The following article has been written in response to a query.
Query:
Saeed Qureshi Let’s say you have two groups. One given the drug/treatment and the other a placebo. Then, it’s observed that over a long period of time one group suffers certain side effects and the other doesn’t. Can’t we at least determine from this that whatever is in the drug is causing these side effects?
Response:
Your argument is logical and valid, and one can certainly draw inferences from it. However, such inferences remain observations—they cannot be treated as firm conclusions or as valid scientific studies. The key distinction lies in the nature of scientific research: a true scientific study requires controls, or in other words, a controlled design. At a minimum, three critical components must be addressed:
- Input (the drug or treatment)
- The human body (physiology of the volunteer/subject)
- Output (the measured effect or response)
Take the example of an mRNA vaccine. Suppose each volunteer receives one vial for injection. How do we know that every vial contains the same components in the same composition? This issue of manufacturing variability can only be addressed by testing the actual content of each vial, or at the very least, proper testing of the manufactured lot to establish the expected variability. Full details of the contents are required—not just the active ingredient (mRNA) but also all excipients, along with corresponding test results. Since the mRNA and other constituents are not fully characterized or available as reference standards, no valid test exists to verify them. Thus, the “input” remains unknown and variable, even though physicians and medical experts often assume it to be constant—an incorrect and unscientific assumption.
2. Placebo
Another challenge is the definition of a placebo. In some cases, proposals suggest using water or a saline solution as a placebo. However, scientifically, the placebo should contain everything in the vial except the active ingredient (mRNA). If the actual vial content is not fully known, a true placebo cannot be prepared. This makes it impossible to isolate and study the specific effect of mRNA. At best, such comparisons yield only superficial insights, but they do not provide a valid measure of causality.
3. Human Physiology
Human physiology adds another layer of complexity. Variability arises not only from genetics, sex, and age, but also from diet, lifestyle, and countless other factors. It is virtually impossible to completely control for these variables. Yet, clinical trials often proceed as though these differences can be adequately controlled, which is a flawed assumption.
4. Output
Finally, the outcomes. Are they to be measured only by symptoms? If so, how can one be certain that identical symptoms represent the same illness across different individuals? Scientifically, outcomes must be measurable against validated reference standards. Without such standards, symptom-based conclusions are weak, inconsistent, and open to misinterpretation.
In summary, observational assessments—such as those often carried out in physician-led clinical trials—can yield valuable insights, but they are inherently limited in their value. For research to be truly scientific, it requires properly defined and controlled inputs, recognition of human physiological variability, and valid, measurable outcomes. Without these, what is presented as a “study” remains closer to observation than to science.