Date: Tue, 28 Oct 1997 19:11:11 EST
From: Chris Jenks <firstname.lastname@example.org>
To: Multiple recipients of list <email@example.com>
Subject: Recent News Article
Howard very generously sent me the following article, and after typing it
in I would like to share it with you. It contains some intriguing tidbits
about St. Kitts and Howard's conflict with Dr. Mash.
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Miami New Times by Paula Park, September 11-17, 1997, Volume 12, number
22, pp 16-17, 19, 21, 23, 25, 27, 31. Copyright 1997 by New Times, Inc.
Addicted to Addiction
University of Miami's Deborah Mash believes ibogaine could be the wonder
drug to end all drugs. And she's ready to risk everything to prove it.
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
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, healthcare 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
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
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 monkey's 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 are the odd men and women 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 elevate
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
"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 expertise.
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
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
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 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
Mash was not the only one to challenge Molliver. Outside, the shouts
continued, and as soon as 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 experiment 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
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
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 know 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 dies of apparent overdose, 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 the 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 systems 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
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 made 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 combatting 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 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 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.
These 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 has 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."