Perceptions of the Pharmaceutical Industry can make Normal Business Practices seem Unethical or Illegal

Those who have read this blog know that I am not into making excuses for pharmaceutical industry misbehavior.  At the same time, it is important to understand the impact of how outsiders (those not involved in the pharmaceutical industry) are going to interpret actions and behaviors.   What might appear to be clearly unethical or illegal to an outsider may require an informed interpretation of circumstances or intent.

Think about it.  At what point are consulting assignments and advisory payments to physicians a bribe or kickback?  Could providing lunch for the office staff really be a bribe or kickback?  Is any comment about product efficacy or safety that is not verbatim out of the package insert possibly “off-label” promotion?  When are graphic interpretations or implications from an advertisement “off-label” promotion?  At what point do random side effects and adverse reactions become “hidden” if not publicly broadcast to the media?  Are systematic miscalculations of pricing always an indication of fraud?  When is competitive pricing considered price fixing?  At what point does editorial assistance become “ghostwriting?”

I am not an attorney and this is not a legal discussion.  Rather, this is about past history of proven and alleged pharmaceutical industry misbehavior including illegal activities.  Perhaps most disappointing has been the fact that as prosecutors pieced together their better informed perspective of alleged illegal activities they often found both willful intent and additional even more egregious activities to support the initial allegations.   The seemingly endless offenses have tainted the perception of prosecutors, legislators, healthcare professionals, regulators, industry critics, and of course, patients.  Virtually everything the industry does is now suspect and often transformed into allegations of unethical if not illegal activities.  Even normal course of doing business activities (e.g., presenting a favorable product profile, trying to influence prescribing, and providing samples) are now being viewed as inappropriate and possibly illegal.

It all boils down to a lack of trust and credibility.  The industry can’t even credibly defend itself to maintain normal business practices because there are just too many cases that demonstrate companies are willing to betray this trust and take advantage of the market for financial gain.  Unfortunately, the pharmaceutical industry doesn’t seem to be too concerned or you would have seen a dramatic change in behavior.

Before trust and credibility can be reestablished the industry and company executives must be on their best behavior.  Once again, actions and consistent behavior will speak louder than words or intermittent gratuitous gestures.  Trust and credibility are much harder to reestablish than to maintain.

mike@pharmareform.com

  • http://www.trustedadvisor.com/trustmatters Charles H. Green

    This is a very thoughtful and I think useful blogpost. Thank you.
    With the most recent eruption of dysfunctional pharma behavior (Avandia) introducing a new catch-phrase (may it “not see the light of day”), close on the heels of the disappointing J&J performance in light of their Credo, it is even harder for the average citizen to muster empathy for and understanding for those in Pharma. The temptation to say ‘what were they thinking!’ and let that be the end of it is very high.

    Many in pharma feel this is unfair. Certainly they do not ‘feel’ guilty of bad motives, hence the attacks feel personally unfair as well.

    But in the end, I think your conclusion is the only right one; they are being held to a higher standard? It is useless to complain about it, the only way ’round it is to live up to a higher standard. Fair? That’s got not much to do with it.

    There is one behavior that can be pointed out and which can be changed, and that is the typical response of Pharma companies to risk. It is to put the lawyers in charge, restrict outside contact, be careful what you say, screen everything written to expunge violations, and so forth. In short, watch what you say.

    This is a recipe for backfire. If the culture is ‘watch out what you say,’ then you encourage secrecy and paranoia, closed doors, secret memos, and the like. This appears to me anyway to be exactly what happened at GSK; memos were buried.

    You can blame lawyers, PR people, marketers, or general management: but until pharma stops focusing on preventing risk, and instead gets comfortable with telling the truth, they will not earn the reputation for trust and credibility that you rightly suggest they need.

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

    Charles,
    Thank you for taking time to share your insight and perspective. Your comments reflect your expertise as the “trusted advisor.” Thank you. mike@pharmareform.com

  • mdb

    Sales is sales. I don’t think a pharma sales person is any more or less trusted than a car sales man, appliance man or any other sales man. The main difference is people want to believe a drug will make them better and therefore suspend their critical thinking. Long before big pharma, snake oil sales man figured this out and made a fortune.

  • http://www.trustedadvisor.com/trustmatters Charles H. Green

    Mike,
    You may already know, but congratulations for having your blogpost chosen as Absolutely Essential Reading on the Political Calculations blog carnival at
    http://politicalcalculations.blogspot.com/2010/08/on-moneyed-midways-august-6-2010.html

    Congrats!
    Charlie Green

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

    mdb,
    Thank you for your comment.

    The questionable activities and behaviors that have resulted in the poor public perception and lack of trust in the industry have in many cases been corporate headquarters initiated programs and were often encouraged by management. This is not about the trustworthiness of individual representatives but rather about corporate officers and management at pharmaceutical companies establishing cultures of integrity, demanding compliance with legal and regulatory expectations, setting an uncompromising example, and being personally accountable for the actions and behaviors of their organizations.

    You comments about pharmaceutical sales people seem a little misdirected. First, pharmaceutical sales people rarely discuss products directly with patients so in your assessment the physician must suspend there critical thinking to prescribe based on the sales person’s pitch. Most physicians I have ever met or made product presentations to were quite analytical and certainly had not suspended their critical thinking.

    Second, I don’t believe most pharmaceutical sales people view their sales responsibilities as just another sales job. When patient health and well-being are at stake and in many cases, patient lives, there is no room for manipulative selling or misstated claims, and even less room for intentionally misleading physicians about the efficacy or safety of prescription drugs that can potentially cause harm or even result in death.
    mike@pharmareform.com

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

    Charlie,
    Thank you for letting me and the Pharma Reform audience know about this recognition. Much appreciated. mike@pharmareform.com