Moral Dilemma and the Ethics of Pharmaceutical Marketing

You are the product manager, marketing manager, or even VP of Marketing.  You understand the regulatory and legal constraints on your marketing but are there ethical considerations depending upon how your product compares to other therapeutic options?  Let’s start with the easy one ….

You have the treatment of choice with few, if any, other therapeutic options that can help patients for a particular indication.  Any ethical issues in promoting your product?  Probably not, unless you really go out of your way to exaggerate the efficacy or safety of the product beyond what you can prove.  How about when your product benefit and indication is for a small patient population for which you already have a majority of the market and the company expects you to grow revenues next year? Any ethical issues now? Probably not if you continue to promote within your market but what about bigger “off-label” indications?.

How about a product that is as good as everything else to treat a particular disease?  Your product is no better or no worse than the other products.  You might have a few features that are better but the other products have a few that are better than yours.  Neither your product nor competitors has a clear efficacy, safety, or feature advantage that clinically matters.   What are the ethical issues for promotion in this situation?  How about comparative advertising when you know there is no difference?  Can you make your product look better than the other products? This is probably the most likely scenario for most products today.  Probably not too many ethical issues yet unless you exaggerate your benefits beyond your clinical proof or downplay your safety issues to create a competitive advantage.

Now, same scenario as above (no difference) but you are the branded product and there are several generic versions of therapeutic alternatives (in the same class of drug) for the indication?   Are you tempted to make a difference out of no difference to maintain your branded product sales? Is it ethical to expect patients (or insurers) to pay more for the same therapeutic outcome? I can hear it already…branded products are de facto better than generics.

How about when you have a product that is not as effective or as safe as competitive products or therapeutic alternatives?  Getting more interesting isn’t it?  The company still has revenue growth expectations so what are you going to do?  Should you be trying to get more patients on your product if it isn’t as safe or effective as other products?  You are probably thinking it is the physician’s choice, not you making that decision….right?  If you can convince the physician to use your product, it’s their decision…right? How do you feel about that?  How does your manager feel about this?  How does your company feel about this?  What would they say if you raised the issue with them?

While I’m not certain product managers or companies for that matter are thinking this way,  they are faced with these issues everyday in the pharmaceutical industry.  Think about the products your company promotes.  Which scenario do each of the company’s products fit into?  How are they being promoted?  How do you feel about that? Anybody in the company asking these questions?

What’s the answer to this dilemma?

How about company executives (VP Marketing or higher) recognizing the issues and making the call so as not to put front line marketing managers in a difficult, potentially career jeopardizing position?  In the future,  have more products in the first scenario ….innovative clearly differentiated products that you are proud of and that you can promote without having to compromise your ethics.

mike@pharmareform.com

  • http://www.physicianassistantsite.com/ physician assistant

    Keep posting stuff like this i really like it

  • http://blog.pharmaconduct.org/?src=PharmaReform+20100306 Pharma Conduct Guy

    Good post Mike. Do you think that the Prisoner’s Dilemma might also be at work here? For example, if I don’t take extraordinary measures to increase sales, my peer will. He/she will benefit while I will be punished. Every pharmaceutical company has a list of sublime, virtuous sounding values that every employee is expected to uphold. These values are prominently displayed in conference rooms and on the web, and most pharma companies have even incorporated them into the annual performance review. Yet you and I both know there is another unwritten set of values. My question is this: what needs to change for companies to actually follow those values? For example, if a marketing manager is found to be increasing sales through unethical means, instead of turning a blind eye to how the increase was obtained and handing out a large year end bonus, what if the VP of marketing made an example of him/her and terminated him? I assert that the current system is so corrupted that the only way the change I describe will come about is through a fundamental restructuring of the business.

  • http://www.pharmareform.com Mike Wokasch

    Pharma Conduct Guy,
    Great question. You bring up two issues that are related. First, the issue of a person feeling pressured into doing something they otherwise might not consider doing. Second, what corrective measures to take when wrongdoing is identified, so you stop the unwanted behavior.
    Organizational pressure comes from three sources:
    • The individual who wants to do well can put tremendous pressure on themselves to find ways to exceed expectations. This is personal motivational drive.
    • The second is peer pressure which comes in the form of either encouragement from others to do something or, as you identified, the person feels they will be at an internal competitive disadvantage (career risk) if they don’t do something.
    • Another very powerful organizational pressure that can instigate the first two is that applied by management (which often trickles down from the top of the organization) with either implicit or explicit performance expectations. “You need to grow XX% next year and if you can’t do it we’ll find somebody who can.”

    From my review, most of the illegal promotion programs, including off-label promotion, or intentional non-disclosure of safety issues that have been investigated, prosecuted, or subsequently brought to settlement involved an apparent corporate intent to drive or protect sales with little regard for legal or regulatory considerations or concerns for patient safety. While there have no doubt been maverick, rogue sales reps doing whatever it takes to make sales, it appears that most of the big (resulting in meaningful revenues and profits or numbers of patients at risk) prosecuted cases appear to have been orchestrated corporate programs and it is hard to believe senior management and corporate executives were totally unaware of these programs. It is easy for C-level executives to set expectations that are not achievable within the legal and regulatory constraints (or with the real safety profile of the product), indirectly pushing subordinates all the way down the hierarchy to do whatever it takes to deliver the results. The executive can always claim that illegal (or deceptive) activities were not what they intended. With quarterly results to deliver and huge executive bonuses on the line, however, there is also little incentive for them to intervene, even if they are aware of the illegal or questionable activities.

    So firing front-line employees and managers might give you a bunch of scapegoats and set an example but that would not get at the real problem.

    I believe compliance starts at the top and when companies are found to have illegally promoted their products (or put patients at risk because of intentional non-disclosure of safety issues), punishment should also start at the top. Holding C-level executives personally accountable for their organization’s indiscretions will have a far greater impact (get them to stop) than firing a bunch of front line managers trying to meet corporate expectations.

    mike@pharmareform.com

  • http://www.yams.com TomPier

    great post as usual!

  • http://www.pharmareform.com Mike Wokasch

    Tom,
    Thank you. Mike