|
We're From the Government and We're Here to Help
[FDA] 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.So the Government gets to decide who gets it and who doesn't. Death panels, anyone? 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. During 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. Posted by: Deacon Blues 2021-09-07 |
| http://www.rantburg.com/poparticle.php?ID=611903 |