Matt Whalen & Linda Strause GCT 2012


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Matt Whalen & Linda Strause GCT 2012

  1. 1. The Global Relationship:Corporate Social Responsibility (CSR), Applied Research Ethics, & the Clinical Research EnterpriseLinda Strause, Ph.D Matthew Whalen, Ph.DVical Incorporated IMPACT LLC Global Clinical Trials Philadelphia, PA, USA September 15-16, 2011
  2. 2. The ‘Grand Bargain’ / Social Contract “What we are witnessing is the unraveling of a ‘grand bargain’ between the pharmaceutical industry and society … a complex, implicit social contract. … As the twenty-first century begins… this grand bargain is in tatters and public mistrust and resentment of the industry run feverishly high. … The time has come to renegotiate [it].’” Dr. Greg Koski Ethics and the Pharmaceutical Industry (2005)
  3. 3. Public Mistrust
  4. 4. the ‘Triple’ bottom line“In practice, business sustainability consists ofmanaging the ‘triple bottom line’ … decision-makingthat takes into consideration financial, social, andenvironmental risks, obligations and opportunities.Sustainable businesses survive over the long termbecause they are intimately connected to healthyeconomic, social and environmental systems.” Bertels S, Papania L, Papania D. Embedding Sustainability in Organizational Culture: A Systematic Review of the Body of Knowledge. Network for Business Sustainability
  5. 5. So, being socially responsible is … “Growing jobs and clients/customers” by  Aligning “Private Profits” &“Public [Health] Interests”  Renegotiating the “grand bargain / social contract,” explicitly  Using a “triple bottom line” of Sustainability (economic, social, and environmental)
  6. 6. AGENDA Overview of Corporate Social Responsibility  Business Ethics in the 21st Century Applied Research Ethics  Protection of human subjects  Ethical decision-making: subjects facing life threatening illnesses Enterprise Sustainability, Governance  Clinical Research Sustainability, Feasibility of Studies  Accountability/Liability and Access/Transparency
  7. 7. Between the Research Enterprise & Society Economic Public Health Development FAIR SUSTAINABLE FEASIBLE VIABLE Innovation
  8. 8. Corporate Social Responsibility A brief Overview“According to our [global Pharma industry] experts, CSR is not a “nice to have” addition to company policies, but an integral part of today’s overall business strategy.” Robin Robinson, “CSR gets a Makeover,” PharmaVOICE (June, 2011), Page 14
  9. 9. CSR in the 21st CenturyCSR has evolved to focus on: s Business Ethics s Enterprise Sustainability s Corporate Governance ….on a global scale, given the international nature of business.
  10. 10. To ‘translate’ CSR to Clinical Research where Applied Research Ethics is Business Ethics where Enterprise Sustainability takes into account new research paradigms, public health-centric priorities, and the feasibility (including viability) of the studies themselves where Corporate Governance is synonymous with Accountability and Transparency
  11. 11. Reinforcement: The EU’s Single Market Act & CSRDue to be passed into law by the end of 2011, it iswidely expected to contain some form of mandatoryCSR requirement for medium and large sizecompanies; and, “the Commission will also adopt aCommunication on corporate social responsibility(CSR) -- a wider concept than social business -- whichencourages all businesses to pursue actions withsocial or environmental objectives as part of their dailyactivities.” COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Single Market Act Twelve levers to boost growth and strengthen confidence "Working together to create new growth” § 2.8 Social Entrepreneurship
  12. 12. Reinforcement: The U.N. Global Compact and CSRThe 10 principles of the Compact with internationalbusiness focus on:s Human Rights (i.e., abuses, collective bargaining, child labor, discrimination);s Environment (i.e., challenges, responsibilities, and ‘friendly’ technologies); and,s Transparency (anti-corruption in all its forms, including extortion and bribery).
  13. 13. Applied Research Ethics
  14. 14. Scientific Advances … ramifications“As science speeds ahead, it oftenpushes the edges of society’sreadiness to cope with itsconsequences… Increasingly, researchcreates possibilities before theaccompanying ethical, social, and legalramifications have been resolved.” Editor, “Science on the Ethical Frontier” series Washington (DC) Post, 1998 – 1999
  15. 15. Applied Research Ethics:8 Principles for International Trials 2. Social and Scientific Value 3. Scientific Validity 4. Fair Subject Selection 5. Favorable Risk-Benefit Ratio 6. Independent Review 7. Informed Consent 8. Respect for Enrolled Subjects 9. Community Perspective NIH’s Center for Bioethics
  16. 16. Applied Research Ethics: Social Value & Community Perspective “Social Value” relates to the public health priorities of a country and “varied disease burdens.”  some regulatory bodies deny studies with no long-term benefit to its citizens,  drug developers need to work with governments to identify how studies will aid both trial participants and, eventually, the wider population. “Community Perspective” is “sharing the benefits” not just the risks;  value of the research to the country  if the results include approval, will that therapy actually be available to patients in the country.
  17. 17. Applied Research Ethics: Scientific Validity & Fair Subject Selection Scientific Validity relates to  Design of the study, e.g., placebo use  Study Product in comparison/contrast to approved and available therapies  ‘Mechanisms of action’; Fair subject selection and the principle of “justice” relates to  Fairness in distribution and what is deserved  Distribution of benefit and risk: 1. to each person an equal share, 2. to each person according to individual need, 3. to each person according to individual effort, 4. to each person according to societal contribution, 5. to each person according to merit.
  18. 18. Applied Research Ethics: Risk/Benefit Ratio & Respect for Subjects Balancing the potential risk to the potential benefit:  Equipoise provides the ethical basis for clinical research involving patients assigned to different treatment arms.  Clinical equipoise means that there is genuine uncertainty over whether a treatment will be beneficial. While ensuring that the autonomy of the subject is protected:  Vulnerable populations  Real understanding of informed consent process, therapeutic misconception, and recruitment/selection
  19. 19. Applied Research Ethics:Independent Review & Informed Consent Nuremburg gave us the Institutional Review Boards:  Responsibilities (and roles) of the sponsor of the research, investigator conducting the research, and the ECs/IRBs overseeing protecting the rights and welfare of research participants Understanding that informed consent is more than a piece of paper, it is a process:  societal needs v. the individual  evaluable data v. therapy  therapeutic misconception (“white coat syndrome”)
  20. 20. Applied Research Ethics: Therapeutic misconception“…was present in 70% of respondents,who expected to receive better care andignored the consequence of randomisationand treatment comparisons. This waspositively associated with the acutenessand severity of the disease.” J Med Ethics, 2008 Sep;34(9):e16. “Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception.” Durand-Zaleski IS, et al
  21. 21. Applied Research Ethics: Coercion“… [A] patient suffering from a life-threatening disease may feel as thoughshe has little choice regardingtreatment. Physicians should be awareof how vulnerable patients may be tothe coercive influence of unrealistichope, especially those suffering fromchronic, life-threatening disorders.” Berg, Applebaum, Lidz, and Parker, Informed Consent: Legal Theory and Clinical Practice. 2001.
  22. 22. Applied Research Ethics: CoercionIn a study of terminally ill cancer patients whoenrolled in a Phase I study. Do you feel pressure to enroll in the study?  Over 80% report yes. How much pressure do you feel from?  Family 9%  Researchers 7%  Growing Cancer 75% IS THIS COERCION? 2011 The Hastings Center: Unrealistic Optimism in Early-Phase Oncology Trials, Jansen,
  23. 23. Applied Research Ethics: CoercionIn a study of terminally ill cancer patients whoenrolled in a Phase I study. Do you feel pressure to enroll in the study?  Over 80% report yes. How much pressure do you feel from?  Family 9%  Researchers 7%  Growing Cancer 75% since cancer This is NOT coercion is generating the pressure 2011 The Hastings Center: Unrealistic Optimism in Early-Phase Oncology Trials, Jansen,
  24. 24. Ethical Perspective Therapeutic misconceptionTwo Cousins, Two Paths Thomas McLaughlin, left, was given a promisingexperimental drug to treat his lethal skin cancer in a medical trial; Brandon Ryanhad to go without it. 10Sep13: Monica Almeida/The New York Times, Drug Trial Stirs Debate on Rules – Melanoma
  25. 25. Applied Research Ethics: a Balancing Act Patients seek new drugs for hope of personal benefitNew drugs need testing in clinical trials
  26. 26. Applied Research Ethics: a Balancing Act  What risk could be worse than the risk of death?  New drugs could have toxicities that involve or increase the risk of suffering and pain, and acceleration of death.“There are things worse than death – being made todie faster, being made to die more miserably, orhaving one’s dying prolonged … with no increase inquality of life.” Bioethicist Arthur Caplan, 2007
  27. 27. Applied Research Ethics: HOPE HOPE:  Understanding and innovation inspire HOPE  Does ‘therapeutic misconception’ abolish HOPE  “You can take away my misconceptions, but you can’t take away my HOPE”. -- Judy Olson, Research Participant Is HOPE a deterrent to clinical trial participation? -- Personal Story
  28. 28. Applied Research Ethics: Situational Ethics“Ethics is the study of reasons people give forthe behavioral choices they make. Ethics triesto get people to reflect on their behavior andhow they justify that behavior, not just choosingwhat to do but offering a rationale for whatyou’re going to do” (Dr. Baasten) The ethical decisions that we make are more often NOT between Good and Bad but between Good and Good.
  29. 29. Enterprise Sustainability(including Feasibility of Studies) & Governance
  30. 30. Enterprise Sustainability “Paradigm-breaking business …”“… transitions to sustainability may involve the need forparadigm-breaking business models or approaches.” Perhaps like …s New Regulatory Sciences Systems thinking/Holistic approach (e.g., MIT)s Alternative/Complimentary Medicine researchs “Virtual Physiologic Human” (e.g., Univ. of Nottingham +)s “Culture of Safety”s Collaborations in research (e.g., PhRMA and academic Research Centers)s Translational Science (e.g., NCATS -- government and industry)s “Point-of-Care” Clinical Trialss Adaptive Trial Design (especially Phases II, II/III)
  31. 31. Enterprise Sustainability Public Health-centric Prioritizing including competing for scarce resourcesIn addition to “varied disease burdens” and “sharedbenefits:”  “Participatory [or patient-centric] Medicine”  The research enterprise as critical to Economic Development in ‘developing’ countries  The research enterprise’s continuing central role in Economic Development in ‘developed’ countries
  32. 32. Sustainability and the Feasibility of Studies Standards, Experience, Priorities as CSRs Record of abiding by International Standards, including any history of ethical abuses and established track-record of robustness of review (regulatory/ethics) processess Determining what exists as a Standard of Cares Correlation of protocol with overall as well as disease state-specific research experiences Prioritized Populations based on country- specific health authorities and objectivess Adequacy of safety profiles including any comparators and rescue medications
  33. 33. Sustainability and the Feasibility of Studies What Sponsors look for in CROs and being socially responsible5. therapeutic expertise6. cost feasibility/viability7. a global footprint8. clinical research associates quality; and,9. upfront contingency planning … that is, “having backup plans to manage changing circumstances as a clinical trial progresses.” Source: CRO Quality Benchmarking Report (released by Industry Standard Research, a Cary, North Carolina CRO research firm in June 2011) is ISR’s annual survey of pharmaceutical company executives and professionals from around the world.
  34. 34. Sustainability and the Feasibility of Studies A Caution“Today, wherever you stand in the world, the largerpart of the data from clinical trials comes fromsomewhere else, so you have to have confidence inthe framework in which those trials were done.… [T]here is no evidence that clinical trials conductedin developing economies are any worse than thosedone in the West. However, lack of evidence is not thesame as positive proof.”Fergus Sweeney, head of compliance and inspections at the London-based EMA, Europes equivalent of the FDA as quoted in “Special report: Big Pharma’s global guinea pigs” (Reuters, May 6, 2011) --
  35. 35. GovernanceAccountability, liability of individualse.g.: “GSK Acquittal Casts Doubt On Government Cases That TargetIndividuals” vs “FDA Increasingly Holding Executives PersonallyResponsible For Violations” Media headlines on verdicts, May, 2011Access & Transparency re: Trade Secrets/IP“Drugmakers often succeed in convincing judges to issue protective ordersso that certain info - sometimes labeled as trade secrets - remains sealed.And attorneys for plaintiffs generally agree in order to advance the cases.” “A Senate Bill To Unseal Secret Pharma Documents,” Ed Silverman, May 19th, 2011,… “’While it may hurt their business, the fact that the same information maybe hurting patients using their drug or devices should take priority overtheir trade secrets.’ ”David Egilman, an expert witness in litigation filed against drugmakers and a clinical associate professor in the department of family medicine at Brown University.
  36. 36. Governance (continued)Access & Transparency re: Rumors“[Matrixx] argues [before the US Supreme Court] that rumors should nothave to be disclosed, but the government’s legal team countered that if therumors will influence stock prices, investors should be informed.” FDLI SmartBrief (1/12/11) summarizing a New York Times (1/10/11) articleAccess & Transparency and Physician Decision-making“[R]esearchers say that despite the existence of hundreds of thousands ofclinical trials [,] doctors are unable to choose the best treatments for theirpatients because results are reported selectively. This distorts the picture ofhow well a drug works by leaving many negative trial results …unpublished…. [They] are now calling on other drug regulatory agencies tofollow [EMA’s] suit … [making access to] documents … quicker and easierfor scientific scrutiny.” From summary of a British Medical Journal article (Peter Gøtzsche and Anders Jørgensen, Denmark)
  37. 37. Conclusion The “paradigm-breaking” R&D worldof personalized medicine, translational science, etc. combined with Economic development priorities: of developing as well as developed countries Coincide for CSR to be a foundation for the transformation of the clinical research enterprise.
  38. 38. Between the Research Enterprise & Society Economic Public Health Development FAIR SUSTAINABLE FEASIBLE VIABLE Innovation
  39. 39. Thank youLinda Strause, Ph.D Matthew Whalen, Ph.D IMPACT LLC Vical Incorporated Gambrills, MD San Diego, CA
  40. 40. Q&A
  41. 41. References Foundations of Applied Research Ethics Nuremburg Code Declaration of Helsinki ICH (International Conference on Harmonisation) CIOMS (Council of International Organizations of Medical Sciences) EU Directive Belmont Principles  Autonomy - Respect for persons  Beneficence - do no harm  Justice – equally for all
  42. 42. References Robinson, R. (2011). “CSR gets a Makeover.”PharmaVOICE. June 2011. Schumpeter (2010). “Companies aren’t charities: In poor countries the problem is not that businesses are unethical but that there are too few of them.” The Economist. October 21. Schumpeter (2010). “Corporate constitutions: The world knows less about what makes for good corporate governance than it likes to think.” The Economist. October 28.
  43. 43. References (continued)Karnani A. (2010). “The Case Against Corporate SocialResponsibility.” Wall Street Journal. August 23.Whalen M, Goebel P. (2010). “From Silos to Bridges inClinical Research.” The Monitor. 24(3): 36-40.Bertels S, Papania L, Papania D. (2010). “EmbeddingSustainability in Organizational Culture: A SystematicReview of the Body of Knowledge.” Network for BusinessSustainability.
  44. 44. References (continued) “Abbott Laboratories 2010 Global Citizenship Report” “Pfizer 2009 Corporate Responsibility Report” Edwards, B., Olsen, A., Whalen, M., Gold, M. (2007) “Guiding Principles of Safety as a basis for Developing a Pharmaceutical Safety Culture.” Current Drug Safety. 2: 135-139.
  45. 45. References (continued) Santoro MA and Gorrie TM, eds. (2005) Ethics and the Pharmaceutical Industry. Cambridge: Cambridge University Press, including: Koski G. “Renegotiating the Grand Bargain: Balancing Price, Profits, People, and Principles” Murray, Alasdair, Corporate Social Responsibility in the EU, Centre for European Reform (CER), 2003 Emanuel EJ, Wendler D., Grady C., “What Makes Clinical Research Ethical ?” Journal of the American Medical Association (2000)