I was listening to a news report the other day about the reasons for COVID vaccine hesitancy and one individual articulated an oft-cited concern: “I don’t want to put something in my body that the FDA has, so far, only approved for emergency use.” Some folks seem to feel this way even though the FDA approved emergency use based on clinical trials involving tens of thousands of people and nearly everyone with a medical degree is begging people to get it, having taken it themselves. Many everyday people apparently think that despite this, it’s their best medical judgement (sadly based on lethally- bad information) to risk serious illness and death to themselves and others in order to wait for the venerated seal of full FDA approval.
And then I thought, “should we tell them”?
Most of the drugs and supplements that we all ingest every single day have never gone through anything close to the clinical pre-market emergency approval process that the COVID vaccine already has. Here are some examples:
Generic drugs. More than 80 percent of the drugs we take are generic. NONE have gone through any sort of clinical trial or pre-market approval process. These drugs are in the marketplace because they are supposed to be “bioequivalent” to brand name drugs, which have been FDA-approved. But despite what is commonly believed, generic drugs often do not match their brand name counterparts. They may contain some lower quality ingredients, which can affect a drug’s absorption into the bloodstream. The FDA sometimes approves a strength or dosage that hasn’t been tested at all. Even small design differences between generic and brand-name drugs can have health consequences. And to top it all off, we have no legal recourse if injured due to a generic drug’s unsafe design or labeling. (And that is thanks to the U.S. Supreme Court ruling against patients with horrendous generic drug injuries.)
Medical devices. As we wrote in 2012,
The FDA has a special rule –510(k) of the Federal Food, Drug, and Cosmetic Act – whereby drugs and devices that are “substantially equivalent” to a device already on the market are not required to go through more rigorous FDA approval. This allows companies to market dangerous products for uses never really “approved” by the FDA, yet with the stamp of FDA approval! [For example], the FDA approved surgical meshes for procedures like abdominal surgery. But [Johnson & Johnson] began marketing them for use in a women’s vaginal area, treating problems like incontinence. Subsequently, hundreds of women became severely injured and some died as the meshes began disintegrating, growing into tissue and becoming impossible to remove. … The FDA [much later said] that the company should not have used 510(k) to fastrack these. Not exactly quick work by the agency.
Supplements. Who here takes vitamins? Or any other kind of herbal or dietary supplement? The FDA doesn’t test any of them before they hit the market. The agency doesn’t even consider them to be “drugs.” As the American Cancer Society writes,
[Supplement] manufacturers are not required to test new ingredients or supplements in clinical trials, which would help find risks and potential interactions with drugs or other substances. The [law] gives the FDA permission to stop a company from making a dietary supplement, but only when the FDA proves that the product poses a significant risk to the health of Americans. This means they are found unsafe only after they cause harm. This is the reverse of the way prescription and non-prescription drugs are handled.
As we wrote in 2013:
Dr. David A. Baker, a professor of obstetrics, gynecology and reproductive medicine who has studied supplements, “called the state of supplement regulation ‘the Wild West,’ and said most consumers had no idea how few safeguards were in place. ‘If you had a child who was sick and 3 out of 10 penicillin pills were fake, everybody would be up in arms. But it’s O.K. to buy a supplement where 3 out of 10 pills are fake. I don’t understand it. Why does this industry get away with that?’”
Of course, it shouldn’t. The point is, however, that the COVID vaccines are already far more regulated, and proven safe and effective, than nearly any other drug, device or supplement that we put in our bodies today. Plus unlike generic drugs, medical devices and dietary supplements, COVID vaccines have the eyes of the world on them - and they’re working. Not to mention the fact that more than 96 percent of doctors have already been vaccinated, fulling trusting their safety. It’s hard to feel safer than that.
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