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.