The Validity for Questioning the FDA & Big Pharma


It’s late 1948. You’re a happy, young, married woman early in your second trimester, headed to the doctor for a prenatal checkup. You’ve been feeling well, but you know that doesn’t always mean anything early on; you’ve had miscarriages before. Today is a little more than just your typical check up. Last visit, your doctor talked to you about getting your DES shot. The doctor tells you they help prevent miscarriages. You don’t know much about medicine, but you trust him and the FDA approved it, so you trust that it’s safe so you didn’t think to ask too many questions.

This isn’t your first DES shot. You had one with your previous pregnancy. You ended up miscarrying that baby, but you didn’t really think much about it or what caused it. The doctor said the DES has a good success rate, and the FDA approved it, so you didn’t really ask many questions.

Several months later you give birth to a healthy baby girl – thank goodness! 2 years later you are pregnant again. Again, you go to your doctor and receive your DES injection that was approved to prevent miscarriages. Again, sadly, you miscarry that child. But you don’t think the two are connected, so you don’t ask any questions.

In 1971, DES is taken off the market. You’ve already had your first bout of cancer, cervical cancer. This was one of the cancers that they found out DES caused; one of the reasons it was taken off the market. 10 years after this, the woman your beautiful baby girl grew up to be will have the second of her 3 miscarriages. It’s sad, but you don’t feel it’s your business, so still you ask no questions. It’s not until after the third of her three miscarriages, your daughter finds out from her OB/GYN that being exposed to DES in-utero is why she’s struggled to carry to term.

These were just 2 of the many long-term side effects that were found to be caused by DES injections. The FDA approved DES in 1947 for the use of prevention of miscarriages, but it took until 1971 and at least 2 additional research studies to confirm that DES was a harmful substance not just to the women who were injected, but also for their offspring.

Every year, the FDA pulls drugs and treatments off the market because they are found to be unsafe, in contrast with their original data that the FDA used to approve them. They’re easy to find since the FDA is a public domain and is required (in essence at least) to publish this information for the public good. Looking at the first page, there are 377 entries listed and the first 30ish are only from 2021 – at cursory glance, at least 3 of the entries are from Pfizer. The laundry list of flubs the pharmaceutical industry has made with the help of inept FDA oversight is long and unfortunate. One of the worst – and relevant specifically to vaccines – is the Cutter Incident.

During the height of the polio fright in the US, several polio vaccines were created. One was approved and deployed over the others, for reasons that seem to have little to do with the vaccines themselves and more to do with social animosity between mean-spirited and cranky men. Cutter Labs deployed their vaccine but soon learned that it was giving children polio. How could this be? “The lack of experience and expertise at Cutter Laboratories, undetected by the inspectors, caused the disaster.”

Whether done in ignorance or purposefully, it was tragic. The scary part it, pharmaceutical companies, have a long history of pushing things to market that shouldn’t be there for the sake of profits. Two good resources that cover different aspects of this are Katherine Eban’s book “Bottle of Lies” about the FDA approval process and generic drugs and Gary Greenberg’s “Manufacturing Depression” about how drug companies often bury inconclusive research results and heavily favor and publicize anything that shows even a small benefit of their new product they are trying to patent. They are both maddening but supremely done.

For those that want to demonize people who are “vaccine hesitant” (I hate that this is now a catch phrase, it’s stupid and ridiculous. Are vegans now considered “meat hesitant”? asking for a friend) consider these instances where the all powerful machine of FDA approval apparatus failed. Science is the process of formulating questions and hopefully finding some answers. Sometimes those answers aren’t the ones you want to find. Being skeptical of new explanations or new drugs is something that we should be. There are reasons why these processes often take years to properly test a drug’s safety and efficacy. Not everything happens right away, as the DES example illustrates.

To say that anyone asking questions or being skeptical falls into the dreaded but now completely watered down “anti-vaxx” category is itself foolish and unscientific. If no one is allowed to ask questions, how do we move forward? Those who think otherwise make it obvious that they are unaware of some of the mired history of the FDA approval apparatus or the pharmaceutical companies. Don’t mistake me for saying that these things shouldn’t exist. There should be ground rules and I take no issue with pharma company’s existence, just that these are not infallible organizations; far from it. So it’s probably a good idea to do a little – even the most minuscule amount – of research for yourself, because those companies aren’t always doing it on your behalf.

I think the worse part of all this is the idea that laymen out there shouldn’t be questioning anything. This is preposterous. Being your own healthcare advocate is one of the most imperative things I can think of. If you don’t ask questions yourself, who else do you expect is going to do that? Sure, the doctor is there to help you, but he can’t answer questions that aren’t voiced. The doctor isn’t a mind reader and probably has no idea what you’re concerned about or what information you’re looking for UNLESS YOU ASK. This is where the woman from the opening story (a true story about a family member) became a hindrance to herself. Especially with medical decisions, you have to speak up for yourself, or it’s likely no one else will.

For a product that was billed as the savior to the pandemic which has been out for less than a year, doesn’t prevent infection, sickness, or spread, and ongoing doses are already being discussed, this hardly paints a picture of a glowing endorsement. Your shot doesn’t protect anybody else, only yourself, and even that isn’t fabulous. Sure, avoiding a trip to the hospital or death is preferable and for some demographics at inflated risk of COVID, that makes total sense. But for some people, the risk-benefit equation is incomplete at this point. If this is happening now, what’s going to be the case in a year, two years, longer?

These are not only fair questions to ask, but necessary ones. Humans are terrible at being aware of the potential unintended consequences of something done, especially in a moment of fear or panic. Maybe for once we could try to change that? Maybe, for once, let’s not have a meltdown when someone decides to ask a question that doesn’t have a clear answer yet, or better yet, an answer that you don’t want to acknowledge or admit to. And for the love of Pete, take two minutes to go down a small rabbit hole of history to better understand why people want to ask questions or wait and see just a little longer. Otherwise we’re just a bunch of majestic owls awkwardly hippity hopping along with our wings clipped.

Wrong Speak