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In the traditional “Big Pharma” drug development model, a new drug is created to address a disease and, based on objective evidence, reviewed and labeled for treatment for a specific list of ailments (although a physician can Rx it for off label uses). Many come from traditional treatments – like willow bark tea for a headache and other pains. I admit it is much easier to swallow an aspirin that find a willow tree and extract tea from its bark. So it makes perfect sense to find the single active ingredient and create a pill which contains it. While a couple of drugs have been developed from cannabis, the pharmaceutical companies cannot really separate the dozens of active cannabis compounds into separate salable pills so easily. It should be just as (or much more) effective to use cannabis (or its extracts) in their native form – no pills needed. It is safe – humans have used cannabis for thousands of years and there are no objective reports of any deaths related to its use. Cannabis includes dozens of active “drug” molecules that bind to the endogenous CB1 and CB2 receptors in our bodies. When consumed, it medical physiological actions are really from the combination of those drug molecules acting on many endogenous receptors simultaneously. A single cannabis component in a pill, by itself, would not have the combined effect. The FDA will assume control over our industry (a “when” not a “if”). We must plan now to avoid an intrusion of the pharmaceutical giants into our industry. Some actions are: source: https://www.linkedin.com/groups/78665/78665-6140315298881949698 Marked as spam
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Michael Chellson, RAC
Andrew, You couldn't be more correct about "Not if...But When". I expect to see FDA create and draft regulation shortly after the cannabis is removed from Schedule I. With half the states already recognizing and authorizing the medical use of cannabis, ans several with recreational authorized use there will be a "Turf War" between FDA and ATF. And we as regulatory professionals should help guide this discussion to ensure the needs and safety of both the population and industry are maintained.
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Cathy Behrendt
Great point, Michael! I think the National Institute of Health would want to add inputs to the guidance.
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Andrew Kyle
I disagree with 'intoxication' - cannabis is not alcohol. It is not toxic like tobacco or ethyl alcohol or opioids. Many drugs are used for life - like for high blood pressure What is wrong if it helps your mood too? Better than anti-depressants! You are too young to understand the degeneration of your body today
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Andrew Kyle
Mr. Garman - what objective evidence do you have that daily use does not have medical uses? Many drugs are prescribed for life Mental health maybe improved and the many ineffective anti-depressant and 'dementia' drugs might not be needed That possibility and the need for a complex mixture of compounds - both THC, CBD and others can be grown in your backyard or home from seeds.
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Daniel Davis
Mr. Kyle, in response to your disagreement with "intoxication" why don't you come to Oakland/Berkeley CA and spend a week walking up and down Telegraph ave. Dive around the city, and smell the "medicine" wafting from the car windows! (see driving under the influence). It may surprise you how many young, seemingly health adults have glaucoma, or fibromyalgia or any other bogus malady. Seems we have a epidemic, sickness everywhere you turn!
Why can't you just say it like it is? People want to get "high". Period! Of course there are those that it most definitely helps, and for those, let's get them that needed relief......but the young and healthy? You may find your preconceived notions about medically needed cannabis vs intoxication just that, preconceived. Marked as spam
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Andrew Kyle
My presumption is that you never drink. Is that correct? I walked over drunks in Warsaw who drank their wages as soon as possible. What are you against - all intoxication? Chocolate binds to CB1 receptors - ban chocolate? Why not make enjoying the sunshine "Rec" and only allow being outside to supplement Vitamin D. You belong in the Middle Ages
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Andrew Kyle
Your remarks are more correct for ethyl alcohol. I am sure you never 'rec' on any substance or life itself.
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Daniel Davis
Good afternoon sir, first off, really no need to insult my intelligence nor make assumptions on what I am against or for. I never implied I was against ALL intoxication, however this discussion involves substances that intoxicate. For the sake of this dialog, intoxication: Verb; to affect temporarily with diminished physical and mental control by means of alcoholic liquor, a drug, or another substance, especially to excite or stupefy with liquor." and the pathology is "to poison". To be clear, I AM against public intoxication, ethyl alcohol or THC. I am also a huge believer in help for alcoholics. Terrible disease.
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Daniel Davis
I would like to know if you think it's perfectly fine to get behind the wheel of a car and "smoke a joint" or for that matter sip a cocktail? Are you in the habit of doing either one while walking down the street? (just as absurd as your chocolate/sunshine crack) Does "normal behavior" now present as someone who must imbibe at anytime, anywhere simply because we have the "right" to or more likely because it "feels good man" and how dare anybody question that? Very childlike. Look, your agenda is clear, and yes, the Bay Area is a "different place"......coming to a city near you!
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Daniel Davis
And your absurd question weather or not I am against making "sunshine" or "chocolate" against the law or outlawed is asinine at best!
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Daniel Davis
I get it, let's get this medicine in the hands of those who truly need it. But let's try and get the "hip" out of it, and keep it away from those prone to addiction and out of the hands of children.
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Andrew Kyle
Daniel, I am sorry that you have somehow read something I wrote had this line of information therein and am sorry you were offended.
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John G. Caruso
F. (Insurers and VA) Absolutely but expect a fight from the right.
Another area that has to be addressed is plant contamination and pesticides. A guaranteed list of ingredients and assurance of purity of medicine is essential. An organic certification system needs to be in place with reliable testing and tracking of product. Marked as spam
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John G. Caruso
I agree with the idea that action is required to avoid intrusion by any number of industries using lobby groups trying to get, or make sure that maintain their piece of the pie. Pharmaceutical giants are just one.
Looking at your action items, I think you need to consider how divided people still are on the issue. Progress is made through education, never through isolation of skeptics. Therefore, A and B, and how they’re approached are very important. A and B (Public education) are accomplished with PSA’s. Willing celebrities are everywhere and can be enlisted. Renowned medical professionals such as former Surgeons General alongside of celebrities would be most effective. C (medical hybrids) is being done in labs now to some degree. This is an area we have to be wary of becoming a problem when large companies get involved. Crossbreeding is one thing, but unregulated genetic modifying can cause problems in the future. Marked as spam
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John G. Caruso
D (Rx) is a great idea but a bit complicated when it comes to dosages and tolerances.
E (Partnerships) Partnerships should be pursued with most medical industries, including some Pharmaceuticals. I’m a natural food advocate and believe the natural form is almost always best. However, a pill or liquid form of the complete cannabinoid profile would help a great deal of people who will not, or cannot take it any other way. Some doctors might be more likely to prescribe a pill or liquid as well. While “big Pharma” may seem like a monster here. The right partnership could be very helpful. I’m not sure how helpful the medical device industry is going to be. They just don’t have much involvement. Well maybe the exception being when a few seniors get stoned for the first time in decades and think they can skateboard and do cartwheels! Other industries, such as sports medicine, hospice, pediatrics, geriatrics, and any companies working with oncology might be more helpful places to start. Marked as spam
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Andrew Kyle
Mr Garman - Thank you for your insult. I have not insulted you, so the Santa Clause reference is not really required. Whether you like it or not, this is a change that will occur.
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Daniel Davis
Andrew, good luck to you. And John C, you look old enough to know that anything that will make a handsome profit will ALWAYS be swallowed up by "big Pharma" or big "fill in the blank".
The important thing to remember is that we are all having this discussion. Have a great day! Marked as spam
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John G. Caruso
This simple fact that no one seems to be able to write a comment on this thread without attempting personal insults shows how polarized and emotional people still are about the multiple issues surrounding medical marijuana.
There is and has been a "handsome profit" made in the alternative medicine and natural health industries for decades, by both large and small players. There is also a lot of people (new investors) with the resources that are ready to invest in marijuana ventures. The traditional pharma industry funding model may not apply to this new industry. Marked as spam
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