Big Pharma Bias: FDA Grants 'Breakthrough' Status to Ecstasy for PTSD While Prohibiting Pot


Cannabis and ecstasy are both Schedule 1 drugs and both show incredible promise for treating PTSD, but FDA only approves of the pharmaceutical one.
 
 
 
If there’s one refrain we hear from politicians more than anything else, it’s “I support the troops.” However, their definition of “support” changes with the political wind, and more often than not is a farce.
One example is the ongoing denial of medical cannabis to war veterans suffering from a range of conditions, from chronic pain to post-traumatic stress disorder (PTSD). Despite plenty of evidence—both scientific and real-world—that cannabis effectively treats these conditions, those who purportedly fought for freedom come home only to lose freedom under the War on Drugs.
The Veterans Administration (VA) still prohibits doctors from recommending cannabis or its extracts—including cannabidiol (CBD) which does not produce a high—even though most U.S. states acknowledge the science and have legalized medical cannabis.
The VA, perhaps emboldened by the Trump administration which is populated by 20th century prohibitionists, is digging in its heels. It funded two dubious studies questioning the effectiveness of medical cannabis—one finding “insufficient evidence to draw conclusions about benefits” for PTSD, and another concluding “limited evidence suggests that cannabis may alleviate neuropathic pain in some patients.”
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This contrasts with a much larger review of literature carried out by the National Academies of Science, which concluded “patients who were treated with cannabis or cannabinoids were more likely to experience a significant reduction in pain symptoms.”
The VA doesn’t appear to care what the nation’s leading science body has to say, and it has no interest in finding out if cannabis works for PTSD. A major study on medical cannabis and PTSD in veterans being carried out by Dr. Sue Sisley is in danger of shutdown due to lack of participation by the VA.
It seems that every time there is hope for veterans to gain legal access to medical cannabis, those hopes are dashed by a minority of lawmakers. The latest letdown was the Veterans Equal Access amendment, which would have allowed access in states with medical cannabis laws, but the amendment was stripped out in committee.
Facing this betrayal by lawmakers and the VA, veterans must become criminals if they want to try medical cannabis where prescription drugs have failed.
While federal government keeps cannabis as a Schedule 1 drug with “no medical use,” the same government has just granted “breakthrough therapy designation” to another drug in the Schedule 1 category—MDMA or ecstasy.
The ‘party drug’ was used in Phase 2 trials on roughly 200-300 patients with severe PTSD. Results showed a remarkable improvement in most patients, with 61 percent reporting no PTSD symptoms after 2 months and 68 percent being PTSD-free after a year.
With the “breakthrough” status granted by FDA, Phase 3 trials can proceed much more quickly, and with input on “design, primary endpoint, and statistical approach” from FDA.
For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way,” said Rick Doblin, Executive Director of the Multidisciplinary Association of Psychedelic Studies.
Pharmaceutical companies will surely be looking to cash in on this development with patented versions of ecstasy. Government appears completely willing to set aside the drug war for manufactured compounds in their “controlled substances” roster, but when it comes to medicine that people can grow themselves, no such freedom is allowed.
Cannabis and psilocybin both show promise for treating PTSD, perhaps even more so than MDMA. Psilocybin has demonstrated incredible ability to heal mental illness in clinical trials, but it hasn’t received any “breakthrough status,” just as medical cannabis remains mired in federal prohibition.
These natural substances cannot be monopolized by Big Pharma like manufactured chemical drugs, so they get no help from federal government. Meanwhile, veterans continue paying the price.
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