FDA OKs Cannabis-Based Ovarian Cancer Treatment

Ovarian Drug

If a rogue foreign terrorist group slaughtered 14,270 American women on television every year, would we be paying attention?  Hello everybody, meet ovarian cancer.

Ovarian cancer is the fifth leading cause of cancer death among American women. In 2014, it killed more than 14,000 women. Given the rate of diagnosis, there are more women in the pipeline for next year and the next and the one after that. If you are not fighting this disease, you probably know someone who is.

That’s yesterday’s news. Today’s news is that the Federal Drug Administration is willing to support continued research into a treatment option that is based on Dronabinol, a cannabinoid, which is one of the many non-THC derivatives of the cannabis plant. The prospects for the future include not only better treatment options for those diagnosed with ovarian cancer, but more research into the largely untouched medical potential of cannabis.

 

Ovarian Cancer

It is a hard disease to detect and treat. The symptoms of the early stages, when it is most curable, are subtle and many women dismiss them. It is resistant to current treatments, particularly after the first drug round. Much depends on the stage at which this kind of cancer is diagnosed, but the overall five-year survival rate is less than half.

So, message number one for all you ladies out there, especially if you are white and over 60, is to get yourselves into the doctor’s office for a checkup.

 

Treatment Options and Issues

When the diagnosis is ovarian cancer, doctors often recommend aggressive measures, including two or more different types of treatments. The options include surgery, chemotherapy, hormone therapy, targeted therapy and radiation therapy. Each can have life-threatening complications.

Insys Therapeutic Inc.’s Liposomal Encapsulated Paclitaxel, a drug which contains Dronabinol, may soon be part of the package of options. In drug trials it has reportedly been effective in the treatment of the nausea and vomiting associated with cancer chemotherapy as well as anorexia associated with weight loss in patients with AIDS.

 

What’s New?

Cannabis as medicine is not new; the recognition that it may be helpful in treating nausea is not new, but the investment incentives that come with FDA greenlighting are new. LEP’s special status under The Orphan Drug Act, qualifies Insys for various development incentives, including tax credits for qualified clinical testing and a seven-year period of U.S. marketing exclusivity upon approval. These incentives may support LEP’s development.

 

Broader Implications

Additional treatment options for patients undergoing chemotherapy or who are otherwise fighting weight loss are important. Development incentives for drug companies should expand those options. That is good for drug companies.

The larger investment picture, however, involves the recognition that cannabis and cannabis derivatives may have acceptable medical uses that are inconsistent with its classification as a Schedule I drug. Every recognized medical use helps to build a stronger case for descheduling. Were cannabis removed from the Controlled Substance Act’s schedules, research into other medical uses would be easier to fund. Investors would be more willing to support research. The virtuous circle of growth and investment could begin to function.

Anne Wallace is a New York lawyer who writes extensively on legal and business issues. She also teaches law and business writing at the college and professional level. Anne graduated from Fordham Law School and Wellesley College.

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