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Data Integrity & Ethical Capacity Building
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  • Great Compilation! I like the emphasis on ETHICS - that is the crux of the Data Integrity problem - also connected is the Indian penchant for 'Jugad' by which end justifies the means and 'standards' fly out of the window!
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  • 1. This presentation is compiled by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 2/20/2014 1
  • 2. Data Integrity & Ethical Capacity Building  Individual  Organizational  Industry  Regulatory & Regulatory System  Country 2/20/2014 2
  • 3. Man Jailed in pre-clinical dada scam 2/20/2014 3
  • 4. Man Jailed in pre-clinical dada scam  Steven Eaton was sentenced to three months in prison  First time (MHRA) has successfully used “ the Good Laboratory Practice Regulations 1999”  Aptuit identified serious irregularities in pre-clinical data  Informed MHRA  The irregularities involved changing or providing false analytical data 2/20/2014 4
  • 5. Ethical capacity of Individuals  Individual employees are responsible for own behaviour & are driven by  Own internal sets of values  Own principles  Own personal character  Own courage to live by these values and principles.  Individuals will do what they have to do to succeed.  Few have the courage to put themselves and their families at risk based on principles 2/20/2014 5
  • 6. Ethical capacity of Individuals Warning Letter to a Large Indian Company  “Your microbiologists reported the microbiological plates as “nil” while each plate contained one (1) colony forming unit (CFU)”. 2/20/2014 6
  • 7. Ethical capacity of Individuals – FDA form 483 issued to a medium sized Indian company  “Established laboratory controls are not followed and data is not recorded at the time of performance:  Sample and standard analytical weight print outs are not printed at the time of weighing.  Analytical balance clocks are set back in order to create falsified weight printouts that appear to be printed at the time of sample weighing.  Drug product test method validation data is falsified” 2/20/2014 7
  • 8. Ethical capacity of Individuals 2/20/2014 8
  • 9. Why Good Managers Make Bad Ethical Choices  A belief that the action is not really unethical or immoral (“everyone does it”);  A belief that the action is in the best interests of the company (growth, profits, maximising shareholder value, and possibly the worst assumption);  A belief that the action is unlikely to be detected and  A belief that because the action helps the company, the organisation will condone and even defend such action. 2/20/2014 9
  • 10. Ethical capacity of Individuals • A dangerous triad. – Performance pressure, – Temptation and – Opportunity 2/20/2014 10
  • 11. Ethical Capacity of Organizations  On Sept. 29, 1982, two people living in Chicago died of cyanide poisoning after consuming an OTC Paracetamol  Within a few hours of learning of first deaths, the company set up tollfree numbers  Company immediately recalled 91 000 units of the affected batch  In the next four days, five more people died of cyanide poisoning.  The CEO of the company and his team met the FBI and FDA  The CEO suggested that all 31 million bottles of the product on American store shelves be removed. 2/20/2014 11
  • 12. Ethical Capacity of Organizations  FBI and the FDA counselled the CEO against the recall  The company spent more than $100 million recalling 32 million bottles from store shelves  Before 1982, nobody ever recalled anything  The CEO placed himself before news cameras and apologized.  Replaced the packing with new tamper-proof packaging.  Another recall in 1986 led to changing the capsules to caplet to prevent deliberate poisoning. 2/20/2014 12
  • 13. Ethical Capacity of Organizations  The recall threatened to decimate companies leading share of the market  Instead, consumers applauded company's openness  Sales rebounded within a year.  Three decades later, the move is still regarded as a shining example of corporate social responsibility. 2/20/2014 13
  • 14. Ethical Capacity of Organizations 2/20/2014 14
  • 15. Ethical Capacity of Organizations  We  Conduct workshops to define values and processes  Display missions and goals on posters and in manuals  Conduct orientation sessions for new hires that describe what the company stands for  Print value statements on the backs of business cards as reminders to employee  Think the culture of our organization is what we want it to be. 2/20/2014 15
  • 16. Ethical Capacity of Organizations  However Company's culture is defined by what we do as mangers and bosses  Employees model their boss's behaviour because  They get paid by the boss,  Recognized by the boss, and,  Eventually, promoted by the boss.  That makes the top leader ultimately responsible for the culture of his organization—including the ethical culture. 2/20/2014 16
  • 17. Ethical Capacity of Organizations 2/20/2014 17
  • 18. Ethical Capacity of Organizations 2/20/2014 18
  • 19. Ethical Capacity of Organizations  The Same company acted so differently  It took 20 months form the Initial complaint to recall product  And that after severe hammering from the FDA.  The company also had a so called Phantom Recall – i.e. asked a third party to remove product from the stores by buying it back.  The leader was not James E. Burke but Bill Weldon 2/20/2014 19
  • 20. Ethical Capacity of Organizations  Employees must be able to see  Decisions being made within ethical boundaries.  Boss is willing to accept ethical behaviour as a constraint or a cost.  Employees recognized and promoted for ethical behaviour even at a short-term cost to the bottom line.  Employees who have behaved unethically are fired / held accountable  Company leadership’s ethical behaviour 2/20/2014 20
  • 21. Ethical Capacity of Organizations Warning Letter to a Large Indian Company  “This disproportionate detection of microbial contamination during FDA inspections questions the validity of the data generated by your microbiology laboratory”. 2/20/2014 21
  • 22. Ethical Capacity of Organizations “Warning Letter to a Medium size MNC in India  Samples, data and results outside of quality system  Your firm also repeatedly delayed, denied, limited or refused to provide information to the FDA investigators  HPLC units and PCs were removed from the facility for the duration of the inspection to conceal data manipulations  This raises serious concerns regarding the integrity and reliability of the data generated by your company 2/20/2014 22
  • 23. Ethical Capacity of Organizations Warning Letter to a Large Indian Company  Hire a data integrity consultant who should  Identify any historical period(s) during which inaccurate data occurred  Identify and interview your current employees who may have contributed to inaccurate data reporting.  Identify former employees whether they possess any relevant information regarding any inaccurate data reporting.  Determine whether additional facilities were involved  Determine the extent of top and middle management involvement 2/20/2014 23
  • 24. Ethical Capacity of Organizations • Global Competiveness Report 2013-14 • Ethical Behavior of Firms – Scale 1 to 7 Rank Country Score 1 New Zealand 6.6 12 UK 5.8 13 Canada 6.2 15 Germany 5.7 14 UK 6.0 32 USA 4.9 54 China 4.2 86 India 3.7 24
  • 25. Ethical Capacity Building The real threat to business is from within, from poor ethical standards and lack of integrity that can do incalculable harm. History has proven repeatedly that business ethics, shared value and corporate governance determine the longevity of an enterprise. Azim Premzi - Forbes India 25
  • 26. Ethical Capacity Building • Like anything else in business, what is required is ‘capacity building’ towards deeper ethical behaviour. • The capacity building begins not only at the top, but at the bottom also. • Employees must know, feel and be reassured about the fact that they work in an environment that is safe in every sense of the word. • They need to know that compliance is not a tick box activity. • They need to witness their organisations transcending compliance and infusing ethical practices into everyday action. • They need to be empowered to thwart unethical action in their work environments. • They need to appreciate the fact that business integrity standards are maintained and are directly related to the future success of the company. • They must realise that maintaining those standards insulates them, their families and their company from legal and social action. It securitizes their livelihoods. • Azim Premzi - Forbes India 26
  • 27. Ethical capacity of the Industry 27
  • 28. Ethical capacity of the Industry  EMA GMP-Non-Compliance Statements  What is really freighting is the number of NCR’s which cite data falsification in their report as critical issue  Out of the 34 Non Compliance reports for the Indian Companies 50 % cite Data Falsification as a Critical issue. 2/20/2014 28
  • 29. Ethical capacity of the Industry The current problems have basically to do with Data Fraud and Data Integrity by few companies and not so with US Rules. Data Integrity is a basic requirement of any regulatory system 29
  • 30. Ethical capacity of the Industry Unless a deeper, institutional change is ushered in to break the nexus between drug companies and the regulatory regime, Indians consuming drugs may be exposing themselves to serious risks 30
  • 31. Ethical capacity of the Industry Lapses by a few drug makes clouded the good manufacturing practices by others. 2/20/2014 31
  • 32. Ethical capacity of the Industry . Why the Indian Industry Associations could not see the problem in this way . The credibility of associations and the Industry would have got a tremendous boost. 2/20/2014 32
  • 33. Ethical Capacity of the Regulator & the Regulatory System 2/20/2014 33
  • 34. Ethical Capacity of the Regulator & the Regulatory System The Health Minister is expected to look after the consumers in this case the Indian Patients and not Indian Industry 2/20/2014 34
  • 35. Ethical Capacity of the Regulator & the Regulatory System 35
  • 36. Ethical Capacity of the Regulator & the Regulatory System We want to conduct surprise Inspections of MNC plants in India and in the West to achieve parity with US FDA process of inspections and not because it is essential to Protect Indians and assure them of Safe and Efficacious medicines. 36
  • 37. Ethical Capacity of the Regulator & the Regulatory System 2/20/2014 37
  • 38. Ethical Capacity of the Regulator & the Regulatory System The Health, Labor and Welfare Ministry is going to set up a committee to look into details of the cases where data was faked. The debate on the proposed law, called the Pharmaceutical Affairs Law, is thought to start this week. There are ethical rules set up in Japan, but there is not a strict law that regulates clinical studies, so the researchers in the case were not subjected to any punishment. Will the Indian Government ever Act in this way ? 2/20/2014 38
  • 39. Ethical Capacity of the Regulator & the Regulatory System Will India Ever have a Commissioner who will make the Patient as his focus 2/20/2014
  • 40. Ethical Capacity of the Regulator & the Regulatory System 2/20/2014 40
  • 41. Ethical Capacity of the Regulator & the Regulatory System The Regulator had certified the same plant as meeting the EU standards for API exports to EU under Falsified Medicines Regulations. These standards are similar to the US requirements which is as per ICH Q 7. If we are serious about continuing to be a global player, we need to put a much higher value on human life than we do at present. The earlier assumption that we could have two different sets of standards — one for the domestic market and the other for exports — is no longer tenable. 2/20/2014
  • 42. Ethical Capacity of the Regulator & the Regulatory System 2/20/2014
  • 43. Ethical Capacity of the Regulator & the Regulatory System At least now SEBI has taken up for companies to have a WHISLE BLOWER Mechanism in place. Though SEBI covers financial laws , we need to wait and see the details as this may force Listed Indian Companies to have similar policies for reporting Quality Fraud. 2/20/2014
  • 44. Ethical Capacity of the Regulator & the Regulatory System 2/20/2014 44
  • 45. Ethical Capacity of the Regulator & the Regulatory System Department of Justice in the US has fined several Multinational Companies to the tune of more than 20 billion US $ in the US for various lapses of the regulations. 2/20/2014 45
  • 46. Ethical Capacity of the Country 46
  • 47. Ethical Capacity of the Country 47
  • 48. Ethical Capacity of the Country • India raised concerns about action taken by US FDA against Ranbaxy & Wockhardt • Not even once the Government or investigated if something was wrong. • The Government , Health Minister & the DCGI say that US standards are different. • These companies were basically cited for Data Fraud and Data Falsification. • Data falsification and fabrication claims aren't something which can be ignored. • Falsified data can make a drug seem stable, bioequivalent, pure, potent, sterile, bio-available and safe whereas in reality it may not be stable, bio-equvalent, pure, potent, sterile, bio-available and safe. • On the other hand have look at following slide to see what action US DOJ has taken against MNC companies for violation of law. • We can never expect Indian Government to take such an Action. 48
  • 49. Ethical Capacity of a Country 2/20/2014 49
  • 50. Ethical Capacity of a Country 2/20/2014 50
  • 51. Ethical Capacity of a Country 2/20/2014 51
  • 52. Ethical Capacity of a Country 2/20/2014 52
  • 53. Ethical Capacity of a Country 2/20/2014 53
  • 54. Ethical Capacity of a Country 2/20/2014 54
  • 55. Ethical Capacity of a Country 2/20/2014 55
  • 56. Ethical Capacity Building Azim Premzi 2/20/2014 56
  • 57. Ethical Capacity Building Azim Premzi • An ethical organisation is one that is made up of people with unimpeachable integrity. • People with integrity think with greater clarity and take better decisions. • They act appropriately in the short term without compromising on the firm’s long term interests. • Such thinking is of great value in managing the unexpected and in adapting to change. • It prevents the organisation from falling prey to the Titanic syndrome as it is able to act far in advance of any iceberg sighting, minimizing any collateral damage in times of crisis. • The economic value of sound and prudent decision making such as this is immeasurable. 2/20/2014 57
  • 58. Thank you 2/20/2014 58