Next Steps for PhRMA and Marketing (Part 3): Let the Sunshine In

Concluding our series of proposals for pharmaceutical marketing to reclaim the high ground. We've already suggested re-defining the mission and combining the Pharmaceutical Research & Manufacturers of America's various codes of conduct.

Today, step three: Let the Sunshine In

“Transparency” is now everybody’s favorite buzzword in Big Pharma. Merck CEO Richard Clark urged his colleagues to embrace the call to "create transparency" during his inaugural address as chairman of PhRMA.

Indeed, the immediate impetus for PhRMA’s effort to update the marketing code came when Congress got serious about pushing “sunshine” legislation. (And the Code is already a success, since that initiative did not make it into law this year.)

The problem with transparency: by definition, you can’t see it. Obstruction you can see. Transparency is invisible.

Since the calls for transparency are motivated fundamentally by mistrust of industry, how will the public (or at least its elected representatives) ever be satisfied that industry is in fact being transparent? Put another way, if industry chooses to hold anything back—for competitive reasons or otherwise—why wouldn’t the assumption continue to be that some ugly truth is being hidden away?

Our suggestion: invite the public in to those conversations. Every pharma company should appoint a transparency committee, a group of independent outsiders--preferably well-known critics. The transparency committee (though we prefer the name "sunshine band") would have carte blanche to review anything and everything related to the company's procedures on information disclosure. They would be empowered to make recommendations that the company would be obliged to respond to. (Not necessarily implement--but at least acknowledge and explain a decision not to implement.)

The transparency committee should report directly to the board—or even better, to a central transparency committee convened by PhRMA. We even have the perfect chairman: Cleveland Clinic Cardiologist Steve Nissen. (He may have bigger plans for his career that rule him out, but still.)

Nissen is a particularly articulate critic of industry on issues like publication bias and clinical trial result reporting. But he is also a clinical investigator and an experienced author of academic research, so he understands the importance of protecting information as well.

That whole idea may sound crazy, but give us a second, we're just getting warmed up.

Industry could go yet one step further than letting its critics shape disclosure policies: it could ask them to review and approve its marketing plans in the first place. Now we know this sounds crazy. Pharma companies went ballistic over a provision in an early draft of the FDA Amendments Act that would have explicitly authorized FDA to review a company’s marketing plan in the context of assessing a proposed Risk Evaluation & Mitigation Strategy.

That provision came out--but the spirit lives on. In fact, we would argue that a suitably motivated FDA can and will demand access to marketing plans for drugs under the REMS authority. And even if FDA doesn't push that way on its own, the fact that Congress thought about it once means it is likely to come up again later.

More to the point: industry says marketing is about delivering valuable scientific information to doctors and patients. It is about education. So why not ask those being educated to review and respond to the curriculum? Who knows, they might even get excited about the new medicine...

Enough opining from us. What do you think?

Next Steps for PhRMA and Marketing (Part 2): Combine the Codes

Continuing our free advice for Big Pharma marketing groups on ways to reclaim the high ground. (And yes, you do get what you pay for...)

Yesterday, we suggested a new mission statement for marketing.

Today, step two: Combine the Codes

PhRMA has statements of principle governing professional promotion, direct-to-consumer advertising and clinical trial disclosure. But industry’s critics do not see them as separate issues. Neither should industry.

Let's start with the two "marketing" codes, one for DTC and one for interactions with physicians. It is easy to see why there are two: there are very real differences in the regulatory oversight of DTC and professional promotion, reflecting the fact that DTC is a "new" phenomenon (at least in the sense of broadcast television ads), while sales reps calling on doctors is a venerable industry institution.

But when it comes to defending marketing in the political realm, it is silly to try to differentiate. Indeed, association CEO Billy Tauzin acknowedges that many of the public perception issues facing the industry require addressing both DTC and professional promotion. So PhRMA is upgrading its principles of consumer advertising too.

In an era when informed patients often know more about their medical conditions than the physicians who treat them, it is also absurd to argue that there is a fundamental need to craft different messages based on who has the MD. (Different messages based on knowledge level yes, but sometimes that means dumbing it down for the docs and engaging more scientifically with patients.)

We might also highlight the danger for industry if doctors—not the biggest fans of DTC in the first place—begin to really get upset about it now that they spend more time in front of the TV and less time at industry sponsored dinners.

Updating the DTC code is a nice first step. But PhRMA and its members should go further. In age when Big Pharma is rethinking everything (or should be), it is time to challenge the mindset that professional marketing and consumer promotion are two different activities. A sales rep visit is indeed different than a TV commercial during the Super Bowl. But both are probably equally inefficient.

If industry wants to reclaim the high ground for marketing it must take a stand on who the marketing is supposed to benefit. The updated PhRMA code does that, by the way: "Our relationships with healthcare professionals are regulated by multiple entities and are intended to benefit patients and to enhance the practice of medicine."

If the goal is to benefit patients, then it is nonsensical to consider sales force activities and DTC as in any sense separate. If either the patient or the physician lacks the necessary information to make an informed therapeutic choice, then the marketing campaign failed.

The code of conduct for clinical trials is less obviously part of the same picture, but PhRMA would do well to look at it in that light. Industry bristles at claims that its big R&D budgets are really just to support marketing. But let’s face it: the questions asked and answered by clinical trials and other industry sponsored research are indeed the primary source of information about medicines—and so the very essence of all industry marketing.

Put another way: no one objects to industry sponsored research. They object to the perception that the results are skewed or hidden based on a commercial agenda. In other words, they think marketing trumps R&D.

PhRMA’s current clinical trial code covers issues related to reporting and disclosure, but Congress has already taken that issue much further. If PhRMA wants to reclaim the high ground, the association will need to take another look at that policy—especially in the context of even bigger steps to rebuild its reputation.

Tomorrow: Step Three—Let the Sunshine In

Next Steps for PhRMA and Marketing (Part 1): Define the Mission

Our hats are off to the Pharmaceutical Research & Manufacturers of America task force on professional practices. It is no simple matter to get three dozen companies to agree on anything—much less something as politically and commercially sensitive as the rules governing marketing to physicians.

And to do so in a way that addresses real-world, day-to-day operations is so much tougher. PhRMA’s updated Code on Interactions With Healthcare Professionals wrestles with the nitty gritty details of how physician marketing works, and doesn’t shy away from tough, specific directives on everything from pens to meals.

So no one can say PhRMA is hiding behind bland statements of principle rather than addressing the real world.

But perhaps you can say the opposite: that in getting into the weeds of how marketing works, PhRMA has lost site of some bigger principles. Debates over pizza and pens may help in that cause, but they don’t come close to justifying marketing as a vital, necessary activity for society.

In that spirit, may we suggest three modest proposals of our own?

Step One: Define the Mission

It is time (past time, perhaps) for PhRMA and its members to redefine the role of marketing and reclaim the high ground.

Every marketing organization should have a mission statement that it can embrace and brag about. The goal cannot be simply to increase sales. The goal should be to ensure the widest appropriate use of life-improving or life-extending medicines. Marketing done right means a medicine reaches more of the right people; it maximizes the benefit society receives from medical science.

PhRMA’s updated code on interactions with physicians suggests this mission in the preamble: “Appropriate marketing of medicines ensures that patients have access to the products they need and that the products are used correctly for maximum patient benefit.”

Hopefully, every marketing organization believes that already. The hard part is convincing the rest of the world to see it that way.

To do that, you can’t just say that’s what marketing is—you have to mean it. For example, do companies compensate marketing personnel based on “maximum patient benefit”? Its hard to say yes if sales reps get bonuses for boosting prescription market share in their territory: that is compensation based on maximizing revenue.

Of course, coming up with bonuses tied to maximizing appropriate use requires some real creativity, and probably a complete rethinking of the marketing effort.

But that’s only step one.

Tomorrow: Step Two--Combine the Codes