Anti-scientific, Anti-GMO Propaganda

Summer feels like it’s finally here in Canada (well, Toronto at least). Here’s what I’ve been reading.Diet and Nutrition

Don’t take your vitamins

I’ve written about Paul Offitt before. He’s an infectious disease specialist at the Children’s Hospital of Philadelphia. If you haven’t read his book, Autism’s False Prophets, I strongly recommend it. Paul has a new book with a broader focus, entitled, “Do You Believe in Magic?: The Sense and Nonsense of Alternative Medicine.” Here’s an excerpt from today’s New York Times:

Derived from “vita,” meaning life in Latin, vitamins are necessary to convert food into energy. When people don’t get enough vitamins, they suffer diseases like scurvy and rickets. The question isn’t whether people need vitamins. They do. The questions are how much do they need, and do they get enough in foods?

Nutrition experts argue that people need only the recommended daily allowance — the amount of vitamins found in a routine diet. Vitamin manufacturers argue that a regular diet doesn’t contain enough vitamins, and that more is better. Most people assume that, at the very least, excess vitamins can’t do any harm. It turns out, however, that scientists have known for years that large quantities of supplemental vitamins can be quite harmful indeed.

There was also a much longer and more detailed excerpt in The Guardian, yesterday:

The vitamin and supplement industry has successfully created a false dichotomy. On one side are natural products: vitamins, minerals, dietary supplements, plants and herbs. Because they’re natural, they’re safe. On the other side are drugs. Because drugs are man-made, they’re supposedly more dangerous. However, many drugs, including antibiotics, are derived from nature. Furthermore, the notion that natural products aren’t dangerous is fanciful.

The possibility of harm caused by natural products sold in health food stores isn’t theoretical. Blue cohosh can cause heart failure; nutmeg can cause hallucinations; comfrey, kava, chaparral, crotalaria, senecio, jin bu huan, usnea lichen and valerian can cause hepatitis; monkshood and plantain can cause heart arrhythmias; wormwood can cause seizures; stevia leaves can decrease fertility; concentrated green tea extracts can damage the liver; milkweed seed oil and bitter orange (Citrus aurantium) can cause heart damage; thujone can cause neurological damage; and concentrated garlic can cause internal bleeding. Indeed, one of the worst dietary supplement disasters in history occurred in 1992, when about 100 people developed kidney failure from a “slimming” mixture found to contain the plant aristolochia; at least 70 patients required kidney transplants or dialysis, and many later developed bladder cancers. In 2008, more than 200 people – including a four-year-old – were poisoned by massive doses of selenium contained in Total Body Formula and Total Body Mega. The products were supposed to contain 200 micrograms of selenium per serving; instead they contained 40,800 micrograms.

Herbal remedies can also cause harm: two infants died from a tea containing pennyroyal and another from a decongestant containing capsaicin. Because the dietary supplement industry is unregulated, only 170 (0.3%) of the 51,000 new products brought to market since the 1994 Supplement Act have documented safety tests.

So much for the routine claim from advocates that “natural supplements have never hurt anyone.” Offit’s book looks excellent. I have written before that there is little evidence for the routine consumption of vitamin supplements in the absence of a clear medical need. It will be interesting to see the response from the pharmacy profession. Any predictions?

How to Really Eat Like a Hunter-Gatherer: Why the Paleo Diet Is Half-Baked. Another excellent column on this diet fad that’s probably health, but based on a faulty premise:

The Paleo diet not only misunderstands how our own species, the organisms inside our bodies and the animals and plants we eat have evolved over the last 10,000 years, it also ignores much of the evidence about our ancestors’ health during their—often brief—individual life spans (even if a minority of our Paleo ancestors made it into their 40s or beyond, many children likely died before age 15). In contrast to Grok, neither Paleo hunter–gatherers nor our more recent predecessors were sculpted Adonises immune to all disease. A recent study in The Lancet looked for signs of atherosclerosis—arteries clogged with cholesterol and fats—in more than one hundred ancient mummies from societies of farmers, foragers and hunter–gatherers around the world, including Egypt, Peru, the southwestern U.S and the Aleutian Islands. “A common assumption is that atherosclerosis is predominately lifestyle-related, and that if modern human beings could emulate preindustrial or even preagricultural lifestyles, that atherosclerosis, or least its clinical manifestations, would be avoided,” the researchers wrote. But they found evidence of probable or definite atherosclerosis in 47 of 137 mummies from each of the different geographical regions. And even if heart disease, cancer, obesity and diabetes were not as common among our predecessors, they still faced numerous threats to their health that modern sanitation and medicine have rendered negligible for people in industrialized nations, such as infestations of parasites and certain lethal bacterial and viral infections.

Science and Politics, and GMOs

Keith Kloor is one of my favourite bloggers. He’s always insightful and a great writer on science and technology. In a post this week he pointed out that so called “progressives” can be as anti-scientific as conservatives that they like to mock for their anti-science views:

It’s downright hypocritical of progressives and enviros to call out others for “anti-science” behavior–be it denial of climate change or evolution–when they are the ones leading the crusade against biotech research and GMOs.

It’s like Newt Gingrich preaching family values. If progressives want to remain a credible voice on science, they’re going to have marginalize the growing forces in their midst that have strayed into the world of biotech pseudoscience and fear-mongering.

Here’s an experiment to try. Speak to one of your progressive friends (or make a post on Facebook) about GMOs. Wait to see the response. How many comments before someone mentions Monsanto?

What is at the root of denial? A Must Read from Chris Mooney in Mother Jones Excellent review, via Denialism Blog:

Scientific reasoning and pragmatism is fundamentally unnatural and extremely difficult. Even scientists, when engaged in a particular nasty internal ideological conflict, have been known to deny the science. This is because when one’s ideology is challenged by the facts you are in essence creating an existential crisis. The facts become an assault on the person themselves, their deepest beliefs, and how they perceive and understand the world. What is done in this situation? Does the typical individual suck it up, and change, fundamentally, who they are as a person? Of course not! They invent a conspiracy theory as to why the facts have to be wrong. They cherry pick the evidence that supports them, believe any fake expert that espouses the same nonsense and will always demand more and more evidence, never being satisfied that their core beliefs might be wrong. This is where “motivated reasoning” comes from. It’s a defense of self from the onslaught of uncomfortable facts.

Vaccines

Robert F. Kennedy Jr.: Anti-Vaxxer from Phil Plait:

RFK Jr. has a long history of adhering to crackpot ideas about vaccines, mostly in the form of the now thoroughly disproven link to autism. He’s been hammering this issue for a decade now, and his claims appear to be no better and no more accurate now than they were when he first started making them.RFK Jr. has a long history of adhering to crackpot ideas about vaccines, mostly in the form of the now thoroughly disproven link to autism. He’s been hammering this issue for a decade now, and his claims appear to be no better and no more accurate now than they were when he first started making them.

Drug Use and Drug Safety

Prescribing antibiotics: It’s time to draw a hard line:

This is a call to arms to my fellow providers to protect our patients from themselves and our willingness to comply with their requests.  We live and practice in a society filled with fear of medications and their side effects.  People will not take blood pressure, cholesterol, or diabetic medication because of the side effects they have heard or read about.

However, these same patients will take antibiotics every day of the week for a sniffle or a scratchy throat that started this morning.  Are we facing an epidemic of patients actually addicted to the use of antibiotics?  Where does this laxity in taking antibiotics come from?  Why do the majority of patients believe that antibiotics are harmless, yet pills to prevent stroke are dangerous?

Drugs kept in ambulances can be unusable in weeks

More adulterated supplements for sale in Canada. Yet another consequence of a regulatory structure that seems to prioritize industry interests ahead of consumer rights to safe and effective products.

Probiotics for the prevention of antibiotic-associated diarrhea and Clostridium difficile infection among hospitalized patients: systematic review and meta-analysis. Expect a more thorough analysis in the future. Not that the results of this review are for hospitalized patients, not ambulatory patients. Their conclusion:

Our findings illuminate the benefits of probiotics in preventing both AAD [antibiotic-associated diarrhea] and CDI [Clostridium difficile infection] in the specific patient population of adult inpatients requiring antibiotics. On the basis of the current review, probiotics can be recommended for such patients in the absence of contraindications; however, the prevalence of AAD and CDI should be taken into consideration before guidelines are developed. The literature does not clearly indicate a favoured choice of probiotic, although there is stronger evidence for Lactobacillus-based formulations.

The journal Focus on Alternative and Complementary Therapies has an entire issue dedicated to CAM (complementary and alternative medicine) for pharmacists. It’s behind a paywall but the entire issue looks excellent. I hope to review some of these articles in the future:

• Commentary: the law, unproven CAM and the two-hats fallacy
• Homeopathy for insomnia and sleep-related disorders: a systematic review of randomised controlled trials
• Why homeopatohy is unethical
• The ethics of using homeopathy in clinical practice
• Is evidence-based complementary and alternative medicine a contradiction in terms? ‘Yes’
• Is evidence-based complementary and alternative medicine a contradiction in terms? ‘No’
• Efficacy of herbal supplements containing Citrus aurantium and synephrine alkaloids for the management of overweight and obesity: a systematic review
• Why pharmacists should not sell homeopathic products
• Factors affecting the pharmacokinetics of herbal preparations and their impact on the outcome of clinical trials

The Elixir Tragedy, 1937 – A nice review of the rationale for drug safety legislation. See my take, here, which I called Oh yeah? Thalidomide! Where’s your science now?

FDA Urged to Prohibit Sale of Ginkgo in Wake of Cancer Study. My take on Ginkgo is that the product is ineffective and therefore should not be consumed.

Other Reads

Drowning doesn’t look like drowning: A must-read for parents. Everyone, really.

A Drunk Driver Killed My Family

Photo from flickr user andreas musta used under a CC licence.

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Feeling thirsty?

If you grew up in the seventies, you may remember the same food fads as I do. There was the oat bran buzz that was replaced by the wheat germ movement, the family fondue set and the homemade yogurt maker. And for a while I remember my father making what I called “aquarium water” – a foul-looking jug sitting on the kitchen counter with a gelatinous white mass floating on top. Despite the assurances it was good for me, I declined the taste tests. They didn’t push it and I never volunteered to drink this “cure all”. I thought kombucha had gone the way of gelatin-based salads and entrees, until a friend told me she was drinking it. Not only is it still a home-brew darling, kombucha isn’t just for hippies: There’s probably some for sale at your local organic grocery. Yet after a bit of digging, kombucha culture still seems mired in the 1970′s. It’s still touted as a panacea, and it’s still one of the more questionable folk remedies out there.

I understand the intrinsic appeal of the folk remedy. In an era where we can buy everything we possibly need, there’s something meaningful and satisfying about making your own food from scratch. I prefer bread, particularly sourdough – but I’m not making any health claims. Like food recipes, some home remedies are handed down from generation to generation, or passed on by word-of mouth. The attractiveness is both an appeal to antiquity combined with pattern-seeking and anecdotes. We remember the “hits” of those home remedies but not the misses. And we never test causality. Is it possible that kombucha could have medicinal effects? Sure. Beer and wine didn’t come out of a medicinal chemistry laboratory either – and look how helpful those fermented products are. As a fan of beer, cheese, sauerkraut, and yogurt, I’m strongly pro-fermentation. So while we can’t make Tylenol in our bathtub, or grow our own antibiotics, how about an odd-flavoured tea-based beverage filled with the magical healing properties of yeast and bacteria? I’m told it’s all about the microbiome, so perhaps they were on to something in the 1970s. Authentic and artisanal is where it’s at today, and what could be more artisanal than home fermentation of a remedy?

As with most folk remedies there are multiple claims for kombucha’s ancestry, from the Ukraine to Asia, from “millennia ago” to a few hundred years ago. However or whenever it occurred, the recipe is similar. Kombucha is sweetened black tea fermented by a mixture of yeasts and bacteria that form what looks like a “mat” on the surface. Sometimes called a symbiotic colony of bacteria and yeast (SCOBY), the “mushroom” or simply the “mother”, this “zoogleal mat” ferments the sugar, producing alcohol, vinegar, and other by-products. To get started, you need to obtain a starter mat – you can order them online, or ask someone that already grows their own. The result of fermenting on your counter is exactly what I remember growing in our kitchen, though it actually looks more brackish than I remember. After fermentation it’s lightly carbonated. Taste reports of kombucha vary from “refreshing apple cider” to “vomit”.

Like other folk remedies, kombucha’s efficacy is apparently legion. HIV, aging, hair growth, gout, diabetes, hemorrhoids, memory loss, PMS, cancer, hypertension, and the perennial “boosting” the immune system are no match for the healing and restorative power of kombucha.

What is that growing on and in my drink?

Several researchers have examined the bacteria and yeast in the kombucha mat. Content can vary considerably, based on the geography, climate, and local bacteria and yeasts. Bacteria include Bacterium xylinum, Bacterium gluconium, Acetobacter hetogenum, Pichia fermentons. Sometime antibiotic-producing bacteria like Penicillium species can be detected. And then there’s the toxic bacteria that has been detected, such as Bacillus anthracis – anthrax. Yeasts include Schizosaccharomyces pombe, Torulaspora delbrueckii and Zygosaccharomyces bailii. Contamination with Aspergillus fungus has also been reported, as well as Candida. Yes, that fungus that’s poisoning us all (according to alternative medicine proponents). Various Candida species including C. albicans, C. kefyr, and C. krusei are also found in kombucha.

The final ingredients vary with the bacteria and yeast in the mat, as well as the extent to which fermentation has taken place. Analyses have identified small amounts of alcohol (usually under 0.5%), substantial acetic acid (vinegar), ethyl acetate, glucoronic acid, and lactic acid. There’s some residual sugar, depending on how long it’s been fermenting. Caffeine is still present and may be responsible for some of the energy claims. It’s claimed to contain B vitamins, though I could locate no reliable source to confirms this.

The kombucha “mother”

The evidence

Despite the hundreds of thousands of posts on kombucha praising its medicinal and health effects, I was unable to identify a single clinical trial for any specific use. There’s a systematic review by Edzard Ernst dating to 2003 that also failed to find any clinical trials or even case series that suggest kombucha has medically beneficial uses. So there is no evidence to demonstrate or even hint at efficacy. Based on what’s known about the active ingredients, there’s no reason to expect it would offer any medicinal effects other than the consequence of low levels of alcohol or caffeine.

The toxicity

Given this is usually a home-brew concoction, there is the significant risk of contamination. In contrast to the lack of benefit, there is good documentation of the potential for harms associated with kombucha:

• an alcoholic developed jaundice after two weeks, which resolved after discontinuation
• dizziness, nausea and vomiting that resolved with discontinuation and restarted with rechallenge
• toxic hepatitis that resolved with discontinuation
• metabolic acidosis and disseminated intravascular coagulopathy, resulting in subsequent cardiac arrest and death
• metabolic acidosis, cardiac arrest (with recovery)
• anthrax infections of the skin through topical application of kombucha
• lactic acidosis and acute renal failure
• lead poisoning secondary to making it in a ceramic pot

Given the potential for kombucha to grow potentially dangerous pathogens, it’s particularly important for those with compromised immune systems to avoid the product. Given the risks, pregnant or lactating women should avoid kombucha as well.

Kombucha sells out

Kombucha isn’t limited to the home brewer anymore, there are several commercial suppliers such as Synergy (touted by Dr. Oz, of course) and the requisite story of the breast cancer survivor who credits kombucha for her health (but not the chemo and radiation she also accepted). The claims come fast and furious: the fermented liquid heals all and cures all – digestion, immune system “boosting”, amino acids that “detoxify”. You can now find it combined with different juices and flavors, for those that don’t like the taste of the original. The recipes are the same, and the final products are not pasteurized, a situation that caused products to be pulled in the United States until producers found ways to stop the alcohol from exceeding 0.5%.

The bottom line

The best that can be said about kombucha is that it probably won’t kill you. There are no documented health benefits, so unless you really like the taste, there’s no clear reason to consume it. As I have written before, health decisions should be based on an evaluation of the risks and benefits. In the case of kombucha, the benefits, other than the subjective, are unsubstantiated. The risks are real, but also rare. So if that bet still looks attractive, kombucha may be for you. To each his own fermentation. As for me, I’ll stick with my own favourite fermentations: IPA and wheat beer, and pass on the moonshine panacea.

Photo from flickr user parkerthompson and flickr user Jasonunbound used under a CC licence.

An example of #badpharmacy

The photo above is from a pharmacy in Toronto. Acid base nonsense? Check? Cancer quackery? Check. Endorsed by a pharmacist? Check. Send me your own pictures of ludicrous pseudoscience and quackery for sale in a pharmacy, and I may feature it in a future post.

Here’s today’s updates to engage, inspire and possibly infuriate you…

This is appalling: Homeopathy: Pharmacists dispense with professional guidance:

There are people who swear by homeopathic remedies, and everyone’s entitled to their opinion. However, if you ask your pharmacist whether a homeopathic remedy works you’d expect their response to be based on scientific evidence. This is the Royal Pharmaceutical Society’s (RPS) official advice: ‘The pharmacist should advise on the lack of evidence on the efficacy of homeopathic products… and provide advice relevant to the patient’s condition.’ However, in our snapshot investigation, 13 out of the 20 pharmacies our trained mystery shoppers visited failed to follow this guidance.

On a much more positive note, here’s some positive pharmacist action, from Professor Kelly Grindrod: How the threat of antibiotic apocalypse helped a pharmacist find her voice:

I also learned that, all those years ago, when the physician criticized me for questioning an antibiotic prescription, I should have been angry. Not humiliated. The prescription may have been appropriate but her criticism of me was not. As a student pharmacist and antibiotic steward, it was my responsibility to question every prescription. I should have walked away determined to improve my approach to physicians, not determined to look the other way. I have worked with enough caring and collegial physicians to recognize that now.

Pharmacists have the right and, yes, the invidious responsibility to question unnecessary antibiotic prescriptions. It is our job and our professional obligation. When I was still in pharmacy school, research by David Latif^21,22 found that pharmacists who have worked in community practice for many years have lower moral reasoning than students or pharmacists new to practice. We fill prescriptions with no indication and sell medications with no proven benefit and the moral conflict shapes us as practitioners. My early experiences showed me the constant ethical struggles I would face and I looked for a way out.

Evening primrose oil is ineffective for eczema: a fascinating tale of mischief:

The very wide-spread notion that EPO is effective for eczema and a range of other conditions was originally promoted by the researcher turned entrepreneur, D F Horrobin, who claimed that several human diseases, including eczema, were due to a lack of fatty acid precursors and could thus be effectively treated with EPO. In the 1980s, Horrobin began to sell EPO supplements without having conclusively demonstrated their safety and efficacy; this led to confiscations and felony indictments in the US. As chief executive of Scotia Pharmaceuticals, Horrobin obtained licences for several EPO-preparations which later were withdrawn for lack of efficacy. Charges of mismanagement and fraud led to Horrobin being ousted as CEO by the board of the company. Later, Horrobin published a positive meta-analysis of EPO for eczema where he excluded the negative results of the largest published trial, but included results of 7 of his own unpublished studies. When scientists asked to examine the data, Horrobin’s legal team convinced the journal to refuse the request.

It’s time to stop giving acupuncture a pass. Acupuncture is a theatrical placebo: the end of a myth:

Although it is commonly claimed that acupuncture has been around for thousands of years, it hasn’t always been popular even in China.  For almost 1000 years it was in decline and in 1822 Emperor Dao Guang issued an imperial edict stating that acupuncture and moxibustion should be banned forever from the Imperial Medical Academy. Acupuncture continued as a minor fringe activity in the 1950s.  After the Chinese Civil War, the Chinese Communist Party ridiculed traditional Chinese medicine, including acupuncture, as superstitious.  Chairman Mao Zedong later revived traditional Chinese Medicine as part of the Great Proletarian Cultural Revolution of 1966 (Atwood, 2009).  The revival was a convenient response to the dearth of medically-trained people in post-war China, and a useful way to increase Chinese nationalism.  It is said that Chairman Mao himself preferred Western medicine. His personal physician quotes him as saying “Even though I believe we should promote Chinese medicine, I personally do not believe in it. I don’t take Chinese medicine”

This is absolutely fascinating: The German Granddaddy of Crystal Meth, with links back to Nazi Germany. And this idea of drug-induced super soldiers continues today: There’s a military arms race to build soldiers who fight without fatigue.

This is a good read on the pharmaceutical industry, debunking a widely-perpetuated myth: Another Look At Marketing Vs. R&D In Pharma:

So let me take a stronger line: Big Pharma does not spend more on marketing than it does on R&D. This is a canard; it’s not supported by the data. And let me reiterate a point that’s been made here several times: no matter what the amount spent on marketing, it’s supposed to bring in more money than is spent. That’s the whole point of marketing. Even if the marketing budget was the same as the R&D, even if it were more, it still wouldn’t get rid of that point: the money that’s being spent in the labs is money that came in because of marketing. Companies aren’t just hosing away billions of dollars on marketing because they enjoy it; they’re doing it to bring in a profit (you know, that more-money-than-you-spend thing), and if some marketing strategy doesn’t look like it’s performing, it gets ditched.

Food, Diet, Science, and GMOs:

• Why GMO Myths Are So Appealing and Powerful
• Time to call out the anti-GMO conspiracy theory
• Organic industry’s credibility eroded by misinformation about GE foods
• “”Eat what you want. Just leave the damn cavemen out of it.” This is awesome: Archaeologists Officially Declare Collective Sigh Over “Paleo Diet”:

When asked what she would tell people who wished to pursue a true paleolithic diet, Dr. Hoyes laughed harshly before replying. ”You really want to be paleo? Then don’t buy anything from a store. Gather and kill what you need to eat. Wild grasses and tubers, acorns, gophers, crickets- They all provide a lot of nutrition. You’ll spend a lot of energy gathering the stuff, of course, and you’re going to be hungry, but that’ll help you maintain that lean physique you’re after. And hunting down the neighbor’s cats for dinner because you’ve already eaten your way through the local squirrel population will probably give you all the exercise you’ll ever need.”

Why Rational People Buy Into Conspiracy Theories

Dr. Oz’s not-so-sweet artificial sweetener recommendations

So much for “Never Harmed Anyone”: Supplements and herbal meds result in calls to poison control centers

I’ve had questions about this product, and this helps with the risk assessment: E-cigarettes – the unanswered questions.

Causes of death in the 20th Century, Visualized.

Dr. Paul Offit argues it’s time to end religious exemptions from vaccines. And from Respectful Insolence, The legacy of Andrew Wakefield continues.

Blood Purity: How a Bizarre Obsession Advanced Science. This belief continues to manifest today in quack “blood type diets” you see promoted.

Coconut Oil: Health or Hype? You get one guess. And another take, from Harriet Hall.

Australian Government Cracks Down on Bogus Claims for “Black Salve”

Anti-scientific beliefs are just as prevalent on the left as they are on the right: Progressive Mythology.

Other must-reads

My Wife Looks Nervous: A Drunk Driver Killed My Family

Fascinating and infuriating: Senseless: Bicycle helmets do an outstanding job of keeping our skulls intact in a major crash. But they do almost nothing to prevent concussions and other significant brain injuries.

Cocaine Incorporated. Unbelievable story of the Mexican cocaine trade.

These 31 charts will destroy your faith in humanity. Actually, no, not really.

Continuing Education!

Stanford School of Medicine is offering a free “Statistics in Medicine” course, starting June 11. I’m registered.

Filed under: Weekend Reading Tagged: andrew wakefield, antibiotic resistance, black salve, coconut oil, conspiracy theories, crystal meth, dr. oz, evening primrose oil, GMOs, homeopathy, pharmacy practice, vaccines ]]> http://sciencebasedpharmacy.wordpress.com/2013/06/02/weekend-reading-20/feed/ 0 scottg416 An example of #badpharmacy http://sciencebasedpharmacy.wordpress.com/2013/05/26/why-the-fight-against-antivaccinationists-is-important/ http://sciencebasedpharmacy.wordpress.com/2013/05/26/why-the-fight-against-antivaccinationists-is-important/#comments Sun, 26 May 2013 04:03:55 +0000 Scott http://sciencebasedpharmacy.wordpress.com/?p=4949 ]]>

The risks we face in our lives have been utterly transformed by vaccines. With the exception of clean water, no other health intervention has been as effective: More than 20 million lives in the past 25 years have been saved. Our parents and grandparents faced the risk of illness and death from diseases like smallpox, diptheria, and polio as a fact of life. Mass vaccination completely eradicated smallpox, which had been killing one in seven children. Polio is next.  Public health campaigns have also eliminated diptheria, and reduced the incidence of pertussis, tetanus, measles, rubella and mumps dramatically. More than 100 million infants are now immunized against the most common preventable childhood illnesses each year, saving more than 2.5 million young lives each year.

Yet as long as there have been vaccines, there has been those that oppose them.  I’ve spent quite a bit of time outlining the tactics and tropes of the antivaccine movement as well as considering ways in which health professionals and science advocates can improve the way they respond to antivaccinationism. And this battle continues, after over 100 years of immunization, and over two dozen diseases becoming vaccine-preventable.

Debating antivaccinationists can be dispiriting, especially if you’re a health professional. Getting personal insults in your email regularly isn’t encouraging. Your peers may not share your understanding of the issue, and your passion for it. Personally, I see  vaccine advocacy as part of public health advocacy, and part of my responsibility as a health professional, a science advocate and a parent. I’ve spent a lot of time along with my fellow bloggers at Skeptic North and Science-Based Medicine discussing the tactics of the antivaccine movement, and helping to educate and motivate. There is evidence that antivaccinationists can influence vaccination decisions.  There are four main tactics that they use:

• Skewering the science of vaccine safety and efficacy, while trying to create legitimacy for unfounded or discredited theories of harm.
• Shifting the hypotheses and the villain, from MMR, to thimerosal, to other “toxins”, and more recently, “too many, too soon”.
• Censoring criticism, whether it’s at Age of Autism, Mothering.com, or other antivaccine sites that delete comments or restrict access to their events.
• Attacking the opposition – whoever is an advocate.

How do antivaccinationists attack? Viciously. Imagine you’re the parents of a child that died of a vaccine-preventable disease. And you’ve used this tragedy to publicly advocate for improved vaccination programs, which could have prevented the death of your child. What do you think the response would be? If you’re Toni and David McCaffery, parents of of Dana McCaffrey, this isn’t a thought exercise – it’s exactly what happened. Dana died at four weeks old of pertussis (whooping cough). The reaction from antivaccinationists? Heinous:

 The couple has been accused of being on the payroll of drug companies; they have had their daughter’s death questioned and mocked; they have even been told to “harden the f . . . up” by an opponent of vaccination.

“The venom directed at us has just been torture and it’s been frightening, abhorrent and insensitive in the extreme,” says Toni, who has not had the strength to talk about this until now.

The invasion of the McCafferys’ grief started the day before they buried their baby girl. Meryl Dorey, who heads up the Bangalow-based Australian Vaccination Network, rang the head of the North Coast Area Health Service, Paul Corben, to demand Dana McCaffery’s autopsy reports. She wanted proof that Dana actually died of whooping cough. Dorey has no medical training, but she wrote this on a blog defending her actions.

And this was just the beginning of the despicable action from the Orwellian-named Australian Vaccination Network (AVN), and its head, Meryl Dorey.

One man, a regular on AVN forums, emailed the family via Dana’s website. The email reads: “It must be tragic to lose a daughter and I wish you all sympathy and trust that God delivers unto you. We find it amazing that some people firmly believe that God was not perfect.

“Apparently, according to these people, God forgot to add the heavy toxic metals, pig cells, chicken cells etc that are found in vaccines, sorry, but I believe Dana passed away because of different reasons than you claim. All the same, please accept my sympathy for your tragic loss.”

Unbelievable, isn’t it? It seems the AVN has had a bit of a free ride in Australian media in a misguided attempt to introduce “balance” into discussions on vaccine safety and efficacy. Given the data overwhelmingly support vaccine, the result was “false balance” which allowed the AVN to create fear, uncertainty and doubt based on implausible, refuted or even demonstrably false information. Through the tireless work of Rachael Dunlop and other science advocates within and outside Australia, the tide has turned on the AVN. In November 2012 it was ordered by the Department of Fair Trading to change its name.

Why are the McCafferys’ telling this story now? Because they want to share honest information about the need for vaccines. Tori, Dana’s mother writes:

You may see an article in the Sunday Telegraph dated 26 March 2013 regarding the vilification we have been subjected to since Dana died.

Why have we released the details now?

1. After seeing all the recent coverage on vaccination and the number of parents that have fears, we felt it is important to remind people to be very careful of the sources of your information. There is so much vitriol and lunacy out there. Please understand, these diseases are not benign and are not beneficial, they are dangerous for our most vulnerable – who depend on all of us to protect them.

2. We feel safer since the NSW Parliament passed amendments to the Health Care Complaints Act, providing the HCCC with greater powers to investigate health services that spread dangerous lies and misinformation that can risk the health of the community.

3. Despite our repeated requests, the AVN has not retracted the litany of lies about our daughter and our family on their website and associated sites around the world. This is not only hurtful and disrespects our daughter, it could mislead a parent and place a child at risk of catching a vaccine-preventable disease and worse, not seek appropriate medical attention. That was the purpose of our HCCC complaint.

4. Our greatest heartbreak is that we were never warned about Whooping Cough or told that adults need boosters. We promised Dana we’d fix it, and there’s still such a long way to go:

We all need to work together:

• Children and adults need regular boosters – on-time – to maintain immunity

• We all need to be on alert for symptoms

• Doctors need to be vigilant and test people with a persistent cough – especially tiny babies

• Governments need to proactively educate the community about infectious diseases and the importance of vaccination; dispel the myths and address fears with fact.

We love and miss you everyday Dana
Love Mummy and Daddy

We all owe a great debt of gratitude to the McCaffrey family for turning their tragedy into positive advocacy that saves lives. After all, if you could prevent the following, wouldn’t you do everything in your power to do so? (Warning: this video of an infant with pertussis may be distressing to watch):

If you’d like learn more about the AVN please follow Stop the Australian (Anti)vaccination Network on Facebook.

The intravenous vitamin industry is a sideshow to science-based health care. Yes, there is an established medical role for injectable vitamins, though it’s no energy-boosting cure-all – they’re used to replace what we should obtain in our diet. As a hospital-based pharmacist I used to prepare sterile bags of total parenteral nutrition (TPN), a mixture of vitamins, carbohydrate, protein and fat that completely replaced the requirement to eat. TPN is effective, but not without risks, and far less preferable than getting your nutrients the old fashioned way – by eating them. There’s also the routine use of injectable vitamins like B12, or iron, all of which can be science-based when used to address true deficiencies, or to manage specific drug toxicities. IV vitamins (particularly thiamine) are also used in the emergency room, given to alcohol-dependent patients in order to prevent Wernicke’s encephalopathy. And there is the therapeutic use of high-dose minerals like intravenous magnesium for acute asthma attacks. But there is no medical justification to infuse vitamins into a vein when you can more appropriately obtain those nutrients in your diet.

So if they’re not necessary, where does the demand come from? A review in the Globe and Mail illustrates the hype and the promise:

Alison Dantas, chief executive officer of the Ontario Association of Naturopathic Doctors, says people’s fast-paced, frenetic lives are what is prompting more interest in naturopathic medicine and IVMT [intravenous micronutrient therapy]. While underscoring the difference between a recreational boost like caffeine and the injections, which must be given by trained professionals, she takes no issue with their trendy turn. “It raises awareness about complement therapies and medicines that assist people in staying healthy,” she says.

Of the 867 practising naturopaths in her province, Dantas says, 156 are intravenous-certified. She expects that number to increase. “We see a growing need because of the lifestyle of the population; it’s very effective in mitigating the risks of chronic disease but also managing chronic disease,” she says of Myers’ cocktail.

A 2011 survey by Caulfield and Rachul observed that that IV therapies are among the most popular services advertised by naturopaths. If it’s not “Myers’ cocktail”, (the intravenous version of a multivitamin pill), it’s high-dose vitamin C, which is explicitly marketed to cancer patients (One naturopath even recommends a video “Vitamin C better for cancer than chemo“.) Nothing subtle about it. Like Myers’ cocktail, vitamin C infusions are also touted as a panacea for the prevention or treatment of pretty much everything. As noted above, naturopathy organizations explicitly endorse the practice, and have even created a certification for the service. Given naturopaths argue that naturopathy is scientific and that the services they offer are science-based, I took a closer look at the scientific evidence supporting these services.

The Premise
Blame Linus Pauling. Actually, to be fair, the idea of injectable vitamins precedes Pauling. But Pauling, with two Nobel Prizes, brought attention and interest to vitamin C far beyond what any evidence suggested. He seized on the observation that many species can produce their own vitamin C, while humans, apes and some other species lack this ability. Pauling surmised that some disease may be due to vitamin C deficiency, which could be addressed with massive supplements. Linus moved from vitamin C for colds and on to vitamin C for cancer, teaming up with surgeon Ewan Cameron to conduct a clinical “trial” which claimed efficacy, but was so poorly designed no conclusions could be drawn. He continued to tout the potential of vitamin C, wrote a few books on the subject, and founded the Linus Pauling Institute of Medicine, creating the foundation for the entire “orthomolecular” pseudoscience you see today. (Orac has more.) Unfortunately it seems Pauling was a victim of Nobel disease, where prize-winning scientists subsequently become enamored with scientifically unsound ideas. At the time of his death in 1994, Pauling’s vitamin C theories were considered quackery within the scientific community, but those ideas had gone on to be embraced and widely promoted by complementary and alternative medicine (CAM) purveyors.

Fast forward to today, and not much has changed. Pauling’s theories on the efficacy of vitamin C have never been substantiated. Despite the lack of evidence, the routine use of vitamins has continued to expand in popularity over the years. With the growth in sales of vitamin pills, there seems to be a similar rise (though admittedly hard to quantify) of intravenous vitamin injections. The most popular seems to be Myers’ cocktail, an arbitrary concoction of vitamins and minerals including magnesium and calcium. It’s named after Baltimore physician Dr. John Myers who apparently administered injectable vitamins to his patients regularly. After he died in 1984, the practice was taken on by another physician, Dr. Alan Gaby. Gaby admits that he doesn’t know what was in the original Myers’ cocktail, so he made up his own recipe and took on the practice of offering multivitamin injections for the treatment of various maladies. The use of Myer’s cocktail seems to have gained more prominence after an article by Gaby appeared in Alternative Medicine Review which is essentially a collection of anecdotal claims of benefit for conditions that include asthma, migraine, fatigue, fibromyalgia, depression, cardiovascular disease, upper respiratory tract infections, allergies, urticaria, narcotic withdrawal, athletic performance and hyperthyroidism.

The advertisements you’ll find online above make it clear – it’s not what vitamins are good for – they’re clearly good for everyone. Infusions run from $50 to $250 for a few pennies worth of vitamins delivered intravenously. You’ll find no shortage of explanations from providers as to why intravenous injections are superior to dietary sources, from food sensitivities and “intolerance”, to greater demand by the body in times of disease or recovery. There are even claims the higher levels in the bloodstream “coax” vitamins into the cells and mitochondria, where presumably they’re beneficial. It sounds impressive, but these claims betray a profound ignorance of physiology and biochemistry. Strangely missing from these descriptions is an explanation why pushing megadoses of vitamins directly into a vein (and bypassing the liver’s first pass metabolism) is somehow still considered a “natural” treatment.

The Villains
As expected, being a pharmacist, I’m blamed (along with other health professionals) with standing in the way of the widespread use of intravenous vitamins. Apparently it’s our bias against nutritional treatments of illness. Oh, and blame Big Pharma too – apparently you’ll never see research on a vitamin (unless you do) or on products you can’t patent (unless you do) or on cancer treatments that aren’t industry funded (unless you do). We love the prescription pad too much – but just for drugs, not for vitamins. (Never mind that it’s pharmaceutical companies manufacturing the injectable vitamins in question.) The fact that conspiracies are often cited should tell you all you need to know about the veracity of these statements. But I’ll risk the wrath of the Pharmaceutical-Industrial Complex™ and tell you the real reason science-based health professionals don’t recommend or use vitamin injections in routine practice. It’s because there’s no convincing evidence they are useful.

The Evidence Check
I looked in PubMed for evidence with injectable vitamins that would demonstrate a therapeutic or preventative effect. With respect to Myers’ cocktail, there is no published evidence to substantiate claims of efficacy for the prevention or treatment of any condition. The only paper in the medical literature is the review paper by Gaby (which collates impressive anecdotes, but no trials). Shrader published a study examining injectable vitamins for the use in asthma, but the study was unblinded with no placebo group. There is also a randomized trial by David Katz examining efficacy for fibromyalgia, which failed to show any efficacy. (Katz discusses this on Dr. Oz, and admits there’s a lack of efficacy). And that’s it for published evidence.

Looking specifically at vitamin C, there are hundreds of citations – there’s no question that vitamin C has been extensively studied. Advocates for vitamin C always find reasons to criticize the negative trials, so let’s look at the most positive trials only. Some of the “evidence” proponents of vitamin C like to cite includes the following papers:

• Pharmacologic ascorbic acid concentrations selectively kill cancer cells: Action as a pro-drug to deliver hydrogen peroxide to tissues. Discussed and critiqued here and here in detail. Preliminary data that hasn’t been substantiated in human studies.
• Phase I clinical trial of i.v. ascorbic acid in advanced malignancy. Discussed here. Showed high-dose injectable vitamin C can be well tolerated, but also showed a lack of any efficacy for advanced cancer.
• Intravenously administered vitamin C as cancer therapy: three cases. Discussed here. These are case studies, and even the authors acknowledge that these reports increase plausibility, but don’t provide conclusive evidence given other factors could have contributed to the positive observed effects. The accompanying commentary is appropriately cautious.
• Effect of high-dose intravenous vitamin C on inflammation in cancer patients. Unblinded. Doesn’t measure relevant clinical outcomes.
• Vitamin C reduces fatigue in breast cancer. Unrandomized and unblinded. Is it any surprise the patients who accepted vitamin C felt better subjectively?

On balance, the data supporting the use of vitamin C are unimpressive – it’s no wonder that few scientists are advocating for more use or even more research. An optimistic review article from 2009 reluctantly admitted that the evidence supporting efficacy is still lacking despite 50 years of research. When we look at current clinical trials, it’s equally unimpressive. Notably, two trials (NCT00441207 and NCT00626444) have concluded in the past few years but have still not reported any results, suggesting the results were negative.

Overall, the evidence for vitamin C seems to suggest that if there really is an anticancer effect, it is so modest that it’s not detectable in clinical trials. While there are lots of anecdotes claiming benefit, there are also ones claiming it’s useless:

Celebrated physicist Sir Paul Callaghan has ended his experimental intravenous vitamin-C treatment for cancer, saying there is “absolutely no evidence” it worked. He is concerned that alternative medicine advocates are now using his “unusual experiment” to promote the controversial treatment in a misleading way. The New Zealander of the Year, who has terminal colon cancer, began receiving high-dose intravenous infusions of vitamin C in June last year, along with several alternative herbal remedies. The 64-year-old began the treatment during a six-month break from chemotherapy, tracking its effectiveness through a blood test for protein carcinoembryonic antigen (CEA), which indicates cancer levels. Yesterday, he told The Dominion Post he had ended his experiment after analysing data from six months of blood test results. “I have, as a result, learned enough to say that there is absolutely no evidence of any beneficial effect of high-dose intravenous vitamin C in my case.”

(Callaghan died in 2012.)

Given the lack of efficacy, my take on the efficacy of vitamin C for cancer is along the lines of what the American Cancer Society recommends – get your vitamin C from your food. When it comes to the use of injectable vitamin C for other conditions, no obvious benefit has been shown. There is no evidence to support the use vitamin C infusions for the prevention of disease, or for general “wellness.” In light of the lack of documented benefit, vitamin C infusions should really only be offered (or accepted) as part of a research study, and only in situations where its use is not expect to delay the use of more effective treatments. For any other conditions, the science-based approach would be the same: maximize the consumption of vitamin C-containing foods like fruits and vegetables, rather than relying on supplements – injectable or otherwise.

The Risks
If you trust the sterile technique of vitamin infusion purveyors, and are willing to chance the small risk of infection, then the risks associated with the different vitamin infusions appear to be quite low. You generally don’t get adverse effects when there’s no effect, which may be why these products are well tolerated.  While good data have not been compiled, there are also few case reports that document harms. Based on the ingredients themselves, that’s what we’d expect. Vitamin C infusions are generally well tolerated though the osmotic load (fluid shifts) from huge doses may be problematic. There are also case reports of kidney stones from intravenous infusions, an association also seen with vitamin C oral supplements. There are also harms to consumers with glucose 6-phosphate dehydrogenase deficiency – the risk of blood cells bursting (hemolysis) which can be life-threatening. Of course there are the cases compiled at What’s the Harm?, but reassuringly, most of the documented harms seem to be the result of avoiding appropriate treatments, rather than due directly to IV vitamin therapy. There is some evidence suggesting high dose vitamin C may reduce the effectiveness of chemotherapy (reviewed in detail here). There are also specific concerns about concurrent use with bortezomib (Velcade). Given there is no demonstrable benefit to vitamin C infusions for cancer, it’s probably safest for cancer patients to avoid vitamin C infusions entirely.

The Bottom Line
With so many purveyors of vitamin infusions, one would hope the practice was grounded in good science. But it isn’t, and that shouldn’t be a surprise. Despite the lack of good evidence, there is a near-obsessive devotion to touting the benefits of intravenous vitamins while railing against the mysterious entities which are blocking The Truth. But the reality is more mundane. In the absence of a deficiency, vitamin infusions don’t do much of anything. To the worried well, intravenous vitamins are going to be a harmless panacea that just succeed in enriching the revenues of the purveyor. Just as That Mitchell and Web Look said of the homeopath, “Bottle of basically just water in one hand, and a huge invoice in the other.” So if you value health theater over health care, and don’t mind paying mightily for the illusion, vitamin infusions may be your thing.

I have a much different opinion when these products are promoted to patients fighting for their lives, particularly with illnesses like cancer. There is good evidence to show that delaying treatment or substituting CAM for established cancer treatments dramatically worsens outcomes. Touting unproven treatments and then profiting from their administration is appallingly opportunistic. Real diseases require real treatments, not fake ones. They may look sciencey, but the reality is that intravenous vitamin injections are modern-day snake oil.

It’s the May Long Weekend – in Canada at least. The flower above is the Trillium, commonly seen in cottage country at this time of year.  Here’s some links, articles, and podcasts I enjoyed this week:

Dirty Medicine. If you read one link, make it this. I don’t think I’ve ever read an article about a pharmaceutical company that made me as furious as this one about Ranbaxy. Some excerpts:

Fortune’s investigation yields the first comprehensive picture of how one under-policed and far-flung generics company operated. It is not a tale of cutting corners or lax manufacturing practices but one of outright fraud, in which the company knowingly sold substandard drugs around the world — including in the U.S. — while working to deceive regulators. The impact on patients will likely never be known. But it is clear that millions of people worldwide got medicine of dubious quality from Ranbaxy.

and

Thakur knew the drugs weren’t good. They had high impurities, degraded easily, and would be useless at best in hot, humid conditions. They would be taken by the world’s poorest patients in sub-Saharan Africa, who had almost no medical infrastructure and no recourse for complaints. The injustice made him livid.

Ranbaxy executives didn’t care, says Kathy Spreen, and made little effort to conceal it. In a conference call with a dozen company executives, one brushed aside her fears about the quality of the AIDS medicine Ranbaxy was supplying for Africa. “Who cares?” he said, according to Spreen. “It’s just blacks dying.”

The fact that no one is in jail because of this international fraud makes this even more infuriating.

Other reading:

The quack view of preventing breast cancer versus reality and Angelina Jolie. And see Part 2. Angeline Jolie’s case has brought out the worst from alt-med promoters, all seeking to profit from her story, as Josephine Jones documents.

Why You Should Worry about a Case of Polio in Somalia: Scientific American

For years, major pharmaceutical companies have been testing new drugs in developing countries like India. The practice is forbidden, but the use of subcontractors makes it difficult to detect.

Missed Warnings on Cold Medicine for Children – WSJ.com – note that cough and cold products for children are not only useless, they may be harmful. The ones that remain are inert – homeopathic remedies without any active ingredients. You’re buying sugar syrup.

Most parents who opt-out of vaccinations are being guided by “irrational fears” that are a luxury of living in the developed world, a leading world health expert says.

What we can learn from one of the worst charities in the world, “Homeopaths Without Borders”?

The homeopathy aisle is an organized, state-sanctioned scam.” Homeopathic Pain Medicine Contains Poison

The Eradication of Smallpox is a Blueprint for Polio’s Demise.

Compare and contrast! What a naturopath says about cupping versus a skeptic. Who has the better grasp of science?

The FDA vs. supplement manufacturers: Jack3d, Round 2.

Complementary and alternative medicine seems to have no effect on cancer outcomes, and users report lower quality-of-life compared to non-users.

More on the dubious naturopath study published recently in the CMAJ: The deceptive rebranding of aspects of science-based medicine as “alternative” by naturopaths continues apace.

I want to see better evidence. Antibiotics for back pain: hope or hype? On the same story, Reporters fall prey to back pain study’s shady PR push. And check out Harriet Hall’s take on the study.

Gluten elimination diets: Facts for patients on this food fad. Unfortunately, pharmacies promote unnecessary elimination diets through the sale of clinically unvalidated “food intolerance” tests like Hemocode.

Like science? Like exercise? Check out Evidence-Based Fitness.

Mark Bittman may be a popular columnist, and people tell me his cookbooks are good. But his grasp of science is tenuous.

Herbal Happenings

Ginkgo biloba: not only does it not work, there are suggestions it may be harmful.

No-one is thrilled with using steriods for eczema, but they work. The same cannot be said for evening primrose, which seems to have no effect.

There’s a new website that looks at CAM and cancer therapies. Looks promising.

Heinous quackery: Calif. doctor who promised fake herbal cancer cure sentenced to 14 years in prison.

Watch

Chiropractor Ad Will Make You Wince

Distractions

The Extraordinary Science of Addictive Junk Food

Genius. Sad Cat Diary.

Gorgeous Black-and-White Photos of Vintage NASA Facilities

Hungry Planet: What the World Eats – in pictures

Photo from flickr user Bob from Caledon used under a CC licence.

It bears repeating that vaccines are one of the greatest of all the medical innovations ever invented. This infographic illustrates their success.
Here’s the source: Why vaccinate from vaccines.com using CDC data.
h/t @a_picazo

Keep the heat on Health Canada: http://www.stopnosodes.org

Here’s what’s keeping this pharmacist engaged and sometimes outraged:

Health Canada explicitly puts the financial interests of homeopathy manufacturers above broader public health goals. From the BC Medical Journal, Health Canada licenses homeopathic vaccines:

Remarkably, at the same time as Health Canada focuses on influenza education, flu shots, and other proven prevention measures, that same body has licensed 10 products with a homeopathic preparation called “influenzinum.”[8] According to providers, in­fluenzinum is for “preventing the flu and its related symptoms.”[9] Homeopathic vaccines are available for other infectious diseases as well. Health Canada licenses homeopathic preparations purported to prevent polio,[10] measles,[11] and pertussis.[12] Health Canada continues to assure Canadians that it tests products for safety and efficacy before allowing them to enter the market. All approved homeopathic products are given a DIN-HM number. The website states, “A NPN or DIN-HM means that the product has been authorized for sale in Canada and is safe and effective when used according the instructions on the label.”[13]

Pharmacist John Greiss compares Health Canada and the FDA and their action on opiates. The results are striking and reiterate the question above: Is Health Canada putting public health objectives above manufacturers?

Say it again and again. Natural does not equal safe. Beware the naturalistic fallacy.

Correlation vs. Causation. Erik Davis poders if he really cured his own gout.

Six Ways to Separate Lies From Statistics.

Eat fish, not supplements. Another study examines fish oil and finds it useless for any of the studied cardiovascular endpoints. On the positive side of dietary interventions, a study that examines monounsaturated-rich Mediterranean diets for the primary prevention of cardiovascular disease has been published and the results are promising.

Many people believe in “full moon effects” on hospital rooms and other events. It’s a fallacy.

Antibiotics could cure 40% of chronic back pain patients! Or so the headlines claim. Here’s an excellent critical appraisal from NHS Choices. And it seems there is a conflict-of-interest issue that few identified.

That CMAJ study purported to show naturopathic treatments are effective? This is what a meaningless study looks like. (Will try to do my own review of this at some point). Also see Colby Vorland’s take on the study.

Interesting debate between Arnold Relman and Andrew Weil from way back in 1999 on the idea of “integrative” medicine. (I wonder if this was the earliest reference to “science-based medicine”.) It should be no surprise that any appearance of the word “integrative” is a huge red flag for quackery. It’s almost always pseudoscience. Orac discussed “integrative oncology” quackery this week at Respectful Insolence.

Stem cells are an area of science where the hype vastly exceeds the science. This post from Orac looks at the impact of deregulating stem cell treatments in Italy.

10 ‘reasoned’ responses to “10 reasons we don’t need #GMOs”. Also on GMOs: When Media Uncritically Cover Pseudoscience.

Colby Cosh on the “Liberation Treatment” for multiple sclerosis: The only thing liberated was their wallets.

Supermarkets cash in on unfounded fears about food and health. Products that are marketed as being free from GM, aspartame, MSG and parabens perpetuate myths and ignore evidence.

I enjoyed and recommended neurologist Robert Burton’s On Being Certain: Believing You Are Right Even When You’re Wrong. Here’s a review of his latest book, A Skeptic’s Guide to the Mind: What Neuroscience Can and Cannot Tell Us About Ourselves.

Alternative medicine providers like chiropractors, naturopaths and acupuncturists are trying to position themselves as primary care providers who are equivalent to family doctors. Jann Bellamy at Science-Based Medicine shows why that’s a real problem.

One area where alternative medicine purveyors target their business is in pediatrics. This post at Science-Based Medicine on Alternative Medicine and the Vulnerable Child is excellent. It made me recall this older but also excellent related post by Dianne Sousa over at Skeptic North.

One of the most naive pieces on drug pricing I’ve ever read – from Harvard Business Review. As was noted on Twitter, ” that article reads like: ‘What’s the answer to $100k drug? A $200k drug.’”

Don’t fear the meter. There’s no evidence that smart meters are harmful.

Vaccines

The anti-vaccination fraud: Health officials forced to get tough as once-dormant diseases returning:

Fifteen years ago, in an act of scientific fraud that has since gone down as one of the biggest lies in modern medical history, a onetime University of Toronto researcher named Andrew Wakefield published a study claiming a link between autism and the vaccines that prevent measles, mumps and rubella. The findings have been debunked, the study has been retracted, and Mr. Wakefield has been stripped of his medical licence and accused of collecting more than half a million dollars from lawyers drawing up litigation based on his bogus claims. Regardless, Mr. Wakefield’s unholy creation, the idea that vaccines are a threat to public health, lives on in a worldwide scourge of plummeting vaccination rates — and a troubling resurgence of once-dormant diseases.

Outbreaks of measles are putting Europe’s commitment to eliminate the disease by 2015 under threat, the World Health Organization (WHO) has warned.

The biggest worry about antivaccinationism is in the developing world, where there are concerns that unfounded fears will spread from the developed world.

Anti-vaccine sentiment has been around almost as long as vaccines themselves. Opponents of vaccines often claim a range of different reasons or justifications for their opposition, but for the majority of people who are swayed by these minority voices – enough to choose not to vaccinate their children – it usually comes down to nothing more than fear. Ironically when vaccination rates fall, they end up facing a real but very different kind of fear. Indeed as parents in Wales take their place in line at catch-up clinics to have their children and teenagers vaccinated – the so-called “missing generation” – they are in the unenviable position of seeing first-hand what it is like for parents in developing countries.  The difference is, those in Wales had a choice.

Looking for an example of scientific ignorance and logical fallacies common among hard-core antivaccinationists? Take a look at some of the comments Science-Based Pharmacy received this week.

Listen

Great Radiolab episode on preemies: 23 Weeks 6 Days.

Hear James Randi’s scathing critique of “psychic” Sylvia Browne in an interview on CBC Radio.

Unrelated distractions worth checking out

The 29 most Canadian things to ever Canada in Canada. I though everyone bought maple syrup in 4L containers.

66 behind-the-scenes pictures from The Empire Strikes Back.

The astonishingly repulsive origins of the phrase “grandfather clause” via Dan Gardner.

Barns Are Painted Red Because of the Physics of Dying Stars.

The Two Spocks in a Very Funny and Smart Commercial

People caught on Russian dash cams doing really nice things.

For regular updates from Science-Based Pharmacy, please follow our Facebook page.

Has one physician uncovered the secret to Olympic Gold medals? And is that secret as simple as undiagnosed low thyroid function? That’s the question posed in a recent Wall Street Journal column entitled U.S. Track’s Unconventional Physician. The narrative is familiar: Lone physician fighting the establishment of “conventional” medicine. This is the medical practice of Dr. Jeffrey S. Brown, who sees thyroid illness where others see normal thyroid function. He has his critics, but his high-profile athlete patients have won a collective 15 Olympic gold medals. Case closed & Q.E.D.? Not quite. The WSJ actually does a pretty good job questioning the validity of Brown’s claims, which are far removed from the current medical consensus:

In athletic circles, Brown is a medical hero. He’s a paid medical consultant to Nike. The most renowned running coach at Nike, Alberto Salazar, calls Brown the best sports endocrinologist in the world. And athletes in growing numbers are coming to share Brown’s belief that heavy training can suppress the body’s production of the thyroid hormone, leaving them too exhausted to perform at peak. On the wall of the medical office of Jeffrey S. Brown is a photograph of Carl Lewis, the nine-time Olympic gold medalist. Lewis is one of several former or current patients of Brown’s who have climbed the Olympic podium, including Galen Rupp, who won a silver medal in the 10,000 meters at the London Olympics. “The patients I’ve treated have won 15 Olympic gold medals,” said Brown. Among endocrinologists, Brown stands almost alone in believing that endurance athletics can induce early onset of a hormonal imbalance called hypothyroidism, the condition with which he diagnosed Lewis and Rupp. Brown said he knows of no other endocrinologists treating athletes for hypothyroidism, a fatigue-causing condition that typically strikes women middle-aged or older. Several endocrinology leaders had never heard of hypothyroidism striking young athletes.

Now when I read “unconventional” and “stands alone” my skeptical alarm starts ringing. There is no shortage of debate about thyroid disease, ranging from the utter nonsense offered by “alternative health” practitioners like naturopaths and homeopaths, to valid scientific discussions about the thresholds where normal function is considered abnormal and subject to treatment. Brown is an endocrinologist, however, and he’s treating elite athletes who are pushing their physical conditioning far beyond that seen by most medical doctors and almost all endocrinologists. So what’s the basis of the concern? The WSJ story goes on to discuss two different issues: What the proper threshold is for thyroid disease, and whether thyroid replacement is performance enhancing. Let’s take each of these in turn. I’ve covered thyroid diseases and its related pseudoscience before, and a summary of the standard approach is necessary before we look at the some of the broader questions that have emerged from the story. All I know about these patients is what the WSJ is describing, so for the sake of brevity I’m going to focus on the types of cases that Dr. Brown appears to be identifying and ignore other causes of thyroid disease, which would require different treatment approaches.

The Diseased Thyroid
Simplistically, they thyroid gland acts as a sort of thermostat for the body. If it runs too high, you’re hyperthyroid: heat intolerant, anxious, a high heart rate, and maybe some diarrhea. If it runs low, you’re hypothyroid: cold, tired, constipated, and possibly even depressed. These multi-organ effects are triggered by the presence or absence of two thyroid hormones: thyroxine (T4) and liothyronine (T3). Normal thyroid function is something you never notice. But low thyroid function is common (4-10 % of adults), particularly in women. The overwhelming majority of cases (95%) of low thyroid, or hypothyroidism are primary, and the major cause of primary hypothyroidism (in parts of the world where we get adequate iodine) is autoimmune thyroid disease (Hashimoto thyroiditis). That is, the body attacks its own thyroid. As the thyroid’s function decreases, and T4 levels drop, the pituitary releases thyroid stimulating hormone – it’s effectively trying to “turn up the thermostat” to continue my analogy. A highly elevated TSH signifies thyroid dysfunction. There are other tests that can be done to confirm the diagnosis, including measurements of circulating T4 and antibody measurements, but TSH is the test we rely on as the primary diagnostic test.

Like any laboratory measurement, what’s considered a “normal” TSH is based in part on clinical studies, but also on the testing standard. Most labs identify an upper limit of TSH at 4 to 5 mU/L, but there are proponents of both higher and lower thresholds. Consequently there will be variations in practice between physicians in what they consider a “high” TSH and what’s considered “normal”. There is also some debate about a condition called “subclinical hypothyroidism”, where there are some laboratory signs of a thyroid dysfunction (a “normal” T4 and a slightly elevated TSH), but it’s not sufficient to warrant a diagnosis. A Cochrane Review suggested that treating subclinical hypothyroidism doesn’t seem to result in meaningful differences in symptoms or quality of life, nor does it decrease cardiovascular morbidity. But neither did these studies look at the performance impact in elite athletes.

Not unexpectedly, Dr. Brown is a proponent of a using a low threshold to diagnose thyroid disease, setting a threshold that most endocrinologists consider normal:

According to American College of Endocrinology literature, the range of normal TSH level is broad, from 0.5 to an upper limit of near 5, depending on a patient’s gender, age and other factors. In practice, many endocrinologists consider TSH levels above 4—combined with symptoms such as fatigue—evidence of an underactive thyroid. Brown and a small camp of other endocrinologists argue that thyroid insufficiency can be signaled by a TSH level as low as 2, for which Brown cites some recently published research. By their standards, about 10% of the population is hypothyroid—double the 5% that is cited by mainstream endocrinology. Jeffrey Garber, American College of Endocrinology president, said hypothyroidism increasingly is being diagnosed in people who don’t have it, by endocrinologists whom Garber labeled as “alternative.” “The alternative crowd is saying, ‘Gee, this is why you’re not feeling better, because these [mainstream] doctors are clueless,’ ” Garber said. So if this reporting is accurate, Brown is looking at the same test results and seeing what he believes to be thyroid disease, where his peers see normal thyroid function.

Perhaps not surprisingly, Brown has his defenders, including bloggers who rail against “mainstream” endocrinologists who “stubbornly cling to the outdated ideas that hypothyroidism is easy to diagnose”. Sound like familiar rhetoric? It will if you’re a regular reader of this blog, you’ll recognize the standard response from the defenders of pseudoscience. But they’re usually not Olympic gold medalists:

Medical privacy rules forbid Brown from naming all the athletes he has treated for that condition. But among those who have publicly acknowledged being treated for thyroid problems by Brown or unnamed other physicians are American runners Ryan Hall, Galen Rupp, Amy Yoder Begley, Bob Kennedy and Patrick Smyth. “I knew hypothyroidism was kind of like something that was being diagnosed more among elite runners,” said Smyth, a marathoner who in 2011 started feeling chronically tired. When a physician near his California home found no evidence of thyroid dysfunction, Smyth flew to Houston to see Brown, who conducted some blood tests and diagnosed him with the condition. Smyth, now retired, said the medication never enhanced his performance.

The WSJ suggests that there may be some relationship between the rigorous training and the thyroid function itself, in which case the thyroid supplementation is simply restoring “normal” function. This seems to be what Brown believes, seeing dysfunction where other physicians see normal thyroid activity. Setting aside whether or not these athletes actually do have “low” thyroid, we can ask if thyroid treatment is actually offering a performance benefit when administered to patients with a TSH between what appears to be Brown’s cutoff of 2 and the standard cutoff of 4 or 5. Certainly Brown thinks so, or he wouldn’t be prescribing thyroid replacement. Given the extent to which these athletes push their bodies, even a subtle amount of fatigue, if ameliorated, could potentially improve performance. And overtraining leading to fatigue is likely a risk for athletes training at this intensity. From this perspective, it raises the question of whether thyroid replacement can be considered a form of doping – a recovery-enhancement or fatigue-deferring boost not available to athletes who didn’t go see Dr. Brown. T4 is a hormone, after all, and it will have effects on fatigue and recovery from exercise.

One of the differences that thyroid replacement has from other forms of sports supplementation is that there is a clear peak point – normal thyroid function. Thyroid replacement in the absence of real deficiency could create a hyperthyroid state which would possibly hurt athletic performance as much a hypothyroidism. Overt hyperthyroidism causes anxiety, insomnia, weakness, perspiration, and mood swings – nothing an athlete wants. Even subtle hyperthyroidism could have negative effects for elite athletes. And the long-term consequences are significant. Thyroid replacement is a life-long commitment. And long-term it has side effects including cardiovascular and bone risks – excess thyroid is a definite “bone eater”, with bone resorption stimulated and osteoporosis being the result.

Conclusion
The Wall Street Journal‘s profile of Dr. Brown and his unorthodox management of elite athletes raises interesting questions about the basis of disease, the conditions for drug treatment, and the implications on the ethics of sports. Over time, thyroid replacement could go one of two ways. It could continue to be treated like inhaled anti-asthma medications, where asthmatic athletes who require treatment would otherwise be at a serious disadvantage in athletic competitions. We’d consider this simply a leveling of the playing field for those athletes. Or it could be that thyroid replacement could be scrutinized even more closely, perhaps requiring better documentation to justify use in an athlete, requiring clearly-demonstrated medical need based on a specific set of parameters, recognizing that there’s thyroid replacement, and then there’s unnecessary supplementation. From my personal perspective, I’m skeptical of medical mavericks who haven’t yet produced enough evidence to convince their peers and change the medical consensus. Until I see the evidence, I’m staying skeptical of Dr. Brown’s approach.

Photo from flickr user lobstar28 used under a CC licence.