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Archive for Politics and Regulation

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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Smoking Cessation and the Affordable Care Act

A young child and a chicken — neither of whom should smoke.

A young child and a chicken — neither of whom should smoke.

Smoking is the leading preventable cause of death. Each year it kills more than 5 million people around the world, 480,000 in the US alone. And for every person who dies, about 30 more have serious illnesses caused by smoking. On average, smokers die 10 years earlier than nonsmokers. Anyone who is concerned about preventive medicine must consider smoking cessation a priority. Fortunately, the Affordable Care Act (ACA) has taken a step in the right direction.

The ACA’s provisions

The Affordable Care Act requires health plans and health insurance to cover tobacco-use counseling and interventions without cost sharing or prior authorization. It requires screening of all patients for tobacco use and covering at least two attempts to quit each year. For each quit attempt, it authorizes four tobacco-cessation counseling sessions, each at least ten minutes long (including telephone, group, and individual counseling) and any FDA-approved tobacco-cessation medications (whether prescription or over-the-counter) for a 90-day treatment regimen when prescribed by a health care provider. In a separate provision, it requires that states not exclude FDA-approved cessation medications from existing Medicaid programs. These provisions should encourage providers and patients to increase their smoking cessation efforts. (more…)

Posted in: Politics and Regulation, Public Health

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2014: Chiropractors, naturopaths and acupuncturists lose in state legislatures

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

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.

(more…)

Posted in: Acupuncture, Chiropractic, Diagnostic tests & procedures, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation, Traditional Chinese Medicine

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SFSBM Report upsets naturopaths. We’re fine with that.

Sisyphus
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…)

Posted in: Diagnostic tests & procedures, Homeopathy, Legal, Naturopathy, Politics and Regulation, Vaccines

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Ontario fails to protect the life of a First Nations girl with cancer

First Nations

A few weeks ago, Steve Novella invited me on his podcast, The Skeptics’ Guide to the Universe, to discuss a cancer case that has been in the news for several months now. The case was about an 11-year-old girl with leukemia who is a member of Canada’s largest aboriginal community. Steve wrote about this case nearly a month ago. Basically, the girl’s parents are fighting for the right to use “natural healing” on their daughter after they had stopped her chemotherapy in August because of side effects. It is a profoundly disturbing case, just as all the other cases I’ve discussed in which children’s lives are sacrificed at the altar of belief in alternative medicine, but this one has a twist that I don’t recall having dealt with before: The girl’s status as part of the First Nations. Sadly, on Friday, Ontario Court Justice Gethin Edward has ruled that the parents can let their daughter die.

The First Nations consist of various Aboriginal peoples in Canada who are neither Inuit nor Métis. There are currently more than 630 recognized First Nations governments or bands in Canada, half of which are located in Ontario and British Columbia. This girl lives in Ontario, which is basically just next door to Detroit, just across the Detroit River. Unlike previous cases of minors who refuse chemotherapy or whose parents refuse chemotherapy for them that I’ve discussed, such as Sarah Hershberger, an Amish girl whose parents were taken to court by authorities in Medina County, Ohio at the behest of Akron General Hospital, where she had been treated because they stopped her chemotherapy for lymphoblastic lymphoma in favor of “natural healing,” or Daniel Hauser, a 13-year-old boy from Minnesota with Hodgkin’s lymphoma whose parents, in particular his mother, refused chemotherapy after starting his chemotherapy and suffering side effects, there’s very little information about this girl because of Canadian privacy laws. I do not know her name. I do not know anything about her case except that she has acute lymphoblastic leukemia, that she started treatment but her parents withdrew her because of side effects.
(more…)

Posted in: Cancer, Faith Healing & Spirituality, Politics and Regulation, Religion

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Political Science: Chronic Lyme Disease

Tick

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…)

Posted in: Critical Thinking, Health Fraud, Legal, Politics and Regulation

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Using the fear of Ebola to promote the placebo legislation that is “right to try”

rick-snyder

Perhaps the most pervasive medical conspiracy theory of all involves stories that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or various other alternative medicine cures that are being “suppressed” by the FDA, FTC, state medical boards, and various other entities, usually at the behest of their pharma overlords. The second version is less extreme but no less fantasy-based. It tends to be tightly associated with libertarian and small government fantasists and a loose movement in medicine with similar beliefs known as the “health freedom” movement, whose members posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA reined in, free market innovation would flourish, and the cures so long suppressed by an overweening and oppressive regulatory apparatus would burst the floodgates. Under this views, these cures, long held back by the dam of the FDA, would flow immediately to the people, and there would be much rejoicing. (Funny how it didn’t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can’t help but note that in general, in this latter idea, these fantastical benefits seem to be reserved only for those who have the cash, because, well, the free market fixes everything. At least, that seems to be the belief system at the heart of many of these conspiracy theories.

The idea that the FDA is keeping cures from desperate terminally ill people, either intentionally or unintentionally, through its insistence on a rigorous, science-based approval process in which drugs are taken through preclinical work, phase 1, phase 2, and phase 3 testing before approval is one of the major driving beliefs commonly used to justify so-called “right-to-try” laws. These bills have been infiltrating state houses like so much kudzu, and the Ebola outbreak has only added fuel to the fire based on the accelerated use of ZMapp, a humanized monoclonal antibody against the Ebola virus, in some patients even though it hadn’t been tested in humans yet (more on that later). Already four of these laws have been passed (in Colorado, Missouri, Louisiana, and now Michigan) with a referendum in Arizona almost certain to pass next week to bring the total to five states with such laws. Basically, these laws, as I’ve described, claim to allow access to experimental drugs to terminally ill patients with a couple of major conditions: First, that the drug has passed phase I clinical trials and second that the patient has exhausted all approved therapies. As I’ve explained before more than once, first when the law hit the news big time in Arizona and then when a right-to-try bill was introduced into the legislature here in Michigan, they do nothing of the sort and are being promoted based on a huge amount of misinformation detailed in the links earlier. First, having passed phase 1 does not mean a drug is safe, but right-to-try advocates, particularly the main group spearheading these laws, the Goldwater Institute, make that claim incessantly. Second, they vastly overstate the likelihood that a given experimental drug will help a given patient. The list goes on.
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Posted in: Cancer, Clinical Trials, Pharmaceuticals, Politics and Regulation

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“Quackery: A $10 Billion Scandal”

Rubber ducky
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.

(more…)

Posted in: Acupuncture, Cancer, Diagnostic tests & procedures, Health Fraud, Herbs & Supplements, Politics and Regulation

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Ebola conspiracy theories: Same as it ever was

tinfoilhatbrigade

Does anyone remember the H1N1 influenza pandemic? As hard as it is to believe, that was five years ago. One thing I remember about the whole thing is just how crazy both the antivaccine movement and conspiracy theorists (but I repeat myself) went attacking reasonable public health campaigns to vaccinate people against H1N1. It was truly an eye-opener, surpassing even what I expected based on my then-five-year experience dealing with the antivaccine movement and quacks. Besides the usual antivaccine paranoia that misrepresented and demonized the vaccine as, alternately, ineffective, full of “toxins,” a mass depopulation plot, and many other equally ridiculous fever dream nonsense, there was the quackery. One I remember quite well was the one where it was claimed that baking soda would cure H1N1. Then there was one of the usual suspects, colloidal silver, being sold as a treatment for H1N1. Then who could forget the story of Desiree Jennings, the young woman who claimed to have developed dystonia from the H1N1 vaccine but was a fraud? Truly, pandemics bring out the crazy, particularly the conspiracy theories, such as the one claiming that the H1N1 pandemic was a socialist plot by President Obama to poison Wall Street executives, which was truly weapons-grade conspiracy mongering stupidity. Oh, wait. That last one was a joke. It’s so hard to tell sometimes with these things.

Yes, pandemics and epidemics do bring out the worst in people in many ways, but particularly in terms of losing critical-thinking abilities. This time around, five years later, it’s Ebola virus disease. To the average person, Ebola is way more scary than H1N1, even though H1N1, given its mode of transmission, had the potential to potentially kill far more people. Now that cases of Ebola virus disease have been reported in the US, the panic has been cranked up to 10 in certain quarters, even though the risk of an outbreak in the US comparable to what is happening in West Africa is minimal. We’ve seen quackery, too, such as homeopaths seriously claiming that they can treat it and quacks advocating high-dose vitamin C to “cure” Ebola. The über-quack Mike Adams is selling a “natural biopreparedness” kit to combat Ebola and pandemics, while the FDA is hard-pressed to track down all the quacks, such as hawkers of “essential oils,” who—of course!—also think that their wares can cure Ebola. (more…)

Posted in: Critical Thinking, Politics and Regulation, Vaccines

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Connecticut “modernizes” naturopathic scope of practice

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.

(more…)

Posted in: Diagnostic tests & procedures, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation, Vaccines

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