(Here is my take on this article Therapeutic Use of Cannabis and Cannabinoids A Review JAMA Network, 11/26/25. On a personal side, I use CBD to help me sleep, and with a little (5%) addition of THC, it is a great anxiety calmer – Sally Torgeson, AnCan Blood Cancer Moderator & Multiple Myeloma Coach)
Unapproved Cannabis
The FDA has NOT approved the cannabis plant (botanical marijuana) for any medical use or indication.
Because it is classified as a Schedule I controlled substance under federal law, the FDA has not found it to be safe or effective for the treatment of any disease or condition [1.1, 1.7].
It is currently illegal to market CBD by adding it to food or labeling it as a dietary supplement in interstate commerce [2.1, 2.5].
FDA-Approved Cannabinoid Drugs
The FDA has approved a small number of prescription drugs containing either a purified cannabis-derived compound or synthetic cannabinoids:
Epidiolex (Cannabidiol or CBD): The only FDA-approved drug that contains a purified substance derived directly from the cannabis plant. It is approved to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex in patients one year of age and older [1.8, 2.1].
Marinol and Syndros (Dronabinol): Contain synthetic Δ9-tetrahydrocannabinol (THC). Approved for:
Nausea and vomiting associated with cancer chemotherapy in patients who have not responded to conventional antiemetic treatments [2.2, 2.3].
Anorexia associated with weight loss in patients with HIV/AIDS [2.3].
Cesamet (Nabilone): Contains a synthetic substance that is chemically similar to THC. Approved for chemotherapy-induced nausea and vomiting [1.1, 2.3].
Regulatory Context
The FDA maintains its authority to regulate products containing cannabis or cannabis-derived compounds, even those derived from hemp (cannabis with less than 0.3% THC), under the Federal Food, Drug, and Cosmetic (FD&C) Act [1.4].
The FDA supports the development of new drugs through proper clinical trials to ensure they meet standards for safety and effectiveness [1.1, 2.4].
FDA-Approved Cannabinoid Drugs and Their Conditions
* Nausea and vomiting caused by cancer chemotherapy (when other antiemetics have failed) * Anorexia (loss of appetite) associated with weight loss in patients with HIV/AIDS
Cesamet (Nabilone)
Synthetic cannabinoid (similar to THC)
* Nausea and vomiting caused by cancer chemotherapy (when other antiemetics have failed)
Key Takeaway
Epidiolex is the only drug approved that contains a substance derived directly from the Cannabis plant (CBD). It represents the strongest evidence for cannabinoid efficacy in reducing seizure frequency in certain rare forms of epilepsy [1.1, 1.2].
The synthetic THC compounds (Dronabinol and Nabilone) are used primarily as a last resort for severe nausea/vomiting related to chemotherapy and for appetite stimulation in AIDS patients [1.2, 2.8].
The FDA has not approved the use of the whole cannabis plant for any medical condition, stressing the importance of standardized, tested pharmaceuticals for patient safety and proven effectiveness [1.7].1
Off-Label Use vs. Unapproved Use
1. Off-Label Use (Legal and Regulated)
This applies only to drugs that the FDA has already approved.
What it is: Using an FDA-approved drug (like Epidiolex, Marinol, or Cesamet) for a condition, dose, or patient population that is not specifically listed on the drug’s official label.
Legality: It is legal for a licensed physician to prescribe an approved drug for an off-label use if they believe it is medically appropriate for their patient.
FDA Position: The FDA does not regulate the practice of medicine; however, the manufacturer cannot market or promote the drug for the off-label use. The safety and efficacy for the off-label use have not been verified by the FDA’s rigorous testing process.
Example: A doctor prescribing Marinol (Dronabinol), which is approved for nausea from chemotherapy, to a patient for chronic pain. The drug is approved, but the condition (chronic pain) is not on the label.
2. Unapproved Use (Non-FDA Approved Products)
This applies to the cannabis plant itself and most CBD/cannabinoid products on the market.
What it is: Using the whole cannabis plant (botanical marijuana) or non-FDA-approved cannabis-derived products (like most CBD oils, edibles, or topicals) for any medical purpose.
Legality:
Federal: The whole plant is a Schedule I controlled substance and is not federally approved for any medical use.
State: Use may be legal under state medical or recreational cannabis laws, but this does not change its status as an unapproved drug under federal FDA law.
FDA Position: The FDA considers these products unapproved drugs and/or illegally marketed products (especially when CBD is added to food or marketed as a dietary supplement), as they have not been tested for safety, effectiveness, or quality assurance.
Example: A patient using a CBD tincture (which is not Epidiolex) to treat anxiety, or using THC flower to help with multiple sclerosis symptoms.
To correspond with Sally, please send an email to info@ancan.org, and we’ll be sure to send along.
NEW monthly GAY & BISEXUAL MEN’s Prostate Cancer Group starting Tue, Oct 14. Sign up at https://ancan.org/contact-us/
AnCan is grateful to the following sponsors for making this recording possible: Bayer, Novartis, Johnson and Johnson, Myriad Genetics, Telix, Blue Earth Diagnostics, and Foundation Medicine.
WELCOME all to our newly recorded Low/Intermediate Prostate Cancer Group. To receive notice when new recordings are posted, either follow us on this YouTube Channel or sign up to our Blog via https://ancan.org/contact-us/ – check New Blog box.
AnCan respectfully notes that it does not accept sponsored promotion. Any drugs, protocols or devices recommended in our discussions are based solely on anecdotal peer experience or clinical evidence.
AnCan cannot and does not provide medical advice. We encourage you to discuss anything you hear in our sessions with your own medical team.
AnCan reminds all Participants that Adverse Events experienced from prescribed drugs or protocols should be reported to the pharmaceutical manufacturer or the FDA Adverse Event Reporting System (FAERS). To do so call 1-800-332-1066 or download interactive FDA Form 3500 https://www.fda.gov/media/76299/download
AnCan’s Prostate Cancer Forum is back (https://ancan.org/forums). If you’d like to comment on anything you see in our Recordings or read in our Reminders, just sign up and go right ahead. You can also click on the Forum icon at the top right of the webpage.
All AnCan’s groups are free and drop-in … join us in person sometime!
Editor’s Pick: Treatment recommendations including whole-gland radiation versus active surveillance. (bj)
Topics Discussed PSA history; biopsy results and the importance of getting a second opinion; imaging for staging & PIRADS scoring; molecular/genetic testing including Polaris molecular predictive tests; treatment recommendations including whole-gland radiation versus active surveillance; PSMA PET scans and their high success rate for detection; various biopsy techniques stressing the importance of getting a MRI before a biopsy; Prostox as a test for predicting urinary issues following treatment; radiation treatments and the potential for urinary and erectile side effects.
Chat Log
AnCan – Stuart sent a chat · 7:45 PM Dr. Ming Zhou – Mt Sinai Health System Email: Ming.zhou@mountsinai.org Phone: 212-241-8881 Dr. Jonathan Epstein – https://advanceduropathology.com/ Email: jepstein@imppllc.com Phone: 516-760-2037
David Keller Jacksonville, Florida sent a chat · 9:01 PM Thank you for a good meeting. Need to go. Have a great week.
Jim Stewart Reno, NV sent a chat · 9:15 PM signing out, good night all!
Henry sent a chat · 9:31 PM I was also informed to have surgery because of the enlarged prostrate . It changes things, when the prostate is larger than usual.
Mark WV sent a chat · 9:34 PM Sorry have to go. good night
CNTV’s recent video features an interview with AnCan founder, Rick Davis. He explains that he started AnCan after his own diagnosis in 2007, after realizing inadequate support options, especially for those in remote areas. AnCan aims to eliminate barriers to entry for its various support groups, which range from cancer to chronic diseases. AnCan empowers patients to “Be your own best advocate” by providing them with the knowledge to speak confidently with their healthcare providers and offering peer-to-peer support.
In our prostate cancer world, getting 2nd opinions is critical. It’s easy to find a medical second opinion, and you can have your pathology reread by the best. But MRIs – that’s been challenging.
Now there’s an affordable AI-validated option that’s proven very reliable* – ProstatID
Founder and Developer, Randall Jones, PhD, explains the technology and its uses. Hosted by AnCan Advisory Board Member and prostate cancer peer, Cdr. Mike Crosby
AnCan thanks the following sponsors for making this recording possible: Bayer, Novartis, Johnson and Johnson, Myriad Genetics, Telix, Blue Earth Diagnostics, and Foundation Medicine. Views expressed in this Recording are solely the opinion of AnCan Foundation, our Moderators, and Participants.
AnCan does not accept sponsored promotions. Any drugs, protocols, or devices discussed are based solely on anecdotal peer experience or clinical evidence. AnCan cannot and does not provide medical advice. We encourage you to discuss anything you hear in our sessions with your own medical team.
AnCan reminds all Participants that Adverse Events experienced from prescribed drugs or protocols should be reported to the pharmaceutical manufacturer or the FDA Adverse Event Reporting System (FAERS). To do so, call 1-800-332-1066 or downloadthe interactive FDA Form 3500 https://www.fda.gov/media/76299/download
To SIGN UP for any of our Virtual Support groups, visit our Contact Us page.
“Someone I once loved gave me a box of darkness” –Mary Oliver
I was at a 12-Step-oriented workshop about grief recently, and it made me think about Men Speaking Freely (MSF). We are vaguely aware of grief in all MSF groups, it hangs over us, and we have at times focused on some specific griefs/losses, such as vitality, or a longer life. It is commonly thought that not thinking about a loss, not talking about it is the manly thing to do. Here in MSF we get relief by sharing our common losses with each other.
The presenter of that workshop, Marcia C., had some ways to specifically talk about grief that were new to me. She gave me permission to use some of her material here. She pointed out some types of losses that I hadn’t realized. For example, the loss of who I would have been if cancer didn’t happen, the grief of estrangement, loss of work, of status, of friendship; the loss of never having had something, that of aging, of trust, or of giving up something.
She said there is “unacknowledged grief” when such losses are never fully brought to consciousness. When I looked at her long list of examples I saw many that I have. We ought to watch for unacknowledged grief.
She described “non-finite” grief, which has no end-point other than death. Ours could be in that category, since as time goes by our loss increases instead of lessens.
Marcia said, ‘’Sharing your grief is a way to receive validation and compassionate witnessing. It can help you begin a path to healing and/or finding a way to live with grief.
Consider the questions below:
1. Are there griefs you haven’t realized you have or have been afraid to face?
2. Are there griefs about which you’d like to share?
3. Do you have grief practices that might be helpful to others?
4. Make a list of griefs you’ve experienced.
5. Choose a tool from the list that might help you process your grief.”
That list of “tools” was long; it included things like: write a letter or poem describing our loss…Create a ritual of letting go…Share with others who have had similar losses…Visit a place that is meaningful…Make or buy a talisman that helps you feel protected…Dance, run, yell to get your feelings out of your body…Plant something in remembrance or as a new beginning…Start a new tradition…Do an intentional funeral… These are ways to bring acknowledged, unacknowledged, and non-finite grief out for a conscious conversation. Moving from covert to overt, with the goal of making a relationship with the loss, and getting rid of the unconscious silent prolonged scream that I, for example, think I harbor.
We think of grief as emotional, but in “Dealing With the Physical Impact of Intense Grief” by Batya Swift Yasgur, the author describes the variety of physical reactions to grief. Ranging from elevated blood pressure to takotsubo cardiomyopathy — sometimes called “broken heart syndrome” — which is a “stress response that balloons the heart.” We often wonder about the reaction on our immune system, and its implications to our overall survival. In fact, probably nearly all our systems react to grief in some way.
There is a fairly new grief-related diagnosis in the Diagnostic and Statistical Manual and the International Classification of Diseases, describing a “persistent and pervasive grief response” that goes on longer than a year., and is now called Prolonged Grief Disorder. In order to be diagnosed with Prolonged Grief Disorder, a person must experience at least three of eight additional symptoms that include “disbelief, intense emotional pain, feeling of identity confusion, avoidance of reminders of the loss, feelings of numbness, intense loneliness, meaninglessness, or difficulty engaging in ongoing life” according to Columbia University’s Center for Prolonged Grief. For an adult to meet the criteria for a PGD diagnosis, the death of a loved one must have occurred at least one year ago, and the symptoms must be present most days since the loss and nearly every day for at least the last month.
Our situation is different from losing a loved one (although it includes that) and waiting for the grief to go away. Instead of a major loss which goes farther and farther into the past, our major loss is in the future. We have sort of a reverse Prolonged Grief Disorder. For instance, I expect my losses to get worse and worse until death.
AnCan Foundation, the innovator of virtual support groups, is coming to our 10th Anniversary in less than 10 months. We’ve grown – about one-third of US nonprofits fail in that time, and we have flourished. Starting with 3, or was it 4, meetings, AnCan now boasts 33 virtual monthly events for 16 different conditions. If that’s not evidence enough, annually we serve around 7,000 live; approx. 33,000 through our recordings, and we have close to a half-million who make contact with the AnCan logo somehow or other annually. That’s a lot. Watch out for our new Impact Report that’s in the works.
It’s certainly more than one person can handle. In fact, it’s more than myself, a volunteer, plus 4 contract people and an outside bookkeeper can handle. I’m not the only volunteer. I am so honored and privileged to say it’s more than around 100 volunteers can handle, and we could not manage without your efforts – much gratitude.
For some time, the executive function has been too much for me to manage alone, even with the help of our volunteer Executive Board made up right now of Bill Franklin, David Muslin and Stuart Jordan – btw, we’re looking to add to that too. We’ve been looking to hire executive help and the perfect solution has presented itself.
Some of you may be aware of the term, Fractional Executives – The Charity CFO just ran a podcast. AnCan has been fortunate enough to find one who knows us intimately. Courtesy of the USAF and subsequently, extensive consulting experience at The Mitre Corporation, our Board President, Bill Franklin, is voluntarily reducing his hours at Mitre to take on a contract position of 16-20 hours a week with lil’ ol’ AnCan.
As our Board President since August 2021, Bill knows all the ins and out, he’s seen us grow, and most significantly he’s willing to work with me! Bill’s also looking to phase out of Mitre and find new challenges as he approaches retirement. AnCan provided a great solution and we welcome him as our new Chief Operating Officer.
Bill will continue as Board President as well as assuming oversight over many of the operating and administrative duties, from finance and control to insurance, compliance and many special projects – viz. the Impact Report !?! To be honest, Bill’s been doing a lot of this informally but can now spend legitimate time a couple of days a week to help us put our ship, or maybe we should say ‘our bird’, in better order.
Personally, I am thrilled and excited. There’s no one I can think I would rather work with. I welcome him sharing this job with me, and keeping me on the straight and narrow as he has done since joining the Board many years ago. One other person to thank – another aviator, Bill’s wife Misa. If she hadn’t gotten on his case for spending many volunteer hours with AnCan, Bill wouldn’t have come up with this great solution.
Welcome aboard, Sarge… or should I say, Mr. Prez! AnCan welcomes Air Relief
Off-Label Use vs. Unapproved Use
AnCan Foundation, the innovator of virtual support groups, is coming to our 10th Anniversary in less than 10 months. We’ve grown – about one-third of US nonprofits fail in that time, and we have flourished. Starting with 3, or was it 4, meetings, AnCan now boasts 33 virtual monthly events for 16 different conditions. If that’s not evidence enough, annually we serve around 7,000 live; approx. 33,000 through our recordings, and we have close to a half-million who make contact with the AnCan logo somehow or other annually. That’s a lot. Watch out for our new Impact Report that’s in the works.