He and his company, Cannabis Science, hope to one day make marijuana available nationwide to kids and teens — as well as adults — in the form of a medicinal throat lozenge.
While medical marijuana has garnered a great deal of attention lately in helping patients deal with chronic pain, Melamede has another application in mind; he believes it can curb death risk from the swine flu.
The approach relies on the principle that the chemicals in marijuana known as cannabinoids have a dampening effect on the immune system. Melamede said doctors may be able to take advantage of this effect to curb the risk of death from the immune system overdrive that resulted in many of the deaths of young adults during the 1918 influenza pandemic — a scenario that some worry could occur once more if swine flu were to become more virulent.
It’s a controversial approach — and few infectious disease experts believe health officials will be quick to approve marijuana prescriptions for sick kids. Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City, is one expert who is troubled by the implications of “giving out THC like water.”
“I don’t think many parents would want their kids ‘on drugs’ for a mild, flu-like illness,” he said, “and it’s sure to raise hackles with the anti-drug people.”
Still, Cannabis Science, an emerging pharmaceutical cannabis company of which Melamede is president and CEO, is working on an edible form of medicinal marijuana that its officials think will help treat many infectious diseases, swine flu included. Last month, the company announced its intention to apply to the U.S. Food and Drug Administration’s fast track approval process in the hope of making its anti-flu lozenge available for a possible second wave of swine flu.
Melamede said he has already tried the approach himself. In February, when he contracted a nasty flu — a bout he suspects was related to the H1N1 swine flu virus — he said he took medicinal marijuana to help his body fight it off.
The concentrated cannabis lozenge was an idea pioneered by Steve Kubby, who, up until two weeks ago, was himself the president and CEO of Cannabis Science. He, too, said he has self-tested his lozenge.
“Within half an hour of taking it, my runny nose, aching muscles and throat congestion are all significantly relieved,” Kubby said, adding that users of the lozenge will not get the “high” or “stoned” effects that come with smoking marijuana.
Though Kubby and the company parted ways over “financial differences,” new CEO Melamede is pushing forward on this idea with even more vigor.
“Contemporary antiviral medical technology is currently inadequate to meet the world’s immediate challenges,” Melamede said in a press release issued last week. “We believe that cannabis extract-based medicines can reduce influenza deaths.”
The fact that smoking marijuana suppresses your immune system has been known for years, but it wasn’t until recently that researchers began to realize that this suppression could be a good thing.
When you catch the flu, your immune system launches a massive attack on the virus that causes excessive inflammation. This is where the runny nose, sore throat and achiness come from.
While it is necessary for fighting off the virus, this overwhelming inflammation can start to kill your own cells and, if it gets out of hand, it can lead to organ failure and death.
When inflammation goes off the handle, the body releases endocannabinoids, which are natural chemicals that suppress the immune system, taking down the inflammation before it does more harm than good. This endocannabinoid system, as it’s called, is one of the many systems responsible for maintaining balance and health in the body.
In more severe strains of the flu, like avian flu, the endocannabinoid system can’t always keep up. When this happens, the organs, particularly the lungs, fail.
“They die not from the virus itself but from their own immune response,” Melamede said.
This is where, according to Cannabis Science, marijuana comes in. Because the marijuana plant contains natural, plant-based cannabinoids, called phytocannabinoids, giving cannabis to someone with the flu supplements their body’s endocannabinoid system and helps take down the inflammation.
But could it work for swine flu? Though the current and ex-CEO might not meet eye to eye on many things right now, both feel that the potential for using marijuana for serious strains of the flu, like H1N1, is enormous.
“It’s such a changeable virus that vaccines might not work,” Kubby said. “But changing the way our bodies respond to the virus [with cannabis] does work.”
While marijuana’s anti-inflammatory properties are widely accepted as a treatment for glaucoma or arthritis, its use as an antiviral raises eyebrows even among pot-friendly physicians.
“Though it may have some antiviral effects, these have not been proven scientifically,” says Dr. David Allen, a chest surgeon and cannabinoid research scientist from California.
Even if suppressing the immune system were the key to fighting off the ravages of swine flu, Horovitz points out, “there are many other immune modulators already on the market that are not derived from illegal substances.”
Dr. Peter Katona, a member of the FDA’s advisory committee on new antibiotics, shares the apprehension, saying, “I must be skeptical until there is more data”.
And given that parents, not to mention the federal government’s war on drugs, are trying to get kids to “just say no” to marijuana, Melamede’s company will face an uphill climb. Though Kubby noted that the lozenge is a special formulation that acts differently in the body than inhaled marijuana, to get the FDA on board with giving an illicit substance to kids, Cannabis Science will need to put forth a pretty compelling case for the drug’s potential.
Though it’s still early in the development of this potential drug, since Steve Kubby left the company two weeks ago, Cannabis Science has gone into marketing overdrive, publicizing its “talks” with the FDA and broadcasting the company as a hope for the shaky future of the swine flu pandemic.
Mary Ruwart, who recently left the company along with Kubby, thinks that Cannabis Science might be putting the cart before the horse. The preliminary studies required to apply for FDA clinical trials take months to complete, she said, and “since these studies were not even on the drawing board when I left three weeks ago, they cannot have been completed.”
When asked about this publicity, Kubby said he finds it “damaging to the mission” and feels that Cannabis Science is “not playing by the rules,” by publicizing the talks as though the FDA were already onboard.
Though no longer with the company, Kubby plans to continue his work on the lozenge, which he claimed he has the exclusive rights to.
“It’s a mystery to me how [Cannabis Science] think[s] they are going to use this technology,” he said.
But Melamede denied this, maintaining that the rights are the property of the company and hence are his to develop. Either way, both men are moving forward with the technology in the coming months, but it will be a couple years — if at all — before edible products like the cannabis lozenge make it through the FDA’s clinical trials.
Whether marijuana will make the shift from being smoked in the parking lot of the corner drugstore to gracing its shelves remains unknown.
One thing, however, is clear: Smoking marijuana in lieu of the lozenge likely will do much more harm than good if you happen to have a respiratory infection — not to mention that smoking anything is damaging to someone with flu-related respiratory ills.
As Horovitz put it, “No doctor in his right mind would tell a flu patient to go smoke a joint.”