Yes, it's true the President talked about setting up a commission in the early days of his presidency to look at "vaccine safety". Anyone interested can read more about it here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6413645/ Key words from the article: "Trump stated during the campaign that he is “totally in favor of vaccines, but I want smaller doses over a longer period of time." As far as I can tell the "commission", which was to be led by Robert Kennedy Jr, perhaps from the opposite end of the political spectrum but sharing a concern about vaccines, never got off the ground.
I don't believe there has been any significant change in US vaccine policy under President Trump, someone correct me if I've misstated the case. One item impacting health care that did pass under President Trump is the so-called "Right-to-Try" Law. Analysis suggests that this law has had limited impact on the health care of most Americans, given that EUA and compassionate use programs are already in place for many medications. Again it's a subject for discussion if anyone is interested.
Also related to HCQ, there's news that a conservative doctors' group in the US has filed suit against the FDA, claiming that the FDA's policy (under the EUA) of restricting HCQ use to hospitalized patients or patients participating in a trial is unfair. You can read about that here:
So, we have PERHAPS doctors on the left fudging data to discredit the President... doctors on the right now suing the FDA over what seems to be a REASONABLE policy pending further data.... with a background of individuals stressed out and police stressed out sometimes making very bad decisions.... people marching in the streets and sometimes worse.... and patients continuing to die of C-19 in large numbers as the virus moves about the country. The past week has been a strange mix of highs and lows for the US imo. But all that said, we cannot abandon science. We need good "unbiased" studies in order to make good treatment decisions. Otherwise we're really lost. All of my investigation continues to support the decision of Dr Mehra and his two colleagues to request retraction of the two papers they co-authored.
Finally, I wanted to say a couple of quick words about ECMO (Extra Corporeal Membrane Oxygenation) since it's been mentioned a few times on another thread in relation to Nick Cordero, a 41-year old actor who received that therapy. First, Cedars Sinai Hospital (a hospital used by many of the stars near Hollywood, California) and Mt Sinai Hospital in New York City on the other side of the country, have nothing that binds them other than the name "Sinai", again someone correct me if I'm wrong. I suspect the company Capricor is supplying the cells to the actor under their EUA program, and at this late stage they are almost certainly being tried to prevent the fibrosis problem in the lungs that many C-19 patients develop. I do not regard Capricor as a competitor. The patient PROBABLY lost his leg, not directly due to the virus, but due to a complicaton of ECMO. Think of it as a type of heart-lung bypass machine as might be used in open-heart surgery. Canulas are placed into veins, and some cases arteries, to circulate blood into a machine outside the body for oxygenation and CO2 removal. The procedure can save lives but requires full anti-coagulation with heparin and has a number of potential complications. One of those is clotting of vessels that have been canulated. ... leading to the observed adverse outcome.
In terms of the impact on the use of rem-L, patients on ECMO are excluded from the phase 3 study. There's only one molecule under study that accepts C-19 ECMO patients to my knowledge: leronlimab. However, it may be for "show" only since that molecule excludes patients with a P/F ratio under 150, and most patients aren't gong to get ECMO unless they are under that level, ie down in the "serious" ARDS range on the Berlin scale.
My analysis of what happened during March and April 2020 suggests that ECMO was NOT being used in New York City, or only on extremely rate occasions. Mainly because it ties up too many skilled personnel around-the-clock to just one patient already at high risk or mortality. It's the same equation that enters into decisions on "Do Not Resuscitate". Yes, medical triage is occurring, or certainly occurred in April, in US hospitals in the age of Covid-19. While I have no doubt as to the veracity of the President's claim, "any American who needs a ventilator gets a ventilator"... the same does not apply to high risk potentially low success procedures like ECMO in the setting of ICU overload. Anyone can verify my assertion through a search on the internet if they know where to look and what to listen to. I'm not going to post it because it serves no useful purpose. Of course, the equation is different for a 40 year old compared to a 70 year old, but in general the intensivists are not talking about ECMO. They're talking about ventilator settings and proning.
All of this means that the field is fertile for a medication like rem-L which should be able to carve out a niche for use BEFORE ECMO if its promise of significantly reducing C-19 mortality is realized. ECMO cases are reimbursed at something like $150,000 under Medicare DRG... and there's also a company out there called Cytosorbents (CTSO) that has an ECMO membrane that removes/reduces inflammatory markers as blood is circulated extra-corporeally, so in conjunction with ECMO it becomes a "competitor" for these patients. Data are being collected under its EUA. ECMO is not going away and some younger, baseline healthier patients will probably receive it as a C-19 ARDS treatment. You'll note it was also used on one of the children in the Lancet study of PIMS.
Obviously a rem-L infusion that lessens the need for that type of high risk procedure would be the preferred route for any patient's care young or old. And once rem-L is approved there's nothing to prevent it from being used after ECMO has been tried. That seems to be the case with the use of stem cells for Mr. Cordero. We wish him well. Any of us could end up with a similar unexpected downturn in our health. Vaccines are one thing, but effective treatment for ventilator cases is essential.
I continue to see rem-L as THE leading contender for moderate to severe C-19 ARDS. Time and trials will tell.
MSB Price at posting:
$3.73 Sentiment: Hold Disclosure: Held
(20min delay)