By Michael E. Miller
By Allie Conti
By David Villano
By Jose D. Duran
By Michael E. Miller
By Allie Conti
By Kyle Swenson
By Luther Campbell
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."