Big Pharma Is in a Frenzy to Bring Cannabis-Based Medicines to Market

By Paul Armentano, AlterNetPosted on July 5, 2008, Printed on July 6, 2008http://www.alternet.org/story/90469/
The US government's longstanding denial of medical marijuana research and use is an irrational and morally bankrupt public policy. On this point, few Americans disagree. As for the question of "why" federal officials maintain this inflexible and inhumane policy, well that's another story
One of the more popular theories seeking to explain the Feds' seemingly inexplicable ban on medical pot goes like this: Neither the US government nor the pharmaceutical industry will allow for the use of medical marijuana because they can't patent it or profit from it.
It's an appealing theory, yet I've found it to be neither accurate nor persuasive. Here's why.
First, let me state the obvious. Big Pharma is busily applying for -- and has already received -- multiple patents for the medical properties of pot. These include patents for synthetic pot derivatives (such as the oral THC pill Marinol), cannabinoid agonists (synthetic agents that bind to the brain's endocannabinoid receptors) like HU-210 and cannabis antagonists such as Rimonabant. This trend was most recently summarized in the NIH paper (pdf), "The endocannabinoid system as an emerging target of pharmacotherapy," which concluded, "The growing interest in the underlying science has been matched by a growth in the number of cannabinoid drugs in pharmaceutical development from two in 1995 to 27 in 2004." In other words, at the same time the American Medical Association is proclaiming that pot has no medical value, Big Pharma is in a frenzy to bring dozens of new, cannabis-based medicines to market.
Not all of these medicines will be synthetic pills either. Most notably, GW Pharmaceutical's oral marijuana spray, Sativex, is a patented standardized dose of natural cannabis extracts. (The extracts, primarily THC and the non-psychoactive, anxiolytic compound CBD, are taken directly from marijuana plants grown at an undisclosed, company warehouse.)
Does Big Pharma's sudden and growing interest in the research and development of pot-based medicines mean that the industry is proactively supporting marijuana prohibition? Not if they know what's good for them. Let me explain.
First, any and all cannabis-based medicines must be granted approval from federal regulatory bodies such as the US Food and Drug Administration -- a process that remains as much based on politics as it is on scientific merit. Chances are that a government that is unreasonably hostile toward the marijuana plant will also be unreasonably hostile toward sanctioning cannabis-based pharmaceuticals.
A recent example of this may be found in the Medicine and Health Products Regulatory Agency's recent denial of Sativex as a prescription drug in the United Kingdom. (Sativex's parent company, GW Pharmaceuticals, is based in London.) In recent years, British politicians have taken an atypically hard-line against the recreational use of marijuana -- culminating in Prime Minister Gordon Brown's declaration that today's pot is now of "lethal quality." (Shortly thereafter, Parliament elected to stiffen criminal penalties on the possession of the drug from a verbal warning to up to five years in jail.) In such an environment is it any wonder that British regulators have steadfastly refused to legalize a pot-based medicine, even one with an impeccable safety record like Sativex? Conversely, Canadian health regulators -- who take a much more liberal view toward the use of natural cannabis and oversee its distribution to authorized patients -- recently approved Sativex as a prescription drug.
Of course, gaining regulatory approval is only half the battle. The real hurdle for Big Pharma is finding customers for its product. Here again, a culture that is familiar with and educated to the use therapeutic cannabis is likely going to be far more open to the use of pot-based medicines than a population still stuck in the grip of "Reefer Madness."
Will those patients who already have first-hand experience with the use of medical pot switch to a cannabis-based pharmaceutical if one becomes legally available? Maybe not, but these individuals comprise only a fraction of the US population. Certainly many others will -- including many older patients who would never the desire to try or the access to obtain natural cannabis. Bottom line: regardless of whether pot is legal or not, cannabis-based pharmaceuticals will no doubt have a broad appeal.
But wouldn't the legal availability of pot encourage patients to use fewer pharmaceuticals overall? Perhaps, though likely not to any degree that adversely impacts Big Pharma's bottom line. Certainly most individuals in the Netherlands, Canada, and in California -- three regions where medical pot is both legal and easily accessible on the open market -- use prescription drugs, not cannabis for their ailments. Further, despite the availability of numerous legal healing herbs and traditional medicines such as Echinacea, Witch Hazel, and Eastern hemlock most Americans continue to turn to pharmaceutical preparations as their remedies of choice.
Should the advent of legal, alternative pot-based medicines ever warrant or justify the criminalization of patients who find superior relief from natural cannabis? Certainly not. But, as the private sector continues to move forward with research into the safety and efficacy of marijuana-based pharmaceuticals, it will become harder and harder for the government and law enforcement to maintain their absurd and illogical policy of total pot prohibition.
Of course, were it not for advocates having worked for four decades to legalize medical cannabis, it's unlikely that anyone -- most especially the pharmaceutical industry -- would be turning their attention toward the development and marketing of cannabis-based therapeutics. That said, I won't be holding my breath waiting for any royalty checks.
Oh yeah, and as for those who claim that the US government can't patent medical pot, check out the assignee for US Patent #6630507.

Paul Armentano is the senior policy analyst for the NORML Foundation in Washington, DC.

Prescription Drug Use in America

The Startling Numbers And Their Implications

In 2002, Americans filled 3,340,000,000 outpatient prescriptions.1 That's 12 prescriptions for every man, women, and child in America. Has the American dream become 2 kids, 2 cars, and a dozen drugs in each person's medicine chest?
Despite a cold economy in which most industries have seen sales drop, U.S. drug sales increased substantially in 2002, reaching $219 billion. According to NDCHealth, overall drug sales (all sources) grew 12% 2002, 18% in 2001, and 15% in 2000 (based on wholesale acquisition costs). 1
The trend of doctors writing more and more outpatient prescriptions each year continues without pause: 1,2

2002: 3,340,000,000 Rx
2001: 3,200,000,000 Rx
2000: 2,979,000,000 Rx
1999: 2,821,000,000 Rx
1998: 2,523,000,000 Rx

The cost of these drugs has more than doubled in five years.
The outlook for the future? According to Pharmacy Times last year: "For the past 3 years, prescription volume has grown by 25% in the United States, and there doesn't appear to be a slowdown in sight."2
I'm not anti-medication. Medications do a great deal of good, but we must ask, what is the goal of the drug industry? To simply sell as many drugs as possible? Yet, medications aren't like other commodities. Prescription drugs aren't the same as cars, cosmetics, or CD players. Drugs have direct, powerful effects on human systems. Some of these effects are negative, and taking multiple drugs -- as 25% of Americans do -- increases the risks exponentially. Psychologically, the growing attitude that drugs are the answer for every ache and angst is destructive for individuals and societies.
Prescription medications are vitally important for treating medical conditions, but they are also the #4 leading cause of death, cause more than 1 million hospitalizations annually, and are a major cause of disability and drug dependency.3 Over-use of medications is rampant.
Many doctors treating high cholesterol and high blood pressure turn to drugs without ever discussing diet and exercise, although many of these disorders are nutritional, not medical. Many patients prefer a pill to changing harmful habits. With drug advertising everywhere, what is the message being drummed into us and our children: that for every symptom and sensation the solution is a pill?


"The drug industry has been the most profitable industry by far year after year. Drug companies need profits to conduct research, but how much is enough, when most profits go to marketing, promotions, and the development of unneeded me-too drugs?"



The drug industry has been the most profitable industry by far year after year. Last year, Public Citizen stated: "While the overall profits of Fortune 500 companies declined by 53% [in 2001], the top 10 U.S. drug makers increased profits by 33%. These companies had the greatest return on receipts, reporting a profit of 18.5 cents for every $1 of sales, which was eight times higher than the median for all Fortune 500 industries."4
Meanwhile, drug costs are driving health insurance expenditures and your premiums through the roof. They are driving thousands of people to Canada and Mexico for drug prices they can afford. For many people, it comes down to medications or food. For many healthcare systems, Rx drugs cost more than all of their doctor visits or hospitalizations combined. Drug companies need profits to conduct research, but how much is reasonable, especially when the greatest proportion of these profits go to marketing, promotions, and the development of unneeded me-too drugs?
Here are the big $ales winners in 2002:

1. Lipitor (cholesterol-lowering): $5.58 billion (up 18%)
2. Zocor (cholesterol-lowering): $4.069 billion (up 18%)
3. Prevacid (ulcers, reflux): $3.894 billion (up 4%)
4. Prilosec (ulcers, reflux): $3.341 billion (down 22% after going generic in 2002)
5. Procrit: >$2 billion, exact numbers N/A
6. Zyprexa (neuroleptic): $2.716 billion (up 15%)
7. Paxil (SSRI antidepressant): $2.509 billion (up 13%)
8. Zoloft (SSRI antidepressant): $2.445 billion (up 13%)
9. Epogen: >$2 billion, exact numbers N/A
10. Celebrex (anti-inflammatory): $2.380 billion (up 5.3%)
11. Nexium (ulcers, reflux): $2.000 billion (new drug)
12. Neurontin (seizures, pain): $2.000 billion
13. Norvasc (antihypertensive): $1.814 billion (up 5%)

Prescription drug use and costs are like a runaway train. Where is it heading? Can we, should we, try to slow it? Is there an optimal balance between effective medication use and overmedication? Can we find it?
The mission of this newsletter and website is to discuss issues about drug use, drug safety, and proven-effective alternative methods that mainstream medicine and the media ignore. These issues affect every family in America and the developed world. I'll have a lot more to say on these issues in subsequent newsletters.


References:
1. NDCHealth, a healthcare information services company. Atlanta, GA, Apr. 1, 2003:www.ndchealth.com.
2. Top 10 Drugs of 1997-2001. Pharmacy Times, April editions in respective years.
3. Lazarou, J, Pomeranz, BH, Corey, PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA, 1998 Apr 15, 279(15):1200-5.
4. Public Citizen. Pharmaceuticals Rank As Most Profitable Industry, Again. Public Citizen, 4/18/02:citizen.org.