Pubdate: Sun, 4 May 2008
Source: Sunday Times (UK)
Copyright: 2008 Times Newspapers Ltd.
Author: Amy Turner
Cited: Multidisciplinary Association for Psychedelic Studies
Bookmark: (Ecstasy)
Bookmark: (Harm Reduction)


Ecstasy Is the Key to Treating PTSD

At last the incurably traumatised may be seeing the light at the end 
of the tunnel. And controversially, the key to taming their demons is 
the 'killer' drug Ecstasy

An Ecstasy tablet. That's what it took to make Donna Kilgore feel 
alive again - that and the doctor who prescribed it. As the pill 
began to take effect, she giggled for the first time in ages. She 
felt warm and fuzzy, as if she was floating. The anxiety melted away. 
Gradually, it all became clear: the guilt, the anger, the shame.

Before, she'd been frozen, unable to feel anything but fear for 10 
years. Touching her own arms was, she says, "like touching a corpse". 
She was terrified, unable to respond to her loving husband or rock 
her baby to sleep. She couldn't drive over bridges for fear of dying, 
was by turns uncontrollably angry and paralysed with numbness. When 
she spoke, she heard her voice as if it were miles away; her head 
felt detached from her body. "It was like living in a movie but 
watching myself through the camera lens," she says. "I wasn't real."

Unknowingly, Donna, now 39, had post-traumatic stress disorder 
(PTSD). And she would become the first subject in a pioneering 
American research programme to test the effects of MDMA - otherwise 
known as the dancefloor drug Ecstasy - on PTSD sufferers.

Some doctors believe MDMA could be the key to solving previously 
untreatable deep-rooted traumas. For a hard core of PTSD cases, no 
amount of antidepressants or psychotherapy can rid them of the horror 
of systematic abuse or a bad near-death experience, and the slightest 
reminder triggers vivid flashbacks.

PTSD-specific psychotherapy has always been based on the idea that 
the sufferer must be guided back to the pivotal moment of that trauma 
- - the crash, the battlefield, the moment of rape - and relive it 
before they can move on and begin to heal. But what if that trauma is 
insurmountable? What if a person is so horrified by their experience 
that even to think of revisiting it can bring on hysterics? The Home 
Office estimates that 11,000 clubbers take Ecstasy every weekend. 
Could MDMA - the illegal class-A rave drug, found in the system of 
Leah Betts when she died in 1995, and over 200 others since - really 
help? Dr Michael Mithoefer, the psychiatrist from South Carolina who 
struggled for years to get funding and permission for the study, 
believes so. Some regard his study - approved by the US government - 
as irresponsible, dangerous even. But Mithoefer's results tell a 
different story.

MDMA was patented in 1912 by the German pharmaceutical company Merck. 
To begin with, it was merely an intermediate chemical used in 
creating a drug to control bleeding. In the 1920s MDMA was used in 
studies on blood glucose as a substitute for adrenaline. The Merck 
chemist Max Oberlin concluded that it would be worth "keeping an eye 
on this field". Still, no further studies were carried out until 
1952, when the chemist Dr Albert van Schoor tested the toxicity of 
MDMA on flies. "Flies lie in supine position, then death," he recorded.

MDMA's therapeutic potential wasn't realised until 1976, when the 
American chemist Alexander Shulgin tried it on himself. He noted that 
its effect, "an easily controlled altered state of consciousness with 
emotional and sensual overtones", could be ideal for psychotherapy, 
as it induced a state of openness and trust without hallucination or 
paranoia. It quickly became known as a wonder drug, and began to be 
used widely in couples therapy and for treating anxiety disorders. 
None of these tests was "empirical" in the scientific sense - no 
placebos, no follow-up testing - but anecdotally the results were 
almost entirely positive.

Word, and supplies, of the new "love drug" got out, and in the early 
1980s it became popular in the fashionable clubs of Dallas, LA and 
London, where it was known as Ecstasy, X or "dolphins". As use became 
widespread, the US authorities panicked, and by 1985 MDMA was an 
illegal, schedule-1 drug. UK laws were even tighter: MDMA, illegal 
under the 1971 Misuse of Drugs Act, was categorised class A in 1977, 
carrying a sentence of up to seven years for possession.

Criminalisation put paid to MDMA research almost overnight, at least 
until Mithoefer's current programme began. But it didn't stop the 
ravers. The drug was popular in the late 1980s and early 1990s for 
its energising, euphoric effects. There are no official figures for 
that period, but the Home Office estimates that in 2006/7, between 
236,000 and 341,000 people took Ecstasy. Experts say the drug is far 
less fashionable now than in its heyday in 1988, the second so-called 
"summer of love".

The MDMA used in the studies - the drug Dr Mithoefer gave Donna and 
other patients - was the pure chemical compound, not the black-market 
Ecstasy bought by recreational users. "A lot of Ecstasy pills aren't 
MDMA at all," says Steve Rolles of the drug-policy reform group 
Transform. "They may be amphetamines, or unknown pharmaceuticals, or 
they can be cut with almost any drug in pill or powder form. That's 
when you magnify risks associated with taking a drug that's already 
toxic. Plus, people use it irresponsibly, mixing it with other drugs, 
not drinking enough water or drinking too much."

The images of Leah Betts and Lorna Spinks lying in hospital on 
life-support, bloodied and bloated, are familiar to all of us - we 
know drugs cost lives. But has MDMA's reputation been tarnished so 
badly that its potential medical value has been overshadowed? That 
question is the reason that Donna agreed to speak to The Sunday Times 
about her MDMA treatment. "It's so important people know what it did 
for me, what it could do for others," she says. Her voice trembles: 
it isn't easy to talk about what she went through.

In 1993, Donna was brutally raped. She was a single parent living in 
a small town in Alaska, working as a dental nurse for the Air Force. 
She was due to work an early shift the next day and her two-year-old 
daughter was staying with a friend for the night. She was alone at 
home. At midnight she opened the door to a stranger who said he was 
looking for his dog. He asked if her husband was at home, and a 
second's hesitation was enough. He burst in, backing her up against 
the fireplace in the living room. Donna picked up a poker to defend 
herself. He said: "If you co-operate, I won't kill you. I've got a 
gun." And he reached into his jacket.

"I dropped the poker and that was it," she says. "I thought, this is 
how I'm going to die. No life flashed before my eyes, I didn't think 
about my daughter. Just death. I left my body and I stayed that way. 
The next thing I remember, the cops were coming through the door with a dog."

She endured the rape with her eyes squeezed shut. That she hadn't 
physically struggled would later form a large part of the guilt and 
shame that contributed to her PTSD. "I guess a lot of women would 
say, 'Someone would have to kill me before I'd let that happen.' 
Well, I did what I thought I had to do to survive," she says. When 
she heard a shuffle of feet outside the door she screamed for all she 
was worth. Her attacker beat her. Two policemen, probably alerted by 
a neighbour, broke down the door and arrested the man, then drove 
Donna to the Air Force hospital where she worked. "Of course it was 
full of people who knew me," she says. "It was completely 
embarrassing. And after that, nobody knew what to say. People avoided 
me, they looked at me funny. It was miserable."

Afterwards, convinced that getting on with life was the best thing 
for herself and her child, Donna carried on as usual. She was 
embarrassed that people who knew her also knew about the rape, 
particularly as she was still working at the hospital. But she 
couldn't remember much of the attack itself, and didn't try. So she 
was surprised when, four years later, her symptoms started to kick 
in. "I had no idea it was PTSD. I couldn't understand why I was so 
angry, why I was having nightmares, flashbacks, fainting spells, 
migraine, why I felt so awful, like my body was stuffed with cotton 
wool. Things had been going so good."

She started drinking heavily and went from relationship to 
relationship, finding men hard to trust and get close to. Convinced 
that she was dying and wouldn't live to see her next birthday, she 
went to the Air Force psychiatrist. "And that's where it started - 
take this pill, that pill. I've been on every kind of antidepressant 
- - Zoloft, Celexa, Lexapro, Paxil. Wellbutrin made me feel suicidal. 
Prozac did the same. The pills were just masking the symptoms, I 
wasn't getting any better."

Yet she met her "soul mate", Steve, and married him in 2000. "When I 
first saw him I thought, 'This is the man I'm going to spend the rest 
of my life with.' We were like one person, finishing each other's 
sentences," she says. They muddled along, with Donna putting on a 
brave face. She had two more children. But getting close wasn't easy: 
"The longer we were married, the worse I got."

Once, Steve and Donna were watching TV when she had a vivid flashback 
to the night she was raped. "I looked at the door, I saw it open, and 
that feeling came over me all over again.

I thought, 'My God, why won't this go away?' Steve tried to 
understand, but unless you've been through this, you don't know what 
it's like."

Donna moved to South Carolina in 2002 when Steve - also in the 
services - was posted there. She began seeing a psychiatrist called 
Dr Marcet, who diagnosed her with PTSD and attributed it to the rape. 
It helped to know that whatever it was had a name and a cause: "I was 
like, why hasn't anybody told me this before?" It was Marcet who 
referred her to the Mithoefers.

Donna had never taken Ecstasy before. "I was a little afraid, but I 
was desperate. I had to have some kind of relief. I didn't want to 
live any more. This was no way to wake up every morning. So I met Dr 
Mithoefer. I said, 'Doctor, I will do anything short of a lobotomy. I 
need to get better.' " That's how, in March 2004, Donna became the 
first of Mithoefer's subjects in the MDMA study. Lying on a futon, 
with Mithoefer on one side of her and his wife, Annie, a psychiatric 
nurse, on the other, talking softly to her, she swallowed the small 
white pill. It was her last hope.

"After 5 or 10 minutes, I started giggling and I said, 'I don't think 
I got the placebo,"' she recalls. "It was a fuzzy, relaxing, 
on-a-different-plane feeling. Kind of floaty. It was an awakening." 
For the first time Donna faced her fears. "I saw myself standing on 
top of a mountain looking down. You know you've got to go down the 
mountain and up the other side to get better. But there's so much fog 
down there, you're afraid of going into it. You know what's down 
there and it's horrible.

"What MDMA did was clear the fog so I could see. Down there was 
guilt, anger, shame, fear. And it wasn't so bad. I thought, 'I can do 
this. This fear is not going to kill me.' I remembered the rape from 
start to finish - those memories I had repressed so deeply." 
Encouraged by the Mithoefers, Donna expressed her overwhelming love 
for her family, how she felt protected by their support and grateful 
for their love.

MDMA is well known for inducing these compassionate, "loved-up" 
feelings. For Donna, the experience was life-changing.

So what happened when she went home? Was she cured? She sighs. "I 
don't know if there's such a thing as a cure. But after the first 
session I got up the next day and went outside, and it was like 
walking into a crayon box - everything was clear and bright. I did 
better in my job, in my marriage, with my kids. I had a feeling I'd 
never had before - hope. I felt I could live instead of exist."

What makes MDMA so useful, Mithoefer believes, is the trust it 
establishes. "Many people with PTSD have a great deal of trouble 
trusting anybody, especially if they've been betrayed by someone who 
abused their trust, like a parent or a caregiver," he says. "MDMA has 
this effect of lowering fear and defences. It also allows more 
compassion for oneself and for others. People can revisit the trauma, 
feel the original feelings but not be retraumatised, not feel 
overwhelmed or have to numb out to cope with it."

Before they can take part in Mithoefer's study, every participant 
undergoes rigorous testing. There are 21 participants per phase and 
the study is now in its second phase. First, they must be diagnosed 
with PTSD. Then its severity is measured on the Clinician 
Administered PTSD Scale (Caps) - it must be at least "moderately 
severe". They must be "treatment-resistant", meaning they have failed 
to respond to at least one other type of psychotherapy and also drug 
treatment with an SSRI (selective serotonin reuptake inhibitor) 
antidepressant. They must sign a 20-page document giving informed 
consent; they cannot have an addiction, psychosis or bipolar 
disorder, because these conditions affect the ability to give 
consent. Then they have a physical examination, a full 
medical-history check and lab tests for cardiovascular disease.

After the screening, the patient has two 90-minute "preparatory 
sessions" with the Mithoefers, to begin to build trust and get an 
idea of what may lie ahead. "We make sure they understand that 
symptoms will be stirred up, that painful feelings will come before 
they feel better and that they should experience them as fully as 
they can, and express them, rather than blocking them out," Mithoefer 
says. "We have one rule: during the session they don't have to talk 
at all if they don't want to, or they can talk about anything they 
feel like. But if, after an hour, the trauma topic hasn't come up, we 
can bring it up. But it always does come up," he chuckles.

The patient lies on the futon in the Mithoefers' living-room-style 
office in Charleston, South Carolina. They wear eye shades to 
encourage introspection, and headphones through which relaxing music 
is played. Annie keeps an eye on the blood-pressure cuffs and 
temperature gauge. Mithoefer sits opposite, taking notes. Each 
patient is given a recording of their session afterwards.

The patient takes either a 125mg tablet of MDMA or a placebo pill, 
followed by a 62.5mg dose about two hours into the therapy session. 
The study is double-blind, so only the emergency nurse who carries 
the drugs from the safe to the office knows whether the patient is 
getting the drug. "We can always tell whether it's real or placebo. 
The patient can't - some people thought they got MDMA when they 
didn't," says Mithoefer. "But we're seeing very encouraging results. 
There's a real difference between placebo patients and patients who 
got MDMA, in terms of their ability to relive the trauma."

Michael and Annie Mithoefer "aren't your typical kind of therapists", 
says Donna. She was dubious about Michael's ponytail and sandals when 
they first met, but she is emotional as she talks about him now. "I 
don't think I've ever met two people who cared so much about people 
getting well. I'd see tears in their eyes when I told them what I 
went through." Three other former patients of the Mithoefers who 
contacted me about this article described them as "heroes", 
"pioneers", even "life-savers".

At the time the Mithoefers treated Donna, in March 2004, their study 
had been a long time in the pipeline. Convinced of MDMA's potential, 
Rick Doblin, founder of the Multidisciplinary Association for 
Psychedelic Studies (Maps), had been in and out of the courts seeking 
permission from the Food & Drug Administration for clinical research 
since 1984. Maps, a group set up to fund psychedelic research, agreed 
to fund Mithoefer's study in 2000. The next year the FDA approved it. 
Then approval was withdrawn because of research by the neurologist 
George Ricuarte, at Johns Hopkins University, claiming that MDMA was 
lethally toxic. Even a single use, he reported, could cause brain 
damage and possibly Parkinson's disease. Ricuarte retracted his 
findings in 2002 when it turned out that bottles had been mixed up 
and the monkeys used as subjects had received lethal doses of 
methamphetamine (speed), rather than MDMA. "It was incredibly 
frustrating," Mithoefer says.

Mithoefer's study, which looks set to cost $1m by the time it 
finishes in four years' time, is scrupulously monitored. Doblin had 
1,000g of MDMA made specially, each gram costing $4. Mithoefer had to 
obtain a licence from the Drug Enforcement Administration (DEA), 
which keeps track of exactly how much MDMA each licence-holder has, 
and periodically checks the stocks for purity. A defibrillator must 
be kept in the building at all times in case of cardiac arrest, and 
an emergency nurse must be present during the treatment session. Once 
the study is complete, it will be subject to peer review. Then, all 
being well, Mithoefer hopes to see MDMA therapy available on 
prescription, administered in controlled surroundings, in 5 to 10 years.

Interest is growing in the UK too, but scientists admit it will take 
time to change hearts and minds. Dr Ben Sessa of Bristol University's 
Psychopharmacology Unit has been writing papers on MDMA therapy for 
two years. "The Mithoefers' struggle has been ludicrous," he says. 
"There's plenty of anecdotal evidence that it could be really useful 
in psychotherapy. There they are, qualified doctors with experience 
and medical backup, giving people this tiny dose of MDMA with 
safeguards in place. It took them 20 years for Maps to get it off the 
ground and it costs $1m. The irony is that thousands of people are 
taking this stuff every weekend and there's a 15-year-old on the 
street corner who'll sell it to you for a tenner."

Sessa would like to set up a programme of research in the UK, 
pointing to the thousands who could benefit: "For severe, unremitting 
PTSD sufferers, it could be a lifeline. What they're seeing in the US 
is people who have suffered for years suddenly saying, 'Wow, for the 
first time in my life I can talk about this, I can live with it.' And 
these are not young ravers. They're people in their thirties, 
forties, fifties who have never taken drugs. It's quite remarkable."

But what about the potential for post-study abuse? Might someone who 
felt deflated after the elation of their MDMA session find the urge 
to self-medicate irresistible and pop to that 15-year-old on the 
corner for a quick fix? Not at all, says Sessa. "I prescribe Valium 
all the time, and when the course is finished the patient could go 
and buy Valium on the street, but they don't. Very few people are 
interested in recreational drugs."

I ask Donna the same question. "Would I take the drug again? Yes, 
definitely," she says. "But not without a therapist. It's illegal."

Another former patient of Mithoefer's, a 42-year-old woman, had 
severe PTSD after being repeatedly and horrifically beaten and locked 
in a basement by her father during childhood. She wished to remain 
anonymous because she is still in contact with her parents. When I 
asked her the question, she replied: "I did it to get better, not to 
get high. Before the treatment, I would drink to hide my symptoms. 
But I don't want to get drunk now, let alone take drugs. I just don't 
need it any more."

The harmful effects of MDMA are still under investigation. The type 
of research that is carried out - normally with animals or with 
recreational users who also take other drugs - means that the exact 
levels of toxicity it causes are unknown. In 2006 Dr Maartje de Win 
of the University of Amsterdam published research showing that 
Ecstasy could cause depression, anxiety and long-term memory damage 
after one small dose. "We really don't know how much Ecstasy affects 
the brain in the long term," she says. "I would be very cautious 
about giving it therapeutically. We need to conduct much more 
research. And even then it should only be given as a last resort, 
after weighing the benefits against the risk of harm."

Sessa is adamant that research into MDMA is justified. "Look at 
heroin. It's a class-A drug that's dangerous when used 
recreationally, but it's used widely in medicine, and so it should be 
- - it's a very useful drug. Can you imagine saying to the Royal 
College of Anaesthetists, 'You can't use morphine or diamorphine 
[heroin] or pethidine or codeine or any opiate-based drugs because 
heroin is dangerous and people abuse it?' It's culturally bound. MDMA 
has been demonised."

In 2004, the most recent year for which there are records, 46 people 
died after taking Ecstasy, as against 8,221 alcohol-related deaths. 
And most of those who die with MDMA in their system have mixed it 
with substances such as alcohol or cannabis, which confounds the picture.

Earlier this year, the police chief for North Wales, Richard 
Brunstrom, called for the drug to be reclassified, claiming it was 
"safer than aspirin". He was widely shouted down, but Steve Rolles of 
Transform believes he may have a point. "It's not appropriate to have 
Ecstasy in class A. In terms of indicators of harm - toxicity, 
mortality, addictiveness and antisocial behaviour - it's not 
comparable to heroin or cocaine. But the government won't reclassify 
it. Reclassifying cannabis [from class B to C] in 2004 caused years 
of grief from opposition parties and the media."

The minister for drugs policy, Vernon Coaker, declined to comment on 
reclassification for medical purposes, but a spokesman said: "The 
government has no intention of reclassifying Ecstasy. It can and does 
kill unpredictably; there is no such thing as a 'safe dose'. We 
firmly believe it should remain a class-A drug. In addition, the 
government warns young people of the dangers of Ecstasy through the 
Frank campaign."

It does. But it also gives advice on safe Ecstasy use - or "harm 
minimisation". This is precisely the mixed message that Rolles 
believes is damaging. "Harm reduction is reducing the harm that's 
created by illegal supply in the first place," he says. "So you have 
harm-reduction information within a legal framework that maximises 
harm. It's a clear contradiction."

Then there is the problem of funding. MDMA therapy is based on the 
idea of a single treatment, or a course of treatment sessions, rather 
than long-term prescriptive use. This presents little or no benefit 
to drug companies that have huge budgets for research as long as 
there's a saleable product at the end. And if MDMA does prove 
effective, companies could stand to lose millions from lost sales of 
long-term antidepressants prescribed for PTSD.

Sessa says: "There's no financial incentive for the pharmaceutical 
companies to look into it. Psychotherapy is notoriously underfunded 
and discredited by the drug companies. It could benefit the 
government to look into MDMA, but their funding is a drop in the 
ocean next to a company like Pfizer's research budget. So who's going 
to pay for a multi-centre psychotherapy trial for 10,000 people - the 

PTSD therapy currently costs the NHS UKP14m a year, and with more 
veterans returning from Iraq and Afghanistan, that figure is set to 
rise. Last year, 1,200 new veterans sought treatment for PTSD from 
the organisation Combat Stress, compared with 300 in the year 2000. 
But realistically, would the government ever sanction MDMA research? 
"It's not impossible, but it's improbable," says Sessa. "It takes a 
very brave politician to look at the evidence and say, 'Well, there 
might be positive aspects to this class-A drug. Let's look into it.' 
It's a conceptual, social battle which won't be easy to win." 
- ---
MAP posted-by: Richard Lake