2 July 2015

Resolving the economic crisis in Athens may well require the combined endeavours of the ancient heroes. Public comprehension seems to be based on views of the loudest commentator.  As Shakespeare had Casca comment in Julius Caesar.  “…for mine own part, it was Greek to me. …There was more foolery yet, if I could remember it.”

What is intriguing is how the situation in Greece precipitated a downward spin in international markets on Tuesday – although there has been a strong bounce back since (except in Chinese markets). The cause seemed to be $3 billion default in IMF repayments.

Yet more comprehensible foolery is being reported in the United States where more than $3 billion is being sought by the Department of Justice as damages and fines from Novartis, the Swiss drug manufacturer found to have manipulated the market for two of its products, causing federal health care programmes – amongst others – to “over pay” for medicines. Investigations have been assisted by several whistleblowers previously employed by Novartis who provided information on kickbacks and inducements to promote sales of Myfortic used for kidney transplants and Exjade used in problematic blood transfusions.

Pharmaceutical companies are periodically being caught out acting quite differently from the ethics espoused by their industrial organisations – and this latest incident confirms a belief that in the United States compliance with the PHrMA  code seems to have limited penetration in the senior ranks of some large companies. In March, results of a survey of ethics and compliance specialists at the Pharmaceutical Compliance Conference in Washington indicated increasing recognition that values and ethics are crucial to compliance programmes. There appeared to be a growing acceptance that building a values and ethics-based culture rather than simply a ‘compliant’ organisation would inspire employees “…to work hard, think big, and do the right thing”; that ”…a profound and lasting outcome can be a work environment where compliance is just a natural outcome of living the company values.”

But drug companies are renown for spending big on influencing the medical profession. They have been found building bias into research they fund, tailoring research results they publish, and ghost writing papers for publication under the names of medical specialists. They have acquired pharmacy records to data mine the prescribing patterns of GPs, funded speaking tours for GPs to engage with colleagues, and deluged practitioners with gifts and free samples.

Many jurisdictions have regulated to minimise these practices. Whistle-blowers who will  give evidence in the Novartis prosecution later this year, will speak of the company paying for lavish trips and providing kickbacks to doctors to induce them to prescribe Novartis drugs. In the March 2015 ethics and compliance survey referred to above, when asked which processes have the least significant impact on creating ethical employees,

  • 34% said hospitality and entertainment rules are least impactful
  • 32% said adverse health effect reporting rules
  • 21% said improper inducement laws and
  • 13% said off-label use guidelines

These results confirm well known integrity principles that recognise that self interest is moderated best by energetic values-leadership underpinned by explicit disclosure and transparency processes.

http://blogs.wsj.com/pharmalot/2015/06/30/how-much-feds-wants-novartis-to-pay-3-35b-for-kickback-schemes/

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