Doctor's Data Facing Multiple Lawsuits

Stephen Barrett, M.D.

Doctor's Data, Inc. (DDI), a laboratory whose hair and urine tests have been used for decades to mislead consumers, is finally getting the negative attention it deserves. Since 2008, four lawsuits by aggrieved patients have included DDI as a co-defendant.

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 llab separated from separated from Miller Pharmacal about 20 months later [1]. Doctor's Data's curent president is George Hickock's son Darrell Hickok.

Doctor's Data is now located in St. Charles, Illinois. Its current Web site describes 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 several types of hair and urine tests that provide little or no medically useful information about the patient 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 analyisis 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 carry out the test, a sample of a person's hair—typically from the back of the neck—is sent for measurement of its mineral content. DDI states that since 1972, it has 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. Unfortunately for patients, hair analysis is not reliable for evaluating the nutritional status of individuals [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]

The company's Web site 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 [10], and practitioners who offer chelation therapy or other "detoxification"methods use the "toxic element" levels to persuade people to be "detoxified."

Dubious Urine Tests

DDI also offers urine tests for amino acids and toxic metals. It describes the 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 (homocystine), 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” (eg. 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 [11].

The sample report on DDI's Web site includes three pages of measurements and three pages of clinically useless biochemical tidbits, diagnostic speculations, pseudoscientific blather, and recommendations for further testing. 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 [12]. The obvious purpose of DDI's urine amino acid test is to promote the sale of unnecessary supplements.

DDI describes 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. More common, however, is a chronic, low-level exposure to toxic metals that can result in significant retention in the body that can be associated with a vast array of adverse health effects and not chronic disease. Once cannot draw valid conclusions about adverse health effects of metals without assessing net retention. For an individual, toxicity occurs when net retention exceeds physiological tolerance. Net retention is determined by the difference between the rates of assimilation and excretion of metals. 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 [13].

Tests done after administering a "metal detoxification" (chelating) agent are called "provoked" tests and are bogus. So is the concept of "hidden body stores." Many people have harmless amounts of lead or mercury in their body. Provoked urine testing forces them 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 "elevated" or "very elevated" when no problem exists [14]. Practitioners use this deceptive presentation 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.

Victims Strike Back

Since 2008, four people who were victimized by chelationists using DDI's urine toxic metals test have filed lawsuits against DDI as well as the practitioners.

The Bottom Line

Several networks of fringe practitioners are using hair and urine tests from Doctor's Data to persuade patients to buy dietary supplements and/or undergo "detoxification" that they do not need. My advice is very simple. If you encounter a doctor who does either of these things, terminate your relationship, complain to your state licensing board, 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. Urine amino acids. Doctor's Data Web site, accessed, April 19, 2010.
  12. Barrett S. Dietary supplements: Appropriate use. Quackwatch, Oct 17, 2006.
  13. Urine toxic metals. Doctor's Data Web site, accessed, April 19, 2010.
  14. Barrett S. How the "urine toxic metals test" is used to defraud patients. Quackwatch, April 19, 2010.
  15. Rick Pfister v. Treatment facility, Lab facility, Physician. Marion Superior Court No. 10 Cause No. 49D10-0802-CT-005046. Filed Feb 1, 2008.
  16. Barrett S. CARE Clinics, Doctor's Data, sued for fraud. Casewatch, July 15, 2009.
  17. Complaint for damages. Ardis and Henry Morschladt vs. Alireza Panahpour, DDS et al. Orange County Superior Court Case No. 30-2009-00323131, filed Nov 24, 2009.
  18. Complaint for damages. James Coman v. Anju Usman, MD et al. Cook County Circuit Court, Case No. 2010L002776, March 3, 2010.

This article was revised on August 14, 2013.