The National Institutes of Health is all but closing the door on the use of chimps in drug research in the U.S., handing retirement papers out on more than 300 government-owned primates. Those chimps will be gradually relocated to sanctuaries, but a group of 50 will remain on call and available for research programs that meet the NIH's special guidelines. And they'll be housed in a facility that more closely mirrors their natural habitat.
The decision is a victory for animal rights activists, who won over key government officials after years of protests.
"Americans have benefitted greatly from the chimpanzees' service to biomedical research, but new scientific methods and technologies have rendered their use in research largely unnecessary," said NIH chief Francis Collins. "Their likeness to humans has made them uniquely valuable for certain types of research, but also demands greater justification for their use. After extensive consideration with the expert guidance of many, I am confident that greatly reducing their use in biomedical research is scientifically sound and the right thing to do."
Of course, the fact that chimps are our closest relatives made them ideal for drug research, and the decision isn't likely to sit well with investigators who have relied on chimps for their work. But biopharma companies have found this topic too hot to ignore. A few months ago, Gilead ($GILD)--which is deeply involved in hepatitis C work--reportedly joined GlaxoSmithKline ($GSK), Idenix ($IDIX) and Novo Nordisk ($NVO) in swearing off the use of chimps after the Humane Society raised it as an issue with investors.
The move at the NIH this week follows a decision to drop all government support for research using chimps. And the Fish and Wildlife Service is reviewing its policy and is expected to start listing all chimps as an endangered species, dropping the controversial practice of designating wild chimps as endangered and captive chimps "threatened," a split classification that allowed the captives to be used in research work.
The government-owned chimps are among about 850 in the U.S. available for research purposes, says Kathleen Conlee, the vice president of animal research issues at the Humane Society. But it's hard to say just how often they're used. Few companies actually discuss their use of the primates in drug research, though the Humane Society has been pressing Merck ($MRK) to publicly swear off the use of chimps after finding they were involved in the company's hepatitis C investigations.
Merck has "been one of the most recent using chimps and they have not taken a policy position on this," says Conlee. But once the wildlife service adopts new rules, any use of a chimp in research will require a permit, which they plan to track--and protest--should any come up.
The road to today's decision began in early 2011, when the Institute of Medicine was asked to look at the controversial issue. Their report concluded that any use of chimps in research should be stringently restricted, but the committee was split on the use of these animals in research related to new vaccines for hepatitis C. Only chimps and humans can be infected with HCV, and some of the committee members dug their feet in, insisting that any experimental vaccines should be tested on chimps before they could be ethically tested on humans.
At least one biotech which relied on a chimp for research says they've moved on to humans.
"We conducted a short-term, two-dose study of our HBV candidate ARC-520 in a single chimpanzee. As with HCV, the chimpanzee is the only primate species we are aware of (other than humans) to contract hepatitis B virus and develop chronic infection," noted Vincent Anzalone, director of investor relations at Arrowhead Research, in an email to FierceBiotech. "As your article points out, there are many experts that believe that in certain infectious diseases, the chimpanzee is the only model available that is truly relevant to human disease. That being said, we have no plans to conduct further studies in chimpanzees so this should not affect our development program or timelines at all. We have completed all preclinical work and a regulatory filing has been submitted to begin a phase 1 first-in-man study of ARC-520, which we anticipate will begin shortly."
It's likely that the big chimp retirement party will help accelerate the use of other technologies in preclinical research. Monkeys, meanwhile, will continue to be used in research in the U.S., Europe and other countries around the world. Drug R&D is a global business, with operations in scores of countries around the world.
- here's the press release from the NIH
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