GAO report on dietary supplement flaws released today in Senate hearing

Regular readers know that I hold equivocal views of the broad area of dietary supplements, particularly botanical supplements. On one hand, I have seen some great new compounds come from the systematic investigation of herbal and fungal concoctions to the point that 25% of prescription drugs are derived from natural products. On the other hand, some corners of the dietary supplement industry are little more than turn-of-the-last-century snake oil operations, with offenses so egregious that even their own trade associations try to distance themselves from those who adulterate, mislabel, and misrepresent their wares.
Just use the search box in the left sidebar and search this blog for “adulteration” to get a flavor for some examples (here, I’ve done it for you). Here’s one I haven’t gotten to that I just found thanks to the article mentioned below: the May 1 FDA consumer warning (but not recall) on Vita Breath supplement (for plumb fresh breath!) because it contains 10,000 times the lead content permitted in candy.
In today’s New York Times, Gardiner Harris gives us a preview of a report from the US Government Accountability Office (GAO) that will be presented to a Senate hearing in preparation for an overall plan on US food safety.

Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants, and some supplement sellers made illegal claims that their products can cure cancer and other diseases, investigators found. . .
. . . Senator Herb Kohl, a Wisconsin Democrat who will preside over Wednesday’s hearing of the Senate Special Committee on Aging, said that while improvements had been made in recent years in the oversight of supplements, “the F.D.A. needs the authority and tools to ensure that dietary supplements are as safe and effective as is widely perceived by the Americans who take them.”
Among the witnesses at the hearing will be Dr. Tod Cooperman, president of ConsumerLab.com, a company that has tested over 2,000 dietary supplements made by more than 300 manufacturers and has found that one in four have quality problems. According to Dr. Cooperman’s written testimony, the most common problems are supplements that lack adequate quantities of the indicated ingredients and those contaminated with heavy metals.

Go read and draw your own conclusions. I’ll look forward to seeing the whole report.
P.S. – I may be a little punchy today after a few days of grant reviews but I love that the Senator from Wisconsin is named “Herb.” In fact, Senator Kohl has been a big supporter of the Wisconsin ginseng industry. And Steve Mister, president of the trade group Council for Responsible Nutrition, is referred to as Mr. Mister. I can only think of this.

Orac needs a movie deal. . .

. . .or a spread in Playgirl.
Huh?
Orac has a nice essay today for your Christmas Eve reading about a USA Today article yesterday by Liz Szabo that called out celebrities for their pseudoscientific proclamations and advice entitled, “Are celebrities crossing the line on medical advice?”
So that’s where I came up with this thought: it would be great if some folks who talked science-based sense became celebrities so they’d at least have the same platform to counter people like Jenny McCarthy. On his comment thread, I suggested that we can only hope that Orac someday gets a movie deal and acquires the public celebrity that some of these jokers have.
From Liz Szabo’s USA Today article:

Celebrities have the power to do tremendous good, Hesse says. Lance Armstrong, who survived testicular cancer, has advocated for funding and policy changes to help cancer patients and has raised more than $325 million through his foundation.
“People like Katie Couric and Lance Armstrong can do a lot to teach people that it is important to talk to their doctors about screening for cancer,” Hesse says. “Some would say they have done more for the cause of public awareness for cancer than most scientists.”
Yet celebrities also can spread misinformation much faster than the average person with a wacky theory, Hesse says.
Correcting that misinformation — even with a mountain of evidence — can be a challenge, says Paul Offit, chief of infectious diseases at Children’s Hospital of Philadelphia. “It’s much easier to scare people than to unscare them,” Offit says.

Okay, so maybe we don’t need Orac in Playgirl. Perhaps just winning a few Tours de France or anchoring The Today Show or the CBS Evening News.
But then I thought about the MDs out there who have celebrity. They are also most commonly also jokers who are scaring people or otherwise offering dubious, misleading, and pseudoscience-based advice.
The truth – Eat moderately-sized, primarily plant-based meals, exercise at least three days a week, don’t smoke, and drink alcohol in moderation if you must – is not as glamorous as creating hysteria, feeding conspiracy theories, or trying to sell the latest supplement, book, or “practice.”

Naturopathy drug prescribing proposal in Ontario: Rx for a liability nightmare

Canadian flag.jpgTwo weeks ago, Canadian Skeptics United published on their Skeptic North site a piece by an Ontario pharmacist criticizing a proposal by the province to grant limited prescribing rights to naturopaths. The essay, which was reprinted in the National Post on Tuesday, outlines the intellectual and practical conundrum presented by allowing those with education that diverges from science-based practices to prescribe drugs.
The naturopath lobby has come out in force and appears to be relatively unopposed in the 54 comments that follow, primarily because the NP closes comments 24 hours after online posting. Therefore, those with a more rational and considered viewpoint based in facts have been locked out from commenting. This is quite disappointing to me personally and professionally because of the wildly emotional appeals, strawman arguments, and smears and attacks on the author himself without, of course, addressing his well-founded criticism of the prescribing proposal before the provincial government. At the Skeptic North post, the piece even drew a naturopath who equated the criticism of his/her field with the Nazis and Mussolini. However, ad hominem attacks, especially Godwin’s Law, are quite common when one’s stance is flawed.
Naturopathy, sometimes called naturopathic medicine, is an unusual and inconsistently regulated alternative medical practice that co-opts some evidence-based medicine, often in nutrition and natural product medicines, but also subscribes to “vitalism” (vis medicatrix naturae) and makes use of homeopathic remedies that defy the rules of physics and dose-response pharmacology.
Naturopathy is, however, a warm and fuzzy term, especially when equated with “natural medicine” and the fact that people with naturopathy degrees advertise themselves with the honorific of “Dr.” The increasing popularity of naturopathy is also supported by cultural influences. I’ve written before that many, uh, natural product enthusiasts have become interested in naturopathy following the relocation of musician Dave Matthews from Charlottesville, VA, to Seattle, WA, where his wife, Ashley Harper, earned a naturopathy degree at Bastyr University.
In addition to the description of the practice in the NP op-ed, an excellent review and critical analysis of naturopathy by Kimball C Atwood IV, MD, can be found at Medscape General Medicine. The abstract is as follows:

“Naturopathic medicine” is a recent manifestation of the field of naturopathy, a 19th-century health movement espousing “the healing power of nature.” “Naturopathic physicians” now claim to be primary care physicians proficient in the practice of both “conventional” and “natural” medicine. Their training, however, amounts to a small fraction of that of medical doctors who practice primary care. An examination of their literature, moreover, reveals that it is replete with pseudoscientific, ineffective, unethical, and potentially dangerous practices. Despite this, naturopaths have achieved legal and political recognition, including licensure in 13 states and appointments to the US Medicare Coverage Advisory Committee. This dichotomy can be explained in part by erroneous representations of naturopathy offered by academic medical centers and popular medical Web sites.

Like many alternative practices, naturopathy claims to harness the body’s own healing power as if differentiating that fact-based medicine does not also employ the body’s capacity to heal. The very same drugs that naturopaths wish to prescribe are those which can only work because they interact with targets in the body for which our endogenous compounds already act.
It seems to me that naturopathy adopts either science-based medicine or pseudoscience depending on the venue in which it serves the organization.

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The Detox Delusion: Kudos to Duke Integrative Medicine Nutritionist

Yesterday, the real-life mailbox brought the Pharmboy household the Fall 2009 issue of DukeMedicine connect, a biannual publication on current news from the Duke University Health System. Produced by DUHS Marketing and Creative Services, it “strives to offer current news about health topics of interest” to its readers. This issue is not yet online but you can see the Spring 2009 issue here.
What caught my eye was a cover teaser titled “Detox Delusion” and an article on detoxification diets focusing on an interview with Beth Reardon a nutritionist with Duke Integrative Medicine.
(Note added 17 Nov 2009 – the article is now available online here. The author is June Spence, a freelance writer, author, and blogger at Unshelved)
The article focuses on the fallacy of detoxification diets, extreme and sometimes dangerous regimens of purges, enemas, supplements, herbs, with the misguided goal of clearing one’s body of “toxins.” These amorphous toxins are never named, much less denoted with an IUPAC chemical name, but prey upon the fears of our “chemical” environment.
The article refers to the current “Master Cleanse” craze, known also as the Lemon Cleanse or Maple Syrup Diet. Not mentioned in the article is that the diet was developed in 1941 by an unlicensed practitioner named Stanley Burroughs and popularized most recently in the 2005 Peter Glickman book, Lose Weight, Have More Energy and Be Happier in 10 Days and his MasterCleanse/Raw Food website.
So, I was very pleased to see this:

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Is artemisinin really behind this case of hepatic toxicity?

220px-Artemisinin_skeletal.svg.png
Artemisinin is a natural product isolated from the leaves of the annual wormwood, Artemisia annua. Used originally in Chinese herbal medicine, the pure compound is employed in Africa as an inexpensive antimalarial drug. In April, 2009, the multinational pharmaceutical company Novartis received FDA approval for a combination drug called Coartem®, comprised of the semi-synthetic artemisinin analog, artemether, and another novel antimalarial, lumefantrine.
An herbal preparation of artemesinin has recently been associated with a single case of hepatic injury as reported in this week’s issue of the CDC publication, Morbidity and Mortality Weekly Report (MMWR).

On August 21, 2008, a man aged 52 years in Seattle, Washington, went to his primary-care physician with symptoms of severe fatigue and dark urine. His medical history included lactose intolerance and irritable bowel syndrome but no known hepatic dysfunction or alcohol abuse. His only medication was a multivitamin. Two weeks earlier, the patient had visited a naturopathic provider for long-standing abdominal discomfort that the provider attributed to a parasitic infection after stool studies reportedly showed an “unidentifiable protozoan.” The naturopathic provider had started him on a 6-week course of an herbal supplement containing 100 mg of artemisinin, two capsules orally three times a day, resulting in a dose of 7.5 mg/kg/day of artemisinin. The supplement was manufactured and sold through a company in the United States. Approximately 1 week into therapy, the patient developed worsening abdominal pain and dark urine. Three days later, on August 18, he stopped taking the supplement when his symptoms did not abate, and 3 days after that, he went to his primary-care physician.

I’ll leave it to my clinical colleagues to evaluate whether this workup by the naturopath was appropriate.

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Locopops solves DSHEA dietary supplement labeling issue

In the United States, herbal and non-herbal dietary supplements can be sold without any assurance of safety or efficacy as a result of a hastily-passed, late-night, final-session piece of legislation put forth by Sen Orrin Hatch (R-Utah). (Aside: Utah has several large dietary supplement manufacturers.) This piece of legislation is named the Dietary Supplement Health and Education Act of 1994, or DSHEA. A FAQ for consumers is provided by the US Food and Drug Administration here.
An unusual aspect of the law is that supplement manufacturers can make a variety of wellness or structure-function claims as long as 1) they do not refer directly to disease treatment or prevention and 2) that the following statement appears somewhere on the label and in advertising:

“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”

This statement is lovingly referred to by my physician-blogger colleague, PalMD, as the Quack Miranda Warning. This disclaimer is usually printed in such small font on labels and websites as to be unreadable by people over 35 (the primary dietary supplement demographic) and we all know it is, well, – sensitive readers: please cover your eyes and ears – bullshit. These products are often available in pharmacies, right beside drugs with proven efficacy and known safety profiles. And even though people pay out-of-pocket for these remedies while complaining to the pharmacist about their $20 co-pays on prescription drugs, the industry racks up around $20-30 billion in sales.
So, it was with great mirth that I took this photograph last time the PharmKid and I were at our favorite purveyor of Mexican-style paletas, Locopops (2006 interview with founder, Summer Bicknell, here).
Locopops Cure wide 515px.jpg

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Michael Jackson: Cherilyn Lee, Diprivan® (propofol), and Myers’ Cocktail

Judging from the press inquiries I’ve had since 5 am EDT today, expect today’s focus in the Michael Jackson case to be on the anesthetic drug, propofol (Diprivan®).
Last evening, California nutritionist and registered nurse Ms Cherilyn Lee gave an interview to Campbell Brown on CNN (and this AP exclusive report) describing Michael Jackson’s repeated requests of her for the intravenous sedative drug for his insomnia. She wisely rejected his requests, instead providing him with a vitamin and mineral “energy” injection called Myers’ cocktail.
However, four days before Jackson’s death she reported a frantic phone call from a Jackson staffer to her that led her to believe he had somehow procured the drug or something like it:

While in Florida on June 21, Lee was contacted by a member of Jackson’s staff.
“He called and was very frantic and said, `Michael needs to see you right away.’ I said, ‘What’s wrong?’ And I could hear Michael in the background …, ‘One side of my body is hot, it’s hot, and one side of my body is cold. It’s very cold,'” Lee said.
“I said, `Tell him he needs to go the hospital. I don’t know what’s going on, but he needs to go to the hospital … right away.”
“At that point, I knew that somebody had given him something that hit the central nervous system,” she said, adding, “He was in trouble Sunday and he was crying out.”
[. . .]
“I don’t know what happened there. The only thing I can say is he was adamant about this drug [Diprivan],” Lee said.

In the photo of Ms Lee that accompanies the AP report and the video interview now at ABC News, she looks terrifically distraught and was obviously very concerned about Mr Jackson. My thoughts go out to her as I suspect she is second-guessing what she might have done differently to help him.
What is Diprivan (propofol) and how is it normally used safely?

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“Cosmetic Acupuncture” – seriously?

While I lack the intestinal fortitude of my colleague, Orac, who actively seeks out the most impressive examples of pseudoscience and quackery, examples come to me without even looking for them.
This week’s case is in the form of a book announcement press release from a Denver-based “practitioner” who specializes in cosmetic acupuncture. Yes, the needle without the Botox®.

Martha Lucas, Ph.D., L.Ac., Denver-based acupuncturist and practitioner of Traditional Chinese Medicine (TCM), has authored “Vanity Calamity: Your Guide to Cosmetic Acupuncture for Anti-aging.” The announcement is made by Dr. Lucas who says “Vanity Calamity tells the history of vanity and what women have been willing to do to look younger or more beautiful. Now there’s a healthy, safe option – Cosmetic Acupuncture.

Note that the qualifiers are “healthy, safe” and not “effective.”
And if procedures and books aren’t enough for you, you can blow $375 on a workshop:

An internationally known instructor, Dr. Lucas leads seminars for TCM practitioners about both Cosmetic Acupuncture and Pulse Diagnosis theory. For more information visit: http://www.cosmeticacupunctureseminars.com or http://www.pulseseminars.com

Seems to me that the only wrinkles you’ll fix are the ones on your buttocks where your wallet used to sit.

Who is AP’s Marilynn Marchione and why is she doing such a terrific job exposing alternative medicine dangers and deception?

As tipped off by Brother Orac this morning: from “60 pct of cancer patients try nontraditional med”:

Some people who try unproven remedies risk only money. But people with cancer can lose their only chance of beating the disease by skipping conventional treatment or by mixing in other therapies. Even harmless-sounding vitamins and “natural” supplements can interfere with cancer medicines or affect hormones that help cancer grow.

This is mainstream sci/med journalism done right. Period.

Why we tolerate “mystical mumbo jumbo” in academic medicine

Yet another hat tip this morning to anjou, a regular reader, commenter, and human RSS feed on all things cancer and alternative medicine (not to mention turning me on to Vanessa Hidary, the “Hebrew Mamita” spoken-word artist).
Last night anjou brought to me a superb AP Impact article, Alternative medicine goes mainstream, from medical writer Marilynn Marchione. I know that AP has been skewered as of late by various science bloggers but this particular article by Marchione is one of the best treatments I have seen in the last two years regarding the truth behind the alternative medicine industry and its infiltration into academic medicine.
It’s no surprise then that this article is being picked up extensively by US newspapers this morning.
[See also commentary from my academic physician-scientist colleague, Orac, at Respectful Insolence.]
We in academic medicine are complicit:

They are doing Reiki therapy, which claims to heal through invisible energy fields. The anesthesia chief, Dr. Richard Dutton, calls it “mystical mumbo jumbo.” Still, he’s a fan.
“It’s self-hypnosis” that can help patients relax, he said. “If you tell yourself you have less pain, you actually do have less pain.”

Like “Big Pharma,” there really is such an industry as “Big Woo” that co-opts a little science with classic marketing techniques:

“Herbals are medicines,” with good and bad effects, said Bruce Silverglade of the consumer group Center for Science in the Public Interest.
Contrary to their little-guy image, many of these products are made by big businesses. Ingredients and their countries of origin are a mystery to consumers. They are marketed in ways that manipulate emotions, just like ads for hot cars and cool clothes. Some make claims that average people can’t parse as proof of effectiveness or blather, like “restores cell-to-cell communication.”

“An Associated Press review of dozens of studies and interviews with more than 100 sources found an underground medical system operating in plain sight, with a different standard than the rest of medical care, and millions of people using it on blind faith.”

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