Chris Austin pictured in January 2012 with screening robots at the National Center for Advancing Translational Sciences.{credit}Meredith Wadman{/credit}

A Harvard-trained physician and neurogeneticist with a boyish grin who worked in industry for seven years before moving to the National Institutes of Health (NIH) will head the biomedical agency’s fledgling translational medicine centre, agency director Francis Collins announced this morning.

Christopher Austin, who will take the reins at the $575 million National Center for Advancing Translational Sciences (NCATS) on 23 September — the day he turns 52 — has headed NCATS’ pre-clinical innovation efforts since the centre’s inception last December.

Austin has worked in translational medicine efforts at NIH since 2002, directing its Therapeutics for Rare and Neglected Diseases programme, founding its molecular libraries initiative and heading the NIH Chemical Genomics Center (NCGC). The centre, now part of NCATS, uses high-end instrumentation to help develop molecular probes with the goal of hastening drug discovery.  Prior to his time at NIH he worked for the pharmaceutical giant Merck at the company’s West Point, Pennsylvania facility in a number of roles. His research there was on genome-based efforts to discover new molecular targets and drugs.

Austin’s combined experience, Collins told the inaugural meeting of NCATS’ Advisory Council today, “make[s] him an ideal candidate to lead NCATS into the future.”

“This is a really hard, ambitious but deeply important mission we’re all on,” Austin told the council, joking that his experience as a hurdler in high school track may prove useful as NCATS seeks to tackle obstacles to the timely and affordable development of new drugs.

One of a dwindling number of major air carriers that continue to transport non-human primates for research said yesterday that it will stop such shipments.

“We have stopped conducting this business,” Air China declared in an e-mail sent yesterday to People for the Ethical Treatment of Animals (PETA). Fewer than 24 hours earlier, the animal-rights group had asked its Facebook and Twitter followers to telephone the air carrier’s cargo office at New York’s John F. Kennedy airport, demanding that it stop shipping primates bound for research labs. The company was inundated with phone calls. They followed at least 24,000 e-mails sent to the airline by PETA supporters since 12 July, according to a press release from PETA.

The move by Air China follows a similar announcement last month by Israel’s El Al Airlines, and is part of a larger trend that has seen most major air carriers refusing to fly primates bound for research, as Nature reported in March.

According to Justin Goodman, the associate director of the laboratory investigations department at PETA in Washington DC, Air China’s decision leaves China Eastern as the only major airline known to be flying the animals out of China, the country that ships more than 70% of the non-human primates bound for US labs.

Michael Hsu, the president of the animal-breeding company Shared Enterprises in Richlandtown, Pennsylvania, which maintains a macaque breeding colony in Shanghai, confirmed that Air China has not flown animals out of the country since last week. He says that the result will be to make the flights more expensive, driving up the costs of research and ultimately of therapies.

“Where is the concern for human life that PETA shows for animal life?” Hsu asks, noting that non-human primates are used in research on maladies including Alzheimer’s disease, Parkinson’s disease, cancer and HIV/AIDS.

Hsu also maintains that the ultimate effect of the airline campaign will be to drive the research off of US shores, to countries where it is less well regulated. “This is a lose-lose situation, for the [US] economy, for the research and for the patients,” he says.

The carriers that have stopped transporting primates for research include American, Delta, Lufthansa, British Airways, Virgin Atlantic and Air India. Those under pressure to stop doing so include Air France, Air Canada and Continental Cargo, a subsidiary of United Airlines.

Leaders of the US National Children's Study have struggled to define a sampling strategy for the 100,000 children they aim to recruit. {credit}Image source/Corbis{/credit}

The US National Children’s Study (NCS) came into being in 2000 as an ambitious effort to track influences on the health of 100,000 US children from before birth to age 21. Now the nature of that effort has been significantly redrawn, in a revised recruiting plan issued on 24 July by study leaders at the US National Institutes of Health (NIH) in response to complaints from US lawmakers.

Among the politicians’ main concerns: the study has spent US$1 billion since 2000 to enrol, as of mid-June, 3,650 subjects.

Part of its problem was its expensive recruiting approach, much of it relying on going door to door in 105 far-flung locations that were scientifically selected to represent the entire US population, to obtain a ‘national probability sample’. But in February, study leaders proposed abandoning that approach in favour of a ‘convenience sample’ drawn mainly from the client lists of various health-care providers.

That change drew criticism from many corners, because it meant that the study would lose much of its power as a tool for teasing out disease risk factors and prevalences for all US children. Senate lawmakers who oversee the study’s funding told its leaders to “make every possible effort” to enrol a statistically representative sample of children. This month their counterparts in the US House of Representatives ordered them not to make any changes to the current design until the Institute of Medicine (IOM) has reviewed the proposed changes.

According to the revised plan, the study would still recruit 100,000 subjects: some 40,000 from a “birth cohort” recruited from a geographically dispersed, nationally representative selection of hospitals and birthing centres; another 50,000 or so in a “prenatal cohort” of pregnant women recruited from clinics and physicians’ offices that refer patients for delivery to that same set of hospitals; and 10,000 recruited from the same clinics and offices, but before they become pregnant — a ‘preconception cohort’. That group of 10,000 would also be used for deep dives to assess particularly under-represented populations, or those with specific exposures. (A group of pregnant women exposed to fracking is an example the document puts forward).

Last week Nature spoke with Steve Hirschfeld, the paediatric oncologist who is director of the NCS, the day after the revised plan was presented to the study’s advisory committee:

Continue reading →

A key figure bearing on the fiscal fate of the US National Institutes of Health (NIH) was published today: the US House of Representatives subcommittee that funds the agency proposed sustaining it with a flat, US$30.6 billion budget in 2013 — the same figure that President Barack Obama requested in February. Because the NIH-funding committee in the Senate has already called for a $100-million boost for the biomedical agency next year, the agency looks likely, in a financially precarious time, to have escaped the absolute cuts of the budget axe, at least for the moment.

However, says Darrell Kirch, the president and chief executive of the Association of American Medical Colleges: “The bill’s rigid requirements for the National Institutes of Health research-grant awards process, coupled with a freeze of that agency’s budget, would undermine NIH’s ability to support the most promising, scientifically driven research proposals at medical schools and teaching hospitals nationwide.”

In a departure from typical funding bills, the proposed law stipulates that the NIH  “maintain an allocation of 90% to extramural activities, 10% for intramural activities, and at least 55% toward basic science activities.”  It is also required to fund a precise number — 16,670 — of training awards and fellowships for undergraduates, doctoral students and postdoctoral researchers.

A summary of key figures in the House subcommittee bill is available here, and the full bill can be perused here.

Continue reading →

The news that the US Food and Drug Administration (FDA) conducted a vast, covert operation that tracked and collected the computer communications of five scientific employees has been further fleshed out in a letter from US Senator Charles Grassley to the FDA Commissioner, Margaret Hamburg. It says that the FDA’s top legal official approved the operation in writing.

The letter came three days after the agency’s assistant commissioner for legislation, Jeanne Ireland, detailed and defended the agency’s actions in this seven-page letter from the FDA to Grassley on 13 July.

Beginning in 2010, the secret operation captured thousands of e-mails and related documents sent from the scientists to members of US Congress, congressional staff, lawyers and others.  The agency captured, among other things, every keystroke on the scientists’ government-issued computers, and screenshots taken at five-second intervals. The scientists — four of whom were fired or not rehired by the agency when their temporary positions came up for renewal — were concerned with the agency’s approval of medical devices that they thought were unsafe.

The agency collected more than 80,000 pages of documents as it tracked the scientists, who worked in the FDA’s Center for Devices and Radiological Health (CDRH). These were inadvertently posted on a public website by an FDA contractor, Quality Associates, located in Fulton, Maryland. The cache — which has since been removed from the website — was first reported in this New York Times article on 14 July.

Continue reading →

{credit}US Supreme Court{/credit}

In a 5-4 vote on the signature legislative achievement of Barack Obama’s presidency, the US Supreme Court today upheld the Patient Protection and Affordable Care Act, including the central, controversial provision requiring  the uninsured to buy health insurance. Chief Justice John Roberts, who usually votes with the court’s conservative majority, switched sides for the crucial fifth vote that upheld the law — and delivered a decisive victory to the Obama administration.

In a key passage of this 59-page decision by Roberts,  the chief justice writes of the so called “individual mandate” requiring the purchase of health insurance:

“Those subject to the individual mandate may lawfully forgo health insurance and pay higher taxes, or buy health insurance and pay lower taxes. The only thing they may not lawfully do is not buy health insurance and not pay the resulting tax.”

With that, the court rendered moot the question of whether other parts of the law that touch on biomedical research could be preserved if the mandate were struck down; with the law upheld in its entirety, the following provisions relevant to biomedical research and commercialization are preserved: Continue reading →