PODCAST: Stephen Goldner, the Father of Methadone, has a new Cannibinoid-derived Addicition Treatment

Stephen Goldner is the co-inventor of the liquid formulation of methadone, the only real option in the treatment of opioid addictions currently in wide use. Dr. Goldner has created a new line of medical products based on cannabinoids, which are going to be available under the brand name “Pure Green”. He joins us today to discuss his illustrious career and what drove him to cannabis.

James West:    Stephen, thank you for joining us today.

Stephen Goldner:     Thanks so much. I really appreciate the opportunity, James.

James West:    Stephen, you have had what is best categorized as an utterly fantastic, interesting, diverse career across sectors that intersect and also don’t intersect. In this conversation, I’m interested in learning about the trajectory that has taken you to the point of our meeting, and we’ll get into that a little later. Let’s start off with, what is it you actually do? And, how did you come to be doing that?

Stephen Goldner:     Well, that’s a great question, and there certainly has been a trajectory to it, so I’ll just try to hit the highlights out of this 45 years of professional work or so, starting as a forensic toxicologist and running through 18,000 autopsies as a New York Medical Examiner. I developed the techniques, the methods to detect recreational drugs of abuse, like LSD, marijuana, cocaine. It’s important to do in forensic toxicology.

James West:    I didn’t know those were recreational, I thought those were cultural!

Stephen Goldner:     Good for you. Well, they’re not necessarily medicinal. So there are people who take some of those just for the pure recreation, I suppose.

So that started my first testing laboratory on Long Island, and that created an industry called drug testing, or urine screening for employment, much to my surprise. And the next year I formulated a liquid drug that people could drink and use to get off of heroin, and it’s called methadone.

James West:    Wait a sec. You’re the one who created methadone?

Stephen Goldner:     Well, somebody has to do it all the time, you know? There were other drug companies that had done it, but I made a product that was truly consumer-friendly; the consumers were heroin addicts, but they really liked the taste and the format of it, and it was much more controllable, much more usable by the customer and by the patient. And I thought that was really helpful to them. I sold those two off to a large drug company, and while working there, went to law school, and I became an FDA attorney working in the pharmaceutical industry.

So if I tell people I’ve combined science and law for 45 years, and it’s worked out – I have a consulting company with a good number of employees, and over the last 20 years, we’ve gotten nearly 300 health care products approved by FDA, HPP and in 40 other countries around the world – that started 200 companies and it employs over 10,000 people.

So that’s what I did up until the time that cannabis came around and started to become popular. So now my interests have switched to how can I really help people using these pure compounds that we can extract from the cannabis plant for pain relief, or to get off of opioids, or help them go to sleep. So that’s what I’m working on now.

James West:    I see. So, the migration to the cannabis sector is as a result of hanging out with dead people, heroin addicts and federal regulators?

Stephen Goldner:     Yes, yes. And some of them were more fun than others to work with…

James West:    The dead people at the top of that list, I’m assuming.

Stephen Goldner:     Yes, yes, right. Well, they never complained about the work that we did; everyone else had a different way of thinking about it.

James West:    Okay. Well, interesting. So now you’re going to take your lifetime of experience in creating drugs that help people, and you’re going to derive them from cannabinoids. What is it in the cannabinoid pharmacopeia, if we can use that term at this point, that is so applicable for, for example, with getting people off of heroin addiction?

Stephen Goldner:     That’s a great question, it truly is. You know, I was 23 years old when I formulated my methadone, and I’ve learned to do much better out of that. Now we see that there really are molecules, THC, CBD and others, that are true active ingredients in the cannabis plant that we can use for pain relief, and they’re non-toxic, and after all, that’s really what opioids are for people; they’re really pain relief, in one way or another.

So if you can provide pain relief to people, without something toxic and without something addictive, now you’ve got a good deal. Now you can really help people. Plus, cannabis is really cost-effective. It’s a weed that grows by the side of the road, so it’s not that expensive, especially compared to all of these other drugs that are so bad for the body.

James West:    Sure. Now, does this kind of stuff, the products that you’re working on now, derived from cannabinoids: are they going to require FDA approval to be used by the general population?

Stephen Goldner:     Well, that’s also – you’re a great interviewer, great questions!

James West:    Why thank you!

Stephen Goldner:     Well, in the United States, no, they don’t require FDA approval because of the way the State regs have been set up in combination with federal policy. So as long as we set up a factory within some particular state in America, then we can produce the product, ship the product and have it consumed within that state. So I don’t have to go through the exercise that I’ve done with so many other drugs, investing $80 million, $90 million, $100 million or more and seven or eight years to get FDA approval.

Plus, frankly, cannabis has been used in one form or another for hundreds, for thousands of years by millions of people. So FDA would look at this as sort of an over-the-counter drug, like sunscreen or medicated baby powder. It’s so safe, people actually know how to use it. So we’re not going to go down the route of waiting years more to prove something to FDA’s satisfaction. We need to help people now.

James West:    Okay, so then, people will be able to access your products when they’re ready for market. When is that going to be?

Stephen Goldner:     Well, we hope to launch in our first state in first quarter of 2018, and then do a state by state rollout throughout the United States, three to four states a year, for the next number of years. As quickly as we can open factories and ship. We’ve already spent two years doing a great deal of research and development sort of in stealth mode, and now that we’ve done that, and we’ve done clinical testing, and we’ve creating our manufacturing records and tested them all, we’re ready to launch properly.

James West:    Okay. And you’re not exactly an unknown quantity in the universe of new pharmacological products, as evidenced by your creation of liquid methadone. Now, I want to know: you’ve got some association with the United Nations in the capacity of a representative of the United States, and with the World Bank?

Stephen Goldner:     Well, certainly with the United Nations. Back in 2016, second quarter of that year, there was a major meeting for a week long at the United Nations called UNGA, which is the event to change the war on drugs policy. So I went as USA representative from the ISO group, and had a chance to interact with hundreds of delegates for the United Nations, all of whom were so eager to see that there might be a change in this 50-year-old policy.

James West:    When was that meeting?

Stephen Goldner:     That was May of 2016.

James West:    Right. That was the event at which the Minister of Health announced Canada’s intention to legalize cannabis for recreational purposes, if I’m not mistaken.

Stephen Goldner:     That’s exactly right. Good fellow, very, very sincere. We had a chance to talk, and he invited us nicely to come set up a factory in Canada, and we are looking forward to finding good collaborators in Canada to set up our first, outside the US operation.

James West:    Interesting. That’s fascinating. Stephen, we’ve run out of time, and I just want our listeners to know that this is the first in a series of interviews with Dr. Stephen Goldner, who has so many touchpoints in the cannabis industry and its emergence that we could fill hours of podcasts. But for this episode, there’s your introduction to Stephen Goldner. Mr. Goldner, thank you so much for joining us today. We’re going to come back to you sooner rather than later and look forward to carrying on this conversation.

Stephen Goldner:     Thanks so much for the opportunity. Look forward to speaking with you again anytime. Take care.