A few years ago a friend asked me to comment on advice given to her adult daughter by a psychiatrist whom she’d consulted for depression. The psychiatrist had recommended testing samples of saliva and urine for hormone and neurotransmitter levels, the results of which would likely indicate a need for supplements to correct deficiencies or imbalances. According to the psychiatrist, who had an academic appointment at a medical school in New York City, “I have been using these supplements with a great deal of success.” My friend is not medically or scientifically sophisticated, but this made her a little uncomfortable. In that, she was entirely justified.

During our recent panel discussion at the NECSS, a member of the audience identified himself as a clinical pathologist at a major medical center, and wondered what he might do to become involved in the good fight against encroaching pseudoscience in medical schools. Clinical pathology is the medical specialty that concerns itself, in summary, with laboratory tests—their development, their validity, their interpretation, their usefulness and, by implication, their misuse. A topic that we haven’t much featured on SBM (we touched upon it here, here and here, and probably elsewhere) is that of bogus laboratory or other diagnostic tests.

Early in my own education in modern quackery, I found it particularly distasteful not merely that quacks misuse laboratory tests, but that several commercial laboratories market misleading tests. To the untrained eye these laboratories appear to be legitimate, even to the point of their being approved by apparently legitimate certifying bodies. We’ll discuss that below, but first let’s look more closely at the psychiatrist’s recommendations to my friend’s daughter and at other examples of bogus tests.

A Full Service Company

If my friend’s daughter had followed her psychiatrist’s recommendation, she would have sent her saliva and urine samples to a company called NeuroScience, which would have had them tested for certain hormones and neurotransmitters. The psychiatrist would have chosen those tests based on prompting by NeuroScience itself. Here’s what would have happened next:

Based on the laboratory results, NeuroScience, Inc. works with healthcare providers to develop Targeted Amino Acid Therapy (TAAT™) protocols designed to address the spectrum of neurotransmitter and hormone imbalances. Addressing neurotransmitter and hormone imbalances through TAAT™ can lead to significantly improved patient outcomes for a number of today’s most challenging conditions. Why wait? Get Started with NeuroScience, Inc. today.

NeuroScience will even help providers convince insurance companies to pay for the tests. And there’s no extra waiting time, because NeuroScience sells not only the tests, but the remedies. But it sells them exclusively to practitioners, who are then expected to resell them to their patients for a markup (look here for an example of the report that the practitioner will receive). If all goes according to plan, that sweet deal will last quite a while:

It is possible to decrease chances of excitatory overload by introducing inhibitory support for one to two weeks prior to the addition of excitatory support. This 1st phase strengthens just the inhibitory system, allowing it to regain control over the excessive excitatory activity during the night. This often leads to improvements in the quality of sleep in many patients. Excitatory support is then introduced in the second phase to enhance excitatory neurotransmission throughout the day, to increase motivation and reduce fatigue.

The second phase of therapy is structured in a way that mimics the body’s natural circadian rhythms. Excitatory neurotransmitter support, if needed, is typically recommended earlier in the day, when the body requires the energetic and cognitive effects of the excitatory transmitters. Likewise, inhibitory support is typically suggested in the latter half of the day, to calm the body and set the stage for sleep.

Even though specific amino acids can change single neurotransmitter levels rapidly, it is difficult to predict when a patient will experience symptomatic improvement. Many report improvement within the first week, whereas others may require several months of continued therapy to note significant changes. It is our experience that 3-6 months is the average amount of time it takes to optimize neurotransmitters overall.

The transition to the final phase of therapy is recommended when the patient has reached their health goals and their neurotransmitter levels have been optimized, as determined through follow-up lab tests. This phase serves as a maintenance phase, whereby the dosing of products is reduced to the minimum level that maintains the symptom resolution. The unfortunate reality of any approach to neurotransmitter imbalances is that the effects of the intervention may not be maintained with discontinuation. Due to ongoing factors that influence neurotransmitter levels, including stress, diet, and genetics, some individuals will require long-term neurotransmitter support. Hence the focus of the third phase is to maintain optimal neurotransmitter levels long-term to offset factors contributing to their imbalance and in the interest of preventing a recurrence of symptoms. (emphasis added)

Wow! Not only can “addressing neurotransmitter and hormone imbalances through TAAT™ lead to significantly improved patient outcomes,” it can also lead to significantly improved practitioner incomes! What a company! What doc, squeezed by diminishing 3rd-party reimbursements, wouldn’t be tempted to sign up?

There are only a couple of problems. Hormone levels measured in saliva are almost never legitimate. There is no physiologic reason to measure most salivary hormone levels and no generally published ranges of normal levels of hormones measured in saliva. Hormones are typically measured in blood, which makes physiologic sense; some hormones and their metabolites can usefully be measured in urine, but not for the purposes that NeuroScience claims. On the other hand, it is likely easier for NeuroScience to solicit samples when blood-drawing is not involved, and easier for the company to make assertions about “test results” that are unfamiliar to most physicians or labs.

Moreover, even if the test results are technically accurate, I’m aware of no science that links them to non-optimal levels of hormones or neurotransmitters, other than in extreme cases such as pan-hypopituitarism or pheochromocytoma (which are quite different from what NeuroScience is claiming). Nor, even if the tests were entirely legitimate, is there any evidence that the proposed treatments will “optimize” neurotransmitter or hormone levels.

Finally, the conflicts of interest among the seller of the tests, the wholesaler of the supplements, and the retailer of the supplements (i.e., the physician) are obvious.

When Bogus Tests fall into the Wrong Hands

In 2005, an autistic 5 year-old boy died in the office of Dr. Roy Kerry in Butler County, PA, after receiving an intravenous injection of disodium EDTA, the same chelating agent that is being used in the NIH-sponsored Trial to Assess Chelation Therapy (TACT). Kerry, a member of the Mother of all PPOs, the American College for Advancement in Medicine (ACAM), had given this agent to the boy ostensibly to treat “heavy metal toxicity” involving aluminum, mercury, and lead, among other possibilities.

According to the PA medical board’s Factual Allegations, Kerry had used at least two bogus tests to make these purported diagnoses. The nature of the first is unclear, because in the written record Kerry described it only as “testing for the deficiency indicator.” Such vague language suggests not a legitimate blood test but, perhaps, a quack “electrodiagnostic” device such as the “Vegatest” or “Electroacupuncture according to Voll.”

The second bogus test was a “post-provocative urine sample” collected a few hours after the first chelation treatment. This yielded an “elevated” urine lead level, but that is exactly what would be expected for anyone who has just been treated with such a chelating agent, and is thus not indicative of true lead toxicity.

Kerry had also diagnosed the boy with “candidiasis” and “multiple food allergies,” two highly unlikely possibilities that suggest other bogus tests, such as “cytotoxic testing” or the paranormally-based applied kinesiology. He may or may not have used these tests, but such “diagnoses” are common among quacks who preach “detoxification” or who belong to the ACAM.

The Commercial Laboratory Hall of Shame

We are not told the name of the laboratory that Kerry used for the “provocative urine test,” but it was likely Doctor’s Data, Inc. (DDI), a company with a long history of dubious offerings. DDI and another company, Genova Diagnostics (GDX), formerly the Great Smokies Diagnostic Laboratory, sell such bogus tests as hair analysis, urinary amino acids, “intestinal permeability,” “DNA oxidative damage assay,” and various “comprehensive panels” that generate reports explicitly or implicitly calling for “detoxification” schemes, “supplements,” “nutriceuticals,” or “bioidentical hormones,” which participating practitioners are only too happy to provide. Doctor’s Data is proud of its close ties with such PPOs as the ACAM and DAN!, and like GDX is a “supporter” of the ACAM.

Genova also has a cozy relationship with naturopath Michael Murray, a long-time shill for “natural remedies” and co-editor of the Textbook of Natural Medicine, previously discussed here. One of Genova’s former divisions was BodyBalance, which peddles “test kits” directly to consumers ostensibly to measure minerals, hormones, “antioxidant reserves,” and “the body’s natural safeguard for optimal sleep, mood and cell function — melatonin” in saliva, hair, or urine. According to the current BodyBalance website,

BodyBalance is a division of Dr. Murray Natural Living, Inc., that specializes in direct to consumer health screening products. Dr. Murray is one of the world’s leading authorities on natural medicine and the author of over 30 books on natural healing. Dr. Murray and James Kammann, the General Manager of the BodyBalance Division, played key roles in the initial launching of the BodyBalance product line in 1999 when it was launched by Great Smokies Diagnostic Laboratory. BodyBalance was acquired by Dr. Murray Natural Living, Inc. in January 2007.

Our goal at BodyBalance is to help empower consumers to take charge of their health by providing them access to the world’s leading functional medicine laboratory — Genova Diagnostics (see http://www.GDX.net). Established in 1986 as Great Smokies Diagnostic Laboratory, Genova Diagnostics today serves over 8000 primary/specialty physicians and healthcare providers, offering over 125 specialized diagnostic assessments. BodyBalance has the exclusive rights to direct-to-consumer testing with Genova Diagnostics’ innovative tests — a lab that has achieved the highest national and certain state certification standards including CLIA (Clinical Laboratory Improvement Amendments) and the College of American Pathologists.

How is it that commercial laboratories can so easily flout the standards of their field? Don’t the “certifications” just mentioned mean anything? Well, yes and no. The Centers for Medicare & Medicaid Services (CMS) regulates laboratories through the program identified above, the Clinical Laboratory Improvement Amendments (CLIA). There are other certifying bodies and various state requirements. These initiatives have made it more difficult for laboratories to peddle some dubious tests, but clearly there is still ample opportunity for what amounts to diagnostic testing fraud. Doctor’s Data, for example, calls itself

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.

The company offers numerous other “Qualifications,” including “Chinese Certified Hair Standard GBW 09101.” Genova Diagnostics, as previewed above, is just as confident:

a fully accredited medical laboratory, certified in the areas of clinical chemistry, bacteriology, mycology, parasitology, virology, microbiology, non-syphilis serology, general immunology, hematology, toxicology, as well as molecular genetics by six separate health agencies including the Centers for Medicare & Medicaid Services which oversees clinical labs in the United States under the federal Clinical Laboratory Improvement Amendment (CLIA).

NeuroScience also boasts of the legitimacy of its laboratory tests. It outsources these to a convenient “independent” lab, Pharmasan, which seems to be right next door and which shares its founder with NeuroScience:

Gold Standard Laboratory Testing
NeuroScience, Inc. uses an independent, CLIA certified testing lab that is licensed in every state–including New York, which holds the highest level of qualification standards.

Quackwatch: Your Guide to Bogus Diagnostic Tests

You can’t help but have noticed that many of the links in this post are to articles on Quackwatch. That’s because the site is chock full of useful information about bogus tests, far more than can be found elsewhere. There you will find a more comprehensive list of bogus tests than I’ve mentioned here, and a larger list of laboratories peddling them. You’ll also find an article on “Dubious Genetic Testing” co-authored by the Quackwatch founder, Stephen Barrett, and our own Harriet Hall, and an article about bogus “biomedical treatments” for autism showing that—surprise!—Doctor’s Data and Genova Diagnostics are major players there, too.

One place where you will find nothing at all about bogus diagnostic tests is the NCCAM website. This is unfortunate, because the site is widely touted as providing information necessary to “be an informed consumer.”

To the clinical pathologist who asked the question at NECSS, if you’re reading this, and to any others who may be out there: There is a real need for those with expertise in lab tests to get involved in the effort to expose pseudomedicine. This is especially true for any of you who are involved with CLIA. Let’s hear from you!