as I stated in my written testimony, since the commercial value was not a matter that was discussed in that context at the time, one could read it another way and simply say that the disclosure is the nature of the research; that is to say, what is the information that we're looking for? So it would not be so clear cut that we would insist that any investigator who failed to disclose that would be functioning outside our rules.

Dr. Blake and Dr. Levine both said that an IRB alert to these issues might indeed go ahead interpreting the rules and require such disclosure, but, I think, it's not so clear that we could find somebody at fault if they failed to do so.

Mr. PACKARD. Let me followup on that with you, either Dr. Blake or Dr. Levine. How difficult is it to evaluate beforehand whether a research project-or a treatment procedure with a patient-will evolve into perhaps a marketable product?

Dr. LEVINE. I think-
Mr. PACKARD. Or a patent, for that matter.

Dr. LEVINE. I think-let me draw on experience where we know about the outcomes. I referred earlier to the fact that we take blood, urine, and so on in the course of doing drug trials where there already is a patent. And by the time we're in the middle of phase II, we're virtually certain that there will be a marketablevery close to certain-that there will be a marketable product. We state the purpose in the consent form. We further state our expectation of benefits to others, other than the patient. So far we have not been alert to advise these people that they're not entitled to share in the profits from that drug development.

To get to your more specific question, it depends upon-you can tell whether or not the researchers are trying to find something that could have commercial value. It would be very, very difficult to predict in which case they will find it. As I tried to bring out in my prepared remarks, for every success there are at least hundreds of failures. Now, if what you want to do is to negotiate in advance with people about what their share might be in the market of the product, you then have to decide how many people are entitled to participate in those negotiations. It could very well be that we'd have to advise very nearly everybody if you are persuaded-as I'm not—that all of the people who contributed themselves to the development of hybridoma technology in the first place contributed to the development of the monoclonal antibody I discussed.

Mr. PACKARD. How do you evaluate liability? I presume that for any marketable product coming out of our medical research, there are also side effects or there are some liabilities. Has there been any thought as to how you would divide out or apportion out that liability, not only as it relates to a researcher, funding source, university, industry that might participate, but a patient that might now be considered?

Dr. LEVINE. Well, see, I have not before thought of human beings as vendors of pieces of themselves, which once those pieces got out into the marketplace could be subject to considerations of product liability.

Mr. PACKARD. But in fact, if they were to be considered as bene factors, would they then-on the other side of the coin-be considered to be subject to the apportionment of the liability?


Dr. LEVINE. I think you'd better ask a lawyer about that.

Dr. MURRAY. Say it were a patented item. Would the holder of a patent be liable for somebody's—I just don't know what the law is on that regard. Or would the manufacturer be liable?

Dr. BLAKE. I don't know exactly the law, but Mr. Reimers raised this question earlier and I raised it in my prepared remarks.

If you could think of the scenario of a donor who is asked to provide some blood who is homosexual, who has never had an AIDS test and doesn't know whether or not he has AIDS, provides that blood under a sale arrangement, and it is then used as a product. It would seem reasonable to me for a court to decide for the plaintiffs that this seller of the original materials was at the very least negligent in not providing sufficient quality control over that product. And I raise that concern because, I think, there are more issues here in converting the donor to the vendor than have been raised in prior discussions of this.

Mr. PACKARD. Well, we had a hearing- I guess it was one of our other subcommittees—last week on product liability, which is a major issue in this country today; it is a major, major issue. And if there are salable products coming from biomedical research, with the law as it now is, the deep pocket theory, et cetera, you're going to have to deal—if you deal with benefits—to a division of benefits of a marketable product, then there has to come into the question the division of liability of those products.

Dr. LEVINE. I agree, certainly, that product liability is an enormous problem. I think it's worthwhile distinguishing if, for some reason, the patient or subject develops an equity interest in the marketable item, then as anybody else having an equity interest, they would have exposure to that product liability. Even a minor stockholder has, you know, far removed a little bit of exposure there.

Mr. PACKARD. On the other hand, if it's a major stockholder, then they have a little more liability there.

Dr. LEVINE. Of course. But I want to suggest, sir, that we are not talking now about taking pieces of the patient's body and encapsulating them and selling one here and one there. What we are doing instead is instructing a hybridoma, for example-we're instructing a cell, perhaps a bacterial cell-how to reproduce exact replicas of some piece of that patient's body. It is no longer a patient's body. I mean, I can go out and buy a bottle of adrenalin; that adrenalin is exactly the same chemical that my own adrenal glands make, but it is not as if it's part of me. Well, if they learned how to make adrenalin because they studied my adrenal glands and then pro ceeded to manufacture it and distribute it, it's not as if they're selling pieces of me; it's just that they learned, using a bit of my tissue, how to do this.

Mr. PACKARD. I understand.
Thank you, Mr. Chairman.

Mr. TRAFICANT. Dr. Levine, you gave me an example of how Yale would have handled the Hagiwara case, if I'm correct. Should informed consent be different in each case? Supposing the researcher doesn't know at the beginning, but midway realizes, the commercial benefit. What do they do then?

Dr. LEVINE. It's very common that in the course of conduct of research we find cause to revise informed consent. Usually we do this in prolonged protocols, in prolonged projects where an individual subject is involved for a long period of time. We may go back and say, for example—I think this morning you brought up the example of developing cures for acne. Well, that presented us with precisely such a problem recently, where there were reports that drugs that are being developed to treat acne could cause birth defects.

In the midst of those studies, then, we had the investigators go back to subjects who were already enrolled and say, "There is a new problem here. We call upon you to reconsider whether you want to continue." And for all the new subjects coming in, we advised them of this new risk, of which we were previously unaware.

Now, when we're dealing with the sorts of research we're talking about today, though, are generally one-time contacts; in fact, more commonly, no contact whatever. They take the blood; usually give the subject a bit of money-not to buy the blood, but we call it to pay them for their services" in delivering this blood specimen. And at that point the relationship between subject and investigator is terminated. They are finished dealing with each other.

Now if the investigator comes up with reason to suspect that something marketable is coming along, until this day it would not have occurred to the members of my IRB to ask that investigator to go back and find those subjects and renegotiate with them. In fact, as I discussed earlier, in the interests of preserving privacy interests, most commonly the investigator would have no way of discovering whose cells he or she was working with.

Mr. TRAFICANT. In line with that, and in regards to a hypotheses that, Dr. Murray, you advanced earlier relative to making a gift to commercial research, the patient is unaware of any commercial po tential of that biological gift. How is that particular situation resolved, or what is your response to that?

Dr. MURRAY. Well, I guess that's the big question today, how should we think about that, and at least what are the moral obligations and rights in a situation like that. Again, I really can't speak to the legal ones.

I guess I'll take recourse to my cookbook analogy. To the extent that we can trace back who gave the gift, to the extent that the gift is unmodified, to the extent that the gift is unique, and then somebody else got wealthy off it, our sense of justice might well be outraged by that if there is no effort to also compensate the person who was the giver of the gift. I urge that we at least think about it that way for a while, to see whether we might—whether it might not make sense.

Mr. TRAFICANT. Have there been any cases where those dynamics have developed and subsequent action similar to what you just discussed had actually and literally taken place, or remuneration was retroactive relative to a gift, where a potential was perhaps not understood?

Dr. MURRAY. I don't know. I didn't know about the Hagiwara case until today; I don't know how to think about that. Apparently, the family of the giver, under very peculiar circumstances, did end

up getting a piece of the action, of the gift. But that might not be a good case as a precedent; I'm not sure.

It's basically a new phenomena, so it's really hard—there's very little opportunity for that to have happened before.

Mr. TRAFICANT. In general terms to the panel, how do you characterize the nature of the doctor/patient and researcher/subject relationship now because of what rights and obligations presently exist for each now, and how well these rights and obligations protect the interests of each group? So specifically, in that relationship, Dr. McCarthy, in your regards—can you respond?

Dr. MCCARTHY. I think that traditionally, we have been concerned primarily that before the research subject enters into a research situation, that we create a situation in which the subject, so far as we can control the environment, the subject is uncoerced. Furthermore, the subject understands the nature of the research and enters into a trust relationship that Dr. Blake referred to this morning with the investigator. And generally, the motivation appears to be a combination of things-one, altruistic. Most subjects feel they are contributing to society. In the case where the subject is also a patient, the patient also stands to benefit, and so they have a motive for their own well-being.

We have not had many cases where there is something so unique and peculiar to this particular subject that-something that that subject has that no one else has—will turn out to be commercially valuable. Consequently, in most cases, even when a commercial product occurs, the commingling of resources from many, many subjects are involved and to date few, if any, of those groups of subjects have claimed any kind of share in the commercial product that might result. And so it really has not been a problem. The only case, as I mentioned, that has come to our attention is the one that's currently in the courts, and we don't want to prejudice that case one way or the other in our discussions of it. But we will watch it carefully, and should there be additional cases of this unusual situation where we can identify a single individual who provides something unique that subsequently turns out to be of commercial value, then, I think, we will have to consider, at least, whether we will amend the regulations. But I think hard cases tend to make bad law, and we would be reluctant on the basis of one reported case to change regulations that would affect thousands, perhaps hundreds of thousands, of research subjects all around the country.

So we are not prepared to act at this time, but that's not to say that we're indifferent or not watching the situation closely.

Mr. TRAFICANT. Before I move forward, is there anybody on the panel that disagrees with that particular response from Dr. McCarthy?

No response.)

What responsibilities or rights, in your opinion, do patients have to enquire about the commercial potential of research that uses their biological materials? If you could, Dr. Blake?

Dr. BLAKE. Let me first say that part of the consent procedure that we did not describe instructs the subject where that subject may go-to whom that subject may go-to obtain further information, so a person who can provide further information to the sub

ject is identified and is expected to provide answers to any questions that the subject may raise concerning the research. So if the subject either doesn't understand or wants information in addition to that which was disclosed in the consent process, they know where to go to obtain that information, and that is a requirement of the regulations. So it's always conceivable that a subject could obtain information about commercial results, even though that isn't set forth in the original consent document.

Mr. TRAFICANT. Relative to that specific policy that we talked about just briefly before we had to adjourn, we talked about a policy that the representatives of the respective disciplines were to, hopefully, prepare in a voluntary mode; failing that, you say, Congress must act.

Without belaboring the panel, has anybody come forth with any type of a policy? Is there such a mechanism in place, or are there any recommendations that have been placed before any congressional committee of any sort, to your knowledge?

Dr. MCCARTHY. Not to my knowledge.

Dr. MURRAY. I am not aware of any such, but I think the policy-I believe it was Dr. Blake who described it earlier-at Hopkins, how they split the royalties between the researcher, the inventor, the departmental research fund, and, I presume-does the university get the rest? That would be a model. It's quite possible to come up with policies like that that all parties can agree on as reasonable, and that has happened in other realms of biotechnology, in university/industry relationships, in research/university relationships. It seems to have worked fairly well; no one has addressed this issue yet.

Mr. TRAFICANT. Well, I want to thank you for appearing. You've been here for quite some time, and you've enlightened many of the members and answered quite a few questions. We would appreciate any other additional information you might have; you can submit it in writing. So at this particular point we'll move forward, and I'll turn the chair back over to our chairman.

Mr. VOLKMER. I, too, wish to thank the last panel.

Our final panel consists of one person, Mr. John Moore. I would appreciate it if Mr. Moore would come up to the witness table, before a microphone. And let the record show that Mr. Moore is accompanied by his counsel, Mr. Gage.

Mr. Moore, do you have a prepared statement?
Mr. MOORE. Yes, I do.
Mr. VOLKMER. You may proceed with reading that.



Mr. MOORE. First of all, I would like to say thank you for the opportunity to express my particular story that involves this area that we're talking about, discussing today, really, from what I consider as the “person" aspect of the issues that are involved.

I think I have a rather unusual story, and I'd like to have the opportunity to share it with the subcommittee at this time.

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