DarthKeller's Blog

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Posts Tagged ‘FDA’

Why I Approve of the FDA

Posted by darthkeller on February 26, 2010

I’m writing this post in answer to this article. Before I begin, please allow me to state for the record: I respect Dr Melissa Clouthier. This is not an article attacking her, this is just an answer to her opinion on the subject matter. She has opinion “A”, I have opinion “B”, nothing more.

I hate to do it Mel, but I have to disagree with you. I don’t have the numbers, but my wife might since she’s the pharmacist, but her take on a drug being approved by the FDA only to find out there was a problem that was not foreseen is this: Without FDA approval, no side-effects would be known, so everything you take would be a “best guess” as to whether or not it’s safe.

For example: Take Chantix (I know this drug since I was a smoker) – This drug had several known side effects from the amount of testing that it had to go through in order to have “FDA Approved” stamped on it. But, they were giving this drug to 1000, 2000, maybe even 5000 people during their drug trials. Since it was released, it has been prescribed (based on the wife’s “sources”, which I guess are super-secret pharmacist sources… not real sure) MILLIONS of times! It was only AFTER launch that they realized this drug can cause suicidal tendencies. Did the company that makes Chantix miss something? Did the FDA? No. “Millions” of people is a slightly larger sample size than 5000, and with that increase in sample size, you get an increase in data, which was used to determine that there was a side-effect which was missed. It happens to almost all drugs which are “prescription” based.

Why is there such a difference? Simple: It’s the type of people that are chosen for the drug trials. Based on discussions with Raven, the first round of drug trials that take place are done on people that are taking no medication, and are not using this drug for anything (to continue using the Chantix metaphor, they give the drug to NON-SMOKING, healthy, volunteers such as med students, pharmacy students, college students, etc). From this they get a “starter set” of side-effects. The people are generally healthy, so they have a good base-line to start with.

The second round will generally include people that are “healthy” but ARE smokers. This way they can determine the drug’s effectiveness. This is why, when looking at an ad for Chantix, you see “Smokers were able to quit XX% more effectively versus placebo”. A second gain of step 2 is this: Dosing. This is determined by giving thousands of patients varying amounts, at varying times, charting and plotting each and every data point. The end result: A nice label on your bottle which says “Take X tablets X times a day.”

A third, fourth, fifth round of testing may be necessary, but even those might not hit upon a particular person’s physiology. For example: I’m approximately 5’9″ tall, and I weigh 250 lbs. This puts my BMI at just over 37, which is OBESE. I haven’t been to a doctor since I was last sick, and at that time I was a smoker, but my blood pressure was still within normal range. For an obese smoker to have normal blood pressure is pretty rare. I doubt they would’ve been able to test Chantix on someone like that. So of course it will react differently in my body than in Test Subject 123.

I have taken Chantix on two different occasions (long story, not getting into it here) and not one time did I feel suicidal (the first time I took it, suicide was not listed as a side-effect). I had some AWESOME DREAMS, but no suicide. Friends that I have that have also taken it didn’t experience “vivid dreaming”. To say that the FDA is a failure because they did or did not find every side effect is unfair.

I hate having government control over stuff, I want the smallest government possible. But, this is the one time where the government model of red-tape and paperwork actual benefits us. A company simply cannot throw chemicals together in a beaker and call it a drug. It has to go through a rigorous amount of testing, then paperwork, then more testing, then red-tape, then even more testing, so that when it finally hits the shelf, it’s “safe”. I understand that all prescription drugs have a risk associated with them. Here’s the dirty little secret, natural supplements have some of the same risks, you just never hear about them, until it’s too late. I would rather KNOW that when I take my penicillin that the company has been looked at again and again by SOMEONE. The “free-market” system is great for a LOT of things, but the only way to know that COMPANY X, which makes the particular pill that I’m about to swallow, isn’t run by a tweaker with no more knowledge about pharmaceuticals than I have, is to have SOMEONE look into them. I would prefer that someone be unbiased, with my well-being as their sole-concern.

The only way a free-market system can work is to have success and failures, and when it comes to drugs, “failures” often means death. That is simply not a risk I will take. This is why, of all the pharmacists I know (and I know a lot since most of Raven’s friends are also pharmacists), they have all said that they will NEVER take anything that has not been FDA approved.

In almost all cases, the companies that produce natural supplements would seek FDA approval, that is, if they had any hope of actually proving the truth of the claims on the bottle. Why? Because with that seal of approval, your product gains credibility in the medical profession.

I know the FDA isn’t perfect. It’s a government agency which means it’s subject to the same abuses as are all other agencies. However, I would rather have a wooden damn protecting me from the raging river than no damn at all.

To close: Again, this is not an attack on Mel, even though it might sound like it. This is just one area of medicine that I have some clue as to what is going on, since I speak with Raven about her career quite often. If you feel as though I’ve missed something, please let me know, I’d be glad to hear about it.

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