Truth or truth?

Almost two years ago, I published the article below. Please take a moment and refresh yourself with the points in that one prior to reading these additional thoughts, as that is an important piece of context.

I am constantly struck by the irony of how rapidly some things change, while simultaneously seemingly to never change. This concept of "off-label" promotion was the topic du jour then in our industry, as it remains today. In my 2016 article, I looked at this from the perspective of whether or not something is misleading and suggested some applicable tests from a review/confidence standpoint. Since that time, the FDA has issued a draft guidance clarifying some of these questions from their point of view. However, the question remains. What do we want to do?

As we continue to consider promotional claim support in all of the contexts discussed in the previous article, I think it is vital to also approach this from a "Truthful/truthful" perspective, as we consistently use that term in a definitive way as it is the ultimate test for our ability to promote a prescription drug claim. As the regulations allow, if a claim is truthful (and not misleading), we may promote it. The regulatory test for supporting a claim, after all, is that the claim must be truthful and not misleading.

So, my question. What is truthful in science? Truth in science is somewhat of a slippery slope, as just when we think we know the truth, we are often surprised. The "definitive" study is replaced, and contradicted by, another "definitive" study. And, to what standard of truthfulness should we hold ourselves when patients lives and health are at stake, regardless of what might pass the regulatory test?

As one would imagine, there are numerous definitions and thoughts on the most appropriate definition of truth and there are arguments on all sides for their appropriateness. I can only imagine the incredible conversations among the great philosophers! For our purposes, though, I will simplify and use just two of those thoughts with a little license of my own.

First, truth with a small "t." To me, the small "t" truth is the fact that we are accurately reporting what the study says. That, taking one approach, is truthful. However, as I said in my article below, does that study publication take into account all aspects of the study? Does it draw conclusions that the data does not support? Even using the small "t" truth, there may be some serious omissions, inaccurate conclusions, and ultimately, inappropriate drug use. Certainly, the FDA draft guidance addresses many of these questions from their perspective, though a final guidance has not been published and will only happen with much external input and deliberation.

Now, Truth with a capital "T." Even if the study data and publication pass all rigorous statistical tests, and even if we include appropriate disclosures/disclaimers, how confident are we that the study is definitive and robust enough to support a solid definition of scientific truth when considering the entire environment and complete evidence? Considering data has to first pass the definition of "truth" to support a claim, how do we represent this appropriately in the overall context of truthful and not be misleading? Does a disclaimer really clarify the overall importance (or not) of the data? Might a disclaimer actually make something Truthful? Even if so, have we objectively tested our assumption that the disclaimer works as we believe it does? How do we know when the overall data is robust enough and where the tipping point is for Truthful?

My goal here is to be provocative. There are no bright lines and there are many views. And, much of the question lies as much in the promotional approach and language as it does in the data itself. Take a few minutes and contemplate these thoughts, as well as those in the original article about our imperative to contemplate other legal and competitive considerations for our own business reasons. I am certain we all agree on this: The patients we serve deserve the most honest, authentic, complete, emotionally and business-neutral evidence and presentation as possible. To that end, the question is not only, what is the data standard the government and the environment require of us? The real question is, how do we define our industry standard of Truth?

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