Hi-Risk/Recurrent/Advanced PrCa Video Chat, 1/27/26
AnCan is closing out its Annual Fundraising Campaign. If you haven’t donated yet, consider the priceless value we bring . Please donate – especially if you watch our recordings and are not on our Mailchimp list. https://ancan.org/donate/
AnCan thanks the following sponsors for making this recording possible: Novartis, Johnson and Johnson, 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 promotion. 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 download interactive FDA Form 3500 https://www.fda.gov/media/76299/download
All AnCan’s groups are free and drop-in … join us in person sometime! You can find out more about our 12 monthly prostate cancer meetings at https://ancan.org/prostate-cancer/ Sign up to receive a weekly Reminder/Newsletter for this Group or others at https://ancan.org/contact-us/
Join our other free and drop in groups:
Men (Only) Speaking Freely…1st & 3rd Thursdays @ 8.00 pm Eastern https://ancan.org/men-speaking-freely/
Veterans Healthcare Navigation… 1st & 3rd Tuesdays @ 8.00 pm Eastern Schmier Room https://ancan.org/veterans/
Veterans Speaking freely… 4th Tuesday @ @ 8.00 pm Eastern Schmier Room
HEADS-UP: another marathon session!!
Editor’s Pick: Disruptor attends solely to advocate for Dr. Kwon… and makes AnCan’s case with his own inappropriate overtreatment.
Topics Discussed
Potentially de novo metastatic Gent prefers faith to treatment; … and this de novo Mx man has fared well on doublet and radiotherapy RT; he’s more interested in chastising AnCan over Kwon than his own overtreatment; radiation proctitis discussion; kidneys backwashed from possible radiation damage; Clomid slow to restore T… give it time Dr. Jack; considering immunotherapy well before its time; raises the question – does TMB differ between tissue and blood samples?; v. low testosterone may not be related to previous PrCa treatment; new GU MO needed in Central Florida; PSMA is negative but started on Lupron; why shlepp to MDA – what’s wrong with Chicago?; back- end Newbie needs a GU med onc rather than uro; Kwon proselytizer won’t give up; Canadian placed on doublet per AnCan navigation is feeling good and grateful
Chat
Jon McPhee Toronto sent: 4:13 PM
Toronto is in Canada
Dan – Schenectady, NY sent: 4:41 PM
Thank you Bob
AnCan – Rick sent: 4:55 PM
Telephone # for tech assistance: 877 582 7011
Frank Ciambra sent: 5:25 PM
got to go ,see guys net week everyone have great weekend
Bruce Schrimpf sent: 5:38 PM
Got to go. Best to all of you! BDS
Lee Baylin sent: 5:45 PM
Good night.
AnCan – Rick sent: 5:45 PM
my DEXA showed -2.0 in spine and forearm last week. Doc just wants me to supplement with calcium and D.
oh… and resistance exercise!!
Steve Roux, North Michigan sent: 5:46 PM
I’m doing the same +K2
I resist exercise daily.😆
Peter M sent: 5:57 PM
good night gents!
Steve Roux, North Michigan sent: 5:58 PM
Great Meeting gang. I gotta run . Good night all.
Jim Marshall, Veteran, Alexandria, VA sent: 6:05 PM
Hey, 3 1/2 years on a Treatment Holiday and all is good. Jim
Julian – Houston sent: 6:15 PM
Thanks All – I will contact Dr E!
Thomas Matica sent: 6:15 PM
Good night. Thanks to everyone. Peace. Thomas.
Ron S Regina SK Canada sent: 6:21 PM
Thanks all. Gotta go.
Richard B, Silver Spring, MD sent: 6:27 PM
Goodnight gentlemen, I appreciate the feedback tonight. Very helpful
Jon McPhee Toronto sent: 6:29 PM
Nite all.
Bob Schwartz U.S.N. Venice, FL. sent: 6:32 PM
Good mtg., see you next week.
Jim Marshall, Veteran, Alexandria, VA sent: 6:58 PM
Hi-Risk/Recurrent/Advanced PrCa Video Chat, 1/19/26
AnCan is closing out its Annual Fundraising Campaign. If you haven’t donated yet, consider the priceless value we bring . Please donate – especially if you watch our recordings and are not on our Mailchimp list. https://ancan.org/donate/
AnCan thanks the following sponsors for making this recording possible: Novartis, Johnson and Johnson, 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 promotion. 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 download interactive FDA Form 3500 https://www.fda.gov/media/76299/download
All AnCan’s groups are free and drop-in … join us in person sometime! You can find out more about our 12 monthly prostate cancer meetings at https://ancan.org/prostate-cancer/ Sign up to receive a weekly Reminder/Newsletter for this Group or others at https://ancan.org/contact-us/
Join our other free and drop in groups:
Men (Only) Speaking Freely…1st & 3rd Thursdays @ 8.00 pm Eastern https://ancan.org/men-speaking-freely/
Veterans Healthcare Navigation… 1st & 3rd Tuesdays @ 8.00 pm Eastern Schmier Room https://ancan.org/veterans/
Veterans Speaking freely… 4th Tuesday @ @ 8.00 pm Eastern Schmier Room
Editor’s Pick: After 15 years, Prostate cancer recurs for one Gent; and the 2nd time, 13 years later, for another.
Topics Discussed
Newbie needs to switch to a GU MO; PrCa metastasizes after 15 yrs; singlet to doublet during RT; Pluvicto failing after 10x sessions – STEAP1 xaluritamig (AMG509 ) next but heads up!; early signs of 2nd recurrence; Eligard vs Firmagon (agonist vs antagonist LHRH); first GU med onc appointment coming up; managing hot flashes; Oxybutynin again; doc can’t get approval right so switches drug; PSMA shows Nodes may not need RT; abiraterone dosing;
Chat
Rick Davis sent: 6:10 PM
PLEASE – no mention of the Championship Game tonight. Some peeps are recording it.
Need to leave – pass my bedtime. Catch you all next week!
Bob Schwartz U.S.N. Venice, FL. sent: 7:03 PM
Another GOOD Mtg., have to go, see everyone next week.
Rick Davis sent: 7:26 PM
Xaluritamig (AMG 509) is a novel bispecific T-cell engager (TCE) immunotherapy
Bob Y — Los Angeles sent: 7:27 PM
Appreciate everyone. I, too, have to go. See you next week.
Len sent: 7:30 PM
STEAP1 (Six-Transmembrane Epithelial Antigen of the Prostate 1) is detected in prostate cancer (PCa) primarily through tissue analysis (immunohistochemistry), showing overexpression in malignant cells, and via liquid biopsies (extracellular vesicles in plasma), using methods like nanoscale flow cytometry,
AnCan–John A sent: 7:31 PM
thanks Len
Frank Ciambra sent: 7:32 PM
thank you
Rick Davis sent: 7:32 PM
Doubling time very unreliable at such low levels, Neil
dan-s sent: 7:40 PM
I also have to scoot… thanks all.
Barbara and Joe sent: 7:54 PM
are you saying lupron?
Jim Marshall, Veteran, Alexandria, VA sent: 7:55 PM
Lupron & Eligard are the exact same drug. Jim
Rick Davis sent: 7:56 PM
Are you asking about the Depot shots?
Rick Davis sent: 7:57 PM
Oxybutynin…. good for hot flashes if you are on abi
Steve L sent: 7:57 PM
Must leave at 7, Best to all.
Alain sent: 7:58 PM
See you next time guys!
Barbara and Joe sent: 7:58 PM
I was asking about a two tier therapy
Steve Lsent: 7:59 PM
no , thank you.
Alfredo in Houston, TX sent: 8:00 PM
I must disconnect shortly. Thanks to everyone; I learn something new from every session.
Rick Davis sent: 8:01 PM
ADT + ARSI = doublet. ADT can be one of several drugs.
Thomas Matica sent: 8:02 PM
Signing out. Thanks to everyone. Peace.
Len sent: 8:02 PM
Dan – Trade name for oxybutynin is Ditropan.
Barry Blomquist sent: 8:06 PM
Thanks guys!
Richard B, Silver Spring, MD sent: 8:09 PM
As much as I would like to remain I need to bow out for the evening. I can save my question until next session. Always appreciate the information on these meeting. Good night!
Hi-Risk/Recurrent/Advanced PrCa Video Chat, 1/13/26
AnCan is closing out its Annual Fundraising Campaign. If you haven’t donated yet, consider the priceless value we bring . Please donate – especially if you watch our recordings and are not on our Mailchimp list. https://ancan.org/donate/
AnCan thanks the following sponsors for making this recording possible: Novartis, Johnson and Johnson, 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 promotion. 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 download interactive FDA Form 3500 https://www.fda.gov/media/76299/download
All AnCan’s groups are free and drop-in … join us in person sometime! You can find out more about our 12 monthly prostate cancer meetings at https://ancan.org/prostate-cancer/ Sign up to receive a weekly Reminder/Newsletter for this Group or others at https://ancan.org/contact-us/
Join our other free and drop in groups:
Men (Only) Speaking Freely…1st & 3rd Thursdays @ 8.00 pm Eastern https://ancan.org/men-speaking-freely/
Veterans Healthcare Navigation… 1st & 3rd Tuesdays @ 8.00 pm Eastern Schmier Room https://ancan.org/veterans/
Veterans Speaking freely… 4th Tuesday @ @ 8.00 pm Eastern Schmier Room
Editor’s Pick: Denovo metastatic BRCA2 Newbie stumps us all!
Topics Discussed
High volume denovo Mx Gent with BRCA germline can’t fiing a treatment that controls his T or his PSA; starting IMRT along with constipation; 2nd docetaxel easier with less fatigue than the first; liver returning to normal after 6x docetaxel; so back to full daro dose; T returns within 3 months of stopping 12 mo of orgovyx; BCBS turns down Prolia for -2.7 osteoprosis – did doc ask for wrong denosumab; ‘ciiling cap’ discussion; opting for new Plan Ds (drugs); Inherited Mutations discussed;
the relatively long half-life of injectable testosterone undecanoate means its effects can last for weeks, but probably not months
Jeff Marchi – San Francisco sent: 5:08 PM
has anyone had VMAT radiation?
Gary Martin sent: 5:09 PM
I had that prostate inflammation first and second round docetaxel. my oncologist did not know cause. Suggested UTI, which have the same symptom I had in round 1 and 2. I figured it was chemo working on prostate.
Julian – Houston sent: 5:13 PM
Jeff, I have had VMAT radiation.
Jeff Marchi – San Francisco sent: 5:13 PM
how well did it work? any side effects?
Jack sent: 5:14 PM
Enzalutamide blocks androgen binding which disrupts the negative feedback loop that normally supresses testosterone this leads to compensatory increases in LH and subsequent increases in testosterone
Julian – Houston sent: 5:14 PM
It worked quite well – I have been in remission for over 5 years. I am now having some radiation effects but not severe
I had insurance denial of Prolia (bone strengthening)- anyone encounter denial of Prolia?
Julian – Houston sent: 5:34 PM
Aetna no longer approves Prolia.
Larry (Alaska) sent: 5:36 PM
Bone loss is largely drivenby estradiol deficiency (just as it is in post-menopausal women). Testosterone deprivation also lowers a man’snatural estradiol. A low-dose estradiol suppement can avoid the need for bune-building agents. Agents which are expensive and bring their own set of adverese side effects.
Larry (Alaska) sent: 5:43 PM
Calcium + Magnesium:
AI Says: Why Separation Helps Competition for Absorption: High levels of calcium can block magnesium absorption in the intestines, and vice-versa. Optimizing Intake: Spacing them out (2-4 hours apart is a common suggestion) minimizes this competition, allowing your body to absorb each mineral more effectively. When It’s Okay to Take Them Together Multivitamins: If they are in smaller, balanced amounts within a multivitamin, the interaction is usually not an issue. With Food: Taking them with food can also help with absorption and reduce digestive upset.
Hi-Risk/Recurrent/Advanced PrCa Video Chat, 1/5/26
HAPPY NEW YEAR to all AnCan’s YouTube viewers. AnCan is closing out its Annual Fundraising Campaign. If you haven’t donated yet, consider the priceless value we bring . Please donate – especially if you watch our recordings and are not on our Mailchimp list. https://ancan.org/donate/
AnCan thanks the following sponsors for making this recording possible: Novartis, Johnson and Johnson, 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 promotion. 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 download interactive FDA Form 3500 https://www.fda.gov/media/76299/download
All AnCan’s groups are free and drop-in … join us in person sometime! You can find out more about our 12 monthly prostate cancer meetings at https://ancan.org/prostate-cancer/ Sign up to receive a weekly Reminder/Newsletter for this Group or others at https://ancan.org/contact-us/
Join our other free and drop in groups:
Men (Only) Speaking Freely…1st & 3rd Thursdays @ 8.00 pm Eastern https://ancan.org/men-speaking-freely/
Veterans Healthcare Navigation… 1st & 3rd Tuesdays @ 8.00 pm Eastern Schmier Room https://ancan.org/veterans/
Veterans Speaking freely… 4th Tuesday @ @ 8.00 pm Eastern Schmier Room
HEADSUP – another long session!
Editor’s Pick:Like London buses, topics come in clusters this week – post-surgery recurrence, and monotherapy daro
Topics Discussed
Recurrence 3+ months post-surgery is confusing given medical reports; sitting on hands post 2017 RRP has dire cinsequences; more rapid recurrence requires PSMA scan for younger Gent; low T post treatment raises question whether to force it castrate; oxybutinin manages hot sweats… ARSI makes no difference; Gent considers going from doublet to mono; recently diagnosed denovo Mx man learns he’s 5+4; should he keep one Pluvicto session in reserve?; get a DEXA scan before starting bone stregthener; can a layman read their PSMA scan?; is he ready for mono daro?; should a FAP (Fibroblast Activation Protein Inhibitor) scan be considered?; PSMA needed as PSA rises post IHT; connections between prostate and thyroid cancer; Gent resumes doublet but doesn’t watch PSA – more concerned with duration?!?
Chat
RJ Smith (Seattle) sent: 6:17 PM
Hey Bob! Infusion tomorrow, so today is a good day. Sucked on a lot of ice for round #2 as you recommended, so mouth/taste was fine. Proctitis (mostly damage from ton of radiation) is pain in the a**, though–quite a bit of pain this time, but no pain today, so I’ll take it!
Bayer Patient Assistance Foundation could provide free Nubeqa (darolutamide) if you qualify. https://www.patientassistance.bayer.us/en/ I am on my third year in the program.
House guest, must go. Thanks to AnCan and Rick D for referral to Dr. Guancial in Sarasota. Had great visit last week. ADT working, PSA May 4.7, today .01, no side effects, Testro 50. Orgovyx working
Larry Schuller – Alaska sent: 7:06 PM
Orgovyx/relugolix pills and Firmagon/degalarix injections are both LHRH/GnRH ANTAgonists. In my opinion, superior to LHRH agonists, Lupron/leuprolide. Bot inferior (again, my opinion and personal experience) to trans-dermal estradiol (see the web site “estradiolinitiative.org” for more information or cantact me directly at ljschulr@alaska.net.
Bob Schwartz U.S.N. Venice, FL. sent: 7:07 PM
Jeffrey Green, you can also get the Embr Wave at Amazon (my wife got mine there).
Jim Marshall, Veteran, Alexandria, VA sent: 7:08 PM
Family commitment have to sign off…Happy New Year everyone
Jim Marshall, Veteran, Alexandria, VA sent: 7:36 PM
My solution for HOT FLASHES at night has been is even if the room is 55, I have a 12″ fan blowing directly on my face. This is done year round.
Paul Schomer sent: 7:50 PM
I am not, no, Jim
RJ Smith (Seattle) sent: 7:50 PM
NTD–will update next week on how Chemo#3 goes (docetaxel infusion tomorrow, fingers crossed).
Thomas Matica sent: 8:07 PM
Leaving the meeting. Thanks to everyone. Happy New Year.
Jim Marshall, Veteran, Alexandria, VA sent: 8:11 PM
Eric – When you are fatigued, go out and exericse despite the body telling you NOT!!!!
S. Datta sent: 8:14 PM
FAPI (Fibroblast Activation Protein Inhibitor)
Larry Schuller – Alaska sent: 8:18 PM
It is not crazy to want your testosterone back. Intermittent ADT can do that and it is showing promise as a tactic. Bipolar ADT (BAT) is a little crazier, but has some promise also. If you want to go wild, check out Dr Robert Gatenby’s work at Moffit in Florida. Intersesting stuff there.
Jay Mills Chatanooga- Though I didn’t follow the whole conversation, I heard you say something to the effect of, “I may have mets all over the place, in addition to what shows on PSMA.”
Barry Blomquist sent: 8:28 PM
Have to jump – thanks everyone. Happy New Year
Eric Curtis sent: 8:30 PM
Thanks all – gotta go
Jeffrey Green sent: 8:31 PM
Got to start winding down here. Thanks for all you guys. See you next time.
Len sent: 8:34 PM
Source is AI: Bidirectional Risk: Men diagnosed with thyroid cancer have a roughly 28% to 30% higher risk of later being diagnosed with prostate cancer compared to the general population. Conversely, men with prostate cancer are more likely to be diagnosed with thyroid cancer.
Robert sent: 8:35 PM
Thanks Len. I read the same thing.
dan-s sent: 8:49 PM
Thanks all… another good session. Have to sign off for the evening. Happy New Year…
Jay T in MN sent: 8:50 PM
My hospital was charging the insurance company about $20,000.
gary peters sent: 8:50 PM
I did not know this about thyroid C and PC. Thank you.
Jon McPhee Toronto sent: 8:50 PM
Do a PSA test once a month. Cheap. PSMA/PET is expensive and harder to get.
Jay T in MN sent: 8:51 PM
I “only” had to pay $1000 for my portion of PET PMSA
Hi-Risk/Recurrent/Advanced PrCa Video Chat, Dec 23, 2025
AnCan is in its Annual Fundraising Campaign. Please donate – especially if you watch our recordings and are not on our Mailchimp list. https://ancan.org/donate/
AnCan thanks the following sponsors for making this recording possible: Novartis, Johnson and Johnson, 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 promotion. 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 download interactive FDA Form 3500 https://www.fda.gov/media/76299/download
All AnCan’s groups are free and drop-in … join us in person sometime! You can find out more about our 12 monthly prostate cancer meetings at https://ancan.org/prostate-cancer/ Sign up to receive a weekly Reminder/Newsletter for this Group or others at https://ancan.org/contact-us/
Join our other free and drop in groups:
Men (Only) Speaking Freely…1st & 3rd Thursdays @ 8.00 pm Eastern https://ancan.org/men-speaking-freely/
Veterans Healthcare Navigation… 1st & 3rd Tuesdays @ 8.00 pm Eastern Schmier Room https://ancan.org/veterans/
Veterans Speaking freely… 4th Tuesday @ @ 8.00 pm Eastern Schmier Room
HEADSUP – long session
Editor’s Pick: AFib may dictate use of ARSI – 2nd line anti-androgen
Topics Discussed
Dublin EI Newbie needs a GU MO; … and so does 85 yr old from Eau Claire, WI who’s Mayo doc has lost the way; roller coaster metastatic Gent starting with Kishan at UCLA; almost through RT, and finds germline CHEK2; doing well and very thankful to AnCan; germline BRCA2 man not gettiing SoC in Mississippi; great chemo results – now explore debulking; should a man with Afib be on abiraterone?; waiting for PSMA scan after 3x Pluvicto; fatigue & brain fog from abi doublet; avoid 6-month depot LHRH; Dr. Szmulewicz recommends debulking; Florida vacay interferes with treatment plan; 2nd opinion on Bx required; SBRT vs IMRT for man with urinary issues
Dr. Ming Zhou Mount Sinai Health System Department of Pathology, Box 1194 Annenberg Bldg. 15th FL 1468 Madison Ave New York, NY 10029 Email: Ming.zhou@mountsinai.org Telephone: (212)241-8881
Jeff Marchi – San Francisco sent: 6:49 PM
Gotta run. Merry Christmas and happy new year to all.
(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.
Off-Label Use vs. Unapproved Use