Oh I thought I can take a day off from typing up blogs but wow!!! Things come at me from friends and colleagues with the speed of light. I am outraged! So here is a new killer article for you!
Who ever in his or her mind would have thought that epidural steroid injections that many insurance companies request to be given prior to surgery were never ever FDA approved procedures?!
Oh my!! Now there is big trouble! Because they were not approved!
There is big trouble on two fronts and let me list them in order of importance where off-label use is number one!
- Off-label use of any drug should be illegal! We now have seen several examples where off-label use of a drug hurts people. I have written about off-label use before but let me cover it again in the quick. When the FDA approves a drug, it has extremely strict guidelines for everything, including label which must contain what it is to be used for; how it is used; each dose has a separate label; all adverse reactions must be listed. Nothing can change on this label unless the FDA says it must be changed and when the FDA says it must be changed that is bad news! There is an inconsistency in the labeling of FDA that allows an innocent appearing sentence: “your doctor may prescribe this for causes other than listed” or something similar. This is an under-the-table permit for off-label use. But this is a double-edged sword. On the one hand, the drug is not permitted to be used for anything that is not included on the label and on the other hand it permits the drug to be used for things that are not on the label. I wonder why lawyers are not yet chewing at this sentence from all angles? Is that possible they have not noticed the logical inconsistency? Lawyer? Not noticing? Nah….
- The steroid injections used in epidural form to be injected into the spine are now black-boxed by the following strong statement by the FDA:
Injectable corticosteroids are commonly used to reduce swelling or inflammation. Injecting corticosteroids into the epidural space of the spine has been a widespread practice for many decades; however, the effectiveness and safety of the drugs for this use have not been established, and FDA has not approved corticosteroids for such use
Let me rephrase this making my point: Injecting corticosteroids epidural has been a widespread practice for many decades but FDA has not approved corticosteroids for such use. Wow! They have killed two birds in one swell swoop!
On the one hand they admit to allow an FDA non-approved process to happen and sort of encouraged it for decades??? For decades??? As a widespread practice? And on the other hand they have strict guidelines that will not allow a dot to be changed on the label and all drugs must be approved by the FDA prior to use?
Am I missing something here?
Will someone please tell me why we need to have the FDA? Does it have any reason to exist and oversee the safety of our drugs with such double standard? They look the other way for decades over illegal use of a procedure that ended up hurting people? Oh yeah. Let’s talk about the kind of injuries:
[04-23-2014] The U.S. Food and Drug Administration (FDA) is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.
Oh I am tickled to tears to know that after decades of people getting hurt the FDA finally puts a new label out–not that it prevents its use even though it admits it does not show any benefit yet either: “the effectiveness and safety of the drugs for this use have not been established” so my question is dear FDA: Why are you letting a drug that is so dangerous as a result of its procedure to be continued?
Those of you who are told by your insurance companies that you should try an injectible corticosteroid epidural before other procedures, please print this article and hand it to your medical provider along with a note that the medical provider and your insurance company must sign: in case I get injured you are all responsible in court! I think you will not be forced to have that injection after all!
And if you are an attorney, please do yourself and the rest of all a huge favor and start a class action lawsuit! This is your chance!
Comments are welcomed and encouraged!!!