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Gulf War Illness Update Briefing with Dr. Bernard Rostker and Dr. Ross Anthony

Presenters: Dr. Bernard D. Rostker, Special Assistant for Gulf War Illnesses
April 19, 1999 1:30 PM EDT

Also participating in this briefing is Dr. Ross Anthony, Rand Corporation.

Captain Doubleday: Good afternoon.

This is a special briefing with an individual who I think is well known to most of you. Dr. Bernard Rostker is the Under Secretary of the Army and also our Special Assistant to the Secretary and the Deputy Secretary for Gulf War Illnesses.

He is going to give an update on the Department's continuing efforts to investigate and to gain greater understanding of the illnesses which afflict so many of the individuals who served during the Gulf War.

He's brought with him part of his team of experts to help out with the briefing, but Dr. Rostker will start first and then turn it over to other experts for more on this, and then we'll be happy to answer some of your questions.

Dr. Rostker?

Dr. Rostker: Thank you, Mike.

We are releasing today a case narrative prepared by my office and the Rand Corporation which is under contract to us to do a number of analytic tasks. We're releasing two papers. The first paper on military use of drugs not yet approved by the FDA for CW/BW detection. And an important paper on the scientific literature as it pertains to Gulf War Illnesses, and the topic here is depleted uranium.

I'd like to spend a few moments talking about the cement factory case. This is the 14th case narrative describing the potential uses of chemical weapons during the war. This particular case narrative deals with a reported chemical incident in which two Marine Fox vehicles alarmed for a chemical agent. It's an important case because it's the first example where actual soil samples were taken and where Fox, at least one of the two Fox vehicle tapes have survived.

The results of the soil samples were analyzed within weeks of their being taken. They were analyzed here in the United States and they both showed no indications of chemical agents. They did show residuals from hydrocarbons and diesel fuel, and those are properties that could have caused the false alarm.

Unfortunately, when the samples arrived in the United States, it was noticed that they were no longer airtight, so it is possible that there was some evaporation of substance during its shipment. For that reason we can't be perfectly sure that there were no chemical agents at the time the samples were taken, but there certainly were no chemical agents when the samples were analyzed, there were no residuals or breakdown products from chemical agents.

Two Fox vehicle tapes were taken at the time. They have not been located in government archives, but one of the tapes was duplicated by the Fox vehicle driver. That tape has been analyzed by two independent laboratories and again, it shows no indication of chemical agents. The indications are consistent with the assays from the soil sample.

We made the judgment that it was definitely, the site was definitely not a chemical fueling site for mines because no chemical mines have been located, there's no indication that the Iraqis had chemical mines.

In terms of chemical agent we've made a determination that it is unlikely that there were chemical agents there. That's based upon the samples. We could not be totally sure because of the inability to preserve the samples in a pristine manner, in an airtight container, and the missing Fox tape. But all of the evidence that is available points to the conclusion that chemical agents were not present.

This is an important case because it also illustrates one of the main lessons I think to be learned from the Gulf. These findings were never communicated back to the Marines who made the initial detection. In fact upon their inquiry during the Gulf War period they were told they didn't have a need to know. That's very unfortunate, and we have been stressing with the Chemical Corps the importance of documenting all alarms, whether it's later determined to be false or not, and preserving all of the evidence and providing that feedback to those who were engaged in the possible detection of agents.

We found in a number of cases where this has not been done it's resulted in suspicions, it's resulted in reports that later have been determined not to be chemical agents, but it's important that we provide that follow-through and we'll continue to work with the Chemical Corps and the services to ensure the change in doctrine.

I'd like to introduce Dr. Ross Anthony from the Rand Corporation who will talk about these two papers which Rand is releasing today.

Rand has been doing a number of analytic studies for us. I think probably the most important are those relating to the review of the scientific literature that pertains to some of the suspected cause for unexplained illnesses in the Gulf. And as many of you know, depleted uranium has been an issue of concern and Dr. Anthony's prepared to summarize the Rand findings. The reports are available, and both Rand or my office are available for further inquiries about the findings that Rand is presenting today.

Ross?

Dr. Anthony: Thank you, Dr. Rostker.

I'm pleased to be here today to release on the part of Rand -- and for those of you who don't know, Rand is a non-profit research institute dedicated to research in the public interest. We're today announcing the release of the two reports that were so indicated already by Dr. Rostker.

I am the principal investigator on all of the reports, and if you look on the second page of either report there is a whole list of the entire list of projects. As such, I'll try to summarize briefly the reports, but I am not the primary author on either report. If there are any other questions that need to be followed up on, I'd be glad to get you answers to those.

We actually have engaged in two kind of separate categories of reports. One is the scientific review of the literature which depleted uranium fits into that category and I'll talk about that second. There are eight of those reports. Then there are a set of other reports on other issues, more policy oriented. The first report which we'll talk about is the military use of drugs not yet approved by the FDA for CW/BW defense. That report by Dr. Dick Rettig reviews in essence the history around the relationship between the FDA and the Department of Defense when the Gulf War began to, in essence, allow for the use of, in this case, two specific investigational new drugs -- PB and the BotTox vaccine.

There was an interim rule that was approved allowing for the waiver of informed consent so that those products could be used during the Gulf War. But frankly, that regulation, once the war was finalized, lay dormant for some time. There was a lot of discussion back and forth which the report goes into in great detail. Finally, in 1997 another rule was, at least a publication of a rule for comment was put out to finalize the rule. The discussion was reactivated.

Frankly, the whole discussion revolves around who has the authority to order the use of these drugs. Is it the FDA under the Food, Drug and Cosmetic Act? Or does the preeminent power lie with the President of the United States as the Commander in Chief of the military?

The issue was in fact finalized or at least decided by Congress in the so-called Byrd Amendment last year. If you look in the text on page 97 there's a postscript that deals with that. Now the President of the United States has the authority. However, there are a number of conditions to that authority that are laid out on page 98 including a written order must be put forth that puts forth reasons for obtaining that consent, including it is not feasible to do something else, it's not contrary to the best interest of the member, and it's in essence in the interest of national security.

Although the law has been passed, this has not been yet formalized in regulation, so this report we feel is very timely and offers a great deal of information and a historical sense to help people be provided information on those issues.

The second report's on depleted uranium, and I'm listed as a fourth author there. I'm an economist, as Dr. Rostker indicated. But as we started to look at the issues around depleted uranium, it quickly became apparent that there were two primary areas of concern. One of the radiological effects of uranium; and secondly are the toxicological effects. So we at Rand decided that we needed to get expert help and assistance in putting together this report and went out to find some experts that were recognized, but also who had not, in addition to being recognized, had not written extensively in the area so that they were thought to be biased on one side of the equation or the other.

Naomi Harley is the radiology expert, and Dr. Ernest Fooks is the toxicological expert. You'll find at the end of the report on page 119 there's a short biographical sketch of each one if you're interested.

In addition to that, we felt it was important to get medical expertise in the form of physicians, so Dr. Lee Hillborn is also an author. He is a long time Rand researcher, and he's also a physician at UCLA in charge of quality at the UCLA Medical Center.

Arlene Hudson did much of the research, while I, as the fourth author, primarily pulled together reports, made sure that all the parts were consistent. Oftentimes there were small differences, and we wanted to be sure that we had a report that represented all of the scientific literature.

What we did is we tried to review in an impartial way the scientific literature as relates to depleted uranium and come up with whatever conclusions seemed appropriate.

First of all I might indicate that the literature on depleted uranium is not great, however the literature on natural and enriched uranium is really quite prolific, and that's important because in the case of the toxicological effects of natural uranium it's exactly the same as depleted uranium because of their chemical characteristics.

On the other hand, in the case of the radiological effects, you find out that natural uranium is 40 percent less radioactive than depleted uranium, so any conclusions that you can draw on natural uranium, say of a negative nature, can be applied equally well to depleted uranium.

Having said that, let me briefly outline the structure of the report, and then I'll try to summarize quite briefly the conclusions, and I'd recommend the entire study to you for further details.

What we did is we looked at the radiological and toxicological effects by the various routes of exposure. And in this case there's external exposure; and secondly there's internal exposure. In the internal exposure category you actually have either ingested, inhaled, or embedded fragment exposure. The report deals with all of those cases, and also takes a look at a few other issues like the effects on reproduction, for instance, also.

Let me try to summarize the conclusions briefly and quickly, and I'll read at least one of them from the text so I'm sure I quote the authors accurately.

In the case of external exposure, really we're only looking at the radiological effects. We don't really have any toxicological effects to look at. You find that the primary particles emitted by depleted uranium are alpha particles. They do not penetrate the skin. And all of the studies indicate that they really have not been found to be a negative health problem.

In the case of internal exposure, let me deal with the toxicological effects first. What happens both in ingested or inhaled exposure, eventually some of the particles or the depleted uranium reaches the bloodstream, and research has found that the most important or the target organ is the kidney. So what we were interested to see is what effects might happen on the kidney as the organ that would be most radically affected. We found in looking at the literature that although it's certainly true at very high levels any heavy metal will have effects on the kidney, we do not find that the levels of exposure likely in the Gulf War, that there were any consequences in the literature of those levels from a toxicological perspective.

On the radiology side, actually the findings were similar. At the levels we see in the Gulf War we did not find that the radiology would have any real effect.

I'd like to read one quote that I think puts both of those in context a bit, and explains why in fact you do find that. I'm reading from page 18 of the summary of the text. "Although any increase in radiation to the human body can be calculated to be harmful from extrapolation from higher levels, there are no peer-reviewed published reports of detectable increases of cancer or other negative health effects from radiation exposure to inhaled or ingested natural uranium at levels far exceeding those in the Gulf War. This is mainly because the body is very effective at eliminating ingested and inhaled natural uranium and because the low radioactivity per unit mass of natural and depleted uranium means that the mass of uranium needed for significant internal exposure is virtually impossible to obtain."

The reason for that is that the body is just extremely effective at taking whatever is ingested or inhaled and in getting rid of it, so in fact the levels that you would need or the amounts that you would need to inhale or ingest to get a toxicologic dose are really quite high.

Now let me turn to the final category which is embedded fragments. And the case of the Gulf War is the first time we've really seen evidence or had evidence to research of embedded fragments. There's an ongoing program right now at the Baltimore VA Medical Center to look at 33 people that have been identified as being in vehicles that were struck by depleted uranium munitions, and I believe 17 of those people actually have embedded fragments.

They have been studied quite extensively by Dr. Melissa McDiarmid and her team, and if we look at them as the most exposed group we find that they do have elevated urine uranium levels, and that there are some other tests that she cannot fully explain, and that these people do have some significant health effects as a result of their wounds. But when one looks at the actual effects of depleted uranium, one finds that there is neither toxicological or radiological negative health effects that she's been able to identify.

So with that in mind, we believe and conclude in our report that we believe that research should continue on this issue, particularly in the case of the embedded fragment issue. Primarily because this is a new area. We don't know everything there is to know there and we believe that research should continue. Also because this has been a real concern for veterans in general and we shouldn't leave any stone unturned if there in fact are additional studies or research that would add light to the problem.

That pretty much summarizes what I have to say. I'd be glad to take any questions, and I know that Dr. Rostker wants to indicate a bit about some of the follow-up training programs that they're doing at OSAGWI.

Q: I have a question on the uranium. Does this in essence essentially rule out depleted uranium as a potential cause for this Gulf War Syndrome? That's what a Veterans' group representative who was briefed on this said to him that's what it means.

Dr. Anthony: It means, and I'm going to stick to our charge. I want you to understand what my charge is. My charge is to look at the scientific literature, and we're combining that, at least Dr. Rostker's office is combining that with what actually happened in the Gulf War, and you have to bring those two pieces of evidence together. Sometimes one outweighs the other one. But at the levels of exposure that I'm aware of, and unless there's something that I'm not aware of, the scientific literatures does not find that there is a negative health effect. You can draw the inferences that you wish to, but that is in fact what the scientific literature has indicated.

Dr. Rostker: We had a statement that has been reviewed by the President's Special Oversight Board, it's on page 10 of our original case narrative, and let me read you that one sentence. "Based on data developed to date, the Office of the Special Assistant believes that while DU can pose a chemical toxicity and radiological hazard under specific conditions, the available evidence does not support claims that DU caused or is causing the undiagnosed illnesses some Gulf War veterans are experiencing." So that is the position we've taken.

Q: That's on the report...

Dr. Rostker: Page ten of this report.

Dr. Anthony: I might add that in some senses you shouldn't be surprised by the findings in the Rand report. They are consistent with every other group's that I'm aware of, whether it's the Institute of Medicine, the British have put out a recent report, and a number of other groups have reached similar conclusions.

We think this is a useful document because it pulls all that information in one place and tries to present it in a way that is acceptable to veterans and the scientific community, but it's not, in essence it's not inconsistent with what we've seen before.

Q: Could you tell us a little more about the 33 individuals with the embedded fragments?

Dr. Anthony: What would you like to know?

Q: Who are they, where do they come from? Is it listed in here?

Dr. Anthony: It's not. There is a small... We've primarily dealt with the published peer-reviewed literature, and although we have included that information because it's obviously quite important, but there has not been much of a published record so far, so all the results, although we did give the VA an opportunity to review this so they were sure we quoted them correctly, I think you have to keep in mind that anything that's in this publication actually is preliminary and subject, of course, to the changes that they find.

I have not spent a lot of time doing that but I think there are some others, maybe Dr. Kilpatrick or Dr. Daxon who are more familiar with actually what's going on there, can provide you more specific information if you'd like.

Q: Yeah. Who are these 33?

Dr. Rostker: These 33 are soldiers who were involved in friendly fire incidents.

Q: Do you have a list of their names?

Dr. Rostker: We certainly do but because of privacy considerations it is not available.

Q: What's the privacy considerations? Have they asked they not be identified?

Dr. Rostker: Under the law, they constitute a requirement that we not make that information available. You're welcome to contact the VA in Baltimore. They're the ones who are running the study. If they want to make those names available...

Q: Did you make them available to the Rand Corporation?

Dr. Rostker: No. They reviewed, the interviewed Dr. McDiarmid and have talked about her findings. They have not discussed individual medical cases with Dr. McDiarmid. That would not have been appropriate.

Q: Do you have a list of these incidents where it happened?

Dr. Rostker: The incidents are in this case narrative. They constitute the tier one incidents. We've extended the medical program to all tier one soldiers and all those engaged in cleanup that would have been exposed, those are tier two. They have all been... We've attempted to notify every one of them. Most of them have been notified and some group of them have gone to local VA or DoD hospitals to participate in the medical screening. That screening program continues. Dr. McDiarmid, completely independent of the Department of Defense, is the prime investigator. We've done everything we can to support her investigations.

Q: Seventeen of these 33 have...

Dr. Rostker: Embedded fragments. These are very small fragments that are too small to be removed surgically.

Q: But they're radioactive?

Dr. Rostker: They are depleted uranium, and the 17 have elevated levels of uranium count in their urine.

We can provide more information, and let me get one of the experts.

Col. Daxon: This is really a good news story because it's something that the Army basically initiated on its own to try to follow these veterans up. It was identified in theater that this follow-up should take place, and the Office of Surgeon General started the follow-up.

We basically transferred the program to the Department of Veterans Affairs. I really don't know the timeframe, but I can get it. So that they would follow them.

Part of the logic was the Department of Veterans Affairs is going to be home for a lot of us when we're finished, so we wanted that continuity of care. The other part of it was the folks in Baltimore are pretty darn good.

Q: The 17 have radioactive particles in their bodies now?

Col. Daxon: As do we all, but yes, they have embedded fragments.

Q: I mean they have a little more than I do, I think.

Col. Daxon: Yes, sir.

Q: What are these levels? Is it in this report?

Col. Daxon: Yes, sir. It is.

Q: Are you saying it's not harmful? Is that the conclusion?

Col. Daxon: The direct conclusion that we got from the folks at the Baltimore VA, is that right now we should use standard surgical removal procedures for removing fragments, which means in terms of balancing the risks of surgery versus the risk -- which is really what you're talking about -- of allowing these fragments to remain, at this point in time the risks are comparable to lead, steel, and other shrapnels in the body.

Q: These 17, have you weighed these decisions and found you can't surgically remove these fragments?

Col. Daxon: Absolutely. The first time I heard about this my initial response was take it out. But when you see the X-rays, and it's not just one, but it's like a shotgun shell. I showed this to a surgeon. His first response was, well, take it out. I showed him the X-ray. He said oh, now I understand. Maybe you could get that one, maybe you couldn't get that one. But each one of these, there's one individual where we counted anywhere from 10 to 20 fragments that range from very small to something maybe half the size of a pinkie. Each one of them is a separate surgical operation, to the point where if you tried to take them out, the individual would lose probably the use of his leg.

Q: My understanding of radiation is it accumulates in the body.

Col. Daxon: Absolutely.

Q: It isn't eliminated. So is there an accumulation process going on with these fragments?

Col. Daxon: By accumulation, is the dose increasing with time? Yes, it is. And that's being considered in the decision to remove it all.

The thing to remember, I need to correct one thing, depleted uranium is 40 percent less radioactive than the natural uranium you all have in your bodies right now. That gets factored into dose equations and we basically include that as part of the risk of allowing these fragments to remain.

Q: Could you project toxicological effects on these 17?

Col. Daxon: No, I can't project it, which is part of the reason that we're following it. Based on the stuff that's been in the past, the level that they're excreting in their urine are such that we don't anticipate any effects on the kidney, and that in fact has been seen so far for this particular population, and we don't anticipate any radiological... I shouldn't say that, but the risks, the radiological risks are within acceptable ranges at this point.

Q: What would be threatened initially by even these low levels? The lymph nodes or...

Col. Daxon: Low level of radiation or the chemical part?

Q: What part of their bodies are...

Col. Daxon: The kidneys. Chemical toxicity is the primary thing we're talking about.

Dr. Anthony: They dissolve over time and circulate in the body and are partly excreted, but the kidney is the part that is the most susceptible.

Col. Daxon: And there are some very specific tests that can be done to determine. What we found is the kidney is exceptionally robust, even with occupational exposure for very, very high levels, much higher than we have right now, the kidney has basically recovered.

Q: What's the prognosis on the 17 men?

Col. Daxon: I really can't answer that. Dr. McDiarmid can. But right now I believe it's pretty good.

Dr. Rostker: In terms of radiation, these are men who survived a very traumatic event, being their vehicles were hit with depleted uranium rounds. They are, frankly, lucky to be alive. These are extremely lethal weapon systems which have given us a tremendous advantage on the battlefield. So the soldiers we're talking about here have first and foremost battle injuries that are not directly related to uranium per se, but are related to their vehicles being brought under fire.

In terms of the radiation, there are no impacts to date. We continue to monitor them. Dr. McDiarmid continues to monitor them and we support that.

But I would point out that these are those who have been in friendly fire or in fire incidences. The mass of troops in the Gulf were not in those kinds of incidences.

Q: The 33 we're talking about are the most intensely affected by DU.

Dr. Rostker: That's correct.

Q: Then you have a body of mechanics, welders...

Dr. Rostker: Right.

Q: What are the total population...

Dr. Anthony: I'd just like to add one other quick thing. There have been now animal studies, which are not the same as human studies, to try to duplicate embedding fragments in animals to see, to try to measure some of the toxicological or radiological effects you're mentioning. At levels, if you try... Again, making these comparisons is a bit difficult, but at levels so far tested there seem to be no real highly negative effects until you get a very, very high dose.

Q: What's the total population that you have now for DU? Is it in your figures, the number of people involved?

Dr. Rostker: I'm just looking for the table. It goes to the issue of the various bands or tiers. It's several hundred involved in either the friendly fire incidences or the cleanup, and it's some place in this report. I just can't put my... Each one of those people have been notified, or we've attempted to notify but we've not been successful in every case, but multiple phone calls, letters. They've been invited to come in to take a urine, 24 hour urine test to see if there's an elevated urine, and then with the appropriate follow-up.

I would also add it any soldier in the Gulf War is concerned about depleted uranium, we welcome them to take the test. It's open to everyone, so we're not excluding anybody.

Q: But that's sort of a key figure to journalists, is how many people are involved here.

Dr. Rostker: It's in here someplace. We can search for it now or after.

Q: Also, if it isn't in here, if you can break it out on severity. Clearly the guys that have it in their body are most severely affected.

Dr. Rostker: Correct.

Q: The people who are on the outside of it... So we should be able to have a statistical picture...

Dr. Rostker: We do. On page 23, for example, this is a list of all of the Army units, type of vehicles, the incidences, and that's the 113 who are on tier one.

Page eight... This page here, Pat, is the various levels, the numbers involved, what we believe the exposure duration was. And we are looking at calling in the tier one and most of the tier two people.

That will both help us understand particularly whether there are other depleted uranium fragments in their bodies -- these are the people who worked around it -- or whether there's any residual uranium from other means like ingestion, and somehow they continue to be contaminated. Some people think that's an issue.

Q:...airborne uranium in these battlefield things? Is it brief, longer than we would think?

Col. Daxon: Brief.

Q: Seconds, minutes?

Col. Daxon: Yes, it sort of depends on the scenario, but the levels, we've actually measured levels around tanks during tests, and what we found for the airborne stuff is greater than 50 meters away from the vehicle the levels are just well below any of the standards in terms of allowable concentrations of uranium.

The stuff does settle out. You hear a lot of folks say that depleted uranium travels great distances, and that's true. Some of the particles are small, they do travel great distances. But there's not that much of it that makes it there. The majority of the stuff is relatively heavy and does settle relatively close to the vehicle. But after it's struck, or even in a fire. But the smaller particles can travel far, they can be detected, but they're not of concern. The amount, which is the focus of this, the amount of these particles, the number is so low that after 50 or so meters it's very hard to even detect.

Dr. Rostker: We have actually, in concern for force protection last year when we were sending troops, potentially sending large numbers of troops last January back into the Gulf, we had the environmental health people draw soil samples all over Kuwait in battle areas and the like, and only one area had samples shown above background. That was at the boneyard where all these vehicles were collected. They took a sample in the rain catchment areas where rainwater would have washed down. That sample was elevated, but at a level that was one-third that with which EPA would allow us to return the land to general use.

Q: I'm under the distinct impression a lot of those American vehicles that were struck were returned to this country.

Col. Daxon: Correct.

Q: So what are you looking at? Iraqi stuff?

Dr. Rostker: Yes, a lot of it.

This is a good segue into our ongoing program to improve depleted uranium training. We do this not because we believe that there is a hazard here that is acute and imminent to our soldiers' health, but we have a requirement and a responsibility to the NRC and to our soldiers to provide them with the best awareness training we possibly can. My office has taken a lead in coordinating this across the Department of Defense. In the Army, for example, it is one of the soldier common tasks that every soldier must be trained on every year. We've included that in that regimen.

We also have modified the training to make the protective measures consistent with the level of hazard which is extremely low. So where our training years ago said get into MOPP gear, that's completely inappropriate to the level of hazard. The training now talks about if you're going to go into the vehicle for just a few moments to retrieve something, put a bandanna on; and if you're one of the workers who are cleaning up the vehicles, then an industrial respirator like you'd use for painting is the appropriate method to prevent unnecessary ingestion. But just as we would with paint, if you were to do some painting without that, you don't immediately expect to be sick, and we wouldn't expect that that would be, but it is the right, safe way to do it, and we're committed to ensure that that training goes to our soldiers. So we have a sizeable effort to ensure that we do the right thing.

Q: I have a question on the drug issue. In the real world the new law that we're going to use I guess with regulation, is it designed... There was so much criticism that the soldiers weren't told about this program. Is it designed to ensure that the soldiers are given the opportunity for informed consent except for in the most... I think you mentioned national security. In the most unusual circumstances? Or what's the policy designed to do?

Dr. Rostker: Let me say that in this regard I'm the historian. I'm talking about what happened in the Gulf. The issue you raise is actively under consideration by Health Affairs, and the White House and National Security Council, because the President is now explicitly named as the decision authority.

They're working on a policy. I don't know the details of that. We can get you that information from Health Affairs if you'd like, but I really am not qualified to comment on that today.

Q: So the finding of the study that was critical of, well, a lot of ways the policy was carried out...

Dr. Rostker: The study really was commissioned to help us understand what happened. There was a lot of discussion. Many of the people who participated in the events in 1990 and 1991 were no longer in the Defense Department, and we commissioned the study primarily to understand what happened.

The study comes out at a time, in a timely fashion and we have made sure that those who are building the new policy at the NSC and here in DoD at Health Affairs have this and they've told us that this has been very helpful to help frame the debate and understand all of the issues. But I'm really not up to speed on where they are in the development of the policy.

Q: Can you tell me if there is any experimental drug being used now for say soldiers who are serving in the Gulf region or even around...

Dr. Rostker: I frankly have no idea one way or the other. It's not something that I deal with.

If there are no other questions, thank you very much.