Health Meaning

Fires FDA warning shot at the Australian Vaccine Maker -

MELBOURNE, Australia- A warning letter from the Food and Drug Administration (FDA) to Australian vaccine manufacturer CSL Biotherapies has shaken confidence in the country's biotechnology superstar. The letter dated June 15 accuses CSL not properly investigate why its vaccine against influenza Fluvax last year caused a strongly higher rate of febrile convulsions in children under five. "There was no analysis of all critical parameters and critical processing steps to try to determine differences in the 2010 batch associated with adverse event reports compared to lots from previous seasons" the letter. The CSL letter has 15 days to respond to its concerns or risk losing its license to sell Fluvax the United States, where it is marketed under the name Afluria.

"We take very warning letter serious, "said Jeff Davies, executive vice president of CSL Biotherapies, in a prepared statement. "Our technical team is preparing more substantive detail about our corrective actions to meet the requirements of the FDA."

CSL Biotherapies is one of the best interpreters of biotechnology Australia, with 2010 revenues of $ 4.8 billion; Fluvax global sales were $ 130 million, including $ 56 million in the United States. After adverse reactions to the vaccine against influenza reported in 2010, the FDA sent inspectors in June to CSL manufacturing plant in Melbourne. After a second visit last March, the FDA issued its warning letter, which stated that the quality control unit of CSL had failed to "assume its responsibility to ensure the identity, strength, quality and the purity of your monovalent bulk of the flu and the final products of the drug. "

a recent study by Paul Armstrong at the Ministry of Health, Western Australia, and colleagues reported that the rate of seizures fever in young children was 3.3 per 1000 doses 0 times that reported in a study on the safety of vaccines against influenza in the United States. the same study found that febrile seizures were related to the CSL vaccine but not to similar such as vaccines Influvac and Vaxigrip.

in the June issue of the journal vaccine , Christopher Blyth at the University of Western Australia and colleagues found that Fluvax (but not other vaccines against influenza) have triggered the release of high levels of cytokines in isolated blood cells from children who had febrile seizures. Cytokines are natural immune system molecules that induce fever. Investigations by independent laboratories and CSL failed to determine why Fluvax appears strongly raise the cytokine levels.

According to the letter from the FDA, the CSL manufacturing methods hampered the ability to root out the cause of adverse effects. CSL vaccine prepared by killing the flu virus and divide. The degree of separation could influence how the vaccine triggers an immune response, said a vaccine against influenza expert who requested anonymity. But the FDA said the degree of separation has not been determined in the different lots. "You failed to determine the optimal separation conditions for new virus strains before the strains are used in the production," said the FDA's letter to CSL. The FDA also said that the release agent used to fragment the virus, sodium taurodeoxycholate (TDOC) had failed a test to confirm the identity of the chemical. Another criticism is that the FDA CSL failed to identify what the FDA calls "dark particles" in some vials. In addition, the FDA said that CSL failed to properly document its procedures for investigating why the vaccine caused the adverse reactions.

A spokesman said CSL Science Insider in an email that the investigations by the company and by the regulatory body of drugs in Australia, the Authority Therapeutic Goods (TGA), currently identified no contaminant in the manufacturing process. In addition, they stressed that although TDOC failed a first test, he spent a further test of his identity. "We hope to be able to draw conclusions [about the cause of the elevated rate of febrile convulsions] in the coming months and will be totally transparent about our results," wrote the CSL spokesman.

Concerns about Fluvax cause the anxiety in the community of biomedical research in Australia. "I've never been convinced by the cost-benefit equations for the vaccination of healthy people or children against the flu, but one of the things that I do not think that there was a problem with the manufacturing process, "says Peter Collignon, director of infectious diseases at the medical school of the Australian national University in Canberra. He says he is concerned that the FDA not TGA, broadcast for the first concerns about the vaccine. "This raises questions about the transparency of our own regulator," he said.

On June 21, TGA revealed that he had sent letters in May 2010 after five audits CSL reported problems ranging from "inadequate investigation" to "poor management of corrective and preventive actions", and cleaning "insufficient" and testing regimes. CSL Davies told the media that TGA was "fully aware" of the problems, but did not consider it appropriate to publish the correspondence with the regulator.

the FDA warning letter raises the stakes. It "means that they will be doing things rather quickly or they will not make these more vaccine," says Collignon. "If you can not market in the United States because it is not enough safe, then it will not be very satisfactory for Australia either."

Magnetic nanoparticles Fry Tumors -

Any parent fretting about the fever of a child knows that temperatures a few degrees above normal can kill. But cancer researchers have now found a way to cure high temperatures. In a new study, a team found that injecting mice with tiny magnets and start up the heat eliminated tumors in animal body, without apparent side effects.

The idea of ​​killing the cancer with heat is not new. Researchers know that, like normal cells, cancer cells start to die when the mercury rises above 43˚C. The trick is how to kill the cancer without damaging the cells of the body. A promising idea, known as magnetic hyperthermia, involves injecting "nanoparticles" essentially tiny microscopic bits of iron oxide or other compounds in tumors to make them magnetic. The patient is placed in a magnetic field that changes direction thousands of times per second. Magnetic nanoparticles are excited by the applied field and start to get hot, heating and potentially destroy the tissue surrounding cancer. Because the healthy tissue is not altered by the magnetic field, it does not heat and are not damaged.

But the therapy has not yet made its way to the clinic, with only one trial reported in humans (with limited success). This is largely because conventional nanoparticles interact weakly with the applied field, so a large dose quite is required to generate sufficient heat to damage the tumor. Although nanoparticles are not particularly toxic in large quantities, they can trigger the body's immune system to attack, causing allergic reactions.

Nanoscientist Cheon Jinwoo of Yonsei University in Seoul and colleagues set out to create a nanoparticle that would get hotter than traditional nanoparticle so not much would need to be injected into the body. They nanoparticles in two layers, each containing a core of a magnetic mineral within an envelope of another. Due to an interaction between the two esoteric mineral, called exchange coupling, these nanoparticles "core-shell" interacted more strongly with the magnetic field to traditional nanoparticles and released 10 times more heat. This means that we would need to give only 10% of the initial dose for patients to achieve the same degree of hyperthermia with conventional nanoparticles.

The team tested the technique on three mice whose abdomens had been grafted with human brain cancer cells. The researchers injected tumors with core-shell nanoparticles and placed mice in a coil of wire (see illustration). They are focused on an alternating current in the coil, creating a magnetic alternating field. While researchers are not able to measure the exact temperature inside tumors, their estimates range between 43˚ and 48C. After 10 minutes, the team removed the mouse from the coil and monitoring of tumors for the next 4 weeks.

All traces of cancer have disappeared from the mice without apparent side effects, the team reported online June 26 in Nature Nanotechnology . For comparison, another group of mice were treated instead with a single dose of doxorubicin, a traditional anticancer drug. Although initially shrunk some tumors, they pushed to four times their original size at the end of the trial. The heat treatment after injection of traditional nanoparticles of iron oxide had no significant effect on the tumors.

Nanoengineer Naomi Halas of Rice University in Houston, Texas, is impressed. "This group has solved the key impasse that has stopped the development of magnetic nanotherapies, that is, the poor response of the nanoparticle to the applied magnetic field," she said. "I am so happy that many of these types of hyperthermic therapies based on nanoparticles are developed to increase the arsenal of weapons against cancer."

How Blasts injure the brain -

By some estimates, more than 300,000 US troops have suffered traumatic brain injury (TBI) in the current wars in Iraq and Afghanistan. Most of these injuries resulted from roadside bomb blasts and other explosives planted by insurgents. Lack of knowledge on how an explosive blast injures the brain has hampered efforts to treat those injuries. Now, two studies provide a potentially important insight, showing a mechanism that has not been taken into consideration.

The lead author of the study, bioengineer at Harvard University Kevin Kit Parker, said he had an interest in research. Parker moved his heart of attention to research on the brain after two tours in Afghanistan as a US Army infantry officer. "I saw some friends of mine get hit and thought," Okay, I'll take a look at this and see if I can get an angle on it. ""

Back at Harvard, Parker and his laboratory has designed a breath simulator for the cells. In a study published today in PLoS ONE , the researchers grew rat neurons in a culture dish, then joined an elastic polymer sheet. A high-precision motor gave a carefully calibrated to tug the sheet post neurons Parker mechanical forces calculated to be comparable to those produced by an explosion.

Through a microscope, the researchers found that the "explosion" caused swelling, rupture, and other signs of injury to axons and dendrites of neurons slender that send and receive signals from other neurons. A series of biochemical experiments found that the mechanical strength of disturbed proteins called integrins that help anchor cells to the protein scaffold that surrounds them. Integrins play a role in a wide range of biochemical signaling pathways, but Parker's team identified a particular channel which appears to play a role in injury to axons. A drug that blocks a component of this cascade called Rho kinase reduces damage to axons.

This result is intriguing given the recent results from damage to the white matter of the brain, which is composed of axons, Iraq veterans injured in the blasts, said Parker. Still, he warned that much more work is needed to see if these culture dish results are relevant to what happens in the brain of a soldier exposed to a blast. "It would be inappropriate to extrapolate from a flat head to a guy," says Parker.

A second document of the group Parker, published last week in the Proceedings of the national Academy of sciences , suggests that the same integrin signaling mechanism may contribute to vasospasm, another damaging process associated with TBI. in experiments with muscle cells in the wall of blood vessels, the researchers found that a sudden mechanical force returns a genetic switch in these cells, making them more likely to contract. this contraction would choke the blood supply wherever it occurs in the brain and aggravate an injury starving brain tissue of oxygen, said Parker.

"They duplicated in vitro a finding that was confusing for clinicians," says Jack Tsao, a neurologist and neuroscientist at the Uniformed Services University of science health in Bethesda, Maryland. Vasospasm usually results after a blow to the cause of the bleeding head in the space between the brain and the thin tissues that surround it. But in many troops with TBI shots, clinicians see the stroke symptoms as indicative of vasospasm, even when brain scans show no signs of bleeding. The new results provide a possible explanation for how this could happen, says Tsao.

"These are two very stylish documents," said David Hovda, a neuroscientist and director of the Brain Injury Research Center at the University of California, Los Angeles. Most research on the mechanisms of TBI focused on neurochemical changes on the wound site, such as metabolic alterations and ion imbalances within neurons, he said. But the new findings suggest a mechanism that has not been taken into consideration. The idea that integrins may play a role makes much sense and raises interesting possibilities for the treatment of TBI or minimize its effects with drugs given prophylactically, he said.

Hovda said he sees no reason why these mechanisms do not contribute to other types of brain damage also from car accidents to shaken baby syndrome. "I do not think it's specific to explosion."

Mass Exodus roils Brazilian Neuroscience Institute -

A rebellion in the ranks scientists created some recent turmoil at the famous research center on the brain of Brazil, the International Institute of Edmond and Lily Safra of Neuroscience of Natal (ELS-SSEETT). Since late July, 10 principal investigators closed their laboratories at the center, which opened its doors in 05 under the leadership of Brazilian neuroscientist Miguel Nicolelis. An ambitious project to build an institute of world-class neuroscience in the northeast poor region of the country, ELS-SSEETT garnered praise for its socially conscious mission to promote economic development and has been cited as an example of booming Brazil's research enterprise.

The defectors include a co-founder of the institute, Sidarta Ribeiro, a former postdoctoral fellow with Nicolelis. In total, over 100 people have left, Ribeiro said, including students, postdocs and technicians. Frustrated by what they describe as management problems that have hindered access to equipment and facilities, the group decided to form their own institute, which will be directed by Ribeiro to the proximity of the Federal University of Rio Grande do Norte, which will fund the effort. Previously, researchers had all appointments at the Federal University, which paid their salaries and some of their operational costs, but maintained laboratories ELS-SSEETT. This situation has become untenable, Ribeiro said, because of disagreements on how to manage the installations. The new institute is funded by the university, with resources from the Ministry of Education.

Questions was that decisions that affected the operation of laboratories daily often had to go through the private foundation in São Paulo which administers ELS-SSEETT, or Nicolelis, who runs a lab at Duke University in Durham, North Carolina. "We believe that local problems must be solved by local scientists," Ribeiro said.

"It is unfortunate, but it is their decision," said Nicolelis. He noted that those who left are mostly Brazilian young scientists who have been trained in public institutions in the US and Europe. "They are not used to do science in a private institute with regulations and standards. As an organization nonprofit in Brazil, we have to follow a lot of rules," says Nicolelis. He defends rules that defectors are expensive, saying that compliance is required by the various ministries that enable the Institute to function. in return, the recruits ELS-SSEETT got 70% of their operational costs paid with private funds, access to equipment and technical support, plus R $ 500,000 (approximately $ 315,000) in seed money for their laboratories, an unknown advantage in Brazil, Nicolelis said. "They received things that nobody in Brazil n ' has ever received. "

Nicolelis insists departures will not have a serious impact on ELS-SSEETT. The heart of the development of the institute is on systems and Translational Neuroscience, including the development of treatments for diseases and spinal cord injuries Parkinson's, and most of those who left did research in other fields. Nicolelis said seven main researchers remain SSEETT, and the institute is actively recruiting other five.

Advocacy for impact assessments of health -

In 07, the developers of a senior-housing project planned in Oakland, California, decided to move the entrance 'adjacent to a busy road in a quiet Court. The change would make it safer for residents as they walked to and from home. The idea, from a group based in Oakland called Human Impact Partners, sent a small but important health problem that might otherwise have been ignored.

A report released yesterday by the National Research Council National Academies of Canada (NRC) provides a ringing endorsement of these efforts, called an assessment of the health impact (EIS). The report not only provides guidelines for conducting these analyzes, but also argues for their value on both public and private construction projects, from urban farmers markets to federal highways.

"I think there is a real need to incorporate impact assessments on health in future decisions of multiple layers of our society, starting with the US government on the bottom "said Richard Jackson of the University of California, Los Angeles, who chaired the NRC Committee on the evaluation of the impact on health. The first report in the US was born from a 1999 proposal to boost the minimum paid salaried workers employed by contractors hired by the city of San Francisco. In 06, state lawmakers Washington has authorized the State Council of Health to conduct similar reports to EIS, although the funding of these reports has since been cut, said Gordon MacCracken, spokesman for advice.

The panel's report recommends that each HIA should start with a basic health assessment in a given community. In the case of the proposed Oakland housing, it could mean the collection of data on accidents involving pedestrians elderly. Planners would then estimate, through community surveys and epidemiological data, the way the project is likely to affect this basis.

Lili Farhang, associate director of Human Impact Partners, said she supports efforts to bring EIS in the projector. But she recognizes that EIS may seem "faddish" outside. "People just want to know," How do you do? and "How do you do well? "She said.

The biggest EIS face obstacle may be the status quo, although the report notes that federal laws may already meet them. The National Environmental Policy Act of the United States (NEPA) requires that federal agencies to conduct environmental impact assessments on threats or boons to "the quality of the human environment" as well as the natural environment. This requirement is largely forgotten, said committee member of Aaron Wernham, director of the project impact on health, a joint venture of the Pew Charitable Trusts and the Robert Wood Johnson Foundation, which helped pay for the study. He said the problem is often that particular mission agencies lack expertise to explore the health consequences of their actions. "health must be at the table," says Wernham.

However, some experts expressed reservations about rolling EIS in the process NEPA. "the people fear that the impact assessments on health do not become too bureaucratic and not another box that is checked in a process, "says Wernham.

Howard Frumkin, dean of the School of Public Health at the University of Washington, Seattle, sees the NEPA process as an "appropriate framework" for some EIS. In 07, Wernham and his colleagues did just that when they examined the health consequences of leasing land in the North Slope of Alaska developers of oil and gas. This HIA, in collaboration with other environmental assessments under NEPA, made several proposals on factors ranging from pollution monitoring of the management of herds of caribou for subsistence populations, many of which were then accepted by the Bureau of Land Management US. "I do not think anyone is in serious disagreement with the idea that we should make the policies as beneficial to health as possible," Frumkin said.

Economic realities, however, can prevent EIS to spread throughout the federal government. An organization like the Department of the US Forest would probably need a partnership with the US Centers for Disease Control and Prevention (CDC), who co-sponsored the NRC report, said Frumkin. But CDC was "very hard hit," financially, said Frumkin, who previously ran a center at CDC.

CDC spends money to train local governments in the EIS drivers, said Federico Feldstein, a spokesman for the agency. "the role of CDC in the NEPA process is currently under consideration," adds Feldstein. "as part of this process, CDC leadership opportunities are explored."

Senate Panel Trims NIH budget to $ 10 million -

A panel of the Senate today approved a 2012 bill spending slightly reduce the National Institutes of Health budget ( NIH), the cutting of $ 10 million to $ 30.5 billion. The bill would also make a priority of director Francis Collins NIH creating a new center dedicated to the translation of basic discoveries in treatment.

biomedical research lobbyists say that overall fiscal pressure data, they feel pleased that the NIH has received an essentially flat funding. "In the current environment, it could have been worse," says Jennifer Zeitzer, director of legislative relations for the Federation of American Societies for Experimental Biology in Washington, DC

When creating a new center National advancing translational sciences (NCATS) Bill also abolishes the National research Center Resources-completion of a major reorganization of the 27 institutes and centers of the NIH proposed by the NIH that was very controversial. NCATS is one of several initiatives in the bill "will leverage systemic change," according to Senator Tom Harkin (D-IA), chairman of the Senate subcommittee credits on labor, health and human services (HHS), and education.

in NCATS, the bill contains $ 20 million for the Cures acceleration network, a program created last year by law to reform health care has not yet received funding. It will focus on the provision of subsidies to develop "high need cures" that are not far enough to be picked up by companies, according to a press release from the Senate Appropriations Committee.

The full committee will vote on the bill tomorrow, how much more detailed numbers are available.

The House of Representatives corresponding appropriations subcommittee scheduled to approve the bill labor / HHS last week, but could not reach agreement and abandoned the effort, Harkin said. Instead, the two chambers should forge a so-called omnibus appropriations bill that rolls finance many government agencies into a single bill. The brand of the Senate for NIH could give lawmakers a starting point for NIH funding level in the omnibus bill.

The 2012 fiscal year begins on October 1, but lawmakers will not make this deadline for approving new credits. Instead, they are expected to approve a continuing resolution that funds organizations at 1.4% below 2011 levels to 18 November, how Congress could extend the resolution continues or approve the omnibus bill.

Chronic Fatigue Syndrome Researcher Fired middle controversial New -

Judy Mikovits had some rough weeks. September 22, Scienc he posted online a new laboratory study widely considered the last blow to the theory, defended by Mikovits and colleagues in 09 Science paper October, which recently detected mouse retrovirus might play a causal role in chronic fatigue syndrome (CFS). A letter in the same issue of Science of one of the laboratories contributing to the 09 report revealed that the contamination had marred his contribution detection-PCR and sequencing mouse virus, dubbed XMRV. Mikovits and colleagues have defended the validity of the remainder of the study, known as the Lombardi et al ., Which detected the virus by several other methods, so Science has issued a rare partial withdrawal of the original article.

Then on September 29, Mikovits was fired from his post as research director of the Whittemore Peterson Institute for Neuro-Immune Disease (WPI), a private organization in Reno, Nevada, dedicated to research and the treatment of CFS. Both Mikovits and CEO of WPI, Annette Whittemore, say the shooting was not related to the disappearance of the theory of XMRV.

The next day a graduate student who wrote a sarcastic blog that was critical of Mikovits and XMRV theory raised questions about whether a figure in Lombardi et al . had been distorted. Science Editor Monica Bradford said in a statement that the review examines the allegation. "As our policy in cases of alleged manipulation figure, we follow with the authors of the research from our own review of the claim is over," said Bradford. " Science takes these matters seriously and seeks to answer fully and effectively."

Fury turns around an image of the lower half of Figure 2C in Lombardi et al .- shows that XMRV proteins CFS patients but not healthy controls . In known as VRE (endogenous retroviruses) blog, Abbie Smith September 30 noted the striking similarities between 2C and Mikovits slide presented at a meeting of the CSA in Ottawa, Canada, September 23. Smith, who is working on his doctoral thesis at the University of Oklahoma, Oklahoma City, and HIV studies, wrote an anonymous informant had reported to her that the two identical pictures looked, but had a different number of patients and experimental conditions. Smith asked if this was a simple mistake or an attempt to recycle the old data to a new argument.

The slide Ottawa supports the thesis that although Mikovits XMRV could not be detected in CFS patients, and others roamed gammaretroviruses their chromosomes. Mikovits describes how it treated cells two CFS patients with chemical 5-azacytidine, which takes methyl groups of the DNA. This procedure prods cells that harbor latent versions of retroviruses to produce them, and the image on the slide shows the protein resulting in what is known as a Western blot gel. In Lombardi et al . what appears to be the same image shows "XMRV protein" and makes no mention of 5-azacytidine use.

Mikovits collaborator, Francis Ruscetti of the National Cancer Institute (NCI) in Frederick, Maryland, who ran all Western blots, confirmed that the slide Ottawa uses the same image that appears in Lombardi et al . Ruscetti and Mikovits, in a joint email to Science for this article, said many patients and their doctors, Daniel Peterson (who has since had a falling out with WPI), knew the original coded numbers so the researchers changed them for publication science "to protect patient privacy." Ruscetti said it was a mistake for Mikovits have used the codes from the original patients in Ottawa. " We were under so much pressure, we missed, "said Ruscetti.

regarding the use of 5-azacytidine, and Ruscetti Mikovits said in their email that" there was no attempt in the original document to hide anything. " They say the purpose of Lombardi et al , the use of 5-azacytidine was not germane. They were simply trying to show that CFS patients had viral proteins not seen in controls. At the time of the Ottawa meeting, they say they have realized that this experience does not actually show XMRV proteins but a larger family gammaretroviruses.

After Lombardi et al . appeared, several laboratories have reported that they could not detect XMRV in CFS patients. But Ruscetti Mikovits and noted that most of these studies relied polymerase chain reaction, which used DNA sequences of XMRV to fish pieces of the virus from blood samples. These tests, they point out, have missed other gammaretroviruses with different sequences. The Western blot test they used in Lombardi et al . so happened to cast a wider net that discovered the protein of any member of the family gammaretrovirus. Moreover, they say, the use of 5-azacytidine said these infections would be missed in routine testing, because these viruses often exist in a latent state.

On the blog of VRE, Smith and others have also argued that the study lacked appropriate controls: healthy controls in this experiment are not 5-azacytidine added to their samples. "My [principal investigator] say," Why did you run this gel? if I gave him, "wrote Smith.

Vinay Pathak, a retrovirologist the NCI who earlier damaged the XMRV theory / CFS with a study published in Science who documented how the virus was created accidentally in experiments laboratory, said he was "perplexed" by Ruscetti of and explanations about Mikovits Figure 2C. "If [5-azacytidine] was used in the original experiment, it is clearly wrong to leave him out of the Science paper, "says Pathak. "It makes a difference how I interpret the results."

Jonathan Stoye, a retrovirologist who once supported the XMRV / CFS hypothesis, but then changed his mind after his own studies have failed to replicate the finding, said its time to retract Lombardi et al . in its entirety. "I think there is a point where Science has to say, there is no substance to this document," said Stoye. "It was published with a message, and that message is party. "

neither Lombardi et al . or questions on the slides were mentioned in September 30 letter from Whittemore end formally the contract Mikovits, sent the day after the two had a heated telephone conversation. In this letter, Whittemore asked its high profile researcher to be "insubordinate and insolent." Mikovits was immediately locked out of his laboratory.

Three letters between Whittemore and Mikovits say the articulated shooting that Mikovits spend on a cell line that was sent to Vincent Lombardi, the first author of 09 Science paper in October that directs UNEVX (formerly known as VIPDx), a diagnostic laboratory belonging to WPI. Until recently, the laboratory has sold a test for XMRV and related viruses.

In a written response to October 1 Whittemore, Mikovits argued that it was "entirely appropriate" for her as director of research, not to Lombardi cell line. The line cell was not linked to studies on gammaretroviruses but Lombardi wanted to use for experiments related to a grant Mikovits had obtained US National Institutes of Health to study the possible causes of CFS. Mikovits argued that Lombardi " would not take my direction "and should not be undertaken a new project," while neglecting other duties. "She also questioned its ability to carry out this experiment.

Annette Whittemore issued a statement Science in which it strongly defended the performance of Lombardi. "Dr. Lombardi is a valuable and important part of our team, and conducts research accordingly, "says Whittemore." While personnel matters are generally confidential, statements made by Judy Mikovits are false, baseless and those of a disgruntled former employee. "

in an interview with Science Mikovits argued that his shot was also linked to a long battle of the decision WPI sell by VIPDx / UNEVX, a test for human gammaretroviruses. the laboratory began offering the tests, which cost about $ 500, soon after Lombardi et al . reported a link between XMRV and CFS. Some patients tested positive continued to take antiretroviral drugs, "I said," No, no, no, no. "says test Mikovits" I asked them for the better part of two years to show me that what we have in Lombardi. et al . The same thing they sell to patients. "

The issue came to a head with the recent publication by Science study of new laboratory. The Working Group blood is called, which included laboratories managed by Mikovits and Ruscetti, failed to find XMRV reliably or other gammaretroviruses in blind samples from people who had previously tested positive for the virus. both Mikovits Ruscetti and co-author of the paper, which invalidated their own tests for XMRV. WPI said UNEVX stopped offering diagnostic tests, but did not give details on the timing or the reasons.

Whittemore, which refers to CFS as myalgic encephalomyelitis (ME) -a common name for CSA in Europe stressed that the Institute remains dedicated to human gammaretroviruses study "ME and related diseases" and that person there "would never put personal interest before the search or find the causes of ME."

Mikovits, who said she currently does not have access to his laboratory notebooks, is looking for another institution to continue its work.

With reporting by Martin Enserink .

Mummy In The oldest case of prostate cancer in ancient Egypt -

There are some 2250 years in Egypt, a man known only today that M1 has struggled with a long, painful, progressive disease. A dull pain throbbed in the lower back, then spread to other parts of his body, making most movements a misery. When M1 finally succumbed to the mysterious disease between the ages of 51 and 60, his family paid for him to be mummified so that he can be reborn and enjoy the pleasures of the afterlife.

Now, an international research team has diagnosed that ailed M1: the oldest known case of prostate cancer in ancient Egypt and the second oldest event in the world. (The first diagnosis of prostate cancer came from the 2700-year-old skeleton of a Scythian king in Russia.) In addition, the new study currently in press in the International Journal of Paleopathology suggests that previous investigators may have underestimated the prevalence of cancer in ancient populations, because high-resolution computed tomography (CT) scan can find tumors only 1 to 2 millimeters in diameter only became available in 05. "I think previous researchers probably missed a lot without this technology, "says team leader Carlos Prates, a radiologist in private practice in Imagens médicas Integradas in Lisbon.

prostate cancer starts in the prostate gland size of a walnut, a part of the male reproductive system. the gland produces a milky fluid that forms part of semen and is located below the bladder of a man. in the case of aggression of the disease, cancerous prostate cells can metastasize or spread through the bloodstream and invade the bone. After performing high resolution analysis of three Egyptian mummies in the collection of the National Archaeological Museum in Lisbon, Prates and colleagues detected many small, round, dense tumors in the M1 tank and the lumbar spine, as well as in his arms and upper leg bones. These are the most commonly affected by metastatic prostate areas. "We could not find evidence to challenge this diagnosis," Prates said.

"I agree that it is a case of metastatic prostate cancer," said Andreas Nerlich, a pathologist at the Munich-Bogenhausen University Hospital in Germany, which was not involved in the research project. "This study is very well done."

Researchers have long struggled to detect signs of cancer in the skeletons and mummified flesh of the former death. But registered cancer cases in older populations are rare . Indeed, a study published in 1998 Journal of Paleopathology calculated that only 176 cases of malignant bone tumors have been reported in tens of thousands of ancient human reviewed. the small number of cases caused a theory that the cancer has started flourishing in the modern industrial era, when carcinogens became more prevalent in foods and in the environment and when people began to live longer, giving tumors more time to grow and proliferate.

But ancient populations, says Albert Zink, a biological anthropologist at the Institute for Mummies and the Iceman in Bolzano, Italy, were no strangers to carcinogens. Soot from fireplaces and wood burning fireplaces, for example, contains substances known to cause cancer in humans. And bitumen that ancient boat builders heated to seal and waterproof ships has been linked to lung cancer and tumors in the respiratory and digestive tracts. "I think the cancer was widespread in the past," says Zink, "more widespread than we could see."

But this could change, Prates said that physical anthropologists have access to the new generation of high resolution scanners. The equipment that Prates and his colleagues used to study M1, for example, has a resolution of 0.33 mm pixels, which allows radiologists to visualize lesions fleck same size.

For scientists studying the origins of cancer and the complex interaction of environmental, food and genes on the prevalence of the disease, such as improving the detection could shed light new about a disease that has struck humanity for thousands of years, if not more. "And of course, there is always the hope that achieving a better understanding of cancer roots will contribute in some way to a cure," says Zink.

Bails Out of Geron stem cell -

Geron, the company that helped pioneer research embryonic stem (hES) of human cells, said yesterday that it stops its first-in -the-world clinical trial and pulling further work on stem cells. The company, based in Menlo Park, California, will instead focus on its cancer therapies, CEO John Scarlett said in a statement. "Deciding to leave the company on stem cells was a very difficult decision," he told investors and reporters this morning.

Geron helped finance the work of James Thomson at the University of Wisconsin, Madison, who in 1998 was the first to isolate hES cells. The agreement gave the company exclusive licenses for a number of hES cell patents. Last year, he launched the first clinical trial in the world, was designed to treat eight patients with spinal cord using neuronal cells derived from hES cells. Four have been treated so far, and Geron says it will continue to follow them. However, it will not enroll new patients ,. The company returned a $ 6.5 million loan from the California Institute for Regenerative Medicine (CIRM), an organization funded by taxpayers set up to support research on stem cells, in particular hES cells. CIRM agreed earlier this year to pay Geron up to $ 25 million to finance the trial.

Scarlett, who joined the company in late September, said the decision enables Geron to continue to operate without raising new funds for the next year and a half when he awaits the results of a half dozen phase II trials of two drugs against cancer. As part of the downsizing on stem cells, the company will reduce by 66 full-time positions, 38% of its workforce.

Stephen Kelsey, medical director of Geron, told the conference that patients to date have shown no significant side effects or no improvement in their condition. Given the small scale of the study, he said, early cessation may not be such a loss. "We requested and received permission to run a very small safety study with a low dose of cells," he said. "We are half-way, and the data were remarkably consistent. We will be presenting the results, and it will be a fair reflection of what would have happened if we had completed the study. "

Some observers have expressed reservations about the trial from the beginning, worrying that animal results are not strong enough to justify a human trial. But many were pulling for the company all the same. "It is with a sense of loss that I see this news," said Roger Pedersen of the University of Cambridge, UK, who was one of the researchers receive funding from Geron in mid-190 to try to obtain hES cells. He said the company can respond not only to the long timeline to bring cell therapies to the clinic, but also a possible weakening of its intellectual property portfolio. the development of induced pluripotent stem (iPS) cells, which are adult cells reprogrammed genetically to resemble those embryonic, meaning that exclusive licenses Geron can worth less. "The progress in the field of stem cells are disruptive innovations that have the potential to supercede previous innovations, hES cells being one of them. I do not know if Geron looks that way, but I do" said Pedersen.

Neuroscience courtroom Not Ready for Prime Time -

LONDON -The tantalizing prospect of using a brain scan to determine whether a witness is lying, or genetic analysis to determine if a murder suspect is predisposed to commit violent crimes, are premature and unrealistic, according to a new report on neuroscience and the law presented today by the Royal Society of the UK. But neuroscientists may be able to provide evidence to determine if head injuries are accidental, and if a violent offender is likely to strike again.

As advances in neuroscience, it is easy to see why lawyers are tempted to put its stake tools on behalf of their clients, say the authors. "Neuroscience is committed to understanding the behavior and the law is involved in the regulation of behavior," experimental psychologist Nicholas Mackintosh, University of Cambridge, who led the working group of the Royal Society on neuroscience and the law during a press conference last week. Although it is not known whether the lawyers have made mental health reports or brain imaging in courtrooms in the United Kingdom as evidence, mental health is used as a defense 0 times per year in the US, the report noted, especially in murder trial where the defendant can get the death penalty.

A useful application of neuroscience in the courtroom would be the ability to detect lies using functional magnetic resonance imaging (fMRI). But at best, Mackintosh said, as the imaging may be able to detect deliberate lies; it would be useless if a witness really believed he was telling the truth. This limitation has not stopped at least two US-based companies to market such sensors lies, however, and "we take a singularly skeptical view of this," said Mackintosh. "Neuroscience, though promising, is very young."

legal expert Roger Brownsword of King's College London warned that as forensic DNA evidence, neuroscientific evidence could be subject to "easy translations" by juries of lay people or the media. "Perceptions of jurors could be quite dangerous unless they have been tutored in what science is," he said. Juries, for example, might be too impressed with the brain images presented in the courtroom if they do not understand their limitations.

the authors recommended that law schools and judicial systems do more to build "bridges" between scientists and those involved in the act. UK law schools for example, could offer courses on neuroscience as some American law schools such as Yale University are already doing.

One area where Mackintosh said neuroscience holds the potential to provide "tangible evidence" is in the area of ​​risk assessment. determine which criminals are released, are likely to reoffend for example, a gene that encodes monoamine oxidase ( MAOA ) was introduced as the "gene of violence" because many violent criminals who were abused as children have a form of the gene. Although other genes and environmental factors are certainly involved, Mackintosh said: "If this gene even slightly increases the probability of recurrence, whereas that risk assessment is all about," he said. " it is at least something worth thinking about. "still, he noted," the risk assessment is a risky business and is notoriously inaccurate. "

Most neuroscientists and the Royal Society, however, rejects the idea that "having a psychopathic brain" is a general defense against criminal charges. "It does not require you to behave in a criminal way," said Mackintosh.

Another issue discussed report is the age at which children should be held fully accountable for crimes. In Britain, the age of criminal responsibility is 10 years, one of the lowest in the world. This young age has been controversial in the past, in particular in several cases of recent murders involving children, and more recently the wave of riots in August Although the Royal Society took no position on what should be the age, Mackintosh said "Science certainly suggests that the brain 10 years is immature in many ways. It also suggests that it is huge individual variation "and that therefore, other factors must be considered. Perhaps, he added, "it should not be an arbitrary age limit for criminal responsibility."

Other ways in which neuroscience might be closer to bear fruit in the courtroom is to determine whether the head injury of a baby is accidental or the result of shaken baby syndrome Mackintosh said. Pathologists are more or less agree on which symptoms constitute evidence of shaking a baby over 6 months, but it is controversial whether these criteria can diagnose abuse in young infants. Researchers are also studying whether brain scans could one day be used to determine if the amount of pain a person is reporting arises, or if the person is faking in order to obtain government benefits. Mackintosh warnings reported pain does not always correlate with the actual extent of injury and many other mental phenomena come in.

Penn Institute Investigator Sues Prominent More Discoveries, seeking $ 1 billion -

The President of Memorial Sloan Kettering Cancer Center in New York City Craig Thompson received a packet unpleasant vacation: A $ 1 billion lawsuit by the cancer center, he used to head. The Leonard and Madlyn Abramson Family Cancer Research Institute, part of the Abramson Cancer Center of the University of Pennsylvania, alleges that Thompson, a prominent researcher who worked at the institute for 12 years, hiding his involvement with a biotech company. The lawsuit claims that when confronted, Thompson led the institute to believe that he has no intellectual property rights on discoveries now in dispute, rights which he says he has. Co-defendants in the trial are a Thompson helped shape society, Agios Pharmaceuticals of Cambridge, Massachusetts, and Celgene Corporation of Summit, New Jersey. Celgene has recently strengthened its investment in Agios $ 150 million.

Lawyers for both parties were tight-lipped. Through his lawyer, Thompson declined to comment beyond the release of the following statement: "The allegations in this lawsuit are baseless and without merit It is unfortunate that the Abramson Family Cancer Research Institute has chosen to. go this route. "

Clifford David Burger, a lawyer with Robinson Brog Leinwand Greene Genovese and Gluck representing the Abramson institute, said that "I can not develop in a telephone conversation the facts alleged in the complaint." The document, he believes, "the story."

in a complaint filed 13 pages December 13 with the US District Court, Southern District of New York, the Institute describes Thompson as "an unscrupulous doctor "who" chose to abscond with the fruits of the Abramson largess. "the Abramson Cancer Center was renamed in 02 after the Abramson family donated over $ 100 million, adding that the money be used for research and treatment of cancer and that the institute has all or some of the discoveries have been made there. Thompson became the founding scientific Director of the research Institute of the Abramson family cancer in 1999 and in 06 took the head of the Abramson Cancer Center.

The complaint said that Thompson had first come on the possibility that he would form a company based on his work in the metabolism of cancer cells. Among other things, in 07, he said his work suggested that metformin diabetes drug could reduce the risk of cancer. But the complaint continues, it does not alert the institute when he helped start a company in August 07, which was later renamed Agios Pharmaceuticals.

However, the trial did not specify that Agios was deliberately concealed the fact that Thompson was a co-founder. In 09, the complaint notes, the company has publicly stated that Thompson was one of three founders. Seeking press releases Agios also found that the first set by the company in 08 the list Thompson as co-founder.

But the complaint alleges that Abramson did not know it at the time. In October 2011, it was reported publicly as $ Celgene invested $ 20 million in Agios above 130 million invested in April 2010. The April 2010 Agios press release announcing the agreement did not name Thompson as co-founder, the suit said.

"Because of the concealment of Mr. Thompson, the Institute has not learned from Dr. Thompson's participation in Agios until the end of 2011," the complaint bed The university asked Thompson "if its association with Agios was a matter within the jurisdiction of the University Centre for Technology Transfer." Thompson said no, according to the complaint.

The Institute of Cancer Abramson argues that Thompson "knowingly misrepresented in Agios and Celgene it had the property of all the work financed in whole or in part by the Institute related to the platform research on cancer metabolism. "Although the damage is difficult to calculate, the institute said they are" estimated at more than $ 1 billion in the end. "

Thompson took a leave of Abramson there about a year to start his position as President and CEO at Sloan-Kettering and formally Abramson left at the end of October this year. He remains chairman of the scientific advisory board of Agios, according to the company Web site.

Thompson, companies and their lawyers have until early February to file a response with the court.

Leukemia drugs and Magnet Japan Net Price -

TOKYO -A trio of US scientists will share this year of Japan Prize for their work on bringing a drug against leukemia from a basic discovery to clinical success, while a Japanese scientific equipment takes another price for a breakthrough with permanent magnets.

Janet Rowley of the University of Chicago, Brian Druker of Oregon Health & Science University in Portland, and Nicholas Lydon Blueprint drugs in Cambridge, Massachusetts, jointly won the price of health care and medical technology for the development of a drug against leukemia called imatinib, better known as Gleevec in the United States and Glivec elsewhere. In the 1970s, Rowley identified several chromosomal translocations in which a part of a chromosome is transferred to another, in patients with chronic myeloid leukemia (CML). Lydon then Ciba-Geigy (now Novartis) in Basel, Switzerland, Druker and later collaborated to develop compounds that inhibit the activity of the enzyme resulting abnormal translocations, which causes cell proliferation runaway. They imatinib led clinical trials from 1998.

Now used as a pill once a day, the drug has CML, once fatal within 3 to 5 years, "a manageable disease, "Druker said at the press conference today prize announcement. He added that "hundreds of other drugs in development" are based on the same approach to block the activity of specific enzymes associated with a given type of cancer.

Masato Sagawa, based Kyoto Intermetallics Co., won the award in the field of environment, energy, and infrastructure to work on neodymium-iron-boron alloy is the high performance permanent magnets in the heart of energy efficient motors used in all kinds of hard drives for construction equipment. Sagawa made his key research at Fujitsu Ltd. and Sumitomo Special Metals in 1970 and 1980. He continues to refine the material to expand the range of applications.

The three winners health also will share a $ 650,000 prize; Sagawa only gets an equal amount. All four will receive their prizes, including commemorative gold medals, at April 1 ceremony in Tokyo.

Mixed Numbers to CDC -

The Centers for Disease Control and Prevention (CDC) would see a minimal increase in total funding in 2013 budgeting $ 39 million bringing its total to $ 11.2 billion . However, more than half of this total is not discretionary funds, but from other sources, including nearly $ 4.3 billion for a mandatory program to vaccinate children. CDC discretionary budget to increase from $ 5.7 billion, the level of the last 2 years, $ 5 billion in 2013.

The agency is to get some extra leeway through 03 million, he would get the "prevention Fund $," money that comes through legislation on health of President Barack Obama and disease prevention funds at different levels of government. the dollars prevention Fund will, among other to promote early detection of disease outbreaks and reduce the spread of various diseases.

US officials Leaps Into Legislator H5N1 flu controversy -

It was only a matter time it appears. After months of silence members of Congress, a member of the US House of Representatives itself publicly inserted into the debate on two controversial studies that have shown how to make the avian flu H5N1 transmissible between mammals.

Representative Jim Sensenbrenner (R-WI), a former head of the House committees on science and justice, and is currently Vice Chairman of the House Committee on Science, Space, and technology, last week sent a "letter made -Find" White House science adviser John Holdren, asking pointed questions about how the US government has treated the controversy and whether it would have funded the two flu studies .

"the answer [Obama] administration appeared ad hoc, delayed and inadequate," said the letter, which was reported by Chemical & Engineering News . And a recent request an advisory board of the government to conduct a second review of two studies "only adds to the confusion," Sensenbrenner wrote. "An ad hoc approach is insufficient to balance the priorities of public health and the free flow of academic ideas. "

Washington insiders were somewhat surprised by the lack of public reaction to the Congress controversy H5N1. Similar recent controversies such as the 05 debate over the publication by Science a document detailing the reconstruction of the influenza virus that caused the 1918 pandemic, sparked criticism from some members of Congress, and even an effort, ultimately unsuccessful account, adopt a resolution opposing publication of this document. this time, however, key legislators and their staff members appeared content to receive private briefings on the issue of senior managers at the National Institutes of Health ( NIH) and its parent agency, the Department of Health and Human Services (HHS).

Observers debate about the flu also noted that Holdren has not played a prominent role in the public debate on the issue; his predecessor in the presidency of George W. Bush, the late John Marburger, took a more public role to explain and discuss biosafety policies of the government. This time, however, other staff-Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases of the NIH, HHS official and Amy Patterson were the public face of the Obama administration. By sending a letter to Holdren, however, Sensenbrenner may focus on scientific adviser to the president.

The full text of the Sensenbrenner letter follows:

March 1, 2012

The Honourable John P. Holdren
Office of Science Policy and technological
Executive Office of the President
725 17th Street, Room 5228
Washington, DC 20502

Dear Dr. Holdren:

last summer, two research teams funded by the National Institutes of Health (NIH) genetically virus H5N1 bird flu making it capable of respiratory transmission between ferrets, as amended, and probably between humans. The National Science Advisory Board for Biosecurity (NSABB) recommended that newspapers not to publish details of the search because he felt that the benefits outweighed the risk that terrorist groups could use it as a recipe to create a biological weapon. Yesterday, the NIH announced that it will ask the NSABB to meet to review new versions of both studies.

The specter of a deadly flu pandemic is really scary. While explaining its recommendation, the NSABB asked, "Could this knowledge in the hands of malicious individuals, organizations or governments to allow the construction of a virus genetically modified influenza capable of causing a pandemic with a higher mortality than the epidemic of "Spanish flu" of 1918? "

The risk of biological attack is large enough that Secretary of State Hillary Clinton took the unusual step of traveling to Geneva to meet the Convention on Biological Weapons UN Review 7 December 2011. Clinton warned that the threat of biological diversity weapons could no longer be ignored and that "there are warning signs," including "evidence in Afghanistan ... al-Qaida in the Arabian Peninsula made a call to arms for, and I quote-'brothers with degrees in microbiology or chemistry to develop a weapon of mass destruction. "

the outstanding question is why the least NSABB recommended against publication that is why this research was done at all. I place great importance on the open scientific research and the free flow of ideas, the principles are really the foundation of scientific innovation and advancement, but in this case, the researchers created an organization that, if released, could kill millions of people worldwide. At a time when malicious actors are actively seeking biological weapons of mass destruction, scientists have managed to create an organization that we all prayed nature would not.

The management response appeared ad hoc, delayed and inadequate. NSABB against the recommendation of the publication came only after the research was completed and submitted for publication. According to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, the risks to the health and safety of the H5N1 research "did not hit the radar screen", or in research institutions home or during multilayer review system of the NIH.

Underscoring the danger, Dr. William Schaffner, professor and chair of the Department of Preventive Medicine at the School of Medicine at Vanderbilt University, argued that it could be too late to control research . Dr. Schaffner said, "We have a pyramid of more and more people who understand these data, the pyramid will continue to grow over time"

recent request NIH that the NSABB. reconsider its recommendation only adds to the confusion. an ad hoc approach is insufficient to balance the priorities of public health and the free movement of academic ideas. in addition, if the circumstances are a legitimate threat to global health, government needs an evaluation system that is able to identify and prevent the spread of dangerous search, ideally before the search is performed. Broad supervision is necessary both nationally and worldwide by objective scientific with expertise in relevant fields

please answer the following questions before March 31, 2012.

1. How NSABB weigh the risks and potential benefits of dual use research? When is pleading against the publication?

2. What systems exist to identify and, where appropriate, the early control of dual-use research?

3. Science editor Bruce Alberts said he takes the NSABB recommendations seriously and was willing to withhold information, but only if the government creates a system to provide the missing information legitimate scientists who need them. What is the current system of government for the distribution of legitimate dual-use research in the world? How is the system implemented from the articles in question?

4. Does the NIH review system to identify research potentially dangerous dual-use? Why has it failed to identify research on bird flu until it was completed and submitted for publication?

Thank you for attention to this issue and look forward to your response.

Sincerely,

SENSENBRENNER F. JAMES, JR.
Vice President, the House Committee on Science, Space, and Technology

Panel Calls for Closer Monitoring Biomarker Tests -

[1945017grandsproblèmes] A long awaited review of the research flawed at Duke University found using genetic signatures to guide the cancer treatment. The Institute of Medicine (IOM) said that so-called diagnostic tools tests- "omics" on the molecular basis of the grounds are very prone to errors; it recommends that they be rigorously validated before being used in clinical trials. The report also called magazines, donors and institutions to take action to avoid what he calls a "failure" of oversight that allowed the problems to go unnoticed at Duke.

The fallout from the Duke case includes 27 papers that Duke expects to be partially or completely retracted, three canceled clinical trials, and a lawsuit against Duke by patients in the trials. What happened reflects "a rush" to pass tests based on genomics in the clinic and market, said Chairman of the Board Gilbert Omenn, a biologist computing at the University of Michigan, Ann Arbor. "There are many lessons here probably apply to other places," says Omenn.

The controversy began after Duke researchers led by Anil Potti and his mentor, geneticist Joseph Nevins cancer has reported that the patterns of gene activity or gene expression in tumor cell lines could be used to predict how individual patients responded to various chemotherapeutic drugs. Their results were published first in a Nature medicine paper in 06 and later in other journals. the university has launched three clinical trials in which patients with breast cancer and lung were to receive medications appropriate to their expression results gene.

Meanwhile, two biostatistician at MD Anderson Cancer Center in Houston, Texas, Keith Baggerly and Kevin Coombes, found apparent errors in Nature Medicine paper and related publications review published in September 09. The National Cancer Institute (NCI), which had questions about the results of a genetic signature Duke, he wanted to use in a new trial, also began to investigate. Duke stopped testing for examination, but restarted a few months later.

Then, in July 2010, after Letter cancer , Washington, DC, a newsletter, reported that Potti had falsely claimed to be a Rhodes Scholar, over 30 statisticians and bioinformatics wrote to NCI Director Harold Varmus asking to investigate NCI. Varmus asked the IOM study, and Duke has launched a new investigation and arrested the test a second time.

IOM found many potential problems inherent in tests based on omics, which he defines as a search that looks for patterns in large sets of molecules such as proteins, DNA, the RNA, or metabolites. These tests offer great potential to guide patient care but because they can be difficult to reproduce, less than expected have reached the clinic, the report notes.

A major problem, according to the report, is "overfitting" Because studies often wear models in hundreds of biomolecules using a relatively small sample of patients, it is easy to find correlations that do not reflect the biology of the disease patients. The report recommends a series of measures to validate tests such as repeat the test on blind samples in a different institution. Magazines and donors should also require data and document templates are available free of charge so that other researchers can verify results.

Before evaluating the test at the clinic, researchers need to "lock" or freeze the calculation model used so that it can not be changed, the report said. Researchers should also consult with the Food and Drug Administration (FDA) long before they use the test in a clinical trial-that Duke did not. And the FDA needs to clarify its requirements.

The IOM committee also found problems with control at Duke, where "several systems in place ... to ensure the integrity and rigor of the scientific process has failed." A 31-page annex provides piecemeal account of what happened to the Duke. She notes that financial conflicts of interest (Duke investigators had patents on the technology and links with developing societies, testing) and deference to a senior professor may have influenced the university to dismiss concerns about papers. Duke attributed his failure to "missed signals."

To avoid these problems, the institutions need to strengthen their oversight of interests and conflicts process to answer questions on published research.

Baggerly MD Anderson said his report of initial reading is "quite positive." If all the recommendations had been implemented, "I think a lot of the problems could have been short-circuited," said -he.

The NCI Lisa McShane, who spent months trying itself to validate the results of Duke, said the IOM committee "did work really well" by asking the questions. NCI now plans to require its cooperative groups that want to use omics tests follow a checklist similar to that in the IOM report. NCI has not yet decided whether to add new requirements for omics tests in its review process Peer Grants Initiative researchers. But "we hope that this report will increase making everyone aware," says McShane.

In a statement, the duke said he "appreciate [s] reflected the work and depth carried out by the IOM committee "and expects to incorporate the recommendations in" ongoing efforts to reinforce the rigor of our research enterprise. We have learned of our situation, "the statement said.

Potti left Duke in 2010 and later joined a medical practice in South Carolina, but after 60 Minutes aired a segment on the controversy in February, he was released. an investigation of scientific misconduct Duke is underway, according to the university.

Dangers of Chinese medicine revealed by DNA studies -

Traditional Chinese medicine (TCM) is enjoying increasing popularity throughout the world. But two molecular genetic studies published this week show that fashionable treatments can be harmful as well. The documents draw attention to the fact that not all the ingredients are listed, or even legal, and some can cause cancer.

"These two studies clearly show the danger of TCM products can be," says Fritz Sörgel, the head of the Biomedical and Pharmaceutical Research Institute in Nuremberg, Germany, who was not involved the work. "The public needs to be better informed about these dangers."

Hundreds of millions of dollars are spent on TCM products every year an increasing share of it on the Internet and some scientists are looking for these preparations in the hope of discovering new pharmacological substances. Many would like to emulate the success of Tu Youyou, the Chinese scientist who isolated artemisinin, now drug against malaria the most important in the world from an ancient Chinese medicine. You won a Lasker Award last year and is rumored to be a Nobel candidate.

But critics have long warned that certain mixtures may also contain naturally occurring toxins, contaminants such as heavy metals, added substances such as steroids that make them seem more effective, and traces of animals that are endangered and restricted trading.

Now, researchers at Murdoch University in Australia studied the problem using modern sequencing technology. The team, based at the Australian Wildlife university Forensic Services and Ancient DNA Laboratory in Perth, has analyzed 15 samples of traditional Chinese medicine seized by Australian authorities of the border.

"We took these traditional preparations, in pieces, and the powder extracted DNA," says molecular geneticist Michael Bunce. The scientists then caught two copies of specific genes trnL , a common chloroplast gene to all plants, and 16S rRNA , conserved among plants and animals, and multiplied and sequences. in comparing the sequences of those databases genetic they could identify animals and plants used to make the drug. "Sometimes we really had trouble assigning a particular DNA to a particular species," says Bunce. But as genetic databases grow, it should become easier.

Some products contained material from animals classified as vulnerable or critically endangered, as Asiatic black bears and saiga, as the producers claimed. But often ingredients, the drug has also not feed on the packaging, the team announced today online in PLoS Genetics . "For instance, a product labeled 100 percent Saiga antelope contained considerable quantities of goat and sheep DNA," Bunce wrote.

"Using DNA to identify the species and thus prove the illegal trade is very elegant," says Dietmar Lieckfeldt, working in molecular forensics at the Leibniz Institute for Zoo and Research wildlife in Berlin, Germany. Identification of animals by their DNA has been possible for some time, he said, but the new generation sequencing technology to nail species in a mixture very quickly.

In preparations herbal, Bunce and his colleagues found members of 68 families of different plants, including the plants of the genera Ephedra and Asarum . Both can contain toxic chemicals such as aristolochic acid, a compound banned in many countries because it causes kidney disease and cancer of the upper urinary tract (UUC). Upon detection of DNA of a species does not mean a toxin produced by this plant is present, the chemical analysis of one of the four samples containing Asarum DNA was rotated until to aristolochic acid.

The threat aristolochic acid is also highlighted in an article in the Proceedings of the National Academy of Sciences on Monday. The researchers, led by pharmacologist Arthur Grollman of Stony Brook University, focused on Taiwan, the country with the highest rate of UUC in the world. Previous analysis showed that nearly a third of the Taiwanese population consumed herbs may contain aristolochic acid.

Scientists have sequenced the tumors of 151 patients with UUC. Among patients with characteristic mutations in the tumor suppressor gene important TP53 -which make people more vulnerable to cancer of 84% also showed a molecular signature of known exposure to aristolochic acid, they found. The study provides compelling evidence that aristolochic acid is a main cause of UUC in Taiwan, the authors state.

Bunce and his colleagues also found the DNA of known plant families contain important medicinal species that could pose risks when used in combination with other drugs and DNA soy and plants of the family of cashew nuts, which may contain allergens. . "It just shows that the ingredients in these preparations are not reported accurately," says Bunce Indeed, said Sörgel, studies show that participating in traditional Chinese medicine herbal is a gamble: "We do not know enough."

The publication of the Dutch government study H5N1 OK -

AMSTERDAM -The Dutch government gave virologist Ron Fouchier of Erasmus MC an export license for its H5N1 transmissibility controversial study, allowing Fouchier to send a revised manuscript of his paper science .

The license "is in my inbox," says Fouchier. "Now we can go."

The decision by Henk Bleker, Minister for Agriculture and Foreign Trade was announced this afternoon in a press release (in Dutch) posted on the ministry's website. It comes four days after a closed meeting in the Hague, where government officials have discussed the risks and the benefits of research with an international group of scientists and security experts According to today's statement.

Minister Bleker weighed the benefits and risks of publishing research on avian influenza, and has mostly looked the freedom of research and publication, health and safety. It also took into consideration the ideas of national and international experts in the fields of safety, health and research; the positive opinion of the US National scientific Advisory Board on biosecurity [NSABB] for the government of the United States about the publication of research; and the US government decision to follow this advice.

Fouchier was fiercely opposed to an application for an export license, which he says is an inappropriate tool to control the flow of scientific information. He eventually filed the permit while disputing the obligation to do so.

Fouchier said he is "pleased but not surprised" by the decision. "It would be strange" if the government had held up publication after NSABB and a group of experts from the World Health Organization recommended publication, Fouchier said. The Rotterdam Lab will not break the champagne until the paper actually comes out, he said. "Then let's have a party."

Bleker also sent a letter to the Dutch House of Representatives today (Dutch) in which it promised to inform the House about the results of the meeting Monday at the latest on May 16

Psychiatric Drug May Kill Cancer stem cells -

A well known medicine for treatment of schizophrenia can be a cancer killer, too. In laboratory studies, the drug eliminated a precursor of leukemia cells without harming normal cells. That means it could give doctors a long way out to eliminate any trace of leukemia patients so that the cancer may never return.

While surgery, chemotherapy and radiation can get rid of tumor cells or leukemia, the cancer often returns months or years later. One culprit may be called cancer stem cells, which give rise to cancer cells. These stem cells are resistant to chemotherapy and radiotherapy, and persist in the body. Some researchers believe that combining conventional cancer drugs with a drug that targets cancer stem cells may be the best way to defeat some cancers. But because these cancer stem cells are rare and difficult to grow in the laboratory, some of these drugs have been identified and none are in clinical use.

Now a Canadian team has found a new way to test drugs that target cancer stem cells. They used human pluripotent stem cells, which are made from cells of embryos or reprogrammed adult cells that have the ability to develop into different types of tissue. There are a few years, stem from the team of Mickie Bhatia cell researchers at McMaster University in Hamilton, Canada, stumbled across multiple lines of pluripotent stem cells that share some characteristics of cancer stem cells: The cells continue to divide and will not develop or differentiate, and more specialized cells.

In her new work, the Bhatia Group tested whether various chemical compounds could coax the cells to differentiate, or mature, in normal cells so that they stop dividing abnormally and die a natural death . The researchers hope that this could be a less toxic way to get rid of cancer stem cells by directly killing cells.

After screening hundreds of compounds, including approved drugs, researchers have found a few that did what they wanted: The chemicals caused cancer stem cells like to differentiate without damaging normal, healthy stem cells needed by the body. One of the most potent compounds was thioridazine, an antipsychotic medication used to treat schizophrenia. The drug also blocked the growth of acute myeloid leukemia (AML) stem cells taken from patients. And he overthrew the number of AML stem cells in mice injected with these cells that have developed leukemia, but spared normal blood stem cells.

When combined with thioridazine, the standard drug used to treat AML was 55 times more powerful in killing AML cells in a laboratory dish he was alone, Bhatia and colleagues report today ' hui in cell . The team is now planning a clinical trial to test the drug combination in 15 AML patients who no longer respond to standard drugs alone. "Our feeling is, as it is approved and this synergistic effect, we want to go directly into the patients," says Bhatia.

The study also revealed a curious finding. Thioridazine, which blocks receptors for the neurotransmitter known as dopamine, also seems to work on leukemia stem cells by blocking these receptors. Bhatia said that so far, no one noticed that cancer stem cells have receptors for dopamine, which normally associated with neuronal signaling and found mainly in the brain. But his group also found them in breast cancer stem cells. It suggests a test that measures the amount of dopamine receptors in samples of blood or tissue can detect cancer or to predict a patient's prognosis.

cancer biologist Piyush Gupta of the Whitehead Institute in Cambridge, Massachusetts, who used a different cellular system to find drugs that target cells cancer stem, he says he would not necessarily expect the pluripotent stem cell system to mimic cancer. But "the relevance is shown convincingly by the authors in the context of a leukemia cancer model."

He and others say they are happy to see a new technique to identify drugs that act against cancer stem cells. But the Hudson Thomas cancer researcher at the Ontario Institute for cancer research in Canada says he would like to know more about the mechanism by which dopamine receptors are cell a cancer stem cell.

A breath of fresh air microbubbles -

John Kheir knows what it is to lose a race against time with oxygen. In October 06, the pediatric intensive care physician treated a girl of 9 months, admitted to the Boston Children's Hospital with viral pneumonia. As his illness worsened, his hemorrhaged lungs filling with blood and stop breathing. Kheir jumped into action, pushing a breathing tube down his windpipe to help get air to the lungs, CPR, and eventually put the baby on a machine that has taken to its heart and lungs. But within minutes it took to restore the flow of air into the body of the girl, her brain had already suffered permanent damage due to lack of oxygen. She died a few days later.

Devastated, Kheir began looking for the best ways to get oxygen into the body. Now he has found one. In a new study, published online today in Science Translational Medicine , he and his colleagues report the development of microparticles filled with oxygen gas that can be injected directly into the blood. The particles rapidly dissolve, releasing the gas and maintenance of organs such as the brain, suffocating.

"This is a potential breakthrough," says cardiac intensive care doctor Peter Laussen of Children's Hospital Boston, who has not participated. "You can apply this through care health of the battlefield to the emergency room, intensive care unit or operating room. "

the microparticles are tiny bubbles whose surfaces are membranes already used clinically to deliver drugs chemotherapy and ultrasonic colorants. But while these microparticles release their contents slowly Kheir and colleagues designed particles containing oxygen which dissolve as soon as they hit the bloodstream. they then tested the microparticles in respiratory rabbits low-oxygen air. within seconds of receiving the microbubbles, oxygen levels in the blood of rabbits rose to a dangerously low level of 70% to almost 100% saturation, the ideal level .

"Basically, as soon as we started to inject clinically we started to see an effect," Khair said. But if the injection is stopped, the levels have dropped just as quickly, he said, indicating the need for the microparticles to be administered continuously.

Kheir said the treatment could have saved the brain of his patient of pneumonia, or the lives of countless other patients whose organs have failed to oxygen deprivation. If it works in larger animal tests that are currently in progress and moves to human clinical trials, the therapy could eventually be used on anyone with a lung infection, asthma, or blocked airways. it could even be an addition to CPR, Laussen added. "this is still in its infancy," he says, "but the idea of ​​a new and innovative way to efficiently deliver oxygen is, I think, very exciting. "

for now, the microparticles are washed so fluid, especially in young or small-volume patients is a limiting factor in how long people could receive the infusion. The maximum current is about 15 to 30 minutes, says Kheir. "If we could increase the ratio of microparticles to fluid, we may be able to use for even longer and even more indications."

Infectious Disease chief US urges scientists flu "Engage," Supporting research H5N1 Moratorium -

NEW YORK, NEW YORK [1945015moratoire] -A voluntary on potentially dangerous experiments to understand the highly virulent H5N1 flu is expected to continue for the time being, the National Institute of allergy and infectious diseases (NIAID) Director Anthony Fauci in a flu scientists meeting here. But, he added, efforts to increase scientists should engage with the public to get support for the vital work but risky.

"The scientific community flu can not be the only player in the discussion on this research," said Fauci. "You certainly lose the battle for public support for your research if you ignore this." Fauci remarks, delivered at the annual meeting of the flu research of excellence NIAID centers, also echoed a call for openness and transparency he made in June in the pages of science , published by AAAS, which publishes science Insider.

The moratorium announced by 39 scientists this past January, came amid controversy over the publication of two studies that described how the researchers made H5N1 more transmissible between mammals, perhaps setting stage for a flu pandemic. After a long review, the US National Science Advisory Board for Biosecurity (NSABB) finally recommended that the US government allows full publication of two studies. One, by a team led by Yoshihiro Kawaoka, who has a joint appointment at the University of Tokyo and the University of Wisconsin, Madison, was published by Nature . The other, a team led by Ron Fouchier of Erasmus MC in Rotterdam, the Netherlands, was published by Science .

What to do about the moratorium, however, has been the subject of controversy. It was originally supposed to last only 60 days, but was then extended indefinitely. In April, Fauci - which has not signed the moratorium, but conducting a major research funding agency of the flu and encouraged scientists to take a break in an attempt to calm public fears, told a Senate committee US that the moratorium should continue pending further discussions. In June, he said that the research community still had "a lot of homework to do ... and some check boxes" before the moratorium could be lifted, including an agreement on what influenza types of research have earned . risks

in remarks today, Fauci stressed a particularly sensitive area of ​​research: supposedly experiences "gain of function" that allow scientists to create and study the virus the flu are more pathogenic than those found in nature. a key argument for such experiences, he noted, is that they allow scientists to understand how a virus might evolve in the future.

"There is a real and present danger of the natural evolution of the virus and that is why you do the experiments that might seem risky to some," he said. "You make the experience so we can stay ahead of the risk to evolve naturally."

Many critics, however, whether such experiences are really useful, and if scientists can safely contain potentially dangerous new pathogens. "The world sees things differently," Fauci said, "and they ask the question ... namely: If these experiments should be conducted and / or published in the first place"

Scientists , he says, often "answer that the benefit outweighs the risk. ... However, it is essential that we respect public concerns nationally or globally, not ask them to take the scientific speech flu. "

with concerns about bioterrorism to the documents published to guide deliberate efforts to whip up a pandemic, Fauci said he worried about the laboratories 'unregulated' maybe outside the US, do the work "sloppily" and leading to a pandemic inadvertently. "accidental release is what the world is really concerned," he said.

to address these concerns, Fauci suggested more dialogue and patience. Before lifting the moratorium, scientists need to take more time to share information with the public and discuss compromises inherent in influenza research, he said, perhaps through workshops and international meetings.

Not taking such measures, he said, would be against-productive. "If we, without this broader input, say, 'we will lift the moratorium," the consequences of this would make it harder to get back on the track to do this research, "he said.

Fauci also suggested that there are many potentially important H5N1 experiences that are not covered by the moratorium. eligible experiences, for example, could test the hypothesis that a flu virus infecting a small mammal such as a ferret could infect monkey. Or, he says, researchers could begin more studies to answer questions about how the immune system responds to the virus.

"the game has changed for scientists pandemic influenza and the organizations that support them, "he said. NIAID, the National Institutes of Health and the Department of Health and Human Services "can not recommend or go along with the moratorium is lifted ... so that the issues I have just mentioned and raised remained unanswered. "

This position got a mixed review of predictable audience members, which included both supporters and opponents of lifting the moratorium. But several scientists have publicly thanked NIAID Director for his comments francs . "I think [Fauci] articulated the case for continuing the moratorium today better than the case for continuing the moratorium was articulated above, and what is important," virologist Nancy Cox of the Centers for Disease Control Atlanta said Science Insider Fauci after the session. She was among the signatories of the original moratorium. During the session, she also said that "there must be a better explanation of what kind of work on the H5N1 virus may continue under the moratorium and what can not."

Fouchier, for one, Fauci said it was time for the moratorium to end. "I think we have done what we can do about accidental release," he said. "at the outside the accidental release of the US can not be treated by regulation, "he noted, adding that some of the signatories to the moratorium does not receive US funds. he also stressed that laboratories worldwide have already dangerous pathogens at hand, including hundreds with samples from 1957 H2N2 pandemic virus. "If this virus [gets released] it will kill 1 to 2 million people," he said, suggesting that the infectious disease community has shown that it can work with dangerous pathogens responsible.

Response to Fauci Fouchier: Share this argument with the public. Fouchier said that "does not receive transparency airing it deserves," said Fauci. "This argument you made must be done in a forum that people can understand what you say."

At the end of the one hour session, it appeared that the researchers were not about to solve when, or if, the moratorium should end. "In case of disagreement between the people in this room, how a decision will be taken?" asked virologist Adolfo García Sastre Mt. Sinai School of Medicine in New York.

Fauci said that it is developing detailed guidelines for universities and other institutions to carry potentially risky research of concern (DURC) dual-use will help you spell out an answer. As part of his speech, he shared the progress made by the US government on Durc guidelines, which have been shaped by a new committee, inter-yet-to-be-named including national leaders Institutes health. The group meets to develop rules and Fauci expects their release "reasonably soon." After their release, Fauci said he hopes they will be subject to public comment and receive feedback from an international consultative conference. The guidelines now cover 15 pathogens and agents "likely will be modified in the future to include more than 15." In the past, Fauci said the publication of the Guidelines would be needed before he would support lifting the H5N1 research moratorium.