Hard Science, Not Hype, Will Drive Medical Cannabis in the 21st Century

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Medical cannabis is defining healthcare in the 21st century. Up to this point, the legalization of medical cannabis has spread rapidly to 33 states and Washington, D.C. Medical cannabis is prescribed to treat all sorts of conditions, from chronic pain and post-traumatic stress disorder to anxiety and epileptic seizures.

We have a lot to gain from medical cannabis, and millions of patients are already benefitting. What’s missing, though, is the hard science behind it: we need more clinical trials proving that cannabis is beneficial in treating patients for the wide range of indications for which they’re being prescribed.

Clinical trials, and subsequent approval by the U.S. Food and Drug Administration (FDA), is the next step in developing 21st century medical cannabis, or “second generation” medical cannabis. In fact, it’s the next evolution in the healthcare industry at large.

CBD is a great example of how medical cannabis needs to catch up with 21st century healthcare through hard science. Successful clinical trials with CBD will lead to better regulation and better treatment of patients.

In society today, CBD is everywhere. You’ve seen it in doctor’s offices if you’re in Florida, or bodegas if you’re in New York, or in shopping mall pop-up stores if you’re anywhere else. It’s even for sale in gas stations in some places. CBD is in pills, bottled water, face cream, massage oil and a whole host of other cosmeceuticals. In the Wild West of CBD retail, it’s being pitched as a natural miracle drug for 21st century healthcare.

But what is CBD, really? That’s a great question. The answer can be elusive since the product is unregulated and was only just recently legalized with the passage of the Farm Bill in 2018.

To put it simply, CBD is a molecular compound: a cannabinoid from the cannabis plant. It does not get you high, like its famous cousin THC, which is also from the cannabis plant. CBD has clear medicinal value. Epidiolex, a drug from GW Pharmaceuticals that’s derived from CBD, was recently approved by the FDA to reduce epileptic seizures.

People are using CBD for many different indications, based largely on anecdotal hype, rather than hard science. But that is changing, as CBD’s medical benefits are well-documented in mice, where studies have shown anti-inflammatory effects. We know, empirically, that CBD can also benefit humans, based on the clinical trials conducted by GW Pharmaceuticals.

The bottom line is that we need more clinical trials to prove its efficacy in humans, and federal law is largely to blame for the slow progress of medical cannabis science in the U.S.

How do you conduct serious research on a substance that’s illegal?
CBD has a unique backstory. The compound was first discovered and isolated by Raphael Mechoulam of Hebrew University in Jerusalem in the 1960s. He patented CBD in the U.S. in the 1990s, even though the compound was illegal (you’re still allowed to patent things that are illegal).

This resulted in an extraordinary situation, where a potential therapeutic was patented but didn’t result in any investment due to the federal prohibition on this non-psychotropic compound and the plant it comes from. Consequently, the 20-year patent expired, and CBD is now in the public domain.

Without a patent, there isn’t much financial incentive to pay for expensive clinical trials, so it’s harder to pinpoint the medical benefits of CBD. What we’re going to do at Katexco is combine CBD with other compounds that are patented to prove whether that new CBD compound has any medical benefit.

It will take at least eight years (assuming the trials are successful) to develop a new CBD compound therapy for the FDA’s review. In the meantime, we’re going to add CBD to an existing therapy that we already know is beneficial, and which is already protected by patent.
One of Katexco’s directors, Prof. Sir Marc Feldmann of Oxford University, is the inventor of Humira, an anti-TNF blockbuster that’s used to treat inflammatory diseases. We believe that CBD has efficacy as an anti-inflammatory, so we’re going to combine it with Humira so see if there’s any added efficacy in treating inflammatory diseases.

If that’s borne out by clinical trials, then we should be able to gain FDA approval in a much shorter time span than it would probably take to put a new CBD compound through trials from start to finish. Getting an established, patent-protected, anti-inflammatory on the market earlier ultimately means that patients won’t have to wait so long for treatment, and it will also help to fund our other medical efforts going forward.

Of course, this won’t happen quickly enough for the millions of patients who are already suffering from inflammatory diseases. We need the FDA to get involved now in regulating the vast array of CBD products that are already on the market. At the very least, these patients with high unmet clinical needs who are spending money on CBD products should be able to know what they’re getting.

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Dr. Jonathan Rothbard
Katexco Pharmaceuticals

Dr. Jonathan Rothbard, CEO of Katexco Pharmaceuticals, is responsible for helping to establish a variety of biotech startups.

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