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…)
Today is Thanksgiving, a national holiday in the U.S., and I am taking the day off to celebrate with my family. See you in two weeks.
New York may soon join a handful of other states who reject science-based guidelines for the treatment of Lyme disease in favor of ideological guidelines based on the vociferous lobbying of patients and “Lyme literate” health care providers. Ignoring science is an unfortunate but well-known legislative phenomenon. I’ve discussed it a number of times on SBM, in the form of Legislative Alchemy, the process by which credulous state legislators turn practitioners of pseudoscience into state-licensed health care professionals, such as naturopaths, chiropractors, homeopaths and acupuncturists.
Lyme disease is an infectious disease transmitted by a tick bite. Its symptoms are a rash, fever, headache and fatigue, although not all symptoms may appear. According to the Infectious Diseases Society of America (IDSA):
Lyme disease is diagnosed by medical history, physical exam, and sometimes a blood test. It may take four to six weeks for the human immune system to make antibodies against Borrelia burgdorferi and therefore show up in a positive blood test. That is why patients with the Lyme rash usually have a negative blood test and diagnosis is based on the characteristic appearance of the rash. Patients with other clinical manifestations such as Lyme arthritis will usually have a blood test. Anyone who has symptoms for longer than six weeks and who has never been treated with antibiotics is unlikely to have Lyme disease if the blood test is negative.
Treatment with antibiotics usually eliminates the symptoms, but delayed treatment can result in more serious problems. (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.
Yahoo News appears to have confused NaturalNews with actual news. It’s not. NaturalNews is the in-house propaganda organ for Mike Adams, whom I’ll introduce in a minute (although he needs no introduction for most readers here). A couple of recent examples:
A recycled story, over a year old, from NaturalNews, appearing on Yahoo News last week. It starts out as a fairly straightforward report of the Japanese’s governments suspending its recommendation if favor of the HPV vaccine pending further research, although government health officials were still standing by the vaccine’s safety. Actually, Medscape reported that the actual rate was 12.8 serious adverse side effects reported per 1 million doses, a fact not revealed in the NaturalNews story. These effects were correlated with the vaccine; there is no evidence of causation.
After this rather tame start, NaturalNews cranks it up to 11 and beyond, as David Gorski would say. Governments which still recommend HPV vaccinations “remain under the thumb of Merck’s vaccinations spell” even though Merck is “an organization of murderers and thieves.” A scary list of adverse events are described as “side effects of Guardasil” even though causation has not been shown.
Two days ago there was an “ongoing debate”? There is no ongoing debate about “whether or not vaccines cause autism” because there never was any credible evidence that vaccines cause autism and there still isn’t.
Medical school clinical training
A new law in Missouri will allow medical school graduates who have not completed a residency to practice in underserved areas. They will be able to call themselves “doctor” but will be licensed as “assistant physicians” with significant limitations on their practice. (The first link is to Senate Bill 716, the bill that was passed and signed by the governor. It covers several subjects, so you will need to skip to page 8 to find the portion we’re discussing.)
The Missouri State Medical Association supports the new law and helped draft the original bill. It is designed to address the state’s critical need for primary care physicians – 40% of Missouri’s population lives in underserved areas but only 25% of the state’s physicians practice there, according to a 2009 survey. Underserved areas have high poverty rates, high infant mortality, large senior populations and fewer primary care physicians per capita. (more…)