I am a scientist and used to run experiments with drugs on volunteers. I had to go through application after application and the approval process for a single short experiment can take over a year. Why am I bringing this up? According to the Agency for Healthcare Research and Quality 1 out of 5 prescriptions today are written by the clinician for off-label use. Off-label use is using a drug for a condition without FDA approval. This makes it equivalent to research on humans with drugs without their consent.
The FDA says it is legal. Can it be legal? Should it be legal?
Clinical doctors do not practice scientific research; they treat sick people with medications created for the illnesses they have. So how is that possible that clinical doctors can prescribe a drug that was created for illness X to see if it will treat illness Y without the approval of the FDA; without rigorous research that drug created for illness X will also benefit illness Y; and without the patient’s written or even verbal consent!?
I am not quite sure how the medical industry is getting away with this activity of using sick people as guinea pigs without their consent. I find it not only irresponsible and dangerous but downright clueless. Clinical doctors are not trained to do research thus when they prescribed Sumatriptan to adolescents off-label for migraine, after a year of doing so, the FDA came out with not permitting it for the following reasons
“• We did not agree trial SUMA3005 (acute adolescent efficacy study) demonstrated efficacy.
• We provided draft labeling recommendations that needed to be agreed to prior to approval of the supplement.
• We expressed concern that an insufficient number of subjects were exposed for 1 year in trial SUMA3006 (long term trial).
• We requested additional information on the nasal mucosa examinations performed in trial SUMA3006.
• We requested the sponsor provide a safety update for the NDA.” (page 5 of linked document)
Now this is a document from 2003 and since then this drug may or may not be approved for adolescents but that is not the point.
The critical point is that the drug was experimented with on adolescents for 1 whole year as off-label drug and then found to not meet the requirements. This is a huge oops when it comes to medicines in general, since if 1 out of every 5 prescription is for off-label use, than 20% of all drugs in the US are experimented on people without their consent, and without FDA approval.
I really would like to know why this is legal. I actually want to take it a step further and make it illegal! We the people are not guinea pigs or lab rats. We chose to have medications that are proven to treat our specific illnesses if such medications exist. I do not want to have one more doctor in my life tell me “oh but it seems to work for this other condition.” I have heard that before many times. No more.
I recommend you also tell your doctor NO for off-label prescription. It is better to have no medication than something that may make you sick in some other way on top of your already existing illness! If the doctor is not saying whether a drug is prescribed to you off-label or not, do yourself a favor and ask!
Amended after crucial finds. Did you know that you can report if you have an unlisted adverse side effect from a drug? It need not be off-label but any drug, both prescribed and over the counter. The link to consumer reporting is here. Such reporting has lead to a near exponential growth of additional side effects that were originally not listed on drugs at the time of FDA approval. You can see the growth through 2013 via this link and see how much your reporting matters!
Comments are welcomed!