Health Meaning

Issues continue to dog the testing of Ebola drugs and vaccines - At a hearing of the US Congress today that examined the response of the public health of the country Ebola, an official of the Food and Drug Administration (FDA) said it is working to develop "a flexible and innovative protocol" to assess the experimental treatment of the disease. The fact that such a common protocol is already talking to the complex practical and ethical issues surrounding the use of untested medicines and vaccines in the explosive propagation environment of a virus that kills more than half of people infected.

Given the unprecedented scale of the epidemic, a panel of bioethicists and infectious disease specialists convened by the World Health Organization (WHO) in August unanimously decided that it was ethical to use treatments and unproven prejudices against this deadly disease. The group also said there was a "moral obligation" to gather and share scientific data relevant to whether these products were safe and effective. But he did not indicate how it should happen, and that the testimony of the FDA's representative said, new views are still emerging while others are under development.

In recent months, WHO further consultations and articles of important public opinion by experts and health ethicists statement detailed visions on how to conduct experimental Ebola drug tests. The questions, both practical and ethical, are radically different for drugs and vaccines. unproven medicines go to the sick, who are fighting for their lives and often have few options, while the experimental vaccines were tested in healthy people the most are the frontline workers to protect against the deadly virus. "The ethical arguments are not the same for all levels of risk," noted 17 leading researchers and ethicists from 11 countries in an editorial on screening for Ebola published online drugs on 10 October in The Lancet .

the gold standard for the design of clinical trials for drugs and vaccines is the randomized controlled trial (RCT) in which half the participants are distributed random to receive experimental medicine, while the control group received conventional care, including sometimes a placebo. Médecins Sans Frontières (MSF) has treated more patients Ebola in West Africa than any other group, opposes ECR in the affected countries either for treatments or vaccines. Annick Antierens MSF, who oversees "experimental platforms" for experimental products Ebola, said "this can not be defended ethics."

The Lancet Editorial, led by Piero Olliaro wHO and the United Kingdom of Oxford University, sided with MSF for treatment. in their case, the authors question the sense of "balance" a fundamental ethical principle behind RCTs told investigators should not know whether an intervention is better than what is offered to the control group. "Equipoise is a useful principle, but it can decompose when conventional treatments offer little benefit and mortality is extremely high," write the . authors "This is precisely the problem with the Ebola virus: current standard care does not change much clinical outcomes and mortality is as high as 70%. When conventional care means such a high probability of death, it is problematic to insist on randomization of patients to it when the intervention arm has at least the opportunity to benefit. "

The editorial refutes an article published online September 11 in the Journal of the American Medical Association by Steven Joffe bioethicist at the University of Pennsylvania (Penn) and a previous by bioethicists Annette Rid of king's College London and Ezekiel Emanuel Penn who ran online August 21 in the Lancet. These authors state that "compassionate use" experiments Ebola drugs outside the ECR, as has happened in some patients with the antibody cocktail called zmapp and a drug manufactured by Tekmira, jeopardize the ability to gather scientific evidence and, Joffe wrote, "will not necessarily prevent more deaths than would the drug in a well designed clinical trial. "

Rid said Olliaro and co-authors wrongly assume that receiving an experimental treatment is necessarily better than receiving care that is effective support not available to many people infected in West Africa. She further contends that the editorial "minimizes the possibility that experimental interventions can make people worse" and "neglected concerns the population level, even if interventions are not the worst individuals, they may be ineffective and we would end badly allocate scarce resources. "

the design of real-world studies to test whether the Ebola virus vaccines work has even triggered heated discussions. Many researchers at a WHO consultation held on 29 and September 30 came to the meeting thinking that traditional RCTs were on the table: The feeling seemed to be leaning towards a strategy known as tiered corner that name give all participants the Ebola vaccine at different points in time and then look to see if people who received later were more vulnerable to infection. But at the meeting, Ripley Ballou of GlaxoSmithKline (GSK), which has most of Ebola vaccines in development, has won wide support for its argument that the fastest, most ethical to determine if the product works with RCT is using an "active control" -as a vaccine against a disease proved to be rather irrelevant to a dummy placebo shot.

following that meeting, some wonder if a check active is more ethical than placebo. Peter Smith, an epidemiologist at the London School of Hygiene & Tropical Medicine, who attended the meeting and a consultation 2013 wHO on the use of placebos in trials vaccines, argues the question is practical, not ethics: an active control can convince more participants to join the study "While it is easier to criticize if you use an active control rather than a placebo. then fine, try it this way, "says Smith. "But believe it is more ethical than the other is not the issue." He stressed that the main advantage of joining a vaccine trial, especially in tense resource countries such as these, is that people who develop the disease "are usually looked after better than people not in testing. "

Arthur Caplan, a bioethicist at the University of New York in New York who co-wrote the last editorial Lancet ECR for opposing Ebola drugs, supports their use of Ebola vaccines. But he fears that an active control can cause problems. The immune responses triggered by the vaccine in the active control arm, he notes, "might complicate the interpretation of results" in people who received the Ebola vaccine. It also raises ethical dilemmas if an active control arm uses a vaccine that the country can not afford to use consistently.

Bioethicist Nir Eyal of the Harvard School of Public Health in Boston, who also supports ECR for the Ebola vaccine, said it is "a huge privilege" to offer a chance to participate in a trial that gives people a chance to receive a vaccination with some promise of success of 50%. "Of course, nobody wants to placebo," said Eyal. "But the point of medical tests is not to provide the procedure is medically best for the research topic. It is to establish something that is important and this is crucial-for a much larger population and to prevent a human catastrophe. "

Even MSF does not exclude other types of tests that offer the Ebola vaccine to all participants. Apart from the regime intensified corner, researchers could hold less rigorous testing" observation "which are usually used after the vaccines arrive on the market to see how they work in entire populations." after licensure, there are many observational studies that give us results very, very that we believe useful and meaningful, "said Arthur Reingold epidemiologist at the University of California, Berkeley.

In this scheme, the vaccine is distributed without an organized study and investigators should examine the Ebola rate in a cohort of vaccinated people say, health care workers in a hospital or evaluate vaccination rate in people who develop Ebola. "The key question when you start to calculate vaccine efficacy is whether people who receive the vaccine and those who did not receive the vaccine are relatively comparable," Reingold said.

Yet another hot issue is one that should be entitled to receive experimental drugs or treatments. unusual treatments such zmapp preferably have gone to health care workers because, as the consultation in August WHO stressed, they put their lives at risk for others and they are required to control the epidemic. Emanuel Rid matter and if it makes sense, noting that health workers have close ties with the medical community and relatively high levels of income. "Their priority may be considered more focus on the well-off already, especially in contrast to those who provide care without being trained as health professionals."

On the front of vaccines, GSK can have up to 20,000 doses ready for effectiveness testing in January, but it still means there will likely participants much more interested in the product. The latest WHO consultation said frontline workers should go first, not only doctors and nurses to a group that includes anyone who helps care for patients or even bury those who die.

For convenience, participants meet Michael Selgelid Monash University, Clayton, Australia said it is more logical to offer the vaccine to the "traditional design" concept of a worker Health care. "They are better able to give proper informed consent, and it is crucial in this scenario that we really good informed consent," he said. At the end of the day, Selgelid said, regulators such as the FDA probably will strongly influence the trial design as it is they who will ultimately decide whether these products can come to market. "Just how flexible the regulators will be is a matter for them rather than me," he said

* Ebola files :. Given the current Ebola outbreak unprecedented terms of 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.

Scientists grow tiny human stomachs in lab dishes -

The colorful snakelike image above is actually fluorescently labeled tissues from a section of a stomach that is smaller a pea. But he stomach of an extraordinary little animal; it's a mini-cultured human stomach in a dish by scientists who hope to use it to study the gastrointestinal diseases. Because the digestive systems of mice, flies and other model organisms different from those of humans, researchers have struggled to find a way to study the development of human intestinal diseases such as peptic disease duodenal. Thus, several groups have turned to the derived pluripotent stem cells-cells of human embryos or reprogrammed adult cells that can develop into any type of cell in the body to try to develop the digestive organs in the laboratory. Last week, a group of researchers announced the creation of a small intestine grown in the lab from stem cells. Today, one of the various reports of the online team in Nature they have perfected the recipe of molecules needed to coax the two types of stem cells to grow into small spheres which, despite their size, have all a stomach functional properties. When the researchers exposed the ministomachs to the bacteria Helicobacter pylori , infections that are blamed for many stomach ulcers and cancers, they saw the same molecular and cellular changes already known to occur in the scale of stomachs.

Saving lives without new drugs -

Star statistician Hans Rosling takes on Ebola -

MONROVIA- Hans Rosling is a global health celebrity, a former head of the World Health Division at Karolinska Institute in Stockholm whose riveting lectures him a star of TED talks, and editing of the World economic Forum in Davos, Switzerland did. But since October 20, he held the room 319 of the Liberian Ministry of Health and Social Welfare, a big yellow building, not far from the Atlantic Ocean. Working alongside the head of Ebola surveillance countries, Luke Bawo, it helps the Department of sense largest Ebola outbreak ever recorded.

Rosling came without any affiliation, who says he allows it to remain independent. "He just walked into the office and introduced himself," said Bawo.

He feels bad for not coming sooner. Ebola arrived in Liberia from Guinea in March and then spread south of Monrovia, where it exploded in August The hospitals were closed and Ebola treatment units were submerged. "I thought the Ebola epidemic could be stopped locally," says Rosling. "I was not smart enough." (He also felt he was too old to work in a processing unit.)

When he saw the epidemic curve go to Sierra Leone and down in Liberia in October, he was skeptical, and he decided to find out first hand what was happening. He canceled his lectures and contacted the Liberian government. "I'm not a virologist, and I am not a clinician, but I have considerable experience investigating messy epidemics in poor regions of Africa," he said.

This a quarter of a century, he faces a threat that seemed even more terrifying than the Ebola virus. in August 1981, Rosling worked as a district doctor in northern Mozambique when he was sitting in front of a line of 30 women and children whose legs became paralyzed during the past month. "I had this big book of neurology, and their disease did not exist in the book," says Rosling. A south African submarine had was spotted in a nearby bay a few weeks earlier. "it was quite possible that it was biological warfare."

When he came home that evening, he told his wife to take their children and lead them to a safer place a few hours. he did not sleep the next 48 hours. "When you face a disease that can be infectious, 98% of your intellectual ability is blocked. You become so afraid, thinking you're going to die, thinking that you can be crippled, thinking about your children." He took 2 weeks before it became clear the affliction was not contagious. (Now konzo it is caused at least partly by toxic compounds in cassava roots.) A group of Italian nuns helped Rosling overcome his fears. "I do not think I could do it without them," he said.

experience has left Rosling with a fresh approach to health crises and a strong sense of what it takes to fight against a disease in one of the poorest regions of the world. Shortly after his arrival in Monrovia, he became convinced that the decline of Liberia is real, largely through behavioral changes that reduce the risk of infection. Liberia now reporting only some 10 new cases per day. that's good news, but it also presents great challenges. While the Ebola virus was the cause of death, security funerals were essential. now that new infections are less frequent, people might take, in principle, traditional funeral practices that include contact with the body, for death is not due to the Ebola virus. But the dissemination of this message could get people to drop their guard with Ebola victims, too, which led to new infections. "Any decision will be many complicated consequences," says Rosling.

Rosling learned that lesson, too, in konzo home. Because he was initially unable to comment on an infectious disease, the Mozambican government has set up a roadblock to stop the spread of the disease. a group of people took a boat along the coast to escape the blockade, and sank. "I stayed and saw the bodies 18 women and children who drowned because of this dam, "he said." it stays with you. Eighteen bodies of people you killed. "

After arriving in Monrovia, Rosling began by doing simple things, like proofreading epidemiological reports of the ministry, he said nobody had time for. It changed a key detail in updates. Instead of listing "0 case" for counties that has not reported figures that could be misleading, he empties he then addressed the problem behind the missing data Some workers. health could not afford to hire their reports because they paid the phone is charging, Rosling has set up a small fund to pay for scratch cards that gave them the airtime [

A recent "Factpods" Hans Rosling on YouTube discussed the spread of Ebola in West Africa.

now it focusing on how to get the number of new cases to zero. That means finding all cases, monitoring contacts of this patient, and isolating those with symptoms-a huge challenge in a country where many villages are hours away, the symptoms of Ebola, as the diarrhea and fever are common, and the fear of the deadly virus causes the contacts to skip town and look for a traditional healer. "We have to make a perfect system meticulously working in a country where such a system can not exist," he said. "This is the greatest intellectual challenge that I took part in my life."

on a whiteboard in his office, Rosling developed a complicated chart to show how the patient information and contacts moves through the system. the data is lost in several stages. Some people die on the way to the hospital; others give different ages or names at different points Rosling's goal is to know how many newly discovered Ebola patients are already on one of the contact lists but until now it has had.. hard even to know what county every patient originated.

further on the front lines welcome with Rosling. Kevin de Cock, head of the US Centres for the team the ground in Liberia Disease Control and Prevention (CDC), it "an eminent epidemiologist with great African experience calls. He brings a strong technical and intellectual contribution. "Bawo said he admires the commitment of Rosling, but worries that he himself overuse. "He is welcome to stay, but I make my case it takes a day off a week," said Bawo. "Every Sunday, I do not call, he does not ask me, and I do not want he send me an email. "

Rosling says he is tired of Africa's representation as a continent incompetence, superstition and rampant corruption. "I'm amazed how people are that I work here, how dedicated, severity," he said. When The New York Times reported that the infighting of the government hampered the Ebola response Rosling tweeted: "Don McNeil distorts Ebola response from Liberia to win the MOST BAD aBOUT ARTICLE Ebola AWARD." His self-assurance and impatience with opinions he disagrees with may grate on the other, "I find it quite irritating. "said a Western colleague." most of the time, as it turns out to be right about most things. "

Rosling is critical of the Western response to the crisis. Whereas experts from elsewhere in Africa came as colleagues and stayed for long periods of time, for example, organizations such as CDC replace their staff every few weeks, which hampers continuity Rosling said. (CDC is like Cuba, Rosling said: "amazing people, bad system.") the US military will not transport patients or even blood samples in their helicopters, he added. " Welcome to the continent less superstition "

Rosling finally wrote his doctoral thesis on the epidemic of konzo, helped set up the Swedish chapter of Doctors Without Borders, and became a professor of global health at the Karolinska Institute, where he retired in 2012. talks still garner "obscene costs," said some, $ 0,000 per year, which serves to finance the Gapminder Foundation, a nonprofit, he set up to present development of statistics to a large audience. His talks were seen by millions, 0,000 people follow him on Twitter and has rich and powerful fans. "Mark Zuckerberg called me yesterday," said -it at some point, ask how his money could help against Ebola.

06 talk of Rosling TED debunked myths on the developing world.

in his talks, which have stunning graphics, Rosling is keen to stress that the opinion of most people of the world will not. He often asked how many children receive vaccines-20 standard childhood%, 50% or 80%? Most people answer 20% but is 80%. "The problem is that the education systems in North America and Europe and the media are not transmitted a view based on the facts of the world."

Similarly, many people lump all of Turkey in Somalia as well as developing countries, blurring the differences between middle-income countries and those dominated by extreme poverty. He likes to say that 1.5 billion people have a bulb and a washing machine, 4 billion have only the bulb, and about 1.5 billion have neither. The people of Liberia, Guinea and Sierra Leone fall mostly into the latter category, he said. "And that is one reason that we can have a huge epidemic of Ebola here."

Eradicate extreme poverty should be a top priority, said Rosling, who was critical of programs that focus on a single disease, such as the initiative of several billion dollars to eradicate polio. This put him at odds with Bruce Aylward of the World Health Organization (WHO), who heads the campaign. Now Aylward is also responsible for the Ebola response from WHO, but in this case, there is no disagreement: "Ebola is different," Rosling said, adding that Aylward gave him important information. Rosling Aylward praised as a "value added."

Although it is not in contact with Ebola patients, Rosling was a time when the fear of infectious disease has returned. One night in his hotel Monrovia he developed diarrhea. he skipped dinner and locked in his room. "I had to plan. Should I tell my family? Should I not? "He said. he decided to take his temperature every 2 hours and monitor itself for additional symptoms. "But I finish my report before going to bed." It felt good the next morning, and he does not expect to return to Sweden soon. "I canceled Christmas with the family," he said. "But I hope to be home for Christmas Eve the summer solstice."

* 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.

Can e-cigarettes actually help smokers quit? - ] Medical devices usually come in flavors like "Spiked Nog," "Apple Jaxx," or "Aphrodite case," but proponents e-cigarettes introduced in 06, argued that the pen-shaped nicotine vaporizers could help cigarette smokers to quit the habit. Now, a review of the scientific literature published today, gives credibility to this claim, although the issue is far from settled.

Led by the UK Cochrane Centre, the review focused on testing two randomized, but has also examined data from 11 cohort studies that compared people who were already trying stop with and without e-cigarettes. Overall, the data "suggest that electronic cigarettes may be useful [for] stop smoking and reduce cigarette consumption," says lead author and specialist Hayden McRobbie behavior of the Wolfson Institute of Preventive Medicine in London.

After 1 year, trial participants who used the devices were more than twice as likely (4% against 9%) to quit successfully compared to those who used a placebo spray without nicotine. Another 36% of users e-cigarettes have been able to reduce the number of traditional cigarettes they smoked by 50% or more. But 28% of placebo users also reduced their cigarette consumption by at least 50%, suggesting that some can leave the e-cigarette can be derived from the simple fact of "smoke" it.

Because there are so few studies of how e-cigarettes work as a tool to leave the examination of confidence levels are low and estimates for efficacy may change. But still, McRobbie said he would recommend e-cigarettes to a friend or family member who was trying to stop smoking, and he thinks that health professionals should be more open to recommending the devices.

The Cochrane review looked for signs of severe adverse reactions to the therapy e-cigarette, but found none. This is certainly not to say that electronic cigarettes are completely harmless. "We do not yet know the long-term use of risk," said McRobbie. Previous analyzes of their vapors were found numerous toxic chemicals and heavy metals. These compounds are present in sufficiently large doses to cause long term health problems remains to be seen. But compared to the dangers of tobacco, "the effects on the real health are quite likely to be smaller because the e-cigarette vapor ... has fewer toxins in it," says Schick Suzaynn a biologist at the Centre research for the fight against smoking and education at the University of California, San Francisco.

of course, the safest thing to do is to avoid or otherwise-e-cigarettes altogether. But for those who are already addicted to nicotine, electronic cigarettes may be the lesser of two evils. "now, I want the debate can move on the best way that we can advise and support smokers who use these products to stop smoking completely as soon as possible, "said Ann McNeill, professor of tobacco dependence in national addiction Centre at King's College London, in an official statement. The Cochrane review called for further study, specifically comparing e-cigarettes with other methods of quitting, like the patch in terms of safety and efficiency. "We need more data to strengthen the evidence," said McRobbie.

Bad luck and cancer: A science reporter’s reflections on a controversial story -

We reporters or it, in any case, often fail to anticipate the gripping stories that readers and that will quickly disappear into oblivion. Given that, maybe I should not have been surprised that a story that I live out of the printing press in the lull between Christmas and New Year has generated more comments than any other, I ' wrote.

The piece, which appeared online with the title "the simple calculation which is why you can (or not) a cancer" (and in the section of the journal News with the title "bad luck Cancer . "), describes an article published in the edition of January 2 science as I and many other reporters explained, the study suggested that" bad luck "single mutations - RANDOM accumulate in stem cells healthy may account for about two thirds of cancers than the risk conferred by environmental and genetic factors combined. A message was that some cancers could not be avoided and detect early was key to fight .

the players wasted little time skewer the authors, mathematician Cristian Tomasetti and geneticist at Johns Hopkins University's Bert Vogelstein cancer in Baltimore, Maryland Their statistics were defective, some argued. they included many rare cancers and left several more common. Earlier today, the International Agency for Research on Cancer, the World Organization of cancer arm of health, put on a press release stating that unusual "strongly disagree" with the report. The agency said that "almost half of all cases of cancer worldwide can be avoided." He accused the authors push for early detection "if misinterpreted ... could have serious negative consequences both cancer research and perspectives of public health. "

Reporters, if anything, do less well." please journalists, get a clue before you write about science, "argued an angry column in the Guardian , co-written by an evolutionary biologist who goes by the Twitter handle and @GrrlScientist statistician Bob O'Hara at the biodiversity and climate research Centre in Frankfurt, Germany

given the fury I wondered :. was I wrong? Had the authors? Answering these seemingly simple questions have proven surprisingly difficult, exposing the challenges that come with scientific communication and the desire to scientific authors and journalists in order to streamline the story they are trying to say.

I started with my own story, working behind the science that spawned it. I wrote that the theory of random mutations in stem cells, "says two-thirds of all cancers." Immediately, I knew that I had written some of this sloppily, to put it generously: The study did not include all cancers. In fact, he did not include two of the most common, prostate and breast cancer, because the authors were not able to identify the size of the stem cell compartment or frequency of stem cell divisions in the tissues . Although my piece then recorded the number of cancers in the study, I pointed out the earlier omissions.

Encore, was "two-thirds" referring to the number of cases of the study include cancers, like me and other journalists had suggested or something else? Journalists like figures that shorten a study at a ball point. I immediately asked if this finding two thirds could be such a gem. Tomasetti had explained to me in a long interview that "if you go to the American Cancer Society website and check what causes cancer, you will find a list of things either inherited or environmental. We say two thirds is not one of them. "I ran the text of my" two-thirds "phrase by him before publication and he had no objection (there were other details).

Last week we talked again. Tomasetti had received over 0 emails. Parents of children who were cancer deaths were grateful that it could have happened entirely by chance, suggesting that there was nothing they could have done. biologists and statisticians disputed its findings or simply surprised that so many cancer could be random.

"We do not claim that two-thirds of cancer cases are due to bad luck," Tomasetti said softly. what the study argued, he explained, is that two-thirds of the variation in cancer rates in different tissues can be explained by random bad luck (a point made by others). what meant, I wondered? Tomasetti, chatting by phone, had me draw graphs to help me understand. At the end of the day, I'm still not sure I grasp the essence.

Tomasetti was friendly. "There are many scientists who need clarification" on the document, he said, with some statisticians. He was preparing a technical report with additional details, and Johns Hopkins had just put a press release explainer. "Honestly, I feel and what I say to the BBC, and you can definitely quote me on this-general, reporters who have interacted with made us a very honest and sincere effort to be as accurate as possible. "

it was only after several hours of interviews that I finally understood the figure of two thirds. Some fabrics are overwhelmed by the cancer more easily than others, and accumulating mutations in stem cells explained two-thirds of this variability, Tomasetti and Vogelstein had concluded. It was my "aha" moment, and it came too late, after my initial deadline.

I contacted some of the criticism. "I just read your article, and I do not think it falls into the wrong category (at worst, it bypasses the lip without dropping in)" wrote O'Hara, author of Guardian room, in an e-mail to confuse me further, because I had not goofed up? By phone, he explained that one of his quibbles was the word "luck" -present in the summary document, emphasized by the authors, and highlighted in almost every news story. He looked sexy, but O'Hara felt it was inaccurate, because virtually all cancers is a product of chance in a sense.

"It is too easy to blame the media," said David Spiegelhalter, a biostatistician at the University of Cambridge in the UK, who blogged about the story. ( "Your article is fine," he assured me.) In this case, he felt, "most of the coverage is very reasonable, most cases of cancer are due to chance."

However, mistakes were made along the way, which has not surprised. "this is very difficult things," said Spiegelhalter. "I feel for you. It's one of those things that is so superficially simple, yet superficial simplicity is not correct. "

The authors of the paper, many felt, also were guilty of trying too hard to develop a simple message. The document included a diagram visually arresting splitting cancers in green and blue categories. the green cancers were "mainly due" to mutations suggesting random-write the authors, they were less likely to be prevented by changes in behavior or diet. However, this category included cancer and melanoma of the esophagus, both of which are considered to have close links with environmental factors such as excessive alcohol consumption and exposure sun, respectively.

Melanoma sitting just a bit inside the green border, but still, it was green, which left many readers exercised. "They have ignored some of the basic lifestyle factors," said Graham Colditz, a specialist in cancer prevention at the University of Washington in St. Louis. "Obviously, they had good intentions," said Anne McTiernan, a physician and epidemiologist at the Fred Hutchinson Cancer Research Center in Seattle, Washington. But, she continued, the authors assume that a correlation exists between the number of divisions of stem cells and cancer risk was meant one behind the other, something their data could not prove. Tomasetti agreed that this is correct, but noted that "all the biology that we have on this subject supports" the idea that the accumulation of random mutations in healthy cells can trigger cancer. Some scientists have argued that the graphic carried a missive for the prevention, with huge risk differentials between cancer caused by environmental or genetic, such as lung cancer in smokers or head and neck related to human papillomavirus and cancer at the same site without obvious cause.

The shades were many. Although they quibble over the details, most would agree that random mutations play a real role in cancer - but for many other things. Despite the fury, this common ground is shared by the two authors of the paper and its critics. "This is a really fascinating pattern they observed, but it is a small message," said Timothy Rebbeck, a specialist in cancer prevention at the University of Pennsylvania. "It does not exclude the ability to prevent and treat cancer. It does not exclude our need to better understand the causes of cancer" bottom line of the paper was not simple, but the message was for me. The science is complex, and people care deeply about the biology of diseases that affect their families and themselves. Distillation history-with space constraints, with a clear desire to write that will hold readers' attention and help them understand-has risks for scientists and for journalists. They are the ones that I hope will never forget, even if I wrong now and again

Revised 2:53 p.m., 01.14.15 :. This story has been revised to remove references to unpublished letters to science.

Childhood neglect erodes the brain -

In perhaps the most famous study of neglect in childhood, the researchers monitored the progress, or lack of celui- one, in children who lived as infants in dark orphanages in Romania and are now teenagers. A new analysis now shows that these children, who have a variety of behavioral and cognitive problems, have less white matter in their brains that make a comparable group of children in local families. affected brain regions include the nerve bundles that support the attention of the general cognition, and processing of emotion. The work suggests that sensory deprivation early in life can have dramatic anatomical effects on the brain and may help explain the long-term negative effects previously documented behavior. But there is some good news possibilities: A small group of children who had been abducted orphanages and moved to shelters to 2 years seemed to bounce back, at least in brain structure

"This is an exciting and important. study, "says Harvard Medical School psychiatric researcher Martin Teicher, who runs the Biopsychiatry research program development at McLean Hospital in Belmont, Massachusetts. The "crucial question" of whether children can recover from the setback of early adversity has not been answered before, he added.

The work is based on MRI and other measures taken in Romania by researchers at the Bucharest Early Intervention Project (BEIP). The group, led by neurologist Charles Nelson of Harvard Medical School, was moved to action by the collapse of Nicolae Ceausescu regime in Romania in 1989, which had shunted tens of thousands of unwanted children in orphanages run by the state. Nelson said that guards in orphanages worked factorylike team; children could see as much as 17 different guards in a week. Infants rarely enjoyed the interactions one-on-one, which are considered essential to normal development.

Orphanages have sharply reduced their consumption today. But there's more than a decade, when they were still in favor of BEIP leaders saw a need for humanitarian assistance; they also saw a rare opportunity to study the effects of child neglect. Drawing mainly on the research funding from the US government, BEIP offered a limited number of children a chance to get out of orphanages in foster care, providing desperately needed attention. BEIP also worked with Romanian officials to recruit orphans and local children in clinical studies.

BEIP initially enrolled 136 children in research. Only 69 participated in the MRI study published online today in JAMA Pediatrics . Of these, 23 have been established in the group randomly assigned to foster care, 26 from a group assigned to remain in orphanages, and 20 of the local community, as witnesses. The lead author Johanna Bick, a clinical psychologist at Children's Hospital Boston, and colleagues in the BEIP group used an MRI imaging technique called diffusion tensor to watch 48 microstructural white matter tracts in each child, comparing the results at 2 and 8 years of age.

The analysis revealed that children who remain in orphanages were still worse off with the less mature development in four key sets of white matter. The most affected routes included neural circuits involved in cognitive overall performance, emotion, maintaining attention and executive function and sensory processing. Further analysis suggests that the foster care group was more like the community group in brain development, but this conclusion seems to be less robust.

Other non-randomized studies have reported broad cognitive deficits or reduced white matter in adults and some children who have suffered neglect or abuse in the past. They stressed "the same areas we find ourselves affected by the negligence of early life. These results and those of BEIP converge, "claims Bick.

More importantly, Bick said, compared with the children taken by adoptive parents suggests that the loss of white matter may be reversible. What worked in Romania to improve the brain development of children moving in an environment breadwinner could work elsewhere as a remedy for child neglect. "This has very important implications," she said. He suggests that the damage that occurs in a family setting may reversible, too

In a prepared statement, a psychiatric researcher Andrea Danese of King's College London has welcomed the study but noted that more research is needed to determine how these changes in the white matter are related to changes in behavior.

Bick agrees on this point. "What I'm really interested in the investigation right now," she said, "is whether the improvements [seen in the foster children’s white matter profiles] effectively support improvements in the security superior capabilities" such as IQ, the attention and control of emotion. BEIP plans to collect new neurological data this year Romanian orphans as they turn 16.

Related Content:

• "Experience of the zero parenting"

White House fleshes out Obama’s $215 million plan for precision medicine -

revealed the White House today a price tag and other details Precision Medicine Initiative announced in the State of President Barack Obama of the Union address last week. As expected, most of the $ 215 million proposed to launch the multi-agency initiative in fiscal 2016, which begins in October, will support the construction of a cohort of 1 million US volunteers to genomics and other research biomedical. Another part of the money will fund efforts to understand the genomes of cancer cells. (Click here for a fact sheet from the White House on the map and here for a National Cancer Institute [NCI] fact sheet.)

Precision medicine, a term for tailoring treatments to the constitution genetics, microbiome of an individual, and other factors, is "a game changer" that "has the potential to revolutionize the way we approach health in this country and ultimately the world," said Jo Handelsman, deputy director for science in the White House office of science policy and technology, in a call with reporters yesterday to discuss the initiative. The $ 215 million will be new money added to the budgets of agencies, not funds redirected from existing programs, says the National Institutes of Health (NIH) Director Francis Collins.

Like Science Insider previously reported, the centerpiece of the initiative funded by $ 130 million in 2016, is a longitudinal research cohort consists of at least 1 million volunteers. Such studies large cohort of both healthy people and patients who represent the general population, often called biobanks already-established in countries such as the UK and Japan.

The cohort of US will be assembled by connecting the existing cohort studies. There are at least 0, from the Framingham Heart Study to basic genetic and medical data of patients at Kaiser Permanente in Northern California, which may be invited to join, Collins said. The initiative can also recruit new volunteers to "fill the gaps" and ensure diversity, Collins said.

In addition to developing information such as electronic medical-records and analyzing the genomes of existing patients, the study may have participants wear devices to monitor their health and activities, as Fitbits. And in a departure from traditional cohort, patients will be actively involved in the design of the study and control the use of their data, officials said. (These characteristics make it "more of a biobank," said Collins.) A blue ribbon panel will plan the study, advised by the working groups and a firm compound, ethicists, and others are already forming watching protect privacy, Handelsman said.

another $ 70 million will go to genomics NCI NIH cancer. NCI is wound a 9-year project called the cancer genome Atlas who cataloged the mutations that appear to stimulate the growth of cancer cells, and has several ongoing trials to treat patients based on changes in their tumor. This area is "cutting edge precision medicine," said Collins ; many patients, such as people with breast cancer already receive genetic or other molecular tests to determine the best medication.

The new funds will enable the organization to expand the testing of genetically tailored treatments, explore the biology of cancer, and together a "knowledge network on cancer" to share this information with researchers and oncologists treating patients.

The Food and Drug Administration (FDA) will receive $ 10 million to hire experts to help assess the tests based on sequencing of large portions of the patient's genome, and build disease mutation databases, such as that used to examine two new tests for the genes for cystic fibrosis, said the FDA commissioner Margaret Hamburg.

another $ 5 million will go to the Office of the National Coordinator for Health Information Technology to develop ways to share and preserve the confidentiality of patient data safely.

President Obama is expected to unveil details of initiatives at 11 am ET today at the White House before an audience of researchers, pharmaceutical company executives and others. Congress must approve ultimately spending on the initiative, which will be part of the 2016 budget request the White House is expected to unveil Monday.

Click here to see all of our coverage of the 2016 budget

* Updated January 30 2:55 p.m. a statement that was falsely attributed to Dr. Collins has been corrected.

'Positive' results for Ebola drug upsets plans for trials -

Even researchers whose trial of a potential drug for Ebola made headlines last week worked hard to minimize the glare efficiency, it showed. "It is a weak signal in a non-randomized trial," Yves Levy, director of the French Institute of Health and Medical Research (INSERM) in Paris said Science on the data, which has not published INSERM. Low or not, the ratio The New York Times that favipiravir, a drug against the Japanese flu had halved mortality in a group of patients Ebola in Guinea was a piece of good news that complicates prospects for testing over other Ebola drugs.

the Guinean government has already announced that he wants to favipiravir to more people, and if the results hold for further review, they could force a change in the design of further clinical trials move on front. Meanwhile, the decline in new cases investigators revamping or even cancellation of tests at a time when manufacturers have finally enough material to test some of the most promising experimental drugs. The balance sheet of the epidemic checked last week, Guinea, Liberia and Sierra Leone-three countries counted 124 confirmed cases most affected, against 99 cases the previous week. As Bruce Aylward said the World Health Organization (WHO) at a press conference on 5 February: "The virus has told us this week, loud and clear:" I will not go the way you me expected. "Still, the figures represent a sharp drop in the height of the epidemic in September when there were more than 700 cases reported in one week in West Africa.

Last week, the Wellcome Trust, a charitable organization in the UK which funds several Ebola trials, announced that the trial of Liberian brincidofovir, antiviral developed by Chimerix Durham, North Carolina, would be canceled because the company withdrew its support. "It was quite a surprise to us and a bit of a mystery," said Peter Horby, a researcher at the University of Oxford in the United Kingdom who led the study. Chimerix said he made the decision after discussions with the US Food and Drug Administration (FDA), noting that the trial was also to have patients of difficulty recruiting. Horby said his group was planning to open a second test site in Sierra Leone, where the numbers are much higher. Luciana Borio FDA said Chimerix also refused the request of the agency to make public its correspondence with the company. Chimerix said he focused on the completion of drug trials treat other infections :. cytomegalovirus and adenovirus

Although a trial is canceled, others are about to move forward. Horby said his group hopes to begin evaluating an RNA inhibitor called TKM-Ebola soon. the drug, manufactured by Tekmira Pharmaceuticals in Burnaby, Canada, has worked in monkeys, but has been in short supply.

The test is about to begin on the zmapp antibody cocktail. Seen by many researchers as the best shot to treat Ebola due to promise monkey studies, zmapp was used in nine patients last summer before the company behind it, Mapp Biopharmaceutical of San Diego, California, announced he had no more supplies. Now the company says it has enough doses to begin a clinical trial in Liberia this week. But there may be too few patients in this country for the experimental drug to prove its value, says Clifford Lane, director of clinical research at the US National Institute of Allergy and Infectious Diseases, which launched the study in Monrovia with the Liberian Ministry of Health and welfare.

So far, Guinea and Sierra Leone, where the Ebola virus is still infecting dozens of people a week, declined invitations to join the study. Their main stumbling block is the test design. Zmapp will be the first Ebola treatment that will be tested in a randomized controlled trial. "I think that the only way to know if these drugs are safe and effective," says Lane.

The governments of Guinea and Sierra Leone as well as Doctors Without Borders, which operates centers Ebola in these countries were for ethical reasons reluctant to participate in treatment trials using a randomized design, controlled. Jeremy Farrar, director of the Wellcome Trust, also opposes the randomized controlled trial design for Ebola drugs given the high mortality rate of the disease. "given the data we have animals and individual patients, I would not be comfortable to be random," he said.

Lane notes that the trial may not need many participants: If the drug is 100% effective and Ebola kills 50% of people infected, he said, as little as 30 people will need to receive zmapp to see if it works. And even if there are not enough patients to provide a clear answer on efficiency, Lane says that scientists could still get valuable information by looking at parameters such as blood levels of Ebola virus in those treated with the drug and the control arm.

study favipiravir in Guinea illustrates the complexity to discern clear answers without robust control and difficulties in communicating. Test data are reviewed every 20 patients by an independent supervisory board. On January 26, they evaluated data from 80 patients. Because they have detected a signal of efficacy, they asked the researchers to share information with regulators in Guinea and France, said Levy. INSERM researchers do not make public their data up to February 25, at the Conference on Retroviruses and Opportunistic Infections in Seattle, Washington. "It is important to have a scientific debate about what these results really mean," said Levy, noting that the organizers of the meeting stressed the data under embargo. A researcher who had seen the data and asked not to be identified said Science favipiravir that did not help all patients treated with it at two test sites in Guinea. In a subset of trial participants who had low levels of Ebola virus in the blood, however, the mortality rate was only 15%. Among similar patients who entered centers earlier and did not receive favipiravir, mortality was 30%. Marie-Paule Kieny, Assistant Director-General of WHO, said it was difficult to make sense of the data at this stage. "You can say it means nothing or you can say that it is promising. More research is needed to know what happened."

Meanwhile, the study in Guinea continues and has enrolled more than 100 patients. "The end result can still be different," says Levy. But preliminary data have already led the Guinean authorities to increase the number of sites where favipiravir be used.

Further tests may be more difficult organize and interpret if favipiravir is widely distributed. a study testing the use of convalescent serum began in Guinea this week. "if there is a decision now to use favipiravir everywhere, what happens with this trial ? »Request Kieny. The zmapp trial may also be affected. This trial is designed to compare zmapp with the standard of care. "If the level of care changes, as is the control used in the trial," said Lane. But he did not see any results, he said. "The only information that I have seen in this study are what was in the New York Times "

* Ebola files. Since the Ebola current epidemic, unprecedented in terms of 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

* Correction February 13 11:05 :. This story refers to evil zmapp a trial, an Ebola antibody cocktail, as a placebo-controlled trial. as reports of history, zmapp will be tested in a trial which, for the first time, used a randomized control group. But the control group will receive a placebo. People in the control arm will receive the current standard of care, which comprises providing intravenous fluids, balancing electrolytes, maintaining the state of oxygen and blood pressure, and treating other infections if they occur.

Common ingredient in packaged food may trigger inflammatory disease -

The ingredients that give a stable smooth ice cream, chocolate bars and other packaged snacks can promote certain inflammatory diseases chronic. This is the claim of a new study, which finds increasing metabolic diseases and intestinal inflammation in mice fed two emulsifiers commonly used in processed foods. The authors are far from confirming the similar effects in humans, but they suggest that these ingredients cause damage by disrupting the barrier between the immune system and the microbiome-the collection of microbes that inhabit our bodies.

The finding, published online today in Nature is "credible and remarkable," says Karen Madsen, a microbiologist at the University of Alberta in Edmonton, Canada, who was not involved in the study. "It sends a clear message that the changes in our food supply are altering our microbiota and our health."

Gut microbes help us fight infection and resist to allergies, but there is one thing we do not want them to do. touch our intestinal mucosa "These trillion bugs have sort of got to be kept away from us," said Madsen. Normally, mucus layer separates the intestinal cells of the intestine bacteria. But if these bacteria reach the cells, they can stimulate the immune system and cause inflammation. This inflammation of the digestive tract out-of-control is the hallmark of the inflammatory bowel disease (IBD), which causes diarrhea, fatigue and abdominal pain. Chronic inflammation has also been associated with metabolic-a set of concomitant requirements syndrome, including obesity and high blood pressure, that increase the risk of heart disease and diabetes from one person.

Benoit Chassaing, a microbiologist at Georgia State University in Atlanta, wonders if such bacterial invasion could explain what he described as a "perfect correlation" between the increasing use of food additives in industrialized countries and the incidence of IBD. (The disease affects more than one million people in the United States and appears to be rising.) The work by other groups led Chassaing and his colleagues to focus on emulsifiers detergentlike-Coax compounds in a surface smooth, creamy mixture of the ingredients that might otherwise prefer to separate, as the milk fat and water in the ice cream. A 09 study found that carboxymethylcellulose emulsifier supply (CMC) in genetically engineered mice that were already predisposed to intestinal inflammation has led to excessive growth of bacteria in their small intestines and increased inflammation.

In the new work, researchers fed two common emulsifiers, CMC and polysorbate 80, both a strain of genetically susceptible mice and type mice wild-without genetic mutations that put them at increased risk of IBD or metabolic syndrome. Among the sensitive mouse, eat or drink emulsifiers for 12 weeks increased the risk of developing symptoms of colitis mouse model of intestinal inflammation seen in humans with IBD - 40 to 80% %. wild type mice do not develop colitis, but showed a low-grade inflammation in their intestines and several features of the metabolic syndrome: slight weight gain, increased body fat and food intake, and higher levels of blood sugar, which indicates poor regulation of glucose associated with diabetes.

How emulsifiers induce these changes is still uncertain, but the study offers some advice. microscopic imaging of the intestines has shown that the average distance between intestinal bacteria and intestinal cells was reduced by more than half; bacteria seemed to move toward the intestinal mucosa. And fed emulsifier mouse feces showed a greater number of bacteria known to digest and penetrate the mucus. The feces contain a microbiome also seemed more "pro-inflammatory", meaning more highly activated receptors bacteria that trigger inflammation but it is not yet clear that bacteria have that effect. The conclusion of Chassaing: Either emulsifiers damage the mucus layer directly, leaving vulnerable to bacteria, or change the composition of the microbiota, favoring mucus microbes penetrating

This is not at all surprising that these substances have a . effect on intestinal microbes, said Mia Phillipson, a physiologist at the University of Uppsala in Sweden, which studies the interactions of gut inflammation and mucus bacteria. All to be vegetarian to be born by Caesarean section may change the composition of our microbiome significantly, she notes. But relatively few studies to date have examined the effect of food additives on the microbiome in this level of detail. "I think we're just about to realize how important this is," she said. Regarding the implications in humans, Phillipson said it is too early to make general recommendations, but it suggests that people with IBD or a family history of the disease consider avoid these ingredients.

Chassaing, too, is careful not to throw these emulsifiers as the ultimate villain. "Of course, society has changed so dramatically in the last century ... and so many other factors were used in the foods that we can not really even know that the most important role we play." His group is preparing a more ambitious study comparing microbiomes of people who avoid completely emulsifiers for several weeks with those on a standard Western diet.