On the verge of a nervous breakdown Part IV
We come now to one final discussion regarding the state of drugs in today's healthcare system. This blog is by no means the last I will ever write on these topics as the issues blogged about will not go away, and these problems will I believe no doubt spiral ever downward.
The final part of this disaster that I would like to comment on is the state of drug labels. Drug labels have, like everything else in life, have gotten more complicated and less useful. They should provide basic information adout the drug, how to take it and the IMPORTANT side effects.
It is of no value to print out a list of 3 dozen side effects which then invariably cause patients to call and ask “why am I taking this drug if it is going to ...?" Some drugs have common and well understood side effects and some drugs have very real side effects that need close attention to. It is my duty to assess the problem and prescribe a drug or drugs that has appropriate risk vs benefits to that appropriate patients. All patients are different and the equations are not exact.
The labels are not random. They are generated by the FDA, and the company wishing to sell them after the results of the trials are completed. Changes are made to labeling when new data becomes available that warrants adding new concerns. If a very large concern pops up, then that concern is placed in a “black box." The problem is that it is now common for most drugs to have a “black box." This overuse lessens the power of the message.
What happens when a drug goes generic? Well, the label must be the same for a generic drug, and depending on who you ask, the brand name drug company is still responsible for the label. The generic drug company can propose to the FDA that a stronger label should be in place but cannot on its own change it. This, of course, makes even less sense when the brand name company no longer manufactures the drug.
This is America, and the only reason anyone cares about this is because you have to know whether to sue in state court or federal court. Patients in a recent case attempted to sue the company that makes generic metoclopramide in state court because they developed the rare but important side effect of Tardive dyskinesia. Tardive dyskinesia is a movement disorder that can be severe and may not reverse when you stop taking the drug. They prevailed in state court, and the decision was accepted for review by the Supreme Court. The Supreme Court ruled that the state court had no jurisdiction in a 5-4 decision.
So, basically, Joseph Heller’s Catch-22 is again at play. Labels should reflect current knowledge which can not be changed independently of the parent company. No real post marketing data is ever obtained, so when Vioxx-like problems arise, no one knows until the whole issue comes crashing down on our heads.
Don’t know what Catch-22 is? During WWII the aviators that flew bombing missions over Europe had to fly a certain number of missions until they were rotated home. As the war went on the number increased. The only way out was to be crazy. If you didn’t want to fly because you were crazy, then you must be sane because who in their right mind would want to do this? Therefore, no one who wanted to not fly was by definition sane and had to fly.
It seems that Heller had it right. If you want to make a drug label reflect current data, you can’t because it is not your job even though you are the only manufacturer of the drug.
I guess it doesn’t matter because who knows if the drug is even in the pill.
Good luck to us.