There is no justice without a fair trial
LEGAL BATTLES / CLOSING ARGUMENTS
There is no evidence that a single consumer complaint was ever filed with the State concerning the efficacy of T-Up's products or any representations made by the company.
By Kathleen Deoul
This prosecution is not consumer driven. It is an ill-conceived creation of the State. There is no evidence that a single consumer complaint was ever filed with the State concerning the efficacy of T-Up’s products or any representations made by the company. In fact, the State did not introduce any expert testimony to establish that Respondents’ products do not provide precisely the medical benefits represented. Rather, the State acknowledged that its case was focused on whether the literature Respondents provided to the State, which the State provided to its experts, supported the Respondents’ representations in the Tape and Brochure.
Mr. Ziperman stated:
“... we are not asking our experts ... to ... give any opinion testimony ... whether or not this product worked... . They’re giving an opinion that the literature doesn’t support their claims.” (Tr. at 709).This is a remarkable concession. Having contacted many T-Up and cesium chloride users, the State likely was satisfied that substantial benefits were safely being derived by consumers using T-Up and cesium chloride. However, this information was immaterial in the State’s decision to attempt to put this company out of business and eliminate the availability of its products. The fact that thousands of consumers are benefiting from the product was immaterial to the State’s decision making process.
The failure of the State to produce any expert witness who was familiar with the complex composition of aloe vera, who also was qualified to opine on how aloe vera effects the immune system and the illnesses related to the immune system, is fatal to its case. Drs. Humphrey and Gallant’s mandate from the State was to review State Exhibit 56 and opine that there were no FDA approved Phase I-III studies in State Exhibit 56. Since Phase III studies are typically multi-state, multi-institutional, double blind controlled studies, it was not difficult to thumb through State Exhibit 56 to determine that there were no such studies. Respondents would have so conceded. Drs. Humphrey and Gallant were unqualified to opine on the quality, reliability and conclusions of the aloe vera researchers in State Exhibit 56, as well as the significance of the unprecedented avalanche of anecdotal evidence (which, in many instances was confirmed by medical records) because of their acknowledged ignorance of aloe vera.
Had there been credible complaints from consumers indicating that the Respondents had made deceptive representations, then perhaps the State would have been justified in initiating this proceeding. However, the antithesis occurred. Lacking a single consumer complaint, the State went out and solicited consumers who otherwise were satisfied with their relationship with the Respondents1 and interrogated them in such a manner as to develop support for the position the State wished to assume.
Similarly, had there been a legitimate concern over the safety of the products, the State would have sought immediate injunctive relief to prevent the continued sale of T-Up and cesium chloride. The State’s failure to seek such relief is most telling. Respondents are still selling the same products. The State knows that Respondents’ products are safe. If it suspected otherwise and failed to act, it would have failed in its obligation to protect the public’s interest. Although there was much “hullabaloo” in the State’s opening statement concerning the safety of Respondents’ products, no evidence was introduced to indicate they are unsafe. To the contrary, the affirmative evidence established their safety. Appropriate disclosure of potential side effects was provided.
The State’s primary consumer witnesses, Ms. Daley and Ms. Crabbe, are relatives of patients who were hopelessly ill and had been left by conventional medicine to die. Neither had considered the Respondents in any way responsible for the ultimate death of their loved ones or for having made deceptive representations, until after contacted by the State. Then they incredulously claimed that Allen Hoffman (“Hoffman”) or an employee of T-Up had guaranteed a 100% miraculous cure for their Stage IV cancer-infested loved ones. These witnesses evolved from the investigation of Dr. MacNay and his intravenous use of cesium chloride and aloe vera. But for the investigation of Dr. MacNay, the State would have had no more interest in prosecuting the Respondents than it has in prosecuting the sellers of aloe vera products who outrageously and falsely advertise their products as containing levels of aloe vera that they do not possess and who promise beneficial effects to one’s health that are impossible to achieve from the diluted and altered aloe vera products they are selling. (See claims made in the Internet aloe product materials used by the State (D327) in a futile attempt to show T-Up’s lack of concentration, compared to the findings in The Brevard Teaching and Research Laboratories (“BTR”) report on these same products (D363B)).
This action was instituted in reckless disregard for the truth concerning T-Up’s safety and effectiveness. No complaints had been received. Customers’ monies were refunded upon request. With some few possible exceptions, only satisfied customers existed until the State dredged up several uniquely isolated consumers who were involved with Dr. MacNay and the intravenous use of T-Up and cesium chloride.
An indictment of Big Medicine and Their Suppression of the Cesium Cancer Therapy.
Despite the fact that the State possessed samples of T-Up for many months before it filed the Statement of Charges and knew, early in the trial, that the Respondents were performing laboratory tests on T-Up for comparison purposes, it apparently never bothered to have T-Up tested to determine its contents and strength compared to other aloe vera products on the market. It is illogical to believe that the State did not test T-Up before filing charges since T-Up’s concentration representation was so central to the State’s allegations. In light of the proven high concentration of T-Up, it is more likely than not that the results of such supported Respondents’ representations.
Either way, because of the political fallout from the MacNay matter, the State, either in total ignorance, or contrary to its own test results, blindly plowed ahead and leveled charges involving misrepresentations concerning concentration, uniqueness and the quality of T-Up’s product. The State is still pursuing these allegations in spite of the uncontradicted evidence provided by the BTR report.
However, the State’s evidence on this issue has been reduced to its laughable “teaspoon” theory. If the State did not test T-Up to determine its concentration and quality before leveling charges that T-Up’s representations concerning its concentration and quality were false, then the State flagrantly abused its power. If the State tested T-Up and obtained the equivalent results obtained by the BTR analysis, then its abuse of power is equally egregious. The State is in a no-win situation in its claim that Respondents’ representations concerning the uniqueness and concentration of T-Up are false.
The down-the-line significance of this failure by the State is considerable. Because the medicinal effect of aloe vera is dose and concentration-dependent and the only evidence before the Court is that T-Up is the most concentrated aloe vera product on the market (and of greater concentration than any of the aloe vera products tested in any of the research papers), the State has failed to prove that this unique and concentrated aloe vera will not be as, if not more, effective than the already positive results described in State Exhibit 56.
After contacting many of the almost 4,000 customers of T-Up, the State could only come up with a handful of customers who had anything adverse to say about the company, its products and particularly, about Hoffman and Neal Deoul (“Deoul”). On the other hand, Respondents had approximately 32 consumer witnesses and more than 80 affidavits from satisfied and fervently loyal customers who swear to the medicinal benefits that T-Up and cesium chloride have provided to them. Further, Respondents’ claims are supported not only by research results and a long history of the beneficial use of aloe vera in the country, but by established medical knowledge concerning the immune system and how aloe vera safely affects the immune system.
By admission, not a single State expert had personal knowledge of T-Up, its active ingredients, its safety, or its effectiveness in treating disease. Not one of the State’s experts has personally used either product in their medical practices. Nevertheless, the State has accused T-Up of selling products which are dangerous, not as concentrated as represented in the company’s marketing materials and ineffective in treating illnesses. The State did not prove any of these allegations. The BTR report and Dr. Heggers’ interpretation of this report proved that T-Up was the concentrated product Respondents’ represented and that it contained many fold more of the important ingredients that trigger the synergistic effect of aloe vera on illnesses. The State did not contest the accuracy of the BTR report.
With respect to the State’s claims in the Statement of Charges regarding the safety and efficacy of cesium chloride, the State has failed to meet its burden of proof. The State did not present testimony by a single qualified expert witness that cesium chloride was either unsafe or ineffective in treating cancer.2 As a result, the Court must find against the State on all of its charges concerning T-Up’s representations relating to cesium chloride.
The State bases its entire case upon its experts’ opinions that the scientific articles contained in State Exhibit 56 do not constitute the kind of FDA-approved double blind, placebo clinical trials required for the approval of a new drug. Their testimony is meaningless. No one ever represented that State Exhibit 56, in and of itself, provided the basis for T-Up’s claims about its products in its marketing materials. State Exhibit 56 is a miscellaneous accumulation of research papers, newspaper articles and promotional materials that the company had available when requested to produce documents.3 Therefore, the fact that these documents do or do not satisfy the State created criteria of FDA Phase I-III studies is meaningless. Besides, the existence of FDA Phase I-III studies is not the standard imposed by law.
What matters is whether or not the Respondents had a reasonable basis for their efficacy claims. Respondents had a right to rely upon the case histories, medical literature, research results and the scientific conclusions of authoritative scientists in making their efficacy claims. Deoul presented expert testimony by Dr. Heggers, an immunologist, microbiologist, and pharmacologist with extensive experience testing and researching aloe vera. Dr. Heggers testified that based on his review of the scientific literature, as well as his knowledge of the active ingredients of aloe vera, the functioning of the immune system, and his personal experience, aloe vera stimulates the immune system, increases healthy T-cells in the body, and is capable of effectively fighting a number of diseases, including HIV, AIDS and cancer.
Dr. Pearce, a well trained and experienced physician and neurologist, testified that based on his study and review of scientific literature concerning aloe vera, as well as his use of T-Up and other aloe vera products in treating patients in his medical practice for a number of years, T-Up was an effective treatment for auto-immune disorders such as multiple sclerosis, lupus, rheumatoid arthritis and Sjogren’s Disease. Dr. Pearce studied and researched aloe vera for a number of years before he was engaged as a witness in this case. He also reviewed State Exhibit 56 and various books containing information regarding aloe vera which were provided to him in connection with his engagement.
He based his opinion that T-Up was a safe and effective treatment for both immune and autoimmune disorders on his knowledge concerning aloe vera which he acquired from all of the above-referenced sources, his medical background, as well as his years of experience using aloe vera and T-Up in his medical practice with favorable results. He also testified that aloe vera was a potent stimulator of the immune system. Dr. Pearce was the only expert who could testify from the perspective of a physician who had recommended T-Up to his patients and had concluded T-Up was a beneficial treatment for his patients who had auto-immune illnesses.
Dr. Winters was the sole expert produced by the State who testified that aloe vera was a weak stimulator of the immune system. Dr. Winters was impeached by various lectures he had given where he had described aloe vera as a potent immune stimulant. Dr. Winters was offered the opportunity to review all of his lectures to determine if he had ever indicated in any lecture that aloe vera was a weak immune stimulator. When Dr. Winters returned to complete his testimony, he was forced to acknowledge that he had never indicated in any of his lectures at any time that aloe vera was an ineffective or weak stimulator of the immune system.
His lectures also contradicted his “stand alone” personal opinion that if aloe vera stimulated the immune system, it would do so like a “rifle shot”, that is, very narrowly. (See for example, D315 at 15-16). His “bell shaped” curve analogy to describe the dose-response to aloe vera by the immune system is contrary to every published work on the topic, including experts he conceded were authoritative, as well as the testimony of Drs. Heggers and Pearce. There can be no question that aloe vera produces a dose-related straight line response. The higher the concentration and dose, the greater the immune response. Moreover, a reading of Dr. Winters’ lectures indicates that he strongly believes that aloe vera not only is a strong stimulator of the immune system, but that it also is capable of acting in a modulating capacity to control overactive cellular activity, which would be beneficial in auto-immune illnesses. (D315 at 15).
Dr. Winters’ testimony on this subject is directly contrary to the testimony of Dr. Humphrey that there is no one substance that can address both an overactive and underactive immune system. (Humphrey, Tr. at 856). As discussed below, Drs. Humphrey and Gallant’s testimony concerning what aloe vera or T-Up can or cannot do should be disregarded in its entirety.
The personal experience and knowledge of Deoul’s expert witnesses’ concerning aloe vera and T-Up starkly contrasts the complete lack of knowledge of aloe vera and T-Up conceded by the State’s experts Drs. Gallant and Humphrey (as well as Dr. Winters, who disclaimed any expertise on how aloe vera effects humans). As highly qualified as Drs. Gallant and Humphrey may be in their respective fields, both admitted that they had never used aloe vera or T-Up in their medical practices and knew nothing about aloe vera. They neither studied nor researched aloe vera either prior or subsequent to their engagement by the State and had no idea of its active ingredients or medicinal effects.
The State’s experts based their opinions that T-Up was not an effective treatment for HIV, AIDS and cancer exclusively on their review of the journal articles contained within State Exhibit 56. Because State Exhibit 56 did not contain FDA Phase I-III studies, they concluded that the Respondents’ efficacy claims were false. That was the only basis for their opinions. Nevertheless, both doctors were quick to interpret aloe vera research papers despite the fact that they knew nothing about aloe vera.
An example of this irresponsible attitude is demonstrated by Dr. Humphrey’s testimony concerning State Exhibit 56r, a toxicity study of aloe vera gel with prednisolone and cancer cells called HeLa cells. Dr. Humphrey opined at Tr. 840-842 that because the HeLa cells proliferated when exposed to acemannan in a petri dish, that aloe vera was a favorable growth substance for cancer cells. This bizarre and hopelessly erroneous testimony proves the inappropriateness of Drs. Humphrey and Gallant’s interpretation of research papers on a complex natural substance about which they know nothing. Aloe vera does not kill cancer cells in isolation. It requires normal cells to act upon (which were non-existent in the petri dish in State Exhibit 56r).
When addressing cancer or other illnesses, aloe vera is an immune stimulator. It stimulates the macrophage which sets in motion the cascade of events described by Dr. Heggers when he was using the poster chart in the courtroom, copied from State Exhibit 56f, Figure I. Aloe vera stimulates the macrophages which produces cytokines, which results in the production of interleukin, interferon and tumor necrosis factor, which in combination, kill cancer cells. In 1989, Dr. Winters proved that: “[aloe vera was] found to markedly promote attachment and growth of human normal, but not tumor cells and to enhance healing of wounded cell monolayers... .”
(S56ww, Abstract). Tumor cells will always continue to proliferate unless attacked by cytotoxic components such as interleukin, interferon and tumor necrosis factor which result from the stimulation of the immune system. It also is noteworthy that Dr. Humphrey failed to appreciate in this 1969 paper (S56r) that aloe gel was the aloe product being tested. Aloe gel’s composition lacks the beneficial content of acemannan, the whole leaf aloe vera and T-Up. (Hennessee, Tr. at 1767).
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.
Further evidence that T-Up and cesium chloride are both safe and effective in treating a number of different health problems is the affidavit testimony of Dr. Powers, who both used T-Up personally and has provided it to his cancer patients to assist them in combating their cancer. Dr. Powers is the Director of the Cancer Treatment Center at Divine Providence Hospital. In his affidavit, Dr. Powers testified that he read and understood T-Up’s literature and found the company’s representations to be truthful based on his experience with the company’s products.
The State has failed to make a prima facie case to prove its claims in ¶¶ 5 and 6 of the Statement of Charges against Neal Deoul. The State claims that Neal Deoul participated in the day-to-day operations of T-Up, but did not provide any proof to substantiate this claim. Rather, the overwhelming weight of the evidence was to the contrary. Virtually every consumer witness who testified at the hearing reported having conversations with Allen Hoffman, not Neal Deoul. Most of the consumer witnesses never heard of Neal Deoul and had no contact with him. In addition, Scott Van Horn testified that, to his knowledge, Neal Deoul had little involvement in the company. Mr. Van Horn testified that he is not sure what Neal Deoul did when he was in the office, and that he frequently was out of the office traveling with his wife. Dr. Knudsen, the sole witness out of almost 4,000 potential witnesses who testified that he spoke about T-Up with Neal Deoul over the phone at Mr. Deoul’s home, is a flimsy and grossly insufficient basis to hold Neal Deoul in this case. This isolated conversation does not satisfy the State’s burden.
There simply was insufficient evidence for the Court to conclude that Neal Deoul participated in the daily operations of T-Up, and in particular, in the creation and implementation of T-Up’s advertising practices.
About Kathleen Deoul
Internationally acclaimed wellness advocate Kathleen B. Deoul founded Cassandra Books. In taking this step, Kathleen hopes to bring her message of health and hope to people all over the world. Full profile
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