I had the pleasure of attending the Cannabis World Congress and Business Expo (#CWCBExpo) at the Jacob Javits Convention Center in New York City from June 14th-17th recently and learned a great deal about all aspects of the growing legal Cannabis industry.
The cannabis industry is taking shape at the state level, and at the time of the conference, 25 states plus the District of Columbia had legalized cannabis for recreational or medicinal use – many for both. This amounts to just over half of the country. Half is likely past a tipping point allowing us to now say that marijuana will be legal throughout the United States in the near future. In fact, Libertarian party candidate for President Gary Johnson suggested that current President Obama may legalize marijuana before leaving office in January 2017.
Such an action by the President may be advisable as state-by-state legalization provides both a benefit and a problem to the cause of medicinal cannabis.
The Up Side
Those who believe the FDA drug approval process is ripe for improvement should be cheering medical marijuana legalization by state capitals. Perhaps without intending to, a precedent is being set for a medicinal drug approval pathway – that skips the FDA!
If medicinal cannabis proves of value to patients then what better validation can there be to all the voices saying the FDA process is too long, too onerous, too costly, etc., etc. For efforts to streamline the FDA, this nationwide movement must be a tremendous benefit.
The Down Side
On the other hand, a state-by-state process creates its own unique problem for the advancement of US healthcare – one the FDA specifically resolves.
If a company goes through the FDA process and wins approval to market their drug – they can do so throughout the United States.
Cannabis growers, cultivators, and processors, however, may only operate within the state where they are licensed. The drugs and products they produce can only be marketed within that state and cannot currently be taken across state borders – even to other states where medical marijuana is legalized, and even to other states where that grower is licensed.
It’s simply unlikely for any organization to gain a license in all 50 states. This means that residents of different states will have different medical treatment options available to them. In the worst case, this may adversely impact any kind of consistent population health across the country.
Now, some will say that the true medical value of cannabis for any condition is not factually established through rigorous double blind, or “gold standard” human subject clinical trials. Frankly, there is some truth to this.
Are any medical cannabis growers/processors working towards producing consistent, reliable, medical-grade drug(s) whose efficacy in the treatment of a medical condition are validated through human subject clinical trials? This remains to be seen.
For instance, medical cannabis is most often recommended for the treatment of chronic arthritic pain. Current treatment for chronic arthritic pain includes opioids – which are both expensive and contribute to America’s current opioid epidemic. Humira, the #1 selling arthritis drug had sales of $11.8 Billion in 2014.
Should any cannabis grower produce a strain of cannabis that, through trials, is indicated for the treatment of arthritic pain – they will have created a treatment for arthritis sufferers in their state which will likely cost less than Humira, and for which the rest of the country can quite fairly ask, “Why isn’t this treatment available to us?”
In that case, would 49 Secretaries of Health and 49 state Governors deny their residents and constituents a viable, recognized medical treatment? Doing so would be against one of the principles of the American system – that access to resources, especially critical resource such as healthcare, be equally available throughout the country.
Solve the Problem?
This isn’t to suggest we go back to the FDA as a sole clearinghouse, but that states consider expanding the list of who may supply medicinal grade cannabis within their state. To better understand the problem, we need to recognize that the state-by-state licensing requirement enables each state to both make revenue from establishing a legalized marijuana industry as well as control or at least manage industry growth. After all, marijuana remains illegal on the federal level and is a Schedule 1 controlling substance.
By allowing growers in other states to simply enter their market, states may feel they cannot profit from or manage the industry’s growth. This may make sense for recreational cannabis, however, when we are talking about medicinal grade products designed to ease suffering, improve health, and taken under a physician’s supervision, one should err on the side of access.
So is there a way to ensure the medicinal cannabis from out-of-state licensed growers and producer are available to in-state patients in a way that protects each state’s ability to profit from this new industry?
Perhaps states should make licenses available, for a fee, to out-of-state licensed medicinal cannabis growers and processors if they can present valid evidence of the medical and therapeutic value of their products.