Dangerous Drugs Board OKs cannabis use for epilepsy

MANILA, Philippines — It’s one small step, but it’s practically one foot in the door.

Advocates pushing for the legalization of cannabis as medicine scored a virtual victory when the Dangerous Drugs Board (DDB) recently approved “in principle” a resolution to allow the use of cannabidiol (CBD) for alleviating severe forms of epilepsy.

The DDB is the government’s policy-making and strategy-formulating body on the prevention and control of drug abuse.

Among hundreds of components in cannabis, CBD, a pain reliever, is one of the two most active, the other being tetrahydrocannabinol (THC) which produces the “high” or its psychoactive effects.

Backed by science

A report by the World Health Organization (WHO) says: “In humans, CBD exhibits no effects indicative of any abuse or dependence potential … To date, there is no evidence of public health-related problems associated with the use of pure CBD.”

There has been scientific proof that CBD — which is derived from the hemp plant, a “cousin” of cannabis — alleviates seizures in people with epilepsy.

One of the most recent studies was undertaken by Dr. Orrin Devinsky, a professor of neurology, neurosurgery and psychiatry at New York University (NYU) School of Medicine and director of NYU Langone’s Comprehensive Epilepsy Center.

Reducing seizure burden

“This new study adds rigorous evidence of cannabidiol’s effectiveness in reducing seizure burden in a severe form of epilepsy and, importantly, is the first study of its kind to offer more information on proper dosing,” said Devinsky, whose findings were published online on May 17, 2018, in the New England Journal of Medicine.

Undersecretary Benjie Reyes, a DDB permanent member, told the Inquirer that the WHO has recommended to the Commission on Narcotic Drugs (CND) — the DDB’s counterpart in the United Nations — to allow CBD with 0.2 percent THC to be reclassified in the 1971 United Nations Convention on Psychotropic Substances as Schedule 4, or substance with currently accepted medical use in treatment and has a low potential for abuse.

US approval

The Philippines is a signatory to the UN Convention on Psychotropic Drugs.

In a quick turn of events in 2018, the United States Drug Enforcement Agency  approved the legal use of CBD with 0.1 percent THC.

In the same year, the US Food and Drug Administration (FDA) approved the legal use of Epidiolex, a CBD oral solution manufactured by GW Pharmaceuticals, for the treatment of seizures associated with two rare and severe forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome — in patients 2 years of age and older.

This is the first FDA-approved drug that contains a purified substance derived from cannabis. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, who is a doctor.

Who can benefit

There were an estimated 250,000 children in the Philippines, as of 2014, suffering from epileptic seizure disorder, according to Dr. Donnabel Cunanan, a dentist and founding member and spokesperson for the Philippine Cannabis Compassion Society (PCCS), the lead advocate of House Bill No. 279.

If that bill becomes law, it will legalize and regulate the medical use of cannabis found to have beneficial and therapeutic uses in treating chronic or debilitating medical conditions.

It will also establish Medical Cannabis Compassionate Centers (MCCC), which are authorized to sell, supply and dispense medical cannabis to qualified patients or their caregivers through S3-licensed pharmacists.

‘No need for a bill’

“Actually, our position is, there is no need for a bill,” said DDB’s Reyes. “It can hasten (the process), if the legislature will pass the bill. We don’t have to wait for the CND decision because our local laws will take precedence.”

“But even without the law, as long as it’s in medicine form, it (CBD) can be registered,” he said. “Just like opiates, morphine, those are dangerous drugs, but in medicine form, it can be used. Cocaine is used for anesthesia.”

He said the DDB conducted public hearings with PCCS, specifically on the following points:

1) The reclassification of medicines containing CBD with no more than 0.1 percent THC from Schedule 1 (no currently accepted medical use in treatment in the Philippines) and Schedule 2 (has currently accepted medical use) to Schedule 4 (has currently accepted medical use in the Philippines and has low potential for abuse);

2)  Creation of guidelines for the DDB board resolution titled “Requirements for the Issuance of a License to Acquire, Possess and Use Unregistered Drug Products Containing Dangerous Drugs for Personal Use.”

“We adopted it in principle last December,” Reyes said.

“If Epidiolex is a recognized medication by the US FDA, why deprive Filipinos of the same medication?” he added.

Special form

But in the meantime, he said, “if you’re a doctor who wants to prescribe Epidiolex, you need a yellow prescription pad, a special form for prescribing dangerous medication. If the patient has relatives in the US, the relatives can buy the drug, as long as there is a prescription from the Philippine doctor.”

The drawback, for now, is that Epidiolex costs $32,500 per patient, enough for one year’s use.

Sen. Bong Go, chair of the Senate health and sports committee, is working to have a budget allocation amendment for the medication, Reyes said.

The plan, said Reyes, is to authorize the University of the Philippines College of Medicine to import Epidiolex, create a registry for patients who really need it, for them to have the drug for free.

“It will take some time because we need a budget allocation from the Senate,” Reyes said.

In a statement, the PCCS said: “It is a welcome development for ‘cannahopeful’ patients, their families, and advocates that cannabis is finally reclassified to Schedule 4. It recognizes that cannabis is medicine, and has low potential for abuse.”

Step in right direction

“Also, the efforts of the DDB, after talks in Malacañang, to create a mechanism for access to cannabis by patients is another welcome development. It departs from the intensely prohibitive stance of government bodies towards this plant that has the potential to heal and help so many people,” PCCS said. “We are hopeful that this step in the right direction will pave the way for affordable, safe, and available medical cannabis for all patients.”

Reyes believes cannabis “really has medical use.”

“But we need to be careful when we talk about medicine, because it has two sides—the good effects and the side effects. The benefits should outweigh the negative effects. But I’m sure, eventually, with technology, we can remove the impurities,” he said.