• Monkey Business Threatens U.S. Drug Discovery

    From Matt Beasley@21:1/5 to All on Mon Mar 13 11:56:00 2023
    Monkey Business Threatens U.S. Drug Discovery
    By David Wainer, March 3, 2023, WSJ
    The monkey business is in trouble.

    While many of us would prefer not to give it much thought, monkeys are often used in lab tests during the development of key medical products such as the Covid-19 vaccines. Sadly, the global trade in nonhuman primates can involve murky dealings,
    including smuggling of illegal animals. The resulting blowback is of great concern to America’s world-leading medical research.

    Due to rising biomedical-research needs—and the limited supply of long-tailed macaques from breeding farms in Southeast Asia—there has long been a black market for monkeys caught in the wild. Rampant smuggling was a key reason behind the
    International Union for Conservation of Nature’s decision last year to change long-tailed macaques’ status from “vulnerable” to “endangered.”

    The U.S., the world’s largest importer of the animals, finally is doing something about it, but coordination among various government agencies has been faulty. Federal prosecutors in November charged eight people with running an international operation
    to poach wild monkeys. Among those charged were two Cambodian wildlife officials, one of whom was arrested in the U.S.—while traveling to an endangered-species conference. The largest U.S. monkey importers have received subpoenas as part of the probe,
    leading them to temporarily halt shipments from Cambodia. For its part, the Cambodian govt said it was “surprised and saddened” by the arrest.

    The crackdown is exacerbating a shortage of nonhuman primates for research in the U.S. About 60% of the 30,000 biomedical-research monkeys imported annually to the U.S. used to come from China, but Beijing banned those exports during the pandemic,
    forcing American companies to pivot to Cambodia. The Chinese move, many in the industry say, was designed to give that nation an edge in the biomedical field in the midst of a pandemic and a trade war between the two superpowers. The Chinese embassy in
    Washington didn’t respond to a request for comment. The shortage has driven up the cost of a nonhuman primate to more than $30,000 this year, from about $2,500 prepandemic, according to Elizabeth Anderson, an analyst at Evercore ISI.

    While Ms. Anderson says there is some speculation China could soon reopen for exports, it currently remains shut off, and Cambodia had been supplying about 60% of the monkeys imported annually.

    The most visible financial impact has been felt by clinical research orgs like Charles River Labs. The company’s shares dropped 10% when it announced last month it was suspending shipments of monkeys after receiving a subpoena from the U.S. Justice
    Department, relating to shipments received by the company from its Cambodian supplier. Charles River said the situation will result in study delays and have a negative impact on its revenues this year. Shares of Inotiv, another major supplier, are down
    by more than 70% over the past year. The contract drug researcher in November disclosed that executives at its main Cambodian supplier were among those charged in the indictment. Two of Inotiv’s subsidiaries have received grand-jury subpoenas.

    Study delays already might be affecting biotech companies, though how significantly isn’t clear since executives refrain from talking publicly about animal testing. Matthew Bailey, president of the National Assn for Biomedical Research, says he is
    hearing from companies that their projects are being delayed. While allegations haven’t been made against Charles River or Inotiv, the U.S. Fish and Wildlife Service is working with U.S. laboratories to determine whether monkeys already in the U.S.
    are wild-caught. U.S. authorities could seize monkeys from companies that can’t adequately document their origins, said a biotech lobbyist, a move that would exacerbate the shortage.

    “We recently had a number of shipments of NHPs from our Cambodian supplier denied clearance by the U.S. Fish and Wildlife Service,” a Charles River spokeswoman said in an email, adding that the company believes that its monkey imports have adhered to
    all relevant requirements.

    Future shipments from Cambodia are now being held up until new procedures such as genetic testing can be developed, in agreement with the U.S. Fish and Wildlife Service, to weed out wild-caught monkeys.

    “The U.S. govt is saying, you can’t bring them in yet,” Charles River CEO James Foster said during an earnings call with Wall Street analysts last month. “And the ones that you have in country—and we have some in country—you can’t use yet,
    until we sort of work out and ensure that they are indeed purpose-bred.”

    Mr. Bailey says the actions taken by the Fish and Wildlife Service have “unilaterally shut down the drug-development process in the U.S.”

    A spokeswoman for the agency said it hasn’t implemented a ban and evaluates the legality of primate imports “on a case by case basis.”

    Eric Kleiman, a researcher at the Animal Welfare Institute, an advocacy org, says that suspending all imports from Cambodia is a necessary measure until there is a foolproof way of determining the origin of the monkeys. The nation’s November statement
    about the arrests denied the allegations and made no mention of efforts to crack down on smuggling. “Given Cambodia’s response to the allegations were not exactly fulsome, we believe there should be more controls on the demand side,” Mr. Kleiman
    said.

    The shortage is leading to a scramble to find different sources for research primates. But raising monkeys for laboratory testing takes years, so there is no immediate fix, even though alternate sources are growing in places like Mauritius, Indonesia,
    Vietnam and the Philippines. The U.S. has in recent years boosted funding to breed monkeys at national facilities, but the numbers are small. While it is hypothetically possible to breed larger monkey colonies, it would take years and a more serious
    commitment from the U.S. govt to get anywhere close to the levels needed for research, says Mr. Bailey, pointing to the different climate as one of several hurdles.

    Mr. Bailey says his group has formed a coalition of affected parties that is now working with Congress as well as executive-branch agencies, but there isn’t yet a sense of urgency at the highest levels of government. Chris Meekins, a Washington analyst
    at Raymond James, says it appears senior govt officials in the Biden admin don’t have this on their radar screens. The CDC and the NIH are at least marginally aware, he wrote, “but we also suspect they are not sure what can be done.”

    Three years after a pandemic shut down the country and killed more than a million Americans, the lack of urgency and coordination at the highest levels is perplexing. There is more than just money at stake.

    https://www.wsj.com/articles/monkey-business-threatens-u-s-drug-discovery-e9e71409

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