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FDA Approves Large Clinical Trial For Ecstasy As Relief For PTSD Patients (arstechnica.com)
An anonymous reader quotes a report from Ars Technica: The Food and Drug Administration on Tuesday approved the first large-scale, phase 3 clinical trial of ecstasy in patients suffering from post-traumatic stress disorder (PTSD), the New York Times reported. The regulatory green-light follows six smaller-scale trials that showed remarkable success using the drug. In fact, some of the 130 PTSD patients involved in those trials say ecstasy -- or 3,4-Methylenedioxymethamphetamine (MDMA) -- saved them from the devastating impacts of PTSD after more than a decade of seeing no improvement with the other treatment options available. Currently, the best of those established treatment options can only improve symptoms in 60 to 70 percent of PTSD patients, one expert noted. However, after one of the early MDMA studies, the drug had completely erased all traces of symptoms in two-thirds of PTSD patients. The new Phase 3 trial will involve at least 230 patients and is planned to start in 2017. Like the other trials, it is backed by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit created in 1985 to advocate for the medical benefits and use of psychedelic drugs, such as MDMA and marijuana. Also like the others, the new, larger trial will involve a limited number of MDMA treatments administered by professional psychotherapists as part of a therapy program. In previous trials, patients spent 12 weeks in a psychotherapy program, including three eight-hour sessions in which they took MDMA and talked through traumatic memories.
If this proves to be a success, then this treatment will definitely be something to rave about.
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As long as I can CCW.
Here's the ruling
here is the story
I don't know the process here between FDA and DEA, which has which ultimate powers regarding final say on drug scheduling, but I have a feeling the drug is going to be rescheduled by the FDA (it is a "good," drug, a miracle drug, and the benefits to patients far outweighs the damage to those who abuse drugs), and then something fishy will happen at the DEA, and someone will overstep their authority, just like last time, and it will again be decided in court who gets their way, the nanny-staters and asshole control freaks or the doctors, scientists, and patients that need the drug.
The Admin and the Engineer
...going on a drug trip is the cure? Might as well just get drunk, it's cheaper.
Most research on drugs like MDMA and THC are attempts to bypass regulations and enable recreational use of substances that are dangerous and have no medicinal value. Substances like these are classified as schedule I by the DEA because it's proven that they have no legitimate uses. I'll trust the professionals at the DEA instead of a couple of drug addicts claiming to be doing scientific research. If anything, this proves the power of the placebo effect. There was no way to administer MDMA to patients because of restrictions, therefore any improvement was due to the placebo effect. Inevitably, patients prescribed these useless drugs to supposedly treat their conditions will become addicted and move on to even more dangerous drugs like heroin. MDMA is a gateway drug, and we shouldn't be risking addiction by patients who already have mental health issues.
than to prevent them from ever experiencing joy and happiness again? Is Joe Rogan leading the clinical trials?
...are former owners of an exploding Samsung Galaxy Notes 7 ? Surviving the explosion must have caused a severe PTSD.
Lets hope they remember to give the patients something for the tuesday blues.
On the other hand, patients will suffer from low nutrition issues due to the Dragons in the kitchen.
To clarify what catmistake means by "just like last time": MDMA was a psychotherapy drug used for, among other things, PTSD. That's how it got its start, before breaking out into the recreational scene. When the FDA considered banning it, there was a court hearing on the topic, which turned into a constant stream of psychiatrists stepping up and saying, "Don't do this!". The FDA at the time was unaware that it was used in psychotherapy. The judge ruled that it should be classed as a Schedule III drug, aka something with an established medical use but also the potential for abuse. However, the DEA administrator overrode him and classified it as a Schedule I drug. The DEA was sued by a Harvard psychiatrist for misclassification, and he won; the court stripped the DEA's Schedule I classification. The DEA responded by simply reclassifying it yet again as Schedule I.
The scheduling has made research difficult over the years, but the widespread attestment to its effectiveness is compelling. Research in other regards has shown that the act of recalling a memory also involves, to some degree, writing it back; there's been treatment researched for trauma wherein the patient recalls memories while on drugs that induce mild amnesia. I wouldn't be surprised if something similar is at work here.
People said I was dumb, but I proved them.
FDA Approves Large Clinical Trial For Ecstasy As Relief For PTSD Patients
That drug's bust was pretty traumatic ... I need to enroll
It's not even a syndrome. It's just a thang, donchano.
Sarah Palin for Secretary of VA
Because when the going gets tough, Bluto reaps the wraith
IIRC Tim Ferriss mentioned throwing in his influence and leverage in the background to advance research and approval of unconventional medication in the area of PTSD treatment. IIRC he specifically mentioned this trial and it might even be prepared under his guidance. (It's in some Tim Ferriss Show podcast somewhere IIRC)
AFAIK he has been doing some brain-drug experimentation himself, having owned a brain-drug company before his success as a bestseller author. He also covers brain drugs in his book "The 4-hour body".
Say what you want, but he actually puts his money where his mouth is and tries to move regulations away from tradition-based misconception about some consciousness-altering drugs and towards an effective treament of PTSD. Doing useful stuff with his money, fame and success. Nice.
We suffer more in our imagination than in reality. - Seneca
Bureaucrats in agencies that have no constitutional authority to exist in the first place can be such unbelievable assholes.
-jcr
The only title of honor that a tyrant can grant is "Enemy of the State."
We have unelected bureaucrats effectively making laws outside the legislative process.
And that's OK WHY?!?!?!
But hey, remember to yell at (other) people to "PAY YOUR FAIR SHARE!!!" so we can get MORE of this bullshit from our overweening government.
From the summary (no, I didn't read the article): "Currently, the best of those established treatment options can only improve symptoms in 60 to 70 percent of patients" and " the drug had completely erased all traces of symptoms in two-thirds of PTSD patients." To me, the 60 to 70 percent sounds very close to the two-thirds of patients (roughly 66.667%). So, this is better how? I did see in the summary that this drug is reaching some patients who were not helped by other therapy (perhaps part of the 30-40 percent?), so that is a good thing, but the rate of help is not better. What are the (projected) long-term side-effects? Is it worth the long-term costs?
I'll trust the professionals at the DEA instead of a couple of drug addicts claiming to be doing scientific research.
I'll trust scientists and physicians over badge wearing gun toting grunts any day.
There is also evidence that peyote can also treat PTSD.
We have folks coming back from these wars with serous mental health issues. In in most cases, traditional therapies aren't working.
And I have seen compelling evidence that these treatments can actually get people OFF of heroin addiction.
See, contrary to the moralizing anti-drug crowd who consider addiction to be a character flaw, people don't wake up one day and say, "I think I'll become an addict." They are suffering and most of the time have lived in very abusive environments. They are told they should just buck up and deal and when they can't, it makes them feel worse.
If we want to help these people, we as a society need to grow up, accept the science and actually help these folks.
And lastly, all of the latest and greatest research on this topic is being done in Europe. So, if you would like to learn more, I suggest reading journals from there. Because here in America, we're pretty backwards.
Given that the FDA's purpose is to approve drugs for their therapeutic value, why don't they have the ability to overrule the DEA? Why does the DEA have the authority to block access to drugs with a compelling case for therapeutic value to the extent that you can't even perform research to prove their therapeutic value?
I mean, I can't escape the (only slightly) tinfoil hat explanation that they do it to perpetuate and expand their power and ensure they have a near immutable list of banned substances to justify their power and budget. And of course they hang onto marijuana as schedule I because it provides the vast bulk of "illegal" drug use, and complete legalization might usher into public consciousness the idea that the entire premise of the DEA is suspect.
It seems highly likely that most drugs with a recreational potential are likely to have some kind of therapeutic use as well. I guess we're just fortunate that opiates, amphetamines and tranquilizers had a long and mostly irrefutable clinical history of therapeutic value before the DEA existed or they would have long ago scheduled them away.
How could they just simply "re-classify" it? Once a Judge has ruled a given way, they can appeal all to the Supreme Court level or they have to abide by any ruling that doesn't run counter to the Constitution.
Seems to me someone dropped the ball there, because if I had gotten that ruling, I'd have the DEA's ass drug back into the Court for Contempt of Court.
Myself and others who actually suffer from PTSD (In my case CPTSD) are always looking for a way out. It's a disorder caused by experiencing severe trauma- in my case the traumatic experience went for a period of 15 years as a kid. Child abuse victims and those who were abused as POWs are the ones who suffer the most from this disease. But remember this disease is caused by traumatic things happening around you, or worse, traumatic things done to you.
This is a disease that is inflicted on it's victims both others.
You never really get out of the PTSD symptoms... flashbacks keep repeating. Your current day relationships are held hostage to your condition. In some cases (like mine) it's accompanied by a sleep disorder. And the combination of flashbacks and lack of sleep can lead to psychosis. As you age you become unable to "tough it out" by staying up for a couple of days. So working becomes difficult or impossible. I used to be an IT executive.
Sure there are treatments like "Eye Movement Desensitization and Reprogramming". And they help a little. Or you can drug yourself out. Or just do the best you can and hope your loved ones are willing to keep you in food and housing. As a non veteran my chances at disability through Social Security are zero.
The only drug that has ever worked for me to totally eradicate the symptoms- are narcotics. If I can legally obtain them for another legitimate issue then I get to be normal for a few days, or a week. Norco and Hydrocodone seem to work the best.
So if someone told me I could get my PTSD treated at a pain clinic with narcotics- under doctors supervision I'd be there in a second. The hell I go through is shattering.
So- this new treatment is making me so happy. I want to get in on the trial... or try the therapy as soon as possible.
If you have a heart for people who are truly suffering. Please support these trials and be supportive of the idea. You'll be helping a lot of people.
Another consultant who stuck it out.
"We are the Priests, of the Temples of Syrinx..."
If patients are getting it through the medical system, at least they don't have to deal with the nasty shit that is often missold as Ecstacy. A major issue though for recreational users, even with a supply of reasonable quantity, is tolerance buildup. After a dozen or so doses, it no longer has the same positive effects, and the serotonin depletion "hangover" is no longer worth the hassle. In recreational use, this limits the scope for long term addiction, as most users will either quit or move on to other drugs when they reach this point. For medical use, it probably limits the usefulness to where a short program can completely cure the disorder.
is already known to cause brain damage seems to be of little concern.
Are you fucking kidding me? Ecstacy? Everyone freaks out about weed being legalized. But, the FDA says, "Hey guys, try out ecstacy for your mental issues!". Wow, what an ass backwards fucking world we live in here in the US of A.
A single dose of magic mushrooms can make people with severe anxiety and depression better for months, according to a landmark pair of new studies.
Best Slashdot Co
I doubt this issue will really come up. MDMA is an amphetamine that isn't really anymore dangerous or prone to abuse than methamphetamine. It will be classified as Schedule II, if it is approved.
I don't know the specifics of this case but it's not unusual for a court to rule that a decision was made improperly. It doesn't necessarily mean that it will be reversed. That's why we have such things as retrials.
many users of BSD ass until I hit my charnel house. a popular 'news I don't want to halt. Even Emacs Dying. AAl major *BSD is dead.
How could they just simply "re-classify" it? Once a Judge has ruled a given way, they can appeal all to the Supreme Court level or they have to abide by any ruling that doesn't run counter to the Constitution.
Seems to me someone dropped the ball there, because if I had gotten that ruling, I'd have the DEA's ass drug back into the Court for Contempt of Court.
Exactly. The DEA Director is a presidential appointment, the agency itself an executive branch entity, so the underlying unspoken validation is "this is what the President wants." DEA administrative law judges are federal judges, but they lack contempt powers. A DEA ALJ doesn't have the ability to hold the DEA Director, or the President, or anyone, in contempt. They can call upon federal judges that do have contempt powers and report lawyers to their bars who fail to comply with orders, but that's about it. Once that lawsuit and its appeals started, the authority switched in full to the judicial branch... but then the appeals court sided with the DEA Director, so the validation ultimately was tested in court. The court flip flopped twice, and MDMA landed on Schedule I.
Coming soon: a sudden change of heart on allowing imports of those generic medications that keep being shkrelied.
The army's on ecstasy, so they say I read all about it in "USA Today" They stepped up urine testing to make it go away 'Cause it's hard to kill the enemy on ol' mdma! Oysterhead
Given that the other pharmaceutical options are SSRI meds that only treat the symptoms of trauma while simultaneously creating dependency, this is a hugely important study. I work in a hospital as a chaplain. Mdma overdoses come in dehydrated and sad. They're out our doors in three bags of saline. Conversely, people with ptsd come in marinated in vodka or in dt's from anti-depressants constantly. I'm an advocate for anything curative that might jam that revolving door.
Those flashing lights, beats and other people..
TFS says:
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is backed by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit created in 1985 to advocate for the medical benefits and use of psychedelic drugs, such as MDMA and marijuana.
--
Group formed to advocate for the use of psychedelic drugs, because they like using psychedelic drugs, claims that using psychedelic drugs is good.
So are patients going to be trading one form of delusions for another? That really makes no sense to me but perhaps I'm simply looking at it from an engineering standpoint.
Go read up a bit. It has come up. Several times. They've fought back & forth on it.
Variants of heroin and meth are used to treat pain and ADHD respectively. The stuff is illegal because it can fry your brain, or certain body organs. I guess it is considered socially acceptable for drugs to kill people around their late 60s.
FYI The dosing is important, it is for talk therapy. I saw a lecture from one of the main doctors who does this research⦠There are formal quantifiable skills for evaluating PTSD. The highest success rate is finding the dose of the drug that allows you to have extremely effective talk therapy, the drug that helps you process information about traumatic events without your system going wild and then shutting down . But too much of the drug and you're having a good time but you are not verbal in the way that is useful for talk therapy, and they can quantify this⦠They might've had a good time but their PTSD is not better afterward.
I have a novel idea. Let people decide what substances they want to use. From a public health perspective, we can ensure a transparent market, provide honest education on the benefits and dangers of different substances, provide treatment for addiction and give more doctors' supervision because users will be less compelled to lie or avoid the doctor.
Got some powder. I just did smaller amounts to get a nice feeling. I know from past experience you can get cranky as hell a few days after E but with small amounts if was interesting how clear my head was for a few days after wards but there was a issue. If I did enough to really start feeling it my heart would race and get some crazy palpations once in a while. When you're 20 you don't care but at 42 lol the irregular heart beats are noticed more.
by TheSpoom (715771) Uncaring Linux user here. I have nothing to add to this but please continue. *munches popcorn*
The FDA decides if your manufactured drug is approved, and if the drug itself is approved for a use, and how to label it; the DEA decides if it's scheduled, and has to follow UN conventions--it can overschedule a drug (UN SCH3 means US SCH1-3), or schedule a non-UN-covered drug (UN uncontrolled = US SCH4 for some drugs).
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Actually, their constitutional authority to exist is that the Executive Branch calls them into existence to execute the provisions of laws passed by the Legislative branch. Drugs are scheduled as different levels of controlled substances in different states (Florida's controlled substance schedule is hilarious--most food is illegal). In theory, the Federal Government doesn't have the power to enforce in a state which has passed law declining Federal enforcement; however, if the manufacture and sale of drugs in Colorado results in illegal smuggling drugs from Colorado to Nevada, that impacts interstate commerce, and thus gives the Federal agency jurisdiction over the activities in Colorado.
Constitutional law is weird.
In theory, none of that gives the Federal government power to enforce usage restrictions: since you're a consumer of a drug produced in your state, you aren't doing anything involving interstate commerce. Consumers are typically not considered to participate in commerce, in the sense that they consume what is within reach of them and so are not a part of the production and distribution infrastructure and not liable for products being imported across state lines--unless they knowingly traffic something from one state to another (e.g. by ordering it online!). In practice, this is a flexible concept in court.
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This is epic info. Will reduce crime too.
I doubt this issue will really come up. MDMA is an amphetamine that isn't really anymore dangerous or prone to abuse than methamphetamine. It will be classified as Schedule II, if it is approved.
The scheduling isn't really based around "danger", even though it's presented as such. Look at the contents of the schedules. Most of the heavily abused drugs are in schedule II. The bulk of schedule I is relatively low-danger, infrequent abuse psychedelic drugs.
With Trump and the republitards at the helm you can kiss your miracle drug goodbye.
Given that the FDA's purpose is to approve drugs for their therapeutic value, why don't they have the ability to overrule the DEA? Why does the DEA have the authority to block access to drugs with a compelling case for therapeutic value to the extent that you can't even perform research to prove their therapeutic value?
I mean, I can't escape the (only slightly) tinfoil hat explanation that they do it to perpetuate and expand their power and ensure they have a near immutable list of banned substances to justify their power and budget. And of course they hang onto marijuana as schedule I because it provides the vast bulk of "illegal" drug use, and complete legalization might usher into public consciousness the idea that the entire premise of the DEA is suspect.
It seems highly likely that most drugs with a recreational potential are likely to have some kind of therapeutic use as well. I guess we're just fortunate that opiates, amphetamines and tranquilizers had a long and mostly irrefutable clinical history of therapeutic value before the DEA existed or they would have long ago scheduled them away.
Cinch that tin foil hat down tight for this one...
If you really want to dig deep on this, look how killers like cigarettes, alcohol, and opiates are all legal, while marijuana is not. Understand that the more harmless a drug is, the less of a chance it will be accepted legally.
Sounds crazy, but here's why. Harm to humans not only helps manage finite resources via population control, but it also creates jobs, secures patents, and bolsters revenue.
How many jobs have been created treating alcoholism and all associated diseases and ailments?
How much revenue has been generated by putting opium in a pill and handing it to a doctor?
How would our global population issues differ today if 6 million humans were not dying every year due to tobacco use?
Yeah, I know. Tin foil hats aren't comfortable. You can take it off now and go back to believing whatever you want now...
Schedule I drugs are also commonly used by undesirable people like hippies, progressives and minorities.
"In America, first you get the sugar, then you get the power, then you get the women..." -H. Simpson
Is this the erase and rebuild method applied to brain dysfunction?
Right. The idea of scheduling drugs is a good one, but as it has been implemented it is completely ridiculous.
I'm on board with most of that, but if economics was a good enough explanation we wouldn't have seen the DEA making opiates much harder to obtain -- more intensive prescription databases to get doctor shoppers, more intensive audits of prescribing physicians, and the rescheduling of hydrocodone from III to II. The irony, of course, is that it has jacked up street prices and moved many low-level pill users accustomed to uniform dosing to street heroin, which despite DEA enforcement has become cheaper than made-in-the-USA pills, and with all the worse addiction and overdose outcome you'd expect.
I'm more inclined to think that the DEA was largely a political creation designed to attack the counterculture of its founding era, using criminalization of LSD and marijuana as an excuse for law enforcement action. This I think goes a long way towards explaining the DEAs aggressive moves against any substance with recreational value.
Actually, their constitutional authority to exist is that the Executive Branch calls them into existence to execute the provisions of laws passed by the Legislative branch.
It took a constitutional amendment to ban alcohol, and that amendment has been repealed. This leaves no authority for any branch of the government to prohibit the manufacture, sale, or use of any drug. Any act of the congress that purports to do so is not a law at all, it is as James Madison would describe it, a usurpation.
-jcr
The only title of honor that a tyrant can grant is "Enemy of the State."
Actually, we could pass a constitutional amendment banning the private printing of United States money if we wanted. That doesn't mean the private printing of US money isn't already illegal or bannable under Federal law.
Frequently, the role of a constitutional amendment is to establish the constitution of a country (surprising, that). For example: nothing in the U.S. Constitution establishes any sort of equal rights treatment for gay marriage--or any recognition of any marriage--and yet we had a short-lived effort to ban gay marriage with a constitutional amendment. At the time, it was understood that the Federal government could not be legally-compelled to accept gay marriages as legitimate; the goal of a Constitutional amendment was to make sure no future Federal government would, unless the states ratified an amendment repealing the one banning gay marriage.
The Federal government has unilateral right to repeal the prohibition of marijuana and other drugs (barring international treaty). This would result in a scrambling of other states to re-implement DEA controls, and to provide duplicated DEA resources to control any substances they believe should be controlled. It also heavily impacts interstate commerce because of Utah being right next to Colorado, thus being flooded with smuggled drugs across the UT-CO border as UT tries to keep MJ illegal. Thus Utah would be interested in a constitutional amendment prohibiting Marijuana, although they'll never get it: they have a great interest in making sure a coalition of states can uphold their ideal moral fiber and prevent other states from snapping it.
The prohibition of alcohol was the same: the states didn't realize what they were getting into when they all decided alcohol was detrimental to the moral fiber of the United States and that it should be constitutionally banned. They knew they wanted to prevent legislative pressure from constituents in multiple states from pushing back after the ban went into effect; they didn't realize the pressure would be so great as to distort the moral fiber of the United States, glorifying illegal drug smuggling operations as heroic efforts against tyranny and undermining their important puritan message. The social and economic impacts were so great that the states actually repealed that amendment; and they will never give up that much flexibility again without good reason.
When FDR did it, he instated a separate payroll tax to fund Social Security and unemployment, thus giving contributors a legal, moral, and political right to collect their pensions and unemployment benefits. This was to prevent future politicians from scrapping the social security system--the same way a constitutional amendment might make it a tiny bit difficult to repeal your new anti-Budweiser law. Defense against hostile successors is a common thread in lawmaking.
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