Nutritional and Health benefits of Organically Grown Food?

I recently read a commentary  by Dominic Lawson, in the Times of London Sunday edition, entitled “Organic Food is Just a Tax on the Gullible.He was referring to  a couple of systematic reviews (health benefits and nutritional content) that suggest there are no measurable health benefits an no meaningful nutritional superiority associated with organically produced food .  The studies and the commentary add some useful detail to my previous comments about nutrition myths, and they illustrate nicely the seldom-appreciated complexity of making sound decisions about producing food, whether for animals or humans.

Now I’ll admit to a certain sympathy with organic food production, particularly as it seems likely to be less harmful to the environment than conventional industrial agriculture. And I have no doubt that the economic incentives of the agriculture industry lead to just as much malfeasance as those in the pharmaceutical game, or really any other area of economic activity. I believe we now produce more food, of better quality, more efficiently in terms of calories per acre that ever before, and that is itself a good thing, at least for our health as individuals and as a species. However, this increased production comes at a cost, and the use of fossil fuels and pesticides has consequences we must be mindful of.

Nevertheless, I believe in applying the same standards of evidence to all scientific claims, including those I personally find appealing. And I have been skeptical in the past of the nutritional and health claims of organic food proponents, which seem to be based more of the naturalistic fallacy  than on any evidence I’m aware of. A reader here suggested I had missed this evidence: “there are increasing numbers of studies documenting that (certified) organic food is more nutritious than conventional (non-certified organic food). They find significantly more minerals, vitamins, antioxidants in most all foods researcher look at.” Unfortunately, the person never responded to my subsequent request for details on these studies.

The first of the reviews Lawson comments on examined the literature from 1958-2008 and found only 11 studies that addressed the question of health benefits from organically produced foods or specific food ingredients. Of these, only 3 studies met the a priori defined criteria for methodological quality. The authors concluded, ” because of the limited and highly variable data available, and concerns over the reliability of some reported findings, there is currently no evidence of a health benefit from consuming organic compared to conventionally produced foodstuffs.” Clearly, this study does not definitively show that there are no health benefits to organically produced foods. But it does show that there is no high quality evidence for such benefits in the literature, which leaves the burden of proof squarely on those who make claims for the health benefits of eating organic foods.

The second study reviewed the literature for the same period, and did slightly better in terms of finding high quality studies. Of over 3000 studies examined, 55 met the quality standards. Based on these, the authors concluded:

“No evidence of a difference in content of nutrients and other substances between organically and conventionally produced crops and livestock products was detected for the majority of nutrients assessed in this review suggesting that organically and conventionally produced crops and livestock products are broadly comparable in their nutrient content. The differences detected in content of nutrients and other substances between organically and conventionally produced crops and livestock products are biologically plausible and most likely relate to differences in crop or animal management, and soil quality. It should be noted that these conclusions relate to the evidence base currently available, which contains limitations in the design and in the comparability of studies. There is no good evidence that increased dietary intake, of the nutrients identified in this review to be present in larger amounts in organically than in conventionally produced crops and livestock products, would be of benefit to individuals consuming a normal varied diet, and it is therefore unlikely that these differences in nutrient content are relevant to consumer health.”

These two reviews have been criticized, not surprisingly, by organic food producers, primarily for their exclusion of studies which support the producers’ claims. Ben Goldacre has already responded to the substance of these criticisms. Clearly, these two reviews cannot not be the final word on the subject. They strongly suggest that when the scientific literature does not support the claims that organically produced food is healthier or more nutritious than conventionally produced foods, but they also show that the evidence is sparse and of poor quality, so we must keep an open mind on the subject. And, of course, none of this bears on the other potential benefits of organic agriculture, including decreased environmental harm and subjective benefits such as better tasting food. These are themselves issues which ought to be investigated in a rigorous way.

Finally, Lawson’s commentary made what I thought was a critical point, nicely illustrate by an anecdote that is humorous, rather than tragic, only because it ended happily. I’ll let him tell it:

“A few years ago my wife decided we should have an entirely organic vegetable garden. To this end she refused all man-made fertilisers [sic] and ordered a truckload of pigeon droppings. What could be more natural? Neither was there anything unnatural in the germs I inhaled through the spores of our organic manure, thereby contracting psittacosis. This developed into “atypical” pneumonia, which was of course resistant to all standard antibiotics. Had a hospital doctor not guessed the cause and put me on a drip with the appropriate drugs – ooh, chemicals! – I could have become a fatal casualty of the organic movement. Obviously my wife might have ordered cow manure rather than pigeon poo[p]; then I could have been felled by E coli instead.”

This is a powerful illustration of a concept promoters of CAM often ignore; every choice has an array of costs and benefits that have to be evaluated and balanced. Vaccines do sometimes cause harm, but to a far lesser degree than the harm of not using them appropriately. And there may be benefits to reducing the use of chemical fertilizers, but one cannot just blithely follow the naturalistic fallacy and assume that organic fertilizers are always better. This sort of cost benefit analysis is always difficult, tedious, and fraught with uncertainty, and it lacks the appeal of simplicity, but it is a crucial part of making the best decisions about medicine, agriculture, or any other complex endeavor.

Posted in Nutrition | 7 Comments

Bach Flower Essences for Animals

What is it?
Dr. Edward Bach was a physician and homeopath in England in the late 19th and early 20th centuries. He eventually gave up his medical practice to focus full-time on developing a system of treatment based on elements of homeopathy and his own ideas about health and disease. He believed that all disease was primarily spiritual in origin and due to negative emotions. These emotions are the manifestation of a conflict between the divine energy of the spirit and the limitations and weaknesses of the physical body and the mind. He became convinced that certain flowers posses unique energetic resonances that can help dispel negative feelings and re-establish balance between body and spirit.

Dr. Bach identified the healing properties of specific flowers intuitively, by touching a flower or putting a petal on his tongue and then observing changes in his own feelings. He compiled an extensive list of specific flowers and combinations indicated for specific emotions and situations. The most popular Bach remedy currently is Rescue Remedy®, a mixture of five flower essences purported to be calming during sudden emotional crises.

Dr. Bach initially treated people with dew from flowers, which he believed absorbed the signature energy of the plant, but because of the limited quantity of dew which could be produced he began instead to soak flowers in water and then collect this. The water was then mixed 1:1 with brandy and this stock solution dispensed to patients. The patient generally would take several drops of the stock solution directly or mixed into a beverage. The Dr. Edward Bach Centre continues to produce flower essences by these methods and holds the rights to the term Bach Flower Essence, though other manufacturers make products produced in the same manner under other brand names.

Due to the extreme dilution of the remedies, flower essences contain only very small quantities of alcohol, and they are unlikely to contain much in the way of residual chemicals from the plants used in their preparation. Though they are widely available as an over-the-counter product, Bach flower essences are often dispensed by alternative medicine providers, such as homeopaths, or by Bach Flower Remedy Practitioners (BFRP), who have taken an educational course offered by the Bach Centre. The Centre also promotes the veterinary use of flower remedies, and these products are sometimes given to animals by owners, veterinarians, or alternative medicine practitioners.

Does It Work?

There is no evidence for the reality of Dr. Bach’s model of health and disease. By their nature, emotions are subjective and individual and so difficult to study scientifically. And the concept of divine spiritual energies is a religious, rather than a scientific concept.

It is possible, however, to study whether patients respond differently when taking a flower remedy or a placebo substance not thought to have any healing properties. Several such studies have been conducted with Bach flower essences, and the results clearly demonstrate that humans report positive changes in their feelings when they are given either treatment, with no difference between a flower remedy and a placebo.

For humans, such placebo effects may provide some comfort even if the remedy is nothing but water and has no actual activity. If a person believes their unpleasant emotions will improve when they take such a remedy, this belief may itself be enough to change how they feel. However, since the substance has no actual activity in the body, any physical illness the patient has will remain unchanged.

For veterinary patients, who cannot reflect on and express their own feelings, it is difficult to see how one would choose which remedy to apply. However, some Bach flower practitioners have adapted Dr. Bach’s list of emotions and the corresponding flowers for veterinary use. There have been no controlled studies of these remedies in animals, however in general placebo effects that require a belief or expectation of improvement do not benefit veterinary patients. Such effects based on belief or expectation can, however, influence the owner’s and the practitioner’s interpretation of the pet’s behavior, leading to an impression of improvement where none has actually occurred.

Is It Safe?
Because Bach flower essences are greatly diluted, they generally contain only water and very small traces of brandy or substances leeched out of the flowers. It is unlikely, then, that they would cause any direct harm. However, because they have no actual effect on physical disease, their use can cause indirect harm if it leads to a delay in appropriate diagnosis and treatment for any underlying illness.

Summary
*There is no evidence to support the notion that disease is caused primarily by spiritual and emotional imbalances or that flowers contain any mysterious energy that can correct these imbalances and improve health or treat illness.

*Clinical studies have shown that Bach flower remedies are no different from inert placebo substances in their effects on the emotions of humans using them. While the belief that they will help may itself change a person’s feelings, the remedies have no actual effect on mood or physical illness.

*No objective research on the effect of flower essences has been conducted in animals. Because their effects in humans relies on belief and expectation, it is unlikely that they would have benefit for veterinary patients. However, because owners and others providing care to animals are influenced but beliefs and expectations, they perceive a benefit for an animal given a flower remedy even if no real change has occurred.

References and More Information
Armstrong, NC, Ernst, E. A randomized, double-blind, placebo-controlled trial of Bach flower Remedy. Perfusion 1999;11:440-446.

Bach, E, Wheeler, FJ, The Bach Flower Remedies, Rev. ed. New Canaan, CT. Keats Publishing; 1997.

Ernst, E. “Flower remedies:” a systematic review of the clinical evidence. Wiener Klinische Wochenschrift 2002;114:963-966.

Ernst, E, Pittler, M, Wider, B. eds. The Desktop Guide to Complementary and Alternative Medicine 2nd Ed. Philadelphia, PA: Mosby Elsevier; 2006: 306-308.

Pintov, S, Hochman, M, Livne, A, Heyman, E, Lahat, E. Bach flower remedies used for attention deficit hyperactivity disorder in children-a prospective, double-blind, controlled study. European J Paediatric Neurol 2005;9:395-398.

Thaler, K. et al. Bach Flower Remedies for psychological problems and pain: a systematic review. BMC Comp Alt Med. 2009;26:9-16.

Walach, H, Rilling, C, Engelke, U. Efficacy of Bach flower remedies in test anxiety: a double-blind, placebo-controlled, randomized trial with partial crossover. Anxiety Disord 2001;15:359-366.

© Brennen McKenzie, 2009
http://www.skeptvet.com

Posted in Miscellaneous CAVM | 8 Comments

A Few Common Pro-CAM Arguments and Some Possible Responses

In addition to substantive arguments about evidence, clinical studies, and underlying biological or physical rationale, many arguments between supporters and skeptics of veterinary CAM involve myths, stereotypes, logical fallacies, and other rhetorical devices or conceptual errors unrelated to the actual merits of the case being made. The recent discussion in response to Narda Robinson’s article on the Pet Connection Blog has revealed some of the archetypical forms of these, and I thought I’d offer a few possible responses.

1. Argument from Faith-

This, of course, underlies much CAM. Supporters “know” things work because of their firsthand experiences or they have faith in the wisdom of tradition or individual gurus. Apart from the cognitive errors that make anecdote and firsthand experience rather unreliable, the propensity for self-validating belief is a problem in itself. Faith is, by its very nature, self-reinforcing. Belief begets belief, and humans are notoriously loath to give up beliefs regardless of evidence. We hate to have to accept the ambiguity and uncertainty of knowing our personal impressions are less reliable than the objective and impersonal process of science. There is a powerful psychological incentive to reject evidence-based medicine because it takes away our illusions. Supporters of CAVM can claim that because they have believed and practiced these methods, because they have “seen for themselves,” that their wisdom and position of authority must be respected. Sadly, their intelligence and passion and conviction may make them convincing to others, but they don’t make them right. Only well-designed and conducted research which take the biases of passion and conviction out of the evaluation process can prove their case, and they often disdain such because it seems to them beside the point, a mere frill to “prove” what they already “know.”

The emotional intensity of true faith also contributes to the tendency of CAM supporters to perceive disagreement as disrespect, or to act as if respect ought to be a substitute for evidence, but such is the nature of faith-based medicine.

While we should be free to disagree about facts, I find CAM proponents often identify disagreement with suppression of the truth, ignorance, or some sort of political conspiracy. This is part of the David and Goliath Myth I’ve written about before. I try to take their belief in the benefits of the methods they espouse in good faith, and I believe they have their patients’ best interests at heart. Mature and respectful disagreement requires that they treat dissenting opinions likewise because their belief is often a matter of personal faith, they can be quick to dismiss other opinions as disingenuous or motivated  by something other than the best interests of our patients.

2. Tu Quoque Fallacy

There are several versions of the “you too” argument. One is that mainstream medicine is itself not evidence or science based and so CAM has an equal claim to legitimacy and efficacy. The specific citation that “only 15% of allopathic medical treatments were based on scientific studies” has been well-debunked.

There is a grain of truth to this assertion. Many mainstream practices have been “grandfathered in” (as, I might add, has the US Homeopathic Pharmacopeia, which was automatically exempted from proving safety and efficacy when food and drug safety laws were instituted in the U.S.). These practices do not have the level of evidence behind them they would require if newly discovered today. However, the level of evidence behind mainstream medical practices is far higher than for alternative practices. And the underlying principles are not grossly inconsistent with established principles of the biological or physical sciences, as is often the case for CAM methods. And rather than considering centuries or millennia of unquestioned use to be a point in favor of a therapy, as does the CAVM community, scientific medicine holds all practices as open to criticism based on logic, reason, general scientific principles, and of course clinical evidence.

Another fallacious form of this argument says that because mainstream scientific medicine makes mistakes and there are bad doctors in scientific as well as alternative medicine, that this is somehow evidence in support of homeopathy, TCM, or other alternative therapies. There is no connection. Scientific medicine makes mistakes, but science is always changing and improving and these mistakes eventually get corrected. Scientists are imperfect human beings, but the scientific method applied over time but many individuals compensates for our flaws. Therapies based on unwavering respect for ancient traditions and validated primarily by personal experience and belief, on the other hand, have no reason to seek and correct mistakes. If Palmer and Hahnemann and the ancient Chinese physicians had it right, then our duty is to follow their advice and not question or challenge it. Western mainstream medicine made this mistake in canonizing Galen and the other Greek physicians and accepting without question both what they were right about and what they were wrong about. And medicine stagnated in a miserable state for centuries. The scientific method changed that and made active questioning and critique a virtue. I know some CAM proponents will disagree and say that we are all drowning in toxins and disease and that the pre-scientific age was a Golden Age, but the history of the succeeding couple hundred years suggests to me that the scientific approach works much better.

In any case, the lack of perfection in scientific medicine is not an argument that no progress has been made or that the method doesn’t work. And it’s certainly not an argument that the exact opposite philosophy is the better alternative.

3. Health Care Choice

A popular defense of CAM in the U.S. these days if the argument that consumers (not “patients”) should be free to choose what kind of health care they want, apparently regardless of whether it works or not. The “free choice” argument is a popular strategy as it plays into the general cultural suspicion of government and the respect for individual freedom. But the “choice” between methods which help and those which do nothing or even harm a patient is not a truly free choice. If one accepts that the government has any role at all in protecting public health, than one has to accept that establishing some reliable and objective standards of safety and efficacy is an appropriate government activity. If, of course, you believe government should stay out of everybody’s business altogether, than you won’t accept this, but that’s really a political not a scientific debate. There is a segment of the libertarian movement that aggressively supports CAM for clearly political reasons, though thankfully there are also many solidly skeptical libertarians as well.

History suggests to me, that the methods of science are better at determining safety and efficacy than tradition and personal experiences. For a thousand years doctors and patients believed bloodletting, purging, cupping, casting out demons, and lots of other non-scientific method of treatment were helpful. Those people were just as smart as we are, but they had the same flaws and cognitive vulnerabilities. We now live longer and healthier lives and eschew those methods because we have developed a better way to determine what works and what doesn’t. This is not cultural chauvinism, it’s just a pragmatic evaluation of reality. And if this is true, then a caveat emptor approach to health care where we are “free” to choose whatever snake oil is sold to us, and the salesmen are free to claim whatever they like without reasonable proof, seems a step backwards and a guarantee of much unnecessary suffering.

The history of government regulation of food and drugs shows some real benefits to limiting the medical therapies that can be made available to those which have some reasonable, scientific plausibility, and the weakening of such laws through legislation such as the 1994 Dietary Supplement and Health Education Act have clearly led to harm, and this argues against the benefits of so-called “health care freedom.”

Posted in General | 29 Comments

From Pet Connection-Falling for “Hope-Based” Medicine…

This is an insightful essay illustrating the ultimately faith-based nature of much CAM. Statements about safety and efficacy and the indications of a treatment are determined by tradition, appeal to authority, or instinct and then justified by anecdote without any objective supporting evidence. What I find as informative as the essay are the voluminous comments, including from the legendary CAVM guru Dr. Pitcairn, illustrating how passionate people become when you suggest that their intuition and personal experience, their faith, may not be a sufficient justification for medical recommendations that don’t have any other evidentiary basis. Enjoy!

Posted in General | 12 Comments

GAO Acknowledges FDA Oversight of Dietary Supplements Inadequate

It is widely understood that the 1994 Dietary Supplement Health and Education Act has created a wide open and lucrative market for herbal remedies and dietary supplements that don’t have to pass even minimal standards of evidence that they are safe or effective. The act was  introduced by Tom Harkin and Orrin Hatch, apparently true believers in CAM and certainly recipients of a great deal of campaign money from the supplement industry. Though some have hoped the new respect paid to objective science by the current administration might lead to reconsideration of this disastrous act, it hasn’t seemed very likely. But there is at least a glimmer of hope.

A report prepared by the General Accounting Office (GAO) evaluating the FDA’s ability to safeguard the public from untested dietary supplements and has concluded that the agency should “request additional authority to oversee dietary supplements, issue guidance on new dietary ingredients, and take steps to improve consumer understanding of dietary supplements.” The report further states that “without a clear understanding of the safety, efficacy, and labeling of dietary supplements, consumers may be exposed to greater risks.” and adds that the “FDA generally agreed with GAO’s recommendations.

Undoubtedly, such reports are generated and molder unheeded in the halls of government all the time. But official recognition from outside the FDA that the current law is inadequate to protect consumers is welcome, and hopefully a sign of things to come.

Posted in Herbs and Supplements, Law, Regulation, and Politics | Leave a comment

You Can’t Believe Everything You Read-Even in a Scientific Journal!

Many proponents of Complementary and Alternative Medicine (CAM) reject the very idea of scientific evaluation of their methods. If scientists say they can find no trace of Ch’i or vertebral subluxations or water memory, well that shows that science doesn’t know everything, right? These are the easiest CAM believers to deal with because there is nothing to be done except agree to disagree. If mystical and undetectable entities can only be seen and understood by those who have faith in them, then there’s no foundation for productive debate.

More challenging are those promoters of alternative medicine who seek to claim legitimacy through scientific credentials or research. Of course, who could object to scientific training for CAM providers or proper research into their claims? Well….

The first problem is that the general public sometimes imagines scientific credentials to be validation in and of themselves for the scientific claims one may make. Sadly, this is not true. Linus Pauling was a brilliant scientist who happened to be dead wrong about the value of megadoses of Vitamin C. Andrew Weil may have an M.D., but he is much more a priest of New Age mysticism than a doctor of scientific medicine. Scientists, intelligent or not, are not much less susceptible to the errors that lead to false beliefs in medicine than non-scientists. We experience non-specific (aka “placebo”) effects, we fall prey to availability bias, confirmation bias, and all the other cognitive traps that the method of science is designed to help us avoid. If we don’t follow the method, we’re just as likely to be wrong as the next guy.

And just as scientific credentials are often erroneously interpreted as evidence for one’s claims, scientific publications are frequently granted more respect than they deserve. For many different reasons, simply being able to produce citations in a journal does not constitute a QED for a medical claim. For starters, publication bias leads to the publication of positive findings and the quiet lonely demise of negative findings often enough to make conclusions based on published literature less reliable than we’d all like. This is more of a problem in some countries than others. In China and Russia, for example, nearly 100% of the clinical trials published show positive results. Perhaps the scientists in these countries are smarter and better at their work than those in Europe and the U.S.? Or, perhaps there is a cultural stigma to publishing negative results? In any case,  no one is immune from the pressure to report positive and dramatic results from one’s research, to justify not only the publication but the time and money spent on the research, as well as to show oneself to be a smart and productive scientist, and this reduces the reliability of published research results.

Judging the credibility of published research requires looking at how the research was conducted. There is a hierarchy of reliability for clinical evidence, from the easiest to find and least reliable, personal anecdote and clinical experience, to the most rigorous controlled clinical trial. And though we open ourselves to charges of cultural or institutional bias by saying so, there is a hierarchy of reliability for the journals in which clinical trials are published. Even excluding countries in which negative results simply aren’t published, there is a meaningful difference in reliability between a study that appears in the New England Journal of Medicine or the Lancet versus one that appears in the Journal of Complementary and Alternative Medicine or The Chiropractic Journal. Journals that exist solely for the purpose of publishing research that does not meet the publication standards of established high-quality journals are clearly going to be more ideological, less evidence-based, and less reliable as a guide to the truth about clinical therapies.

Sadly, the scientific literature in veterinary medicine is not only sparser than for human medicine, it is frequently of inferior quality. As a simple function of resources, trials are smaller and less well-designed, and they are often funded by pharmaceutical companies, commercial firms, or others with a vested interest in the outcome, which has been clearly shown to affect the outcome of research studies. A review of published studies in veterinary dermatology recently found widespread misuse and misinterpretation of basic statistics and data presentation methods.

So with cognitive biases, ideological biases, publication bias, the influence of funding source, and all the other factors that limit the reliability of published research, how are we to decide which therapies work and which don’t, what are the risks and the benefits of various therapies, and all the other question that we need to answer to provide good care?

To start with, we should follow the principles of science-based medicine, which differs in a small but highly significant way from evidence-based medicine in considering the plausibility of the underlying physiologic rationale as a key component in evaluating a therapy. Running a hundred clinical trials, with all the errors to which they are prone, in order to test the efficacy of manipulating mysterious energy fields that can only be real if everything science has shown us is all wrong makes no sense. As one bloger described it, this is Tooth Fairy Science. You can conduct a well-designed study to evaluate how much money the tooth fairy leaves for each different type of tooth, age of child, etc. You can even do statistical analyses on the findings. None of this means the Tooth Fairy exists.

Next, we can educate ourselves about the source of information. A study of chiropractic funded by chiropractors, conducted by chiropractors, and published in an all-chiropractic journal isn’t automatically wrong, but it’s a good bit less reliable and more susceptible to bias than an independent study published in the New England Journal of Medicine. A journal that follows the principles of the CONSORT statement, that requires registration of trials with stated primary endpoints in advance and full disclosure of funding and potential conflicts of interest is more likely to be reliable than one that does not.

Finally, we can read each study in a critical and thoughtful way. Not just the abstract and the discussion section. I’m am frequently amazed at how often those parts of a paper do not present an accurate interpretation of the actual data reported. Looking at studies critically also means recognizing the limitations of different kinds of evidence. A small case series is less reliable than a retrospective cohort study, which is less reliable than a prospective randomized controlled double-blinded study, and so on. This means more work for the individual clinician, of course, but that is a price worth paying for better medicine.

Posted in General, Science-Based Veterinary Medicine | 5 Comments

Pet Food Nutrition Myths

I’ve previously written an analysis of one of the most popular veterinary nutrition myths, the idea that cats and dogs should eat raw food. I was recently asked by one of my colleagues to address a couple of other veterinary nutrition myths, and by a happy coincidence Dr. David Dzanis, a board-certified veterinary nutritionist and consultant, gave a brief talk on the subject at the American Veterinary Medical Association conference from which I just returned. While I hope to someday put together a more comprehensive and thoroughly referenced list of such myths, I thought I’d share a few tidbits I learned from Dr. Dzanis, and a few other sources, on the subject of pet nutrition.

 

“Good” vs “Bad” Ingredients

Popular mythology assigns food ingredients statues as “good” or “bad,” ill-defined categories which are seldom based on any scientific facts but which have a powerful impact on the purchasing decisions of the pet-owning public. Unfortunately, pet food manufacturers play along and exacerbate this mythologizing of certain food ingredients for marketing advantage. When the public begins to believe a common ingredient is harmful, manufacturers will sometimes begin proudly announcing their foods are free from the ingredient, and this will appear to be confirmation of the myth. The chemical preservative ethoxyquin is a perfect example. While there is no evidence this ingredient causes any harm, and it is clear that spoilage of “preservative free” food can pose a real health risk, the ingredient is now rarely used because uninformed and unscientific public opinion demanded its removal from pet foods. A similar sort of process lead to the removal of thimersal from human vaccines despite the clear science refuting the public concerns about this preservative.

Often the growth of a movement against a food ingredient  is a purely aesthetic issue with no scientific merit. Eating chicken feet and viscera, unborn calf fetuses, and so on sounds gross, so people assume these aren’t healthy pet food ingredients. But the aesthetic standards of cats who like to chew on dead lizards and dogs who eat socks, rubber, and poop are different from ours, so it’s a meaningless way to judge such food constituents.

Such food ingredients are also disdained because of the confusion in many people’s minds of nutrients and foods. People will claim that “sea salt” is somehow different from mined salt or that wheat proteins are somehow less nutritious than beef proteins. The fact is that, properly prepared, many things we would not consider appropriate as foods in their original state can provide vital nutrients of the same quality, or better, as more aesthetically pleasing sources.

It is particularly common these days for people to claim that grains are “bad,” and that wheat and corn in particular are harmful or “allergenic” for our pets. As Dr. Dzanis puts it, “Corn and wheat are often criticized as inferior to other grains such as rice. While rice is generally more digestible than corn, that also means the starches are reduced to sugars and absorbed much more quickly. This may not be desirable for animals with clinical problems related to blood glucose control. As far as potential allergenicity, historical use of rice in therapeutic diets as a “novel ingredient” for diagnosis or control of food allergies may have led to a false impression. In cases where the cause of a food allergy has been determined, the incidence of allergy to corn is equivalent to the incidence of allergy to rice.”

The popular suspicion of wheat is likely related, to some extent, to the incident in which a Chinese firm supplying many American pet food manufacturers with wheat gluten adulterated their product with melamine, leading to kidney failure, sometimes fatal, in pets who consumed the tainted food. While this is a tragic and infuriating example of venality and inadequate regulation in China, it has nothing to do with the appropriateness of wheat as a pet food ingredient. And while a few breeds, such as the Irish Setter, have genetic gluten sensitivity, in general wheat is a healthy and nutritious ingredient perfectly appropriate as an energy and protein source in pet food.

Corn has also gotten a sinister reputation from popular author Michael Pollan. While I enjoy, and agree with, the balance of Mr. Pollan’s writing, his indictment of the corn industry and the use of corn-derivatives in food products can easily encourage an irrational and hysterical assessment that corn is somehow poisonous and nutritionally vacuous, which is simply not true. Corn and wheat proteins are common allergens for dogs and cats not because they are especially “allergenic” but simply because they are common proteins in pet food. As they are replaced, under the misguided pressure of public mythology, with rice and soy and so on, these newer ingredients will become the predominant allergens in pets who develop hypersensitivities or true allergies to commercial foods.

Hidden Food Ingredients

Pet food manufacturers are often accused of slipping roadkill, old shoes, and all sorts of other bizarre and disagreeable things into commercial pet food. While these companies exist to make a profit and certainly do what they can do encourage the public to view their products favorably, even if this involves a little slight-of-hand when it comes to describing the content of their foods, the reality is that they are legally required to identify any ingredient they use, and there is no evidence that they ignore this requirement in any routine or egregious way. Which brings me to one off the most shocking, and farfetched, concerns about pet food:

Dead Pets in Pet Food

Soylent Green is….Rover? Probably not. Promoters of this story take a few facts and weave them into an unlikely, but shocking narrative. It is true that in some parts of the country, euthanized dogs and cats are disposed of by rendering, a process which breaks whole carcasses down into potentially useful constituents. This is usually done by commercial services, and at facilities, not associated with slaughter and rendering of the agricultural animals generally used as pet food ingredient sources. however, the practice of using rendered cattle as an ingredient in cattle feed, and the subsequent epidemic of Bovine Spongiform Encephalopathy (BSE, aka “Mad Cow Disease) illustrates that there are potential risks to such practices. However, from a purely economic point of view, using rendered pets as an ingredient in pet food makes no sense. Additionally, the Pet Food Institute, an industry lobby which represents the manufacturers of  ~98% of commercial pet foods, specifically prohibits rendered pet ingredients in their members’ products.

 

FDA studies in 1998-2000 did find miniscule quantities of pentobarbital (2-32 parts per billion) in many commercial pet foods. This is an anesthetic often used to euthanize animals, and the finding provided some ammunition for those who claim dead pets have made their way into pet foods.

However, the same studies did not find any cat or dog DNA in the proteins from any of the tested foods. While the source of the pentobarbital was not identified, the best guess is that it comes from small numbers of cattle or possibly horses euthanized and then rendered and used in pet foods. In any case, follow up studies estimated the minimum amount of pentobarbital which has any measurable physiological effect and found that even the smallest dog eating large amounts of the food with the most pentobarbital could not get to this dose. So while the FDA cannot guarantee, that no rendered pet material ever makes it into any pet food, it is highly unlikely, and there is no evidence that even if this were the source of the anesthetic detected that there is any health risk associated with such miniscule amounts of the contaminate.

People concerned about such “toxins,” whether in food or vaccines, often fail to understand the concept of dose-dependent toxicity. As I’ve pointed out before, water and oxygen can kill in sufficient doses, despite being vital for life. And even an anesthetic which, when given as an overdose can kill, can be harmless in quantities measured in parts per billion.

The Role of AAFCO (Association of American Feed Control Officials)

AAFCO is a private organization that establishes non-binding guidelines for the production of animal feeds, including pet foods. While it is not a government agency, only government officials can be members. Most are from the U.S. but there are members from the FDA/USDA equivalents in other countries. It is often labeled, by promoters of raw or home-cooked pet diets, as an organ or lackey of the pet food industry. Industry and private groups can attend AAFCO meetings and contribute advice or information to task forces or working groups, but they cannot vote. Such groups have included pet food manufacturers, but also veterinary groups such as the Academy of Veterinary Nutrition, the American Veterinary Medical Association, and the American Animal Hospital Association, as well as advocacy groups such as People for the Ethical Treatment of Animals, Defend Our Pets, and others.

AAFCO creates guidelines and models but has no regulatory authority. However, their ingredient definitions and nutritional standards are often adopted by the FDA in their regulation of pet foods.  A food can be certified as meeting AAFCO standards based on nutrient analysis done by the manufacturer. Or it can be certified as “feeding trial tested” based on trials conducted by the manufacturer. These often last 10weeks (for growth diets) to 6 months (for maintenance diets) and involve regular clinical and laboratory monitoring. Unfortunately, a food can also be certified as “feeding trial tested” without an actual feeding trial if it is ruled by FDA substantively similar (in the same “product family”) to a food that has undergone feeding trial testing. Clearly,, this is less than ideal but without the political will to fund government testing of all pet foods marketed, these standards at least ensure a minimum level of adequacy, and they are certainly preferable to the complete lack of standards that apply to most home-cooked diets or those marketed outside the official regulatory system. Which leads me to the last category of veterinary nutritional mythology:

“Natural” and “Organic” Foods

By legal definition, to be “natural” an ingredient must come from an animal, plant, or mined source and must be minimally processed (it can be heated, fermented, and so on). Most vitamins added to foods are synthetic and do not meet this requirement. However, to be legally marketed, “natural” foods must still conform to the nutritional standards established by AAFCO and regulated by the FDA. There is zero evidence, of course, that this designation has anything to do with the safety or nutritional value of a food/food ingredient. It’s really a marketing issue, not a scientific one. The popularity of this designation is an example of the “naturalistic fallacy,” the idea that “natural” is synonymous with “good” or “healthy.” Salmonella, hydatid cyst disease, poison oak, and gamma radiation are all “natural,” while most antibiotics, antiparasitics, anti-inflammatories, and cancer treatments aren’t, but if I am unlucky to run into these “natural” things I’d sure like to have the “unnatural” ones around .

“Organic” foods and food ingredients, similarly, have a specific legal definition, enforced by USDA not FDA, that has detailed requirements for how a food ingredient can be grown and processed. The best way to ensure something is truly “organic” is too look for the USDA Organic seal. There is no evidence that food produced by these standards is superior in terms of health and nutrition. There is, however, good evidence that organic production methods have less harmful impact on the environment than more common industrial methods, so there may be some value to the designation despite its unfortunate affiliation with the mythology of the naturalistic fallacy. 

References

 

 

Comprehensive proceedings from the 2009 Hill’s Symposium on Nutrition Myths and Truths, Facts and Fallacies. Cats and Carbohydrates- What are the Concerns.

Cowell CS, Stout NP, Brinkmann MF, et al. Making commercial pet foods (Ingredient myths and facts). In: Hand MS, Thatcher CD, Remillard RL, et al. P (eds). Small Animal Clinical Nutrition, 4th

Edition. Topeka, KS: Mark Morris Institute, 2000; p. 141.

 

Food and Drug Administration/Center for Veterinary Medicine: Report on the risk from pentobarbital in dog food [Online]. Available: http://www.fda.gov/cvm/FOI/DFreport.htm. 31 March 2009.

 

 

Posted in Nutrition | 47 Comments

The David and Goliath Myth

CAM proponents often present a picture of the relationship between CAM and mainstream medicine that is as dramatic as it is fanciful, and it bears a resemblance to the myth of David and Goliath. Scientific medicine is portrayed as a venal cabal of big corporations and corrupt government bureaucracies determined to maintain a lucrative monopoly on health care by suppressing safe and effective, but unprofitable natural cures such as herbs, homeopathy, acupuncture, chiropractic, reiki, and so on. CAM, in contrast, is portrayed as a loosely-affiliated network of individual healers all dedicated to promoting health and well-being and to bringing people the freedom to choose their own path to wellness outside the rigid and coercive structures of government, the Cancer Industry, Big Pharma and the rest of the nefarious medical-industrial complex.

Like most myths, this one contains a few grains of truth amidst the chaff of fantasy and marketing. The pharmaceutical industry, for example is enormous, wealthy, and driven primarily by profit. While there are many individuals working in pharmaceutical and biotechnology research who are dedicated to relieving suffering through science, the institutions exist as entities of the market, and as such they often prioritize their efforts based on profitability, and they often work vigorously to manipulate health care providers, consumers, and government in ways that have more to do with return on investment than promoting health and welfare. Any corporate, for-profit company must consider making money a goal or it ceases to exist. This is true for pharmaceutical companies veterinary hospitals, and — hey, wait a minute. It’s true for herbal medicine manufacturers, dietary supplement companies, chiropractors, acupuncturists, and all those CAM folks too!

Reliable figures are hard to come by, but there’s no doubt CAM is big business. In 2005, consumers spent more than $21 billion on supplements in the U.S. and $66 billion worldwide, according to the Nutrition Business Journal (1). One study estimates total annual CAM sales at £4.5 billion in the UK, $2.4 billion in Canada, and $80 million in Australia.(2) Many of these supplements are sold by corporate giants such as Herbalife (2008 earnings $2.15 billion) and GNC (2008 earnings > $16 million). And even 10 years ago mainstream pharmaceutical giants were getting involved in the vitamin, supplement, and herbal products market, and this involvement has only increased. Most veterinary herbal and neutraceutical products are manufactured by the same pet food and drug giants the CAM community so derides. So in many ways, Big Pharma is Big CAM.

The image of alternative medicine providers as individuals fighting to practice and tell their side of the story against the organized opposition and censorship of mainstream medicine is also disingenuous. The supplement and herbal medicine industry is highly organized and has a vigorous, well-funded lobby that has successfully fought government attempts to regulate their products in a way comparable to other medicines on the market. The United Natural Products Alliance and the Council for Responsible Nutrition are among the biggest supplement industry advocacy and lobbying groups, and they have aggressively and successfully supported a fox-guarding-the henhouse strategy of industry self-regulation and opposed government attempts to require published evidence of safety and efficacy for their products.

Chiropractors are also highly organized, well-funded, and politically active. They successfully defeated the efforts of the American Medical Association to curtail the acceptance of chiropractic as legitimate by government and the health insurance industry. After organizing to defend individual chiropractors against injury lawsuits, the chiropractic lobby supported a successful anti-trust lawsuit which has left the AMA very reluctant to oppose the spread of chiropractic despite its poor evidence of efficacy and its very real risks. (3)

And in the United Kingdom, The British Chiropractic Association has successfully pursued a libel lawsuit against Simon Singh, a journalist who wrote an article in the Guardian Newspaper critical of their promotion of chiropractic for childhood asthma, colic, and other conditions for which chiropractic is proven ineffective. Hundreds of thousands of pounds have been spent by the chiropractic lobby suppressing the evidence-based opinion of one journalist in one newspaper article. This is hardly consistent with the image the industry promotes of itself as the well-meaning and plucky underdog.

CAM proponents often complain about the resistance to their ideas in academic institutions, and portray themselves as inheritors of folk tradition and wisdom that does not require academic validation. Yet they aggressively promote their agendas in these same academic institutions and set up their own credentialing and degree programs to take advantage of the legitimacy and respectability conveyed by the imprimatur of academic institutions they disdain.(2) And while CAM proponents talk about “health care choice” and keeping government out of the business of regulating the claims of health care products, they have successfully supported spending over $1 billion of taxpayer money through the National Center for Complementary and Alternative Medicine at the NIH on research which has yet to validate and clinically significant CAM therapy.

So while the CA as David and the Medical/Industrial Complex as Goliath marketing strategy has been creative and effective, it is not an accurate portrayal of reality. In both CAM and scientific medicine, there are mostly hard-working people genuinely dedicated to relieving suffering. And in both areas, there are venal and unscrupulous individuals seeking money, fame, and other self-serving goals. This has no bearing on the issue that should be the center of any discussion about CAM and science-based medicine, which is what works and what doesn’t. The David and Goliath frame is a fantasy designed to distract from the realities of the evidence and to shield the CAM industry from the scrutiny and supervision mainstream medicine is expected to undergo.

1. Hurley, D. Natural Causes: Death, Lies, and Politics in America’s Vitamin and Herbal Supplement Industry. Broadway Books, New York. 2006.

2. Shapiro, R. Suckers: How Alternative Medicine Make Fools of Us All. Vintage Books, London, 2008.

3. Ernst, E., Singh, S. Trick or Treattment: The Undeniable Factts About Alternative Medicine. W.W. Norton & Company, New York. 2008.

Posted in General | 5 Comments

Licensing Woo in WA

A fellow veterinarian recently drew my attention to a glaring example of the disconnect between the logic of science and the logic of politics, and how Big CAM is, sadly, better at playing politics than scientists seem to be. A proposal has been filed with the Washington state Department of Health to revise the scope of practice for acupuncturists. Apparently, the acupuncture lobby in Washington(1) wants to expand its role in primary health care beyond sticking needles in people. What they are requesting is:

“the addition of seven modalities that will enhance public health. These
modalities are: breathing, relaxation, and exercise techniques; qi gong, health education; in-office testing of temperature, blood pressure, oscultation[sic], weight, body fat percentage, urine, saliva, stool, and blood to assist the practitioner in determining the need for referral to a primary care physician and to assist in treatment; massage and tui na; heat and cold therapies; and recommendations and dispensing of herbs, vitamins, minerals, and dietary and nutritional supplements.”

They would like this new conglomeration of diagnostic and therapeutic techniques to be labeled “Asian Medicine” by the state, since “Acupuncturist” implies they limit themselves to acupuncture, which they clearly do not. Now, it would seem from the perspective of science that the logic of licensing acupuncturists is itself not ironclad. A method of therapy that has never demonstrated itself to be more than an unusually good placebo gains more from the implicit endorsement of government licensure than the public health would seem to gain from regulating the practice. Still, one could argue that regulations such as requiring disposable sterile needles and so forth might be appropriate to minimize the admittedly small harm that acupuncture can do since people are going to have the treatment whether it is licensed or not.

But giving official imprimatur to a hodgepodge of techniques united only by their basis in ephemeral, and unverifiable, energies and forces seems questionable. And allowing practitioners of such methods, who frequently denounce the core principles of scientific medicine, including the germ theory of disease, to handle body fluids and make themselves the first line of primary health care seems obviously misguided. But the logic of politics is not the logic of science. Public demand for the services involved, and the marketing successes of the applicants, will likely count for more than any hard evidence that the practices involved are ineffective and based on erroneous theories.

Still, the political playing field is one we in science-based medicine had better get used to if we truly want to serve public health. So any of you in Washington, take a lok at the proposal and make your voices heard.

1. American Association of Acupuncture and Oriental Medicine (AAAOM)
PO Box 162340
Sacramento, CA 95816
916-443-4770
916-443-4766 Fax
866-455-7999 Toll-Free
Washington Acupuncture and Oriental Medicine Association (WAOMA): 223 members
Advocates for the Advancement of Asian Medicine (AAAM): Unknown number of members
South Sound Acupuncture Association: 29 members
Southwest Washington Acupuncture Group: 26 members

Posted in Law, Regulation, and Politics | Leave a comment

Neoplasene-The Latest Head of the Escharotic Hydra

A reader recently drew my attention to a form of CAM that is particularly dangerous and irresponsible but that like the mythological Hydra manages to raise its ugly head again and again despite efforts to kill it. Its latest incarnation in the veterinary field is as Neoplasene, yet another example of how CAM can achieve success through marketing unsupported by any evidence of real benefit.

According to the marketing materials, the ingredient in Neoplasene is “one of the prominent candidates deserving of the wonder drug designation.”(1) Pretty exciting, no? The promoters go on to follow the well-traveled road of CAM marketing, explaining why scientific medicine has missed the obvious truth, and only the iconoclastic promoters of the “wonder drug” can see it. “[Pathologists] clearly have not made reliable sense out of biopsy analysis…they just aren’t up to the task of reliable diagnostics.”(1) Of course, that doesn’t really matter since “this author…believes that inordinate attention is paid to diagnostics because, until now, little could be done to eliminate neoplastic disease so instead of treatment mainstream protocol has been to study the symptoms a lot and treat the disease a little.”

Oh, instead of studying the disease, we should be treating it!!! Gosh, how could we have been so blind? Oh, maybe because of “the barriers to the development and use of really effective cure oriented chemical treatment of neoplasm which are intertwined with political, economic and regulatory realities.”(1) See where this is going? “Cancer treatment and research are big business. Tremendous resources of facilities, personnel and funding are allocated to address education, equipment, real estate, personnel and patented designer drugs. Big organizations have momentum; they do not change direction easily or quickly…It has been viewed by drug developers that patentability may not be attained on some pharmaceuticals.”(1) So we in mainstream haven’t seen that “these alkaloids clearly attack neoplasm preferentially” and “this fact has been known and largely ignored by pharmaceutical researchers for nearly two hundred years” because of institutional inertia and the fear that we won’t make back the cost of developing such a miraculous cancer cure.

Such clichés seem as obviously ridiculous and unbelievable as the fake moon landing sort, yet they are just as persistent, and even more dangerous in that they drive people away from real medicine and into the arms of CAM.

The Neoplasene marketing materials go on in some detail, using testimonials and sloppy semi-scientific verbiage to clearly claim that the product treats, and even cures cancer, despite a few lame disclaimers to the contrary. And what is this miracle elixir the bloated bureaucracy of scientific medicine has overlooked?

Neoplasene is a derivative of bloodroot, which is one of several caustic herbal products known as escharotics(2). When applied topically in sufficient concentrations, these derivatives burn the flesh and cause tissue necrosis, often leaving thick scabs called eschars, and tremendous local devastation of healthy tissue. The danger of these products is well-illustrated by case reports in the scientific literature(3,4). Though the promoters claim the chemicals somehow recognize cancerous tissue and spare healthy tissue, there is no clinical evidence of this. Some preliminary in vitro research certainly shows the chemicals can kill cells. And there is some limited evidence that they may even be better at killing diseased cells than healthy cells in culture.(5) But when you smear the stuff on your skin to “draw out” the neoplastic cells and leave untouched the healthy tissue, you’re likely to wind up with a gaping hole and a lot of plastic surgery to look forward to. If you’re especially lucky, though, some deeper neoplastic cells will be left behind, and the provider of the salve can then explain why the recurrence or metastasis of your cancer despite its apparent removal by the product is not their fault. Probably chemicals in the water or something.

The promoters of Neoplasene acknowledge, while downplaying, the risk of tissue damage from topical use of their product. They say you should “expect a wound to manage. It size will be in proportion to the extent of the tumor and the amount of Neoplasene compound applied…expect some scarring.”(1) The relevance of their earlier claim that “bloodroot chemicals and Neoplasene are simply not escharotics. They do not burn flesh” isn’t entirely clear, since they seem to be arguing that causing tissue to die and slough off leaving a bloody great hole is fine, so long as it’s through some mechanism other than chemical burn. Hmm.

The FDA has actually gone so far as to ban importation and marketing of bloodroot and other escharotics for cancer treatment, an all-too-rare example of government challenging “Big CAM” which further illustrates how frightening these products are(2). And yet these products are easily found on the Internet and used by a depressingly large number of CAM-oriented veterinarians, likely with a genuine belief that they are curing cancer through a miraculous means ignored by the corrupt and blind medical-industrial complex. I can’t say whether the active use and promotion of such products in the veterinary field, free from government sanction, is due to a loophole in the law or just the fact that the Hydra has many more heads than the FDA has paid investigators.

The only FDA-approved use of a bloodroot derivative, sanguinarine in dentifrice, is no longer popular as it proved to be a significant risk factor for leukoplakia, a potentially pre-cancerous disease(6). And while removal of low-risk, superficial skin tumors can be accomplished with escharotics, there are safer and more effective methods. Far from being a “wonder drug,” these products are an inappropriate and dangerous substitute for real scientific diagnosis and therapy of cancer. And contrary to the nonsense about the venality and blindness of the “cancer industry” and their own great insight, the promoters of Neoplasene are simply the latest head of the corrosive hydra that is bloodroot derivative cancer salves.

1. Fox, T.S. Discussion of and clinical guide for: the treatment of neoplasm, proud flesh and warts with sanguinarine and related isoquinoline alkaloids. Buck Mountain Botanicals, Inc., www.neoplasene.net, 2008.

2. Barrett, S. Don’t use corrosive cancer salves (escharotics); Quackwatch. www.quackwatch.org, 2009.

3. McDaniel, S., Goldman, G.D, Consequences of using escharotic agents as primary treatment for nonmelanoma skin cancer. Arch of Dermatol 2002; 138:1593-1596.

4. Moran, AM., Helm, K.F. Histopathologic findings and diagnostic difficulties posed with use of escharotic agents for treatment of skin lesions: a case report and review of the literature. J Cutan Pathol 2008; 35:404-406.

5. Ahmad, N., et al. Differential antiproliferative and apoptotic response of sanguinarine for cancer cells versus normal cells. Clin Cancer Res 2000; 6:1524-1528.

6. Mascarenhas, A.K., Allen, C.M., Moeschberger, M.L., The association between Viadent use and oral leukoplakia-results of a matched case-control study. J Public Health Dent 2002; 62:158-162.

Posted in Miscellaneous CAVM | 89 Comments