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.