US primate research centre evacuated

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A massive explosion at a nearby chemical plant yesterday forced the evacuation of nearly 250 personnel from the New Iberia Research Center, a major primate center that houses 360 chimpanzees and 6500 macaques and other monkeys in southern Louisiana.

No one was hurt in the 3:40 pm explosion at the Multi-Chem Corp. plant, which is 300 metres from the research centre. But it was followed by multiple additional explosions over a period of hours and generated an immense black plume of smoke (pictured) as well as intense heat near the facility. An area within a one-mile radius of the plant was evacuated, and the primates were left untended until authorities allowed a team of a dozen employees to reenter the complex around 10:30 pm.

Closest to the fire were between 800 and 1000 rhesus macaques housed in 42 enclosures on the eastern edge of the 100-acre primate research center. (Pictured in foreground, second photo, courtesy of The Daily Iberian.)

The 43-year-old center, partially funded by the National Institutes of Health, conducts studies for government, industry and academic clients. It is part of the University of Louisiana at Lafayette, and is coincidentally featured this week in a Nature article examining US funding for chimpanzee research.

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Chair of US chimp research committee withdraws

uch2_stobo_jancolumnstory.jpgAn Institute of Medicine (IOM) committee that is studying whether the United States should continue to fund chimpanzee research last month saw two of its provisional members withdraw, after animal welfare activists raised questions about their ability to be objective.

Now, the committee’s chair, John Stobo, the senior vice president for health sciences and services at the University of California, has also withdrawn from the committee. This listing of current committee members notes that he withdrew on June 8.

Stobo, who ran the committee’s first meeting late last month, referred questions about his departure to the IOM, where spokeswoman Christine Stencel said by e-mail: “The review process is confidential. We appreciate Dr. Stobo’s willingness to share his time and expertise.”

She added: “The committee appointment process is a dynamic process that involves public feedback to a list of provisional committee members as well as internal review of their expertise, interest in serving, and any possible conflict of interest, whether perceived or actual. As a result of this multifaceted process, it was mutually determined that Dr. Stobo would not serve on the committee after all.”

Stencel said that the IOM expects to name a new chair in the next few days.

Animal rights activists, who have filed complaints about several committee members, but not Stobo, were bemused.

“We unfortunately do not have any sense of why he is no longer on the committee,” said Jeanne Stuart McVey, a spokeswoman for the Physicians Committee for Responsible Medicine.

Added Andrew Rowan, the chief scientific officer at the Humane Society of the United States: “It may simply be that he decided to withdraw. An [IOM] committee chair has a fairly onerous job, especially when the topic is controversial in the way this one is.”

Public comments on the remaining 12 committee members continue to be accepted; hit the “feedback” button at the bottom of this link.

NIH finds a few new friends in budget chill — UPDATED

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At a moment in which US politicians are seeking to outdo each other as proponents of fiscal restraint, it is relatively rare to find senators speaking up to defend spending. But today, roughly a third of senators are doing so on behalf of the National Institutes of Health (NIH), asking the Senate’s spending chiefs to protect the $30.8 billion biomedical agency as they negotiate its 2012 budget in the next few months.

Senator Richard Burr (right), a North Carolina Republican who is a fiscal conservative, and Senator Bob Casey (left), a first-term Pennsylvania Democrat, on Wednesday began asking other senators to sign on to a “Dear Colleague” letter dated today (June 10). It is addressed to the leaders of the powerful Senate Appropriations Committee, and to the senior members of the subcommittee that funds the NIH. As of this morning, the letter had gathered a total of 31 signatures, four of them from Republicans.

“As you and your colleagues prepare the Fiscal Year 2012 appropriations bills,” the letter begins, “we respectfully ask that you maintain a strong commitment to funding for the National Institutes of Health.” It goes on to call medical research funding “essential” for controlling ballooning health care costs, for treating and curing diseases and for keeping the country the “world leader in research and development.”

The letter’s timing is not accidental. On July 26, House lawmakers are scheduled to hammer out the details of their version of the spending bill that funds the NIH. The pot of money they have been given to work with, to fund all agencies covered by the bill, is 12% lower than it was for the current fiscal year; and NIH represents almost 20% of the funding provided by the bill. (The Senate has not yet produced a similar allocation of funds for its spending subcommittees to work with.)

Francis Collins, the NIH director, told a committee of external advisors yesterday: “The [funding] prospects ahead for FY 12 are a source of really deep concern.”

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NIH provides detailed budget of new translational medicine center

Several months behind the rest of its 2012 budget proposal, the National Institutes of Health (NIH) has produced the much-awaited minutiae of how it intends to fund a new center for translational medicine beginning in October.

The detailed budget chart for the proposed National Center for Advancing Translational Sciences (NCATS) is part of this letter sent to Senator Tom Harkin (Democrat, Iowa) on June 6 by Kathleen Sebelius, the secretary of Health and Human Human Services, NIH’s parent agency. Harkin chairs the subcommittee that funds the NIH, and his approval of NIH’s reorganization plan will be crucial to the agency’s ability to launch the NCATS. Director Francis Collins has pushed hard to have that happen at the beginning of the government’s 2012 fiscal year, on October 1st.

“Chairman Harkin is a supporter of the NCATS concept in principle, but will be examining this specific proposal,” Harkin’s communications director, Kate Cyrul, said in an email on June 7.

As the subcommittee writes its spending bill for 2012, others will be looking at it closely too: Sen. Richard Shelby (Alabama), the senior Republican on the subcommittee, pressed Collins last month on why he had not yet delivered the detailed plan to the subcommittee. He also questioned “whether NCATS is the right approach” to speeding experimental drugs to patient bedsides.

(Sebelius wrote confidently to Harkin that NCATS will do just this, “accelerating the development and delivery of new and more effective diagnostics and therapeutics.” She also reminded him that the proposal is not asking for new money beyond that already sought by the Obama’s administration’s 2012 budget request.)

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Study to examine use of chimpanzees in US research — UPDATED

An Institute of Medicine (IOM) committee that will recommend whether the US government should continue to support chimpanzee research opened its inaugural meeting yesterday in Washington, D.C. and began wrestling with the thorny questions it has been set.

The Committee on the Use of Chimpanzees in Biomedical and Behavioral Research is charged with determining “if chimpanzees are or will be necessary for research discoveries” to improve public health – and for determining the safety and effectiveness of new drugs and vaccines. Its task also includes looking at whether the animals, humans’ closest living relatives, are necessary for progress in behavioral research.

Sally Rockey, NIH’s Deputy Director for Extramural Research, told the committee: “We are expecting a highly objective study, one that is going to consider the scientific ramifications of the use of chimpanzees….If they are needed, why are they needed? You need to describe that to us.”

The National Institutes of Health (NIH), the agency that supports chimpanzee research, asked the IOM to undertake the study in January, after three senators wrote this letter to NIH director Francis Collins. They were reacting to a controversial NIH proposal to move 176 government-owned chimpanzees out of semi-retirement and back into active research.

Yesterday, in a public session in a small, crowded room at the National Academies’ Keck Center in downtown Washington, the committee members asked pointed questions of invited guests that included officials from the NIH.

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Opponents in stem cell case find themselves in rare agreement: UPDATED

The US government has changed its procedural strategy in a lawsuit that challenges its funding of human embroynic stem cell research, agreeing with the plaintiffs that a lower court judge should receive additional briefings before deciding the case on its merits.

Lawyers for the Department of Justice initially opposed a request by plaintiffs James Sherley and Thersa Deisher, who on 9 May asked Judge Royce Lamberth of the US District Court for the District of Columbia for permission to file additional arguments in their attempt to influence his decision in Sherley v. Sebelius. But today, in this filing, the plaintiffs’ attorneys announced that the government’s lawyers have changed course and are not opposing the request, which now asks that both sides file additional, 10-page, briefs by June 24.

It is up to Lamberth to allow or deny the requests as he ponders arguments in the case. Last autumn, both the government and the plaintiffs asked him to render speedy, “summary” judgment in the matter. In April, the Court of Appeals for the District of Columbia Circuit overturned Lamberth’s preliminary injunction shutting down National Institutes of Health funding for the research. But the heart of the case still lies with Lamberth to decide.

Separately today, different “Perspectives” papers in the New England Journal of Medicine offered opposing views on the significance of last month’s appeals court decision.

Here, I. Glenn Cohen of Harvard Law School and Eli Adashi, at Brown University’s school of medicine, proclaim that the decision means that the “Battle [is] Won, but Not the War.”

In this paper, George Annas, of the School of Public Health at Boston University, said that the decision amounts to “sudden death” for the legal attempt to kill NIH funding of hESC research.

Watch this space for continuing coverage of the litigation.

UPDATE: May 19, 2011, 12:48 pm

Judge Royce Lamberth today approved the plaintiffs’ request that they and the defendants be given the opportunity to file 10-page, supplemental briefs by June 24. Lamberth will consider these while deciding whether, and if so, to whom, to grant summary judgment in Sherley v. Sebelius.

Collins: NIH grant application success rate heading for historic low

Testifying on Capitol HIll today, Francis Collins, the director of the National Institutes of Health (NIH), projected, “with some uncertainty,” that success rates for scientists trying to win grants from his agency will end up between 17% and 18% for the 2011 fiscal year, which ends on September 30.

“That will be the lowest in history,” Collins told the Senate Appropriations Subcommittee on Labor, Health and Human Services and Education, which funds the NIH. “For every six grants, we will fund one of them, and five are going to go begging.”

The agency’s grant application success rate in 2010 was 20%.

The agency sustained a 1%, $323 million cut in the budget law passed by Congress last month, which funds it for the rest of the fiscal year. President Barack Obama in February asked Congress to provide the agency with $31.8 billion in 2012 — a 2.4% increase on its 2010 funding.

Collins also faced questions about the proposed National Center for Advancing Translational Sciences (NCATS), which he is planning to launch in October, when the new fiscal year begins.

Senator Richard Shelby of Alabama, the senior Republican on the subcommittee, complained that the administration’s 2012 budget request “does not provide adequate details on the [NCATS] reorganization.”

“How can the subcommittee be expected to support a program that does not yet exist” and for which NIH hasn’t provided adequate budgetary details, Shelby pressed Collins. “And when will we receive more details?”

Collins called Shelby’s questions “very fair,” and replied that NIH has completed budget planning for the new center, which is now being vetted at the Department of Health and Human Services and the Office of Management and Budget. “We hope to get that to you within the next few weeks,” he said.

Collins also responded to concerns that Shelby expressed in his opening statement, that, by launching NCATS, the agency is tackling a problem — translating basic discoveries from bench to clinic — that, if it were easy, would have been solved by industry, where drug pipelines are in fact languishing.

“As we review this proposal, we need to consider the fact that NIH is not a drug developer or an expert in the therapeutics world,” Shelby said. “NCATS may be the answer to solve this complex issue. But it also may not.”

Collins replied, in part, that “NCATS will complement—not compete with—the private sector….It will reinforce, not reduce, NIH’s commitment to basic science.”

Collins’ prepared statement for the hearing is available here.

Minor movement on US stem cell legal challenge

Plaintiffs challenging the US government’s funding of human embryonic stem cell research today asked the judge now considering their case for a chance to make additional arguments to him in writing.

Adult stem cell researchers James Sherley and Theresa Deisher today submitted this request to Judge Royce Lamberth of the US District Court for the District of Columbia. Lamberth is considering their request for summary judgment in Sherley v. Sebelius.

A higher court 11 days ago found that Deisher and Sherley are unlikely to prevail on the merits of the case, and overturned a preliminary injunction issued by Lamberth last August. It is now up to Lamberth to rule on the merits of the case; both sides have asked him to do so speediliy.

In light of the April 29 decision by the US Court of Appeals for the District of Columbia Circuit, Sherley and Deisher ask for a chance to submit a 10-page, supplemental, brief to Lamberth by June 3.

Their attorneys write in the petition: “A divided panel of the D.C. Circuit filed an opinion and judgment that vacated the preliminary injunction but expressly left numerous issues unresolved…. The supplemental briefs would aid the Court” in considering both sides’ request for speedy judgement, they add.

They suggest to Lamberth that the government be allowed to respond to their supplemental brief in ten written pages by June 24, and that they have a chance to rebut the government’s arguments once more in a 5-page reply to be submitted by July 6.

The government is not interested, apparently. “Defendants oppose this Motion because they feel it is unnecessary,” the petition notes.

Watch this space for an update when Lamberth rules on the request.

Q&A: Novel study suggests autism three times more prevalent than thought

Richard_Grinker_260.jpgIn the ever-more-visible field of autism epidemiology, a new study grabbed headlines today. It suggests that the prevalence of the poorly-understood mental and social disorder is nearly triple the most recent, 0.9 percent, estimate from the US Centers for Disease Control and Prevention (CDC).

The study, led by Young Shin Kim of the Child Study Center at the Yale University School of Medicine with senior author, Roy Richard Grinker (pictured), an anthropologist at George Washington University, among others, appears online today in the American Journal of Psychiatry. It estimates the prevalence of autism spectrum disorder (ASD) at 2.6%, or 1 in 38 children, in a population of roughly 55,000 schoolchildren, aged seven to twelve, in the Ilsan district of Goyang City, South Korea. It is the first comprehensive autism prevalence study to survey an entire population, rather than to rely on case reports, as do studies by the CDC and other epidemiological groups; the case report approach misses undiagnosed cases which are not in school or health facility records.

Autism Speaks, an advocacy group that is the lead funder of the six-year study, said in a press release today that the study “does not suggest that Koreans have more autism than any other population in the world. What it does suggest is that autism is more common than previously thought and that, if researchers look carefully, especially in previously understudied, non-clinical populations, they may find more children with ASD.”

Arthur Caplan, who runs a program on mental health ethics as the director of the Center for Bioethics at the University of Pennsylvania, called the findings “significant” and “important’, and added that the new number might help research advocates’ cause on Capitol Hill.

The study also belies claims that a rise in autism is linked to vaccination programs, Caplan says. "You wouldn’t see a sudden explosion in cases unless there was a sudden explosion in vaccinations. And there was nothing like that in South Korea. It puts another dagger in the heart of ‘vaccines are the cause’.”

Today, Nature caught up briefly with Grinker as he rode to a television interview. Our question and answer exchange with him appears below:

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Members named to panel to evaluate US chimpanzee research

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Should the United States remain the only country apart from Gabon to fund chimpanzee research? The membership of an Institute of Medicine (IOM) committee recently asked to pronounce on that question was made public yesterday, three weeks in advance of the group’s inaugural meeting.

The Committee on the Use of Chimpanzees in Biomedical and Behavioral Research will spend the next eight months studying whether the US, through the National Institutes of Health (NIH), should continue to fund the controversial research, which takes place at four primate centers supported by the agency. (NIH also supports a fifth center, the Alamogordo Primate Facility, which houses chimps but does not conduct research.)

The 15-member panel aims to issue a report by the end of December. Its first meeting will take place in Washington on 26 and 27 May.

John Stobo (pictured), a medical doctor who is the senior vice president for health sciences and services for the University of California, will chair the committee. Other members include Floyd Bloom, the former editor-in-chief of Science; Alan Leshner, who, as chief executive of the American Association for the Advancement of Science, is currently the journal’s publisher; Letti Medina, the associate director of animal welfare and compliance at Abbott Laboratories; and Margaret Landi, the vice president of global laboratory animal sciences and chief of animal welfare for GlaxoSmithKline, which in 2008 voluntarily stopped using chimpanzees in its research. The panel does not have representation from any animal welfare or rights group.

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