MR. SELIGMAN: Stuart Farber.

MR. FARBER: I don't have a booming voice like Dr. Egilman, so I'll need the mike.

My name is Stuart Farber and I'm here as a representative of an endeavor that I've gotten off the ground called Radium Experiment Assessment Project, which represents a broad variety of individuals who received nasal radium irradiation either experimentally or medically throughout the time it was in vogue.

The issue initially was going to be ignored by the Advisory Committee but I'll explain a little bit of the history and how it came forward.

As noted, it became the most risky of all experiments noted in the final report but they still managed to avoid any notification or follow-up recommendations.

I basically am an environmental scientists trained in radiation risk assessment. I've got 20 years in radiation monitoring in the environment around fixed nuclear facilities primarily and I've spent my whole career designing radiation monitoring programs. I'm not involved as -- really, I came into this very much from left field.

Back in 1991, I co-authored a letter to the editor of the New England Journal of Medicine called Radium Exposure of U.S. Military Personnel and it was co-authored at the time with Dr. Allen Ducketman who was a former Navy epidemiologist to whom I brought the issue to his attention.

At that time, he was involved in not in radiation epidemiology but chemical assessment in his prior career. He was impressed with the size of the cohort involved in terms of approximately 10,00 submariners received this treatment through the Navy as part of their training in Groton, Connecticut, and he investigated through his associates in the Navy what went on with this procedure.

He came back to me and basically said to me, this is the biggest bleeping cover up I've ever seen. I'll agree to write a letter to the New England Journal with you. That's as far as I can go.

We co-authored the letter and we brought it to the attention of the scientific community. The responses, as I've said before in some of the presentations, was underwhelming.

The Navy was given a chance to respond and at the time they said much the same. Military individuals involved had a right to privacy, not a right to know, as we had suggested, that they were at risk. They also said the risks were so trivial that they kind of were in the range of, as they put it, food additives in the food supply and it would be impossible to ever ferret out. Therefore, a meaningful study could not be completed. And they dismissed the entire issue out of hand.

So the issue sat there basically in nowhere land in 1992, January 2nd, '92. In early '94, when the whole human radiation experiments issue came forward, I decided that if this issue was ever going to get the attention it deserved in the context of the focus on human radiation experiments, this was the time to do it. I set out on a little campaign to give attention to it.

I started interacting with a number of Senators and Congressmen and news media and in a short while we had articles all over the country. The Albuquerque Tribune did a feature article -- oops, it's not part of this one. It's called -- they did an early article in January that went national on the Scripps-Howard news wire. People started to call me. I started to realize the broad scope of this within the civilian community. And dozens of articles got written.

I thought I'd have an overhead transparency projector but I don't.

Articles got written everywhere about this issue and it continued to expand.

Senator Leiberman finally held a news -- not a news, a Senate subcommittee hearing assessing the effects of nasal radium or radium treatments, August 29th, '94 at which I testified on the issue, at which he finally dragged to the table some representatives of the Army, the Air Force, the Navy, myself and some submariners who were trying to organize around the issue, and put forward some document that basically the government bureaucracies involved committed to nothing at the time. They just said we're not notifying anyone of anything. It was the final answer as a result of that Senate Environment and Public Works Committee Subcommittee on Environment, Clean Air and Nuclear Regulation hearing.

The issue kind of faded a bit. Again, in early '95 -- I should say at that time, Senator Leiberman petitioned the President in a letter, a direct letter, to include nasal radium irradiation as a human radiation experiment. He wanted the President to direct the Advisory Committee on Human Radiation Experiments to take up the issue and that petition and that entreaty was ignored.

In early '95, I wrote a detailed letter to the President's Advisory Committee in which I laid out the technical basis for them in evaluating the issue as a human radiation experiment. I noted in that letter regarding the 7,600 military personnel who, as part of published reports, were noted as being subjects of an experiment that met the definition of a human radiation experiment per the Executive Order that set them up.

I said their actions appear to highlight an inconsistent and illogical approach to the mission of the Advisory Committee. This failure by the Advisory Committee to fully review the implications of radium experiments on military personnel, even after that earlier pressure from Leiberman, coupled with the failure of the Navy, Air Force, CDC, VA and HHS to commit to taking any definite steps to even provide notice to irradiated vets regarding potential effects represents a serious failure by the U.S. government.

They finally did an internal memo shortly after that. "They," being the Advisory Committee staff to the Advisory Committee. They put together a memo reviewing the issue, claiming they were going to take it up in a public meeting shortly thereafter. This was March 27th, '95.

In that memo, Dr. Eli Gladstein, one of the members of the Advisory Committee and the most senior radiation oncologist on the panel was quoted as saying, "I think there is no question these individuals need to be monitored. I'm not sure we can, quote, protect their health, but they should be monitored to see if there's any substantive problem that results from their exposure."

When the final Advisory Committee report was written, all the content of the final report came from that memo with the exception that the notice recommendation was dropped.

When I first learned that the recommendation for no notice and no follow-up of nasal radium irradiation, I called the American Brain Tumor Association of the North American Brain Tumor Coalition, which are independent medical groups involved with brain cancer risk. And I asked them, do you agree with these recommendations. The doctor I spoke to, their medical advisor, said who are the doctors on this panel. I can't believe they would come forward with such a recommendation.

I said Dr. Eli Gladstein was one. She goes, he can't agree with that. He's too knowledgeable. She said, you call him up and tell him we're going to protest these findings and get his reaction. See if they'll change it.

I called Dr. Gladstein and I read him the quote I just read you that was in that memo. He said, yes, those are my feelings. I feel they should have been notified. I said, why did none of that make it into the final report. He said to me, this was a Committee, as you know. I was outvoted 13 to 1 by the other Committee members not to notify anybody about it.

I said, on what basis were you outvoted? What were the considerations? He said, the other members said they could not come to a recommendation to notify this many people because it was not saleable in today's political climate.

When I said to him that's an outrage and that you should have filed a minority report or still could because this was September, prior to the issuance of the report, he said to me, you have to remember on filing minority reports, I was appointed by the President and it's not polite -- and this is an exact quote -- it's not polite to make waves.

And I'm sorry, but this is gross hypocrisy. These are conflicts of interest. These are people covering their butts.

The medical profession is protecting the medical profession against what they see as opening up risks to their interests, very narrowly defined. This is not ethics and science and medicine brought to right past wrongs. This is an utter abuse of the process.

(Applause.)

MR. SELIGMAN: Thank you.

Paul Schulte?

MR. SCHULTE: Thank you.

My name is Paul Schulte. Prior to my current job I was Chief of Screening and Notification Section for NIOSH in Cincinnati, Ohio. Today I'm here to talk to you a bit about the NIOSH approach to notifying subjects of its epidemiologic studies. There's been some mention of the NIOSH approach and to the extent that it can contribute to this discussion, I will try to give you a brief overview of it.

When we're talking about notification, in our terms -- and we use the term worker notification -- we mean informing the subjects of epidemiologic studies of the results of those studies. This seems a fairly simple process but indeed it's quite complicated. And until the mid-1980's, no one routinely did this.

No government agencies, no labor unions, no corporations actually informed the individual subjects of epidemiologic studies of the total results of those studies. We were the first people to push this concept, starting in the 1970's, after groups went before Congress at the behest of the labor unions and various concerned citizens and the directors of NIOSH and the National Cancer Institute were asked by the Congress why they didn't notify such subjects.

The response of the Director of NIOSH was as follows: We do disseminate information to the participants in our epidemiologic studies, and we do it by telling companies and unions, by putting it in the scientific literature, by passing it on to representatives of workers, if there are no unions, and by posting the results in plants.

So it wasn't that NIOSH didn't do this. In fact, we did it quite extensively. It was that there was more of a realization that individual people might have use for this information.

What wasn't gathered in this discussion was the fact that epidemiological research doesn't tell specific risk information about individuals. Epidemiologic information tells information about groups. The best one can say at the end of an epidemiologic study was this group had such-and-such a risk of disease.

And so to an individual person, to tell them what their risk is, there's no specific way of doing that. All one can say is you were a member of this group. If you had the average exposure of this group, then your risk might approximate what the group's was. But an epidemiologic study on its own does not give that kind of information.

Nonetheless, we felt that it was important that NIOSH notify the subjects of epidemiologic studies of the group risk, and so we proceeded to evaluate the situation and found indeed that we had a backlog of some 60 to 100 studies that we had completed where we had done public dissemination but where we hadn't done individual notification.

We went through a process to try to identify which of these 60 to 100 studies required or could be candidates for notification and we separated from them all the ones that were negative, all the ones that were incomplete and it brought us down to a group of 64 candidate studies. We then looked further and found there were actually 29 that might be candidates for notification.

Well, how did we make this kind of decision? We asked our board of scientific counselors, which is an independent group of scientists who advise NIOSH on how to conduct its research and affairs, to give us some guidance in this area and they came up with a set of criteria that said look at the following factors:

Is there substantial evidence of an association between an exposure and a disease? Was the study done -- did it have good methods to be able to make such a conclusion? Were the results plausible biologically? Were they consistent with other findings?

And they said use these as guidelines in assessing these candidate studies and on that basis, try to make a determination.

They also -- and just to remind you of the point that was made earlier. These were not exposures caused by anyone. These were the effects of workers' experience in particular industries or in particular jobs. And what we do in those jobs is -- in those kinds of studies, we go into a factory. We identify all the people that had ever worked there. We find out who's alive, who's dead, and we look at the experience of the dead people to see if the patterns of death by type of disease or cause of death differ from the general population.

Notification, then, is of the surviving people who were in those groups or cohorts. That in itself is a bit of a leap because we don't know that the people who are in the surviving groups had the same kind of experience and exposures as the people who died. But we felt that since we could identify this population and because we had the names and addresses of these people, which is a crucial and important bit of information, that we could reconstruct actually the full group that worked in these plants, that we could then fairly confidently target that information program to notify them of the results of the study.

Then the advisory group who gave us the guidance to do this kind of notification also said, you can notify in a number of ways. You can use a range of options, and they gave us three options from very general, which is the kind of thing that we had done in the past, broad dissemination, to individual notification.

And generally, the only kinds of studies that met the criteria for individual notification were those that -- they gave us two criteria; one for relative risk, how the risk in these workers compares to the general population. And they said when the risk there is about 200 percent would be the category that would be important to look at. And they said if the lifetime risk attributable to this exposure, the exposure that we were studying, was larger than one in 1,000, and when you had the convergence of those two kinds of risks, then you should consider notification. And they clearly made it that this was a matter of a suggestion, a recommendation, but not necessarily a hard and fast rule. And they said to use professional judgment.

So that's the approach that NIOSH has used. It's been very difficult.

I see my time is up. I'll stop and I can fill in further with questions.

I think it's important to remember that there's a difference between what NIOSH has done with epidemiologic studies and other kinds of experiments that are being discussed here.

Thank you.

MR. MILLER: This is a very interesting panel for me to be on. I received a phone call a week ago inviting me to come down for this.

Now, just in the interest of full disclosure here, Dr. Egilman has at times counseled either our union or plaintiffs we've been involved with and has provided excellent work to us.

Geoff Sea has actually I followed in Geoff Sea's shoes in a number of occasions when I was stumbling around various DOE facilities and said, oh, yeah, Geoff Sea pointed that out a few years ago.

Recently, we had a particularly contentious situation in Fernald in which the management wanted to remove the workers' health and safety provisions, which included, by the way, rights to access to information on body snatching. And lo and behold that language had been drafted by Geoff Sea and hammered out in 1985.

So I just thought I would acknowledge some panelists who I haven't seen in years. In fact, I hadn't met Geoff Sea until today. And we were both schooled under Tony Misake so I guess we're bound by something here.

I want to just lay out what our stake is in this because we have not been a central player. I've been an observer. Our union's been observing with some interest the Advisory Committee's work.

What's at stake is that if there's going to be a medical care provision -- and I'm going to choose words carefully here -- as opposed to medical surveillance, if there's going to be a medical care presumption that's afforded to people, I don't want it to be inconsistent with or set a lower standard than that which should and could and needs to be afforded to workers.

In other words, if we have differing standards and criteria for providing care, then what ends up happening is we wind up getting played off against, one group against another, for the lowest common denominator. So I want to just flag that as an issue for the Department of Energy when they think about this.

One of the things that jumped out, at least for me, in reading the appendix to the Recommendation Number 4, was that they said, okay, prisoners with up to 600 rad of exposure to their testicles would not be notified. They would be afforded, though, voluntarily, if they wanted to get health care.

Well, our concern is that if any worker that we represented had 600 rad of exposure to a particular organ, we would start with the presumption that they should be notified and we should start with the presumption that they should be afforded continuing health care.

And I don't want to pick at the Advisory Committee's report, only that stood out because it was so clear to me that there was a distinction to be drawn between how workers would be afforded.

Now, Senator Glenn and Congressman David Skaggs passed a piece of legislation in 1992 which was part of the 1993 Defense Authorization Act which provided for -- well, some will call medical surveillance. We view it as a medical care obligation to a certain extent.

It was very interesting in the debate over this legislation -- and the reason I'm going to lay out the politics is that we came with a comparable set of demands to the table and said workers who worked in Rocky Flats and Port Smith and Hanford clearly had had a tremendous amount of exposure. People were in denial.

There were studies done that were designed to be inconclusive and we knew for a fact that what the Advisory Committee revealed, which was that lo and behold the employees weren't told about the problems because they're worried about bad publicity. They weren't told because they were worried about litigation. And they're worried about higher union demands for wages, my god, for high risk activity.

And, of course, it's what we all suspected. And it really nice to see it spelled out in some of the Advisory Committee documents that at least I hadn't seen. And I want you to know that we're using that for our training materials for our worker health and safety program, much to the chagrin of the contractors. They think it seeds a bad attitude. We think it's creates a good attitude because you watch out for yourself first.

What I want to raise, though, is if we're going to have -- let me back up. First, it's our concern that if you think you want medical surveillance, you'd better ask whether surveillance is going to find anything because you may spend a lot of money on very expensive tests. You may notify people, give them laboratory tests. You may send them to doctors. You may spend thousands of dollars and you may not learn anything because the reality is that with the exception of certain defined types of exposures, it's very hard to know.

And in fact, our hunch is that, as I say, unless there's a really good likelihood that surveillance does you any good, don't waste money on it.

Secondly, this Advisory Committee and the various interagency groups, I have heard estimates of $20-22 million has been spent getting the report and the documents, the research, the disclosure, maybe getting you all to this point and the public to the point where they understand what they know.

Here's the question. What is the likelihood that even $20 million will be afforded for any kind of follow-on care? What is the likelihood of appropriating even that level of funds?

This is not a question to say you shouldn't try or that in this political climate our realities should be somehow tempered. The reality is that four years after -- at least from our point of view -- four years after Congress passed legislation to provide some kind of care for former workers, we still really don't have a funded program out there.

And so all I can say is that it really does take a level of outrage. It does take a sense of mobilization. It does -- I have to confess here. Dr. O'Toole probably hasn't heard me say this before. But we probably should have sued her a long time ago to compel and get the program off the ground. Because being polite didn't really get us where we wanted to be. Okay?

But nevertheless, you know, we may not have gotten a whole lot more, even if we had the Justice Department sit down and work out a settlement with us. And I don't know what the best path forward is in order to get medical care, but I do think that medical care for people who have been harmed is valuable.

However, I question this. Is it necessary, is it valuable, is it appropriate to take people who -- notify people on a broad scale basis where you set some arbitrary risk level, you create some presumption of care and you say does everybody get entitled to it? Is everybody entitled to care, whoever has been the subject of any tracer experiment? Who's been the subject of any experiment whatsoever?

At the point at which you do that and you have to arm yourself to make the case to get the resources to do it, just keep in mind you're in a fight with us on the other side to try to accomplish exactly the same thing for the workers who have been deceived in working in these facilities. There is a competitive political marketplace out there.

This isn't a message not to advocate your position. It's simply a message to be aware that we have a stake in how well you succeed in establishing an appropriate level of care. And we want you to succeed. And at the same time, we're also out there on the Hill lobbying from the same Congressmen and Senators for resources to care for in many cases former workers.

Finally, I guess, we had a question we posed to the Advisory Committee: What is an experiment? If workers go to work and they're told they're protected by the boss, the boss says we're going to look out for your well-being and we'll tell you if you're not being properly cared for or that if something happens to you, we'll notify you. And we know, of course, that that didn't happen.

And then there were studies done to examine what happens to those workers over their course of employment or after they leave their employment and they do morbidity and mortality studies. And the workers never volunteered to become part of anybody's study. They just wanted to show up and get a paycheck. And they became parts of studies. And I would only leave open this. We've always been very curious that if you're in an employer-employee relationship and you're subjected to whatever the working conditions are, and we know that the employer has not done everything they reasonably and possibly can do to protect the well-being of the individuals and they then turn around and study them and we all advance medical science as a result of it, aren't they also subjects in experimentation?

And that is not simply something limited to the government. It is the conduct of industry and business today.

I don't have anything else to add.

(Applause.)

MR. SELIGMAN: Okay. Thank you.

I'd like to take a 15 break now. We'll reconvene at 11:05 for further discussion.

(Whereupon, a recess was taken.)