In an unprecedented U-turn, the French government has asked drug manufacturer Merck to return to the market a thyroid hormone replacement drug named Levothyrox that the company had phased out and replaced with a new formulation just 6 months ago. The move, which overturns a decision by France's National Agency for Medicines and Health Products Safety (ANSM), comes after thousands of patients complained about side effects from the new drug, creating a media storm and a political problem for the French government.
The old formulation will once again become available in pharmacies on Monday, under a new name, Euthyrox; the two versions will coexist for an undetermined period of time.
About 3 million French people, 80% of them women, take Levothyrox, which replaces the hormone thyroxine in patients with hypothyroidism. Among their complaints over the past few months: hair loss, weight gain, extreme fatigue, headaches, diarrhea, and heightened heart rates.
A congressional spending panel has backed scientists running a $516 million network of bench-to-bedside research centers in their fight with the National Institutes of Health (NIH) in Bethesda, Maryland, over how it manages the network. It’s the latest step in a long-running tug-of-war over the direction of the Clinical and Translational Science Awards (CTSAs) program.
The CTSAs were created in 2006 by then–NIH Director Elias Zerhouni as part of his larger push to turn lab findings into treatments. In 2012 they became the lion’s share of the new National Center for Advancing Translational Sciences (NCATS) at NIH. Since then, CTSA investigators have clashed repeatedly with NCATS Director Chris Austin.
Austin began adding a clinical trials innovation network and other elements to the CTSA program, an expansion that CTSA investigators feared would come at the expense of their centers' budgets. Austin has also begun trimming the length of renewed awards, from 5 to 4 years, for centers that don't do as well in review. Rumors earlier this year that NCATS wanted to eventually cut funding for the CTSA program, from about 90% to 50% of the overall NCATS budget, heightened tensions. (NCATS Deputy Director Pamela McInnes told ScienceInsider that no such plans exist.)
Mona Nemer, a cardiology researcher and vice president of research at the University of Ottawa, has been named Canada's new chief science adviser by Prime Minister Justin Trudeau.
“Scientists need to have a voice,” Trudeau said, making the announcement in Ottawa today.
Nemer's office will have a CA$2 million budget, and she will report to both Trudeau and Minister of Science Kirsty Duncan. Her mandate includes providing scientific advice to government ministers, helping keep government-funded science accessible to the public, and protecting government scientists from being muzzled.She will also deliver an annual report to the prime minister and science minister on the state of federal government science.
Jim Woodgett, director of research at the Lunenfeld-Tanenbaum Research Institute in Toronto, knows Nemer well and called her an excellent choice for the job. “Mona's fantastic, she has a very good reputation among Canadian researchers and has had a long and productive career,” he says. “She's got all the cred.”
He added that during her 10 years in university administration, she has picked up political skills as well. “In my interactions with her she has always listened, asked questions and then came to her own decisions, she's not the kind of person who makes rash decisions,” he says.
Neither the prime minister nor the science minister made any reference to that report, known as the Naylor report, in their remarks today.
But Katie Gibbs, executive director of the science campaign group Evidence for Democracy in Ottawa, was encouraged by Nemer's own words at the announcement. “She talked a lot about making Canadian science the best in the world,” Gibbs said. “I'm hopeful that she will take up the Naylor report as part of her mandate.”
Gibbs said she was thrilled with the choice, especially because she thinks Nemer's experience as vice president of research gives her an understanding of administration and funding, as well as fundamental research. “She understands the science community and will be a strong voice for us,” Gibbs said.
Canada's first chief science adviser was appointed in 2004 by Prime Minister Paul Martin of the Liberal Party; the position was eliminated in 2008 by Prime Minister Stephen Harper of the Conservative Party.
As Hurricane Maria hammered the Caribbean last week, a handful of researchers hunkered down in concrete buildings at the Arecibo Observatory with food, well water, and thousands of gallons of diesel fuel for generators. They had done their best to secure the observatory, a 305-meter-wide radio dish nestled in the karst hills of northwestern Puerto Rico. They stowed removable antennas and waveguides, locked movable instrument packages in place, and installed storm shutters on control room windows. Now, they have emerged to find only moderate damage to the observatory, on an island that has been devastated elsewhere. “It’s a thing to be thankful for,” says Arecibo Deputy Director Joan Schmelz.
But many are worried that the damage, likely on the scale of millions of dollars and apt to keep the observatory closed for weeks or months, will further threaten the existence of Arecibo, which is already on a short list of facilities facing possible closure or downsizing by the National Science Foundation (NSF) in Alexandria, Virginia. “I fear that if there is significant damage, that will provide the decision point to decommission the observatory,” says space scientist John Mathews of Pennsylvania State University in State College.
The surface of the dish was largely unscathed, and the observatory’s most vulnerable component, the instrument platform suspended high above the dish by cables strung from three towers, each more than 80 meters tall, was still in place and seemed undamaged, says Schmelz. She is based at the Columbia, Maryland, headquarters of one of Arecibo’s operators, the Universities Space Research Association, and spoke with staff in Puerto Rico who first used a ham radio and then a single working satellite phone. But the roofs on some observatory buildings were blown off, the sinkhole under the dish was flooded, and other equipment was damaged by rain and fallen trees. Most significantly, a large portion of a 29-meter-long antenna—the 430-megahertz line feed used for studying the upper atmosphere—appears to have broken off and fallen from the platform into the dish. Mathews estimates a bill of several million dollars to replace the line feed alone.
CHICAGO, ILLINOIS—Once you’ve submitted your paper to a journal, how important is it that the reviewers know who wrote it?
Surveys have suggested that many researchers would prefer anonymity because they think it would result in a more impartial assessment of their manuscript. But a new study by the Nature Publishing Group (NPG) in London shows that only one in eight authors actually chose to have their reviewers blinded when given the option. The study, presented here at the Eighth International Congress on Peer Review, also found that papers submitted for double-blind review are far less likely to be accepted.
Most papers are reviewed in single-blind fashion—that is, the reviewers know who the authors are, but not vice versa. In theory, that knowledge allows them to exercise a conscious or unconscious bias against researchers from certain countries, ethnic minorities, or women, and be kinder to people who are already well-known in their field. Double-blind reviews, the argument goes, would remove those prejudices. A 2007 study of Behavioral Ecology found that the journal published more articles by female authors when using double-blind reviews—although that conclusion was challenged by other researchers a year later. In a survey of more than 4000 researchers published in 2013, three-quarters said they thought double-blind review is “the most effective method.”
BALTIMORE, MARYLAND—Add your name to a waitlist for a kidney transplant in the United States today, and you’ll join around 100,000 people, many of whom have already been waiting years. The scarcity of life-saving organs for transplants has raised hopes for substitute organs from pigs, which have a similar anatomy to humans. But decades of scientific setbacks have kept clinical trials of that approach, called xenotransplantation, on the horizon.
Now, a few teams are chomping at the bit. Exhilarated by recent results in monkey experiments, some researchers here at a meeting of the International Xenotransplantation Association are eyeing human testing.
“What we thought was very far away seems to be coming to the near future,” says Muhammad Mohiuddin, a cardiac transplant surgeon at the University of Maryland School of Medicine here. He moderated a premeeting session where scientists discussed advances with officials of the U.S. Food and Drug Administration, which would review any application for a clinical trial.
Are climate scientists ready to air preliminary findings—mistakes and all—before their papers are reviewed?
That question will soon be put to the test. The American Geophysical Union (AGU) in Washington, D.C., the giant of earth and planetary science publishing, announced plans yesterday to launch a preprint server that—much like arXiv.org and its descendants, bioRxiv and ChemRxiv—would host studies prior to peer review. The site, called the Earth and Space Science Open Archive (ESSOAr), should open early next year, with a demo at the AGU's fall meeting in December.
ESSOAr will have company. In a separate initiative, a grassroots group of scientists will start, as soon as next month, EarthArXiv. That preprint site would be powered by the Center for Open Science, a nonprofit based in Charlottesville, Virginia, that has provided similar support for several nascent servers, including SocArXiv and engrXiv. Though AGU's effort is partially funded by Wiley, a for-profit publisher, and built on their software, EarthArXiv would remain independent, says Thomas Narock, a data scientist at Notre Dame of Maryland University in Baltimore, who is helping to lead the effort.
For about $75, the governments in South Africa and Kenya will soon be able to treat an HIV-infected person for 1 year with a pill taken once a day that contains a “best-in-class” combination of three antiretroviral (ARV) drugs. The backbone of the new pill is dolutegravir, a remarkably powerful and safe ARV that inhibits HIV’s integrase enzyme and has been too expensive for most poor and middle-income countries to afford. The annual per-person cost of the new pill, made by generic manufacturers, is also about $25 less than the least expensive similar triple-ARV combo pill on the market. “This is a major breakthrough,” says Michel Sidibé, head of the Joint United Nations Programme on HIV/AIDS (UNAIDS) in Geneva, Switzerland.
The new pill, announced today by Sidibé and others at a press conference connected to the UN General Assembly meeting in New York City, will help speed efforts to offer treatment to all 37 million HIV-infected people in the world, Sidibé says. Currently, only 19.5 million are receiving ARVs. The pill will be offered as a first-line treatment, and the hope is that its excellent “profile”—powerful suppression of HIV, low toxicity, and ease of use—will make it simpler for people to stay on treatment for their lifetimes and reduce the chances of ARV resistance emerging. The other two ARVs in the cocktail are lamivudine and tenofovir, both of which are already in widespread use.
South Africa, which has more HIV-infected people than any country and is the biggest purchaser of ARVs, estimates it will save $900 million over 6 years. The pill “will greatly benefit our patients due to its superior therapeutic qualities,” said Aaron Motsoaledi, South Africa's minister of Health in Pretoria, who said the country expects to make the first purchase in April 2018. UNAIDS says the intent is eventually to offer this in 92 countries
Marine scientists are warning that if the Trump administration rescinds fishing protections around eight Pacific islands, the United States will lose one of its best laboratories for measuring how a warming climate affects marine life.
“We need baselines,” says Alan Friedlander of the University of Hawaii at Mānoa in Honolulu. “We need pristine reefs to see what we’ve lost elsewhere, to better manage damaged reefs and to isolate the effects of climate change.”
A proposal from Secretary of the Interior Ryan Zinke, leaked to The Washington Post last week, argues that regulations on waters around the islands—Howland, Baker, Johnston, Wake, Jarvis, Palmyra, Rose, and Kingman Reef—“should be amended ... to allow commercial fishing.”
The world’s oldest operating nuclear reactor is in the twilight of its life, but the scientists who rely on it for their research are not going gentle into that good night. Canadian scientists are upset about the imminent closure of the Chalk River research reactor and are lobbying the government for a CA$200 million ($162 million) commitment so they can continue to perform materials research using the neutron beams that research reactors provide.
“You need an organization somewhere that’s providing central support and stewardship for a national program,” says John Root, director of the Canadian Neutron Beam Centre in Chalk River, Ontario, which relies on the 60-year-old reactor. “If you don’t have this central hub, you don’t really have a national program. You have somebody sending checks to laboratories in the United States or Europe, and Canadian individual researchers are on their own.”
In February executives of the University of Saskatchewan in Saskatoon and McMaster University in Hamilton, publicly launched the Canadian Neutron Initiative to lobby the federal government for a 10-year, CA$200 million commitment, a figure that sounds large but pales in comparison to the CA$100 million the government spends annually to keep the reactor running. Root would like to see this funding open up beam time at other neutron sources around the world, as well as maintain a critical amount of neutron beam research within Canada until another large-scale neutron source might be built. The Canadian government has remained silent on the matter so far.