Haleigh’s Hope low-THC Oil Will Be Available This Month

Modern Health Concepts (MHC), a South Florida-based medical cannabis provider, is proud to announce that the Florida Department of Health granted the company authority to process and dispense medical and low-THC cannabis.
 
Led by a team of physicians, pharmacists, and medical experts, MHC holds Florida’s only license to manufacture and sell Haleigh’s Hope™, a low-THC cannabis oil that has provided relief to patients suffering from severe epilepsy, seizure disorders, and muscle spasticity.
 
Haleigh’s Hope oil will be available this month to patients enrolled in the Department of Health Compassionate Use Registry. Haleigh’s Hope pre-filled oral syringes and capsules will be available later this year. In early 2017, medical cannabis products will also be ready.
 
To make these products accessible to patients, Modern Health Concepts will offer a mobile delivery program as well as appointments at the company’s initial dispensary in southern Miami-Dade
County. Registered patients may schedule appointments online at www.modernhealthconcepts.com.
MHC will launch additional retail locations in 2017.
 
“The Modern Health Concepts team has worked diligently to ensure that from seed to sale our medical cannabis products meet or exceed the state’s safety and quality standards and, as a result, the Department of Health has approved Modern Health Concepts to process and dispense,” shared Richard Young, Modern Health Concepts CEO. “We are pleased that by using the most medically precise and technologically advanced production techniques, Modern Health Concepts is ready to provide qualified patients in Florida with the relief they need from a source they can trust.”
 
About Modern Health Concepts
Based in South Florida and founded by a third-generation farm with over 50 years of horticultural expertise, Modern Health Concepts (MHC) is one of the original five dispensing organizations licensed to cultivate, process, and dispense throughout the state of Florida. MHC is committed to offering patients relief through a range of medical cannabis products, including low-THC, high-CBD cannabis and full medical cannabis. More information regarding Modern Health Concepts can be found at www.modernhealthconcepts.com.


There are many facets to the debate concerning the legalization of marijuana. However, the focus of this article is on one of the consequences legalization is likely to have for Florida’s healthcare community.

 
 In 1970 Comprehensive Drug Abuse Prevention and Control Act classified THC, the active ingredient in marijuana, as a Schedule 1 drug. That is, one that has a high potential for abuse, no currently accepted medical use, and lacking accepted safety standards for use under medical supervision
 
In 2014 the Florida Legislature passed and Governor Scott signed into law the "Compassionate Medical Cannabis Act". This statute authorized physicians who were specifically licensed to do so, to prescribe a form of marijuana known as "Charlotte’s Web" to a:
 
qualified patient suffering from cancer or a physical medical condition that chronically produces symptoms of seizures or severe and persistent muscle spasms; order low-THC cannabis to alleviate symptoms of such disease, disorder, or condition, if no other satisfactory alternative treatment options exist for the qualified patient …
 
§381.986(2), F.S.
 
 It seems likely that there will be efforts to expand the use of medical marijuana in Florida to additional individuals who might benefit from using this drug in treating their physical or psychological ailments. Whether or not those efforts succeed, healthcare providers face a difficult decision concerning how to deal with their employees and independent contractors for whom a physician has prescribed marijuana.
 
Drug testing has become a routine function of many healthcare providers’ HR department responsibilities. Healthcare professionals found to have performed their duties while intoxicated or under the influence of a prohibited drug may be referred to the Florida Impaired Practitioners Program.
 
Does, or should, the outcome change when a healthcare practitioner or student is found to be taking marijuana, as authorized under Florida law?
 
On the one hand, the employee is doing nothing that other employees are permitted to do – taking a prescribed medication to treat a medical or psychological condition. On the other hand, the FDA continues to classify marijuana as a Schedule 1 drug, one having no accepted medical use. Consequently, prescribing, dispensing, and possessing marijuana remain violations of federal law- notwithstanding state statutes. Indeed, the physician who prescribes, the party who dispenses, and the patient who receives marijuana pursuant to Florida’s Compassionate Medical Cannabis Act bear the risk, however remote, that the FDA or another federal agency might seek to sanction this activity.
 
At least one state has considered the issue. Significantly, that case did not involve a healthcare provider. Instead, it involved an employee of Dish Network in Colorado who was discharged after testing positive for marijuana. The employee, a quadriplegic, used medically prescribed marijuana outside of work hours. Notwithstanding a statute protecting workers engaged in any "lawful activity" outside of the work environment, in a unanimous decision the Colorado Supreme Court held that because it violated federal law this individual’s use of marijuana did not meet the statute’s requirements and his discharge was justified.
 
Until the status of marijuana as a Schedule 1 drug is altered, Florida’s employers in general and healthcare providers in particular have a difficult decision: Ignore their employees who have prescriptions to use marijuana, or treat these cases in the same manner as other instances of alcohol or drug abuse. Will that approach change if the FDA alters the status of marijuana? In any case, all employers need to focus on this issue, review their employee handbooks, decide which position they want to take, and make their employees and independent contractors aware of how they will be treated if they are prescribed marijuana in Florida.


CBD, CBD, it is legal in all 50 states! CBD is short for cannabidiol, which is one of at least 113 active cannabinoids (chemical constituent) identified in Cannabis. A number of purveyors and entities selling hemp-derived CBD (versus what might be called whole plant CBD allowed in Florida under the Compassionate Medical Cannabis Act of 2014) claim it is effective to fight certain conditions and assert that industrial hemp derived CBD is federally legal, unlike marijuana. This claim can be seen in new store fronts across the country as well as many a web page touting industrial hemp-derived, CBD. In fact, we know this claim is not necessarily true, as demonstrated by the State of Missouri’s recent Petition for Injunction and other remedies against a number of hemp-derived CBD purveyors in Missouri.

Pursuant to Title 21 USC 802 Section (16) The term "marihuana" means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

Proponents of the position that hemp-derived CBD is legal, point to the lack of a specific definition under the above description and the Ninth Circuit’s opinion in Hemp Indus. Ass’n v DEA, 333 F.3d 1082 (9th Cir. 2003). They further buttress their belief by citing the DEA’s clarification of Hemp in the Federal Register released in October 2001 and the 2014 Farm Bills’ definition of Industrial Hemp. Much of the foregoing has been extended to even support opinions that hemp derived CBD from domestic sources under the Farm Bill is legal for distribution nationwide.

Opponents of the Hemp derived CBD is legal (putting aside the issues with imported hemp and contaminants etc.) argument point to the exception to the exception in the definition of “marihuana” i.e. to actually get a workable form of CBD from Hemp, the preparation of the stalk puts you into the resin category which is excepted from the terms that are specifically not included in “marihuana”. In regard to HIA v. DEA cited above, opponents posit that the court decision, never mentions CBD, and the HIA maintains that this ruling did not legalize CBD.

On August 11, 2016 perhaps muddying the waters even greater, the DEA, USDA and FDA as part of the rejection of rescheduling cannabis issued a Statement of Principles on Industrial Hemp (non-binding) which attempted to provide guidance especially as it pertains to the commercial sale of CBD under the auspices of state industrial hemp programs. The Statement, at face value seems to indicate domestically grown and processed hemp-derived CBD developed and sold under the state programs is impermissible under the 2014 Farm Act. Furthermore, the Statement made other broad assertions in regard to industrial hemp-derived CBD that could affect what heretofore has been a million dollar industry which proponents argue has provided relief to many individuals suffering from certain health conditions. While the Hemp Trade Associations have asked the USDA Secretary Tom Vilsack for clarification, as it stands today if industrial hemp CBD sales were in a gray area prior to August 11, they may now be in a dark gray area. The question is, will there be wholesale enforcement taken either civilly or criminally and ultimately should the resources even be expended in that regard?



The medical marijuana / cannabis (MMJ) legalization process has begun in Florida with exaggerated hesitancy and over-regulation. Physicians are steering clear of MMJ altogether because, in addition to the plant’s controversial reputation, the steps necessary to prescribe it combined with legal complexity are simply not worth the hassle for most.

Florida passed the Compassionate Medical Cannabis Act in 2014, but more than two years later there are only two dispensaries with operational storefronts. Meanwhile the others growers, in spite of mammoth investments and startup costs, are still trudging through red tape to obtain licenses to process or dispense MMJ.
 
Patients have fared little better in terms of navigating the MMJ process. As a physician with my own Florida practice (Florida Marijuana Doctors, www.FMD.green) that focuses on conditions treatable with MMJ, I have yet to speak with a patient who has a clear understanding of the current MMJ laws. The whole process has proven confusing and has left many feeling betrayed and angered.
 
Patients are upset, for one, that there is a mandatory 90-day waiting period before they are eligible to obtain a ‘prescription’ for MMJ and placed on the FLDOH’s Compassionate Use Registry.
 
This 90-day wait is unique for patients seeking medical relief, and is inarguably cruel to a large percentage of the population that qualifies for MMJ treatment, none more so than the terminally ill. These patients have been diagnosed as having less than one year to live, and our legislators are making them wait a minimum of three months to receive what should be considered palliative care.
 
As a physician licensed to prescribe MMJ in Florida with considerable medical experience in California and other states, this is the most complicated and cumbersome medical process that I have ever encountered.
 
Involving myself at the forefront of the Florida MMJ circus has been intimidating and confusing. The simplest part of the process was becoming credentialed to ‘prescribe’ MMJ. While the course itself was informative and similar in content to other CME courses, after completing it in 2015, I was displeased to realize that the State still had not made MMJ available, and yet I would have to renew my credentials (and pay again) upon my next medical licensing cycle.
 
We physicians find it difficult to understand the new laws and their nuances, and how to apply them to actual patients. For instance, out of the four primary medical categories that qualify patients to use MMJ – terminally ill diagnosis, cancer symptoms, seizure disorders, and severe muscle spasms, the latter condition has the broadest interpretation. Chronic (and painful) spasms are difficult to separate from ‘chronic pain’, which is pointedly not a qualifying condition; neither is ‘chronic pain’ included in the proposed Amendment 2 that would broaden application of MMJ for patients and allow full potency MMJ to be used for a wider range of medical conditions. Currently, only terminally ill patients qualify for full potency MMJ.
 
While the Florida Office of Compassionate Use has provided a physician liaison, I have sent questions through email and have either received no answer or confusing legal jargon that carefully avoids answering the actual questions and fails to offer concrete directives.
 
Physicians are already bogged down by today’s medical bureaucracy. Adding additional patient disclosures, documentation, and reporting requirements to prescribe MMJ only multiplies the inefficiency of the system. All of this in addition to shouldering the onus for interpretation and application of the law has produced an MMJ environment where physicians choose not to participate for fear of making a costly misstep.
 
Since few physicians feel comfortable prescribing MMJ, even in states with much more liberal laws, why would we bother prescribing medical marijuana in Florida?
 
The answer is clear: MMJ has legitimate medicinal qualities, and the response from patients has been overwhelmingly positive and gracious. Patient narratives of enduring chronic illnesses and painful conditions are compelling and real, and their sheer gratitude for being given the opportunity to try MMJ as an approved medication is our catalyst to stick to our ideals, however challenging.
 
As the topic of MMJ continues to become more prevalent, physicians should recognize that many of their patients feel very strongly about the right to use marijuana as medicine. Thus, medical practitioners should either consider becoming a licensed prescriber themselves, or they should refer patients to a doctor who is licensed to prescribe MMJ and has the knowledge and background to effectively oversee this treatment option.
 
While Florida’s MMJ “r”evolution has thus far left patients, growers, investors, and physicians feeling frustrated, mistreated, and abandoned by Florida legislators, we reflect on the relative progress we have achieved, and continue to forge ahead with great hope and optimism. And with marijuana’s excellent safety profile and proven efficacy in treating a wide array of serious medical conditions, physicians, even if not prescribing MMJ themselves, should be supportive of their patients who wish to use MMJ and should keep an open mind about its use as a viable medical option.


The latest debate in Florida is the legalization of medical marijuana. This is a highly debated issue because of the lack of evidence using marijuana for certain medical conditions, and the adverse effects and consequences of marijuana, particularly on youth. In addition, Floridians are just now recovering from a terrible prescription drug epidemic, and the introduction of another addictive substance creates some concern.

To understand what “medical marijuana” is you really have to focus NOT on the herb, but the substances contained in that herb, known as cannabinoids. Specifically, marijuana contains several psychoactive ingredients. Marijuana is like a salad; there are some things in it that are beneficial and some that are not. THC (tetrahydrocannabinol) is the major psychoactive compound, which creates the euphoria and “high”, while cannabidiol and cannabinol are also psychoactive, but tend to reduce the excitatory effects of THC.
 
The biggest problem with medical marijuana is the fact you are burning it and inhaling the products of combustion. Like tobacco, marijuana contains carbon monoxide, ammonia, hydrogen cyanide, acetaldehyde, acetone, benzene, toluene, phenol, naphthalene, benzanthracene, and benzpyrene. In fact, compared to tobacco smoke, each inhalation of marijuana is typically 2/3 larger, inhaled 1/3 deeper, held 4 times longer, and 50% higher in tar. Therefore, 2-4 marijuana cigarettes are roughly equivalent to 20+ tobacco cigarettes.
 
There is a disproportionate negative effect of marijuana on youth. Specifically, the rate of marijuana dependence or addiction is roughly about 10% for anyone over 18 who experiments (which is the same rate of addiction to anything in the general population), 27 % for age < 18, and 9% for age > 18. This is because the human brain does not fully develop until about age 21, and the parts that develops last are the prefrontal and frontal areas, which are responsible for decision making. Anyone who has teenagers knows that this population often makes poor decisions; because their brains have not matured.
 
Cannabinoids are produced naturally in our brains and responsible for their development. If outside cannabinoids are introduced to a developing brain, they can cause changes in brain development. Studies have shown a relationship between early cannabis use and a host of psychological conditions, including psychosis, bipolar disorder, schizophrenia and addiction. Also, the marijuana consumed today contains much higher concentrations of THC than that consumed in the 1960’s-1990. High THC cannabis can cause psychosis, paranoia, and extreme stimulation.
 
Marijuana disrupts short term memory, increases appetite, and reduces spontaneous motor activity. Competitive athletes know this because being off a second in your response time can mean the difference between victory and defeat.
 
So with all of these effects, how has marijuana been used medically and why is there such a push to legalize its medical use. Well, THC (Marinol) can be prescribed by physicians to treat protracted nausea and loss of appetite frequently seen in cancer patients and the chronically ill. Marijuana has been used to treat spasticity as seen in multiple sclerosis. High cannabidiol marijuana, (low in THC) has been used to treat intractable epilepsy in children, the so called “Charlotte’s Web” strain, which has been legalized in Florida, but cannot be smoked and is only approved for epilepsy and myospastic disorders. Sativex spray which is made from marijuana (GW pharmaceuticals) is available in Canada and the EU to treat cancer pain (currently undergoing trials in the U.S.).
 
Clearly there is potential for the medical use of cannabinoids, not necessarily marijuana. Cannabinoids bind to 2 types of receptors, one in the brain (CB1) responsible for the psychoactive effects, and the other (CB2) in blood, spleen, and intestines. The CB2 receptor has been shown to modulate pain and there is research being conducted to develop CB2 receptor drugs to manage chronic pain (without the euphoria).
 
We are still a long way off from fully appreciating and understanding the medical use of marijuana. We know cannabinoids can be useful for certain medical conditions. The question is how to make them available to the public in a safe and effective manner.