BOULDER, COLORADO—While the media is gripped with pictures of waters swallowing freeways and pouring into homes and offices in southeastern Texas, geoscientist Robert Brakenridge is waiting for images of his own.
Breaking news and analysis from the world of science policy
The U.S. Food and Drug Administration (FDA) today approved a new cancer therapy that involves genetically modifying a patient’s immune cells. The agency called the decision a “historic action” because the therapy, developed by Novartis, is the first gene therapy treatment approved in the United States.
The new treatment involves removing immune cells called T cells from a patient’s blood and giving them a gene for a protein called a chimeric antigen receptor, or CAR, that directs the T cells to target leukemia cells. The modified cells are then transfused back. Although the treatment sometimes causes severe side effects, in a Novartis clinical trial the drug caused remission in 83% of 63 young patients with a certain type of leukemia, B cell acute lymphoblastic leukemia (ALL).
FDA approved the Novartis drug, called Kymriah (tisagenlecleucel), for children and adults up to age 25 with B cell ALL who have not responded to conventional therapy or who have relapsed. About 3100 people under age 21 are diagnosed with ALL each year in the United States, though most respond to standard therapy.
China is tightening the screws on internet access, again. The latest crackdown—an evolving effort to ban virtual private networks (VPNs) not under government control—could seriously erode scientists' ability to stay connected with peers abroad.
"Internet accessibility is a major obstacle for our research. It makes international collaboration difficult and damages the reputation and competitiveness of Chinese science institutes," says an astronomer in Beijing who, like others contacted for this story, feared possible repercussions for criticizing official policy and asked to remain anonymous.
China's Great Firewall routes virtually all incoming international internet traffic through a handful of access points, where government servers block access to blacklisted domain names and internet protocol addresses. The list of forbidden sites—Wikipedia tallies at least 3000—includes social media platforms such as Facebook, YouTube, and Twitter. China reportedly has 50,000 internet police who monitor domestic social media sites, deleting posts deemed seditious or merely critical of the government. Sites now commonly used for research are also blocked. These include Google Scholar, important for scholarly searches; Google Docs and Dropbox, which allow scientists to share materials for organizing conferences and managing collaborations; and even, unfathomably, the NASA Jet Propulsion Laboratory.
Last weekend, Hurricane Harvey put an end to a lucky streak: It became the first major hurricane to make landfall in the United States since 2005. The Category-4 storm barreled into Texas on 25 August, lashing the coast with 200-kilometer-per-hour winds, and deluging Houston with more than a meter of rain. As the third hurricane of the season, Harvey also gave weight to predictions from the National Oceanic and Atmospheric Administration (NOAA) that 2017 will be an above-average year for Atlantic storms. For decades now, storms have been getting a boost from a powerful but still mysterious long-term cycle in North Atlantic sea surface temperatures, which appears to be holding steady in its warm, storm-spawning phase.
For years, U.S. forecasters have envied their colleagues at the European Centre for Medium-Range Weather Forecasts (ECMWF) in Reading, U.K., whose hurricane prediction models remain the gold standard. Infamously, the National Weather Service (NWS) in 2012 failed to predict Hurricane Sandy’s turn into New Jersey, whereas ECMWF was spot on. But two innovations tested during Hurricane Harvey, one from NASA and another from the National Oceanic and Atmospheric Administration (NOAA), could help level the playing field.
One of the main targets in the war on drugs could well become a drug to treat the scars of war. The U.S. Food and Drug Administration (FDA) has designated 3,4-methylenedioxymethamphetamine (MDMA), better known as the illegal drug ecstasy, a "breakthrough therapy" for posttraumatic stress disorder (PTSD), a status that may lead to faster approval.
The agency has also approved the design for two phase III studies of MDMA for PTSD that would be funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit in Santa Cruz, California. MAPS announced the "breakthrough therapy" designation, made by FDA on 16 August, on its website today; if the group can find the money for the trials, which together could cost an estimated $25 million, they may start next spring and finish by 2021.
That an illegal dancefloor drug could become a promising pharmaceutical is another indication that the efforts of a dedicated group of researchers interested in the medicinal properties of mind-altering drugs is paying dividends. Stringent drug laws have stymied research on these compounds for decades. "This is not a big scientific step," says David Nutt, a neuropsychopharmacologist at Imperial College London. "It’s been obvious for 40 years that these drugs are medicines. But it’s a huge step in acceptance."
The Department of Energy (DOE) denied today that it's banning the use of "climate change" in materials after a public letter alleged scientific censorship and sparked a Twitter storm.
Jennifer Bowen, an associate professor at Northeastern University in Boston, posted a letter on Facebook showing a DOE official asking her to remove the words "global warming" and "climate change" from her research proposal on nutrient loading in salt marsh carbon sequestration.
The National Institutes of Health (NIH) in Bethesda, Maryland, has confirmed that the agency’s definition of clinical trials now includes imaging studies of normal brain function that do not test new treatments. The change will impose new requirements that many researchers say don’t make sense and could stifle cognitive neuroscience.
Although NIH revised its definition of clinical trials in 2014, the agency is only now implementing it as part of a new clinical trials policy. Concerns arose this summer when an NIH official said the definition could apply to many basic behavioral research projects, including brain studies—for example, having healthy volunteers perform a computer task while wearing an electrode cap or lying in an MRI machine. Scientists say the new requirements—such as training and registration on clinicaltrials.gov—are unnecessary, will impose a huge paperwork burden, and will confuse patients seeking to enroll in trials.
NIH told ScienceInsider in July that the agency was still deciding exactly which behavioral studies would be covered by the new definition. On 11 August, the agency released a set of case studies that has confirmed many researchers’ fears. Case No. 18 states that a study in which a healthy volunteer undergoes MRI brain imaging while performing a working memory test is now a clinical trial because the effect being evaluated—brain function—is a health-related outcome.
President Donald Trump’s efforts to boost fossil fuel extraction face a courtroom hurdle of his own making.
His March 28 executive order “promoting energy independence and economic growth” rescinded the Obama administration’s calculation of the “social cost of carbon” — a metric that had been central to the process of crafting and justifying government rules addressing human-driven climate change.
The highly endangered North Atlantic right whale is having its worst year in decades. At least 13 of the whales—out of a population believed to be about 450—have died this year, most of them during the past 2.5 months in the Gulf of St. Lawrence off Canada's eastern coast.
That is "an unprecedented number of deaths," says whale biologist Moira Brown of the New England Aquarium in Boston. If the deaths continue, she says, "the population can't withstand this."
Researchers are still working to pin down how the whales died, but at least three appear to have been hit by ships, and one perished after becoming entangled in fishing gear. In a bid to prevent more losses, Canadian officials are scrambling to improve protections for the animals, which can reach 15 meters long and 72 tons. They've started near-daily reconnaissance flights to spot whales snared by ropes or nets, and imposed new restrictions on shipping and fishing until the whales migrate south later this year.