Opioids in Chronic Pain Management – Guide for Patients
Dec 14, 2017 For Immediate Release
Contact: Dan Youra, agent
TITLE: Pot Stays Listed as Dangerous
[Following is a Letter to the Editor, written by J. Kimber Rotchford, M.D., in responce to action taken by DEA and FDA to continue classifying marijuana as "dangerous."]
As a physician and specialist in the fields of addiction and pain management, I believe that I have a unique perspective on the story, “DEA Says Marijuana Has No Medical Use; Pot Remains Listed As Dangerous,” written by Bob Hotakainen, published in The Seattle Times on August 11, 2016.
Indeed, the front page story sparked in me some new insights.
Commenting on the Drug Enforcement Administration’s (DEA) decision to deny a petition to legalize pot, DEA acting administrator, Chuck Rosenberger, is quoted in the story as saying that the DEA put enormous weight on the recommendation of the Food and Drug Administration (FDA). He states, “This decision is based on whether marijuana, as determined by the FDA, is a safe and effective medicine. And it’s not.”
Before reading this article, my opinion was quite similar to that of Chris Gregoire, Washington State’s former governor, who, with then-Gov. Lincoln Chafee of Rhode Island, filed the original petition to legalize marijuana.
Chris Gregoire is quoted in the story questioning the laws and regulations on the books, which reflect common, irrational assumptions, beliefs, and prejudices about marijuana use, which have become codified in our laws and cultural morals. While I continue to agree with former Governor Gregoire, after reading the article, I am now more likely to say that the problems related to how we regulate marijuana are reflected in how this country’s laws regulate medical care, medical products, and substances of abuse.
While science and the scientific method acknowledge that a lack of evidence is not adequate to assume there is no efficacy, the FDA regulates drug use and assumes that substances and medical devices have no medical value, until proven otherwise by using the same tools, which are used to test and allow pharmaceuticals to come on the market. However, if one were to use the same criteria on all medical interventions that the FDA uses to establish efficacy for pharmaceuticals and medical devices, there would be few, if any, surgical procedures allowed.
The vast majority of safe and effective medical interventions have no proven efficacy, when judged by FDA criteria for a medicine.
We live in a culture where, what constitutes effective medicine, requires the FDA’s blessing. This is a form of “religious” zealotry. Without FDA approval, stiff and even criminal penalties may follow if one attempts to call something a medicine or a medical device. Throughout history medicines have been defined and used without any FDA. There are many countries in the world with medical outcomes better than those of the United States that do not require a substance to be FDA approved or FDA designated as a medicine. Despite these “realities” well educated colleagues determine that a substance or a plant product is not a medicine because it has never been designated as such by the FDA!
While the United States promotes religious freedom, in the domain of medicine government enforces burdensome regulations, which determine what qualifies as effective medicine and approved devices. Government agencies and third parties, such as insurance companies, although influenced by biases and financial incentives, determine what constitutes proper medical care.
Do average Americans and even licensed physicians really have freedom with regard to the medical care they receive and provide?
Are patients really better off now than before, when medical care was provided by physicians, who were subjected to a challenging selection process, demanding education, and ethical principles?
Physicians made their therapeutic decisions based on the needs of individual patients and the context of their situation. The primary intent was to serve the patient.
Some may assume that the FDA is “objective” and has no biases. In order for acupuncture needles to obtain FDA approval in the 90’s more than sixteen lines of evidence were required and even then there was reticence on the part of the FDA to approve their use. For the typical pharmaceutical agent only three lines of evidence are generally required for approval. If the FDA were a for profit corporation, no one would doubt that it has significant biases. Consider the money and government jobs that are maintained by the FDA’s current, regulatory apparatus.
What’s more, one could say that the FDA promotes the economic power and political influence of the large pharmaceuticals through effectively limiting natural market forces. One needs to have the financial means of a large pharmaceutical company, if one is going to be able to tithe the FDA and its regulatory efforts. In addition, big Pharma is not interested in encouraging the use of cannabis for medical purposes.
Cannabis is a product that can be easily and cheaply produced and obtained. It is likely safer to use then most pharmaceuticals used for similar medical indications. I even wonder about the house of medicine’s role (what is this? “house” ?). Use of medical cannabis legally can and often does obviate the need for other medical care. Indeed, the lack of proper medical oversight and access, regarding other more effective interventions, is one of the current major risks of medical cannabis use.
After reading The Seattle Times story, I now conclude that the DEA’s findings and actions are predictable. I don’t believe it is so much about the DEA’s long term zeal of putting marijuana users behind bars or its long term role in the “War on Drugs.” Rather, its response, as admitted by its administrator, stems largely from laws and a regulatory apparatus, as embodied in the FDA, which, as in any institution, tend to maintain its current beliefs, power, and prestige.
Government agencies even have the audacity to claim the ultimate authority for determining what constitutes a “medicine,” let alone a safe and effective one. Big corporations benefit, when they have the means to afford the services of the FDA. I challenge the FDA and all regulatory agencies to subject themselves to an evaluation by criteria similar to those, which they demand for new medical products and devices. Do the benefits truly outweigh the risks of their regulatory efforts? I am not referring simply to laws being followed or money generated. I refer to the actual health of our nation and its citizens.
I propose that the FDA, DEA, and other governmental agencies evaluate the indirect and long-term complications, as well as purported benefits, of their regulations. We must as Americans be prepared to hold our government and regulatory agencies accountable and not assume that they are always the best “authorities” based on current evidence, public health, or reasonable thought. We can’t even assume that they follow the law!
The agencies themselves are caught up in antiquated laws, sometimes made with the best of intentions, but often causing devastating consequences to the constituencies they are meant to serve. Too often prohibition and misguided regulations are cultural responses to issues around substance abuse and other dysfunctional behaviors. Critical questioning of regulations and unceasing vigilance over regulators are demanded of citizens, who hope to benefit from a government of the people, by the people and for the people.
J. Kimber Rotchford, M.D. is director of Olympas Pain and Addiction Services (OPAS) in Port Townsend, WA. Website: DrRotchford.com
Dr. Rotchford's website is OPAS.us or DrRotchford.con