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…)
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…)
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.
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…)
Science is under attack, and not just from anti-vaccine celebrities and parents with degrees from Google University. Scientific illiteracy is being woven into the very fabric of our society through legislative assault. If you dismiss this as alarmist hyperbole, you haven’t been paying close enough attention.
Every day thousands of pediatric health care providers throughout the country provide safety advice to patients and their parents during routine health maintenance visits. As part of this important routine we ask a series of standard questions to assess the safety of our patients’ environment. Some of these questions are easy and straightforward, and some are more personal and potentially awkward for patients and their parents, including questions pertaining to sexual practices and preferences and psychosocial history. An important series of questions focuses on potential hazards in the home, such as how toxins and medicines are stored, how pools are secured against curious toddlers, and whether there are guns in the home and how they are stored and secured. Parents are usually appreciative of the advice we provide, and thankful for our concern and attention to these issues. Occasionally patients or parents are taken aback by some of these questions, and very rarely they prefer not to answer them (in my 20 years in practice, I can recall only one time this has occurred). We ask these questions because accidental injuries and deaths are common occurrences in the pediatric population, and there is good evidence that patients tend to follow the advice we provide our patients. (more…)
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…)
What’s in a name? Will sugar by any other name taste as sweet? Well, yes, but calling sugar “evaporated cane juice” in an ingredient list may get food manufacturers into trouble. Consumers in several class action suits allege that companies are trying to disguise the amount of sugar in their products by calling it something else.
Robin Reese filed a class action suit against Odwalla, a subsidiary of Coca-Cola, saying use of the term “evaporated cane juice” instead of sugar fooled her into thinking she was getting a healthier product when she purchased Odwalla juice. Odwalla told the judge the suit should be dismissed because it’s up to the FDA to decide the issue. The FDA issued draft guidelines, in 2009, taking the position that the term “evaporated cane juice” should not be used because it’s not a “juice” as defined in the Federal Regulations. For unknown reasons, no final guidelines were issued and food companies seem to be honoring the draft guidance more in the breach. The FDA reopened the draft guidelines for comment in March of this year, for 3 months, but still hasn’t decided. Meanwhile, similar class actions against other companies were dismissed or stayed pending the FDA’s making up its mind. (more…)
I suppose it was inevitable. In fact, I’m a bit surprised it took this long. SGU Productions, the Society for Science-based medicine, and I are being sued for an article that I wrote in May of 2013 on Science-Based Medicine. My SBM piece, which was inspired by an article in the LA Times, gave this summary:
The story revolves around Dr. Edward Tobinick and his practice of perispinal etanercept (Enbrel) for a long and apparently growing list of conditions. Enbrel is an FDA-approved drug for the treatment of severe rheumatoid arthritis. It works by inhibiting tumor necrosis factor (TNF), which is a group of cytokines that are part of the immune system and cause cell death. Enbrel, therefore, can be a powerful anti-inflammatory drug. Tobinick is using Enbrel for many off-label indications, one of which is Alzheimer’s disease (the focus of the LA Times story).
The claims and practice of Dr. Tobinick have many of the red flags of a dubious medical practice, of the sort that we discuss regularly on SBM. It seems that Dr. Tobinick does not appreciate public criticism of his claims and practice, and he wants me to remove the post from SBM. In my opinion he is using legal thuggery in an attempt to intimidate me and silence my free speech because he finds its content inconvenient.
Of course, we have no intention of removing the post as we feel it is critical to the public’s interest. This is what we do at SBM – provide an objective analysis of questionable or controversial medical claims so that consumers can make more informed decisions, and to advance the state of science in medicine.
We also feel it is critical not to cave to this type of intimidation. If we do, we might as well close up shop (which I suspect the Tobinicks of the world would find agreeable). Defending against even a frivolous lawsuit can be quite expensive, but we feel it is necessary for us to fight as hard as we can to defend our rights and the work that we do here at SBM.