The curious case of leronlimab and the FDA.

COVID related opinion

So the FDA has issued a statement regarding leronlimab from CytoDyn, saying it shows no benefit in the treatment of COVID. In fact, they re-issued it during a CytoDyn conference call earlier this week, in some sort of chest beating reinforcement of their omnipotence. This would be funny if it wasn't so sad, and potentially resulted in so many unnecessary deaths.

Easily available information demonstrates the FDA statement on effectiveness is premature at best. But let's assume for the moment it's true. Those who believe leronlimab is ineffective will point to trial results that they say demonstrates that leronlimab missed all its endpoints, and the FDA would never approve drugs that miss their trial endpoints. Right?

Uh, no.

It seemingly depends on who is requesting approval. Case in point. Actemra. Tocilizumab. Big Pharma. Despite missing all primary and secondary endpoints, it has been granted approval for an indication that is nowhere as critical or urgent in nature as the pandemic, where the U.S. is still averaging over 700 deaths daily. 

Why would they do that? Well, it seems Roche and the FDA did some post hoc analysis on data subsets (sound familiar?) that found certain data marks improved sufficiently enough to warrant accelerating its review status, despite missing all endpoints and some worrying safety signals. Post hoc analysis. Data subsets. Yeah. The sins that the FDA says CytoDyn committed. Acceptable for a rare indication, but unacceptable for a pandemic? Really?

The FDA can and does make approval decisions based on post hoc analysis of patient and data subsets. And they should. But, it appears, only if you're a large pharma company. You know, the firms that provide the lion's share of the FDA/NIH budget. This is one example.

Call me crazy, but this inconsistent behavior doesn't appear to me to have anything to do with their stated mandate of protecting the public health.

I won't even get into FDA decisions on approving CP, HCQ, or remdesivir, none of which have demonstrated an impact on mortality, and all that have concerning safety signals, but the evidence seems to point to this: the FDA/NIH just can't wrap their heads around the MOA of a non-antiviral drug (humanized monoclonal antibody) that has indicated effectiveness against critical COVID. After only two shots. Imagine the results with the sponsor recommended 4 shots in the upcoming Brazil and India trials. You know, the sponsor recommended dosage the FDA denied in the recently completed RCT. A dosing level that has been used safely weekly by HIV trial extension patients for years. But denied for the sickest of patients? It is not unreasonable to conclude that this limitation in dosing, given what we now know about the trial results for the critical COVID patients in the trial, very likely contributed to the endpoints being missed. But in the meantime, the FDA is comfortable with refusing easy access to leronlimab via EUA. When data to date suggests that even with only two shots, 30%+ of critical COVID patients might live if they receive it. Or about 200 Americans a day. So this is the estimated price of not issuing an EUA for leronlimab. A drug that is SAFE. That DOES NO HARM. That is injectable. That could be self administered at home. That is the last chance of living for so many Americans. Never mind the price that has already been paid. My view: Illogical. Immoral. Unethical. All in pursuit of a p-value.

And where is the NIH in all this? Still running remdesivir combo trials! Really? A drug from Gilead shown in multiple studies to have no impact on mortality, is still being trialed with other drugs. And has been fully approved by the FDA without an AdComm hearing. And Gilead has been provided with a priority voucher, which is worth millions. For a drug the WHO says does not work against COVID. The CTAP (Coronavirus Treatment Acceleration Program) advisory board has multiple members with financial interests in Gilead. But I'm sure that has nothing to do with any of this, including the ongoing research. Research that is like beating a dead horse. But it does supplement the research budgets of large, extremely profitable pharmaceutical companies with additional tax dollars. Hurray for that. While denying even a single penny to promising therapies from small companies with no revenues in the clinical stages of their development. I guess I'm just misinformed about the whole purpose and objective of having a NIH. My bad.

My view is that leronlimab has shown sufficient promise to warrant at least a few dollars of the NIH/BARDA budgets in support of a therapy that has a novel and SAFE approach to addressing not only COVID, but many other neurological and immunological indications. It appears both organizations disagree. In fact, BARDA recently announced they will be de-emphasizing funding for COVID therapeutics. I guess because COVID is over? The critical thinking process being used to arrive at these decisions eludes me.

It is questionable how useful the FDA and NIH services provided this country and the world have been. The very organizations that are supposed to be the thought leaders, the pioneers of medicine, the paradigm busters, are themselves caught within their own regimented and outdated thinking. I feel like I'm reliving the AIDS epidemic, and the answer is AZT for everyone. Making bad decisions affecting countless lives, while doctors in the field plead for access to drugs that they know work. These doctors have put their reputations on the line. So has the FDA. My view: the FDA has lost.

Yet, for all the FDA sins, the power is still theirs to remediate them. What they choose to do from this point forward is unfortunately still up to them.

I would have fired all of the leadership last August when they trumpeted the EUA for CP instead of leronlimab. If nothing else, I’d like to see an answer to this question, because the FDA letter surely didn't address it: What is the downside to an EUA approval for leronlimab? I see none. Enlighten me, please.

In the meantime, those that know better will be following the science, get vaccinated and hope they don’t get COVID. They will also be listening to Dr. Jay's interview (below), which I'm sure they will find enlightening.

And CytoDyn will stay focused on what they can control. Working with other research organizations and countries to save the lives of their citizens, and protect their public health.

The India variant is now in the U.S. And spreading. Many people have no plans to get vaccinated. Children under 12 still can't get vaccinated. Variants don't care about FDA letters.

Have a great day.