Doctor's Data Involved in Many Lawsuits

Stephen Barrett, M.D.

Doctor's Data, Inc. (DDI), one of several laboratories whose hair and urine tests have been used for decades to suggest that people need treatment, was included as a co-defendant in five suits by aggrieved patients. In each case, the plaintiff charged that DDI's urine toxic metals test was used to persuade them that they had a problem with heavy metals for which they should undergo detoxification with chelation therapy. In another case, DDI was not a defendant but was forced to disclose documents related to its hair analysis reports.

Background History

Doctor's Data was founded in 1972 as Bio Medical Data, Inc. and changed to its current name in the early 1980s. It was originally owned by Miller Pharmacal, a company that markets dietary supplements [1]. Miller Pharmacal's founder was John J. Miller, Ph.D., who, from 1947 through the mid-1950s, had been chief research chemist for J.B. Roerig, which was purchased in 1953 by Pfizer. The Miller Pharmacal Group site states:

In 1958, he and his associate Michael Wohead launched the Miller Pharmacal Company for the purpose of developing pharmaceutical preparations based on Dr. Miller's lifetime research in the field of chelation chemistry. They were motivated by the fact of having learned the importance of using the "organically bound" or "chelated and complexed" forms of minerals as essential elements in the prevention and treatment of disease [2].

When Dr. Miller died in 1977, three new owners took control: George Hickok, the President of Miller Pharmacal at that time, John Errera, President of Bio-Medical Data (BMD), and Ted Lucken, President of Doctor's Data Inc. The lab separated from separated from Miller Pharmacal about 20 months later [1]. Doctor's Data's current president is George Hickok's son Darrell Hickok.

Doctor's Data is now located in St. Charles, Illinois. In 2010, its Web site described the company this way:

Doctor’s Data, Inc. (DDI), a premier clinical laboratory with over 30 years’ experience, provides specialty testing to healthcare practitioners around the world. A specialist and pioneer in essential and toxic elemental testing of multiple human tissues, the laboratory offers a wide array of functional testing. DDI’s tests are utilized in the assessment, detection, prevention, and treatment of heavy metal burden, nutritional deficiencies, gastrointestinal function, hepatic detoxification, metabolic abnormalities, and diseases of environmental origin.

DDI is a licensed CLIA laboratory with appropriate state certifications and participates in numerous quality assurance/proficiency testing programs including the College of American Pathology, New York State DOH and Le Centre de Toxicologie du Quebec [3].

The mention of New York State is interesting because in 1985, the New York Attorney General sought a court order to stop DDI from soliciting or accepting specimens without a valid permit from the New York State Department of Health. The case arose in connection with an unlicensed "nutritionist" who was using DDI's hair analysis tests as a basis for prescribing dietary supplement and herbal products [4]. Documents in the case indicate that DDI held a permit to operate within New York State for a brief period in 1982 but the permit was revoked when the authorities discovered that the laboratory director (Oscar G. Rasmussen, Ph.D.) did not have a requisite degree in chemical, physical, or biological sciences [5]. In addition, the New York Department of Laboratories regarded hair analysis for the purpose of determining body nutrient levels as an inaccurate test and would not authorize such a test. The case was settled in 1986 with a consent judgment under which DDI agreed to pay $25,000 and stop accepting specimens from New York State unless and until it received a permit from the State Department of Health [6]. DDI finally became licensed in 1997, but the license only permits it to do tests that are FDA-approved or have special approval from the state health department.

DDI's tests include hair and urine tests that, in my opinion, provide little or no medically useful information but serve as marketing tools for the practitioners who order them. Hair analysis was the lab's only product until 1985, when it began offering trace-mineral analysis of blood, packed cells, and urine, as well as amino acid fractionation and quantitation of plasma and urine [1]. Many other types of tests were added later.

Dubious Hair Tests

DDI offers two hair analysis tests: a "Hair Elements" test and a "Hair Toxic Elements Exposure Profile." To obtain either test, a sample of a person's hair—typically from the back of the neck—is sent for measurement of its mineral content. In 2010, DDI stated that since 1972, it had performed over 4 million of these tests [7].

The"Hair Elements" test reports compare the measured values of various minerals with "reference ranges" and classify the results as low, normal, or high. DDI claims that the levels of nutrient minerals such as magnesium, chromium, zinc, copper and selenium are correlated with levels in organs and other tissues and can help in formulating treatment programs. The prevailing scientific view is that hair analysis is not reliable for evaluating the body's nutritional status [8].

The "Hair Toxic Elements Exposure Profile" reports the hair levels of arsenic, aluminum, cadmium, lead, antimony, and mercury and several other substances that are reported as as high when the amount is near the top of its "reference range." However, "high"merely means that the specimen contained more than most other specimens handled by the lab. It does not mean that the level is abnormal or that the level within the patient's body is dangerous. In 1998, company officials acknowledged that "compared to interpretation of commonly measured analyses in blood or serum, interpretation of elemental analyses from hair seems primitive." Despite, this, the authors claimed that it would be prudent to "adopt a reference range consistent with what is observed in 95% of a healthy population." [9]

DDI's Web states that neither test should be considered a stand-alone diagnostic but should be "used in conjunction with patient symptoms and other laboratory tests." As far as I can tell, however, practitioners who order these tests use them to justify the use of the products and services they recommend. The test reports include several pages of biochemical tidbits and speculations that practitioners can interpret for patients. Chiropractors, "nutrition consultants," naturopaths, and other offbeat practitioners use the nutrient-related test results as the basis for prescribing dietary supplements, and practitioners use the "toxic element" levels to persuade people to be "detoxified." [10]

In 2014, in response to charges that company employees had been exposed to toxic amounts of benzene and heavy metals, a Labor Court judge in Brazil ordered Eli Lilly's Brazilian subsidiary and a successor company to pay damages of 300 million reals. The order also called for medical care for the allegedly affected workers and their offspring, plus other measures, that could cost an estimated 700 million more. Lawsuits with similar claims have been filed by individual former employees. The judge's decision was based substantially on mineralograms (another name for hair analyses) performed by Doctor's Data or its affiliated Brazilian entities. Lilly, which appealed the verdict, contends that (a) there was no evidence that the site had dangerous levels of the identified chemicals and (b) it is well established that hair analysis should not be used as a sole basis for diagnosing heavy metal poisoning—as was done by the doctors who diagnosed these patients. During the appeal proceedings, Lilly filed a 28 U.S. Code § 1782 discovery action in Chicago's federal court to obtain the workers' test reports plus documents that explained the test's methodology [11]. As part of its response, Doctor's Data issued a report stating that it "strongly concurs with Lilly that the use of mineralograms to diagnose heavy metal toxicity (poisoning) from occupational exposure is improper and unsupported by all responsible authority" and that "if the primary, if not exclusive basis of diagnoses of health problems due to heavy metals were hair analyses reports, then the 'experts' against Lilly deviated from occupational exposure standards promulgated by almost all the world's experts in heavy metal toxicology." [12]

Amino Acid Testing

Many practitioners use urine amino acid tests as a basis for recommending supplements. For many years, DDI has described its amino acid test this way:

Many individuals have “hidden” impairments in amino acid metabolism that are problematic and often go undiagnosed. These impairments may or may not be expressed as specific symptoms. They may silently increase susceptibility to a degenerative disease or they may be associated with, but not causative for, a disease. Because of the wealth of information provided, it is suggested that a complete amino acid analysis be performed whenever a thorough nutritional and metabolic workup is called for.

Amino acid analysis provides fundamental information about nutrient adequacy: the quality and quantity of dietary protein, digestive disorders, and vitamin and mineral deficiencies (particularly folic acid, B12, B6 metabolism, zinc and magnesium). In addition amino acid analysis provides important diagnostic information about hepatic and renal function, availability of precursors of neurotransmitters, detoxification capacity, susceptibility to occlusive arterial disease (homocysteine), and many inherent disorders in amino acid metabolism.

The patient’s results are presented in a functional format that permits ease of interpretation. A comprehensive summary of “presumptive needs” (e.g. B6, B12/folate, Mg) and “implied conditions” (e.g. maldigestion/malabsorption, abnormal gastrointestinal flora, impaired detoxification, oxidative stress) is presented based upon each patient’s results. Patient specific amino acid supplement schedules and user-friendly commentary paragraphs are provided to simplify nutritional intervention [13].

The sample report on DDI's Web site includes four pages of measurements and four pages of clinically useless biochemical tidbits, diagnostic speculations, pseudoscientific blather, and recommendations for additional tests, including some from DDI. Unfortunately for patients, amino acid analysis of urine does not provide basic information about the individual's general health, metabolism, nutrient status, or dietary adequacy, and the supplement recommendations lack a rational basis. It is not possible, for example, to figure out what people eat by looking at what they excrete. And finding a substance does not mean that it came from a single source or metabolic pathway.

DDI's sample report recommends taking 12 amino acids as supplements even though adequate amounts are readily obtainable from the protein foods that most people eat. The appropriate way to assess dietary adequacy is to record and analyze what people eat over a period of several days [14]. The obvious purpose of DDI's urine amino acid test is to promote the sale of unnecessary supplements.

Urine Metal Tests

Many practitioners use urine metal tests as a basic for recommending "detoxification." In 2010, DDI described its urine toxic metals test this way:

Urine toxic and essential elements analysis is an invaluable tool for the assessment of retention of toxic metals in the body and the status of essential nutrient elements. Toxic metals do not have any useful physiological function, adversely affect virtually every organ system and disrupt the homeostasis of nutrient elements.

Analysis of the levels of toxic metals in urine after the administration of a metal detoxification agent is an objective way to evaluate the accumulation of toxic metals. Acute metal poisoning is rare. . . . To evaluate net retention, one compares the levels of metals in urine before and after the administration of a pharmaceutical metal detoxification agent such as EDTA, DMSA or DMPS. Different compounds have different affinities for specific metals, but all function by sequestering “hidden” metals from deep tissue stores and mobilizing the metals to the kidneys for excretion in the urine [15].

Tests done after administering EDTA, DMSA or DMPS (chelating drugs) are called "provoked" tests. Many people have harmless amounts of lead or mercury in their body. The provoking drug forces greater-than-usual amounts to be excreted over a short period of time, which raises urine levels artificially and temporarily. 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. DDI's reports compare the artificially raised values to reference range that it says represents a healthy population under nonprovoked conditions. As a result, many of its reports say that the patient's level is "higher than expected" when no problem exists, and practitioners use this information to frighten patients into undergoing chelation therapy. Several state licensing board have disciplined practitioners for using provoked testing, and several lawsuits have been filed by alleged victims.

The front page of DDI's Urine Toxic Metals test reports includes two columns of numbers and a three-color graph. The numbered columns list the measured results and reference values selected by DDI. The graph section, which is by far the most prominent part of the report, spans columns that are colored green, yellow, and red (the colors of a traffic light). The green column is headed "within reference." The yellow and red columns are headed "outside reference. The reports also contain two pages of general commentary plus commentary about each metal that is detected in concentrations that are higher than its reference range.  

The prevailing scientific belief is that it is improper to compare a provoked test results with non-provoked reference values and that it is misleading to do so [16]. Non-provoked reference values are scientifically meaningful only when applied to non-provoked test samples. DDI actually acknowledges this with a statement in its commentary that "reference intervals shown are not recommended for comparison purposes with provoked test results." In various legal proceedings, it has claimed that these words and others elsewhere in the report are intended to mean that if the specimens are provoked, the reference values and graph should be ignored. If DDI thinks they should be ignored, the obvious question is why it puts them in the reports. When asked this question, DDI claims that federal regulations require the reports to contain them.

I do not believe that is correct. The relevant regulation—42 CFR § 493.1291—does not require that reference values be listed in lab reports. It merely says: "Pertinent 'reference intervals' or 'normal' values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests." [17] DDI 's Urine Toxic Metals Test reports do not contain pertinent reference intervals. If it wanted to provide them, it could derive them from its huge database of previous reports—as has been done by MetaMetrix and Trace Minerals International (TMI). MetaMetrix uses "chelated 95% reference ranges" created by pooling samples received from patients that were provoked with any chelating agent. TMI's reference ranges are specific for each chelating agent. These reference values are much higher than those used by DDI. If DDI used TMI's methodology, only 5% of the measured values would be outside the reference range and DDI's reports would be much less useful as sales tools.

Lawsuits Filed

Since 2008, five people who believed they were misled by chelationists who used DDI's urine toxic metals test have filed lawsuits against DDI as well as the practitioners.

In each of these cases, DDI argued that it should not be held responsible because (a) it had had no direct contact with the patient, (b) treatment was determined entirely by the practitioners, and (c) the test reports contained notices that the values found for provoked specimens should not be compared to the reference values. In the Pfister and Young cases, the courts accepted this argument and dismissed the suits—Pfister in 2012 [23] and Young in 2016 [24]. Young's case against the other defendants is still pending. Stemp's lawyers did not oppose DDI's motion for dismissal and, soon after it was filed, dismissed Stemp's case against all of the defendants. Because this puzzled me, I asked Stemp's wife what happened. She told me that his health had deteriorated so much that he did not wish to continue. The Mohrschladt case was settled with undisclosed terms that I assume included payment. The Coman suit was voluntarily withdrawn, but this type of withdrawal preserves the right to file it again until the boy reaches 19 years of age.

The Bottom Line

Many fringe practitioners use hair or urine tests to persuade patients to buy dietary supplements and/or undergo "detoxification" that they do not need. My advice is very simple. If you encounter anyone who does this, terminate your relationship, complain to your state licensing board and/or attorney general, and e-mail me an account of what happened.

References

  1. The history of Doctor's Data. Doctor's Data Web site, archived Oct 23, 1997.
  2. Our founders. Miller Pharmacal Group Web site, accessed Aug 28, 2010.
  3. Doctor's Data home page, accessed April 19, 2010.
  4. Dickerman HW. Letter to Oscar G. Rasmussen, Ph.D., Dec 9, 1982.
  5. Verified Petition. People of the State of New York vs. Doctor's Data Laboratories. New York State Supreme Court Index No. 42127/85, July 22, 1985.
  6. Consent judgment. People of the State of New York vs. Doctor's Data Laboratories. New York State Supreme Court Index No. 42127/85, filed Oct 16, 1986.
  7. Hair elements test. Doctor's Data Web site, April 19, 2010.
  8. Barrett S. Commercial hair analysis: A cardinal sign of quackery. Quackwatch, Nov 21, 2008.
  9. Druyan ME and others. Determination of reference ranges for elements in human scalp hair. Biological Trace Element Research 62:183-197, 1998.
  10. Bass DA, Urek K, Quig D. Clinical Chemistry 45:A164, 1999. (Poster presented at the American Association of Clinical Chemistry Conference, New Orleans, July 1999)
  11. Initial memorandum of law in support of Lilly Do Brazil LDTA's application for an order of judicial assistance pursuant to 28 U.S.C. §1782. In re application of Eli Lilly do Brasil Ltda.
    to obtain discovery for use in various proceedings of the Courts of São Paulo State and Paranà State, Brazil.
  12. Fields D. Doctor's Data, Inc., Report to Eli Lilly Do Brasil LTDA., issued in 2015.
  13. Urine amino acids. Doctor's Data Web site, accessed April 19, 2010.
  14. Barrett S. Dietary supplements: Appropriate use. Quackwatch, Oct 17, 2006.
  15. Urine toxic metals. Doctor's Data Web site, accessed, April 19, 2010.
  16. Barrett S. How the "urine toxic metals test" is used to defraud patients. Quackwatch, Jan 15, 2016.
  17. Standard test report, § 493.1291. Code of Federal Regulations, Oct 1, 2015 edition.
  18. Rick Pfister v. Treatment facility, Lab facility, Physician. Marion Superior Court No. 10 Cause No. 49D10-0802-CT-005046. Filed Feb 1, 2008. First amended complaint filed Jan 19, 2012.
  19. Barrett S. CARE Clinics, Doctor's Data, sued for fraud. Casewatch, July 15, 2009.
  20. Complaint for damages. Ardis and Henry Mohrschladt vs. Alireza Panahpour, DDS et al. Orange County Superior Court Case No. 30-2009-00323131, filed Nov 24, 2009.
  21. Complaint for damages. James Coman v. Anju Usman, MD et al. Cook County Circuit Court, Case No. 2010L002776, March 3, 2010.
  22. Second amended complaint. Lizette Young vs. Shiva Lalezarzadeh, MD, Health and Vitality Center Medical Corporation, Doctor's Data, Inc., and Sean Hakami, DDS. Los Angeles Superior Court Case No. BC540484, filed June 10, 2015.
  23. Order granting Doctor's Data Inc's motion for summary judgment. Rick Pfister v. Medical Wellness Institute, LLC, Doctor's Data, Inc., and Vinu A. Patel, M.D. Marion Superior Court No. 10 Cause No. 49D10-0802-CT-005046. Filed Oct 29, 2012.
  24. Judgment re: Doctor's Data Inc.'s motion for summary judgment. Lizette Young vs. Shiva Lalezarzadeh, M.D., Health and Vitality Center Medical Corporation, Doctor's Data, Inc., and Sean Hakami, DDS. Los Angeles Superior Court Case No. BC540484. filed May 18, 2016.

This article was revised on June 30, 2016.

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