Clifford Mintz, Ph.D., President and Founder at BioInsights, Inc
Clifford S. Mintz, Ph.D. is a seasoned bioscience professional with over 18 years of experience in drug discovery/development, biomanufacturing, commercialization and regulatory compliance. He holds a Ph.D. in bacteriology from the University of Wisconsin-Madison. Dr. Mintz spent seven years as a faculty member in the Department of Microbiology and Immunology at the University of Miami School of Medicine where he conducted laboratory research and taught microbiology and molecular biology to undergraduates, graduate students, and medical students.
After leaving academia and spending several years in the private sector, he founded BioInsights, Inc a biopharmaceutical consulting and medical writing firm. He currently serves as its President and Principal consultant. For the past several years, Dr. Mintz has been investigating and writing about the potential therapeutic value of cannabis and cannabinoids.
[00:00:01] You're listening to thinking outside the bud where we speak with entrepreneurs investors thought leaders researchers advocates and policy makers who are finding new and exciting ways for cannabis to positively impact business society and culture. And now here is your host business coach Bruce Eckfeldt.
[00:00:30] Welcome everyone this is thinking outside the bud. I am respectful. I'm your host today. I'm here with guest Cliff Mintz. Cliff welcome to the program. Hi Bruce.
[00:00:39] So why don't we start with just a little bit of information on your background in a professional and I can talk a little bit about how you got into the cannabis space and then talk a little bit about what you're doing in the space now and we can hear a little bit about the blog and some of the other things you're going to cut us a little bit about professionally Where did you come from and how did you get into cannabis.
[00:00:57] I have a Ph.D. in microbiology and started my career as a medical school professor and found my way into writing and what I like to call scientific journalism. I've been a professional medical slash science writer for the last 15 years. Prior to that I worked in the pharmaceutical industry and have a strong background in regulatory approval of prescription drugs and generally as a medical writer and science writer stayed abreast of current things happening in prescription medicine as well as scientific discovery.
[00:01:38] I found my way into the cannabis field mainly because as a former pharmaceutical research scientist I saw value in the medicinal properties of cannabis and started to think a little bit about traditional pharmaceutical drug discovery and back in the old days circa 1950s through the 1990s many new prescription drug discoveries emanated from Natural Products Research on the plants found all around the world even including hotsprings in Yellowstone Park as well as the thermal events and as a microbiologist who has a background in medical microbiology.
[00:02:23] Most people now understand that antibiotics came from fungi and plants and cannabis has always been a plant that has enormous medicinal properties. For some reason that I really cannot explain. I've never been really thoroughly investigated by scientific or research based discovery efforts and I started going back into the scientific literature and noticed that much like many of the claims that have been attributed to cannabis anecdotally or through urban myths. There is a enormous scientific literature that most American scientists don't know much about. That describes many of the anecdotal properties attributed to the medicinal use of cannabis actually are true.
[00:03:15] There is in fact scientific basis or at least early scientific basis for a lot of the claims that people are asking and much to my surprise there's a lot of very modern research that's been done on China is that Americans simply do not know about. So I started looking at cannabis strictly from a scientific perspective and came to the conclusion that there was really no difference between cannabis and other plants that have medicinal value because of the compounds that can be extracted from the plant and as much as I hate to bring this plant into the discussion if we look at poppies which are another source of opioids which have spawned a multibillion dollar business as well as a multibillion dollar problem in the United States. They Poppys sort of represent a good example of what plants have to offer and hopefully by looking at cannabis in a very different way than the pharmaceutical industry looked at and exploited opioids I believe that there can be a lot of very positive medicinal benefits unlocked by looking at cannabis as a source of prescription based drugs that will benefit many people with chronic illnesses as well as short term solutions for people who suffer from acute problems.
[00:04:45] I'm curious thing just give us a sense of how I guess this typically works and normally works because I think that's what I'm fascinated by is that there are processes in place inside the pharmaceutical industry for finding compounds inside natural plants researching them figuring out how to test them in various ways looking at methods of interaction like how does this normally happen for the pharmaceutical industry in terms of developing developing drugs from plant based products.
[00:05:13] So sadly like everything else in life and business cycles the pharmaceutical industry goes through cycles. So up until the late 1990s every pharmaceutical company had a natural products division and that's boys as I previously mentioned most drugs came from natural products mold fungi plants mushrooms you name it. And with the advent of sequencing of the human genome etc. etc. etc.. People in the pharmaceutical industry erroneously thought that we could dispense with natural products discovery in favor of strictly molecular based approaches to drug discovery. That said the way things work is that you identify a disease process or condition say for example cancer and you typically in the old days microbiologists would scour the planet come back with fungi or plants because of information suggesting from writer sources rather be anecdotal or scientifically based basic research that these natural sources had of compounds in them that would be useful to treat certain conditions zaibatsu modern examples that I could give you is a drug named Taxol which is sold under a number of different brand names to treat breast cancer and other types of cancer. So there was a tree in certain parts of the world I think in Africa and Asia that had compounds that looked like they may be useful to treat certain types of cancer or at least cancer in general there was Taxol is the generic name of the molecule from this.
[00:06:49] This Planetree I forget the name of it. This plant source or tree I forget the name of it that scientists look that they went in and got some of these stres extracted Taxol from the trees based on inhibits cell division or some other process that's out of whack and cancer. They they tested in the laboratory they say well that's good. They then advance it into animals and said well from a from a safety standpoint it looks like it's safe enough to be tested in humans. Then they move to the next stage which is human clinical trials. Finally people with breast cancer or other types of cancer actually gave the compound in a metered dose to these patients and they ran clinical trials and lo and behold based on a Phase 3 clinical trial which is the final trial that is used by the FDA and other regulatory agencies determine that based on the results of this phase 3 trial that is patients with breast cancer patients who got Taxol fared better than patients that got standard chemotherapy doses and low baseline on those data. The FDA divined that this product was safe enough and effective enough for it to be approved as a prescription drugs that oncologists can use to treat patients with certain types of breast cancer and other types of cancer.
[00:08:15] So that said there's this patch. So this process is in place like this is a standard way of doing things and the pharmaceutical industry.
[00:08:21] This process was divined way back in the 1930s or maybe earlier and has been refined over the last 18 years or so to meet modern standards of drug safety and efficacy. Yes. So it's been in place. It's a tried and true process. This is what every pharmaceutical and biotechnology company knows is the pathway that they must follow to get new drugs approved and then placed on the formularies of various institutions hospitals insurance companies etc. to be used by patients just to say now if we start like a cannabis why has cannabis not followed this path or why have they not been able to do this but so compounds in cannabis.
[00:09:12] So the best thing that I can tell you from my position as a pharmaceutical drug observer is is that I think the benefits of this plant have been skewered by the political and sociological aspects of cannabis.
[00:09:36] So yeah that's the base scientifically. There is absolutely no reason why cannabis should not have been treated as a source of potential medicines as compared with any other plant. For example the opioid epidemic is strike this country. I mean I would argue from a scientific standpoint that opioids have been known for the last hundred years cannot not be the best substances to put into human bodies because of the awareness that they were always truly addictive drugs.
[00:10:16] That said they are the opioids that are in use today are very very effective to treat acute surgical pain. Some other types of pain that patients exhibit during certain conditions. I said the best possible draw for post surgical. Yeah possibly a good drug for break out cancer pain. You know patients that are in the terminal stages of cancer. There is no better drug out there than opioids to treat these conditions. So that said cannabis on the other hand has been around as long or longer than opioids and because of the political and again whatever the gestalt of the current cannabis use whatever it just ends up.
[00:11:09] Yeah and it's been a conundrum to me as a scientist to really wrap my there's no basically there's no scientific or pharmaceutical discovery process to prevent exploration of cannabis as a source of prescription drugs.
[00:11:28] So let's talk about the plant a little bit because I think that understanding what cannabis really offers or how even it's kind of structured will give I think will give us a better sense of why we have some of the complications are where are we in terms of understanding. Thanks Joe. Give us an overview of the cannabis plant pharma sort of pharmacological point of view like how does the cannabis plant fit in terms of sources of drugs.
[00:11:54] What do we know about how the plant is structured from a chemical point of view.
[00:11:58] And where are the opportunities that people have initially SIRF seen.
[00:12:02] So that's a great question and I'm going to try and answer it succinctly and cogently as possible because we're covering a lot of ground.
[00:12:11] But essentially there is a system in the human body known as the endo cannabinoid system and this is based on the discovery that there are receptors found throughout the central nervous system as well as other parts of the body most notably in the inflammatory inflammation and and immunological spaces where there are these two types of receptors known as cannabinoid receptor 1 and confirmatory receptive to GA. There are natural kidnapping noite molecules that are found in the body that bind the CB1 and CB2. So these are known as endocannabinoids and these molecules come into play primarily during neuropathic or neurological pathways are activated as well as in inflammation and immunological pathways become activated. So the bottom line is is that the human body has cannabinoids like molecules of receptors that play a role in mediating pain as well as inflammation in the body. Now when we look at the cannabis plant south cannabis produces saying Snowden's Fido can have anoints which are molecules produced by the plant that bind to both CB1 and CB2 receptor. Okay so that means that if we ingest cannabis there are certain molecules that are found in the plant itself or in the smoke from the plant that will bind to these two receptors and obviously THC which is the predominant Fido China have annoyed and found cannabis binds CB1 receptors that results in the fort or psycho act that many people that smoke or smoke or or do whatever else they do when ingested through the lungs. That's the effect you find. Now if we look at the phyto cannabinoids that are found in cannabis itself there are over 100 phyto Kanab annoyed that scientists have detected using pharmacological methods and assets that may be useful to treat various and sundry conditions that are experienced by the Centers.
[00:14:47] And that's just to kind of summarize a little bit. So far so so THC is a the FIDO cannabinoids and there is. But that's one of 100 that exists within the plant. And and we have two receptors that do all of these. All these hundreds bind with both of these receptors.
[00:15:03] That's a great question of whether all of the phyto cannabinoids bind to both or either or and the answer is some bind to CB1 some bind to and some bind in either the receptors. So the ones the cannabinoids like THC that bind to th one receptors that provide euphoric or psycho active effects. There are other ones that bind Bernama CB1 and those are thought to be the ones that may play a role in the neurological aspects of cannabis molecules. That said one of the issues that I think that has interfered with the exploration of THC and others is obviously that people who smoke cannabis yet. Yeah. And yeah there's psychological effect. Right. And so from a from a prescription drug effect you don't want people to get high when they take that. Right. So that's always been an issue. But some of them like CBT which is another cannabinoid which has gotten a lot of Grafs CBD which is found in cannabis sativa as well as hemp plants CBD is a seems to be a very pharmacologically active cannabinoid which doesn't really bind to the CB1 receptor and has modest buying properties. CB2 CB2 receptors CBD seems to mediate a lot of very positive pharmacological effects and interestingly enough we're doing this interview or digests day after FDA approved a product called the Polacks or empathy Polacks by a company called CW pharma and this is the first time in history that the FDA has approved a cannabis derived pharmaceutical after the Rolex is made exclusively from that molecule or can Avonlea called CBD this product that received approval yesterday has been approved for the treatment of trial childhood epilepsy conditions such as Turvey syndrome and Lenexa gestalt syndrom. So this is a historical event that I think will usher in the likelihood that other cannabis derived products i.e. made from extracts or molecules found in extracts plant will be also approved for other conditions.
[00:17:44] So this product is literally derived from the cannabis plant processed and put into a drug form prescribed by HADOS and to the extent that you can make to this in detail that you have a great banto.
[00:17:57] So right now we have got this federally illegal states state specific legality for prescribing basically cannabis based products that are you know various forms vaporization and insurers and edibles and so as a physician right now inside of a state that's medically illegal I can prescribe these cannabis passed product. This is now a product that is federally illegal that is derived from the cannabis plant focused on a CBD a seemingly molecule yes.
[00:18:30] So that is absolutely right so we have to be careful how we parse our words. Yeah it's though because the other products you may have mentioned in state to state variability right now because of this is a complicated question that try and make it simple. All right. Cannabis is illegal at the federal level but it is now as you well know and your listeners well know and 30 or so states it's approved for medicinal use. And I think in eight or nine now it's approved for adult use recreational purposes. Now the states are able to do this by basically saying that the federal government has made it illegal. But that doesn't mean that we as states have to follow federal law because we have a constitution and we believe that there is value in this plan even though the powers that be have not been convinced that it is. So if you go to a state where medical marijuana is legal physicians can give you a current or a recommendation letter suggesting that a patient will benefit from the effects of cannabis. Now all the products you mention tinctures edibles capsules patches. These are products that have not undergone the process that we discussed conscription drugs at the federal level that has been in place for it for 70 years plus or something. What that means is is that because some states have opted out of that federally mandated process there are no safety or efficacy claims that can be made by any of the products that are being sold either in plant based products or extracts or gels or patches from the plant which essentially means that as a physician in those states you're going to give a patient a card because you yourself believe not because any federal agency or there's consensus amongst your peers that this works on or on a prayer and a song you're going to say I believe that this patient will benefit.
[00:20:54] So this patient gets a card and is now able to legally purchase either but or products that have no history of being assessed for safety or ethics to treat their medical conditions. Now now this is different than what happened yesterday. So I don't know the specifics of the approval. But based on what I do know from previous examples that the product empathy Rolex is now federally approved which necessarily means that this product needs to get a waiver from the DEA to suggest that this product is no longer classified and settle on a schedule one drug. It's now been either declassified to two or three so that this product now can be distributed nationally and written as a prescription drug by physicians without fear of running afoul of schedule. So there have been other products that have been approved that are cannabinoid like. But those two or three to other products were synthetic THC based drugs that so because they were not extracted directly from the plant. Now there was a kind of a loophole that says well this is a plant based thing. This is a chemically modified Raber THC but we understand that even though it's chemically modified it does run afoul of the a Schedule 1 status.
[00:22:42] So what they're probably going to do for you all x they schedule the previous synthetic THC to a different schedule level reclassification. But unlike this product which is completely naturally derived from from CBD which the natural substance from cannabis is these synthetically derived molecules of THC patients really didn't like it and it didn't sit well with patients because they could eliminate the psycho active component of the effects of the synthetic molecules. And in many cases because they modified it the the psychoactive fats were actually enhanced rather than move. So patients didn't like. So as somebody as somebody who way back in the day ate cannabis products. You know it's a very different experience. And if you vaporize it or inhale it. So if you're a patient that is not comfortable feeling different than you typically feel even though it may reduce nausea and vomiting or enhance your appetite as a cancer patient or somebody suffering from a disease where you no longer want to eat your nutrition is deficient may result in your death.
[00:24:08] Patients we don't like. Now with the with the Rolex this has been approved for children. And as I'm sure you're aware there are children that suffer from multiple seizures on a daily basis. And the only relief that these patients can get these kids can get is by eating or vaporizing or using a patch base you know laced with CBD. So this this is a even though it's been approved it's been approved for a small subset of nations. So just because it's approved for childhood epilepsy it cannot. Now there are caveats here. OK. Right now it's approved for childhood epilepsy treatment. That said if you're a licensed physician in the United States you are allowed to take any prescription drug that has been approved by FDA and use it as you see fit. Interesting. So that means if you think that the All Blacks can benefit somebody who suffers from adult epilepsy you're well within your right. As a physician to prescribe for those patients if you think that CBT will be useful to treat patients with PTSD or cancer patients then then you can prescribe it for those patients. Now note the approval of this product is very stark because what is going to happen is that physicians that have been on the fence about the benefits of CBD mainly because they were afraid of legal prosecution if they gave court.
[00:26:03] Even in states this is going to open the floodgates for physicians to now understand go ahead and prescribe empathy outlets for any indication that they believe will be it will be effective against some kind of a wedge in this whole issue where you've got to know him less as Shriner's in the beginning of the end of the the psychological warfare that has been waged on cannabis and its problems. So this is very historic. Most people in the cannabis face don't know this. So you could be the first one to break the story that some guy with a Ph.D. to be in New Jersey is saying this is a historic event. Now that's if the federal government doesn't intervene. Yeah right. Right now if the federal government tries to inhibit this so-called what we call the industry off label use there will be lawsuits that you wouldn't believe coming from the American Civil Liberties Union from the AMAA from every medical society saying wait a minute you cannot do that.
[00:27:18] This is about you're here coming in and and right and trying to try to play a game with one particular candidate.
[00:27:24] So there I think it's historic in a lot of ways but I think that if I was a company in the medical space in the sense of making medical products that have been sold on the market for the last five years I would be a little bit worried.
[00:27:43] Yeah. Now Tom like us and I'm curious to see how this plays out.
[00:27:48] So Jim tell me a little bit more about what what your goal is right now inside the Kennedy Space so you're Arab you're coming out of pharmacy a pharmaceutical science looking at the research medical writing. I know you're you've got a blog running right now. What what are you trying to do in terms of the cannabis space in the pharmaceutical space and what are your goals.
[00:28:11] So I do have a blog it's called the Cannabis Science Blog. W WW Cannabis Science blog Dot Com and going back to what we were talking about before we got onto the the approval of the Rolex. My goal in the can of his face is to provide consumers and health care professionals with as much scientifically based information or medically based information that I can offer in the cannabis space so that that is my goal. In a nutshell. So there's a lot of anecdotal unsubstantiated scientific claims out there and what I'd like to do is provide a a focal point for folks who are interested in whether or not cannabis may be right for them in terms of the medical conditions that they suffer from or chronically or acutely that that may benefit them. So as long as there is scientific evidence to suggest that cannabis can be used to treat PTSD or chronic pain or other indications like cancer then I want people to be able to go to that information and look at it for themselves and determine whether or not cannabis may be right for them. Yeah and that's pretty much my goal. And also as an aside to also look at some scientifically based or technologically based concepts for cannabis that may or may not be true for example you know is this delivery device really the device for you is will it deliver the best medical impact for you. Is is this patch that's being sold now on the market. Does that patch really provide any medical benefit or none at all. Now you no just to look at whether technology's delivery technology is growing technologies whether it trends like they're being or are safer now from a scientific perspective now do you have to worry about the or the organic molecules that are usually carcinogenic that people use to extract stuff today. M You know they're homebrew laboratory so just basically to monitor the cannabis industry from a safety and medical benefit perspective not only from a pharmaceutical perspective but also from a lifestyle perspective.
[00:30:41] And certainly as as this space matures and grows and becomes kind of more more part of the general culture and the general population these are going to be the key issues. It's been kind of this Neish thing for a long time and figuring out how to make it useful and sustainable for a larger population is key and we're going ahead time here. Cliff that's it really. It's been highly educational it's been really fascinating. If people want to find out more information about you about the blog what's the best way to contact you and get that go.
[00:31:11] Go to my blog w w w Dunn cannabis science blog Dot Com and you can contact me directly or I'm not sure whether or not I should give out my e-mail address. Good. I think we give out an e-mail address if you want to talk to me directly and not go to the blog it's cliffs and Zea at Yahoo dot com right now.
[00:31:32] I will make sure that those links are in the show notes here. Cliff this was great. There's probably a series of episodes we can do around a couple of these topics and you know we'd love to schedule those in the future. But this was a great kind of initial discussion around sort of the pharmaceutical on the science side of this which is fascinating. It's really important. I think it's just become more and more of a topic in the cannabis space as we go forward. I appreciate your time.
[00:31:57] Thank you Bruce was a pleasure chatting with you. Hopefully we could do it again right.
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