We’ve all read articles in the mainstream media condemning certain products because of their effects on laboratory animals. The evidence can be quite compelling to the average consumer.
We’ve all read articles in the mainstream media condemning certain products because of their effects on laboratory animals. The evidence can be quite compelling to the average consumer. This is why the attorney for the plaintiff in a personal injury case will often present animal studies to juries. But the extrapolation of animal studies to the human population has sparked a great deal of controversy in the scientific community, which can benefit the defense’s case.
Animal studies are often used to predict a substance’s effect on humans. In many cases, animal models have led to advances in the biological and medical sciences. However, scientists have questioned the validity of this approach in numerous scholarly articles (e.g. Hogan 1983; Van der Worp 2010; Shanks 2009). In one study, the authors found that animal models lacked predictive power in the fields of carcinogenicity and teratology.
In fact, Mike Leavitt, the former Secretary of Health and Human Services, noted: “Currently, nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies.”
If the plaintiff’s attorneys are relying on animal data in your drug or medical device toxic tort case, you can use the following three strategies to counter this approach:
1.) Explain the physiological differences between animals and humans.
Vast differences exist between animals and humans in terms of the absorption, distribution, metabolism, and excretion of chemicals. In addition, we’re still facing many unknowns regarding the influence of environmental and epigenetic changes on an organism’s response to chemicals. In fact, we’ve seen great diversity in the response and processing of drugs in the human population alone.
2.) Point out animal studies often use unrealistic doses.
Animal studies often use doses that far exceed the levels that humans would likely receive. This means two extrapolations must occur to apply the results from an animal study to the human population. First, the data must be extrapolated to doses humans are likely to receive, and second, the effects on the animal species studied must be extrapolated to humans. As noted by the EPA, these extrapolations, among others, introduce uncertainty into the dose-response analysis.
3.) Convey that statistical significance does not equate to biological significance.
Statistical significance does not always equate to clinical significance. The same is true when it comes to biological significance. Statistical significance may have little or no biological importance.
As Martinez-Abrain explains: “It is as if statistically significant meant in our minds that an effect is not only biologically relevant but that, on top of that, this fact is supported by mathematical evidence. This is absolutely wrong. On the contrary, only if a priori power tests have been performed, for an effect size of our interest, a ‘significant’ p-value, statistically speaking, will correspond to a biologically relevant effect.”
When confronted with animal studies in the courtroom, you can weaken your opponent’s case by discussing the physiological differences between humans and animals, the unrealistic doses used in animal studies, and the limited relevance of statistically significant data.
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