By Michael E. Miller
By Ryan Yousefi
By Kyle Munzenrieder
By Sabrina Rodriguez
By Michael E. Miller
By Carlos Suarez De Jesus
By Luther Campbell
By Kyle Munzenrieder
The NIDA application stalled in the Peer Review Committee -- ten scientists appointed by the agency who, in August 1996, returned her application with the comment: "Not for further consideration."
"That was the worst thing a scientist can hear," Mash says. "I never got that. In my entire career I had never gotten a 'not for further consideration.' I'm a woman who gets funded on the first admission. I'm the person who gets very high percentile scores. I don't get 'not for further consideration.' You're told, 'You're crap -- you're out.' To get that message from peer review was a real slap."
Mash says she couldn't even determine why the panel rejected the proposal. Two of the three NIDA reviewers selected to publish opinions complained that she hadn't done enough research to determine whether the drug would be safe -- even though she had received FDA approval to conduct safety trials for that very purpose. The third suggested that Mash and her team also try to determine whether ibogaine actually curbed drug cravings -- but the FDA hadn't given her permission to do so.
"Clearly there wasn't a systematic followup of all the people treated over the last few years," says Richard Hawks, NIDA's chief of chemistry and pharmacology, explaining why the agency itself chose not to develop the drug. "You didn't know what happened to all those people. The reports in the field became less compelling, and on the other side, [Molliver's study showing brain damage in rats] became more of an issue." In addition, a NIDA survey of respected pharmacologists yielded a negative vote for continued funding of human testing.
Shortly after NIDA rejected Mash's application, Stanley Glick says, he and other researchers in Albany repeated Molliver's rat study. They found that the treatment doses of ibogaine caused no neurotoxicity and that the brain damage caused by high doses was insignificant. "If a human suffered the same damage, and that's probably unlikely, it would probably be undetectable, at least neurologically," he says.
But NIDA these days is promoting development of a vaccination by the Scripps Research Institute in La Jolla, California, to block the craving for cocaine before a person ever tries it. Mash has grave doubts about such an immunization. "I just don't think it's going to work, and the reason that is that when you look at addiction as a problem, it's a problem of the mind, the body, and the spirit," she says. "If individuals want to escape reality, if existence in the world is so painful, then they're going to use some other substance to self-medicate."
Mash attributes NIDA's reluctance to political considerations. "The question," she says, "is, from a policy standpoint, is NIDA going up before Congress and saying, 'Will you please fund an African rain-forest psychedelic that we're going to give to young addicts in the inner city?'"
But Mash refused to give up. She says she took stock of the project and decided that research on the effects of ibogaine on humans would not be financed in the United States unless she could present clear and convincing evidence to NIDA that the chemical was safe. Prior to her work, the only existing research on humans had been done by Lotsof, on patients treated in hotel rooms in Europe. Three patients -- two of them Lotsof's -- had died. (A third fatality occurred in Switzerland in 1994; doctors believed that underlying heart problems contributed to the woman's death.) "This was always the hardship," Mash says wearily. "We couldn't get the credibility on an academic basis, and God knows I tried. God darn it, I tried. Mr. Lotsof [had] poisoned the well."
She simply had to gather more data, she says, if she ever hoped to obtain funding for any kind of research or treatment in the United States.
So in the spring of 1996, Mash took the most precarious step of her career. She and her husband Geller began asking their friends to invest (neither Geller nor Mash is saying who invested or how much) in an ibogaine treatment program her team designed. Last October the Healing Visions Institute for Addiction Recovery Ltd. opened a clinic on the Caribbean island of St. Kitts. The island, a former British colony, is not subject to U.S. patent laws.
"The vision was to form an institute where we could develop the technology, where we could do the science, where we could invite the experts to come down and witness the treatment," she says. The University of Miami has no affiliation with the institute, which is a for-profit company owned by the investors. Mash works as a research consultant and her husband acts as general counsel. Thus far the institute has not been profitable, though Mash and Geller hope that will change.
The institute has hired a psychiatrist; researchers from around the U.S. and Canada work either as employees or as unpaid consultants. Among them is her former laboratory partner, Dr. Juan Sanchez-Ramos. A medical team from St. Kitts provides 24-hour supervision during the two-week treatment program. Most of the twenty clients she has treated so far are addicts who contacted Mash after learning of her team's research in ibogaine, she says. Only patients who have exhausted all other legal methods of treating their addiction are accepted. The institute charges a sliding-scale fee for service. Mash will not release the fee amounts, but she claims they are comparable to the cost of a two-week residential detoxification program. Currently women are treated at no cost because so little information exists on the drug's effects on or possible dangers to them.