Animal drug testing is cruel and unusual punishment (which for humans we supposedly don’t do to other humans since our 8th Amendment of the Bill of Rights prevents us from doing so).
The drugs are tested on animals, then if the FDA approves the drug for at least one indication, then any doctor in the US can write an off label prescription for any indication that they see fit.
So the drug companies are beta testing on thousands and millions of people albeit with their informed consent, yet this consent is manufactured and built on animal testing instead of being based on human testing from the start.
This is bad and unethical science. According to the Humane Society.
“The Food and Drug Administration (FDA), which regulates various products such as drugs, medical devices, food, fragrances and color additives, will not approve potential drugs unless they are first tested on animals, which usually includes dogs.
In addition to tests on dogs, mice and rats, rabbits, birds and primates are also used to test pesticides and drugs. These types of tests have been performed for years, regardless of whether they provide valuable information.”
The History of Modern Bioassay with psychedelics.
1897-Arthur Heffter discovers mescaline, bioassays himself through ingestion.
1943-Albert Hoffman discovers LSD, bioassays himself ingestion.
1957-Albert Hoffman synthesizes psilocin, bioassays himself through ingestion.
1959-Albert Hoffman isolates LSA In 1959, bioassays himself through ingestion.
1963-Nick Sand resynthesizes dmt, bioassays himself through smoking.
1976-Sasha Shulgin resynthesizes mdma, bioassays himself ingestion.
1983-Ken Nelson milks toads (5-meo-dmt), bioassays himself through smoking.
1993-Daniel Siebert extracts Salvinorum A from Salvia Divinorum identifying Salivnorum A as the primary psychoactive substance of Salvia divinorum through bioassay with himself and friends through ingestion.
2001-Jonathan Ott extracts and purifies bufotenine, bioassays himself through smoking.
2021-Church of the Sacred Synthesis fruits psilomethoxin, members bioassay themselves through ingestion.
Jonthan Ott’s comments on Ethics and Psychonautic Bioassays by Basement Shamans
The term psychonauts was first coined in German (Psychonauten) by Ernst Jiffiger, in his logbook of pharmacological voyages in inner space – which he named the psychocosmos (Ringer 1970). Of late the term psychonautic bioassay, to refer to self-experiments with psychotropic drugs, has gained currency, and I here employ the substantive psychonautics in characterizing such research.
Some might regard this to be a euphemism for getting stoned, mayhap with justice in some cases, such as its common use by basement shamans (popularized as the name of a botanical supply firm in Illinois) to describe non-novel, unstructured and uncontrolled (and generally unreported) ingestion of psychotropic agents. On the other hand, amateur reports posted on the Internet or in publications like The Entheogen Review can be valuable sources of human pharmacological data, albeit requiring winnowing of precious little wheat from abundant chaff.
Moreover, psychonautic bioassays have proven invaluable in phytochemical investigation of visionary compounds. Although alkaloids had first been isolated a decade before from péyotl, Lophophora williamsii (Lem.) Coult. (Cactaceae), self-experiments by Arthur Heffter in 1897 were required to determine that mescaline was the main visionary agent.
Based on animal assays, Sandoz Ltd. pharmacologists had in 1938 rejected LSD as lacking interest, but intuition led Albert Hofmann to resynthesize the compound in 1943, provoking its accidental ingestion and his subsequent psychonautic bioassay, hence the discovery of one of the most potent drugs known.
Hofmann later found animal assays useless to guide the isolation of visionary compounds from Psilocybe mexicana Heim (Agaricaceae) and Turbina corymbosa (L.) Raf. (Convolvulaeae). Although in both cases other groups had a head-start, Hofmann alone was successful (finding psilocybine/psilocine and lysergic acid amides, respectively), thanks to his use of psychonautic bioassays.
While salvinorin A was isolated pursuant to animal assays, it had previously been found during research on novel terpenoids, and a decade passed before basement shamans demonstrated conclusively it was the visionary agent of Salvia divinorum Epl. et Jativa (Labiatae) (Siebert 1994).
Insofar as animal assays have proven ineffective in some areas of research on visionary compounds, the ethics of their use is dubious. This goes double for many types of research on so-called drugs of abuse, given the fact that these are studied owing to their human popularity, pursuant to their subjective effects. Some proponents of purportedly objective double-blind animal research dismiss psychonautic bioassays as being subjective, although this is fundamental to scientific interest in many “abused” drugs.
As Shulgin and Shulgin (1991) have argued, ethics dictate that the researcher her- or himself be the first to ingest a novel, putative psychotropic drug, and that subsequent human testing be conducted only with fully-informed volunteers advised as to the identity of the compound, its dose, and the nature of effects already experienced.
The Shulgins denominate such secondary testing “double conscious” (after Gordon Alles), and characterize double-blind studies in these cases as “pointless” and “verg[ing] upon the unethical.” In countries where a particular drug is illegal (i.e., bufotenine in the U.S.), it might he argued that any testing of it is unethical absent official authorization, although I would maintain it would still be ethical to test it on oneself (albeit perforce entailing criminal possession).
The Church of Psilomethoxin’s approach to double conscious drug development, aka Community Based Dieta Drug Development
Safety is and has always been a first and foremost concern for the leadership at the Church. As such, when we first discovered Psilomethoxin, we took great care and attention in dispensing the sacrament. To this end, we slowly distributed our sacrament to members of our existing communities of entheogen-based religious/spiritual practitioners. In doing this, we were careful to collect the maximum amount of feedback from everyone so involved. Through this process, we kept an open heart and mind, seeking to collect data in a non-biased, fair and equitable manner.
In terms of safety, the initial data indicates that our sacrament does not have a significant risk profile. After dispensing sacrament to over 2,000 individuals, who consumed the sacrament and reported back, we have yet to receive one negative report indicating the sacrament might be dangerous and/or comes with any undesirable or harmful side effects. We remain open to receiving contrary evidence and will pass on any pertinent data received to our members and the general public.
It must be noted that FDA-approved clinical trials utilize a significantly smaller population of people in validating the safety profile of new drugs. For instance, during Phase I of clinical trials, which is focused on the safety of a specific compound, only about 20-80 people are utilized. Phase II clinical trials, which is mostly focused on effectiveness, utilizes 100-300 people. Phase III, which is a study aimed at a much larger population, can include anywhere from 300-3,000 people. By the time 2024 rolls around, we feel confident that we will have dispensed sacrament to more people than even the largest of clinical trials.
In order to validate our existing data, as has been previously stated, we will be rolling out a third-party research platform which will collect anonymously, among other measures, safety data. Therefore, we will be able to further substantiate the anecdotal reports and analyses we have received to date. We are very fortunate and blessed to have been given an opportunity to engage the scientific community in monitoring our members’ safety and progress over time. We are committed to sharing the independent third-party reports of the data received to our membership and the general public as information is received and analyzed.
In conclusion, the safety profile of our sacrament has, and always will be monitored by the Church, with an open heart and mind. It is against our most deeply held and felt beliefs to ever cause harm to another, under any circumstances. As data is gathered in the future it will be shared. However, to date, a substantial pool of data already collected indicates our sacrament has an impeccable safety profile.