Well, the good news is that hospitals are finally using another drug to treat COVID aside from the failed remdesivir. The bad news is that this drug comes with a rare FDA “black box” warning of causing blood clots and also costs a fortune. Why is it that our government trashes every cheap, safe outpatient therapeutic that has been used for decades without problems, but only approves expensive therapeutics that cause blood clots or renal failure (in the case of remdesivir)? This is the ultimate case of therapeutic nihilism.
Last November the FDA quietly gamed emergency authorization use to baricitinib, a drug used for acute rheumatoid arthritis, which is produced by Eli Lilly under the brand name Olumiant. The specific authorization is for COVID patients requiring supplemental oxygen, non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Unlike remdesivir, baricitinib is an anti-inflammatory Janus kinase (JAK) inhibitor, which helps ratchet down pro-inflammatory cytokines. As such, it's very likely that it does have more efficacy during the inflammatory stage than the worthless remdesivir. The problem is that it comes with an FDA black box warning about causing blood clots, the very condition you are trying to treat at the critical stages of COVID illness. Here is the warning on blood clots:
Thrombosis: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.
Pulmonary embolism is literally the most delicate condition intensivists must deal with when treating COVID patients in the ICU. It's liking fighting a fire with a blowtorch!
At the beginning of the month, the FDA announced it was updating its warnings because drugs like “Olumiant and Rinvoq have not been studied in trials similar to the large safety clinical trial with Xeljanz, so the risks have not been adequately evaluated.” However, because it has the same mechanism of action, it is suspected to have the same side effects as Xeljanz.
Black box warnings are rare and unlike the common disclaimers that are placed on any drug label. As noted by Drug Watch, “A black box warning is the FDA's most stringent warning for drugs and medical devices on the market. “
Yet baricitinib takes its place along with remdesivir as the only standard of care for inpatient COVID treatment from the NIH.
Contrast this to ivermectin, which won a Nobel Prize by proxy, is one of the safest drugs, and has been dispensed billions of times in Africa for parasitic infections and millions of times for COVID in India without incident. Yet the very same hospitals that have zero problem using a black box drug, particularly for blood clots, on a COVID patient in danger of thrombosis will go to court to fight the use of ivermectin, even for a patient with no other option.
Several weeks ago, I had Buffalo-based attorney Ralph Lorigo on my podcast to discuss his legal fight against hospitals denying ivermectin treatment. All but one of the patients on ventilators for whom he legally secured a right to ivermectin treatment recovered when they almost assuredly would have died. So visceral is their desire to block this treatment that hospital doctors have even fought in court to stop ivermectin for patients they already planned to take off life support! Here is what he told listeners of my podcast:
I had a doctor on the stand and I asked him the obvious question: why won't you provide the ivermectin? … You've got a patient with less than 20% chance of survival, you are done with the protocol and it hasn't worked, and you won't give ivermectin? And the robot answer is it's not FDA-approved. It's been so bad, I've had doctors actually say to my client you should consider removing life support, and the client said, “No, I want to try ivermectin,” and the response was: “I don't know, that could have negative effects.”
Isn't it interesting that the only treatments they will use either cause blood clots (Olumiant and the vaccines) or renal and liver failure (remdesivir)? Even the WHO recommends against using remdesivir. How could they be so cautious against common, safe, cheap drugs but liberally use the most dangerous, ineffective, and expensive therapeutics?
The answer lies in political science, not life science. Olumiant is an on-patent drug made by the cool kids with a lot of lobbyists and former employees who work at the relevant HHS agencies. There's a lot of money to be made.
Just remember, the same political science that governs the approval of therapeutics also determines the policies behind the COVID shots.
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