FDA Approval of Cannabis is a Red Herring (by Wayne Reiss)

The following is a guest post from longtime Stasher Wayne Reiss of Brooklyn, NY…

There is no legal, medical or ethical reason for cannabis to pass FDA approval. Like cannabis, pharmaceutical drugs such as morphine, penicillin, aspirin and several others never passed FDA approval and became part of the medical pharmacopeia based on anecdotal evidence alone. For these reasons, most politicians and some physicians argue that cannabis cannot be considered medicine (despite hundreds of peer reviewed research to the contrary) until it passes FDA approval yet they make no such claims regarding any pharmaceutical medications which meet the identical criteria. Moreover, aspirin which can cause bleeding of the stomach lining and accounts for hundreds of deaths per year would never pass FDA approval today, and none claims it should. Nor do these detractors make similar claims regarding any of the hundreds of other homeopathic medicinal herbs which physicians are free to recommend and are available at most pharmacies.

Cannabis was used medicinally in China and India for thousands of years. No medicine survives that long if it is not effective. Prior to cannabis prohibition, it was prescribed by American physicians for 100 years, it was used in 50% of all medications, and was sold by pharmaceutical companies such as Bristol Myers Squib, Merck, Parke-Davis, Eli Lilly, and Smith Bros. Before its prohibition, neither doctors nor pharmaceutical companies complained that dosage was impossible to control, nor did they argue that only chemicals, not herbs, are medicine. It was prohibited despite the objections of the AMA. During the first three years of cannabis prohibition Harry Anslinger, head of the Federal Bureau of Narcotics (FBN), prosecuted more than 3,000 AMA physicians for prescribing cannabis. The AMA relented, and in the next decade, Anslinger only prosecuted three physicians. In response to this attack on physicians, medicine and science, in 1944 Mayor LaGuardia commissioned a panel of medical experts which concluded that none of Anslinger’s concerns regarding the harms of cannabis was justified, but despite science and reason the FBN prevailed. Marijuana would be legal medicine today (without FDA approval) if it were not for this irrational war on cannabis users.

Who will fund FDA approval?

Double blind control studies necessary for FDA approval cost approximately $200 million, sometimes more. Who will pay this tab? The US government? The head of the Office of National Drug Control Policy (ONDCP), Drug Czar Gil Kerlikowske, is mandated by law to oppose all efforts to legalize marijuana for any reason. The National Institute of Drug Addiction (NIDA), the sole source of government funding for cannabis research, largely because of the ONDCP mandate, denies funding any research into the medical utility of cannabis and only grants funding for research that studies the harms of cannabis. Although 70-80% of the public has supported medical marijuana for the last 20 years and according to the latest Gallup poll 50% supports recreational legalization, only one senator and less than 1% of congress support legalizing cannabis even for medical reasons. The DEA is the sole provider of legal cannabis in the U.S. They have consistently denied providing cannabis or license to grow it for research into its medical efficacy. Without this cannabis FDA approval is impossible.

The federal government actively lobbies to maintain cannabis prohibition, denies it has any medical utility, and is the primary obstacle preventing cannabis research and FDA approval.

Neither will the pharmaceutical industry fund cannabis FDA approval. Pharmaceutical companies recoup the enormous cost of FDA approval by patenting medicines and then selling them exclusively once approved, but plants cannot be patented. In addition, pharmaceutical companies benefit by keeping cannabis, a powerful competitor, illegal because it is cheap (when not prohibited) and it successfully treats many diseases and symptoms, such as glaucoma, neuropathic pain, depression, anxiety, insomnia, nausea, gastrointestinal distress, lack of appetite (aids wasting syndrome), spasticity (epilepsy, multiple sclerosis, etc.), migraine, menstrual cramps, asthma and many others. Pharmaceutical companies have many economic incentives to maintain cannabis prohibition and have no incentive to fund its FDA approval.

The legal cannabis industry also cannot fund FDA approval. Although its existence depends upon the legalization of cannabis, the legal cannabis industry is cash strapped and only provides 2% of the funding for legalization efforts. (Wealthy philanthropists supply 98% of this funding.) To the extent that some in the quasi legal cannabis industry profit from prohibition, they too oppose FDA approval.

In theory, states could provide the revenue for cannabis FDA approval, but in today’s political and economic climate, this is unrealistic. California, the only state to ever fund cannabis research, spent $9 million over three years (far from the $200 million needed for FDA approval) to fund the Center for Medical Cannabis Research. This funding has been exhausted and was not replenished. No other state has ever provided funding for cannabis research.

The claim that cannabis must pass FDA approval, unlike many lethal pharmaceutical drugs and hundreds of other medicinal herbs, is based on political agenda, not science. Most who make this disingenuous claim are aware that there is no entity capable of funding or willing to fund this effort. Cannabis would still be legal medicine as it has been for thousands of years if it were not for prohibition which has confounded science for the last 75 years and still continues to do so.