I’m a volunteer in the clinical trials for the Pfizer vaccine. I knew there was some risk in volunteering to take an unproven medicine. But I hoped that my participation might help me do well against the virus, and might also help me do good for humanity. My efforts to do well and do good have worked out fine, until now.
Understand that these studies are conducted with two distinct groups. One group gets the vaccine. The other group gets a placebo. The placebo is not medicine. It’s a simple saline shot that does nothing at all.
The reason for these two groups is to establish a placebo-taking “control group” against which both the efficacy and side effects of the vaccine can be measured in the vaccine-taking group. The study is “blinded,” meaning that the patients themselves don’t know whether they got the vaccine or the placebo. That’s to avoid tainting the results with “placebo effect” and “reverse placebo effect” symptoms.
In the case of Pfizer, out of 22,000 patients who got the placebo, about 150 later contracted the virus. In contrast, out of another 22,000 patients who got the vaccine, only 14 contracted the virus. Statisticians crunched the numbers to determine within an acceptable margin of error that this disparity indicates a vaccine efficacy of 95%.
That’s far higher than anyone dared hope. In addition, the side effects are manageable, even minimal.
This is great news! The British have already granted approval to the Pfizer vaccine based on the same data that Pfizer submitted to our own FDA two weeks ago, and citizens there are receiving the vaccine right now. Our FDA is sure to grant approval as well, when it’s ready to do so.
But what about the patients who got the placebo? They’re still at risk. Moreover, they don’t know who they are.
Pfizer has indicated that it is requesting permission to unblind the study. Identifying the placebo-takers would permit them to get the vaccine right away in recognition of their trouble and risk. Conversely, identifying the vaccine-takers would enable them to skip taking the vaccine again, thereby freeing up a dose for someone else.
Pfizer’s request is consistent with normal protocols for clinical trials. If the early results of a trial indicate that the medicine is highly effective and safe, the trial is cut short so that the medicine can immediately be given to the placebo-takers. To do otherwise is considered inhumane and unethical because the placebo-takers are at risk of contracting the disease until they receive the medicine. The placebo-takers can literally die on the altar of data-gathering for a medicine already proven to be life-saving.
But experts this time are recommending that the placebo-takers not be moved toward the front of the line for the vaccine, but instead be moved all the way to the end of the line. They would not receive the vaccine for another year or two. The experts want to gather more data on how many of them get the virus, how many get sick and how many get dead.
No good deed goes unpunished.
This desire to trade the health and lives of placebo-taking patients, for more data on a medicine already determined to be effective and safe, is not only unethical but unworkable. If the study is not unblinded, all the patients in the study will simply arrange for a vaccine through ordinary channels such as their physician’s office.
Patients who already got the vaccine, but have no way of knowing they did, will thus get another through their ordinary physicians. That will use up a dose that could have gone to another person and perhaps saved that other person’s life. And by receiving two vaccinations, the vaccine group will taint the data going forward, because then the data-collectors will unknowingly be collecting data on patients that received a double dose while assuming they received only the ordinary single dose.
As for patients who got the placebo, but similarly have no way of knowing they did, they will get the vaccine through their physicians for the first time. That too will taint the data going forward, because the data-collectors will unknowingly be collecting data on patients who received the vaccine while assuming they didn’t.
In any event, some 40% of Americans say they will refuse to take the vaccine. Even if only 1% wind up refusing, that constitutes a non-vaccine-taking control group that will be far, far larger than the placebo groups in the clinical studies. The incidence and lethality of the virus in that non-vaccine-taking group can substitute for the placebo groups in the studies.
The experts are bright people and they undoubtedly recognize that risking lives to generate more data, even if justifiable, will generate only data that is useless or, at best, duplicative of what they will have anyway with the non-vaccine-taking population. But like a lot of people over the course of the last ten months, they apparently need to wield their power.
Jonas Salk, who developed the polio vaccine, had views on all this. He declared, “I would feel that every child who is injected with a placebo and becomes paralyzed will do so at my hands.” Such an approach, he lamented, “would make Hippocrates turn over in his grave.”
The regression of Western Civilization thusly continues. Hippocrates lived in 400 BC.
It doesn’t matter what the experts say; people can and will choose to be vaccinated (or not) and there’s nothing that Pfizer or anyone else can do to change that. From an ethical point of view, those who are proposing not to vaccinate those who received the placebo are violating ethical guidelines that have been developed since the Tuskegee experiment in which syphilis-infected black men were not treated with penicillin in order to “follow the course” of untreated syphilis. Researchers who advocate that the recipients of the placebo not be vaccinated should be embarrassed by their lack of understanding of bioethics.
Please don’t ever use The NY Times as a source for your articles. It diminishes its credibility. I enjoy your writing so much.
Political correctness demands that the placebo group not be given any special consideration, but the analogy with Tuskegee is compelling. And, as you state, the follow-up will be tainted in many ways. Of course they should be given priority for the risks that they took for the benefit of all of us. Also, I am no statistician, and experts are such, but with the raw numbers given, it seems more like 91% effective instead of 95%.
Just a reminder…Commie Harris….video time spot….2:15- 5:49.
If your traveling to Pitkin County…vee vill require your vax papers!
And that’s a good way to add a dis-incentive to future potential volunteers!
Glenn go give blood most blood bans are testing for antibodies. My wife and I both are in the moderna trial, after giving blood she was loaded with antibodies, I had none. We both work in a hospital in Palm Beach County. I’m too busy caring for covid patients to continue the trial with a placebo. Also our hosp was told by the state Fri we would have 7000 doses of vacinne by Dec 21 to begin doing health care staff, local fire police etc.
most blood bans *BANKS*
Screw the “experts” and their “science” and data collection, and screw all the “Plandemic” powers that be. Look out for yourself, Glenn, and get the vaccine from from your physician (if you actually want it). Reasoning about such things as cheating someone else out of a dose, or contaminating the data, strikes me as silly — on a par with driving a Prius because you don’t want to kill the planet.
I am in a vax trial right now and when it is over we will be told if we had the real deal or the placebo and that if we are in the placebo group we will be offered the vax, gratis. Oh, I have it in print. I find that you will not be told very strange.
I strongly suspect that you’re misconstruing the document. It may indeed say that the vaccine will be administered to placebo-takers when the study is “over” but these studies are not being declared “over.” To the contrary, patients will continue to be monitored.
What is happening is that the FDA approval is being granted on an emergency basis before the studies are declared “over.”
Notably, the FDA itself remarked in October that early approval would “not necessarily mean” that the studies would be unblinded nor would it necessarily mean that the vaccine would be administered at that time to the placebo-takers.
The moderna trial is 2 years. Glenn you are correct.
Excuse me. Not everything is about you, researcher. I get it, you need data so you can complete your papers and get the next grant. The lawyers say the company needs defensibility. Well, too bad.