Good Morning. My name is Joan Pastor. Mr. Chairman, members of this committee, I feel honored that you asked me to be here today. I just wish that my invitation were under different circumstances.

I was asked here today to tell you about the retaliation that I experienced after reporting a number of ways my supervisor, W. Bruce Dunkman, MD.,at the Philadelphia Veterans Administration Medical Center (VAMC) violated state and federal laws, rules and regulations and actions that posed a substantial threat to the health and safety of the hospital patients. I was a research nurse at the Philadelphia VAMC in the Special Cardiology Clinic, working on NIH and Pharmaceutical Company sponsored clinical research studies from August of 1995 to May of 1998. During my tenure, I was harassed, intimidated, slandered, excluded from my job and ultimately dismissed from my position for trying to help and protect the patients in the clinic.

The retaliation began in August 1996, after a male Pulmonary Function Technician sexually attacked me. My supervisor, Dr. Dunkman, blamed me for the assailant's actions. After repeatedly pleading with my supervisor to not allow this man to work in my office area, my supervisor had the perpetrator brought to my office and said "You do not make the rules around here, I do". After discussing with Dr. Dunkman how physically threatened I felt in the assailant's presence, my supervisor repeatedly threatened to bring the assailant over to my work area, told me that my sex life would be exposed if the sexual attack was reported and threatened to fire a research nurse (insinuating that to be me). He added that the perpetrator's attack was a romantic gesture and men who kiss their victims do not try to rape or kill them.

My supervisor never told me about the Equal Employment Opportunity (EEO) process nor did he report this incident to the EEO office or to other management officials. My supervisor exclaimed that the assailant was a tech that he did not want to lose. I asked my supervisor if the perpetrator could be moved to another area of the hospital. Dr. Dunkman replied "NO". I then asked to use one of the empty offices farther from the assailant's work area but my request was turned down and I was told that I was asking for too much.

My supervisor did not make any accommodations to decrease the possibility of this man physically attacking me again. The assailant remained in his office across the hallway from my office area and was not moved to another work area, until after I reported the attack and my ongoing fear to Human Resources in February, 1997.

For six months, I endured my supervisor's repeated threats of possibly bringing the man that attacked me into my office area. Finally, after my supervisor pounded his fist on the desk and demanded that I leave my office area so the assailant could come over to my area and take over one of my job responsibilities, I went to Human Resources. I felt terrorized by my supervisor because his actions of bringing the assailant to my office, pounding on the desk, blocking my office doorway so I could not exit and walking closely behind me down the hallway were aggressive acts and indicated his escalating anger.

I went to Human Resources (in February of 1997) to inquire about other positions within the hospital. The Acting Human Resource (HR) Director, asked me why I was exploring new opportunities. I made several disclosures to the Acting HR Director that included:

* the sexual attack;

* Dr. Dunkman not reporting the incident to management;

* Dr. Dunkman repeatedly exclaiming that he was going to bring the assailant over to my office area;

* Dr. Dunkman having the assailant brought to my work area;

* Dr. Dunkman's medication redistribution practice from one patient to another; and

* Exposure to radiation during a research study.

The Acting Human Resource Director requested that I write a statement summarizing our discussion. I did so in an effort to protect not only myself but also the patients.

After I delivered my report to HR, the medication redistribution "stash" was removed from the clinic by a health care team that consisted of the Chief of Pharmacy, Police, Chief of Medical Services and her assistant. Dr. Dunkman had been redistributing medications from one patient to another for years. These medications being distributed in the clinic had already been dispensed to other patients, been handled and some were obviously dirty and were expired or past their expiration dates and were not to be consumed but Dr. Dunkman distributed the medications, anyway. Dr. Dunkman never kept records of the medications he distributed in his redistribution scheme or to whom they were distributed.

After the medication "stash" was removed by the health care team, the Acting Human Resource Director told me that my safety was in jeopardy at the Philadelphia VAMC and that I should not return to work. After I told the Acting Human Resource Director that I wanted to come back to work, she presented three alternative positions for employment. The positions presented were:

* doing filing for the secretary in research services,

* answering phones for a clinical research nurse or

* being a technician.

None of the positions required my skills or educational background of a BS in Chemistry and BSN in Nursing.

Upon my return to work, I was isolated in an office in the basement and not given anything to do. I was not even permitted to do the paperwork associated with my job. I objected to this and decided to return to my previous position even though no safety measures were afforded me. I spoke to the Acting Human Resource Director before I returned to the research clinic and she gave me the number of the police and told me to call them if anything happened.

When I returned to my office, my supervisor, Dr. Dunkman, repeatedly yelled at me "to get another job". If I asked him a question about the work that needed to be completed he would ignore me or tell me that he did not have time to answer my question. Dr. Dunkman excluded me from the daily clinic meetings and denied my access to research study files. He would meet with my co-worker behind closed doors and would stop talking if I entered the room. Dr. Dunkman then resorted to lurking outside my office door during the workday to listen to any possible conversations inside.

I had previously been allowed to attend clinical research study meetings and graduate school at the University of Pennsylvania. After reporting my supervisor's wrongdoing, I was permitted to attend meetings for only one of the three studies being conducted in the clinic. Dr. Dunkman did not allow me to attend and/or perform duties related to the other studies that listed my name as a clinical research coordinator. Dr. Dunkman also tried to deny paying for one graduate class per semester which was a benefit agreed upon during the time of my hiring at the Philadelphia VAMC.

Dr. Dunkman enlisted help from my co-worker and others inside and outside of the hospital to retaliate against me. Initially, Dr. Dunkman requested my co-worker to keep track of my time and record it. My co-worker determined that if the door to my office was closed then I was not present at work and he could mark me absent.

I had inquired about the inaccurate recording of my time in the computer. Mr. Robert Lyle, Administrative Officer for Research began to scream at me for questioning the records. He said that if I was not at my post then I would be marked absent. I was shocked that he was yelling at me because I had had a good relationship with him previously.

In April of 1997, I was referred to Ms. Ann Lovell, the Radiation Safety Officer (RSO) at the Philadelphia VAMC (PVAMC), to discuss and determine the degree of my radiation exposure during a clinical research study. I had worried for a year and a half about the radiation exposure but had never known whom to consult about it. After I reported that I was a radiation worker to Human Resources and that Dr. Dunkman had neglected to send me to radiation safety training, I was given the appropriate training and my radiation exposure was estimated.

Since the RSO had not been aware of the clinical research I was doing, we reviewed the informed consents and protocols. Ms. Lovell and I discovered that the research studies had not been approved by the Radiation Safety or the Biohazard Committees as was required by the license granted by the Nuclear Regulatory Commission (NRC) and the PVAMC regulations.

Since the radiation experts within the hospital had never calculated the dosage of radiation received by the patients in the study, the informed consents either neglected to state or under-estimated the amount of radiation that the research patient would receive during the protocols. I notified the Hospital Director, Mr. Earl Falast of the inaccuracies in the research study's informed consents because I felt that this matter was of a serious nature and required his attention. Mr. Earl Falast never replied back to me about my memo. After this issue was further investigated one of the on-going studies required all 90 hospitals (30 VA and 60 non-VA) conducting that research to change their informed consents to reflect a more accurate calculation of the radiation exposure of the research patients.

In May of 1997, my co-worker, aided by my supervisor, filed criminal charges against me with the PVAMC police charging me with taking patient files because they could not be located. I was on vacation the day the charges were filed but was available by phone. When I returned to work the next day, Dr. Dunkman stated that he had filed criminal charges against me for taking missing patient files. I showed Dr. Dunkman that the files were beside the other research files where they had been for months. After inquiring further as to why Dr. Dunkman and my co-worker filed criminal charges for not being able to locate patient files, my co-worker began screaming at me and came within four inches of my face without Dr. Dunkman so much as chastising him for his anger. Meanwhile, I had to endure the humiliation and slanderous repercussions of having been the subject of a police report.

Dr. Dunkman and my co-worker worked in synergy telling other employees and patients that I was not doing my job and that I was trying to close the clinic. I heard Dr. Dunkman tell a management official that I was psychotic and a co-worker reported that Dr. Dunkman told them that I was crazy.

I was very upset that Dr. Dunkman tried to slander me to cover up for his wrongdoing. I only reported his actions because the patients’ health and safety were at stake. I made him aware that his actions were against federal rules and regulations. But he repeatedly refused to abide by the structures that were set up to protect patients and employees.

I went to the PVAMC's medical ethicist to discuss the ethical issues pertaining to the misleading and inaccurate statements contained in the informed consents for the research studies. The Philadelphia's VAMC Medical Ethicist was not only the ethicist but also a member of the Institutional Review Board (IRB). Although she was outraged that the informed consents were inaccurate and that the necessary approvals for the research were never obtained, she said that she could not say anything to the IRB, the committee that approves the research in the hospital, because she feared she would lose her job. She further explained that she needed the financial income for her daughter's college tuition and the VA's health insurance benefits.

In May of 1997, the FDA audited the "Special Cardiology" clinical research site. Dr. Dunkman demanded that I only essentially answer "yes or no" to the FDA investigator's questions. I placed a revised Informed Consent for one of the research studies in the Regulatory Binder during the audit as required by the study's clinical research associates. Dr. Dunkman became very upset with me because he thought that the FDA inspector might have noticed the changes in the informed consent regarding radiation and that it had been improperly approved by expedited review. According to the FDA regulations, the informed consent on studies utilizing radiation could not receive expedited review. The FDA auditor never seemed to notice this violation and it was not noted in the #483 report, Findings of the FDA Audit.

During the FDA audit, the investigator questioned me about the delinquent and absent reporting of patient deaths and serious adverse events in the research study. The FDA regulations and the study's protocol state that research patient deaths must be reported to the study sponsor within 72 hours and to the FDA within 10 days. I reported to the FDA auditor the names of the patients and dates of the existing reports. Many of the required reports had not been filed. Dr. Dunkman busied himself trying to complete them during the audit and backdated them. The FDA caught him in the act but to my knowledge never did anything about it. The most frustrating part of being a whistleblower has been that the agencies responsible for correcting the wrongdoing often do not take any action to enforce their own laws, rules and regulations. In this situation, the FDA has gone so far as to say that they have an unwritten rule that study patients who die in the course of protocol allegedly not caused by the study medication as determined by the researcher do not have to be reported to the FDA.

The Nuclear Regulatory Commission (NRC) came to the Philadelphia VAMC to inspect the facility beginning in 1996 and continued through 1997. The NRC inspector interviewed me about the unapproved clinical research being conducted in the facility. Although the NRC auditor knew that the violations of conducting research without proper Radiation Safety and Biohazard Committees review and approval was contrary to the NRC license of the Philadelphia VAMC, she warned me that my reporting of these violations would ruin my career. In a follow-up letter to me from the NRC, the NRC stated that clinical research did not fall entirely under their jurisdiction and therefore the FDA would be consulted on some of the issues I had raised. The investigations by both agencies, the FDA and the NRC, are still open on those issues today.

Beginning in June of 1997, Dr Dunkman repeatedly consulted the hospital administrator, Director and Human Resource personnel to find a way to terminate me. Dr. Dunkman announced in the hallway to the Chief of Cardiology that he was going to Human Resources to find a way to terminate me. Dr. Dunkman told my co-worker that he was going to terminate me but that it would take time. He wrote a memo to Ms. Meg O'Shea, Associate Hospital Director, indicating his wish to eliminate me due to my whistleblowing. Dr. Dunkman stated in a deposition that he knew that the traditional route of termination could be a lengthy and a laborious process indicating that another avenue was preferred.

In September of 1997, I was again exposed to radiation without my consent or knowledge. My co-worker left a radioactive blood sample in my office area at the desk where I often sat. This specimen not only contained radiation but was also hazardous waste. The co–worker had been previously instructed to draw blood prior to patients being injected with radiation to limit potential exposure. Yet he neglected his training and drew radioactive blood from a patient and then left the blood in my office area. This co-worker had performed blood draws numerous times before and had never left the blood in my office area before this date. It was therefore either grossly negligent or purposeful. Dr. Dunkman did not chastise, discipline or retrain my co-worker for this dangerous action.

I attended the September, 1997 Radiation Safety Committee meeting. At the meeting, the Chief of Radiology yelled at me in front of my peers and management officials to get another job. Subsequent to the meeting, Dr. Dunkman admitted that he had asked the Chief of Radiology to tell me to get another job.

Dr. Dunkman continued his campaign to elicit help to intimidate and harass me into getting another job. Dr. Dunkman had said that I had been awarded a four-year term appointment that could not be terminated easily; therefore he had to get me to quit. He went so far as to instruct a non-PVAMC employee, a clinical research associate working on a study for which I was the study coordinator, to tell me to get another job. She told me this in a derisive manner.

Dr. Dunkman would scream at me saying that I was only at the Philadelphia VAMC to collect a paycheck and that I did not want to work. Yet he had been pleased with my performance prior to my making the protected disclosures. To assure that I was adequately performing my duties, I had repeatedly asked for performance appraisals but I never received one despite the fact that my co-worker did receive one. Dr. Dunkman explained in a deposition that he did actually prepare one in April, 1997 but that since he could not bear to talk to me to review it, he gave it to the Associate Director of Research to go over it with me which he did not. Dr. Dunkman never checked to see if I had received it, which I had not. I also requested a job description from Dr. Dunkman but one was never presented.

Finally, after Dr. Dunkman had had many discussions with Philadelphia VAMC management about the easiest way to terminate me, the then Acting Human Resource Director suggested a plan to eliminate my position by depleting the funds in my supervisor's accounts. Dr. Dunkman then carried out this plan.

On April 29, 1998, a letter from one of the studies indicated that the research funding would cease if Dr. Dunkman decided not to enroll patients. While Dr. Dunkman alleged that management asked him not to enroll patients in this study, it was clear that he chose to cease enrollment and eliminate his funding. This study was terminated at the PVAMC and the research patients were transferred (in September 1998) to the Hospital of the University of Pennsylvania where Dr. Dunkman was also on staff.

The initial letter from the Cooperative Studies Center (COOP) indicated this action was being taken due to the investigations instigated by Dr. Dunkman’s research nurse. This sentence was later changed in a subsequent letter to try and hide the fact that their actions were in retribution for my voicing concerns about wrong-doing at the PVAMC. Both letters were sent not only to the Philadelphia VAMC but to other hospitals such as the University of Pennsylvania, further damaging my career.

Armed with the COOP study center's letter and an unverified statement showing that one of Dr. Dunkman's many funds had only $2,000 in it, Dr. Dunkman held a meeting with the Acting Director of the Hospital, Mr. Michael Sullivan. Mr. Sullivan agreed to terminate my position. In the termination notice of my employment, I was informed that I (as well as my co-worker) was being terminated due to lack of research funds. After termination of my research nurse position, my co-worker was re-hired into the clinic to perform the duties of the research nurse position from which I had been terminated. Dr. Dunkman tried to justify this by alleging that he paid my co-worker with pharmaceutical company money, not federal funds. Dr. Dunkman testified that he had planned to find a way to re-hire my co-worker and informed the co-worker of this prior to our termination.

Prior to and after my termination, I applied for Philadelphia VAMC nursing positions. I asked Human Resources to notify me of any available nursing positions within the hospital. I had filed a universal nursing application for employment and had specifically applied for several open positions of which I was aware. I was not considered for the open positions or notified of any other positions or re-hired because I was being retaliated against for my reporting radiation safety concerns and clinical research violations within the Philadelphia VAMC.

I am now living with the aftermath of having tried to protect my patients’ health and welfare. My reports of impropriety and wrongdoing have left me without a job to support myself and have damaged my career irreparably. I went into nursing to help people. I felt my work in the clinical research area could accomplish helping millions of people by developing new technology for those of us that suffer with incurable illnesses.

The sick, my patients, committed themselves to me and the medical professionals at the PVAMC. My patients implicitly trusted that their welfare would be protected and the truth about the risks of the research studies would be told to them. From my perspective, this was not happening in the clinic where I worked. I stood firmly for the rights of the patients and gave them the respect and care that is deserved by any individual, especially our veterans. My efforts have righted some wrongs but I have suffered greatly for coming forward.

I am here today to ask only one thing of this committee. I ask that the medical professionals who stand up for the patients’ rights be protected and not have to suffer. Those who want the truth to be known and try to abide by the government's rules and laws set up to protect people should be applauded, not retaliated against and fired.

Remember, we will all be patients someday and will want to commit our trust to our physicians and nurses who care for us. If a whistlebower/nurse stands up for our rights, I would hope that we would want them to be praised, and not to endure untold suffering, as I have in the past years.