Before I describe and issue the challenge, I have to state that most controlled tests of drugs never meet adequate standards of science.
There are flaws and gaps and holes.
How should a controlled trial be done?
Let us suppose we are going to test the safety and efficacy of a new vaccine to prevent X, a disease researchers claim is caused by Virus Y.
There will be two groups. The first group of 700 children will receive the vaccine. The second group of 700 will receive a neutral harmless solution.
No one operating the trial will know which group actually gets the vaccine and which group gets the “placebo.”
Here are the conditions that should be met in the study.
First, we must establish that disease X is really caused by Virus Y. A third group of 700 children who have been diagnosed with X are tested. In at least 90% of the 700, Virus Y must be found by direct isolation. This means no indirect tests are run. (No antibody assays or PCR-type assays are acceptable.) Technicians must find Virus Y in at least 630 children.
Second, in these 630 children, technicians must find Virus Y in sufficient quantities to make it obvious that the virus can cause harm. Mere traces of Y are not enough. You need an army to make war on the body.
I will tell you that this first step alone, this first condition, will disqualify the rest of the study in many instances. It will turn out there is insufficient evidence to maintain that researchers have found a specific disease entity caused by a specific germ.
If, however, this first condition is met, we go on to phase two.
This second condition assures us that the two groups of 700 children are initially comparable.
The general immune-system status of all 1400 children must be matched. We can’t have an overbalance of immuno-compromised children in one group, for example.
Likewise, the general nutritional status of the two groups must be evenly matched. This is common sense, as well. If 500 children in the first group are eating a junk-food diet, as opposed to 100 in the second group, that would be a major flaw. Tests for nutritional status would be conducted.
The medical and medical-drug histories of all the children in both groups would be brought to the table. We need to make sure these histories are clean, because we don’t want children weakened by such past treatment to take part in the trial at all.
As closely as possible, we want to make sure that children who have suffered adverse effects of environmental chemicals are ruled out of the study.
Now, we give the vaccine or the placebo to all 1400 children.
The children are closely monitored for 18 months, during which time all possible adverse events are recorded. These would include any episodes of illness, fever, mental imbalance, and, of course, any cases of disease X that arise in either group.
At the end of the 18-month period, the frequency of all possible adverse events are investigated, and we have a picture of the placebo group versus the vaccine group.
We continue to monitor both groups for the next five years, to record how many cases of disease X occur in the placebo group versus the vaccine group.
Then we will know something. Did the vaccine work to prevent disease X? Was the placebo group just as successful, or more successful, in warding off X?
(I will grant that markers and tests for initial immune status and nutritional status and definitions of vaccine-related adverse events—all these factors are up for grabs and controversies. But unless these matters are settled, no accurate studies can be done.)
Here is my assertion: this kind of controlled study on vaccines has never been done. It has never been done for any vaccine anywhere, at any time.
And I have no reason to believe it will ever be done.
If you can show me the existence of this kind of controlled study on a vaccine, send me the citation.
If none exists, we can say that the kind of test which would assure us vaccines are safe and effective has never been carried out.
Of course, researchers are fond of arguing back that the reduction of infectious diseases in populations by vaccines is an established fact. Sorry. There is a literature that claims most, if not all, infectious diseases were dying out before vaccines were introduced. And if a disease that was vaccinated against did not appear later on, but other strange and troubling and severe disease conditions surfaced, we are not assured the vaccine was safe. Nor should we be.