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  Testimony of Paul Sullivan

November 16, 1999

I. Introduction

Chairman, members of the subcommittee, thank you for the opportunity to testify on behalf of the National Gulf War Resource Center regarding the adverse health effects of pyridostigmine bromide, an investigational new drug (IND) given to as many as 250,000 U.S. soldiers during the Gulf War in 1991.

Each time humans engage in warfare, almost everyone suffers, even some who at first may appear to have survived without visible injury or illness. Amid the chaos of gunfire since the start of the Gulf War in 1990, some laws regarding human rights and medical experimentation have fallen short, fallen silent, or been disregarded. In hindsight, the history of Gulf War may show the well-intended use of PB pills backfired.

Similarly, the demolition of Iraqi chemical warfare agent stockpiles, the use of depleted uranium ammunition, and the presence of other toxins could very well represent the world’s largest friendly fire incidents all rolled into one never-ending conflict.

Today, the NGWRC urges Congress, based on new information released by the Department of Defense (DoD), to reexamine the utility of current research and benefits laws that have failed to adequately address Gulf War veterans’ illnesses.

The mission of the NGWRC is very narrow: request our government to determine why so many of our comrades are ill and disabled, to provide medical treatment to those in need, to provide compensation to the disabled, and to learn from mistakes made in the Gulf War so that future toxic exposures and illnesses may be reduced or prevented.

II. NGWRC Position on the Need for Research and Treatment

The NGWRC is here today to re-state our justifiable anger and strong disappointment at the Pentagon for failing to admit earlier that PB pills cannot be ruled out as associated with some of the illnesses reported among Gulf War veterans. The DoD has possessed this information for years. Gulf War veterans have been aware since 1991 due to our battlefield experience with PB.

The military remains, for the most part, unresponsive to calls by Gulf War veterans for more research and treatment, not only on PB pills, but on other matters, including oil well fire particulate matter, depleted uranium radioactive toxic waste, the anthrax vaccine, and low-level chemical warfare agent exposures, among others.

The NGWRC urges Congress to review three main issues:

1. Consider funding immediate and aggressive research and treatment into the neurological and other disorders found believed related to the PB pills. This includes synergistic effects of PB and other toxins, and the possible genetic predisposition of some veterans to be at higher risk, as was found by Dr. Robert Haley.

Of the 25 studies launched by the VA and DoD on PB, more than 20 remain on-going. Research shows there may be a connection between PB and Gulf War illnesses. The NGWRC strongly supports full funding for the Gulf War illnesses research agenda developed by the Centers for Disease Control and Prevention earlier this year. Appropriate and effective treatment remains a top priority.

2. Consider hearings on the VA’s role in granting direct service-connection for conditions science associates with taking PB pills, either alone or in combination with other toxins. This would follow the intent of Congress when it passed the "Persian Gulf War Veterans Act of 1998," Public Law 105-277. Once direct service-connection is established, then Gulf War veterans should be provided promptly with existing symptom-based treatment and any new treatment modalities found to provide relief.

3. The NGWRC urges Congress to investigate a major lesson from the PB controversy. After Congress funded PB research in 1993, adverse effects were subsequently found. Congress should consider funding additional specific research into the adverse effects of the anthrax vaccine, oil well fire particulate matter, and other Gulf War toxins.

In 1993, Congress funded research on inhaled, ingested, and imbedded depleted uranium (DU). DU is a radioactive toxic waste used as ammunition. However, the DoD chose to research only imbedded DU shrapnel. The NGWRC urges Congress to investigate the failure of the Pentagon to research inhaled and ingested DU in accordance with Section 271 of PL 103-160, enacted on November 30, 1993.

On April 15, 1999, Bernard Rostker, in his dual role as Undersecretary of the Army and the Special Assistant for Gulf War Illnesses, was asked by the NGWRC to conduct research on inhaled DU. Rostker publicly refused, saying there was "no need" to conduct research on inhaled DU.

In a 1999 report prepared for DoD, RAND recommended more research into depleted uranium. Several peer-reviewed, published research reports from the Armed Forces Radiobiology Research Institute (part of DoD), recommended research into the possible links between cancer and depleted uranium. The NGWRC asks Congress to hold hearings on how Bernard Rostker and Army Colonel Eric Daxon may have undermined the intent of Congress. The NGWRC believes objective, independent research on inhaled and ingested DU must begin soon.

III. Conclusion

The NGWRC finds that the military failed to collect data regarding PB exposures, ignored the claims made by Gulf War veterans and scientists regarding PB pills for years, and delayed research into the adverse effects of PB. After much hesitation, and only after dozens of Congressional hearings and public outcry by disabled veterans, did the Pentagon begin research into PB pills.

The preliminary findings now strongly suggest problems associated with PB pills, thus vindicating Gulf War veterans and scientists such as James Moss and others. Additional research and treatment must be launched in earnest.

The NGWRC urges Congress to press the VA for immediate regulations for direct service-connection for all PB-related conditions. The NGWRC also urges Congress to apply the lesson learned regarding PB to DU and other toxins: once research was launched into PB, some of the mystery of Gulf War illnesses was unlocked.

This concludes my testimony. I ask that a letter dated November 5, 1999 sent from Dan Fahey of the Military Toxics Project to Representative Lane Evans, the Ranking Member of the House Veterans’ Affairs Committee, be included in the record.

Thank you. I will be happy to answer any of your questions.

Attachment #1: NGWRC Position on the Required Use PB Pills

The NGWRC is not testifying today to cast blame on the individuals who may be responsible for the decision to take the pills, the failure to keep records, or the failure to launch research on PB pills when veterans first began experiences problems.

The NGWRC is not here to debate the issue of human rights and the Nuremberg Code prohibiting the use of experimental drugs on unknowing participants. The NGWRC position remains clear: the use of PB is a mistake, and the possible adverse effects have been well documented and accepted – with the notable exception of the DoD.

Even Dr. Galomb, writing for the Pentagon and RAND, asserts the continued use of PB may be problematic, and she claims the PB

… issue is a complex one, involving trading off uncertain health risks – but risks now shown to be biologically plausible – against uncertain gains from use of PB in the warfare setting [xxxiii].

…there remain some concerns regarding the efficacy of PB in protection against nerve agent threats. For some nerve agents, such as sarin, evidence was not adequate to exclude a possible harmful effect by use of PB as a pretreatment [277].

The NGWRC stands by our May 1996 conclusion that the on-going use of PB pills is a "mistake." The recent RAND report cannot rule out a link between the PB pills and Gulf War illnesses.

Furthermore, the RAND report calls into question the effectiveness of PB against soman, and highlights the possible adverse effects of PB when sarin is present.

Although these critical issues should be addressed and resolved, they are not the focus of our testimony today.

Attachment #2: Historical Perspective of PB use by the NGWRC

At the start of the Gulf War, the Department of Defense, in a reasonable attempt to protect U.S. troops against the chemical warfare agent soman, may have unintentionally injured or disabled some of us by ordering the use of PB pills. The DoD estimates between 250,000 and 300,000 U.S. troops took the PB pills.

In August 1990, Iraq invaded Kuwait, and U.S. troops were deployed to the region. The military learned that Iraq was armed with the same chemical warfare agents (some supplied by U.S. and other nations) that Iraq had previously used against Kurds inside Iraq, including soman, sarin, cyclosarin, mustard, and others.

In late December 1990, the DoD requested a waiver from the Food and Drug Administration (FDA) so the military could order U.S. troops to take investigational new drugs (INDs), including PB pills. The use of PB pills was needed because Iraq was able to obtain dual-use technology and equipment as well as pre-cursor chemicals from the U.S. and other nations needed to manufacture weapons of mass destruction.

As part of the request for the waiver to order the use of an FDA approved drug for a non-FDA-approved purpose, the DoD wrote,

In all peace time applications, we believe strongly in informed consent and ethical foundations … but military combat is different.

Then, starting January 17, 1999, when Iraq began launching SCUD missiles and the U.S. began bombing Iraqi chemical weapons manufacturing, storage, and deployment sites, U.S. troops were ordered to begin taking PB pills.

As part of the FDA waiver, the DoD agreed to keep records documenting who took the PB pills and to determine the long-term effects, if any, of taking the PB pills. As pointed out in many sources, some soldiers, under the belief that "if one PB pill is good, then several more are better," took unknown amounts of PB pills for unknown lengths of time.

In early 1991, the first public hint of a serious problem surfaced as thousands of Gulf War veterans reporting unusual symptoms to private healthcare providers as well as to the DoD and VA. DoD research in 1991 was limited to whether PB interfered with the combat mission – not on the long-term health consequences. Congress responded promptly to the unusual illnesses in 1992 and 1993 and required the DoD and VA to establish registries for the unusual illnesses.

In December 1994, the Senate Veterans’ Affairs Committee sounded a loud alarm on the PB pills. Many non-DoD scientists, including James Moss, a former Department of Agriculture scientist, claimed there may be a problem associated with the use of PB pills at the same time other toxins were present.

Led by Senator John Rockefeller, the panel’s staff reached a firm conclusion that

… pyridostigmine bromide pretreatment makes individuals more vulnerable to other nerve agents, such as VX and Sarin.

Sarin, cyclosarin, and mustard agents were released into the air as a result of post-cease fire demolitions efforts by U.S. troops, including two such incidents at Khamisiyah, Iraq on March 4 and March 10, 1991. Many others remain under DoD investigation.

Shortly after Senator Rockefeller’s report was released, the DoD and VA began additional medical research into the PB pills, with total appropriations of $20 million since 1994. This is commendable, yet DoD failures between 1990 and 1994 cost years of precious time for Gulf War veterans seeking answers and treatment.

More disturbing information was released in April 1996, as research conducted by Mohamed Abou-Donia at Duke University was published in New Scientist to

… suggest that an anti-nerve gas [PB] pill taken by many of the troops may have interfered with the body’s natural defenses against the toxic effects of an insecticide and an insect repellent they routinely used to protect against disease-carrying flies and mosquitoes. A year ago, the researchers reported that chickens exposed to relatively low levels of all three chemicals developed nerve damage. Last week … the researchers outlined a possible mechanism behind the damage.

There were other official warnings, too. Later in 1996, the National Academy of Science’s Institute of Medicine, in their report, "Health Consequences of Service During the Persian Gulf War," found

A third hypothesis that there were synergistic reactions among some combination of PB pesticides, and insect repellents used by the troops. It has been known for many years that the simultaneous or sequential administration of two anti-AchE drugs can have an additive or even synergistic effect.

And then there were more warnings in 1996, as the Presidential Advisory Committee on Gulf War Veterans’ Illnesses concluded

Ongoing federally funded studies should help the scientific community draw conclusions about the synergistic effects of PB and other risk factors.

Congress continued working on the issue of PB pills, and in August 1998, the Senate Veterans’ Affairs Committee, under the leadership of Chairman Arlen Specter and Senator John Rockefeller, published a scathing report on Gulf War illnesses, confirming

DoD kept no records to document who took PB and how much was taken despite FDA’s requirement to do so. DoD believes that about 250,000 personnel took at least some PB during the deployment.

… PB may also interact with pesticides and potentially create adverse health effects at lower doses of these agents, although the health consequences of such multiple exposures are unknown.

The 1998 Senate report also contains a lengthy report prepared by James Moss on the "Possible Potentation of Pyridostigmine Bromide by Pesticides." Moss was one of the first non-Pentagon researchers to raise awareness on the potential adverse role of PB pills in 1994.

In early 1999, Richard A. Rittig, working for the RAND Corporation at the request of the Department of Defense, concluded

The DoD Gulf War experience in the use of PB [pills] … was characterized by poor record keeping, inadequate data collection, and other violations of the terms agreed to in the FDA waivers.

Simply put, this means that research into the long term effects of PB pills will be seriously hampered by the lack of data – information such as how many troops took the pills, how many were taken, over what period of time were the pills taken, and what other toxins may have been present at the time the pills were taken.

All that remains now, unfortunately, is the memory of the some veterans who have reported illnesses. In a very sad irony, many Gulf War veterans who took PB pills also report memory problems, further complicating an already difficult research situation.

This is why Congress wisely passed Public Law 103-446, thus providing healthcare and other benefits to Gulf War veterans with undiagnosed or not clearly defined illnesses. The law, enacted 1994, presumes that lay evidence presented by a Gulf War veteran as to exposure and current medical condition should be believed.

Then, last month, the Department of Defense reversed their long-standing position that PB pills were not associated with Gulf War illnesses. Beatrice Alexandra Golomb, working for RAND Corporation at the request of the Pentagon, found

1. PB cannot be ruled out as a possible contributor to the development of unexplained or undiagnosed illness in some [Gulf War] veterans [xxxiii].

2. In summary, present evidence cannot exclude a role of PB as a contributor to chronic illnesses in [Persian Gulf War] veterans mediated through several possible pathways, individually or in concert [277].

Thus, after almost nine years, with ill Gulf War veterans in the lead followed by non-military scientists and a White House commission, the Pentagon finally woke up and listened to reasonable concerns about the possible dangers of PB pills.

On October 20, 1999, Dr. Joyce Lashof, ex-dean of the Berkeley School of Public Health and former chair of the Presidential Advisory Committee on Gulf War Veterans’ Illnesses, was interviewed by the San Francisco Chronicle. In response to the Pentagon’s about-face on PB pills, she declared

We left the same door open…. It’s a real illness. People are sick.

The NGWRC believes that now is the time, in light of this dramatic shift in military policy on PB pills, for the VA, DoD, HHS, and non-government scientists to take aggressive, immediate action to benefit ailing Gulf War veterans, including more research, developing treatment, and exploring other Gulf War toxic exposures with vigor and rigor.

Attachment #3: Public Law 103-160, Signed into Law on November 30, 1993

SEC. 271. RESEARCH ON EXPOSURE TO DEPLETED URANIUM BY MILITARY PERSONNEL WHO SERVED IN THE PERSIAN GULF WAR.

(a) GRANT TO SUPPORT RESEARCH ON THE EFFECTS OF DEPLETED URANIUM- From the funds appropriated or otherwise made available in fiscal year 1994 for research, development, test, and evaluation for the Department of Defense, the Secretary of Defense is authorized to make a competitive award of a grant in the amount of $1,700,000 to a medical research institution for the purpose of studying the possible health effects of battlefield exposure to depleted uranium, including exposure through ingestion, inhalation, or bodily injury. The selection of the institution to which the grant is awarded shall be made in accordance with established defense acquisition procedures.

(b) RESEARCH PROGRAM- The research to be conducted at the facility for which a grant is made under subsection (a) shall explore the possible short-term and long-term health effects of exposure to depleted uranium, including exposure through ingestion, inhalation, or bodily injury, and the individual susceptibility of service personnel to such exposure. Such research shall focus on (but not be limited to) persons who may have been exposed to depleted uranium while serving on active duty in the theater of operations during the Persian Gulf War. The specific objectives of the study shall include investigation of the pathology of depleted uranium fragments under controlled conditions, including--

(1) assessment of the toxico-kinetic properties of the various chemical forms of depleted uranium that could be inhaled, ingested, or imbedded;

(2) examination of whether there are depleted uranium cancer induction mechanisms similar to those observed in Thorotrast-specific liver cancers;

(3) determination of whether the radiogenic effects described in paragraphs (1) and (2) occur and, if so, at what fragment densities and latent periods;

(4) assessment of long-term, low-dose-rate irradiation of specific tissues, such as those of the nervous system;

(5) determination of the potential for chronic nephrotoxicity as a function of the organ exposed to depleted uranium; and

(6) conduct of pathological studies of tissue surrounding depleted uranium particles.

(c) REPORTS TO CONGRESS- Not later than October 1, 1994, and annually thereafter for the period that research described in subsection (a) is being carried out under the grant made under this section, the Secretary shall submit to the congressional defense committees a report on the results of such research during the year preceding the report.

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