Blowing the Whistle on a Therapeutic Experiment

Description

This case discuss an actual incident of whistleblowing at a private psychiatric facility involving informed consent and human research subjects.

Body

Part 1

Part 2

Part 3

Part 4

Part 5

Part 6

Outcome

This case is based on a real incident of whistleblowing that occurred in the late 1970s and early '80s. For more details on the specific case, readers should refer to the reference list located at the end of the participant commentary. At various phases of the case, readers are prompted to reflect upon what action they would take or recommend and provide a rationale for their response based on the ethical issues at stake at the time.

Part 1

Jan, an experienced nurse with a master's degree in psychiatric nursing, accepted a head nurse position in a private psychiatric facility. She was responsible for a unit where several experimental programs were in progress. One program was designed to test the potential benefits of orthomolecular therapy in psychiatric patients. The basic premise of the therapy was that psychiatric illness was due to cerebral allergies.

Within months, Jan began to suspect that the orthomolecular program abused patients. First, she found no informed consent documents for this experimental therapy in the patients' records. Psychiatric patients were admitted to the unit, taken off all medication, including psychotropic medications, and given bottled water for four to seven days, along with megadoses of vitamins, which they frequently vomited. After this fasting period, foods were introduced one by one to determine whether the patient was allergic to the particular food. Patients were confined to the unit to ensure adherence to the protocol.

Jan recalls that patients were emaciated, and they walked around like zombies, searching for food in garbage cans. More disturbed patients ate anything they could get their hands on, such as tissue and tampons. Several patients who were physically restrained chewed through their mattresses to eat the stuffing.

1. What action should Jan take?

A. Discuss her concerns with her immediate supervisor, the director of nursing (DON).

B. Discuss her concerns with the orthomolecular physician.

C. Contact the Institutional Review Board (IRB) to determine whether the IRB has reviewed the experimental programs.

D. Document her observations and forward them to the DON.

E. Do nothing.

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Part 2

Jan voiced her concerns to the director of nursing (DON) and also to the medical team during weekly grand rounds. The orthomolecular physician claimed that he had a 90-100 percent cure rate. To bolster his claims, he published an article on the success rates of his therapy. Admissions to the unit were growing rapidly, mostly from families desperate for a cure. Jan knew that something was very wrong, but found it difficult to challenge a "noted authority."

Over the course of the next six months, Jan witnessed numerous incidents of physical and psychological abuse of patients. For instance, one patient in an agitated state grabbed the orthomolecular physician's jacket. The physician struck the patient and pushed her into a hospital room. When she tried to come out of the room he slammed the door on her hand and quickly left the unit. When Jan reported the incident to the DON, she was told not to write up the incident because it was "too serious." In another case, Jan observed a physician eating in front of a fasting patient. Begging for food, the patient became enraged. The physician ordered Jan to put the patient in restraints and start intravenous vitamins. Jan refused and reported the incident to the DON and the medical director. The medical director voided the order and said that the physician was out of line. Jan had been documenting such occurrences on incident reports and in written memos at weekly grand rounds, yet nothing seemed to change.

2. What action should Jan take?

A. Resign and report the situation to state or federal authorities.

B. Meet with the hospital administrator and discuss her concerns.

C. Contact the state nurses' association for advice.

D. Continue to document misconduct

E. Contact external agencies for assistance (e.g., Health and Human Services (HHS), Joint Commission for the Accreditation of Hospitals (JCAH), etc.).

F. Go to the media with her documentation.

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Part 3

Jan scheduled a meeting with the hospital administrator. He told her that because this particular physician brought a lot of money into the hospital, essentially, his hands were tied. She learned that the experimental programs had not been reviewed by the hospital's Institutional Review Board (IRB). The hospital owner and administrator told the IRB that it was not necessary to review the experimental protocol, and the IRB was unwilling to override this decision. The hospital had no medical misconduct committee, but it did have an Internal Review Committee. Jan sent them all her documentation and requested that they address her concerns. Moreover, Jan contacted the hospital attorney and gave him her documentation. Subsequently, the attorney drafted a list of concerns and recommendations, which was sent to the medical committee. Some changes occurred. A protocol for the therapy was written, and a consent form for treatment was developed. Despite these formal changes, unethical and illegal conduct continued. Families were pressured to sign consent forms to admit their ill family members into the orthomolecular program. The physician was very charismatic in his approach to families, promising them a cure, and most families complied with his recommendations.

When the public health department (PHD), HHS and JCAH came for their annual inspections, orthomolecular patients and their medical records were moved off the unit. Jan was instructed by the hospital administrator not to discuss the program with the agencies. Jan felt she had no choice but to follow the gag order. The inspectors interviewed Jan in the presence of the DON, medical director and hospital owner. Jan was not permitted to have any private conversations with inspectors.

3. What action should Jan take?

A. Resign and report the situation to state or federal authorities.

B. Remain in her position; notify each inspecting agency of her concerns, and provide them with her documentation.

C. Go to the media/press with her documentation.

D. Wait to see whether the inspecting agencies cite the hospital for any violations.

E. Continue to document unethical, illegal or incompetent behavior.

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Part 4

Jan gave serious thought to quitting her job; however, the hospital administrator told her that he planned to open another facility and he wanted Jan to be the administrator. She would be given full authority to set the standards for the new facility. In the meantime, the PHD, HHS and JCAH reports came back citing no violations of mental health standards of care in the hospital. Serious violations of patients' rights continued to escalate on Jan's unit, and one prompted Jan to think seriously about blowing the whistle. A 36-year-old man who had been in the orthomolecular program for a week told the physician he wanted to discontinue this form of therapy. The physician threatened to have him committed if he refused to continue orthomolecular therapy. The physician called in the family and asked them to "create reasons" why the patient was not competent to make an informed decision about his medical treatment. Jan had developed a therapeutic relationship with the patient and knew he was competent. However, she was unsuccessful in advocating the patient's request with the physician. She put the patient in a conference room with a phone, although the physician had cut off his phone privileges. The patient contacted the state Guardianship and Advocacy (G'&'AC) Commission. An attorney from the commission came to the hospital the following day and talked to the patient and Jan. Privately, the lawyer advised Jan to contact the Human Rights Authority (HRA) about the unethical and illegal violations occurring on her unit. Jan was a divorced, single parent caring for four children. She feared reprisal.

4. What action should Jan take?

A. Remain in her position and inform external authorities about the abuses.

B. Secure another job, resign and then report the misconduct to state and federal authorities.

C. Contact the state/national nurses' associations for advice.

D. Remain in her position until she is promoted.

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Part 5

Jan obtained a copy of the state agency's enabling statute and asked the G&A attorney if her story would be kept confidential. Jan was assured of complete anonymity and confidentiality. She contacted the HRA. The following day, agency representatives came to her house and for four hours taped her report of misconduct in the hospital.

Shortly thereafter, the DON called Jan into her office. The hospital administrator was present, and he informed Jan that she was "too intelligent for them." The HRA had disclosed to the hospital that she had reported unethical and illegal practices on her unit. The administrator offered Jan an entry-level position on another unit. Jan refused. He asked her if she would quit, and she said no. Jan decided to take a sick leave to buy some time. She got a doctor to legitimize a sick leave. Then Jan contacted her state nurses association. They attempted mediation with the hospital but were unsuccessful. They advised Jan to obtain written documentation of her employment status; if the administration refused to provide documentation, they told her to report to work. Jan went to the hospital and met with the DON and hospital administrator. When she asked what her employment status was, the administrator told Jan that she was trespassing on private property and should leave immediately.

Still lacking verification of her employment status, she told the DON and administrator that she would be reporting to work in the morning. She was told the police would be waiting for her the next day, and she would be arrested for trespassing.

5. What action should Jan take?

A. Report to work the following morning.

B. Resign and report the situation to state and federal authorities.

C. Go to the media/press and disclose her story and documentation.

D. Hire an attorney.

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Part 6

Jan was not permitted to return to work. She contacted the PHD for assistance and gave them all her documentation (i.e., all her memos and incident reports). No action was taken. Without a job or source of income, Jan sought other employment. She applied to numerous agencies without success. She discovered that the hospital was answering job-reference inquiries by describing her as a "psychotic" who was "professionally incompetent." Moreover, sympathetic agencies told her that they admired what she had done, but they did not want her working in their institutions. When Jan tried to apply for unemployment compensation, it was denied. The hospital said she had not been fired, but failed to report to work. Six months after blowing the whistle, Jan was awarded unemployment compensation.

Numerous employees from the hospital called Jan and came by her home to tell their stories of similar patient abuses. Jan and other employees of the hospital met with the HHS. Subsequently, the HHS conducted a surprise investigation of the psychiatric facility. Shortly thereafter, the orthomolecular program was shut down, and the hospital's licensure was temporarily suspended.

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Outcome

It was too late for the 36-year-old patient Jan had assisted to make an outside call. The lawyer from the G and A Commission did represent the patient in court arguing that the patient's right to informed consent had been violated. Nevertheless, the judge sent the patient back to the hospital and set another hearing date. The orthomolecular physician placed the patient on 15-minute checks around the clock; that is, he was awakened throughout the night every 15 minutes. By the time the court date arrived, the patient was truly psychotic. The judge ruled that the patient should remain at the facility and continue therapy

Jan decided to sue the hospital for reinstatement. Without the finances to hire an attorney, Jan represented herself. The judge ordered reinstatement, compensatory damages and punitive damages. The hospital appealed. Jan was told an appeal would be too complicated for her to handle. She borrowed money and hired an attorney. Two years later, the appeals court upheld the decision and in fact increased the amount of damages. The hospital took the case to the supreme court, which refused to hear the case, stating it had been "fully litigated." When the case was sent to the trial judge, the judge precluded Jan from getting an execution of the judgment. She was not notified of the court hearing date. When she did not show up for court, the case was thrown out. Jan contacted the Federal Bureau of Investigation and described the handling of her case in the court system. They assured her they would take care of the matter, since it appeared there was clearly judicial misconduct. Nothing was done. To this day, Jan has not received a penny of compensatory or punitive damages.

General Discussion Questions:

  1. If you were presented with this situation today, what would you do?
  2. What formal and informal institutional mechanisms are necessary to protect a health professional who is considering blowing the whistle on unethical or illegal behavior?
  3. What changes are needed in state and federal legislation and/or enforcement practices to protect whistleblowers from retribution?
  4. What curriculum changes are needed to prepare health care researchers and practitioners to effectively address unethical practices?
  5. Historically, professional associations have set the standards for entry into professional practice and standards of practice. However, in this case the professional association had little impact on ensuring quality of care and enforcing practice standards. What measures, if any, could be taken to give professional associations the clout to enforce ethical and legal standards of care?
Notes

Brian Schrag, ed., Research Ethics: Cases and Commentaries, Volume 1, Bloomington, Indiana: Association for Practical and Professional Ethics, 1997.

Citation
. . Blowing the Whistle on a Therapeutic Experiment. Online Ethics Center. DOI:. https://onlineethics.org/cases/graduate-research-ethics-cases-and-commentaries-volume-1-1997/blowing-whistle-therapeutic.

Roger Boisjoly, who is well known as the whistleblower on the Challenger disaster, often mentions Albert Hirschman's book, Exit, Voice, and Loyalty. He looks back on his own experience from the perspective of those choices. In light of the way Jan's case history is written, it may be useful to frame the analysis in terms of those broad options. At choice points in the story, the leading question would be, "Given her perceptions of her situation in the research facility, should Jan leave, should she exercise voice, or should she remain?" If the answer is "Remain," then the further question is, "Whom should she consult about her concerns?"

Some revision in the telling of the story is still needed to create some distance between the author of the case study and Jan. These are Jan's perceptions of the situation as it evolved; they cannot be the author's. So, for example, the last sentence of the first paragraph of "Situation" might read, "As she understood it, the basic premise of the therapy was that psychiatric illness. . . ."

The first choice point should come when Jan begins to suspect that patients are being mistreated. The first question might then be, "What options does Jan have for dealing with her concerns about the treatment of patients?" The list of options should include as A. Discuss her perceptions with other nurses and the nurses association, and as F. Quit her job. A. would be a good response if she does not choose to exit from working in a situation in which she thinks she observes the systematic mistreatment of patients. Discussing the situation with other nurses might give her an opportunity to check her perceptions, to determine whether others are reacting similarly, and to note whether there is any possibility of joint action. Talking to people in the nurses association might give her an overview of her work situation, with information about the employer's almost unlimited right to fire. She might learn how to proceed responsibly with least damage to herself in this situation of perceived mistreatment of patients. As the situation evolves, Jan seems dangerously isolated, without peers to give her a "reality check" or any form of support.

Segment 2 of the case history is puzzling. It is hard to understand how a professional who had heard such a response from the orthomolecular physician and witnessed the incidents described could remain on the job for another six months. In light of her perceptions of the experimental program, she had reason to consult the hospital administrator at a much earlier point. Once she had consulted the administrator and gathered more evidence of what seemed to her to be failure to comply with federal regulations, she was at a choice point, facing the options of exit, voice or loyalty. (Unfortunately, the narrative includes no discussion of how she assessed her options at this or any other choice point.)

If Jan's description of the situation is accurate, at this juncture, the situation is not rectifiable internally. Jan has all the evidence she needs to conclude that she is in a thoroughly corrupt operation. Remaining in the situation as she perceived it would mean not only acting unprofessionally but might even mean becoming implicated in the mistreatment of patients. The most likely outcome of exercising voice in some way before resigning (perhaps even whistleblowing) would would be that she would be forced to resign. Unless she has some reason not hinted at in the case for preferring that choice, her best option is to exit. She cannot make a difference or get satisfaction from her work. Given her perceptions and account of the operation of the program, she has no reason to trust the administrator's offer of a better job in a new facility.

Assuming that Jan decides to exit, we should ask whether she has a duty to do anything more about the mistreatment of the patients. Response A. in Part 3 would be responsible professional conduct. Her own circumstances might make it too costly for her to report the situation promptly since she needs to find a job to support her family. But she should eventually transmit a report to any agency with oversight responsibility for this facility and to her local nursing professional association.

According to the narrative, Jan remained in the situation for a considerable time and eventually came into conflict with her employer. By that time, her employment situation had deteriorated beyond the point when the intervention of the state nurses association could help. From a practical point of view, Jan should have contacted the nurses association at a much earlier point (see above). We reasonably expect professional associations to supply the information practitioners need to make decisions that do not expose them to undue risk when they find themselves in what appear to be corrupt organizations.

I suggest that after the meeting with the hospital administrator, the narrative should not be interrupted with questions about what Jan should do. It is the story of Jan's perception of the deterioration of her work situation and ends with the observation that Jan received no damage award. The story does post questions about where professionals can turn for good information about how to deal with work situations that seem to be corrupt and what information professional associations should be expected to make available to professionals for their self-protection in dealing with employers.

Author: Vivian Weil, Illinois Institute of Technology.

Jan's story is sad, but predictable. We all presume a high level of professional conduct on the part of our colleagues, and it takes a while finally to recognize a situation where this standard is not met. We are just not willing to recognize the situation for what it is. We assume there must be something we don't understand about the situation, and we give our colleagues the benefit of the doubt.

With hindsight, Jan should have become aware of the unethical conduct and her own untenable situation immediately and, before she spoke with anyone, gathered irrefutable evidence of wrongdoing. With this evidence in hand, but not necessarily revealed to anyone except her attorney, she should have approached the option of whistleblowing by first discussing the problems with the Director of Nursing (DON) and so on up the ladder to the hospital administration, using as little of her ammunition as needed at every step. It is possible that somewhere up the ladder the situation would have been resolved. If not, Jan should have found herself a good job in nursing or even outside nursing and then quit, blowing the whistle from a position of security and power.

But that's easy to say, of course. As I suggest, few people have such foresight.

Jan's actions in this case are not nearly as interesting as the ethical problems of the Director of Nursing. The DON would certainly be aware of the central issues in the situation (maltreatment of patients), and he/she would be in a situation similar to that of the Morton-Thiokol managers who made the decision to allow Challenger to fly. As engineers (and they were all engineers), they saw the long-range problems to the company if they did not acquiesce to NASA's clear wishes. The DON, both a nurse and a manager, would be in a similar situation. Just as it is more interesting to consider the problems of the Morton-Thiokol managers than the decisions by Roger Boisjoly and his colleagues, so it would be more interesting in this case to evaluate the actions of the DON. What should he/she have done? Does he/she have any responsibility now for what has happened to Jan? Jan clearly did the ethical thing and suffered for it. But we don't know what the DON has done, and what effect these actions have had on his/her career. By focusing on the DON, the case might have been written with less passion and more disinterested journalism.

Author: P. Aarne Vesilind, Duke University.

For the purposes of this case, "whistleblower" refers to any employee who reports unethical, illegal or incompetent acts to appropriate agencies outside the employer's facility. On the basis of this definition, the decision to blow the whistle to external authorities is a potentially risky endeavor fraught with moral conflicts and professional and personal risks. In reflecting upon when and how to report violations, many questions arise: Will the potential benefit outweigh the possible harms? Who can be trusted? Will confidentiality be maintained so that the whistleblower is protected against retaliation? What is the likelihood that change will occur if the person goes public? Will professional associations stand behind whistleblowers when they follow through on their professional obligations to exhaust all internal mechanisms before blowing the whistle?

As Jan's situation and other whistleblowing cases demonstrate, there are no definitive answers to whether a given act results in the desired outcome until the consequences of the action can be evaluated. Hindsight is often credited with 20-20 vision, but in reality it may or may not provide the insights necessary to protect the public welfare or future whistleblowers from retaliation. I will argue that the nursing profession (and other so-called helping professions) must re-evaluate the paradigm that currently underlies the profession's goals, values and ethics. I suggest that unless the paradigm shifts to include the care giver as a recipient of the same ethic of care, then current codes of professional ethics and statutory protections for the whistleblower will fail to provide the comprehensive protection needed for professionals and the clients they serve.

Jan did deliberate on the correct ethical and legal questions and opted to act upon her professional obligations -- obligations that are grounded in the Nurse Practice Act, standards of care and the profession's code of ethics. The Code for Nurses (American Nurses' Association 1985) explicates the values and goals of the profession and provides a framework to guide the nurse's ethical deliberations and actions. The notion that the nurse acts as a client advocate is a pervasive theme throughout the code and is a core element of nursing education. According to the code, nurses as client advocates act "to safeguard the client and the public when health care and safety are affected by incompetent, unethical, or illegal practices by any person." (ANA 1985, p. 6) The ANA expands on this guideline to include specific recommendations for appropriate action:

  1. Express concerns about inappropriate or questionable practices to the person carrying out the practice and attention called to the detrimental effect such practices have on client welfare.
  2. When factors in the health care delivery systems threaten the welfare of the client, similar action should be directed to the responsible administrative person. If indicated, the practice should then be reported to the appropriate authority within the institution, agency or larger system.
  3. There should be an established process for reporting and handling of incompetent, unethical or illegal practice within the employment setting so that such reporting can go through official channels without causing fear of reprisal.
  4. Written documentation of the observed practices or behaviors must be available to the appropriate authorities.
  5. State nurses associations should be prepared to provide assistance and support in the development and evaluation of such processes and in reporting procedures.
  6. When incompetent, unethical or illegal practice on the part of anyone concerned with the client's care is not corrected within the employment setting and continues to jeopardize the client's welfare and safety, the problem should be reported to other appropriate authorities such as practice committees of the pertinent professional organizations or the legally constituted bodies concerned with licensing of specific categories of health workers or professional practitioners. Some situations may warrant the concern and involvement of all such groups. (ANA, 1985, 6).

The code specifies that if internal mechanisms are followed and change does not occur, then the nurse may need to go outside the institution to protect the welfare and safety of clients.

Jan followed the ethical and legal guidelines of her profession. So what went wrong? The same thing that went wrong when the Thiokol engineers blew the whistle on the Challenger explosion. The same thing that can go wrong when any professional who follows their codes of ethics. If the organization views whistleblowers as trouble makers who should be punished for violating organizational norms of silence, then no professional code of ethics is adequate to protect whistleblower from retaliation. Furthermore, even the most comprehensive legislation is inadequate to protect whistleblower from personal and professional risks if the ethical milieu of the organization does not assist and reward employees for reporting unethical or illegal behavior. Even when structural mechanisms are in place (e.g., ethics committees, misconduct committees, IRBs), the political structure and power dynamics of corrupt organizations may find a way around these safeguards.

Jan's case is an exemplar of the way altruistic professions, such as nursing, are caught in a Catch 22. Nurses are taught that it is their professional obligation to act as client advocates. An ethic of care is one of the profession's most cherished values, if not its highest moral ideal. It seems that something is fundamentally wrong when we teach students in health-related fields the value of caring for others but neglect to teach them how to care for themselves as professionals. It is a no-win situation for the client and the nurse. Within the current system, a nurse who is committed to maintaining her professional integrity within an organization that refuses to change its unethical or illegal behaviors has limited options, most of which entail high stakes for the nurse, both personally and professionally.

Lennane (1993) conducted a survey of whistleblowers from various occupations who had exposed corruption or danger to the public. All subjects (N=35) in this nonrandom sample suffered adverse consequences. For 20 of the subjects, victimization started after the first internal complaint. Retaliation took many forms including dismissal, demotion, resignation or early retirement due to illnesses associated with victimization. Twenty-nine subjects had stress-related symptoms, 15 were started on long-term treatment with medication, 17 considered suicide, 30 reported adverse effects on their children, and almost half subjects reported reductions in income of 75 percent. One could raise questions about the generalizability of these findings. However, when one reviews the literature on whistleblowers and attends to the actual stories of whistleblowers, Lennane's observations and conclusions are, more often than not, supported. Lennane concludes, "Although whistleblowing is important in protecting society, the typical organizational response, causes severe and long lasting health, financial, and personal problems for whistleblowers and their families." (Lennane 1993, 667)

Ethical decision making among professionals in health care and the scientific community is about ethical principles and scientific integrity as much as it is about politics and power. Ethical theory and professional codes of ethics will remain abstract entities unrelated to real-life situations until we acknowledge that inequities of power and status in the hierarchy of systems have a profound impact on individuals who witness misconduct and not only want to protect the public, but deserve to be protected from professional and personal retaliation.

The nursing profession is particularly vulnerable to retaliation if misconduct is reported. In a predominantly female profession, employed primarily in hospital settings where they are paid by the institution, nurses have a variety of potentially conflicting loyalties: to the patient, the physician, the institution, to society at large, and (let us not forget) to self. When unethical or illegal conduct is reported through appropriate channels and nothing is done, the nurse is forced to choose between ignoring the situation and doing nothing, or ultimately finding it necessary to hire an attorney for legal representation. How many nurses are willing to take this risk, given their economic situation? Jan ended up having to act in isolation because she could not rally any of her nursing colleagues to stand with her.

Nothing less than a paradigm shift is needed to protect the public welfare and safety, as well as the welfare and safety of nurse professionals. The preparation and socialization of health care personnel must allow them to maintain their professional and moral integrity and also enable them to report colleagues' unethical, illegal or incompetent behavior. The public has entrusted its faith and its economic resources in health care professionals, who should be able to act in the best interests of the public without fear of retaliation.

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References

  • American Nurses' Association, Code for Nurses With Interpretive Statements. Kansas City, Mo.: American Nurses' Association, 1985.
  • Lennane, J. K. "Whistleblowing: A Health Issue." British Medical Journal 307 (1993): 667-70.
  • Whistleblowing. Video production through the University of Illinois at Chicago, College of Nursing, 1988.
  • Witt, P. Personal communication, May 26 and June 1, 1996.
  • Witt, P. "Notes of a Whistleblower." American Journal of Nursing 83 (1983): 1649-1651.
  • Zorn, E. "Whistle-blower Saved Lives, Lost Everything Else." Chicago Tribune, June 21, 1987, pp. 1, 2.