From Your Mouth to God's Ear
Yesterday, Friday May 15, POTUS and members of the administration confidently proclaimed that the U.S. will be able to distribute a full-scale coronavirus vaccine by the end of the year. The project, POTUS explained to the world, has been given the name Operation Warp Speed. Explaining its purpose and aims, POTUS, in an overly repetitively redundant bit of rhetorical puffery, called it “A massive scientific, industrial, and logistical endeavor unlike anything our country has seen since the Manhattan Project. You really could say that nobody has seen anything like we’re doing . . . . Nobody has seen anything like we’re doing now, within our country, since the Second World War. Incredible.” As I listened to the least truthful president in American history proclaim, once again, that his newest scientific gambit would see a successful, surefire anti-Covid-19 vaccine available for all those who want it - hopefully - by the beginning of next year, all I could think of was the old Yiddish expression “פֿון דיין מויל צו גאָט ס אויער” (pronounced fun dyne moyel tzu gaht’s aoyer, and meaning “From your mouth to God’s ears”).
From the political point of view, 45’s creation of “Warp Speed” is perfectly understandable - although filled with foul air. After having been caught accusing his predecessor of engaging in the “biggest political scandal in the history of the United States” (Obamagate) he had to quickly change lanes when Majority Leader McConnell admitted to having lied about Obama leaving the incoming Trump administration without any plan or background info on an upcoming pandemic. So how to live this down? Simple . . . a return to happy talk and empty promises. And BTW, ‘45 even managed to throw a bit of red meat to his most strident supporters by mentioning that the upcoming vaccine would only be for those who “wanted to take it” - thus leaving room for those who believe vaccines are part of a conspiracy funded by George Soros and the rest of the Lesbian Left.
From a purely scientific/medical point of view, ’45 is once again delving into areas he knows nothing about . . . like how much time, effort, trial and error it takes for vaccines, medical devices and new procedures to earn the Good Housekeeping Seal of Approval: in this case, the imprimatur of the Food and Drug Administration (FDA). Even if a med. vaccine or device is granted “humanitarian use” status, it’s not going to start changing the world overnight. And for good reason.
In the world of medical research, there are a ton of hoops to jump through before a med, vaccine or device is approved. Welcome to the largely unknown world of medical ethics and Institutional Review Boards. In order to understand what we’re talking about, let’s quickly go back to the so-called “Doctor’s Trial” at Nuremberg. On December 9, 1946, an American military tribunal opened criminal proceedings against twenty-three leading German physicians and administrators for their willing participation in war crimes and crimes against humanity. Officially called United States of America v. Karl Brandt et al, the trial was the first of twelve similar proceedings against Nazi doctors held by the United States following World War II. Without getting into too much detail, the trials proved that nearly two-dozen German doctors were responsible for carrying out horrific medical experiments on mostly Jewish “patients” without either their knowledge, much less their consent. As a result of the trials’ findings, a movement began which eventually made it mandatory that anyone participating in clinical trials be protected and have full knowledge of what was about to be done by way of experimentation. And, perhaps most importantly, making it crystal clear that any such participation must be both voluntary and retractable.
Thus was a new world - and a new level of protection - created in order to safeguard the rights of people engaged in medical experimentation.
Over the past 75 years, the world of medical ethics (which a lot of idiots consider to be an oxymoron) has become an integral part of clinical trials - the pursuit of creating new medicines, devices and procedures while keeping an ever watchful eye on the safety of human subjects. Personally, I have been an active member of an Institutional Review Board - the technical name for such panels - for the past quarter century; 18 with the Cleveland Clinic and the past 7 with Advarra, the largest such group in the world. Our board, by law, is made up of MDs in various specialties, pharmacologists, bio-engineers and at least two “civilians” whose responsibility is vetting and translating informed consent documents into understandable English. The latter has long been my specialty. As such, I have been privy to literally thousands of medical protocols, modifications, informed consent forms (ICFs) and continuing review documents.
Through all these years, I have learned an awful lot about the world of medicine. I have seen up close and personal just how much time, effort money and brilliance goes into taking an idea or theory and eventually turning what once was a mere pipe dream into a panacea. A high percentage of the “pipe dreams” will never pass muster; will never get FDA approval and thus become marketable. In order to succeed, “drug X,” “device Y” or “surgical procedure Z” must first go through animal studies, then a minimum of 3 separate “phases,” which first are given or undergone to (or by) healthy human subjects . . . with their full knowledge and retractable consent.
In these “phase 1” studies researchers investigate whether the drug in question is safe. This is accomplished by looking closely at maximum dose tolerability, pharmacokinetics “PK” - a branch of pharmacology which looks at absorption, distribution, metabolism and excretion (ADME), pharmacogenetics “PG” - which is concerned with the effect of genetic factors on reactions to the drug in question, and pharmacodynamics “PD” which investigates how the drug affects the human body. In phase 1 studies, subjects are informed that not only is their participation voluntary, it must not be considered a treatment for any known disease of medical issue.
In “phase 2,” the question for researchers becomes “does the treatment (or drug-in-the-making) work? In phase 2 clinical trials, participants actually have some form of the disease in question. With regards to some phase 2 trials for Covid-19, subjects may have a mild form of the disease or have recovered. Herein, researchers are likely to investigate whether or not the body has developed antibodies which may, in turn, be used to create vaccines. In phase 2 trials, subjects may receive the the same dose amounts, a Single Ascending Dose (SAD), a Multiple Ascending Dose (MAD) or be part of what is called “double-blind, placebo-controlled trial. “Double-blind” means that neither the investigator(s) nor subject(s) know what dose is being administered, or whether the unknown dose is the drug in question or a “dummy” pill or infusion. This is called a “placebo.”
Now on to “phase 3,” in which, generally speaking, these clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment. Because doctors do not yet know if the new drug is better than the “standard of care” (SOC), subjects are usually randomized to get either the standard treatment or the new treatment.
Under normal circumstances it takes at least a year - and frequently far more - to go from animal studies to phase 3. In the case of Covid-19, things are different; these are by no means “normal circumstances.” There is as yet no “standard of care.” At the moment, there are a minimum of 100 ongoing studies around the world. Many deal with the creation of a full-blown vaccine; some deal exclusively with creating better and more effective test kits; others are investigating things like T-cells found in Covid -19 patients and whether this will bode well for long-term immunity. Biopharma and biotech companies across the globe are approaching the fight against Covid-19 with various weapons—repurposed drugs, antivirals, vaccines and clinical antibodies. This is pure science. The fact that so many agencies within the federal government, university medical laboratories and private corporations are working around the clock is a hopeful sign.
The politics of Covid-19 is something else. In recent weeks, we’ve seen and heard POTUS hawking the use of Hydroxychloroquine and the antibiotic Azithromycin (“Z-Pak”) as a panacea for the treatment and eventual eradication of Covid-19. Besides being totally devoid of any knowledge of things pharmacological, POTUS is causing time, talent and money to be wasted trying to prove that he is correct. Just the other day, the website of the National Institutes of Health informed the public that they were entered a phase 2b clinical trial investigating whether this “cocktail” can be efficacious. This comes on top of POTUS’s recent - and utterly reckless - suggestion that ingesting or infusing bleach into the human body might be effective. Shortly after having the entire medical/scientific community come down on him like the front line of the New England Patriots, he changed his tune and said he was merely being “sarcastic.”
Now comes “Operation Warp Speed.” From what I know about medical ethics and the closely-watched procedures involved in creating new medications, there are precisely two possibilities that Operation Warp Speed will be approved by the FDA and be made available to the public by the end of 2020: absolutely none and less than that. That is unless POTUS forces the NIH, FDA, HHS and a host of other scientific watchdogs to turn a blind eye to medical oversight . . . to turn back the clock to a time just after the “Doctors’ Trials.” This is truly unconscionable, immoral and, to my way of thinking, overtly illegal.
On the bright side, some of the best medical/scientific minds on the planet are working day and night to rein in this ghastly pandemic. From where I sit and the protocols we at Advarra have already been privy to, Covid-19, like the Spanish Flu of 1918/19 (not 1917, as POTUS believes) shall be overcome.
What America and the world needs now, more than ever, are leaders who are acutely aware of what they do not know, and get on with the work of saving the world because of what scientific and medical researchers do know.
פֿון אונדזער מויל צו גאָט ס אויער
(fun undzayr moyel tzu gaht’s aoyer “From our mouth to God’s ear!”)
174 days until the next election.
Copyright©2020 Kurt F. Stone