By Ryan Yousefi
By Chuck Strouse
By Terrence McCoy
By Terrence McCoy
By Terrence McCoy
By Michael E. Miller
By Kyle Munzenrieder
By Michael E. Miller
There to lend support to Mash's application was the man who claimed to have discovered that ibogaine could end the craving for heroin and cocaine. Howard Lotsof had been a nineteen-year-old college dropout, a heroin addict, when he first tried ibogaine for kicks in 1962. To his surprise, he discovered -- after a protracted experience filled with visions (in newspaper interviews since, Lotsof refuses to call them "hallucinations") -- that his cravings for the illegal drugs had vanished. Though he relapsed a few years later and went through methadone treatment, in the mid-Eighties he became an active promoter of what he saw as ibogaine's potential to counter addiction without the side effects of withdrawal.
NIDA itself had, in fact, bestowed on Lotsof a certain credibility. In a 1993 Capsule publication, the agency stated, "NIDA decided to evaluate ibogaine as a potential treatment medication in April 1991, after NDA International Inc. [Lotsof's company] met with NIDA with compelling evidence from about 25 heroin addicts who reported losing their craving for heroin after taking ibogaine." (Since 1984 Lotsof had been administering ibogaine to addicts -- some of them for a fee -- in the Netherlands.)
Lotsof -- who is partly responsible for the Ibogaine Dossier (the major ibogaine resource on the Internet, which lists research papers, international conferences and abstracts, testimonials, and more) -- founded NDA International in 1986 for the treatment of addicts. He was out of work, collecting disability for a back injury, when he decided to explore the research on ibogaine. He spent a year reading the literature and, between 1985 and 1991, obtained patents on future uses of ibogaine -- for treatment in amphetamine, heroin, cocaine, alcohol, and tobacco dependencies -- thus positioning himself for a possible financial bonanza in the fairly likely event that any successful research would have wider anti-addiction applications.
Since June 1992, in fact, Lotsof and the University of Miami had been research partners. Initially their agreement allowed Lotsof to retain all rights to and ownership of ibogaine treatment procedures, including any "discoveries, inventions, or improvements in any way relating" to the treatment methodology he had developed in the Netherlands, according to the contract they signed. In exchange the university would be able to use those patented procedures to treat addicts with ibogaine; the university's access to the procedures would also serve to support Mash's application for FDA approval of human safety trials.
The contract underscored Lotsof's need for reputable scientific research into the controversial drug, without which he would have little hope of ibogaine ever being commercially produced. At the same time, the university could not proceed without at least preliminary assistance from Lotsof owing to his patents and his treatment experience.
Two years later the university and Lotsof negotiated a new contract. But both agreements have since broken down, and Mash and Lotsof are now adversaries. Moreover, Mash -- without informing Lotsof -- has taken her ibogaine research to the Caribbean island of St. Kitts, where she now offers her own treatments to drug addicts and where Lotsof's patents are not protected.
But on that August morning in Maryland, Mash's greatest concern was Dr. Mark Molliver, a Johns Hopkins researcher who -- Mash already knew -- was going to recommend against her human safety trials. A few months earlier Molliver, an internationally renowned neurologist specializing in human brain anatomy, had informed the FDA of the results of his own NIDA-funded ibogaine study. Working on rats, Molliver had found evidence that ibogaine, administered in high doses, destroyed cells that relay messages from the cerebellum -- that part of the brain controlling balance and coordination. "Any time you get degeneration of nerve cells, that is considered very dangerous," Molliver says today. "We've got to use every one we've got." Unlike other nerve cells in the body, central nervous system cells do not regenerate.
Mash knew that the committee might conclude from Molliver's presentation that ibogaine was too harmful for human safety trials, that ibogaine could cause permanent damage to the brain. As he spoke, she fidgeted in her chair, preparing her rebuttal. She had, after all, done her own preclinical studies, had administered the drug in progressive doses to nine monkeys whose brains, at necropsy, exhibited no cell loss. She even had doubts about Molliver's research; he hadn't proved convincingly, she says, that ibogaine caused significant damage to the rats' brain cells. Nor had he determined whether the doses he used had any relationship to possibly damaging doses in humans.
Even before the Johns Hopkins researcher had finished his presentation, Mash strode to the podium. "I was asking critical questions," she says. "He hadn't quantified the data. He was giving some ridiculous dose -- four times the human dose." But Molliver stood his ground. Only high doses would have enabled him to clearly detect cell loss, he said. (Molliver would later attack Mash's reliability as a scientist and allege that she'd lost her objectivity.)
Mash was not the only one to challenge Molliver. Outside, the shouts continued, and as soon she finished speaking, addicts in the audience rose to address the committee. "They went up to the podium [one after another]," she recalls, "and said, 'Look, I was cocaine-dependent, I took ibogaine, and I'm not cocaine-dependent now. And by the way, I walk fine.'"