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
Deborah Mash and her three colleagues from the University of Miami strolled into the meeting room of a Rockville, Maryland, hotel in August 1993, and right away they knew they had trouble. The room was set up for a crowd, and they hadn't planned on this. At the far end near a podium, long tables had been arranged for the Federal Drug Administration's Drug Abuse Advisory committee. And there were enough folding chairs to accommodate 200 onlookers.
To compose herself before the session began, Mash went off to the women's lounge to meditate. In college she'd learned to blend a dogged scientific curiosity with mystical intuition, and she credits both for the insights that have led to her most significant findings in the lab. That day she wore a silk shirt adorned with Aztec designs. The Fendi briefcase (a gift from her husband, Joe Geller, chairman of the Dade County Democratic Party) was a twentieth-century success symbol.
Mash and her fellow researchers had come to Maryland to address the advisory committee -- eleven scientists, health-care workers, and laypeople who would decide whether the UM team would be the first in the nation to clinically test in humans the safety of high doses of ibogaine, a controversial psychedelic drug used by addicts in Europe and elsewhere to reduce cocaine and heroin cravings. Ibogaine is an alkaloid extracted from the roots of the iboga plant found in West Africa. Like other alkaloids -- morphine, cocaine, mescaline, and nicotine are all examples -- it produces acute physiological reactions in humans. Its use among some communities during sacred and healing rituals is well documented. In large doses ibogaine causes visions that are believed to be an aid to psychological well-being. In lesser doses the drug acts as a stimulant; mountain climbers take it in powder form to extend endurance. The French, who first studied the alkaloid at the turn of the century, have synthesized it.
Mash was no stranger to groundbreaking scientific research or federal bureaucracies. Back in 1990 she and her lab partners discovered that cocaine and alcohol used in combination could be more lethal than either substance by itself. That discovery had put her on the front page of USA Today. In her ten years as associate professor in the University of Miami's neurology department, she'd won more than $6.5 million in federal and private research grants. And she'd addressed numerous scientific and lay panels.
But she hadn't counted on an audience that day, and certainly not on the pack of reporters who filed in. Nor did she expect to see representatives from the National Institute on Drug Abuse (NIDA), the federal agency that finances addiction studies and the development of treatments. She wasn't prepared either for the demonstrators -- members of the International Coalition of Addicts for Self-Help -- who'd been massing outside the hotel to demand FDA approval of the UM test proposal.
The implications of all this attention could not have been lost on Mash, now 44 years old. The scientific community had spent the previous two decades shunning psychedelic drug research. Amid the political and moral backlash that followed the Sixties -- that harrowing era when LSD leaked out of the lab and into our consciousness to produce Haight-Ashbury, flower power, and countless bad trips -- there was far too much to lose, both in funding and career advancement. "There never was a policy saying that psychedelic research was prohibited," says Dr. Curtis Wright, deputy FDA director for the Division of Anesthetics, Critical Care, and Addiction. "But legitimate researchers were so scandalized by the irresponsible behavior of some in the scientific community -- Timothy Leary comes to mind -- that they didn't want to jeopardize their careers."
But in the late Eighties, as America's war on drugs was getting under way, things began to change. Armed with statistics -- 5.5 million addicts in the United States, according to one study at the time -- and discoveries about the neurological triggers of addiction, the government began to open doors again for limited research into hallucinogenic drug therapy, and it invited scientists to submit grant applications. In March 1990 NIDA established its Medications Development Program and sought help from the pharmaceutical industry as well, urging companies to study compounds from their stockpiles that could wean addicts from heroin and cocaine. But despite promises of increased funding and an accelerated review process, the industry response was guarded; doubts remained about the stigma of working with populations of addicts, product-liability risks, and uncertain profits. Of 30 firms approached by NIDA, only 12 had agreed to work with the agency six months later, and two industry-friendly funding bills failed in Congress.
Nonetheless, by 1991 NIDA's Medications Development Program decided to pursue preclinical scientific research into ibogaine and by 1993 had sponsored eighteen animal studies by researchers around the nation. Mash had been one of the recipients of that funding, receiving $50,000 for a safety study of ibogaine in monkeys' brains. She had every reason to be hopeful that day when she walked into the Maryland hotel to discuss her application for human safety trials, the next step in the drug development process. Instead the hearing would turn into a contentious debate played out before hordes of reporters. "We were the odd men and woman out," Mash says. "We were isolated. We were a small group of investigators from a Southern university.... We were pretty much cornered, and it felt like we were set up for the kill."
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.'"
But Molliver's research dominated the session. Mash spent precious time discussing his conclusions, not those of her own team, and defending her own studies against Molliver's, which had the backing of one of the most renowned scientific institutions in America. Glancing at the panelists, Mash could see she was losing the debate. Reporters had begun to leave to file their stories. Frantic, she followed, pressing them to ask Molliver about the extent of the cell damage, just as she'd been doing. "I'm running out trying to speak to the media, trying to get them on track -- then running back in and asking Dr. Molliver very tough questions," she says. "And I had had it. I had had it. I had had it!"
Under FDA rules, researchers may request confidential forums for discussing their applications for drug trials because they may have pending patents to protect. In frustration Mash invoked that prerogative. "I said, 'Okay, meeting closed!'" she recalls, defiance still clear in her tone. "I was the investigator, and I had the right to say, 'Meeting closed.' It looked like we were going down in flames. It was over."
In fact, Mash's colleagues -- certain the panel would refuse their application to study ibogaine -- had already given up and left for the airport. Mash braved the closed session alone. And it wasn't until late into the night -- twelve hours after she'd first gazed around the meeting room -- that the FDA advisory committee reached a decision, a compromise really. Mash had hoped she would be free to define her own parameters for human safety trials of ibogaine, but that was not to be. The University of Miami team could administer the drug safety trials on humans at dosages established by the FDA, but only on those who had already used ibogaine and who would participate in the experiments at their own risk.
After the vote, Mash made her way to a hotel elevator and began to cry. A reporter who followed her inside patted her arm and said, "You've won." But Mash remembers that she felt no joy: "I had never, never felt so beaten up in my entire life."
Mash says she first heard about ibogaine in 1991, when a man approached her after a speech she'd given at the University of Miami on the chemistry of cocaine abuse. He wanted to know if she'd heard of an African plant that could wean people off cocaine and alcohol. "I believe I looked [at him] in total disinterest," she recalls. "I said, 'Thank you, but I need to talk to these other people.'"
But later that year, at a NIDA conference in Palm Beach County, she listened in as a group of researchers discussed the chemical structure of ibogaine and whether it could reduce drug cravings. Returning to her UM office, she found an intriguing message on her answering machine. The caller was Howard Lotsof, who gave her his background and briefly explained the work he'd done with ibogaine.
"I said, 'What's this about ibogaine? What is ibogaine?'" Mash recalls. "It was like curiosity gets the cat. Lotsof described his studies in the Netherlands, his treatment, and what his results were. I got so curious as a pharmacologist. I just wanted to know what it was. What did the molecule look like? Was it a new class of compounds? Was there something unique about it? What did it teach us about addiction in the brain?"
In December 1992 Lotsof flew Mash and Dr. Juan Sanchez-Ramos, the neurophysician on her research team, to Liden, the Netherlands, to observe him treat three male ibogaine volunteers, each of whom was addicted to either heroin or cocaine. Lotsof had settled the men into hotel rooms for the duration of the 36-hour treatment. Mash sat at one man's bedside as he experienced the drug, and she interviewed all three after its effects had subsided.
Under the supervision of a Dutch psychiatrist, the addicts were given capsules of ibogaine. One reported no unusual perceptions. The other two told Mash they experienced the sensation of viewing significant events in their lives -- as if they were watching a video. The patients hardly moved. They consumed only fluids but were provided food once ibogaine's effects had lessened. A day later one patient declared he had no cravings for cocaine or heroin and that he suffered no withdrawal symptoms. The visions, while traumatic, helped him understand the causes of his addiction. (Mash has maintained contact with him; he is now attending art school in New York.)
Before witnessing the treatments, Mash had been fascinated, curious, and eager to explore the drug. Afterward her interest escalated to a firm resolve to secure permission to conduct human trials. Her reports on the three ibogaine patients had in fact helped persuade the FDA advisory committee to allow limited human trials. But even so, she was without sufficient funding to continue much longer. "We did everything with a loaf and a fish," she says. "We never had significant dollars -- we were piecing together small amounts of money and asking investigators [from the University of Miami and other institutions] to donate their time and expertise."
And then in the Netherlands, one of Lotsof's patients, a young woman, died. Though ibogaine wasn't proved to have caused her death, it has never been ruled out.
Today Lotsof and Mash disagree about what happened next, but both say it marked a change in their relationship. Lotsof maintains he had tried for years, unsuccessfully, to obtain permission to administer his ibogaine treatments in Dutch hospitals, where, he says, 24-hour medical supervision and emergency care would have been available. After the young woman died, he made the decision to move his treatment to a country where he could admit his patients to hospitals.
Mash, however, insists that she suggested the move. At the time, she explains, a Panamanian doctor doing research in South Florida heard about her ibogaine research and offered to assist and supervise treatments in his country so that information about patient doses, vital signs, and medical well-being could be carefully controlled. She says she instructed Lotsof on how the Panamanian medical authorities should proceed with the treatment protocol. Patients began to arrive in Panama in 1994, paying up to $15,500 for a three-day treatment course under medical supervision.
Even though Mash helped establish Lotsof in Panama, she says today that she began publicly to distance herself from him as much as possible by not asking him to speak on her behalf in NIDA hearings or other government meetings. She knew that the death of Lotsof's ibogaine patient would heighten other scientists' disapproval of the psychedelic research project and threaten her standing as a responsible investigator.
And she had standing to lose.
As a 31-year-old doctoral student at UM in 1984, she'd received national recognition both for herself and the university when she discovered a chemical pathway in the brain that would be a key to formulating medicines that counteract Alzheimer's disease. "I remember I was at a meeting of the Society of Neuroscience [in Minneapolis], and I was sitting in, listening to a presentation on Alzheimer's -- and that's when the light bulbs went off in my brain," says Mash. "I said, 'Oh my God, I know what I've got.'" When she returned to Miami, she approached one of the UM faculty members who was working on Alzheimer's and asked, "Do you have any Alzheimer's subjects? If you do and they die, can I have the brain?"
Her discovery helped her win a Harvard fellowship, and after two years she accepted a UM tenure-track position, one of the first offered to a female scientist. "She very rapidly took off as a scientist, on her own," says Robert Rubin, a former vice provost at the university who had extensive knowledge of her ibogaine work and in fact signed the first university contract with Lotsof. "She was a woman in pretty much a man's world. She was coming out of an environment that required a lot of aggression. It was very competitive. [Yet] as she finished her postdoctoral training, she was able to get funding on her own from the government, and that was rather unusual. She again and again proved she was ahead of the game -- her science was always a bit more unusual than the national average."
Mash harbors few illusions about what motivates her to succeed in science: "I'm addicted to achievement," she admits. When the university hired her as an associate professor of neurology in 1986, she decided that she needed more "live" material to study, so she proposed creating a brain bank in the hopes of persuading people to pledge their brains to science. (The bank, which she still manages, now has 750 donors, making it one of the largest in the nation.)
Mash never intended to study addiction, she says. But her attitude changed during the late Eighties in Miami, and she felt compelled to examine the cresting cocaine epidemic. "People were dropping like flies from cocaine," she recounts. "You'd see young people in autopsy who didn't belong there." During that period Lee Hearn, one of Mash's colleagues from graduate school, was in charge of the toxicology lab at the Dade County Medical Examiner's Office, where as a UM researcher he could do much of his toxicology work on the human brain. Hearn called Mash in 1989 to tell her of a discovery he'd just made: While examining the blood of cocaine users who had died of apparent overdoses, he'd found a chemical called coca-ethylene, which forms in the body through the combination of cocaine and alcohol. Before Hearn's discovery, scientists had thought it a byproduct of cocaine and alcohol that was simply discarded in urine, rather than being active in the blood and brain.
Hearn and Mash began to examine coca-ethylene and were able to prove that the chemical prolonged the sensation users experienced. The team also found that coca-ethylene was more potent than cocaine and that the body could not tolerate it at the same levels as cocaine. In 1990 the university obtained a grant from NIDA to study its properties.
"Again we get a wave of national recognition," Mash says, adding that they had beaten out a Yale research team that eventually came to the same conclusion. "Home run number two. The timing of that was pretty spectacular. Under the Anti-Drug Abuse Act of 1988 [which sets penalties for crack cocaine use and funds programs to combat it], Congress had appropriated money, particularly to recruit new investigators. I didn't have a track record in drug abuse -- I was doing degenerative diseases. And I go to this Society for Neuroscience to do a national press conference."
Mash's work on coca-ethylene also led her to an advisory role with NIDA and participation on peer-review committees evaluating grant proposals -- high-level contacts that would help her in developing her FDA application for human ibogaine trials.
But obtaining the FDA's permission to perform safety trials on ibogaine veterans ended up creating research obstacles that Mash hadn't anticipated. Because many experienced ibogaine users were middle-aged, they were at risk of developing other medical conditions -- heart or liver disease, for example -- that would make it difficult for the team to isolate the effects of ibogaine. Others were too ill, their immune and vascular systems ravaged by prolonged drug use.
Mash finally tracked down nine research subjects in acceptable physical condition, all of them current or former patients of Lotsof. But flying them to South Florida -- from their homes around the globe or from Panama, where Lotsof's treatment program was under way -- added greatly to the cost of testing.
Then in May 1994, one of the university's ibogaine research subjects, a 36-year-old woman with a twenty-year history of drug abuse, died in Fort Lauderdale, where she had come to participate in medical tests as part of the university's study. The patient, "N.H.," had been undergoing ibogaine treatment in Panama and had agreed that when she died she would donate her brain to assist Mash's research. "If she died because of ibogaine," says Mash, "I needed to tell the FDA."
Mash assisted in the postmortem. The cause of death proved to be loss of blood to the bowel, caused by an obstruction. The following day Mash examined the woman's brain in her lab at the University of Miami. "She had taken [ibogaine] four times at the high end of the FDA doses," Mash says. "The high end, the high-end FDA doses, and no brain damage!" That fact would help to show that the drug could be safe for human trials.
During the same year Mash's team discovered a metabolite -- a chemical created by the body's processing of ibogaine -- that she believed could be even more effective than ibogaine in combating addiction. She says she shared her discovery with Lotsof, explaining what "noribogaine" was and how the researchers had come upon it. Lotsof agreed to give the university a share of any profits from noribogaine, and in December 1994 NDA International and the university amended their original contract so that it guaranteed the university a twelve-percent share of any possible future sales of noribogaine and its derivatives.
Mash and her colleagues later formulated a theory that noribogaine combined with chemicals found in the brain called betacarbolines could possibly work more effectively than either ibogaine or noribogaine alone. At the time, she was still studying Lotsof's ibogaine treatments in Panama, and she says she kept him fully informed about her discovery. (Lotsof contends he already knew about noribogaine and its potentially enhanced effects in combination with betacarbolines.) But any further research into these new chemical relatives depended on Mash first testing ibogaine's safety in humans, and the high costs had made those trials increasingly difficult to complete.
Mash was trying to obtain more money from NIDA for her research, and she believed that the new information she had developed, both from studying the brain of N.H. and from noribogaine, could only help her. Armed with this new data, she returned to the FDA in 1995 and asked for permission to expand her trials so she could administer the drug to cocaine addicts and others who had never tried ibogaine. The FDA agreed. Finally, Mash would be allowed to study the effects of ibogaine on subjects with no previous exposure to it.
To complete the study, Mash and her team estimated they needed to raise at least $7000 per patient per dose of ibogaine in order to pay the costs of medical tests done before and after the treatment, and she says she could not responsibly launch such a study if she didn't have a guaranteed source of funding.
During 1993 and 1994 Mash's team submitted four grant requests to NIDA to finance parts of the investigation, but the agency rejected all the proposals.
"NIDA has totally backed away from [ibogaine]," says Dr. Stanley Glick, chief of the pharmacology department at Albany College of Medicine in New York; he has performed extensive research on ibogaine and its effects in rats. In 1989 Glick had also worked with Lotsof, who paid the Albany research team for its work. "There's no question that there's a political barrier. Why it's there I really don't understand, but I received advice from people I know at NIDA, who were acting in my best interest, advising me to work on something else."
Mash's last, and largest, funding request was for a $1.5 million NIDA grant to underwrite a team of 22 researchers. The plan was to slowly increase the dosage and determine at what levels it could safely be administered. Mash also designed the study so that it could answer some preliminary questions about the drug's efficacy, in case the FDA eventually approved further testing. NIDA held several public hearings about the drug, and Lotsof, who continued his ibogaine treatments in Panama, attended every one. But Mash was careful not to ask him to testify in favor of her application, even though she had been running tests on his patients.
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.
While the FDA's Dr. Curtis Wright says that drug companies are known to perform investigations overseas because they've grown frustrated with the long U.S. approval process, few academics pursue such projects. Adds Stanley Glick, the ibogaine researcher at Albany College of Medicine: "I don't know of anyone else who's done anything like this. In one sense, I admire her for doing it. In another sense, I think she's crazy. She's taking a significant risk in terms of her credibility in the scientific establishment. She's taking a risk by working in a country that's not bound by our laws, and this could affect her ability to get funding in this country." (On the other hand, one high-ranking NIDA official contends that data from the St. Kitts project might actually prompt the agency to reconsider a grant application from Mash.)
In December 1996 Mash filed a federal lawsuit against Lotsof and NDA International, alleging that he failed to complete an application for a noribogaine patent as he was obliged to do, and that he had taken credit for inventing "noribogaine plus," an ibogaine-related concept for the combined use of two substances that Mash claims her team discovered in 1994. Instead he obtained his own patent for noribogaine plus in January 1997.
Those two actions, she contends in her lawsuit, invalidate Lotsof's agreements with the University of Miami and will deprive her, her colleagues, and the university of their share of any profits from the development of both noribogaine and noribogaine plus.
James Gale, a Miami attorney who specializes in patent law, says it is highly unusual for such a lawsuit to be filed, since Mash was never a party to the contract between Lotsof and the university. Nor can Mash ever gain the rights to noribogaine plus, even if she successfully challenges Lotsof's patent, he says. Under federal laws, a patent can be corrected only if it was erroneously filed -- not if a person alleges willful deceit.
Lotsof's New York City attorney, Michael Ronemus, contends that Mash simply wants to control the drug's use and production. "Dr. Mash clearly wants that contract revoked so that she can do her own thing, so she can do what she is not permitted to do," he says. "I think [Mash's] lawsuit was nothing more than an effort to get out of [UM's] contract [with Lotsof]."
Lotsof says he was so infuriated by Mash's work on St. Kitts and her lawsuit that he decided he too should take legal action. But it wasn't until last month that he finally filed his own lawsuit in New York, accusing the University of Miami of allowing its investigator, Mash, to violate its agreements with him when she set up her own treatment center and when she obtained patents for discoveries she made while studying the process he invented. (This past April Mash and a colleague at the University of Minnesota obtained a patent for a new class of ibogaine-related compounds.) "Howard had worked on this for a number of years," Ronemus says. "He's cited in nearly everybody's research, and Mash is not. Mash appropriated what [the university was] entrusted with."
Chris Dudley, a university spokesman, would not comment on either lawsuit. Mash says that her department chairman is aware of the work she's doing offshore but stresses that the university is not involved. Geller, who is acting as Mash's attorney, says: "I don't believe in trying cases in the press. I will say that Mr. Lotsof's suit is totally without merit and is nothing but an attempt to divert attention from his own wrongful acts.