Pubdate: Mon, 30 Mar 2015 Source: Daily Review (Towanda, PA) Copyright: 2015 The Daily Review Contact: http://www.thedailyreview.com/ Details: http://www.mapinc.org/media/1015 Authors: James Loewenstein, Eric Hrin and Max Bennett Series: Looking at marijuana legalization in PA. A MEDICAL VIEW ON MEDICAL MARIJUANA LEGALIZATION Many Doctors Want More Research to Be Done on Medical Marijuana Before a Decision Is Made on Whether to Legalize It Editor's Note: This is part two of a three-part series by The Daily Review looking at the possibility of legalization of marijuana in Pennsylvania. Most states now allow the use of medical marijuana, and Pennsylvania could be one of the next ones to legalize it. Last year, the Pennsylvania Senate passed legislation which would legalize the use of an extract of the marijuana plant for certain categories of medical problems, and the bill has been reintroduced in the Legislature this year as Senate Bill 3. The election last year of Gov. Tom Wolf, who supports Senate Bill 3, increases the chances that it, or similar legislation, will be enacted in the Keystone State. Testing limited with Schedule 1 drugs But most doctors believe that more research needs to be done on medical marijuana before a decision is made on whether to legalize it, according to Dr. Martin Mikaya, a physician who works in the Emergency Room at Memorial Hospital in Towanda. The "main difficulty" with medical marijuana is that proper scientific studies have still not been yet done to show that it would be safe and effective for doctors to prescribe it to patients, he said. The "gold standard" in medical research is "peer-reviewed, randomized, double-blind" studies, which all medicines are subjected to before the Food and Drug Administration will allow them to be prescribed by doctors to their patients, said Mikaya, who added that none of those studies have been conducted on medical marijuana. In the case of medical marijuana, those studies would show, among other things, whether medical marijuana "is effective as a medicine" and "whether its benefits outweigh its risks," Mikaya said. And Mikaya and the Pennsylvania State Nurses Association blame the lack of research on the fact that the federal government has classified marijuana as a "Schedule 1" drug, which says no medical value exists with the drug. Being Schedule 1 means testing is extremely limited, and most tests other than a few federal tests, are done internationally, said Betsy Snook, CEO of the Pennsylvania State Nurses Association. "We cannot do extensive studies in the United States with it being Schedule 1," she said. Other examples of Schedule 1 drugs are LSD, peyote, heroin, and ecstasy. It would be easier to do research on medical marijuana if the federal government reclassified marijuana to, for example, a Schedule 2 controlled substance, Mikaya said. Oxycontin and other narcotics are Schedule 2, which is a lesser labeling, Snook said. A scientific issue, not political "What we are seeing now is more like a movement" of people who are pushing for the legalization of medical marijuana, Mikaya continued. There is a "group of people" who are "demanding" that medical marijuana be legalized, he said. And the position of most medical societies in the United States, including the Pennsylvania Medical Society, is that before a decision is made on legalizing medical marijuana, the proper research needs to be done on it, he said. "In other words, we shouldn't (legalize medical marijuana) just based on a political movement. The decision should be based on sound scientific research," he said. The Pennsylvania Medical Society outlined its concerns about legalizing medical marijuana in a 16-page white paper, which it presented to the Pennsylvania House Health and Judiciary committees on March 24. "While many states have pushed for new laws to legalize the use of marijuana for medical reasons, there are few well-controlled studies that demonstrate its effectiveness," the Pennsylvania Medical Society noted in a news release that it issued about the white paper. "As such, most major state and national medical professional societies have not yet supported its use in patient care until further research is conducted to show it is a safe and effective medicine for use in a wide variety of settings." Despite the shortage of adequate studies, public support appears to be growing for medical marijuana, particularly since the 2013 release of CNN's documentary "Weed" featuring Sanjay Gupta, MD, the medical society noted in its news release. "Currently, 11 states have legalized CBD (cannabidiol) for medical use, while 23 others to some degree have approved CBD and THC," the news release states. "CBD and THC are two of marijuana's cannabinoid components. THC is marijuana's psychoactive component, while CBD is thought to have little, if any, psychoactive effect." "There are positive, anecdotal stories of medical marijuana having helped patients - for example to treat children with seizure disorders and veterans with post traumatic stress disorder," Dr. Steve Shapiro, a pediatrician and trustee of the Pennsylvania Medial Society, said in the medical society's news release. "We have to acknowledge that we have patients and families looking for help and hope with the reality that we do not know a great deal about how medical marijuana works, what it is best used for, and what the actual dosing and other requirements are to best prescribe it. As a pediatrician, concerning to me is using marijuana to treat children and not knowing the long-term effects of THC on brain development. As scientists we need to know more." "We have joined other national groups in calling for more research and making it easier for researchers to have access to marijuana for scientific purposes," Karen Rizzo, MD, president of the Pennsylvania Medical Society, said in the news release. Those who push for legalization point to "hundreds" or "thousands" of studies that have been conducted around the world demonstrating marijuana's benefit in treating health issues, the medical society's news release states. However, few of them have what is considered to be the "gold standard" in medical research - large randomized, double-blinded placebo-control studies, the medical society noted in the news release. "According to the white paper, with the exception of Marinol and Cesamet (two man-made cannabis medications) which have gone through the rigorous FDA approval process, providers looking to recommend other forms of medical marijuana will find themselves unable to answer important questions concerning non-approved versions," the medical society stated in the news release. Studies needed for use with seizures While doctors hear, anecdotally, that medical marijuana has helped children who have been having seizures, those are "just stories," Mikaya said. There needs to be a large study done on whether medical marijuana would be appropriate to give to such children, and it should involve a large number of patients, and be peer-reviewed and double-blind, he said. Problems have resulted from giving medical marijuana to children with seizures in Colorado, where marijuana and its derivatives are now legal, according to a March 22 letter that American Epilepsy Society president Amy Brooks-Kayal, MD wrote to state Rep. Matt Baker, who is chairman of the Health Committee in the Pennsylvania House of Representatives. Brooks-Kayal, who works at Children's Hospital Colorado, stated those problems were documented in a study by a team from Children's Hospital Colorado that was presented during the AES Annual Meeting in December 2014 and has recently been accepted for publication in the journal Epilepsy & Behavior. The study found that artisanal (traditionally prepared) 'high CBD' oils resulted in "no significant reduction in seizures in the majority of patients and in those for whom the parents reported improvements, these improvements were not associated with improvement in electroencephalograms (EEGs), the gold standard monitoring test for people with epilepsy." She continued: "Additionally, in 20 percent of cases reviewed seizures worsened with use of cannabis, and in some patients there were significant adverse events. These are not the stories that you have likely heard in your public hearings, but they are the reality of practitioners at Children's Hospital Colorado who have cared for the largest number of cases of children with epilepsy treated with cannabis in the U.S." "The families and children coming to Colorado are receiving unregulated, highly variable artisanal preparations of cannabis oil prescribed, in most cases, by physicians with no training in pediatrics, neurology or epilepsy," the letter reads. "As a result, the epilepsy specialists in Colorado have been at the bedside of children having severe dystonic reactions and other movement disorders, developmental regression, intractable vomiting and worsening seizures that can be so severe they have to put the child into a coma to get the seizures to stop." Brooks-Kayal noted that not a lot is known in these situations. "Because these products are unregulated, it is impossible to know if these dangerous adverse reactions are due to the CBD or because of contaminants found in these artisanal preparations," she wrote. Criteria needed to avoid abuse Dr. Stephen Renzi in Troy said prescribing medical marijuana would need to follow strict criteria in order to avoid abuse by people who go "doctor shopping," which is when people seeking drugs find doctors who easily prescribe the drugs being sought. "If it becomes legalized medically, you're going to have the same problems as oxycontin and oxycodone," said Renzi, who is an internist. For that reason, Renzi said criteria must be established for prescribing the drug. One factor Renzi was concerned about was the type of work a patient may be involved in. "If you have a Commercial Driver's License, you can't use (medical marijuana)," he said. "If you're doing manual labor, you could have a chance of getting hurt." Renzi said only one situation exists where he would feel comfortable prescribing marijuana. "End of life type pain would be the only reason I would prescribe it," he said. "Those people could live normal lives." As for more typical uses for medical marijuana such as chronic pain, Renzi said other drugs are available to relieve such conditions and diseases. Regarding the debate, Renzi said it will be one to watch, especially for what patients are included in the final version of the bill, and that he is neither for nor against Pennsylvania's foray into medical marijuana. Education essential The Pennsylvania State Nurses Association (PSNA) has been actively touring the state to educate health care professionals on medical marijuana and have been one of the state's strongest advocates of making marijuana available to certain patients. "In our position, the first thing we recommend is to educate everyone about this," PSNA CEO Betsy Snook said. Snook talked about a nurse who came to one of PSNA's "Medical Marijuana: Myths & Medicine" education presentations. Snook said the nurse, who works at a skilled nursing facility, said her patients asked her about medical marijuana and the nurse said she did not know enough about it to discuss it with said patients. "That's not a good enough answer for a nurse," Snook said. She said health care providers not only need to be educated, but need to comment on the topic to make the best possible bill in Pennsylvania. While the current version of the bill places limits on what diagnoses are needed to prescribe marijuana, Snook said in talks with Gov. Wolf's office, it's been established that room exists in the bill to include or exclude more diagnoses. "We're going to continue to make it the best bill we can," she said. Some drugs that treat spasmodic disorders leave patients in "catatonic states," she said. Snook said doctors prescribed marijuana tinctures in the 1800s for spasmodic disorders before marijuana prohibition took effect. The PSNA supports the legalization of medical marijuana under three conditions: it must be medically prescribed, tightly controlled, and strictly monitored. Snook also said because marijuana is still illegal on the federal level, the PSNA is pushing for doctors to be protected from federal punishment for prescribing the drug. On Monday, April 6, look for part three in The Daily Review's series, when we will discuss the possibility of recreational marijuana legalization in Pennsylvania with local representatives and area members of the law enforcement community. - --- MAP posted-by: Jay Bergstrom