The pharmaceutical company KannaLife takes aim at the N.F.L with a cannabis-derived drug to treat brain trauma.
America’s most concussive pastime opened its new season this past week, and in between Peyton Manning’s Favreian dominance, first overall pick Jadeveon Clowney’s abrupt knee injury, and the revival of Tony Romo’s butterfingered Tony Romo-ness, news emerged that the league and the players union are negotiating revisions to the N.F.L.’s drug policy. The new policy reportedly aims to toughen enforcement against D.U.I. arrests, institute blood testing for human growth hormone, and reclassify certain stimulants and diuretics as substances of abuse, rather than as performance enhancers. Discussions have stalled however, partly due to disagreement on marijuana.
The league’s relationship with marijuana is decidedly antagonistic, most recently evidenced by the 16-game suspension of star Cleveland Browns wide receiver Josh Gordon. Gordon is one of six players who, over the past year, have been suspended by the N.F.L. more severely for marijuana use than Baltimore Ravens running back Ray Rice originally was for assaulting his fiancée. Even in the world of professional athletics, the N.F.L. is strict on weed; last year the World Anti-Doping Agency, which oversees drug testing for the Olympics, raised its threshold for a positive marijuana test to a level ten times higher than that currently required by the N.F.L.
Yet in January, Commissioner Roger Goodell spoke publicly about the potential for marijuana as an analgesic. “I don’t know what’s going to develop, as far as the next opportunity for medicine to evolve and to help either deal with pain or help deal with injuries,” he said, when asked whether he could envision a future in which players use marijuana to treat pain. “But we will continue to support the evolution of medicine.”
While Goodell stopped far short of expressing tangible support for medical marijuana, the “evolution of medicine” may already be reaching that future to which the commissioner alludes. Last month the pharmaceutical company KannaLife signed a licensing agreement with the National Institutes of Health to commercialize a 2003 patent called, “Cannabinoids as Antioxidants and Neuroprotectants,” which the company hopes to use to develop treatments for chronic traumatic encephalopathy.
Yes, that’s the same C.T.E. that has shown up in so many recently deceased professional athletes’ brains, often credited as a cause for depression, memory less, dementia, and aggression. The disease, marked by the degeneration of brain tissue and believed to result from an accumulation of head injuries, is the reason so many N.F.L. players have pledged to donate their brains to science.
Dean Petakanas
Dean Petakanas, the C.E.O. of KannaLife, believes the cannabinoids in marijuana (of which there are at least 85, even though you typically only hear about the two most prominent, T.H.C. and C.B.D.) have the unique ability to protect brains from degeneration. On Friday morning, after the Seahawks routed the Packers, Petkanas spoke via phone about why the current medical marijuana landscape is a mess, why the N.F.L. is in denial, and why scientists and patients desperately need some industry standards. He only used the phrase “shit show” twice.
I had done some work in the biotech space in natural plant-based medicines. I was originally involved in a deal, way back in '92, where I took a company public that was involved in the production of paclitaxel, which is an anti-cancer drug. The same company opened a subsidiary called Zeta Farm that was in natural products, extractions, and the nutraceutical industry...Years later, I rallied back with them on a project for the treatment of sickle cell disease. And again, that was plant-based medicine. That took me through 2007.
[quote position="full" is_quote="true"]Regulatory burdens in this country have formed a death-defying wall in front of those who dare to leap.[/quote]
Two years later my business partner called me. He wanted to be involved in a medical marijuana play, and he asked me to bring my best effort to the table. At some point, I wanted to walk away from it. I didn't think that his business model or plan was something I wanted to dive in after. It was really just dispensaries, growing, and what not. My attitude was that we're taking this to the scientific level.
We're going to get in at this point to help bring some practice to the industry. If nothing else, we'll work on drug development, and see if we can help some people along the way. I kind of knew that cannabis was a repository of pharmacologically active compounds, and that it's just that regulatory burdens in this country have formed a death-defying wall in front of those who dare to leap. You can't be an entrepreneur without a gateway of capital. I thought the timing was right. And then the water broke a little bit. Once the water broke, we received some early-stage seed funding. We put it to good use, and we have some serious intellectual property.
It was muted because of Bush. Bush's presidency was like going back to the Stone Age. He destroyed stem cell research in this country. I'm a deeply committed man of God, and I will tell you, I have no tolerance or patience for evangelical bullshit. I think it's anathema to our production and productivity in this country, and any decent churchgoer who's with the spirit of God will not stand in the way of progress helping kids relieve themselves from intractable epileptic seizures. You look at that and you say, ‘What are we doing here?’
But to answer your question, in terms of the chemistry of it, we’re talking about terpinoid-based medicines, cannabinoid-based medicines. It was stuff we were talking about...all the time anyway. [KannaLife is] just different in the sense that [with paclitaxel], we were looking at anti-cancer. We were looking at a diterpene, which is a bacatin... It came from bark, but make no mistake, it had a terpinous quality to it, a pine-y, terpinous quality. And similarly, we have a plant here that has many of these chemicals. When you have a little bit of basic knowledge of it, you say, ‘We have to turn our attention to this.’ Once your turn your attention to it, you're pressed to do something about it.
If you’re going to practice medicine, you have to do it from a different perspective. This isn't some shit show in Colorado where you got a pig farmer pretending to be a pharmacist or a compounder. This is a serious business that you have to take seriously if you expect to get a drug passed through the F.D.A. That's the approach that we took. We said, ‘Let's be a scientific company.’ These growers know nothing about pharmaceutical products. Quite frankly, they're recreational pot farmers. All of a sudden they felt that some spaceship from Pleiades landed on Earth and validated their existence by saying, ‘Medical marijuana.’ They're just hucksters. They're people who are out there pretending to do something. They have to step up and meet the regulatory burden that any other drug has to be met with, including the F.D.A.'s guidance on botanicals in 2004, and also new regulatory acts in 2013 that control compounding.
Regulatory standards are very important. We have to practice what we preach. If we bring any drug into the market, it's going to go through the rigors of the F.D.A. If it's a nutraceutical or if it's a supplement, we're going to treat it with the same rigors that anybody would use if they were doing a compound supplement in contract with a laboratory and a manufacturing facility. You have to follow these rules. Ninety-five percent of the market is making too much money on the recreational side. They want to do some backroom alchemy and pretend to the mothers out there that they're bringing something beneficial to the table.
Cannabis is going to be used in ways that we haven't even imagined yet. Why I say that is because of the number of pharmacologically active and potentially active compounds in the plant...You could look at it. There's a chemistry chart on what happens to this very complex sugar in this plant. But until we start zero'ing in on modes of treatment, no one's really going know. What we do now is that it's the plant matter that matters. It's the plant matter that matters.
I think a million people should march on Washington with green hoods as the C.C.C., the cannabis clux clan or something. It's a silly question because in a sense, you have to look toward the regulatory side of the marketplace. They've got everything they need. I'm not in with the stoners, or what do you call it, the activists, who just pop off like a Roman Candle everywhere. The story's been told. It's done. It's over. The playing field has been leveled. We don't hear politicians saying, ‘It's not medicine.’ They’ve given up on that argument.
[quote position="full" is_quote="true"]It's not going to take anything except observance and vigilance from political leaders, politicians, and bureaucrats. Their political life is at stake now. The secret's out.[/quote]
When you look at the playing field and see where it is right now, Congress is the mover. Have you ever seen, at baseball games, those little videos, ‘Which train is going to win the race at Yankee stadium?’ Is it going be Congress that violates the Controlled Substance Act with new legislature? Is it going to be the Supreme Court that turns its head and says, ‘ok, this is part of the commerce clause.’ Or is it going to be the executive branch of the government that just writes this itself?
That's where it really is right now. It's not going to take anything except observance and vigilance from political leaders, politicians, and bureaucrats. Their political life is at stake now. The secret's out. This mid-term election is going to be interesting. Not only will it have some character to it, in regards to the politicians and their beliefs about medical cannabis, but also there will be another two or three states that jack up on referendums and pass medical marijuana and compassionate care laws, following New York. Once the scale tips past 25 states, it's on autopilot. Then it's requisite of lobbyists and policy makers to say, ‘Uh oh, we have a constitutional situation at hand here.’ I think it won't take much more than the gravity of the situation at hand.
When I started researching the field, there were two areas I didn't want to touch. We originally looked at pain, way back when. Even if you take 10 percent of the opiate market as an industry, that's a pretty potent area. But the sad and practical reality is that I don't want to go to a gunfight with a knife in my mind. That's what it looked like. The prospect was not very good. There was already another player in our space at GW Pharmaceuticals, so I didn't want to grab the tail of the tiger and say, ‘Ah, I'm just gonna come in and compete with you.’ It didn't make sense.
The patent that we were looking at, “Cannabinoids as Antioxidants and Neuroprotectants,” is really above the neckline. It's brain-related stuff. I always wanted to be in brain therapeutics. I was already fascinated with above-the-neckline and the brain. That was the last frontier in medicine because of the blood-brain barrier. What I learned about cannabis is that its lipophilicity [ability to dissolve in fats and lipids] will allow it to do just that, break the blood-brain barrier. Now, what's attributable in dosing is a different story. But something that breaks the blood-brain barrier could be used as a carrier agent for [paclitaxel]. A million things could be done with it. And if it has pharmacologically active factors as a cannabinoid, and you work in the brain-related area, you can do some good.
[quote position="full" is_quote="true"]You can't treat smoking marijuana the way you treat the component of marijuana[/quote]
I kept researching and I found a pathway that I really like called the hepatic pathway. It's like two tin cans and a string. It's attached to your brain and to your liver. All throughout the peripheral and central nervous system, you have signaling going on through the endo-cannabinoid system. It's not just trapped in the brain area. You have endo-cannabinoids all over your body, most notably in your adipose tissue and in your liver. So the liver had a very prominent role with regards to possible endo-cannabinoid-based medicines.
I looked at the patent and I realized I had something for this. It wasn't even mentioned in the patent: Hepatic encephalopathy. If we were very successful, we could probably provide relief to the liver, in terms of hepaticite function. It could also act as a neuroprotectant in the brain for protecting brain cells from toxic insult like pneumonia and ethanol.
Sometime in late-March, early-April, I called Thoma Kikis, my business partner. I said, ‘I got something.’ He said, ‘Well, what do you have?’ I said, ‘Well, I have a disease indication I want to go after. I want to go to the National Institutes of Health and ask them for an exclusive license of this technology, so I could apply it directly to this disease.’ He goes, ‘What is it?’ I said, ‘Hepatic encephalopathy.’ Guy just sits there on the phone, doesn't say a word. I said, ‘You can't say the word? You can't compose these tongue-tying, tongue-twisting. Say it.' I said, 'say it. Come on, say it.’ And he says, ‘My father has the disease.’
I knew we were on the right path. I had no idea his father had the disease. So now it really had meaning for me...a lot of meaning. This is a must. I have to do this. So we pressed and went with an application to N.I.H. It took two years to get it. There were death threats from idiots, psychopaths, stoners, activists: ‘You're the government. You're the big bad wolf. Blah blah blah. You should die and I'm gonna kill you. And you'll never get the patent. We're gonna destroy you.’ It's a sad indictment of the state of affairs in this country because here I am trying to build a bridge to what they've been fighting for, and the first person they want to kill is the profiteer.
This is the specific cannabinoid compound that KannaLife's patent shows to be particularly useful as a neuroprotectant.
We were interested in Alzheimer's, but I told my partner and advisors that it would be too difficult of a first target...We knew that right behind Alzheimer's was C.T.E. We knew this a while ago. But the thing that you can't do, when you're looking and pining for an exclusive license, is begin by telling the bureaucrats that you want to do everything. First of all, they're not going to believe you. Second of all, they're going to think you're an idiot. So we had to stick to H.E., which I thought was a much better first position for us to take on neuroprotection. You have an actual, physical toxic insult that you can use to monitor the effect of the drug immediately.
When you're dealing with proteins as they're unfolding, it's a different ballgame. It’s live body activity vs. something that is a traumatic injury that just sits there. If you want to protect the brain from that trauma that already exists, that's H.E. If you want to protect the brain from the trauma that's about to happen, that's C.T.E. The trauma, in actuality, is the concussive injury, but the real damage comes later on when you have decomposition of tau protein in the brain.
[quote position="full" is_quote="true"]We wanted to prove neuroprotection. We did that.[/quote]
It could be gradual. You look at Ronnie Lott. He can't be on T.V. anymore. He's a great color analyst. I enjoyed listening to him. Where the hell did he go? Sure enough, he can't compose his thoughts. And of course, you can't have a guy like that on camera, even if he's a Hall of Famer. He's lost the ability to produce, to be an earner, even after his football career, because of the damage. It's an image that comes up on you. We decided last year that once we felt comfortable where we were on the clinical research side of H.E., an encephalopathy-related disorder, we said, ‘Let's turn our attention now. Let's go after C.T.E.’
I've wanted to do that for a long time, ever since the report that Chris Benoit, the professional wrestler, killed himself and his family. You look at that and you say, ‘What the hell?’ There's no occult going on in his house. There's nothing of the occult. This is just a guy who used to divebomb other athletes off the top of a turnbuckle and headbutt their chests and their heads. There's contact. There's nothing to protect it. And over time something happened to this kid, and he just...
Football players shoot themselves in the heart these days because they want their brains to be preserved for science, so science can find out what the hell's going on. 'Why am I feeling suicidal? Why do I want to kill myself? And why did this happen?' We were sensitive to this, but we didn't want to frontload the N.I.H. and say, ‘We want this, we want that,’ like a kid in the candy store. We could've gone after C.T.E. originally, but that's a much tougher nut to control in terms of clinical and pre-clinical research. We wanted to prove neuroprotection. We did that.
I'll tell you, theoretically, what I believe it is: You have a group of scientists that are working in quasi-governmental fashion. It's intramural. You have universities and government guys. And they came up with this idea. They say, 'we think this theoretically works and we want to patent it.' So they file for patent protection in '99. It takes a couple years to get patents issued, especially those that may have some detail in terms of number of claims and structures, and the complexity of the patent and such. Finally it gets issued.
Think about when it gets issued, in 2003. I know what planet I was on in 2003. I was on burn-the-witch-mother-fucker planet. That's the planet I was on. So the burn-the-witch-mother-fucker planet says, ‘Fuck stem cell therapy. Fuck cannabis hard. Burn the plants. We're not letting this one out of the cage.’ I think what happens in this process is that the government owns that technology by default because its an intramural research program. So at that time, when you had the administration in the White House that you had, what investment bank in their right mind would finance anybody in the cannabis industry? It's not even possible. So you can't even match investment to idea. Even if you have the greatest idea in the world, it's in violation of the Controlled Substances Act. So what happens? No money goes into it and you don't get any research.
Wasn't Thomas Jefferson a slave owner? I think he was. You know what I think it is? I think it's the old timey, old-boy bullshit network. Do as a say, not as I do. And you know what, I applaud that Irsay got that 16 game suspension because finally the league has to hop out of its position of hypocrisy. Its like any other big self-regulating organization where the enterprise, the league, is controlled by the big players, by the big teams. You have the commissioner and you have a league whose policies are not there for the players, but to protect the investment behind the players.
So you have these old boy hicks who own football teams like legacy slave owners and plantations. They're going to say, ‘Not on my farm.’ Why? Why can't a player smoke marijuana? Josh Gordon is going to get a full season suspension? What did he do? He was the leading receiver last year for a marginal team without a quarterback. You have to be a psychopath, as a team owner, to put this guy's contract in jeopardy and his career in jeopardy. He has to go a full year without playing, can't practice with the team, nothing. And for what? For marijuana? Marijuana? Are you kidding me?
[quote position="full" is_quote="true"]They want these ballplayers to perform. They put them back out there with painkillers, put them back out there with all sorts of really nasty opiate derivatives. That's not pushing drugs?[/quote]
I think there are options on the T.H.C. side for pain. You can certainly take a percocet or a percodan or a suite of products. Marvin Washington will tell you just exactly how it goes. You have a guy with a pushcart and a pharmacy going around the locker room: ‘What do you want, what do you want, what do you need?’ But you know what's not on that pushcart? Marijuana.
But what's really ironic and what's really upsetting to me about the hypocrisy of the N.F.L. is that they refuse to talk to us about a dynamic that I put forth, which is that you have to treat the chemicals separately. You can't treat smoking marijuana the way you treat the component of marijuana, C.B.D., as a neuroprotectant. You've got athletes that are putting holes in their hearts, man. Big players. These are role models. You want kids to grow up thinking, ‘Maybe I don't want to play the game?"
The league is in denial. The league is totally in denial. Restricting marijuana consumption? You can say, ‘ok, we're going to work on the therapeutic side. We're going to give you all the C.B.D. you need. Get it on your ballplayers.’ It's a prophylaxis. Keep them on it as a supplement, even after they retire, and perhaps maybe, maybe, they'll have restorative brain function through a period of time when they're not being concussed. But the league doesn't want to hear this. The league just wants to go, ‘Ahh marijuana. The devil's lettuce.’ They're stuck in that reefer madness bullshit, and controlled by plantation owners, the team owners, who don't know jack shit about anything. Yet they want these ballplayers to perform. They put them back out there with painkillers, put them back out there with all sorts of really nasty opiate derivatives. That's not pushing drugs? Come on. This thing is a fucking joke.
We want to see that whatever gets developed, whether we do it or whether we certify somebody else's product, that it's meeting the needs of the patient and the doctor. It's not some hocus pocus. KannaLife should be a leader in regulatory guidance, should be a leader in the production of a target drug candidate to meet these two diseases in which it's going to be heavily involved, and doing it in a manner that meets the expectations of a marketplace that's filled with coalitions that want to see a product perfected. They don't want ad hoc. They don't want snake oil. They want to understand what this product or products are going to do, and why they are going to do it.
Oliver Miller, my friend's son, has knockout epilepsy. Any cannabis-based drug for Oliver might have to be customized, and he has to be monitored and blood-worked because, at any given time, his body chemistry could be such that his body won't be adaptive to the product. And then what do you do? Updose? Downdose? Take a few days off? Nobody understands administration.
Cannabis is cumulative. It is oily substrates. We don't know where the clinical range is going to be for people who have different chemical responses in their own body, or how adaptive they're going to be to a substrate like T.H.C.
I see KannaLife as being a very important participant in the industry to help bring some logic to administration and treatment. Connecting doctors and patients with producers, and bringing forth knowledge in a database that doctors can rely on, so they can look at dosing. It's going to take a couple years. We could have the database ready tomorrow, but you know what's not going to be ready? The throughput, the patients. The doctors are afraid.
They don't practice eastern medicine in the United States. It's practically never happened since the age of antibiotics and penicillin. So you have generation after generation after generation of medical schools doing the same thing, and medical boards doing the same thing. These guys, unless they’re an osteopathic or a naturopathic doctor, know nothing about eastern philosophical medicines, to which cannabis belongs. Traditional health care models include herbal medicines. Cannabis is an herbal medicine. Doctors here don't understand it. It's easier for them to write a script on a synthetic analog.
They're spoon-fed by pharmaceutical companies that say, ‘Just take this. It's great.’ And what are the side effects? Well there are side effects because synthetic medicine does have them. Overconsumption, accumulation, heart conditions and stuff like that, nausea, diarrhea or whatever. But this is what doctors are used to, very potent drugs. And there's nothing wrong with pharmaceutical drugs. There's nothing wrong with it. It's part of proxy medicine. Everything comes from nature. You isolate your single molecule drug, you synthesize it, and now you have a nice profit margin for the shelves of your company. Doctors feel comfortable prescribing it.
If you treat cannabis the same way, guess what? They'll feel comfortable prescribing it. But you have to give them a body of knowledge, so that they have the option to do that. They don't have an option right now. There's nothing out there that tells them, what do I use for this? It's just a bunch of kids in a dispensary sticking their greasy little nubs in a jar...already breaching anything in the form of a pharmaceutical control. When you go to a pharmacy, and there's a compounding pharmacist behind the counter making a new medicine, he's doing it with gloves. He's not sticking his grubby little paws into medicine and contaminating it.
The way they're treating the medical cannabis industry in the marketplace around the United States is a fucking farce. We want to educate people. Treat it like a drug and doctors are going to prescribe it. Treat it like it’s your cocktail at your local bar, and doctors won't have it. They'll stay away from it, and it's going to make it a lot more difficult for Oliver Miller to get his medicine. That's what I want KannaLife to do, speed the process up.
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