Health Meaning

In an ironic twist, the institute which employs James Sherley, one of two scientists who pursued to block research on stem cells financed by the federal government, is weighing on the other side. Today the Boston Biomedical Research Institute (BBRI) requested to support the call for a preliminary injunction on August 23 that temporarily closed National Institutes of Health (NIH) funded research on human embryonic stem cells (hESCs ) of the government.

CSEC wants to join an amicus curiae (friend of the court) previously filed by the Coalition for the Advancement of Medical Research, the State of Wisconsin, and genetic Policy Institute. In a move of 3 pages, the institute, which has 25 principal investigators, said it wants to expand its regenerative biology program funded by the NIH using human adult stem cells to hESCs include "but is limited by the injunction to do. CSEC is severely limited in the development of potential treatments for human disease. " In addition, the research center of muscular dystrophy NIH-funded Institute would like to study hESC with mutations of this disease, but notes that it did not accept an offer of such cells because of the injunction .

This supports "the perspective of the parties amicus they provided the Court with regard to the severe negative impact of the preliminary injunction on patients who should benefit from advances in medical science. .. and the strong public interest in the continued funding of [hESC] research, "says BBRI motion, filed in the US Court of Appeals for the DC Circuit.

Sherley and another scientist argue in their suit that the NIH hESC policy is illegal and harms their chances of winning funding to study adult stem cells.

the Appeals court will hear oral arguments on December 6. Meanwhile, Royce Lamberth chief judge of the US district court in Washington, DC, could decide on the underlying case and issue a permanent injunction. Any decision is subject to appeal.

Eight bioethicists at the University of Minnesota are charging their own institution committed an "alarming series of ethical violations" in a clinical trial where a young man committed suicide in 04. the eight, including nearly half of the faculty members of the university basic Bioethics, yesterday issued a letter to the Board of regents of the University, asking the board implement an external investigation into the death of Daniel Markingson. He committed suicide violently while enrolled in a trial of antipsychotic drugs through the University Department of Psychiatry. The letter says that his death has not been adequately studied earlier.

"bioethicists should not ignore the catastrophe in their own backyard," said Mary Faith Marshall, one of the signatories. Marshall came to the University of Minnesota in 05 after serving in the political arena of federal bioethics. Among other things, she chaired a committee investigating the death of 19-year-old Jesse Gelsinger in 1999 in a gene therapy experiment at the University of Pennsylvania.

the letter has bioethicists was conducted by Carl Elliott, a permanent faculty member in the department who studies conflicts of interest in the pharmaceutical industry. Elliott wrote a scathing article on the case in Mother Jones magazine this fall . Since there is documented Markingson was included in a clinical trial all seriously mentally ill and against the will of his mother, he also alleges that the university's psychiatry department was to gain financially by registering and remember in the trial. In a survey after the death of Markingson, the US Food and Drug Administration authorized the university of any wrongdoing and said there was no evidence that Markingson could not voluntarily consent to the study.

This has not assuaged Elliott. "For me, the main motivation is personal shame. I feel embarrassed to work at a university that would treat humans and their families in this way, "he said.

After Elliott started talking about the case in the fall, the Advocate General of the University, Mark Rotenberg, issued a statement claiming the university side of the history. The death Markingson was reviewed to varying degrees by outside investigators, he noted. "No complaints with the faculty involved, and none found no causal link" between the study and Markingson suicide.

But eight bioethicists wrote in their letter to the university that the piece Mother Jones and a 08 series in a local newspaper, the Pioneer Press " raise troubling questions that to date has not been addressed in the response of the University of the death of Mr. Markingson ".

Asked whether the university had a response to the letter, spokesman Daniel Wolter wrote in an email: "There is no additional information at this stage because it is not really something new beyond Professor Elliott repackage its position in new and different formats. "Advocate General University was not available to discuss the matter before Science Deadline Insider

After hearing the comment Wolter, Marshall said.: "I always say, when a research subject dies in one of your studies, the public and the private message should be," We're really sorry about this and we are going to do everything we can do to ensure that it never happens again. ""

Wherever he is buried in the body, illness leaves traces in the blood, or so the thinking goes. But finding these biomarkers, which can help catch the disease early on, was a futile exercise, with a promising candidate after another lose its luster once it receives scrutiny. A team of chemists and other researchers now offer a new way to pick up the biomarkers with a blood test: the detection of antibodies the body makes in response to specific diseases. So far, the group has reported results for only a small number of patients with Alzheimer's disease. But they hope the approach will and could be used for everything from lupus to cancer.

There are two common strategies to find biomarkers in blood or elsewhere in the body. The first is to focus on what is known about a disease for example, looking for the deterioration of certain areas of the brain in Alzheimer's disease. The second is essentially a fishing expedition in which researchers compare, for example, protein patterns from patients who have a particular disease with patterns of people who do not. Both methods have encountered roadblocks. In the case of Alzheimer's disease, PET, MRI, spinal taps and remove some of the fluid that surrounds the brain and spinal cord have had some success in the early diagnosis, but they are expensive or invasive. Although there is no cure for Alzheimer's disease, researchers are eager to find easy to use and reliable biomarkers, which would ensure that people in clinical trials of Alzheimer's disease really have the disease and make early treatment possible if it eventually becomes available.

chemist Thomas Kodadek of the Scripps Research Institute in Jupiter, Florida, and his then-postdoc, M. Muralidhar Reddy, considered biomarkers that exploit a classic feature of the biology of the disease: antibodies, proteins that the immune system churns in the presence of invaders. Scientists do not know that each disease causes antibodies, but certainly some diseases do. "Antibodies are proteins rocks the world," not easily damaged when studied in the laboratory, said Kodadek. This has made the idea of ​​measuring the blood attractive.

Many other researchers have examined the value of antibodies as biomarkers, but they were thwarted by the common strategy used to test for them. To know which antibodies to search, you need to determine what molecules stimulate the immune system to produce antibodies. This requires "a phenomenal understanding of the progression of the disease early," said Kodadek, something we do not have for most diseases.

Kodadek, Reddy and colleagues took a different approach . They have turned to "libraries" of thousands of peptoids, molecules that are developed in drugs that have a myriad different structures. the idea was that some peptoids, by chance, would bind to all that the antibodies could be there even a few thousands of randomly selected shoes could fit your feet-allowing researchers to determine whether people with a disease had an abundance of certain antibodies that healthy people were missing. at mice with a version of multiple sclerosis, a library of 4,0 peptoid identified three antibodies, the team used to diagnose the disease in other mice.

Six people with Alzheimer's disease, the same strategy, using 15,000 peptoids, picked up two antibodies found at high levels. The antibodies are also abundant in the blood of an additional 16 Alzheimer's patients. But these were rare proteins in the blood of a handful of people with the disease or lupus Parkinson.

The antibodies are also prevalent in two of 16 healthy controls. Their presence may indicate that the biological markers are not specific to Alzheimer's disease. Or it might suggest that these two women, aged 75 and 65, have early Alzheimer's disease. "We support this hypothesis, but it can not be concluded with certainty," the authors report in the January 7 issue of cell .

"There is a new idea," says Norman Relkin, a neurologist and neuroscientist at Weill Cornell Medical College in New York. "You are looking for immune responses that may be specific to the disease." However, Relkin said that for Alzheimer's disease at least, it will take much more work to do reliable test, especially because even with healthy aging, "the immune system tends to produce antibodies more dysfunctional."

Although the results need to be replicated and more people to ensure that the antibodies are specific to Alzheimer's disease, the paper "looks like a very thorough job," says Kaj Blennow, neurochemist to Sahlgrenska university hospital in Gothenburg, Sweden. a blood test would have great advantages over current Alzheimer's diagnosis, he says

Kodadek, Reddy, and others formed a company, Opko Health Inc. to further develop the technology. Reddy is the Chief scientific Officer. "as you can tell, I'm pretty excited about it," said Kodadek. But he tries to keep his enthusiasm in check. "There is a long history of biomarkers hit the cemetery," and although he is hopeful that will not happen here, "the point is, you never know."

in November when the researchers revealed positive results of the first large-scale trial of anti-HIV drugs to prevent the sexual transmission of virus, a barrage of questions immediately surfaced on how best to use what is called pre-exposure prophylaxis (PrEP). Today, the US Centers for Disease Control and Prevention (CDC) published the first recommendations to health care providers about PrEP. Although the "interim guidance" a few surprises and is only a temporary solution until the US Public Health Service issues more formal recommendations, clinicians are welcoming the entry. "It is an important step in the development of recommendations," said Robert Grant, a virologist with the J. Gladstone Institutes of the University of California, San Francisco (UCSF), who led the positive PrEP trial.

the study, reported online November 23 in the New England Journal of medicine , found that daily use of two anti-HIV drugs combined into one pill called Truvada reduced the risk of transmission in men and uninfected women transgender who have sex with men 44%. the efficiency jumped to 73% in a subset of participants who reported taking their pills every day at least 0 % of the time, indicating that prevention was closely linked to the respect of the testing protocol. the results received reports of widespread media and have been recognized by scientists worldwide as a significant advance in the field of prevention HIV tired failure.

Grant and his colleagues pointed out at the outset that the results apply only to this population, and interim CDC guidance repeats this warning. It also recommends that clinicians carefully test patients for HIV infection before prescribing Truvada as a preventive and follow up with tests every 2 to 3 months. CDC suggests the same dosage, the board and the daily supply of condoms as used in the study and said requirements should be 0 days, which would give clinicians a formal way to periodically confirm that their patients are still negative. (In people with HIV, Truvada is used only in combination with other antiretroviral drugs to prevent the emergence of resistant strains of the virus drugs.)

CDC said it has published guidelines provisional because of concerns that "dangerous and potentially less effective PrEP practices could develop" before final recommendations are made as Truvada is already an approved drug for the treatment and HIV clinicians already prescribe its off-label use preventively . specifically, the CDC said he wanted to discourage clinicians prescribe other anti-HIV drugs as PrEP, using a dosing schedule other than the one proven to work in the study, supply orders without advice and condoms, not properly test and monitor patients for HIV infection.

the guide says it will take "several months" for PHS to issue further recommendations, as now is the collection "of expert and public input."

Davey Smith, an HIV / AIDS clinician at UC San Diego, said one outstanding issue is cost. "The main hold-up is going to be who will pay for it," says Smith. "It is also the lowest socioeconomic gays men who have already burden. They are the neediest of the needy, and they are those who do not have access to health care. I do not think we've been very good to think about the other side of the coin. "

Have you missed the funding cut despite a stellar score on your U.S. National Institutes of Health grant (NIH)? Do not give up hope. The National Health Council (NHC), a nonprofit umbrella group based in Washington DC, to some 100 groups of patients and companies, unveiled a database on Monday that connect rejected projects and donor potential funding.

The site, called funding health research, is supposed to be "the Match.com funding agencies," the NHC spokeswoman Emily Noonan. Any researcher who had a proposal that NIH deemed worthy of peer review, but has no funds can display their abstract and contact information at no cost. registered funding agencies (but nobody else) will be able to troll the summaries of projects they like.

At this time, the site has information of only the 42 patient advocacy groups such as the American Cancer Society and the Alzheimer's Association. enterprises can be added later, perhaps for tax, said Nancy Hughes, assistant vice president NHC for communications and marketing.

NHC offers the database there are more than 3 years, but it took a while to round financing ( $ 112,000 divided roughly between Pfizer and NIH) and build the database, said Hughes. On his blog, NIH extramural chief researcher Sally Rockey called "good news on the front I-going-to-get-my-grant-funded in today's economy-where-am."

Would you know if you have cancer? There may soon be an app for that. Cancer researchers have developed a small device that, using a smart phone could allow physicians to know within 60 minutes if a suspicious mass in a patient is cancerous or benign.

Instead of immediately cutting the masses they suspect are tumors, oncologists often use a large needle to remove a few cells from a piece for analysis at a laboratory of pathology. But the tests used there, such as the examination of cell shape and coloring for various proteins, are sometimes inconclusive. Laboratory tests also several days.

Alternatively, the physician-researcher Ralph Weissleder team at Massachusetts General Hospital (MGH) in Boston has developed a miniature version of a nuclear magnetic resonance of the workhorse tool (NMR) machine that allows researchers to identify chemical compounds by the way their nuclei react in magnetic fields. The researchers also found a way to attach magnetic nanoparticles with proteins so that the machine can take these specific proteins from a Gemisch chemicals, such as those found in a sample of tumor cells. NMR machine with a standard laboratory chemistry is approaching the size of a filing cabinet, but the new device is only about as big as a cup of coffee.

To see how this could be used in the cancer clinic, MGH researchers used the standard needle procedure to collect suspicious cells from the abdomen of patients. They were then labeled cells with different magnetic nanoparticles for binding to known cancer-associated proteins and injected cells in their miniature NMR machine. The device, which data can be read with a smartphone application in place of a computer, detected levels of nine protein markers for cancer cells.

biopsies Combining the results for four of these proteins, the MGH team diagnosed accurately for 48 of the 50 patients in less than an hour per patient. The micro-NMR diagnosis was correct 100% of the time in another series of 20 patients, the MGH team reports today in Science Translational Medicine . In contrast, standard pathology tests on similar samples were correct only 74% to 84% of the time.

Weissleder hoped the device would allow a doctor to test a biopsy sample needle just minutes from the collection and tell the patient the results as soon as he or she wakes up from the procedure. Currently, patients come for a biopsy, go home, and wait several days for the results. "Our patients hate this week not know if they have cancer," he said. The strategy should also reduce repeat biopsies, which typically cost thousands of dollars, he said.

Eventually, researchers hope to use their mini-NMR apparatus to monitor the cancer and whether patients respond to drugs by detecting the levels of specific proteins in blood samples.

tumor immunologist John Greenman of the University of Hull in the UK, which also works on devices called lab-on-a-chip, called "extremely interesting" study as an early example of this technology. What is essential, he said, is that the MGH group compared his test with standard tests, which "is essential to obtain the support of the medical community." Such devices may have many applications beyond cancer, such as environmental monitoring and detection of biological weapons, he said.

As workers struggle with damaged Fukushima nuclear plant in Japan, the potential risk of more radiation will be released remains unknown. But the events unfolding since Friday earthquake gave those responsible for public health time to plan ahead, contrary to what happened after 1986 Chernobyl accident. And that means they can reduce human exposure to radiation, said a scientist who has studied the disaster.

The effect of the most significant health Chernobyl was a sharp increase in children with thyroid cancer - more than 6,000 cases, according to a recent UN report. To reduce the chances of such an increase, people living near the plant were being given potassium iodide tablets. The idea is to flood the thyroid with iodine and block inhaled radioactive iodine-131 or ingested into the thyroid. But "the time is critical," said Fred Mettler, emeritus professor of radiology at the University of New Mexico, who led an international team that investigated the health effects of the accident. If taken 1 day before exposure, pills are 80% effective, he said, if taken during the exposure point 100% effective; 8:00 later, 30% (except for pregnant women there. not many reasons adults over 20 to take the tablets, Mettler adds, because their risk of cancer is low.)

in Chernobyl, iodine-131 was also obtained in food supply through the milk of cows that had fed in pastures contaminated with radioactive iodine. Japan can prevent this by banning cows grazing in contaminated pastures, he said, or storing dairy or cheese for 80 days until the radioactivity disappeared.

Another risk is cesium-137, which can also be spewed into the air from a nuclear power plant. Its half-life is 30 years. In Chernobyl, he entered the food chain through the soil and eventually into the meat, berries and mushrooms. One solution is to dig half a meter or more above the ground, said Mettler. But the isotope also leaves the body within 2 months, so another option is to feed the livestock own food for a few months before slaughter, says Mettler. (People who accidentally ingest radioactive cesium are sometimes given a chemical called Prussian blue, which binds to cesium and helps the body to excrete. But by taking pills for cuts exposure weeks only 50%, and levels Japan will probably be too low to justify such action, said Mettler.)

Japan is also to minimize the exposure of people evacuating the area 20 km around the plant and advise people less than 10 kilometers outside of the area to stay indoors. These measures will reduce their exposure to both gamma rays (which are attenuated by walls) and radioactive particles in the air.

The bottom line, Mettler said, is that the radiation levels measured by monitors that do not correspond with what actually between people's bodies. "The trick is to keep people from being exposed."

Baruch Blumberg, who went by the nickname Barry, is best known for winning the Nobel Prize in Physiology or Medicine in 1976 for discovering hepatitis B virus and development of a vaccine against this disease. But he often lived life away from the laboratory. It therefore seems appropriate that when he died Tuesday at age 85, apparently of a heart attack, he was hundreds of miles from his home base in Philadelphia, at a NASA conference in California. Blumberg had spent many years involved in the astrobiology program at NASA, including at one time as its leader.

Last summer Science Blumberg visited at his home in Philadelphia city center for a story about the retirement of researchers who have large collections of samples. Blumberg it was among the most massive: when we talked, he guessed he had amassed 450,000 blood samples during his career. To acquire, he checked where he had traveled: West Africa, the Arctic, Romania, Italy, Taiwan, the Pacific Islands, and more. "I wore a lab worldwide," he said. Its geographical scope was so great that his face appeared on stamps in the Maldives and Angola.

Blumberg has spent most her career at Fox Chase Cancer Center in the city and was eager to talk about hepatitis B and the importance of vaccination. But he was just as happy talk about its other activities. he was then president of the American Philosophical Society, which was founded by Benjamin Franklin and was still kayaking and hiking and an active amateur photographer was also a member of the Explorers Club of New York- "There is a branch here in Philadelphia. " he said.

This reporter had scribbled "young 85" in his notes when talking with Blumberg. The verve with which he still lived life made this plain.

The National Institutes of Health (NIH) and biomedical research groups are jubilant that an appellate court Federal canceled today a preliminary injunction that briefly halted research on human embryonic stem cells (hESCs) last year. The decision allays 2-1 months of fears that the research could be stopped again, at least temporarily. But the legal battle is not over, and the end result is an enigma.

The complaint was filed in 09 by James Sherley and Theresa Deisher, scientists who study adult stem cells. They claimed that the new NIH guidelines expanding research on hESCs violated the Dickey Amendment, a 1996 law banning the use of federal funds for research that destroys embryos. In August 2010, a judge of the US District Court Royce Lamberth agreed and issued a preliminary injunction that stopped the funding of hESC. The ban was held for 2.5 weeks until the US Court of Appeals for the D.C. Circuit blocked the injunction while a panel of three judges deliberated.

The long-awaited decision strongly encourages NIH. Writing for himself and Thomas Griffith judge, Judge Douglas Ginsburg disagreed with Lamberth in a condition to allow the preliminary injunction to stay: it would not hurt seriously hESC scientists. The effects on hESC research "would be certain and substantial. ... Their investment in project planning would be a loss, their expenditures for equipment a waste, and their staff on a job," said the ruling.

importantly, the judges also weighed on the underlying question of whether the interpretation of the Dickey-Wicker NIH is incorrect. about half of the 21 memory pages is devoted to these arguments, with Ginsburg conclusion: "We conclude the plaintiffs are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC [embryonic stem cell] from an embryo, it does not prohibit funding a research project in which an ESC will be used. "

the decision was not unanimous, however ,. a third judge, Karen LeCraft Henderson, found in a dissenting opinion that his colleagues "strain mightily to find the ambiguity presses the government." She called the separation of the derivation of hESCs and research on the cells themselves of his colleagues "linguistic jujitsu . "(the dissenting opinion is probably why the court has taken months longer than expected to the rule, said the professor Hank Greely of Stanford Law School in Palo Alto, Calif.)

the split decision gave the plaintiffs a little hope that the full court is ready to hear the case, according to Samuel Casey comments, one of their lawyers, made Nature blog. (This is known as a bench hearing.) Greely think they would have little chance of winning, though: ". Much lower" Ginsberg's decision "was very well written and clear" while Henderson was also notes that three or more active members of the full court appointed Clinton who are more likely to another with the government.

Greely also thinking of the Supreme Court of the United States refused to hear an appeal of the decision to Ginsburg because the case has no disagreement among the circuit courts.

that still leaves the underlying case before Lamberth. last fall, two plaintiffs and the government have filed briefs asking Lamberth for "summary judgment," which means that the facts are not in dispute and they want to decide the case quickly without trial. Because the appellate court found that NIH correctly interpreted Dickey-Wicker, "it is much more difficult now" for Lamberth to rule on the contrary, since his decision would "almost certainly be slapped down" by the same court of appeal, said Greely.

However, the door is still open a crack to the plaintiffs because the appellate court did not weigh on another of their arguments: that the guidelines are unlawful because NIH did not follow the appropriate procedures when he developed them. (Greely think that argument is weak.)

How long these decisions and appeals take to play? Applicants should ask the appeals court to bench notice within 45 days, says Greely. Lamberth could rule on the underlying case a day or it could decide to hold a trial, which could take several months. Yet Lamberth of rules, its decision would be appealed to the appellate court and eventually the Supreme Court of the United States.

Greely scientists think can breathe easy. "No matter how you look at it was a very good day for the research community on human embryonic stem cells. The best chance seekers had was with this [appeals court] panel, and all by a low likelihood for them" says Greely. Tony Mazzaschi of the Association of American Medical Colleges are not as optimistic. "it will be a long fight," he predicted. "it will be a long time before it's over."

Five years, Rob Summers was 20 years old and about to enter his first year State University of Oregon in Corvallis, where he was a baseball team's pitcher. One night when he went out to get a gym bag from his car, another car jumped the curb, hit him, and then took off. Summers was paralyzed from the chest down. Today, in a case report published in The Lancet , physicians and researchers reveal that Summers has regained the ability to stand for a few minutes and do some voluntary movement of his legs, through electrodes they implanted in his spinal cord.

Other researchers say that the degree of recovery is remarkable, perhaps even unprecedented, but they warn that the procedure has not produced a complete cure and may not work as well for patients who are older or have more serious injuries. At a press conference today announcing the results, the researchers who conducted the study, neuroscientists V. Reggie Edgerton of the University of California, Los Angeles, and Susan Harkema of the University of Louisville Kentucky, framed their method as a way to make the most of the neural circuit that remains intact after an injury to the spine, as opposed to restoring the severed connections.

After his injury, Summers was unable to move his legs or trunk, although he had some ability to feel a light touch or bite in these areas. Two years of intensive physical therapy have failed to restore voluntary movement. The reason for spinal cord injuries cause lasting paralysis is that neurons in the adult spinal cord can not sprout new axons armlike extensions that neurons use to connect to each other. As a result, parts of the cerebral cortex that plan and initiate movements remain disconnected from spinal neurons that normally help their bidding.

In December 09, Summers became the first patient enrolled in a clinical trial of a pioneering method in studies with rodents and cats by Edgerton and others. Louisville surgeons placed a small strip of electrodes on the hard, protective layer surrounding the spinal cord. Summers has regularly undergone physiotherapy sessions during which the researchers spent pulses of electrical current through the electrodes to stimulate neurons in the spinal cord. After a few sessions, Summers was able to stand with assistance. At the end of 80 sessions over 7 months, Summers was able to stand up and support his own weight for several minutes and, with help, to step. Lying in bed, he was able to move his toes, feet and legs on command. Although these exploits require the pacemaker to be on, Summers also reported improved bladder control and sexual function, even with the stimulator off, Edgerton and colleagues reveal in The Lancet paper.

Research in animals with lesions of the spine showed that this type of epidural stimulation can activate neural circuits in the spinal cord and allow them to use sensory information to coordinate leg contractions necessary to act and take a step muscle, Edgerton said at the press conference. The results show for the first time that this method works in humans, Edgerton said.

"This is the first time someone with complete, chronic motor paralysis demonstrated any type of voluntary movement," said Gregoire Courtine, a neuroscientist at the University of Zurich in Switzerland.

"it is an individual, so you should take it with a grain of salt," says Michael Beattie, a neuroscientist at the University of California, San Francisco. "on the other hand, it is really very impressive." the fact that Summers has taken a voluntary movement suggests that at least some nerve fibers from the cortex to the spinal cord should have been spared by the injury, Beattie said. He noted that patients with spinal cord severed probably could not recover all voluntary movements.

in a press release issued by the Lancet , Summers said the treatment has done wonders for his sense of well-being. "This procedure has completely changed my life for someone who for four years was unable to even move a toe, to have the freedom and ability to stand on my own is the most amazing feeling. "

Although Courtine think there is still much room for improvement. Improvements to the design of the stimulation electrodes and more sophisticated models of electrical stimulation could produce better effects. So could stimulant, in conjunction with injections of drugs into the liquid bathing the spinal cord to improve neuronal repair, he said.