Rudolf Brenneisen was a professor of pharmaceutical science at the University of Berne. The careers of Dietschy and Brenneisen had been closely entwined. During the turbulent years of Swiss drug policy reform, Brenneisen had become Dietschy’s closest scientific ally. He conducted most of the basic science research, which Dietschy needed to back up his often difficult administrative decisions. Together they had shaped one of the most adventurous episodes in the history of twentieth-century drug policy. Reminiscing about the 1990s, they looked back on a time when the current regulatory regime governing the scientific and medical uses of controlled substances in Switzerland was still in the making. Dietschy began:
When I started my job in 1989, there was a medical association for psycholytic therapy, which wanted to do research on patients with LSD, ecstasy, and psilocybin. As these substances are prohibited, the Swiss Medical Association for Psycholytic Therapy had to get a federal license according to Article 8, paragraph 5 of the Narcotics Law. Hence, they asked the SFOPH for permission. My predecessor Dr. Jean-Pierre Bertschinger and the then director kept putting this off. It wasn’t quite clear how to deal with it. Nobody had any experience in Europe. What did one have to take into account? Thus there was a vacuum and the response was continuously postponed. But then this medical association complained to the minister in charge. He gave brief directions to the federal office: No matter what, but come to a decision! In 1987 or 1988, the SAPT was given authorization without further requirements. When a renewal was due in ’89, my then chief of staff came up to me and told me where to sign. I glanced over the document and asked, “Where is the approval of the ethics commission?” And he said, “The ethics what?” At this point in time, ethics commissions were only just being introduced into human trials in Switzerland. This was pushed by the Swiss Academy of Medical Sciences. The state didn’t care yet. Shortly after I began my job, I had a meeting with this group of physicians and I told them, “Hey, the ethics commission is missing and I can’t see a neat study design. I want to see more.”
Considering that, in the United States, institutional review boards had been introduced in 1966 (Rothman 1991), it is striking that, on the federal level, Switzerland only came to police pharmaceutical research activities in the 1990s. In 1989, Dietschy was among the first to make the approval of an ethics commission a requirement. At the time, drug regulation was organized by the cantons, that is, the states of the Swiss confederation—some strict, some more permissive. To homogenize the Swiss regulatory landscape, an intercantonal control agency coordinating cantonal regulations issued guidelines for clinical trials in the mid-1990s. Only in 2002, when Swissmedic was established, did the Swiss state put an end to the cantonization of its regulatory regime. “We were in a field that was just emerging,” Dietschy remembered. In the late 1980s, the Narcotics Law only stated that the SFOPH could grant special permits for scientific research and limit medical applications of prohibited substances. “A completely open wording,” Dietschy said. “This provided us with latitude, which we don’t have anymore today.”
But this regulatory freedom was accompanied by much uncertainty, especially when internationally prohibited drugs like heroin or hallucinogens were involved. “We had zero experience with this,” Dietschy recalled. “Apart from England, there was no research on illicit drugs in Europe, which could have served as a foundation. I was a civil servant who actually had nothing to do with research. My task was a different one. But I always got applications for research projects. I was in the situation that I constantly had to face problems for which I couldn’t find an answer anywhere.”
This was how Rudolf Brenneisen became involved. The administrative decisions Dietschy had to make were politically and medically risky. As the prohibition had also choked off pharmacological research on heroin and the hallucinogens, a lot of information he would have needed was missing in the medical literature. Consequently, the SFOPH invited Brenneisen to conduct the studies necessary to fill in the blanks. Brenneisen scientifically supported Dietschy, who was in charge of the logistics of the Swiss heroin program. But he also helped him assess applications from the renascent field of hallucinogen research. For this purpose, Brenneisen’s doctoral student Felix Hasler generated drug-safety data for psilocybin, which the SFOPH needed in order to assess applications like the one submitted by the Swiss Medical Association for Psycholytic Therapy.
It did not take long for Dietschy to realize how vital questions of drug safety were in this area. In 1990, one of the patients treated by SAPT president Peter Baumann died during a therapy session. After a number of prior irregularities, Baumann had taken the woman to a remote, ill-equipped lodge in France (not Switzerland), far away from an emergency room, where he gave her ibogaine, a powerful plant hallucinogen used for ritual purposes in the West African spiritual tradition of Bwiti. Ibogaine was not among the substances approved of by the SFOPH. Dietschy also claimed that, after this fatal incident, other patients came forward reporting that, while in the clinical trial, they had come to suffer from severe depression. “Probably their serotonin supplies had been depleted,” Dietschy said. “Exactly the opposite of what one had aimed for had happened. They were not, as they told us, taken care of. The doctor just pushed them aside because it didn’t fit into his preconceptions.” Soon charges of medical misconduct were filed against a second member of the SAPT.
By this time, Dietschy had grown deeply mistrustful of the organization: “We became very reserved. We felt that there was a lack of scientific seriousness. They were freaks who thought, ‘Here we get a chance to make our mark.’ My impression was, they don’t want to stick to the rules.” Because of the experiences and data provided by Brenneisen, however, Dietschy continued to believe that psychedelic drugs might have a great potential to treat severe mental disorders. Therefore, he told the SAPT that he was not opposed to hallucinogen research in principle but that, in the future, he would only support applications that had a clear study design and were approved by an ethics commission.
At this point, Franz Vollenweider entered the scene proposing to test psilocybin on humans. Dietschy was impressed:
The application was scientifically perfectly neat and correct. I have rarely seen such a solid documentation. The SFOPH waved it through relatively quickly and, to a certain extent, we also supported his research because it was an important part of the puzzle for us to be able to decide later on whether to test these drugs in humans again. This is how Vollenweider got involved and I have to say that I have always only seen top-quality work from him. Few researchers—Brenneisen and Vollenweider among them—never had any problems with us regarding approvals. The SFOPH also supported them financially. Today, Swissmedic doesn’t have research funds anymore. Back then we had budgets for international projects and for research. When you saw a new problem, you could decide relatively spontaneously. Those were the days.
And Brenneisen seconded: “It was an enormous privilege to have authorities that massively supported research. I admit, for me this was the chance of my academic career. Without the politics and the research support of the SFOPH, financially and ideationally, this would not have been possible.”
Paul Dietschy (PJD) and Rudolf Brenneisen (RB) brought their account of hallucinogen research to a close by relating two more reminiscences explaining how Vollenweider’s lab managed to leave behind its local rivals and move to the forefront of the global resurgence of psychedelic science.
| PJD: | Reminiscence 1: I left SFOPH in 2001 and gave up these responsibilities. Until then, the SAPT did not get another approval. Within ten years they did not manage to turn in a dossier complying with the usual standards of good clinical practice. The second point is a funny reminiscence: At the beginning of the 1990s, we got some psilocybin back for disposal, as we were the authorities in charge of this. It was really ancient material. | |
| NL: | Who gave it to you? | |
| PJD: | We got it from someone who had used it for experiments, syntheses, for various things. The laboratory assistant called and said, “Mr. Dietschy, I got some psilocybin. How shall I dispose of it?” I took a look, called Brenneisen, and said, “I would like to know whether the substance still meets any quality standards.” The answer came a few days later: “It meets all standards!” Suddenly we had 100 g of pure psilocybin. Nobody else in the world had
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