A Skeptical View of RealTime Laboratories
and Its President, Dennis Hooper, M.D.
Stephen Barrett, M.D.
RealTime Laboratories, Inc. (RTL), located in Carrollton, Texas, specializes in detecting toxins produced by molds in human and environmental samples. Its president and medical director is Dennis G. Hooper, M.D., Ph.D., a clinical pathologist who has been embroiled in controversy for many years. Its flagship test is a Mycotoxin Panel which reports the levels of three mold-produced substances in urine specimens. RTL claims that its testing is "unique in its ability to determine if a patient's health problems are associated with toxic mold exposure . Several hundred doctors, many of whom portray themselves as "environmental medicine" specialists, are using its reports as the basis for diagnosing and treating patients. They are also being used in lawsuits and other proceedings by people who believe or fear that mold exposure had made them ill . However, the prevailing medical opinion is that urine mycotoxin testing has no valid medical use.
The information in this section was assembled mainly from depositions and medical board documents. For each of the adverse events, Hooper denied wrongdoing and asserted that he was treated unfairly. His explanations can be accessed by reading the depositions linked from the references section of this report [3-6].
Hooper received a B.S. degree from the University of Utah in 1971 and a master's degree in microbiology from the University of Missouri in 1973. In 1976, he enlisted in the Navy as a microbiologist, became a lieutenant in the medical service corps, and began working toward his doctoral degree in microbiology at the University of California-Davis. In 1979, he began medical school at the University of Nevada under Navy sponsorship. He completed his Ph.D. in 1982 and finished medical school in 1983. After that, he completed a year of general medicine internship and 4½ years of postgraduate training in pathology at the Naval Hospital in San Diego. After finishing his residency program, he joined the Naval Hospital staff, was promoted to the rank of commander, and in 1989 became chairman of the hospital's pathology department. In 1991, he was promoted to captain (the Navy's equivalent to colonel). In 1994, he resigned from the hospital after being investigated for allegedly using government resources improperly. He remained in the Naval Reserve for another 9 years before retiring from the Navy.
In 1995, Hooper opened a laboratory and performed consulting work for other laboratories. He also started a number of business ventures in which others invested considerable amounts of money. One he directed was called Nevada Biosciences Laboratory. In 1999, this lab was ordered to cease testing and had its certificate revoked for "misrepresentation of facts in obtaining its CLIA certification and failure to allow inspection."  In 1999, he filed for bankruptcy.
In 2000, Hooper was hired as a pathologist by Martin Luther King, Jr./Charles R. Drew Medical Center in Los Angeles, where he hoped to engage in AIDS research. However, concerns about the quality of his work resulted in lawsuits against him, investigation by King/Drew, and ultimately investigation by the Medical Board of California. In 2005, Tracy Weber and Charles Bernstein of the Los Angeles Times won a Pulitzer Prize for Public Service for their lengthy series of reports titled, "The Troubles at King/Drew." One part of the series focused on how the hospital permitted Hooper to stay on the job despite concerns about his work .
Hooper stopped working at King/Drew in 2001, but in 2006, the Medical Board of California concluded that he had been repeatedly negligent, grossly negligent, and incompetent in failing to diagnose cancer or mistakenly diagnosing it in four patients at King/Drew. He was placed on probation for five years, ordered to undergo an intensive clinical assessment and training program, and assessed $22,844.62 for the cost of the board's investigation and prosecution costs. The board also said that until his enhancement program was completed, he could not engage in the clinical practice of pathology unless all of his final diagnoses were reviewed by another physician .
In 2002, Hooper acquired a Texas medical license and began working as a contract pathologist with AmeriPath of South Texas (APST), which provided pathology services to Baptist Hospital System (BHS) and three other hospital systems in San Antonio, Texas. In 2004, after learning of the pending board action in California, APST informed Hooper that his employment would be terminated and he resigned from all hospitals at which he had staff privileges. BHS conducted an external peer review of over 300 of his surgical pathology readings and identified four cases where his diagnosis was incorrect. In 2004, Hooper set up Medical Services Consultation P.A., through which he provides consultations and expert testimony.
RealTime Laboratories is a wholly-owned subsidiary of Medical Services Consultations International LLC (MSCI), which Hooper and two others registered in 2006 . RealTime Laboratories LLC was registered a few months later  and was converted to a corporation in 2011 . In a deposition, Hooper said that MSCI was created in response to an approach by William J. Rea, M.D., who operates the Environmental Health Center in Dallas, Texas, a clinic that also maintained a laboratory. According to Hooper, Rea was interested in mycotoxins and invited Hooper to validate the test in his laboratory.
In 2007, Hooper and the Texas Medical Board signed an agreed order under which he could practice clinical pathology (laboratory work) but could not practice surgical/anatomical pathology until the California matter was resolved and he presented evidence of competence to the Texas board .
Rea is the primary promoter of the spurious diagnosis of "multiple chemical sensitivity (MCS)." In 2007, the Texas Medical Board charged him with (a) using pseudoscientific test methods, (b) failing to make accurate diagnoses, (c) providing "nonsensical" treatments, and (d) failing to properly inform patients that his approach is unproven . The case was settled with a consent agreement under which he was placed on probation with restrictions on what he could do .
In 2009, Hooper asked the Medical Board of California to end to his probation, but the board refused because he had failed to undergo the clinical assessment and pay the assessed costs . During depositions, Hooper said he could not meet California's requirements unless he practiced there, which he cannot do while living in Texas. In 2012, the board cited him again for not paying the assessed costs .
Hooper obtained certification in anatomical and clinical pathology in 1990 and was recertified in 2001. However, his certification expired in 2012 and he did not apply for renewal. He has several patents in the area of mold testing and has several patent applications pending.
In a 2012 deposition, he said that he had been hired as an expert in about 20 cases and that RTL was getting referrals from 520 doctors and had done about 4,000 urine mycotoxin panels during the previous 10 months [5:121, 153-157]. The list price of the test is $699.
Why RTC's Mycotoxin Panel Is Untrustworthy
According to the RTL Web site:
All of us have been exposed to mold or mold spores through the environment in which we live. Simply put, molds are parasitic, microscopic fungi that produce spores that float in the air like pollen and are common triggers for allergies. They can be found in damp areas, such as the basement or bathroom of your house, as well as in the outdoor environment in grass, leaf piles, hay, mulch or under mushrooms. If you can smell a musty odor or see mold (although not all molds are visible to the naked eye), you have a mold problem. In fact, there are estimated to be over 50,000 different species of mold but only about 200 species may present serious health risks to human beings and animals (like the beloved family pet). These harmful species of mold are referred to as toxic producing molds and are potentially poisonous because they can produce toxins or poisons (known as mycotoxins). The impact on your health or that of a loved one can be life-threatening. Therefore anyone exposed to mold should consider being tested even if the symptoms have yet to be experienced. Preventive medicine can be a life-saver 
The word "symptoms" in the above paragraph is hyperlinked to a page that lists alleged symptoms in three groups:
- Mild reactions to mold: nasal stuffiness, cough, eye irritation, wheezing, and skin irritation.
- Severe reactions may include, but are not limited to: fever, chills, muscular ache, respiratory problem, asthma, shortness of breath, chronic rhinosinusitis, and pneumonia.
- Central nervous system problems: headache, confusion, depression. fatigue, irritability, sleep disorders, cancer, and death .
This advice is dead wrong. Molds and other fungi can adversely affect human health, and mold has been associated with health issues such as coughs, asthma, and hay fever. However, the symptoms described above are found in many conditions and mycotoxin testing has not been proven useful as a diagnostic tool even in the management of mold-related problems.
RTL's Mycotoxin Panel reports the amounts of aflatoxin (a small group of mycotoxins), ochratoxin, and trichothecene (a large group of mycotoxins) are allegedly present in the person's urine. For each, it states the concentration in parts per billion and whether that level should be considered "negative," "equivocal," or "positive."  However, the mere presence of mycotoxins in urine is not evidence of disease. Andrew Saxon, M.D., Professor of Medicine and Emeritus Chief of Clinical Immunology/Allergy at the UCLA School of Medicine, has pointed out that:
- Everyone is exposed to mycotoxins, primarily through diet. Thus all humans have some level of mycotoxins in their urine. To make a test meaningful, it is necessary to know what levels are in the normal healthy population ("reference ranges") and what levels are associated with adverse effects. No such determinations have been established for urine mycotoxins .
- Moreover, even if such values were available, the methods used by RTL to make its measurements have not been validated. RTL currently says it uses ELISA technology, but the gold standard tests for measuring urine mycotoxin levels are mass spectroscopy  and high-pressure liquid chromatography . In 2013, Hooper was excluded from testifying in a case because during the discovery process, he refused to provide the documents relevant to his claim to have scientifically validated his mycotoxin test .
- Since urine production is variable and is influenced, for example, by fluid intake and other conditions, samples obtained at different times can differ in concentration. Levels of toxin excreted per day are appropriately determined by testing a 24-hour specimen or approximated by measuring the amount of materials per gram of urinary creatinine. The fact that specimens sent to RTL reflect only part of a day's production adds an additional degree of imprecision to its test results.
- No causal relationship between inhaled mycotoxins in the home, school, or office environment and adverse human health effects has been scientifically demonstrated.
- The half-life of most mycotoxins is only a few days or less, so that when measurements are made weeks, months, or years after an alleged exposure, even if accurate, the measured level will have little or no relationship to the level present at the time of exposure. Furthermore, this very short half-life of mycotoxins essentially prevents their bioaccumulation so that chronic exposures do not lead to an increasing body burden. Ochratoxins, associated potentially with renal disease, are an exception with a half-life of 3-5 weeks.
The American American College of Occupational and Environmental Medicine (ACOEM), the American Academy of Allergy, Asthma and Immunology (AAAAI), and the Center for Disease Control and Prevention's National Institute for Occupational Safety and Health (NIOSH) have published additional reasons why urine mycotoxin testing is not useful.
- The ACOEM report concluded: "Mold growth in the home, school, or office environment should not be tolerated because mold physically destroys the building materials on which it grows, mold growth is unsightly and may produce offensive odors, and mold is likely to sensitize and produce allergic responses in allergic individuals. Except for persons with severely impaired immune systems, indoor mold is not a source of fungal infections. Current scientific evidence does not support the existence of a causal relationship between inhaled mycotoxins in home, school, or office environments and adverse human health effects." 
- The AAAAI report noted: "The evidence does not support the contention that mycotoxin-mediated disease (mycotoxicosis) occurs through inhalation in nonoccupational settings. Furthermore, the contention that the presence of mycotoxins would give rise to a whole panoply of nonspecific complaints is not consistent with what is known to occur; when a toxic dose is achieved (eg, through ingestion of spoiled foods), there is a specific pattern of illness seen for specific mycotoxins." 
- The NIOSH report concluded that "using unvalidated laboratory tests to diagnose work-related illness can lead to misinformation and fear in the workplace; incorrect diagnoses; unnecessary, inappropriate, and potentially harmful medical interventions; and unnecessary or inappropriate environmental and occupational evaluations." 
Hooper's Largest Customer?
Hooper's largest customer may be Marvin Sponaugle, M.D., who operates the Sponaugle Wellness Institute in Oldsmar, Florida. According to the clinic's Web site:
Since 2006, Dr. Sponaugle has successfully treated over 2,000 patients who unknowingly were suffering from Mold Toxicity! Dr. Dennis Hooper, the medical director of the Real Time Mold Toxin lab in Dallas, has informed Dr. Sponaugle that he is now 30-to-1 the top mold doctor in North America utilizing their mold toxin testing. . . .
As of February 2015, I has [sic] performed analyses of 6,045 mold-mycotoxin levels from the Real Time Lab in Dallas," Dr. Sponaugle said .
The site further claims:
Every patient suffering neurodegenerative disorders, Alzheimer's, Multiple Sclerosis, ALS, Parkinson's, and Autism, that we have treated at Sponaugle Wellness Institute, has proven to have HLA DRBQ genetics and undiagnosed mold toxicity .
Urine mycotoxin testing is also available through a number of entities operated by Michael A. Pugliese, CMI, CME, CMT, CMR, CPCA, CCH, PSc.D., whose Web site states:
Michael now sees mold exposure victim patients in Atlanta Georgia, providing an unmatched knowledge base of mold exposure. From the environment in which the exposure was contracted, to the laboratory, and into the exam room, no one person has a more complete understanding of mold exposure and the adverse health effect, symptoms, and disease it causes. Their 6,000 square foot Integrative Medical Center can in no other words be described as but, "simply amazing".
Michael A. Pugliese, nationally and internationally published author, lecturer, guest radio talk show celebrity, world class environmentalist, and one of the worlds leading medical researchers regarding mold exposure, mycotoxin poisoning, and environmental health, shares with you the absolute facts surrounding the toxic effects of mold exposure, the symptoms of mold exposure and health care protocols to defeat mold sickness Bermuda flew in the leading mold experts in the illness, detoxify the human body from mold allergies, fungal and yeast infections, and mycotoxin poisoning .
The Web site for Pugliese's National Treatment Centers for Environmental Disease (NTCED) describes it as "the nation's most unique medical facility" and "the nation's largest medical facility treating patients with environmental exposures." The site further states that its "team of mold doctors . . . is not one physician with one point of view, but a team of multitalented professionals that understands multiple disciplines of science and medicine regarding mold sickness and environmental exposure." 
NTCED's "team" is further described as "MD's, Doctors of Internal Medicine, Homeopathic and Naturopathic physicians, Doctors of Oriental Medicine, Acupuncturists Neuropsychologists, and Neurotoxicologists," none of whom is identified on the site. Nor does the site reveal the address of the Center's clinic, which seems strange to me. I emailed him to ask for these details but so far have not received a response. I also searched the PubMed database to see whether any of Pugliese's alleged research had been published in a recognized scientific journal. No papers authored by "Pugliese M" with the words "mold" or "mycotoxin" in their title were listed. Although Pugliese's personal Web site site depicts him wearing a stethoscope, I do not believe that any of his stated credentials give him the legal right to perform medical examinations.
Pugliese has also done business as Environmental Health Assessment Program Laboratories (EHAP), Mold Centers of America, American Medical Laboratories, BioTrek Laboratories, and BioSign Laboratory Corporation, all of which have addresses in or near Atlanta, Georgia. One report I have seen from EHAP indicated that the test was performed by RealTime Labs. However, BioTrek subsequently appeared to be doing all of Pugliese's mycotoxin testing.
In 2014, NIOSH investigators performed a health hazard evaluation (HHE) of the offices of the Cook County Marriage and Family Counseling Department in Chicago. Ten years previously, the facility had had some drywall and carpeting replaced due to water damage that had occurred while putting out a fire. The situation arose because an employee who had ordered a urine mycotoxin test online had concluded that various symptoms she had were mold-related and had aroused concern among other employees. The lab report had stated that the employee's levels of trichothecene and ochratoxin were "elevated," but the investigators determined that (a) the levels were just above the threshold for detection, the levels were not unusual (b) there was no evidence of a mold problem at the facility, and (c) it is not unusual for employees to wrongly attribute nonspecific symptoms to their work environment . The company that marketed the mycotoxin test was not identified in the report, but it is safe to presume that it was operated by Pugliese.
In 2015, NIOSH investigators performed a HHE of potential exposure to mold in four buildings leased by the U.S. Department of Agriculture and the appropriateness of mycotoxin tests performed on five of the employees at a "Georgia facility" that I assume was operated by Pugliese. Their report concluded that the buildings had been water-damaged, but there was no objective evidence that any symptoms reported by the employees were due to mycotoxin exposure. The report stated:
Based upon our phone conversations with employees. . . it appears that the use of inappropriate and unvalidated medical testing from the Georgia facility has generated a great deal of concern among employees. We are concerned because we learned that the Georgia facility is providing those who have positive mycotoxin test results, which they attribute to workplace exposure to molds, with medical treatment protocols that have no scientific evidence of being beneficial, and that have the potential to cause harm. We are familiar with these "protocols" from past HHEs. They include such things as antifungal medications, dietary modification (eating only canned chicken and white rice), and several nonstandard medical treatments (bowel evacuation or hydrocolonic irrigation, cupping therapy, and an "ionic nasal spray," among other things). There is no scientific evidence to support these therapies to address work exposure and illness related to damp buildings. Antifungal medications have a role in treating fungal infections, but not in illnesses caused by toxins produced by fungi .
In 2016, Fox 5 Atlanta aired a 3-part series about Pugliese and his companies [34-36] that noted:
- The cost of a visit to NTCED was $3,300 up front. Mold testing cost $699 and a special nasal spray and vitamins cost hundreds more.
- At least some of these products were packaged without the use of gloves or a mask in the laundry room of a building that Pugliese used.
- A former employee said that every one of the more than 500 mold tests he sold had a "positive" result (indicating a mold problem).
- BioTrek Laboratories was forced to stop processing test samples in 2015 after government inspections questioned their accuracy.
- The Georgia Composite Medical Board is investigating complaints from former employees and patients. One of the complaints came from a group of seven family members and friends who had received identical test results. Another came from a family of four who said they wasted thousands of dollars being tested and falsely told that their house had mold that was making the mother sick.
- Pugliese is being sued by a former patient.
The Regulatory Loophole
Hooper likes to point out that RTL is certified by CLIA, the federal agency that certifies laboratories. CLIA examines how tests are performed, but it does not consider how their results are interpreted. Widely used diagnostic tests require FDA clearance or approval, but the agency has not attempted to regulate tests that are used only by the laboratories that develop them. During the past few years, however, the FDA has become concerned about laboratory-developed tests (LDTs) that are used to guide treatment decisions . In 2014, the FDA notified Congress that it had drafted a regulatory framework that includes pre-market review. In November 2015, it reported on twenty LDTs, noting that some of them can cause patients to undergo unnecessary treatments and potentially delay diagnosis of their true condition . RTL's Urine Mycotoxin Panel was not mentioned, but it fits the selection criteria for the report.
The Bottom Line
The prevailing medical opinion is that urine mycotoxin testing has no valid medical use.
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This article was revised on June 6, 2016.