The Challenge to the Industry
We have a civic responsibility to take action and improve the lives of those that we have the ability to do so. Orion GMP Solutions hopes that by extending this letter that cannabis patients, researchers, and industry stakeholders take the initiative to put their representatives on notice and voice their concerns.
Cannabis used for Phase 2 and 3 clinical research must meet Good Manufacturing Practice Guidelines, such as the 21 CFR parts 210 and 211. Without FDA Approved GMP Cannabis, legitimate researchers are at a loss for understanding the true effects of cannabinoid therapies in treating disease.
Differences in Perspective
We are not here to discredit any institution, but the University of Mississippi is not meeting needs of researchers under the scope that cannabis is a drug of abuse versus a therapeutic medicine. Please take note, that UMiss operates in conjunction with the National Institute of Drug Abuse, not with the Office of New Drug Development. The two institutions have drastically different approaches to drug substances:
NIDA – “To advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health.”
OND – “To ensure that safe and effective drugs and biologics are available to the American people.”
Drug abuse is a real problem that must be addressed, however, complete and rigorous scientific studies of medical cannabis cannot be treated in the same way as studies of common addictive drugs. Current research needs to not only study cannabis as an intoxicant or recreational drug, but also to be able to study its differing medical effects depending on the specific blend/formulation of cannabinoids. Having unreliable or unknown cannabis raw materials for research prohibits the kind of research that needs to happen to fully understand the medicinal properties of cannabis. Only when we can fully quantify and have reliable supplies of the cannabis used for scientific studies can we prove or disprove its health effects.
There are no universally accepted standards for cannabis manufacturing to date, and it makes it incredibly difficult to generate standards without having authority from the government to perform clinical research. Public health cannot be protected, and cannabis manufacturing cannot be standardized without researchers being able to tell the industry what is safe and what is not. We are talking about helping sick people obtain access to what equates to a pharmaceutical substance that is not being manufactured under GMP guidelines.
For now, we must rely heavily on a Risk Based Approach to manufacturing, taking into account how the drug is manufactured relative to the risks posed to a patient.
ASTM D37 Cannabis Standards Committee is drafting guidelines for cannabis manufacturing, but both clinical research and the risk based approach must continue to progress regardless of what standards are being used.
Raw Materials for Clinical Research effect the Quality of the Research
The quality of research or a product is dependent on thousands of variables of the raw materials. Quality of raw materials is particularly important, as it influences the reproducibility of the scientific investigations. If researchers do not have raw materials of consistent quality, their research results will be be taken as inconclusive and cast doubt on an industry surrounded with uncertainty. How can researchers depend on the one government sanctioned supplier, whose quality has been questioned by the DEA, and whose primary aim is to view cannabis from the “drug of abuse” perspective? Here is another perspective – Medical researchers cannot determine the safety and efficacy of a drug if they do not have access to it.
Our team sees these problems while performing GMP Audits in FDA Registered GMP Facilities, whether it’s with product quality or research materials. Groups manufacturing GMP Cannabis will be at a loss for FDA Registration until the clinical research is done to prove the efficacy. Before clinical research can be done, the DEA must get past the hurdle with the Justice Department.
Mr. Sessions is developing his platform, and we are left with little to do but contact our representatives. This open letter is in support of changing the perspective.
Cannabis is gaining worldwide support from the medical clinicians who can only recommend cannabis. At present, clinicians and pharmacists are unable to prescribe cannabis, as there are no specifications for it as an FDA approved drug. Without clinical research, cannabis will never be able to gain full acceptance by the medical community.
Please Take Action!
Follow these links to contact your representatives:
Copy and paste this letter into your correspondence to your representatives:
I am not only writing to thank you for your support of legislation in regard to cannabis, but also to express my concern for the advancement of cannabinoid therapies. I respectfully request your consideration in being a champion for clinical research that could lead to a better understanding of cannabinoid therapies and treatments that so many can benefit from.
While much progress has been made, the United States is not leading the international community in clinically tested cannabis products. The supply of pharmaceutical grade cannabis is low, as the University of Mississippi is the major supplier of such research materials, and does not fully meet the needs and quality specifications demanded by legitimate researchers, as mentioned in the Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Rules and Regulations.
In August 2016, the DEA opened the opportunity for private companies to manufacture pharmaceutical grade cannabis for legitimate research purposes. This provided a means for researchers to obtain pharmaceutical grade cannabis to prove/disprove the potential of cannabinoid therapies to help people with disease conditions that are not fully treated by currently available pharmaceuticals.
At present, there are running hypotheses that the endocannabinoid system is a physiological regulatory system that interacts with and controls multiple physiological systems. The multiple disease states that cannabis has subjective evidence of helping patients is the best evidence the scientific community presently has. Peer reviewed scientific research is the only way to prove/disprove these hypotheses.
While we have positive subjective evidence for cannabinoid therapies treating disease states, we are unable to make it objective because of the current regulatory environment. Allowing the private industry to manufacture DEA sanctioned Schedule 1 pharmaceutical grade cannabis is a necessary step to treat people with incurable diseases that are not otherwise treated by current pharmaceuticals, and for the United States to remain a leader in innovation.
Unfortunately, the opportunity is being held up by the Justice Department, which pushes back the opportunity for legitimate researchers to help people that are suffering.
I respectfully request your support in making DEA Schedule 1 Pharmaceutical Grade Cannabis available to the medical research community so we may build objective evidence for its applicability in treating disease.
As the CEO and Founder of Orion GMP Solutions, and speaking on behalf of our team of scientists and engineers, we would like to thank you for your support in ensuring that medical research can take place.
CEO and Founder, Orion GMP Solutions
ASTM D37 Cannabis Standards Committee, Quality Management Systems Chairman