By Peter Pitts
August 6, 2014 at 8:00 am ET
This past April, PhRMA held its 14th annual meeting in Washington DC.
During his inaugural remarks, incoming PhRMA board chair Ian Read shared his concern about the industry’s failure in getting the message out about “the value we generate.” His key message, “We need to fix the misperception gap.”
Specifically he talked about the industry’s need to broaden the conversation from the economic performance of biopharmaceutical companies to the value that accrues to society and called for a “dialogue with society.” Bravo.
He asked, “Where are the headlines?” They’re not about societal value – and they need to be. There’s a strong story to tell. It’s not happening. And it needs to, because minus that narrative, nothing the industry wants to make happen (with government being a focus since the meeting was in Washington, DC) will be possible.
Read called for “industry speaking for itself.” After all, if you can’t be your own best advocate, you’re suspect in the minds of many – and rightfully so. He spoke to “better ideas and clarity” versus “more tactics.”
They were the right words – but what’s happened since that fine oration? One thing that comes to mind is the debate over the price of Sovaldi. Another is ASCO’s decision to get into the comparative effectiveness game. Both of these issues are tailor-made for a Read-led discussion on price vs. value. And neither has generated a regular and robust response from either industry or it’s trade association.
That’s not to say there hasn’t been a debate. The Center for Medicine in the Public Interest (www.cmpi.org) has been writing and speaking with both force and frequency on these issues as have other public policy institutes (aka, “think tanks”) and thought leaders across the healthcare policy spectrum.
But there has been precious little in terms of by-lined commentary from pharmaceutical executives – especially of the C-suite variety.
To achieve Ian Read’s noble goal of “dialogue with society,” there needs to be a… dialogue. And it can’t only be via third party groups – as worthy and invested in the debate as they are. Pharma must speak for itself. Can you quote any useful answers from the folks at Gilead relative to Sovaldi pricing?
Pharma must embrace a new paradigm. Rather than focusing on traditional ROI (Return on Investment), they must now also consider Return on Integrity.
Integrity comes in many forms. Honesty. Virtue. Morality. But it also means (in more common parlance) “doing the right thing.” It means not waiting to be told to do it or waiting to see what others do first. Integrity means being principled and, as my father used to say, “A principle doesn’t count until it hurts.”
The current risk-averse position of many in pharma does nothing if not reinforce the general perception that the industry only cares about profit. Mr. Read’s words hit the nail on the head – change is required and we must drive it! But the gearbox has remained firmly in neutral.
For there to be Return on Integrity, integrity must first be demonstrated – publically demonstrated with names attached. This is especially true in the age of social media where the public is watching and commenting. And nature abhors a vacuum.
In June the FDA issued “Guidance for Industry Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.” Per the FDA:
If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in this draft guidance, FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising, if any.
From a regulatory perspective, that’s a lot of wiggle room and should provide significant food for thought in erring on the side of more rather than fewer voluntary corrective actions.
This provides industry with a tailor-made opportunity to demonstrate integrity at little or no risk – by correcting the mistakes of others about their products in a transparent and appropriate manner.
Who will step up to the plate? Who will be first? Who will earn the return on integrity?
Integrity without knowledge is weak and useless, and knowledge without integrity is dangerous and dreadful. –Samuel Johnson
Peter J. Pitts is a former FDA Associate Commissioner and the president of the Center for Medicine in the Public Interest