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Tuesday, November 27, 2007

PTSD Researchers Ecstatic About MDMA?

This is another issue that's been floating around for a bit, but I'm only now getting to posting on it: PTSD researchers are now testing the efficacy of the hallucinogenic drug MDMA, or ecstacy, to treat post-traumatic stress. The Washington Post Magazine ran an article ("The Peace Drug") on the issue this past weekend:

PTSD is usually triggered by combat, rape, childhood abuse, a serious accident or natural disaster -- any situation in which someone believes death is imminent, or in which a significant threat of serious injury is accompanied by an intense sense of helplessness or horror. Not all or even most trauma victims develop PTSD, but enough do so that nearly 24 million Americans, or 8 percent of the population, have suffered from it at some point in their lifetime. It is estimated that in any given year, more than 5 million Americans have active PTSD -- a costly problem in humanitarian and economic terms. Drug and alcohol abuse are all-too-frequent consequences of PTSD, as is loss of productivity and the need for expensive, long-lasting medical treatment.

The ever-lengthening Iraq war will count among its other costs a legacy of thousands of veterans in need of psychiatric treatment. The government estimates that already more than 50,000 soldiers -- about 4 percent of those who have been deployed to Iraq and Afghanistan -- have been treated for symptoms of PTSD. Many more might actually have it: Military studies put the number at 12 to 20 percent of those returning from Iraq and 6 to 11 percent of those returning from Afghanistan. And the news gets worse.

"Vets with PTSD are particularly costly to the [Veterans Affairs] system," says Linda Bilmes, a lecturer in public policy at Harvard's Kennedy School of Government. "They constitute 8 percent of the claims, but 20 percent of the payments." Bilmes, who has studied the ongoing costs of the wars, estimates that treating Iraq vets with PTSD over the next 50 years will cost taxpayers $100 billion. This is based on findings that one-third of vets with PTSD will remain unemployable, and all suffering with PTSD will have a much higher than normal likelihood of needing treatment for physical ailments. And that's just the direct costs to the budget. "Assuming that the war continues, though with lower deployments, through 2017," she says, and assuming the rate of PTSD isn't being underreported, the cost of lost economic productivity to the U.S. economy will be in excess of $65 billion.


In educational interest, article(s) quoted from extensively.

Continuing:

THE CAPSULES RESIDE IN A SAFE, armed with an alarm and bolted to the floor of Mithoefer's office, a 1950s-vintage cottage on the road between downtown Charleston and Sullivans Island. It's been tastefully remodeled to create a softly lit, high-ceilinged sanctuary in the back, scattered with art and furnished with, among other things, the ever-so-slightly inclined futon where Donna got crooked.

The elaborate security is occasioned by what is inside the capsules: MDMA, a synthetic compound that is a chemical cousin to both mescaline and methamphetamine. Unabbreviated, MDMA is a real mouthful -- 3,4-methylenedioxymethamphetamine -- but it is far better known by its street name, ecstasy, millions of doses of which are synthesized in criminal labs from the oil of the sassafras plant. At one point, Mithoefer recounts, agents of the Drug Enforcement Administration, there to inspect the security arrangements, inquired about the therapist who rents the office adjoining the safe room.

"I guess they were concerned she might drill through the wall into the safe and steal the MDMA," Mithoefer says. "Though there's such a small amount in there, and it's so readily available on the street in such large quantities, I don't see how that would be worth the effort, even if she were so inclined."

Mithoefer became a psychiatrist in 1991, after a decade as an emergency room doctor -- he had found himself less interested in the bodily traumas his patients suffered than the psychological traumas that so often preceded their appearance in the emergency room. He's got that mellow, empathic vibe that they just can't teach at therapy school. He always seems moments away from a sympathetic chuckle, an understanding murmur or a sage observation. A fit 61, with a brown ponytail and relaxed dress code, Mithoefer has become the accidental point man of a movement to revive medical research into psychedelic drugs. His Food and Drug Administration-approved PTSD study that began with Donna Kilgore in April 2004 is now nearly completed, with 18 of 21 subjects having undergone the double-blind sessions. Two Iraq veterans with war-related PTSD, the study's first, are cleared to begin. Close behind are similar studies in Switzerland and Israel. At Harvard's McLean Hospital, researchers are set to evaluate MDMA therapy as a way to alleviate acute anxiety in terminal cancer patients. In Vancouver, Canada, the effectiveness of an ongoing program to treat drug addiction with another potent psychedelic drug, ibogaine, is under scrutiny. There is a proposal, based on case histories, to study the ability of LSD to defuse crippling cluster headaches.

All of these studies are directly or indirectly funded by a surprisingly robust organization whose roots stretch back 40 years to the psychedelic movement of the 1960s. Before Harvard lecturer Timothy Leary started channeling aliens and urging college kids to turn on and drop out, an intense cadre of doctors and researchers had come to believe that psychedelic drugs would revolutionize psychiatry, providing those with a wide spectrum of psychological problems -- or even just ordinary life difficulties -- the ability to, basically, heal themselves.

But Leary's bizarre career, which morphed from doing research on psychedelics to cheerleading their widespread abuse, obscured whatever medical potential the drugs may have had. Instead, authorities focused on the risks, and often exaggerated them. Richard Nixon famously called Leary "the most dangerous man in America." After a slow start, regulators and legislators cracked down hard. Millions of dollars in enforcement efforts were unable to end abuse of psychedelic drugs, but they effectively stamped out sanctioned research into their healing potential.

A small group of psychedelic researchers and therapists willing to break the law continued their work clandestinely. A much larger group did not flout the law, but waited in the wings and is now emerging. Experience had convinced these therapists that psychedelics, along with significant risks, had potential for even more significant benefits.

This may have been especially true of MDMA. ...

THE PROMISE OF A BLOCKBUSTER TREATMENT, one that doesn't just address symptoms but defuses underlying causes, is a particularly seductive vision right now. A report issued last month by the National Academy of Sciences' Institute of Medicine emphasizes the uncertain effectiveness of current PTSD treatments, and the urgent need of returning soldiers who will suffer from it.

To a non-scientist, the very preliminary results of Mithoefer's study would suggest that MDMA might be just what the doctors ordered. Of the subjects who have been through both the MDMA-assisted therapy and the three-month post-experiment follow-up tests, Mithoefer reports, every one showed dramatic improvement.

But scientists are a cautious lot. "It's potentially nice to hear those things," says Scott Lilienfeld, an associate professor of psychology at Emory University. But until results are statistically analyzed and peer-reviewed for publication, "you can't really judge them. The plural of anecdote is not data." Especially with a drug that has considerable risk, Lilienfeld cautions, it pays to be skeptical.

A.C. Parrott, a psychologist at Swansea University in Britain who has devoted a large part of his career to studying the dangers of MDMA, is far more than skeptical. "MDMA is a very powerful, neurochemically messy and potentially damaging drug," he says. The government "should never have given it a license for these trials. Certainly I would not give it a license for any further trials."

But one of the nation's premier PTSD researchers, Roger K. Pitman, a professor of psychiatry at Harvard Medical School, disagrees. Morphine is a powerful, potentially damaging drug, Pitman says, "and we use it to treat the pain of cancer patients. Sound medical reasons should trump."

Current treatment for PTSD is "partial at best," he says. "There's a lot of room for improvement, and we need to be looking for novel treatments."

Though Pitman calls the MDMA study "a fringe hypothesis" -- "I've never heard anybody talk about it at any PTSD meeting I've ever attended in 25 years" -- he also observes that, based solely on a description of the preliminary results, "this seems worth further study. A lot of new ideas meet with rejection and skepticism, and we need to be careful not to be prejudiced against something just because it seems wacky. If it has a 5 percent chance, or even a 1 percent chance, of being effective in treatment of PTSD, it's worth pursuing."

Read the rest.

Writer Tom Shroder had a follow-up online chat at WaPo:

Blacksbug VA: Tom,

I enjoyed reading "The Peace Drug" and I thought it was well-balanced. Having observed various aspects of the MDMA story over 30 years, what is your opinion on where it is going from here? For the sake of argument, let's assume studies demonstrate impressive efficacy in assisting psychotherapists to help treat PTSD. Can you see, for example, specialized clinics/training centers sprouting up across America in 10 years? Do you see the military (here and elsewhere) "buying in" to MDMA-assisted psychotherapy as an option for treating soldiers with PTSD? Or will MDMA remain "fringe" at best?

Tom Shroder: I think the key, as always, is what the scientific studies demonstrate. If the current phase II studies have very positive results, which they certainly appear headed for, and a many-times larger phase III study, with hundreds of subjects and dozens of therapists all across the country also demonstrated -- for the sake of argument -- spectacularly positive results, then yes, I do believe that MDMA would become part of the treatment arsenal for PTSD. If it works as some hope, the fact that very limited use of the drug -- a handful of sessions -- can effect lasting change in the underlying psyche of PTSD sufferers and untangle the knots that cause their symptoms would make it an extremely appealing option. But it's a long way from a phase II clinical study and that eventuality. There are very many drugs that appear promising in phase II studies only to falter later on.

_______________________

New York, NY: MDMA will be almost certainly be invaluable to thousands of people some day, but it does break my heart to see these initial guinea pigs getting the short end of the stick, with no chance of continuing treatment. I guess it's better than nothing, although the relapse rate over the years might end up being quite high for them -- making the study look bad -- when all it would take would be one or two treatments every other year for several years or so and they might be cured.

Is there any provision in Dr. Mithoefer's study to follow these people over the years, to observe how they fare? Or are they waiting until Phase III trials to do that sort of thing?

Tom Shroder: A followup on the subjects who have been through the study so far is happening now, which means that some subjects have been post-treatment for more than three years, Donna Kilgore in the story was subject 1, so she's been the longest. And she was only allowed two treatments -- the study was since modified to allow three MDMA treatment sessions.

_______________________

Amherst, Ohio: The VA for years has been looking for a miracle cure for PTSD to erase the money spent for PTSD claims, do you fear as I do this might be looked at for just that purpose?

Tom Shroder: First of all, the VA and the Pentagon have had nothing to do with this research. But to the larger point of your question, it seems to me a backward way of looking at it: The only reason this treatment would save the VA money would be if it actually works. Then that would be a very good thing, no? PTSD, as it became clear to me when I was interviewing the subjects mentioned in the story, is a particulary cruel disorder. When Donna Kilgore told me that she could put her finger on her arm and feel like she was touching a corpse, I nearly wept for her right then and there. So making them feel whole again is a very good thing indeed. And Spending less tax money on people who are cured -- also very good thing..

_______________________

No VA: I'm curious to know if there are any follow-up studies on the long term effects of the use of these drugs? Especially with large numbers of young soldiers returning from Iraq and Afghanistan, we have to ask not just if the benefits of these drugs will outweigh the suffering in the short term, but also if they will need long term treatment, and what that might mean for their health.

Tom Shroder: This is an important issue, and it emphasizes what Dr.Mithoefer always cautions: Phase II trials are very early in the process of determining if a drug is beneficial. In the case of MDMA, if it proves effective, then it will take years to determine the best way to use it -- and how treatment with MDMA will unfold over the years. Will some people be cured outright and forever? Will periodic MDMA sessions be necessary to maintain the benefits? Could unforseen problems arise with long-term therapeutic use? None of these questions have even begun to be answered.

NPR also has an interview up with Shroder.

Meanwhile, Israel is conducting trials. And since 2005, researchers in South Carolina have been conducting this controversial research. From a February 2005 Guardian article:

American soldiers traumatised by fighting in Iraq and Afghanistan are to be offered the drug ecstasy to help free them of flashbacks and recurring nightmares.

The US food and drug administration has given the go-ahead for the soldiers to be included in an experiment to see if MDMA, the active ingredient in ecstasy, can treat post-traumatic stress disorder.

Scientists behind the trial in South Carolina think the feelings of emotional closeness reported by those taking the drug could help the soldiers talk about their experiences to therapists. Several victims of rape and sexual abuse with post-traumatic stress disorder, for whom existing treatments are ineffective, have been given MDMA since the research began last year.

Michael Mithoefer, the psychiatrist leading the trial, said: "It's looking very promising. It's too early to draw any conclusions but in these treatment-resistant people so far the results are encouraging.

"People are able to connect more deeply on an emotional level with the fact they are safe now."

Finally, the issue of trying to determine the efficacy of MDMA to treat PTSD has been around for a while, as witnessed by the following video featuring the late Peter Jennings of ABC News. [He and Bob Woodruff team up together for a 43-minute documentary on the subject, available here.] I don't have air dates for either, but they're informative and worthy of including.



Clinical information on MDMA/PTSD treatment.


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