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April 2006
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Why the FDA is irrelevant

First, it’s important to note (as major media outlets have already) that the recent controversial FDA comments were politically motivated, were wrong, and ignored scientific evidence.
But it’s also important to understand that, in practical terms, the FDA’s opinion regarding medical marijuana has as much relevance as if they had made a statement regarding whether ice cream tastes good.
And here’s why.
The purpose of FDA approval of medicines is to insure their safety and efficacy. In fact, versions of the phrase “safe and effective” were used 8 times in the FDA release. So let’s take a look at those two terms.
Efficacy is another way of asking “Does it work?” Why this is important to know is that choices are made in medical treatment. If you choose one course and it’s not effective, then you may not be following a course that is effective. In treating major illnesses, this could mean life or death.
The prime example here is the controversial drug laetrile, an un-approved drug derived from apricot pits which was promoted heavily as a cure for cancer. By most scientific evidence, it did not work, and it meant that desperate patients who were looking for a cure and turned to laetrile may therefore have missed out on treatments that were less radical, but might have provided some value. Preventing “quack” cures is therefore a logical reason for the FDA’s efficacy standard (although there are also those who say that a government agency is not the right solution to that potential problem).
It is also important to understand the difference between a cure and a symptom reliever. Laetrile was promoted as being a cure for cancer, and that made its overall efficacy critical. You needed verifiable and reproducible data — you couldn’t just decide on an individual case-by-case basis to use it, because by the time you found out whether it worked or not, it was likely too late to do anything about it. A symptom reliever, on the other hand, gives immediate feedback.
When people have a cold, many of them take chicken soup as “medicine.” As far as I know, chicken soup is not an FDA approved medicine, and it’s not certain that it has any actual medical value. But there is no “cure” for a cold — all you can do is try to relieve the symptoms so you can function through the course of it. If chicken soup makes someone feel better when they have a cold, then it is an effective symptom reliever. No other measurement is necessary.
The same is true, for the most part, with medical marijuana. While there is a ton of fascinating potential for marijuana to function as a “cure” in some conditions, and much more research needs to be done (and not blocked by the FDA) to learn about this potential, the primary current use of medical marijuana is as a symptom reliever. It is used to reduce nausea for those taking toxic drugs during chemotherapy treatments. It is used to reduce pain in a variety of conditions. In all of these cases, it is not necessary to conduct large studies to prove efficacy.
Different symptom relief treatments work for different people, and the best way to determine the best treatment is between patient and doctor. And it’s very easy. Let’s say that you have nausea from chemotherapy that is preventing you from taking or keeping down necessary medicine. So you try marijuana. If it doesn’t work, then you and your doctor try something else. If it works — if it relieves the nausea so you can take your other medicine — then it is efficacious. Period. Regardless of what the FDA says.
And medical marijuana has been proven to work in thousands of cases.
The only question is whether it works on its own, or whether it works psychologically (you believe in it so it works). Testing of new drugs uses control groups with placebos to measure this factor, and in the case of very expensive drugs, this information is useful even with symptom relievers (why spend thousands of dollars on something that only works because you believe it does?) But in the case of medical marijuana, it doesn’t matter. If it works because it works, or because you believe it works, it still works. And the cost is so minimal that, just like chicken soup, nobody really cares if it is only psychological.
So when drug warriors claim that the medical marijuana movement is perpetuating a “cruel hoax” on patients (the phrase has been used by many, from McCaffrey to Barthwell), they are clearly and obviously lying. There can be no cruel hoax when it comes to symptom relief. If something relieves the symptoms, then it was successful, and cannot be a hoax. The only thing “cruel” would be to withhold a genuine symptom reliever from a patient.
The second factor in evaluating medicines is “safety.” Chicken soup helps relieve cold symptoms, and is also safe (unless you’re allergic to chicken). But let’s assume for a moment that cyanide relieved cold symptoms. That would make it efficacious, but not safe. (Note: Laetrile contained cyanide, and several patients being treated with laetrile died of cyanide poisoning.)
So the FDA also checks medicine for safety through drug trials, which includes coming up with the often voluminous list of side-effects. Causing side-effects up to, or even including, death, is not necessarily an impediment to FDA approval, depending on the intended use (or the amount of political or economic pressure wielded by the pharmaceutical company).
With a new drug, testing for safety is important. You’d hate to take a medicine for headache relief, only to find out a few years later that it causes mutations and you’ve got a third arm growing out of your forehead.
Marijuana, however, is not a new drug. It has been used extensively for thousands of years. There has probably been more informal safety testing done on marijuana than any drug that the FDA has approved.
Where are the bodies? With thousands of years of use, there has not been a single fatality directly resulting from marijuana use. And with all the various studies that have been done, the worst that has been found is that heavy smoking of marijuana (if you choose that method of ingestion) can cause bronchial conditions (although not as much as legal tobacco).
So the real question is, with all the information we have, can a doctor make an informed decision as to the safety of marijuana for symptom relief? The answer is clearly “yes.” There’s very little that an FDA approval could add to the voluminous information we already have as to the safety of marijuana.
The FDA approval process may have some value insuring a control on the safety and efficacy of many pharmaceutical drugs, but when it comes to medical marijuana, FDA opinion is irrelevant, and their recent statement is nothing more than absurd political grandstanding.

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