Testimony of Howard B. Urnovitz, Ph.D. (1/24/02)

U.S. House of Representatives Committee on Government Reform, Subcommittee on National Security, Veterans Affairs, and International Relations

Howard B. Urnovitz, Ph.D. -- 01/24/2002

I am grateful to the Subcommittee for allowing me the opportunity to present my views on Gulf War Syndrome or GWS. My name is Dr. Howard B. Urnovitz. I received my doctorate degree in Microbiology and Immunology from the University of Michigan in 1979. My entire CV is submitted with my written testimony. I currently hold the position of Scientific Director of the Chronic Illness Research Foundation as well as my current position as Chief Executive and Science Officer of Chronix Biomedical, a privately-held genomics company. I receive no government grants or support for my work.

The Subcommittee has asked me to testify on the status GWS research. My reply is simple: We have reached a stalemate. My purpose of being here today is to explain why.

In my last testimony to this Subcommittee, on February 2, 2000, I pointed out that the human genome appeared to play a critical role in GWS. In fact, I testified that the major opportunity GWS presents to medical science is that neither a single bacterium nor a virus could be blamed for the illness. I have stated repeatedly in public for the past several years that the mycoplasma causal theory for GWS was based on poorly conducted research and the claims had never been validated. Finally, an excellent controlled scientific study has put this matter to rest. I will state again for the record what I believe to be the basis of GWS: it is the genome, not the germs.

So why is there a stalemate?

The letter from the Pentagon included in the GAO Report (GAO-01-13, April 2001) cautioned the authors of the report not to be "hasty" in drawing the conclusion that there might be fewer health complaints from the French troops. This letter indicated to me that the military continues to take what I would call a "denial of the clues" position. Denying or refusing to recognize scientific clues, controlled studies (including ours) and even facts about GWS has created this stalemate, a stalemate that has implications bigger than the disease itself. These denials are manifestations of the weaknesses of large-scale, government-funded research. This weakness delays any and all attempts to treat GWS veterans and hinders any and all attempts for a medical defense against the next generation of chemical, biological and radiation terrorist weapons.

What is the source of this "denial of clues" position with regard to GWS and other medical mysteries? I believe it is the US Department of Health and Human Services (HHS). HHS is the largest and most powerful medical research entity in the world today. It strongly influences the financing, communication, and priorities of the world's medical research agenda, including military medicine. Its Fiscal Year 2001 budget was $429 billion. In my opinion, this agency is completely out of control because of, in part, its continued violations of medical ethics.

I argue that the response of the entire federal health establishment to recent acts of bioterrorism constitutes a violation of medical ethics. Despite ample evidence from military usage over the last decade that the existing anthrax vaccine is highly reactive with possible deleterious long-term health effects, the October 2001 terrorist attack that employed mailed anthrax spores triggered an extremely questionable reaction from the Health and Human Services Department and its Centers for Disease Control and Prevention.

Both HHS and CDC made the still unlicensed vaccine available to potentially exposed postal workers and congressional staffers not as an immunization, but as a treatment supplemental to antibiotics - without a scintilla of scientific evidence that such inoculations could help prevent the disease in exposed individuals. Even the HHS and CDC officials responsible refused to recommend the workers actually take the shots. In the fields of advertising, public relations, and political speech writing, this approach is sometimes called the "The Spaghetti Theorem" - throw an untried idea against the wall and see if it sticks. It has no place in science or medicine.

And now we learn from the CDC-authored informed consent documents for such civilian shots that the anthrax vaccine may be connected to birth defects if the inoculation is given during pregnancy. The data come from a preliminary Navy study still under review. So far the Pentagon has refused to provide further details.

Further, we now have learned from the October 23, 2001, GAO report "Anthrax Vaccine: Changes to the Manufacturing Process" that the FDA has blatantly turned a blind eye in its oversight and surveillance of the Bioport anthrax production facility.

A less recognized yet more flagrant medical ethics violation by HHS is its endorsement and defense of the so-called "Durban Declaration." Ironically, the Durban Declaration memorialized 20 years of frustration and failure by the AIDS research community to successfully treat the disease by eliminating the associated virus, HIV, with either drugs or vaccines. The Declaration claims to be based on an exhaustive medical literature. But this literature is substantially comprised of opinions, poorly conducted studies, and reviews of poorly conducted studies. Instead of using the milestone of 20 years as a "call to arms" to encourage novel and non-traditional research approaches, 93 HHS employees from agencies including the NIH, FDA and CDC, published a declaration in the journal Nature stating that HIV is the sole cause of AIDS and that the scientific debate is closed. As a scientist, I was outraged to see such a declaration which seems totally at odds with the tradition of the scientific method.

Here is what lies ahead for people who suffer from emerging chronic diseases like GWS and AIDS as well as for efforts to protect the population at large from mad cow disease and chemical and biological terrorism. Rather than recognizing and reporting on the failures to cure, prevent, or successfully treat a disease, HHS scientists will continue to deny that billions of taxpayer dollars and decades of medical research has yielded little or no progress in the understanding of chronic syndromes. Yet, they will publish documents that will mandate how future medical research should and should not be conducted. Scientific journals will publish these documents and imply that they are scientific in nature. Mainstream media, without asking any hard questions, will then distribute the information to the general population and label all who challenge the documents as "dissidents."

Label us what you want, but misrepresentations are misrepresentations. We continue to use the Internet to describe our scientific position. You can view our correspondence with the HHS on our website, www.chronicillnet.org (Government Relations). It asks how HHS scientists can take the position that a virus is the sole cause of AIDS based on opinions, poorly conducted studies and reviews of poorly conducted studies.

By allowing its 93 employees, all of whom are ostensibly public servants, to abuse their powerful government positions by signing the Durban Declaration, HHS has signaled the American people that it will permit its scientists to take a public position on unsolved medical problems instead of finding the answers through rigorous research. Research into GWS is directly affected by these unethical practices. How?

Genomes and germs.

Exemplified by the Durban Declaration, the American medical science complex is unwilling to accept and, in fact, vigorously opposed to the idea that epidemics and disease clusters can happen without a single microbe as the prime causative agent. The original successes of Pasteur and Koch in the late 1800's with a select number of bacterial maladies do not hold true for all diseases, especially the chronic diseases. This "one size fits all" single-germ approach of medical science is why diseases like GWS, childhood paralysis, and AIDS have not been conquered. By allowing HHS to mandate how science will be conducted, a clear government sanction has been established. This sanction will prevent the discovery and innovative research needed to attack the tough medical issues we face today.

Allow me to give you an example of why the "one size fits all" approach does not work for chronic illnesses. For 100 years, since Landsteiner and Popper transmitted poliomyelitis from a boy to a laboratory animal, every doctor in the world will tell you that the childhood paralysis was caused by a single entity called the poliovirus and can be completely stopped by polio vaccine. The chronicillnet.org web site has posted a detailed special report questioning why the polio vaccine has not eliminated childhood paralysis world-wide and even challenging medical researchers to produce the hard science to show if there was ever was a poliovirus epidemic. Diseases cannot be conquered if scientists refuse to admit they are wrong, go back into the laboratory, and work until they find the truth.

This astonishing abuse of the scientific method by political scientists has led us to the stalemate we are in today. Clearly, science has been trapped in similar stalemates before. In the 1600's, Galileo, equipped with a new invention, the telescope, was able to confirm Copernicus' heliocentric theory that the Earth revolved around the Sun and not the reverse. The political system and religious institutions of the time made sure Galileo’s ideas, teachings and writings were suppressed. Galileo was charged by the Inquisition with heresy and sentenced to house arrest for life. It took hundreds of years for scientific fact to overturn political opinion. We are facing the Galileo effect today in medicine.

What are the implications of our current stalemate?

The world cannot defend itself against biological/chemical/radiation terrorism until this stalemate is brought to an end. The single-germ-theory will not allow science to define the genomic conditions necessary to render an individual susceptible to a disease process. Terrorists will soon learn how to make their next move so that the weapons become more effective. Our next move has to be the development of medications that can focus and strengthen the genomic reaction to toxic injury. The current scientific stalemate prevents us from making this type of progress. We cannot take this critical next move because the stalemate has you believing that vaccines and conventional antibiotics are the way to stop terrorism even though none of the data I have seen support this claim.

Scientific Revolution Tactics: Where Do We Go From Here?

I would like to go on record stating that the single-germ-theory as the cause of chronic diseases will disappear once scientists learn the proper use of their new "telescope," i.e. genomics.

I am sure you have heard about the power of genomics, but even in this brand-new discipline we have a stalemate created by scientists trying to cram square pegs into round holes. Most genomic scientists want you to believe that diseases occur as a result of mutations in the genes that make proteins. Nature is telling you that many of the major diseases are not in the protein coding genes but in what are misleadingly referred to as the "junk" DNA. A quarter-century ago, I began my doctoral research in a lab that studied how to create poliomyelitis in mice without any poliovirus: by manipulating the junk DNA with toxic chemicals or radiation. GWS has convinced me that these same interactions of toxic exposures and chronic diseases occur in humans as well. So, the clues are now telling us that the cause of chronic diseases is the JUNK genome, not the germs.

Who is listening to me?

I predicted in my last testimony to this Subcommittee that GWS research would lead to medical breakthroughs in all areas of chronic disease research. I subsequently chose to study a disease that would have commercial implications so as to raise investment capital to prove my point. In less than 3 months' time and with only one other scientist, we are now validating a new test for Mad Cow Disease that does not require the cow to be killed before testing. Our test looks at the same genomic elements I found in GWS veterans. I am confident that the validation of this test will prove the positive predictive value of blood junk gene tests and have enormous value in protecting the food supply and human health.

It is unfortunate, due to the stalemate, that this genomics test probably will never be used in GWS research. The April 2001 GAO report on GWS has clearly outlined the obvious study that should be done: use a variation of the genomics test on the Persian Gulf War vets, deployed and non-deployed, from the US, UK and France. If the French soldiers truly have a lower incidence of GWS, the genomics test will confirm it. The follow-up studies can then refine the testing procedures so that treatment options can be judged against a soon to be validated laboratory marker.

How do we break out of this stalemate? Let me share some of my thoughts.

First, if science and government wish to continue any kind of responsible partnership, a new paradigm must be developed. It must allow scientific and public discourse on fresh research ideas, even if they contradict long-held doctrines. .

Second, the federal structure must end the de facto government sanctions that exist as a result of an inherent bias toward "maverick" research -- defined as any study that contradicts the conventional wisdom that germs cause all infectious diseases and ignores an avalanche of findings about the human genome. It's the genes, not the germs.

Third, we must leave behind a dim decade of "denying clues" that has not only deprived Gulf War veterans a possible pathway out of illness, but even worse has established a template of refusal to consider almost any new ideas on any medical subject. We must not continue to allow stale dogma to trash true science.

I am certain we will overcome this stalemate. Scientific discovery and new treatment modalities will prevail. Results-minded researchers will go to the private sector, as the global marketplace is proving.

The role of Congress should be to do what it does best -- keep the pressure on. As you are all-too-aware, we are engaged in a long-term war that involves hideous brands of terrorism, invasions of our homeland for the first time in 187 years, and a life-and-death necessity to realize: We don't have years to change the way we protect our troops and our people against chemical and biological warfare -- at best, we have months. You will never be able to protect the citizens of this country if HHS is not held accountable for its actions that continue to discourage scientific discovery in the ways I have described.

In conclusion, I want to thank this Subcommittee for its leadership in trying to understand the complexities surrounding the treatment of GWS. I also want to thank the staff of the GAO for its first class reports on GWS related issues as well as calling them as they see them.

I again thank the Subcommittee for recognizing the contributions I have made to the GWS medical literature and for my modest attempt at trying to keep the scientific debates open.

I ask that the full text of my statement be submitted for inclusion in the record of the hearing.