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Amber Waves of Woo

As a pediatrician I have an opportunity to observe a wide variety of unusual and sometimes alarming parental efforts meant to help children through illness or keep them well. I have recently noticed one particular intervention that seems to be becoming more prevalent, at least in my practice. I’ve begun to see more and more infants sporting Baltic amber teething necklaces. These consist of multiple small beads of amber on a string that is worn around a baby’s neck, and are supposed to relieve the discomfort of teething. Before I had any idea what these necklaces were for or how they were supposed to work, my first reaction was to inform these parents of the dangers of necklaces or anything placed around an infant’s or young child’s neck. Strangulation is a known cause of accidental injury and death in children, and pediatricians are trained to discuss this as part of the routine anticipatory guidance we give to parents. In addition, we strongly advise against giving infants or young children any small items that could be accidentally aspirated, such as the beads found in a necklace of this sort. But I was equally surprised to learn that these necklaces are not intended for babies to chew or gum. Instead, they are supposed to ease a baby’s teething discomfort simply by lying against the skin.

I will not discuss teething here, or the many myths that surround it; that was well covered in a previous post. I will reiterate that there is little-to-no evidence that the majority of concerns parents have about teething are actually due to teething, including fever and diarrhea. The irritability associated with teething also tends to wax and wane for only several days before and after the emergence of a tooth. But let’s assume for the moment that these necklaces actually work to ease the discomfort of teething, and whatever other problems parents tend to associate with the long period of time during which infants and young children develop their teeth. Assuming these necklaces work as recounted in the glowing testimonials on countless websites and parent blogs, how do they produce their dramatic results?
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Posted in: Critical Thinking, Energy Medicine, Health Fraud, Herbs & Supplements, Pharmaceuticals

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New evidence, same conclusion: Tamiflu only modestly useful for influenza

Tamiflu

Does Tamiflu have any meaningful effects on the prevention or treatment of influenza? Considering the drug’s been on the market for almost 15 years, and is widely used, you should expect this question has been answered after 15 flu seasons. Answering this question from a science-based perspective requires three steps: Consider prior probability, be systematic in the approach, and get all the data. It’s the third step that’s been (until now) impossible with Tamiflu: Some data was unpublished. In general, there’s good evidence to show that negative studies are less likely to be published than positive studies. Unless unpublished studies are included, systematic reviews are more likely to miss negative data, which means there’s the risk of bias in favor of an intervention.

The absence of a full data set on Tamiflu (oseltamivir) and the other neuraminidase inhibitor Relenza (zanamivir) became a rallying point for BMJ and the AllTrials campaign, which seeks to enhance the transparency and accessibility of clinical trials data by challenging trial investigators to make all evidence freely available. (Reforming and enhancing access to trial data was one of the most essential changes recommended by Ben Goldacre in his book, Bad Pharma.) In 2009, Tamiflu’s manufacturer, Hoffman-La Roche committed to making the Tamiflu data set available to investigators. Now after four years of back-and-forth between BMJ, investigators, and Roche, the full clinical trials data set has been made freely available. An updated systematic review was published today in BMJ (formerly The British Medical Journal), entitled “Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments.” This will be a short post covering the highlights. As the entire study and accompanying data are freely available, I’ll await continued discussion in the comments. (more…)

Posted in: Clinical Trials, Pharmaceuticals, Public Health

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Tylenol May Not Be As Safe and Effective As We Thought

I’ve always thought of Tylenol (AKA acetaminophen in the US and paracetamol in the UK) as one of the safest drugs around, with essentially no side effects when used as directed. But it has been in the limelight lately. Several SBM articles have addressed it here, here, and here. We know there is a risk of liver damage and death with acetaminophen overdose or accidental ingestion (458 deaths a year in the US). Since it is included in many other products (painkillers, cold and cough remedies, etc.) consumers may not realize how much they’re taking. The FDA has addressed this problem, and reformulations and lower daily dose recommendations are being implemented; but there is still no guarantee that consumers will realize that their “non-aspirin pain reliever,” pain pills like Vicodin, and many cold, sinus, and cough remedies have the same ingredient as Tylenol.

We have gradually become aware of other dangers not associated with overdose. Acetaminophen has been associated with kidney damage (especially with long-term use), gastrointestinal symptoms, and cardiovascular events. Combining the recommended dose with alcohol ingestion can lead to liver failure. It can also interact with some other drugs, for instance isoniazid. Allergic reactions can occur, and 7% of patients who are allergic to aspirin or NSAIDs also react to acetaminophen. It is excreted in breast milk, but in very low concentrations. The manufacturer’s professional product information includes detailed listings of reported reactions, drug/drug interactions, and safety studies in patients with various diseases. There is no need to adjust dosage for the elderly or for those with liver or kidney disease. For most patients, including those with chronic disease, acetaminophen is the pain-reliever of choice due to its low risk. But recently a draft recommendation from the UK’s NICE (National Institute of Health and Care Excellence) has warned us against using it, at least to treat the pain of osteoarthritis. (more…)

Posted in: Pharmaceuticals

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The Pollyanna Phenomenon and Non-Inferiority: How Our Experience (and Research) Can Lead to Poor Treatment Choices

Pollyanna, a popular children’s book written in 1913 by Eleanor H. Porter, introduced the world to one of the most optimistic fictional characters ever created. She always saw the good in people and her approach to life frequently involved playing “The Glad Game”, where she attempted to find something to appreciate in every situation no matter how unfortunate. She was glad about receiving crutches rather than a doll one Christmas because it was great that she didn’t actually need them. She teaches this philosophy to those around her, even her cantankerous Aunt Polly, and the entire town is transformed into a veritable Mayberry, USA. Later, when she actually does require the use of crutches, her resolve is tested but she triumphantly finds a silver lining.

The Pollyanna principle, first described by Matlin and Stang in 1978 and also known as positivity bias, is a psychological tendency for people to place greater importance on, and assume better accuracy of, descriptive statements about them that are positive. This goes on behind the scenes while our conscious brain tends to dwell on what is perceived as negative stimuli. Though many folks do come across as pessimistic, we are subconsciously biased to accept praise and reject criticism. Anyone who isn’t clinically depressed is on some level more like Pollyanna than Eeyore.

This positivity bias also plays a large role in how we remember past events. As has been covered extensively in prior posts here on SBM, and on Dr. Novella’s excellent Neurologica blog, memory isn’t a replayed video or audio recording of prior events and our interpretations of them, but rather is a reconstruction that is prone to errors during processing and editing that accumulate over time. This leads to false memories that feel no less real than our recollection of what happened five minutes ago.

In this case, the Pollyanna principle results in positive information being more accurately processed and recalled than negative experiences. It also causes our memory of negative events to gradually become less negative as the years go by. I couldn’t have done that terribly during my first high school trumpet solo because I remember people telling me it was pretty good afterwards, right?

So what does this have to do with the practice of medicine? Biases that affect memory also impact how physicians and patients interact. I once assumed the overnight care of a child who had undergone a lumbar puncture performed by one of my female colleagues earlier that day. I ordered no tests and performed no procedures during my brief exposure to the family—yet over a year later when I admitted the same child for a completely different reason I was accused of being the terrible doctor who had unnecessarily subjected their baby to a spinal tap during the last hospitalization. Even after I showed them the documentation which proved that I had nothing to do with that (very appropriate) decision, and that I did not put a needle in their child’s spine, they refused to accept the evidence and had great difficulty trusting my diagnosis and recommendations.
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Posted in: Clinical Trials, Pharmaceuticals

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Twenty days in primary care practice, or “naturopathic residency”

The metastasis of alternative medicine throughout the health care system comes, in no small part, at the hands of the federal and state governments, mostly the latter and most particularly the state legislatures. Under their jurisdiction rests the decision of who can, and cannot, become a licensed health care practitioner, and what they can, and cannot, do. This is the gateway through which much of pseudo-medicine flows.

I’ve read many CAM practitioner licensing statutes (all of the chiropractic practice acts, in fact) and many legislative proposals to license or to expand the scope of practice. Typical of the boilerplate recited in support of this legislation is the education and training of these practitioners, which is touted as a means of protecting the public from charlatans and quacks out there selling snake oil to the credulous. Naturopathic licensing bills routinely require graduation from a naturopathic “medical” school accredited by the Council on Naturopathic Medical Education. (See, for example, Michigan House Bill 4152, which both David Gorski and I have discussed on SBM.) Unfortunately, what CAM provider legislation often does is simply provide legal cover for selling that very same snake oil.

Naturopaths are licensed in 17 states so far, although what they can and can’t do varies considerably. In some states, they have a scope of practice similar to that of an M.D. or D.O. primary care physician. At the most liberal end of this spectrum, N.D.s can prescribe drugs (as Michigan’s bill would allow), although this, too, varies depending on what’s listed on the state’s naturopathic formulary.

All of this has led me to conclude that the state legislatures do not have internet connections. Because, if they did, it would be pretty easy to Google around and figure out just what this naturopathic “medical” education entails and how practicing naturopaths apply their education and training in actual practice. In fact, I’ve done this myself and reported the results here on SBM. In the last day or so, I found out even more by looking around the websites of the Council on Naturopathic Medical Education, the American Association of Accredited Naturopathic Medical Schools, and its member institutions. We’ll get to the fruits of that research in a minute. (more…)

Posted in: Herbs & Supplements, Homeopathy, Legal, Naturopathy, Pharmaceuticals, Politics and Regulation

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Does treating fever spread influenza?

Influenza

One of these things is not like the other

Treating a fever with medication like Advil or Tylenol is reflex action when we come down with colds and influenza. But could treating fevers actually worsen an illness and contribute to its spread in the population? That’s the impression you may have gained from the headlines and press last week, where antipyretics (fever-reducing medications) were described as some type of “anti-vaccine”:

Fever-reducing meds encourage spread of flu: McMaster report

Taking over-the-counter flu medication to cut your fever might help you feel better, but it might not be so good for the people you come into contact with.

When it comes to fever, your mother really did know what’s best

Who would have thought that the simple giving of a fever reducing agent, to either one of our family members or ourselves before we go off to school or work, may inadvertently lead to the death of someone that we see that day?

Use of fever-reducing drugs may lead to tens of thousands more influenza cases

The bottom line is that fever suppression increases the number of annual cases by approximately five per cent, corresponding to more than 1,000 additional deaths from influenza in a typical year across North America.

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Posted in: Epidemiology, Pharmaceuticals, Science and Medicine

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You can’t beat the common cold, and that’s a fact

>> Disclaimer: nothing in this post is meant to be taken as medical advice. Always consult your own provider.

For those of us dedicated to supporting science-based medicine and fighting the ever-widening reach of sCAM, pseudoscience, and health fraud, finding a new woo-filled claim or a dangerous, evidence-lacking trend to write about is relatively easy. Many of us may not realize, however, that some of the most commonly used and recommended treatments, one of which at least is probably sitting in your medicine cabinet as you read this, is equally devoid of evidence to support its use.

Every drug store has row upon row of medicines designed to treat or prevent an acute upper respiratory tract infection, otherwise known as the common cold. Despite this, very few are able to live up to their promise. In most cases, particularly where children are concerned, the side effects of these medicines can be worse than the symptoms they are intended to treat. Because I am a pediatrician, and because the evidence for cough and cold medicines (I will refer to them here as CCMs) for children is particularly absent and because adverse events due to CCMs are most frequently seen in children, I will focus mainly on this population. (more…)

Posted in: Pharmaceuticals, Science and Medicine

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And Now for Something Completely Different

This will be a departure from my usual posts. Several announcements in the news and medical journals have caught my attention recently, and as I delved into the details, I thought I would share them with our SBM readers. Topics include AIDS cures, the continuing danger of polio, eating nuts for longevity, racial differences in vitamin D, and the use of pharmacogenetic testing to guide the dosage of anticoagulant drugs. They are all examples of science-based medicine in action.

Have patients been cured of AIDS?

I read that the HIV virus had returned in patients thought to have been cured by bone marrow transplants, and I mistakenly thought they were referring to the original claim of cure I had read about. Nope, that one still stands. (more…)

Posted in: Clinical Trials, Nutrition, Pharmaceuticals, Vaccines

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New Cholesterol Guidelines

On November 15, the American College of Cardiology and the American Heart Association released an updated guideline for the use of statins to prevent and treat atherosclerotic cardiovascular disease (ASCVD). The full report is available online. It has already generated a lot of controversy. The news media have characterized it as a “huge departure” from previous practice and have trumpeted that it will lead doctors to prescribe statins to millions more people. As usual, the truth is much more nuanced. There are some problems with the guidelines, but on the whole they represent an improved, more rational approach to prescribing statins.

Statins have always been a source of controversy: people seem to either love them or hate them, and discussions about them generate a lot of emotion. The International Network of Cholesterol Skeptics denies that cholesterol has anything to do with cardiovascular disease. An article on HuffPo calls statins “an unsafe, unnecessary product that will now be recommended to healthy people to make them sicker.” Mercola says they can actually make heart disease worse and cause premature aging, and no one should take them unless they have the genetic defect of familial hypercholesterolemia. A website collects patient self-reports of adverse effects; but like the vaccine reports on VAERS, these are only anecdotal reports of correlation, not evidence for causation.

At one time the evidence only supported using statins for secondary prevention and for men. We now have better evidence showing that they are effective for both primary and secondary prevention in patients of both sexes and all ages, and that they are more effective for those with higher risk factors. (more…)

Posted in: Pharmaceuticals

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“Low T”: The triumph of marketing over science

A man on TV is selling me a miracle cure that will keep me young forever. It’s called Androgel…for treating something called Low T, a pharmaceutical company–recognized condition affecting millions of men with low testosterone, previously known as getting older.

The Colbert Report, December 2012

 

And now for something completely different…sort of.

After writing so much about the latest developments in the ongoing saga of the cancer doctor who is not an oncologist and not a legitimate cancer researcher, plus a rumination on what’s up with President Obama’s nominee for Surgeon General and our favorite form of unscientific medicine, so-called complementary and alternative medicine (CAM), also known as “integrative medicine,” I thought it was time for a change of pace. I wasn’t sure what I was going to write about as Sunday rolled around, but fortunately, as sometimes happens, the New York Times dropped a topic right in my lap, so to speak, both figuratively and literally. It comes in the form of a long article on something that directly concerns men of a certain age, which unfortunately happens to mean men of my age and older. I’m referring to what pharmaceutical company advertising campaigns have dubbed “low T,” short for low testosterone. It’s not clear how the term “low T” originated but Dr. Abraham Morgentaler, founder of Men’s Health Boston, claims to have coined the term when his patients were embarrassed by their difficulty pronouncing the word “testosterone.” Other sources report that it was Solvay Pharmaceuticals that coined the phrase. It doesn’t really matter where the term “low T” came from. The term has stuck, even though the more “correct” medical term would be hypogonadism, as in a man’s testes not working.
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Posted in: Clinical Trials, Diagnostic tests & procedures, Pharmaceuticals, Science and the Media

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