This Is a Big Win for Marijuana and Researchers

Over the past decade, the legal wins enjoyed by marijuana and its supporters have far outnumbered the losses.

Despite Florida failing to become the 24th state to legalize medical marijuana in last year’s election (by a mere two percentage points), we’ve still seen a rapid rise in the number of new states willing to give medical marijuana a try in recent years, and four states (plus Washington D.C.) experimenting with the legalization of marijuana for recreational purposes.

Recent studies have also suggested that marijuana could hold a number of clinical benefits. Various studies have shown marijuana’s ability to possibly heighten the cancer-killing effects of radiation on aggressive forms of brain cancer; to remove or lower beta-amyloid plaque levels, the material that sticks to our brains and causes Alzheimer’s disease; and to potentially even fight type 2 diabetes, a disease affecting more than an estimated 29 million people in the United States.

However, researching the possible benefits of marijuana isn’t easy. Researchers and drug developers have struggled to utilize marijuana or cannabinoids derived from the cannabis plant due to the daunting red tape put in place to better control the currently schedule 1, or illicit, drug.

Last week, though, the current administration took its scissors and began cutting through 16 years’ worth of red tape.


This is a big win for marijuana and researchers
In 1999 it became a requirement for marijuana researchers to undergo a separate Public Health Service review prior to commencing research into the benefits of marijuana for any indication. The PHS would help determine research quality, the dosage amount that would be equivalent to a certain amount of smoked marijuana, and the guidelines to ensure all trials would be well-controlled clinical studies.

That sounded great on the surface when only around a quarter of the American public favored the legalization of marijuana and few, if any, studies demonstrated that marijuana had any medical benefit. But 16 years later things have changed, and the process required to begin research using marijuana or any cannabinoid-based compound is too long, arduous, and costly — and the Department of Health and Human Services realizes this.

In consultation with the Food and Drug Administration, National Institutes of Health, and the Office of the Assistant Secretary for Health, the HHS announced the removal of the PHS review process, noting that it closely overlapped with the investigational new drug application process that the FDA currently follows.

The FDA’s IND process focuses on “adherence to good clinical and laboratory practices,” and examines dosages, safety, and efficacy, and ensures that trials are well-controlled. In other words, while not identical, the FDA’s IND process and the PHS review support the same goals: helping humans get therapies that could be beneficial to treating their diseases or disorders.


How will removing the PHS review really affect drug developers and consumers?
The first benefit researchers will see is a decrease in development time and cost. The review process itself and the hurdles that researchers were required to jump through sometimes took years. GW Pharmaceuticals (NASDAQ:GWPH) and Insys Therapeutics (NASDAQ:INSY), the two most reputable drug developers currently working on cannabinoid-based drugs, were required to practically jump through hoops to initiate research on drugs containing THC or CBD. Removing the separate PHS review process should shave off the time it takes to get approval from the FDA to run human clinical trials, saving money for these drug developers and possibly bringing life-changing medicines to pharmacy shelves much quicker.

On a broader scale, removing some of the red tape surrounding marijuana and cannabinoid-based research should allow Congress and the president to reach a quicker conclusion as to whether marijuana might merit nationwide approval on a medical basis, or perhaps a rescheduling and/or decriminalization. We have decades’ worth of data regarding the negative aspects of marijuana, but we’ve been lacking mature positive data to support the position of marijuana proponents. The HHS’ actions should help facilitate a quicker solution.

How the HHS’ ruling affects you
For consumers and investors, the HHS’ new stance isn’t going to change much.

As noted above, GW Pharmaceuticals and Insys Therapeutics, along with other cannabinoid and marijuana researchers, will be able to avoid some of the lengthy process involved with getting approval from the FDA to conduct clinical research. Since time is money, we could be looking at lower expenses for these companies.

However, we still don’t have any definitive answer as to whether marijuana or cannabinoids are solutions to some of the world’s most serious diseases. GW Pharmaceuticals’ Sativex, for instance, failed to meet its primary endpoint in the first of three late-stage trials in the U.S. for cancer pain. It’s true that this is just one trial of dozens currently being conducted on marijuana-based compounds, but it’s a good reminder that marijuana isn’t a guarantee to succeed.

Additionally, we have to keep in the back of our minds that a rescheduling of marijuana, which would be the ultimate goal of drug developers and researchers, is likely still years away (if it ever happens at all). Lawmakers still need long-term data before they’ll even consider changing the existing laws directed at marijuana.

Long story short, cannabinoid-based drug developers are in better shape than they were a week ago, but marijuana as a whole still looks like a very risky investment that would be best off avoided for the time being.

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