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Regulating CAM Aussie Style

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CAM proponents view National Health Interview Surveys recording the supposed popularity of CAM, an amorphous conflation of anything from conventional medical advice to mythical methods, as an invitation to unleash even more unproven remedies on the public. My interpretation is quite different. I see the same figures as proof that we are doing too little to protect the public from pseudoscience.

In fact, state and federal governments are acting as handmaidens to the CAM industry by legalizing practices and products that have insufficient proof of safety and efficacy and, in some cases, are so scientifically implausible that they can never meet that standard. The federal government keeps “integrative” medicine centers at major academic institutions and private foundations afloat with taxpayer money by funding research that has failed to improve public health or the treatment of disease, despite seemingly endless trials, because “more research is needed”.

As we shall see, Australia has a more effective regulatory system for dealing with CAM. And the advocacy group Friends of Science in Medicine (FSM), an organization with goals similar to our own Society for Science-Based Medicine, is keeping the government on its toes, investigating violations of the law on its own and reporting them. We in the US could learn something from their two recent successful campaigns attacking misleading health claims. (more…)

Posted in: Chiropractic, Diagnostic tests & procedures, Guidelines, Legal, Naturopathy, Politics and Regulation

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Lyme Testing

The little burrowing bacteria that bores into your pores to cause Lyme disease, EEEEEWWW!!!

The little burrowing bacteria that bores into your pores to cause Lyme disease, EEEEEWWW!!! Darkfield 400x microscopy image of the 10-25µm long Borrelia burgdorferi spirochaete which causes Lyme disease (1993). Provided by the CDC’s Public Health Image Library (PHIL #6631) via the Wikimedia Commons

I hate those oh hell moments. I was up way too late last night, but who can pass up the opportunity to see Patti Smith playing Horses (and more) for the 40th anniversary of the album. Only 44? Behind the Eagles? No way. I would nudge it up a few more spaces. Hard to believe I was 18 when that album came out. Horses is one of the few albums that made the transition from vinyl to CD. It was a tremendous show, and at 69 Patt performs with the energy and passion of a 29 year old. And she sure can spit. I had the evening off, so food and drinks at Swine until well past midnight. First time my wife and I closed a bar. I am too old for this.

But as I was blearily drinking my a.m. coffee on a dreary PDX morning, I opened the browser to SBM and there was a post by Jann. Oh hell. That means I have a post due tomorrow and I had lost track of the time over the holidays. I thought my next post was next Friday. Oh. Hell. So unlike most posts which I write over a week, this one was done in about 4 hours. And I am sure it will show.

How do you diagnose an infection?

Not always so simple. You always start with a history and, for infectious diseases, an exposure history is paramount. People get what they are exposed to, so you want to know travel, animals, diet, water, sex etc. If you have ridden a horse to have sex in an Indian lake while drinking raw milk (not really an unusual history in my practice; people do the darndest things) you have exposure risks for a variety of infections. If you have not left the Willamette Valley it is unlikely that the cause of the illness is malaria, although you always have to consider that the infection came to the patient rather than the other way around. (more…)

Posted in: Basic Science, Diagnostic tests & procedures, Lyme, Science and Medicine

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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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Lemons and Lyme: Bogus tests and dangerous treatments of the Lyme-literati

Tick

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…)

Posted in: Diagnostic tests & procedures, Science and Medicine

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Why Doctors Order Too Many Tests

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…

(more…)

Posted in: Diagnostic tests & procedures

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