Yves here. Yours truly has long been saying “no” to doctors pushing tests and treatments that look to be beside the point…but how many are wired that way? Particularly when sick with Covid and having heard monoclonal antibodies can help?
And that’s before getting to the fact that Americans have been indoctrinated to think that surely there is a magic pill or procedure for every ailment and therefore pressure their doctor to provide them. That attitude is behind the widespread bad practice of MDs handing out antibiotics like candy to patients show up in their office with a bad case of flu. The US instead needs placebos that get new names every year or more often to satisfy patient demands that the MD Do Something when not much can be done.
Having said that, I wonder why the monoclonals are able to be used at all. Even under Delta, when they were beneficial, my understanding is that access was restricted because even then the supplies weren’t high enough to meet surge-level demand, plus they are also pricey. So only patients who met certain specific criteria could get them. So it appears there are still quite a few who meet the requirements for a now-pretty-likely-to-be-ineffective treatment (although it would make sense to sequence to be sure it isn’t actually Delta).
By JoNel Aleccia, a Senior Kaiser Health News Correspondent focused on aging and end-of-life issues on the KHN enterprise team and previously, a health reporter at outlets including The Seattle Times, NBCNews.com, TODAY.com and MSNBC.com. Originally published at Kaiser Health News
As the omicron variant completes its sweep across the U.S., states with scarce supplies of monoclonal antibody therapies continue to use two treatments that federal health officials warn no longer work against the highly contagious version of the virus that causes covid-19. The antibody treatment now most recommended is sotrovimab from GlaxoSmithKline and Vir Biotechnology, and it’s in short supply.
Use of the newly ineffective treatments produced by Regeneron Pharmaceuticals and Eli Lilly and Co. is highest in a dozen states. They include several Southern states with some of the nation’s lowest vaccination rates, but also California, which ranks in the nation’s top 20 for fully vaccinated residents, a KHN analysis of federal data shows. Many hospitals and clinics are still infusing the costly treatments — often charging hundreds of dollars a session — that public health officials now say are almost certainly useless.
That’s because of the near-total dominance of omicron, which accounted for 99.5% of new covid infections in the U.S. during the week that ended Jan. 15, according to the Centers for Disease Control and Prevention.
That point was underscored this week by updated guidelines from the National Institutes of Health that now recommend sotrovimab as the primary monoclonal treatment for the disease.
Unless providers are certain they are still treating patients infected with the delta variant, they shouldn’t use the others, said Dr. Mark McClellan, director of the Duke-Margolis Center for Health Policy, who is also a former commissioner of the FDA and former administrator of CMS. And the delta variant is increasingly rare, accounting for 3% of cases in Louisiana, 7% in California, and 10% in Ohio, as examples.
“There’s not a medical justification based on the evidence on the Regeneron and Lilly products,” McClellan said.
Determining which patients are infected with the delta vs. omicron variant is complicated, said Dr. Christian Ramers, chief of population health and an infectious disease specialist at Family Health Centers of San Diego.
His clinic is one of the few sites in the nation using laboratory screening of positive PCR covid tests that can tell whether patients are infected with delta vs. omicron — and then treating them accordingly. “Otherwise, you’re giving this false sense of security to a patient that they’re getting treatment,” Ramers said. “I don’t think it is ethical, and it goes against the principle of doing no harm.”
Overall, U.S. hospitals used about 72,000 doses of the Regeneron and Lilly monoclonal antibody therapies from Jan. 5 through Jan. 18, according to the latest figures from the Department of Health and Human Services. Data regarding hospital-level use of sotrovimab, which became available more recently than the other products, is not yet available on the HHS site.
By comparison, hospitals used about 153,000 courses of the Regeneron and Lilly treatments from Dec. 22 through Jan. 4. They used about 169,000 courses from Aug. 26 through Sept. 8, near the height of the delta surge.
On Jan. 19, hospitals still had about 295,000 doses of the Regeneron and Lilly treatments on hand.
Nationwide, the federal government is distributing more than 50,000 courses of sotrovimab per week, though it remains in short supply. The Biden administration has agreed to buy about 1 million doses, including about 600,000 promised by March, GSK officials said.
Respectively, Michigan, Florida, Indiana, Missouri, Louisiana, California, Oklahoma, Kansas, Georgia, Ohio, New York, and Mississippi used the most courses of the Regeneron and Lilly treatments from Jan. 5 through Jan. 18, KHN’s analysis showed.
In Florida, which used more than 5,200 courses of the outdated treatments during that two-week period, Republican Gov. Ron DeSantis has said he is not convinced that the Regeneron and Lilly products don’t work against omicron. In Florida, omicron accounted for 97% of cases as of Jan. 20; delta accounted for 3%.
“We have had practitioners give both of those to people with omicron who said the symptoms got resolved,” he said in a Jan. 5 speech provided by his spokesperson, Christina Pushaw.
Federal health officials managing allocation of the monoclonal antibody therapies paused shipments of the Regeneron and Lilly treatments on Dec. 23, after laboratory tests showed they were less effective against the surging omicron variant than the delta variant. But the Biden administration resumed shipments on Dec. 31, after complaints from DeSantis and some doctors that those therapies could still help people in places where the delta variant persisted.
Regeneron itself has said its antibody treatments are ineffective against the omicron variant. It contains more than 30 mutations in the virus’s spike protein, which makes the variant better at dodging the monoclonal antibody treatments.
“It’s really not justified at this point unless there’s some other underlying secondary gain, political pressure, or perhaps the providers are truly not in touch with the reality of the variant proportions,” Ramers said.
Earlier this month, HHS officials indicated that shipments of the three monoclonal antibody treatments would continue through Jan. 31, despite the growing proportion of omicron cases. A department spokesperson on background said the agency would continue to assess “any impacts to covid-19’s therapeutic allocations.”
Monoclonal antibody treatments are lab-based molecules that mimic the body’s immune response to infection. They are most often given through IV infusion, though some can be delivered with an injection. The federal government has agreed to purchase millions of doses of the Regeneron and Lilly products at a cost of about $2,100 per dose. The medicines are free to consumers, though hospitals and clinics do charge fees for administering the drugs and monitoring patients during the process.
Other treatments expected to be effective against omicron in high-risk, non-hospitalized patients include AstraZeneca’s Evusheld, a long-acting injectable monoclonal antibody for immunocompromised people, and a three-day infusion of Gilead Sciences’ remdesivir, which is approved by the FDA. New oral antiviral pills also are expected to be effective, although they, too, remain in short supply.
Providers in several states that have continued to use the Regeneron and Lilly products have offered varied reasons. Some said they believed delta infections continued to circulate locally; others said they felt desperate to try something.
Officials in Michigan, which used more than 5,800 doses of the Regeneron and Lilly products during the most recent two weeks, and California, which used more than 3,400, have allowed health care providers to use their clinical judgment about which treatment to prescribe.
But in Mississippi, where omicron is rampant and fewer than half of residents have been fully vaccinated, state health officer Dr. Thomas Dobbs called for an end to the use of the treatments.
“We will be recommending that clinicians and physicians do not use these products right now based on the distribution of omicron vs. delta,” he said during a recent press conference.
At Ramers’ clinic in San Diego, care providers have been dispensing scarce doses of the monoclonal antibody treatments only when they’re confident they’ll help. That has meant sending batches of positive PCR tests to a laboratory in nearby Irvine, where they are screened to see whether one of three target genes is not detected, a known marker for an omicron infection.
Patients infected with the delta variant were able to be treated with REGEN-COV, the Regeneron product, preserving sotrovimab for the growing number of omicron cases, said Pauline Lucatero, the clinic’s director of nursing.
“Looking into my patients’ eyes and seeing fear, just fear, all I could tell them is we believe this treatment works and we’re going to do everything we can to save as many people as we can,” she said.
Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.
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The NYT also wrote about this, if of any interest.
https://www.nytimes.com/2021/12/21/health/covid-monoclonal-antibodies-omicron.html
And, once again, nary a mention of the drug that must not be named.
I tell you Slim, it is starting to get like an old Benny Hill sketch-
‘Of course there are many drugs out there, not to mention Ivermectin.’
“Ivermectin?’
” I told you not to mention it!’
Yup. That’s it. The unmentionable drug.
We have taken to using Oscar Wilde quality euphemisms to “name” ‘the stuff.’ I would observe that this is a very subtle form of self censorship. From some of the things I am reading about physicians being punished for “off label” prescribing the “Stuff,” I find our self-preservative impulses to have been warranted.
It’s getting similar to those old tyme situations where we don’t mention aunt Agatha and her, *cough*, excessive imbibing habit. [You know Aunt Agatha. The sweet old woman we lock in the attic whenever visitors come to call.]
“The medication that must not be named” is, I think, a tongue in cheek reference to the circumlocution for the dark lord “Voldemort” in the Harry Potter series. I have interpreted these uses to be poking fun at the medical establishment, that seems determined to suppress mention of the agent.
It strikes me as a valid form of protest, not a form of self-censorship.
I suggest “Ivor Cutler”, the Scots poet/musician who is sort of the Weird Al of the UK 60s.
https://www.youtube.com/watch?v=uwNcxd9Jf9I
Oh yes, and Spike Milligan and the Goons., Firesign Theatre, Monty Python and many more. There is a place and need for ‘eccentrics’ in our world, our lives.
Someone has to tell the truth.
One of the issues is the inability of clinicians to differentiate between delta and omicron and get the correct treatment to the patient.
Testing does not differentiate between strains at a hospital level. They are run in batch samples at a state level.
With the prevalence of omicron you can presume, but not be certain. You can guess, but you better be right when you do.
With early sars cov 2, the old antibody treatment given early was lifesaving.
My entire extended adult family, all recently vaccinated, all with multiple co-morbidities, got probably delta back in August of last year.
They all received Regeneron and rapidly recovered, with the exception of one.
There was a huge shortage of the monoclonal and up to a five day waiting period to receive it. He waited dutifully until his turn in line. He had been vaccinated four months prior. He was not sick initially.
On the way to the hospital to get the antibody treatment, walking to get in the car he fell on the lawn. Got up and fell again. Crawled up the steps of the house and fell again. Tried to walk back to the car and fell again. My elderly and frail mother had to call the fire department to assist. Was subsequently transported to the hospital for a fall evaluation and was admitted for a Covid infection.
Did fine for four days. Was worked up for a fall. He had a kidney stone and a urinary tract infection. No fractures. They wouldn’t give him the antibody treatment in the hospital because that was their policy. It was the policy everywhere.
On the fifth day he had an oxygen requirement and was started on standard treatment with dexamethasone and remdesivir. He did fine for ten days. Some oxygen requirement but only nasal cannula.
On the eleventh day onto bipap. intubated on day thirteen. Severe sepsis with acute kidney injury. Secondary unspeciated gram negative pneumonia. Treated, improved, extubated then reintubated.
Pneumomediastinum. Pneumothorax. Secondary VAP With a nasty multi drug resistant pseudomonas. Severe acute kidney injury. Chest tube. Tracheostomy then transfer to an LTAC.
A third then a fourth pneumonia. Tracheotomy out. Aspiration. Stridor. Inspissated secretions. Granulation ingrowth. Emergency tracheostomy. Two weeks on the ventilator with the fifth, now aspiration related pneumonia.
Now languishing with severe subglottic stenosis. An in dwelling cuffed tracheotomy with no facilities which can offer a tertiary level referral for tracheal reconstruction. They are all full.
Ran out of Medicare.
It’s broken my mother’s heart. It quite likely will consume the remainder of her retirement savings after being a school teacher for nearly fifty years.. And despite my ability to see the medical issues with clarity, he cannot get definitive care due to resource constraints.
Therapeutics have been sorely neglected. Off label agents have not been definitively studied. There have been retracted papers in prestigious journals. Clinicians have a severely limited toolbox of official approved therapies, none of which are terribly effective at altering the course of severe disease.
Resources have not been focused on bringing therapeutic treatments to fight this disease. I don’t know if it’s a bug or a feature.
It would not seem to me to be difficult to set up a few very well designed smaller but with adequate statistical power, multi center randomized double blinded short evaluations to get some definitive answers.
We are two years into this thing and those studies have not been done. And with the tight enforcement of evidence based guidelines around this disease, a host of potentially useful things are unavailable to people care for people with this disease.
It’s a travesty.
This is just terrible. I’m so sorry this happened to your family, and that it is happening, not just to anyone, but to so many.
I recommend to anyone who is able to attend, in person or via a live-stream, a one-hour documentary, “The Power to Heal.” Narrated by Danny Glover, it is about how pressure was brought on the Johnson Administration to use the introduction of Medicare to force de-segregation of American hospitals and medical care. The film illustrates how terrible, really terrible, the plight of sick African Americans was in the mid-60s with a separate and unequal healthcare system. Then it shows how a functioning federal government was able to use a brand-new program, Medicare, to force the destruction of that system.
In its depiction of a federal government at work, the film is inspiring. That we have not seen anything like it since is both tragic and utterly enraging.
Don’t miss “The Power to Heal.”
I am so sorry for what has happened to your family. If it is any consolation, thank you for sharing, as it serves as motivation to continue to work to fix this broken mess we have in the US and I agree, 2 years in, you would think more studies would be done on therapeutics.
what is not mentioned is that there IS data that unvaccinated hospital cases in some locales are still dominated by Delta.
See this for example:
https://www.huffingtonpost.fr/entry/covid-omicron-cas-delta-reanimations_fr_61e1aabee4b0d8b6656ab527
banned from the CBC comments for mentioning Ivermectin/zinc, Quertecin/zinc, HCQ, I may as well stick my two cents in here. Its all about money, how can it not be all the early treatments which are virtually banned, are cheap. The newest money maker I think is Barictinib which Eli Lilly has patented in some countries and sells for $2,326 per treatment. The Indian manufacturer claims it could be sold for $5.50 and in Bangladesh for $6.70. What is not clear is that it was already approved for rheumatoid arthritis.so is it a new drug or just an off label use?
Why are these people not in jail?
one more thing:
the data that the older versions wont work is all lab based. Why not in vitro data now? Couldn’t Florida run their data?
Of course, Florida could run the datasets. I’m guessing any statistics teacher or any epidemiologist could run them, but Florida doesn’t want the embarrassment, even though every state and territory in the Union got hammered, and it is not profitable enough for the corporate data pushers to do so.
Florida is too corrupt and politically ignorant to run the datasets. Floridians are on their own healthcare-wise.
That is mot the case. FL has an intelligent and caring governor who decided to offer the top of the line, most successful early treatment to FL residents, at FL’s taxpayer expense, after it became obvious that the vaccines weren’t doing much good. Regeneron cured almost all who took it within 24 hours, at least until Biden monopolized supplies and prevented FL from buying more. Monoclonal antibodies kept thousands of Floridians out of hospitals, and there was never a shortage of them. If your state never had them, you need to ask your governor and state legislators WHY.
As IM Doc reports today, no other country in the world uses monoclonal antibodies to treat Covid because in about 1 out of every 3 cases, it fries the kidneys to the degree it can result in death. He’s been party to two recent fatalities. That is also why it was withdrawn as a possible Ebola treatment.
And IM Doc has never seen it help a Covid case, and he’s been party to a fair number of administrations.
Btw, FL did keep statistics. At their mobile monoclonal antibody sites, they show that there were 3 to 4 times more fully vaxxed patients with Covid showing up for treatment compared to every unvaxxed patient. And all were tested for Covid prior to being treated, although those at high risk of complications from Covid were allowed to take the monoclonals if they had only been exposed.