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Archive for May, 2012

POM: Not So Wonderful

“POM Wonderful” is a brand of pomegranate juice. It is manufactured by a company owned by Linda and Stewart Resnick, California billionaires who pretty much single-handedly created a multi-million dollar market for pomegranate juice where none existed before. Or, as LA Times columnist Michael Hilzik wrote,

It has long been clear that the most wonderful thing about Pom Wonderful pomegranate juice is the spectacular marketing skill that persuades consumers to fork over their hard-earned cash for a liquid that sells for five to six times the price of, oh, cranberry juice.

He’s right about the expense: a daily 8 oz. dose of POM Wonderful juice costs about $780 annually according to a recent Federal Trade Commission case, which we’ll get to soon.

The Resnicks parlayed their success selling pomegranate juice into two additional products, both dietary supplements, in the form of POMx pills and POMx liquid. The Resnicks and their companies have shelled out $35 million in sponsored research to determine what health benefits might arise from ingesting pomegranate juice or its components, research they have not been shy about using in touting their products. The couple apparently has a flair for taking the mundane and making it appear, well, wonderful to the consumer – they also own Fiji Water and the Franklin Mint, among other business interests.

In 2010, the Federal Trade Commission (FTC) filed a complaint against Resnicks, one of their business partners, and two of their companies (which I’ll refer to collectively as “POM”), alleging unfair and deceptive trade practices. POM, according to the FTC complaint, made false and misleading claims that its POM products treat, prevent, and reduce the risk of heart disease, prostate cancer and erectile dysfunction.

An Administrative Law Judge (ALJ) agreed with the FTC and on May 17, 2012, issued a 335-page decision and cease and desist order, ruling POM lacked competent and reliable scientific evidence that drinking 8 ounces of POM Wonderful Juice daily, or taking one POMx pill, or one teaspoon of POMx liquid, treats, prevents or reduces the risk of heart disease, prostate cancer, or erectile dysfunction. In the Matter of POM Wonderful, LLC, et al., F.T.C. No. 9344 (May 17, 2012).

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Posted in: Clinical Trials, Herbs & Supplements, Legal, Nutrition, Politics and Regulation

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Reporting Preliminary Findings

While scanning through recent science press releases I came across an interesting study looking at the use of a pharmaceutical grade antioxidant, N-Acetylcysteine (NAC), in the treatment of certain symptoms of autism. This is a small pilot study, but it did have a double-blind placebo controlled design. The press release reports:

During the 12-week trial, NAC treatment decreased irritability scores from 13.1 to 7.2 on the Aberrant Behavior Checklist, a widely used clinical scale for assessing irritability. The change is not as large as that seen in children taking antipsychotics. “But this is still a potentially valuable tool to have before jumping on these big guns,” Hardan said.

But concluded:

“This was a pilot study,” Hardan said. “Final conclusions cannot be made before we do a larger trial.”

I also noticed that two of the authors list significant conflicts of interest – patents on the use of NAC, and one has equity in the company that makes it.  It occurred to me that a larger question than the efficacy of NAC for these autism symptoms is this – if this is a pilot study only and we should not base any firm conclusions on the results, then why the press release?

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Posted in: Herbs & Supplements, Science and the Media

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“How do you feel about Evidence-Based Medicine?”

That was the question asked on a Medscape Connect discussion

I did a double-take. How do you feel? Could anybody object to the idea of basing treatments on evidence? The doctor who started the discussion asked:

Besides using EBM, a lot of my prescribing comes from anecdotal experience and intuition. How about you? Where do you get your information from that you use to treat your patients? Do you always ascribe to EBM, or do you deviate from it with certain medical conditions/patients?

I had naively thought that my profession uniformly embraced EBM. How could they not? The commenters broke my bubble big-time. Some of them summarily reject EBM… although it appears that what they are rejecting is not what I understand EBM to mean. (more…)

Posted in: Science and Medicine

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Bleaching away what ails you

I’ve been at this blogging thing for over seven years, over four of which I’ve been honored to be a part of this particular group blog dedicated to promoting science as a basis for rational medical therapies. For three or four years before that seven year period began, I had honed my chops on Usenet in a group known as misc.health.alternative (m.h.a.). So, although I haven’t been at this as long as Steve Novella, I’ve been at it plenty long, which led me to think I had seen just about everything when it comes to pseudoscience and quackery.

As usual whenever I think I’ve seen it all, I was wrong.

I’m referring to something that has been mentioned once before on this blog, namely something called “Miracle Mineral Solution” (MMS). I must admit that after a brief reaction of “WTF?” I basically forgot about it. I shouldn’t have; I should have looked into it in more detail at the time. Fortunately, being a blogger means never having to say you’re sorry (at least about not having caught a form of quackery the first time it made big news), and fortunately MMS was brought to my attention in the context of an area of quackery that I frequently blog about. You’ll see what I mean in a minute.

What happened is that MMS was brought to my attention again by a couple of readers and, not remembering it other than vaguely, I did what I always do when confronted with these situations. I Googled, and I found what I needed to know. Basically, MMS is 28% sodium chlorite in distilled water. In essence, MMS is equivalent to industrial strength bleach. Proponents recommend diluting MMS in either water or a food acid, such as lemon juice, which results in the formation of chlorine dioxide.
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Posted in: Health Fraud, Neuroscience/Mental Health, Vaccines

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What to make of Medical Dogs

For thousands of years we have guided the evolution of dogs to fulfill our needs for work and companionship.  Service dogs are pretty remarkable.  I love to watch herd dogs mimicking the dance of predator and prey.  When you see a guide dog help someone navigate a building or street, you can’t help but to be impressed by the dogs “devotion” and “skill”.

It seems there is a new canine skill in the news every day.  Now, in addition to the traditional roles guiding the blind and deaf, and helping the physically disabled, dogs are claimed to be able to calm autistic children, detect blood pressure changes and seizures, and find cancers. Dogs have been used in the bed bug epidemic to find the critters (with little scientific evidence of success).

Humans and dogs have co-evolved successfully to create strong owner-dog attachments (to the point of pit bull owners defending their dogs rather than acknowledging a dog’s danger to humans).  It seems intuitive, and is quite plausible, that dogs can calm us, can help lead us in ways analogous to their roles in nature (if “natural” can even be applied to dogs). It’s easy to see how herding behavior can be adapted into guide dog behavior, or hunting behavior into chemical detection.

What’s less clear is whether any of these roles are based on fact rather than intuition.
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Posted in: Science and Medicine

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Choosing Wisely: Five things Pharmacists and Patients Should Question

Is the health care spending tide turning? Unnecessary medical investigations and overtreatment seems to have entered the public consciousness to an extent I can’t recall in the past. More and more, the merits of medical investigations such as mammograms and just this week, PSA tests are being being widely questioned. It’s about time. Previous attempts to critically appraise overall benefits and consequences of of medical technologies seem to have died out amidst cries of “rationing!” But this time, the focus has changed – this isn’t strictly a cost issue, but a quality of care issue.  It’s being championed by the American Board of Internal Medicine Foundation (ABIM) under the banner Choosing Wisely with the support of several medical organizations. The initiative is designed to promote a candid discussion between patient and physician: “Is this test or procedure necessary?”. Nine organizations are already participating, represent nearly 375,000 physicians. Each group developed its own list based on the following topic: Five Things Physicians and Patients Should Question. Here are the lists published to date:

ABIM has partnered with Consumer Reports to prepare consumer-focused material as well, so patients can initiate these discussions with their physicians. How did this all come to be? A candid editorial from Howard Brody in the New England Journal of Medicine in 2010:

In my view, organized medicine must reverse its current approach to the political negotiations over health care reform. I would propose that each specialty society commit itself immediately to appointing a blue-ribbon study panel to report, as soon as possible, that specialty’s “Top Five” list. The panels should include members with special expertise in clinical epidemiology, biostatistics, health policy, and evidence-based appraisal. The Top Five list would consist of five diagnostic tests or treatments that are very commonly ordered by members of that specialty, that are among the most expensive services provided, and that have been shown by the currently available evidence not to provide any meaningful benefit to at least some major categories of patients for whom they are commonly ordered. In short, the Top Five list would be a prescription for how, within that specialty, the most money could be saved most quickly without depriving any patient of meaningful medical benefit.

Health care professionals are, in general, self-regulating professions. That is, governments entrust them to set the standards for their profession and regulate members, in the public interest. Consequently, attempts by payors of services (i.e., government and insurers) to guide medical practice are usually met with substantial resistance. No-one wants insurers interfering in the patient-physician relationship. That’s why it’s exciting to see this initiative in place -it’s being driven by the medical profession itself.

As a pharmacist I’m also a member of a self-regulating profession, one in which the public places a considerable degree of trust in. In order to maintain the public’s confidence, it is essential that the pharmacy profession maintain the highest professional and ethical standards, and do its part to reduce unnecessary testing and investigations. With this in mind, I’ve taken up Brody’s challenge and developed my own list of Five things Pharmacists and Patients Should Question. While eliminating them may not provide the most savings to patients, they are pharmacy-based, widely offered, and offer little to no benefit to consumers. Here are my top five candidates: (more…)

Posted in: Health Fraud, Pharmaceuticals, Politics and Regulation, Science and Medicine

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Bee Pollen Supplements – Not Safe or Effective

Among the myriad of supplements being offered to the public are various bee products, including bee pollen. The claims made for bee pollen supplements are typically over-hyped and evidence-free, as is typical of this poorly regulated industry. The claims from bee-pollen-supplements.com are representative:

The benefits are enormous and the substance has been proven by many health experts. This particular substance is known as an effective immune booster and one of the best ways to achieve a sound nutritional regime.

The pollen from the bee has been proven to increase sexual functions in both men and women. It stimulates our organs, as well as our glands and is known to improve the natural increase on a person’s lifespan.

What you never find on such websites are references to published peer-reviewed studies that substantiate the specific claims being made. There are also concerns about safety which have not been adequately studied.

Safety

A recent case report highlights one safety concern regarding bee pollen products – allergic and even anaphylactic reactions. The Canadian Medical Association Journal reports:

A 30-year-old woman with seasonal allergies but no history of allergies to food, drugs, insects or latex had an anaphylactic reaction after taking bee pollen. She had swelling of the eyelids, lips and throat, difficulty swallowing, hives and other life-threatening symptoms. After emergency treatment and discontinuation of the bee pollen supplements, there were no further reactions.

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Posted in: Herbs & Supplements

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Bach Flower Remedies

May is the month associated with flowers, so I thought it would be timely to look at flower remedies. You may have heard of “rescue remedy” or other Bach flower remedies. (The preferred pronunciation is “Batch,” but it’s also acceptable to pronounce it like the composer.) They contain a very small amount of flower material in a 50:50 solution of brandy and water, and are said to work by transmitting a vibrational energy through the memory of water (not the same as homeopathy, but equally implausible).

Bach was trained as a homeopath and even created some bacterial homeopathic nosodes, but then he branched out. He used his intuition to access a psychic connection to plants. He would hold his hand over different plants to see which one affected his emotional state, and he would collect the dew from that plant to use as a remedy.

The Remedies

A facsimile edition of Bach’s 1936 book The Twelve Healers is available free on the Internet. It makes interesting reading. It starts off:

From time immemorial it has been known that Providential Means has placed in Nature the prevention and cure of disease, by means of divinely enriched herbs and plants and trees. The remedies of Nature given in this book have proved that they are blest above others in their work of mercy; and that they have been given the power to heal all types of illness and suffering.

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Posted in: Energy Medicine, Herbs & Supplements

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More “bait and switch” acupuncture studies

Acupuncture has been a frequent topic on this blog because, of all the “complementary and alternative medicine” (CAM) modalities out there, it’s arguably the one that most people accept as potentially having some validity. The rationale behind acupuncture is, as we have explained many times before, little different than the rationale behind any “energy healing” method (like reiki, for example) in that it claims to redirect the flow of “life energy” (the ever-invoked qi). The only difference is that acupuncturists claim to bring this therapeutic qi rearrangement about by sticking thin needles into the pathways in the body through which this qi is fantasized to flow. These pathways, called meridians, are just as much a fantasy as qi itself or the “universal source” that reiki masters claim to be able to channel through themselves and into believers. Contributing to the popularity of acupuncture is its mythology as having been routinely practiced for over two thousand years, a myth that was the creation of Chairman Mao, who elevated what was a marginal practice at the time to a modality that the state supported and promoted (1,2,3,4).

In addition, because acupuncture involves sticking actual metal objects into the skin rather than simply laying on hands or making magical gestures over the patient, it retains some credibility, even among doctors. It doesn’t matter that, reviewing the totality of the research, one finds that it doesn’t matter where you stick the needles or even if you stick the needles in the skin. The results are the same and indistinguishable from placebo. The inescapable conclusion is that acupuncture is placebo medicine with needles. Personally, I’d prefer my placebo medicine without needles, but that’s just me.

Yet, the studies keep rolling in, trying desperately to demonstrate that acupuncture works or assuming that acupuncture works . Two more popped up within the last couple of weeks, and one of them, if you read the press releases, sounds really convincing. As is frequently the case, for this latter study, there is less to it than meets the eye. I’ll start, however, with a study that is a followup to a study I blogged about a couple of years ago that I characterized as another overhyped acupuncture study misinterpreted. This one, thankfully, is not nearly as hyped as the study from two years ago—or as the second study I will discussed, but it is very instructive how the original misinterpreted story is leading to a classic CAM “bait and switch” applied to acupuncture.
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Posted in: Acupuncture, Basic Science, Energy Medicine, Science and the Media

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Cannibalism?

For all the goofiness that is SCAM, I never thought I would have a post with Cannibalism in the title.  The ability for humans to find imaginary healing properties in everything from duck liver and heart diluted 1:100 200 times, rhinoceroses horns, and waving hands over people to adjust energy fields that do not exist is remarkable.  Somehow I never thought Jeffrey Dahmer would be at the forefront of alternative therapies.

Wednesday evening while my wife was reading me the paper (it is how I usually consume the local newspaper, my wife reads stories she finds of interest out loud.  Otherwise I do not think I would bother with anything beyond the comics and sports page) she let it be known that Korean officials has confiscated medications containing aborted fetuses and stillborn babies.  Instead of the usual distracted, uh huh, that’s interesting, this caught my attention.  Say what?

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Posted in: Herbs & Supplements, Pharmaceuticals, Science and Medicine

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