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Healthy Skepticism Library item: 18339

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Electronic Source

Condor
Compliance Week: Where Should The Compliance Officer Report?
Shearlings Got Plowed 2010 July 2
http://shearlingsplowed.blogspot.com/2010/07/compliance-week-where-should-compliance.html


Abstract:

Or, “How Asking The WRONG Question Yields A Mostly-Meaningless Answer.”


Full text:

This is quite an age-old debate, but given our discussion just yesterday of “corporate integrity” agreements [largely a misnomer, as usually corporations under criminal and civil investigation for deeds involving a lack of integrity end up signing them!] — it is worthy of revisiting. Do go read it all, at ComplianceWeek — but here is a bit of it:

. . . .[O]n April 29, the U.S. Sentencing Commission submitted to Congress proposed changes to the U.S. Sentencing Guidelines which, among other things, seek to bolster the authority and independence of the CCO to address such a situation. Under the amended guidelines, if the CCO has direct access to the board (and the corporate malfeasance was addressed in an appropriate manner) a company may still receive sentencing credit for having an effective program. Without direct access to the board, the company cannot obtain credit for its compliance program when a high-level corporate executive has committed an offense. . . .

The OIG has put these words into action, too. In a corporate integrity agreement it signed with Pfizer in 2009, for example, the inspector general mandated that the CCO “shall report directly to the chief executive officer.” And Pfizer’s CIA — as well as those of healthcare giants such as Merck, Bristol-Myers-Squibb, Quest Diagnostics, Aventis, and Bayer — all specify that the CCO cannot be, or be subordinate to, the general counsel or the CFO. . . .

So what this boils down to is how much leniency will be offered, if the chief compliance officer (CCO) reports directly to the board or CEO. Lovely. How about an independent, post-hoc assessment (in order to get sentencing credit) driven by actual outcomes — actual results, and demonstrated independence? I mean, if we are discussing sentencing (i.e., clearly something is “very wrong”, inside the affected company) — why should that company have the benefit of any pre-ordained certainty about leniency? Just a thought. If the CCO has shown real independence, as determined by the US Attorneys on the case, then a credit is awarded (leniency granted). If not, then. . . not.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909