Sunday, December 13, 2009

Medicine: SNAFU

Have you ever wondered about the medicines in your medicine cabinet? All those pills that come in different shapes and colors. In tablets and capsules and liquids. Do you ever stop and really think about them? After all, they are in essence chemicals. Synthesized molecules meant to perform certain functions. To a chemist there is pharmacokinetics to be considered. To the public there is only, “what dose will work?” and “what side effects are there?” After all, how complicated is acetaminophen or Tylenol? Or loratadine or Claritin? Most of us learned how to dose these medicines either from our family and friends or by reading the bottle. So what’s the big deal? Apparently, the FDA and bandwagon jumpers would have you believe there is a big deal that concerns your health. And because you are such an ignorant fool, they have to protect you from it.

Pharmaceutical companies spend billions on research and development of medications. It exceeds even that spent on marketing, though not by much. As part of the research, different doses are tested, and efficacy, metabolism, and adverse reactions are all tracked, so that a dose that optimizes all three factors can be determined. It is this dose that is ultimately seen on the shelves of your pharmacy. Take Tylenol, for instance. After much testing, it was determined that doses of 325mg was enough to allow treatment of pain. For pain that is more severe, a 500mg dose was also created and marketed as “extra-strength”. In the medical world, as “extra-strength” Tylenol was not always available, 2 regular tabs were used for pain, giving 650mg Tylenol. And for severe fevers, 1000mg, or 2 “extra-strength” tabs were used. Eventually, this practice trickled to the public, and it became commonplace to take 2 regular Tylenol for pain, resulting in 650mg of Tylenol. In the same way, doubling the “extra-strength” dose also became commonplace.

Now fast forward to today. Given some newfound concern over Tylenol toxicity, someone had made it his or her personal mission to bring the dangers of Tylenol to the forefront of medicine. And because of those efforts, the FDA has decided to remove the “extra-strength” dose of 500mg Tylenol from the shelves. It will still be available, but only by prescription. Now what in the world is the point of that? And more importantly, what sort of commentary is that on the American public? If you needed pain control and chose to use Tylenol, and decided to take 500mg because that is what has worked for you in the past, you would find that 500mg is no longer available. Would you then take 325mg of Tylenol? Of course not. You would take two 325mg tablets for a total of 650mg of Tylenol, effectively increasing your ingestion of Tylenol overall. How does that help to prevent toxicity?

Do you remember anything other than a news snippet about Tylenol this year? I don’t. But yet there will be a paucity of “extra-strength” Tylenol at your local store next year. What does that tell you? It tells me that the FDA thinks the American public is composed of 60% morons and 40% idiots. They truly believe that the best and perhaps only way to alter human behavior is to change the environment in which they live. The problem is that people can do simple math and realize that 325mg Tylenol will not cut it for pain control, so the next best thing is to double it. The best way to have handled Tylenol would have been to educate the public about it’s potential for toxicity, so that taking 650mg of Tylenol is not such an easy reflexive decision.

Let’s look at another “mission” for healthcare reform. Take Dennis Quaid. His story was quite popular this year. If you do not remember, his twins received an overdose of heparin after birth in the hospital. It would seem that the nurse either drew up too much heparin solution either by visual error or by calculating the amount incorrectly. (Heparin comes in solution of so many thousands of units per milliliter.) Fortunately, no detrimental effects resulted, but because of it he used his celebrity to “raise awareness” of the dangers of heparin. Now rather than spawning an inservice educational wave across the country about heparin and calculating its dosage correctly, the FDA decided that the potency of heparin should be reduced by 10% in order to reduce toxicity risks.

You can guess what happened next. The FDA issued a statement to patients and healthcare providers that heparin will be made less potent, and that a higher dose of heparin may need to be prescribed in order to maintain therapeutic efficacy. I kid you not. So not only will people still have to titrate the dose of heparin, they will now have to correct for the 10% loss of potency. There will already be some medical errors from miscalculation of heparin. It is a fact of life. But now you are adding another calculation and expecting that it will reduce medical errors. Really? It is far more likely that while you might reduce the adverse outcomes when heparin is actually overdosed (which is not that common), you will introduce far far more adverse events from patients being underdosed with heparin. It takes a really ignorant medically untrained celebrity to come up with that brand of logic.

I am not really sure what the FDA will try to screw up next. Perhaps they will remove the gallon size of milk for fear of calcium intoxication. Or they will cut all table salt with flour in order to better treat and control hypertension. This is standard operating procedure for a government agency, but perhaps best described as SNAFU.