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5-hour Energy

What should you do if you feel tired? Taking a nap isn’t always possible. The ever-inventive capitalist marketplace has come up with another option.

5-hour Energy is a flavored energy drink sold as 2 oz “shots.” It was invented by Innovation Ventures in 2004. It is intended to counteract the afternoon slump, to increase alertness and energy, to help you stay sharp, improve attention, leave grogginess behind and sail through your day.

Ingredients

According to the label, its ingredients are:

  • Niacin 30 mg — 150% of the RDA
  • Vitamin B6 40 mg — 2000% of the RDA
  • Folic acid 400 mg — 100% of the RDA
  • Vitamin B12  500 mcg — 8333% of the RDA
  • Energy blend: taurine, glucuronic acid, malic acid, N-acetyl L tyrosine, L-phenylalanine, caffeine, and citicoline. Total amount of blend: 1870 mg. The caffeine content is not specified on the label, but it is supposedly comparable to a cup of the leading premium coffee.

It contains only 4 calories, with no sugar.

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Posted in: Herbs & Supplements

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Quackademic medicine trickles out to community hospitals

One of the major themes of this blog has been to combat what I, borrowing a term coined (as far as I can tell) by Dr. R. W. Donnell, like to refer to as “quackademic medicine.” Quackademic medicine is a lovely term designed to summarize everything that is wrong with the increasing embrace of so-called “complementary and alternative medicine” (CAM) or, as it’s increasingly called now, “integrative medicine” (IM) into academic medical centers. CAM/IM now a required part of the curriculum in many medical schools, and increasingly medical schools and academic medical centers seem to be setting up IM centers and divisions and departments. Fueled by government sources, such as the National Center for Complementary and Alternative Medicine (NCCAM) and private sources, such as the Bravewell Collaborative (which has been covered extensively recently not just by me but by Kimball Atwood, Steve Novella, and Mark Crislip), academic medical centers are increasingly “normalizing” what was once rightly considered quackery, hence the term “quackademic medicine.” The result over the last 20 years has been dramatic, so much so that even bastions of what were once completely hard-core in their insistence on basing medicine in science can embrace naturopathy, Rudolf Steiner’s anthroposophic medicine, reiki and other forms of “energy healing,” traditional Chinese medicine, and even homeopathy, all apparently in a quest to keep the customer satisfied.

Of course, in a way, academia is rather late to the party. CAM has been showing up in clinics, shops, and malls for quite a while now. For example, when I recently traveled to Scottsdale to attend the annual meeting of the American Society of Breast Surgeons, I happened to stop in a mall looking for a quick meal at a food court and saw this:

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Posted in: Acupuncture, Herbs & Supplements, Medical Academia, Medical Ethics, Science and the Media

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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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