Washington Agency Aims To Meet The Needs Of Drug Researchers

Federal office helps scientists get controlled substances, but the price is paperwork and secrecy WASHINGTON - Pharmacologist Louis Harris keeps his drugs in a massive safe bolted securely to the floor of his lab at Virginia Commonwealth University. Barbara Slifer, a behavioral pharmacologist at the University of New Orleans, refuses to tell her lab partners where she's stashed the chemicals for their next experiment. They and thousands of their colleagues around the country can wait weeks and sometimes months to get essential supplies. All of these scientists, who are trying to better understand how drugs behave chemically in the brain and affect people's behavior, are familiar with the quirks of working with illicit substances such as heroin, cocaine, and LSD. Once a small community, their ranks are growing rapidly in step with the nation's increased attention to combating the problem of drug abuse in United States society. "We're trying to attract a lot of bright people into this field," says Frank Vocci, chief of the developmental therapeutics branch at the National Institute on Drug Abuse (NIDA). Last year the agency began a Medications Development grants program to support work in the field; in 1991 it hopes to spend $40 million on the effort. But Vocci's new recruits may not know what they are getting into. The scientific challenges these researchers face are formidable, and the logistics of getting and keeping these drugs and chemicals may be even more intimidating. The drugs can be hard to come by. The work is often shrouded in secrecy, with investigators not even able to trust the postdoctoral scientists and students working with them. And there is the seemingly endless red tape and rec-ord-keeping involved in applying for a license to experiment with the drugs, in ordering them, and in parceling them out for study. Controlled substances are classified according to the danger they pose and their potential medical use. Schedule 1 drugs, like heroin, are frequently abused and have no known medical use. Schedule 2 substances, such as cocaine, are equally dangerous but have some therapeutic qualities. There are 1,683 researchers in the U.S. licensed to work with heroin and other tightly controlled, Schedule 1 drugs. They are a subset of the 4,310 scientists licensed to use the less tightly regulated Schedule 2 drugs. Daily life in a controlled-substances laboratory has its quirks. Some drawbacks are trivial, others can be major impediments to their investigations. Drugs can be hard to come by. Supply houses and pharmaceutical firms may be loath to supply chemicals in the small amounts required. "Often the synthesis is difficult, time-consuming, and expensive" for the companies, says Robert Walsh, who runs an NIDA program to supply drugs. For these reasons, he says, many supply companies and pharmaceutical firms have little incentive to make or supply controlled drugs to laboratories. This was the situation Jack Mendelson found himself in more than a decade ago when he decided to investigate the therapeutic properties of a powerful opioid called buprenorphine. An injection of the low-dose form of the substance - available by prescription as Buprex - can relieve a cancer patient's physical torment. But Mendelson, a biochemist at the McLean Hospital in Cambridge, Mass., speculated that the high-dose form might work as a remedy for the agony of the addict hooked on "speed ball," a lethal cocktail of heroin and cocaine. To his dismay, the drug was not available from its U.S. distributor in the high-dose tablets. So Mendelson turned to its British manufacturer. But he was stymied by legal restrictions on the importation of controlled substances. Finally he asked the U.S. government to supply him with the drug. NIDA was happy to help out. Through its Drug Supply Program, established in 1967, the Public Health Service has been making life a little easier for scientists like Mendelson. The program was set up, with a budget of less than $150,000, to supply LSD to scientists. Today, it spends $1.5 million annually to send out 500 different drugs to 2,000 scientists across the country. The number of researchers receiving drugs - none of whom pays a penny - has increased by 20 percent to 30 percent annually for the past three years, says Walsh. Some pharmaceutical firms and chemical supply houses may refuse to supply the drugs because they fear their names or products will be tainted by an association with drug addiction. "A good example is methadone," Vocci says. "It's a useful analgesic, but sales have been damaged by the fact it's also used in addiction treatment programs." Such limitations have forced many scientists to become experts at casing the drug market. "If I need a prescription-form drug like Valium, Hoffman-LaRoche will supply it graciously," says Slifer, a behavioral pharmacologist at the University" of New Orleans. She also checks out what is available at chemical supply companies like Sigma Chemicals in St. Louis. But, she points out, "chemical companies tend to be expensive, so the smart thing is always to see if you can get it [free] at the pharmaceutical company first." After 10 years in the business, however, she's learned that it's even better to come to NIDA. Robert Balster agrees. "Without [NIDA] I don't know what I'd do," says the Virginia Commonwealth University pharmacologist. But finding a good source isn't the only problem facing the drug investigator. NIDA, for instance, requires a level of record-keeping that would seem excessive to most scientists. The agency also limits the amount it will supply of a drug. Simply qualifying to use a drug requires a fair amount of paperwork. To get a license to use Schedule 1 drugs like heroin or buprenorpine, a scientist must first apply to the local branch of the federal Drug Enforcement Agency (DEA). The next steps are to apply to the Washington headquarters of both DEA and the U.S. Food and Drug Administration (FDA). Once that's done, the researchers mail their study protocols to DEA, which forwards it to FDA for a review of scientific merit. Eventually, an approved order form emerges at NIDA, which ships off the request in unmarked brown boxes. Those orders take a while to be filled. "A few years ago I wanted an opioid that people were interested in because of its PCP-like qualities," says Slifer. At the time, she notes, there were several researchers studying the drug. "I had to wait over three months," she says, "and ultimately I was forced to study a different, less desirable compound." In general, a wait of weeks is standard with NIDA, she says. Sometimes, if she needs a drug in a hurry, she can order it from Sigma. The luxury of getting essential chemicals overnight is worth the hefty retail price, she says. Slifer says she entered the field because she is curious about why people abuse drugs. An experimental psychologist studying LSD introduced her to the subject when she was a graduate student at the University of Wyoming in the mid-1970s. Several years later a painful attempt to quit smoking led her to work with nicotine addiction. "I would start craving a cigarette when I sat down for a cup of coffee or to call a friend on the phone," she says. That feeling of withdrawal made Slifer realize that drug dependency is the result of an interaction between the pharmacological action of a drug on the brain and environmental cues, a lesson she now plans to apply to cocaine addiction. The unmarked box in which Slifer's drugs arrive is just one precautionary measure to keep drug users from stealing substances. In some labs, security is so tight that even the postdoctoral fellows don't know where the drugs are locked up. Harris, who heads the health science division at Virginia Commonwealth University in Richmond, keeps his stash in a 760-pound safe bolted to the floor of his lab. No one has managed to break in so far, but Harris remembers one incident in which burglars, believed to be students, broke into a freezer. "[They] ripped off our supply of tetrahydro-cannabinol," he recalls. "It wasn't in a form that could have been of much use to them, however. We found it later, thrown away by the side of the road." His colleague, Robert Balster, relies on two techniques to foil more subtle forms of theft. "One of the keys is record-keeping," he says. "You have to keep track of small, incremental diversions. The other is that we aren't clear to people about where these substances are stored because that would be inviting disaster. The drugs aren't stored in the lab, and we don't advertise." While these scientists try to keep their drugs to themselves, NIDA's Walsh can't wait to serve the anticipated wave of newly licensed drug researchers. He's already installed a new computer system to shorten processing time and plans to increase his stocks of cocaine. And he's counting on his regular customers to teach their colleagues the art of studying these substances.

Washington Agency Aims To Meet The Needs Of Drug Researchers

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