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!

On Tuesday night PBS FRONTLINE aired an episode about the anti-vaccine movement entitled The Vaccine War (which, by the time you read this, should be available for online viewing in case you missed it). When I first heard that this show was going to air, I was a bit concerned. My concern, of course is what I’m always concerned about when journalists do a story about pseudoscience, be it the anti-vaccine movement, “intelligent design” creationism, various “alternative medicine” modalities, or whatever. We’ve written about such things right here on SBM on more than one occasion, be it Dr. Jay Gordon on The Doctors or Andrew Wakefield being interviewed by Matt Lauer. Although FRONTLINE has done a pretty good, science-based job on controversial topics, I felt some trepidation, particularly after seeing some of the promos for the show, even though it featured Dr. Paul Offit, and other physicians and scientists.

Fortunately, I needn’t have worried. The Vaccine War is not perfect. There are some definite flaws, but by and large it is a rare thing on TV: A science-based discussion of a pseudoscientific movement. True, the opening montage did bring back a bit of that anxiety that this was going to be a “tell both sides” bit of false balance in that it included J.B. Handley blathering and Jenny McCarthy spewing her same false dilemma of measles versus autism. (She’d choose the measles, of course.) I was able to forgive that, because it’s very clear that the producers were just setting up the story. The show then launched straight into a birth and a list of the vaccines that children get, with Melinda Wharton of the CDC and Paul Offit pointing out how much good vaccines do, how we no longer see diseases that once killed thousands or even milions.

Then it was straight to Ashland, OR and the woo, personified by a mother named Jennifer Margulis, a writer for that “natural” repository of woo Mothering Magazine. She wasted no time spewing nonsense about “natural immunity” versus vaccines, claiming that it is better than vaccine-induced immunity. (Yes, it may be more long-lasting, but it comes without the risk of actually getting the diesease.) Dr. Donna Bradshaw-Walters was then introduced, and she described how 28% of Ashland’s children are missing some or all of their vaccines, pointing out that it is only a matter of time before there is an outbreak there. (I wonder how far Ashland is from Portland. Our intrepid fellow SBM blogger Mark Crislip is in the Portland area somewhere.) It was refreshing to note that there are actual pro-vaccine parents in Ashland, one of whom predicted that it would get ugly if there were an outbreak in which vaccinated children started to get sick because of unvaccinated children forming a repository for disease that can spread to vaccinated children whose vaccines didn’t “take,” for whatever reason. The show then described the San Diego measles outbreak and how unvaccinated children are a vector for infection, even to the vaccinated, who are less likely to be infected but not immune, as no vaccine is 100% effective.

Next, there was a segment at Pfizer. This may not have been the best idea strategically, given how it feeds into the distrust of big pharma exhibited by the vaccine fearful, although the scientist interviewed, Dr. Emilio Emini, did a good job of pointing out how vaccines prevent disease. Still, right there, I could envision doubting parents becoming suspicous. Then, of course, there was Dr. Paul Offit, who, although he is the Dark Lord of Vaccination to the antivaccine movement, is nonetheless the one of the most effective provaccine voices. Happily, Offit makes no apologies for having gotten rich from a vaccine. He is enormously proud of it, as he should be. But what he’s proud of is not having gotten rich, but have invented a product that has saved thousands upon thousands of children’s lives. That is truly something to be proud of.

One thing The Vaccine War revealed that I didn’t know was that bioethicist Arthur Caplan had actually contracted polio in his youth. No wonder he is so effective when he argues for vaccines. Equally effective is a scene in which paramedics are being trained, part of their training being to watch videos of children with pertussis and rotavirus. The video of the child with pertussis is horrifying; the suffering of such children is incredible. This class even pointed out that chickenpox can actually be fatal, showing a child with staph sepsis in the pox lesions.

Unfortunately, at this point the aforementioned Margulis demonstrates her extreme ignorance by asking why we are still vaccinating for polio as polio has become more rare. This woman was truly irritating in her arrogance of ignorance. Worse, she kept popping up throughout the show, sadly enough. But that wasn’t enough. There had to be Barbara Loe Fisher, too, spewing her usual anti-vaccine line. Unfortunately, here’s where FRONTLINE fell down on the job. The show actually described BLF not just once, but multiple times, using terms like “vaccine watchdog” or “vaccine safety” advocate, rather than what she is, an anti-vaccine propagandist. Bad FRONTLINE!

Similarly, the interview with Jenny McCarthy was infuriating, as usual. I suppose I should be used to her smug anti-science attitude. Buried in McCarthy’s assault on science and reason, though, there was a rather interesting tidbit. However, you have to go to her complete online interview to find it:

How long after the MMR was that first seizure?

You know, a lot of people think, and probably from me saying in some interviews, that it was after the MMR I noticed changes.

I don’t think it was just the MMR shot that caused any kind of trigger with autism. I think it was a compilation of so many shots to a kid that obviously had some autoimmune disorders. So I would say maybe a couple of months, a month or so after the MMR, I started to notice some physical ailments such as constipation, rashes, eczema. That was like the first little sign. And then the train just kind of descended from there.

This is very different from the stories McCarthy was telling around the time she released her first book, and she even seems to be acknowledging it as she dances around a very simple question. Indeed, I remember McCarthy saying in interview after interview how she saw the “light go out of Evan’s eyes” soon after the shot. That’s why her story resonated with the anti-vaccine movement so strongly, as shown when anti-vaccination activist Ginger Taylor cited what Jenny McCarthy said in her 2007 interview with Oprah:

Jenny says even before Evan received his vaccines, she tried to talk to her pediatrician about it. “Right before his MMR shot, I said to the doctor, “I have a very bad feeling about this shot. This is the autism shot, isn’t it?’ And he said, ‘No, that is ridiculous. It is a mother’s desperate attempt to blame something,’ and he swore at me, and then the nurse gave [Evan] the shot,” she says. “And I remember going, ‘Oh, God, I hope he’s right.’ And soon thereafter-boom-the soul’s gone from his eyes.”

Notice how Jenny appears to have changed her story from its being the MMR to its being a gradual process due to too many vaccines. Truly, her story shifts more than the sands of the Sahara, or the waves of the ocean, or your favorite metaphor for something shifty and lacking substance.

Speaking of shifty and lacking substance, the first Jenny McCarthy segment ran right into an interview with J.B. Handley. There was really nothing new there in that J.B. claims that “tens of thousands” of parents tell him that their children were “never the same” after vaccines, combined with his simplistic mantra: Vaccines cause brain damage and autism is brain injury. Ergo, to him, vaccines cause autism. Of course, it is not really true that autism is “brain injury.” It is a difference in the brain, but there’s no good evidence that autism is primarily due to “brain injury,” although there’s all sorts of quackery out there that purports to treat “vaccine injury” to the brain.

Here’s another point where the FRONTLINE special dropped the ball a bit. The show immediately went into the MMR fear mongering provoked by Andre Wakefield. The problem is that J.B. Handley wasn’t really about MMR, at least not until recently. He was about mercury and thimerosal. Indeed, Generation Rescue until a couple of years ago proclaimed on its website that autism is a “misdiagnosis for mercury poisoning.” (And guess where that mercury exposure came from? That’s right, vaccines.) But the MMR has never had mercury in it, ever. In conflating these issues, FRONTLINE confused two related issues that are not really the same thing, particularly when it started showing a speech by Robert F. Kennedy, Jr. at the Green Our Vaccines rally from two years ago. As someone who knows about the anti-vaccine movement and its history, this was irritating, and it is more than just a nit to pick.

That being said, I do like how, right after a segment in which Jenny McCarthy claims that scientists won’t study whether vaccines cause autism, the show immediately launched into a segment that demonstrated conclusively that that she is either mistaken or lying (take your pick). The issue has been studied extensively in multiple countries, and no link between vaccines and autism has been found. Thus, right after McCarthy made a claim, the claim was demolished totally. Moreover, FRONTLINE did a good job of explaining how correlation does not necessarily mean causation. Just because a diagnosis of autism is made soon after a vaccine does not necessarily mean the vaccine caused autism. It finished this middle part of the documentary by documenting the fall of Andrew Wakefield, in particular pointing out how some of the children in his studies had been referred through lawyers suing vaccine manufacturers.

The beauty of this segment is how FRONTLINE showed that, no matter how much evidence, with J.B. Handley saying, “I don’t give a fuck about what the MMR study said.” (Yes, he did use the F-word, although it was bleeped out and turned to “crap” in the online transcript. Stay classy, J.B.) This was rapidly followed by a demonstration of Barbara Loe Fisher shifting the goalposts asking for more epidemiological studies and basic science studies. It is, as Dr. Offit put it, a classic shifting of goalposts, with Jenny McCarthy blathering about her “mommy warriors” and how “Evan is her science.” In fact, I particularly liked how Dr. Offit explained exactly how the anti-vaccine movement is constantly shifting the goalposts in a way that a lay peson could understand.

Unfortunately, this segment depressed me, because it showed just how much science doesn’t matter in trying to persuade these parents and how the web perpetuates not just the old vaccine myths, but facilitate the spread of new ones. It demonstrates just how much the Internet’s “democratization” of knowledge devalues knowledge, expertise, and science. The forces of pseudoscience proliferate and infiltrate, and, quite frankly, those of us who promote science-based medicine are way behind the eight ball in trying to counter these messages. One thing I had no idea about was just how effective the Desiree Jennings story had influenced high school students not to vaccinate. Roughly half of one class who hadn’t taken the H1N1 vaccine said that the reason they didn’t take the vaccine was because they saw Desiree Jennings on YouTube. This makes me think, more than ever, that blogs such as this one and others are essential in tearing apart such bad information. The result of this information is people like the mothers in Ashland that I discussed last time who ask, “If vaccines work, who am I hurting by not vaccinating?”

The result was shown in the story of a baby who came down with pertussis and almost died. Her situtation was so bad that a chaplain was brought in for possible last rites.

Near the end of the show, there was presented a focus group of people who discussed vaccination. What was interesting is how much vaccination is viewed as a parental choice rather than a societal duty. This in and of itself is not necessarily a bad thing. It’s completely consistent with the psyche many people in the U.S. and the principles of limited goverment and self-reliance. The problem is that this choice is being increasingly undermined by misinformation on the Internet and elsewhere in the media. The message of the anti-vaccine movement that the days of “paternalism” are over echoes very strongly with the whole “health freedom” movement. The problem with this “freedom” is that refusing vaccination endangers more than just the child of the parent making the choice. It endangers other children, vaccinated or unvaccinated. It’s very difficult for anyone to make a well-informed choice when most of the information that pops up when you search the Internet is from the anti-vaccine side.

In the end, I was mostly relieved by The Vaccine War. It was science-based, and it pulled no punches in asserting that there is no good scientific evidence that vaccines cause autism. True, it did confuse the issue of the MMR vaccine and thimerosal-containing vaccines, and that’s more than a minor mistake. It also failed to address the valid reasons why we vaccinated for hepatitis B to neonates. Worse, it was far too kind in its treatment of Barbara Loe Fisher, calling her organization, the National Vaccine Information Center a “vaccine safety” advocacy organization, when it is an anti-vaccine organization, plain and simple. It did a little better with Generation Rescue, showing a bit of the sheer insanity behind the organization and how, no matter how much evidence there is against its position, it never loses sight of its founding principle, namely that it’s absolutely, positively always the vaccines. Always. Those complaints aside, FRONTLINE did a far better job than I expected in deconstructing the anti-vaccine movement. It didn’t compromise on the science, although it may have compromised a bit in how it describes, for example, the NVIC and Generation Rescue.

Will The Vaccine War change minds? Maybe. There’s no way it’s going to change the minds of hard core antivaccinationists of J.B. Handley’s ilk. Almost nothing I can think of can. But it might–just might–reassure parents on the fence that all that horrible stuff they’re hearing on the radio, seeing on TV, and, above all, reading on the Internet about the evils of vaccines are not based in science. That’s actually quite an achievement.

ADDENDUM: There was a segment in which a pro-vaccination parent in Ashland was profiled. In a shot in which she was surfing the ‘net, guess what blog showed up?

Yep: