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If Only We Enabled ‘Right to Try’
Did you know the vaccines were developed in days early in 2020 (Pfizer in January of 2020!)? The rest of the year was spent in regulatory work, some of it purely inane.
All Trump and Congress had to do was incentivize “Right to Try” – allow people to take experimental vaccines at their own risk. If I could have signed away any legal recourse and taken an experimental vaccine, I would have done so happily. Given the opportunity to take the risk of Covid off the table, millions of Americans would have taken that bet, avoiding so much needless fear and all the concomitant destruction.
Freedom is the answer to most questions. If doctors were given full freedom to try HCQ, Ivermectin, Dexamethasone, and countless other options on their patients, we would have put this pandemic to bed months ago. Because, counter to the “official” line repeated ad nauseam, all illnesses have treatment options that can help or hurt the patient. We just have to let people figure it out. Heck, Vitamin D makes a heck of an impression on Covid response – but as others have pointed out, Big Pharma has no profit in Vitamin D, HCQ, Ivermectio, or Dexamethasone.
Hindsight is always 20/20 – and at the end of 2020, we all have it. But there are many of us who have been advocating “Right to Try” forever, back to Milton Friedman’s “barking cat” metaphor to describe the FDA’s willingness to rapidly approve new drugs. The FDA should be relegated from “Veto” to “Recommendation” authority, allowing the free market to solve our medical challenges.
This is the real lesson of Covid: the top-down path advocated by Republicans and Democrats alike, is what led to the most loss of life. The experts have all failed us. But we can still maximize freedom and responsibility, encouraging solutions instead of panic. Each of us is responsible for our own choices, so we should be free to make them.
If only.
Published in General
Not all of us. Big Pharma did well. Corporate media did well. The Dems did well. BLM did well. $6 Trillion in national debt was good for somebody. TDS was the greater epidemic.
I would be open to making some kind of I.Q. test mandatory for people to sign up to these more experimental trials. I think it’s worth it in many circumstances but they need to be able to understand the risks that they are taking.
It would be nice to be able to try the rapid, at-home antigen tests. There is no personal health risk to trying those, but the FDA won’t let us do it. Because maybe people will do the wrong thing with the information they get.
And then a morality test so they don’t lie and cheat with the research or the research agreements.
I dig.
As I recall, South China Morning Post reported that a scientist at one of the Hong Kong universities had a vaccine.
In January.
A tragic irony is that–with the nurse collapsing and the dreadful allergic reactions of those two people in Britain–we are still in a partially experimental phase, and those who take the vaccine are still exercising their right to try. (@caroljoy.)
But what if they cheat on the morality test?
It seems like the safety of the vaccine could be determined in the volunteer trials far more quickly than the effectiveness. A month or two after the first volunteer injections, and you have a pretty good idea if it’s safe. At that point it really does make no sense to restrict access to it.
“Did you know the vaccines were developed in days early in 2020 (Pfizer in January of 2020!)?”
But had any significant testing on either safety or efficacy been done at this point? It seems unlikely.
Even if there were no such thing as an FAA approval requirement, would you want to fly on an airplane that had been designed and built but not test-flown?
And vaccine performance seems like a much less-deterministic and well-understood field than is aeronautical engineering.
Lots of really bad assumptions here. Sure, lots of the red tape is bogus but Trump eliminated all of that. Much of that “inane regulatory work” is because most vaccine trials at best don’t work and at worst are worse than what they are trying to fix. Should you have the right to stupidly take a deadly vaccine to fight a virus that is nothing to 99 percent of us? I guess. Of all the arguments against big Gov, this is probably among the silliest though.
iWe, I like the idea that those who want to take an experimental vaccine can go ahead and do so.
But this is not about a virus, nor is it about one set of vaccines.
Notice that the people running the show have stipulated that once most people have received the jab, you will still face masking and lockdown restrictions, This will occur even with the most Pollyanna-ish indications of 95% efficacy rating for the vaccine, that reveal there could still be 5% of all people still spreading COVID. (Even under a 100% mandated situation.)
You should also be aware that most people – 58% – do not want to be risking their bodies’ future health for a vaccine that has been so poorly tested. Especially given that in a risk vs benefit analysis, COVID is a totally survivable event. Fatality rate is a mere 0.047%.
On Oct 9th, 2020 NIH/CDC issued another new guideline that doctors should not treat any person testing positive for COVID who feels sick until that person is actually in a hospital and on supplemental oxygen.
This is in addition to the PTB depriving Americans of five separate modalities known to conquer COVID, including high Vit C therapy, ivermectin, HCQ protocol with zinc.
Notice that despite the insanity of those two overbearingly destructive policies – not offering a remedy and not treating some one who is sick until in the hospital – it is the public that gets slammed for COVID case rates and hospitalization rates going up.
Held up because no company will take the legal risk before going thru the regulatory hurdles. You could say- the recipients can sign a waiver/consent absolving the vaccine company of liability. Fat chance:
1)Any consent signed by the person desiring the vaccine before testing wouldn’t hold up 5 minutes in a court case. Most medical consents are a joke-of course the patient wasn’t competent enough to evaluate the risks and alternatives to the procedure-the developers spend years in training- in my case I have spent years getting that competency- the patent can’t acquire after a few minute talk. I am certain that the literally 20,000+ consents I have had patients sign weren’t worth squat in court-but if I didn’t have it I was legally deadmeat.
2)Look at all the people here who don’t trust the vaccines even after the trials- if someone got an unapproved vaccine and suffered a side effect- people like the vaccine refuseniks would be in the jury-a trail lawyers dream!
America literally has the best scientists and some of the worst laws to promote science.
None. And still Americans take all sorts of weird homeopathic or botanic or naturopathic remedies that may or may not have any efficacy or cross-effects with other medication, etc.
If I believed the alternative was death? Of course.
Actually, the analogy breaks down quite quickly, because aircraft are designed and built to highly exacting standards. They are quite safe even BEFORE they are test-flown.
Sure. But the core idea behind a vaccine is old and well established: attenuate the virus, and inject it. That is, apparently, what these vaccines are after all. As long as the virus is truly not capable of taking hold and killing you, there is virtually no downside risk to taking the vaccine.
I know others here are much more hesitant about taking an experimental vaccine. And that is their right. Government should have no role in limiting my freedom to take a medical risk.
This is simply not so. “Warp Speed” is better than Regular Speed – but it was still plenty regulation-heavy.
And some of it was making sure there was a big enough sample of different races to satisfy Woke priorities. I understand this one requirement delayed release by a month.
These two vaccines aren’t done with attenuated viruses. They instead inject rna that when inside your cells will cause the production of one (or a set?) of the same proteins that the viruses produce, and cause your immune system to react it and built up defenses against it. That way it will be prepared if/when a real virus comes. So in that sense these vaccines are far less dangerous than vaccines that use attenuated viruses. There isn’t the danger that they weren’t attenuated enough and will start reproducing and causing the disease. Doesn’t mean nothing can go wrong, though.
The mRNA vaccine technology has been on the cusp for awhile-it is why Dr Slaoui was confident months ago that Operation Warpspeed would have 2 vaccines with at least 70% efficacy before the year was out. The real hope for mRNA vaccines is to use in cancer therapy.
addendum- I call him Dr altho he doesn’t have an MD but he has a real doctorate unlike Jill Biden.
Are attenuated viruses dead viruses?
It is alive but less virulent. There are also dead virus vaccines
I would not have taken the vaccine without it being fully proven out. Heck I’m an engineer. I know what can happen when a design or an idea has not completed development and qualification.
As an engineer you understand design constraints and how that effects design- Same with risks in medicine. You need to assess and weight the risks. Operation warpspeed was the use of parallel rather than serial design/production to speed up the process- that doesn’t mean major corners were cut. Typically, you create the vaccine, then test it, then get approved, then build the manufacturing facility and only then start production. All those steps take years. Operation warpspeed (OWS) started construction of the factory & production of the vaccine while it was in trial- so as soon as the trial was over & data analyzed they could get approval & start vaccinations. A very small decrement in safety was accrued by cutting the time from the end of the trial to vaccination- the truth is it is very rare for problems to appear among trial recipients while the factory is constructed and after the trial is over. It is unlikely a private corporation would assume all the financial risks of both building a factory & making vaccines w/o knowing the vaccine would work- so OWS essentially removed that risk by the feds providing $ to many of the private concerns. The added risk is very small and the potential benefit of a vaccine was huge from the feds standpoint.
addendum- another reason for OWS success was that mRNA vaccine technology, while never having made a vaccine before, was nearing maturity- and those vaccines were the 1st successfully made. As Slaoui said the “platform” was well developed.
Top down doesn’t work in large political entities. Even large private companies with their limited products will die or rot if they fail to pay close attention to consumer feedback and if they can avoid it through political control the nation will rot and die as well. That is where we’re headed.
This is what I was thinking. First we’d have to enact tort reform (loser pays), but even that wouldn’t make medical waivers worth the paper they’re printed on in court.
I was not speaking if the vaccine as final product now. I was referring to taking the vaccine back in February when the OP says it was first developed.
Then in the words of Roseanne Roseannadana- never mind…..
Sure, if it were a situation like in “The Flight of The Phoenix”. While I would not “want” to fly on it, the alternative being death, I would willingly try.
Kind of like in a pandemic.
Concur.
You are under the impression that those in power want to “save lives”. They can careless about saving anybody’s lives but their own and their people. The whole charade is about money, power, reach. Nothing more, nothing less. Your average public officials would not cross the street to piss on you if you were on fire. The fact we have destroyed the worlds economy and many small, medium business while unemploying a significant part of the population what is effectively a bad flu pretty much sums it up. All mainly to remove Trump. You notice they had an antidote ready in days if not before the virus went wide. I notice their bureaucracy waited until the day after Biden was elected.
Sadly Trump allowed himself to be played, we all did, many still are and will continue too.
I’m all for right to try. What I am not for is “forcing those of us who have resarched vaccines and have come away with some very painful realities:
Part two
4. The efficacy rating of 95% offered by Pfizer for their vax is questionable. The trial lasted 8 weeks. Some 120 days later the report on the vax was handed to the three people at the FDA who then approved it. So the only thing we know is those who had the vaccine and not the placebo had a 95% chance of not getting COVID in 120 days or less. This 95% of not getting the infection might be around the same percentage as those of us who haven’t gotten the vaccine. It is an extremely pathetic bar of achievement. The smallpox vaccine I received at age 5 still has a 50/50 percent shot at protecting me should a wild version of small pox break out next week. And that vax was given to me almost 65 years ago. Bill Gates has stated these COVID vaccines will need to be given every single year, I guess until the individual dies. He doesn’t think much of the efficacy rate himself. He did seem quite concerned about having complete liability from any and all injuries or deaths that result.
5. Already over 3,000 American health workers have had such serious adverse effects from the COVID vaccine that they have missed work. Such effects are foreshadowings of future unfavorable ailments that could be lifelong and much more serious.
6. Pfizer’s vaccine is the first mRNA vaccine human beings have had inserted into them. But a corona vaccine that was mRNA-based was given to a group of cats, who fared quite well after getting the jabs. However, when introduced to a corona virus slightly different than the one the vaccine was for, they were vulnerable to becoming infected, and developing serious cases. So in the end, a lot of the cats died. It will be a tremendous irony if the next Wuhan lab virus that reaches our shores does in the people who were so eager to get this vaccine.
7. Since it is such an important point I will make it twice: a vaccine should always be considered in light of risk vs benefit. The fatality rate for COVID against cases is 0.047%. If you take elderly people with comorbidities out of the equation, the fatality rate drops much lower. Not much of a risk, except the progressive crowd has insisted anything is better than even one person dying of COVID. (However numerous draconian restrictions have already caused the escalating rate of suicides to eclipse the rate of COVID deaths.) Since no one knows what the risks for these vaccines will be, I hope to all that is holy that those of us who already know they don’t do well with vaxxes, or who look at the risk vs benefit angle with logic and not media inspired fear, will be given a pass, and the rest of you can double up on getting the vaxxes, as that will probably make you feel even safer.
Be careful with CarolJoy’s medical “facts”-like her claims that the AMA has reversed its stance on HCQ, they are often incomplete if not wrong.
1) pregnant women are typically not vaccinated nor included in vaccine trials d/t legal risks that are epidemic in the US-a man made epidemic. Many drugs used on pregnant women aren’t “approved” for pregnancy b/c no pharmaceutical company wants the legal risks involved in the study nor the use. That is not the same as medically dangerous.
2) the cancer and vaccine situation in animals is very different than humans. There are big problems in using data from one species to another in cancer. The same for teratogenicity studies.
3) the so called “severe” side effects of the Pfizer vaccine are headache, fever, fatigue etc-transient symptoms that in common parlance would NOT be called severe-people hear severe and typically think life threatening-that isn’t the case here-but anti-vaxxers are trying to inflame the rhetoric. These symptoms are actually typical manifestations of an immune response and are more common in young people and after the 2nd dose (in truth consistent with the successful induction of an immune response in the recipient).
4) she doubts the well documented efficacy data of the Pfizer & Moderna vaccines yet claims that HCQ works even though the vast majority of studies show it doesn’t.
5) the risk benefit ratio of the vaccine isn’t based on aggregate & INCOMPLETE population data (ie if 200K more die this winter the death stats will look worse) but depends on your individual status. If you are a healthy 20 year old your risk is low-but if you are 55-64 your death rate is 30x higher than a 20 year old (65-74 it is 90x higher, 75-84 it is 220x higher). If you have comorbidities it is also substantially increased.
6) there are substantial gains to be made by herd immunity-particularly if we achieve it w/o 100-200,000 more deaths-ie via vaccination. Allowing the virus to remain endemic in the human population is inviting problems. CarolJoy likes to state “we don’t know the risks of “ all sorts of conjectures- we also do not know the risks of allowing a virus with significant mortality to remained endemic in the human population-perhaps mutating to become more lethal in the future-better to stamp it out ruthlessly. Do I have any data to back this up? No, but I have as much data for that as many of the anti-vaxxers claims of unknown risks from the vaccine.