Attachment 17 Legislative Testimony Heller, Bill My name is Tom Toombs. I am Administrator of the Corrections Division. I am here today in response to the Chair's April 17 letter requesting that I appear and respond to questions pertaining to HB 2914. Also in attendance with me today are Dr. DiIaconi, Chief Medical Officer at the Oregon State Penitentiary, and Catherine Knox, Corrections Division Health Services Program Director. Dr. DiIaconi and Ms. Knox are also prepared, at the Chair's request, to answer questions. Before I answer those specific questions posed in the Chair's letter and field any others which the committee might have, I wish to establish that there was no Corrections Division during the period in time when the Heller projects begin at the Penitentiary. The Superintendent of the Penitentiary or Warden, as he was known in that era, reported directly to the Board of Control, which was composed of the Governor, the Secretary of State, and the Treasurer. The Corrections Division as an organizational entity did not come into existence until 1967. For my part, although I went to work at the Penitentiary in 1964 as an Associate Psychologist and I have remained employed in Corrections except for two year's military service from 1966-68 and two years with the Children's Services Division from '83-85, I had no personal experience or responsibility for the Heller experiments or health care programs at the Penitentiary until September, 1985, when I was appointed Administrator. Accordingly, my responses to these questions, except for those that relate to activities that have occurred since September, 1985, are based on what the records we were able to locate reflect. 1. For what reasons were radiation experiments, conducted by Dr. Carl Heller between 1963 and 1973, initially allowed. Dr. Carl Heller began a medical research program at the Oregon State Penitentiary in 1957. The purpose of Dr. Heller's research program, as understood by Mr. Gladden, who was Warden at the Oregon State Penitentiary until 1968, was to: 1) investigate various causes of male sterility; 2) study the effects of various hormone preparations on the male reproductive process; and 3) time the development of sperm. Warden Gladden understood the radiation research, which began in 1964, to be an extension of the original research program established by Dr. Heller. In Dr. Heller's proposal to the Division of Biology and Medicine of the U.S. Atomic Energy Commission, dated February, 1963, he states that the objectives of his research proposal were to apply known amounts of radiation directly to the testes of normal men in order to ascertain specific cytological and hormonal information. The proposal further describes specifically what cytological and hormone effects he expected to be able to measure. He stated in the conclusion of this research proposal that all of the effects listed had been routinely measured in the earlier phase of the research program, which dealt with the administration of hormonal drugs and the resulting alterations in testicular function. A copy of Dr. Heller's proposal for hormone research has been provided and is labeled Attachment A. Dr. Heller's proposal for radiation research is also provided and is labeled Attachment B. 2. Who made the decision initially allowing the experiments? The Board of Control approved Dr. Heller's proposal for endocrinological investigation at Oregon State Penitentiary in 1957, with the understanding that participation of inmates would be on a strictly voluntary basis. The letter of permission from the Board is labeled Attachment C. Again, the original study dealt with the administration of hormonal drugs upon reproduction in the human male. During the 1960's, the Board of Control actively solicited federal funds for institutional research. They formed an Institution Research Committee, and established positions and funding for institution research with the Board of Control. One of their tasks was to establish policy and procedure for institutional research, and this was accomplished in November, 1963, when the Board promulgated the first administrative rule on the subject. In Dr. Heller's proposal to the Atomic Energy Commission for the radiation research project, he states that he consulted with the Chief Radiologist at Salem Memorial Hospital, the Radiation Committee of the Oregon State Board of Health, the Head of the Department of Radiology of the University of Oregon Medical School, the legal consultant for the Oregon State Board of Medical Examiners, and the Secretary of the Oregon State Medical Society to determine whether there were any legal or ethical problems involved in the proposal. Dr. Heller's proposal states that there were no barriers identified by the groups that were consulted. He indicated that a signature form would be developed to establish the participants consent to the project. Copies of the consent forms have been provided and are labeled Attachment D. Dr. DiIaconi's recollection, and he may wish to comment on this further, is that his opinion on the research proposal was sought only after these groups I have just listed had reviewed the proposal and found no problems with proceeding to the investigation phase. Archival records contain a request by Warden Gladden for a formal Attorney General's Opinion concerning the legality of him, as Warden of the Penitentiary, permitting outside interests to conduct medical research programs using inmates as patients. Mr. Gladden asked more specifically if an inmate of the institution could legally authorize or be permitted by the Warden to have a vasectomy performed or have his reproductive organs subjected to various medical research programs, experiments, and tests. A copy of his request has bene provided and is labeled Attachment E. The formal request was accompanied with another letter which describes in more detail the Warden's concerns about Dr. Heller's intent to perform research using radiation. A copy of this letter is labeled Attachment F. The Secretary of the Board of Control was also made aware of Warden Gladden's requested assistance from the Executive Department in establishing a position for the Board of Control on the subject. This material is labeled Attachment G. In January, 1964, the Warden received a written opinion from the Executive Department to the effect that prisoners were not prevented based upon their incarceration or custody status, from the right to make a contract, including participation in medical research. It was only after receipt of this memorandum that the radiation research program was initiated at Oregon State Penitentiary in 1964. The memorandum is labeled Attachment H. The program continued until January, 1973, when Amos Reed, who was then Administrator of the Corrections Division, ordered all medical experimentation programs at Oregon State Penitentiary ceased. This action was based upon his conviction that it was not possible for prisoners to freely consent to participate in these programs. The memorandum from Mr. Reed is labeled Attachment I. Furthermore, during the 1973 Legislative Session, the Corrections Division assisted in development of the language and testified in support of Senate Bill 383, which was enacted at the close of the session as ORS 421.085. This statute expressly prohibits medical experimentation with prisoners. 3. What costs has the Corrections Division incurred, including increases in providing health care to inmates who participated in the experiments? It is estimated that the Corrections Division has incurred about $7,000 in costs, which can be directly related to inmates' participation in the Heller research experiments. These costs include $2,215, paid 1979 in settlement of lawsuits filed in 1976. This money was distributed to nine inmates. In 1976, 13 inmates requested an independent physical examination. This was scheduled with internal medicine specialists in the community and is estimated to have cost approximately $650. Again, in 1985, the Corrections Division agreed to provide physical examinations for six inmates by an independent physician. This was arranged with the Oregon Health Sciences University, which agreed to provide the examinations at no charge to the Division. The costs of lab work which was performed in conjunction with these exams was approximately $358. The Corrections Division also incurred approximately $2,000 in costs for additional follow-up of one inmate who was found to have a benign nodule on his testicle. The remaining $1,700 is the estimated costs of the physicals which were just completed by the Health Sciences University the first week in April, 1987, including the costs of transportation to the Health Sciences University. While this may not be an exhaustive list, other costs would be indirect and not possible to calculate because they fall within the regular operation of the Division. It should be pointed out that while prisoners are in the custody of the Corrections Division, they may request medical care at any time. The Division is obligated to provide access to this care and medically necessary treatment. Some of the inmates who volunteered for Dr. Heller's research program do have complicated medical histories. However, none of the various physicians who have treated these inmates have ever indicated that their medical problems, however serious, were a direct result of radiation exposure. Therefore, we are not able to attribute any substantial increase in the costs of health care provided because of inmates' participation in Dr. Heller's research programs. 4. What benefits, particularly monetary, did Corrections Division gain from the experiments? Neither the Penitentiary nor the Corrections Division gained any benefits, monetary or otherwise, from the experiments. This is reflected in Dr. Heller's proposal to the Atomic Energy Commission for funding, which lists costs to the Penitentiary, which included $8,000 for payment to inmates at $200 each for their participation, and a total of $300 for postage, chemicals, and equipment, which were used by Dr. Heller. This information was further confirmed by Corrections Division staff who contacted the Penitentiary Assistant Business Manager, who is now retired. He states that the only funding for the research project handled by the Penitentiary were those funds which were received by inmates. There was no evidence found that the State itself received any money or other benefits from the federal government or Dr. Heller's research foundation. 5. Since the experiments ended, what follow-up procedures have been used to assess resulting impacts on inmate health? Why were these particular procedures used? After Dr. Heller's program was stopped, the researchers left no specific instructions or recommendations pertaining to medical follow-up. By this time, Dr. Heller had suffered his second stroke, and his research associate, Mavis Rowley, was the chief contact person for the project. In October, 1975, The National Enquirer published an article quoting Mavis Rowley as appealing "for these people to see their family doctors for a thorough check-up as soon as possible." "Some of them could have damage they aren't aware of yet. Unless something visible appeared, like cancer they could see, there is no way for them to detect any danger." "...and they should go back to their family doctors every two or three years for regular check-ups." However, in a deposition taken in 1979, Mavis Rowley denies that she ever made these statements to The National Enquirer. One month following the article in The National Enquirer, a meeting occurred with the inmates at Oregon State Penitentiary, and representatives of Dr. Heller's research foundation, as well as a Dr. Sagan, from Palo Alto, California. This meeting consisted of questions posed by the inmates and answered by members of this group concerning primarily the possible adverse physical effects of the radiation exposure which occurred during the research project. The only notes of the meeting were taken by an inmate and indicate that the researchers who were present made contradictory statements as to the purpose of the hormones that were administered as well as the radiation. The effect of these contradictory statements was that inmates were confused and their concerns about adverse health effects heightened. The notes from this meeting have been provided and are labeled Attachment J. During January, February, March, and April of 1976, the Corrections Division attempted to get recommendations and make arrangements for medical follow-up with both the Pacific Research Foundation and the Energy Research and Development Administration, the federal agency which replaced the Atomic Energy Commission. The records do not indicate that Corrections ever received a response to this request from either of the sponsoring agencies. Copies of this correspondence are labeled Attachment K. However, the Penitentiary did make arrangements for an independent medical examination by internal medicine specialists for the thirteen inmates who made requests. This is confirmed in a response to the Superintendent from Dr. DiIaconi labeled Attachment L. Dr. DiIaconi's recollection, and he may wish to comment further, is that these examinations were provided at the request of inmates because of their anxiety and concern about possible health hazards from the exposure to the radiation. The medical records of these inmates, indicate that in no case has medically necessary treatment been denied during the course of their incarceration. In 1984 the Corrections Division received a list from the Department of Energy of persons who were, supposedly, part of the Heller Research Project. This is the only reference list that has ever been made available to the Corrections Division since the time the research program was discontinued. During 1985, the Corrections Division was again made aware of inmates' concern about the possibility of adverse health effects from the radiation experiment by two articles which appeared in the Statesman-Journal in March. That same month, the Division contacted the Health Officer and Deputy Administrator of the State Health Division and asked for his advice and recommendations for medical follow-up. He consulted with Dr. William Moss, Chief of Radiology, and Dr. Eugene Fuchs, Chief of Urology, both with the Oregon Health Sciences University. Their recommendation was to examine each of the inmates, perform a laboratory analysis of blood for three hormone levels, and to do a semen count on any inmate who had not had a vasectomy. In July, 1985, an internal medicine specialist joined the Corrections Division medical staff, and he was asked to review these inmates' medical records and to examine those inmates who gave consent. This physician also reviewed the Corrections Division file on the Heller Project and reviewed the articles which had been published by Dr. Heller about the research and his findings. On August 1, he met with Dr. Fuchs and Dr. Wright to discuss their recommendations for follow-up examinations. Specifically, the recommendation for medical follow-up described by the Corrections Division staff physician included a digital testicular and scrotal examination, semen analysis for sperm number and motility, and sampling of plasma for pituitary and testicular hormone levels to document the inmates' current hormonal status. The review was directed to discovering cancer of the testes or scrotum, any abnormalities of hormonal action, and the current state of fertility or the lack thereof. It was also recommended that these examinations be performed by an independent medical practitioner, and this was conveyed to Bob Watson, who was the Corrections Division Administrator in August, 1985, and discussed more fully with staff from the Attorney General's office. In October, 1985, one month following my appointment as Administrator, I made the decision to arrange for the recommended follow-up examinations with the Oregon Health Sciences University. The rationale for this decision was that 1) these inmates had verbalized complaints of various physical symptoms alleged to have resulted from participation in the Heller project; 2) given that the Heller Project was experimental and comprised interventions not commonly part of current medical practice, an expert medical evaluation was necessary; 3) any positive findings would be treated according to the medical consultant's recommendation. In addition, notices were put in inmate newsletters at Oregon State Penitentiary and the Oregon State Correctional Institution, and letters were sent to 48 persons on the list of participants in the Heller Program who were no longer incarcerated informing them of the recommendations for follow-up examination and that they were advised to schedule a similar examination with their private physicians. Letters were also sent to each state corrections system and the Federal Bureau of Prisons informing them of the recommendation, with the offer to provide additional information. Eleven jurisdictions responded requesting further information, which was provided by the Corrections Division. It was not until the end March, 1986, that all six of the inmates who had requested the examinations had complied with the request to come to the institution infirmary to have the laboratory specimens obtained and then sent to Capital Medical Laboratory for analysis. On April 30, 1986, a urology resident from the Oregon Health Sciences University, came to the institution and completed examinations of the six inmates. The resident physician made recommendations to further evaluate two inmates. These recommendations were carried out by Corrections Division. 6. What role did Dr. DiIaconi have in the experiments? Did he participate in the selection of inmates for participation in the experiments or participate in the actual conducting of the experiments? The only role that Dr. DiIaconi had in Dr. Heller's research program was to assist with the testicular biopsies and the vasectomy. He did not participate in the selection of inmate volunteers, nor did he have any decision-making role in the conduct of the research itself. 7. After the experiments, did he (Dr. DiIaconi) monitor the physical condition of inmates who participated in the experiments, and does he now monitor any of those inmates? There has been no specific program to monitor the physical condition of inmates who participated in the Heller research program, although on several occasions just described in this testimony appointments have been made for consultation with physicians in the community for medical examination of these inmates. Dr. DiIaconi, as the Chief Medical Officer at the Penitentiary, has arranged for these independent medical evaluations. With the exception of emergencies and communicable disease control, provision for medical care is initiated at the request of inmates, although health care providers determine the type of evaluation and treatment that is necessary. Dr. DiIaconi and other physicians on staff see inmates who request a physician appointment. Dr. DiIaconi is also a surgeon with privileges at Salem Memorial Hospital, and he acts as the surgical consultant for the Corrections Division. Therefore, Dr. DiIaconi does see those inmates who participated in the Heller research program, but this in relation to specific medical complaints that require evaluation and treatment. The medical records reflect that these inmates have also been seen by other Corrections Division physicians, as well as consulting medical specialists in the community. 8. In 1985, the Corrections Division requested physicians from the Oregon Health Sciences University to conduct medical follow- up of inmates who participated in these experiments. The physicians consulted recommended blood and semen analysis. Why did these physicians not receive access to blood and semen samples or results of laboratory analysis of these materials? The staff physician who was assigned responsibility for the follow-up medical examinations in July of 1985, left employment with the Division without completing the assignment. The Health Services Manager at the Penitentiary, who assumed responsibility for the project, also failed to identify the omission, even when attempting to obtain a written report from the examining resident physician at the Health Sciences University. There is no excuse for these acts of omission. The error has been corrected since it was brought to our attention.