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Bogus Diagnostic Tests

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 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.

Regulation?

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 mischief. 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!

The State Regulation Series:

  1. Pitfalls in Regulating Physicians. Part 1
  2. Pitfalls in Regulating Physicians. Part 2: The Games Scoundrels Play
  3. The Pseudomedical Pseudoprofessional Organization (PPO*)
  4. A New Twist for Autism: A Bogus “Biomedical” Board
  5. How State Medical Boards Shoot Themselves (and You) in the Foot
  6. “Integrative Medicine Experts”: Another Barrier to Effective Discipline
  7. Bogus Diagnostic Tests

Posted in: Diagnostic tests & procedures, Health Fraud, Medical Ethics, Politics and Regulation

Leave a Comment (29) ↓

29 thoughts on “Bogus Diagnostic Tests

  1. Marge says:

    At least one of the labs in your hall of shame accepts test samples from the UK – not just hair samples, but blood samples too. What sort of information can you get out of a blood sample that’s gone across the Atlantic in the post?

  2. mxh says:

    Wow, thanks for the overview. I know that bogus test places exist, but I thought that they were more involved in direct to patient marketing. I was hoping that real, licensed physicians were using them (and had no idea that insurance companies were paying for it). Pretty sad.

  3. DavidCT says:

    This sort of thing is pervasive. I had a patient who was trying to get health care professionals to display pamphlets for nutricuticals and to help push these offers. The package included what seemed like bogus testing combined with supplements that could be sold to treat the deficiencies discovered. She was very enthusiastic about the whole thing as a way to start her own business. To me it appeared to be the con trifecta: Bogus tests, expensive supplements, and sales people working in a multilevel marketing scam.

  4. DevoutCatalyst says:

    Brings back memories. Orthomolecular medicine was the gateway thug that first conned me. MDs with white coats, stethoscopes and bogus tests are all very convincing to the shearling. Went back for repeat visits. It’s bad enough to have paid the bills afterwards, but what gets my goat is not to have noticed the bill on the doctor’s face at the first appointment. Quack!

  5. Kylara says:

    Isn’t it even illegal in some states (or at least some of the time) for doctors to sell products they’re prescribing?

    We have stopped patronizing the only compounding pharmacy in town, because to “keep [their] profit margins up,” they now sell an enormous range of neutriceuticals and generalized woo, including at-home tests to tell which neutriceuticals you need. It made me sick to hear the pharmacist standing there telling people about the glories of ridiculous vitamin levels to cure everything that ailed them, and it made me question his professional competence. (Like, one woman there was pregnant, and even I know that ultra-high vitamin A levels are a concern during pregnancy.) They started trying to upsell me vitamins when picking up a prescription antibiotic for my cat.

    Since it’s the only compounding pharmacy in town we periodically have no choice, but I make sure whenever a doctor or veterinarian suggests them to express my discomfort with their practices and how much I DON’T want to go there. And I certainly don’t trust the pharmacists there to know a damned thing about drug interactions or other pharmacist-y things.

  6. keleton says:

    Great post, this is very interesting to me. I am a medical technology student, currently working as a microbiology lab assistant and phlebotomist (at a hospital, not a dubious lab). I wonder if this topic will be covered at any time during my education.

    We do run tests for many naturopaths in the area, and a lot of the testing seems unneccessary or of doubtful clinical utility to me. It kills me to have a young child come in for a blood draw with orders from a naturopath for every vitamin and hormone test under the sun.

  7. Calli Arcale says:

    Unfortunately, a growing number of compounding pharmacies have been falling into that. Some of it is doubtless financial; peddling these things offers easy money, and it’s hard to turn that down, especially if you don’t see anybody being directly hurt. Even regular pharmacies are falling into this, but at least with them, you have more options if one goes bad.

    I had a vet once, whom I never saw again after this one appointment, who was clearly suckered into the bogus testing stuff. She recommended switching my dog to an “allergen free” kibble (absent any evidence he was allergic to the one he was on at the time), and said what a difference it had made for her dog. Why, she hadn’t even known he was allergic to soy until she sent a blood sample off to a mail-order lab that purports to do allergy testing. That was suspicious enough, but she went on to say that the lab had saved her a lot of heartache by detecting allergies to things her dog had never yet been exposed to, and which now, she could avoid him ever seeing. Of course, for anyone who knows anything about allergies, this is complete BS — you cannot be allergic to something you’ve never encountered.

    She was also convinced my dog was obese, because no standard poodle should weigh over 60 pounds. Yes, the breed standard does say that, but not all purebreds will meet the breed standards, and she wasn’t looking at the actual dog in front of her and noticing that he was also a good deal *taller* than the average poodle. (And I’ve known poodles much bigger than mine.)

    Scam tests are a goldmine. They even fool a lot of professionals, who really should know better.

  8. Scott says:

    Isn’t it even illegal in some states (or at least some of the time) for doctors to sell products they’re prescribing?

    Ah, but they’re not PRESCRIBING them. They’re simply observing how useful they’d be to the patient, and the patient can buy them from whoever if they like.

    My own PCP moved practice recently, and there are two things that are really bothering me about the new location:

    1. The other doctor in the new office has a bunch of posters in the waiting room advertising the supplements he sells.

    2. The new location is a pain in the neck.

    I’m not sure which bothers me more.

  9. SkepticalLawyer says:

    @Kylara:

    Isn’t it even illegal in some states (or at least some of the time) for doctors to sell products they’re prescribing?

    I don’t think it’s illegal for doctors to sell products that they are prescribing. I quickly took a look at New York’s law (I don’t practice law in New York, but just choose that state because of its large population).

    What I found was that in New York it is illegal for doctors to take kickbacks for sending patients to certain providers of drugs; a doctor may not

    directly or indirectly request[], receive[] or participate[] in the division, transference, assignment, rebate, splitting, or refunding of a fee for . . . a credit or other valuable consideration as a commission, discount or gratuity, . . . for or in connection with the sale, rental, supplying, or furnishing of clinical laboratory services or supplies, . . ., hospital or medical supplies, . . ., medication, or medical supplies, or any other goods, services, or supplies prescribed for medical diagnosis, care, or treatment under this chapter, . . . .

    If the medical board or a court found that the price of the drugs sold to the doctor constituted a “discount” so that the doctor could then sell the drug to patients for a profit, then the situation described in the post might be illegal for the doctor.

    Also, under New York law, it is illegal for a doctor to

    Exercis[e] undue influence on the patient, including the promotion of the sale of services, goods, appliances, or drugs in such manner as to exploit the patient for the financial gain of the licensee or of a third party;

    or to

    Directly or indirectly offer[], giv[e], solicit[], or receiv[e] or agree[] to receive, any fee or other consideration to or from a third party for the referral of a patient or in connection with the performance of professional services;

    or to

    Enter[] into an arrangement or agreement with a pharmacy for the compounding and/or dispensing of coded or specially marked prescriptions . . . .

    Whether these last three prohibitions apply here would depend in part on the intent or mental state of the doctor.

  10. daijiyobu says:

    @ SkepticalLawyer:

    It would be interesting to see how the NDs practicing within NY justify their ‘dispensaries,’ wherein they often compound their herbal tinctures and whereby sell their supplements from. I’ve often heard that NDs make close to half their monthly income from such.

    They’re not licensed there YET.

    -r.c.

  11. Josie says:

    This post horrifies me.

    My company recently switched health care providers and also changed from an HMO style to a savings account style of payment.

    That was weird enough to me…but then the rep started explaining how we as patients get to be more involved with the care we receive. We get to do research ourselves on the internet. Yes, she actually told us that instead of seeking professional medical assistance we should first figure out what was wrong and what treatment we would like based on internet research.

    Don’t get me wrong, I do use the internet to inform myself..but it is with a skeptical layman’s eyes.

    The rep also bragged that they offer massage and acupuncture as covered treatments.

    This is not a small insurance company, this is Aetna.

    So now with today’s blog post I am disheartened. I cannot trust my insurance company to be rational in their covered treatments, I can’t trust my doctor to order valid diagnostics and somehow I am supposed to figure out my ails on my own through teh intarweb.

    Maybe I should have gone to medical school instead of graduate school.

  12. Versus says:

    Now you can bypass your doctor altogether and get lab tests of questionable value all on your own. A franchise operation, “Any Lab Test Now,” http://www.anylabtallahassee.com/wellness.html, can provide “thousands” of blood tests to anyone who walks in off the street. No medical advice is given so I’m not sure how one is supposed to use this information. The website says “Doctor’s order provided,” but I called and the person who answered the phone said I did not need a doctor’s order for any of their tests. Here are a few of the many “panels” offered:

    Cancer Screen & Tumor Marker Panel Female CBC, Chem Profile , Alpha-Feto Protein, Beta 2-Microglobulin, CEA, Neuron-Specific Enolase, Amylase, HCG serial monitor, CA 125, CA 15-3 $899.00 [$$$!]

    Fatigue Panel CBC, Chem Profile , Lyme AB, Monospot, Epstein Bar, TIBC, urinalysis $499.00 [$$!]

    Fibromyalgia Screening Panel You hurt all over. It’s impossible to sleep at night. And during the day you can barely function because of the pain and relentless exhaustion. These symptoms may all be a result of Fibromyalgia – a chronic condition causing pain in muscles, ligaments and tendons. $169.00

    Micronutrient Panel There is overwhelming evidence that vitamin deficiencies are associated with the chronic disease process and the overall condition of one’s health. $399.00

    Heavy Metal Panel Metals are natural elements from our Earth but are extremely toxic (even in low concentrations) and can have damaging effects on your body (especially your lungs and kidneys.) You can be exposed to certain types of metals from the air, household products, contaminated foods and drinks, and possibly at your place of employment (manufacturing facilities) or at home. Exposure to metals can have very serious consequences to your body, especially children. The problem is you may not even know you’ve been exposed. Find out now if you’ve been exposed to heavy metals. Lead, Mercury, Copper, Zinc $299.00

  13. SkepticalLawyer says:

    Speaking of non-doctor-referred lab tests, many years ago, someone asked my wife to use her fax machine to fax a blood sample to some “laboratory.” I think she did it.

    Isn’t it amazing how somebody can believe that a lab can analyze blood from a fax? This was not a stupid person.

  14. overshoot says:

    Looks to me like about time for another round of “what’s that sample?”

    In this entertaining game, you send a sample to a bogolab. The bogolab returns results, and you can have hours of fun comparing the lab’s results to the origin of the sample.

    The usual donors are dogs and cats, but there have been amusing instances involving reptiles and fish. Reports threatening debilitating diseases of aging in response to paediatric samples are also good for bonus points.

    The best one I know of, though, is apocryphal. The lab supposedly announced all sorts of toxins and metabolic problems in response to a sample that was 100% lab-created using reagents and pigments.

  15. criticalist says:

    I think this is a great post, but one minor point. The statement:

    ” There is no physiologic reason to measure most salivary hormone levels and no generally published ranges of normal levels of hormones measured in saliva.”

    is not correct. Most hormones circulate in blood bound to plasma proteins, but it is only the small percentage of free hormone that is biologically active. Salivary levels are mostly free, and so give a more accurate estimation of active hormone levels than do the plasma estimations. There is advantage to measuring salivary cortisol levels in particular, and published reference ranges do exist.

    Ref: Salivary steroid assays – research or routine?
    Ann Clin Biochem 2009; 46: 183–196.

  16. JMB says:

    Part of the reason some doctors will sell naturopathic and homeopathic remedies is because some states have outlawed doctors from selling medicine they prescribe. No prescription is required for naturopathic/homeopathic sale, so they can avoid the requirement of the law.

    Medicine abounds with conflicts of interest. The last time conflicts of interest in medicine was effectively dealt with through legislation was in the 1960′s, when a lot of states passed laws prohibiting doctors from owning the pharmacy where their patients would fill their scripts.

    The only problem identifying conflicts of interest in a healthcare practice is believing the evidence before your eyes.

  17. The statement: ‘There is no physiologic reason to measure most salivary hormone levels and no generally published ranges of normal levels of hormones measured in saliva’ is not correct.

    Criticalist, I may have overstated those points (see below), but I didn’t overstate them by much. When I wrote “most salivary hormone levels” in that sentence and “almost never legitimate” in the previous one, the point was to allow for one or a few exceptions, mainly cortisol. I didn’t feel it necessary to identify cortisol by name because the link to the Aetna Clinical Policy Bulletin did it for me.

    That policy bulletin cites a review article by Gröschl that emphasizes that only hormones that enter the saliva by passive diffusion—lipid-soluble hormones (steroids, mostly) and amines—are likely to have salivary concentrations that reflect their (free) concentrations in blood, but even those do not always behave predictably as such; nor are there (with the exception of cortisol) established normal ranges for most of them. For sex hormones, for example:

    Reliable analysis of salivary sex steroids is very challenging…Salivary testosterone measurements can be substantially influenced by sample collection methods and are sensitive to storage conditions. Moreover, the variability of androgen levels in relation to age, especially during puberty, makes a clear interpretation of salivary testosterone values difficult, particularly because of the scarcity of defined age- and sex-dependent reference intervals.

    The abstract of the article that you cited (I haven’t got the whole paper yet) agrees, but for a different reason:

    The diagnostic value of salivary oestradiol, progesterone, testosterone, dehydroepiandrosterone and aldosterone testing is compromised by rapid fluctuations in salivary concentrations of these steroids. Multiple samples are required to obtain reliable information, and at present the introduction of these assays into routine laboratory testing is not justified.

    Measurements of salivary catecholamines are also likely to mislead:

    The pituitary-adrenal cortex axis is responsible for the chronic stress response, but acute stress parameters such as catecholamines are difficult to assess in saliva because of the low concentrations and rapid degradation of epinephrine and norepinephrine and the difficulty of stabilizing these hormones in the sample. (Gröschl)

    Peptide hormones and conjugated steroids are not lipid soluble and are therefore dependent on other means of entry into saliva, such as active transport, that can obviously yield concentrations different from those found in blood:

    Because reference intervals are not available for salivary concentrations of peptide hormones, researchers generally use salivary peptide hormones qualitatively as marker substances for specific oral diseases rather than as a noninvasive alternative to plasma for quantitative measurements. (Gröschl)

    Gröschl warns against exactly what this post is about:

    An unfortunate development in salivary hormone determination during the last few years must be mentioned in this section. An increasing number of vendors offer saliva analysis directly to patients through the internet. Customers order a collection set and send the saliva sample back to the vendor, who provide the results of the (hopefully valid) steroid analysis by mail. When presenting these data to their physician, patients are surprised to learn that the results are practically worthless for a clinical interpretation. If these data were to be used to initiate hormonal replacement therapy without consulting an experienced and critical endocrinologist, the procedure would carry incalculable risks for the customers’ health. Physicians should therefore inform their patients of the lack of reliability of these non-approved services.

    From Gröschl’s conclusion:

    Several factors have limited the acceptance of salivary analysis even after years of investigation. Much effort will be required in the long term to achieve broader acceptance of saliva use by clinicians. Specific and standardized analytical tools are required, as have been in place for decades in the analysis of serum and plasma. The definition of reference intervals related to age, sex, and time of day and the establishment of round-robin trials for salivary hormone measurements are overdue. No data are available to indicate whether commercial immunoassays from different manufacturers deliver equivalent results, especially for well-established parameters like cortisol, testosterone, and melatonin.

    In summary, standardization of both collection and analysis must be achieved to gain better comparability of published salivary hormone data and to improve the acceptance of saliva as a reliable additional sample matrix in endocrinological investigations.

    Criticalist, thank you for motivating me to look into the latest information on salivary hormone testing, and I’ll grant that there seems to be more promise for it than I would have thought only yesterday (I’m neither an endocrinologist nor a clinical pathologist or chemist, so I can’t make any real claims of expertise in this field—just enough general medical knowledge to be aware of some of its content and to read its literature in a semi-sophisticated way). There is even a purported physiologic rationale for measuring cortisol in saliva, which is that cortisol levels increase in response to ‘stress’—which may accompany blood-drawing, thereby causing a spurious elevation. Nevertheless, for most purposes (and for all purposes claimed by the commercial laboratories cited in the post), salivary hormone tests are still not ready for prime time.

    KA

  18. criticalist says:

    Kimball, I agree entirely with your detailed response. In fact, it was such a minor point, and so tangential to the major very useful point of your article, that I very nearly didn’t bother to post it. (My nerdy science side got the better of me though). My interest in the field is primarily with cortisol which as you say has the potential advantage in saliva of avoiding the stress response associated with venepuncture. The other advantage is as a estimation of free cortisol in situations where total cortisol measurements may be misleading – critical illness and sepsis for example, which where my background lies. To be honest its not ideal in those circumstances either.
    Anyway, thanks for the response, and apologies for the derail.

  19. Calli Arcale says:

    SkepticalLawyer:

    Speaking of non-doctor-referred lab tests, many years ago, someone asked my wife to use her fax machine to fax a blood sample to some “laboratory.” I think she did it.

    Isn’t it amazing how somebody can believe that a lab can analyze blood from a fax? This was not a stupid person.

    It is amazing what can seem sensible, even to very smart people. I work in computers, and it’s amazing how many people, even people who design the blasted things for a living, will switch off major parts of their critical faculties the moment they sit down in front of one.

    Your story reminds me of the stories of people attempting to send software by faxing the disk. I’ve heard of actual software vendors doing this — people who really should know better.

  20. Zetetic says:

    Anybody heard of a lab named Metametrix? It appears that they perform all sorts of non-standard testing and I’ve heard they are heavily used by naturoquacks. However, they do appear to be CLIA certified.

  21. Filipok says:

    http://medicinalcolorado.org/taxonomy/term/1258

    DEA agents have hit another marijuana testing lab — Colorado Springs-based Genovations — not long after the lab applied for the same license.”…

    Genova Labs.. a.k.a. Great Smokies.

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