Archive for Diagnostic tests & procedures

Breast Milk Testing: Scaremongering, Not Science

New mothers, especially first-time mothers, tend to worry about whether they are doing what is best for their babies. A new service, Happy Vitals, will only add to those worries. We know that breast is best, but these folks make women question whether their breast milk is good enough. They say:

Happy Vitals provides families with the tools they need to monitor and improve the long-term health of their children. With our simple and easy-to-use tests, mothers can learn for the first time about the nutrient make-up of their breast milk, improve their diet and nutrition, and safeguard against exposure to heavy metals and other toxins that are harmful to a child’s growth and development.

After a crowdfunding/pre-sale campaign, they plan to start shipping kits this month. They offer various packages. For $149.95, they will analyze a sample of breast milk for four key nutrients: glucose, lactose, protein, and fat. For $559.95, they will also test for:

  • Four “indicators of immunity”: cortisol, IgA antibodies, IgG antibodies, IgM antibodies.
  • Eleven micronutrients: calcium, folate, iron, vitamin D, vitamin A, ferritin, magnesium, phosphorous, sodium, potassium, and vitamin B12.
  • Four heavy metal toxins: arsenic, lead, mercury, and cadmium (based on samples of infant’s hair and nails.)


Posted in: Diagnostic tests & procedures, Nutrition

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“Liquid biopsies” for cancer screening: Life-saving tests, or overdiagnosis and overtreatment taken to a new level?

Could a blood draw be all you need to diagnose cancer and identify the best treatment for it? Not so fast...

Could a blood draw be all you need to diagnose cancer and identify the best treatment for it? Not so fast…

I’ve written many times about how the relationship between the early detection of cancer and decreased mortality from cancer is not nearly as straightforward as the average person—even the average doctor—thinks, the first time being in the very first year of this blog’s existence. Since then, the complexities and overpromising of various screening modalities designed to detect disease at an early, asymptomatic phase have become a relatively frequent topic on this blog. Before that, on my not-so-super-secret other blog, I noted that screening MRI for breast cancer and whole body CT scans intended to detect other cancers early were not scientifically supported and thus were far more likely to cause harm than good. That was well over ten years ago. Now we have a company offering what it refers to as a “liquid biopsy” for the early detection of cancer. I fear that this is the recipe for the ultimate in overdiagnosis. I will explain.

The problem, of course, is that disease progression, including cancer progression, is not always a linear process, in which the disease progresses relentlessly through its preclinical, asymptomatic phase to symptoms to complications to (depending on the disease) death. There is such a thing as disease that remains asymptomatic and never progresses (at which point it’s hard to justify actually calling it a disease). As I pointed out in my first SBM post on the topic, at least three-quarters of men over 80 have evidence of prostate cancer in autopsy series. Yet nowhere near three-quarters of men in their 80s die of prostate cancer—or ever manifest symptoms from it. This is what is meant by overdiagnosis, the diagnosis of disease that doesn’t need to be treated, that would never cause a patient problems.

When teaching medical students and residents, I frequently emphasize that overdiagnosis is different from a false positive because overdiagnosis does diagnose an actual abnormality or disease. For example, ductal carcinoma in situ (DCIS) diagnosed by mammography leading to a biopsy is a real pathological abnormality; it is not a false positive. We just do not know which cases of DCIS will progress to cancer and which will not, leading to a question of how DCIS should be treated or at the very least whether we should treat it as aggressively as we do now, particularly given that the apparent incidence of DCIS has increased 16-fold since the 1970s, all of it due to mammographic screening programs and the increased diagnosis of DCIS and early stage breast cancer has not resulted in nearly as much of a decrease in the diagnosis of advanced stage breast cancer as one would expect if early diagnosis were having an impact in reducing the diagnosis of late stage disease.

Overdiagnosis would not be such an issue if it didn’t inevitably lead to overtreatment. DCIS, for instance, is treated with surgery, radiation, and anti-estrogen drugs. Early stage prostate cancer used to be treated with radical prostatectomy, but now more frequently with radiation. Many of these men and women didn’t actually need treatment. We just don’t know which ones. This is why over the last six or seven years a significant rethinking of screening for breast and prostate cancer has occurred. There has been a backlash, of course, but the rethinking seems to have taken hold.

Not everywhere, of course. (more…)

Posted in: Basic Science, Cancer, Diagnostic tests & procedures, Public Health

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Here be Dragons: Caring for Children in a Dangerous Sea of sCAM

Here be dragons large map

As a pediatrician working in a relatively sCAM-inclined region, it is not uncommon to find myself taking care of patients who are also being followed by so-called alternative medicine practitioners. This often creates a major obstacle to providing appropriate care and establishing an atmosphere of mutual trust in the provider-patient/parent relationship. It usually makes me feel like I’m battling invisible serpents in a sea of sCAM.

While these double-dipping parents utilize a variety of sCAM providers, including naturopaths, homeopaths, chiropractors, and a smattering of “holistic healers”, most are taking their children to one of a few “wellness” centers near my practice where they are seen by actual medical doctors practicing so-called “integrative medicine”. Many of these children have vague, chronic, usually non-specific complaints that are difficult to explain and thus to treat. Some have behavioral and mental health problems, or neurodevelopmental conditions such as autism for which parents are seeking explanations and treatments.

What I find to be a common theme with these patients is that they and their parents are summarily taken advantage of by their alternative care providers when they are given a fictitious diagnosis and treated with a variety of useless potions, elixers, and false hopes. Often, parents bring their children to these providers because they are frustrated by their child’s chronic complaints of fatigue, pain, or other somatic issues that have eluded a satisfactory diagnosis or treatment. Invariably, the diagnosis that has remained so elusive to me is quickly found and treated by these much more “holistic” and open-minded providers. In fact, I have never seen a consultation note from one of these providers indicating any uncertainty as to diagnosis or treatment regimen. Typically a large battery of expensive, inappropriate, and sometimes outright fraudulent lab tests is ordered, often from equally questionable laboratories. Again, there are invariably interesting findings prompting tailored and bizarre treatments. In typical red-flag sCAM fashion, some of these providers have their own supplement store, available online only to their patients, prominently displayed on their website. These providers are perceived as being more holistically informed about health and wellness then “conventional” doctors like myself, as if there are two distinct ways of treating illness and maintaining health…as if there is truly such a thing as alternative medicine.

It can be very difficult to manage patients who are being simultaneously “treated” by such providers. Sometimes the treatments complicate or confuse the picture, but it always indicates a failure of trust in the “conventional” method of practice, which is science and evidence based, and in science itself.

Below are a few examples of patients cared for by my practice and simultaneously followed by alternative medicine practitioners. They provide a good picture of just how problematic these co-practitioners can be. No names or identifying information are revealed. (more…)

Posted in: Diagnostic tests & procedures, Herbs & Supplements, Naturopathy, Pharmaceuticals, Science and Medicine

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Learning quackery for Continuing Medical Education credit



The Integrative Addiction Conference 2015 (“A New Era in Natural Treatment”) starts tomorrow in Myrtle Beach, SC. Medical doctors, doctors of osteopathy, naturopaths and other health care providers will hear lectures on such subjects as “IV Therapies and Addiction Solutions,” given by Kenneth Proefrock, a naturopath whose Arizona Stem Cell Center specializes in autologous stem cell transplants derived from adipose tissue. Proefrock, who was disciplined for using prolotherapy in the cervical spine without proper credentialing in 2008, claims that stem cells treatments are an “incredibly versatile therapy” and uses them for variety of conditions, such as MS and viral diseases. At the same time, he admits that they are not FDA approved and he is not claiming they are effective for anything (and he’s right), which leads one to wonder why he employs them.

Proefrock also offers a typical naturopathic mish-mash of services, from oncology to urology to “naturopathic endocrinology,” and claims he specializes in treating influenza, high blood pressure and kidney stones, as well as addiction. In other words, he doesn’t seem to be the sort of expert you’d find speaking at a science-based conference on addiction medicine.

You’ll find similarly troubling bios of some of the other speakers, as well as dubious treatments for addiction, on the conference website. Here, for example, are speaker Giordano’s and Eidelman’s websites.

Dalal Akoury, MD, is the “Title Sponsor” of the conference and appears to be running the show. Although she is listed by the S.C. Board of Medicine as board certified in pediatrics, she is the founder of the “Integrative Addiction Institute” and runs the “AwareMed Health and Wellness Resource Center” in Myrtle Beach. Like the Arizona Stem Cell Center, it offers a range of treatments that defy categorization as any particular specialty: addiction recovery, “adrenal fatigue” treatment, stem cells, “anti-aging,” weight loss, “functional medicine” and “integrative cancer care“. Yet, only Akoury and one licensed practical nurse are on the staff of the Center. Again, it is questionable whether she is has sufficient qualifications in addiction medicine to run a conference on the subject. (more…)

Posted in: Acupuncture, Cancer, Chiropractic, Dentistry, Diagnostic tests & procedures, Energy Medicine, Homeopathy, Medical Academia, Medical Ethics, Naturopathy

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“Hands On Learning Solutions”: Untested Solutions for Problems That May Not Even Exist

Get started...for as little as $14,000!

Get started…for as little as $14,000!

Hands On Learning Solutions, a business in Gig Harbor, Washington, evaluates and treats children for learning disabilities and claims to identify the underlying causes and help eliminate the symptoms. Much of what they do is questionable, and at least one of their methods is clearly bogus. Their program is reminiscent of the Brain Balance program that I wrote about in 2010. I’ll describe one child’s encounter with Hands On Learning Solutions and let you decide for yourself whether it sounds like a legitimate, helpful service.

Billy (not his real name) is an 11-year-old boy who is in the fifth grade at a Catholic school. He didn’t learn to talk until age 3, but he got speech therapy and is currently doing well in school, with a GPA of 86%. On his last report card, the section on “Successful Learner” rated him above average on working cooperatively with others, and satisfactory in all other categories, such as organizational skills, using time well, listening attentively, following directions, and completing work on time. His mother took him to Hands On Learning Solutions on the recommendation of a friend. On the intake questionnaire she expressed concerns about his written/oral expression, organization, study skills, attention focus, and motivation/behavior. She did not check the boxes for concerns about reading, spelling, comprehension, letter reversals, graphomotor skills, math, memory, poor grades, or slow work. (more…)

Posted in: Diagnostic tests & procedures, Neuroscience/Mental Health

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Dubious MTHFR genetic mutation testing

Naturopathic catnip for patients.

Naturopathic catnip for patients.

Naturopaths, along with some chiropractors, acupuncturists and a few “integrative” physicians, are advising patients that they should be tested for MTHFR genetic mutations. Typically, the naturopath will start with the pitch that “conventional” medical doctors are ignoring your genes as a possible source of your health problems. (And it is mostly naturopaths who are doing this – just Google “naturopath MTHFR genetic mutation” and see what comes up.) NDs know better, of course – it could be a MTHFR genetic mutation causing your maladies.

Just what is the MTHFR gene? Allow me to introduce some actual scientific information here. According to Genetics Home Reference, a service of the National Library of Medicine,

the MTHFR gene provides instructions for making an enzyme that plays a role in processing amino acids, the building blocks of proteins. This particular enzyme is important for a chemical reaction involving forms of the vitamin folate (also called vitamin B9), a reaction required for the multistep process that converts the amino acid homocysteine to another amino acid, methionine. The body uses methionine to make proteins and other important compounds.

Back to pseudoscience. Next comes the scare tactic: telling you how a MTHFR mutation might affect your health: anxiousness, adrenal fatigue, brain fog, cervical dysplasia, increased risk of many cancers (including breast and prostate), low thyroid, leaky gut, high blood pressure, heart attacks, stroke, Alzheimer’s disease, diabetes, and miscarriages. (more…)

Posted in: Chiropractic, Diagnostic tests & procedures, Health Fraud, Herbs & Supplements, Naturopathy, Nutrition, Obstetrics & gynecology, Vaccines

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“Finally…The Low Back Pain Solution”: A Chiropractor Makes Questionable Claims

Pictured: Railgun patient launcher Magnetic resonance imaging machine

Pictured: Railgun patient launcher Magnetic resonance imaging machine, not a useful tool in identifying the cause of back pain

The ads in my local newspaper are a never-ending source of questionable health claims, most often from diet supplement manufacturers and chiropractors. There’s no single spokesman like Dr. Oz, but as a group they remind me of Oz’s unending series of weight loss miracles, each one the perfect solution until the next one comes along. The proliferation of chiropractic ads is bad advertising for the efficacy of chiropractic itself, since chiropractors are increasingly turning to adjunctive treatments like lasers and decompression machines.

The latest ad that annoyed me was from the Objective Diagnostics Research and Rehabilitation Institute (ODRRI). What an impressive name! On their website, not only do they advertise “the low back pain solution,” but they offer to fix herniated discs without surgery. They say they treat the underlying cause and say their approach is “based on solid and leading edge diagnostics, scientific research, and experience.” While not a complete lie, that statement is certainly misleading. (more…)

Posted in: Chiropractic, Diagnostic tests & procedures

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Less benefit, more risk. Our assumptions about health treatments are probably wrong.

Patient discussing treatment options with a pharmacist.

Patient discussing treatment options with a pharmacist.

I’m a health professional, but sometimes a patient as well. And like most patients, I generally don’t want health decisions being made without my input. Yes, I want the best medical information, and the advice of medical professionals, but ultimately I want to make my own decisions about my care. That’s the norm in health care today, but relatively new in the history of medicine.

Medical paternalism, where patient preferences are secondary (or even ignored), is disappearing. Even informed consent, where patients are given information on risks and benefits, doesn’t adequately describe the drive towards a two-way exchange, with an empowered, engaged patient. Today the goal is shared decision making, which describes a mutual decision that is informed by a health professional’s medical knowledge and advice, but also incorporates a patient’s own preferences and wishes. Truly shared decision-making includes an explicit consideration of a treatment’s expected benefits and potential harms, yet reflects patient values.

Screening is a textbook example of why shared decision-making should be our goal. Given the benefits of a disease screening program may be modest, and not without harms, understanding and incorporating individual preference is essential. Some may value the small but incremental benefits of screening, and choose to be screened despite the risks of false positives, investigations, and possible overtreatment. Given the exact same circumstances, another individual may opt to forgo screening, making a different, yet equally acceptable decision. While there are some health interventions for which the benefits are unequivocal, and others for which the harms are just as clear, most health treatments (and interventions like screening) have both benefits and potential harms that must be carefully assessed within the context of patient preferences. Research published earlier this year has identified a significant barrier to truly effective shared decision-making and risk assessment: Across a wide range of interventions, we routinely overestimate the benefits of health treatments, and underestimate their risks. (more…)

Posted in: Diagnostic tests & procedures, Pharmaceuticals, Science and Medicine, Science and the Media

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Alternative Medical Alert Systems in the News

Belvidere, NE- Bref Albright was taking an unfamiliar route home from work because of a stalled 18-wheeler when he passed by the cell phone tower. As the electromagnetic field washed over him, symptoms of his sensitivity quickly set in. He first noticed a tingling sensation throughout his body and an odd dryness in his mouth and throat. Then nausea and headache. Once the palpitations and difficulty concentrating on the road began, he knew he had to pull over in order to avoid an accident.

An elderly woman, shown here about to be strangled by a conventional doctor and/or pharmaceutical industry representative, is wearing an EmergenQi pendant

An elderly woman, shown here about to be strangled by a conventional doctor and/or pharmaceutical industry representative, is wearing an EmergenQi pendant

“Getting off the road was the right thing to do,” Albright explained. “I couldn’t risk injuring somebody else if I lost control of my truck, but it left me vulnerable. I was a sitting duck!” As expected, Albright’s condition worsened because of continued exposure to the deadly yet fundamental force of nature. Despite blurry vision and difficulty remembering his wife’s cell phone number, he managed to place a call. No answer. His wife, home brewing kombucha, had left her phone in another room.

Albright, a 53-year-old taxidermist for the Belvidere Parks Commission, then pressed the red button that activated his alternative medical emergency alert system. Within seconds, a satellite had pinpointed the location of Albright’s pendant and a team of emergency alternative medicine experts was soon on its way. While on route, a member of the team was even able to contact Albright’s wife Norleen and ask a few questions about Bref’s alternative medical history.

Posted in: Acupuncture, Diagnostic tests & procedures, Humor

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New FDA regulatory role threatens bogus diagnostic tests

lab test
The FDA regulates in vitro diagnostic devices (IVDs) as medical devices. IVDs analyze human samples, such as blood, saliva, tissue and urine. However, in the past, the agency did not use its authority to regulate what are known as “laboratory-developed tests” (LDTs), tests developed and performed at a single laboratory, with all samples sent to that particular lab for testing. Instead, it focused on commercial tests kits, which are broadly marketed to laboratories or the public. These tests had to undergo the same pre-market approval process as other medical devices regulated by the FDA, including, in some cases, clinical studies demonstrating that the device is safe and effective for its intended use.

Historically, LDTs were developed by hospitals, researchers and academic medical centers for their own use. That is no longer true. In the past 15 years or so, there has been an explosion in the use of LDTs by commercial labs and biotechnology companies. The FDA now estimates that there are about 11,000 LDTs offered by 2,000 laboratories. One estimate is that the results of clinical lab tests (although not exclusively LDTs) influence 70% of health care decisions. (See the Congressional Research Service Report’s exhaustive analysis of FDA regulation of IVDs and inclusion of LDTs for more on the history and current use of LDTs.)

Do you have any idea whether the IVDs that have poked around in your blood or tissues are FDA-approved or unapproved LDTs? (Does your physician?) Do you know what evidence (if any) there is standing behind these tests? No? Me either. That’s because there is no requirement that anyone give you this information. (more…)

Posted in: Diagnostic tests & procedures, Legal, Medical devices, Naturopathy, Politics and Regulation

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