Closing Argument (5)

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The Respondents were deprived of the opportunity to refute Drs. Humphrey and Gallant's testimony concerning the efficacy of aloe vera because of the decision by the Office of Administrative Hearings ("OAH") to preclude examination of them concerning their testimony about the various aloe vera research papers they sought to interpret. The OAH made this ruling precisely because of Drs. Humphrey and Gallant's concession that they lacked knowledge about aloe vera. As a result, no meaningful cross-examination on their analysis of any of the papers in State Exhibit 56 was permitted. (Humphrey, Tr. at 982-984). The OAH stated:

"... I am not going to allow a line of questioning of this witness about aloe generally because it is not within his area of expertise... . So I am going to disallow the line of questioning about a study of aloe generally in this book and further questions along this line... ." (Humphrey, Tr. at 984).

Respondents therefore conclude that the OAH will disregard all of Drs. Humphrey and Gallant's testimony concerning aloe vera, other than their testimony that there are no FDA Phase I-III studies in State Exhibit 56 and their opinions that such studies are necessary before any efficacy claim can be made.

Significantly, neither doctor was asked (and could not have been asked, given the Court's ruling and their admitted ignorance about aloe vera) to express an opinion concerning the quality, reliability and nature of the conclusions reached by the many researchers whose worked was contained within State Exhibit 56. Drs. Humphrey and Gallant further lacked a basis to evaluate the experience, knowledge and competence of the researchers and authors of the medical and scientific literature they reviewed. They were unable to opine on whether or not, independent of the non-existence of Phase I-III studies, a reasonable basis existed for the Respondents' representations regarding their products.

Drs. Winters, Heggers and Pearce all testified that there never have been any double blind, placebo FDA Phase I-III trials performed on any dietary supplement of which they were aware. Since dietary supplements do not require FDA approval before they legally can be sold, there has been little motivation to conduct these kinds of extensive, time-consuming and massively costly studies on dietary supplements. 21 U.S.C.A. § 350b (Supp. 1998); Food Labeling; General Requirements for Health Claims for Dietary Supplements, 59 Fed. Reg. 395, 396 (1994).

In addition, as Drs. Winters, Heggers and Humphrey acknowledged, without the funding typically provided by a large pharmaceutical company, it literally is impossible to obtain the considerable funds needed to conduct the kind of disease-specific clinical trials which the State claims are a prerequisite before Respondents can represent that T-Up is capable of effectively combating any health condition. Dr. Humphrey testified that Phase I-III studies would be required for each illness which Respondents claimed were beneficially effected by T-Up. He conceded that the costs would be several hundred million dollars. Therefore, obtaining the type of approval the State insists is necessary in this unique case is a practical impossibility. The law cannot be interpreted to impose a standard that is impossible to meet as a condition for making a safe dietary supplement known to consumers.

The importance of anecdotal evidence in evaluating the effectiveness of aloe vera cannot be overstated, particularly considering the magnitude of such evidence in this case. Every expert in this case has acknowledged the importance of anecdotal evidence in evaluating the safety and effectiveness of a product. Anecdotal evidence involving a plant substance such as aloe vera, which has been used for a multitude of therapeutic purposes for hundreds of years and has authoritatively and extensively been researched (albeit not FDA Phase I-III studies) is particularly reliable (especially where safety is unquestioned). A plant substance does not pass this kind of test of time if it is unsafe or lacking in therapeutic value. Significantly, every research paper, without exception, reporting on the toxicity of aloe vera concluded that it was non-toxic and safe. Similarly, every research paper that has analyzed cesium chloride has determined that it is safe at the prescribed levels.

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