Crash Cart: Llama antibodies fight COVID

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REAL PHYSICIANS DISCUSS RECENT HEALTHCARE HEADLINES

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Llama antibodies fight COVID
https://www.upi.com/Health_News/2021/09/23/covid19-llama-antibody-human-treatment/8001632402502/


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Nanobodies binding to a virus reducing viral loads in hamsters is not the same as decreasing mortality in humans.  Let’s see some results in humans before jumping on yet another bandwagon that may not pan out.

Salim R. Rezaie, MD

Nano antibodies from a llama would be a godsend.  Especially if I could spray something up my nose that would give me hair like that.


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—Mark Plaster, MD, JD

The good news is that study participants showed lower COVID viral loads. The bad news is that study participants developed this inexplicable tendency to spit in other people’s faces. OK, OK, I know it’s a recycled joke, but this stuff never gets old.

 William Sullivan, DO, JD

Llamas are pretty fantastic animals.  If this pans out to be beneficial for humans as a treatment, they might become my favorite.


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 Drew Kalnow, DO, FACEP

Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

https://www.bmj.com/content/375/bmj.n2635

Why am I not surprised there were protocol issues with vaccine trials in the middle of a pandemic?  The focus for COVID vaccinations was certainly in large part speed and I don’t say that to be critical, I wanted a vax in my arm as much as anyone.  This is a report of a third party vendor having issues with protocols and I highly suspect these same issues occur with many large scale trials regardless of how pressing the timeline is. Hopefully this report will help to move the needle on trial safety and protocol adherence moving forward.

Oh, and let’s not confuse this with concerns over COVID mRNA vaccine safety for the recipient.  These vaccines have proven both safe and effective in a very large, ongoing real-time study.

 Drew Kalnow, DO, FACEP

With Pfizer paying $2.3 billion to the DOJ to settle criminal and civil charges of fraudulent marketing in 2009 (https://b.link/PfizerDOJ) and with allegations of conflicts of interest with many FDA committee members approving Pfizer drugs and immunizations (https://b.link/FDAPfizerCOI) (why is no one discussing this?), Pfizer hasn’t exactly established a strong track record.

Now, after their vaccine was approved based in part on study data showing that the vaccine reduced serious illness in a total of only three patients out of more than 35,000 (https://www.fda.gov/media/144245/download), there are serious allegations that in achieving those impressive results, Pfizer broke multiple study protocols during vaccine testing then targeted staff that reported those violations? And the medical community shrugs its shoulders while walking away whistling a happy tune.

 William Sullivan, DO, JD 

The bigger story here isn’t the mess of how this particular research was conducted, but that this is not too uncommon, hard to detect and even harder to prove. Anything in life that is rushed, usually involves cutting corners and results in poor quality.

—Salim R. Rezaie, MD

Sloppy work, even when it doesn’t bear directly on the outcome, is a sign of poor discipline in the research.  It would naturally cause one to question the quality of the results.

—Mark Plaster, MD, JD

FDA warns alcohol-based hand sanitizer in eyes can cause serious injury

https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-getting-alcohol-based-hand-sanitizer-eyes-can-cause-serious-injury

Alcohol in the eyes is harmful.  Duh.  Do we actually pay for this kind of research?

—Mark Plaster, MD, JD

Based on the way my hands feel after a string of shifts “foaming” in and out, I am not sure hand sanitizer is good for my hands, let alone my eyes.

 Drew Kalnow, DO, FACEP

Don’t put alcohol in eyes. Check. In case you missed it, don’t put cayenne pepper juice in eyes either. You want to talk about real harm from hand sanitizer? I’m more concerned about patients drinking hand sanitizer out of hospital dispensers. FDA should add that to the list. What about immolation by hand sanitizer. Yeah, you read that right. This guy doused himself in hand sanitizer then went up in flames when police used a Taser on him. https://www.timesunion.com/hudsonvalley/news/article/Catskill-man-burst-into-flames-after-police-16595504.php. Can’t make this stuff up.

 William Sullivan, DO, JD

Let me get this straight…getting alcohol in the eye is not good for the eye?  I didn’t need the FDA to tell me that getting alcohol in my eye can cause irritation, pain and conjunctivitis.

—Salim R. Rezaie, MD

$465M verdict thrown out

Certainly companies like Johnson & Johnson bear some responsibility for the opioid pandemic, but so do a lot of other companies, organizations and people.  I do find it ironic that the lawsuit was files based on a “Nuisance Law.” I think the opioid issue is a bit more than just a nuisance. *Insert face-palm emoji*

 Drew Kalnow, DO, FACEP

A single attorney practicing in a rural county in Oklahoma —  population barely over a quarter million — files a lawsuit against multiple pharmaceutical companies seeking $17 billion (lawyer’s fee $6.8 billion).  Now that’s swinging for the fences.  His district judge was trying to get him a paltry $465 million (attorney’s fee $186 million).  But noooo.  You get nothin’ buddy.  Dang!!  Even though we don’t like it, sometimes common sense wins out.

—Mark Plaster, MD, JD

The current opioid pandemic we are in is more nuanced than the companies that make the medications. If we are going to sue companies that make opioids, then we should also sue companies that make sugar or fast food chains for the obesity pandemic we also have in this country.

Salim R. Rezaie, MD

While everyone can agree that the opioid epidemic has resulted in multiple patient deaths and was likely fueled both by pharma advertising and Joint Commission mandates, I think the Oklahoma Supreme Court got it right in overturning the verdict. The prosecution relied on an antiquated “public nuisance” law to prove its case. As Sal and the judges noted, applying the same reasoning to other industries could make the fast food industry liable for obesity and the car manufacturing industry liable for health harms due to air pollution. For some reason, outside attorneys hired by the state attorney general (who contributed heavily to the attorney general’s election campaign) dropped other allegations (such as fraud) before trial to focus on the public nuisance claim. Bad move, counsel.

 William Sullivan, DO, JD

ABOUT THE AUTHORS

EDITOR-IN-CHIEF Dr. Rezaie is founder and editor of R.E.B.E.L EM.

SENIOR EDITOR DR. SULLIVAN, an emergency physician and clinical assistant professor at Midwestern University in Illinois, is EPM’s resident legal expert. As a health law attorney, Dr. Sullivan represents medical providers and has published many articles on legal issues in medicine. He is a past president of the Illinois College of Emergency Physicians and a past chair and current member of the American College of Emergency Physicians’ Medical Legal Committee. He can be reached at his legal web site http://sullivanlegal.us.

Andrew Kalnow is an emergency medicine physician and associate program director at OhioHealth Doctors Hospital in Columbus, OH.  He is also a co-host for EM Over Easy, a podcast focusing on #MoreThanMedicine.

FOUNDER/EXECUTIVE EDITOR Dr. Plaster has been an emergency physician for more than 30 years, working exclusively night shifts for the past 20 years in emergency departments across the country. During that period, he joined the U.S. Navy and served two tours in Iraq. Dr. Plaster is the founder and executive editor of Emergency Physicians Monthly and the founder of Plaster Publishing.

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