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Current controversies in clinical ethics

Current controversies in clinical ethics. Bernard Lo, M.D. April 21, 2009. Overview of talk. Organ transplantation Conscientious objections to providing care Conflicts of interest. Ethical controversies regarding organ transplantation. Need >> Supply. Questions about organ transplantation.

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Current controversies in clinical ethics

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  1. Current controversies in clinical ethics Bernard Lo, M.D. April 21, 2009

  2. Overview of talk • Organ transplantation • Conscientious objections to providing care • Conflicts of interest

  3. Ethical controversies regarding organ transplantation • Need >> Supply

  4. Questions about organ transplantation Are there ethical problems with: • Advertising for donors? • Donation after cardiac death? • Payment for organs?

  5. Ethical concerns about fairness • Portrays candidate as exception to allocation criteria • May have poor survival after transplant • Other candidates have moving stories • Favors wealthy and well-educated

  6. Donation after cardiac death (DCD) • Life support withdrawn in OR • Death declared • Organs promptly retrieved • More potential donors than after brain death

  7. Original ArticlePediatric Heart Transplantation after Declaration of Cardiocirculatory Death Mark M. Boucek, M.D., Christine Mashburn, B.S.N., Susan M. Dunn, M.B.A., Rebecca Frizell, B.S.N., Leah Edwards, Ph.D., Biagio Pietra, M.D., David Campbell, M.D., for the Denver Children's Pediatric Heart Transplant Team N Engl J Med Volume 359(7):709-714 August 14, 2008

  8. Time between asystole and declaration of death • First 2 donors 3 minutes • 3rd donor 75 seconds

  9. Is asystole in donor irreversible? • Autoresuscitation not reported after more than 65 seconds • SCCM: wait 2 minutes after asystole before declare death, preferably 5 • IOM: wait 5 minutes after asystole before declare death

  10. Ethical concerns • Was declaration of death manipulated to allow organ transplantation? • May not compromise care of donor or cause death by remove organ • May not end one life to benefit another

  11. Payment to donors • Compensation for expenses • Neither loss nor gain • Travel, costs of donation

  12. Payment to donors • Insure against future losses • Future disability • Future medical expenses • Give as insurance rather than cash

  13. Payment to donors • Cash payments for organs • Exploitation of poor • Commodify human body • Undermine altruistic donation

  14. Predictions • Tighter rules on advertising, DCD • More compensation and insurance

  15. Conscientious objection

  16. May MD refuse to provide medical care because of conscientious objection? • Yes • It depends • No • Not sure

  17. Benitez v. North Coast Women’s Medical Care Group • Ms. B denied IVF in 1999 • Exclusive contract with insurance plan • After 11 months of treatment, refused donor insemination because she is lesbian • Told other MDs would do insemination

  18. California Civil Rights Act • “No discrimination because of sex, race, color, religion, ancestry, national origin, disability, medical condition” • Protected categories • Courts include sexual orientation

  19. CA Supreme Court (8/08) • Refusal violates Civil Rights Act • MDs free to voice objections • Does not substantially burden religious belief or practice

  20. Federal regulations (Dec 2008) • Recipients of federal funding may not • Require HCWs to perform or participate in • Abortion • Health service contrary to religious beliefs or moral objections • Counseling or referral • Discriminate for refusing to perform

  21. Federal regulations (Dec 2008) • No provision to communicate refusal to patients or institution

  22. Dilemmas because countervailing ethical guidelines • Respect conscientious objection • Not require people to violate their core moral belief or integrity • Respect even if disagree with belief • Often closes off discussion

  23. Dilemmas because countervailing ethical guidelines • Provide care to patients • No discrimination • Difficult for patient to change providers • Continuity of care

  24. Dilemmas because countervailing ethical guidelines • Balance conflicting obligations • Inform institution and patient in advance • Before relationship established • Obligation may fall on institution to find willing provider to provide care

  25. Conflicts of interestQuestions for audience Investment advisor gets payment from a stock fund in addition to commission from clients and does not tell them. Is this ethically appropriate? • Yes • No • Not sure

  26. What is a conflict of interest? • Primary interest in well-being of clients, patients or integrity of research • Secondary interest in personal gain ($, professional advancement) • Special relationships of trust, dependency

  27. Conflicts of interestQuestions for audience • Changed practice based on article sponsored by drug manufacturer? • Had meal from drug manufacturer? • Given patients drug samples? • Received payment from drug company?

  28. Biederman case • Research supporting diagnosis of bipolar disorder in children and treatment with antipsychotics

  29. Biederman case • Ties to manufacturers of psychiatric drugs • Research grants and consulting • Director of J & J Center for Pediatric Psychopathology Research • “Move forward the commercial goals of J & J”

  30. Biederman case • Did not report $1.4 million in income from drug companies, as required by • Universities • NIH

  31. The New York Times Expert or shill?

  32. Concerns about COIs • Disagreements and errors inevitable • Due to reasonable differences of opinion, lapses, or financial gain? • Disclosure not remove risk of bias

  33. Concerns about industry-sponsored clinical trials • Academic investigators lack • Access to data • Independent statistical analysis • First draft by medical writers

  34. Concerns about industry-sponsored clinical trials • Favorable conclusions • Not report negative findings

  35. Not report negative findings • SSRIs in children • Aprotinin • Ezetimibe plus statin

  36. Biased reporting has impact on • Clinical practice • Practice guidelines

  37. Mission of drug companies • “Drug companies have to continue to be successful businesses… But their primary mission is products that save lives and improve lives.” • “This is an area that’s different from ice cream, bubble gum, and automobiles.”

  38. New FDA regulations • Disclose results at clinicaltrials.gov • Loopholes

  39. Drug samples • Provide access and cost savings to patients • Patients who lack drug coverage • Trial of new drug • Companies spent $20 billion for detailing, $16 billion for samples

  40. Evidence regarding drug samples • Poor and uninsured slightly less likely to receive samples • MDs tend to use samples rather than their usually preferred drug • MDs whose Rx did not follow practice guidelines more likely to provide samples

  41. New developments • Bans on gifts • PhRMA, • Ban meals • Partners, Hopkins • Ban payment for attending a presentation

  42. New developments • Bans on speakers bureaus • Hopkins, Partners, UCSF • Bans on drug samples • Hopkins, Iowa, Florida State • Only to central pharmacy

  43. New developments • Public disclosure of payments by companies to MDs • Required by some legal settlements • Some state laws (MN, VT, MA) • Voluntary by some companies • Recommended by MedPAC

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