Health Meaning

After months of inactivity, a lawsuit challenging the legality of the National Institutes of Health (NIH) __gVirt_NP_NN_NNPS <__ funding for human embryonic stem cells (hESC) research may soon be moving again. Today, plaintiffs' lawyers in Sherley v. Sebelius asked US District Judge Royce Lamberth to allow the two sides to meet an April 29 decision from a federal appeals court.

In a victory for NIH, this decision overturned the preliminary injunction Lamberth last August that briefly stop hESC research.

The complainants note that 2-1 opinion of the court of appeal "expressly left many questions unanswered." They want to be given until 3 June to a page file 10 (or less) additional memory, the defendants respond to 10 pages by June 24, and that claimants until July 6 to submit a response five pages. In September the two parties asked Lamberth's prompt action in the case; the latest submissions were filed in October.

Whether or not cell phones cause brain cancer is an issue that has been debated (but no answer) for years, and aujourd 'hui the World health Organization (WHO) stepped into the fray. A WHO committee that evaluates various potential carcinogens found that radiofrequency electromagnetic fields, including cell phones are "possibly carcinogenic" to people. The announcement was seized upon and published in dozens of news outlets in minutes.

The International Agency for Research on Cancer (IARC) has concluded a possible carcinogenicity after a review of eight days of the literature by 31 experts in Lyon, France. The ranking is in the middle of the hierarchy of the IARC risk, joining a group of more than 250 potential carcinogens that also includes lead, engine exhaust, and occupational exposure to dry cleaning. In a sign of how difficult it is to determine that something does not cause cancer, one of some 00 agents that IARC has evaluated, caprolactam, a component of fibers and plastics, falls into the category "probably not carcinogenic".

Regarding cell phones, "we found some evidence of son tell us how cancer can happen, but I think that there are gaps and uncertainties recognized," said Jonathan Samet , chairman of the IARC working group and a physician and public health expert at the University of Southern California in Los Angeles, at a press conference. the working group was particularly influenced by an international study called Interphone which is to examine whether exposure to electromagnetic fields from cell phones radiofrequency causes cancer. last year, the INTERPHONE study group wrote in International Journal of Epidemiology it saw "no increased risk of glioma or meningioma." He continued: "There were suggestions of an increased risk of glioma at the highest exposure levels, but biases and errors" make it is difficult to demonstrate that the phones were the cause. "The possible effects of long-term heavy use of mobile phones require further investigation," they concluded.

IARC would like more research as well. Samet noted that, at this stage, there are almost 5 billion cell phone subscriptions worldwide, and "we expect an ever larger population that is exposed for longer and longer." That said , moving the cell phone category "possible" in a final will not be easy. epidemiological studies like tend to match Intercom healthy people with those who have brain cancer and ask both to remember their cell phone use. "We know that is inherently flawed," said Samet. And because these studies take time to complete, they inevitably look older technology. animal studies looking at the risk of radio frequency electromagnetic fields were mixed, both to know if they see a danger and why this might be.

what IARC reassess the risks of cell phone, the committee said, will depend on what new research comes out.

The chairman of a committee set up to help US National Institutes of Health decide to pursue biomedical and behavioral research with chimpanzees resigned . The organizers of the committee - the Institute of Medicine (IOM) and the National Research Council, revealed in an oblique noted June 8 that President

John Stobo, who oversees health science and service the University of California system (UC), "will not be on the committee." Stobo did not respond to an inquiry about his departure.

Stobo, who chaired the first meeting of the committee on May 26, is the third scientist was "provisionally approved" to participate and then removed. ( Nature news blog first reported on the committee changes earlier today.) Although it is not known why Stobo left, a committee member who asked not to be named said Science Insider IOM said it "could be considered" as Stobo was biased for animal research because of its position UC.

The Humane Society of the United States (HSUS) complained to the President of IOM Harvey Fineberg in a letter on May 24 that the committee was "significantly unbalanced," noting alleged conflict of interest of several members. Neither UC nor Stobo was mentioned in the letter, but he made only the institutions behind the other two members who left the committee. One was Alan Leshner, executive director of the AAAS Science s editor. The Board of AAAS advocated research primates in the past. The other member of the former committee was veterinary Leticia Medina of Abbott Laboratories, which used chimpanzees in research on hepatitis C.

HSUS is a key sponsor of a bill now before the US Congress, the Great Law of the cost savings of the Ape protection and prohibiting search "invasive" captive chimpanzees.

Christine Stencel, a spokesman for the IOM, said he did not discuss details of service to members. "We have mutually determined that these people will not be on the committee," said Stencel. "The process is confidential."

Despite the Italian researchers HIV / AIDS gain a level above berth in the field, the government has no plans to continue the National Programme AIDS research, which in its heyday in the 190s, received € 25 million per year. The program, long part of the Istituto Superiore di Sanita (ISS), the equivalent of the US National Institutes of Health in 09 was transferred to the Ministry of Health and given less than € 10 million which will be available until this year. The money will be executed in 2012, and there was no new call for funding. "There is no plan to boost the AIDS research program," complains Stefano Vella, who heads the research group on HIV, hepatitis and global health to the ISS in Rome. "The time here are tough "

immunologist Guido Poli of the scientific Institute San Raffaele in Milan noted that this" very quiet funeral for public funding of research on HIV / AIDS "comes at a most damaging moment.: Rome will host the International AIDS Conference July 20 17- sponsored by the International AIDS Society. "What I find unacceptable silence and resignation that is noticeable within the research community," said Poli. He further complained that Italy is the only G8 country that has not recently contributed to the Fund global fight against AIDS, tuberculosis and malaria. Vella, representing Italy at the European Commission Directorate General for research in Brussels, says the country is inefficient with collaborations based in Europe. "the total absence of strategic and it suicidal for the country is the main cause of poor performance at the European level, "says Vella.

ISS President Enrico Garaci said the Ministry of Health "is determined to continue to support the effort" and that "the possibility to fund AIDS research through a dedicated project remains on the table actively pursues the coming years (from 2013 and beyond). "He also notes that researchers of HIV / AIDS can also be financed through other avenues in Italy and the European community . "In conclusion, the availability of a dedicated project on AIDS must be justified, but it should be felt not as replacement of a broader competition with other Italian and European scientists active in different fields," written in Garaci an e-mail.

Poli replies that "option" has been on the table for several months, and notes that HIV grants / AIDS often suffer when they compete for the general fund because of the perception that they will receive support through the National AIDS Programme. He noted that the Ministry of Health in 09 has provided HIV / AIDS projects that € 2 million on a pot of € 100 million, and one of these projects was for basic research. "research on HIV / AIDS in disadvantaged effect in the absence of a dedicated fundraiser," concludes Poli.

* This article was corrected on June 30 to reflect that the National AIDS Research Programme transferred to the Ministry of Health in 09 and given less than € 10 million, not less than 2 million €, which become available until this year.

hundreds weekend floods in Copenhagen destroyed cell lines Biobank of the Danish Cancer Society. Scientists are still working to assess the full damage, says Jørgen Olsen, head of the biobank; they were able to recover more than 1 million tissue samples, however, including a prospective study of nutrition and cancer for 20 years.

Heavy rains flooded the streets and sewers of Copenhagen on Saturday, causing considerable damage in the city. the basement of the cancer society filled with 2 meters of water in about half an hour on Saturday night, says Olsen. "This was about 20 centimeters too high for freezers," he said, which filled with water, thaw cell lines and tissue samples. The researchers are not able to reach their samples to the Sunday mid-day, when the water had partially retreated. Right now, a refrigerated truck arrived Jutland, allowing refreeze samples researchers.

The cell lines are unlikely to survive the thawing, but the tissue samples are less delicate, Olsen said. "It does not matter that they have been warmed for a few hours, as long as you freeze again," he said. Some of the lost cell lines were shared with other laboratories and can be retrieved, but Olsen believes that dozens have been permanently lost. He said the cleaning and complete assessment of the damage will take months.

The biomedical research community is excited by the decision of the Federal Court today to throw a trial that threatened to close research funded by the federal government on human embryonic stem cells (hESCs). United States District Court for the District of Columbia Chief Judge Royce Lamberth, who earlier ruled against the National Institutes of Health, this time came down on the side of the NIH in several key arguments in the case.

The plaintiffs expect to appeal, and could end up before the Supreme Court of the United States. But their chances seem slim because the 38-page opinion strongly favors NIH, say some who read it. "It was a great decision to slam dunk even if Lamberth clearly somewhat reluctantly," said Anthony Mazzaschi of the Association of American Medical Colleges in Washington, DC "They can keep uncertainty alive for another 2 to 3 years but [their suit] is on life support, "said Stanford University law professor Hank Greely.

Harvard Medical School researcher George Daley stem cells is safer." I hope we're done for now, but nothing surprises me anymore, "said Daley.

the suit, Sherley v. Sebelius , was filed in 09 by groups that included two scientists who study adult stem cells. They argued that the execution of the July NIH guidelines of an order from President Barack Obama to lift the limits on hESC research violated the Dickey Amendment , a law that prohibits federal funding for "research in which a human embryo or embryos are destroyed."

In a ruling, Lamberth concluded that the plaintiffs were likely to win. It issued a preliminary injunction in August 2010 that stopped briefly NIH funding for hESC research before an appeals court suspended the injunction. But that court, the Court of the United States call for the DC Circuit, in a 2-1 decision in April overturned the preliminary injunction, allowing research to continue until Lamberth ruled on the background of the underlying case.

And this time, Lamberth sided with the NIH. Much of its decision based on deference to the conclusion of the Court of Appeal that NIH can interpret Dickey-Wicker to allow funding for hESC research but not on their derivation because the definition of "research" the law is ambiguous. "In the absence of a compelling reason to depart from this operation, the Court has to take at this stage of the proceedings," said the notice.

However, Lamberth did not seem happy about it. Citing the dissenting appeals court judge, he wrote: "While it is true that by following the Court of Appeal's conclusion as to the ambiguity of" research ", this Court become a reluctant partner in a bout of 'linguistic jujitsu, "... such is the life of a penultimate court."

Lamberth did not buy the argument of the plaintiffs that the hESC research puts embryos at risk by creating demand for hESCs. by that reasoning, even research involving a propane tank that took place in a laboratory adjacent to a place where the embryos were stored would be contrary to law, the notice said .

Finally, Lamberth threw on the complainants' request that NIH had improperly ignored tens of thousands of comments from opponents looking hESC when he developed the guidelines. President Obama had directed NIH to loosen search limits in hESC imposed by President George W. Bush. To prohibit research on hESCs instead of changing the rules "have violated the law," Lamberth wrote.

Steven Aden of the Alliance Defense Fund in Washington, DC, one of the plaintiffs' lawyers, said in a statement they "weigh all their call options." The plaintiffs would appeal first to return to the court of appeal, where the same three-member panel would likely hear the case, says Greely. If they lose again, which seems likely, applicants can appeal to the Supreme Court. "I think they will lose [in the Supreme Court], but it is probably worth it for them to give it a shot," said Greely.

Barbara Alving, director of the National Institutes doomed of Health (NIH) National Center for Research Resources (NCRR) announced earlier this week that she resign at the end of September.

The decision Alving to resign after six years in charge of NCRR is no surprise. The center of $ 1.3 billion, which funds biomedical resources such as large instruments and animal models, is scheduled to have its programs distributed among the other NIH institutes, on 1 October under a controversial plan by the NIH Director Francis Collins to establish a National Centre for the advancement of translational sciences (NCATS). Alving was one of many scientists who opposed the reorganization, arguing that it would be more logical to extend NCRR instead of scrapping it completely.

Alving said Science Insider she's leaving now because it has completed its "major goals", including the establishment of translational and clinical science major support scholarships, grants set up 5 years ago to support -to-bedside research bench in major academic medical centers. This program, which replaced a popular clinical research program, offers lessons for how reorganizations should be performed, Alving suggests. "Many voters are not happy," she said. But "there was a lot of discussion, a lot of buy-in. ... There was a calendar, finances have been developed, we knew where the funding would come, Congress has kept its part of the agreement. "

These things" not done optimally "with the current reorganization NIH, she said. NIH "tried to get community buy-in" of stakeholders NCRR but only "after the fact."

But Alving stresses that the disappearance of NCRR is not guaranteed. The Congress should not pass a . draft 2012 spending legislation for NIH October 1 the Committee of the House of representatives that funds NIH questioned the reorganization, although Senate budgeteers are more favorable, the 2012 budget of the NIH may liquidate part of a continuing resolution, a bill that extends the funding a year earlier. legislators should carve out an exception to dissolve and create NCATS NCRR. "I actually think NCRR will continue for an indefinite period of time," says Alving.

The uncertainty left in limbo NCRR members of staff who have been told they will spend their programs to other institutions, but have not received individual assignments. farewell note Alving advises them to "keep calm and carry on."

Alving, 65, is a hematologist who served as deputy and acting director of the National Heart, Lung, and Blood Institute (NHLBI ) and also led health Initiative of the woman before she comes to NCRR, first as acting director. she now plans to explore opportunities in health and global consultation, she said.

Two days after announcing Monday Alving, Collins published an NIH notes across its appreciation for "his unconditional service" at NIH and "his dedication and commitment." NCRR Deputy Director Louise Ramm will become acting director NCRR.

The resignation of Alving adds several NIH director positions. Anthonio Scarpa, director of the Center for Scientific Review, leaves later this month. Scarpa said the NIH staff at the end of July he was leaving in part to make room for someone who will "better reflect the [NIH] vision and the director of management style." NIH is working on a statement by Collins on the starting Scarpa, the press office said NIH. And Jeremy Berg, head of the National Institute of General Medical Sciences, NIH left in June; no replacement has yet been named.

The NHLBI also lacked a permanent director since Elizabeth Nabel left at the end of 09. That's five of the 27 institutes and centers of the NIH soon be without a permanent leader. (The fifth vacancy to the Information Technology Center, the center of the IT campus of NIH.)

* This article has been updated to reflect the fact that even if Alving was the director of NCRR since 07, it began as acting director in 05, and was therefore in charge of NCRR for 6 years and not 4 years.

The Bill & Melinda Gates Foundation today announced that Trevor Mundel, who currently heads the giant development team pharmaceutical Novartis International AG, will take over as president of its global health program on 1 December. Mundell, a scientist and physician pharmaceutical, replace Tachi Yamada, who retired as chairman of the program in June.

The program, which draws from $ 36.3 billion endowment of the Gates Foundation, fundraising, development and implementation of projects to fight against diseases such as HIV / AIDS, malaria, malnutrition, polio and tuberculosis in poor countries. To date, the program has granted $ 14.7 billion in grants, including funds in efforts to understand the disease kwashiorkor malnutrition and develop potential treatments against HIV.

Several pharmaceutical companies, including Alkermes Inc., Parke-Davis, Pfizer and Novartis, Mundel brought to shake their research and development programs and streamline the translation process from basic research on new drugs. Mundell is a big proponent of the "modeling and simulation" according to a 09 article in the Bio-IT World, using complex mathematical models to optimize and accelerate all biochemical medicines mechanisms for decision making and profits.

The appointment of Mundel probably reflects the will of the Gates Foundation to apply this approach to their health plans and drug development, said Denise DeMan-Williams, founder and CEO of the biotech Bench International recruitment firm (who recruited Mundel Novartis for work). "Trevor is someone who is probably several years ahead of his time," she said. "I think he will do flawlessly."

A US based company received permission to begin the first clinical trial in Europe involving human embryonic stem cells (hES). Advanced Cell Technology (ACT), based in Marlborough, Massachusetts, today received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to begin a trial that will treat 12 patients with macular dystrophy Stargardt. The disease strikes people between the ages of 10 and 20, causing a progressive loss of vision. There is currently no treatment.

Eye surgeon James Bainbridge of Moorfields Eye Hospital and University College London will lead the UK trial. He and his colleagues will inject into patients' eyes of the cells of the pigment epithelium of the retina that ACT-derived cells hES. In animal models, the cells were able to delay or even reverse the progression of the disease. Phase I / II will primarily examine the safety of the treatment, however.

Robert Lanza, scientific director of ACT, said the trial was essentially the same design as the US trial of the company with Stargardt's patients, which was approved last year. The fact that the US Food and Drug Administration approved the trial, however, was not a shoo-in with U.K. authorities said Lanza. "I thought it was going to sail through I was wrong; .. They were very strict"

The new trial is the first using hES cells to be approved outside the United States, said Lanza. the company plans to apply for approval for a second UK trial for macular degeneration, he added, would complement its US-based assay for the same condition. They then plan to wait until that the first results are in before starting any additional tests, he said. the first two US patients received cells of the company in July-a patient with Stargardt's disease and with related macular degeneration age. the first indications are positive, Lanza said. "We are very pleased with what we see today."

Women who donate their eggs for research in the UK should be compensated for the discomfort, risk, and inconveniences they suffer, according to a report published yesterday by the Nuffield Council on Bioethics. In its report "The human body: donation for medicine and research," influential think tank recommends that the U.K. National Health Service (NHS) to pay for funerals of organ donors.

The debate about the ethics of paying egg donors was revived after the news last week that researchers in New York came a little more to use human eggs to transform cells adults in embryonic stem cells. The group paid their donor $ 8,000 each. At the same time, another set of scientists published an account of their failed attempts donor recruitment eggs in Massachusetts without pay.

Currently British regulators cap the reimbursement of sperm and egg donation £ 250 ($ 30). The amount is intended to cover the direct costs such as travel or parking. The new report recommends that donors for fertility treatments are reimbursed for lost wages as well.

Women who are willing to donate eggs for research should also receive payment for their time, inconvenience and discomfort, the report said. "We see egg donation for research purposes, really quite comparable to those who volunteer for phase I clinical trials," says Albert Weale, chairman of the Nuffield Council. The report stresses that it should be limits on the number of times a person can donate.

in its recommendations, the report said researchers should share the tissue donated by patients or the general public. " it is unacceptable for individual researchers or research groups to obstruct, inhibit or deny access to other researchers for research scientifically valid "on samples freely given, the report said.

the Board recommends that NHS conduct a pilot study to pay for the funerals of organ donors to see if such a program could increase donation rates. under the plan, the NHS should pay for funeral expenses for those who were on organ donation national registry if they have died in circumstances where their organs could be donated. It also recommends to ask the families when they authorize organ donation if they would also be willing to give other tissue for research purposes.