MedPod Today: New COVID Variant; FDA Eye Drop Warning; CRNA Scope Creep?

The following is a transcript of the podcast episode:

Rachael Robertson: Hey everybody, welcome to MedPod Today, the podcast series where MedPage Today reporters share deeper insight into the week’s biggest healthcare stories. I’m your host, Rachael Robertson.

Today, we’re talking with Sophie Putka about a new COVID variant. And after that, Kristina Fiore shares her reporting about some concerns about amniotic fluid in eye drops. Last but not least, Jennifer Henderson will tell us about conversations happening in California about certified registered nurse anesthetists’ scope of practice.

On to the show.

There’s another COVID variant circulating, and it’s starting to take over the other dominant variants this cold season. It’s called XEC, and it’s a descendant of other Omicron variants, and cases have been steadily growing in Germany, where it was first spotted. Sophie is here to tell us a bit more about this latest COVID update.

Sophie, what do we know so far about XEC?

Sophie Putka: Yeah. So I spoke to Amesh Adalja, MD, an infectious disease physician from Johns Hopkins, and he told me XEC is not too different from the other variants in circulation. He told me that whatever advantage it does have over these other variants represents a “fairly minor evolution,” although by definition, it may be more immune evasive, which would give XEC a small advantage in transmission, like the other dominant variants that came before.

Robertson: So where are we seeing it right now, and is it making its way over to the U.S.?

Putka: So right now, XEC is mostly being spotted in central Europe, where it was at around 10% of cases last week, so probably a little bit more than that now. And it actually hasn’t been picked up by the CDC’s variant tracker yet, but another estimate puts it at almost 2% of cases in the U.S., and most of these are concentrated on the coasts. So right now, the most dominant variants in the U.S. are still the other Omicron descendants, KP.3.1.1 and KP.2.3, at 52.7% and 12.5%, going by CDC estimates.

Robertson: What about our vaccines? Are they still good for protection against XEC?

Putka: So far, Rachael, experts say the answer is yes. The COVID vaccines we have available right now were designed for slightly different subvariants, like KP.2 for Pfizer and Moderna’s most updated shots, and JN.1 for Novavax’s. But Adalja told me they’ll still protect against serious illness and hospitalization, which he said was “the primary function of our current first generation COVID vaccines.”

Even so, he said, the rapid mutation of the virus means it will always be getting better at infecting people and we should be focusing on a way to protect against infection, not just severe disease, like coming up with a universal COVID vaccine, maybe made with different technologies. So XEC is just the latest version of these continuing mutations, but it’s not looking like it will make much of a meaningful difference for people’s day-to-day lives.

Robertson: Well, thank you for that reporting, Sophie.

Putka: Thank you, Rachael.

Robertson: Over the last 2 years, the FDA has turned its eye to eye drops. Some products have been recalled for bacterial contamination, and the agency warned that major retailers may be selling some risky products. It even sent Amazon a warning letter over some of the eye drops sold on the site. This month, the FDA warned about another potential problem with eye drops: they may contain amniotic fluid. Kristina Fiore is here to tell us more about this.

Kristina, what’s going on with eye drops that have amniotic fluid in them?

Kristina Fiore: Yeah, Rachael, so the FDA actually warned people to stay away from eye drops containing amniotic fluid about 2 years ago, and at the same time, it sent what it calls “untitled” letters to two of the companies that sold these products. Now the FDA has upped the stakes with one of those companies, sending a much more powerful “warning” letter to the Florida-based Regenerative Processing Plant over its Regener Eyes products.

FDA said these products are unapproved new drugs because they make claims about treating dry eyes, and it found many violations of current good manufacturing practices at the facility where these drugs are made. But the most interesting part of the warning letter to me is that the FDA lays bare its strong suspicion that the company is still producing eye drops with amniotic fluid, even though it said it stopped making those drops in 2021.

Robertson: Why does the FDA suspect it’s still making those eye drops?

Fiore: So during a 10-day inspection in 2023, the FDA found that the company continued to receive shipments of amniotic fluid. Now the company said it uses this for research, but many of the lot codes from the eye drop products actually matched the amniotic fluid donor IDs, so the FDA was very suspicious of that.

Now if the drops do indeed contain amniotic fluid, the company would need an approved biologics license to sell them. And this gets back to FDA’s June 2021 guidance on regenerative medicine that basically says all stem cell/birth tissue products are experimental and they need FDA approval or an investigational new drug application in effect, to conduct research.

Robertson: So why don’t you want to put amniotic fluid in your eyes? Slash, why do these products exist in the first place?

Fiore: Yeah, well, the main reason comes down to the problems with the other eye drops: contamination and risk of infection. Sandra Brown, MD, an ophthalmologist in North Carolina and a board member of the advocacy group Dry Eye Foundation, said there are no established quality controls on the supply chain of amniotic fluid and no standards for rendering it sterile. She said, “The fluid could be contaminated with bacteria or viruses, including organisms that cause sexually transmitted diseases.”

Now, this all sounds pretty straightforward, but there’s still demand for products containing stem cells and birth tissues, even though the FDA has tried to warn us again and again that these products really aren’t ready for prime time. So Paul Knoepfler, PhD — he’s a stem cell expert at the University of California Davis – he wrote in a blog about the Regener Eyes warning letter that FDA’s actual enforcement of the rules for these products is “slow and incremental.” He noted that even after a firm gets a warning letter, sometimes a few years go by before it “becomes compliant or switches products or continues under a new name, maybe a new location.”

Robertson: So it sounds like this problem could be with us for quite a while then.

Fiore: I think so.

Robertson: Yikes. Well, thank you for your reporting on this, Kristina.

Fiore: Thanks, Rachael.

Robertson: There’s been a lot of attention on the scope-of-practice for certified registered nurse anesthetists, or CRNAs. California has been at the epicenter. In fact, the state’s Department of Public Health penned a letter to general acute care hospitals outlining the requirements for using CRNAs in hospital anesthesia services. Before that, two hospitals in Modesto, California were hit with “immediate jeopardy” violations, and those were issued in part due to reports of CRNAs operating beyond their scope of practice. Jennifer Henderson is here in the studio to tell us more about these recent developments.

Jennifer, tell us more about this all-facilities letter from the California Department of Public Health. What does it specify?

Jennifer Henderson: The letter states that in California, a CRNA administering anesthesia services is not required to be under the supervision of the operating practitioner or an anesthesiologist. But the letter also has some provisions. For instance, it specified that a CRNA is not authorized to practice medicine or surgery. Additionally, a hospital is responsible for policies and procedures that grant expanded privileges to registered nurses, regardless of whether they are employed by the hospital or not, according to the letter. This would apply to the assessment, planning, and direction of diagnostic and therapeutic care of patients.

Robertson: Okay, so how have people from different sides of this issue been reacting?

Henderson: As a whole, the reaction has been favorable. Sandra Bordi is president of the California Association of Nurse Anesthesiology, which previously pushed back on the citations at the Modesto hospitals. Bordi commended the Department of Public Health for maintaining a precedent set by a 2012 court decision. But Bordi also said that “despite the all facility letter’s clarifications of existing state and federal law and regulations, false statements about CRNAs’ scope continue to decimate care in underserved regions of the state.”

Antonio Hernandez Conte, MD, immediate past president of the California Society of Anesthesiologists, likewise told me that the letter is “very much appreciated.” However, he said, it is important that “patients have a transparent informed consent process.” Additionally, healthcare providers should accurately represent their title, licensure, education, and board certification, he noted. And providers should use the title or introduction of “doctor” only when appropriate in healthcare settings.

Robertson: All right. So what previously happened at those Modesto hospitals?

Henderson: So earlier this year, the Modesto Bee reported that hundreds of surgeries were canceled or rescheduled at two hospitals after they suspended CRNA practice in response to “immediate jeopardy” citations they received following surveys of their facilities by the State Department of Public Health.

Some of the findings reportedly included that a CRNA had changed a doctor’s order for general anesthesia for a surgery to higher risk spinal anesthesia and sedation. Also, several patients had negative health outcomes following care provided by CRNAs and that hospital policy had been that physicians oversee anesthesia, according to the Modesto Bee. At the time, CRNAs in California pushed back, arguing that state law allows them to operate without physician oversight.

Robertson: We’ll be sure to come to you whenever there are more updates on this situation. But thank you so much for being a guest today, Jennifer.

Henderson: Thank you, Rachael.

Robertson: And that’s it for today. If you like what you heard, leave us a review wherever you listen to podcasts (Apple, Spotify) and hit subscribe if you haven’t already. We will see you again soon.

This episode was hosted and produced by me, Rachael Robertson. Sound engineering by Greg Laub. Our guests were MedPage Today reporters Sophie Putka, Kristina Fiore, and Jennifer Henderson. Links to their stories are in the show notes.

MedPod Today is a production of MedPage Today. For more information about the show, check out medpagetoday.com/podcasts.

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