Tuesday, October 8, 2013, by Llogan Walters
In the past, even in the most ancient years of scientific research, toxicology and effectiveness testing for substances and procedures to be used on humans was conducted using animals as research subjects. But it is often suggested that the institution is more trouble than it is worth. One arguably obvious problem with the animal testing model is that it does not fit its final intended beneficiaries—humans. More simply put, that the problem with animal testing of human products is that animals are not human.
The use of animals as research subjects is a practice that was used as early as ancient Greece; the practice is nearly 2,500 years old. Lately, however, the practice has begun to come under fire from activists and scientists alike. The result has been a sharp increase in the amount of regulation of animals used in scientific and medical research in recent decades. However, “methods of testing that do not use animals are being and continue to be developed which are faster, less expensive, and more accurate than traditional animal experiments[.]”
“‘It has been shown that the technology is such today that animal testing is outdated,’ Moran said. ‘I do think that animal testing will one day be a dim memory.’ . . . Notably, many chemical companies have said they support alternatives to animal testing and some have already switched to such methods.”
[S]imply put, that the problem with animal testing of human products is that animals are not human.
One popular example of these methods is explant tissue culturing. An explant culture may involve specific types of cells or multiple cells types which may be obtained from humans. Established cultures can be used for observational or experimental purposes, including scientific and medical testing. Normal tissues have also been manipulated to develop disease.
Regulations are not nearly as strict for cultured tissue research subjects as they are for animal subjects. These lighter requirements may act as incentives to use alternatives such as explant culture for many facilities. An additional incentive to use explant culturing is the scientific concern of accuracy, which is higher in explant tests than in animal tests. The goal is noble, the concern valid, and the regulations well-placed to put pressure on researchers to do away with a flawed system; at times, the courts have made contributions of their own.
Decided in 1993 by the Supreme Court of the United States, Daubert v. Merrell Dow Pharmaceuticals, Inc. established the current standard governing when experts are allowed to give testimony based on opinions that they have developed through their research. The Court created what is sometimes referred to as the two-prong Daubert test, charging courts with determining whether expert witnesses possessed “scientific knowledge” that would “assist the trier of fact to understand or determine a fact in issue.”
The Supreme Court of North Carolina, however, expressly rejected Daubert In Howerton v. Arai Helmet, Ltd. Instead this court currently applies its own standard—laid out in State v. Goode and known, appropriately, as the Goode analysis. The court supported its original reasoning by stating that the standard formed in Daubert was actually far more austere than it should be.
Hines v. Wyeth and Bourne v. E.I. Dupont de Nemours & Co. are two cases in the Fourth Circuit in which the plaintiffs brought suit against companies due to alleged adverse effects from chemical exposure. In Hines, plaintiff Leah Royce Hines was diagnosed with breast cancer after being prescribed hormone replacement therapy drugs. Hines brought several products liability claims against Wyeth LLC and Upjohn, the manufacturers of the three drugs which she had been prescribed. Two expert witnesses, Doctors Tilley and Austin, were to testify in the case; each believed that Provera (or medroxyprogesterone acetate (MPA)) was unsafe for women needing hormone replacement therapy. The court granted the defendants’ motion to exclude the doctors’ testimony due to their research methods.
Dr. Tilley based his testimony in large part upon a 2006 study performed using Wood monkeys as test subjects. The results indicated that the monkeys given the MPA drug were more highly predisposed toward the development of breast cancer. The court, using the Daubert standard, refused to apply the results of the Wood monkey experiment to humans because of the lack of any verified data that MPA drugs had a significant carcinogenic effect on humans. The court explicitly stated that “animal studies cannot be reliably extrapolated to humans.”
In Bourne, the plaintiff sued the manufacturer of a chemical fungicide known as benomyl, stating that exposure to the chemical during pregnancy had caused her child to be born with severe birth defects. The Bourne court, also applying the Daubert standard, excluded the testimony of expert witnesses who conducted in vivo and in vitro tests for the effects of benomyl on rats, which the court found insufficient to justify expert witness testimony that the chemical had caused plaintiff’s birth defects.
In both cases, plaintiffs’ experts based their testimony upon results obtained from animal subjects. The courts in both cases relied on the two-prong Daubert test. And in both cases, the courts ruled that findings based upon animal tests failed.
North Carolina courts, unlike others in the Fourth Circuit, currently bind themselves to a precedent which places its focus on the amount of evidence that a court admits to trial, rather than the relevance thereof—a standard of quantity rather than quality. Not only does the relevance of testimony protect plaintiffs’ interests but stricter standards may, just as increased regulations on animal research have, incentivize the use of more modern technologies. If researchers are pushed to utilize methods that are more accurate to humans, such as explant culture, it would have a positive lasting in the sense that public concerns regarding animal testing as flawed and often inaccurate would be alleviated.
Animal research is a long-lived practice, however it is not the only method of conducting scientific research meant for the benefit of humans. At the same time, explant culturing and the collection of human tissues therefor have remained largely unregulated, and explant culture continues to surge forward in its applicability to humans and public health and welfare. At current, there is an opportunity for efficiency to intersect with justice; will simply being more comfortable with its older standard lead North Carolina to miss it?