How the "Urine Toxic Metals" Test
Is Used to Defraud Patients

Stephen Barrett, M.D.

Many patients are falsely told that their body has dangerously high levels of lead, mercury, or other heavy metals and should be "detoxified" to reduce these levels. This article explains how a urine test is used to defraud patients.

The report pictured to the right is a "urine toxic metals" test from Doctor's Data, a Chicago-based laboratory that performs tests for many chelation therapists and other offbeat practitioners. The patient who gave it to me was told by his doctor that his mercury and lead levels were high and should be reduced with EDTA chelation therapy.

The report classifies the man's lead and mercury levels as "elevated because they are twice as high as the upper limit of their "reference ranges." However, this classification is misleading because:

  • The report states that the specimen was obtained after patient was given a "provoking agent," but the reference range is based on non-provoked tests.
  • The levels, whether provoked or not, are not high enough to conclude that the patient has a problem that requires attention.
  • Even if a problem exists, chelation may not be the best course of action.

Doctor's Data also processes the urine toxic metals test for The Great Plains Laboratory, Inc., of Lenexa, Kansas. Urine toxic metal testing is also performed in the United States by Genova Diagnostics (Asheville, North Carolina) and Metametrix Clinical Laboratory (Duluth, Georgia), which Genova purchased in 2012.

Why Provoked Testing Is a Scam

Mercury is found in the earth's crust and is ubiquitous in the environment. Because of this, it is common to find small amounts in people's urine. The body reaches a steady state in which tiny amounts are absorbed and excreted. Large-scale population studies have shown that the general population has urine-mercury levels below 10 micrograms/liter, with most people between zero and 5 [1]. Similarly, many people circulate trivial amounts of lead.

Urine lead and mercury levels can be artificially raised by administering a scavenger (chelating agent) such as DMPS or DMSA, which attaches to lead and mercury molecules in the blood and forces them to be excreted. In other words, some molecules that would normally recirculate within the body are bound and exit through the kidneys. As a result, their urine levels are artificially and temporarily raised. How much the levels are raised depends on how the test is administered. The standard way to measure urinary mercury and lead levels is by collecting a non-provoked urine sample over a 24-hour period. Because most of the extra excretion takes place within a few hours after the chelating agent is administered, using a shorter collection period will yield a higher concentration.

When testing is performed, the levels are expressed as micrograms of lead or mercury per grams of creatinine (µg/g) and compared to the laboratory's "reference range." Well-designed experiments have demonstrated how provocation artificially raises urinary output.

Both of these studies used a 24-hour urine collection period. Because most of the extra excretion occurs toward the beginning of the test, it is safe to assume that the provoked levels would have been much higher if a 6-hour collection period had been used.

Practitioners who use the urine toxic metals test typically tell patients that provocation is needed to discover "hidden body stores" of mercury or lead, which they also refer to as "body burden" or "mercury efflux disorder." However, the above experiment proved that provocation raises urine levels as much in exposed workers as in unexposed control subjects and that rise is temporary, should be expected, and is not evidence of "hidden stores." The scientific community does not recognize "mercury efflux disorder" as a diagnosis or even as a theoretical possibility.

The "hidden stores" notion was further debunked by a study that compared non-provoked and DMSA-provoked urine specimens from 15 children with autism and 4 normally developing children who ranged from 3 to 7 years old. After a baseline specimen from each child was collected, the DMSA was given in three doses over a 16-hour period, and the specimens were collected for 24 hours and tested for lead, mercury, arsenic, and cadmium. The testing was performed by the Mayo Clinic's laboratory, which used reference ranges of 80 ug/liter as the upper limit of normal and over 400 µg/liter for the lower limit of the potentially toxic range for lead and 10 µg/liter as the upper limit of normal and over 50 µg/liter for the lower limit of the potentially toxic range for mercury. All of the normal children and 12 of the autistic children excreted no detectable amount of any of the tested materials. In one child, DMSA provocation raised the urine lead level from undetectable to 6 µg/liter, which the researchers said was far too low to be of concern. In another child, the mercury level rose from undetectable to 23 µg/liter, but after fish was removed from that child's diet for more than a month, it fell to 5. The study showed that when laboratory measurements are accurate and proper reference standards are used, neither autistic nor normal children are likely to have problematic levels of lead or mercury, even when provoked testing is used, but fish-eaters might consume enough mercury to enable provocation to produce an inflated value. The authors concluded that the proportion of autistic participants in this study whose DMSA-provoked excretion results demonstrated an excess chelatable body burden of Arsenic, Cadmium, Lead or mercury was zero [4].

Neither Mayo Clinic, nor any other legitimate national laboratory, has reference ranges for “provoked” specimens. Further, the references ranges for normal urine heavy metal levels used by Mayo Clinic and the largest national reference lab, Quest Diagnostics, are the same.

In contrast, Doctor's Data uses reference values of less than 3 ug/g for mercury and 5 ug/g for lead. Standard laboratories that process non-provoked samples use much higher reference ranges [4,5], which means that if all other things were equal, Doctor's Data is far more likely than standard labs to report "elevated" levels. But that's not all. A disclaimer at the bottom of the above lab report states—in boldfaced type!—that "reference ranges are representative of a healthy population under non-challenge or nonprovoked conditions." In other words, they should not be applied to specimens that were obtained after provocation. Also note that the specimen was obtained over a 6-hour period, not the standard 24-hour period, which raised the reported level even higher.

The management at Doctor's Data knows that provoked testing artificially raises the urine levels and that the length of collection time greatly influences the results. David W. Quig, Ph.D., who is Doctor's Data's vice president for scientific support, communicates regularly with chelation practitioners about how to interpret the urine toxic metal test results and how to discuss them with patients. In 2002, Quig and two others presented a study of mercury levels in urine collected two hours after DMPS administration to 259 patients at a Nevada clinic. More than 75% of the patients tested at 21 µg or higher, and most of the rest fell between 3µg and 20 µg [6]. At these levels, nearly everyone's mercury level would be classified as "elevated" or "very elevated" on the test reports. In a 2006 naturopathic textbook chapter, Quig acknowledged that mercury levels "are higher in specimens collected from 90 minutes to 2 hours after DMPS infusion than with longer collection times, because the peak rate of mercury excretion occurs about 90 minutes after infusion of DMPS." [7] Quig's chapter also states:

In 2004, Irish researchers found that administering DMSA to healthy, symptom-free volunteers multiplied their urinary mercury levels an average of about six times, raising them to levels similar to those reported elsewhere among people who—based on provoked testing—had been diagnosed with mercury toxicity. The researchers concluded: "The oral chelation test using DMSA may lead to misleading diagnostic advice regarding potential mercury toxicity." [8]

In 2005, the Autism Research Institute,which promotes a spectrum of questionable autism treatments, issued a 42-page consensus position paper called Treatment Options for Mercury/Metal Toxicity in Autism and Related Developmental Disabilities [9]. Referring to provoked testing of urine specimens, the document states that "the reference range for the urine or stool generally involves a comparison to people who are NOT taking a detoxification agent, so that even a normal person would tend to have a high result." Quig is identified as one of 33 people who reviewed and endorsed the position statement.

Despite all of this, Doctor's Data's reports classify mercury values in the range of 5-10 µg/g as "elevated" and further state that "no safe reference levels for toxic metals have been established." Practitioners typically receive two copies of the report, one for the practitioner and one to give to the patient. Very few patients understand what the numbers mean. They simply see "elevated" lead or mercury, and interpret the "no safe levels" disclaimer to mean that any number above zero is a problem. (The fact that the reports use the familiar green, red, yellow and red colors of traffic lights may also have an effect.) The patient is then advised to undergo "detoxification" with chelation therapy, other intravenous treatments, dietary supplements, or whatever else the practitioner happens to sell.

This advice is very, very, very wrong. No diagnosis of lead or mercury toxicity should be made unless the patient has symptoms of heavy metal poisoning as well as a much higher nonprovoked blood level. And even if the level is in the 30s—as might occur in an unsafe workplace or by eating lead-containing paint—all that is usually needed is to remove further exposure. Chelation therapy is rarely necessary.

Warnings to Chelationists

Both Quig and attorney Algis Augustine (one of Doctor's Data's lawyer) caution chelationists not to rely solely on provoked urine testing to diagnose heavy metal toxicity. In April 2010, both spoke during the "Heavy Metals Detoxification Workshop" sponsored by the American College of Advancement in Medicine (ACAM), the leading organization that promotes chelation therapy. Quig's talk was titled "Appropriate Laboratory Testing for Metal Toxicology," during which he stated:

Rarely is it a stand-alone test, and you absolutely should not interpret your provocation results against an unprovoked reference range. . . . Consider the results in context with the amounts of all metals. Remember the synergy, physical exam, history of known exposure, symptoms, and other biomarkers. Very importantly, don't conclude metal toxicity based upon higher than average net retention. . . . Current standards of care define toxicity by blood level. So keep yourself off the radar, and don't be running around talking about "My patient has toxicity." No, they have they have significant retention of metals that elicits toxic effects. OK? . . . . Really be careful about using the word "toxicity" when we are talking about subclinical, chronic toxicity [10].  

Slide from Quig's talk

Augustine's talk, called "Legal Update," focused on how doctors can avoid trouble with their state licensing boards. After referring to the provoked urine testing as "nonstandard," he said:

I have a simple rule that I tell people all the time on nonstandard tests. Well, two simple rules. Number one: Don't give every patient the same nonstandard tests—all the time—because it makes it look like you're not thinking. . . . And number 2, and this is the most important thing: Don't base your diagnosis, pure and simple, on a nonstandard test [11].

 

Slide from Augustine's talk

Inappropriate Diagnosis and Treatment

Chelation therapy is a series of intravenous infusions containing a chelating agent and various other substances. One form of chelation therapy is occasionally used to treat lead poisoning. However, lead poisoning is rare and has well-established diagnostic criteria. Slight elevations of lead levels are not poisoning and need no treatment because the body will lower them when exposure is stopped. Proper diagnosis of lead poisoning requires symptoms of lead poisoning, not just a slightly elevated level. Acute poisoning is always accompanied by a rise in zinc protoporphyrin (ZPP), without which it should not be diagnosed. Chronic poisoning would have severe symptoms that would be obvious to anyone in addition to severely elevated lead (and ZPP) levels.

Doctors who offer chelation therapy as part of their everyday practice typically claim that it is effective against autism, heart disease and many other conditions for which it has no proven effectiveness or plausible rationale [12]. One such case was described in a 2009 decision by the U.S. Court of Federal Claims which found no credible evidence that childhood vaccinations cause autism. In that case, Colton Snyder underwent chelation therapy after a Doctor's Data urine test report classified his urine mercury level as "very elevated." After noting that the urine sample had been provoked (with DMSA) and that provocation artificially increases excretion, the Special Master concluded that a non-provoked test would have placed the result in the normal range. He also noted:

The medical records, including reports from Mrs. Snyder, reflected that Colten did poorly after every round of chelation therapy. . . . The more disturbing question is why chelation was performed at all, in view of the normal levels of mercury found in the hair, blood, and urine, its apparent lack of efficacy in treating Colten’s symptoms, and the adverse side effects it apparently caused [13].

In March 2010, in a related case, another Special Master concluded that it made no sense to compare the child's post-provocation urine test result to a reference range that is based upon non-provoked urine testing. [14].

In March 2009, Arthur Allen tried to interview an official at Doctor's Data but received no response to his request. However, he did manage to talk with someone at the company who said that the lab was doing about 100,000 of the tests per year. When he asked about the reference range problem, he was told there was no way to establish a reference range for provoked specimens, because provocation might be done with various chelating agents, at varying doses. "The tests are ordered by physicians, so they can interpret the results," the employee said. "They do what they want with this information." [15]

Despite provocation, the toxic urine test report sometimes shows no elevated levels. But that doesn't deter the doctors who are intent on chelating children. They simply tell parents that the children have trouble excreting heavy metals and the test may not detect "hidden stores." In other words, no matter what the test shows, they still recommend chelation.

In 1999, the Human Biomonitoring Commission of Germany's federal environmental agency stated:

The mobilization test with DMPS to assess an amalgam-related lead burden does not provide significant insight into the determination of spontaneously urine-excreted mercury within 24 hours. No validity can be assigned to such a mobilization test. . . . Furthermore, there do not exist any reference values for the stimulated mercury excretion in urine, and also no scientifically validated data beyond which health concerns exist; therefore, therapeutic consequences can not be deduced from the data of DMPS mobilization tests [16].

In 2003 and 2004, the New Jersey Department of Health and Senior Services and the U.S. Agency for Toxic Substances and Disease Registry investigated a case in which a 5-year-old child was undrgoing chelation therapy for "metals exposure" that was diagnosed with provoked urine testing. The investigators identfied no significant source of mercury contamination and noted that provoked testing was not an appropriate diagnostic test [17].

In 2004, CIGNA HealthCare Medicare Administration, which processes Medicare claims for Idaho, North Carolina, and Tennessee, issued a "Progressive Correction Action Review" which concluded that many claim submissions for chelation therapy had been inappropriate. This conclusion was documented by a study of 40 claims which found that in many cases, "heavy metal toxicity" was inappropriately diagnosed and no need for chelation with edetate calcium disodium was documented. The review criticized provoked testing and noted that it does not provide a basis for diagnosing past or current poisoning [18].

Aetna considers laboratory testing for heavy metal poisoning "medically necessary" for people with specific signs of heavy metal toxicity and/or a history of likely exposure—but "medically unnecessary" for people with only vague, ill-defined symptoms and no history of likely medical exposure. Its Clinical Policy Bulletin on chelation therapy also criticizes provoked testing [19].

In 2005, an ATSDR scientist reported:

Each year, ATSDR receives dozens of calls from individuals who have been chelated (challenged) with DMPS or DMSA prior to collection of any urine samples, and subsequently been diagnosed as having mercury poisoning. The sole basis of these diagnoses was laboratory reports that indicated that the individual had been determined to have toxic levels of mercury, based solely upon comparison of post-chelation mercury values with historical (typically pre-chelation) values. Without exception these individuals have been advised to undergo additional chelation.

Some physicians have also looked to mercury as a possible cause of undiagnosed health problems and subsequent chelation therapy as a treatment for those problems. As a result, the use of chelation has expanded in recent years to include the treatment of mildly symptomatic or asymptomatic patients with no documented history of mercury exposure, and it is becoming increasingly, and unfortunately, common for practitioners to make a diagnosis of mercury intoxication and begin treatment without carrying out an adequate clinical workup [20].

In 2006, a National Institute for Occupational Safety and Health (NIOSH) health hazard evaluation team reviewed the records of two Broward County park employees who had been diagnosed with arsenic poisoning based on provoked urine tests. After concluding that no poisoning had taken place, the investigators notedthat "Provoked urinary testing has resulted in many patients being falsely diagnosed with arsenic poisoning because the test measured the arsenic content of the diet." [21].

In 2007, the Oregon Lead Poisoning Prevention Program advised against the use of urine testing for diagnosing lead poisoning and also said that provoked testing should not be used for diagnostic purposes [22].

In 2009, the American College of Medical Toxicology (ACMT) issued a position statement which concluded that provoked testing "has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning." [23]

In 2009, NIOSH investigators evaluated a suspected outbreak of antimony toxicity among fire fighters in Boca Raton, Florida who had been wearing fire-retardant pants that contained various chemicals. The investigation was triggered by hair analysis and urine toxic metal tests that had been ordered by a chelationist (Leonard Haimes, M.D.) and performed by a commercial laboratory (Doctor's Data). Doctor's Data's reports alleged that all 30 of the fire fighters who had undergone hair analysis had antimony levels much higher than the "reference range" and that 23 who also had urine toxic metal testing showed "high" mercury levels. After a thorough evaluation found no real evidence of toxicity, the investigators advised:

The decision to perform laboratory testing for heavy metals, including antimony and mercury, should be based on whether or not documented health symptoms are consistent with overexposure to these metals. It is important to use reliable and recommended testing methods with well-validated reference ranges to measure the concentration of heavy metals in the body. Because results from elemental hair analysis and post-chelation-challenge urine tests do not provide sufficient evidence of heavy metal toxicity, they should not be used to justify searching the workplace for exposures or to treat heavy metal toxicity. In particular, they should not be used to justify chelation therapy, which can be potentially harmful to a patient [24].

The Online Petition

Many parents have expressed concern about the way that Doctor's Data reports its findings. Several years ago, a petition was posted to petitiononline.com to ask Doctor's Data to stop comparing provoked tests results to non-provoked standards. By February 2006, there were 92 signers. The petition states:

To: To get matching reference ranges to people tested
To the CEO of Doctors data Inc.

We thank you for providing the extensive testing for toxic metals , fecal stools & all the other tests that us parents of children with autism and other disabilities have done at DDI.

However we would like to ask you to please use matching reference ranges to the people tested as it is impossible to get an accurate picture when the reference ranges do not match.

Eg. Urine toxic metals challenge test compares a childs urine sample AFTER provocation with DMSA to an UNPROVOKED reference range population of adults & kids. It is only natural that our kids will show results that are higher than the reference range.

Had the reference range population also been provoked, their results would have most probably been higher, which means our childrens results may not really be that high, it just appears that way.

The present tests compare apples to bananas.... provoked to unprovoked...we'd like to compare apples to apples please.

We the undersigned urge you to please seriously consider this petition and to give us matching reference ranges to the children tested as we need accurate test results in order to be able to do the correct treatments to get them better.

Sincerely,

The Undersigned

Regulatory Actions and Civil Suits

Several state licensing boards have taken action against doctors who used provoked urine testing as a prelude to chelation. In some of these cases, the test was of major importance in the public documents that describe the board actions. In the rest, the board action emphasized other misconduct and the test was either briefly mentioned or I learned of its relevance through other means. There have also been four civil suits against Doctor's Data and doctors who used them that alleged fraud.

The Bottom Line

The urine toxic metals test described above—whether provoked or not—is used to persuade patients they are toxic when they are not. I believe that several agencies can and should do something to stop this deception.

People who have been victimized can also strike back. Practitioners who prescribe or administer chelation based on a urine toxic metal test report can be sued for malpractice, fraud, and battery, and might even be liable for violating their state Unfair Trade Practices Act, which can result in an award of triple damages. Consumers can also complain to the Better Business Bureau about the test.

I recommend avoiding any practitioner who uses the urine toxic metals test as described above. If provoked testing has been used to trick you, please send me an e-mail describing what happened and include your phone number.

Doctor's Data does not like this report. After I refused to their demand
to remove it, they sued me. To read about the suit, click here.

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This article was revised on October 2, 2014.

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