I’m Old enough to remember: The way clinical trials were done.
𝐈’𝐦 𝐨𝐥𝐝 𝐞𝐧𝐨𝐮𝐠𝐡 𝐭𝐨 𝐫𝐞𝐦𝐞𝐦𝐛𝐞𝐫 back when Pharmaceutical Phase 3 human trials included documentation of a participant's EVERY SINGLE HEALTH detail. Participants were asked questions, like if they had any pre-existing conditions, what other medications they were on, and what their family history consisted of. You know, variables that kind of mattered on an individual basis.
𝐈’𝐦 𝐨𝐥𝐝 𝐞𝐧𝐨𝐮𝐠𝐡 𝐭𝐨 𝐫𝐞𝐦𝐞𝐦𝐛𝐞𝐫 when the participants in those Phase 3 trials had to report ANY adverse event they experienced, whether or not it was caused by the experimental product. I recall asking my manager in 2003, back when I was in Pharma sales, why “broken leg” was listed as an adverse reaction to the anti-depressant I marketed to doctors. He explained that for integrity, regardless of cause, if 0.02% of people also had the same outcome, it had to be listed as an adverse event in the prescribing information.
𝐈’𝐦 𝐨𝐥𝐝 𝐞𝐧𝐨𝐮𝐠𝐡 𝐭𝐨 𝐫𝐞𝐦𝐞𝐦𝐛𝐞𝐫 when there was full disclosure of any possible adverse outcome. I was required to provide a “prescribing information” pamphlet, also known as a “PI”, with every sample, cup, or pen I delivered to an office. If I didn't provide informed consent via a PI, I’d risk losing my job.
𝐈’𝐦 𝐨𝐥𝐝 𝐞𝐧𝐨𝐮𝐠𝐡 𝐭𝐨 𝐫𝐞𝐦𝐞𝐦𝐛𝐞𝐫 when pregnant women (back when we knew what a biological woman was & only women could conceive) were adamantly excluded from all trials until long-term safety data was established. Many of the medications I marketed had a “C” safety rating for pregnant or nursing mothers, meaning risk could not be ruled out in humans & that animal studies demonstrated a risk to the fetus.
𝐈’𝐦 𝐨𝐥𝐝 𝐞𝐧𝐨𝐮𝐠𝐡 𝐭𝐨 𝐫𝐞𝐦𝐞𝐦𝐛𝐞𝐫 that if participants were diagnosed with CANCER or DIED while enrolled in the trial, autopsies were mandatory to establish blood serum levels, inflammatory markers, possible neurological damage, organ failure, and if the product could possibly be carcinogenic. That was considered important data to collect.
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But then, for some reason in 2021, in the midst of the largest experimental Phase 3 trial in world history, NONE of those long-standing phase 3 practices seemed to matter to the pharmaceutical industry, our government, our doctors, celebrities, the media and sadly in some cases, our own family.
We were not ASKED to participate in this experiment. Most of us were threatened, lied to, had our freedoms & careers taken away, and worst of all, mankind was mandated to participate in this global Phase 3 trial.
This experimental shot was treated as “one size fits all” regardless of our age, demographic, need, pre-existing conditions, family history, or any interactions it could have with current medications one is on. Why?
These health questions were never asked, much less documented.
Adverse reactions are rarely being recorded. The online recording system is so outdated & cumbersome that it only captures less than 10 percent of injuries. Gosh, you’d think for such a big experiment they’d have better software. Instead of data collection, participants are being gaslighted when they present with injuries. “I don’t know what it is, but it’s not THAT.” It used to be mandatory to ask if they were in the control group (meaning they took a placebo)or the test group (meaning they took the experimental product) to determine if the side effects could be caused by the product in question, or not. That used to be considered vital information, you know, for safety.
No side effects were listed beyond “a sore arm.” Yet the FDA was presented with a list of the most possible adverse events in October 2020, things like myocarditis, seizures, heart attacks, and autoimmune issues, to name a few. Oddly, that list was never made public. And those “PIs” that I was required to hand out? Mysteriously, for the experiment, those are all…BLANK. Maybe Pharma has printer issues.
There are zero long-term safety data on pregnancy, fertility, or infant outcome. There is no pregnancy rating. Not an A, not an F. Nothing. Because no one really knows. The irony is that pregnant women are advised by their doctors against eating sushi because of the potential mercury, and parents are told by pediatricians to introduce just one food at a time to infants to avoid possible food allergies, the same women who were all eagerly encouraged to participate in this Phase 3 experiment.
Lastly, nowadays, and most BAFFLING, when someone DIES SUDDENLY or UNEXPECTEDLY, as many people are, (gosh my Facebook has become more like the obituaries) not only is it NOT diligently looked into, nor are autopsies being routinely performed, but, as a society we told we are not even ALLOWED TO INQUIRE if the person was part of the global TEST group.
We are told we are “𝘪𝘯𝘴𝘦𝘯𝘴𝘪𝘵𝘪𝘷𝘦”.
If you feel I am being “insensitive” and are offended by me asking if these adverse events or unexpected deaths of someone were part of this big experiment, please give me some grace. It’s not personal. I’m trying to make sense of it all and navigate through this completely upside-down way of doing things.
𝘐𝘵 𝘢𝘭𝘮𝘰𝘴𝘵 𝘴𝘦𝘦𝘮𝘴 𝘭𝘪𝘬𝘦 𝘵𝘩𝘦𝘺 𝘥𝘰𝘯’𝘵 𝘸𝘢𝘯𝘵 𝘢𝘯𝘺 𝘰𝘧 𝘶𝘴 𝘵𝘰 𝘬𝘯𝘰𝘸.
In fact, in my defense, there used to be a time not so long ago when it was the professional industry standard. That standard was intended to keep us safe from unethical Pharma practices. It removed harmful products from the market and worked for the people to prevent any further human injury, infertility, suffering, or death.
𝐈’𝐦 𝐨𝐥𝐝 𝐞𝐧𝐨𝐮𝐠𝐡 𝐭𝐨 𝐫𝐞𝐦𝐞𝐦𝐛𝐞𝐫 when that kind of information mattered.
