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…)
I am happy to report some good news: chiropractors, naturopaths, acupuncturists and assorted other practitioners of pseudo-medicine didn’t fare too well in the 2013-2014 state legislative sessions.
We’ve been following their legislative efforts all year over at the Society for Science-Based Medicine. Some state legislatures meet in yearly sessions. At the end of the year, pending bills die with the session. Some meet only every other year. Others meet in two-year sessions and, in some of these, legislation introduced in one year carries over to the next year. All states with two-year sessions ended these sessions at the close of 2014, except New Jersey and Virginia. If you want to see how your state operates, several websites can help you: MultiState Associates, National Conference of State Legislatures and StateScape.
Chiropractors are already licensed in all 50 states and all of their practice acts permit the detection and correction of the non-existent subluxation. Having achieved that goal, the focus of chiropractic legislative efforts is to expand their scope of practice (the holy grail, for some, being primary care physician status), turf protection and mandates requiring insurance reimbursement or their inclusion in various activities, such as sports physicals, concussion treatment, and scoliosis detection programs.
The most interesting chiropractic bill, one from Oklahoma, didn’t fall into any of those categories:
Chiropractic physicians in this state shall obtain informed, written consent from a patient prior to performing any procedure that involves treatment of the patient’s cervical spine and such informed consent shall include the risks and possible side effects of such treatment including the risk of chiropractic stroke.
The Maryland Naturopathic Doctors Association is not pleased with the Society for Science-Based Medicine. Not at all.
That is a good thing, for several reasons. It demonstrates the importance of stopping naturopathic licensing (and practice expansion) legislation in the state legislatures. It shows how they handle legitimate criticism of their practices. And it is a lesson in their modus operandi of obfuscating the facts with platitudinous- but-vague pronouncements about their education, training and practice, pronouncements that wither under criticism.
Why is the MNDA so upset with the SFSBM?
We’ll answer that question soon, but some background first. The Maryland Legislature passed a naturopathic licensing bill this year. Fortunately, as I’ve written, the Legislature didn’t give naturopaths everything they wanted, such as the right to prescribe real drugs. That’s not stopping them from coming back to the Legislature to revisit the issue. According to naturopathic school Bastyr’s website:
The [Maryland] law limits some parts of the naturopathic scope of practice — such as intravenous (IV) therapies and prescription drugs — that the state association will work to secure in the future.
Instead of giving naturopaths their own regulatory board, like they wanted, the Legislature put them under the authority of the Maryland Board of Physicians. The Legislature created a Naturopathic Advisory Committee to recommend regulations governing naturopathic practice to the Board. The Maryland Naturopathic Doctors Association (MNDA) states, incorrectly, on its website that the Committee will actually be promulgating the regulations and implementing the law. The statute is quite clear that this is not the case. Those duties are entirely within the jurisdiction of the Board. (more…)
Screen detection and tumor growth rates. Cancers have different growth rates, which determine their potential to be detected by screening. Tumor A remains microscopic and undetectable by current technology (although more sensitive tests in the future might render it detectable). Tumor B eventually becomes detectable by screening (*), but its growth rate is so slow that it will not cause symptoms during the life of the individual; its detection will result in overdiagnosis. Tumor C is capable of metastasizing, but it grows slowly enough that it can be detected by screening (*); for some, this early detection will result in survival. Tumor D grows very quickly and therefore is usually not detected by screening. This will present as an interval cancer (i.e. detected clinically in the interval between screening examinations) and has a particularly poor prognosis. Note that of the four tumor types, only Tumor C has the potential to benefit from screening. Red dashed lines represent the natural history of a tumor in the absence of detection by screening. (Figure 1 from Gates, 2014).
A new stool DNA test was recently approved by the FDA for colon cancer screening. My first reaction was “Yay! I hope it’s good enough to replace all those unpleasant, expensive screening colonoscopies.” But of course, things are never that simple. I wanted to explain the new test for our readers; but before I could start writing, some other issues in cancer screening barged in and demanded to be included. They exemplify the dilemmas we face with every screening test. We have covered these issues before, but mainly in reference to mammography and prostate (PSA) screening. My article morphed into a CLT sandwich: colon, lung, and thyroid cancer screening.
The current issue of American Family Physician has a great article on cancer screening. It uses lucid graphics to illustrate lead time bias, length time bias, and overdiagnosis bias, as well the effect of varying tumor growth rates on screening success rates, all concepts that have been covered by Dr. Gorski here. Briefly, screening may do more harm than good if:
- It detects cancerous cells that never would have developed into invasive cancers or harmed the patient in any way;
- Early diagnosis and treatment decrease quality of life without reducing death rates; or
- The test falsely indicates cancer in patients who don’t have it or fails to indicate cancer in some who do. (more…)
Who would you guess authored a 250-page report which begins with this Preface?
This report marks the culmination of an intensive four-year review of quackery and its impact on the elderly. . . As this report details, quackery has traveled far from the day of the pitchman and covered wagon to emerge as big business. Those who orchestrate and profit from the sale and promotion of these useless and often harmful “health” products are no longer quaint and comical figures. They are well organized, sophisticated and persistent. [We estimate] the cost of quackery – the promotion and sale of useless remedies promising relief from chronic and critical health conditions – exceeds $10 billion a year. The costs of quackery in human terms, measured in disillusion, pain, relief forsaken or postponed because of reliance on unproven methods, is more difficult to measure, but nonetheless real. All too frequently, the purchaser has paid with his life. While the impact of quackery on our lives has been increasing and growing in sophistication, public and private efforts designed to address and control this problem have diminished, been redirected or disbanded.
Naturopathy has been legal in Connecticut for almost 90 years, but with a scope of practice limited to counseling and a few treatments like physiotherapy, colonic hydrotherapy and “natural substances.” There was no specific authority to diagnose and treat. All of that changed on October 1, 2014, courtesy of the Connecticut legislature, which, in the words of the American Association of Naturopathic Physicians (AANP), “modernized” the naturopathic scope of practice.
Actually, the legislature did nothing of the sort. Naturopathy is based on the prescientific concept of vitalism, and we find it right there in the very first paragraph of the new law. Naturopathy is defined as:
diagnosis, prevention and treatment of disease and health optimization by stimulation and support of the body’s natural healing processes, as approved by the State Board of Natureopathic [sic] Examiners, with the consent of the Commissioner of Public Health. . .
Also included in the expanded scope of practice are:
ordering diagnostic tests and other diagnostic procedures, . . . ordering medical devices, including continuous glucose monitors, glucose meters, glucose test strips, barrier contraceptives and durable medical equipment; and . . . removing ear wax, removing foreign bodies from the ear, nose and skin, shaving corns and calluses, spirometry, tuberculosis testing, vaccine administration, venipuncture for blood testing and minor wound repair, including suturing.
Ladies, how would you like a chiropractor to deliver your baby? How about perform your annual well-woman exams, such as breast exam, bi-manual pelvic exam, speculum exam, recto-vaginal exam and Pap smear?
Sound out of their league? I thought so too. Way out. But, in some parts of the U.S., the law allows chiropractors to do all of these things and a great deal more. Including “adjusting” your basset hound.
A 2011 survey asked chiropractic regulatory officials whether their jurisdictions (all states, plus D.C., Virgin Islands and Puerto Rico, but I’ll refer to them collectively as the “states”) allowed 97 different diagnostic, evaluation, and management procedures. The results were recently reported and interpreted in the Journal of Manipulative and Physiological Therapeutics, in an article authored by Mabel Chang, DC, MPH, who was primarily responsible for the survey. Missouri allows the most procedures (92) and Texas, the fewest (30). A handful of states did not respond or did not respond to all questions, but the overall response rate was 96%. Results from a survey of Canada, Australia and New Zealand will be reported in a separate article. (more…)
It’s that time of year when every day I can expect to see at least one patient with a concern about Lyme disease. In Lyme-endemic regions such as Western Massachusetts, where I practice pediatrics, summer brings a steady stream of children to my office with either the classic Lyme rash (erythema chronicum migrans, or ECM), an embedded tick, a history of a tick bite, or non-specific signs or symptoms that may or may not be due to Lyme disease. Sometimes the diagnosis is relatively straightforward. A child is brought in after a parent has pulled off an engorged deer tick, and there is a classic, enlarging ECM rash at the site of the bite. More often the presentation is less clear, requiring detective work and science-based reasoning to make an informed decision and a diagnostic and therapeutic plan based on the best available evidence. Depending on the story, the plan may include immediate treatment without any testing (as in the straightforward case described above), immediate testing without treatment pending test results, or waiting as we watch and see how a rash progresses before doing anything. An example of this latter course of action would be when a patient comes in with a pink swelling at the site of a new tick bite. In this case, it may not be clear if the swelling is a Lyme rash or simply a local reaction to the bite, a much more common occurrence. The classic ECM rash (an enlarging, red, circular, bull’s-eye rash at or near a tick bite) typically develops 1-2 weeks after a tick bite, but can occur anywhere from 3-30 days later. It then expands and darkens over another 1-3 weeks before fading. This classic rash is not the most common rash of Lyme disease, however, as it occurs in only about 30% of cases. Instead, the rash may be uniformly pink or red (or even darker in the center) without the target-like appearance, or may be a linear rash, expanding outward from the tick bite site. In the case of a patient who comes in with a vague, pink swelling within a day few days of a tick bite, we will typically wait and see what happens to the rash. If it is a local reaction, it will likely resolve within another few days. With Lyme disease, the rash will continue to enlarge and declare itself as an ECM rash. Another unclear and not uncommon situation is when a patient comes in with non-specific symptoms such as fatigue, musculoskeletal pains, and headache. If warranted by the history and the physical exam, we may in this case order Lyme testing. This may not give us an answer even if the patient has Lyme disease, because results are often negative in the first few weeks of the disease. In this case, if symptoms persist or evolve, we will repeat the testing in another few weeks at which point true Lyme disease will test positive and can then be treated. The good news is that the treatment of Lyme disease, particularly in the early, localized phase of the disease, is extremely safe and effective with a 14-day course of antibiotics. The testing is also relatively straightforward, with very good sensitivity and specificity when performed correctly. And this is where the bad news comes… (more…)
Last week I wrote about doctors who order unnecessary tests, and the excuses they give. Then I ran across an example that positively flabbered my gaster. A friend’s 21-year-old son went to a board-certified family physician for a routine physical. This young man is healthy, has no complaints, has no past history of any significant health problems and no family history of any disease. The patient just asked for a routine physical and did not request any tests; the doctor ordered labwork without saying what tests he was ordering, and the patient assumed that it was a routine part of the physical exam. The patient’s insurance paid only $13.09 and informed him that he was responsible for the remaining $3,682.98 (no, that’s not a typo). I have a copy of the Explanation of Benefits: the list of charges ranged from $7.54 to $392 but did not specify which charges were for which test. It listed some of the tests as experimental and not covered at all by the insurance policy, and one test was rejected because there was no prior authorization. (more…)
While cleaning out some old files, I was delighted to find an article I had clipped and saved 35 years ago: a “Sounding Boards” article from the January 25, 1979 issue of The New England Journal of Medicine. It was written by Joseph E. Hardison, MD, from the Emory University School of Medicine; it addresses the reasons doctors order unnecessary tests, and its title is “To Be Complete.” Today we have many more tests that can be ordered inappropriately and the article is even more pertinent and deserves to be re-cycled. He says,
When challenged and asked to defend their reasons for ordering or performing unnecessary tests and procedures, the reasons given usually fall under one of the following excuses…