An ambitious project that set out nearly 5 years ago to replicate experiments from 50 high-impact cancer biology papers, but gradually shrank that number, now expects to complete just 18 studies.
“I wish we could have done more,” says biologist Tim Errington, who runs the project from the Center for Open Science in Charlottesville, Virginia. But, he adds, “There is an element of not truly understanding how challenging it is until you do a project like this.”
The Reproducibility Project: Cancer Biology (RP:CP) began in October 2013 as an open effort to test replicability after two drug companies reported they had trouble reproducing many cancer studies. The work was a collaboration with Science Exchange, a company based in Palo Alto, California, that found contract labs to reproduce a few key experiments from each paper. Funding included a $1.3 million grant from the Laura and John Arnold Foundation, enough for about $25,000 per study. Experiments were expected to take 1 year.
Researchers in Japan today announced the launch of a clinical trial to treat Parkinson’s disease with neurological material derived from induced pluripotent stem (iPS) cells, mature cells chemically manipulated to return to an early stage of development from which they can theoretically differentiate into any of the body’s specialized cells.
The study team will inject dopaminergic progenitors, a cell type that develops into neurons that produce dopamine, directly into a region of the brain known to play a key role in the neural degeneration associated with Parkinson’s disease. The effort is being led by Jun Takahashi, a neurosurgeon at Kyoto University's Center for iPS Cell Research and Application (CiRA), in cooperation with Kyoto University Hospital.
Parkinson’s disease results from the death of specialized cells in the brain that produce the neurotransmitter dopamine. A lack of dopamine leads to a decline in motor skills, resulting in difficulty walking and involuntary trembling. As the disease progresses it can lead to dementia. The trial strategy is to derive dopaminergic progenitors from iPS cells and inject them into the putamen, a round structure located at the base of the forebrain. Surgeons will drill two small holes through a patient’s skull and use a specialized device to inject roughly 5 million cells.
TORONTO, CANADA—One year ago, Joel Clement—then a senior scientist at the U.S. Department of the Interior in Washington, D.C.—wrote in The Washington Post: “I am a scientist, a policy expert, a civil servant and a worried citizen. Reluctantly, as of today, I am also a whistleblower on an administration that chooses silence over science.”
And with that, Clement went public about his ongoing feud with President Donald Trump’s administration, alleging that Trump appointees had retaliated against him and transferred him to an inappropriate position because of his work on climate change policy. He filed an official complaint with the U.S. Office of Special Counsel—a complaint that, a year later, is still being investigated. And in October 2017, he resigned from his position entirely.
ScienceInsider caught up with Clement last week here at the North American Congress for Conservation Biology, where he received an award for his work on climate change and his “courage in upholding the highest standards of scientific integrity in government service.” This interview has been edited for clarity and brevity.
Hopes for an easier regulatory road for genetic engineering in European agriculture were dashed today by the Court of Justice of the European Union. In a closely watched decision, the court ruled that plants created with new gene-editing techniques that don’t involve transferring genes between organisms—such as CRISPR—must go through the same lengthy approval process as traditional transgenic plants.
Many researchers had argued that regulators should take a lighter touch when evaluating products created with the new technologies, but environmental groups and their allies successfully argued that they should be subject to the same EU rules that apply to other genetically modified organisms.
“We applaud the European Court of Justice for this forward-thinking decision,” said Dana Perls, senior food and agriculture campaigner at Friends of the Earth (FOE) in Washington, D.C., in a statement. “All products made with genetic engineering, including ones made with gene-editing tools like CRISPR, should be regulated, assessed for health and environmental impacts, and labeled.” FOE’s affiliate in France was part of a coalition of groups that brought the case.
The American Psychological Association (APA) will have a chance next month to modify its policy prohibiting military psychologists from conducting interrogations at the Pentagon’s detention facility at Guantanamo Bay in Cuba and other national security facilities. It is the latest twist in a long-running and contentious dispute within the Washington, D.C.–based professional society over how to respond to revelations that psychologists were involved in abusive interrogation practices in the aftermath of the 2001 terrorist attacks.
The current policy is based on the idea that military interrogations are inherently coercive and thus, violate the profession’s code of ethics to help people. The new policy would retain the ban on participating in interrogations but would allow military psychologists to provide mental health services to detainees at national security sites. The measure—labeled a “clarification” of previous resolutions adopted in 2009, 2013, and 2015—will come before APA’s Council of Representatives on 8 August at the society’s annual meeting in San Francisco, California.
The measure’s advocates say the current rule, which went into effect in 2015, has unfairly restricted their ability to practice their profession. “It was the first time I can recall that APA outlawed a setting rather than a behavior,” says Mark Staal, president of APA’s Division of Military Psychology (Division 19), which drafted the latest resolution.
When Science published a monkey study nearly 2 years ago that showed an anti-inflammatory antibody effectively cured monkeys intentionally infected with the simian form of the AIDS virus, the dramatic results turned many heads. But some skeptical researchers thought the data looked too good to be true and predicted the intervention wouldn’t work on HIV in humans. They were right.
Anthony Fauci, head of the U.S. National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, and a co-author of the Science paper, today reported the failure of a clinical trial that attempted to translate the remarkable monkey success to humans. “We did not see those dramatic results at all,” Fauci said at the International AIDS Conference in Amsterdam that is taking place this week.
In the monkey experiment, the animals infected with the simian immunodeficiency virus (SIV) were treated with antiretroviral (ARV) drugs that suppressed the pathogen, and then given repeated injections of an antibody that blocks a receptor called α4β7 found on immune cells. The researchers then stopped giving both the antibodies and ARVs, and the monkeys still completely controlled SIV for more than 9 months. The virus quickly came roaring back in control animals that had only received ARVs and then had that treatment halted. Some considered the antibody-treated monkeys cured, as they appeared capable of indefinitely controlling the small quantity of virus that persisted without any further interventions.
AMSTERDAM—When gynecologist Wessel Ganzevoort received a request for an urgent meeting from the independent committee watching over his clinical trial last week, he thought it might be good news.
Ganzevoort leads a study to find out whether sildenafil could help poorly growing fetuses if given to their pregnant mothers; the drug dilates blood vessels and in theory could bring fetuses more oxygen and nutrients. A data and safety monitoring committee, however, had looked at the unblinded evidence halfway through the study and wanted to talk. Ganzevoort, who’s at the Amsterdam University Medical Center (AUMC), knew that probably meant one of two things: Either the drug worked so well that continuing to give a placebo to half of the mothers in the trial would be unethical, or the study had to be stopped because sildenafil was causing serious complications. Because previous studies had not shown any major side effects, Ganzevoort expected the former.
He was wrong. At the 19 July meeting, the committee told him that a very specific complication, persistent pulmonary hypertension—in which blood vessels in the baby’s lungs fail to open after birth—had occurred 17 times in the sildenafil-treated group, leading to 11 deaths. There were only three cases of the condition in the placebo group and no deaths. (In total, there were 19 deaths in the treatment group versus nine in the placebo group—the latter not being a surprise given all the fetuses were at high risk because of their poor growth.) “It took us very little time to make the decision to halt the study,” Ganzevoort says. That same day, he and his colleagues began to call the women who participated in the study, including several who are still pregnant or whose babies are in the hospital.
Dolutegravir, which enjoys a reputation as the best of 32 marketed antiretroviral drugs, took a serious hit in May when a preliminary analysis from a study that included more than 10,000 HIV-infected pregnant women in Botswana revealed it may lead to serious birth defects. Today, at the International AIDS Conference in Amsterdam, researchers reported more data from that study that suggest the risk of harm may be lower than first thought. But troubling questions remain about its safety during pregnancy and whether programs that plan to promote it widely should restrict its use in women of child-bearing age.
The potential problem with dolutegravir surfaced because of worries about another anti-HIV drug, efavirenz, which caused what are known as neural tube defects in newborn monkeys. In 2014, researchers in Botswana began a 4-year surveillance study, called Tsepamo, of all babies born to both HIV-infected and uninfected mothers at eight clinics to assess the frequency of neural defects. This rare condition can cause large holes in the spine or can prevent the top of the skull from forming. Two years later, before those results were in, Botswana made dolutegravir a preferred treatment because it powerfully suppresses HIV, people tolerate it well, and drug resistance rarely surfaces.
In April, the World Health Organization (WHO) in Geneva, Switzerland, contacted the Tsepamo team to help with new guidelines being prepared for pregnant, HIV-infected women. Scant data existed about dolutegravir, and Botswana was an ideal place to look for clues: The study was already underway, capturing about 45% of the births in the country, and the prevalence of HIV prevalence there is high. When the researchers took an early peek at their data, they found an association between neural tube defects and dolutegravir—not efavirenz. “We were extremely surprised,” says infectious disease specialist Rebecca Zash, a co–principal investigator of the study who is based at Beth Israel Deaconess Medical Center in Boston. “We thought we did something wrong.”
Senior U.S. Department of Interior officials prepared last fall to eliminate the Northeast Canyons and Seamounts Marine National Monument off the Atlantic coast—even as they had yet to agree on the public justifications for doing so, according to newly disclosed internal documents.
Interior last week accidentally released thousands of pages of unredacted internal emails in response to Freedom of Information Act requests.
Basic brain and behavioral researchers will get more than a year to comply with a new U.S. policy that will treat many of their studies as clinical trials. The announcement from the National Institutes of Health (NIH) appears to defuse, for now, a yearlong controversy over whether basic research on humans should follow the same rules as studies testing drugs.
Although research groups had hoped NIH would drop its plans to tag basic studies with humans as trials, they say they’re relieved they get more time to prepare and give the agency input. “It’s a positive step forward,” says Paula Skedsvold, executive director of the Federation of Associations in Behavioral & Brain Sciences in Washington, D.C.
At issue is a recently revised definition of a clinical trial along with a set of rules in effect since January that are meant to increase the rigor and transparency of NIH-funded clinical trials. About a year ago, basic scientists who study human cognition—for example, using brain imaging with healthy volunteers—were alarmed to realize many of these studies fit the new clinical trial definition.