What the FDA Says About Marijuana Claims
When California becomes the eighth state to legalize recreational marijuana in 2018, the pressure will be high for the Food and Drug Administration to start enforcing some regulatory practices – despite its use being a federal crime. More states around the nation are expected to approve cannabis for recreational and medicinal use, which will likely transform medical claims processing for marijuana pharmacies.
Though many users and doctors who prescribe medical marijuana are concerned about the FDA’s interference, it may be good news when it comes to getting insurance to cover such treatments. Though most of these dispensaries are trustworthy, as with any industry, some bad apples are making processing these claims difficult.
What Are the False Claims Regarding Marijuana?
Most doctors and dispensaries that sell medical marijuana explain to patients that the plant can help many symptoms of diseases from glaucoma to epilepsy. However, there are a few who claim cannabis is a cure-all – some even suggesting it will cure cancer. The FDA is warning consumers about four companies who sell marijuana-derived dietary supplements, gummies, lotions, and oils – all of which claim their products cure cancer. Dr. Scott Gottlieb, the FDA’s commissioner and a cancer survivor himself, wants to make it clear that these are scams.
How the Scam Works
The active ingredient in many of these supplements in cannabidiol, a derivative of marijuana that is not approved by the FDA for any use, medicinal or otherwise. These companies sell supplements over the internet as creams, lotions, oil drops, teas, and more. Many of the websites feature “endorsements” by people who claim they themselves or their loved ones have been miraculously cured of illnesses. Gottlieb points to the obvious danger of these testimonials –when people rely on untested treatments for serious illnesses, they may not seek proven methods of treatment, treatments that could mean the difference between life and death in some cases.
These dispensaries – Green Roads of Florida, Stanley Brothers Social Enterprises, Natural Alchemist, and That’s Natural – each claim their products cure cancer, reverse Alzheimer’s disease, and stop other terminal diseases. It’s because of places like these that medical claims processing for insured marijuana users gets tricky.
The FDA dispensed warning letters to these companies, and many of the websites’ claims to cure cancer have been removed, but, without FDA regulation, it’s impossible to tell the good marijuana pharmacies from the bad. With the promise of regulatory compliance, perhaps these bloated claims will diminish.
Are There Medicinal Benefits to Marijuana?
Though cannabis has been used for medicinal purposes for millennia, possessing and using cannabis is still a violation of federal law, with the exception of research settings. A growing number of states and territories, including the District of Columbia, have approved measures that allow its medical use.
The FDA has not approved marijuana for treatment of any cancer or illness. However, cannabinoids produce a pharmacologic effect by activating certain receptions in the central nervous system and immune system. Because of this, the FDA has approved the use of commercially available cannabinoids, like nabilone and dronabinol, to treat some cancerous side effects. Long known to help ease the pain of cancer treatment, marijuana is now being studied for its effect on malignant tumors. However, there’s been no proof that marijuana changes the affects cancerous cells – only that it can ease the symptoms of cancer-sufferers.
Review of the Literature
There is a growing body of evidence that investigates the link between cannabis, cannabinoids, and possible benefits in treating cancer’s side effects. There have been several controlled clinical trials and a subsequent meta-analysis of these trials found that dronabinol and nabilone have a beneficial effect on chemotherapy-induced nausea and vomiting. The FDA approves these two cannabinoids for both the prevention and treatment for vomiting, but not any other symptom management in cancer patients.
There have also been clinical trials regarding the use of inhaled cannabis in cancer patients. Based on these studies, there is insufficient evidence to suggest that cannabis has a similar positive benefit to those suffering with chemotherapy-induced nausea and vomiting.
A common side effect of chemotherapy and cancer in general is pain. In light of the opioid crisis, practitioners are seeking alternatives to address the painful side effects of cancer and its treatment. A growing number of trials are focusing on the oromucousal (mouth mucous membranes) administration of cannabis extract. National drug regulatory agencies in some European countries and Canada approve this formulation for pain control in cancer patients. The FDA has yet to follow suit, citing a lack of robust evidence.
Can Marijuana Treatments Be Harmful?
There’s no doubt that cannabis and cannabinoids have been beneficial in controlling chemotherapy’s side effects and improving appetite in those with illnesses such as HIV. In some animal studies, cannabinoids have slowed the growth of certain types of cancer cells, but human studies have not shown any positive benefit. As suggested by Dr. Gottlieb, one of the biggest harms of extolling these claims is that it may cause a sick patient to rely on cannabis while delaying or avoiding convention medical treatments. This could have serious or even deadly consequences.
The Dangers of Unregulated Marijuana
It shouldn’t be ignored that marijuana isn’t always just cannabis. Smoking marijuana introduces other harmful substances to users, including some of the carcinogens founds in tobacco smoke. Because it’s unregulated, each plant comes with different levels of active compounds, and it might be created with other substances that can be dangerous to each user. The effects of these substances can be difficult to predict and varies from person. Aside from FDA-approved cannabinoids, there is no established safe dose.
The Future of Marijuana and Its Effect on Billing
Despite marijuana use being a federal crime, Gottlieb says it’s time for the FDA to act. With some states legalizing it for both recreational and medicinal use, some quality control standards should be instated. He emphasizes the need for intervention regarding companies that make grandiose claims that would steer people away from conventional evidence-based treatments. He also believes in broadening the scope of regulating cannabis and cannabinoids in general.
As of now, insurance companies are only accepting claims for cannabinoids dronabinol and nabilone, approved for use by the FDA. Better and more thorough regulation would mean more standardized billing processes, and insurers would likely be more willing to cover marijuana as a treatment – if it’s treating something it can help. Though states are legalizing it for medical use, many dispensaries still operate on a cash-only basis. The future of medical billing for marijuana will likely evolve, and, thankfully, medical billing software will evolve with it.
Sources:
www.marijuanamoment.net/fda-review-medical-claims-marijuana/
www.nytimes.com/2017/11/01/health/fda-marijuana-false-claims.html
www.cancer.gov/about-cancer/treatment/cam/hp/cannabis-pdq
www.cancer.org/treatment/treatments-and-side-effects/complementary-and-alternative-medicine/marijuana-and-cancer.html
www.bloomberg.com/news/articles/2017-10-03/fda-hints-it-may-look-into-medical-marijuana-health-claims
