UNOFFICIAL COPY 22 RS BR 127 Page 1 of 5 XXXX Jacketed A CONCURRENT RESOLUTION calling for the expediting of research regarding 1 the safety and efficacy of the use of marijuana for medical purposes. 2 WHEREAS, people have used marijuana, also called cannabis, for a variety of 3 health conditions for at least 3,000 years; and 4 WHEREAS, 36 states, the District of Columbia, Guam, Puerto Rico, and the U.S. 5 Virgin Islands now allow the use of marijuana for certain medical purposes, and 6 additional states and territories may soon approve the use of marijuana for medical 7 purposes; and 8 WHEREAS, the decisions to legalize medical marijuana in those states and 9 territories have been made by voters or legislators, and not because of a careful scientific 10 evaluation of the benefits and risks of the use of marijuana; and 11 WHEREAS, an advanced society must have well-considered laws and regulations 12 to move forward; and 13 WHEREAS, drugs and pharmaceuticals must meet many safety and efficacy 14 standards to ensure that the public, health professionals, and industry are protected; and 15 WHEREAS, for over 80 years, federal law has directed that biological products 16 directed for human use must meet established standards for purity, safety, and potency; 17 and 18 WHEREAS, multiple tragedies have occurred over the course of United States 19 history as the result of adulterated, deteriorated, impure, and ineffective drugs; and 20 WHEREAS, the thalidomide tragedy was fully understood by 1962 and remains a 21 stark reminder that all drugs should be carefully and fully tested; and 22 WHEREAS, the Elixir of Sulfanilamide disaster in October 1937 caused over 100 23 deaths from an untested solvent; and 24 WHEREAS, marijuana has vastly different strains that each contain varying 25 amounts and ratios of medicinally active compounds; and 26 WHEREAS, the amount and concentration of ingredients is difficult to ascertain 27 UNOFFICIAL COPY 22 RS BR 127 Page 2 of 5 XXXX Jacketed from grower to grower or crop to crop; and 1 WHEREAS, a patient may risk complicating his or her treatment if the patient 2 stabilizes on a certain strain or preparation of marijuana and then finds that the product 3 that he or she was using is no longer available from a dispensary or grower; and 4 WHEREAS, different products may have different pharmacokinetic and drug 5 interaction profiles, causing unforeseen complications in the patient's health or in his or 6 her treatment for other conditions; and 7 WHEREAS, the bioavailability and bioactivity of cannabis depends on whether it is 8 consumed as an edible, oil, vaporized, or smoked; and 9 WHEREAS, the United States Food and Drug Administration (FDA) sent warning 10 letters to companies that illegally sell marijuana products with unsubstantiated medical 11 claims in November 2017; and 12 WHEREAS, researchers have not conducted sufficient, large-scale clinical trials to 13 show that the benefits of marijuana, when consumed as a whole plant, outweigh the risks 14 for the patient that it is meant to treat; and 15 WHEREAS, on May 7, 2019, 30 members of Congress, representing 14 states and 16 the District of Columbia, sent a bipartisan letter to United States Attorney General 17 William Barr and the Acting Administrator of the Drug Enforcement Agency (DEA), 18 Uttam Dhillon, urging them to "do whatever you can to speed up and improve the 19 research application process"; and 20 WHEREAS, 27 of those bipartisan members of Congress represent 11 states and the 21 District of Columbia which have already legalized medical marijuana, yet recognize that 22 "we need more research" to bring "safe and effective medical treatments to those who are 23 suffering as quickly as possible"; and 24 WHEREAS, researchers generally consider marijuana-based medications, like 25 FDA-approved dronabinol (Marinol), nabilone (Cesamet), and Epidiolex, all of which are 26 drugs that use purified chemicals derived from or based on those found in the marijuana 27 UNOFFICIAL COPY 22 RS BR 127 Page 3 of 5 XXXX Jacketed plant, to be more promising than the use of the whole marijuana plant or its crude 1 extracts; and 2 WHEREAS, several other marijuana-based medications have also been approved or 3 are undergoing clinical trials; and 4 WHEREAS, up to 80 percent of people who request medical marijuana want to ease 5 pain, and more than 33 percent cite post-traumatic stress disorder as the primary reason 6 for their request; and 7 WHEREAS, two relevant reviews published in the journal Annals of Internal 8 Medicine in August 2017 found little evidence to support either marijuana's effectiveness 9 or safety in treating chronic pain or post-traumatic stress disorder; and 10 WHEREAS, marijuana can be addictive, and recent data suggests that 30 percent of 11 those who use marijuana may have some degree of marijuana-use disorder; and 12 WHEREAS, marijuana impairs short-term memory and judgment and distorts 13 perception; and 14 WHEREAS, evidence suggests that the risks of marijuana use include poorer 15 educational performance, adverse consequences in the workplace, respiratory problems, 16 increased risk for psychiatric disorders, increased risk for heart attack during the first hour 17 after use, suicidal thoughts and attempted suicide among teens, and harm to unborn 18 babies; and 19 WHEREAS, the United States Surgeon General issued an advisory on November 20 12, 2019, "emphasizing the importance of protecting our nation from the health risks of 21 marijuana use in adolescence and during pregnancy" and noting that "recent increases in 22 access to marijuana and in its potency, along with misperceptions of safety of marijuana, 23 endanger our most precious resources, our nation's youth"; and 24 WHEREAS, the National Academies of Sciences, Engineering, and Medicine 25 (NASEM) published a report in January 2017 that summarizes the current evidence and 26 recommends that steps be taken to overcome regulatory barriers so that the health benefits 27 UNOFFICIAL COPY 22 RS BR 127 Page 4 of 5 XXXX Jacketed and health risks of marijuana could be more fully understood; and 1 WHEREAS, further research is needed to determine whether or not a person whose 2 health has been compromised by disease or the treatment of a disease, such as with 3 chemotherapy, is at greater risk for adverse health outcomes from marijuana use; and 4 WHEREAS, a comprehensive research agenda focused on the potential benefits and 5 adverse impacts of marijuana has not occurred and cannot occur under current federal 6 law; and 7 WHEREAS, improvements and standardization of research methodologies for 8 medical marijuana still need to occur; and 9 WHEREAS, the FDA requires carefully conducted studies, called clinical trials, in 10 hundreds to thousands of human subjects to determine the benefits and risks of a possible 11 medication; and 12 WHEREAS, the Kentucky General Assembly seeks to develop evidence-based 13 policies regarding medical marijuana; 14 NOW, THEREFORE, 15 Be it resolved by the House of Representatives of the General Assembly of the 16 Commonwealth of Kentucky, the Senate concurring therein: 17 Section 1. The Kentucky General Assembly hereby recognizes the important 18 scientific and enforcement work of the FDA, the National Institute on Drug Abuse, and 19 the DEA. 20 Section 2. The Kentucky General Assembly hereby requests that the FDA, the 21 National Institute on Drug Abuse, and the DEA expedite research on the safety and 22 effectiveness of the use of marijuana for certain health purposes. 23 Section 3. The Kentucky General Assembly hereby further requests that the 24 FDA, the National Institute on Drug Abuse, and the DEA adopt the changes 25 recommended in NASEM's January 2017 report, if they would serve to expedite research 26 into both the potential therapeutic benefits and risks of using marijuana for health 27 UNOFFICIAL COPY 22 RS BR 127 Page 5 of 5 XXXX Jacketed purposes so that, as policymakers, the General Assembly may develop evidence-based 1 and scientifically sound medical marijuana policies. 2 Section 4. The Clerk of the House of Representatives is directed to forward a 3 copy of this Resolution to the Food and Drug Administration, 10903 New Hampshire 4 Ave., Silver Springs, Maryland 20993-0002, the National Institute on Drug Abuse, 5 3WFN MSC6024 301 North Stonestreet Ave., Bethesda, Maryland, and the Drug 6 Enforcement Agency Attn: Liaison and Policy Section, 8701 Morrissette Drive, 7 Springfield, VA 22152. 8