“In 1998, Andrew Wakefield, a gastroenterologist at London’s Royal Free Hospital, published a study in the prestigious medical journal Lancet that linked the triple Measles, Mumps and Rubella (MMR) vaccine with autism and bowel disorders in children. The study — and Wakefield’s subsequent public statements that parents should refuse the vaccines — sparked a public health panic that led vaccination rates in Britain to plunge.

Wakefield’s study has since been discredited, and the MMR vaccine deemed to be safe. But now medical authorities in the U.K. have also ruled that the manner in which Wakefield carried out his research was unethical. In a ruling on Jan. 28, The General Medical Council, which registers and regulates doctors in the U.K., ruled that Wakefield acted “dishonestly and irresponsibly” during his research and with “callous disregard” for the children involved in his study.”

…

“The panel also criticized Wakefield for failing to disclose that, while carrying out the research, he was being paid by lawyers acting for parents who believed their children had been harmed by the MMR jab.

The panel’s ruling follows a refutation of Wakefield’s research from the scientific community. Ten of 13 authors in the Lancet study have since renounced the study’s conclusions. The Lancet has said it should not have published the study in the first place, and various other studies have failed to corroborate Wakefield’s hypothesis.”

By Dr. Stephen Barret, M.D.

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.” Several years ago, a well-designed experiment tested workers who had industrial exposure to mercury. The researchers found that provocation with DMSA raised the 24-hour average urine mercury level from 4.3 µg/g before chelation to 7.8 µg/g after chelation [2]. 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 2-3 times as high 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. 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.”

Doctor’s Data uses a reference range 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 [3], which means that if all other things were equal, Doctor’s Data is far more likely than standard labs to find “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, which raised the reported level even higher.  

The management at Doctor’s Data knows that provoked testing artificially raises the urine levels. Yet their report classifies values in the range of 5-10 µg/g as “elevated. The report also states 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 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.

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 [4]. One such case was described in a recent 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 [5].

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 speciments, 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.” [6]

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.

Regulatory Actions

At least four state licensing boards have been concerned about the issue of provoked urine testing as a prelude to chelation.

• Connecticut has included a provoked testing ban in settlement agreements with two practitioners. In 2005, Robban Sica, M.D., signed a consent order under which she was prohibited from using a provoked test to diagnose heavy metal toxicity [7]. In 2006, George Zabrecky, D.C., was ordered to stop all testing that might be preliminary to chelation therapy [8].
• In 2006, Washington’s Bureau of Medical Quality Assurance charged Stephen L. Smith,M.D., with unprofessional conduct for relying on unreliable tests that included a urine toxic metals test. In 2007, he was ordered to pay a $5,000 fine and undergo a practice evaluation [9].
• In 2007, Tennessee suspended the license of Joseph E. Rich, M.D., after concluding that he had mismanaged the care of 15 patients, including three who were chelated after undergoing a provoked urine test. [10].
• In 2007, the North Carolina Medical Board charged Rashid A. Buttar, M.D., with exploiting four patients by charging exorbitant fees for worthless tests and treatments. At a 2008 hearing Buttar indicated that he recommends chelation for nearly all patients who consult him and routinely uses the urine toxic metals testing to evaluate them.

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 [11].

I believe that several agencies can and should do something to stop the fraud. If the FDA has jurisdiction over the software used to generate the test reports, it could ban its use. State licensing boards could prohibit the use of provoked testing and discipline practitioners who use it. State laboratory licensing agencies could prohibit testing of provoked specimens or order Doctor’s Data to raise its reference ranges and to stop comparing provoked test results to these non-provoked ranges. The Centers for Medicare & Medicaid Services’ Division of Laboratory Services can also ban the testing of provoked specimens. In addition, all of these agencies can and should issue public warnings.

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 recommend avoiding any practitioner who uses it. If this test has been used to trick you, please send me an e-mail describing what happened and include your phone number.

References

1. Baratz RS. Dubious mercury testing. Quackwatch, Feb 19, 2005.
2. Frumkin H. Diagnostic chelation challenge with DMSA: A biomarker of long-term mercury exposure? Environmental Health Perspectives 109:167–171, 2001.
3. Brodkin E and others. Lead and mercury exposures: interpretation and action. Canadian Medical Association Journal 176:59-63, 2007.
4. Green S. Chelation therapy: Unproven claims and unsound theories. Quackwatch, July 24, 2007.
5. Vowell DK. Decision. Snyder v Secretary of the Department of Health and Human Services. In the U.S. Court of Federal Claims, Office of Special Masters. Case No. 01-162V, filed Feb 12, 2009.
6. Allen A. Treating autism as if vaccines caused it: The theory may be dead, but the treatments live on. Slate, April 1, 2009.
7. Consent order. In re: Robban Sica, M.D. , Connecticut Board of Health Petition No. 2002-0306-001-043, Feb 15, 2005.
8. Consent order. In re: George Zabrecky, D.C., Connecticut Board of Chiropractic Examiners Petition No. 2003-0109-007-001, Nov 16, 2006.
9. First amended statement of charges. In the matter of the license to practice as a physician and surgeon of Stephen L. Smith, M.D. Washington Department of Health, Bureau of Medical Quality Assurance, Docket No. 05-01-A-1038MD, Filed Jan 3, 2006.
10. Final order. In the matter of Joseph Edward Rich before the Tennessee Board of Medical Examiners, Docket No. 17.18-073557A, Dec 21, 2007.
11. CIGNA HealthCare Medicare Administration. Progressive correction action review,Nov 28, 2004

This article was revised on April 29, 2009.