| Submit your comments on this article |
| Science & Technology |
| Why in the World Is the Government Disrupting the Distribution of Monoclonal Antibodies Now? |
| 2021-09-07 |
| [PJMedia] After demonizing nearly every medication with the potential to reduce the severity of COVID-19 symptoms, the National Institutes of Health (NIH) finally recommended monoclonal antibodies earlier this summer. Before the official recommendation, some providers used them under an emergency use authorization (EUA) granted by the FDA in November 2020. The FDA just granted an EUA to allow their use for SARS-CoV-2 post-exposure and ongoing prophylaxis. This approval will increase demand. Recently, the treatment has gotten quite a bit of media coverage. While the Department of Health and Human Services (HHS) has been promoting the treatment on the Combat Covid website since early summer, one man ensured a nationwide media campaign. Once Florida Governor Ron DeSantis decided to promote outpatient treatment using the antibodies and establish infusion centers, the media reacted because he is a very dangerous Republican. Related: Only Ron DeSantis Would Get Criticized for Doing Exactly What Biden’s HHS WantsDuring the week leading into the Labor Day holiday, DeSantis was on the road again, touting the success of Florida’s program in disconnecting COVID-19 infection from hospitalization in the state. Patients gave personal testimony about their experience with the treatment. Hospitalizations in the state declined 20% during the first few weeks the infusion centers were up and running. Then something interesting happened. On Friday, someone who claimed to be an urgent care specialist tweeted that HHS had informed him that the government would now decide which facilities would receive doses of monoclonal antibodies. Jim Jackson wrote: "So now the government is getting involved in [read: restricting] monoclonal antibody distribution. Before, I could just order as much as we needed, and they shipped it next day air. Now a govt. commission will decide when, if, and how much I will be able to get for my pts [patients]. ’Should you have any questions regarding this update in ordering and distribution procedures, please email the Federal COVID-19 Response Team.’ Wonderful." He added the alert from HHS that confirmed his assertion. Now, only facilities participating in the HHS Protect program can order the treatment, and the agency will review all orders. Suppose the current distribution map provided by HHS includes the HHS Protect facilities. In that case, the new order review process seems like a heavy administrative burden for the program. It may delay or limit treatment for at-risk patients. Monoclonal antibodies are approved and recommended for outpatient use. HHS instructs patients who qualify to access them within ten days of symptom onset. Regeneron also has FDA approval to be used post-exposure and for prevention. All approved uses are time-dependent and not conducive to a burdensome order review process. The timing of the change in how health providers access them is curious. If the supply is genuinely so constrained that the federal government needs to get involved in decisions about distribution, the question should be why. The use of monoclonal antibodies is restricted and only provided for specific at-risk groups. By managing and approving distribution, HHS insulates the manufacturers from actual market demand. Now, some at-risk vaccinated as well as unvaccinated patients require effective treatment, and it is constrained. If new variants emerge and become dominant, that trend may continue. To date, therapeutics and repurposed medications to reduce disease severity have been underemphasized and even demonized. Monoclonal antibodies made it through all the noise and President Trump’s endorsement. It is time for the federal response to encourage increased production of monoclonal antibodies, challenge manufacturers to develop formulations against variants of concern, and get them in the hands of practitioners. Related: Monoclonal antibodies: 2021-08-15 DeSantis Launches Monoclonal Antibody Rapid Response Teams to Prevent Hospital Overcrowding Monoclonal antibodies: 2021-02-20 Five Israelis teams fighting for a COVID-19 cure Monoclonal antibodies: 2020-11-23 Good COVID news: Antibodies may provide lasting immunity; elderly death rates reportedly dropping |
| Posted by:Thing From Snowy Mountain |
| #12 They'e probably seeing Nurse Practitiones in week one if they start coming down with cold symptoms. As near as I can tell they're doing aggressive testing down here. (Disclaimer: I'm not in Florida but elsewhere in the South). |
| Posted by: Thing From Snowy Mountain 2021-09-07 19:33 |
| #11 Doctors? |
| Posted by: Thing From Snowy Mountain 2021-09-07 19:32 |
| #10 Monoclonal antibody treatments work against delta variant when taken in first week of symptoms: doctors. Groovy. How many get to docs in week one? |
| Posted by: g(r)omgoru 2021-09-07 19:04 |
| #9 (b) Since it doesn't induce even temp immunity - that's why it's called passive immunization - it will have to be repeated with every exposure. Only if you're using it on people with no symptoms whatsoever, which as far as I can tell isn't the case; they're being used to treat people that are symptomatic but not necessarily on their last legs. (c) There is evidence that existing monoclonals are NOT effective against delta variant. Linking to a google search? Hmm. the fourth item to come up was Monoclonal antibody treatments work against delta variant when taken in first week of symptoms: doctors. |
| Posted by: Thing From Snowy Mountain 2021-09-07 18:56 |
| #8 By making it exclusive, they can give away more of the vax that doesn't [no longer] work. |
| Posted by: Skidmark 2021-09-07 18:32 |
| #7 ^Let me reiterate. Due to increased demand there is a supply shortage. Thus, IMO, the regulation. p.s. Don't expect them to increase production to accommodate De Santis' political stunt (= very transient rise in demand). In fact, don't expect anyone - except Republican pols - to move a finger to accommodate the anti-vaxxers. |
| Posted by: g(r)omgoru 2021-09-07 17:44 |
| #6 G(r)om, that's the point. It can't possibly compete even with the (dubious) vaccines, but they had to go code red and see to it that it's stopped. Why? Because you're not allowed to compete with the narrative. Somebody might start saying things like 'divert some of the money to look at this'. Can't be having that idea be discussed. |
| Posted by: ed in texas 2021-09-07 17:31 |
| #5 Two thoughts. Monoclonals would be specific to a variant. So wouldn't you need ones tailored to the virus you have? Note this appears to apply to the vaccine too, and more boosters of an ineffective vaccine presumably won't do much good. The monoclonals themselves would not confer natural immunity, but having the infection will. Anyone want to share a paper stating that use of monoclonals prevents or impairs a natural immune response? Which, in the case of Delta anyway, is something like 7x more effective than the vax. |
| Posted by: Angstrom 2021-09-07 13:10 |
| #4 There is evidence that existing monoclonals are NOT effective against delta variant. Or Mu. COVID-19 variant mu detected in 49 states |
| Posted by: Skidmark 2021-09-07 11:47 |
| #3 (a) A course of treatment with monoclonals costs a lot more than active immunization. (b) Since it doesn't induce even temp immunity - that's why it's called passive immunization - it will have to be repeated with every exposure. (c) There is evidence that existing monoclonals are NOT effective against delta variant. (d) With De Santis' cheap publicity trick - since he's perfectly aware of (a), (b), (c) - the demand for monoclonals exceeds the supply. Therefore the new regulations. |
| Posted by: g(r)omgoru 2021-09-07 11:32 |
| #2 ^1. Exactly. They have made it very clear they do not want a treatment. |
| Posted by: Angstrom 2021-09-07 10:55 |
| #1 It's threatening their vaccine gravy train. |
| Posted by: ed in texas 2021-09-07 10:23 |