The study of Massive American children needs major changes, report finds

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The study of Massive American children needs major changes, report finds -
Massive U.S. children's study needs major tweaks, report finds

US Government

A controversial plan to study the health of 100,000 American babies in 21 years some points, but also highlights a multitude of weaknesses that could further delay its launch, an external review concluded. Criticism of Institute of Medicine (IOM) and the National Research Council panel (NRC) raises questions as to whether the national study for children (NCS) can maintain the necessary political support to ensure the financing of ambitious effort, which has already cost $ 1 billion and could require billions more in coming years.

NCS "has enormous potential, but it also presents many challenges ...," says the report June 16 IOM / NRC. To overcome the IOM / NRC recommends that the Chief the study, the National child health and human development Institute (NICHD), undertake major changes, including refine the guiding assumptions of the study and strengthening scientific input and monitoring. and it should drop an existing plan to enroll nearly half of children at birth, and instead register all earlier during the pregnancy of the mother.

"It's not like [NICHD needs] to start to square, "because a lot of ground to NCS has been asked, the president said Greg Duncan committee, an economist at the University of California, Irvine. But the necessary changes would probably delay the initial recruitment, now scheduled for 2015

NCS was born to a congressional request, made 14 years ago, the National Institutes of Health (NIH) follow a large group of children from birth to adulthood in order to understand how environmental factors, including social media and chemical pollutants affect health. Planners decided to recruit 100,000 women and their unborn babies by knocking on doors of households in a random sample of 100 US counties. But this approach was too expensive, so NICHD turned to other designs. Members of Congress have expressed concern in 2012 after NICHD after spending $ 1 billion, decided to pull the plug on 40 NCS sites run by academics and turn to large contractors working track 4,000 families he had already enrolled in a pilot study. In March 2013, Congress called for IOM to review the study and propose improvements.

In general, the panel of IOM / NRC approves the NCS concept. Similar studies are underway in Europe and Japan, he notes, but the American version would be more complete in part because researchers should collect comprehensive data on environmental exposures. The group also agreed with the decision of the NICHD to design the study as a "data collection platform" that will start to concentrate on only the tests some assumptions such as exposure to the kitchen dust exacerbates problems -and respiratory add later. But these "assumptions copies" should be more scientifically robust, IOM / NRC found.

The panel found fault, however, with how NCS planned to recruit subjects. Instead of registering 45,000 babies at birth and the same number before the birth, the panel calculated the study could enroll 95,000 mothers during pregnancy for the same cost, if it dropped plans separate studies of 10,000 women. These small studies should focus on specific issues such as exhibitions of preconception and the effects of natural disasters. Registration siblings, as planned, could also provide useful data on exposures preconception, the panel noted.

Such changes would NICHD to register participants for about $ 1.5 billion over 7 years, the panel estimates, with annual costs peaking at just over $ 300 million. (NIH now allocates $ 165 million per year for the study.) The total IOM / NRC seems to NCS on a least cost path that previous estimates of the NIH, who predicted the study could cost 3 billion $. But the estimate IOM / NRC does not include costs such as data archiving and storage of biological samples, the report notes. If NIH must also reduce costs, the signs said it would be preferable to fewer families that reduce exposure measurements.

The panel could not determine if the NICHD plan to enroll pregnant women through a sample of US hospitals would provide a representative group of the population that the recruitment of women through suppliers prenatal 100 counties in the original NCS. The problem is that "no such list [of all hospitals] exists," said Duncan.

scientific leadership of NCS is a major gap, the report found. Although the study has various advisory committees, "the process by which decisions are taken in the study and approved are opaque, "he said. NCS needs more expertise within its program office, the committee concluded, and a new external scientific advisory group which has the power to approve the design of the study.

These conclusions are justified to some critics NCS, including university scientists who were driven out of the study 2 years ago. "From my perspective, this is excellent," says pediatrician and epidemiologist Nigel Paneth of Michigan State University in East Lansing, who led an ancient site NCS in Detroit. "His conclusions are essentially the same as mine. They just put more good. "

Now that IOM / NRC has had its say, the question is whether NIH embrace its recommendations and if Congress is willing to continue funding the study.

* Correction, June 16, 4:35 p.m. :. the report of the National research Council and Institute of medicine, both part of the National Academies

* update, June 16, 4:35 p.m. NIH Director Francis Collins issued a statement in response to the report saying it "raises significant concerns" it. puts the main study pending. A team of experts will meet in coming weeks to advise Collins if the study is budget constraints "actually achievable" current data and, if so, how to implement the recommendations. Otherwise the panel will look at "new methods to answer key research questions that are most important for pediatric health today."

defective drug trials clinical research tarnish Japan

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In PNG, the epidemic has not been

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In PNG, the epidemic has not been -

empty data despite improved surveillance.

special section on HIV

[Ilya

A decade, the forecast for the island of New Guinea was dire. A heterosexual epidemic was set to explode, leading a team of international epidemiologists predicted in a report AIDS in Asia: Face the Facts . They warned that "everything indicates that the island faces an epidemic that resembles those observed in regions of sub-Saharan Africa." Papua New Guinea (PNG), which shares the island with the Indonesia, structured its response to the epidemic based on these early predictions. But the bomb was never extinguished.

to date, PNG struggles to describe not only why the first predictions were so far from the truth but also the exact contours of the smaller, but still serious, the country's epidemic is today. this confusion has come at a high price, particularly as regards decisions on where to target prevention efforts. "it results in a very vague program," said Stuart Watson, national coordinator in PNG for the joint United Nations Programme on HIV / AIDS (UNAIDS). "We do not know exactly what we respond to, and therefore, we answer everything."

Epidemiologists have long had good reason to fear a serious heterosexual epidemic PNG. condom use is low. Medically supervised circumcision protects heterosexual men against HIV, is rare. Sexual violence, in contrast, is endemic; a study published in the October 2013 issue of The Lancet Global Health revealed that 40% of men surveyed said PNG raping a woman "no partner." A recent study in a highland community and Port Moresby, the capital, found that over 20% of the 154 people tested in sexual health clinics were infected with chlamydia or gonorrhea.

early predictions suggest that by 2014, 10% of PNG in adults is infected with HIV. According to the National Department of Health PNG, the estimated prevalence among adults today is 0.65%. Watson believed that underestimates the true prevalence. "Ask most people face cold if they believe these figures, no," he said. But he believes the real figure is well below 10%.

Angela Kelly-Hanku ( left ) with Jolyn Gane in an AIDS dining General hospital Goroka

PHOTO :. MALCOLM LINTON

"the epidemic in PNG is not much sense in some ways," said epidemiologist Andrew Vallely, who lives in Milne Bay Province and works with both the PNG Institute of medical research (IMR) and the University of New South Wales (UNSW) in Sydney. "Why has not taken off HIV?"

In trying to assess the prevalence of HIV in PNG, epidemiologists have been many more assumptions than hard data. Joanne Robinson, a strategic advisor information to UNAIDS in PNG, as noted from 1993 to 01, the only official data HIV prevalence came from a prenatal clinic at the General Hospital of Port Moresby. "They had very high prevalence, but it was not representative of the rest of the country," said Robinson. Today, data from 380 sites and that monitoring was expanded to rural areas, more more distant, the overall prevalence has decreased.

But the data still give an incomplete misleading image, if not outright. "Our estimates are based on very small samples of the population to date" Watson said. He noted that only 60% of pregnant women attending antenatal clinics only 40% receive HIV tests. the government has not made systematic studies, large-scale several "key populations" which often have a strong HIV prevalence. men who have sex with men (MSM), transgenders and sex workers a small study conducted in Port Moresby by IMR in 2010 showed the prevalence of extremely high HIV among people who sold sex, if they were women (19%), men (8.8%), or transgender women (23.7%).

Moreover, the outbreak is geographically uneven, with strong heterosexual prevalence in some areas. As the Ministry of Health noted that PNG year, only five of the 22 provinces of the country, all in the highlands, accounted for 60% of reported HIV cases even if they have only 40% of the population. "PNG is experiencing a concentrated epidemic, in particular geographic locations and population groups," says a progress report of the HIV / AIDS, he filed in March with UNAIDS.

This patchiness complicates monitoring. for one, it is hard to access many isolated communities on this island of volcanic steep mountains. to reach the Goroka mountainous city of Port Moresby, for example, requires either an expensive flight or a winding 7-day hike. and 800 different languages ​​spoken on the island reflect cultural variation, including sexual practices that may affect the transmission, such as polygamy and age of initiation. "what you say one place is not what you say in another place, "says social anthropologist Angela Kelly-Hanku, who lives and works in Goroka on the team Vallely.

A surprising cultural factor that may have had a role in the fight against the epidemic is cutting traditional penis. Several large studies in Africa have shown that medical male circumcision, which removes all the foreskin reduces under-sterile conditions, the risk of sexual transmission of HIV from women to men by about 60%. While the medical circumcision is rare in Papua New Guinea, up to 70% of men in some communities report having had a traditional penis cut like a boy, a procedure that involves cutting the different types of slots in the foreskin, but not delete it.

videos

PNG circumcision practices, understanding of the scope of HIV in PNG, and HIV in a house PNG image, http://scim.ag /hiv2014.

Following a recommendation from UNAIDS and the World Health Organization in 07 that prevention programs in countries with high prevalence should include male circumcision, officials PNG health were interested in launching a national program. With funding from the Australian government, the group Vallely collaborated on a 4-year study to assess the acceptability of the procedure and the potential impact. What they found surprised them.

When the researchers assessed the penis cut across the country, places that practiced the most had the lowest prevalence of HIV. "It may help explain why the epidemic appears as it does in PNG," Vallely said. "To be honest, we never imagined when we heard these practices that would be the result."

In collaboration with colleagues in PNG, Vallely and colleagues are currently conducting epidemiological studies to see if the link holds up. At UNSW Kirby Institute for Infection and Immunity in society, another group is doing laboratory studies with PNG foreskins to explore fundamental mechanistic questions: How medical circumcision thwart HIV, and traditional cut no impact (see box)? Vallely said that if the cup of traditional penis proves capable of lowering the risk of HIV infection, it may eventually change the public health campaigns. "We do not want to stop something that stops HIV from taking off in PNG," he said.

Watson argues that the confusion over the contours of the epidemic and its pilots waste precious resources. In 2012, most government spending went towards the management of the response, not the provision of services such as prevention, treatment and care. "We have a heavy high national response engulfing nearly 80% of the funding" he said, noting that the National AIDS Council employs over 100 people.

the painful Catch-22 is that PNG is left with little money to improve monitoring and to find the best way to reduce the epidemic. "We do not have resources for this because we are always in response to an epidemic, we do not have," Watson said.

Main narcolepsy flu vaccines conclusions retracted

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Main narcolepsy flu vaccines conclusions retracted -

After 09 swine flu pandemic, about one in 15,000 children in Europe who received the H1N1 vaccine called Pandemrix developed narcolepsy, a disorder that causes uncontrollable sleepiness. A leading explanation for the rash of cases of narcolepsy is a fragment of the H1N1 virus used to produce Pandemrix may have triggered an autoimmune reaction in some vulnerable children. Researchers have struggled to find evidence of this hypothesis, however. This week, the picture grew murkier when Stanford University researchers retracted a paper in Science Translational Medicine , published December 18, 2013, which was hailed as the first evidence to support the immune hypothesis. After several attempts, the scientists say they are unable to replicate a key part of the experience.

For more, see the full article in this week's issue of Science .

Taking antibiotics early in life leaves the mice prone to obesity

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Taking antibiotics early in life leaves the mice prone to obesity -

Your body is not the only thing that grows rapidly during the first years of life. Your microbiome, the population of bacteria that live in your gut and elsewhere in your body has a growth spurt, and too confusing, it could lead to health problems down the line. A new study in mice shows that the interruption of the development of intestinal microbial populations with low doses of antibiotics early in life disrupts their metabolism and increases the risk of obesity later.

In recent years, researchers have realized that the microbes living in your gut are crucial to several functions, including building a strong immune system. Early childhood is a particularly important time for the development of a robust microbiome, a process that begins with the germs of a newborn picks up on its way through the birth canal. Children born by Caesarean section and those who receive antibiotics during their first year of life, have a higher risk of developing immune disorders such as asthma and type 1 diabetes Epidemiological studies show a high risk for obesity in children and, although the effect seems to be very low.

But Martin Blaser, a microbiologist at the University of New York in New York City, suspected that the development of microbiome has a greater impact on metabolism later in life. Studies with animals such as pigs and chickens have shown that low doses of antibiotics when animals are young people caused their faster growth and increased the amount of fat they won. Blaser and his colleagues wanted to determine whether metabolic changes are driven by the way antibiotics changed the microbiome of the animal, and they have turned to mice to study the link.

Blaser and his team were given a low dose of penicillin to mice for the first 4 or 8 weeks after birth and analyzed their gut microbiota and several metabolic characteristics. As expected, penicillin changed the gut microbiota in animals by reducing the number of lactobacilli and several other species that are believed to be beneficial. But this effect disappeared after a few weeks of last dose of antibiotics. Ten weeks later, however, the treated mice who ate diets rich in fat began to gain weight like crazy, reports the team today Cell . Women were particularly vulnerable: They added twice more body fat as their untreated cousins ​​who ate the same diet high in fat. Mice dosed with antibiotics that fed the normal diet did not gain weight, nor older mice who received antibiotics.

To determine whether the mouse'S microbiomes disturbed or the antibiotic itself caused metabolic changes, the team transplanted mice treated microbes in previously kept completely germ-free mice. Beneficiaries immediately began to gain weight when put on a diet rich in fat, suggesting that the cast changed microbiomes was responsible for metabolic changes. Meanwhile, the mouse germ-free given the gut microbes untreated mice did not gain weight.

"This is a very good study because it goes beyond the correlations and prove causality," said microbiologist Willem de Vos from Wageningen University in the Netherlands, who was not involved in the study. Jeremy Nicholson, a biomolecular scientist at Imperial College London, says that the study shows that changes in the overall physiology of organisms may indeed result from relatively small perturbations of the intestinal microbiome ", which could affect the long-term health. "

Vos warned against jumping to conclusions about what it means to study the man whose entrails contain very different bacteria than do those of mice. Moreover, he adds, "you would never give a low dose of antibiotics to a child for a long time. you want to know the impact, repetitive short treatment with a high dose." in addition, future studies need measure the impact of different antibiotics than penicillin, he said.

Blaser agreed that more work must be done, but he is confident that the connection between early life antibiotic use and obesity will eventually be confirmed in humans. "A lot of work on obesity has focused on food and calories. This was not sufficient to explain the obesity epidemic," says Blaser. Antibiotics could be a missing piece of the puzzle.

Proteins and pregnancy woe

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Proteins and pregnancy woe -

preeclampsia, the leading cause of death among pregnant women is a medical mystery and a phenomenon that every obstetrician dreads. Without warning, the blood pressure of a woman apparently healthy pregnant may arise; if the baby is not delivered immediately, she may die. Preeclampsia kills about 76,000 women worldwide each year, but we do not know the cause or how to prevent it. Now, a new study this week Science Translational Medicine shows that as Alzheimer's, Parkinson's, and mad cow disease, preeclampsia is characterized by a folding and clumped proteins. The discovery provides a new take on this complication of pregnancy, and highlights a potential biomarker, so that a simple urine test can definitively diagnose a disorder that missed a gold standard test.

For more, see the full article in this week issue of science .

Experimental Ebola drug saves monkeys, but this will mean for humans?

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Experimental Ebola drug saves monkeys, but this will mean for humans? -

SAN DIEGO, California- Last Wednesday, during a discussion entitled "Stop the deadly Ebola Outbreak" held at the Scripps Research Institute here a journalist from the local TV repeatedly pushed one of the panelists star Kevin Whaley, CEO of San Diego biopharmaceutical Mapp.

After Whaley said he did not know if zmapp now famous experimental antibody cocktail of his business used to treat victims of Ebola, really worked, the reporter went to the press. "from what you've seen in your search and your heart is said you say? "

the audience of 100 or more people broke into nervous laughter.

" I am not prepared to speculate on that, "said Whaley.

the tenacious journalist, he gave another essay, referring to two American health workers who were infected with Ebola in Liberia, returned to the United States and zmapp received, and lived to talk about it. "What joy was to see the two missionaries walk to the hospital?"

"It was certainly very satisfying, and hopefully zmapp played some role in this," said Whaley. "But it remains to be seen."

The exchange sets light the hope of increasing biomedical some action such as treatment-as zmapp allow more people to survive Ebola infections. time and again, however, the hope and hype became knotted together.

Today node is sure to grow tighter with online Nature encouragingly monkey experiment with zmapp, in which 100% of infected monkeys survived. It is sure to further enhance expectations of a cure and further confuse the public about how nearly one remedy might be. Even the authors of the new warning from the study that the extension of monkey results the man could be a long and difficult task.

the experiments conducted by Gary Kobinger of Canada Agency of public health in Winnipeg, first tested combinations of Ebola antibody made by his laboratory Bio Mapp and to find a cocktail that works best in guinea pigs and monkeys. They chose the concoction now called zmapp and gave three groups of six monkeys; all received an intramuscular injection of high doses of Ebola virus. A group of three control monkeys were given dummy medicines.

The treated monkeys each received a total of three doses of zmapp, one every 3 days. Treatment started 3 days post-infection for a group, to 4 days for another, and 5 for a third. All 18 monkeys had evidence of infection, many fell ill and almost died two.

In the end, 100% of the treated monkeys survived, and 100% of control animals died quickly. Although the experiment used an old Ebola virus which is different from the strain currently in West Africa, the researchers showed in a test tube study zmapp also worked against the most recently isolated viruses.

The results are "a monumental achievement," wrote virologist Thomas Geisbert, who studies Ebola at the University of Texas Medical Branch in Galveston, in an editorial Nature accompanying 'study.

"It is a great study," said Geisbert science Insider. "I have shelves and shelves and shelves of things that inhibit Ebola virus in cell culture and a small percent inhibition in guinea pigs or mice. And I have shelves and shelves of things that work in guinea pigs and mice but not in monkeys. If you save 100% of the monkeys up to 5 days after infection, it's a huge bar to clear. "

in a teleconference held by Nature today Kobinger said it was "quite remarkable" that they could save the infected animals which had advanced disease, which he called "a very important step in the fight against Ebola. virus "But Kobinger also pointed out that many unknowns remain about the differences between this monkey model and human infection.

to start, most humans are infected through exposure to bodily fluids of people with Ebola and not by needles which hold a huge bowl of virus injected into their muscles. This kills the monkeys on average in 8 days, then it usually takes 3 to 21 days for humans to develop symptoms. "It is very difficult to translate" the progression of the disease in the monkey model to humans, Kobinger said. But a monkey infected by this route and are not treated for 5 days is 3 days away from death, he said, indicating that zmapp worked well in the disease.

The monkeys were given three doses of zmapp, and he may need a second before the level of the Ebola virus in their blood dropped-viral load. With the seven treated humans, a person who died received a single dose, and no one has yet reported how many doses the others received. Kobinger said he "would not expect" a single dose of work. "What the antibody is really doing is to gain time," said Kobinger, stressing the importance of proper medical treatment on survival.

Kobinger said he did not know whether the antibodies had an effect on viral load in these patients because they were experimental zmapp on a "compassionate use". "When each of clinicians or clinical teams that have been using zmapp release their data, we will have a better idea of ​​perhaps efficiency, but even then it is difficult because it is not really designed study" Kobinger said. "Unfortunately, it may be limited what we will really learn these seven patients."

In preliminary experiments not reported in Nature Korbinger said he in vivo evidence that zmapp works against the strain currently circulating in West Africa. He said future experiments will analyze the impact of providing monkeys infected with effective intensive care. His group also wants to see how low of a dose of zmapp they can give infected monkeys and save them. "One thing that is very urgent for us to do is a dose-escalation study so that we can see that the minimum amount of antibody is then maybe with the same amount of material that we could do more", they say he.

Availability zmapp is crucial for the growing number of people who want access to it on a compassionate basis. Mapp Bio said it now has more zmapp at hand. Kentucky BioProcessing in Owensboro pushes zmapp antibodies in tobacco plants. In a press release in 2012, Chief Operating Officer of the company, Barry Bratcher, said he had a fully automated production system "that works in accordance with good manufacturing practice" and could "generate a new batch of antibodies in two weeks to respond quickly to new threats and new homes. "Bratcher did not respond to an e-mail from science Insider to discuss this prediction.

On the panel talk Scripps, Whaley said science insider they were still trying to solve the problems of production. "It is clear that we have material misstatement [the production time needed]," said Whaley. "This was clearly not our intention."

Questions have also been raised about how it was decided to give zmapp the seven people who received zmapp far, two of which were from Europe and two states. Whaley said the company responds to requests that come through the US Food and Drug Administration and has no say in who ultimately received the product.

Two of the seven patients died zmapp. Their results ultimately say nothing about the treatment: The people received the drug at different stages of the disease, and four were evacuated to rich countries for top-notch care probably the most important factor for survival . No information was released about the effect of the antibodies had their virus levels. Moreover, it is an experience without control. "These people do not have an identical twin who was infected on the same day and not to treat," said Scripps structural biologist Erica Ollmann Saphire, who was a panelist at the event, he helped Mapp and Bio select antibodies. "That's why we need to make the human clinical trial."

Human studies of zmapp should begin in early 2015.

Meanwhile, the Ebola cases continue to rise. The World Health Organization as of yesterday reported 3069 cases and 1552 deaths, a fatality rate of 52%. Senegal today announced its first case

* Ebola files :. Given the current Ebola outbreak unprecedented in terms of the number of people killed and the rapid geographic spread, Science and Science Translational Medicine made a collection of research articles and news on the viral disease available for researchers and the general public.

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vaccines tests unnecessarily delayed Ebola, the researchers say

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vaccines tests unnecessarily delayed Ebola, the researchers say -

Stephan Becker is tired of waiting. Virologist at the University of Marburg in Germany is part of a consortium of scientists that is willing to do a trial of a vaccine candidates for Ebola security. But the doses, it is supposed to test on 20 German volunteers are still in Canada. Negotiations with the US company that owns the license for marketing the vaccine that contains a gene for sewn Ebola surface protein in a pathogen known animal viruses such as vesicular stomatitis virus (VSV) have unnecessarily delayed the start of the trial, Becker and several other scientists say science . "It drives me crazy that we're sitting here and could do something, but things do move forward," said Becker.

Today and tomorrow, Ebola scientists and business representatives and regulators are meeting in its headquarters in Geneva, Switzerland, World health Organization (wHO) to discuss how to accelerate the clinical development of vaccines, a process that normally takes years. more specialists and more public health believe that vaccines will have an important role to play in stopping the catastrophic epidemic in West Africa, which has so far caused at least 6553 cases and over 3,000 deaths in Guinea, Sierra Leone and Liberia (These are the reported figures, the real toll is known to be much higher.).

given the emergency, it is inexplicable that one vaccine candidates developed at the public health Agency of Canada (PHAC) Winnipeg, has yet to go into the arms of the first volunteer, said virologist Heinz Feldmann, who helped develop the any vaccine to PHAC. "It's a farce, these doses are lying around there while people are dying in Africa," said Feldmann, who now works in the laboratories of the Rocky Mountains of the US National Institute of Allergy and Infectious Diseases (NIAID) in Hamilton Montana

in the center of the controversy is NewLink Genetics, a small business in Ames, Iowa, who purchased a license to market the Government of Canada's vaccine in 2010 and is suddenly caught in what WHO calls "the most acute severe public health emergency seen in modern times." Becker and others say that the company is dragging its feet the last 2 months because it is worried about losing control of vaccine development . But Brian Wiley, vice president of business development at NewLink Genetics, says the company is doing all it can. "Our program has grown at an unprecedented rate," he said. Although it took another few months, "we would still break a record in terms of getting this into patients." Wiley explains the holdup is the "administrative process": agreement on a protocol, get employees to sign good contracts, provide insurance in case something goes wrong

Marie-Paule Kieny, specialist vaccines and wHO Director-General, disputes NewLink is dragging its feet. . "So far, we have been able to solve problems along the way, to move as quickly as possible," she said.

Phase I trials for another vaccine candidate, which has pitted Ebola genes into a chimpanzee adenovirus, began in early September in the US and UK. "We have human safety data in approximately 20 people and everything looks good so far," said Ripley Ballou, who is in charge of the Ebola vaccine program (GSK) GlaxoSmithKline in Rixensart, Belgium. Further tests are planned for Switzerland, Mali and Uganda; Ballou said altogether 150 volunteers will receive single-dose vaccine.

A Canadian vaccine developed stock VSV is stored to PHAC in Winnipeg. The Canadian government had 1500 doses 8-1000 which he donated to WHO; the rest is held by NewLink Genetics.

Scientists say WHO bottles have already been sent to research centers who plan to phase trials. Such a trial is scheduled to Walter Reed Army Institute of Research in Silver Spring, Maryland; Other studies by a consortium that includes WHO and Becker are on the drawing boards in Hamburg, Germany, in Geneva, and at sites in Kenya and Gabon. PHAC is ready to ship doses "on a moment's notice," said a representative.

But for a clinical trial to begin, regulators need information on how the vaccine was made, and who resides with NewLink Genetics, which has been slow to release, people familiar with the negotiations say. Wiley said he "knows that the logistics are" not on the manufacturing information. he adds that NewLink wants to be in charge of all security tests. "I do not know think it's unreasonable that we want to be in control of the test and get things done," says Wiley.

Kieny acknowledged that VSV vaccine is behind the candidate GSK, which she says possibly "due to the fact that the partnership behind [the GSK vaccine] is more experienced," she hopes that the tests provided at Walter Reed will soon begin; .. those of Europe and Africa can expect to start in late October or early November, she said Wiley said contracts can be signed at the meeting that is taking place in Geneva.

part of the problem may be that NewLink is a small company with about 100 employees, which focused on immunotherapy to fight cancer in recent years. Research and development by the Authority of a Biomedical Advanced US government agency responsible for accelerating the development of emergency medicines and vaccines recently sent two employees to Ames to help Newlink file documents to the States US Food and Drug Administration, a representative of the US government says. "Our foreign aid commitment has nothing to do with our skill, but with urgency around this issue," said Wiley.

The number of Ebola cases is now almost double every 3 weeks. From the start, the experts of Public Health emphasized that the world knows how to contain the Ebola outbreak: find patients early and treat them using very strict hygiene, track and monitor their contacts, and bury dead quickly and safely. But given the magnitude of this epidemic, which has become almost impossible, said Gary Kobinger PHAC. "You would need an army of epidemiologists for it." This has made rapid development of essential vaccines.

"At first we thought that the epidemic would be by the time we prepared a vaccine," said Anthony Fauci, director of NIAID in Bethesda, Maryland. "But the epidemic continued and got dramatically out of control, it has become clear that we need this vaccine to actually contain the epidemic." This does not mean conventional containment strategies should not be used aggressively, and they need larger scale drastically, said Michael Osterholm, director of the Center for Research and Policy at the University Minnesota, Twin Cities infectious diseases.

at the WHO meeting today and tomorrow, experts discuss the many thorny issues that will occur if one or both vaccines successfully pass their Phase I trials. From there, they should be widely available in the affected countries, said Jeremy Farrar, an epidemiologist and head of the Wellcome Trust research charity in London. "I think the big question now is how do we do it while gathering data on safety and efficacy sufficient to be sure that we are doing well," says Farrar.

Fauci believes that, a randomized controlled trial, in which people receive either the vaccine or a real Ebola unrelated shooting such that the vaccine against hepatitis B, will be needed. "If you deploy a vaccine widely in a country, you better be sure it is effective, "he said. But others do not see the use of placebos as an option. "You create a group of people who are not vaccinated and they do not know it," said Kobinger. "If I was a volunteer, I would not be comfortable with this person."

Farrar accepts, moreover, a placebo-controlled study is simply impossible, he said "We are talking about a system totally destroyed healthcare across Liberia and, to some extent, Sierra Leone," said. Farrar. "We just have to be practical." This does not mean scientists will be unable to tell if the vaccine works, he said. Urban areas like Monrovia will inevitably receive the vaccine before reaching other parts, most rural of the country; scientists can compare the impact of the Ebola virus in both areas, in a so-called wedge step study plan. "If you have an effective vaccine to 0%, you immediately."

The offer is likely to be a problem. GSK has promised to produce about 10,000 doses by the end of the year, paid by the Wellcome Trust and others. the company is already working on how to increase production, however, if the first volunteers of the data show that the vaccine has no adverse effects and their immune systems have similar responses that protect monkeys in experiments that attempted to infect them with Ebola. the first signs of what could be available in less than a month, said Ballou. "We would not begin to produce large numbers unless we had evidence that the vaccine has the potential to work," he said.

vaccine production against VSV is already ramping up. The more than 800 bottles now stored in Winnipeg could give a few thousand doses Kobinger said, according to the exact amount needed per dose. "We are making additional power as we speak," Wiley said. "And we expect to have the ability to manufacture tens of thousands of doses by the end of the year." Two other vaccines, another on the basis of VSV and using a modified poxvirus are a few months behind in development.

at the meeting this week, experts will again discuss who gets the vaccine first. most participants in an ethical meeting earlier agents health should be given priority, as they are essential in the fight against Ebola, while presenting a high risk of contracting. in addition, the protection of a vaccine could help convince doctors and nurses to work in affected countries. the vaccine will also be given to other people involved in the outbreak, such as cleaners, ambulance drivers, teams or funeral, Farrar said. But offer the vaccine to patients' families could increase the likelihood they come forward, which would contribute to the detection and control.

The panel participants earlier agreed that children and pregnant women are especially vulnerable and should also be a priority.

Another question is which country to focus on. If early doses will be sent to Liberia, where the epidemic appears to be growing the fastest, or Guinea, who was about to contain the Ebola virus at least twice? "You could make a good case for either," said Brian Greenwood, an epidemiologist specializing in vaccines at the London School of Hygiene & Tropical Medicine, who chairs a session at the meeting. "These are all very difficult issues, and this is why you need to get a lot of brains all the people who really know it from different aspects and try to come to some sort of consensus."

* Ebola files: given the current Ebola epidemic, unprecedented in terms of the number of people killed and the rapid geographic spread, science and science Translational Medicine made a collection of research and articles on viral disease available for researchers and the general public.

Outsmart the placebo effect

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Stem cell recipe offers diabetes hope

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Congress Ebola discussion paper called PLOS

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Congress Ebola discussion paper called PLOS -

During a monitoring hearing at the US House of Representatives yesterday, lawmakers grilled health officials over the response to the first Canadian case Ebola and asked them to respond to the idea that many Republicans now-promote the prohibition of flights from West Africa. When Tom Frieden, director of the Centers for Disease Control and Prevention, said the restrictions would cause travelers to redirect through other countries, which makes them more difficult to track, representative Henry Waxman (D-CA) came to his defense with a visual aid.

map he presented, illustrating the relative flow of passengers on Ebola-affected countries in West Africa to the rest of the world, came from a article published Sept. 2 in PLOS Currents: outbreaks . One of its authors, the physicist Alessandro Vespignani of Northeastern University in Boston, said he did not know his work was featured in the debate until some colleagues have warned him yesterday. The map shows the complexity of the global travel flows, he said, but in the rest of the document, "we are more quantitative than that." The authors gathered this flight information with equations describing the dynamics of probable transmission in 16 countries high risk of Ebola virus importation to predict the likelihood that each will see a new imported case. According to the most recent forecast of the group, the risk of another infected person arriving in the US on October 31 given the current reductions air traffic is about 25%. the published work simulates how the reduction of travel can reduce the spread of the disease at this time, their estimates assume an overall 80% reduction in travel Vespignani but notes that the reduction of traffic is just "putting off the problem for a finite amount of time." (The 80% decline is equivalent to a delay of 3 to 4 weeks in a probable case, he said.) "This debate is not to divert the discussion from the real issue, which is to win the battle in Africa" .

Ira Longini, a biostatistician at the University of Florida in Gainesville and another author on the paper PLOS , said he thinks "it's fine" for the Congress to use the work an audience, but deplores the fact that "people are notoriously bad on the interpretation of probability." plots show the group how the probability of new imported cases would fall if the flow of travelers has decreased, but did not wade into the complex costs and benefits of a travel ban. "You can point on this plot and argue both ways," says Longini. The group plans to issue a new document next week that looks at the impact of travel restrictions that some airlines and governments have already imposed. "They can point to one side," he said

* Ebola files :. Given the current Ebola epidemic, unprecedented in terms of the number of people killed and the rapid geographic spread, Science and Science Translational Medicine made a collection of research articles and news on the viral disease available for researchers and the general public

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Ebola Liberia real progress, but far from the epidemic under control

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Ebola Liberia real progress, but far from the epidemic under control -

There are two months when the clinician Tim Flanigan arrived in Monrovia to help Liberia fight the epidemic Ebola, it took a few days to ambulances responding to calls, people dying were turned back by the processing units designated health workers ran short of personal protective equipment, and the bodies were left in the street. "There was not enough support and there was a feeling that the world did not understand the severity of this outbreak was," says Flanigan, who works at Brown University and former head of the diseases program infectious there. "Now it is radically different in Monrovia, which is wonderful to see."

Bruce Aylward, assistant director-general in charge of the operational response to Ebola World health Organization (WHO) confirmed at a conference today to the press that the number of reported cases has declined in Liberia, the hardest hit country in the Ebola epidemic. "It seems that the trend is real in Liberia and that there may in fact slow down the epidemic there, "said Aylward, who noted that the processing units in several localities have cots available.

But both Aylward and Flanigan immediately warned against premature optimism. "My god, the biggest mistake now would be if people start to think," Do we really need all these new beds? "Aylward said." I'm terrified that information will be misinterpreted and that people will begin to think, "Oh, great, it's under control." This is like saying your pet tiger is under control. This is a very sick, very dangerous. "

Flanigan stressed that the time has come "to redouble our efforts," especially regarding contact tracing and monitoring their health. "This is a huge task and we need to do a much better job," he said.

the apparent drop in cases could mean that families hiding patients and secretly bury the dead, but it is more likely a combination of factors has reduced the spread of the disease, Aylward said. "there was a rapid expansion in safe burial practices during the month of September," he said adding that many people were isolated in Ebola treatment units, the fight against the spread. It was also intensive community education about the disease, including how it spreads, the value of seeking care, and self-protection strategies.

The situation in Guinea and Sierra Leone, two other hard-hit countries, has not changed dramatically.

in a disconnect with the decline in Liberia, Aylward noted that WHO has raised 13,703 cases -a leap of more than 3000 of [chiffrespubliés on 25 October. He said the sharp increase reflects reports a backlog of cases, "With the huge increase in some countries, especially in September and October, people behind on their data," he said. "They were left with huge piles of paper and we knew we were going to see jumps in the case at times that will be associated with more new data coming in that are actually old cases." He said about 2,000 of the latest cases were from old data to Liberia, where case reports continues to be a problem. "The data for Liberia are missing for 19, 20, 21, 26 and 27 October," the WHO's last update note.

The WHO has warned that the models suggested the epidemic would be increase exponentially and the virus was ahead of the answer. Aylward noted progress, but pointedly did not say the answer was now ahead of the virus. "We are seeing a slowdown in the rate of new cases certainly," said Aylward. "The danger is now instead of a downward trend that we descend to zero, we find ourselves with an oscillating pattern where the disease starts to go up and down and start getting re-infected areas. What happens to the heat this thing and it slows down is not necessarily what brings us to zero. "

Flanigan said the challenge now is to obtain better data for counties, not countries, to better understand the contours of the epidemic and how to respond." Each case has need a very aggressive response, "he said

* Ebola files :. given the current Ebola epidemic, unprecedented in terms of the number of people killed and the rapid geographic spread, science and science Translational Medicine made a collection of research articles and news on the viral disease available free researchers and the general public.

Viruses help keep the intestines in good health

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Viruses help keep the intestines in good health -

Ebola, influenza and cold viruses have given a bad name. But there may be a bright side to these small packages of genetic material. Researchers studying mice have shown that the virus can help to maintain and restore a healthy gut in much the same way that friendly bacteria are.

The work "shows for the first time a virus can functionally substitute for bacteria and provide beneficial effects," says Julie Pfeiffer, a virologist at the University of Texas Southwestern Medical Center in Dallas, who was not involved in the study. "It is shocking."

our bodies are mostly microbes, with each to welcome us trillions of bacteria that our so-called microbiome. These bacteria appear to play a role in all of our weight to our allergies. But the virus also hiding in and around these bacteria and they far exceed the microbes.

as the microbiome, this "virome" may be important to human health. a recent study, for example, found that viruses that are abundant in saliva can eliminate harmful bacteria. Kenneth Cadwell, a virologist at New York University School of Medicine in New York, wanted to know what virus in the intestine could be done. In particular, he was interested in a group called norovirus. Although they are known to cause diarrhea outbreaks on cruise ships and diseases in laboratory mouse colonies, norovirus infect mice without adverse effects.

Indeed, he and his postdoc Elizabeth Kernbauer have now found that certain norovirus have a good side. In the laboratory, the researchers were breeding mice in sterile environments, such as rodents and young people lack the typical portfolio of microbes and viruses than other mice. Germ-free mice are abnormal. They are not quite certain T cells, which are important for immune function, and they are too many other immune cells involved in allergic reactions. They also abnormally thin villi, fingerlike microscopic projections on the intestinal wall that help absorb nutrients. Other researchers have shown that bacteria to mice without giving germs can rebalance the numbers of immune cells and fertilize the villi. Adding a mouse norovirus germ-free has the same beneficial effect, compared Kernbauer, Cadwell and Ding Yi, a pathologist at New York-Presbyterian Hospital in New York online today in Nature . Two other types of norovirus similar help make the healthy gut again, they found.

In a follow-up experiment, the researchers treated normal laboratory mice with antibiotics for 2 weeks, then gave them a norovirus. Antibiotics have upset the balance of immune cells and damage the intestinal mucosa, narrowing of the villi, but as with germ-free mice, the guts of the mice recovered with the help of norovirus. Kernbauer and colleagues then conducted the same experiment, but instead of adding the virus they replaced stunned various bacteria by antibiotics. Each bacterium has helped restore some aspect of the health of the gut, but not the same full range of the virus.

In a final experiment, the team infected mice treated with antibiotics with a pathogen that causes weight loss, diarrhea, and damage to the intestinal wall. Treatment with attenuated these effects. The virus has also helped protect mice against tissue damage from a toxic chemical.

Cadwell, Kernbauer and Ding began to track how the virus gives a hand. They found that stimulates an immune response which comprises a signaling molecule called interferon. "We interferon as a starting point, and now we want to know how interferon is conferred these benefits," said Cadwell

. "The idea that this virus can be beneficial in some way will be very controversial, "since most people think of general virus and norovirus in particular as harmful, says Juris Grasis, an immunologist at the State University of San Diego in California who was not involved in the work. Nevertheless, the study "could give us clues about human health as to what might be important in the immune system to fight or use norovirus."

the work has implications beyond norovirus, Pfeiffer added. investigations of human virome are many viruses that do not cause the disease. "Maybe in some situations, they may be beneficial."

unknown significance

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unknown significance -

The author and her two children in. She asked for genetic testing, as many do, in part to protect their own health as they grow

PHOTO :. © April SAUL

Rarely could I be described in a title in The New York Times , which is why I stayed on a earlier this fall. "Study of Jewish Women Shows a link to cancer without family history," said history September 5 Uncomfortable, I read on. "Women of Ashkenazi Jewish descent who tested positive for genetic mutations that cause cancer in random screenings have high rates of cancer ovarian and breast cancer, even when they have no family history of the disease, researchers reported on Thursday. "

Hmmm.

science has been my professional home for the past 13 years and in that time, I have written and spoken about genetic testing with dozens of experts from the edge of field cut. I chronicle the scientific advances, ethical dilemmas, life saving tests, the anguish he ignites. I've never turned the lens on my own DNA.

Suddenly there was no escaping it. My parents are both of Ashkenazi origin. To my knowledge, nobody on either side of my family has ever had breast or ovarian cancer. But suddenly I saw how a mutation in the genes described in this article BRCA1 and BRCA2 , had slipped unnoticed through a small family of my father, heavy on chromosome Y therethrough; his older brother; my three cousins, two of whom are men. I remembered that my paternal grandfather had suffered from prostate cancer, which eventually spread to her bones and killed him. My uncle had the disease, too. In addition to their storied role in breast and ovarian cancer, BRCA mutations are associated with prostate cancer in men. I had long known that Ashkenazi Jews are more likely to carry mutations in these genes. But that was as far as my knowledge went.

When I probed the numbers, they were not particularly reassuring. A quick Google search, why had I never done this before? -revealed That one in 40 Ashkenazi wear BRCA mutations, compared with as little as 800 in the general population. Like almost all cancer-related genes, BRCA1 and BRCA2 were discovered in families riddled with disease. But the September study, led by Ephrat Levy-Lahad, a medical geneticist at Shaare Zedek Medical Center in Jerusalem, argued that other families shared a high risk if they had the same mutations.

The newspaper article that has everything triggered, published in early September.

PHOTO: © April SAUL

Several authors, including Mary-Claire King of the University of Washington, Seattle, BRCA1 's discoverer, say all women, regardless of family history should know if they have dangerous mutations in BRCA1 and BRCA2 . Other experts are not yet convinced. Perhaps even more controversial is that to track tens of risk genes discovered in the last decade, some tenuous linked to cancer. I could have written a nuanced story Science on both sides of the debate. But when it came to my own health, 486 Israeli women with BRCA mutations, half without a family history, but all very vulnerable to cancer, was all it took.

Time seemed gasoline. I am 38 years old; ovary removal in BRCA carriers recommended by 40. I called the hospital in suburban Philadelphia where my children, now 2 and 5 years, were born and spoke with a genetic counselor. She has a family history and agreed that yes, testing BRCA was worth it, and yes, the insurance would probably cover it in my case.

I booked an appointment. I was about to discover my own tape of the new world of genetic testing for cancer, which would take me beyond BRCA and a more uncertain ground.

THE AUTOMATIC DOORS SWISH soundlessly open as I step into the hospital's cancer center. A genetic counselor with brown, curly hair and glasses approach me, smiling, clipboard in hand. In her office, she released a pedigree of my family sketched in pencil square for men, for women circles, slashes through those who died in the cause of death scribbled next to them. I thought I just loan-after all, I am here only to BRCA tests, and only because of my ancestry, but it turns out I did not. Hysterectomy my grandmother included the removal of her ovaries? (I hazard a guess and members of the family request after the fact, we do not know if I got it right.) Is my grandmother die of stomach or colon cancer? "She was in her 0s," I said. I still carry a vague memory of his visit to the hospital, in 3 years, shortly before his death. "Does it matter when someone's that old ? "

The advisor pulls a sheet of paper and places it on the table. There is a list of 21 genes associated with breast and ovarian cancer. Eleven are in pink and gray labeled "high risk"; three are in the purple category "moderate risk"; and seven are turquoise and described obliquely as "new genes." This is Breast / Ovarian Cancer Panel of GeneDx company in Gaithersburg, Maryland, but as is often the case in oncology, many genes contribute to of other cancers, too. it confers a risk of stomach cancer 40% to 83%. removing the stomach is recommended if the test is positive. another, TP53 , confers a risk cancer in women and a chance of 73% for men of almost 100% TP53 cancers include brain cancers and sarcomas

regarding two genes. on the panel BRCA1 and BRCA2 , there is little doubt that in families predisposed to cancer, screening saves lives: in-depth study of BRCA carriers found that those who have their ovaries removed were 80% less likely to die from ovarian cancer and 50% less likely to die of breast cancer. Prophylactic mastectomy appears to reduce the risk of breast cancer by at least 95%.

But many other genes for which the test was discouraged some years because their impact on health was uncertain are "now regularly offered," said Kenneth Offit, chief of clinical genetics at Memorial Sloan Kettering cancer Center in New York City. "This is the paradox that we fell in." Just as risk genes more cancer were discovered, the cost of their deep sequencing. the result is a proliferation of panels designed to decipher DNA.

how each of these genes increases the risk in individuals, and at what age, is often blurred. "clinical work came out ahead of us," says Fergus Couch, an authority on BRCA and other breast cancer genes at the Mayo Clinic in Rochester, Minnesota. "The [sequencing] The technology changed so fast" that "we did not have time" to develop answers to questions from patients and physicians now asking.

In the summer of 2013, GeneDx launched its breast / ovarian cancer-Panel stimulated in part by the decision of the Supreme Court against the patent claims of Myriad Genetics on BRCA genes. Other companies, including himself and Ambry Myriad Genetics and academic medical centers, jumped with panels of several dozen genes linked to a range of cancers. "We are really looking at things that will provide the physician the possibility of a treatment plan," for example, adding increased surveillance, said Sherri Bale, Director General of GeneDx. The genes on company boards are " a moving target, "she said, with the added culprits and sometimes deleted based on the available scientific evidence. Bale believes that the panels, which cost in the neighborhood of two or three thousand dollars, are suitable for high-risk families, but not for the general population.

THE LIST OF GENES 21 sitting between us, and I consider everything I could learn by simply saying yes. The counselor does not advocate that I sign for the full panel. But it draws my attention to a gene in the purple group to moderate risk CHEK2 . The list of cancers beside him is long: "Breast Female, Male Breast, Colon, prostate, thyroid, kidney, endometrium (serous), ovary." I am vaguely familiar with CHEK2 as a breast cancer gene from my own statement. "Is CHEK2 more common in Ashkenazi?" I ask, still stuck on the heritage that my cancer driver and why I'm in this room to begin.

"No," the adviser responds. But in addition to the prostate, my paternal grandfather had colon cancer. "He was in his 70s!" I protest. Nevertheless, CHEK2 test for me worth considering, the counselor says. A CHEK2 mutation could approximately double the risk of cancer breast, at least 20%. MRI and annual breast mammograms would probably recommended.

I saw thwart. Adding another gene for the test had never occurred to me. and yet, if the test is positive, the share price seems relatively benign and potentially save lives.

"Let's do it," I say. We talked for about 40 minutes.

the counselor fate . a consent form "There is one more thing," she explains a text block is titled It reads, in part. "variant of uncertain significance (SUV)." "I can learn a SUV was identified by this test. this means that a genetic change (variation) has been identified, but it is unclear whether the variant can cause cancer. "A particular cancer gene may have thousands of variations, some showing in a handful of families around the world. Some variants are a major contributor to the disease, while others are benign changes in DNA that, in practice, mean nothing.

again, my years of medical journalism were able to prepare. "How common are these in BRCA and CHEK2 ? "I ask. for BRCA1 and BRCA2 , the counselor explains, about 2% of people have an SUV. (I learn later that VUs rates fluctuate according to the company offering the test.) She does not know about CHEK2 , but is happy to discover. it also stresses that looking for an SUV does not affect medical advice and that the hospital contact me if an SUV is then reclassified as either harmless or pathogens.

I push aside my hesitation, sign the forms, and am off to the lab for a blood test.

Driving home, my intolerance of uncertainty rears its head. Do I really want to know if I am an SUV? What's the point? This afternoon, I send the advisor by email. I told him I'm worried that learning VUSs "cause me anxiety and there will be no benefit in having this information. I wonder if it is possible not to receive information on any SUV which can be found in the tests. ... is that an option? "

the calculation of the risk

How a BRCA1 mutation raises the risk of breast cancer of a woman depends on her age, family history and other variables, such as the examples below illustrate.

She wrote back quickly and pleasantly. She checked with GeneDx and learned that, for regulatory reasons, they are obliged to share information if an SUV is found. It will ask its medical director if the hospital can keep an SUV find me. But she also wondered if "you feel anxious not know whether or not you can be contacted in the future about a reclassified SUV. ... There are chances that you not have an SUV and you may feel a relief to know that you do not have it. "

She later wrote to say that his medical director is retained a comfortable SUV if no pathogenic variants turn up And there's more good news. She learned that the rate of SUV for CHEK2 , by GeneDx, is only 1.6%, much lower than it thought that the well-origin estimates vary depending on who you ask. I SHELVE my inner dialogue where the information I want.

Two days later while GeneDx is the analysis of my DNA, I'm on the phone with Susan Domchek, an oncologist the study of the breast cancer genes at the University of Pennsylvania. We discuss cancer risk genes in people with no family history of disease. Spontaneously, Domchek raises CHEK2 testing . "We do not know how to integrate it into patient care, "she complained, referring to HIV-positive women and their families. "What percentage of the time it really add anything to the situation?" I do not speak my own CHEK2 test is in progress. Instead, I learn about the frequency of CHEK2 mutations in the general population. Domchek the response that people only about one in 0 in the United States is a carrier helps me breathe.

Domchek is one of many researchers trying to clarify the interaction between genes and cancer diseases. With Offit, Couch, and others, has developed an online registry called PROMPT which opened earlier this fall. It aims to save thousands of people who have had the test panel offered by a host of companies, including GeneDx, Ambry, Myriad, Quest Diagnostics, and Pathway Genomics. Their goal is a database that will help them examine how specific gene variations affect health.

"We need to experience the world with all these panels," said Couch. It also highlights an irony: Despite some concern, scientists need him as panel testing to continue, because it is their best shot to collect sufficient data to address research questions. At the same time, "You do not want to do science ... at the expense of the patient," he said. Couch is part of an international consortium called ENIGMA working to sequence the breast cancer genes from 40,000 cancer patients and healthy people. the project nailing the risk conferred by different mutations and study the impact of VUSs about the disease.

a menu of cancer genes

multigene panels for the risk of cancer are increasing and change, including that of 21 genes associated with breast, ovarian and other cancers, shared with the author before his own test

DATA :. GENEDX ONCOLOGY PROGRAM

outside the United States, signs of cancer genes are largely limited to research settings, and investigators often do not share information about the changes that have a small or unknown risk. There is much debate about what to say volunteers. "We struggle with it," said Hans Ehrencrona, a clinical geneticist at the Lund University Hospital in Sweden. "Where do you draw the line, no one knows for sure."

Every woman in Sweden who receives BRCA test is now offered the chance to enroll in a study in which it tested for 63 other cancer genes. The results of only seven of them are shared with participants. Many moderate risk genes are not on the list, said Ehrencrona, who is helping lead the effort. As an example, he points out, " CHEK2 is quite common in Sweden. We will not return. "

ONE TUESDAY MORNING IN OCTOBER minutes after a work conference after the call, my phone rings." I have your results, "the adviser announces. For 19 days I met her. "What do you want to know?"

Well, pathogenic mutations, of course, I say

There is good news, she said :. No pathogenic mutations were detected in one of the three genes.

relief rushed through me. "Do you know about any SUV?" Application does. I think CHEK2 , and the SUV of 1.6%, it cited. What are the odds? "Of course, "I said.

" There was no meaning unknown variants detected in BRCA but unknown significance variant was detected in CHEK2 , "she told me. reading the report GeneDx, she explained that my SUV is a deletion of 15 nucleotides of DNA. the variant was found in two men with prostate cancer, and in vitro analysis suggests that causes partial loss of function of the gene.

I expect distress, ringing in my ears, fear coiling in the pit of my stomach. instead, I almost laughed. I think, "that's it? that's what's shared with patients today?" Two men with prostate cancer cells in a petri dish, a loss of function that may or may not result pathogenicity. This does not deserve my mental energy

"People need to become more comfortable with uncertainty," Sharon Plon, a clinical geneticist at Baylor College of Medicine in Houston, Texas, told me a few days later. But she stressed that the recognition of uncertainty "does not mean that we do not know anything." For many families suffering from cancer, large panels provide constructive advice.

I am writing to my cousin in San Francisco to share my test results; she is the only woman close relative of my father's side, where the cluster of cases of cancer and she is more familiar than most signs: His mother. nonbiological my aunt, is the fight against ovarian cancer and signed for a panel of 41 genes offered by the University of Washington, Seattle. She tested negative for all.

My cousin asked me examine the same panel, which has now expanded to 48 genes. in the end, I explained in my message to her, it was not something I wanted. "I know the signs are often discouraged , "she wrote back. There is a view that it does not share. Even without a clear-cut action plan, she wants to know some message from his DNA carries its future. The only reason she avoided testing for itself is because insurance is unlikely to pay for it. "Knowledge is power," she wrote. "I do not mind at all."

Moratorium on risky experiments lifted for MERS mouse studies

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Moratorium on risky experiments lifted for MERS mouse studies -

The US government lifted a temporary ban on research to develop an animal model for the (Middle East Respiratory Syndrome) MERS virus, a coronavirus lethal spread of camels to the people of the Middle East.

October 17, in an unusual move, the US government stopped federal funding for studies on risk SEAS, SARS or influenza tweak these viruses to make them more pathogenic or transmitted by breathing in the mammals. Among the 18 arrested were at least five projects to work on adapting the MERS virus into mice to generate a strain that sickened animals. This could facilitate studies aimed at understanding the virus and developing vaccines and medicines.

The financial break came as a shock to MERS researchers. At various meetings, including one at the National Academy of Sciences this week, they argued that the development of an animal model for MERS is crucial to tackle the virus, which has infected at least 938 people and killed a third of them. They asked for an exemption set out in the moratorium policy, which allows to continue work "urgently necessary to protect public health."

This exemption has now been approved for at least some of these projects. "We are very happy," said Matthew Frieman of the University of Maryland School of Medicine in Baltimore, who received a call from her program officer at the National Institute of Allergy and Infectious Diseases (NIAID) yesterday. NIAID researcher intramural Kanta Subbarao said its project to develop a rabbit model for MERS was also exempted, and the National Institutes of Health has not responded to a request on other projects at the time of release

* update, December 18, 3:20 p.m. :. NIH confirmed today that the five projects working on a mouse model for MERS were . exempted from the break Two influenza studies have also been granted an exception; no application for exemption were rejected

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The stem cell cancer betting

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The stem cell cancer betting -

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