Lawyers tell the best lawyer jokes—and they’re funny because they’re true. The abhorrently litigious nature of humanity—and that consequential reflection in our corporate culture of “sue first, ask questions later”—has yielded a healthcare system that not only incentivizes itself to care less about the end user (e.g., the patient) but to systemically prioritize dehumanizing and further disenfranchising the very consumer for whom the business’s purpose was to serve.
Yes, the world is more complex and yes, there are so many more moving parts than ever before. But that does not give our multi-billion-dollar friends in the pharmaceutical world the right to exercise their blatant disregard for purpose over profits over and over again. Truth be told, it’s the lawyers who ruin it for everyone. Actually, to be fair, it’s really the law itself, but the lawyers do play a hand in keeping the deck stacked against us and continue to ruin it for both their employer and their client.
Sunshine Helps—And Hurts
What this all boils down to is the godforsaken Physician Payment Sunshine Act, part of the healthcare reform bill that was adopted in March 2010. But it wasn’t until February 2013 that the U.S. Centers for Medicare & Medicaid Services (CMS) released final regulations to implement that act. It was all downhill from there. (See: Regulatory Killed The Radio Star, http://bit.ly/1d5B2DH.) Don’t get me wrong, because good things did come of it. And, in fairness it did curtail some seriously naughty and unethical behavior on the part of Big Pharma.
However, what it also did was fundamentally undermine the democratization of civil liberty for the patient, the fundamental end user for whom this bill was ideally conceived. After all, we must “protect the patient” and “curb undue medical influence” and “make an honest chap out of everyone” to fix all the ills of a broken healthcare system. It was all about the patient. The patient. The patient. That’s purely a crock.
Was It Ever About The Patient?
It was never about the patient. It was about control for the sake of profits at the expense of the patient—to the point where, five years later, today’s hired legal guns who work for Big Pharma have to wear Depends undergarments at work for sake of daring to even come remotely close to having to interpret the law in any manner that may pose an actionable threat from the FDA. These attorneys have taken a slightly less than unethical trillion dollar industry and made it even more litigious and fearful of its own shadow than ever before. And now, there goes patients’ rights, dignities, outcomes and whatnot.
“Compliance” is their fancy word for staying within the interpreted boundaries of Sunshine’s regulatory matrix of suffocation at the expense of innovation. But compliance is the reason that less and less gets done than ever before. It is the very paralysis that keeps the status quo from ever changing. In fact, compliance has essentially neutered Big Pharma. It is the industrial orchiectomy to end all industrial orchiectomies.
CEOs know it—and they’re powerless to do anything at the risk of one FDA slap on the wrist undermining shareholder confidence and tanking their stock. Profits over purpose. Welcome to America. Until now. Why? Because patients aren’t lying down anymore and a new era of influence, dissidence and ruckus making is upon us. The patient is now in control and, lawyers-be-damned, industry has no idea what’s about to happen.
Meaningful Partnership Opps Slip
I have had too many conversations with well-meaning, passionate and highly engaged pharma executives about legit opportunities to partner around something truly meaningful that would quantifiably improve patient outcomes.
Then the lawyers panic at the mere thought of coming close to the third rail and the entire opportunity to do something real and true and valuable gets shot down and thrown in a dumpster—all due to perceived risk and interpretation of Sunshine. It never even stood a chance.
What’s worse, this nonsensical narrative happens deep within Big Pharma’s very own Patient Advocacy divisions, where, technically, they are supposed to be, oh, I don’t know…advocating on behalf of patients? Patient Advocacy departments are supposed to be challenged by muckety-mucks to come up with new, exciting and innovative opportunities to improve outcomes, to learn from patient communities about the patient experience and to drive innovation and engagement with patient advocacy organizations. That is, until the lawyers shut down the conversations because of words like “adverse events,” “off-label conversations” and “patient influence.”
Caution Scuttles Patient Protection
I know everyone’s got to pay the rent, but how can anyone stand to work in such an intractable environment in which the very rationale behind your job description is dismantled in front of you every single day and you are relegated to window dressing on top of a very ornate cake that no one ever gets to taste. Through its own hubris and self-aggrandizing gesticulation for being “patient-centric,” Big Pharma is demonstrating that it’s the exact opposite by letting counsel interpret the law in a way that defies the very paradoxical logic puzzle I put forth. If Sunshine was truly enacted to protect patients, it has failed immeasurably.
It is time to reinterpret Sunshine because, until patients are no longer held hostage under the philosophy of “protectionism outweighing innovation,” we should only expect Big Pharma to intentionally continue erring on the side of trepidation, fear and “let’s not and say we did”-ism.
Dear Pharma: Grow a pair and celebrate your FDA wrist slapping. Bronze your warning letters and proudly post them on Instagram to show the world you actually put patients first. This is the only way you will ever become relevant. Hell, I may even invest in you.
But for now, I’ll stick with Depends. You heard me.