Hurdles Keep Street Drugs Out of Medicine Chest

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.

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