March 18, 2002 – Howard Urnovitz claims that medicine lacks the proper technologies and protocols to solve certain medical mysteries. Specifically he claims that studies on the presence of a class of bacteria (mycoplasmas) in clinical samples have been published without validation and that tests for specific infectious agents that involve a molecular technique, Polymerase Chain Reaction or PCR, are particularly misrepresentative and should not be used by physicians to assist in treatment considerations.
CERTIFIED AND ACCREDITED CLINICAL LABORATORIES
If PCR tests are performed properly by certified personnel in a certified and accredited clinical diagnostic laboratory, I can assure that this is not the case. For patients with certain chronic illnesses, such as Gulf War Illnesses (GWI), Chronic Fatigue Syndrome (CFS), Fibromyalgia Syndrome, Rheumatoid Arthritis, among others, chronic bacterial and viral infections can be at the very least a contributing factor in the illnesses that we and many others feel must be attended to by appropriate treatments. In the case of GWI and CFS claims that the clinical laboratories that perform these tests are somehow sending physicians and their patients bogus results defies reason.
Similar results on the incidence of mycoplasmas in fresh blood of CFS and GWI patients have been published and/or presented independently by four different laboratories, three of which (including our own) have national (Federal CLIA and College of American Pathologists) and state Department of Health certifications and accreditations for performing this type of testing under the auspices of Medicare, Medicaid, Medical, insurance companies, and other organizations. These certifications and accreditations require that the clinical laboratory have valid Quality Assurance programs and fully certified management and technical staff to insure that all tests are accurate, reproducible and properly performed.
The laboratories are also site visited by experts in clinical laboratory testing, and the labs have to perform tests on unknown samples to determine their ability to perform clinical testing. To my knowledge Dr. Urnovitz’s own laboratory is not certified or accredited by any national or state organization for clinical diagnostic laboratory testing, so I find it interesting that he poses as an expert in this area.
Dr. Urnovitz states that culturing mycoplasmas from clinical samples is an essential step in the process of diagnosing the presence of this type of bacteria. Although controlled studies have been done to show that detection of mycoplasma genes and subsequent confirmation of their DNA sequence detects the presence of these primitive bacteria, culturing cannot be done for routine clinical samples and is not generally offered on test menus. For example, we and others have determined that PCR procedures can detect the presence of mycoplasmas in control clinical samples with extremely high sensitivity and specificity. In this case, culturing of mycoplasmas is used for test confirmation only. Mycoplasma experts, such as Prof. Joel Baseman of the University of Texas Health Science Center at San Antonio, warn that it is extremely difficult to grow slowly proliferating mycoplasmas from clinical samples where they hide inside cells and are difficult to remove and culture.
Thus the culture procedure that Urnovitz insists on is not considered accurate for most clinical samples. This is especially true for the types of mycoplasmas found in GWI and CFS, so it is completely impractical to do this with routine clinical samples. Because they hide inside cells in the body these types of mycoplasmas also do not illicit strong immune responses. For this and other reasons serologic testing is not considered very accurate for determining whether an active infection is present. This is why certified clinical diagnostic laboratories offer PCR procedures to determine if such bacteria are present in clinical samples.
One of the most difficult problems in obtaining accurate diagnostic information from clinical samples using PCR is the quality of the samples. At our certified reference diagnostic laboratory we are particularly concerned with sample quality because it can adversely affect clinical test results. We use internal controls to separately test samples sent to our clinical diagnostic laboratory for integrity of the genetic information in the samples. Samples that do not meet our rigorous standards are rejected. For example, attempts a few years ago to test blood samples from the Department of Defense (DOD) proved to be impossible due to the extremely poor quality of the samples that were sent to us. It is no wonder that laboratories that cooperate with the DOD find it difficult to replicate and validate tests based on the samples provided.
WHY ARE WE BEING DISSUADED FROM LOOKING FOR INFECTIONS?
Many clinical conditions of unknown etiologies were later found to be due to infections. A classic example is stomach ulcers which were thought to be caused by many different environmental insults, allergies or even psychological causes but were actually in many cases due to invasion of the stomach wall by bacteria, such as H. pylori.
For years, some elements in our DOD and VA have been trying to convince members of Congress and our citizens that certain bacteria, such as Mycoplasma fermentans–the overwhelming predominant species found in mycoplasma-positive GWI patients, are not present, do not play a role in disease and should not be treated. While this was going on, however, the U.S. Army was publishing that this type of infection can result in death in nonhuman primates as well as in man. They also published that patients with this type of infection can be successfully treated with doxycycline, which is one of the antibiotics that we have recommended can be used for the treatment of certain mycoplasmal infections.
As documented in its pathology workbooks, the Uniformed Services University of the Health Sciences in Bethesda, MD at the Naval Hospital for years taught its medical students that this type of infection is very dangerous, causes multi-symptom illnesses and can progress to system-wide organ failure and even death but can be successfully treated with antibiotics. Interestingly, U.S. Army pathologist Dr. Shih-Ching Lo holds the U. S. Patent on M. fermentans (entitled “Pathogenic Mycoplasma”), and this may be the real reason that the DOD and VA do not want to acknowledge that this bug found its way into our Gulf War veterans. By acknowledging that such infections exist in GWI patients, questions might be raised as to how they got there in the first place.
In several published studies in the U.S. and Great Britain GWI has been related to the multiple vaccines received during deployment. In particular, a study of Gulf War veterans from Kansas found that multi-symptom chronic disease (GWI) was related to 34% of the vaccinated Gulf War-deployed veterans, 12% of the vaccinated, non-deployed and 4% of the non-vaccinated, non-deployed personnel. In support of this study are anecdotal reports that military personnel receiving the anthrax vaccine have developed illnesses resembling GWI. Since it has been shown that mycoplasma contamination is a rather common finding in commercial vaccines (in one published study it was found in 6% of commercial vaccine lots), it is possible that such infections found their way into our veterans by way of the multiple vaccines used during deployment. Recently the DOD has attempted to dispel this notion by sending a few samples of anthrax vaccine (sanitized samples?) from Fort Detrick to the Centers for Disease Control (CDC) for testing.
As expected, the CDC could not find anything. The anthrax vaccine is filter-sterilized and cold-stored, sometimes for decades before use. The DOD has had a bad habit of re-labeling and re-dating its expired anthrax vaccine lots without proper testing as required by FDA regulations. All of this could result in contamination over time. Then there is the important question–what was in the experimental vaccines used in the Gulf War? One of these may have used an attenuated bacteria (a mycoplasma?) to produce immunity to HIV-1. We need to know about all of the vaccines used in the Gulf War, and what happened to hundreds of thousands of shot records that mysteriously disappeared but somehow can be accessed for certain DOD studies.
Although infections by themselves may not be much of a problem in young, healthy individuals, when coupled with the types of chemical and environmental insults received during the Gulf War the result could have been at least some GWI. There were different types of illnesses associated with the Gulf War, and it is completely unrealistic to think that there was only one cause for any of these illnesses.
In my six testimonies to Congressional committees and Presidential Commissions (these can be found on our non-profit institute website www.immed.org along with publications on various chronic illnesses), I have stated that heterogeneous illnesses such as GWI are the likely result of multiple toxic chemical and biological and in some cases radiological and other environmental exposures. This is why we call them Gulf War Illnesses not Gulf War Syndrome, the term used by Urnovitz and some others. It is unlikely that a new specific syndrome evolved from the Gulf War.
WHAT IS THE MOTIVATION OR IS THERE CONFLICT OF INTEREST HERE?
During the last few years Howard Urnovitz has advanced with much fanfare several different hypotheses on GWI and chronic illnesses in general involving viruses (human endogenous retroviruses or HERVs and then polio viruses), immunological disorders (ISIS), etc. His most recent hypothesis, which he has described at conferences as an important breakthrough, involves the observation of polyribonucleotides (fragments of RNA) in the sera (fluid left after blood clots) indicating specific chromosome genetic alterations in subsets of GWI patients that are not found in normal healthy civilians.
Although the Urnovitz observation is intriguing and potentially important, it is extremely unlikely that this explains what causes GWI rather than being a consequence of GWI. Urnovitz indicates that exposure to multiple toxic events could have resulted in the pattern that he has seen. In fact, there had already existed for many years a rich literature on chromosome alterations caused by environmental toxic events, including exposure to certain chemicals and other pollutants as well as viral and bacterial infections. As documented by researchers like Prof. J. Yunis and others particular chemical exposures and microorganism infections as well as cancers and a variety of others diseases are associated with breakage of chromosomes.
So we know that Gulf War deployed personnel were exposed to various multiple chemical and biological toxic events and in some cases radiological and environmental toxins, and a natural consequence of this from the rich literature in the area and the recent addition of Urnovitz’s own data is that genetic damage occurs after toxic exposures. What Urnovitz hasn’t done is identify the exposures (chemical, biological, radiological or other environmental) and tell physicians what to do about it.
I believe that it is now time for the clinical and laboratory researchers who work on GWI and other chronic illnesses to stop the self-serving posturing and collectively join together to provide solutions to the problems of chronic illnesses such as GWI. A multi-disciplinary coordinated attack on the problem is necessary because chronic illnesses are complex and have different causes and treatments and likely cannot be successfully conquered without cooperation and collaboration