Brad Burge:
We have heard about a lot of really exciting new technologies that are making a lot of breakthroughs in how we measure illness and how we treat it. Today, I want to talk to you about a very old technology that is now being put to a new use. A lot of us are clinicians here. A little background for post-traumatic stress disorder-- just knowing how many people have this. We've been hearing a lot about it, especially with the veteran suicide and PTSD epidemic. More than half of us-- if you just look at the person next to you, one or the other side will develop PTSD, at least statistically speaking, in their lifetime. That's about 8% of Americans will have PTSD. About eight million Americans are suffering from PTSD right now.
So people who don't identify as male are more than twice as likely to develop PTSD. And veterans are especially vulnerable, active duty personnel as well. Up to 20% of Iraq and Afghanistan veterans. That's more than the veterans of other wars, statistically. And this has immense costs for taxpayers and the Veterans Administration, costing at least $17 billion per year just in health care benefits for veterans with post-traumatic stress disorder.
PTSD is characterized by a number of long lasting symptoms, all of which are hinging on one deeper issue. One is always being on alert. We're always waiting for the trauma to happen again. Even if we're in places where it's unlikely to happen, we may very well expect it to happen.
We're always avoiding situations that may remind us of the trauma. Whether it was sexual assault, or a military incident, or violent crime, or a volcano, or a natural disaster, or terrorism, we're always looking for ways to get away from those situations to prevent them from happening again.
Re-experiencing-- so once you get away from the trauma, it's still with you. It's still ingrained in the body. It's still ingrained in the brain. We're re-experiencing the trauma over and over again.
This happens whether we are awake or asleep. Disturbing thoughts, nightmares, can be pervasive and long lasting for people with PTSD, who also have more than twice the suicide risk of people without PTSD. PTSD is actually the only anxiety condition that's positively associated with increased suicidal ideation or attempts.
Current treatments for PTSD-- now, they do work for some people. Sertraline-- that's Zoloft-- and paroxetine, or Paxil, both of them were approved in the late '90s, early 2000s. Also, psychotherapy. Psychotherapy, of course, takes a very long time, often many years, in order for patients to see any sort of progress or success. Also with sertraline and paroxetine, we do see some benefits for some people. A third of patients don't respond at all. And for those who do, we must ask, how much are they improving?
MDMA is the old technology that I wanted to talk about today. MDMA chemical name is methylenedioxymethamphetamine. It is a relative of amphetamines and most closely related to mescaline, which is a psychedelic compound found in many cactuses. The generic name, which was just granted last year, is midomafetamine.
A little bit about the history of MDMA. This is not a new chemical. This was first patented in 1912 by the Merck pharmaceutical company. Merck, at the time, this is in Germany. Merck was looking for a styptic medication, a medication that could stop-- that could assist with blood clotting.
Ultimately, they didn't test MDMA. MDMA was never run in clinical trials at this point. To our knowledge, it was never tested even on animals. And it was simply one member of a list of chemicals that Merck decided to patent in case it ever became useful. For Merck, it wasn't.
By 1967, MDMA had become popular among a small but at the time very quickly growing community of psychotherapists and psychiatrists, especially located in the San Francisco Bay Area. Up until 1984, it was a growing-- it was increasingly of interest to people who were treating post-traumatic stress disorder, anxiety, couples counseling, and so on.
By the late 1980s, MDMA had escaped from therapeutic offices and become known as ecstasy. It was sold over the counter in bars until it was criminalized in 1985 during Nancy Reagan's now famous Just Say No campaign. Many of the students who were part of the DARE program, Drug Abuse Resistance Education, Just Say No to Drugs are probably here with us today. Many of them may be doctors. I myself am a DARE graduate.
Now, just to be very clear, because there's a long lasting stigma about MDMA and what it is, MDMA-- and I cannot emphasize this enough-- is not ecstasy. Maybe at one point, for a few months before the drug dealers caught on that they could adulterate and make more money, but MDMA is not ecstasy. In fact, more than half of the ecstasy that is found on the street doesn't contain any MDMA in it at all. These are just a few of the other compounds that are often found in ecstasy tablets. Not to mention that the dosage can be far beyond what is helpful or healthy.
MAPS is the nonprofit Multidisciplinary Association for Psychedelic Studies, or MAPS. MAPS is currently developing MDMA combined with psychotherapy into an FDA approved prescription treatment for post-traumatic stress disorder. We are conducting double blind, placebo-controlled trials with approval from the FDA, the DEA, ethics boards, and everything that a clinical trial needs to obtain approval and to have the results be validated.
We are talking here about MDMA combined with psychotherapy. This is not a take three and call me in the morning kind of situation. At no point is anybody going to go to the pharmacy and pick up a bottle of MDMA pills and take it home. This is an inpatient treatment with clinics, People come in the morning, receive the drug, and go through the treatment for an entire day's session. This is what it looks like.
Because it was first synthesized in 1912, MDMA will be a generic medicine. That means that after a small window of exclusivity for whoever develops the drug, in this case MAPS, three to five years, MDMA will be available to be manufactured and distributed by any licensed chemical provider.
We treated 107 participants, or more than 107. We had 107 in our final data analysis and our phase two clinical trials at six different sites across the US, Canada, Israel, and Switzerland. These are a few of those people.
Here's our placebo response. We saw that 23% receiving just psychotherapy and either low dose or placebo MDMA, up to 40 milligrams, 23% no longer qualified for PTSD after just three sessions of MDMA-assisted psychotherapy. Now, they didn't just have their symptoms reduced. 23% no longer qualified for PTSD. And that's using a cut off on the clinician administered PTSD scale, the diagnostic scale for PTSD.
Here's the active dose. The difference between 23 and 55, that's the MDMA, or at least hypothesized to be so in the phase two trials. Very interestingly, 12 months later, that number actually went up. People continued to get better, on average.
The average length of PTSD for these patients was 19 years. They had already tried other treatments, other medications, and other psychotherapies, and it had not worked for them.
So PTSD is, at its core, a difficult relationship with traumatic memories. All the symptoms that we saw, they are the result of people avoiding the traumatic memories, pushing them away, not wanting to address them. It's one of the reasons why psychotherapy is so difficult for PTSD. The SSRIs try to treat the symptoms, help people sleep better, reduce insomnia, reduce anxiety, reduce depression.
MDMA-assisted psychotherapy, on the other hand, is going at the root cause. We can talk about MDMA as a chemical security blanket for PTSD. It has a lot of neurochemical effects, not just the serotonin system, as with the SSRIs, but also the dopamine system. It directly reduces activity in the amygdala, which is the fight or flight area of the brain, helping people process difficult emotions for PTSD. And very interestingly, MDMA also facilitates the release of endogenous hormones that are associated with trust and bonding and intimacy, helping to increase the therapeutic alliance.
There's a lot of ways to compare MDMA and SSRIs. The main thing, from my point of view, is that we are talking with MDMA about a treatment that is only administered three times. People take the drug three times in the context of a 12-week course of psychotherapy, gaining the insights from those experimental MDMA sessions, and coming out with insights they can integrate into their lives. As opposed to SSRIs, you stop taking them, in general, the benefits end. There are plenty of side effects with MDMA, but in the trials, we've seen no evidence of dependence, intentional misuse, and abuse, not to mention that the side effects all go away once the drug effects wear off.
We have received a special protocol assessment-- that's approval on the phase three clinical trial design-- and breakthrough therapy designation from the FDA this month. And this is no longer a stigmatized topic in many circles. We have 12 different phase three clinical trial sites, with Food and Drug Administration approval expected in 2021. We're doing this through a public benefit corporation model, with a $26 million cost, and $8 million still needed with no government funding.
So because MDMA has risks, we're also making sure that it's certified, that it's only administered in certified clinics. We are training therapists in how to administer the treatment method. We're selecting sites where administering MDMA-assisted psychotherapy can be a holistic treatment, involving other modalities as well, working with a number of research institutions across the world, and also working to develop smoked cannabis into a treatment for symptoms of PTSD. Again, this is not a fringe treatment. We see 56% of people would try this when it's legal.
And just to wrap up, I just want to highlight this issue of empathy that we've been seeing so much at this event-- is that MDMA can help open up empathy and hopefully provide a window into treating PTSD that we haven't seen before. Thank you so much.
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