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Medical marijuana: Is it actually medicine?

Date: 8/27/2015

Editor’s note: This is the second in a three-part series in which Reminder Publications will explore issues related to medical marijuana in Massachusetts – the current status of registered marijuana dispensaries, medical uses of marijuana, and law enforcement.

Dr. David Getz is a true believer.

When the Act for the Humanitarian Medical Use of Marijuana was overwhelmingly approved by voters in November 2012, Getz, physician and owner of MariMed Consults, was excited to have the opportunity to offer patients with debilitating conditions another option for relief.

“It’s another arrow in the quiver,” Getz said.

With the passage of the law and subsequent formation of regulations, those with certain medical conditions can legally obtain marijuana as part of their treatment.

Marijuana is now an approved treatment for cancer, glaucoma, HIV/AIDS, hepatitis C, ALS – also known as Lou Gehrig’s disease – Crohn’s disease, Parkinson disease, multiple sclerosis (MS), and other conditions, provided it is documented by a physician.

“It’s symptomatic treatment,” Getz said, explaining cannabinoid medications are approved exclusively for reducing and alleviating symptoms.

“The receptors for cannabinoids are pretty much through the gut and through the nervous system, so they can be used for symptoms related to [gastrointestinal] issues or neurological ones,” he said. “Regardless of the condition that produces them, they can be treated using cannabinoids.”

The law specifically provides an option to utilize medical marijuana to those who suffer from the symptoms of a chronic debilitating condition.

“Meaning it has to impair [a patient’s] daily function in some way – that’s the debilitating part – and chronic usually means six months of longer,” Getz added.

While Massachusetts is one of 23 states in the country that has legalized the use of marijuana for medical treatment, it is not a federally accepted practice and remains classified a Schedule 1 drug by the Drug Enforcement Agency.

Looking for evidence

The Food and Drug Administration (FDA) isn’t necessarily opposed to the idea of the use of medical marijuana. In fact, two FDA-approved prescription drugs, dronabinol and nabilone, both have THC, the psychoactive compound in cannabis and have been on the market for decades to treat nausea in chemotherapy patients and preventing extreme weight loss in AIDS patients, also known as AIDS wasting.

The drugs have also proven effective in lessening withdrawal symptoms in those with marijuana addiction, similar to nicotine gum e-cigarettes.

Currently the FDA questions the effectiveness of cannabinoids for other purposes due to a lack what it would deem proper scientific evidence to illustrate the efficacy of the product.

According to public information provided by the FDA, the federal agency that evaluates drug manufacturers and scientific investigators’ research, “has not found any such product to be safe or effective for the treatment of any disease or condition.”

Getz explained, “There are people who believe it has anti-inflammatory effects, that it might help control Crohn’s disease and it might help with MS, but there’s no proof because there are no placebo-controlled trials.”

However, the National Cancer Institute recently indicated on its website that some forms of cancer could be treated with cannabinoids.

Laboratory and animal tests showed cannabinoids might be able to kill cancer cells while protecting normal cells and a lab trial also showed THC “damaged or killed” liver cancer cells. The latter study also indicated the compound had “antitumor effects” in mice.

Studies in mice and rats also indicated cannabinoids “may inhibit tumor growth” could prevent colon inflammation and “have potential in reducing the risk of colon cancer.”

Cannabidiol (CBD), the non-psychoactive active compound in marijuana was found to produce “cancer cell death” in a breast cancer lab study and mouse studies have shown CBD can lessen “growth, number, and spread of tumors.”

Lab studies also indicate chemotherapy for glioma (brain cancer) patients more effective and mouse tests indicated a combination of THC and CBD could also augment the effectiveness of certain kinds of chemotherapy.

The Massachusetts Medical Society, which opposed the ballot initiative, also continues to be careful in its approach to medical marijuana. While it rescinded a directive opposing the legislation after the 2012 election in order to participate in the subsequent regulation development discussions, its policy still states, “The MMS will educate the residents of the Commonwealth that there is insufficient scientific information about the safety of marijuana when used for ‘medicinal’ purposes.”

Dr. Kevin Hill, director of the Substance Abuse Consultation Service in the Division of Alcohol and Drug Abuse at Boston’s McLean Hospital, assistant professor of psychiatry at Harvard Medical School and author of “Marijuana: The Unbiased Truth About the World’s Most Popular Weed,” thinks some of the prohibitions on medical use will change in the near future.

“Absolutely,” he said. “There are certain conditions for which there is strong evidence that it is effective. Those uses are well established, such as treatment for chronic pain, neuropathic pain and neuroplasticity in patients with conditions like MS. I believe the FDA will also approve new uses in the next few years.”

Hill, however, isn’t as quick to rubberstamp the wide variety of treatments others wish to endorse.

“The problem is there are more than 50 conditions that are being treated with medical marijuana that we don’t have significant evidence to support,” he said.

While both the FDA and MMA state they support responsible studies, researching the medical uses of marijuana is a difficult process, Hill said.

Researchers must be registered with the Drug Enforcement Administration and must obtain the drugs through the National Institute on Drug Abuse, a subsidiary of the National Institutes of Public Health. The FDA conducts an investigational new drug application review and investigates the research protocols before allowing testing on humans.

In the meantime, Getz said, marijuana can be a very powerful tool for physicians hoping to stave off the suffering of their patients without some of the complications that can present themselves with other prescription medications.

“In general, marijuana is so well tolerated with such a low side effect profile, preferable in many ways to things that are prescribed, such as opiates for pain or sleeping pills that have many more side effects,” Getz said.

For example, Getz said marijuana is used to suppress nausea brought on by Crohn’s disease with few, if any unwanted reactions. One of the more accepted treatments, which comes in pill form, can result in involuntary twitches, which may persist even after its use is suspended.

Obtaining certification

According to the relatively new Massachusetts regulations, patients interested in medical marijuana to treat their symptoms must obtain special approval.

According to Scott Zoback of the Massachusetts Department of Public Health, any licensed physician with an established Massachusetts practice, no prescribing restrictions and a Massachusetts Controlled Substance Registration can provide the necessary certification. Physicians must also be registered with the Medical Use of Marijuana Program.

Patients ages 18 years or older, provided they meet the criteria, are eligible for approval, which can be good for up to one year. Minors can only qualify if two physicians, including at least one pediatrician, diagnose the patient with a terminal illness. If the illness were not life threatening, the doctors would be required to illustrate that the benefits of marijuana treatment would outweigh the risks, discuss potential neurological impacts with the patient’s parents or legal guardians and get parental approval.

With a physician’s certification, the patient may then register for the state’s Medical Use of Marijuana Program online through the Executive Office of Health and Human Services Virtual Gateway.

Once an application is reviewed and approved, the patient will receive an ID card.

MediMari_patient-front.jpgOnce the patient has that card in hand, he or she can buy medical marijuana from one of the dispensaries that will eventually be established in the state, which are needed due to the lack of FDA approval, which prevents the sale of cannabinoids in pharmacies.

The card is linked to a statewide database monitored by the Department of Public Health (DPH) and accessible to public health officials and law enforcement, Zoback added.

According to the state, 20,059 total patients were certified as of Aug. 1 and 11,986 applications had been reviewed and approved.

How much is enough and how much is too much?

While Hill supports the use of scientifically supported medical marijuana use, the issue of dosage is one of his significant concerns with the process through which the drug is obtained in Massachusetts.

Hill explained through the current system, unlike other prescription drugs, the approving physician does not have control over the dosage. Without FDA approval, he described that aspect of the indication of the drug as “fuzzy.”

“It’s one of the problems with the medical marijuana process,” he continued. “As much as people like to malign the FDA, FDA approval in the regulatory aspect of things is one way to really control the dose and control safety. Without the FDA involved in medical marijuana, we lose a lot of that.”

Getz also admitted the process is more fluid than prescribing other medications, a result of variations in the species of plants that could be harvested for use.

“There are so many different strains of marijuana and something like 60 active compounds that the plant produces, so it’s pretty much a trial and error thing,” he said.

Building off of Getz’s point, Hill said the wide variety of options offered by dispensaries adds to the uncertainty.

He explained there was a significant difference between a doctor writing a prescription for other prescription medication and issuing a certification for marijuana. While a physician can discuss dosages and make recommendations, it is representatives at the dispensary who discuss which products would work best with the patient.

“[Patients] take that card to the dispensary and then the dispensary talks with the patient about various strains – like “this one’s good for this and this one’s good for this,” which isn’t really scientifically based,” he said.

A patient can purchase up to a two-month supply, which the state has identified as up to 10 ounces of dried marijuana, upon visiting the dispensary.

Getz said 10 ounces every two months would be “far in excess of anything any patient would need,” a notion with which Hill agrees. The approving doctor does have influence on the amount a specific patient can buy, but Hill said he still disapproves of that aspect of the Massachusetts regulations.

In the other 22 states in which marijuana is legal for medical purposes, these possession limits vary, as Hill chronicled in his recent June article in the Journal of the American Medical Association (JAMA). Alaska, Montana and Nevada, for example allow patients to possess up to one ounce of usable marijuana. New Hampshire, allows a patient to obtain up to two ounces in a 10-day period. Oregon allows a patient to possess 24 usable ounces.

“Unfortunately the fact that marijuana is still illegal and is not FDA approved – and the FDA is never going to approve the plants themselves – we need to move towards more standardized use if we’re going to continue to have it,” he said.

Hill also noted in his JAMA paper that the World Health Organization identified a standard marijuana cigarette, also known as a joint, as containing as little as a half a gram of marijuana. Therefore, to smoke a 10-ounce supply of marijuana in 60 days would require smoking 10 times per day. A patient smoking the standard-sized joint one to two times per day would need between a half ounce and one ounce every two months.

“That’s an astronomical amount of marijuana. It’s hard to imagine why that makes sense in any way,” Hill told Reminder Publications. “It’s up to the doctor, but if you start talking about people getting ounces of marijuana, let alone 10 ounces, it’s really hard to see how they’re going to be using it medicinally. I can’t really imagine a scenario by which somebody would be using 10 ounces, medicinally, at least smoking the plant or using a vaporizer.”

The lax nature of that regulation increases the potential for addiction, Hill added. The debate on the addictive properties marijuana may or may not have has been ongoing for decades, however, he said, while the science indicates marijuana is a helpful drug, it also brings with it a risk for addiction.

“There is no question about it. I see in these people every single day that I’m here, whether it’s in my private practice or whether it’s in my clinical trials. People definitely get addicted to marijuana,” he said.

Hill noted the current data indicates a minority of adult users – 9 percent – become addicted.

Hill cautioned however, that the public must understand both sides of the equation – that only a small number of users become addicts, but the impacts of addiction are serious for those who suffer from it.

“Unfortunately, when people talk about marijuana, whether it be medical marijuana or legalized recreational marijuana, they tend to misrepresent the facts,” he said. “You have people who believe that marijuana’s harmless [or] you have people who think that if you use marijuana, you’re doomed. Neither of those things are true, but you do need to recognize that for some people, absolutely it can be addictive and it can be a very serious problem. On the flip side, you need to recognize, like alcohol, that most people who use marijuana don’t have these problems.

“One of the key problems is in society we recognize that alcohol is dangerous, whereas with marijuana, we haven’t progressed that far. The conversations about marijuana are not that sophisticated, unfortunately,” he added.

Specializing physicians

A hurdle facing qualified patients face is gaining access to medical marijuana approvals, Getz said, because many physicians won’t approve their patients’ use the drug – “That’s where I come in.”

Getz’ practice, MariMed Consults, specializes in the specific approvals needed for patients to obtain the drug.

“All us docs, we raise our hand and swear an oath to ease patients’ pain and suffering and now this law allows us to use cannabis to do that,” he said. “Some docs aren’t willing to do that for political reasons, personal reasons or because they’re not convinced it’s efficacious. I know it’s efficacious; I’m convinced. And although I can’t be a doctor for everybody, if they do present with proof that they have such a condition and would like to use cannabis as a treatment of their symptoms of it, I’m glad to be able to approve it.”

Getz’s operation is not a unique one. Since the passage of the law in late 2012, a number of like-minded doctors have opened practices throughout the state through which patients can obtain approval from someone other than their primary care physician.

“I would say that’s exclusively the case,” Getz said when asked if his client base was made up of people whose own doctors refused to approve marijuana as a treatment. “I don’t mean this to end run my own colleagues and I’m very careful that I don’t give access to people who like getting high and present they’re sick.”

Getz also noted he does occasional get referrals from primary care doctors – “But if their own doctor would do it, why come to me?” – as well as pain clinics.

Hill said while there can be a benefit to this practice if physicians are ethical, he also sees dangers associated with that level of specialization, as well as the potential for abuse.

“If I saw 20 to 30 patients and gave them all Prozac, what would you think?” he said. “If you ask the pizza delivery man, ‘What’s for dinner?’ he’s probably going to tell you pizza.”

Getz, however, said he feels he is filling a need in the community.

“After seeing for years people getting in trouble for this, it’s really wonderful to see it finally being used for medical uses,” he said. “The issue of recreational use is something I see as different altogether. We’re treating people with real medical problems with an efficacious medicine that has hardly any side effects as long as you don’t smoke it.”

Getz explained he requires medical documentation of treatment for an active chronic condition, which could range from “office visit stubs” to a note from the treating physician and a completed medical history form.

“An X-ray that you broke your leg five years ago doesn’t count,” he said. “That fact that you’re going to a pain clinic because that freaking leg is still killing you? That counts.”

Hill also said there is potential for poor follow-up care if a patient opts to turn to a medical marijuana specialist.

“There should be a standard of follow up care,“ he said. “With marijuana, there are significant potential side effects. If you choose to recommend marijuana for medical purposes, you need to follow up carefully.”

One of the health risks associated with marijuana use is the negative impacts of smoking. Getz, however, said that is an issue that can be worked around.

“Everyone thinks using marijuana means inhaling smoke, but of course, it doesn’t. Actually, we always tell everybody, ‘Don’t smoke,’” he said.

Getz said marijuana products are available in several forms, ranging from edibles to tabs patients dissolve under their tongue to ointments that absorb into the skin cells and enter the blood stream. He also advocated for the use of vaporizers, in which the vapor “contains the active ingredient for marijuana, but no combustion products.”

Zoback noted that any product other than the actual plant material must approved for use and sale by the state, with restrictions on other ingredients and even packaging.

Cost of treatment

Like any medicinal practice, medical marijuana comes with a price tag. Unlike many, however, it is not covered by any health insurance carriers.

To even register for the medical marijuana program, patients must pay $50. If the patient meets the requirements for a waiver through which they can grow marijuana for personal medicinal purposes, a $100 fee is required. Patients also face a $10 charge for lost ID cards

The state does, however, offer a waiver of the registration fee to those who it deems to be in financial hardship, defined as having an income that does not exceed 300 percent of the federal poverty level. For example, a single person making less than $35,010 or a household of two with a combined income of less than $47,190, the fees could be waived. Waivers also apply to MassHealth or Supplemental Security Income recipients.

In addition to state mandated fees, patients who opt to visit doctors like Getz instead of their own physician can face hundreds of dollars in additional costs in order gain certification. MariMed charges $175 for first-time visitors and does not accept any health insurance.

Another local physician’s office specializing in medical marijuana certifications, DocsConsult, which has offices in East Longmeadow and Greenfield, offers a free screening questionnaire for vetting clients prior to setting up an appointment.

While DocsConsult does not list the cost of its services during the appointment, its website does advise potential clients to have cash, credit cards or debit cards ready before the appointment begins. DocsConsult also offers web consultations to answer questions regarding medical marijuana without commitment for a fee of $75.

Patients are also responsible for the cost of the marijuana, which may vary and are not made public because the state law prohibits dispensaries from advertising their prices.

Reminder Publications attempted to speak with Dr. Jwesi Ntiforo, the physician and owner of DocsConsult, but was unable to arrange an interview suitable with his schedule.

Part three of this series will examine the concerns and challenges law enforcement faces with the new medical marijuana laws.