Are we ready for medical marijuana?

There is a pending bill in Congress, House Bill No. 4477 or the Compassionate Use of Medical Cannabis Bill, which seeks to legalize and regulate the medical use of cannabis, more popularly known as marijuana. In his explanatory note, Isabela Rep. Rodolfo Albano III, the primary author, said the bill intends “to provide accessible, affordable, safe medical cannabis to qualifying patients,” specifically for the following conditions:

• cachexia or wasting syndrome;

• severe and chronic pain;

• severe nausea;

• seizures, including but not limited to those characteristic of epilepsy; and,

• severe and persistent muscle spasms, including but not limited to those associated with multiple sclerosis.

Mixed feelings

Should it be enacted into law, the Department of Health will be mandated to regulate the medical use of cannabis in the country. It will be the one in charge of issuing identification cards to qualified patients, and authorizing their caregivers to supervise in the administration of cannabis.

I have mixed feelings of the bill because of the big tendency for marijuana to be abused. It may be medical marijuana now, but subsequently there will be groups which may propose legalizing it for recreational use. Or some can just creatively skirt the regulatory precautions and claim they’re using the substance for medicinal purposes even if they don’t have any of the allowed medical indications.

Putting the precautionary measures on paper is easy. Ensuring full compliance of everyone would be a draconian challenge.

Several months before the bill was filed, I wrote a series of articles on the pros and cons of medical marijuana in this column. It’s a double-bladed sword which can either be a beneficial medicinal leaf or be a gateway to perdition.

It’s true though that there are a few available studies showing its benefits in patients with severe pain, nausea and vomiting, unresponsive to conventional medicines, and excruciating spasticity of a paralyzed arm or leg following a stroke not amenable to treatment. Some patients and their relatives must have heard of these studies and ask me sometimes if cannabis could be tried to help alleviate their bothersome symptoms. I always answer them “I’ll be a drug pusher if I say yes,” and my negative reply disappoints some of them.

Joint statement

A few days ago, Dr. Tony Leachon, the current president of the Philippine College of Physicians (PCP), e-mailed me the joint statement of the PCP and several other medical associations, which are concerned about the possible passage of the cannabis bill.

“We understand the concerns of patients who may potentially benefit from the use of medical marijuana. However it is our moral and ethical responsibility to safeguard the interests of our Filipino patients,” the statement said.

The medical leaders added that there are already existing provisions by the Philippine Food and Drug Administration (FDA) that allow the compassionate use of yet unregistered medicinal products like marijuana, but under a supervised research setting. If the results in the first few patients given with it via compassionate use is favorable, a clinical trial should be conducted which can enroll more patients.

Creation of task force

The medical societies propose the creation of a task force composed of specialists, scientists, and ethics and regulatory authorities which will address this issue. Possible options the group is looking at include the reclassification of marijuana as a schedule II drug by the Dangerous Drugs Board or DDB. This means that importation of oral cannabis extracts and/or synthetic analogs with proven efficacy for specific conditions not responsive to standard forms of treatment will be allowed. Cultivation under strict supervision and only for research purposes will also be allowed by recognized authorities.

According to Dr. Leachon, although there may be isolated studies showing some benefits of cannabis preparations, review of all current scientific evidences by clinical epidemiologists show no strong beneficial effects that can outweigh the potential harm of legalizing the product for medicinal purposes.

“There should be a focus on efficacy, quality and safety of the drugs—safety is the primary issue,” said Dr. Leachon. He cited a cardinal dictum in medicine—“Primum non Nocere,” which means, “First, do no harm.”

For the good of all

In previous e-mail communications with him, FDA director general Dr. Kenneth Hartigan-Go said that any policy on any medicinal substance must be dictated by the “good of all and equity, and reality of implementability.”

The FDA is a science regulatory agency and, as such, it must closely scrutinize and validate the quality of any product, its efficacy and safety as proven by well-designed studies in humans. For a medicinal product derived from marijuana, it’s a lot more complicated. “We cannot dissociate legit use from the potential for-recreational abuse and misuse,” said Dr. Hartigan-Go.

He reiterated that the FDA must firstly protect the society and all patients/consumers from making wrong choices. “FDA decides based on science, numbers and evidence. It balances innovation with sound regulations, but it also respects risk-benefit and precautionary principle,” the FDA director general explained.

I hope the proposed bill in Congress can address all issues and concerns on legalizing medical marijuana, and propose an ideal middle ground that can balance the favorable effects of this substance and provide sufficient measures to prevent its abuse.