Health Meaning

Do drink plenty of milk to keep you healthy? Yes, according to a press release, 2010 by Wageningen University (WUR) in the Netherlands for a study of the relationship between milk consumption and cardiovascular disease. But on Tuesday, the university seems to withdraw the application after one of the study authors, famous epidemiologist Walter Willett of Harvard University, called "misleading" and "extreme distortion" of the results.

press release last year (the Netherlands) describes a meta-analysis of 17 studies on the effects of milk and dairy consumption on cardiovascular disease and mortality by researchers at WUR Harvard and the University of California, San Diego. The study, supported by the Dutch Dairy Association grant, was published last year by The American Journal of Clinical Nutrition .

The press release, entitled "Effective Milk against cardiovascular disease," city WUR scientific nutrition Sabita Soedamah-Muthu as saying the meta-analysis found that drinking three glasses of milk a day reduces the risk of disease cardiovascular 18%. The text included a play on a popular Dutch advertising campaign of the 60s and 70s with a child cartoon with superhuman strength who also recommended three glasses a day. Joris Driepinter, as the boy was known, "was right after all," he said.

Last month WUR inserted the words "seems to be" in the title and the reference to Joris Driepinter after Wakker Dier, a group of animal rights, filed a complaint with the Dutch Advertising Code Authority . The group says in a recent report that WUR, which depends on contracts for half of its research budget, often using flimsy evidence to act as an "advertising agency" for the dairy lobby. (As it happens, the industry re-enlisted Joris Driepinter earlier this year after three decades of retirement.)

Willett, who received a WUR honorary doctorate in 03, was upset as well when he read the last month statement. he said covered 'only a small subset of the data set. the much greater part of the evidence of the study do not support a benefit for cardiovascular disease. " Soedamah-Muthu said in the press release last month that it was "fundamentally independent" and that the industry had no voice in how the study was conducted. But Willett said that "when a study funded by the industry is distorted to put the industry in a positive light, the concern of the influence is appropriate."

After several weeks of negotiations, the University and US researchers published a "clarification" on Tuesday. He said the press release is based on four European studies with a limited number of cases, but the broader analysis showed that heart attacks and strokes brain, the two most important forms of cardiovascular disease, "are not significantly associated with drinking milk." He also said no nutrition recommendations can be made on the basis of the paper.

the release of original release has not been removed, but a "Note to editors" at the bottom now contains a link to the new statement. Spokesman Simon Vink University insists that the press release "was okay" and "not on the table." "The clarification has been added to show that this is part of a more complex story," he said.

Willett says he is "satisfied" clarification. "I think everyone will be very careful in the future on how the results are transmitted to the public," he said.

Joris Driepinter could not be reached for comment.

The prolonged saga of Judy Mikovits, the lead researcher who tied a mouse retrovirus to chronic fatigue syndrome (SFC), yet another dizzying round decision.

Just over one month after the shooting Mikovits, the Whittemore Peterson for Disease Neuro-Immune Institute (WPI) 4 November filed a lawsuit against his former director of research. According to WPI after Mikovits ended September 29, she mistakenly removed notebooks laboratory and kept other proprietary information on her laptop and flash drives and personal e-mail account. WPI, a nonprofit organization that is based on the campus of the University of Nevada, Reno, also won a temporary injunction prohibiting Mikovits to "destroy, remove or alter" one of the files or data related.

Mikovits lawyer, Lois Hart, said that his client can not talk to the media about the case, but strongly denies any wrongdoing. in an e-mail to Science Insider, Hart stressed that "the integrity of Dr. Mikovits goes to the bone."

Hart refuted the charges against his client in a letter on November 4 at WPI lawyer who appeared on the CFS-related websites. (Hart said she did not release the letter, but checked its contents Science Insider.) "All allegations of theft, embezzlement, data source and various intellectual property, and articles are incorrect and misleading, "Hart wrote.

the complaint filed by WPI focuses on laboratory notebooks kept by Mikovits and his assistants, which she stored in a locked drawer. WPI was a representative of the company that manufactured the desktop to open the drawer after his shot and the statements of complaint and found that "Cahiers were absent." The lawsuit, which alleges breach of contract and misappropriation of trade secrets, says "Mikovits had the only key to the locked drawer in his office."

The Hart rebuttal letter to the lawyer argues that WPI Mikovits was not in his office when she received the phone call that told him she was arrested and she returned never at the institute. "A number of people have keys to the office and laboratory, including administrative staff, laboratory staff and the guard," wrote Hart. "The concern of your customer as to the location of these laptops, and intellectual property should be directed elsewhere. "

Mikovits worked for WPI since its creation in 07. Created by Annette and Harvey Whittemore, whose daughter CFS, the institute also studies fibromyalgia after Lyme disease and Gulf War illness. The data Mikovits "absconded with," WPI alleged in court documents, could harm future efforts of the Institute. "Without these materials, WPI's ability to continue its important research to find a cure for this terrible disease affecting more than 4 million Americans each year is severely hampered," the complaint states. It argues that the information and invention that Mikovits Proprietary Agreement signed stipulates that WPI possessed the books she and others created in the laboratory.

Robert Charrow, a lawyer at Greenberg Traurig in Washington, DC, who specializes in cases involving scientific research, says academia and industry have different standards about retaining their researchers own portable computers and data. Although Charrow stresses he does not know the details of this case, he said the industry generally prohibits researchers to take data with them. "In academic institutions, researchers are requested or required to provide a copy of their equipment and data to the institution, and they can keep a copy for themselves," says Charrow. "This is how it is usually done and that is why there are no more pee games."

Mikovits and colleagues made the following international headlines online publication Science October 8, 09, an article in which they stated that they found a recently discovered retrovirus dubbed XMRV mouse in the blood of 67% of CFS patients they examined. Several subsequent studies, including one that participated in WPI, could not replicate the finding. a separate study, also published in Science provided evidence that XMRV was accidentally created in a laboratory experiment with mice and questioned whether it even infected humans. Science 's editor in chief Bruce Alberts published a concern Editorial expression about the veracity of the document May 31 Science later published a partial withdrawal of the original group paper Mikovits after a laboratory that contributed to mean a contaminant ruined results.

Second Judicial District Court of Nevada will hear a preliminary injunction against Mikovits November 22.

the next time a "stomach flu" you sprint to the bathroom, take heart: a vaccine could be on his path. Based on the results of a new clinical trial, the investigational vaccine is very effective against a strain of norovirus-bugs that may be responsible for over 0% of the collectively known digestive disorders such as gastroenteritis.

According to the Centers for Disease Control and Prevention (CDC) in Atlanta, noroviruses cause about 21 million cases of vomiting and diarrhea in the United States each year. In developing countries, infections cause about 0,000 deaths per year in children under 5 The virus is transmitted mainly through food, water or dirty hands that have been contaminated with the stool of an infected person . Norovirus is often called the "cruise ship virus" Outbreaks are common in confined living quarters, including military bases and hospitals Nursing homes are hot spots as well, the virus is a particular threat. for the elderly.

the development of a vaccine has been a research challenge. "noroviruses can not be grown in culture and do not infect laboratory animals," says clinical virologist Robert Atmar's Baylor College of Medicine in Houston, Texas. A breakthrough came in the early 190s, when Norwalk virus, a strain of norovirus, was cloned in the laboratory of molecular virology Mary Estes, also at Baylor. Estes found that when a certain key protein of the virus has been produced in cultured cells, the protein itself assembled 'particles' viruslike (VLPs) which may produce a strong immune response in laboratory animals. The discovery led LigoCyte Pharmaceuticals of Bozeman, Montana, to license and develop its own line of VLPs that mimic the structure near enough to wake up the immune system of the body against the virus of the virus but do not contain material that allows the virus to reproduce.

A vaccine VLP-greatly reduced both the rate of infection and the severity of symptoms, as shown by the clinical trial conducted by Atmar, Estes, researchers LigoCyte, and three other test centers. Ninety healthy volunteers received either the vaccine or placebo as a nasal spray in two doses three weeks apart. Participants were then admitted to one of four test hospitals, where they drank a powerful viral decoction and waited.

Approximately 80% of the placebo group was infected by the virus (as measured by the antibodies in their blood), but only about 60% of the vaccinated group did. He developed symptoms in 69% of the placebo group, but in only 37% of the vaccine group. The symptoms in the vaccinated group were also less severe and developed more slowly. (The 20%, uninfected subjects treated with placebo were probably immune to the previous exhibition, Atmar said.) The results of the test are presented today in The New England Journal of Medicine .

"This study is a proof of concept, the first to show that a vaccine can be effective against norovirus," Atmar said. Other studies, he said, are needed to monitor the success the vaccine in a home setting or a military base less controlled nurse, for example. Atmar added that if the vaccine protects against more than one strain of norovirus is still unknown. LigoCyte is conducting a trial of an injected form vaccine that works against two different types of virus.

virologist January Vinje CDC called the results encouraging news study. "it is a very safe vaccine as it does not contain viral genetic material," said -he. "A good next step would be to see if the vaccine generates enough of an immune response to provide protection in the elderly," he added, noting that the vast majority of outbreaks occur in long-term care facilities.

One year after councilors made the proposal and after months of controversy, the National Institutes of Health (NIH) obtained a new translational research center. The final step came just before Christmas, when President Barack Obama signed a bill $ 1000000000000 2012 expenses Dec. 23 that includes the NIH funding. The bill also introduces the National Center for the Advancement of Translational Sciences (NCATS) -backed by the NIH Director Francis Collins, who will aim to push the basic discoveries more quickly to the clinic "reengineering" the process drug development.

The creation of NCATS disturbed the biomedical research community in part because the reorganization dismantled the National Center for Research Resources, that had many devoted followers. Some industry leaders also feared that the NIH funding would tilt away from basic science to drug development, which they say academic scientists are not suited to do. Many scientific leaders in the industry still feel that way, said Roy Vagelos, former CEO of Merck. "The generation of new knowledge is crucial" for drug discovery, Vagelos said. "If academia continues to do so, nobody will."

NIH press release acknowledges this concern, promising that the basic research report and applied to the NIH "will not be disturbed" by the creation of NCATS.

NCATS supporters, meanwhile, are delighted that NCATS is finally real. Amy Comstock Rick, CEO of Action Network Parkinson's disease, said his group is not too concerned about the language in the bill on spending indicating that NCATS can not fund clinical trials that go beyond a certain stage. "I am quite sure they can work inside "she said.

The $ 575 million NCATS will start as a collection of existing programs transferred from NCRR and other institutes. The only new program-the $ NCATS Cures Network received only 10 million Bill on spending, far less than lawyers as Rick had hoped for acceleration. But that should be enough to start, Rick said. She is also excited by the plans for the NCAT Advisory Board that will include industry groups and representatives of patients. "It's a new kind of advice," she said.

A note to Collins to staff announcing the creation of NCATS accidentally went six days earlier. This note also announced temporary leaders NCAT: the acting director will be Thomas Insel, director of the National Institute of Mental Health; the Acting Deputy Director Kathy Hudson will, NIH deputy director for science, education and politics. NIH began searching the first director of NCATS this fall.

In the first published results from a clinical trial using human embryonic stem cells, two legally blind patients who received an injection of hESC-derived cells in one eye have experienced no adverse side effects and seem to have slightly better vision. Although the result is preliminary, it is an important step in the hESC field in trouble.

Since their discovery 13 years ago, hESCs have shown great promise for the treatment of diseases, but they were also pursued by security issues and ethical concerns, as deriving cells often destroyed human embryos. In the only ongoing clinical trials of hESC, the biotechnology company Advanced Cell Technology (ACT) of Marlborough, Massachusetts, derived from a type of cell called retinal pigment epithelium (RPE), which supports the light-sensing photoreceptor of the retina. Collaborators at the University of California, Los Angeles, then used these cells to treat a woman who has the dry macular degeneration and a woman in her 50s who has macular dystrophy Stargardt, an inherited disease rare. Researchers injected 50,000 RPE cells suspended in a solution in the retina of an eye of each patient.

Four months after receiving the treatment, patients have not developed tumors or abnormal growths that have sometimes been observed in animals receiving hESC-derived cells, reports the online team today The Lancet . Patients who have received immunosuppressive treatment for 12 weeks to prevent their body from attacking the cells, also showed no inflammation or other cells for signs of rejection.

The researchers detected RPE cells in the patient's eye to Stargardt's disease, but not in the patient with macular degeneration. However, the vision of two women seemed to improve, particularly in patients with Stargardt. She went to see the movements of the hand just to be able to read some letters on an eye chart. The authors caution, however, that the measurement of small visual improvements is difficult and they can not say with certainty that the changes are not the result of immunosuppressive drugs or a placebo effect.

"There is a long time to come. It is gratifying to finally see years and years of research results to the bedside," said Robert Lanza, CEO of ACT.

Other hESC researchers welcome the report, but caution that the study was very small and designed only to test the safety of the procedure. "This is an important step that will provide tremendous encouragement on the ground and [that] promises hope for many families," stem cell researcher George Daley of Harvard Medical School in Boston wrote in an email. "But ceux- these are still very early days and we have much to learn about the safety and efficacy of this new treatment before it can claim success. "

Peter Coffey of the Institute of University College London of Ophthalmology, is working on a similar treatment for macular degeneration, said the results of the security seem "very good". an immune response is less likely in the eye and in other sites in the body, and animal studies have suggested that treatment of the PRT should be safe. But "you never know until you go into the clinical setting," says Coffey. He declined to comment on the effectiveness of treatment up that the trial is completed.

Coffey is part of a trial sponsored by the pharmaceutical company Pfizer pending approval in the UK who drag a patch of hESC-derived RPE cells under the retina instead of injecting them into a liquid suspension. "We think this will work better" because the RPE cells naturally form a single layer of cells, like a carpet, said Coffey.

The ACT test continues: Employees in the UK treated a third patient on Friday. The company plans to inject different cell doses in a total of 12 patients in each trial. "Things will accelerate" now that the treatment appears to be safe, says Lanza. If the trials go well, the company will then seek to treat younger patients who should receive further treatment.

Proponents of hESC research were devastated last November when Geron, the California biotech company that was conducting the first trial using cells derived hESCs to treat injuries of the spinal cord, announced that he interrupted the trial for financial reasons. At the time, the treatment appeared safe, but the company has not seen signs of improvement in patients. Geron always follows the five patients he treated, but has not yet released any results.

The heart disease has long been rated the leading cause of death worldwide. Known as the silent killer, he tracks his prey from conception to adulthood, often striking without warning. A new study suggests that one of the risk factors can begin even before birth, showing how low oxygen in the uterus or fetal hypoxia can impair heart later in life.

fetal hypoxia can be caused by a variety of factors. Mothers living at high altitude, smoke or develop diabetes during pregnancy may starve their oxygen embryos. When fetal hypoxia is prolonged, the heart and the vessels of the embryo change: The walls of the heart and aorta grow thicker, and blood vessels may become less sensitive to signals to relax, making it difficult for blood to flow. Previous research had suggested that these modifications, even if they help the unborn baby survive, are rampant in adulthood, increasing the risk of cardiovascular disease.

But it is not clear how this happens. Physiologist Dino Giussani and colleagues at the University of Cambridge in the UK hypothesized that hypoxia promotes injury in the uterus caused mainly by stress when the low oxygen molecules creates a highly overload reactive called free radicals.

To test this idea, the team conducted an experiment with four groups of pregnant rats: two sets undergoing hypoxic pregnancy and two controls. To create hypoxia, they placed pregnant rats in a room that kept their oxygen levels to 13%, rather than the norm of 21% for the majority of their pregnancy. Some rodents (those in one of two groups and hypoxia in one of the two control groups) received vitamin C water daily to its antioxidant effects.

When puppies are born, the researchers noted significant differences between the groups. Rats born to the hypoxic pregnancy without treatment with vitamin C showed a thickening of the walls of the aorta up to 170% above normal and molecular markers of disease, an increase such as increased protein heat shock the heart, cardiac oxidative stress signal. When the puppies have grown to adulthood in about 4 months, their hearts pumped always harder and faster than normal, which in the long term is a known predictor of eventual heart failure. The pups also showed blockages in their major arteries, just as people in development of cardiovascular diseases are. These changes are not visible in the offspring of newborns and adults hypoxic pregnancies treated with vitamin C, reports the online team today PLoS ONE .

Giussani said the results show that fetal hypoxia programs at both the heart and circulation in adulthood by oxidative stress in the womb. "Although the link between adverse conditions during pregnancy and cardiovascular disease in later life, has been established for many years," he said, "which explains the link had remained an enigma."

The research is "fascinating," says physiologist David Barker of the University of Southampton in the UK and Oregon Health and Science University in Portland, who some consider the father of fetal origins of the field of adult diseases, an offshoot of the so-called development programming. Much of the emphasis in the past has been on long-term consequences of nutrition. The work of the team of Giussani, he said, "highlights the importance of one of the other challenges that the human fetus is facing, which is getting enough oxygen." Adds John Challis from the University of Toronto in Canada, "These results are very interesting taking us several steps forward. ... Now that we understand the mechanism, we are much closer to being able to intervene. " A leading researcher in development programming, Challis said that this study opens the door to thinking about the fight against fetal hypoxia in humans with antioxidant treatment.

Giussani agreed that the ultimate goal is to identify a clinical intervention to prevent heart disease. He is quick to add, however, that vitamin C may not be the antioxidant of choice for the man because of its effects on the human fetal tissue has not been well studied. The next step, he said, is to take research on the human level, specifically looking at the high altitude effect of pregnancy, where there is less oxygen in all the uterus and heart conditions later in life.

Members of an advisory council biosecurity of the US government offer a range of reactions the news they are invited to take a second look at two controversial studies of influenza. Some have not spoken publicly about the issue, which sparked a global debate on biosafety in relation to scientific freedom. And many skeptics say that the new magazine will reverse their opposition to fully publish the methods and results of the two experiments.

The following comments come after months of rapid-fire developments in the search for the H5N1 flu controversy. It started last year when the National Science Advisory Board for Biosecurity (NSABB) recommended that two scientific teams remove key details of the documents submitted to Science and Nature that describe how researchers did the bird flu H5N1 more transmissible between mammals, may provide a plan for starting a pandemic. The risks posed by the research outweigh the potential benefits, 23 voting members of the committee have unanimously concluded, after what they described as hundreds of hours of discussion. The voting members of NSABB are mostly scientists from a wide range of disciplines and institutions, including universities and companies. (There are also 18 non ex-officio voting members of federal agencies.)

The researchers and journals have agreed to follow the recommendation of NSABB, provided that the US government comes with a mechanism to share these details with bona good researchers and experts in public health. The case has attracted much criticism, however, with some scientists saying the redactions went too far, and other supporting research should not have been carried out first.

Then, in January, influenza researchers, including leaders of the two research teams, Ron Fouchier of Erasmus Medical College in the Netherlands and Yoshihiro Kawaoka of the University of Wisconsin, Madison announced 60-day moratorium on many types of studies on the virus. This moratorium, currently set to expire March 20, was designed to ease tensions and public concerns, and allow time for the international discussion of the issue.

Last month, the World Health Organization (WHO) convened a group mainly composed of experts from the flu for two days in Geneva to discuss the studies. Many of the 22 people at the WHO meeting, however, rejected the findings of NSABB and argued that the documents should be published in full. This meeting included talks by Fouchier and Kawaoka, who presented "new data" and, in the case of Fouchier, "clarified the oldest data," according to Anthony Fauci, director of the National Institute of the National Institute of Allergy health and infectious diseases, which funded both studies. Fauci, who attended the meeting in Geneva, says the group also asked the researchers to revise and resubmit their manuscripts NSABB.

Fauci announced that the US government asked NSABB to review new manuscripts, February 29 during a round table in the early morning on the H5N1 controversy organized by the American Society for Microbiology ( ASM) in Washington, DC NSABB "needs a chance to see all the data that we saw in Geneva ... and a little time to talk," said Fauci science Insider .

The reconsideration request apparently took many members NSABB and Washington policy makers by surprise. Sources familiar with the plan say the NSABB meeting tentatively scheduled for later this month could last two days. He also hopes to include presentations by Fouchier and Kawaoka, so the NSABB members could speak to them "to face-off", unlike teleconferences that characterize most previous discussions studies of influenza.

President NSABB Acting Paul Keim of Northern Arizona University in Flagstaff, who moderated the discussion ASM, declined to speculate on how the panel might display the new versions of both studies. But " NSABB recommendations can clearly be modified in the future, "said Keim." We can not go back and change this if this is the best course of action. "

the meeting of the ASM also included a detailed presentation by Fouchier of transmission and apparently fired fatality data from its Science manuscript. in general, Fouchier said the data showed that the version of the H5N1 virus has been designed, however press reports, non-lethal when inhaled by the animals and do not spread "like wildfire" in the air. (Kawaoka had publicly said earlier that his version of the transmitted virus mammal was not lethal in ferrets.)

Following the meeting of the ASM Science Insider has attempted to contact all 23 voting members of the NSABB. Seven have agreed to e-mail, interviews, with several noting that they spoke for themselves, not NSABB phone or in person. They included:

David Relman Professor of Microbiology and Immunology and Medicine, School of Medicine, Stanford University, Stanford, California

"my bottom line: Fouchier began with a very disturbing and sometimes fatal virus to humans and appears to have improved its transmissibility through breathing Nothing in these last days change these facts, [and] not my assessment. risk-benefit ratio. for me, the most important question about [Fouchier's] transmissibility in the ferret model is the direct comparison of the starting strain (wild-type H5N1) and the strain (s) engineering. and the latter is / are transmitted via [respiratory] route than the first. " Kawaoka of the document "has also provided clear guidance on how to improve the transmissibility of H5N1," he writes, and other issues, such as virulence and lethality, were less important.

Susan Ehrlich, retired judge and assistant professor, Department of Microbiology and Immunology, University of Texas Medical Branch, Galveston

"I heard nothing new so much as a different focus at the meeting of ASM could be expected, however, for two reasons: hundreds NSABB members, especially those who working group members have spent hours discussing these manuscripts after. having considered, and it was a public meeting. and of course, none of us has yet seen the revised manuscripts, I have no doubt will be examined with a completely open mind, remembering that the first thought of each of us is that scientific research should be free and complete statement, a point highlighted in each of several reports of NSABB and more specifically in the framework proposed in June 07 to monitor the dual use of life sciences research: strategies to minimize the potential misuse of research information. "

" keeping in mind that I did not read the revised manuscripts, I have some concerns. Dr. Fouchier said the ferret response during the meeting, but the biggest problem is the transmissibility. H5N1 is certainly a dangerous virus, and it has now been made more. Its host range has been extended. search on the modified virus was performed at the same level of biosecurity that research on the virus from the mother. These concerns are at the base of my thoughts on the communication of this research in the context of the responsibility of the NSABB the public should have an accident (bioerror) or a deliberate misuse of incident (bioterrorism), and so i want to continue to proceed with caution. "

Stanley Lemon, Professor of medicine and Microbiology and immunology, University of North Carolina, Chapel Hill

"the main concern was the acquisition of the virus by aerosol transmission capacity in a mammal. "

Lynn Enquist, professor and chair, Department of Molecular Biology, Princeton University, New Jersey

" My message to take away the House. The two groups have experiences that are on the "seven experiments of concern" described in detail in the report Fink [lerapportde03nationalAcademies Biotechnology Research in the Age of Terrorism: Confronting the Dual Use Dilemma ] and our own recommendations. they not only changed the host range of a dangerous pathogen, they also changed its mode of transmission. "

" All other differences in methods or new work or clarified on virulence in ferrets, does nothing to change those facts. "

" While there is no doubt that the work must be done to study the H5N1 virus, and the debate to date has shown the need for further work is, these new derivatives are new entities with unknown consequences if they move into the ecosystem. "

" How does it work on these new agents do? How many laboratories should work along these directions? How should this work will now be communicated and in the future? These are some of the central issues in my opinion. "

"The NSABB should not make these decisions or to review details of the science. We have called attention to the fact that these experiences are looking for dual-use concern."

Arturo Casadevall, chair, Division of Infectious Diseases, Albert Einstein College of Medicine, New York, New York

Casadevall noted that he went into the original NSABB discussions of both documents thinking 'science should be free and nothing should be redacted, but then it became clear to me that there was almost no public good in [publishing] . details "Now he says:" I'll go to the next meeting with an open mind and listen to all this process is supposed to be deliberative and this process is one in which you can think through it and change your mind. .. "

But" the key issue for me is the transmissibility. unless Ron [Fouchier] stands up and he says it is not transmissible from mammal, "Casadevall is unlikely to reverse its opposition to the complete publication. "Having transmissibility is a new feature for H5N1," he added, noting that "this virus has the ability to recombine and we have no idea what will come out." He sees the virulence and lethality of new viruses designed as "mini-debates" that are less important. "We must be very careful. We are dealing with an organization that we know can cause pandemics and can kill many people. And we know we do not have immunity to H5. I recommend caution. "Casadevall also noted that" I am from Cuba. I know something about redaction. "

Michael Osterholm, director of the Minnesota Center of Excellence for Influenza Research and Surveillance, University of Minnesota, Twin Cities

"the information I saw [on 29 February] nothing changed the underlying issue of concern for NSABB, and that was the question of transmissibility. broaden the host range of a dangerous pathogen is one of anything [seven types of experiments identified as raising dual use concerns by the Fink Report]. ... I did not see that fundamentally changes nothing about the NSABB position. ... I am very confident that the criteria that we used for calling for the drafting of this document based on the question of transmissibility was simple and I am not convinced that the more conversation face-to-face would make a difference. "

Michael Imperiale, Professor, Department of Microbiology and immunology, University of Michigan Medical School, Ann Arbor.

"What Ron [Fouchier] is saying now is not what was in the paper. We were led to believe by the paper that aerosol transmission is also deadly." it also said it was news to him that the mutated virus does not spread between ferrets through aerosol as easily as seasonal strains, as Fouchier showed at the meeting of the ASM "This has not really come to me in the newspaper, "he said. "I do not see this kind of comparison."

Again, it is uncertain of the new information will influence his thinking about drafting. "Based on the bare minimal facts, from what I ' heard Fouchier Wednesday, I'm not sure it would be serious. The lethality in ferrets is the same as the starting virus and now it can be transmitted. "Specifically, noted Imperiale :." If the virus from H5N1 is injected intratracheally in ferrets, it kills What [Fouchier's] does is modified so that it is more fecal-oral spread, but aerosol it injects that intratracheal, and it kills. . So it is just as lethal, more now it can be spread by aerosol. You have a virus that kills X percent of humans it infects. based on the ferret data, we would expect to kill same exact percent of men, and now it can be transmitted from human to human. Obviously, I have to see this revised document, but I do not know that this changes anything. "

Imperiale said, in the end, there's just too much uncertainty to take the risk of publishing the details of the experiments. "given the uncertainty, I say go with the precautionary principle. And you wait until you can get rid of this uncertainty. If you deleted, n is not a permanent action. If you leave out is permanent. "

PARIS- We are not alone. Every human being is teeming with billions of microbes that inhabit our guts, our skin, mouth and nose, and our reproductive organs. Scientists call this the microbiome, and in recent years the human microbiome International Consortium has mounted an intense research effort to understand its critical role in health and disease.

But two key programs that helped start this area are coming to an end, and monitoring efforts need to be put in place. It is also unclear if the industry regulators, government, or the public are willing to take ideas microbiome in the clinic. This was the news this week in Paris than 650 researchers gathered for the third annual meeting sponsored by the human microbiome International Consortium, whose members include the National Institutes of Health (NIH), European Commission (EC) and the main health organizations and the science of France, Japan, Canada and several other countries. Both programs microbiome NIH and the EC, which provided $ 140 million million, and $ 27, respectively, in the last five years, are in their stages of sunset at the moment, and the community is waiting new on the future financing of the two sides of the Atlantic.

If the scientific progress made to date is any guide, then there is a lot of justification for such extended financing, according S. Dusko Ehrlich, a molecular biologist at the French INRA research agency and coordinator MetaHIT, the EC-funded program microbiome. "We are now able to not just look at the data, but begin to interpret," Ehrlich said Science Insider. "We see promising avenues for the future", including exploration conclusions that higher degree of biodiversity of microbes in the human body is positively correlated with good health, while low diversity is often correlated with poor health.

Lita Proctor, coordinator of the financed project NIH human microbiome (PGH), added that the field is now mature enough to start having discussions on data, including whether the request controversial that humans can be classified into three different "enterotypes" based on their profiles microbial is valid. "at first, we were just focused on the methodology," said Proctor Science Insider, "but now we have debates on different ideas and perspectives."

regarding the financing of ongoing NIH, Proctor said the agency is currently intense talks with the research community microbiome and internal debates on whether to launch a "HMP2" next year. Proctor said the decision will probably be made this summer. And during the roundtable ending the meeting, Proctor describes what the renewed program would likely focus on: bioinformatics and software tools to manage sequencing microbiomes; large-scale, high-throughput testing to analyze the composition of the human microbiome; and animal models, maybe some researchers have begun to use to see the health effects of experimentally changing the composition of the microbiome.

On the European side, Ehrlich said he hopes MetaHIT, which will expire in 3 months, will continue in some form. "The scientific community expects the EC to call for new proposals in July," said Ehrlich. "Everyone would be very surprised if there were not funded microbiome research, from the signs we get . "

Indeed, the positive atmosphere for microbiome research continues in Europe has helped to attract industry to the research effort, as evidenced by the presence in the final panel of senior three French companies. Danone food conglomerate, pharmaceutical company Mérieux Institute, and a new startup called microbiome Enterome

Pierre Bélichard CEO Enterome, said participants at the meeting that his company is particularly interested in operating the microbiome research to create "biomarkers" for various diseases. and Christian Bréchot, vice president for medical and scientific affairs at Merieux (and former director of biomedical research agency INSERM version NIH France) emphasized the importance of academic researchers patent their results if the microbiome research is to realize its full commercial potential.

In the US, however, the industry has been slow to get involved, according to Proctor, although companies like global health care company Abbott Laboratories and baby food producer Gerber Products Co. now show interest.

But some serious obstacles in translating research base microbiome in clinical trials could come from the US Food and Drug Administration (FDA) warned Richard Sharp, Director of Research in Bioethics at the Cleveland Clinic in Ohio, one of the world's largest private medical centers. "The FDA has adopted a largely conservative position on such clinical trials," said Sharp during his presentation of the panel. "They are coming with huge levels of regulatory burden in many cases, and it could become a major obstacle."

Indeed, Sharp said during the meeting the patients who come to the Cleveland Clinic for the treatment of inflammatory bowel disease express concerns about these approaches, which might include the use of probiotics, the consumption of live microorganisms to treat intestinal and other diseases. "Many patients are concerned about the handling of their gut microbiota," said Sharp, adding that "they see this kind of study through the prism of genetically modified foods. They fear that the manipulation of the gut microbiome could lead to irreversible effects. "

Sharp also urged the research community microbiome and funding agencies, to start making awareness greater public to counter the statements often "grossly misleading" made by the companies that sell probiotic products, including claims that probiotics can cure cancer and treat autism spectrum disorders. "most of what people know about this area of ​​research comes from these retailers, "said Sharp. "We should not rely on these companies to make the first messages about this area of ​​research."

on Friday, the US Food and Drug Administration (FDA) approved a radioactive compound to assess people with cognitive impairment of Alzheimer's disease. The drug called Amyvid, binds to amyloid plaques, the calling card of Alzheimer's disease in the brain. When administered before a PET scan, Amyvid allows doctors to see if amyloid began to build. A negative test reduces the likelihood of cognitive problems a patient is due to Alzheimer's disease, the FDA said in its letter of approval, but a positive test does not necessarily confirm a diagnosis of Alzheimer's disease .

The compound was developed by Avid Radiopharmaceuticals, which was acquired by Eli Lilly and Company in 2010. Last year, a committee of the FDA decided to hold off on the Amyvid approval pending more convincing evidence that different doctors constantly read the scans. Lilly then developed an online training course for neuroradiologists to ensure consistent readings.

Amyvid was used in the research, including clinical trials, for years, said Michael Weiner, a neurologist at the University of California, San Francisco, and lead investigator of the disease neuroimaging initiative Alzheimer. The compound will be a powerful tool for clinicians when used in combination with other diagnostic tests, said Weiner. But there are potential drawbacks, too. "There are a lot of concerns. It might be overused in general, it could be misused and there will be false diagnoses, both false positives and false negatives," says Weiner "The medical community will have to develop its own standards on how to use it. "

an advisory committee met yesterday to consider the design of the national study of Special Education (NCS) is strongly came in favor of an option: the the study should recruit children from a geographic sample that represents the entire US population. But if the National Institutes of Health (NIH) will go with this plan is not yet clear.

Proposed by Congress 12 years ago, NCS aims to enroll 100,000 pregnant women and monitor the health of their babies from birth to 21 years In February, the NIH announced that because the original plan to recruit women to certain addresses in 105 counties was too expensive, he revised the design to cut 15% from the $ 193 billion budget NCS. Instead of recruiting women a probability sample of the population of the United States, the NIH said it might rather find women by physicians participating in the health care system, a so-called convenience sample of providers.

This proposal has attracted the concern of many researchers and questions of Congress. Those who perform pilot studies in 40 centers "vanguard" who have registered thousands of women were also alarmed to learn that some sites would soon be transferred to a new contractor.

At yesterday's meeting of the advisory committee and ad hoc advisers in Bethesda, Maryland, Alan Guttmacher, director of the National Institute of Child Health and Human Development (NICHD), which oversees the study, said that the NIH was looking for "a thoughtful exploration, people informed" of various sampling strategies NCS Director Steven Hirschfeld then stated that the role of 105 counties has not yet been decided.: "We still do not know what places will be in the sampling frame or not."

During the one-day discussion, committee members and others warned about the dangers of a convenience sample of suppliers. "I am very wary of a convenience sample, regardless of how it can be," said Edward Sondik, director of the National Centers for prevention of the Center for Health Statistics and control of diseases. He said a sample that does not represent the geographical diversity of the country could miss important environmental exposures that affect health. based on health care organizations could also leave out certain groups such as immigrants and undocumented workers poor, others said. (a dissenting member is coming of Jeffrey Krischer committee of the University of South Florida, Tampa, who suggested that the results could be "weighted" to reflect the entire population. )

Several people also expressed concerns about the NIH plan to save money by relying on electronic health records providers. Because the methods vary, there will be "problems" even with simple measures such as the height of a young child, warned member of Bruce Gelb committee of Mount Sinai Hospital in New York City.

Others have noted that the NIH has spent several years (and around $ 460 million to more than $ 750 million spent to date on NCS) strengthening relations with hospitals and communities the pioneering websites 40. "Certainly, we should try to use part of the investment," said the epidemiologist Michael Bracken of Yale University, an observer of the meeting.

Bracken was among the 28 investigators of the vanguard of 40 sites many of them spoke at the meeting, which provided the Advisory Committee an alternative plan that suppliers random samples in counties 105. the plan sets out the ways of conducting the main study in a budget of $ 3 billion by cutting biological samples and testing and enroll fewer preconceived women.

Guttmacher said after the meeting that the consensus was clearly in favor of a probability sample. "I think the thing was overwhelming that came from the discussion," said Guttmacher Science Insider. But NIH plans to seek greater involvement of federal statisticians and others before making a decision. "It is not an" either-or ". We must find an exact design at this point, "said Guttmacher.

NIH hopes to have more concrete proposals of the Advisory Committee meeting in July. The agency aims to issue requests for proposals for the study principal before the fiscal year ends on September 30.

Jennifer Culhane of the University of Pennsylvania and children's Hospital of Philadelphia (CHOP) said Science she Insider NIH not believe seriously considering retaining counties 105. "much of this [meeting] is theater," Culhane said, pointing to a recent NIH document prepared for Congress suggesting that he has already decided on a convenience sample . once the two centers vanguard led by CHOP close, she added: "I am planning to be 100% of it and I participated in this study for over 10 years.".