I read Dr. Robert Malone’s recent article with great interest (link). His recognition of the deep flaws in the U.S. regulatory medical system—including research funding, approval processes, and oversight—is both timely and important. However, his critique largely reflects the common physician’s viewpoint, blaming bureaucracy and government agencies such as the FDA, CDC, and NIH for the dysfunction. This perspective, while partly valid, misses the core of the issue.
The problem isn’t just bureaucratic mismanagement. The root of the dysfunction is the fraudulent framework of so-called “medical science” itself—a system run by professionals who claim scientific authority without actually practicing science. Dr. Malone is beginning to see aspects of this breakdown, but he stops short of identifying its real cause: the widespread lack of scientific literacy among medical professionals, particularly in areas where rigorous scientific analysis and measurement are required, such as pharmaceutical quality assessment.
Having worked for over 30 years within Health Canada, and closely with FDA colleagues on the evaluation of pharmaceutical products, I speak from first-hand experience as a scientist trained in chemistry—an actual science, unlike the loosely defined “medical science” that dominates regulatory bodies today. Throughout my career, I have been vocal—often to the point of shouting—about the widespread scientific fraud embedded in regulatory procedures. Unfortunately, these institutions are falsely regarded as “scientific” simply because they are staffed by medical and pharmaceutical professionals. In reality, these individuals lack any meaningful understanding of scientific methodology, experimental design, or data interpretation.
One glaring example is the routine testing of drug release—also known as dissolution testing—for tablets and capsules. This is a standard method meant to determine whether a drug is released from a dosage form under physiologically relevant conditions. Logically and scientifically, such tests should be standardized: the same physiological conditions should be used to evaluate any drug product, to determine if it performs as expected.
But instead, the system is reversed. The product is first assumed to behave in a certain way (e.g., fast- or slow-release), and then a test is designed to match that assumption. In other words, the test is custom-built around the product, not the science. This is not quality control. It is regulatory theater—a performance designed to simulate science while completely bypassing its fundamental principles.
This practice is deeply embedded within the FDA and the United States Pharmacopeia (USP). Nearly every drug product is tested under its own “product-specific” set of conditions, as if human physiology changes from one product to another. It does not. This approach is not just unscientific—it is dangerously incompetent. Yet those responsible for these standards are unable to recognize the problem, simply because they lack the scientific training to see it.
I raised these concerns formally through a Citizen Petition, only to be told—after nearly three years of assessment—that the test method “validates itself” as long as FDA guidelines are followed. This circular logic is now treated as “science” and has been adopted worldwide. But scientifically speaking, this response was absurd. A method does not validate itself by design—it must be independently evaluated against objective standards, using consistent criteria and reproducible results.
Another serious example is the use of bioavailability and bioequivalence (BA/BE) testing. These clinical trials are supposed to show that two drug products perform similarly in the body. BA/BE tests are widely viewed as the gold standard by medical professionals and regulators. Yet they are riddled with flaws. The data is highly variable due to natural physiological differences among individuals, making the test incapable of detecting meaningful differences in product performance.
Worse still, the acceptance ranges for these tests are set arbitrarily tight—sometimes even tighter than what real-world human variation would allow. When a product fails, the failure is often interpreted as the product being defective, which is then paradoxically used to validate the test itself. This is willful negligence dressed up as scientific rigor.
Moreover, companies know how to navigate this broken system. They hire consultants who understand the loopholes, design the tests to fit the expectations, and submit just enough data to satisfy regulators. Potentially faulty products are approved through faulty testing—and everyone profits, except the patient.
These failures aren’t limited to pharmaceuticals. Similar patterns of fraudulent science are evident in the realm of virology and vaccines. Decades of so-called research rely on tests that were never scientifically validated to detect actual viruses or infections. Claims of viral existence are based more on computer-generated images and theoretical models than on direct, reproducible scientific evidence. Yet these models are cited as reality, defended by “experts,” and reinforced by the same faulty logic that governs drug testing. This is not science. It is ritual—medical dogma labeled as evidence.
Changing committee members or replacing one set of medical experts with another won’t fix the problem, but will perpetuate it. These committees are part of the same culture that created the crisis. What’s needed is the involvement of real scientists—particularly analytical chemists and those trained in experimental design and measurement science. These individuals are equipped to develop proper, standardized, physiologically valid testing methods. And once those are in place, much of the current fraud will be exposed and corrected.
Ultimately, the fraud lies not in science itself, but in how it is abused by those who neither understand nor respect it. The path forward begins by recognizing that medical credentials do not equal scientific expertise—and that the system is currently built on a dangerous conflation of the two. Unless we correct this fundamental error, the illusion of scientific rigor will continue to justify poor practices, faulty products, and harmful policies.
FDA acknowledges the use of non-validated drug dissolution testers – cGMP violation! (link)
Time to rescind the regulatory requirements of bioequivalence evaluations and the current pharmacopeial drug dissolution practices as these do not provide quality assessment of pharmaceutical products (link).
COVID-19: The virus does not exist – it is confirmed! (link)