Showing posts with label Medical cannabis. Show all posts
Showing posts with label Medical cannabis. Show all posts

Tuesday, April 24, 2018

2890. Medical Marijuana Could Save Many Addicted to Opioids

By Sanjy Gupta, M.D., CNN, April 24, 2018

Dear Honorable Jeff Sessions,
I feel obligated to share the results of my five-year-long investigation into the medical benefits of the cannabis plant. Before I started this worldwide, in-depth investigation, I was not particularly impressed by the results of medical marijuana research, but a few years later, as I started to dedicate time with patients and scientists in various countries, I came to a different conclusion.
Not only can cannabis work for a variety of conditions such as epilepsymultiple sclerosis and pain, sometimes, it is the only thing that works. I changed my mind, and I am certain you can, as well. It is time for safe and regulated medical marijuana to be made available nationally. I realize this is an unconventional way to reach you, but your office declined numerous requests for an interview, and as a journalist, a doctor and a citizen, I felt it imperative to make sure you had access to our findings.
    Mr. Sessions, there is an added urgency, as we are in the middle of a deadly opioid epidemic that has been described as the worst self-inflicted epidemic in the history of our country.
    The drug overdose scourge claimed about 68,000 US lives in 2017, just over 45,000 of them from opioids alone. Every day, 115 Americans die from opioid overdoses. It has fueled a decline in an entire country's life expectancy and will be remembered as a sad and tragic chapter in our collective history.
    These are desperate times, and while some may consider making medical marijuana widely available to be a desperate measure, the evidence has become increasingly clear of the important role cannabis can have.
    We have seen real-world clues of medical marijuana's benefits. Researchers from the Rand Corp., supported by the National Institute on Drug Abuse, conducted "the most detailed examination of medical marijuana and opioid deaths to date" and found something few initially expected. The analysis showed an approximately 20% decline in opioid overdose deaths between 1999 and 2010 in states with legalized medical marijuana and functioning dispensaries.
    It's not the first time this association between medical marijuana and opioid overdose has been found. Though it is too early to draw a cause-effect relationship, these data suggest that medicinal marijuana could save up to 10,000 lives every year.

    The science of weed

    Cannabis and its compounds show potential to save lives in three important ways.
    Cannabis can help treat pain, reducing the initial need for opioids. Cannabis is also effective at easing opioid withdrawal symptoms, much like it does for cancer patients, ill from chemotherapy side effects. Finally, and perhaps most important, the compounds found in cannabis can heal the diseased addict's brain, helping them break the cycle of addiction.
    Mr. Sessions, there is no other known substance that can accomplish all this. If we had to start from scratch and design a medicine to help lead us out of the opioid epidemic, it would likely look very much like cannabis.

    A better, and safer, way to treat pain

    The consensus is clear: Cannabis can effectively treat pain. The National Academies of Sciences, Engineering, and Medicine arrived at this conclusion last year after what it described as the "most comprehensive studies of recent research" on the health effects of cannabis.
    Furthermore, opioids target the breathing centers in the brain, putting their users at real risk of dying from overdose. In stark contrast, with cannabis, there is virtually no risk of overdose or sudden death. Even more remarkable, cannabis treats pain in a way opioids cannot. Though both drugs target receptors that interfere with pain signals to the brain, cannabis does something more: It targets another receptor that decreases inflammation -- and does it fast.
    I have seen this firsthand. All over the country, I have met patients who have weaned themselves off opioids using cannabis. Ten years ago, attorney Marc Schechter developed a sudden painful condition known as transverse myelitis, an inflammation of the spinal cord. After visiting doctors in several states, he was prescribed opioids and, according to our calculations, consumed approximately 40,000 pills over the next decade. Despite that, his pain scores remained an eight out of 10. He also suffered significant side effects from the pain medication, including nausea, lethargy and depression.
    Desperate and out of options, Schechter saw Dr. Mark Wallace, head of University of California, San Diego Health's Center for Pain Medicine, where he was recommended cannabis. Minutes after he took it for the first time, Schechter's pain was reduced to a score of two out of 10, with hardly any side effects. One dose of cannabis had provided relief that 40,000 pills over 10 years could not.

    Using marijuana to get off opioids

    For Schechter, as with so many others, the seemingly insurmountable barrier to ending his opioid use was the terrible withdrawal symptoms he suffered each time he tried. When a patient stops opioids, their pain is often magnified, accompanied by rapid heart rate, persistent nausea and vomiting, excessive sweating, anorexia and terrible anxiety.
    Here again, cannabis is proven to offer relief. As many know, there is longstanding evidence that cannabis helps chemotherapy-induced symptoms in cancer patients, and those symptoms are very similar to opioid withdrawal. In fact, for some patients, cannabis is the only agent that subdues nausea while increasing appetite.

    Why we can't 'just say no' to opioids

    Finally, when someone is addicted to opioids, they are often described as having a brain disease. Yasmin Hurd, director of the Addiction Institute at Mount Sinai in New York City, showed me what this looks like in autopsy specimens of those who had overdosed on opioids. Within the prefrontal cortex of the brain, she found damage to the glutamatergic system, which makes it difficult for neural signals to be transmitted. This is an area of the brain responsible for judgment, decision-making, learning and memory.
    Hurd told me that when an individual's brain is "fundamentally changed" and diseased in this manner, they lose the ability to regulate opioid consumption, unable to quit despite their best efforts -- unable to "just say no."
    It is no surprise, then, that abstinence-only programs have pitiful results when it comes to opioid addiction. Even the current gold standard of medication-assisted treatment, which is far more effective, still relies on less-addictive opioids such as methadone and buprenorphine. That continued opioid use, Hurd worries, can cause ongoing disruption to the glutamatergic system, never allowing the brain to fully heal. It may help explain the tragic tales of those who succeed in stopping opioids for a short time, only to relapse again and again.
    This is precisely why Hurd started to look to other substances to help and settled on nonpsychoactive cannabidiol or CBD, one of the primary components in cannabis. Hurd and her team discovered that CBD actually helped "restructure and normalize" the brain at the "cellular level, at the molecular level." It was CBD that healed the glutamatergic system and improved the workings of the brain's frontal lobes.
    This new science sheds lights on stories like the one I heard from Doug Campbell of Yarmouth, Maine. He told me he had been in and out of drug rehab 32 times over 25 years, with no success. But soon after starting cannabis, he no longer has "craving, desire and has not thought about (opioids) at all, period."
    For the past 40 years, we have been told that cannabis turns the brain into a fried egg, and now there is scientific evidence that it can do just the opposite, as it did for Campbell. It can heal the brain when nothing else does.
    I know it sounds too good to be true. I initially thought so, as well. Make no mistake, though: Marc Schechter and Doug Campbell are emblematic of thousands of patients who have successfully traded their pills for a plant.
    These patients often live in the shadows, afraid to come forward to share their stories. They fear stigma. They fear prosecution. They fear that someone will take away what they believe is a lifesaving medication.

    Where do we go from here?

    Mr. Sessions, Dr. Mark Wallace has invited you to spend a day seeing these patients in his San Diego clinic and witness their outcomes for yourself. Dr. Dustin Sulak could do the same for you in Portland, Maine, as could Dr. Sue Sisley in Phoenix. Staci Gruber in Boston could show you the brain scans of those who tried cannabis for the first time and were then able to quit opioids. Dr. Julie Holland in New York City could walk you through the latest research. All over the country, you will find the scientists who write the books and papers, advance the science and grow our collective knowledge. These are the women and men to whom you should listen. They are the ones, free of rhetoric and conjecture, full of facts and truth, who are our best chance at halting the deadly opioid epidemic.
    Making medicinal marijuana available should come with certain obligations and mandates, just as with any other medicine. It should be regulated to ensure its safety, free of contamination and consistent in dosing. It should be kept out of the hands of children, pregnant women and those who are at risk for worse side effects. Any responsible person wants to make sure this is a medicine that helps people, not harms.
    Recently, your fellow conservative John Boehner changed his mind after being "unalterably opposed" to marijuana in the past. If you do the same, Mr. Attorney General, thousands of lives could be improved and saved. There is no time to lose.

    Tuesday, March 15, 2016

    2245. Marijuana-Based Drug Found to Reduce Epileptic Seizures

    By Andrew Pollack, The New York Times, March 14, 2016
    Aaron Klepinger says a daily dose of liquid marijuana extract helps prevent his son, Hunter, from suffering severe seizures. CBS News. 

    An experimental drug derived from marijuana has succeeded in reducing epileptic seizures in its first major clinical trial, the product’s developer announced on Monday, a finding that could lend credence to the medical marijuana movement.

    The developer, GW Pharmaceuticals, said the drug, Epidiolex, achieved the main goal of the trial, reducing convulsive seizures when compared with a placebo in patients with Dravet syndrome, a rare form of epilepsy. GW shares more than doubled on Monday.
    If Epidiolex wins regulatory approval, it would be the first prescription drug in the United States that is extracted from marijuana. The drug is a liquid containing cannabidiol, a component of marijuana that does not make people high.

    As many as 30 percent of the nearly 500,000 American children with epilepsy are not sufficiently helped by existing drugs, according to GW. Parents of some of these children have been flocking to try marijuana extracts, prepared by medical marijuana dispensaries.

    A number of states, in response to pressure from these parents, have passed or considered legislation to make it easier to obtain marijuana-based products. And some families have become “marijuana refugees,” moving to Colorado where it has been easier to obtain a particular extract, known as Charlotte’s Web, after the girl who first used it to control seizures.

    Hundreds of other children and young adults have been using Epidiolex outside of clinical trials, under programs that allow desperate patients to use experimental drugs.
    While many parents have reported significant reductions in seizures, experts have been cautious about anecdotal reports, saying that such treatments needed to be compared with a placebo to make sure they work. As such, the results from the GW trial have been closely watched.

    “I’m very proud and happy about this study because it is science — we did things the way they should be done,” the study’s lead investigator, Dr. Orrin Devinsky of the Comprehensive Epilepsy Center at New York University Langone Medical Center, said in an interview. “I would strongly advocate that in the United States we need to do systematic assessments of medical marijuana.”

    The study involved 120 patients with an average age of 10 and an average frequency of 13 convulsive seizures a month at the start of the study, despite taking an average of three other drugs. Half of the children were randomly assigned to take the drug and the other half the placebo, in addition to the epilepsy medicines they were already taking.

    The company said that for the patients who received Epidiolex, the frequency of convulsive seizures fell by 39 percent during the 14-week treatment period, compared with a four-week period just before the treatment started. For those getting the placebo, the reduction was 13 percent. The difference between the two groups was statistically significant.

    Eight patients getting Epidiolex and one getting the placebo withdrew from the trial because of side effects. Major side effects included drowsiness, diarrhea, decreased appetite, fatigue, fever, vomiting and upper respiratory infection. But GW said that over all, the drug was well tolerated.

    One caution is that the full details of the study were not released; the company said they would be presented at a medical conference.

    GW, which is based in London, said Monday that it would meet with the Food and Drug Administration to see if Epidiolex could be approved based on this single study. It is expecting the results of another trial for Dravet syndrome later this year, and the results of two trials in another form of epilepsy, Lennox-Gastaut.

    There are no drugs approved specifically for Dravet syndrome, which typically starts in infancy and affects about 5,000 children in the United States, according to the company. It is not yet known if Epidiolex can help with the walking problems and intellectual disability that can come with Dravet, Dr. Devinsky said.

    American depositary receipts of GW closed up about 120 percent on Monday. The company, which specializes in cannabis-based pharmaceuticals, already sells Sativex to treat spasticity associated with multiple sclerosis. It is approved in many countries, though not the United States.

    While Epidiolex could be the first prescription drug in the United States extracted from marijuana, two drugs already on the market, dronabinol and nabilone, are synthetic chemicals either similar to or identical to delta-9 THC, the component of marijuana that produces the highs.

    Those drugs are approved to treat nausea and vomiting caused by cancer chemotherapy. Dronabinol is also approved to treat weight and appetite loss in patients with AIDS.

    GW executives say that an approved pharmaceutical should be favored by doctors and patients because the other medical marijuana products have not gone through the same rigorous vetting.

    A study last year by researchers at Johns Hopkins University and elsewhere found that medical marijuana products rarely contained the amount of ingredients stated in their labels.

    The F.D.A. has been sending warning letters to some companies, many of them selling hemp oil, saying that they are illegally marketing their products as drugs and that cannabidiol cannot be sold as a dietary supplement because it is being studied for use as a drug.

    But even if Epidiolex wins approval, some parents might stick with other products, either because they do not want to disrupt their child’s treatment or they prefer a fuller plant extract to the single ingredient in Epidiolex.

    “My kid’s stable. I’m not touching it,” said Allison Ray Benavides, whose 6-year-old son, Robby, is using Charlotte’s Web, to which a little of the psychoactive component THC is added.

    Robby used to have 15 to 25 seizures a day, even while taking the approved drug Depakote, and had to wear a helmet all day to protect his head from falls, said Ms. Ray Benavides, a medical social worker in San Diego.

    Since starting on Charlotte’s Web more two years ago, while continuing with Depakote, he has had a total of only five seizures.

    “I don’t need a double-blind placebo-controlled study to know something,” she said, while nonetheless welcoming the Epidiolex trial results.

    Analysts expect Epidiolex to cost $2,500 to $5,000 a month, which would be more expensive than some of the medical marijuana products, which cost from about $100 to more than $1,000 per month. However, Epidiolex might be covered by insurance, unlike the other products.