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Homeopathic regulation diluted until no substance left

Homeopathy is quackery but it is perfectly legal to prescribe homeopathic products and to sell them directly to consumers in the United States as well as other supposedly civilized countries such as the United Kingdom and Germany. This makes as much sense as allowing the sale of batteries that don’t produce electricity.

What makes this state of affairs even stranger is that homeopathic products are classified as drugs under U.S. law. Does this mean that they undergo the same pre-market approval process and are subject to the same post-market requirements as pharmaceutical drugs? No, not by a long shot. In fact, the federal government and the FDA have pretty much handed regulation of homeopathic products over to their manufacturers.

How did this happen?

In 1938, Congress passed the Food, Drugs and Cosmetics Act. The Act’s principle author was Senator Royal Copeland, a physician who practiced homeopathy. He managed to include all articles monographed in the Homeopathic Pharmacopeia of the United States (HPUS) in the definition of drugs within the FDCA, although why he did so remains in dispute. The HPUS is a source for monographs, identity, methods of manufacture, standards and controls and potency levels of homeopathic products, both prescription and OTC. (The vast majority of homeopathic products are OTC.) In short, if the product is in the HPUS, it’s legal.

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Posted in: History, Homeopathy, Legal, Naturopathy, Politics and Regulation

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Important Security Notice: SBM Hacked

UPDATE 2013-04-04 1:25 PM EDT: All passwords have been reset. Users will have to use the “Forgot password” function to set a new password.

UPDATE 2013-04-04 6:06 PM EDT: Those interested in knowing if one of their passwords was one of the less secure may use this tool to check their email address. No matter the result with that tool, the only way to be 100% secure is to change your password on other sites if you also used it here.

ScienceBasedMedicine.org (SBM) was recently hacked, and user account information may have been stolen: usernames, passwords, and email addresses. Most of the potentially stolen passwords were strongly encrypted — that is, extremely difficult to read. About 2000 random accounts, roughly 5% of the total, were not protected as effectively and may be at greater risk.

If your SBM password was used for any other service, website, or account, you should change that duplicate password as soon as possible. (For example: if your SBM password is the same as your password for Gmail, you should immediately go to Gmail and change your password there.)

When hackers get your password from one place, they often try to use the same password with other services and websites. Unfortunately, this is a fairly effective strategy, because many people use the same password for many of their logins. This is why all security experts strongly recommend using unique passwords for all critical services.

What exactly happened to ScienceBasedMedicine.org?

On Sunday, March 10, hackers successfully gained access to the SBM server, and attempted to use it to attack other servers. Eventually it gave itself away by using too much computing power.

On Monday, April 1, our hijacked server was shut down by the service provider. We remained offline for a full day as we repaired the damage and strengthened our protections against hackers. SBM is now back online but all users will have to reset their passwords before commenting again.

There is no way to know if the attacker actually took any data from ScienceBasedMedicine.org itself, but the safest course is to act on the assumption that they did. However, most of that data was strongly protected by encryption — standard practice for user account information on WordPress blogs for exactly this reason. (You can find details on this encryption here.)

Nevertheless, we know that some of the passwords (again, only about 5%) were less protected. (Specifically, they used an older MD5-based encryption.) Therefore, we strongly urge all SBM users to make sure they are not using their SBM password anywhere else.

SBM login is now available, and will require you to reset your password.

Posted in: Science and Medicine

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AAFP CME Program Succumbs to “Integrative Medicine”

For many years I have been using Continuing Medical Education (CME) programs offered by the American Academy of Family Physicians (AAFP). The FP Essentials program consists of a monthly monograph with a post-test that can be submitted electronically for 5 hours of CME credit. Over a 9-year cycle, a complete family medicine curriculum is covered to prepare participants for the re-certification board exams. Some examples of typical subjects are skin cancer, hand and wrist injuries, valvular heart disease, and care of the newborn. I rely on these programs to learn, review, and keep up-to-date in my specialty. Imagine my dismay when I opened the latest package to find a monograph on Integrative Medicine.

First it was called various names like folk medicine, quackery, and unproven/untested treatments, then all of those (the less rational right along with the more rational) were lumped together under the umbrella term “Alternative Medicine,” then it became “Complementary and Alternative Medicine” (CAM), and now it has been re-branded as “Integrative Medicine.” The term is designed to make unscientific treatments seem more acceptable to science-based doctors. “Integrative Medicine” is a marketing term, not a meaningful scientific category. It is a euphemism for combining Complementary and Alternative Medicine (CAM) with mainstream medical practice, unproven with proven, magic with science.  It has been critiqued many times on this blog. We have stressed that there is only one medicine, and that when a treatment is proven to work by good evidence, it is just “medicine.” When the evidence for a CAM treatment is not good, it essentially amounts to experimental treatments and/or comfort measures. Worse, sometimes CAM even persists in using treatments that have been proven not to work or that are totally implausible, like therapeutic touch or homeopathy. (more…)

Posted in: Acupuncture, Cancer, Energy Medicine, Medical Academia

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The final nail in the coffin for the antivaccine rallying cry “Too many too soon”?

There are some weeks when I know what my topic will be—what it must be. These are weeks in which the universe gives the very appearance of handing to me my topic for the week on the proverbial silver platter with a giant hand descending from the clouds, pointing at it, and saying, “Blog about this, you idiot!” Usually, it’s because a study is released or something happens or a quack writes something that cries out for rebuttal. Whatever it is, it’s big and it’s unavoidable (for me, at least).

This is one of those weeks.

The reason it’s one of those weeks is because just last Friday, as I was driving to work, I heard a news story on NPR about a study that had just been released in the Journal of Pediatrics. The story, as it was reported, noted that the study being discussed looked specifically at a certain antivaccine trope and found for yet the umpteenth time that vaccines are not correlated with an increased risk of autism. Normally the news that a study had once again failed to find a link between vaccines and autism would be as surprising as a study finding that the sun rises in the east and sets in the west, or finding that water boils at 100° C at sea level. At this point, the evidence is so utterly overwhelming that there is not a whiff of a hint of a whisper of a correlation between vaccines and autism that it has become irritating that antivaccine activists keep pressuring scientists to do the same study over and over again, coming up with the same results over and over again, and then seeing antivaccinationists fail to believe those same results over and over again. Apparently, antivaccine activists think that if the same sorts of studies are done enough times, there will be a positive result implicating vaccines as a risk factor for or contributing cause to autism. By sheer random chance alone, this might happen someday, given the definition of statistical significance, but so far there has not been a single large, well-designed epidemiological study by reputable researchers that has found a link.
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Posted in: Epidemiology, Public Health, Vaccines

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More shameless self-promotion that is, I hope, at least entertaining

Three weeks ago, I gave a talk to the National Capital Area Skeptics at the National Science Foundation in Arlington, VA. The topic was one near and dear to my heart, namely quackademic medicine.

I was informed the other day that the video had finally been posted. Unfortunately, there were some problems with the sound in a couple of places, which our intrepid NCAS video editor did his best to fix. Overall, however, the sound quality seems decent. The video even includes the Q&A session. In case you’re interested, the guy who asks the question about mercury in vaccines and autism is Paul Offit’s very own stalker Jake Crosby. I feel honored to think that Jake now apparently lumps me in the same category as Paul Offit, whom I admire greatly. Enjoy.

Posted in: Clinical Trials, Energy Medicine, Homeopathy, Medical Academia, Science and Medicine

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Behold the spin! What a new survey of placebo prescribing really tells us

One of the recurring topics here at SBM is the idea of the placebo: What it is, what it isn’t, and how it complicates our evaluation of the scientific evidence. One my earliest lessons after I started following this blog (I was a reader long before I was a writer) was that I didn’t understand placebos well enough to even describe them correctly. Importantly, there is no single “placebo effect”. They are “placebo effects”, a range of variables that can include natural variation in the condition being studied, psychological factors and subjective effects reported by patients, as well as observer bias by researchers studying a condition. All of these, when evaluated in clinical trials, produce non-specific background noise that needs to be removed from the analysis. Consequently, we compare between the active treatment and the placebo to determine if there are an incremental benefits, to which we apply statistical tests to determine the likelihood that the differences between the intervention and the placebo groups are real. Removed from the observational nature of the clinical trial, we can’t expect the observed “placebo effects” to persist, as they’re partially a consequence of the trial itself. A more detailed review of placebos is a post in and of itself, so I’ll refer you to resources that describe why placebo effects are plural, that placebo effects are subjective rather than objective and there is no persuasive evidence to suggest that placebo effects offer any health benefits. What’s most important is the understanding that placebo effects are a measurement artifact, not a therapeutic effect.

Placebo effects are regular topics within in SBM posts because an understanding of placebo effects is essential to evaluating the evidence supporting (so-called) complementary and alternative medicine, or CAM. As better quality research increasingly confirms that the effects from CAM are largely, if not completely, attributable to placebo effects, we’ve seen the promoters of CAM shifting tactics. No longer able to honestly claim that CAM has therapeutic effects, “treatments” such as acupuncture or homeopathy are increasingly promoted as strategies that”harness the power of placebo” without all the pesky costs or side effects of real medical interventions. But this is simply special pleading from purveyors and promoters. Unable to wish away the well-conducted trials that show them to be indistinguishable from placebos, they instead are spinning placebo effects as meaningful and worthy of pursuit – ideally with your favourite CAM therapy. Again, I’ll refer you to posts by David Gorski and Steven Novella who offer a more detailed description of how negative results can be spun to look positive. Because CAM’s effects are indistinguishable from placebo, we should not invest time and resources into pursuing them – we should instead focus on finding treatments that are demonstrably superior to placebo.

But what if physicians are already using placebos widely in practice? Setting aside the ethical issues for now, widespread placebo usage might suggest that physicians believe that placebos are effective treatments. And that’s the impression you may have had if you skimmed the medical headlines last week:

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Posted in: Clinical Trials, Epidemiology, Science and Medicine

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Evidence Thresholds

Defenders of science-based medicine are often confronted with the question (challenged, really): what would it take to convince you that “my sacred cow treatment” works? The challenge contains a thinly veiled accusation — no amount of evidence would convince you because you are a nasty skeptic.

There is a threshold of evidence that would convince me of just about anything, however. In fact, I have been convinced that many scientific claims are likely to be true — sufficiently convinced to act upon the conclusion that they are true. In medicine this means that I am convinced enough to use them as a basis for medical practice.

There are many functional differences between practitioners of SBM and those who accept claims and practices that we would consider to be pseudoscience or fraud, but I was recently struck by one particular such difference — where we set the threshold of evidence before accepting a claim.

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Posted in: Homeopathy, Science and Medicine

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What Does ND Mean?

Chronic Lyme disease almost certainly does not exist, but a growing number of doctors are diagnosing and treating it with long-term antibiotics and other remedies. They are known as LLMDs (“Lyme Literate” medical doctors). This subject has been covered repeatedly on Science-Based Medicine, here, here, here, here, and elsewhere.

I have a correspondent who joined a Yahoo group for Lyme disease (Northern VA Lyme). She shared with me a message to that group that listed the LLMDs in their area. On that list was Patricia Slusher, ND, CN (naturopath, certified nutritionist). Other messages confirmed that Slusher is treating patients for “chronic Lyme disease.” One message specifically described the treatments prescribed by Patricia Slusher:

For the first 3 weeks my Lyme protocol consist of taking 3 supplements from Percision [sic] Herbs, LLC; LYX, Spirex and Puricell and spending 30 minutes 2X a week getting a Quad Zapper treatment. After the 3 weeks, my test for Lyme was negative. But bartonella was still positive. She has changed my supplements to taking Drainage-tone and Amoeba-chord by energetix and 15 minutes 1x a week of the Quad Zapper to fight the bartonella. I have doing [sic] this protocol for approx. 3 weeks. Along with this protocol I am on several other homeopathic supplements to address some of my symptoms, swollen lymph nodes, nerve pain (feels like someone is stabbing me with an ice pick or bugs crawling on me), numbness, inflammation, low vitamin D, etc. Also, supplements to raise the functioning level of my adrenals and kidneys. [Note: the Quad Zapper is a version of one of the infamous (more…)

Posted in: Energy Medicine, Naturopathy

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Once more into the screening breach: The New York Times did not kill your patient

One of the more depressing things about getting much more interested in the debate over how we should screen for common cancers, particularly breast and prostate cancer, is my increasing realization of just how little physicians themselves understand about the complexities involved in weighing the value of such tests. It’s become increasingly apparent to me that most physicians believe that early detection is always good and that it always saves lives, having little or no conception of lead time or length bias. Sadly, just last week, I saw another example of just this phenomenon in the form of an article written by Dr. George Lombardi entitled My Patient, Killed By The New York Times. The depth of Dr. Lombardi’s misunderstanding of screening tests permeates the entire article, which begins with his recounting a story about a patient of his, whose death he blames on The New York Times. After describing the funeral of this 73-year-old man who died of prostate cancer, Dr. Lombardi then makes an accusation:

This one filled me with a special discomfort as I knew a secret: He didn’t have to die. I knew it and he had known it. Had he told?

About 5 years ago he had just retired and had a lot more time on his hands. He was a careful man, lived alone, considered himself well informed. He got into the habit of clipping articles on medical issues and either mailing them to me or bringing them in. They came from a variety of sources and were on a variety of topics. He wasn’t trying to show me up. He was genuinely curious. I kidded him that maybe he’d like to go to medical school in his retirement. ‘No’ he laughed, ‘I just like to be in the know.’

When he came in for his physical in 2008 he told me he’d agree to the DRE but not the PSA (his medical sophistication extended to the use of acronyms: DRE stands for digital rectal exam where I feel the prostate with my gloved finger for any abnormality and PSA for prostatic [sic] specific antigen which is a blood protein unique to the prostate and often elevated in prostate cancer). He had read that the use of PSA as a screening test was controversial. This was the year that the United States Preventive Services Task Force, a government panel that issues screening guidelines, recommended against routine PSA screens for older men. It was often a false positive (the PSA was elevated but there was no cancer), led to unnecessary biopsies, and besides most prostate cancers at his age were indolent and didn’t need to be treated. I countered that prostate cancer was the second leading cause of cancer deaths in men and that it was better to know than not to know. This way it would be our decision. The patient with his doctor deciding what was best. But no, he wanted to stick to his guns and since the DRE was normal no PSA blood test was sent.

After describing a conversation with the man’s daughter, who said, “My father was killed by The New York Times,” Dr. Lombardi then goes on to anecdotal evidence and a cherry-picked publication to support his view, quoting an oncologist who says he’s “seeing more men presenting with advanced prostate cancer” and then referring to a single paper in the current Annals of Internal Medicine about PSA screening. Before I look at the article and a recently published paper on screening mammography that made the news, I can’t help but point out that I (mostly) agree with Dr. Lombardi when he says:

Public health doctors, policy experts and journalists tend to look at the population as a whole. It is a better story if it is one story. It makes a better headline. Their statistics are people I sit across from everyday trying to figure out what the future holds. We each have our job to do.

The problem is, of course, that Dr. Lombardi takes that observation and draws the wrong conclusion, namely that his patient died because of lack of screening. He attacks a straw man, sidestepping the true argument, namely that evidence shows that PSA screening probably causes more harm than good for men at average risk of prostate cancer. Unfortunately, Dr. Lombardi obviously does not understand some very basic concepts behind cancer screening, nor does he apparently recognize that doctors who deal with the population-level data that we have regarding screening tests and try to apply them to individual patients are actually looking in a very systematic way about what the benefits of screening are to the individual patient. More on that later. In the meantime, although I wouldn’t go quite as far as Dr. John Schumann did in criticizing Dr. Lombardi, I do view his lament as a jumping off point to look at some recent data on screening for the two most common cancers, breast and prostate.

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Posted in: Cancer, Diagnostic tests & procedures, Politics and Regulation, Public Health, Science and the Media

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