There are now 37 states with medical cannabis programs on the books. After 2022’s midterm elections, 21 of the states have given the green light to recreational use. As a freelance writer who has spent more than a decade researching all sorts of medical issues, I cannot help but wonder if all this changes the value of clinical trials for FDA approval.
As you probably know, marijuana remains a Schedule I controlled substance under federal law. It cannot legally be prescribed in the same way opioid painkillers are. Instead, doctors can only recommend its use in states where lawmakers have chosen to implement medical cannabis programs. In states where recreational use is allowed, one doesn’t even need a doctor’s recommendation.
What does this have to do with clinical trials? Everything. There are no clinical trials that prove marijuana’s efficacy for anything other than a small number of seizure disorders. Likewise, the only clinical trials conclusively demonstrating the efficacy of stem cell therapy relate to leukemia. Here is the problem: medical cannabis is celebrated as the best thing since sliced bread while stem cell therapy continues to be trashed as quackery.
The FDA Requires Clinical Trials
With the possible exception of COVID vaccinations, the FDA requires a battery of clinical trials before approving new pharmaceuticals and medical devices. You need to provide the agency with tons of data proving safety and efficacy, data that can take up to a decade to produce.
We can debate all day whether FDA requirements are good and necessary. But when the debate finally ends, it demands consistency. Either clinical trials are an ironclad requirement, or they aren’t.
Taking Contradictory Positions
It seems that we are taking contradictory positions when it comes to both medical cannabis and stem cell therapy. In fact, let us also include platelet-rich plasma (PRP) therapy. It’s in the same class of regenerative medicine procedures as its stem cell counterpart.
Just a few short years ago, nearly everyone in the medical and journalism communities with a voice was condemning both stem cell and PRP therapies. The therapies were discounted as medical quackery for the simple fact that there was no clinical proof of their efficacy. Today, this is still the mainstream opinion.
When it comes to medical cannabis though, we have even less clinical data. At least regenerative medicine has been studied at length over the last decade or so. Cannabis hasn’t. Yet we don’t apply the same clinical study requirement on medical cannabis. States approve it based on voter referendums, which themselves are based only on personal preference.
Anecdotal Evidence Is Worthwhile
Most of the evidence in support of medical cannabis is anecdotal evidence. Do not misunderstand, such evidence is worthwhile. The thousands of patients Utahmarijuana.org says rely on medical cannabis for medical canabis for chronic pain treatment in Utah have stories to tell. Their stories of pain relief offer evidence that medical cannabis does work for them.
The question being proposed is why regenerative medicine therapies are afforded the same benefit of the doubt in relation to anecdotal evidence. How many pro athletes need to give PRP therapy credit for getting them back into competition before they are taken seriously? How many osteoarthritis patients need to explain the pain relief they experience from stem cell injections before people start to believe them?
If clinical trials are so important to approving regenerative medicine therapies, they ought to be equally important to legalizing medical cannabis. If we are not going to require them for medical cannabis, we should not require them for regenerative medicine either. They either matter or they don’t.