Okay, so I want to discuss a few things.
1. Those who hide behind the FDA as a reason not to use Exparel on a nerve are being grade A hypocrites because they use off-label use of other drugs all the time. IN fact, BLADE - why won't you use Exparel on a peripheral nerve like sciatic?
Here is what we know about depofoam. It was FDA APPROVED for intrathecal use when morphine was used. These are unprotected nerves that are VERY susceptible to injury - yet the FDA had no problem letting this stuff be place intrathecally. We also know bupivicaine is safe in the intrathecal space. We also know there are lots of reports of Exparel placed on nerves with no data to support any danger.
We also know that Amarin succesfully sued the FDA saying they should be allowed to market OFF-LABEL to doctors as long as they told the truth. Why is this important? Because it means the FDA has no jurisdiction to say how a doctor uses a medication. It has ZERO say - and the court case proves it emphatically and clearly.
2. Those that claim that they won't use Exparel on a nerve until a high quality study is done is saying they refuse to use there brain and refuse to use deductive reasoning, and refuse to use available science - and basically are admitting to NOT be a scientist. This is truly sad. Let me explain further. There is NOT convincing evidence that Exparel does NOT work better than straight bupivicaine. I also agree there isn't convincing evidence that the converse is true. So in the absence of this evidence, we need to seek answers. We need to ask questions. And I have question for those that refuse to use it because they think it isn't superior to plain bupi - Why do you think that is? Why doesn't liposomal bupivicaine not work better than straight bupiviciane? Is it because the liposomes don't actually work and all the bupi is released in 24 hours? Is it because the concentration is so low it is ineffective at the sight? Is it because over 3 days, the solution spreads such that it dilutes as it mixes with serous fluid and eventually becomes too low of a concentration?
These are important questions. Is it possible that it matters where the drug is placed? Is it possible that it works well on the sciatic but not the femoral? Does it work better in fascial planes? Does it need a nerve contained in a tight sheet as to keep the drug in the same area?
Rather than say it doesn't work - perhaps we need to ask better questions and figure this out.
I will tell you two things. Liposomal bupiviciane absolutely works over at least 3 days. It may not be clinically useful over 3 days depending on where you put it - but it absolutely elutes over 4 -5 days. This has been shown very clearly with serum level studies.
Second, it absolutely can numb a nerve for 4-5 days. I have used them on peripheral nerves (median, ulnar, sciatic or selectively tibial or common perineal, etc) and I have had patients say their hand was numb for 5 days. I used it for trigger points in the rhomboids, and the patient said their face was numb for 3 days (I guess the stuff spreads when placed in a fascial plane). I have seen great clinical benefit when placed right between the tibial/CP split (so it is contained in the sheath).
To say it doesn't work - is to deny information that is available.
I understand the cost issue. I also understand that it may not work - but certainly more info is needed.
It clearly isn't dangerous - and likely much safer than a catheter of bupivicaine.
And for all those getting on BLADE like he has some disclosures to expose - that is ridiculous. First of all, Pacira is a very small company. If anything, we need to ask you - are you on the pay roll of On-Q? Did Stryker pay you to come on here and bash Exparel? Have you received payment from Purdue pharma?
You really don't think those huge companies with deep pockets and strong lobby power - didn't have anything to do with the struggles Exparel has had with the FDA? They all stand to loose a TON of money if Exparel succeeds. 70% of the FDA money comes from PDUFA - which means drug companies pull the strings - which means Exparel is screwed because they are up against BIG BIG pharma - and you all sound like you are in their pocket.
