$3 Million Study of Gulf War Illnesses Criticized

Pentagon Bypassed Competitive Procedures in Picking Researcher Who Sees Several `Syndromes'

By David Brown
Washington Post Staff Writer
Saturday, November 8, 1997; Page A10
The Washington Post

The Department of Defense has decided to fund a $3 million study seeking possible chemical origins of the illnesses known as "Gulf War syndrome," even though the research failed to get money through the usual competitive process for government scientific grants.

Although the Pentagon broke no rules in choosing to underwrite one of the largest studies ever on Gulf War illness, the move has been criticized by some scientists, who say it violates procedures designed to guarantee the quality of research funded by the government.

The study, which is underway, is headed by Robert W. Haley, an epidemiologist at the University of Texas Southwestern Medical Center in Dallas. He and his colleagues believe they've found at least three distinct Gulf War syndromes, which they attribute to "generalized injury to the nervous system" from toxic chemicals.

The Pentagon's decision demonstrates how willing military officials now are to entertain once-marginal theories about Gulf War syndrome. It also shows how inextricably entangled science, politics and public opinion have become on this subject, and how the standards of scientists and politicians can diverge.

The notion that pesticides, insect repellents, battlefield drugs, and maybe even nerve gas triggered a wide variety of lasting health problems in some veterans has rapidly gained support in the last year. Many veterans, some members of Congress, and a few scientists favor it over the prevailing hypothesis that psychological stress underlies many, if not most, of the ailments.

"He [Haley] has a fairly attractive following. If it turns out he's right, and we didn't fund it [his research], we would look pretty stupid," said a White House official, who asked not to be identified by name. "The [Clinton administration] made sure they wanted to leave no stone unturned in trying to find out why these guys are sick. I think [the Department of Defense] is responding to that."

Among the more vocal critics of the Pentagon's action, however, are several members of the Presidential Advisory Committee on Gulf War Veterans' Illnesses, which is about to release its final report.

"The process that was used [to fund the Haley project] does not appear to be appropriate to me," said committee member Joyce C. Lashof. "I think it is important we keep to a process in which everyone is assured that projects of the highest priority are the ones that receive the funding, which is limited."

Arthur L. Caplan, a medical ethicist at the University of Pennsylvania and one of Lashof's colleagues on the panel, said he believes that, on a subject as contentious as Gulf War illness, it's especially important for the federal government to follow customary procedures when funding scientific research. The reason, he argues, is that both scientists and the public may question the credibility of studies that have received special treatment.

"Those who doubt the fairness or soundness of the process by which a study gets funded do not forget that, regardless of what the results . . . show," Caplan said.

Since hostilities with Iraq ended in 1991, an unknown number of veterans have suffered muscle and joint pain, mood changes, concentration problems, headaches, insomnia, rashes and intestinal complaints. Various explanations for the symptoms have been offered, including the effects of oil-fire smoke, vaccines, medicines, poison gas, pesticides, depleted uranium armament and exotic infections.

In recent years, however, several independent panels of scientists have reviewed research on the subject and concluded that there's no single cause for veterans' complaints, but that many may be the product of the psychological stress of the war.

However, since June 1996, the poison gas theory -- and, by extension, the toxic chemicals theory -- has gotten increasing attention. That was the month the Defense Department revealed that some rockets containing chemical weapons had been in a huge munitions dump in Khamisiyah, Iraq, that American soldiers intentionally blew up after the war.

Although there's no evidence that soldiers were exposed to poison gas -- none showed any symptoms at the time -- that revelation fueled some veterans' suspicions the Pentagon had withheld (or overlooked) potentially important information. In the ensuing months, military officials came under a barrage of public and editorial criticism. Now, in part as an effort to make amends, military investigators are laboriously interviewing dozens of veterans who have reported other war-time events in which they think they may have been exposed to poison gas.

In three studies published last January in the Journal of the American Medical Association, Haley and his colleagues analyzed the complaints of 175 members of the 24th Reserve Naval Mobile Construction Battalion who reported having serious health problems since the end of the war.

The researchers found that many of the illnesses fell into one of six different "syndromes." (As an example, one syndrome was characterized by problems of attention, memory and reasoning, and was often accompanied by insomnia, depression and headaches.) Three of the syndromes appeared particularly distinct, and seemed to be linked to specific war-time experiences, such as the use of insect repellent dog collars, reactions to the anti-nerve gas drug pyridostigmine bromide, or self-reported exposure to poison gas.

Psychological, neurological and radiological tests on 23 ill veterans showed mild abnormalities in some. The results, however, were neither striking nor consistent enough to distinguish ill veterans from healthy ones. Despite this, Haley and his colleagues concluded that the three syndromes "represent variants of a generalized injury to the nervous system," probably caused by a class of chemicals called cholinesterase inhibitors.

The three papers were praised for their ambitious attempt to tease out common threads from the tangled skein of complaints that is Gulf War syndrome. However, they were also criticized for their scientific methods and conclusions.

Among the studies' alleged faults was the small, self-selected population of veterans studied; the very nonspecific tests they were subjected to; and the unverified nature of the exposures they reported. Four of seven letters later published in JAMA criticized the research, with the authors of one commenting that Haley's team had "advanced from unmerited speculation to fantasy" in reaching their toxic-chemicals conclusion.

The provocative nature of the findings -- and their appearance in a prestigious medical journal -- brought the research wide attention. Less than a month after publication, Haley was invited to the Pentagon to discuss his work with Stephen C. Joseph, who at the time was the assistant secretary of defense for health affairs. He urged Haley to apply for a research grant in an upcoming round of competition.

Haley formulated a six-component project that he described as a "mini-Manhattan Project" for Gulf War syndrome, a reference to the multibillion-dollar, no-holds-barred effort in the 1940s to develop an atomic bomb.

He proposed a $13.8 million, three-year program that would expand the neurological testing to 100 veterans, randomly sample 5,000 others to look for the syndromes, and test various experimental treatments. Basic scientists on the Texas team would simultaneously pursue three areas of laboratory research.

The Defense Department, however, had only $10 million set aside in its 1997 budget for the category of research this would fall into: the possible relationship between "hazardous exposures" and Gulf War illnesses. Although that sum was less than what Haley's team wanted, the Texas researchers decided to apply for a grant anyway.

"We knew it was not going to get funded," Haley recalled recently. "We could have gone through Congress and tried to get funding independently, but we didn't want to go that way. We wanted to go through peer review."

Peer review is the process in which an independent panel of scientists evaluates a research proposal, judges its quality, and (in competitions like this) recommends that it either be funded or rejected. Submitting a research proposal to a peer-reviewed competition demonstrates, among other things, a scientist's willingness to subject his ideas to the skeptical probing of other experts. (Haley's previous work had been paid for largely by the Perot Foundation, which is run by Ross Perot, the Texas billionaire and former presidential candidate.)

A subcommittee of the Persian Gulf Veterans Coordinating Board made the awards. (The board consists of officials from the departments of Defense, Veterans Affairs, and Health and Human Services.) Of 35 research proposals submitted in the "hazardous exposures" category, 14 were "approved for potential funding" based on their scientific merit. Haley's project was not one of them. Ultimately, eight grants were awarded, ranging from $125,000 to $2.3 million.

Haley says the three clinical components of his project were "highly rated" by the peer-review panel of scientists assembled by the coordinating board. Several other sources generally confirmed this. The reviewers' comments are not public information, and Haley would not let a Washington Post reporter look at them for quotation.

When Haley learned in July that he would not be funded, he began lobbying Pentagon officials. Over the next few weeks, telephone calls by Perot helped gain him audiences with Defense Secretary William S. Cohen, Hillary Rodham Clinton, and the chiefs of the four military services.

It appears, however, that the lobbying wasn't necessary because high Defense Department officials were already extremely interested in the research. So were many veterans. When Bernard Rostker, the Pentagon's top Gulf War illness official, held 11 "town meetings" for veterans in various places last spring, Haley's research was brought up at every one.

"Given the potential of better understanding the effects of low-level nerve [gas] agents; given the charges -- totally unfounded -- that the Defense Department was stonewalling this arm of the inquiry; given the editorial [in JAMA] that the research was somewhat overblown but certainly deserved continuing; considering that a few weeks before Congressman [Christopher] Shays [R-Conn.] had criticized the government for not funding research that was out of the mainstream, it was the consensus of everyone involved that we wanted to know more about this," Rostker said recently.

(Two White House officials said that Mrs. Clinton never contacted the Pentagon on Haley's behalf.)

In defending the Pentagon's decision to pick up part of Haley's project, Rostker noted that only those components that got favorable peer-review comments were considered (and not all of them were funded.) Funding the components that got low marks was out of the question, he said.

This distinction, however, did not get very far with the Presidential Advisory Committee.

"He [Haley] competed and wasn't funded. And now you have decided to fund what he competed for and wasn't funded [for]," Lashof sternly told Rostker at the committee's last meeting in September. "That is very unusual, and is not something that the scientific community, I think, will take lightly."

Haley said recently the $3 million from the Defense Department will pay for about six months of work. The research team has started neurological testing on about 50 more veterans, and plans to administer the symptoms-and-exposure survey to about 400 veterans in the Dallas area. Preliminary results will be submitted to the Defense Department in about four months.

If the research is viewed favorably by military officials and their expert consultants, the Dallas team will ask for $4 million more to do the next phase of the work: random sampling of 5,000 veterans.

Since the summer, the Texas researchers have fine-tuned their project and tried to address some of the peer reviewers' criticisms. The total price tag now stands at $16.4 million. Haley hopes the federal government, in incremental contracts, eventually will fund it all.

© Copyright 1997 The Washington Post Company

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