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.

When you pick up a bottle of supplements, should you trust what the label says? While there is the perception that supplements are effective and inherently safe, there are good reasons to be skeptical. Few supplements are backed by good evidence that show they work as claimed. The risks of supplements are often not well understood. And importantly, the entire process of manufacturing, distributing, and marketing supplements is subject to a different set of rules than for drugs. These products may sit on pharmacy shelves, side-by-side with bottles of Tylenol, but they are held to significantly lower safety and efficacy standards. So while the number of products for sale has grown dramatically, so has the challenge to identify supplements that are truly safe and effective.

It’s been covered in depth before, but is worth repeating, that the Dietary Supplement Health and Education Act of 1994 (DSHEA) was an amendment to the U.S. Federal Food, Drug and Cosmetic Act that established the American regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs, and puts the requirement to demonstrate harm on the FDA, rather than the onus on the manufacturer to show a product is safe and effective. The goal was to eliminate barriers to sale, and it worked: Within four years of the DSHEA, supplement sales grew from $4 billion to $12 billion. In Canada, the Natural Health Product regulations have had a similar effect at creating a manufacturer-friendly market: Pretty much anything goes, and today even homeopathic rabbit anus is deemed “safe and effective” by the Canadian regulator, Health Canada.

Notwithstanding the lack of good efficacy data for many products, the absence of good product quality standards is a persistent barrier to the science-based use of supplements. With drugs, the standards are rigorous: Any drug product that is approved for sale must be shown to be equivalent to the product studied in the clinical trials that established its efficacy. This allows us to extrapolate the findings from research into expected effects in patients. And manufacturers must meet stringent quality standards for their products, including verifying the consistency and quality of everything they produce. The same can’t be said for supplements. Even if there is promising data from studies, we can’t make the same inference about the expected effects. Lax regulations translate into lax product standards, and more questions about quality standards, safety, and expected effects. So even if I believe a supplement isn’t expected to interfere with someone’s prescription drugs, I’m basing this on the assumption the manufacturer is actually providing a product that delivers what the label says. And the different regulations mean we must have less confidence this is the case.

One of the more troubling signs that there are serious problems with the supplement market are the continued recalls and warnings from regulators.  Health Canada regularly warns consumers about foreign supplements with unlabelled contaminants (among many others):

• Snake Powder Capsule (for rheumatism) – actually contain piroxicam (an anti-inflammatory), dexamethasone (a steroid), hydrochlorothiazine (a diuretic) and cimetidine (used to treat ulcers). No snake though.
• Jia Rong Zhuang Gu Tong Bi Jiaonang (for joint pain) – actually contains indomethacin, piroxicam and diclofenac (all anti-inflammatories), prednisone (a steroid), hydrochlorothiazide, metoclopramide, theophylline (used to be used for asthma), trimethoprim (an antibiotic) and phenylbutazone (a now-banned anti-inflammatory which is associated with bone marrow suppression).
• Long Ren Tang Fu She Gu Rang Jiao Nang (for joint pain) – actually contains indomethacin, piroxicam, diclofenac, naproxen (yep, four NSAIDs), hydrochlorothiazide, cimetidine, metoclopramide and dipyrimadamole.

If you wanted to create supplements that not only had an irrational combination of ingredients, but also maximized the odds of potentially fatal adverse effect, you would have trouble topping the ingredients in these adulterated products. Now these are imported products, not Canadian-manufactured. There’s a similar situation in the US, where the FDA maintains its own list, which has warnings that are equally frightening:

FDA continues to warn the public about Reumofan Plus—a product promoted as a dietary supplement for the treatment of arthritis, osteoporosis, bone cancer and other conditions. The product contains hidden prescription drug ingredients that can cause potentially fatal side effects. It could be labeled in Spanish and sold in some retail outlets, at flea markets and on the Internet.

Since June 2012, when FDA first warned the public about the dangers of Reumofan Plus and Reumofan Plus Premium, the agency has received reports of fatalities, stroke, dizziness, difficulty sleeping, high blood sugar levels, problems with liver and kidney functions, and severe bleeding in the esophagus, stomach and intestines, as well as corticosteroid (an anti-inflammatory drug) withdrawal syndrome.

Turns out after the recall, the manufacturer just relabeled it – it’s now called WOW, and still contains three undeclared prescription drugs: dexamethasone, diclofenac, and methocarbamol.

How frequently are supplements adulterated with real drugs? It’s a difficult question to answer given the lack of regulation of this market. The best signal may be regulator-initiated recalls. A systematic search was recently published by Ziv Harel and colleagues in JAMA Internal Medicine entitled The Frequency and Characteristics of Dietary Supplement Recalls in the United States, it’s a fairly simple review – a descriptive summary of all drug products listed as dietary supplements with class I (dangerous or defective product) recalls. While supplements are not drugs, once they’re identified to contain unapproved ingredients, they’re treated as unapproved drugs for the purpose of a recall. From the perspective of the supplement industry, the results should be concerning:

• Between 2004 and 2012, 465 products were subject to a class I recall. 51% were supplements – the balance were drugs.
• Most of the recalls occurred after 2008
• Every supplement recall was because of unapproved ingredients
• The majority of the recalled products were manufactured in the United States. Only 24% were imported. This is not just an imported product problem.
• Supplements marketed for sexual enhancement were the most commonly recalled product, followed by bodybuilding supplements, and then weight loss products.

Remarkably, the authors noted that the FDA does not have accurate manufacturer contact information on file for 20% of all supplement manufacturers. What’s further, the FDA has found Good Manufacturing Practice violations to be present in nearly half of the firms it has actually inspected. Importantly, with drugs, manufacturers must prove their products are of high quality before they are sold.  Not with supplements. The FDA notes:

Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to “approve” dietary supplements for safety or effectiveness before they reach the consumer. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is “unsafe,” before it can take action to restrict the product’s use or removal from the marketplace.

Importantly, the FDA does not verify final product quality – it is truly buyer beware.

The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the “Supplement Facts” label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content.

So in light of the lack of regulatory oversight, it’s reasonable to think this list captures only a fraction of the total number of mislabelled and adulterated supplements on the market today.

There are few signals that can guide consumers. Sexual enhancement, weight loss, and body building supplements seem more likely to be adulterated. Given the lack of good evidence to suggest supplements are useful for these purposes, extra caution is warranted. The Canadian Centre for Ethics in Sport realizes the consequences and risks of adulterated supplements, and warns athletes:

What are the risks associated with supplement use?
Supplements may intentionally contain prohibited substances or may be inadvertently contaminated with prohibited substances. The key issue is that there is little government regulation on the supplement industry. Some supplement manufacturers mislabel their products by not accurately specifying the contents or the relative amounts of each ingredient per dose.  It is not uncommon for supplements to be cross-contaminated with banned substances during the manufacturing process if the manufacturer produces other products that contain prohibited substances. Many ingredients are sourced outside of Canada and may be contaminated.

The reality is that there continue to be significant risks associated with supplement use.

While no harms were noted in the recall notices posted by the FDA in the study sample, harms from adulterated supplements have been reported. Pai You Guo was a Chinese-manufactured weight loss supplement adulterated with two banned drug products, sibutramine and phenolphthalein. Despite warnings from the FDA, sales continued. In a survey, almost all users (85%) reported side effects from use.

Conclusion
A lowered regulatory bar for supplements and natural health products has been a boon to manufacturers, but the same can’t be said for consumer protection. In the absence of regulation that puts patient safety and honest disclosure ahead of manufacturer interests, we shouldn’t expect to see any meaningful improvements in product quality, and the list of adulterated supplements will likely continue to grow. This double-standard has made it harder, rather than easier, for consumers to use supplements safely. Until a single, rigorous standard is applied across all consumer health products, “natural” or otherwise, there will continue to be justifiable uncertainty about the safety and quality of these products.

Reference
Harel Z., Harel S., Wald R., Mamdani M. & Bell C.M. (2013). The Frequency and Characteristics of Dietary Supplement Recalls in the United States. JAMA internal medicine, PMID: 23589151

Photo from flickr user stevendepolo used under a CC licence.

A hilarious and scathing examination of the regulatory system for “complementary” medicine in Australia.

It’s been a staggering week, news-wise. As we all watched the events in Boston and Texas, here’s what you may have missed.

Winning antivaccine hearts and minds – good post on the influence of social networks on vaccination intentions. Also, Parents Who Veto Vaccinations Often Seek Like-Minded Opinions.

Naturopathy, functional medicine, and other quackademic medicine at the University of Kansas Medical Center – with a nice summary of the pseudoscience of “orthomolecular” medicine and vitamin C injection therapy.

If you want a single resource on the lack of credible science supporting “paleo” diets, this presentation from Alan Aragon is it.

Good post from Mark Crislip at Science-Based Medicine on the new flu variants.

Naturopathy is a collection of pseudoscientific practices with vitalism, and not science, at its core. Yet The Canadian College of Naturopathic Medicine (CCNM) has applied for accreditation for a new Bachelor of Naturopathic degree program in Ontario. In response to a consultation, the Committee for the Advancement of Scientific Skepticism responded, pointing out the problems will considering naturopathy to be degree-worthy:

The underlying conflict between naturopathy andmedical science, however, goes much deeper than the lack of an evidence basis for many of the treatments offered. For naturopathy is based on the foundational principle of vitalism–the idea thatliving beings are animated by a vital force not found in inanimate nature– and the complete rejection of this principle is the cornerstone of modern biology. For this reason, even those courses which appear to provide standard medical knowledge (anatomy, microbiology) cannot be expected to adhere to what we know about living systems; the curriculum is infused throughout with a failed medieval paradigm.

In the midst of a measles outbreak in Wales, Parents need to know homeopathy does not protect against measles, says MP. And in the same outbreak, the first measles death in years.

Despite the evidence, Parental Fears Toward HPV Vaccines Is Growing.

And Temple Grandin is wrong on vaccines and autism.

Also unfortunate: Jane Goodall’s new book is filled with errors, plagarism and bad science.

Why does the UK’s National Health Service still fund homeopathy in the midst of a measles outbreak? We’ve seen sense on measles, but we’re not yet rid of quacks. Catherine Bennett argues:

With the greatest of respect to the government scientists, “rubbish” and “mad” still seem kindly descriptions of a licensed, potentially harmful idiocy that, so long as it is protected within the NHS, affords professional respectability to the sort of homeopathy writers and practitioners who have nurtured parental suspicion and resistance to the MMR, even after measles epidemics began to threaten children’s long-term health. You can tell people to get immunised, in accordance with the science, or you can fund homeopathy in defiance of it: you can’t rationally do both.

This should surprise no one: Cancer patients who use alternative medicine die sooner.

Analgesic use before marathons can be damaging.

From US-based pharmacist Jerry Fahrni, a provocative post on the American retail “big box” pharmacy: Don’t confuse retail pharmacy with pharmacy practice:

Retail pharmacies are the scourge of my profession. I’ve worked retail. It’s a soul-sucking environment of profit over patient care, and can quite literally cause pharmacists to rethink their career choice. Have you ever met a retail pharmacist that loves his/her job? I haven’t. Best case scenario they tolerate it. Worst case scenario they hate it so badly that they change careers and leave pharmacy behind.

Should the FDA continue to allow drugs to stay on the market, even if they were approved based on fraudulent research?

Drug Patents Don’t Ensure Innovation says Jessica Wapner. And here is Dr. Michael Wosnick’s take on the Novartis Gleevec patent. He sees a regulatory Catch-22.

A founder of the anti-GM food movement on how he got it wrong. Also on GM food, Thinking beyond Argumentum ad Monsantum.

Brian Dunning, creator and host of the popular Skeptoid podcast, (which I have listened to for years) has pled guilty to wire fraud, related to the manipulation of eBay affiliate links through which he earned millions of dollars. Dunning’s podcast was one of my early steps in developing an explicitly skeptical perspective. How this conviction will impact the podcast and the credibility of Skeptoid  remains to be seen. Some reaction here and here.

And unrelated to SBP, but don’t miss: where children sleep around the world.

With Wakefield losing his medical license, the media coverage seemed to start shifting away from “false balance” into communicating a more accurate perspective – that Wakefield’s work was bogus and quite likely driven by undeclared conflicts of interest. Certainly several stories I’ve seen over the past few years have described antivaccinationists views more accurately – as fringe perspectives without scientific credibility. I was heartened fairly recently to see a significant victory in Australia, where the Orwellian “Australian Vaccination Network”, a defiantly anti-vaccine organization, has been ordered to change its name because of its position on vaccines. My hope was that the tide was turning into more cautious and accurate reporting on vaccine safety and public health.

So now that it’s been a decade of addressing fears of vaccines causing autism, has the damage been undone? Sadly, no. Last week I noticed an American poll of over 1200 voters on a variety of conspiracy topics. To the question “Do you believe there is a link between childhood vaccines and autism, or not?” 20% said “do” and 34% said “not sure”, with 46% saying “do not”. If that poll’s accurate, that’s 62 million Americans who believe there’s a link, when that link has been definitively disproved. Quite the legacy for Wakefield. Back in the UK, Wakefield’s home turf, vaccination rates plummeted and while they did start to recover, it wasn’t before before measles was declared endemic in 2008, meaning immunization rates were insufficient to control the spread of the disease. There is currently an active outbreak of measles in Wales – almost 700 cases reported so far, with that number expected to double. And frighteningly, but no unexpectedly, the United Kingdom may have its first measles death in years.

Andrew Wakefield: Concern Troll

Given the demonstrable public health harms driven by Andrew Wakefield, I was stunned to see images of yesterday’s Independent:

MMR scare doctor: this outbreak proves I was right

Cover via Martin Robbins, writing in New Statesman

Yep, it’s Wakefield quoted:

It’s not until the 15th paragraph that his comments are rebutted. It’s textbook false balance. And amazingly, inside the paper, Wakefield’s statement is reproduced in full:

Photo via Margaret McCartney

Now it takes a certain chutzpah (to be polite) to manufacture fears about the MMR vaccine, continue to propagate those fears for over a decade (despite evidence showing you’re wrong), watch vaccination rates drop and measles re-emerge, and then declare victory. Yet that’s exactly what Wakefield does, in a statement that the Independent seems to have copied verbatim from the antivaccine group Age of Autism’s website:

As is usual for Wakefield, he is still disingenuous and lays on the conspiracy theories thick and fast. The MMR vaccine is superior to single vaccines (for which Wakefield had coincidentally sought to patent). Pluserix and Immravax may have had higher risks compared to other MMR vaccines, but it’s not relevant to the drop in vaccination rates – Pluserix and Immravax had been off the market for six years before Wakefield published his “research”. Ryan Mojabi may indeed have suffered a rare adverse effect of a vaccine but was never diagnosed with autism.  And so on. Wakefield does his best concern troll, positioning himself as the voice of wisdom on the safety of the MMR vaccine. It’s the “I’m not anti-vaccine, I’m pro-safe vaccine” tactic so common among antivaccinationists.  He fails to note the extensive data that shows his hypothesis is demonstrably false and there are now hundreds of papers that support this conclusion.

Why would the Independent do this? Martin Robbins, writing in the New Statesmen, writes very critically about the Independent’s health writer, Jeremy Laurance:

On Twitter, the Independent’s health writer Jeremy Laurance has spent the day demanding that critics read the whole piece. “Jeeezus!”, he responded to Ben Goldacre and others at one point, “U have NOT read the story.” What Laurance fails to understand is that few people ever do read the whole story. Any competent journalist understands that people tend to grab the information at the top, and don’t always stick around until the end of the piece.

And besides, it’s not just the headline. Laurance’s article continues to put Wakefield’s point of view for a further 14 paragraphs, before giving over barely half that space to one contrary voice, addressing only a fraction of the points made. It would be a great example of the false balance inherent in ‘he-said, she-said’ reporting, except that it isn’t even balanced – Laurance provides a generous abundance of space for Wakefield to get his claims and conspiracy theories across, and appends a brief response from a real scientist at the end.

As Anthony Cox noted way back in 2007, this isn’t the first time that the Independent’s editor, Jeremy Laurance, has been criticized for its role in the MMR debacle. The Independent in particular seems to have demonstrated ignorance or indifference to the fact that it is also responsible for propagating these antivaccine fears.  As Robbins continues:

Jeremy Laurance has a history of reacting badly to the idea that health and science journalists deserve scrutiny. What he doesn’t seem to grasp is that this is not an abstract public health debate between a few angry people on Twitter – he, and journalists like him, are putting the lives of real children at risk, their clumsy reporting stoking unwarranted fears about a safe vaccine.

Just like it has done before, the Independent is supporting the dissemination of unfounded and unsubstantiated messaging about the MMR vaccine that only serve to stoke fears. It’s clear now that Wakefield’s message would not have been so widespread had the media not fueled this antivaccine fire.  For the Independent to fail to recognize this, in the midst of a measles outbreak, is quite frankly, disgraceful.

Vaccines Work

More posts are imminent…here’s what I’ve been reading.

How the pseudoscientific theories and practices of chiropractic are translated to veterinary medicine. “Some chiropractors will simply treat animals and ignore the fact that it isn’t technically legal for them to do so. “

Are you in danger of spontaneously combusting?

Gwyneth Paltrow’s new cookbook borders on quack science. A third of Americans are now avoiding gluten, led by Paltrow and other Hollywood celebrities. But they’re not the people who should be. As I’ve noted before, it’s driven in part by unproven tests like Hemocode, which identify and treat non-existent “intolerances” to food products.

Why Organic Advocates Should Love GMOs.

Epidemiology—a science for the people. (Lancet PDF)

Pharmacy History! What Was in Patent Medicines.

Vaccines saved lives–scientific evidence – From the Skeptical Raptor, whose blog I am enjoying more and more.
Also on vaccines – a great reference document [PDF] on the science supporting immunization.

Rexall’s dubious homeopathic offerings. From Canadian Business and MSN. Because legal isn’t necessarily ethical.

John Ioannidis on the promise of genetic medicine: This I believe in genetics: discovery can be a nuisance, replication is science, implementation matters.

Neal’s Yard promotes homeopathy for measles. This could kill real children.

Never heard of that open-access journal you’re reading? Be wary, it could be pseudoacademia.

Refugees of the Modern World The “electrosensitive” are moving to a cellphone-free town. But is their disease real?

Great Skeptically Speaking interview with Marlene Zuk on her new book Paleofantasy: What Evolution Really Tells Us about Sex, Diet, and How We Live.

And for something completely different:
Supercut: Every Scene Where Someone is Facing Something Incredible (and Away From You)

Calvin and Hobbes: The Movie (Trailer) – a fake reboot, but it looks awesome.

Remember to “Like” Science-Based Pharmacy on Facebook!