Jump to content
Sign in to follow this  
trix

Feds Won't Supply Pot For Ptsd/marijuana Research

Recommended Posts

Veterans suffering from Post Traumatic Stress Disorder, commonly referred to as PTSD, rely on medical marijuana to treat a variety of symptoms including haunting nightmares and sleeplessness. The good news: Research to explore marijuana as treatment for PTSD was recently approved. The bad: Study cannot begin until the US Public Health Service gives scientists permission to buy pot.

 

Several months ago, a Food and Drug Administration and University of Arizona Institutional Review Board gave researchers approval to begin studying the effects of marijuana on US military veterans with PTSD. However, the study, which is being financed by the Multidisciplinary Association for Psychedelic Studies (MAPS), has been in limbo for the past 14 weeks because the Public Health Service has not authorized them to purchase “study” marijuana.

 

MAPS Executive Director Rick Doblin, Ph.D. says his team intends to investigate the safety and effectiveness of both smoked and vaporized marijuana on a group of 50 US veterans suffering from “chronic, treatment-resistant” PTSD. Interestingly, previous animal studies have suggested that marijuana effectually offers silence to an overactive fear system, but federal prohibition laws have kept scientists from conducting clinical trails on patients suffering from PTSD.

 

“This groundbreaking research could assist doctors in how to recommend treatment for PTSD patients who have been unresponsive to traditional therapies,” said Dr. Doblin.

 

Before the study can receive the official green light, the Public Health Service must first conduct a special review for the requested marijuana. Although there is a hefty supply of government marijuana allotted for FDA-regulated research, disbursement of this “science weed” is big brothered by the National Institute on Drug Abuse and the Drug Enforcement Administration, who have specifically mandated additional reviews be administered for study marijuana -- no extra review is required for any other substance with a Schedule I classification.

 

After having their research rejected in 2011, MAPS resubmitted revisions to the project in October of last year, but they are not holding their breath for timely response. While the FDA is required to respond to inquiries within 30 days, the Public Health Service has no time constraints. Therefore, until the agency decides they are ready to respond, potentially life saving research is on hold.

 

“If the PHS review requirement was removed,” said Dr. Sue Sisley, who would lead the study, “we would gather information that could help veterans today. The stifling of medical research on marijuana stands in the way of our vets returning to a normal life.”

Share this post


Link to post
Share on other sites

That's why Cuomo's mmj law was a political move and not for patients.  He can save face by running the program thru the fed which won't supply it.  Hopefully it gets all his supporters on board to push the senate to finally pass the bill that has gone thru the house a bunch of times.  Hopefully the pressure will eventually get them to make a move.

Share this post


Link to post
Share on other sites

Join the conversation

You can post now and register later. If you have an account, sign in now to post with your account.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Loading...
Sign in to follow this  

  • Similar Content

    • By MR49009
      research completed
    • By MR49009
      research completed
    • By Leagoman
      Calling on all Veterans to help us get out from under the VA Pain Management’s Thumb and Start Healing through Medical Marijuana!!!
    • By Michael Komorn
      Pregnancy and Medical Marijuana
      Expectant mothers are searching for answers about the safety profile of Medical Marijuana. Unfortunately the scientific community has dropped the ball and kicked it off the cliff on this issue. The lack of scientific research is due to marijuana’s illegality. Further, there exist huge biases within the published research. Mostly the research confounds marijuana use with tobacco and/or alcohol, two known causes of fetus and child harm. Separating out marijuana effects from the self-reported research on mothers who also smoke tobacco and drink alcohol is impossible. Likewise no pregnant women are signing up for research studies due to the illegality of marijuana and CPS removing children from mothers for testing positive for marijuana use.
      Many organizations quote from other organizations, who quote from other studies and reviews. The Minnesota Department of Health OFFICE OF MEDICAL CANNABIS quotes from the American College of Obstetricians and Gynecologists Committee report:
      In the American College of Obstetricians and Gynecologists official committee opinion, interim update Oct 2017, the committee found:
       
       
      Uninformed opinion, with zero evidence and lots of fear, uncertainty and doubt (FUD) are used to scare mothers away from a nontoxic plant. These uninformed unscientific opinions are being used by lawmakers to craft laws continuing the cycle of FUD and the illegality of marijuana. “Oh we don’t know what marijuana does, so let’s treat it like heroin” and “if anyone questions our opinion of marijuana, we’ll call them dirty lazy pothead stoner hippies” or “puppets of the marijuana industry”.
       
      But we do know what marijuana does. One cannot live in a bubble and ignore reality and the world around us. Women smoke and eat marijuana while pregnant.
      Cannabis use during pregnancy in France in 2010
      Trends in Self-reported and Biochemically Tested Marijuana Use Among Pregnant Females in California From 2009-2016

      http://news.gallup.com/poll/194195/adults-say-smoke-marijuana.aspx 
       
      Much of the opinions on marijuana are tainted by a small number of poorly designed studies on marijuana. For example, the National Institute of Health gives grants to researchers through NIDA, the National Institute of Drug Abuse, to study marijuana. NIDA’s focus is on drug abuse, so 90% of its grants are for studies on marijuana abuse, not marijuana benefits. When you ignore half of your research, you ignore science. Many of these studies are completed in order to get future grants from NIDA; research is often conducted from the conclusion backwards in order to show some kind of harm from marijuana use. This, in of itself, does not bias research.
       
      https://www.nytimes.com/2010/01/19/health/policy/19marijuana.html 
       
      The bias is introduced when researchers are rushed and forced to publish results, even if the studies were deficient. For example, every website and newspaper ran with the story about marijuana using children lose IQ points. Not many reported on the follow-up study that could not replicate the first study. When eliminating co-founders, the new study found no drop in IQ points. Further, research on twin siblings showed that the drop in IQ was due to parenting, binge drinking or other societal influences, not marijuana.
      https://www.drugabuse.gov/news-events/nida-notes/2016/08/study-questions-role-marijuana-in-teen-users-iq-decline 

       
      Try reading that last sentence again. In a world of science, evidence, reasoning and logic, a doctor makes a statement that decades of use of marijuana might make you lose intellectual function, based on conjecture.
      NIDA also continues to perpetuate the myth that Marijuana is a “gateway drug”.
      https://www.drugabuse.gov/publications/research-reports/marijuana/marijuana-gateway-drug 
      These findings are consistent with the idea of marijuana as a "gateway drug." However, the majority of people who use marijuana do not go on to use other, "harder" substances.
      NIDA, NIH, FDA, DEA, including other federal, state, and local government organizations and private companies continue to perpetuate these and other lies in order to keep marijuana illegal. ASA has filed complaints against the DEA multiple times to get it to remove incorrect statements about marijuana off of the DEA’s website.
      http://www.safeaccessnow.org/iqa_victory 
      A cyclical pattern emerges from the current and past situation surrounding marijuana.
      1.      Stymied scientific research, due to illegality of marijuana and government funding biases
      2.      Using stymied scientific research as a reason to ignore reality.
      3.      Repeating the biased scientific research, long after it was shown to be deficient.
      4.      Using the deficient biased research in “meta-reviews”. Thus taking bad science as a base to create more bad science just by doing an analysis of the bad science conclusions.
      5.      Even after a research study has been fully proven to be deficient and conflicting with better research, continue to hold it up as if it is still valid in some way.
      6.      Publish opinions as if they were facts, without any data to back up any claims.
      Continue reading for more conflicting studies and more calls for research.
      Marijuana: Prenatal and Postnatal Exposure in the Human
      Marijuana use in pregnancy and lactation: a review of the evidence
       
      Marijuana and Pregnancy
      The Association of Marijuana Use with Outcome of Pregnancy
       
      Prenatal Tobacco, Marijuana, Stimulant, and Opiate Exposure: Outcomes and Practice Implications 
      Many of these studies contradict themselves. Some report differences in birth weight, some show no differences. Read the studies yourself!
       
      http://legislature.mi.gov/doc.aspx?2017-HB-5222 
      House bill 5422 will force MMFLA provisioning centers to give patients and caregivers an unscientific pamphlet, as described by the legislature.
       
       
      HB 5222 looks like it will pass. All this fear and doubt of a non-toxic 5,000+ year old medication used by millions of humans in every country in the world.
    • By Michael Komorn
      03/18/2018 08:01 am ET Updated 26 minutes ago
      From America’s Warriors To Victims Of Its Opioid Epidemic
      “All they want is pain relief.” By Erin Schumaker and Anna Almendrala JI SUB JEONG/HUFFPOST When Cpl. Darin Adams got back from serving in Iraq in 2009, he suffered from sharply painful back spasms ― a lingering symptom of an injury from falling off a ladder in the armory during his second deployment. After the fall, it didn’t occur to him to take off any time to rest, and he resumed carrying his 75-pound rucksack the next day.   
      By the time Adams, now 32, returned home, the pain was so bad that he sometimes couldn’t sleep at night or walk more than a few steps around the house. He took ibuprofen to ward off the pain, but his back spasms worsened until 2012, when the pain became so severe that he couldn’t get out of bed some mornings. Finally a doctor at the Veterans Administration put him on a low-dose opioid, which he began taking almost every day.
      Adams worked as a manager at Walmart, which included lifting heavy boxes. He said if he hadn’t been taking opioids, it would have been impossible to do his job.
      SCOTT OLSON VIA GETTY IMAGES Retired Army Sgt. Noah Galloway of Birmingham, Alabama, arrives at Afghanistan’s Bagram Airfield on March 12, 2014. Galloway lost an arm and a leg to an explosion in Iraq in 2005. He was one of five wounded soldiers visiting Afghanistan with the Troops First Operation Proper Exit program, which brings wounded servicemen back to Iraq and Afghanistan to help them come to terms with their injuries. Adams is one of the thousands of Iraq War vets who came home with chronic pain.
      Saddled with injuries that veterans from previous wars would never have survived, 60 percent of military members who fought in the Middle East were returning with chronic pain, a significantly higher rate than older veterans getting care from the VA. And their timing couldn’t have been worse: By 2005, two years into the Iraq War, 10 million Americans were taking prescription opioids for long-term pain relief.
      But as prescription rates grew, so too did rates of overdose, accidental death and use of illicit opioids.  
      A dangerous pattern of pain, prescription and misuse was emerging among veterans. They were encountering serious harm overseas, receiving liberal amounts of prescription painkillers for their injuries and then bringing dangerous coping strategies back home with them.
      A 2013 study on veterans who served after 9/11 illustrates this cycle well. “Joel” suffered serious injuries after a roadside bomb exploded near his tank. During his recovery program, the doctor prescribed hundreds of pills at a time, even though Joel had serious risk factors for addiction.
      “They were giving me pain pills, I was getting Percocet, Vicodin. I was getting fucking OxyContin, Oxycodone. If I fucking wanted it, they would give it to me, no doubt about it,” Joel told the study researchers.
      “I used to get like 460 at a time!” Joel continued. “[I told my doctor,] `Look I’m a heavy drinker,′ and he was like, ’Well, just take one before you start drinking, about an hour before you start, and then don’t take anymore after that until the morning.”
      Opioid prescription in the Veterans Administration health system skyrocketed 270 percent from 2001 to 2012. VA patients were twice as likely as other Americans to die of accidental opioid overdoses, according to a 2011 study, and another study found that 13 percent of all veterans taking opioids had an opioid-use disorder ― about 68,000 people.
      By 2012, the VA had already started to look critically at their doctors who had been excessively prescribing opioids.
      So by the time soldiers like Adams sought treatment, the VA was asking them to take mandatory classes at the VA pain clinic, and he spoke with a specialist about the dangers of opioid addiction. A year later, Adams appealed to the VA to approve surgery on his pinched nerve, which was causing his muscle spasms. But for the VA to sign off on the surgery, Adams had to do six months of physical therapy first.
      In the end, physical therapy paid off. The more stretches and exercise Adams did, the less he needed his daily painkiller. By the end of the six-month waiting period, he had reduced his opioid use to one pill a month.
      By medical standards, Adams’ decrease in the use of opioids is a success story. But his success was hard fought. For many other veterans who were prescribed opioids after returning from Iraq and Afghanistan, the daily pressure to live pain- and opioid-free is a continuing struggle.
      “I guess I’m a unicorn,” Adams said, recounting that he just followed his doctor’s instructions closely. “It was successful for me, but it’s not successful, unfortunately, for everyone.”
      DARIN ADAMS Darin Adams and future wife Laura Tull at her parents’ house in Waterloo, Iowa. (2006) By 2005, two years into the Iraq War, 10 million Americans were taking prescription opioids for long-term pain relief. From 1999 to 2010, prescription opioids sold to hospitals, pharmacies and doctors’ offices nearly quadrupled, according to the U.S. Centers for Disease Control and Prevention, while the amount of pain Americans reported stayed the same. So when vets started coming back complaining of chronic pain, their doctors ― largely employees of the Veterans Administration ― provided them with opioids just as they would any patient.
        Opioid painkillers appeared to be effective at treating pain, were quick to prescribe and, unlike the morphine drips of yore, were simple to administer by pill. Best of all, according to pharmaceutical representatives, they weren’t addictive. Doctors’ beliefs about opioids’ efficacy were similarly misguided. Not only do opioids present serious risks, including addiction and overdose, they’re not even an effective medicine for chronic pain relief. A recent study by VA researchers in Minneapolis found that over-the-counter pain relievers like Tylenol and ibuprofen, neither of which contains opioids, are slightly more effective chronic pain treatments than opioids.
      The medical community at large was lulled into a false sense of security about prescribing opioids until 2011, explained Louis Celli, the national director of veterans affairs and rehabilitation at the American Legion, a nonprofit veterans organization.
      “This drug is extremely addictive,” Celli said. “There was less concern in the beginning, until this national epidemic took hold.”
      Another constellation of factors made veterans more susceptible to opioid addiction. Men who enlist in the army are twice as likely as other Americans to have been sexually abused as children and to have grown up in an environment that included domestic violence and substance abuse. Moreover, 1 in 5 soldiers who volunteer to join the Army had disorders such as intermittent explosive disorder, post-traumatic stress disorder or attention deficit hyperactivity disorder before enlisting, which all increase one’s risk of addiction.
      If the opioid epidemic were factored into the Iraq and Afghanistan body counts, that count would be staggeringly high. Many men and women who enlist are predisposed for substance abuse issues even before they’re issued uniforms. When soldiers from the Iraq and Afghanistan wars returned home, many had gruesome injuries that would have killed soldiers in past generations who didn’t have access to the same medical technologies. And now opioids were considered to be a safe and non-addictive first line treatment and were extensively prescribed to these returning soldiers.
      Worst of all, insufficient research about treating veterans addicted to high-dose pills means that today’s best practices for treating veterans addicted to opioids are based on weak data. In this science-free environment, tapering off high-dosage opioids is akin to an act of faith.
      THE WASHINGTON POST VIA GETTY IMAGES OxyContin is among the opioids often prescribed to veterans with long-term pain. In an effort to lower the risk of overdose and death among veterans taking opioids, the VA has taken incremental steps to lower new prescriptions, help veterans taper off existing medications, allow different centers within the VA to share data on opioid prescriptions for individual patients and be more transparent about how many opioids are being prescribed.
      Consequently, change on opioids has come swiftly. From 2012 to 2017, opioid prescriptions are down 41 percent among patients, and the decrease is spread out across 99 percent of the VA’s facilities. Veterans who seek treatment after these shifts on opioids are benefiting from additional education on addiction risk, an emphasis on non-pharmaceutical or non-opioid therapies, and opioid prescriptions with lower doses.
      In contrast, no other medical system in the U.S. releases comprehensive data on opioid prescriptions, and while almost all states now have databases that can track opioid prescriptions and flag patients for strange activity, most states don’t require doctors to check the database before issuing a prescription to a patient. VA doctors, on the other hand, are required to check the database before starting new patients on opioids.
      Dr. Kenneth Goldberg, chief of staff and acting director of the Durham VA Healthcare System in North Carolina, is not Adams’ doctor, but he said that his story is an example of what the VA is doing right when it comes to opioid prescription.
      “We want to get them on the lowest possible dose that we can,” Goldberg said. “One pill a month was his number. It’s not zero, but it’s definitely better than where it was.”
      While the VA has continued to implement wide-ranging new policies that have resulted in steep cuts to their prescription rates, others who work closely with veterans say that these efforts have left some veterans scrambling for ways to manage their pain and may even be pushing them toward illicit drugs.
      A 2017 study on Afghanistan and Iraq war veterans who had overdosed found that the transition to illicit, risky drugs like heroin was driven in part by the growing scarcity of prescription opioids, said Alex Bennett, a program director of the Opioid Overdose Prevention Program at National Development and Research Institutes who authored both this paper and the 2013 study that interviewed “Joel.” If veterans can’t stretch their limited opioid prescriptions until their next refill, some supplement that prescription with street drugs.
      “In a place like New York City, it is roughly a dollar or two per milligram of Oxy, and a bundle of heroin can be purchased for $60, so people tend to do a cost-benefit analysis,” Bennett said. “Let’s say I have 60 Percs ― I can get rid of those, manage my pain and eat.”
      For instance, “Barber,” a 54-year-old Army veteran featured in Bennett’s study, explained that when the prescribed Percocets weren’t enough to get him through to the next refill, he decided to sell the pills on the street and then use that money to buy heroin, which provided more relief for the two bulging vertebral discs in his spine.
      “These are self-care and self-management strategies, in many ways,” Bennett said.
      Because of this potential pipeline to illicit drugs, as well as other concerns, Dr. Stefan Kertesz, a frontline caregiver and long-term addiction researcher who teaches at the University of Alabama at Birmingham, isn’t convinced that everyone who takes high-dosage prescription opioids should be tapered off them as much as possible.
      “If a patient is currently functioning OK from their point of view, [and then] if you change something that leaves them afraid they’ll function worse, that can be pretty violative,” Kertesz said.
      Without scientific evidence, there’s no proof that weaning veterans off high doses of opioids protects their health. And without that scientific backing, some patients may be better off staying on opioids.
      The existing data on tapering patients’ opioid doses is pretty bleak. A 2017 review of all tapering studies to date finds that among people who volunteer to have their opioid intake reduced, there is only low-quality evidence to suggest that their chronic pain levels and quality of life will improve once they decrease their opioid use. Keep in mind that these results are only for those who actually want to reduce their opioid consumption, said Kertesz, and doesn’t include participants like these veterans, who might feel like the VA is reducing their opioid intake against their will.
      “Certainly we have no solid studies on involuntary mandatory dose reductions at all,” Kertesz said. “That should trouble you, because that means we’re flying blind.”
      But scant high-quality evidence that tapering off opioids will make people safer doesn’t mean that we should accept the status quo, Goldberg explained.
      “I don’t think any patient should take any medication that’s not really helping them,” Goldberg said.
      This is especially because the status quo exposes veterans to opioid tolerance, overdose and death, said Dr. Chris Marx, who works alongside Goldberg as a psychiatrist at the Durham VA Medical Center.
      “These are not medications without risk,” she said.
      As for Adams, while he was skeptical about how physical therapy could help manage his back pain, he was pleasantly surprised by the results. By the end of the six-month waiting period, Adams’ back pain was so well-controlled that he decided to forgo the surgery altogether. Now he takes ibuprofen in addition to continuing his twice-a-day stretching routine. He still has an opioid prescription, but it’s for 25 pills a year — a far cry from his once-a-day routine — and he rarely uses them.
      “The best advice I can give to a vet is if there is an alternative treatment, such as physical therapy, give it an honest shot,” he said. “There was a period of time that I didn’t think physical therapy was working, [and] I had to go a few times before I found a physical therapist that helped me see the light.”
      Erin Schumaker Senior Reporter, HuffPost Anna Almendrala Senior Reporter, HuffPost https://www.huffingtonpost.com/entry/iraq-war-opioid-addiction-veterans_us_5aa17569e4b0d4f5b66eb332
×
×
  • Create New...