Opinion ID: 163852
Heading Depth: 2
Heading Rank: 1

Heading: Health Risks to Uniao do Vegetal Members

Text: 42 The district court found the evidence on the health risks to Uniao do Vegetal members from hoasca use was in equipoise. The dearth of conclusive research on the effects of hoasca and DMT fuels the controversy in this case. One preliminary study, conducted in 1993 by Dr. Charles Grob, Professor of Psychiatry at the University of California, Los Angeles, compared 15 long-term Uniao do Vegetal members, who drank hoasca for several years, with 15 control subjects who never ingested the tea. Researchers administered a series of psychiatric, neuropsychological, and physical tests and compiled life story interviews. In articles published in various scientific journals, researchers reported a positive overall assessment of the safety of hoasca. While acknowledging the limitations of his investigation, Dr. Grob testified: 43 [it] did identify that in a group of randomly collected male subjects who had consumed ayahuasca for many years, entirely within the context of a very tightly organized syncretic church, there had been no injurious effects caused by their use of ayahuasca. On the contrary, our research team was consistently impressed with the very high functional status of the ayahuasca subjects. 44 As the Government emphasized and the district court acknowledged, DMT's Schedule I-listing represents a Congressional finding the substance has a high potential for abuse, no currently accepted medical use, and a lack of accepted safety for use under medical supervision. 21 U.S.C. § 812(b)(1). Addressing the Grob study specifically, the Government highlighted methodological limitations, including the small size, male-only subjects, and selection bias. According to Dr. Alexander Walker, a Professor of Epidemiology at the Harvard School of Public Health, the selection of long-term members of Uniao do Vegetal, individuals who were able to conform to its norms over extended periods, without a similar requirement for stable, long-term, voluntary church attendance applied to the control group, ensured the hoasca -consuming group necessarily had a favorable psychological profile. 45 Testifying for the Government, Dr. Sander Genser, Chief of the Medical Consequences Unit of the Center on AIDS and Other Medical Consequences of Drug Abuse at the National Institutes of Health, testified, existing studies have raised flags regarding potential negative physical and psychological effects of hoasca. Dr. Genser cited a study in which two subjects consuming intravenously administered DMT experienced a high rise in blood pressure, and another had a recurrence of depression. Information about the dangerous effect of other hallucinogenic substances, according to Dr. Genser, raises concerns about hoasca. For instance, especially in individuals with pre-existing psychopathology, lysergic acid diethylamide (LSD), a hallucinogen substance that shares pharmacological properties with DMT, may produce prolonged psychotic reactions or posthallucinogen perceptual disorder, commonly known as flashbacks, defined as the reemergence of some aspect of the hallucinogenic experience in the absence of the drug. 46 In response, UDV emphasized important differences in ceremonial use and reported effects of hoasca. UDV expert, Dr. David Nichols, Professor of Medical Chemistry and Molecular Pharmacology at Purdue University, declared, [o]rally ingested hoasca produces a less intense, more manageable, and inherently psychologically safer altered state of consciousness. Further, he testified, the set and setting in which an individual takes a hallucinogen are critical in determining the experience. Dr. Grob attested to the absence of evidence of flashbacks from hoasca use and the milder intensity and shorter duration of hoasca's effects compared to those of other hallucinogens. He also declared the ritual setting of Uniao do Vegetal members' consumption minimizes danger and optimizes safety. 47 Adverse drug interactions stemming from the beta carbolines in banisteriopsis are a potential danger acknowledged by even UDV. Individuals who ingest hoasca while on certain medications may be at increased risk for developing serotonin syndrome, a condition caused by excessive serotonin levels with symptoms including euphoria, drowsiness, sustained rapid eye movement, overreaction of the reflexes, confusion, dizziness, hypomania, shivering, diarrhea, loss of consciousness, and death. Several types of antidepressants, among other drugs, contain selective serotonin reuptake inhibitors (SSRIs), which trigger the release of serotonin or prevent its reuptake. Monoamine oxidase (MAO) inhibitors, including hoasca, interfere with the metabolization of serotonin. The MAOs in hoasca may hinder the metabolization of greater levels of serotonin made available by the use of SSRIs. 48 Dr. Genser, for the Government, noted irreversible MAO inhibitors, which bind to an MAO molecule and may forever destroy its function, may harmfully interact with many medicines, as well as with a chemical found in some common foods. Conceding a risk of adverse drug interactions, UDV noted the church has instituted a system screening members' use of medications. However, UDV maintained the danger is not so substantial as to warrant a government ban on sacramental hoasca use. First, hoasca does not contain irreversible MAO inhibitors, the kind associated with the most severe drug interactions. Rather, as UDV experts testified, the potential for adverse interaction is reduced and the effect of any reaction is shorter and much milder with hoasca than with irreversible MAOs. Second, Uniao do Vegetal leadership has carefully addressed the possible danger of adverse drug interactions. Dr. Grob declared, [f]ollowing discussions of our concerns with physicians of the UDV, all prospective participants in ceremonial hoasca sessions have been carefully interviewed to rule out the presence of ancillary medication that might induce adverse interactions with hoasca. Finally, according to UDV, the risk of adverse drug interaction associated with hoasca falls within the normal spectrum of concerns. Government experts highlighted other dangerous aspects of hoasca, including the increased risk of psychotic episodes. Based on data collected by the medical-scientific department of the Brazilian Uniao do Vegetal, Dr. Genser testified, pyschosis is definitely of most concern. UDV countered with expert testimony suggesting the link between psychotic disturbances and hoasca is coincidental, rather than causal, and that the reported very low occurrence of psychosis among church members in Brazil is equal or less than the rate in the general population. 49 We see no basis for disagreeing with the district court's characterization of the evidence as in equipoise and hold proper its determination the Government failed to satisfy its RFRA burden on the issue of health and safety risks of hoasca. Although studies of hoasca are preliminary and limited, Dr. Grob's research indicates an overall positive assessment of the health effects of the substance. Dr. Nichols, expert for the UDV, cogently highlighted the differences between the effects of hoasca versus intravenously injected DMT. He further stressed the importance of set and setting — for Uniao do Vegetal, a guided, calm ceremony — in determining the psychological impact of hallucinogens. 50 Critical to this case is that the Government's burden under RFRA was to demonstrate a ban on hoasca use by the Uniao do Vegetal, not a ban on hallucinogens in general, promotes a compelling interest in health and safety. The court acknowledged if it were employing a more relaxed standard to review the application of the CSA to the UDV's use of hoasca, it would be very reluctant to question this Congressional finding concerning DMT. But RFRA provides, [g]overnment may substantially burden a person's exercise of religion only if it demonstrates that application of the burden to the person furthers a compelling interest, not merely application of the law in general. 42 U.S.C. § 2000bb-1(b) (emphasis added). [U]nder RFRA, a court does not consider the [law] in its general application, but rather considers whether there is a compelling government reason, advanced in the least restrictive means, to apply the [law] to the individual claimant. Kikumura, 242 F.3d at 962. 51 Thus, recitation of the criteria for listing a substance on CSA Schedule I and of the general danger of hallucinogens does not, in this record, evince a compelling government interest under RFRA. Moreover, [e]vidence which does not preponderate or is in equipoise simply fails to meet the required burden of proof. United States v. Kirk, 894 F.2d 1162, 1164 (10th Cir. 1990). The Government failed to build an adequate record demonstrating danger to Uniao do Vegetal members' health from sacramental hoasca use. Hardman, 297 F.3d at 1133.