Updated: Dec 14, 2020
The V isn't something we created. They literally represent 'violence.' My artist-wife co-opted the "V" as a symbol for the Black Box Warning Initiative from a civil trial exhibit (Dolin v. GlaxoSmithKline). For my wife, they represented the smile people are promised when they are given psychiatric medications--smiles that are rarely delivered. But for the trial attorneys, the "Vs" represented "particularly violent deaths" during the clinical trials of the SSRI antidepressant, Paxil. The "V" was drawn next to black silhouettes of trial participants who died. That's right, people die in the clinical trials.
I am an attorney by trade and my wife is a novelist, artist, and musician. We learned about this civil trial because the suicidality caused by the SSRI, Paxil, was also a side-effect of the medication my wife was prescribed after a traumatic brain injury. She has suffered with akathisia, a side-effect that has been shown to contribute to suicidality, for over two decades. We live with this, and other side-effects, because medications caused lasting, long-term, permanent damage to her brain.
We knew the drugs my wife were on had risks, but we didn't know how common, how life-changing, and how subjectively they presented. In other words, they insidiously mimic the very things she was being medicated for. Imagine the horror when the boxed warnings on the drug my wife was prescribed began to reflect damage that had already manifested. (It felt less like a warning and safety precaution and more like a CYA.) It was a case of too little, too late for us.
I read up on the FDA's boxed warnings and discovered that these aren't warnings that come when the drug is approved. They don't use data from the clinical trials. These are warnings that are added after the drug has been introduced into the marketplace. Only when these side-effects are voluntarily reported by people who have suffered irreparable harm from the medications are they considered for a boxed warnings. Only when a significant number of people experience them are they added to existing boxed warnings. There is nothing in the current system that is scientific or controlled about determining a drug's side effects. This also means that for the more fatal warnings, people have already died from the drugs.
Paying closer attention to the boxed warnings, now plays an important part of our entire families' medical care. In my own legal practice, I see the impact medications have on people's ability to survive. Life expectancy in the United States is currently declining and that was before the pandemic.
Not too long ago, doctors were plugging cigarettes for your throat. Fifty years ago clear warnings were added to the packs of cigarettes and according to a 2014 Yale study, over 8 million lives were saved as a result. How many lives can you help us save by telling people to pay attention to the warnings on the drugs they are prescribed? How many lives can be saved when we can get the drug ads off our screens and back into the doctor's office (and not in pamphlets and posters in the foyer)? How many lives could be saved if the warnings were more accurate and clear through mandatory reporting? Until we do these things, there are too many "Vs" and black silhouettes in our future.
Do you know your Black Box Warnings?