Is the health care spending tide turning? Unnecessary medical investigations and overtreatment seems to have entered the public consciousness to an extent I can’t recall in the past. More and more, the merits of medical investigations such as mammograms and just this week, PSA tests are being being widely questioned. It’s about time. Previous attempts to critically appraise overall benefits and consequences of of medical technologies seem to have died out amidst cries of “rationing!” But this time, the focus has changed – this isn’t strictly a cost issue, but a quality of care issue. It’s being championed by the American Board of Internal Medicine Foundation (ABIM) under the banner Choosing Wisely with the support of several medical organizations. The initiative is designed to promote a candid discussion between patient and physician: “Is this test or procedure necessary?”. Nine organizations are already participating, represent nearly 375,000 physicians. Each group developed its own list based on the following topic: Five Things Physicians and Patients Should Question. Here are the lists published to date:
- American Academy of Allergy, Asthma & Immunology
- American Academy of Family Physicians
- American College of Cardiology
- American College of Physicians
- American College of Radiology
- American Gastroenterological Association
- American Society of Clinical Oncology
- American Society of Nephrology
- American Society of Nuclear Cardiology
ABIM has partnered with Consumer Reports to prepare consumer-focused material as well, so patients can initiate these discussions with their physicians. How did this all come to be? A candid editorial from Howard Brody in the New England Journal of Medicine in 2010:
In my view, organized medicine must reverse its current approach to the political negotiations over health care reform. I would propose that each specialty society commit itself immediately to appointing a blue-ribbon study panel to report, as soon as possible, that specialty’s “Top Five” list. The panels should include members with special expertise in clinical epidemiology, biostatistics, health policy, and evidence-based appraisal. The Top Five list would consist of five diagnostic tests or treatments that are very commonly ordered by members of that specialty, that are among the most expensive services provided, and that have been shown by the currently available evidence not to provide any meaningful benefit to at least some major categories of patients for whom they are commonly ordered. In short, the Top Five list would be a prescription for how, within that specialty, the most money could be saved most quickly without depriving any patient of meaningful medical benefit.
Health care professionals are, in general, self-regulating professions. That is, governments entrust them to set the standards for their profession and regulate members, in the public interest. Consequently, attempts by payors of services (i.e., government and insurers) to guide medical practice are usually met with substantial resistance. No-one wants insurers interfering in the patient-physician relationship. That’s why it’s exciting to see this initiative in place -it’s being driven by the medical profession itself.
As a pharmacist I’m also a member of a self-regulating profession, one in which the public places a considerable degree of trust in. In order to maintain the public’s confidence, it is essential that the pharmacy profession maintain the highest professional and ethical standards, and do its part to reduce unnecessary testing and investigations. With this in mind, I’ve taken up Brody’s challenge and developed my own list of Five things Pharmacists and Patients Should Question. While eliminating them may not provide the most savings to patients, they are pharmacy-based, widely offered, and offer little to no benefit to consumers. Here are my top five candidates:
#1. Food Intolerance Blood Tests
IgG blood tests like Hemocode and YorkTest are clinically useless for diagnosing food intolerances, yet pharmacies imply otherwise. These tests claim to identify sensitivity to hundreds of products – yet not one has been validated. That’s because there no proven correlation between positive results on an IgG blood test and a true food intolerance. Not only are these tests use to shape dietary modification, they’re also used to sell supplements – another unproven use of IgG testing. Yet despite recent cautions against this testing, it continues to be offered. Not surprisingly, the American Academy of Allergy, Asthma and Immunology (AAAAI) included IgG testing in their own Choosing Wisely list [PDF] -it’s the #1 recommendation:
Don’t perform unproven diagnostic tests, such as immunoglobulin G (IgG) testing or an indiscriminate battery of immunoglobulin E (IgE) tests, in the evaluation of allergy.
Appropriate diagnosis and treatment of allergies requires specific IgE testing (either skin or blood tests) based on the patient’s clinical history. The use of other tests or methods to diagnose allergies is unproven and can lead to inappropriate diagnosis and treatment. Appropriate diagnosis and treatment is both cost effective and essential for optimal patient care.
If the AAAAI, who are the clinical experts, recommend against testing, then why are pharmacies selling IgG tests?
#2. Body Chemistry Balancing
It may surprise the internal medicine specialists out there, but some pharmacies offer tests that they claim can provide insight into metabolism, nutrition, and the need for supplements:
NutriChem Biomedical Laboratory is the starting point for good health, whether you need to measure the effect of your existing nutritional supplementation or you have specific health conditions that need to be addressed naturally. A unique profile of your biochemical makeup will help you discover what you need to lead a longer, healthier life.Our most popular testing package, the Body Chemistry Balancing (BCB) Test, is a combination of specific panels that allows us to take a look at your body’s biochemistry as well as your current hormone status. Included in the BCB test is a thirty minute consultation to review your results and discuss your health goals.From the results of the BCB, a proactive plan of action can be developed for you. This may include a customized vitamin and mineral formula to balance your body chemistry and recommendations for bio-identical hormones that are tailored to improve your individual symptoms of hormone imbalance.
Who needs it? Pretty much everyone:
In our experience, regardless of whether you’ve been diagnosed with a disease or are experiencing a lot of apparently unrelated symptoms, there are underlying nutritional or hormonal issues that have not yet been identified. This causes your body chemistry to be unbalanced.
An unbalanced body chemistry can:
- cause mood and anxiety issues
- lead to fatigue
- trigger vitamin and mineral deficiencies
- affect nutrient absorption and gastrointestinal health
- worsen your ability to deal with stress and fight infection
- create hormonal problems in both women and men
- ultimately, can lead to disease
What does altered body chemistry really mean? Usually a trip to the intensive care unit, followed by death. This is Biochemistry 101. But positioned as a way of “individualizing” your care and determining you need supplements, pharmacies are taking a page out of the alternative medicine playbook. There is no published information to to suggest that pharmacy-based tests can determine the need for supplements or for specific amino acid supplements, as this sample test suggests [PDF]. Given these tests have not been validated, the information they provide cannot be considered credible. Tarot cards, anyone?
#3. Breast thermography
Why do we screen healthy people for cancer? The answer seems obvious: Detect abnormalities sooner, which presumably leads to earlier care and better outcomes. But there are several factors to consider. The perfect screening test would be 100% sensitive and specific – but no such test exists. To evaluate the overall benefit a screening test, the implications of both false positives and false negatives must be taken into account. False positives lead to unnecessary investigations and treatments. (Not to mention terrifying the patient.) False negatives mean that actual disease is missed.
Enter the controversy on mammograms. There is justified debate on the utility. In particular, overscreening those at low risk of breast cancer appears to be harming more than it benefits.(This has been a discussion point for several years here at SBM, David Gorski’s post is a good launching point.) Likely driven by this vigorous debate on the merits of mammograms, thermography has emerged as an alternative therapy offered by naturopaths, homeopaths, and some health professionals. Tumours need a rich blood flow to grow, so cancer cells secrete chemicals to stimulate the development of new blood vessels. More blood flow means warmer tissue. Thermography, sometimes called digital infrared thermal imaging (DITI) uses infrared measurement to detect skin temperature differences. It’s not just for breast cancer, claim some pharmacies. One pharmacy notes the following:
Non-invasive Painless Conditions Detected with DITI
Breast Health Evaluation
Carpal Tunnel Syndrome
Chronic Nerve Injury
Deep Vascular Disease
Headache Evaluation (cervicogenic, migraine, cluster, sinus)
Neoplasia (breast, skin, testicular)
Neck and Back Problems
Peripheral Nerve Abnormalities
Soft Tissue Injuries/Sports Injuries
Stroke Risk Assessment
Let’s focus on a single use – breast cancer detection. While positioned as a diagnostic wonder, the evidence is lacking. There are no controlled trials[PDF] that have compared thermography with mammograms. Evaluations show that thermography is worse than mammography in terms of sensitivity, specificity, and predictive value. That is, it gives more false positives, leading to unnecessary worry and investigations, yet it misses actual cancer. For this reason, thermography is not considered a credible or useful screening tool. This is nothing new – it’s been that way since 1977. A new study announced earlier this month reinforces this finding, suggesting that thermal imaging is not even useful in addition to mammography. Despite the lack of any credible evidence, thermography remains a service offered by some pharmacies. The bottom line with thermography is that it hurts and harms more than it helps. There’s no credible reason for pharmacies to offer it.
#4. Heel Ultrasound Bone Density Testing
With an aging population, preventing diseases more common in the elderly has emerged as a looming health care challenge. Fractures in the elderly can be devastating, with the resulting immobility leading to spiral of other illnesses, hospitalization, and premature mortality. Osteoporosis, the thinning and weakening of bones, is a significant contributor to the risk of fragility fractures. One in three women and one in five men will have an osteoporosis-related fracture in their lifetime. The medical objective is to prevent osteoporosis from occurring, as medications to treat it once it is in place only offer modest benefit.
Assessing patients for osteoporosis is not recommended until age 50, and is based on a detailed history and evaluation of risk factors. Dual-energy x-ray absorptiometry (DEXA) is the gold standard for measuring bone mineral density. But American Academy of Family Medicine, in their Choosing Wisely advices, notes that DEXA screening for screening is not warranted in women under the age of 65 or men under the age of 70:
DEXA is not cost effective in younger, low-risk patients, but is cost effective in older patients.
Despite the limited and narrowly defined role for bone-mineral density evaluation, ultrasound devices that are purported to evaluate BMD are offered in some pharmacies:
Make an appointment to have your bone density tested to determine your risk for possible fractures and the development of osteoporosis.
- Painless ultrasound heel test
- Consultation with a pharmacist regarding bone health and osteoporosis prevention
- Information on risk reduction
While pharmacies position heel ultrasound as a useful screening tool, expert associations advise against their use:
The scientific community has raised concerns about the technological diversity, standards and instrument precision regarding these devices. Quality assurance is another issue: as yet, no formal training or accreditation process for commercial operators exists. Further, heel ultrasound detects fewer cases of osteoporosis than DXA and experts aren’t sure how to deal with the discrepancy between results from the two tests. Many people who undergo ultrasound testing require additional DXA test later, leading to more expense and inconvenience. At this time, DXA remains the diagnostic “gold standard” for identifying individuals with osteoporosis. Moreover, QUS is not sufficiently sensitive to changes in bone structure to be used to monitor ongoing therapy for the disease.
And advice has been issued to family physicians[PDF] who may be presented with ultrasound test results administered by pharmacies:
Currently there is no requirement that operators of ultrasound equipment have formal training in measuring bone density or participate in any formal quality assurance programs. Indeed, none of the private companies offering this service that we have spoken with have had training or accreditation through the International Society for Clinical Densitometry (ISCD) or have developed an ultrasound program that meets the minimal OSC recommendations. Therefore, there is no guarantee to you that measurements are being performed correctly and accurately. Even in the hands of experts, there is uncertainty over how to address the high disagreement rates between the two tests. Ultrasound of the heel detects far fewer cases of osteoporosis than does DEXA and many people (probably the majority) who have had ultrasound testing will require additional DEXA testing. This duplication in testing is inconvenient for patients and generates additional costs. Finally, there is still no scientific consensus on how to use ultrasound measurements in defining fracture risk or diagnosing osteoporosis. [emphasis added]
Published guidelines on the prevention and treatment of osteoporosis do not recommend ultrasound screening as a useful technology. There is no evidence to show that they have any role to play for either screening or routine management of the disease. There is no demonstrated need for pharmacies to offer bone density ultrasound evaluations.
#5. Saliva Hormone Testing
Hormone replacement therapy (HRT) was routinely used by women for decades. Not only was it effective at reducing menopausal symptoms like hot flashes and sleeplessness, it was believed to reduce the risk of osteoporosis, and possibly even heart disease. There was data to suggest some risks existed, but the balance of risks and benefit was believed to favour the use of HRT. The Women’s Health Initiative (WHI) study was designed to provide conclusive answers about the risks and benefits of HRT. And it did, showing that the risks outweighed the benefits in most circumstances.
The term “bioidentical” refers to hormones that are not produced in the body, are but biochemically similar to hormones the body produces. Bioidentical hormones include estrone, estradiol, estriol, progesterone, dehydroepiandrosterone (DHEA), and cortisol. Some drugs are FDA approved and contain bioidentical hormones. But this isn’t what celebrities like Suzanne Somers are promoting. In the popular media, bioidentical hormone therapy refers to products that are custom manufactured in a pharmacy, and are claimed to be safer and more effective than “conventional” HRT. No persuasive evidence exists to show this is the case. BHT often contains combination of estrogens such as triest (estriol, estrone, and estradiol) and biest (estradiol and estriol). Both are arbitrary combinations of estrogens based on weak evidence.
Some pharmacies offer saliva tests to monitor a patient’s response to BHT, and other conditions:
Why Test Hormones in Saliva?
Hormone imbalance can lead to symptoms such as mood swings, lowered sex drive and hot flashes. Saliva hormone testing may reveal hormone imbalances that contribute to chronic health problems like insulin resistance (pre-diabetes), thyroid dysfunction, estrogen dominance and androgen (i.e. testosterone) deficiency. Saliva hormone testing can also be used to monitor hormone replacement therapy (HRT) and is often used in anti-aging and disease prevention pro- grams.
Which Hormones Should I Test?
Generally speaking, we recommend a basic panel of estradiol, progesterone, testosterone, cortisol and DHEA-S for women and a panel of cortisol, DHEAS, estradiol and testosterone for men, to get the best view of how the hormones interact with one another.
Even if you have many symptoms of hormone imbalance, it is important to discuss your symptoms and health concerns with your compounding pharmacist before considering saliva hormone testing. Hormone balance is only one aspect of good health and it is important to have realistic expectations about saliva hormone testing and hormone balance. Our staff can help you determine whether saliva hormone testing is right for you.
Saliva testing to determine if a woman has the “right amount” of hormones has not been proven accurate or reliable. Even blood testing of hormone levels has the drawback that levels vary throughout the day as well as from day to day. More important, the desired levels in postmenopausal women have not been established. In addition, an individual woman’s physical comfort may not even be related to her absolute hormone levels.
The single best method to monitor hormone replacement is simply to see if menopause symptoms (e.g., hot flushes) are alleviated. BHT advocates argue that compounding and saliva allows patients to “balance” their hormones. But the science shows this is implausible. Estrogen and progesterone levels vary day-to-day and hour-to-hour. There are no published studies to demonstrate that single or multiple saliva tests reflect hormone need, or can be used to adjust doses accurately.
Experts advise against it. The testing hasn’t been validated as useful. So why do pharmacies offer saliva testing?
Conclusion: Pharmacists should take science more seriously
Pharmacy, a self-regulated health profession, has a choice to make. It can move to assume an expanded role in the health care system, as a credible contributor to health outcomes, focused on optimizing medication use and minimizing drug-related harms. But to be taken seriously as health professionals, the profession must offer the highest levels of science-based care. Do pharmacists want to be part of the problem in health care? Or part of the solution? The list above is a proposed starting point for some overdue reflection on pharmacist-provided services. None of the tests listed here have any established scientific credibility. Ending their provision today will signal that pharmacists take their professional obligations to patients, and the public, seriously.