Let me go back in history a little bit and describe what happened to me. In 1976 I was working in the State of Alaska, on the TransAlaska Pipeline as a surveyor. And at that time I developed symptoms, easy bruisability, bleeding from the gums, swelling in my abdomen. Very concerned, I visited a physician in Anchorage and he diagnosed me as having a rare blood cancer, hairy-cell leukemia. Naturally, I was very shocked and very frightened. I determined that I needed a second opinion and was referred to the medical center at UCLA, and at that time, when I went to that medical center, the diagnosis was confirmed by my doctor at that time, Dr. David Golde.

The only course of treatment, according to the doctor, was that I have my very enlarged spleen removed. After some considerationit apparently was the only method of treatment that I could undergo at that time, so I chose to go ahead and have the operation conducted.

Prior to the operation I signed a standard-I believe it was a standard-surgical consent form; and then, of course, proceeded into the operation. The surgeon removed my spleen; I think it weighed something like 22 pounds, and after the operation I seemed to recover from the symptoms I had exhibited before.

Everything seemed to be going rather well. At that time—again, my doctor had requested that I continue to periodically see him so that he could continue to check up on the condition of the disease that apparently had gone into-he never used the word remission-but that had been abated, or that I had stabilized. So over the next 7 or so years, I returned to the medical center and to my doctor approximately 12 different times. On each of these times my doctor drew off from me what I considered-not being an expert, I don't know, but what I considered-large quantities of blood. Over the course of these years, as this process went on, from time to time I would travel down to the Los Angeles area with my own finances; some of the work that I did required me to be in Los Angeles. But on several occasions these trips became very expensive for me, and I indicated to the doctor that I could not afford to continue by myself to travel to UCLA and asked him if it wouldn't be possible to have the blood withdrawn from me at some other facility; for instance, in Seattle, which would be much closer.

The doctor was not very comfortable with that particular concept and indicated to me that he would be more than happy-he would be able to find grant funds that would avail me of the flight down. My parents were living in the Los Angeles area and I stayed with them at the time.

In approximately April 1983 on one of the first trips that were paid for by my physician, I was presented with a consent form that was what I considered a very elaborate and very complicated— many paragraphs that were closely-typed spaces, and it was actually presented to me in the context of a formality to be signed, which I did; I signed it at that time. It had a section on it that said "I do/ do not" and I went through the process and, I think, circled the appropriate in the sense of regarding and believing in the requests that my doctor made of me on almost every occasion.

Again, throughout this entire process, I've got to explain to you that I always felt that although the disease was abated, I was

never sure that I had been cured and on each trip I was very concerned. I went into this situation with great nervousness and anticipated getting into it and getting the hell out of it as fast as I could.

So the second trip, the next trip after that, which was in September 1983, I again traveled to Los Angeles. The trip was paid for, again, by the doctor, and I again was presented with a similar consent form. Just prior to reading or going over that form I had indicated to the doctor that, because my parents-who I did stay with when I went to Los Angeles on those trips-were moving back to Seattle, I would no longer be able to afford accommodations. At that time he made a statement to me, something to the effect that "That's no problem; we'll put you up at the Beverly Wilshire," which is a pretty luxurious hotel in Beverly Hills. I also got the consent form; and based on what seemed like a flippant remark to me, based on that and on questions that I had asked, again at that same visit, if there was any commercialization or any product development that would eventually have commercial aspect or impact, and the answers that I received at that time I considered vague and, frankly, quite patronizing as far as I was concerned. And I wanted to be knowledgeable about what was going on, with what was expressed to me as some kind of an almost esoteric research project regarding the tissues and blood that they were removing from me.

I, at that time, did not circle the "I do;" I circled the “I do not,” and the "I do not" was represented or expressed in a paragraph that said, "I do not consent to give away the rights to my cell line and products derived therefrom." Apparently no one noticed that I had signed the consent form in that manner, and when I returned to my parents' house, within a matter of hours there was a phone call from the doctor asking me to return to his office to resign the form in the correct fashion. And that correct fashion, of course, was to circle the "I do" as opposed to the "I do not." I still wasn't in any kind of a-in my estimation-position to confront the doctor, and I decided not to so I essentially put him off and told him that I couldn't return to his office, that he should mail me the form to Seattle and I would do something about it there.

He did; his secretary mailed it to me with a letter saying, "This is the way it should be resigned," and attached to the form at that point on the paragraph, an adhesive label that also said, "Please circle 'I do"". I didn't resign the form; I felt very uncomfortable about the whole procedure. I felt somehow that questions that I had asked, especially the questions regarding the commercial aspects of the products, or if there were any products derived from the cell line, had been very vaguely answered and that I wasn't getting the whole story.

Well, nothing seemed to take place for the next month or so, and then in December, I believe it was, I received a letter from the doctor, again requesting me to resign the form in the correct fashion; and that although a cell line had not been developed from the blood that they withdrew from me at that time, that it would be appropriate for me to resign it that way in keeping with what had taken place in the past.

I think all these things sort of coalesced, and the pressure that I felt from the doctor and from the institution caused me to investigate further in this particular matter. And it's at that time, and over the course of the next several months, that I engaged the services of my attorney, Mr. Gage and his firm. At that point in time, I think, that there is the second story that was revealed to me by the investigative procedures, and after litigation was started, the discoveries that have taken place since the time that I employed the firm, that even my gravest suspicion at the time, when I refused to sign the last consent form, never could have lived up even closely to the truth of the hidden story that was revealed through this investigation.

I discovered that in approximately 1979, the doctor had applied for or sought a patent on the unique qualities of the cell line derived from my blood and tissue, and that in 1984, literally almost at the same time that I was seeking counsel, a patent had been issued to the doctors, the university, based on the unique qualities from my cell line. These properties, I think, were described at one time by my doctor as unique in all the world. I felt that at that time I authorized Mr. Gage to file a suit against the doctor and the hospital and the other people that are so named.

Discovery proceeded, and, I think, that more and more things or discoveries came to light regarding the amount of information, the amount of properties that were available or that seemed to be products of the cell line of mine. I'd like to refer to some notes that I've written here that I hope will sort of delineate some of those properties.

My white blood cells produce an unusual blood protein in a plentiful and unique manner that makes it feasible to study and commercially copy them. My blood cells produce substances that are of great value in the diagnosis and treatment of many serious illnesses, including cancer. My blood cells have been considered and described-again, this is by my doctor-as "unique in all the world." Additionally, my blood cells provide a source for the genes which are responsible for the valuable proteins facilitating large-scale production. My doctor in the hospital and others had made every effort-and this is more discovery-every effort had been made to translate these unique properties of my cells into commercialization and profit without my knowledge or my consent or, especially, my participation.

Further investigation and discovery revealed that not only had my cells this unique quality, but surrounding this there was a financial involvement between the doctor, the hospital, and a biogenetics firm-in this case it was Genetics Institute-there was an actual contractual relationship that led to a significant amount of money, apparently, being exchanged between the biogenetics firm and the university and the doctor, somewhere in the neighborhood of approximately $500,000. This was all based on the apparent exclusive use by this biogenetics firm for the use of the cell line and products derived from my body and my material, blood, and tissue. Again, further discovery-and, I think, this is, for me, probably the most unbelievable aspect of this situation in my case-most recently, we have learned that the doctor also, at the same time, had entered into a contractual relationship, an agreement, a separate

agreement, with a biogenetics firm which led to stock options and the exercising of those options by the doctor, within our calculations, of approximately $2 million. This, again, was for the exclusive access by this firm to the use and development of products derived from my body and tissue, my unique cells and their genetic

structure.

Indeed, also, the huge multinational pharmaceutical company, Sandoz, also is involved in a relationship-I believe it was in 1982-again, allowing them to have access in almost a joint venture with the biogenetics firm and the doctors and the universities regarding the worldwide commercialization and development and eventual marketing of products that were derived from my unique cells, blood, and materials.

Finally, and even within some of the last few days, it has been determined that additional patents are being sought by the biogenetics firm. This corresponds directly to the material in the patent of the cell line. Additional patents are being sought on the cloning of the genetic material responsible for the unique qualities, and these two patents are applied for by the biogenetic firm although, I believe, that these patents have not yet been issued. So in my mind, the scenario seems to continue on where one patent for unique materials leads to additional patents on material and research conducted on this uniqueness of my cell line, and so on.

I would like to say at this time that I believe very firmly in the respect of the rights of the individual and the human rights involved in this particular issue. I do believe as it relates to me, and I'm sure to other people who might potentially be involved in the same situation, that I'm entitled to determine to what extent products and materials are used that are uniquely mine and are from my blood and my tissue. I don't think it is appropriate to be unfairly deprived of that which is essentially my own.

I think, also, that in the light of new technologies, the apparent lack of some ethical guidelines, and the amount of money that seems to be up for grabs, others might be subject to what has happened to me. I think firmly that doctors must respect the rights of patients in these situations, especially patients that place in those doctors a complete trust. I have to go back and say that I had a strict patient/doctor relationship. I wasn't thinking of myself as a subject for some research project; I was, in my mind, a cancer patient in fear for my life, and I trusted completely and explicitly the advice and recommendations of my doctor. And it's that sense of trust that, I think, has to be guarded so very carefully in this particular situation on this kind of activity in the future.

I believe that the doctor has the duty and obligation to inform the patient-as patient, as research subject-in all aspects in the nature of what is being conducted, either in his treatment, his medical treatment, or in any research that is going on regarding the tissue and material taken from him, especially as it may relate to his health care at some later date, or as it may relate to some participation in a commercialized product produced from these materials based on that unique quality that he has provided to the researcher to conduct his research on.

Another particular aspect of this case, of course, is what I think is a disturbing aspect of the conflict of interest in the financial re

lationships that seem to have been developed between the doctor and the biogenetic industry or the particular firm in which the doctor had developed a very specific relationship. I know this point has been addressed several times today, but, I think, that it is a point that needs to be very carefully reviewed as this issue is further looked into.

Another point I wish to stress regarding my own feelings on this situation is that someone who has-well, I've faced cancer; I've had the disease; I've been told that I potentially had, if I was lucky, 5 years, by the original doctor that diagnosed my blood cancer. I believe I've sort of looked it in the face, and I have no desire to impede the progress of research or anything that would lead to the treatment and cure and prevention of these kinds of diseases; that's certainly not even close to the intention that I would have in this particular issue that we're bringing up.

But I also believe that a fully informed patient or research subject, or both, would be much more responsive to the research community and, I think, much more willing to give their all in terms of aiding and abetting that research.

Also, I think it would make-if this entire climate was more open, I think it would also make the breakthroughs in medical science more available, I think, to all groups, all researchers-disseminate the information regarding the research more completely throughout the community.

That really brings to an end my remarks. I would like to end it with the hope that the committee will continue to investigate and address the issues that we've discussed, and that we could have a resolution satisfactory to everyone with regards to this particular issue. Thank you.

[The prepared statement of Mr. Moore follows:]