Profile of an Ethical Scientist

Dr. June Bradlaw: Champion for Better, More Humane Science

In marked contrast to these nightmarish images stands Dr. June Bradlaw, chairperson of the Scientific Advisory Board of the International Foundation for Ethical Research (IFER) and a Science Advisor to the National Anti-Vivisection Society.

In 2001 Dr. June Bradlaw was awarded the Lifetime Achievement Award by the Society for In Vitro Biology as “…the highest honor given by the Society to scientists who are considered pioneers or highly influential researchers in the science and art of cell culture.”

In addition to being associated with IFER since its founding, she has helped guide NAVS in presenting credible arguments for the advancement of alternatives and has helped to judge students’ projects at international science fairs for NAVS’ Humane Science Awards. Dr. Bradlaw has also served on advisory and review panels for the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).

Dr. Bradlaw recently shared some of the challenges she confronted as one scientist who dared to question the way things “have always been done.” She also explains how she works with both animal advocates and scientists.

Dr. Bradlaw, how did you first become involved in alternatives to using animals?
In 1975 while working as a scientist at the Food and Drug Administration (FDA), I proposed that the Division of Toxicology develop methods using human and animal cells cultured in vitro to study the toxicities of potentially hazardous substances. Originally it was planned as a supplement to the ongoing practice of animal toxicity testing in vivo.

Initially, it was not my main intention to save animals, but to develop better science to help make more informed decisions of toxic assessments.

What was your greatest challenge in presenting your program?
In 1976, when I wrote an expanded proposal delineating how such a program could be developed and conducted, a key component included the training of personnel in the art and science of cell culture. My challenge was to convince my directors that this was the wave of the future when most knew very little about cultured cells or understood little of their potential use in all areas of toxicology other than genetics and cancer research.

Can you explain for us why animal models have been used in toxicology?
Traditionally, the science of toxicology used animal models to assess the toxic effects of unknown chemicals, drugs and food additives to make regulatory decisions regarding human safety. The animal models carried the legal authority in regulatory decision-making because these methods were often published in the Federal Register to be used as a checklist by the regulatory authorities.

What was the scientific rationale for using animals?
Although most of these methods had not been validated by adhering to a strict protocol, they were in general use by the toxicology research community, and the sheer weight of evidence provided the justification for their use in regulatory decisions. It was the best, if not perfect, method known at that time. The traditional animal tests had protected the public in the past and engendered trust in their use. There was no urgency to change.

What has changed since you got started 31 years ago?
In the last three decades, there has been a shift in attitudes regarding the use of animals in research. The shift was prompted by the many advances in the development of non-animal methods to include cellular, molecular, and mathematical and computer model systems. Cell and tissue culture methods provided the opportunity to study the biological mechanisms by which a chemical or drug acts in such a way that was never possible in animals. Many pharmaceutical companies and industrial firms have adopted these new methods to accept or reject further development of a product or entity.

Who has supported the development of non-animal alternatives?
There have been a number of groups and organizations that have supported the development and use of the new technology. Non-profit groups such as International Foundation for Ethical Research (IFER) and the Center for Alternatives to Animal Testing (CAAT) at Johns Hopkins University were among the first to support the research efforts of scientific investigators and graduate students in the pursuit of more humane science.

Why is the validation of alternatives important?
Although the concept of alternatives dates back to 1959 when William Russell and Rex Burch of the Universities Federation of Animal Welfare suggested the “three R’s” – Reduction, Refinement and Replacement – as a means of reducing the animal suffering inherent in many studies, only recently are regulators becoming more open to considering alternative test methods. Their reasons for doing so include scientific reasons, lower costs or faster results than traditional animal tests, or animal welfare concerns. Implementation of the “three R’s” means facilitating the regulatory acceptance of alternative methods. In reality, the method will not be used unless it is accepted by regulatory agencies as a replacement for a traditional animal test.

Who oversees this regulatory process?
In the USA, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), made up of representatives of 15 federal agencies, appoints panels of independent experts to review the available literature, including protocols submitted by companies, to assess the validity of a test. Depending on its regulatory mandate, each agency then independently decides whether or not to accept the test.

How many alternative methods have been validated and implemented?
Since its inception in 1997, ICCVAM has accepted 16 alternative methods, six of which have been adopted by regulatory authorities, whereas the others are undergoing improvements. ECVAM (European Center for the Validation of Alternative Methods), ICCVAM’s counterpart, has validated 17 alternatives; nine more are in the last stage of peer review; another 25 are undergoing final trials or analysis. By law, an alternative must be used in Europe once it is validated, but in practice delays of several years are still common. As European regulators become more accustomed to the new methods, they are more apt to accept them. Fortunately, ICCVAM works closely with ECVAM and can benefit from all the challenges confronting a new process.

What is your pragmatic assessment of the near future concerning the development and implementation of alternatives to the use of animals?
Scientific advancement over the years has provided the basic tools to develop methods without causing harm to an animal or human. It is not realistic to think that science will eliminate all animal experimentation immediately, but the direction is toward a considerable reduction in animal use. Alternatives can save billions of dollars and cut years off testing schedules while providing more pertinent data. The new science will not only protect the lives of animals, but humans will also be the ultimate beneficiary.

Why have you chosen to work with the National Anti-Vivisection Society and the International Foundation for Ethical Research?
When I retired from the federal government after more than 30 years as a research scientist, I made a commitment to seeing that progress in this area would continue. And I thought I could do more tackling it from a different perspective. The people associated with these organizations, especially my colleagues from science, are so generous in sharing their time and expertise – it creates real enthusiasm and a sense of accomplishment. I understand that we have a long way to go before solving this problem, but I think we’ve laid a strong foundation on which we can continue to build real progress. Now I can use my scientific expertise to help identify innovative developments in science and science education that will potentially spare millions of animals from being used as research subjects.