Patients, beware: Some states are still pushing ineffective Covid antibody treatments


Ive here. It’s true that your doctor has been saying “no” to doctors pushing seemingly innocuous tests and treatments for a long time…but how many people are so connected? Will it help especially if you have the new coronavirus and have heard of monoclonal antibodies?

Before that, Americans had been indoctrinated into thinking that there must be a magic pill or cure for every ailment, thus forcing their doctors to provide them. This attitude is behind the widespread bad practice of MDs handing out antibiotics like candy to patients with severe flu cases. Instead, the U.S. needs to get a placebo under a new name every year or more frequently to satisfy a patient’s request to ask an MD to do something when they are incapacitated.

Having said that, I wonder why monoclonal antibodies can be used at all. Even under Delta, when they’re favorable, my understanding is that access is limited because even then supply isn’t enough to meet the surge in demand, and they’re expensive. Therefore, only patients who meet certain specific criteria can get them. So there still seems to be a decent number of people who qualify for the now-probably ineffective treatment (though it makes sense to sort to make sure it’s not actually Delta).

By JoNel Aleccia, senior reporter for Kaiser Health News, focusing on aging and end-of-life issues for KHN’s corporate team, and previously health reporter for The Seattle Times, NBCNews.com, TODAY.com, and MSNBC.com.Originally Posted in Kaiser Health News

As omicron variants finish sweeping across the U.S., states with scarce supplies of monoclonal antibody treatments continue to use two treatments that federal health officials warn are no longer suitable for the highly contagious version of the virus that causes covid-19 .Antibody Therapy Now most recommended It’s sotrovimab from GlaxoSmithKline and Vir Biotechnology, which is currently in short supply.

The use of new ineffective treatments by Regeneron Pharmaceuticals and Eli Lilly and Co. is the highest in more than a dozen states. Those states include several southern states with the lowest vaccination rates in the U.S., as well as California, which ranks in the top 20 nationally for fully vaccinated residents, according to a KHN analysis of federal data. Many hospitals and clinics are still infusing expensive treatments—often charging hundreds of dollars per session—that public health officials now say are almost certainly not useful.

This is because omicron is almost completely dominant, 99.5% of new covid infections In the U.S. during the week ended Jan. 15, according to the U.S. Centers for Disease Control and Prevention.

This week’s update highlights that Guidelines The National Institutes of Health now recommends sotrovimab as the primary monoclonal treatment for the disease.

Unless providers are sure they are still treating patients infected with the delta variant, they should not use others, said Dr. Mark McClellan, director of the Duke-Margolis Center for Health Policy and a former FDA commissioner. Former administrator of CMS. The delta variant is Fewer and fewerFor example, Louisiana has 3%, California has 7%, and Ohio has 10%.

“There is no medical reason based on the evidence for Regeneron and Lilly’s products,” McClellan said.

Determining which patients are infected with the delta and omicron variants is complicated, said Dr. Christian Ramers, director of population health and infectious disease specialist at Family Health Center in San Diego.

His clinic is one of the few locations in the country that uses laboratory-screening positive PCR covid tests that can tell if patients have delta and omicron infections, and then treat them accordingly. “Otherwise, you’re giving this false sense of security to the patient being treated,” Lamers said. “I don’t think it’s ethical and it goes against the principle of doing no harm.”

At Dr. Christian Lammers’ clinic in San Diego, care providers dispense scarce doses of monoclonal antibody therapy only when they are confident they will help. Prescribing a monoclonal drug that doesn’t work against the omicron variant “goes against the principle of doing no harm,” Ramers said. (San Diego Family Health Center)

Overall, US hospitals used about 72,000 doses of the Regeneron and Lilly monoclonal antibody therapies from Jan. 5 to Jan. 18. The latest data From the Department of Health and Human Services. Data on hospital-level use of sotrovimab are not yet available on the HHS website and are available more recently than other products.

By comparison, from Dec. 22 to Jan. 4, the hospital used about 153,000 treatments of Regeneron and Lilly. From Aug. 26 to Sept. 8, they used about 169,000 sessions, approaching the height of the delta surge.

On January 19, the hospital still had about 295,000 doses of the Regeneron and Lilly treatments on hand.

Across the country, the federal government is distributing Over 50,000 courses sotrovimab weekly, although it is still in short supply. The Biden administration has agreed to buy about 1 million doses, including about 600,000 it has promised to buy by March, GlaxoSmithKline officials said.

KHN’s analysis shows that from January 5 to January 18, Michigan, Florida, Indiana, Missouri, Louisiana, California, Oklahoma, Kansas, Georgia, Ohio, New York and Mississippi used the most Regeneron and Lilly treatments, respectively.

In Florida, where more than 5,200 outdated treatment sessions were used in those two weeks, Republican Gov. Ron DeSantis said he did not believe Regeneron and Lilly’s products would be ineffective against omicron.In Florida, omicron accounts for 97% of cases As of January 20; Delta accounted for 3%.

“We’ve had doctors give both drugs to omicron patients who say their symptoms are resolved,” he said in remarks Jan. 5 by spokeswoman Christina Pushaw.

Federal health officials managing the allocation of monoclonal antibody therapies suspended shipments of the Regeneron and Lilly therapies on Dec. 23 after lab tests showed they were less effective on the surged omicron variant than the delta variant.But a Biden administration Shipping will resume on December 31, after DeSantis and some doctors complained that the treatments could still help people in places where delta variants persist.

Regeneron itself has said its antibody treatment is ineffective against the omicron variant. It contains more than 30 mutations in the virus’s spike protein, which make the variant better able to evade monoclonal antibody treatment.

“It really doesn’t make sense at this point, unless there’s some other potential secondary gain, political pressure, or maybe the vendor isn’t really exposed to a different scale of reality,” Lamers said.

Earlier this month, HHS officials said shipments of the three monoclonal antibody treatments would continue through Jan. 31 despite the rising proportion of omicron cases. A background spokesman said the agency would continue to assess “any impact on covid-19 treatment allocation”.

Monoclonal antibody treatments are laboratory-based molecules that mimic the body’s immune response to infection. They are most commonly given by intravenous infusion, but some can be given by injection. The federal government has agreed to buy millions of doses of Regeneron and Lilly for about $2,100 per dose. These drugs are free to consumers, but hospitals and clinics do charge fees for medication administration and monitoring patients in 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 Gilead Sciences ) of remdesivir (FDA-approved) as a three-day infusion. New oral antivirals are also expected to be effective, although they also remain in short supply.

Suppliers in several states that continue to use Regeneron and Lilly’s products have cited various reasons. Some said they thought the delta infection continued to spread locally; others said they were desperate to try something.

Officials in Michigan, which used more than 5,800 doses of Regeneron and Lilly products in the last two weeks, and California, which used more than 3,400 doses in the last two weeks, allowed health care providers to use their clinical judgment in which treatment to prescribe.

But omicron is rampant in Mississippi, where less than half of residents are fully vaccinated, and state health official Dr. Thomas Dobbs has called for the treatments to be stopped.

“Based on the distribution of omicron and delta, we will advise clinicians and physicians not to use these products now,” he said in a recent press conference.

At the Lammers Clinic in San Diego, providers dispense scarce doses of monoclonal antibody therapy only when they are confident they will help. That meant sending batches of positive PCR tests to a lab near Irvine, where they were screened to see if one of the three target genes, a known marker of omicron infection, was not detected.

Patients infected with the delta variant are able to be treated with Regeneron’s product REGEN-COV, preserving sotrovimab for the growing number of omicron cases, said Pauline Lucatero, the clinic’s director of care.

“Looking my patients in the eyes and seeing fear, just fear, all I can tell them is that we believe this treatment works and we’re going to do everything we can to save as many people as possible,” she said.

Philip Rees, assistant professor of journalism at California State University, Sacramento, contributed to this report.

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