Marijuana And The Pharmaceutical Industry

By Louis Garguilo, Chief Editor, Outsourced Pharma

An intense shot of pain in my back and side dropped me to the floor. It did not subside. We called 911. A single dose of morphine eased the pain enough so the EMTs could put me on a gurney and into the ambulance for the ride to the emergency room. As I lay in the ambulance my mind wandered.

Morphine is espoused by patients with extreme pain, such as those recovering from major operations like mastectomies. Therefore, anyone over 21 years of age should be able to legally raise poppy plants and/or buy morphine for “recreational” use in their home. We’ll closely monitor any health or other social effects, such as teenage use and car accidents. Sound like a reasonable argument? If not, is there a difference between this thought process and the one of those advocating for legalizing marijuana in the U.S.?

For me it turned out to be a sudden onset of severe sciatic nerve pain from a bad back and hip. I’m fine but for growing older less gracefully than I would like. I have, though, continued my ambulance musings.

Morphine is not marijuana. We all get that. But in one sense, as described by the current president of the United States in a video taped in 2013, it is:

"If it’s an issue of doctors prescribing medical marijuana as a treatment for glaucoma or as a cancer treatment, I think that should be appropriate because there really is no difference between that and a doctor prescribing morphine or anything else."

The president’s point is specific to the use of medical marijuana, which as a schedule 1 drug is illegal to administer under U.S. federal law. Morphine is a schedule 2 drug; pharmacists can sell it and it can be administered without fear of prosecution. This classifies marijuana more dangerously than cocaine or methamphetamine, as well as morphine, all listed in Schedule 2 because of recognized medical uses. Some courts in the U.S. have ruled that the research needed to move marijuana out of Schedule I does not exist.[1]^,[2]

The point of this column is not the president’s, though. It is rather the thought that the medical use of marijuana and any potential reclassification to schedule 2 is being obfuscated by proponents of full legalization in the U.S., and thus seemingly detrimental to continuing scientific debate. Potentially, the pro-recreational-use lobby is actually hindering further clinical study and maybe even the availability of the drug to healthcare patients.

On almost any given day in the U.S. you can read or hear statements like:

• Marijuana is analogous to morphine or other drugs in a clinical setting or otherwise for medical use (the president’s point)
• But then again it isn’t if you want to use it recreationally – in that case it is like alcohol.
• Actually, no: It somehow is less harmful than alcohol.
• And compared to tobacco – which some of the same marijuana proponents have argued to make virtually illegal in the U.S. – marijuana is more spiritual, like some biblical manna from the heavens. Maybe we should call it marimanna.

However, marijuana is not a comparison or a special gift from heaven: It is its own drug with a number of active ingredients.  What have the pharmaceutical companies said about this drug, and about what is transpiring in the U.S., including the state-by-state drive for medical marijuana as well as full legalization?

What Says the Pharma Industry?

Up to now, we have heard very little from the pharma companies, and for understandable reasons. One of the reasons is this subject of obfuscation by the full legalization movement disrupting the potential U.S. pharmaceutical market. You can’t seem to talk about the medical side without either support – often unwanted – or condemnation from vociferous groups in the U.S. and covered by media interjecting the recreational and legalization issue. Whether it is fair to do this or not, the situation will continue to super-charge the political climate and make this more or less an untouchable clinical pursuit.

Other reasons include new evidence of health risks. As reported by the Agence France-Presse (AFP), a recent study by French researchers found young adults who smoke marijuana may be at risk for serious or even fatal heart problems. Although the risk of heart complications appeared small (2% or 35 people) in the study of nearly 2,000 people who sought medical attention for complications related to marijuana from 2006 to 2010, of concern was the high death rate. One in four of the patients with cardiovascular complications died, said the researchers.

"The general public thinks marijuana is harmless, but information revealing the potential health dangers of marijuana use needs to be disseminated to the public, policymakers and healthcare providers," said lead author Emilie Jouanjus, a medical faculty member at the Centre Hospitalier Universitaire de Toulouse in Toulouse, France. "There is now compelling evidence on the growing risk of marijuana-associated adverse cardiovascular effects, especially in young people," Jouanjus said.

Valentin Fuster, director of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital, said the study appeared to support some observations he has made at his own clinic in New York City. "I am concerned about cannabis because we are running a clinic of young people who come to us with coronary artery disease. I have seen a number of cases in whom I was not able to identify any other risk other than the use of cannabis," said Fuster, who was not involved in the research.

"So I think this registry in France supports the issue that cannabis is not free of danger."

Allen Taylor, professor of medicine at Georgetown University School of Medicine, said the overall risk of heart problems from marijuana remains unclear.

"This study shows some preliminary evidence of cardiovascular harm from marijuana but isn't conclusive.” Taylor said more research needs to be done.

"It is a shame that we simply don't know more about a substance that potentially carries the risk of serious bodily harm. It seems that public perception is ahead of the science. We should remain open to the scientific facts as they evolve."

Citing a single study (to gain points for a premise) is not the purpose of noting this trial. Taylor’s point above is salient: research cannot be overlooked and this new data demonstrates again the importance of continuing study, uninhibited by societal and political interference. It just seems the clinical process should be advancing more whole scale, here in the U.S particularly.

Forces for Legalization

A search of on-line media articles and reports about marijuana will show you they gather the largest amount of reader comments. Many of the comments spill vitriol towards the pharmaceutical industry. One charge leveled repeatedly is that the pharma industry is against legalization so it can control the drug and limit availability to increase their profits. In other words, some recreational-use proponents are averse to treating the drug as we would any other substance with potential therapeutic use: Get credible trials through the clinic and let the FDA make a ruling.

Is this implied hindrance of scientific investigation merely a theoretic assertion? Here’s a note from January on The Motley Fool investor website about one pharmaceutical company who has taken medical marijuana through clinical study (Italics/bold have been added):

“GW Pharmaceuticals entered an agreement with French pharmaceutical company Ipsen to promote and distribute Sativex, its controversial cannabis spray, in Latin America…Sativex is used to treat spasticity in multiple sclerosis (MS) patients, and has been approved in 24 countries, primarily across Europe. Sativex is also being tested in phase 3 trials as a cancer pain treatment. GW is also focused on eventually expanding into North America, where it is partnered with Otsuka Pharmaceuticals for phase 3 trials, but faces strong regulatory headwinds due to the controversial nature of medical marijuana.”

This is from a source with no skin in the game, so to speak, other than to look objectively at public companies and viable business models. For patients with painful cancers in the U.S., the usurping of the medical-evidence based, clinical observations on the positive and/or negative effects of natural cannabis for medical reasons by those asserting the right to the drug, this can only be a frustrating state of affairs. Shouldn’t there be the right to run the phase 3 trials to drain out some of the controversy and unknowns? In a twisted irony, could those who would benefit most from knowing more about marijuana actually be applying a negative bias to organizations and drug makers that dampens the pace of study and advancement? Shouldn’t the pro-legalization forces reach out and partner with pharmaceutical companies? Assuredly, the lack of debate and study is frustrating to some on all sides of the issue, and a concerted effort would certainly prove more effective than the current state of affairs in the U.S.

A New York State of Mind

In the U.S., there is now a state-by-state approach to the issue of marijuana, which in most cases directly contradicts U.S. federal law. I (and I’m sure others reading this) will find it surprising that perhaps New York State, progressive and overall liberal (particularly because of the influence of New York City on all state-wide issues), appears to be having a low-octane, steady and even conservative scientific discussion of marijuana.

NYS lawmakers have rewritten an initial piece of legislation that now allows but limits the use of medical marijuana to conditions including cancer, HIV, AIDS, PTSD, multiple sclerosis and Parkinson’s disease.  Patients under the age of 21 cannot smoke the drug; it must be administered via oil form or vaporizer.

Regarding the assertion by Professor Taylor from Georgetown that public perception is ahead of the science, the most recent Siena College poll found that support for legalized medical marijuana by New Yorkers is only about half, at 51%. So perhaps “public perception” is skewed by a vocal and well-covered sub-group.

The Clash of Culture and Science

The complexity of the marijuana debate here in the U.S. only continues to grow, fueled by:

• Recreational use by generations of Americans who now want their drug legalized – based in some cases on personal experience with long-term use
• Some clinical evidence of therapeutic pain relief and other medicinal effects
• The federal government appearing to stand by as the states make their own policies
• And an uneven and at times unfair application of drug laws in courts throughout the U.S.

All this, and we have not even talked about what used to be the foremost buzzword on the subject: decriminalization.

And what about clashes of interest groups and lobbies, such as those supporting tougher anti-drunk driving laws vs. the growing power of those for legalization of marijuana? Is all this holding back the advancement of clinical research and drug development and market strategies by pharma companies?

It does seem clear that the issues surrounding both medicinal and recreational marijuana have become an avenue for some to unfairly criticize pharmaceutical companies, and somehow juxtapose a distrust of the “drug industry” for the actual need of the advancement of science. Again, if we think about who gets hurt here, it is those with medical ailments who might benefit from continued serious clinical investigation. Science should help bring the culture together, not separate it.

Those in favor of marijuana use of course benefit from more knowledge, and somehow should be working with, or even petitioning pharma to pressure federal drug agencies to allow continued (or actively start) clinical investigation. As things stand now, it is no wonder the pharma companies are for the most part quiet on this front.

Perhaps we should leave this subject with two lines from a Mayo Clinic Proceedings report titled “Blurred Boundaries: The Therapeutics and Politics of Medical Marijuana”[3]:  

“Very few drugs, if any, have such a tangled history as a medicine. In fact, prejudice, superstition, emotionalism, and even ideology have managed to lead cannabis to ups and downs concerning both its therapeutic properties and its toxicological and dependence-inducing effects.”

“In each of these respects—recreational vs medical use, benefit vs harm of use, laboratory research and pharmacologic application vs federal restrictions, and state vs federal law—boundaries blur. Contradictions and paradoxes emerge.”

One of those paradoxes is that the pro-legalization group, by singling out pharma as a negative in this overall dysfunctional dance, and tangling medical with recreational purposes, may actually be delaying the advancement of the scientific study of the use of marijuana.