Hurdles Keep Street Drugs Out of Medicine Chest

Sept. 11, 2008— -- The patients at Dr. Michael Mithoefer's clinic in South Carolina all suffer from post-traumatic stress disorder. Some are the victims of rape and child sexual abuse, others -- veterans returning home from Iraq -- bear the psychic scars of war.

They have tried other therapies before but here, under the watchful eye of Mithoefer and his staff, they're trying something new -- MDMA, better known as ecstasy, a drug that if bought on a street corner would land these patients in jail.

The results of the Mithoefer study -- the first Food and Drug Administration-approved Phase 2 trial of MDMA to treat post-traumatic stress -- will not be known until it concludes later this month. But the treatment already shows promise, the doctor says.

"We have had some very dramatic results," Mithoefer said. "We have examples of people on disability for years who have now returned to work. The treatment has had a profound effect on a number of people whose symptoms are now much better. It hasn't been that way for everybody but, overall, this seems to be much more effective than what is currently out there."

Like an ex-con trying to clean up his act and leave behind his criminal past, illicit drugs have a hard time shaking off their bad reputations. Many illegal drugs such as MDMA and marijuana could have pharmacological futures. Others such morphine and cocaine were initially developed for medicinal purposes, and some can be found in your medicine cabinet masquerading under assumed names. But scientists looking to do new research say it is difficult to get funding or approval for studies on drugs with rap sheets.

That marijuana, cocaine, morphine, methamphetamines, even the so-called "date rape drug" GHB, have versions approved by the FDA does not mean securing funds and permission to research these drugs is easy.

"The DEA really slowed us down," Mithoefer said of the U.S. Drug Enforcement Administration. "We submitted a 550-page application to the FDA and we were approved pretty quickly."

"Working with a controversial Schedule 1 drug made getting permission from the DEA difficult," he said of the class of substances the DEA believes has the greatest potential for abuse.

Many of the scientists working on research with illegal drugs say the government bureaucracy and the need to obtain permission from numerous agencies scares off researchers, their backers and institutions.

"The university [the University of South Carolina] didn't want to be involved in the study," Mithoefer said. "It seemed too controversial. Fortunately, we were getting our funding elsewhere. The lengthy delays makes it difficult for many researchers to go forward. This is a real problem. There are many people suffering and there shouldn't be these needless delays."

Those delays, say the FDA and DEA, are necessary to ensuring the most dangerous drugs do not get into the wrong hands or are misused.

Research proposals for human trials need to be approved by the FDA and DEA and, in some cases, as when marijuana is involved, other federal agencies as well.

"There are a lot of players when it comes to drugs," DEA spokeswoman Rogene Waite said. "Different agencies with different authorities each need to sign off."

"From our perspective, we're always concerned about safety and, regardless of the schedule, we're looking at the same set of issues. But when it comes to illegal drugs, there is going to be the highest levels of security and scrutiny on those drugs," she said.

The MDMA study, which involved 21 patients and began four years ago, took years of planning. Although Mithoefer is affiliated with the University of South Carolina, the study was conducted at his private clinic and funded by a nonprofit group. After the DEA stalled approval for the research, he says, the university balked from sponsoring a study involving a controversial and otherwise illegal substance.

But MDMA is not the only drug that has spent time both on the street and in the laboratory.

MDMA, or methylenedioxymethamphetamine, has its roots in the medical community. It was developed and used surreptitiously by psychiatrists in the 1970s. If it was one day to return to the medicine chest, it would follow a long line of other drugs that remain illegal in one form but legal in another.

"If you look back over the history of many so-called 'street drugs,' many have origins in well-intentioned and scientifically sound theories for use in medicine and more noble purposes than just getting high," said Paul L. Doering, a pharmacology professor and director of the University of Florida's Drug Information and Pharmacy Resource Center.

"The distinction between illegal and legal is tenuous," he said. "The door swings in both directions. These drugs have to replace their tie-dye shirts with lab coats."

Though marijuana cigarettes are sold for medicinal purposes in some states, the drug remains technically illegal in federal law in all but one form.

Sold under the name Marinol, THC (the active ingredient in marijuana) is prescribed as an appetite stimulant to treat nausea in cancer patients receiving chemotherapy and weight loss in AIDS patients.

The popular and legal drug Adderall, which is given to children with attention-deficit disorder, is just one carbon molecule away from being the popular illegal drug methamphetamine.

Cocaine, a local anesthetic like Novocain, has the added benefit of restricting blood vessels to stop bleeding. It is regularly used in its liquid form in emergency rooms and in facial surgery.

The "date-rape" drug GHB is classified as a Schedule 1 drug and is illegal if possessed with the intention of drugging someone in a bar, but is classified as a Schedule 3 drug when prescribed as Xyrem for use in the treatment of narcolepsy.

Beyond just governmental bureaucracy, Doering and others say, other barriers remain in the way of conducting medical research on illegal drugs.

"There are several factors keeping these drugs out of the lab," he said. "The main challenge is overcoming their bad reputations and convincing the research community that under the right circumstances -- under evaluation and regulation -- these drugs can be tamed to help humankind."

In addition to government regulation and the drugs' bad reputations, an inability to patent and, therefore, make money off these substances also stall research.

Raw marijuana, literally a weed, cannot be patented and neither can a drug discovered decades ago like LSD.

Salvia divinorum, a hallucinogenic, is perhaps the newest plant to be recognized for both its recreational and potential medical uses.

Still legal in most states, the drug is under review by the DEA to determine whether it should be criminalized.

If it is declared illegal before scientists get a chance to begin research, some fear that the drug will face the same challenges of other illegal substances with medicinal potential.

"Salvia might have all kinds of uses in the treatment of mental disorders and we shouldn't stop research before we've even started," said Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies, a nonprofit that funds research on otherwise illegal drugs, including Mithoefer's MDMA study.

"It is hard to quantify the lost benefits by not allowing this research to go on," Doblin said. "But how can the government justify keeping drugs that improve or save people's lives out of their hands?"