Cannabis Patient Care - November 2021

Cannabis Patient Care November Issue

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11 doctor focus october/november 2021 | cannabis patient care Dr. Sarah Ward did which showed that if you gave cannabidiol (CBD) from hemp together with chemo that it would reduce the chances of CIPN from chemo. So, I wanted to study that. Not only does CIPN impact quality of life when people have pain in their hands and feet, it hurts fine motor skills like buttoning a shirt or opening a peanut butter jar. It ends up impacting quality of life and survival making people less likely to complete their chemo, meaning their care is compromised. I decided I was going to do a randomized double blind tri- al looking at prevention of CIPN with cannabis. So I went to all these researchers and they said: "oh, no, no, no, you'll nev- er get that through the FDA, you'll never get that through NIDA, nobody's done it before." She told me it's not gonna happen, just do it as an observational study, which is not a research ap- proach that is going to change anyone's mind or establish a sci- entific basis for insurance coverage. The FDA wouldn't let me do it together with chemo because they said: 'We don't know what's going to happen when you give both at the same time. There may be a drug-drug interaction where the chemo won't work as well and we can't do that until chemo is over." So ba- sically I started a randomized double blind control trial a year and a half ago that is the first one to be FDA approved and the only one to look at hemp-based CBD and right now we're the only one to do it with any cannabis for people with CIPN. We have a goal of treating 100 patients and we're 1/3rd of the way there. The trial is CBD and placebo for three months. Af- ter three months there is a one month wash out where we see what happens when you stop the product. After that we offer three months of CBD again. People don't know if they have CBD or the placebo upfront, but later on, they will have access to CBD for three months free of charge. We're not just looking at neuropathy, we're also looking at factors like your energy level, your sleep, your anxiety, hot flashes, all kinds of symptoms, not just from CIPN. There's been a lot of positive interest and we look forward to sharing the final results when the clinical trial concludes. To learn more about participation in our CIPN study, please email: or call: 484.476.2756. Q: What type of products did you use in your study? A: Dr. Weiss: To do a randomized double blind controlled trial, the FDA scrutinizes the products. It has to be pharmaceutical grade. Most products out there that may be FDA approved are nutraceutical guidelines where the amount of CBD on the product has to be within 20% of what's on the label. Pharmaceutical products have to be within 10% and also free of heavy metals, pesticides, and mold. Cannabis is a bioremediator product, it is a plant that you would use for centuries to clean fields because it has the amazing ability to suck all the junk out of the ground. So it's very important that the source of hemp or marijuana is medical grade. You have to be sure that you see a certificate of analysis (COA) so that you don't expose yourself as a patient, especially a cancer patient, to the junk that could be in these products. Mold, arsenic, mercury, or other stuff. So the FDA scrutinizes the product. We're using medical grade products and have COA's on everything that we use. Through our study we learned that of the people who are using cannabis, 79% were using it during treatment which is pretty scary when you think about what's in treatment like chemotherapy, radiation and you add to that a cannabis prod- uct that may be vaped or smoked or something like that. You want to make sure these products are safe. So it was clear we needed to learn more about the basis for which these prod- ucts are used, that means doing more research to establish a better understanding of knowledge to base medical decisions on that would be required to get FDA approval and insurance companies to pay for this type of medical care. Q: What can patients do to help? A: Dr. Weiss: Well let me just encourage patients to participate in clinical studies. We're very grateful to the people who've participated in our clinical study which has advanced the understanding of the role of cannabis and presented it to the largest organizations of cancer doctors. We're very thankful to the participants of the clinical trial studies in the hospital because that's how we're going to get a better understanding of what cannabis does and doesn't do and with that we can give people a better quality of life and increased odds of survival. But just like in other aspects of your care, you have to be your own best advocate. If you don't let your doctor know how they can be helpful to you, then you might not be heard, you may not get help and you're the one who will miss the oppor- tunity for better care. So be the one to ask. About the Author DEBBIE CHURGAI is the Executive Director of Americans for Safe Access (ASA), a medical cannabis patient advocacy non-profit whose mission is to ensure safe and legal access to cannabis (marijuana) for therapeutic use and research. Debbie oversees all organizational and program operations in regards to education, training, policy, research, product safety and business compliance. Current projects include na- tional campaigns such as ASA's End Pain, Not Lives campaign and No Patient Left Behind campaign and programs such as ASA's Patient Focused Certification (PFC) program and the Cannabis Care Certification (CCC) program. She serves as a writer and final editor on ASA publications including the State of the States Report, the Patients Guide to CBD, and the Medical Cannabis Access for Pain Treatment report.

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