Committee is split on whether or not to use chimpanzees in US viral drug research...

Acording to an article posted on the Fox News website,guidelines for chimpanzee use in U.S. research are being crafted by committee, however "The committee's 10 members were also split on whether a vaccine intended to prevent or minimize hepatitis C infection would require safety testing on chimpanzees."


First Guidelines for Lab Chimps Drawn Up
By Wynne Parry

For the first time, criteria have been issued on research using our closest relatives in the animal kingdom, chimpanzees.
Guidelines now govern the use of our closest living relatives, chimpanzees, in federally funded U.S. research, and because of them, some biomedical studies are likely to come to an end.

In fact, nearly all research using chimpanzees to develop drugs or answer other questions with medical applications for humans should end, according to a committee charged with establishing the first set of criteria for research on chimpanzees. The committee released its report Thursday (Dec. 15).

Research into genetic or behavioral questions — such as looking for insight into human behavior by studying how chimpanzees help one another out, or searching for the genetic underpinnings of language — are acceptable, or could become so with only minor modifications, according the committee convened by the National Academy of Sciences.

These types of projects are typically less invasive than biomedical research, which could involve, for instance, infecting chimpanzees with a virus.

For example, in behavioral research, chimpanzees — which, like humans, are social — must live with others, and may not be anesthetized by being shot with a dart. However, chimpanzees can be trained to offer their arms to have blood drawn or accept anesthesia so they can be examined, according to the committee.

New principles

The criteria for both types of research are based upon three general guidelines: The knowledge gained by the research must be necessary to advance public health; the research cannot ethically be done on a human being, or is not possible on another animal or in something that is not a living organism; and the chimpanzees used in the research must be given appropriate places to live.

In practice, this means the National Institutes of Health (NIH) will not award any new grants for research until an assessment process is in place, and a project-by-project review will be conducted to determine if ongoing research fits the criteria, said NIH Director Francis Collins, who accepted the committee's recommendations.

"Chimpanzees are our closest relatives in the animal kingdom, providing exceptional insights into human biology, and the need for special consideration and respect," Collins said in a statement on Thursday.

He estimated that about 37 research projects might be affected, and that, of these, about half may not be continued.

These criteria will only apply to research projects that receive some kind of NIH support, including animals used by private groups but housed using federal money, according to committee member Warner Greene, a virologist at the University of California, San Francisco.

The exceptions

Although the committee did not review projects, it did provide two examples of biomedical research that met its criteria to continue, at least temporarily.

Research using chimps to study monoclonal antibodies was given a temporary reprieve to avoid substantially slowing research. Monoclonal antibodies are similar to the regular antibodies your immune system produces, but they are designed to target specific molecules. They are used to treat a variety of conditions, including cancer and autoimmune disorders.

The committee's 10 members were also split on whether a vaccine intended to prevent or minimize hepatitis C infection would require safety testing on chimpanzees.

"I think the committee accurately identified the few biomedical topics for which continuing involvement of chimpanzees is essential," said Joseph Erwin, a primatologist who specializes in the care of captive primates and the neurobiology of aging.

Erwin, along with many others, presented his views to the committee during its deliberations.

"If research is done in humane ways under good conditions with consideration for the animals, I don't see why anyone should be against it," Erwin said. "People who oppose all animal research seem not to be aware that scientific research can be done without harming or hurting animals. In fact, that is the only kind of study I find acceptable."

A future of chimpanzee research?

But Theodora Capaldo, president of the New England Anti-Vivisection Society/Release & Restitution for Chimpanzees, said she believes the new guidelines mean an end to all work with chimpanzees, including those typically considered less invasive, such as for instance, a behavioral study involving an MRI scan.

"If that criteria is scrupulously applied, it is an end to chimpanzee research. We do not believe there are any projects out there that can meet that criteria," Capaldo said.

Even though the committee did leave the door open to future testing on chimpanzees, biomedical research on chimpanzees is on its way out, said Andrew Rowan, chief scientific officer of the Humane Society of the United States.

"Biomedical and research technology has changed dramatically in the last 25 years. What was necessary in 1980 is no longer necessary today, and what is necessary today will no longer be necessary in 2020," Rowan said.

The use of cell cultures — when cells are grown without an organism — allows researchers to generate higher volumes of data under more easily controlled conditions and have replaced animals, including chimpanzees, in labs, Rowan said.

"Chimpanzees deserve greater moral consideration than we are currently giving them. It is going to come to an end, the question now is when," Rowan said.

Bioethics and the use of Chimpanzees in Hepatitis C-related research...

A sobering article from BioEdge.org, a website that focuses on bioethics. There is a tremendous amount of talk regarding Direct Acting Antivirals in development, especially now that we are in the afterglow of data, post-AASLD. What has significantly less mindshare is the pre-clinical processes behind those compounds including research on animals. This article focuses on the ethical implications of animal research within the realm of HCV drug development

Chimpanzee hepatitis C research in the firing line
by Jared Yee | 18 Nov 2011 |

Experiments on chimpanzees have often horrified animal rights advocates and worried the medical community. One story brings the panorama of concerns to light – the story of Katrina. At 9 months, the chimpanzee Katrina was taken from her mother and taken to a New York laboratory – where scientists began disease testing on her. She was infected with hepatitis B,hepatitis C, and HIV. After years of testing, sedation, biopsies, and pain, she was retired in 2002 at the age of 20. However, eight years later, she was sent back to the laboratory.

Last year it emerged that Katrina and 201 other chimpanzees would be sent to the Southwest National Primate Research Centre, for hepatitis C research duties. Debate has since flared, and many are now reflecting on the ethical implications of chimpanzee testing. HIV testing on apes proved ineffective, and better alternatives existed for malaria testing. However, the most contentious disease is hepatitis C. Spread by blood-to-blood contact, hepatitis C kills 340,000 people around the world each year. There is no vaccine, and the chimpanzee is the only non-human animal that can be infected with hepatitis C. But whether chimpanzees are genuinely effective test subjects is hotly debated.

“In the US today, there are far more deaths due to the hepatitis C virus than HIV,” says virologist Stanley Lemon, of the University of North Carolina. “There’s no dispute about the ethical issues. The question is how you balance the need to recognize that with the potential for direct human benefit.” Hubert Blum, hepatologist at the University of Freiburg, said: “Chimpanzees for many reasons are no more the most important model for HCV infection… The possibility to infect cells in culture has revolutionized HCV research, especially in terms of testing antiviral agents.”

Bioethicist Ronald Green of Dartmouth College said:

“There must be overwhelming benefit for something that is truly injurious. I would think a requirement is to look upon these animals as very, very close to human research subjects. You don’t impose the same standards of research as on human subjects – but you’re not totally remote from that. I’d want to ask what the alternatives are, and a clear demonstration that this information is crucial to the control of disease. I’m not an opponent, but the benefits need to be immense.” ~ Wired, Nov 14