Pacira fights back!

[ethilo]

I found this. Interestingly, Pacira is arguing the editor of Anesthesiology has a bias against the use of exparel (#31) in favor of opioids inn the treatment of pain.

https://www.courtlistener.com/recap/gov.uscourts.njd.469581/gov.uscourts.njd.469581.1.0.pdf

I didn't get to read the whole thing but the document looked interesting enough to post! I certainly have change my use of exparel since that journal issue was released.

---

Members don't see this ad.

 

[Endee]

I hope that this gets dismissed and courts don't start ruling on what is or is not "good" scientific procedure or valid results.

 

[BLADEMDA]

I found this. Interestingly, Pacira is arguing the editor of Anesthesiology has a bias against the use of exparel (#31) in favor of opioids inn the treatment of pain.

https://www.courtlistener.com/recap/gov.uscourts.njd.469581/gov.uscourts.njd.469581.1.0.pdf

I didn't get to read the whole thing but the document looked interesting enough to post! I certainly have change my use of exparel since that journal issue was released.

I have used hundreds of bottles of Exparel (maybe even 1,000). I remain unimpressed with the cost vs duration of the product. IMHO, the 133 mg vial is less effective than plain Bupivacaine. The 266 mg vial does last longer than plain Bup but I typically dilute the 266 mg with some plain Bup as well.

For Brachial Plexus and Femoral Blocks only the 266 mg dosage seems to prolong analgesia significantly longer than plain Bup with decadron.

For Fascial plane blocks the Exparel may last a bit longer than 0.25% Bup with decadron.

While I truly wanted the product, Exparel, to be a magic bullet in terms of analgesia the reality on the ground was the drug didn't deliver on its promise.

This lawsuit is without merit and proves Pacira knows its product doesn't deliver the goods as advertised.

 

[Lecithin5]

Also didn’t read it, but wow, getting sued for publishing a study (even if there was some bias in it)- don’t see that too often. Hope it doesn’t set a precedent.

 

[Planktonmd]

I found this. Interestingly, Pacira is arguing the editor of Anesthesiology has a bias against the use of exparel (#31) in favor of opioids inn the treatment of pain.

https://www.courtlistener.com/recap/gov.uscourts.njd.469581/gov.uscourts.njd.469581.1.0.pdf

I didn't get to read the whole thing but the document looked interesting enough to post! I certainly have change my use of exparel since that journal issue was released.

This brings back memories of when the BIS monitor company decided to use intimidation to make people use their monitors to the point of calling it malpractice if you don't. It actually back fired and caused people to stop using it.

 

[coffeebythelake]

Unimpressed by exparel, and even less impressed by its manufacturer

 

[deleted875186]

Taken from the link ....

51. The financial disclosures provided in connection with this article state that coauthor Gabriel had not “performed consulting work for any private company in the last 6 [years].” Ex. 2, Ilfeld Review at 334. Yet the Open Payments database maintained by the Centers for Medicare & Medicaid Services shows that Gabriel received a $2,500 consulting payment from Heron Therapeutics, Inc. (“Heron”) as recently as October 2019.31 Heron is a primary competitor of Pacira, and a manufacturer of a long-acting bupivacaine formulation.

52. Similarly, Ilfeld, the lead author of the article, failed to disclose conflicting interests. Ilfeld’s profile on UCSD’s website states that he received over
$14 million in U.S. Department of Defense funding for research involving treatment modalities that compete with EXPAREL.33 Similarly, Ilfeld has authored multiple journal articles, including two articles published in 2020, 34 and an article published in March 2021,35 in which he disclosed that UCSD received funding from Heron. Notably, Ilfeld did not simply forget his disclosure obligations in connection with the February 2021 article; to the contrary, he disclosed Pacira consulting payments that he received between 2011 and 2014. See Ex. 2, Ilfeld Review at 334. Ilfeld’s simultaneous failure to disclose the Department of Defense funding he received, as well as the relationship between Heron Therapeutics and his employer, is thus all the more striking.

 

[deleted875186]

Ridiculous lawsuit, but I’m sure there are conflicts of interest for some of the authors. Would be a terrible precedent for someone to be able to sue a journal author.

 

[nimbus]

Taken from the link ....

51. The financial disclosures provided in connection with this article state that coauthor Gabriel had not “performed consulting work for any private company in the last 6 [years].” Ex. 2, Ilfeld Review at 334. Yet the Open Payments database maintained by the Centers for Medicare & Medicaid Services shows that Gabriel received a $2,500 consulting payment from Heron Therapeutics, Inc. (“Heron”) as recently as October 2019.31 Heron is a primary competitor of Pacira, and a manufacturer of a long-acting bupivacaine formulation.

52. Similarly, Ilfeld, the lead author of the article, failed to disclose conflicting interests. Ilfeld’s profile on UCSD’s website states that he received over
$14 million in U.S. Department of Defense funding for research involving treatment modalities that compete with EXPAREL.33 Similarly, Ilfeld has authored multiple journal articles, including two articles published in 2020, 34 and an article published in March 2021,35 in which he disclosed that UCSD received funding from Heron. Notably, Ilfeld did not simply forget his disclosure obligations in connection with the February 2021 article; to the contrary, he disclosed Pacira consulting payments that he received between 2011 and 2014. See Ex. 2, Ilfeld Review at 334. Ilfeld’s simultaneous failure to disclose the Department of Defense funding he received, as well as the relationship between Heron Therapeutics and his employer, is thus all the more striking.

I had no idea authors have to disclose the industry relationships of their employer. Ilfield’s employer (the University of California) has thousands of such relationships. Also unclear why DOD and other federal funding need to be disclosed as conflict of interest. Seems like Pacira is projecting their own sleaziness on the federal grant programs and actual scientists. Since they come from the world of hired gun researchers, they must think everybody operates that way.

 

[26B]

There's some interesting history if you dig into the FDA approval process for Exparel. There's a great editorial in the Feb issue of Anesthesiology which goes into additional detail, but this is my summary:

Basically, in 2006, SkyePharma (later known as Pacira) submitted the New Drug Application for Exparel for the indication of surgical site infiltration. Pacira submitted five phase 2 studies and three phase 3 studies comparing Exparel to plain bupivacaine. None of these showed clinical or statistical difference between Exparel and plain bupivacaine.

Since they couldn't show a clear benefit over plain bupivacaine, they then submitted 2 phase 3 trials showing the efficacy of liposomal bupivacaine against placebo (saline). FDA regulations state that a new drug (e.g. Exparel) can be approved as long as it shows efficacy compared to placebo, even if existing, already approved drugs (e.g. plain bupivacaine) are deemed effective. This isn't unreasonable, and is the reason why several long-acting local anesthetics are in current use (Bupivacaine, Ropivacaine, Levobupivacaine, etc). So, in 2011, the FDA approves Exparel for surgical site infiltration.

In 2014, Pacira submits another New Drug Application for Exparel to be used in peripheral nerve blocks. They submitted 2 studies - 1 for intercostal nerve block and 1 for femoral nerve block. The first study did not find a difference between Exparel and placebo, and the second study found that Exparel 266mg was superior to placebo in the primary outcome (pain relief), but not superior in the secondary outcome (time to first opioid rescue). As a result, the NDA was not approved on first review. Note that both of these studies were comparing Exparel to saline, not to plain bupivacaine.

In 2017, Pacira submits 2 new RCTs evaluating efficacy of Exparel for use in femoral nerve block and brachial plexus block. Only the brachial plexus study met both primary and secondary endpoints. Again, both of these RCTs were comparing to placebo and not plain bupivacaine.

Based of the above, the FDA Anesthetic and Drug Products committee met in 2018 to review the NDA, and 6/10 of the members voted against expanding the indication for Exparel to regional nerve blocks. However, the FDA approved Exparel anyway for use in interscalene nerve block.

Based on all of the above, the results of the recent meta-analysis published in Anesthesiology are really not all that surprising. If Exparel was truly a miracle drug when it came to long-acting local anesethetics, why would Pacira have such a hard time showing efficacy even against placebo?

 

[nimbus]

Ridiculous lawsuit, but I’m sure there are conflicts of interest for some of the authors. Would be a terrible precedent for someone to be able to sue a journal author.

Yeah. Several of the defendants are residents. Hopefully their departments have their back.

 

[nimbus]

There's some interesting history if you dig into the FDA approval process for Exparel. There's a great editorial in the Feb issue of Anesthesiology which goes into additional detail, but this is my summary:

Basically, in 2006, SkyePharma (later known as Pacira) submitted the New Drug Application for Exparel for the indication of surgical site infiltration. Pacira submitted five phase 2 studies and three phase 3 studies comparing Exparel to plain bupivacaine. None of these showed clinical or statistical difference between Exparel and plain bupivacaine.

Since they couldn't show a clear benefit over plain bupivacaine, they then submitted 2 phase 3 trials showing the efficacy of liposomal bupivacaine against placebo (saline). FDA regulations state that a new drug (e.g. Exparel) can be approved as long as it shows efficacy compared to placebo, even if existing, already approved drugs (e.g. plain bupivacaine) are deemed effective. This isn't unreasonable, and is the reason why several long-acting local anesthetics are in current use (Bupivacaine, Ropivacaine, Levobupivacaine, etc). So, in 2011, the FDA approves Exparel for surgical site infiltration.

In 2014, Pacira submits another New Drug Application for Exparel to be used in peripheral nerve blocks. They submitted 2 studies - 1 for intercostal nerve block and 1 for femoral nerve block. The first study did not find a difference between Exparel and placebo, and the second study found that Exparel 266mg was superior to placebo in the primary outcome (pain relief), but not superior in the secondary outcome (time to first opioid rescue). As a result, the NDA was not approved on first review. Note that both of these studies were comparing Exparel to saline, not to plain bupivacaine.

In 2017,. Pacira submits 2 new RCTs evaluating efficacy of Exparel for use in femoral nerve block and brachial plexus block. Only the brachial plexus study met both primary and secondary endpoints. Again, both of these RCTs were comparing to placebo and not plain bupivacaine.

Based of the above, the FDA Anesthetic and Drug Products committee met in 2018 to review the NDA, and 6/10 of the members voted against expanding the indication for Exparel to regional nerve blocks. However, the FDA approved Exparel anyway for use in interscalene nerve block.

Based on all of the above, the results of the recent meta-analysis published in Anesthesiology are really not all that surprising. If Exparel was truly a miracle drug when it came to long-acting local anesethetics, why would Pacira have such a hard time showing efficacy even against placebo?

That’s the difference between actual miracle drugs (like sugammadex and propofol) and a bs drug like exparel. The market adopts the miracle drugs very rapidly without shady studies and marketing. I started shortly after propofol was introduced. The rep said she doesn’t need to do anything, the drug just sells itself.

When I was a resident, we used to joke that mivacurium was better than saline. Now we have 2 drugs that are better than saline!

In all seriousness, even Anesthesiology is not saying exparel is an ineffective drug. Only that is has no or minimal marginal benefit over cheap old bupivacaine. Instead of filing stupid lawsuits, they should drop the price to make it competitive.

 

[Lecithin5]

Man, the more I think about this lawsuit the more I get irritated. I hope this lawsuit gets thrown out and the company has to pay all costs for the defense, and then some. How miserable for the defendants to go through this process. Truly, you can sue anybody for anything in this country.

 

[nimbus]

No wonder they are lawyered up.


“NEWARK, N.J. – Pacira Pharmaceuticals Inc. will pay $3.5 million to resolve allegations that it paid kickbacks to doctors in the form of bogus research grants to induce them to prescribe its analgesic EXPAREL, Attorney for the United States Rachael A. Honig announced today. The allegations arose from a whistleblower suit filed under the False Claims Act.

“Pacira tried to accelerate sales of its EXPAREL product through an illegal kickback scheme,” Attorney for the United States Honig said. “Pharmaceutical companies may not entice doctors to use their products by offering research grants in return for sales. Illegal inducements can distort medical decision-making, lead to the use of overpriced drugs, and drive up health care costs for everyone.”

“The payment of kickbacks or bribes in exchange for phony research and other grants, robs the government and every American,” FBI-Newark Acting Special Agent in Charge Joe Denahan said. “Today’s agreement by Pacira Pharmaceuticals Inc., to pay $3.5 million, should send a strong message to anyone thinking about participating in this type of illegal activity. The FBI remains committed to combating these types of schemes and bringing these perpetrators to justice.”

“Offering phony research grants in order to increase sales and fatten the bottom line is illegal and can be detrimental to the medical decision-making process,” Scott J. Lampert, Special Agent in Charge of the Office of Inspector General for the U.S. Department of Health and Human Services, said. “We will continue to work with our law enforcement partners to safeguard our government health care programs and the taxpayers picking up the bill.”

According to documents filed in this case and the contentions of the United States contained in the settlement agreement:

From Dec. 1, 2012, through April 30, 2015, Pacira paid disguised kickbacks in the form of research and other grants to healthcare providers and institutions. Pacira intended these payments to induce sales of its newly-launched local analgesic, EXPAREL, to the targeted physicians and their respective hospitals. The research grants in question were typically initiated by Pacira sales representatives or marketing executives, who discussed internally their sales goals in connection with the grant. Pacira also required that EXPAREL be placed on formulary at the physician’s institution before awarding any research grant.

After awarding the grant money, Pacira expressed little interest in the proposed research. Pacira did not contractually require that the grant recipient adhere to the proposed research topic or achieve certain milestones before payment. In many cases, Pacira did not follow up with the grant recipient to ensure that the work was being performed, and in some cases, the grant recipient did no work at all. Pacira did not document why it needed the research or the fair market value of the proposal. Finally, Pacira executives coached grant recipients and other employees on how to avoid internal scrutiny of the grant payments.

Medicare and Medicaid do not pay for claims that include products tainted by illegal kickbacks. Pacira caused the submission of false claims by using these research grants to induce sales of EXPAREL, which it knew would be used in procedures reimbursed by Medicare and Medicaid.

The allegations were raised in a lawsuit filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allows private citizens with knowledge of fraud to bring civil actions on behalf of the Government and to share in any recovery. As part of today’s resolution, the whistleblower—a pharmacist who brought the misconduct to the government’s attention—will receive approximately $520,000 of the recovery from the federal share of the settlement, plus approximately $118,000 from the state share of the settlement.

Attorney for the United States Honig credited special agents of the FBI, under the direction of Acting Special Agent in Charge Denahan in Newark; special agents of the HHS-OIG, under the direction of Special Agent in Charge Lampert, as well as special agents with the U.S. Attorney’s Office in Newark, with the investigation.

The government is represented by Assistant U.S. Attorney Andrew A. Caffrey, III, of the U.S. Attorney’s Office’s Health Care Fraud Unit in Newark.”

Pharmaceutical Company Agrees to Pay $3.5 Million to Resolve Allegations of Violating False Claims Act

www.justice.gov

Same “pay to prescribe” playbook as Insys.

5 Doctors Are Charged With Taking Kickbacks for Fentanyl Prescriptions (Published 2018)

The doctors are accused of prescribing millions of dollars worth of the potent opioid and earning fees for fraudulent speaking engagements.

www.nytimes.com

 

[Iso4ane]

I was discussing this with some people, it’s only been maybe 8-10 years since I’ve known about liposomal bupivicaine, and I figured if it worked well, people would be scrambling to use it despite the cost.

 

[AnesRunner]

Exparel is garbage. They know it. Everyone who performs technically sound nerve blocks knows it. It is barely better than placebo and no better than plain bupivacaine. Pacira is desperate to save their company. Other than acquiring Iovera, it is their only product and they will do anything it takes to preserve it. Absolute desperation move from a company that will likely not be around in 10 years. Anyone using Exparel for regional anesthesia should think long and hard about being associated with this company.

 

[deleted126335]

Exparel is garbage. They know it. Everyone who performs technically sound nerve blocks knows it. It is barely better than placebo and no better than plain bupivacaine. Pacira is desperate to save their company. Other than acquiring Iovera, it is their only product and they will do anything it takes to preserve it. Absolute desperation move from a company that will likely not be around in 10 years. Anyone using Exparel for regional anesthesia should think long and hard about being associated with this company.

Our orthopods like it. So they use it intraop and request it for selective ISB for shoulders. administration is OK with it. As we don’t round on these patients 24-48 hours later, wedon’t have a sense whether or not it is actually better. We are OK with using it per their request in this fashion since it doesn’t appear to present any increased risk.

 

[BLADEMDA]

Our orthopods like it. So they use it intraop and request it for selective ISB for shoulders. administration is OK with it. As we don’t round on these patients 24-48 hours later, wedon’t have a sense whether or not it is actually better. We are OK with using it per their request in this fashion since it doesn’t appear to present any increased risk.

My nurses personally called about a hundred patients postop who had Exparel. The 133 mg dosage was inferior to Bup plus decadron for ISB. That’s my anecdotal data. Only the 266 mg dosage was better than my standard Bup with decadron and even then the cost rarely justified the extra 10-20 hours of duration of analgesia.

 

[Lecithin5]

My nurses personally called about a hundred patients postop who had Exparel. The 133 mg dosage was inferior to Bup plus decadron for ISB. That’s my anecdotal data. Only the 266 mg dosage was better than my standard Bup with decadron and even then the cost rarely justified the extra 10-20 hours of duration of analgesia.

Plus, even if exparel could give you a block that lasts for several days (and I have had interscalenes that lasted several days with exparel), who wants that? Not me as the doc, and not a lot of patients either. Unless it’s a chronic pain patient or some other extenuating circumstance, I would like most of my blocks to resolve within 24 hours. Otherwise, put a catheter in.

 

[epidural man]

I have been a big fan of Exparel. I think the technology is pretty cool - and from what I understand, they can make the liposome last as long as they want....7 days....5 days, whatever...and put nearly anything in it.

It seems like it could be useful.

However, after hearing about this lawsuit this morning...it made me furious at the company. I will no longer use the product. I will do all in my power to discourage its use in my hospital (surgeons love it).

I sat with the CEO for dinner one time. He seemed really cool and down to earth. He was a poor pharmacist at one point - told me he never imagined being rich like he is now (he buys race horses....the really expensive ones).

This is a picture of him.

In highly unusual move, Pacira sues medical journal for libel over its non-opioid painkiller

A New Jersey biotech whose only approved drug is used as a painkiller after surgeries is suing a scientific journal, its editors and a handful of authors for libel after the publication printed numerous papers and editorials that the company says discredited the drug. Pacira Biosciences filed...

endpts.com

What is kinda funny about the lawsuit - is they are arguing that the statistic used aren't correct. Really? Have they read literature before? There are SOOOO MANY crazy and complicated ways to do statistics. To make that a primary argument is so laughable.

As my older and wiser brother told me when I was mad at something in high school - he said "The best revenge is success." You would think that if Pacira really wanted to stick it to Anesthesiology, they would do it with science and show how stupid those Anesthesiology authors are by publishing excellent, high quality, investigator-initiated trials with results that made those authors look like idiots. That is...if the product works.

 

[anbuitachi]

There's some interesting history if you dig into the FDA approval process for Exparel. There's a great editorial in the Feb issue of Anesthesiology which goes into additional detail, but this is my summary:

Basically, in 2006, SkyePharma (later known as Pacira) submitted the New Drug Application for Exparel for the indication of surgical site infiltration. Pacira submitted five phase 2 studies and three phase 3 studies comparing Exparel to plain bupivacaine. None of these showed clinical or statistical difference between Exparel and plain bupivacaine.

Since they couldn't show a clear benefit over plain bupivacaine, they then submitted 2 phase 3 trials showing the efficacy of liposomal bupivacaine against placebo (saline). FDA regulations state that a new drug (e.g. Exparel) can be approved as long as it shows efficacy compared to placebo, even if existing, already approved drugs (e.g. plain bupivacaine) are deemed effective. This isn't unreasonable, and is the reason why several long-acting local anesthetics are in current use (Bupivacaine, Ropivacaine, Levobupivacaine, etc). So, in 2011, the FDA approves Exparel for surgical site infiltration.

In 2014, Pacira submits another New Drug Application for Exparel to be used in peripheral nerve blocks. They submitted 2 studies - 1 for intercostal nerve block and 1 for femoral nerve block. The first study did not find a difference between Exparel and placebo, and the second study found that Exparel 266mg was superior to placebo in the primary outcome (pain relief), but not superior in the secondary outcome (time to first opioid rescue). As a result, the NDA was not approved on first review. Note that both of these studies were comparing Exparel to saline, not to plain bupivacaine.

In 2017, Pacira submits 2 new RCTs evaluating efficacy of Exparel for use in femoral nerve block and brachial plexus block. Only the brachial plexus study met both primary and secondary endpoints. Again, both of these RCTs were comparing to placebo and not plain bupivacaine.

Based of the above, the FDA Anesthetic and Drug Products committee met in 2018 to review the NDA, and 6/10 of the members voted against expanding the indication for Exparel to regional nerve blocks. However, the FDA approved Exparel anyway for use in interscalene nerve block.

Based on all of the above, the results of the recent meta-analysis published in Anesthesiology are really not all that surprising. If Exparel was truly a miracle drug when it came to long-acting local anesethetics, why would Pacira have such a hard time showing efficacy even against placebo?

how does this work? in the first study they found no difference between exparel and placebo (saline)????? what?!

 

[nimbus]

At least Heron included both bupivacaine and saline in their studies. Overall Zynrelef is equally as unimpressive as Exparel. For stuff like hernias and knee replacements, there was no difference between local infiltration with saline, bupivacaine or Zynrelef.

Heron Therapeutics Announces U.S. FDA Approval of ZYNRELEF™ (HTX-011) for the Management of Postoperative Pain for up to 72 Hours

/PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing...

www.prnewswire.com

https://www.ema.europa.eu/en/documents/assessment-report/zynrelef-epar-public-assessment-report_en.pdf

 

[j4pac]

If it’s fraud then people should be held accountable. Too much if at sake. There is a difference between having disclosures but publishing honor research than morally inept research designed to fatten your wallet. It really could be a public health concern as well. Of course, I don’t know what the researchers knew writing up the research...maybe the research was legit.

 

[BLADEMDA]

I have been a big fan of Exparel. I think the technology is pretty cool - and from what I understand, they can make the liposome last as long as they want....7 days....5 days, whatever...and put nearly anything in it.

It seems like it could be useful.

However, after hearing about this lawsuit this morning...it made me furious at the company. I will no longer use the product. I will do all in my power to discourage its use in my hospital (surgeons love it).

I sat with the CEO for dinner one time. He seemed really cool and down to earth. He was a poor pharmacist at one point - told me he never imagined being rich like he is now (he buys race horses....the really expensive ones).

This is a picture of him.

In highly unusual move, Pacira sues medical journal for libel over its non-opioid painkiller

A New Jersey biotech whose only approved drug is used as a painkiller after surgeries is suing a scientific journal, its editors and a handful of authors for libel after the publication printed numerous papers and editorials that the company says discredited the drug. Pacira Biosciences filed...

endpts.com

What is kinda funny about the lawsuit - is they are arguing that the statistic used aren't correct. Really? Have they read literature before? There are SOOOO MANY crazy and complicated ways to do statistics. To make that a primary argument is so laughable.

As my older and wiser brother told me when I was mad at something in high school - he said "The best revenge is success." You would think that if Pacira really wanted to stick it to Anesthesiology, they would do it with science and show how stupid those Anesthesiology authors are by publishing excellent, high quality, investigator-initiated trials with results that made those authors look like idiots. That is...if the product works.

PACIRA needs to go back to the drawing board and start with safety data on 399 mg dosage. The main problem with the product is insufficient dosage IMHO. Once diluted the Liposomal Bup begins to lose its effectiveness and that is why the product is no better than standard Bupivacaine in many studies.

If the company was willing to invest in trials using 266 mg and 399 mg with less dilution I bet they would be able to show a difference in duration of analgesia vs standard Bupivacaine. But, as things stand now the drug is a failure in terms of cost vs efficacy.

 

[Planktonmd]

PACIRA needs to go back to the drawing board and start with safety data on 399 mg dosage. The main problem with the product is insufficient dosage IMHO. Once diluted the Liposomal Bup begins to lose its effectiveness and that is why the product is no better than standard Bupivacaine in many studies.

If the company was willing to invest in trials using 266 mg and 399 mg with less dilution I bet they would be able to show a difference in duration of analgesia vs standard Bupivacaine. But, as things stand now the drug is a failure in terms of cost vs efficacy.

Exparel users - question for you.

You are planning on sending the patient home with a sciatic catheter. However, you want saphenous coverage as well. Would you feel comfortable doing an adductor canal block with Exparel AND send with a catheter? The dosage of Exparel is about 1/3 the mg if you sent him home with both front...

forums.studentdoctor.net

 

[Matthew9Thirtyfive]

It seems like it could be useful.

When I rotated on surgery and urology, they used it all the time. It was really helpful for some of the urology patients getting EPAs so their taints weren’t killing them for a few days post op. Generally lasted about 48-72 hours.

 

[BLADEMDA]

Exparel users - question for you.

You are planning on sending the patient home with a sciatic catheter. However, you want saphenous coverage as well. Would you feel comfortable doing an adductor canal block with Exparel AND send with a catheter? The dosage of Exparel is about 1/3 the mg if you sent him home with both front...

forums.studentdoctor.net

I think the Liposomal Bupivacaine does indeed work when given in sufficient amounts like 266 mg. But, the company, Pacira, has decided to promote the 133 mg vial which is insufficient to produce analgesia beyond 20 hours. In fact, I found the 133 mg dosage inferior to standard Bup with dexamethasone in terms of analgesia.

But, the 266 mg vial (which the company isn't recommending for ISB) does outlast the standard Bup with dexamethsone combination. IMHO, the same thing applies with adductor canal blocks using Exparel 133 mg.

Again, I think the product is safe and does have its place in our specialty but the company has done a piss poor job of getting the proper dosage FDA Approved so the clinical studies will show greater efficacy vs placebo or standard Bupivacaine.

 

[nimbus]

Pacira starts to back down.



“Now comes word that Pacira’s attorneys withdrew their motion for a retraction after the ASA asked the court for a prompt hearing “to expose flaws in Pacira’s claims.”

“It is vitally important that we defend and stand behind these three works and the integrity and scholarship of those who contributed to them,” said Evan Kharasch, MD, editor-in-chief of Anesthesiology. “These authors are leading physicians and researchers in the fields of anesthesiology and clinical studies. Physicians and patients must have trusted information on which to base clinical decisions and care, and that information needs to be unaffected by commercial interests.”

It is not yet clear if Pacira will withdraw the rest of its libel case. “Our corporate policy is not to comment on pending litigation,” a spokesperson told PNN.”

Legal Fight Brews Over Non-Opioid Pain Reliever — Pain News Network

By Pat Anson, PNN Editor Competition between drug companies can get so intense that some resort to bare knuckle tactics to preserve market share. Such is the case for Pacira BioSciences, which filed a lawsuit against the American Society of Anesthesiologists (ASA) last month for “false and mislea

www.painnewsnetwork.org

 

[Iso4ane]

Pacira starts to back down.



“Now comes word that Pacira’s attorneys withdrew their motion for a retraction after the ASA asked the court for a prompt hearing “to expose flaws in Pacira’s claims.”

“It is vitally important that we defend and stand behind these three works and the integrity and scholarship of those who contributed to them,” said Evan Kharasch, MD, editor-in-chief of Anesthesiology. “These authors are leading physicians and researchers in the fields of anesthesiology and clinical studies. Physicians and patients must have trusted information on which to base clinical decisions and care, and that information needs to be unaffected by commercial interests.”

It is not yet clear if Pacira will withdraw the rest of its libel case. “Our corporate policy is not to comment on pending litigation,” a spokesperson told PNN.”

Legal Fight Brews Over Non-Opioid Pain Reliever — Pain News Network

By Pat Anson, PNN Editor Competition between drug companies can get so intense that some resort to bare knuckle tactics to preserve market share. Such is the case for Pacira BioSciences, which filed a lawsuit against the American Society of Anesthesiologists (ASA) last month for “false and mislea

www.painnewsnetwork.org

I heard the ASA hired some Hollywood level lawyers, they were not going to back down with a fight.

 

[epidural man]

I think the Liposomal Bupivacaine does indeed work when given in sufficient amounts like 266 mg. But, the company, Pacira, has decided to promote the 133 mg vial which is insufficient to produce analgesia beyond 20 hours. In fact, I found the 133 mg dosage inferior to standard Bup with dexamethasone in terms of analgesia.

But, the 266 mg vial (which the company isn't recommending for ISB) does outlast the standard Bup with dexamethsone combination. IMHO, the same thing applies with adductor canal blocks using Exparel 133 mg.

Again, I think the product is safe and does have its place in our specialty but the company has done a piss poor job of getting the proper dosage FDA Approved so the clinical studies will show greater efficacy vs placebo or standard Bupivacaine.

Doesn’t matter. This move to sue some residents for being in a scientific paper is so far over the line that it should piss you off in such a way that the name Pacira should turn your stomach and make you cringe.
We should do all on our power to make sure they never sell another vial.

 

[dabears505]

The empire strikes back