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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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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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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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The drug expiry date: A necessary safety measure, or yet another Big Pharma conspiracy?

Consider this scenario: You’re in good health and take no prescription drugs. You use the following remedies occasionally:

  • Excedrin for the rare migraine
  • Arnica 30CH for bumps and bruises
  • Echinacea capsules, when you feel a cold coming on

Today you look in your cupboard, and notice all three products expired last year. Would you still consider taking any of them? Why or why not?

Your answer is probably influenced by a number of factors, including perceptions of risk and benefit. I’ve encountered patients who believe that drugs are less active as they near the expiration date, and others who see expiry dates solely as marketing ploy from Big Pharma. Few understand how they’re calculated.

Over the past few months I’ve written several posts on different aspects of drug development and testing, including drug interactions, fillers and excipients in drug products, the equivalence testing of generic drugs, and the management of drug allergies. I’ve done this for two reasons. The first is to develop a SBM-oriented resource for common questions and misconceptions about the mechanics of modern medicines. The second, less obvious reason for these posts has been to illustrate the serious credibility gaps with CAM therapies. Largely because of a lax regulatory framework, the CAM industry has ballooned into a multi-billion dollar market without answering basic questions that should be asked of any supplement or drug, “alternative” or otherwise. What’s not well known to consumers, but is glaringly obvious to SBM advocates, is that CAM largely ignores issues of  pharmacology: understanding how a chemical substance, once consumed, behaves in the body. It’s critical to scientific medicine, but an unnecessary step for CAM, where there’s no need to determine if a product has a beneficial biological effect before selling it. Fundamental tests in medicine, like the identification and isolation of an active ingredient, or understanding dose-effect relationships, are simply ignored. As David Gorski and Mark Crislip have pointed out over the past week, we have a reality bias at SBM.  And this bias is equally jarring when it comes to considering expiry dates for products: real drugs, and also CAM.

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Posted in: Basic Science, Herbs & Supplements, Pharmaceuticals

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Funding CAM Research

Paul Offit has published a thoughtful essay in the most recent Journal of the American Medical Association (JAMA) in which he argues against funding research into complementary and alternative therapies (CAM). Offit is a leading critic of the anti-vaccine movement and has written popular books discrediting many of their claims, such as disproved claim for a connection between some vaccines or ingredients and risk of developing autism. In his article he mirrors points we have made here at SBM many times in the past.

Offit makes several salient points – the first being that the track record of research into CAM, mostly funded by the NCCAM, is pretty dismal.

“NCCAM officials have spent $375,000 to find that inhaling lemon and lavender scents does not promote wound healing; $750,000 to find that prayer does not cure AIDS or hasten recovery from breast-reconstruction surgery; $390,000 to find that ancient Indian remedies do not control type 2 diabetes; $700,000 to find that magnets do not treat arthritis, carpal tunnel syndrome, or migraine headaches; and $406,000 to find that coffee enemas do not cure pancreatic cancer.”

The reason for the poor track record is fairly simple to identify – by definition CAM includes treatments that are scientifically implausible, which means there is a low prior probability that they will work. If the treatments were scientifically plausible then they wouldn’t be alternative.

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Posted in: Clinical Trials, Herbs & Supplements, Medical Ethics, Politics and Regulation, Science and Medicine

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Supplements and cancer prevention

The bloggers here have been very critical of a law passed nearly 20 years ago, commonly referred to as the DSHEA of 1994. The abbreviation DSHEA stands for about as Orwellian a name for a law as I can imagine: the Dietary Supplement Health and Education Act. Of course, as we’ve pointed out time and time again, the DSHEA is not about health, and it’s certainly not about education. Indeed, perhaps my favorite description of this law comes from our very own Peter Lipson, who refers to it as a “travesty of a mockery of a sham.” Rather, it’s about allowing supplement manufacturers and promoters of so-called “complementary and alternative medicine” (CAM, with or without a preceding “s,” depending on your taste) who do not want pesky things like government laws and regulations to interfere with their selling of pseudoscience to market various compounds as “dietary supplements” with near-impunity. As Harriet Hall put it so accurately, the DSHEA is “a stealth weapon that allows the sale of unproven medicines just as long as you pretend they are not medicines.”

The DSHEA accomplishes this by making a seemingly reasonable distinction between food and medicine and twisting it in such a way that allows manufacturers to label all sorts of botanicals and various other compounds, many of which have substances in them with pharmacological activity, and sell them as “supplements” without prior approval by the FDA before marketing. As long as the manufacturer is careful enough not to make health claims that are too specific, namely that the supplement can diagnose or treat any specific disease, and sticks to “structure-function” statements (“it boosts the immune system!”), almost anything goes, particularly if a Quack Miranda Warning is included.

Not surprisingly, given what a big business supplements have become in this country largely due to the DSHEA, manufacturers and CAM advocates fight tooth and nail against any attempt to update the DSHEA to correct some of its more unfortunate consequences. Led by Utah Senator Orrin Hatch and Iowa Senator Tom Harkin, who together make up a bipartisan tag-team in defense of the supplement industry and do their best to block any effort to increase its regulation by the FDA. We saw that most recently when Arizona Senator John McCain, of all people, introduced a bill in 2010 to try to tighten up the DSHEA and was thoroughly slapped down by Orrin Hatch. More recently, not satisfied with how good things are for the supplement industry, another Utah Representative Jason Chaffetz reached across the aisle to Jared Polis, teaming up to introduce the Free Speech About Science Act, which basically seeks to allow the supplement industry to make more liberal claims about its products. All it will need is a “peer-reviewed” paper to support it (Mark and David Geier would do!), and you can claim almost anything. Anything to grow the supplement industry, which is currently around $30 billion a year.

That’s why it’s critical, from time to time, to look at actual evidence, and just last week Maria Elena Martinez, PhD, of the University of California San Diego, and co-authors did in a commentary published online in the Journal of the National Cancer Institute entitled Dietary Supplements and Cancer Prevention: Balancing Potential Benefits Against Proven Harms.
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Posted in: Cancer, Herbs & Supplements, Politics and Regulation

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Consumer Reports and Alternative Therapies

Consumer Reports (CR) and its Health Newsletter provide sound advice about nutrition and medicine, with one exception: their recommendations concerning alternative therapies, especially dietary supplements. With regard to dietary supplements, part of the problem is the failure of CR to make a distinction between authentic dietary supplements, such as multivitamins and minerals, and non-vitamin, non-mineral medicinal products. For example, the September 2010 issue of CR contains a table listing “Eleven supplements to consider”. The list includes calcium and vitamin D supplements, and St. John’s wort and Pygeum herbals.

The nomenclatural confusion was created by the Dietary Supplement Health and Education Act of 1994 (DSHEA), which was termed “The Snake Oil Protection Act” by the New York Times. DSHEA, which was passed after a massive lobbying campaign by industry, arbitrarily designated herbals and other traditional medicinal products as dietary supplements. Herbals are used worldwide as medicines and in Europe some are available by prescription only.

The purpose of the Act was to prevent the Food and Drug Administration (FDA) from effectively regulating those products, and it succeeded brilliantly. Sales of dietary supplements rose from $4 billion annually in 1994 to $28 billion in 2007, and reports of severe adverse events caused by those products rose in parallel (1). Another consequence of DSHEA is that designating herbals as dietary supplements misleads consumers about their medicinal nature and conceals their potential for causing severe adverse effects.

The selling points for herbals are that as “natural” products they are safer and gentler than the powerful “foreign” chemicals in purified medications, and they possess unique qualities not found in conventional medications. Dr. Varro Tyler, an expert in the medicinal use of plants, termed those unfounded claims “paraherbalism”, and described herbals as “crude drugs of vegetable origin” (2). In reality, the active ingredients of plants are chemicals that are similar or identical to conventional medications, and many of the latter were first identified in plant extracts. It is no more “natural” to swallow dozens of chemicals in a plant extract than to ingest a single purified chemical – a drug is a drug. Before discussing CR’s advice about supplements, it is necessary to consider briefly basic differences between herbals and conventional medications.

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Posted in: Herbs & Supplements, Legal, Science and the Media

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Spring Update on Prior Posts

Although I write the definitive entries on topics in this blog, new information trickles in after publication.  The new studies are often not worth an entire entry, recapitulating prior essays, but the new information is still worth a mention.  What follows are updates on topics covered in  prior SBM posts.

Raw Milk

In Oregon we are having a small outbreak of infections from consumption of raw milk.  Not a surprise, since milk is a wonderful culture media and the udder is just down the gravity well from the cows anus.  Raw milk violates the classic dictum “Don’t shit where you eat” although I understand the saying concerned dating in its original conception.

Although the sale of raw milk is illegal in muchof the US,  the law can be bypassed by owning the cow rather than buying the milk,  a reverse of dating advice.  Such is the case in Oregon, where 48 people are time sharing the cows responsible for the current outbreak.  There has been the spread of pathogenic E. coli to at least 5 people, mostly  children, and has lead to the hospitalization of at least 3 children.

Of course, it is hard to get infected. Humans have lived in Filth and Squalor (like Minneapolis and St. Paul or Buda and Pest) for centuries, drinking and eating contaminated food and enough survived perpetuate the species.  Most infections in the past would have been from consuming contaminated food and drink.  I have wondered if the reason fevers are often associated with diarrhea and/or vomiting is that it an evolved response for removing infected material as soon as possible.
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Posted in: Acupuncture, Herbs & Supplements, Homeopathy, Nutrition

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