Major Flaws in Self-Sponsored Clinical Trials Ensure
The Results Pharma Wants are the Results Big Pharma Gets
by Dr. Robert E. Marx
Imagine the horrifying and tragic results if pharmaceutical companies were to somehow gain control of the testing required for FDA approval of their new drugs. Unfortunately, neither you nor I have to imagine them. The drug companies are, and have been, controlling–with money and specially designed tactics–the clinical trials of their prospective prescription medicines. This has been true for decades, and I’ve personally witnessed some of the terrible results of terribly tainted trials. In addition, as a researcher, practitioner, and trial adjudicator, I’ve seen the inner workings of sponsored trials, and these are the areas in which they are broken and corrupted:
1. Trials sponsored and designed by the pharmaceutical companies themselves.
Clearly, the first and underlying corruption of the so-called randomized prospective, double-blind clinical trials (RCTs) is their sponsorship by the very drug makers seeking favorable outcomes for their products. Almost all RCTs today are sponsored by drug companies. Incredibly, they are also permitted to write (or hire someone to write) the testing protocols, and it would be naïve to think that a company that stands to make billions of dollars in annual revenues would not bend and shape these to their advantage.
2. “Randomizations” that aren’t really randomized.
Essential to results being representative of the larger populations, “randomization” of patient-subjects selected for the trial is done, not by the principal investigator, but by–you guessed it–the drug company.
3. Experimental trial design to circumnavigate recognition of serious adverse reactions.
A drug corporation can literally choose to look for what they want to find and/or not look for what they don’t want to find.
4. “Blinding” that can easily become unblinded.
The hallmark of RCT validity is the “blinding” of both investigator and patient. Placebos are supposed to be indistinguishable from the test drugs, except, of course, in their effects. Through differences in preparation, color, viscosity, and relative ease of administration, investigators and patients are easily corrupted.
5. Self-serving definitions.
Since the pharmaceutical corporations are sponsoring and designing the trials, they literally define what is or isn’t a therapeutic effect and/or side effect.
6. Misrepresenting old research data as new prospective testing.
Drug companies often give adjudicators old, secondhand reports of serious adverse effects (SAE) in order to determine if these meet the company’s definition of SAE. The reports are presented in an approximated randomized, blinded fashion and then labeled as bona fide, new data.
7. Avoiding discovery of longer-term adverse reaction from accumulation of drugs or treatments by shortening the length of study.
The sponsoring drug company can also choose to end the study at any convenient point for them, lest some side effect of longer-term use be discovered.
The systems, methodologies, and results of these “tests” are thus cynically manipulated, patently corrupted, falsified, and presented at the extreme peril of patient population at-large. Though impressive in name, sponsored RCTs are merely selective, semi-blinded, self-designed clinical “trials,” and one would be forgiven, under these conditions, for doubting drug manufacturers’ assurances that their products are what they say they are. Despite all of that, the results of these RCTs are still highly influential in FDA approvals today. The FDA calls them “Level I Evidence,” apparently no one at the department knowing of, or considering, the cautionary tale of the fox minding the chicken coop.