If I were still practicing medicine, the laws of the State of Arkansas wouldn't allow me to prescribe the smoking of marijuana for my patients,... even though it might be the least costly and most effective form of treatment for their particular problem. That doesn't make good sense, does it?
Make no mistake,... lots of physicians feel the same way I do about the these irrationally restrictive laws. Some even quietly suggest to their patients that they might try marijuana to relieve their symptoms. But, they can't help them to legally obtain that marijuana,... and theyıre not standing up here with me today because,.. for them to speak out would threaten them with loss of their medical license and loss of their permit to prescribe control drugs. I don't fault these doctors for not being here.
If I were still in practice,.. I might not be here either. But I want those doctors who are still in practice to have the opportunity to prescribe for their patients in the most rational manner.
The government argument against them being able to do that, is often the claim that "more research is needed before we can safely allow patients legal access to this substance." That argument works for them because it seems reasonable to the average person. Most folks don't realize this same argument has been put forward for decades. So where is the research? Well, you need to understand what goes into getting permission to conduct drug research.
When a pharmaceutical company wants to test a new drug, they first develop a protocol,.. the procedure they will use to conduct those tests. They submit that protocol to the Food & Drug Administration (FDA) for approval and the FDA either approves it,.. assuming it meets basic scientific objectives,.. or they reject it,... usually with suggestions for change that would make it acceptable. Then, once approval is granted, the study begins.
For marijuana, however, those usual circumstances don't apply. The researchers who want to test marijuana's effectiveness must first write a letter of inquiry to the National Institute of Drug Abuse, or NIDA, before they apply to the FDA. NIDA doesnıt appear to be very friendly to the idea of marijuana research. For example, on at least one occasion, NIDA rejected a study proposal because the protocol had not been approved by the National Institutes of Health, or NIH, even though everyone knows that you canıt apply to the NIH until you have approval from NIDA.
Part of the reason for this convoluted and expensive process is the fact that marijuana is a controlled substance. In fact,.. marijuana is listed in the most restricted category of drugs,.. Schedule I. By definition,.. Schedule I drugs have no medical or research value,.. so this complicates the issue of doing marijuana research. And the fact that so little research has been done,.. is used as the primary reason for keeping marijuana listed as a Schedule I drug. Ever hear of a "Catch-22?"
Since the early 1980s, only one study has made it through this approval process. It was intended to show whether or not marijuana was useful in treating the wasting syndrome associated with AIDS. That study was approved only after the researcher agreed to change the objectives of the study to read: "What HARM marijuana might do to people with the AIDS wasting syndrome." Does that leave any doubt in your mind as to whether or not the federal government has a negative agenda regarding marijuana research?
But let's assume that you are a researcher and NIDA has approved your study proposal. You can now present your research protocol to the FDA for their approval. But the FDA has problems with protocols for marijuana research because, unlike new drugs developed in a laboratory, marijuana isnıt a single active substance. Natural plants like marijuana contain multiple active ingredients, and they work together in a synergistic way to create their beneficial medical effects. The FDA is still struggling to develop guidelines for researchers in writing protocols for studies involving natural plants like marijuana.
The Institute of Medicine issued its report last year, stating that marijuana DOES have legitimate medical uses,.. and that more research is needed because,.. for many patients,.. there is currently no alternative to smoked marijuana. Subsequently, the Department of Health & Human Services issued new guidelines which many scientists and health professionals agree have only made things worse. For one thing, those new guidelines require any marijuana research to address only medical uses for which there is no alternative therapy. This means that if I wanted to study marijuana's efficacy in pain relief,.. my application would most likely be turned down, since there are other pain relief medications already on the market.
The new guidelines also require that marijuana studies address only treatment of "serious or life-threatening" conditions. That means that if I want to study marijuanaıs use in the treatment of migraine headaches or Tourette's Syndrome,.. neither of which are considered "serious or life-threatening,"... approval would probably be denied.
But let's move on. Letıs say my study protocol was approved by the FDA. Next, I must seek the approval of the NIH, which also has grant-awarding authority. They could support my research with money,.. and there's a set of guidelines I must meet in order to qualify for that grant support. But even if I'm not requesting an NIH grant,.. I still have to pursue this lengthy and expensive NIH approval process.
Now, letıs assume Iıve jumped all these approval hurdles,.. I've set up my lab,.. and lined up the people who will participate in my study. It's time to request from NIDA my hard-won supply of legal federal marijuana to use in my study. NIDA grows the only legal marijuana in the country, on a farm in Mississippi. Any research I do must use marijuana from this farm even though, by all reports, it is of very low quality. It usually tests out at about 3-5% THC,... while typical black-market marijuana tests out at about 11% THC. Prime sinsemilla bud has been tested as high as 25% THC.
And I still face the prospect of NIDA telling me their supply is too limited to support my study. They are the only source I can use, and I can't tell them they have to grow more.
But we'll assume that NIDA did have an adequate supply and I, and others, can go to work on our research. The needed studies will take many months and probably years. Conservative estimates put the cost at 2 to 3 million dollars. That's a comfortable budget for research studies by a major pharmaceutical company which will wind up with a product they can sell,.. but not for me. And what happens when I finish my studies? Do I recoup my investment? NO! People will grow the plants in their own back yards. No one will make money as a result of our studies. And THAT'S one of the greatest benefits of marijuana as a medicine,.. it's a potentially free method of treatment!
Let's be honest. We live in a capitalist culture. What investor is going to put up 2-3 million dollars knowing they will get zero return on their investment,.. and that, in fact, they might in fact lose their investment entirely? And why are we even considering all this research when we already know that marijuana has been used for thousands of years,.. by millions of people,.. with apparent safety and effectiveness?
To the best of our knowledge,.. over the 5000 years of know marijuana usage,.. there has never been a dosage fatality or a recorded side effect of a deformed newborn. That's more than we can say for some of the drugs which have been sanctioned by the FDA approval process. But because these facts haven't been scientifically verified through controlled studies, the government clings to the notion that not enough research has been done.
Even when the government has the opportunity to establish the reality of marijuanaıs benefits, it fails to do so. In the late1970s, the federal government began a program which allowed certain people to have marijuana as medicine. These people, along with their physicians, applied for admission to a special FDA program called the "Investigative New Drug" program, or IND. The purpose of the IND was to allow compassionate use of unapproved drugs in extreme cases of medical necessity. And so the few patients whose doctors were willing to help them through the complicated IND application process, began receiving 300 marijuana cigarettes a month from the NIDA farm in Mississippi. One would think the governmentıs interest in having more research on this substance would have prompted them to follow these patients and study the effects of their smoking marijuana,... but this has not occurred.
The first man to enter that IND program, Bob Randall, had been diagnosed with glaucoma in 1975, and was told he would lose his sight within 3 years. Now,.. 25 years later, Mr. Randall can still see, and is in good health despite the fact that he still smokes up to 10 marijuana cigarettes a day,.. but the government agencies involved donıt seem to care. It appears that under the current drug czar policies,.. any substance which was ever used recreationally should be banned completely, without any consideration of it's potential benefits under controlled use,.. as prescribed by a physician.
The only apparent recent change in federal policy is that, as a result of public pressure, they are now urging pharmaceutical companies to develop synthetic marijuana products. This ignores the fact that any such product synthesized and offered on the market will certainly not be as affordable as marijuana,.. and is unlikely to be as effective.
I feel strongly that medicinal marijuana research should proceed as expeditiously as possible, without the restrictive caveats currently imposed by the Department of Health and Human Services. I have written to the Secretary of HHS, Donna Shalala, to urge her cooperation in that effort.
Until such research completely verifies the safety and efficacy of marijuana ,.. which by all accounts could be years,.. people who could legitimately benefit from its use should not have to worry about being arrested for smoking marijuana,.. or risk having their homes and property seized if they grow their own supply. If an individual stands to benefit from the use of marijuana, and is willing to risk its use, knowing it has not received the FDA stamp of approval,.. that decision should be between the patient and his or her physician.
If you agree with me,.. please write your state legislators to let them know how you feel or, at least, consider signing the petition to put the Arkansas Medical Marijuana Act on the ballot.
Media Copy of a May 13, 2000 presentation by Dana Copp, MD