without making any effort to talk with me or know the real facts before filing a suit that night unjustly my reputation. " A spokesman said that Agios Agios "believes he has done nothing wrong ... and fully expects to be justified."

The revolution continues with a study on the health of 21 proposed 100,000 American children known national study Children (NCS). Last Friday, a leading biostatistician who is a member of the NCS advisory committee resigned, just two weeks after another member of the committee resigned. Both are angry about a sudden change in the sampling design of the study.

In an email dated March 16, Jonas Ellenberg University of Pennsylvania presented his resignation to the NCS director Steven Hirschfeld at the National Institute of Child Health and Development (NICHD) . His note contains no explanation, but said: "I urge that the NCS to be examined again by the Institute of Medicine, as I believe that the current view of the NICHD NCS does not reflect the study design parameters reviewed and approved by the IOM in 08. "the reference is to an IOM report that praised the NCS plan to recruit pregnant women living in a statistical sample of 100 US counties. email Ellenberg was reported on Nature blog.

the National Institutes of Health (NIH) has decided that this geographical approach is too expensive. instead, the agency wants to reduce 15% from the current $ 193 million NCS budget in 2013 by recruiting by health care providers, which could mean health maintenance organizations (HMO). "the registered population is no longer a national probability sample but, instead, a well-described cohort followed longitudinally "or many years, a budget document said (see pp. 34-35).

Ellenberg said Science Insider that he resign because the advisory committee was not informed of this proposed change in the sampling plan. "We were told nada" says Ellenberg. "If we are not there to give advice about magnitude of a change, I do not know why we're here."

Ellenberg say that it is not necessarily opposed to a sample-based supplier, which could still be nationally representative. (this could mean randomly sample the nation's health care providers, simple medical practices to large HMO). the population Association of America, which represents demographers, says NIH in a letter on March 6 that its members would support a sample based on the supplier if it is done "very carefully" and not let groups such as immigrants and the uninsured . "Nothing less than a national probability sample of compromising data quality," says the letter.

A Johns Hopkins University environmental health researcher Ellen Silbergeld resigned from the advisory committee on March 5, as reported by Nature blog. She told Science Insider that his impression is that the study will not use a "consistent pattern" of recruitment but will instead use a "mix and community studies based on supplier" who will no data that can be compared between sites. "I do not think it will be scientifically valid," she said.

Some followers of the NCS, including Ellenberg, are also concerned about another issue : the NICHD terminates the contracts of seven centers "vanguard" which enrolled pregnant wife for a pilot study and plans to transform their operations to a single national contractor this summer.

Questions about NCS could come tomorrow and next week in the House of Representatives and the Senate hearings on the 2013 budget of the NIH. An article today about the loss of a South Dakota State University contract (SDSU) $ 13.1 million, 5 years for the center of avant-garde of his condition shows what is at stake for some districts Congress. SDSU expects to lose 27 full-time and eight part-time jobs. Many postdocs and graduate students will also be affected.

The loss of the contract will be "a very substantial loss" for both the university and the local community, Vice President for Research Kevin Kephart said SDSU The Brookings Register . And the Dakotas not HMO, they would be left out of an HMO-based study, the article points out.

chemotherapy drugs are like a shotgun. Although doctors are only intended for tumors, the compounds hit a variety of other places in the body, leading to effects such as damage to the bone marrow and the side hair loss. To improve their goal, researchers have tried to pack these drugs inside small hollow nano-sized containers that can be directed to tumors and bypass healthy tissue. But the size, shape, and composition of these "nanoparticles" can affect considerably when and where they are taken. Now, scientists have identified the landscape of some 100 different formulations of nanoparticles and found that when a conventional chemotherapeutic drug is packaged in the best of these nanoparticles, it is much more effective against prostate cancer in animals the single drug.

The new findings are the first to show promise of therapeutic nanoparticles against cancer. Nearly a dozen of these tiny drug carriers are already in clinical trials. But researchers are still struggling to adjust the size and composition of nanoparticles that work best for conveying drugs to tumors. So for their study, a team of 30 researchers led by chemical engineer Robert Langer of the Massachusetts Institute of Technology in Cambridge, physician-researcher Omid Farokhzad of Harvard Medical School, and biochemical engineer Stephen Zale BIND Biosciences in Cambridge, Massachusetts, decided to adopt a more systematic approach.

Rather than looking at all types of biomaterials from which their particles, the researchers started with six different already approved materials for use by the Food and Drug Administration of the United States, as well as freight anticancer compound already approved called docetaxel. Then they ranged from 10 different factors, including the particle size in which they trapped docetaxel, the density of chemical groups used to wrap the particles of the immune system, additional surface-active compounds used to target the particles to tumor cells interest, the amount of docetaxel they wore, and how fast the particles decomposed and released their cargo.

After a preliminary assessment of more than 100 different drugs nanoparticle formulations, Langer and colleagues installed on a design containing particles of 100 nanometers made from a combination of a biodegradable polymer known as name PLA and a coating of PEG, other polymer which readily binds water molecules and helps hide the particles of the immune system. Some of the PEG chains were also capped with copies of a small molecule called ACUPA which binds to the receptor molecules overexpressed on the surface of cancer cells in the prostate.

Tests on mice, rats and monkeys have shown that delivering docetaxel in nanoparticles produced plasma drug concentrations over a period of 24 hours at 100 times higher than standard docetaxel injections made; 10 times more drug accumulated in tumors, as well. And in an early clinical safety trial of 17 people, the researchers found the drug accumulation in tumors and clinical effects at doses as low as 20% of the docetaxel dose normally prescribed, as they report online today Science Translational Medicine . Additional clinical trials are now testing higher doses, and no new toxicities have been observed to date.

"It is an important result and a great direction to go in," said Joseph DeSimone, an expert chemist and drug nanoparticle at the University of North Carolina, Chapel Hill. The study shows that delivering drugs within nanoparticles has the potential to improve the effectiveness of many conventional anticancer drugs and other therapeutic agents that are limited by side effects, he said: "When you change where the deposition of the drug, you basically change the outcome. "

AMSTERDAM -After an international meeting of scientists and security experts on Monday, the Dutch government said that it can decide quickly whether virologist Ron Fouchier of Erasmus MC in Rotterdam is eligible for an export license that would allow him to resubmit his controversial study transmissibility of H5N1 for publication by science .

Fouchier, for his part, said he decided today to apply for an export license, required for so-called dual-use technology, after a meeting with his co-authors, the board Erasmus MC, and lawyers. But the application to specify that the researchers dispute the obligation to do so, a legal construction that Fouchier says will avoid creating a precedent. Fouchier is still "adamantly opposed" to the requirement of a license, he worried establish a "terrible precedent" for researchers in infectious diseases in Europe.

A government spokesman confirmed that Fouchier filed an application today and said Henk Bleker, Minister for Agriculture and Foreign Trade, is likely to make a decision "within days. " (The fact that the Dutch Prime Minister Mark Rutte submitted the resignation of his entire cabinet yesterday, will not delay the decision.)

The question is studying Fouchier H5N1 transmissibility in ferrets which came under surveillance by the US National science Advisory Board for biosecurity (NSABB), and a similar paper by Yoshihiro Kawaoka of the University of Wisconsin, Madison. NSABB recommended to fully publish the documents at the end of 2011, but reversed that decision last month after studying the revised manuscripts.

The Dutch government has yet to take a position if the Fouchier document should be published. Yesterday's meeting in The Hague was organized by the Dutch Ministry of Foreign Affairs and included scientists and security experts from the United States, the United Kingdom, Japan, Indonesia and Vietnam, as well as representatives of the World Health Organization, Nature and science , the two journals in which manuscripts were submitted. The closed meeting was set up to gather additional information and did not lead to formal recommendations, said Marianne Donker, head of the Department of Public Health at the Ministry of Health, Welfare and Sports , one of eight Dutch ministries involved in aspects of the case.

The government had already spoken at length with Fouchier and consulted two Dutch intelligence agencies. "We now have almost all the information on the table," said Donker. After the recovery NSABB, some expect the Dutch government to try to stop the publication of the document, which was also greenlighted by a group of experts convened by the World Health Organization and the US government . But the government insisted that Fouchier apply for a license to export first.

Last night Donker and Fouchier clashed during a public debate organized by the Royal Netherlands Academy of Arts and Sciences here, where Fouchier was struggling to hide his exasperation. "This is pure censorship, as far as I'm concerned," he said. Donker, meanwhile, asked Fouchier "not to let this degenerate case." "We would like to continue this process with Ron as we're supposed to," she said.

At the heart of their argument is the government's opinion that Fouchier needs an export license to publish the document or even post it on the laboratory website, where it would be accessible to readers outside the Netherlands. the government bases the decision on a regulation of the European Union 09 and a corresponding Dutch law prohibiting the export of certain goods and technologies that could be used for good or evil. an Annex to the Regulation stipulates that the prohibition includes H5N1 and technologies related to the virus and many other human pathogens, animals and plants. But the Regulation provides a exemption for "basic scientific research", defined as "experimental or theoretical work undertaken primarily to acquire new knowledge of the fundamental principles of phenomena or observable facts, not primarily directed towards a specific practical aim or objective."

Fouchier said her study falls into this category, because it is interested in the fundamental question of what makes the flu virus transmissible between mammals. Furthermore, the invocation of the government's export control rules to prevent the publication of an unprecedented document Fouchier said, and he warned that if the Dutch interpretation of EU regulations door the day, work many European researchers could be paralyzed

Donker emphasized that Fouchier himself has always insisted on the practical benefits of its findings may have. - -To Help prevent pandemics to test drugs and vaccines against the H5N1 pandemic strains. "This is not basic research. It is directly applicable," she said.

Fouchier presented his data earlier in the day in The Hague, as did Kawaoka. present to the Ministry of Foreign Affairs, was also longtime collaborator of Fouchier Derek Smith, a mathematician at Cambridge University, who presented the data from an epidemiological document on which Kawaoka and Fouchier collaborated. This document, also presented at the meeting NSABB in March, puts the data in the two manuscripts controversial perspective Fouchier said. A fourth presenter spoke about non-proliferation.

An international panel of experts issued recommendations today for future research on Alzheimer's disease. The recommendations will help guide the research component of the new national plan for Alzheimer announced Tuesday by Health and Human Services Secretary Kathleen Sebelius. The plan sets the ambitious goal of developing effective prevention and treatment strategies for Alzheimer's disease in 2025.

The new research strategy has been developed by experts who gathered at a summit of two days at the US National Institutes of Health (NIH) in Bethesda, Maryland, earlier this week. The group recognizes a number of challenges on the ground, including the need to develop better experimental models and initiate clinical trials in early stages of the disease. Their recommendations include conduct more interdisciplinary research on the biological mechanisms of Alzheimer's disease and drug targets, allowing faster and extensive sharing of data and biological samples, and to encourage more public-private partnerships (the along the lines of the neuroimaging Initiative for Alzheimer's disease, biomarker successfully jointly funded development effort by the pharmaceutical industry and NIH). The group also calls for more research on non-drug interventions, such as lifestyle changes, that might prevent or slow the disease.

A financial stimulus for Alzheimer's research seems to be in the works: draft budget of President Barack Obama in 2013 includes $ 80 million in new funding. Congress has yet to weigh in on the plan.

The National Institutes of Health announced (NIH) today announced details of its $ 20 million program to find new uses for drugs abandoned-and five more participating companies. The expansion of the program brings to 58 the number of compounds shelved that academic researchers can test new applications.

Use the discovery of New therapeutic for Existing Molecules, announced in early May, is the first major initiative of the new NIH National Center for the Advancement of Science Translational (NCATS). The idea is to give university researchers access to compounds that have made through safety tests, but were abandoned by companies for commercial reasons or because they were not working on a specific disease. Initially, three companies-Pfizer, AstraZeneca and Eli Lilly offered to share 24 compounds.

Now, Abbott Laboratories, Bristol-Myers Squibb, GlaxoSmithKline, Sanofi and Janssen Pharmaceuticals signed, bringing the number of compounds to 58. NIH has published a table of compounds that links to a page on cards drugs that include the mechanism of action and clinical results summary. NIH also supports preapplications (due August 14) to grant 2 to 3 years of the program.

The program received a mixed response from experts from the pharmaceutical industry; some think that the chances of finding new uses for the compounds are slim. Others are favorable but have concerns about the NIH model legal agreements developed for companies and academics. In this letter 1 June to NCATS, the Association of American Medical Colleges said that models should be revised because they "require university partners to share data and other information with companies supplying the same compounds when IP [intellectual property] rights do not necessarily go to that information. "

There are two good news and bad news for researchers who were concerned about a new design released this week to the national study of Special Education a plan of $ 3 billion to follow 100,000 children from birth to 21 years of

the good news is that supervisors of the study from the National Institutes of Health (NIH) want to recruit from a geographic sample of hospitals rather than large health care providers. However, to reduce costs, NIH wants to recruit about half of these women when they give birth, not before, the NIH staff admit compromise studies on prenatal exposures. The new plan makes no mention of retaining 105 randomly selected counties where the study was originally to take place, including 40 locations "vanguard", where pilot studies were conducted.

requested by Congress in 00, NCS aims to explore the links between environmental exposures, genetics and health. So far, it has recruited about 3650 babies on pioneering and websites spent nearly $ 1 billion. In February, the NIH announced that trimming the budget NCS and could not afford to recruit women for the complete study as first planned by knocking on doors or using other methods in 105 counties . instead, the agency said it could recruit participants through large health care organizations. NIH also announced that sites vanguard led by 40 academics are awarded to a new contractor.

Vanguard leaders NCS website and some councilors were outraged. They argued that only a probability sample would yield results applicable to all American children, regardless of ethnicity or family income.

After a meeting in April where investigators pioneering NIH urged to stick with the plan 105-county, NIH now says it will recruit in randomly selected hospitals and birth centers in a sample geographic regions that "have yet to be determined." Two "layers cohorts" of women and babies would be recruited: half at birth in hospitals, and half of pregnant women registered by providers that deliver these same hospitals Although these cohorts would make up. 0% of study participants, two smaller cohorts could include women enrolled before conception.

epidemiologist Nigel Paneth of Michigan State University in East Lansing, who runs a pioneering center says the new plan could result in a representative sample at national level. "it is a much better design than we had heard," he said. However, he wonders why NCS can only recruit prenatally. This would allow rigorous studies of prenatal influences on health and make it easier to arrange to collect placentas and umbilical cord blood, he notes. It also questions the apparent decision to abandon the NIH pioneering sites where researchers have built relationships with hospitals. Those using NCS "probably do not realize how difficult it is," he said.

proposed new design of the NIH will be discussed on July 24 by the NCS advisory committee.

Although the councilors approve the new plan, what happens next is unclear. A bill in the House of Representatives directs the agency to hold off on all design changes until the Institute of Medicine did a study. Paneth said investigators fear that the NIH will issue a request for proposals for the main study this fall to avoid Directive House, which probably will not become law before the end of the year.

An unusual flu virus has caught the attention of public health officials because it quickly spread from pigs county fairs in the United States for children. The virus, a variant of an H3N2 strain that infects humans seasonally, did not cause serious illness. little evidence exists that can spread between people, and the vast majority of cases are in two states.

Epidemiologist Joseph Bresee of the US Centers for Disease Control and Prevention (CDC) in Atlanta said on a conference call today 145 cases have been confirmed since July 12, a big jump from last week when CDC tallied only 16 confirmed cases since then. "This is clearly a significant increase from the total of last week," he said, adding that this reflects an increase in the detection and many county fairs that are taking place.

Bresee said that over 0% of cases occurred in children, most of whom have had direct or indirect contact with pigs, and all but two were in Indiana and Ohio. "At this stage, there is no evidence of sustainable, effective, human to human spread in the community," he said. "Our seasonal influenza systems are active and have shown no signs in increased influenza activity. This is not a pandemic. But of course, CDC continues to monitor the situation closely. "

H3N2v surfaced in July 2011 and infected 12 more people before disappearing this winter. The researchers were intrigued because the virus has an internal gene "M" which corresponds to that found in the H1N1 pandemic virus has rapidly infected humans around the world in 09 and 2010. CDC virologist Michael Shaw said he suspect the M gene, which affects how the virus grows in its host, plays a role in the ongoing transmissions. "There is something in this gene that gives it an advantage for circulation in pigs," says Shaw. "And if it becomes more common in pigs, it gives more chance to jump into humans." But Shaw says there is no evidence that this M gene by itself leads to human to human transmission.

Out of this epidemic and pandemic H1N1, CDC has recorded only 35 cases total influenza viruses resulting from the transmission from pigs to humans in the United States over the past 7 years.

Bresee said that two people were hospitalized because of H3N2v infections, but were released. he urged people visiting the animals in the county fairs to wash their hands frequently and not eating or drinking around pigs. studies have shown that the vaccine against the current influenza, which contains an H3N2 component, not probably will not protect against this strain, but adults are likely to have immunity from exposure to strains "wild type" of influenza and previous vaccines provide some protection against the new variant.

CDC plans to release an update on the outbreak of tomorrow in its number Morbidity and Mortality Weekly Report .

The results of the first test of the effectiveness of a vaccine against dengue fever, a sometimes fatal disease endemic in most tropical countries, have led both enthusiasm and disappointment. The vaccine has proven safe, and protected against three of the four virus variants of dengue, or serotypes, but surprisingly it did not provide any protection against the fourth. Scientists are puzzled as to why and think about what this means for the global fight against a serious threat to public health.

"For us, it is encouraging. The technology of vaccine clearly has a biological effect preventing dengue," said Derek Wallace, regional director of clinical development Sanofi Pasteur, the French pharmaceutical company developing the vaccine , which reported the results online today in the Lancet .

other scientists are not so good. "It is true that the vaccine shows protection against three strains, but unfortunately, and this is very disappointing, overall it was not effective, showing no protection for the strain of the most common circulating dengue in Thailand, "said Scott O'Neill, an expert in dengue Monash University, Clayton, Australia.

responsible for public health and affected communities are eager to have a vaccine against dengue fever, because there is no treatment and the disease burden is growing. Transmitted by mosquitoes, the four dengue serotypes infect up to 100 million people, mostly children, around the world each year. Exposure to one serotype generally causes minor illness, and the patient is immune from life to a second infection with the same serotype. But for unknown reasons, subsequent exposure to a second dengue serotype increases the risk of disease progression to severe dengue hemorrhagic fever and sometimes deadly. The World Health Organization estimates that each year about half a million cases of severe dengue require hospitalization, and dengue frequently strikes in homes suddenly plaguing hospitals.

The scientists assumed that a vaccine is just as effective against the four serotypes, fearing that the incomplete protection against someone vaccines could put at risk of serious illness. So for decades, research focused on the development of a vaccine for all four serotypes, and then combining them. But in a case of the assembly being less than the sum of its parts, and these formulations were employed as individual vaccines. Putting together the four vaccines in humans "has met with some interference effect that we do not understand," said Scott Halstead, a senior adviser to the Dengue Vaccine Initiative based in Seoul.

This time, Sanofi Pasteur researchers thought they had solved the problem of the combination. early testing indicated that in humans, the vaccine produced a balanced immune response to all four serotypes. in what was the first test of efficacy of the vaccine, more than 4,000 children in Ratchaburi Province of Thailand were divided into vaccination and control groups. the vaccine has proven quite effective in preventing the disease from three serotypes, reduced rates infection of 55.6% for serotype 1, 75.3% for serotype 3, and 100% for serotype 4 after three injections. But it provided close to zero protection against dengue serotype 2, which is the most widespread in the region and is most responsible for serious diseases worldwide.

"Of course, our desire was to have a vaccine that protects against four (serotypes)," Wallace said. But it is encouraging that so far at least, there is no evidence of a post-vaccination infection with dengue serotype 2 infection results in serious illness.

Wallace suggests that there may be a lag between serotype 2 component of the vaccine and the circulating in Thailand. In an accompanying commentary also appears online at The Lancet , Halstead said another possibility is the problem of interference.

Some understanding of why the serotype 2 component proved ineffective could come from ongoing trials involving 31,000 people in 10 countries. Until these results are available in 2014, Wallace said it would be premature to discuss what comes next with the vaccine. Halstead sees several options. The widespread use of a vaccine that protects against three serotypes may cause fewer cases of dengue haemorrhagic fever and to reduce the overall burden of disease; modeling can be used to study this scenario. Or it may be necessary to reformulate the vaccine to make it effective against dengue serotype 2, which would also require to redo clinical trials. Halstead said, it may be time to reconsider the strategy four vaccines in one. "We may have to think of something dramatic," he said.

evidence is mounting that one of the most frequently used in ICU interventions (ICU) does more harm than good. Data from a clinical trial published today show that patients who received anti-shock drug known as hydroxyethyl starch (HES) were more likely to need kidney dialysis or a kidney transplant than those treated with saline. HES patients were also more likely to die within 0 days, although this difference was not statistically significant.

HES, a synthetic derivative of ordinary starch, is a large molecule that binds liquid and is usually given to patients who have lost a lot of blood. The compound maintains blood volume and prevents their circulation collapse. A first study indicating that HES could be harmful for patients was published in The Lancet in 01, but was largely ignored by regulators, says Tobias Welte, a pulmonologist at the School of medicine in Hanover, Germany, who studied the compound. In June this year, a clinical trial conducted in Denmark, published in The New England Journal of Medicine , concluded that septic patients with HES were much more likely to die within 0 days and need a renal replacement therapy that patients treated with an alternative called Ringer's acetate.

This study has sparked a row between the author Anders Perner University Hospital of Copenhagen, who argued that the results applied to all HES compounds, and the German drug company Fresenius Kabi, who felt his own compound, Voluven, was unjustly accused by the paper. Some researchers have called for the drug to be withdrawn from the market, but regulators have argued that the data from a second clinical trial which was about to finish and uses Voluven essential.

The results of this trial, which took place in Australia and New Zealand, were published today in The New England Journal of Medicine . The crystalloid against Hydroxyethyl Starch Trial (SAFE) includes data from over 60 patients treated in the ICU. Among patients treated with HES, 18% died, against 17% for those treated with saline.

The difference is not significant, but the study author John Myburgh of the George Institute for Global Health in Sydney, Australia, said that perhaps because the patient groups with a rate higher mortality were excluded from the trial, making it difficult to detect a statistically significant difference. "Perner looked septic patients. Our population was a general population of adult ICU patients," said Myburgh, which presents its communication to the Annual Congress of the European Society of Intensive Care in Lisbon today. It also emphasizes that therapy renal replacement was often necessary and there was much higher rates of adverse events such as bleeding or itching in the HES group. Together, the two studies provide no evidence that HES compounds benefit the patient and instead raise safety concerns, he argues.

Perner agrees that the evidence in the same direction. "it has never been shown that any of these compounds benefit patients, "he said." at the very least, they should be labeled that they are against-indicated in patients with sepsis and that extreme caution should be taken when using with other patients at increased risk kidney failure or bleeding. " This includes most patients who routinely receive HES in an intensive care unit, he said.

But the discussion has wider implications, said Myburgh. "We need to examine more closely this fluid we give to specific patients and how" -and perhaps the fluid authorization process must be reformed. "These are really intravenous drugs and must be treated as such . "

in a new article, four London doctors warn of a professional who makes the mistake professional and get on with it: the tooth fairy. They report an 8 year old boy who was sent to an allergist because of his runny nose epic. former regular medical treatment does not work, the next step was a scanner. Analysis showed signs of inflammation in the sinuses. But it also revealed something surprising: a dent in his left ear canal. It turned out that three years before, the boy had awakened "extremely distressed" because the tooth fairy took the tooth under his pillow and stuck in his ear. His parents thought it was rather unlikely, even if the tooth had indeed disappeared. Two doctors who looked into his ear over the years have failed to see anything, but the boy was right, it turned out. An ear, nose and throat surgeon removed the tooth, the authors report in the often awkward Christmas number of BMJ . "The patient decided to keep the tooth for posterity rather than taking the risk to try a new monetary reward," they write. They also point out that there is no standard operating procedures for the tooth fairy, and doctors should be on the lookout for his sloppy work.

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A working group advising the National Institutes of Health (NIH) research chimpanzees today insisted for the agency strongly backs scale biomedical and behavioral studies involving these animals. NIH should remove most of the nearly 700 chimpanzees it supports, many end research projects, and make sure that chimpanzees still being investigated are kept in appropriate living conditions, the panel report said.

If NIH follows through on the report "it is clear that there will be a reduction in the use of chimpanzees in research," said veterinary researcher KC Kent Lloyd of the University of California, Davis, who chaired the working group of the Council NIH advice to journalists. "I do not think it will be to the detriment of progress in research."

The report of 84 pages today is a response to a 2011 Institute of Medicine (IOM) in December which found that most research on chimpanzees was unnecessary. the working group today, part of the NIH Council of councils, was asked by the NIH Director Francis Collins NIH to help implement the report of the IOM, which laid out specific criteria for when the chimpanzee studies are warranted. for example, such a study should take place only if it could not be done ethically in humans or another animal model and if chimpanzees have been kept in a ethologically appropriate environment.

having reviewed 22 research studies funded by NIH using chimpanzees, the working group found that half must be stopped. This includes six new biomedical projects using 81 of the 93 chimpanzees in these studies; Only three of these projects, all involving infectious or immunology, should continue. The working group also recommended to end five 13 comparative genomics and behavioral studies using 10 of about 300 animals. NIH continue to fund seven of eight additional projects to support care chimpanzee colonies; some overlap with the research.

Other projects could continue if they are modified to meet new criteria for living conditions outlined in the report. For example, each chimp must have at least 1000 feet of outdoor space square and live with no less than six other animals.

The Working Group also examined the number of NIH chimpanzees now owns or supports. This includes 451 chimpanzees in research facilities or research reserve and 219 in the chimpanzee retirement home. NIH should withdraw most research chimpanzees and reduce its research provides a single colony of 50 chimpanzees in just 5 years, concluded the working group. Behavioral and genetic studies involving more animals could be done in a non-traditional research framework such as sanctuaries or zoos, suggested the neurologist co-chair working group Daniel Geschwind of the University of California, Los Angeles.

The group also established new criteria for the approval of future projects. The proposals approved by the scientific reviewers should go before a new, yet to be created, independent NIH oversight committee that weigh on whether the project complies with the IOM principles.

Kathleen Conlee, vice president for animal research issues for the Humane Society of the United States in Washington, DC, welcomed the report. "We are very pleased ... and we hope that the NIH will advance to implement the recommendations. I think they largely reflect what the public has been demanding," she said.

The full Council of Councils voted 13 -0 to accept the report. Collins will now open a comment period of 60 days on the report, then decide to accept it, probably at the end of March, said James Anderson, NIH Associate Director for Program Coordination, Planning, and initiatives strategic.

One issue is how NIH will pay for the costs of chimpanzee retirement. In 00, Congress capped how the agency can spend on building and care in sanctuaries federal chimpanzees to $ 30 million, an NIH limit will reach this summer. "It is a concern and something we would have to be discussed at the Congress," said Anderson

Fixed January 24 :. This entry declared that the working group recommended ending five studies using 20 chimpanzees of 13 comparative studies of genomics using 300 chimpanzees. These five studies use 10 chimpanzees

* Correction, 2:40 p.m. , January 29th. the article incorrectly stated the NIH spending that Congress has capped the sanctuaries of federal chimpanzees to $ 30 million per year. the ceiling is the amount accumulated since 00 .

A small parasitic worm is one of the leading causes of blindness worldwide. But now researchers have discovered a molecule in the urine of African patients could help diagnose those infected with the parasite and help eliminate the devastating disease known as river blindness.

The disease, scientifically known as river blindness, is caused by the parasitic worm Onchocerca volvulus . blackfly bites transmit the larvae of the worm to man, and the larvae become adults who form nodules under the skin all over the body. female worms then produce a large number of larvae called microfilaria that move on the skin to be eaten again by biting black flies. The larvae can also enter the eyes, however, which causes blindness. An estimated 500,000 people, mostly in sub-Saharan Africa, have lost their sight because of the parasite.

The World Health Organization has set a goal of eliminating the disease in the Americas by 2017 and Africa in 2025. Infections with Onchocerca volvulus can be treated with ivermectin, which kills the larvae but not the adult worms. The antibiotic doxycycline, which kills bacteria called Wolbachia which lives in symbiosis with the worm, has shown promise in killing adult worms as well and is sometimes used alone or in combination with ivermectin. current control strategies are based on processing of repeated mass of potential patients with ivermectin, however, the diagnosis is often difficult. In some cases, worms surviving adults may spawn a new generation of larvae.

The gold standard for diagnosis is supposedly snip of skin. "You basically cut off some skin and then you can see the larvae of worms," ​​said Daniel Globisch, researcher at the Scripps Research Institute in San Diego, California, and one of the authors of the study. the method is very sensitive, however, especially in less severe infections, which are becoming more common with the progress in controlling the disease, said Maria-Gloria Basáñez, researcher neglected tropical diseases at Imperial College London .

Now Globisch and colleagues identified a new way to test for the disease. They compared the amounts of hundreds of molecules found in the urine samples of infected and healthy Africans and discovered a difference striking: an unknown molecule was present at six times higher in urine samples of infected people than in samples from healthy people the researchers identified the molecule as the rest of a neurotransmitter that the larval stages. excrete worm and which is then broken down in the body before being excreted in the urine, they report online this week in the Proceedings of the national Academy of sciences.

"Finding such a marker was really lucky," said Globisch. "The use of this molecule, we could do a diagnostic test that can be put in a backpack and diagnose if people are infected or not. "This would allow doctors to" specifically address those still infected, "he said. Globisch believes that such a portable diagnostic test could be ready in 3 years.

the approach of researchers "to identify biomarkers is certainly stylish and innovative," wrote Michel Boussinesq, an expert of onchocerciasis in the research Institute for development in Montpellier, France, in an email. But urine samples may not be easier to collect in an African village that skin snips, he warns. An experienced researcher could collect 40 in an hour skin shears, he said, but with urine, researchers must wait until each person can produce the sample. To ensure that the new technique offers an advantage, "it would be necessary to compare the quantitative results of the technique described in the document, and quantitative results of skin snips," he said.

Insomniacs desperate for some ZZZS may one day have a safer way to get them. Scientists have developed a new sleep drug that induces sleep in rodents and monkeys apparently without affecting cognition, a potentially dangerous side effect common sleep aids. The discovery, which originated in the work explaining narcolepsy, could lead to a new class of drugs that help people who do not respond to other treatments.

Between 10% and 15% of Americans chronically struggling to get or stay asleep. Many of them are turning to sleeping pills for relief, and most are drugs such as zolpidem (Ambien) and eszopiclone (Lunesta) prescribes that slow the brain by binding to receptors for GABA, a neurotransmitter that is involved in mood, cognition and muscle tone. But because the drugs target GABA indiscriminately, they can also affect cognition, causing memory loss, confusion and other problems with learning and memory, and a number of strange sleepwalking behaviors including wandering, eating, and driving while sleeping. This has led many researchers to seek alternative mechanisms for inducing sleep.

neuroscientist Jason Uslaner Merck Research Laboratories in West Point, Pennsylvania, and colleagues decided to tap into the brain orexin system. Orexin (also known as hypocretin) is a protein that controls wakefulness and lacking in people with narcolepsy. Previous studies induced sleep successfully inhibiting orexin, but had not examined its effects on cognition. Researchers have developed a new compound called orexin inhibiting DORA-22 and confirmed that it would induce sleep in rats and rhesus monkeys as effectively as GABA-modulating drugs.

Next, the researchers went about testing its effects on animals drug cognition. They measured cognition and memory in rodents rats assessing the ability to recognize objects. They presented rats with new object-say, a cone or a sphere that rats then sniffed and explored. Then they took the absent object for one hour. After this time, the rats were exposed to a new object and that they had come to know; if the rats could remember, they spent less time checking the familiar object. With primates, Uslaner team tested their ability to match colors on a touch screen and pay attention and identify the origin of a flashing light. In all cases, the researchers found the sleeping pills modulating GABA caused both rats and primates to respond more slowly and less accurately. Monkeys taking tests of memory and attention, for example, are 20% less precise on the highest dose of each of the modulation of GABA drugs. But DORA-22 had no such effect on cognition, the team reports today in Science Translational Medicine .

"We were very excited," said Uslaner. "People who take sleep medications should be able to perform cognitive tasks when they wake up, and this [compound] could help them do so without loss of value."

Although DORA-22 has not yet been tested in humans, it is very promising to help people who suffer from sleep disorders, says Emmanuel Mignot, a sleep researcher with the school of medicine Stanford University in Palo Alto, California. "This study is encouraging and exciting, because there are good reasons to believe it would work differently than what we used in the past," said Mignot, who helped discover the link between orexin (or lack ) and narcolepsy. "Not all medications work for everyone, so it's really, really good news to have a potential new drug on the horizon."

A court ordered the European Medicines Agency (EMA) to keep confidential data from two pharmaceutical companies, in contravention of the recent surge in the EMA to share clinical and clinical information as widely as possible. The temporary injunction EU Court supports two pharmaceutical companies on the US side of the pond: AbbVie, headquartered in North Chicago, Illinois, and InterMune in Brisbane, California.

The companies filed separate complaints earlier this year, charging that the EMA policy to disclose information on therapies it is approved or rejected would put their commercial interests at risk. "If the EMA makes this knowledge freely available to other companies (including competitors to InterMune) toll this could facilitate their development programs and allow them to reach the market and compete with InterMune faster than they otherwise would be to be able to do it, "writes Jim Goff, spokesman for InterMune, in an e-mail to science Insider, explaining his company's concerns.

the temporary injunction remains unpublished, and made public complaints of businesses are bare-boned. (See here and here.) But what is clear is that the challenge is the first time the thrust of the EMA for transparency was successfully torpedoed. the agency, which is the European version of the Food and Drug Administration of the United States, changed its protocol in November 2010. at the time, he had just gone through a mirror version of what he knows now: called the Cochrane Collaboration nonprofit requested documents about certain medicines, and EMA refused. The European Ombudsman, a sort of conduct to guard E.Ü. institutions, "spent a lot of time investigating this, and in the end decided that we should release the data," said Martin Harvey-Allchurch, head of EMA communications. Following the decision of Ombudsman, EMA revised its policies and has since honored 613 requests for documents and released 1.9 million pages. About a third of requests from companies. InterMune Goff wrote that demand for his company's data "was made by a potential competitor "and regards its only product available, pirfenidone, which treats a rare lung disease called idiopathic pulmonary fibrosis. Harvey-Allchurch EMA explained that one of the requests in question was by a company and another was by a university.

AbbVie, a much larger entity that InterMune, did not respond to requests for comment from Science Insider. The company was founded in January, when pharmaceutical giant Abbott divided into two entities, one of them being AbbVie.

The aim of EMA is to not make it easier for competitors to manufacture drugs in accessing this information, Harvey-Allchurch said. He regularly redacts information on the manufacturing details or quality testing, as well as protection of the identity of trial participants. But "our position is that clinical trial data can not, for example, be considered as confidential," says Harvey-Allchurch. "There is a legitimate public interest in what we do."

Because the decision applies only to these two cases, EMA plans to continue to release other data that individuals and businesses demand. It is also moving forward with plans to send clinical trial data on its website for all to see. That these efforts continue partly depend on the final decision of the Tribunal; we do not know when it will come. Harvey-Allchurch said he has received many of the EMA position messages of support on transparency and same interest in joining the case as part of the side of the EMA - including, perhaps without surprise, the European Ombudsman.

In the United States, the Pharmaceutical Research and Manufacturers of America (PhRMA) applauded the decision of the European Court.

"Biopharmaceutical companies support sharing data responsibility to protect patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research," said PhRMA Senior Vice -President Matt Bennett, in a statement. "Unfortunately, current and proposed policies EMA fail to respect these principles."

Eight years after the scientists of South Korean stem cells were exposed in one of the greatest scientific fraud ever, a document claims to have reached their faked work is itself under investigation.

Last week, a group led by Shoukhrat Mitalipov of the Oregon National Primate Research Center in Beaverton reported in Cell he had used cloning to produce stem cells customized human embryonic (hESC). The news was widely covered (including Science ) Woo-Suk Hwang and his team claimed to have established hESC individually adapted by cloning skin cells. The report, in Science , soon unraveled when it was found that the team had manipulated images and faked data.

After the report last week, a commentator on PubPeer, a website dedicated to postpublication peer review, alleged several cases of 'picture reuse "in the Cell paper. The speaker also noted that "in the document, it says that the journal Cell has accepted this article only 4 days after the presentation."

The claims image inconsistencies were enough to pique the concern of the journal. "I can confirm that our editorial team evaluates the allegations in the room PubPeer" writes Cell spokeswoman Mary Beth O'Leary in an e-mail to Science Insider. "I'll come back to you as soon as they have fully investigated the allegations in PubPeer"

the National Institutes of Health (NIH) needs to take a greater leadership role in the management of a 7-d'année-old program designed to translate the basic research into clinical therapies, according to a report released today by the National Academies Institute of the United States of Medicine (IOM).

The program, called Price Clinical and Translational Sciences (CSTC), funds 61 centers in universities across the United States. The IOM report states that these centers lack well-defined, measurable steps to assess their success and chances of renewal. Consequently, some CTSAs try to do too much and end up with mediocre results when they should rather specialize in areas where they are strong and work with other CTSAs to compensate for their shortcomings.

"We saw when we studied the CTSAs that some of them are unique to certain things and that all are really trying to meet a lot of areas of expertise, and it became really impossible to them to do something good, "says Sharon Terry, vice president of the report and president and CEO of Washington, DC, health promotion nonprofit genetic Alliance." We are essentially recommending that, no, we do not require all 61 to be good at everything. instead, allow specialization ... and share their expertise. "

Christopher Austin, director of the National Center for the Advancement of Translational Sciences (NCATS), which manages the CTSA, said today that the NIH may not be able to continue to support 61 centers mounting medium budget pressures. "The program is going to be the right size to fit the budget we have now," he said.

The report calls for the creation of a steering committee NCATS-CSTC to set measurable parameters for successfully managing a project "innovations Fund" to stimulate collaboration within and outside the NIH, and direct collaboration between CTSAs. "Leadership will come NCATS with the CTSAs, rather than the CTSAs is trying to provide this kind of leadership," said Terry.

In addition, IOM recommends that NCATS dissolve what he calls too convoluted hierarchy of committees within the CTSA consortium and rationalize its committee structure; KL2 refocus its training grants and TL1 on teamwork, leadership and soft skills; ensure that community engagement remains an integral part of CSEC projects; and double down on the program's commitment to children's health.

Austin said in a statement that it supports the recommendations and with the help of a working group, will begin implementation immediately.

scientific CSEC that Science Insider spoke with were generally satisfied with the report. Joan Lakoski, assistant vice chancellor for education of popular science, health sciences, at the University of Pittsburgh in Pennsylvania, and chemical biology professor at the Institute for Clinical and Translational Science University, said that "in the long term, it will be in everyone's interest to have closer integration [with NCATS leadership]".

CTSAs receive funding for 5 years, after which the program will be renewed. The CTSAs budgets based on the previous NIH support, and the scale and scope of the requested project. So far, the budgets of the centers ranged from $ 4 million to $ 23 a year. The program began with 12 centers in 06 and has grown steadily. Its 2012 budget was $ 461 million, but the total down to about $ 435 million this year because of the sequester cuts from across government.

Last year, CSEC NCATS migrated from its previous home in the defunct National Center for Research Resources. Daniel Ford, head of the Johns Hopkins Institute for Clinical and Translational Research in Baltimore, Maryland, says he will welcome a greater role for NCATS. "I think we do not understand that there is a need for strong leadership and identifying goals and where we want to go," he said.

In recent years, all new parents can go home from the hospital with not just a bundle of joy, but with something else-the complete DNA sequence of their baby. A new research program funded at $ 25 million over 5 years by the National Institutes of Health (NIH) will explore the promise and ethical challenges-sequencing of the genome of each newborn.

The pilot projects are based on decades old state screening programs that take a heel drop of blood almost all newborns and test for biochemical markers for several rare diseases. With some diseases, diagnosis of a child at birth may help doctors prevent irreversible damage, phenylketonuria, a metabolic disorder that can be controlled with diet, is an example.

screening programs of newborns often lack the case or turn to false positives, however. They seek only a few dozen diseases, all 7000 or if not known diseases or presumed caused by defects in a single gene. "We can see the potential value of looking at the genome of a child to examine all the genes or perhaps a particularly informative subset of them early in life," said Alan Guttmacher, director of . National child health and human development Institute (NICHD), in a call with reporters today sequencing Ever-cheaper makes it more feasible: whole genome now costs $ 5,000, and the right decoding encoding a DNA-1% protein of the genome known as exome-can be done for $ 1,000, compared to several hundred dollars to test a single genetic mutation.

to explore how genomes of newborns could be used in medical care, as well as ethical, legal and social issues that this raises, NICHD and the National Human Genome Research Institute (NHGRI) fund four projects. Two separate teams the University of California, San Francisco (UCSF), and the University of North Carolina, Chapel Hill, will sequence the exomes babies, some with known disease, to see if genetic data may strengthen the results of newborn born screening standard. A third group Mercy Hospital for children in Kansas City, Missouri, will examine whether the sequencing of the genome may accelerate diagnosis of hundreds of genetic diseases in newborns sick enough to require neonatal intensive care.

The projects, which also include Boston can also test the genes involved in drug metabolism in the hope that it may help prevent rare overdoses. But they decode all exome or whole genome of an infant, some teams will analyze data only for genes on a short list. Robert Nussbaum UCSF said it would not make sense to tell parents about, for example, mutations in a gene called APOE , which increases the risk of Alzheimer's disease in adulthood. "For the love of God, we do not even have a clear idea of ​​what to do about it in adults," said Nussbaum.

Some projects can go further, however. The team from Brigham and Women's hospital in Boston and the Boston children's hospital randomly assign 480 newborns healthy and sick to two groups that will receive the standard newborn screening, and one that will also have their genomes sequenced . in the coming years, researchers share results with parents and their doctors, including genes that increase disease risk future and consider how this information affects the medical care of the child. NIH wants to learn "how parents feel and what they think, what results they would like, and also [work] with doctors about how they understand and do not understand, "said Tiina URV, a Branch program Director deficiency intellectual and development NICHD.

But wait NIH researchers to follow the letter a recent report of the American College of Medical Genetics and Genomics on the so-called "incidental findings" that the list of risk mutations 57 disease that the group felt should be reported to a patient when its genome is sequenced as part of routine clinical care. This list "was a sort of version 1.0" which "revealed a number of questions to be answered," says NHGRI Director Eric Green.

In addition, because of the sensitive nature of the genomes of newborns, NIH won 't require researchers to submit sequencing data to a shared search database, as the agency normally required for studies of adult diseases.

humans have been looking for a way to slow the aging likely because the first person got wrinkles. A new study shows that research could be interesting. The scientists found that even a moderate decrease of aging increase our life expectancy of more than 2 years and ward off ill health in many older people. But the advance could also send the costs of social security and Medicare booming.

Slowing aging is not imaginary. Researchers can retard the speed of laboratory animals such as mice and roundworms age with a variety of measures, extremely low calorie diets genetic tinkering. So far, however, no one has shown that any medication or diet may delay human aging.

But some scientists, including demographer S. Jay Olshansky of the University of Illinois, Chicago, argue that we now know enough about aging to begin an intensive search for ways several years of delay in people, a kind of Manhattan Project-for durability. "Aging is the underlying risk factor for most things that go wrong with us" as we age, he said. This means slowing down the process would not just add years to our life, but it would also postpone diseases such as cancer, diabetes and heart disease that primarily strikes the elderly. In the new study, Olshansky and colleagues attempted to estimate the gains and pitfalls, including financial costs, the delayed aging.

Using a simulation model called Older future, the researchers asked what would happen if a sort of elixir were available for the entire population of the United States between 2010 and 2030 that reduced the rate causes of age-related death by 20%. In this scenario, people would still die of heart disease, cancer and other diseases, but they would be older when they became ill. "We believe this broad basis that prevention," says lead author Dana Goldman, a health economist at the University of Southern California in Los Angeles.

The simulation results suggest that slow aging lengthen the life expectancy of 2.2 years over the status quo, the researchers report online this week in Health Affairs . According to current projections, for example, a person who is 51 years old in 2030 will probably live to about 87 years but under slowed aging model, that person would probably survive 89. In addition, delay aging has provided a great shot thumb made progress against individual diseases. Reduce the risk of developing cancer or heart disease of 25% would add only a year in the life of this 51-year-old, the researchers conclude.

An additional couple of years might not be very attractive if you're going to be sick and decrepit. But slowing the aging would also allow about 5% more seniors avoid disability between 2030 and 2060 than would the reductions in cancer or heart disease alone. "To my friends who want to live forever, I say it does to the great science fiction," says Olshansky. "Our goal is to extend healthy life, not necessarily life itself."

But as noted Olshansky, "there is a price to pay for the production of healthy elderly." The model revealed that in the context of aging delayed scenario, Medicare and Medicaid would require $ 300 billion more in 2060 than in the status quo. Overall, the increase in longevity will result in a budget deficit for benefit programs such as Medicare and Social Security of $ 420 billion in 2060.

The fiscal woes are obstacles but not insurmountable, says Goldman. "The social and fiscal challenges are manageable with rational public policy." For example, the team calculated that it could eliminate the funding gap with an increase of 3 years progressive of the age of eligibility for the Medicare and an increase of 1 year in the social age security eligibility.

Although researchers have had a general idea of ​​the consequences of aging slows, "it is good to have numbers," said Steven Austad biogerontologist the University of Texas Health Science Center in San Antonio. " the impact on quality of life is very important, "said geriatric oncologist Harvey Cohen of the Duke Medical Center University in Durham, North Carolina, who was not involved in the research. And exploring the effects of the reduction of aging on social programs, the study reveals "a reality that must be addressed," he said.

Olshansky belongs to the Longevity Dividend Initiative, a group researchers (LOI), and organizations have been talking about the benefits of delaying human aging. "the question we have addressed here it is absolutely essential that we have an answer to this question before proceeding," said Olshansky. Now he and his colleagues are ready to take the next step, he said. in 2014, LDI plans to begin fundraising, mainly non-governmental organizations and individuals to fund research to develop anti action -age, said Olshansky. Although researchers are already considering many options, the objective of LDI is to introduce them into human studies and the possible use.

what these steps will be is a mystery although almost every researcher who works at his favorite lab animals. Regarding timing, the scientists warn that we probably have to wait decades for the fruits of that work to reach the public.

astronauts of the future can have a new enemy to contend with: the bacteria space. The scientists found that Pseudomonas aeruginosa , a common contaminant of medical equipment and a cause of urinary tract infections, among other diseases, grows best in zero gravity than it does on Earth, although hungry for nutrients. The researchers grew microbes in simulated urine in both a laboratory linked to the Earth aboard the space shuttle Atlantis (experimental configuration shown) in July 2011. In some samples, the team has significantly reduced concentrations phosphate dissolved and oxygen to simulate conditions that might exist within the equipment used to recycle urine into water on spacecraft during long flights. When nutrients were abundant, bacteria in zero growth rates g conditions and, in particular, concentrations of cells after 72 hours were the same as those grown in the laboratory under conditions normal. But in samples with lower concentrations of phosphate and oxygen, bound Earth bacteria do not grow as fast as they did when fully fed, while those grown in microgravity grew as prolifically than those provided with a full complement of nutrients, the researchers report online today in BMC Microbiology . The reasons for the disparity are not clear, the researchers say, but the results suggest that bacteria introduced into the space stations and spacecraft by people, given enough time, could develop to reach higher concentrations that they are in similar conditions on Earth, even if deprived of nutrients. In addition to helping scientists better understand the risks of P. aeruginosa colonizing the equipment on spacecraft or causing diseases such as urinary tract infections in astronauts, experiments can improve ability of scientists to predict whether other species of bacteria could become more virulent in space.

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