Pubdate: Sat, 11 Nov 2017
Source: New York Times (NY)
Copyright: 2017 The New York Times Company
Author: Khaliya


In July, the Food and Drug Administration took the important step of
approving two final-phase clinical trials to determine whether a party
drug that has long been on the Drug Enforcement Administration's
Schedule I list of banned substances could be used to treat a
psychiatric condition that afflicts millions. The drug is MDMA, a
psychedelic commonly known as Ecstasy, previously deemed to have "no
currently accepted medical use." The trials aim to determine whether
the drug is, as earlier trials have suggested, a safe and effective
treatment for post-traumatic stress disorder, when combined with

The F.D.A. approval is a beacon of hope for the roughly eight million
Americans believed to suffer from PTSD, a group that includes victims
of abuse, refugees and combat veterans. The shortcomings in the way we
have typically treated PTSD mean that many are condemned to suffer
from the condition for years, even decades, with little relief. Less
than 20 percent of patients are estimated to get effective treatment
through prescription psychiatric drugs like Prozac, Paxil and Zoloft,
which, along with psychotherapy, have been the global standard of
mental health care since the 1990s.

This could change with the F.D.A.'s decision, which has given
MDMA-assisted psychotherapy for the treatment of PTSD the status of a
potential "breakthrough therapy." Based on promising early results,
this designation permits the fast-tracking of trials in hopes of
proving the drug, which has psychedelic and stimulant effects, to be
safe and capable of doing what no other drug on the market can.

I consider myself living proof of the effectiveness of MDMA. A few
years ago, I woke up confused and bruised, my head pounding. I had
been the victim of a violent robbery. Although I remember little of
the attack, the experience shattered me. In public, I kept up
appearances. Behind closed doors, I was a wreck. I burst into sobbing
fits for no apparent reason. Sleep, when I managed to get any, was
filled with nightmares. I had PTSD.

After years of struggling in silence, I began to hear stories about
others who had suffered from crippling PTSD, then had their lives
transformed by guided therapeutic sessions with MDMA. I knew those
offering this underground treatment were breaking the law, but I had
to try it. I wanted my mind back. It worked. MDMA-assisted therapy
allowed me to overcome the trauma and return to the person I had been
before I was attacked. Continue reading the main story

To be sure, there are risks to MDMA-assisted therapy. Like any drug,
MDMA has side effects, which can include sweating, sleeplessness,
memory problems, and rapid heartbeat. There's also a moderate risk of
addiction, although it's much lower with MDMA than with opioids.

Also, finding treatment means resorting to practitioners who are
generally well intentioned but not mental health professionals. MDMA
itself is still illegal; possession is a felony in some states.
Determining the origin of the drug can be a difficult, too, and as
with other street drugs, this underground MDMA carries risk of
contamination by other, potentially dangerous substances.

All of these considerations make it more urgent to complete the trials
and clear the way to safe clinical uses of the drug therapy. With the
F.D.A.'s decision, MDMA-assisted psychotherapy has cleared one great
hurdle: the regulatory restrictions on conducting research with
Schedule I drugs. But another obstacle still stands in the way: money.

Despite the therapy's promise, the research that paved the way for
these final-stage trials was funded exclusively by a small
California-based nonprofit, the Multidisciplinary Association for
Psychedelic Studies. It raised $15 million for the research that laid
the foundation for the final-stage trials, which are expected to cost
$26 million. This is a colossal challenge for an organization that
relies on private donors. Without better funding, research progress
will stall.

To put the amount needed in context, the Department of Veterans
Affairs spends about $400 million annually on treating PTSD and other
mental health conditions. According to one study from 2008, the
estimated total societal costs of veterans suffering from PTSD and
major depression is $4 billion to $6 billion.

MDMA doesn't just ease the symptoms of PTSD; in the trials to date,
MDMA-assisted psychotherapy has also been shown to eliminate the
disorder in two-thirds of cases.

For people with PTSD, an overactive amygdala, the area of the brain
that scientists say produces the "fight, flight or freeze response,"
may make people more vulnerable to stress. Some recent fMRI studies of
the brain have shown that in people with PTSD, under stress, activity
to the prefrontal cortex is diminished as activity in the amygdala
increases. In a sense, with PTSD, the reasoning part of the mind gets
cut out of the equation.

MDMA, in contrast, reduces blood flow to the regions in the brain
linked to fear-based emotions and enhances activity in the prefrontal
cortex, which is involved in memory. It also floods the brain with
oxytocin and serotonin, "feel good" chemicals that tamp down fear
while promoting feelings of trust and empathy.

In contrast to a lifetime of palliative care, this type of
intervention could save money and improve lives. Too much is riding on
these trials for them to rely on donations from a concerned few. The
F.D.A. has clearly identified the extraordinary potential of
MDMA-assisted psychotherapy treatment for PTSD. The federal government
should back the scientific findings by underwriting the final-stage
trials, and potentially bring relief to millions of suffering people.

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Khaliya, a member of the World Economic Forum's Future of Health and
Healthcare council, is working on a book about the future of mental
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