Medical Marijuana

September Physician Focus: Is Marijuana Medicine?

Posted in Medical Marijuana, Medicine, Physician Focus on August 28th, 2014 by MMS Communications – Comments Off

Despite a ban by the Federal government, little clinical research into its effectiveness as a medicine, and lack of approval by the Food and Drug Administration, the use of marijuana for medical purposes has been approved by 23 states and the District of Columbia as of August.

In Massachusetts, voters in 2012 overwhelmingly approved a ballot question allowing the use of marijuana by patients with “debilitating medical conditions.” The vote represented a declaration of medicine by plebiscite, a major departure from the nation’s structured way of creating, testing, and approving medications through well-controlled, sanctioned clinical trials and review and approval by the U.S. Food and Drug Administration.

As the regulatory process of overseeing the marijuana program proceeds and marijuana dispensaries prepare to open in the Commonwealth, the September episode of Physician Focus examines a basic question: Is marijuana medicine?

Guests for the show are two physicians who presented at the MMS’s recent CME course on medical marijuana in June: Alan Ehrlich, M.D. (photo, center), Senior Deputy Editor of DynaMed, a clinical reference tool created by physicians that examines medical articles for clinical relevance and scientific validity, and Kevin Hill, M.D., M.H.S., (right), Director of the Substance Abuse Consultation Service in the Division of Alcohol and Drug Abuse at McLean Hospital in Belmont. Hosting the program is John Fromson, M.D., (left) Chief of Psychiatry at Brigham and Women’s Faulkner Hospital in Boston.

The three physicians examine the current evidence surrounding marijuana, the risks of using the drug, what conditions marijuana may help, and what patients should know about the drug if they are considering using it for medicinal purposes.

Physician Focus is available for viewing on public access television stations throughout Massachusetts. It is also available online at www.massmed.org/physicianfocus, www.physicianfocus.org,  and on YouTube.

Physician-Experts on Medical Marijuana: Not a First-Line Therapy

Posted in Medical Marijuana on June 20th, 2014 by Erica Noonan – Comments Off

More than 100 physicians gathered recently at MMS headquarters to take part in a history-making discussion about what the legalization of medical marijuana in the Commonwealth means to them as healthcare providers.

Throughout the half-day CME event, Medical Marijuana: Regulations, Responsibilities, and Communication, physician panelists presented various clinical scenarios in which marijuana certification could be considered. One of the experts, Alan Ehrlich, MD, an assistant professor of family medicine at University of Massachusetts Medical School, polled the audience about whether they’d certify patients in given circumstances. Though physicians’ opinions varied as to how they’d approach each circumstance, two consistent themes emerged.

Medical Marijuana is Not  a First-Line Therapy

 “Marijuana does not fix MS,” emphasized Ehrlich. “Make sure they’re getting treated for the underlying disease.” Multiple sclerosis is not the only qualifying condition in which this notion applies. Whether a patient is suffering from cancer, glaucoma, ALS, MS, or chronic pain, physicians must determine whether patients are undergoing treatments to manage their disease before turning to marijuana to help manage symptoms of their disease, or in some cases side effects of other treatments.

When it comes to marijuana several panelists noted, people often hold biases at extreme ends of a spectrum: that it’s either completely harmless or a drug that sends users on the road to ruin.

Neither of those absolutes hold true, but there are real risks to certain patients that physicians need to take into account, according to Kevin P. Hill, MD, MHS, director of Substance Abuse Consultation Service, Division of Alcohol and Drug Abuse at McLean Hospital and an assistant professor of Psychiatry at Harvard Medical School.

For example, an estimated nine  percent of adults who use marijuana become addicted, which translates to about 2.7 million people out of current users. In addition, patients predisposed to mental-health problems may be prone to marijuana use triggering a worsening of those issues.

MDs Must Consider the Context and “Whole” Patient

Ultimately, the question isn’t whether marijuana use is risky, noted Ehrlich, but how dangerous it may be when compared to other risks, such as a patient not being able to stick with therapy due to intolerable side effects. Alternatively, if a patient drives for a living and has a condition that would call for using marijuana during the day, the relative risks increase.

As with recommending any treatment for patients, physicians have to look at it in the full context of patients’ lives, noted Riley M. Bove, MD, a neurologist with Partners Multiple Sclerosis Center at Brigham and Women’s Hospital. “We always have to look at the patient as a whole person,” she said.

 –Debra Beaulieu-Volk

Links to videos:

 

Alan Ehrlich, MD, assistant professor of family medicine at the University of Massachusetts Medical School, discusses the evidence of the efficacy and harms of medical marijuana.

 

Kevin P. Hill, MD, MHS, director of the Substance Abuse Consultation Service at McLean Hospital in Belmont, Mass., discusses substance abuse, addiction, and other adverse effects of marijuana.

 

Riley M. Bove, MD, neurologist and faculty member of the Partners Multiple Sclerosis Center, discusses the evidence regarding the use of marijuana for patients with multiple sclerosis.

See all videos and slide slows from the half-day MMS CME event, Medical Marijuana: Regulations, Responsibilities, and Communication

 

Recapping a Busy Year: MMS Health Care Advocacy in 2014

Posted in Annual Meeting 2014, Electronic health records, Health Reform, meaningful use, Medical Marijuana, Medicare, Payment Reform on May 15th, 2014 by MMS – Comments Off

Ronald W. Dunlap, MD, president of the Massachusetts Medical Society, kicked off the Society’s 2014 Annual Meeting with a review of five significant advocacy issues from the 2013-14 year:

  • Medicare payment
  • ICD-10 deadlines
  • Regulatory overreach
  • State regulations on EHRs
  • Medical Marijuana

 

Medical Marijuana: One Physician’s Take

Posted in Medical Marijuana, Primary Care, Public Health on May 13th, 2014 by MMS Communications – Comments Off

Long after the vote of the people was recorded, the implementation of medical marijuana in Massachusetts continues to raise multiple questions for many.  One of the most important is this: how vigorously will physicians consider marijuana as a medicine and participate in certifying patients?

While some physicians have already begun to certify patients, others are saying no.  Major impediments to physician participation include the lack of scientific evidence supporting the effectiveness and safety of the drug for the majority of its purported uses and their reluctance to start patients on treatment regiments with which they have no experience or training.

On May 3, the Daily Hampshire Gazette in Northampton published an editorial stating that “The step of certification is the most important one patients take in a multi-step process to obtain medical marijuana.”  The paper, noting that physicians for the most part are shying away from certifying patients, had a clear message for physicians: “We urge doctors to be bold. It seems cruel and inhumane to withhold treatment of a legal drug to people who are suffering and with it may find relief.”

Dr. Alan Berkenwald, a Northampton physician who practiced primary care in the area for 25 years before becoming a hospitalist at Cooley Dickinson Hospital, responded, and the Gazette published his commentary on May 7.  Read Dr. Berkenwald’s, Why I won’t prescribe medical marijuana, here.

 

The President’s Podium: The Business of Medical Marijuana

Posted in Board of Medicine, Department of Public Health, Health Policy, Medical Marijuana, Public Health on November 7th, 2013 by MMS Communications – 3 Comments

By Ronald Dunlap, M.D., President, Massachusetts Medical Society

It’s been one year since Massachusetts voters approved a ballot question DSC_0003 Dunlap 4x6 color 300 ppi_editedlegalizing the use of medical marijuana, adding the Commonwealth to a growing list of states allowing it to be used as “medicine.”

MMS had vigorously opposed the referendum, on the basis that the drug lacks the rigorous testing as other FDA-approved drugs; that claims for its effectiveness are not scientifically proven; that it poses health risks of toxins and cognitive impairment; and that a physician’s recommendation of any drug should be a medical decision made in the patient’s best interest based on scientific and clinical evidence and not by public vote. Voter approval notwithstanding, we still hold those positions.

Following the vote, the MMS House of Delegates adopted a revised policy, stating our desire to work with the Board of Registration in Medicine (BRM) and the Department of Public Health (DPH) in developing regulations that would address key issues of a medical marijuana program in the state. Among these issues were patient diagnosis, physician certification, implications for occupational safety and health, inclusion in the Prescription Monitoring Program, and adherence to established professional tenets of proper patient care.

That effort proved fruitful. When DPH issued its regulations, our reaction was positive, saying DPH had done a “thoughtful and responsible job overall” and that the regulations “have taken into account many of our concerns, especially those that call for physician judgment in determining what conditions may qualify and the inclusion of the Prescription Monitoring Program in certifying patients.”

We are now, however, seeing a troublesome sign: the emphasis on medical marijuana has turned from patient care to business opportunity. And it goes beyond the investment or ownership opportunities related to dispensaries.

Entrepreneurs and physicians alike have established internet companies offering to match patients with doctors who will certify their need for medical marijuana. These companies will provide consultations and certifications – for fees ranging from a low of around $50 to upwards of $200. “Renewal fees” may also be charged.

I have publicly raised concerns about such sites.  I told The Boston Globe in September such activity is “working around the edges” of the rules, and I elaborated with the Business Journal of Western Massachusetts in October, saying “people that I call internet opportunists are essentially getting a doctor or list of doctors they feel will certify patients, and simply inviting patients to pay them money as a finder’s fee.”

One of the key regulations, sanctioned by the BRM and adopted by DPH at the urging of MMS, was that a physician should have a “pre-existing and ongoing relationship with the patient as a treating physician” before a patient should receive certification.

The proliferation of what I call these “certification centers” is disturbing; it erodes, if not skirts entirely, the “ongoing relationship” regulation and has the potential for abuse.

The experience in Colorado, which approved medical marijuana in 2000, is instructive. A June 2013 report from the Colorado Office of the State Auditor found “evidence suggesting that some physicians may be making inappropriate recommendations.” Twelve physicians had certified half of the 108,000 registered patients, and one had registered more than 8,400.

Despite its legality, many unknowns remain about medical marijuana, including appropriate dosage and frequency of use for conditions, strength of the drug from various sources, and clinical effectiveness. The Massachusetts model does not include any provisions for dosage, administration, or other basic elements that would be contained in a prescription for another medication.

Further, we are uncertain of the liability issues and whether insurers will cover defense costs and judgments in cases involving certifications. The drug also remains prohibited by the federal government, raising more questions about physician licensing by the Drug Enforcement Administration, which, contrary to press reports, has firmly stated that it has not relaxed its policy on medical marijuana.

Each physician, after weighing the risks and reviewing a number of considerations, will make his or her own decision about certifying patients and whether it’s in the best interests of both patient and physician. Some are already doing so.  That is another of the many decisions to be made within the physician-patient relationship.

That the business of medical marijuana has taken hold is no surprise; it was inevitable and likely will always be there. But, as physicians, let’s do what we can to refocus the issue back where it belongs: on patient care and patient safety.

The President’s Podium appears regularly on the MMS Blog, offering Dr. Dunlap’s commentary on a range of issues in health and medicine.

Doing No Harm: Physicians Should Just Say No to the Medical Use of Marijuana

Posted in Medical Marijuana, Physician Health on April 9th, 2013 by MMS – 5 Comments

By Steve Adelman, MD

As an addiction psychiatrist, I have seen marijuana do far more harm than good. So with the medical use of marijuana in Massachusetts now legal under state law, what should physicians do?

Last week, I attended a chilling presentation from Dr. Kevin Hill, an addiction psychiatrist at McLean Hospital, at a meeting of the Massachusetts chapter of the American Society of Addiction Medicine on the topic “Medical Marijuana: What is the Proper Role of the Addiction Physician?”

As we all know, the people of Massachusetts have spoken: last November, 63% of the voters endorsed Question 3, “The Medical Use of Marijuana.”

Since that time, the Department of Public Health has been scurrying to operationalize the so-called medical use of cannabis in the Commonwealth. The community of physicians has been scratching its collective head and wondering, “What in the world are we going to do about patient requests to become certified to purchase, or grow, so-called medical marijuana?”

I use the terms “so-called” and “medical marijuana” together, because there is scant scientific evidence to support the use of marijuana as a medication.

The US Food and Drug Administration has yet to approve any “smokable” medications. The Drug Enforcement Agency classifies marijuana as a Schedule 1 substance. Schedule 1 substances are defined by the DEA “as drugs with no currently accepted medical use and a high potential for abuse. Schedule 1 drugs are the most dangerous drugs of all the drug schedules with potentially severe psychological or physical dependence.”

Many users of marijuana become addicted, suffering withdrawal symptoms when they attempt to stop, and experiencing a variety of impairments as a result of chronic use. They continue using because they feel worse when they don’t use. Frequent use of marijuana by young people may impede the development of the brain (which continues until the mid 20s), interfering with education and work performance.

I am not taking a position on the legalization of marijuana, but I am taking a position against the medicalization of marijuana. I strongly believe that it is misguided. Although small numbers of individuals with intractable, debilitating medical conditions may derive some benefit from the use of marijuana “when all else fails,” so-called medical marijuana laws open up a floodgate to entrepreneurs who will profit from the sale of this valuable addictive substance.

All patients with certificates who are covered by MassHealth or by Social Security Disability Insurance (SSDI) will have the option of growing their own. There will be massive amounts of diversion to non-patients, and the price of marijuana will drop. The health and well-being of the greater public will be jeopardized for the relief of a few, and for the profit of the unscrupulous.

Physicians who have taken a pledge to “do no harm” should simply steer clear of the emerging Massachusetts medical marijuana debacle and “just say no.”  As physicians contending with the increasing demands of a complex and unevenly funded healthcare system, we should focus our attention on providing evidence-based care to patients, and sidestep getting involved in a social movement that is medical in name only.

Dr. Adelman is director of Physician Health Services, Inc., a corporation of the Massachusetts Medical Society. For more information, visit www.physicianhealth.org. Opinions expressed here are his own, and do not necessarily reflect those of the Massachusetts Medical Society or Physician Health Services.

A Call For More Research on Medical Marijuana

Posted in Medical Marijuana on March 8th, 2013 by MMS – 3 Comments

By Richard V. Aghababian, MD
MMS President

During the debate last year over the Massachusetts ballot question on the medical use of marijuana, the Massachusetts Medical Society opposed the proposal. We argued that in the absence of large-scale clinical trials on its safety and effectiveness in treating medical conditions, we could not support legalizing the use of marijuana for medical purposes.

Currently, marijuana is a Schedule I controlled substance, which means the federal government has declared it has no accepted medical use. There are serious concerns about its effects on health, particularly among young people.

Therefore, we formally asked the U.S. Drug Enforcement Administration (.pdf) and the White House Office of National Drug Control Policy to reclassify marijuana so that its use for medical purposes may be further studied and potentially regulated by the Food and Drug Administration.

The DEA responded to our request recently (.pdf), stating that marijuana’s Schedule I classification is not necessarily a barrier to the authorization of “bona fide research,” appropriately registered with and approved by the federal government.

DEA Administrator Michele M. Leonhart wrote, “DEA has never denied a research registration for marijuana and/or THC if the Secretary of the [Department of Health and Human Services] has determined that the applicant is qualified and competent and the research protocol is meritorious.”

Given this information, it’s time for medical and scientific communities to develop large-scale clinical trials to determine whether marijuana is safe and effective as a medical intervention. Such research should identify all the treatment protocols that would apply to a standard pharmaceutical therapy, including indications, contraindications, dosages, length of therapy, side effects, and more.

This would be extremely instructive to Massachusetts physicians, now that marijuana’s use for medical purposes is possible under state (but not federal) law. One interesting model to explore is the state-funded Center for Medicinal Cannabis Research at the University of California San Diego, which is starting to report findings from a handful of very small-scale studies.

Massachusetts was the 18th state to authorize medical marijuana. It would also be extremely useful to collect outcomes data from other states where patients are currently using it, some for many years. Is there statistically rigorous research or data about its use?

The issue about the rightful place of marijuana in medicine can only be determined when it is subjected to the same rigorous testing, research and standard-setting as any other drug developed for patients.

If it’s conclusively shown to be effective, and its side-effects are understood and acceptable to patients, then physicians who are reluctant to recommend it today may be able to responsibly consider using it among the treatment options for patients. If not, let’s focus on therapies which can be effective.

Patients, Advocates Speak Out On Medical Marijuana Rules At DPH Session

Posted in Medical Marijuana, Public Health on February 14th, 2013 by Erica Noonan – 1 Comment

The Department of Public Health heard from advocates on both sides of the medical marijuana debate today, during the second of three public “listening sessions” as it develops regulations to implement the state’s new medical marijuana law.

Nearly 200 people attended the session. Official hearings will take place later this spring.
Many of the several dozen speakers at the session were patients suffering from ALS, multiple sclerosis, cancer, nerve damage, post-military service PTSD and other severe illnesses. They cited their use of marijuana as key to alleviating symptoms and controlling pain.

Most urged the DPH not to restrict access to medical marijuana by dictating which medical conditions and patients – and in which amounts – it may be prescribed for.

Karen Hawkes, a former state trooper from Rowley who survived a debilitating stroke seven years ago, said medical marijuana had helped her recovery and allows her to care for her three school-aged children. “Limiting conditions means medical treatments are being mandated by the state,” she said.

Matt Allan, executive director of the Boston-based Massachusetts Patient Advocacy Alliance, said the any new regulations must respect the doctor-patient relationship.

“It is a decision that should be made by patients and physicians together, not by a government list,” he said.

The Massachusetts Medical Society also submitted written comments to the DPH, based on its policy adopted last December, following the passage of the medical marijuana referendum in November.

“The society remains opposed to the recreational use of marijuana, but has adopted policies which should help the Department in its efforts to create a regulatory framework that supports responsible implementation of the new law,” the MMS said in its comments to the DPH.

The MMS agrees with patient advocates that use of medical marijuana should be based on the patient’s diagnosis and the physician’s assessment of symptoms that are not optimally controlled with conventional medical therapy.

The MMS also expressed several concerns related to the provisions of the referendum, including a recommendation that the definition of a bona fide physician-patient relationship should be established by the state Board of Registration in Medicine.

The MMS also recommend to the DPH that the term “licensed physician” should be limited to include only those physicians with an active license from the Massachusetts Board of Registration in Medicine, a Massachusetts Department of Public Health Controlled Substances registration, and a federal Drug Enforcement Agency registration.

A number of speakers at Thursday’s session were public health workers and youth advocates who urged the DPH to closely monitor and restrict the prescription, distribution and use of medical marijuana.

Tara Doran, a manager at the South Boston Action for Substance Abuse Prevention, said her agency sees young people increasingly drawn to marijuana and called a rigorous certification vetting process for patients, and controlled distribution.  She, along with several police officers who offered testimony on Thursday, called for limits on how and where medical marijuana may be advertised to discourage its attractiveness to young people and teenagers.

Doran and other anti-drug advocates also asked the DPH to make medical marijuana subject to the state’s Prescription Monitoring Program.

The MMS also believes patient certifications should become part of the state’s Prescription Monitoring Program; and that any new medical marijuana regulations take into account the implications of the medical use of marijuana on occupational health and safety.

MMS leaders also raised a number of other questions in the testimony, including treatment dosages, the duration of certifications, the amount of an appropriate supply, non-profit criteria for dispensaries, and if licensed individuals may participate in the certification process without concern for their licenses.

—   Erica Noonan

State Publishes FAQ on Medical Marijuana Law

Posted in Medical Marijuana on January 6th, 2013 by MMS – Comments Off

Last week, the Massachusetts Department of Public Health issued its own guidance on the state’s new medical marijuana law. The law gives the state 120 days to draft its regulations, or May 1, 2013.

Here is the FAQ, in its entirety:

In November 2012,Massachusetts voters approved a ballot question which allows qualifying patients with certain medical conditions to obtain and use medical marijuana.  While the ballot question makes medical marijuana legal in the state, the Massachusetts Department of Public Health must consider several important issues to ensure safe and responsible use.

To that end, DPH has been meeting internally to begin the process of developing these regulations. DPH is partnering with a wide range of stakeholders in public safety, patient advocacy groups, the medical community, and municipal governments and will learn from other states’ experiences to put a system in place that is right forMassachusetts.

The following are a series of frequently asked questions about the current status and planned timeline for the implementation of regulations required by the new law:

What happens on January 1, 2013?

The medical marijuana law takes effect on January 1, 2013. At that point, the Department will have 120 days (until May 1, 2013) to issue regulations. Until regulations are in place, medical marijuana dispensaries cannot open, and DPH cannot issue any registration cards. DPH’s regulations will reflect input from various stakeholders, and the Department will hold a hearing and comment period to allow for further public input before the regulations are finalized.

Are qualifying patients eligible for medical marijuana under the new law starting January 1 while DPH is drafting its regulations?

During the time DPH is crafting its regulations, the ballot measure allows the written recommendation of a qualifying patient’s physician to act as a medical marijuana registration card. Similarly, the law allows a qualifying patient to cultivate their own limited supply of marijuana during this period. Under the law, until DPH issues its regulations, it is not involved in regulating any medical marijuana recommendations between physicians and patients, or in defining the limited cultivation registration.

How do I qualify as a patient?

The patient must obtain a written certification from a physician for a debilitating medical condition. The law specifies: cancer, glaucoma, AIDS, hepatitis C, amyotrophic lateral sclerosis (ALS), Crohn’s disease, Parkinson’s disease, multiple sclerosis and other conditions as determined in writing by a qualifying patient’s physician. The law allows qualified patients to possess up to a 60-day supply of marijuana for their personal medical use. The law directs DPH to define a 60-day supply through regulation.

What must DPH decide before dispensaries can be registered and registration cards can be issued?

Beginning on January 1, DPH will have 120 days to issue regulations governing numerous sections of the law. Some of the provisions include: setting application fees for non-profit medical marijuana treatment centers to fully cover the cost to the state; defining the quantity of marijuana that constitutes a 60-day supply; setting rules for cultivation and storage of marijuana, which will be allowed only in enclosed, locked facilities; creating registration cards for qualified patients; and defining rules around registration cards, personal caregivers, employees of medical marijuana treatment centers and individuals who qualify for a hardship cultivation registration.

I want to operate a medical marijuana dispensary. Can I apply for registration while regulations are being written?

No, because the regulations will specify what information and fee must be submitted for an application to be considered. In the first year, the law allows DPH to register up to 35 non-profit treatment centers across the state, with at least one but no more than five centers per county. The non-profit treatment centers would be registered under the law to grow, process and provide marijuana to qualified patients.

Will Massachusetts give guidance to health care providers on the medical marijuana law?

The Board of Registration in Medicine is collaborating with DPH to determine how to ensure that physicians understand the law and its provisions. The Board welcomes the recommendations of the Massachusetts Medical Society and other interested stakeholders, and will collaborate with DPH to successfully implement the law and promote patient safety.

Will health insurers or governments be required to cover medical marijuana?

No. Nothing in the law requires any health insurance provider, or any government agency or authority, to reimburse any person for the expenses of the medical use of marijuana.

Published 12/31/2012

MMS Outlines Proposed Criteria for New Medical Marijuana Law

Posted in Interim Meeting 2012, Medical Marijuana on December 1st, 2012 by MMS – Comments Off

The chief policy-making body of the Massachusetts Medical Society today passed a set of recommendations relating to the state’s new medical marijuana law, calling for the MMS to advocate for the development of appropriate certification criteria for certification for medical marijuana use.

The resolution, approved by the MMS House of Delegates at its Interim Meeting, also calls for the Society to work with the Board of Registration in Medicine to define the physician-patient relationship required for such treatment.

MMS also voted to advocate for the development of physician licensing standards for marijuana certification, and specifications for marijuana registration cards for patients.

Saturday’s resolution also calls for MMS to advocate for regulations reflecting the implications of medical use of marijuana on occupational health and safety. New Massachusetts regulations should include comprehensive treatment recommendations developed in 2010 by the American Society on Addiction Medicine.

Marijuana should be included within the existing state Prescription Monitoring Program, and physicians who prescribe it should be exempted from existing state peer-reporting requirements, the resolution stated.

–Erica Noonan