Negotiating Ethical Challenges in Medical Settings: Juggling Porcupines:

1. Negotiating Ethical Challenges in Medical Settings:Juggling Porcupines: Gerald P. Koocher, Ph.D., ABPP Simmons College www.ethicsresearch.com

2. Special challenges for ethical practice in health care settings: • How do health care delivery and research trigger particularly complex ethical challenges? • Consider some illustrative examples. • Promote a culture that enhances ethical practice and reduces risk.

3. Ethical Fundamentals Beauchamp & Childress (2001) Principles of Biomedical Ethics 5th Edition • Autonomy (give people choices) • Beneficence (do good) • Nonmaleficence (don’t do bad) • Justice (behave fairly) • Fidelity and Responsibility (demonstrate trustworthiness) • Integrity (show honesty and truthfulness) • Respect the Rights and Dignity of Others

4. More Ethical Fundamentals Koocher & Keith-Spiegel (2008) Ethics in Psychology and the Mental Health Professions 3rd Ed. • Fidelity – loyalty, dependability • Pursue excellence • Accept accountability

5. Key ethical challenges in medical settings • Special duties owed to vulnerable others • Sicker patients and more complex treatments • Opportunities for boundary and role confusion • Conflicts of interest and temptations • Institutional culture and peer response • Hierarchy and tone setting • Someone has to coordinate care for optimal results • Tolerance for error • Learning from the “near-miss” and disclosures with apology • Attitudes toward scientific dishonesty • Colleagues as the best defense

6. Creating a culture that encourages reporting of human error • Near-miss recognition and reporting systems (near-miss, zero cost) • Creating a safe climate for sharing concerns in a professional manner and context (engaged colleagues)

7. The Near-Miss • An unplanned event that did not result in injury, illness, or damage - but had the potential to. • Only a fortunate break in the chain of events prevented an injury, fatality or damage. • Human error commonly serves as an initiating event, but a faulty process or system invariably permits or compounds the harm. • Focus on improvement that reduce the chance of error or system failure.

8. Two Cases

9. Anorexia vs Confirmatory Bias • Teri Slim had a petite and slender build, but seemed unusually thin to her father when she donned a bathing suit just prior to her 14th birthday. Her mother, a psychiatric nurse agreed. They took Terri for evaluation at a large medical center near her home and the staff there, unprepared to treat anorectic adolescents, referred her on to a specialized pediatric hospital 150miles away. The psychiatric admission evaluation at the second hospital confirmed the diagnosis of anorexia, and admitted Teri to their inpatient child psychiatry unit for treatment.

10. The hospital staff easily identified family stressors that might account for Teri's emotional problems. Her parents had recently divorced, her father had lost his job as business executive, and her mother (the nurse) who lived in another state, allegedly had a serious addiction problem. At the end of 2 months of treatment, Teri remained malnourished and had made “no progress” in treatment despite the administration of supplements using a nasogastric tube. She occasionally vomited up the Ensure resulting in behavioral restrictions for “acting out.”

11. The staff contemplated initiating intravenous feeding in the face of her progressive weight loss and prepared to transfer Teri to a medical for placement of a venous feeding line. Only then did a senior pediatrician sent to to the psychiatry unit to screen her for transfer ask, “Has anyone evaluated her for Crohn's disease?” Several weeks later, Teri went home from the hospital minus a segment of inflamed intestine and taking anti‑inflammatory medication. She continued to do well in response to the treatment for Crohn's disease.

12. You will give me a number! • Bertram Botch, M.D., served as the chief of neurology at a pediatric rehab hospital and often chaired interdisciplinary case conferences. Reporting on her assessment of a low‑functioning mentally retarded child, Melissa Meek, Ph.D., presented her detailed findings in descriptive terms. Dr. Botch listened to her presentation and asked for the child's IQ. When Dr. Meek replied that the instruments used were developmental indices that did not gave functional ranges but did not yield IQ scores, Dr. Botch demanded that she compute a specific IQ score to use in his preferred report format.

13. Multiple Role Conflicts and the Wonders of Psycho-Pharmacology

14. Anything but Child’s Play…Miller, G. (2010) Science, 327, 192-193 • In the mid-1990s Joseph Biederman and Janet Wozniak proposed the notion that many children with conduct disorder or ADHD diagnoses might have “juvenile bipolar disorder,” and proposed treating them with medications developed for adults with significant mood disorders • Diagnoses jumped by a factor of 40 between 1993-2004 • Is this valid diagnosis or one driven by “Big Pharma?”

15. Joseph Biederman, M.D.http://www.cchrint.org/cchr-issues/the-corrupt-alliance-of-the-psychiatric-pharmaceutical-industry/ • While Chief of Pediatric Psychopharmacology at Massachusetts General Hospital, he received research funds from 15 pharmaceutical companies. The New York Times reported that he earned $1.6 million in consulting fees from drug makers between 2000 and 2007, but did not report all of this income to Harvard University officials. • His marketing of the theory that children have “bipolar” has contributed to the increase in antipsychotic drug sales for pediatric use in the United States—today estimated at 2.5 million children.

16. In March 2009, in newly released court documents, he reportedly promised drug maker Johnson & Johnson in advance that his studies on the antipsychotic drug Risperidone would prove the drug effective when used on preschool age children. • In an e-mailed statement, Dr. Biederman told the Times, “My interests are solely in the advancement of medical treatment through rigorous and objective study,” and he said he took conflict-of-interest policies “very seriously.” http://www.nytimes.com/2008/06/08/us/08conflict.html

17. Charles Nemeroff, M.D.http://www.cchrint.org/cchr-issues/the-corrupt-alliance-of-the-psychiatric-pharmaceutical-industry/ • While Chairman of Psychiatry and Behavioral Sciences at Emory he received $960,000 from GlaxoSmithKline, (GSK) between 2000-2006, but disclosed only$35,000 to Emory. Between 2000 and 2007, he earned more than $2.8 million from various drug makers but failed to report at least $1.2 million. He signed a letter in 2004 promising Emory that he would earn less than $10,000 a year from GSK but on the same day lectured for GSK at a hotel earning $3,000 of what would become $170,000 from the company.

18. In 2006, he stepped down as editor of Neuropsychopharmacology after publishing a favorable review of the vagus nerve stimulation device, manufactured by Cyberonics, for which he was a paid consultant.  • In 2003, he coauthored a favorable review of three therapies in Nature Neuroscience failing to mention his significant financial interests in these, including owning the patent for one of the treatments—a lithium patch.  • He resigned his position at Emory in 2008 and was barred by NIH from receiving federal research funds for two years.

19. Commercial Hazards • Pharmaceutical Sponsorship: Controlled Seduction? • Research • Lectures • Meetings • Junkets • Trinkets

20. Bad Science and Colleagues as the Best Defense Don’t doze off! This applies to clinicians too.

21. Proximal Cause & Scientific Dishonesty • Researchers are most likely to intentionally engage in dishonest acts if : • their commitment to discovering the truth (patient care, or other core values) is not firm or becomes compromised through rationalization, • if the potential for reward exists, and • if they regard the chances of detection as low.

22. For example, an investigator may feel convinced that falsifying data is acceptable because • the actual results would turn out as expected anyway, • taking a shortcut seems necessary to meet an important deadline, and • the chance of uncovering forged data seems nil. • Here some form of situational constraint stands as the primary barrier to intentionally committing a dishonest act. Colleagues in a position to observe or learn about the misbehavior constitute the principal source of such constraint. These same colleagues also provide the most readily available resource for preventing and correcting unintentional errors.

23. What is “Bad Science” Anyway • The big three are FF&P • Fabrication, Falsification, and Plagiarism • Fabrication is usually in the form of “dry lab” data that are simply invented. • Falsification can take several forms. • Actual data can be “smoothed,” or “cooked” to approach more closely the desired or expected outcome. • Collected data points can be dropped (“trimmed”) to delete unwanted information.

24. The Bozo Factor • Sometimes ineptitude or incompetence can result in inappropriate design, poor or biased sampling procedures, misused or wrongly applied statistical tests, inadequate record-keeping, and just plain carelessness. Even though there may be no intent to deceive, inaccurate information can also seriously damage the research record.

25. One might assume (or hope) that such inaccuracies, purposeful or not, will be discovered. But don’t cannot count on it. Whereas errors in alleged scientific advances are assumed to be eventually self‑correcting through replication, funding sources typically do not support replication research, and most scholarly journals do not normally publish replication studies. Thus, there is little incentive for researchers to repeat projects, especially expensive and complex ones.

26. Difficulties in Detection • Most highly publicized data scandals have occurred in biomedical research laboratories. No one knows for sure whether the incidence is higher in biomedical science than in the social and behavioral sciences, or whether it is simply easier to detect fraud in biomedicine.

27. Most social and behavioral research does not involve chemical analyses, tissue cultures, changes in physical symptoms, invasive procedures, or similar “hard” documentation. Social science data often take the form of numerical scores from questionnaires, psychological assessments, performance measures or qualitative data based on interviews or behavioral observations. • The actual research participants have long since gone, taking their identities with them. Such data are relatively easy to generate, fudge, or trim.

28. Rogues’ Gallery • South Korean scientist, Woo Suk Hwang gained notoriety when he falsely claimed to have successfully cloned close to a dozen human embryos. All of Hwang’s previous accomplishments, including Snuppy the allegedly-cloned Afghan hound), are now viewed with skepticism.

29. Rogues’ Gallery • Dr. Eric Poehlman (University of Vermont) became the first academic scientist in the United States to serve prison time for misconduct (not involving fatalities) and a lifetime ban on federal research funding. Poehlman published articles containing bogus data and submitted falsified grant applications that brought in almost 3 million dollars in federal grant money since the early 1990s.

30. Rogues’ Gallery • Paul Kornak was found guilty of criminally negligent homicide for falsely representing results of blood chemical analyses in a chemotherapy study. One participant who should have been excluded from the study died as a result. • Kornakreceived a 71 month federal prison sentence and had to pay over $600,000 restitution to two drug companies and the VA. He is also barred for life from federal research funding.

31. Colleagues as a Defense Against Bad Science NIH Grant No. R01 NS049573 [NINDS/ORI] Gerald P. Koocher, Principal Investigator Patricia Keith-Spiegel and Joan Sieber, Co-Investigators

32. NIH focuses on FF&P, but there’s more… • We surveyed more than 5,000 names in the NIH CRISP data base • 2,599 respondents reported 3,393 accounts of suspected wrongdoing and other errors related to the conduct of research. • Only 406 of those responding stated that they had no incidents to share.

35. What Risks Materialized and Who Got Hurt? • In 1,169 (42%) of the incidents, participants experienced no negative consequences as a result of their intervention. • Another 296 participants reported an elevation in status. • However, almost half of our interveners reported suffering to some degree, although a large portion recounted only emotional distress as opposed to any damage to their careers or social standing. • Some respondents reported serious consequences, such as feeling shunned, forced to leave a job, or losing previously close friends or allies. A few even feared law suits, although none ever materialized.

36. Despite personal risks, two out of three survey participants claimed to have taken it upon themselves to attempt to prevent or correct a wrong in progress, or to minimize damage that had already occurred. • Very few participants initially reported their concerns to another entity, opting to attempt to informally correct the problem or achieve damage control on their own or in partnership with other colleagues. • The most common reasons offered for acting included a commitment to research integrity, to avoid damaging the reputation of oneself or one’s lab or institution, or to prevent an associate from making a mistake. • Almost all respondents took direct action if the questionable act was perpetrated by their own post docs or assistants.

37. Who Takes Action, and Does It Work? • A binary logistic regression analysis profiled characteristics of researchers who intervene: Most likely to take action were those who • held a higher professional or employment status than the suspected wrongdoer • had less regular interaction or involvement with the suspected wrongdoer • based their suspicions on strong evidence (i.e., direct observation or direct disclosure the transgressor rather than second-hand accounts or hearsay) • perceived the transgression as unintentional, and • held a belief that individuals have a primary responsibility to become actively involved in maintaining scientific integrity. • The vast majority of those who felt victimized or who believed that they might suffer blame also proved likely to intervene individually or by reporting the matter, suggesting that acts involving direct threat to oneself will likely lead to taking some type of action. • The highest rates of intervention occurred for projects described as taking place in the context of high stress that compromised research quality.

38. Those Who Did Not Act • About a third of participants did not take action regarding any incident they shared with us. • The largest group revealed that they felt too remotely involved or knew that others were already taking action. • Another third claimed they simply did not know what to do. • Reluctance to deal with a suspected offender perceived of as difficult person or who was their superior were other common reasons for inaction, as was an unwillingness to act when evidence seemed insufficient.

39. Social relationships, job security, and status become more salient in close working conditions. So perhaps understandable, but also disappointing, was the finding that those who worked closely with suspected wrongdoers were less likely to take any action. Thus, the best opportunity to observe wrongs and stop or correct them appears to also be less likely to be utilized. • Finally, we asked if those who took no action on their suspicions experienced lingering reservations. Forty percent of those who did not get involved, even though they had direct evidence of wrongdoing, still felt misgivings, sometimes even after many years had since passed.

40. Culture shifting • Actively engaging colleagues with gentle alternatives to whistleblowing • Offering help • Expressing concern • The “Bullwinlke” approach • Encouraging reporting of near-miss situations • Apologizing when appropriate

41. Understanding how patients view the care they receive • Attending to and communicating about errors • The power of apology

42. Creating a culture that encourages reporting of human error • Near-miss recognition and reporting systems • Creating a safe climate for sharing concerns in a professional manner and context