Elevation of the Chimp May Reshape Research
By JAMES GORMAN
When Dr. Francis S. Collins, the head of the National Institutes of Health, announced Thursday that the government would halt all new grants for research on chimpanzees, it was, in one sense, a familiar Washington moment.
He was responding to the report of one committee by announcing that he would set up another committee -- a working group -- to figure out how to put in effect the recommendations of the first committee. And as anyone in Washington, or Bethesda, knows, there are as many ways to carry out the ideas of experts as there are experts' ideas.
In another sense, however, this was a profound step. The N.I.H. is the source of a river of money that flows into labs around the country where animals in the millions are, to misuse the words of an old Arlo Guthrie song, 'injected, inspected, detected, infected' and a few other things, all in the cause of increasing knowledge and alleviating human suffering, of course.
Here was the person who presides over this cash torrent talking about lab animals as if they were about to join an N.I.H. committee. 'Chimpanzees are our closest relatives in the animal kingdom,' he said, and as such deserve 'special consideration and respect.' It sounded almost as if he were talking about a treaty with another nation rather than a decision on an effective way to use a 'resource,' which is the language often used to describe lab animals, chimps included.
So, while it would be wrong to make too much of Dr. Collins's stance, it would be a mistake to make too little. The moratorium on grants is real, and the public recognition of a lab animal as a relative carries weight. Public words have political effects. Consider the ways officials describe other humans -- as freedom fighters, terrorists, allies, enemies, evildoers. No other species parses its public utterances as closely as we do.
The report that prompted Dr. Collins's announcement came from the Institute of Medicine, one of the National Academies. It was commissioned by the N.I.H. to assess the necessity of using chimpanzees in research. It is well written as reports go, and its intentions are as clear as Dr. Collins's acceptance of it. But it also suggests the weight and intricacy of words and how they affect whether a chimpanzee will be injected.
The report set criteria for how to decide when it is necessary to use chimpanzees in biomedical research, and in less invasive genomic and behavioral and cognitive research. For biomedical experiments, it states that there must be no other animal or laboratory method to do the research. It must be unethical to do the research on humans. And giving up the use of chimpanzees must 'significantly slow or prevent important advancements to prevent, control and/or treat life-threatening or debilitating conditions.' The last mouthful covers so much ground it requires rereading several times to see what advancements it does not include.
The criteria get even stickier when it comes down to cases, as made clear by the committee's consideration of one line of research, the attempt to develop a preventive vaccine for the hepatitis C virus, or HCV. Chronic infection with the virus is the most common reason for liver failure and liver transplants. More than three million Americans, and 130 million to 170 million people in the world, have chronic HCV infections. Each year about 17,000 Americans become infected.
Some experiments on safety and efficacy for potential HCV vaccines can be done only in humans or chimps because these are the only two species that the virus infects. When it came down to whether chimpanzees were necessary for the final stages of testing, the committee members could not agree. They deadlocked, 5 to 5.
The committee could not agree whether it was necessary to have a final test in chimps before an HCV vaccine is tried in humans. A vaccine could go straight to humans in high-risk groups, who would be monitored over time. But that would take years, and most new infections in developed countries are in intravenous drug users, not an easy population to monitor, and one that poses its own ethical problems. The report doesn't mention this particular problem, but one can't help but wonder how to define 'informed consent' when the experimental subject is an addict.
Chimps could be given the vaccine and then purposely infected with the virus to test the safety of the vaccine and how well it works. But there was disagreement here not about language, but about whether chimp physiology is close enough to that of humans to provide certain information on safety and efficacy, and on whether such a chimp trial would speed the process of research.
Actual decisions about research grants will be every bit as complicated as this. Who is doing the deciding and how the rules are written will make all the difference in when and if chimps are used in experiments. The chairman of the Institute of Medicine committee, Jeffrey Kahn, a bioethicist at Johns Hopkins, said this was essentially a 'disagreement about facts,' about the science, not about what the policy should be. But it was also about what the language meant.
The members had to consider whether using chimps would 'significantly slow' an important advancement and, if so, how much slowing would be significant.
Other parts of the report were read differently by people with different interests. The report says, for instance, that more chimps may be needed in the future, which could be seen as suggesting that breeding would be necessary, even though the N.I.H. has a moratorium on breeding of its chimps. Dr. Thomas Rowell, director of the New Iberia Research Center in Louisiana, said the report's noting of possible future need 'supports our decisions not to electively sterilize all animals under our care, thus making it possible to produce animals for future use.'
This is not a hypothetical discussion. New Iberia has its own chimps and N.I.H.-owned chimps, and breeding has continued there, sometimes with N.I.H. chimps. Dr. Rowell says the breeding was within the terms of the center's contract because his center took over the babies and their support.
Asked what issues he thought the working group would have to clarify, he mentioned one concerning humans, not chimps -- the requirement that if chimps are to be used it must be either unethical or impossible to do the work in humans.
'Much of the work we do,' Dr. Rowell wrote in an e-mail, 'is done because the F.D.A. won't allow the drug or vaccine to move into human trials without seeing data in a relevant species.
'Who decides the ethics on moving forward into humans?'
The working group, obviously. And then, whoever is
tasked with implementing their implementation of the first committee's