Breaking news and analysis from the world of science policy

  • Untangling the Trump administration’s lawsuit over an HIV prevention drug

    hand pouring out Truvada pills from a bottle

    The U.S. government says in a lawsuit that Gilead, the maker of the anti-HIV drug Truvada, owes the U.S. public royalty money.

    AP Photo/Rich Pedroncelli

    The U.S. government routinely sues pharmaceutical companies for making false claims, bilking Medicare, illegal kickbacks, and sloppy manufacturing practices. But on 6 November, the U.S. Department of Justice (DOJ) filed suit against Gilead Sciences Inc. of Foster City, California, for reasons that cannot easily fit on a bumper sticker. At the center of the dispute are monkey studies done by researchers at the U.S. Centers for Disease Control and Prevention (CDC) with a Gilead drug called Truvada, and the drug’s use as part of a highly effective HIV prevention strategy called pre-exposure prophylaxis (PrEP).

    Truvada for PrEP has earned Gilead billions of dollars, and the government contends it deserves some of those earnings because it helped develop the intervention. Specifically, the government alleges Gilead failed to obtain licenses to use four patents that CDC obtained on research results related to PrEP. “Gilead has repeatedly refused to obtain a license from CDC to use the patented regimens,” the federal lawsuit states. “Meanwhile, Gilead has profited from research funded by hundreds of millions of taxpayer dollars … but has not paid any royalties to CDC.” The lawsuit contends that “Gilead’s conduct was malicious, wanton, deliberate, consciously wrongful, flagrant, and in bad faith.”

    Gilead has rejected the allegations, arguing that each of the four government patents at issue is invalid. The work conducted by CDC researchers was obvious and proposed by others before they even published their experiment, the company argued in petitions sent to the U.S. Patent and Trademark Office (USPTO) earlier this year. It has asked the agency to cancel the patents.

  • A judge said police can search the DNA of 1 million Americans without their consent. What’s next?

    illustration of DNA
    Design Cells/

    For the first time, a state judge has forced a public genealogy site, GEDmatch, to allow police to search its entire database of DNA profiles. A detective wanted to find distant relatives of a serial rapist in hopes that their family trees could help him home in on a suspect—even though most of the 1.3 million people who have shared their DNA data with the site haven’t agreed to such a search.

    The search warrant, reported this week by The New York Times, raises the alarming possibility of similar police searches of giant direct-to-consumer DNA sites such as and 23andMe that are now closed to everyone except company customers who willingly submit a saliva sample.

    Since police tracked down the suspected Golden State Killer in April 2018 by uploading crime-scene DNA to GEDmatch, forensic genealogy has led to arrests in scores of cold criminal cases. But privacy concerns have arisen because users didn’t know their DNA data were being searched, and because relatives who never took a DNA test could come under suspicion. In May, GEDmatch restricted police searches to participants who had given consent, cutting the number of available DNA profiles to 185,000. Then in September, the U.S. Department of Justice (DOJ) eased some concerns by issuing a policy that limits searches by federal law enforcement agencies to violent crimes and DNA profiles with user consent.

  • Journal stands by paper facing misconduct allegations, but expresses concern about related images

    collage of lionfish images

    A collage of 50 lionfish photos that contained manipulated images was “published in error,” Biology Letters says.

    O. L?NNSTEDT ET AL., BIOLOGY LETTERS 10, 10.1098 (CC-BY 4.0)

    The journal Biology Letters will not retract a paper about lionfish behavior that had come under suspicion of fraud after another paper by the same first author was found to be fabricated. In a statement published today, Biology Letters says it concluded no misconduct marred the study, although the journal is “concerned” by a photo collage submitted by one of the authors during the journal’s investigation that experts say contain manipulated images.

    The decision is “disappointing,” says the whistleblower in the case, who asked not to be identified. He says the journal, published by the Royal Society in London, chose to ignore key parts of the evidence.

    At issue was a 2014 paper showing that zebra lionfish (Dendrochirus zebra) living at Australia’s Great Barrier Reef can invite each other to a collective hunt by flaring their fins. The first author of the paper, Oona L?nnstedt, was found guilty in 2017 of making up data for a Science paper, and the whistleblower had warned Biology Letters editors that the data behind the 2014 paper might be fabricated as well.

  • Top Israeli immunologist accused of promoting antivaccine views

    A person receives a measles vaccine

    A nurse administers a measles vaccine in Hadera, Israel, in May.


    Yehuda Shoenfeld is a well-known immunologist with a long career. Formerly at Tel Aviv University in Israel, he now runs a center for autoimmune diseases at Sheba Medical Center, Israel’s largest hospital. He is editor-in-chief of both journals of the Israel Medical Association (IMA), serves on the editorial board of dozens of other journals, and was elected a member of the Israel Academy of Sciences and Humanities in June.

    Yet a group of Israeli doctors says his ideas are a danger to public health.

    Shoenfeld has long espoused theories popular among antivaccine advocates and spoken at their meetings, causing tensions with the Israeli medical community. The issue came to a boil in September, when Shoenfeld decided to publish a positive review of an anonymous antivaccine book in Harefuah, IMA’s Hebrew-language journal. The two reviewers, who did not have a medical background, wrote that the book “raises a strong suspicion that key aspects of vaccine safety have not been properly tested.”

  • Report sketches vision for U.K. research after Brexit

    Palace of Westminster

    An independent report offers a strategy for U.K. researchers after Brexit.

    Mdbeckwith/Wikimedia Commons (CC BY-SA)

    When it comes to Brexit, many U.K. researchers are hoping the whole thing will eventually be canceled—or that they will at least still be able to tap into EU funding through some sort of deal. Today, an eagerly awaited external report, commissioned by the government, lays out research priorities and options if those relationships with Europe are severed. It calls for increased spending on R&D nationwide, a new research fellowship program, and larger chunks of money for universities to quickly target research opportunities.

    In March, the U.K. science minister, Chris Skidmore, asked for independent advice about how the government should bolster the nation’s R&D after its departure from the European Union, now scheduled for 31 January 2020. The key question: what to do if the United Kingdom decides not to participate, or “associate,” in the European Union’s main funding program, called Horizon 2020. It provides about £1.5 billion to U.K. researchers each year, and the grants make up about 11% of research funding for top U.K. research universities. They also attract talent from Europe and create vital international collaborations.

    The new report, by Adrian Smith, director of the Alan Turing Institute in London, and Graeme Reid, a science policy expert at University College London, sketches out a strategy. (Scientists have urged the government to keep close ties to Horizon 2020, and its successor, Horizon Europe, and ministers have said they will consider participation, if it offers value for money.)

  • Alzheimer’s experts greet China’s surprise approval of a drug for brain disease with hope and caution

    a visitor sits with an Alzheimer’s patient in a hospital room

    A new drug from an alga compound might help the growing number of Alzheimer’s disease patients that are taxing the medical systems of many countries.

    Jankurnelius/Alamy Stock Photo

    A Chinese biotech startup has startled neuroscientists and drug developers with a new plant-based compound it claims improves cognitive function in Alzheimer’s patients by altering their gut microbiomes. In mouse studies published earlier this year, this approach reduced inflammation in the brains of rodents engineered to develop Alzheimer’s-like pathology. The drug’s backers also claim a phase III clinical trial of about 800 people “demonstrated solid and consistent cognition improvement” among those treated versus a control group. Though not yet published, the results convinced China’s drug regulator last week to approve the marketing of the drug, known as GV-971, with the condition that additional data be gathered to demonstrate safety and efficacy.

    “This is very exciting and important; GV-971 is the first drug approved anywhere in the world for Alzheimer’s disease since 2003,” says Jeffrey Cummings, an Alzheimer’s researcher at the University of Nevada in Las Vegas, who is advising the drug’s developer, Shanghai, China–based Green Valley Pharmaceutical Co.

    The news has elicited both hope and skepticism from researchers not connected to the company. “I think it’s fascinating, and if it’s true that [the effects are happening] through the microbiome, that’s fantastic,” says Sangram Sisodia, a neurobiologist at University of Chicago in Illinois who has studied the impact of the microbiome on Alzheimer’s disease in mice but is not associated with the research. But just like China’s regulators, he and others want to see more evidence. Some aren’t yet convinced that the subtle improvement among Alzheimer’s patients measured by a cognitive test is clinically meaningful.

  • Mysterious oil spill threatens marine biodiversity haven in Brazil

    A volunteer cleans oil at a beach

    A Brazilian volunteer cleans oil at a beach in Lauro de Freitas in Bahia state on 2 November. Small blobs have now reached Abrolhos Bank, home to some of Brazil’s most iconic marine species.

    ANTONELLO VENERI/AFP via Getty Images

    Marine scientists in Brazil are closely monitoring the incursion of a mysterious oil spill into the largest biodiversity hot spot in the South Atlantic Ocean. The region, known as the Abrolhos Bank, shelters almost 9000 square kilometers of reefs in shallow, warm waters along the central part of the Brazilian coastline.

    More than 4000 tons of crude oil residue from an unknown source have landed on the country’s northeast seaboard since late August, contaminating hundreds of beaches, estuaries, reefs, and mangroves along a 2500-kilometer stretch of shoreline.

    Concerns escalated earlier last week as the wave of sticky oil patches began to encroach on the Abrolhos Bank’s northern border, on the southern coast of Bahia state. By Saturday morning, the first small blobs of petroleum had landed on the rocky shores of the Abrolhos Marine National Park archipelago, 60 kilometers offshore—home to some of Brazil’s most iconic marine species, such as the endemic Brazilian brain coral (Mussismilia braziliensis) and the endangered blue parrotfish (Scarus trispinosus).

  • U.S. moves closer to withdrawing from Paris climate pact

    Donald Trump

    President Donald Trump is moving forward with his plan to withdraw the United States from the Paris climate pact.

    Gage Skidmore/Flickr (CC BY-SA 2.0)

    Originally published by E&E News

    The United States will start the process of formally withdrawing from the Paris Agreement this afternoon, walking away from a deal that took more than two decades to make and that virtually every other nation on Earth still supports.

    The withdrawal letter will travel from the State Department to the United Nations. That will start the clock ticking on a one-year waiting period that ends with the United States exiting the deal on 4 November 2020—1 day after Americans head to the polls to choose a president.

  • Radiation oncologist tapped for top FDA post

    Stephen Hahn

    Stephen Hahn

    MD Anderson Cancer Center

    President Donald Trump today announced his intent to nominate oncologist and cancer center executive Stephen Hahn to head the U.S. Food and Drug Administration (FDA). Hahn has spent the past 4 years at MD Anderson Cancer Center in Houston, Texas, and in 2018 was named the institution’s chief medical executive. His research has focused on radiation therapy and the treatment of carcinoma and lung cancer.

    Hahn has navigated controversy in his tenures at both MD Anderson and the Perelman School of Medicine at the University of Pennsylvania, where he ascended the ranks to become chair of radiation oncology. In testimony before Congress in 2009, Hahn apologized to patients and their families after it was revealed that the Philadelphia Veterans Affairs Medical Center had administered radioactive implants for prostate cancer at the wrong dose and even to the wrong organ. This spring, after ethnically Chinese scientists were dismissed from MD Anderson for allegedly breaking federal funding rules, Hahn tried to assure the center’s staff and the media that the dismissals were not racially motivated.

  • HHMI to fund expansion of Meyerhoff program to boost minorities in science

    ScienceInsider logo

    Six U.S. universities will get up to $2.5 million each over 5 years from the Howard Hughes Medical Institute (HHMI) in Chevy Chase, Maryland, to prepare minority students for careers in academic research.

    The new competition, first reported by Science in July and officially announced today, aims to tap into lessons learned by the University of Maryland, Baltimore County, in running its acclaimed Meyerhoff Scholars Program. In 2014, HHMI gave 5-year grants to the University of North Carolina and Pennsylvania State University to follow in the footsteps of the 30-year-old Meyerhoff program, which it calls “a powerful example of an effective, student-centered approach.” The new Driving Change initiative extends HHMI’ commitment to changing the culture of higher education to improve the diversity of the scientific workforce.

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