Via Terra Sigilatta (who beat me to this one, as I saw the press release yesterday but never got around to blogging about it), we find yet another case of heavy metal contamination of a popular supplement, this time herbal kelp supplements. This discovery was prompted by the investigation of a case of woman who suffered real harm from these supplements:
The new study, published in this month's issue of Environmental Health Perspectives - available online at www.ehponline.org - was prompted by the case of a 54-year-old woman who was seen at the UCD Occupational Medicine Clinic following a two-year history of worsening hair loss, fatigue and memory loss.
The woman's symptoms had begun with minor memory loss and fatigue. Her primary care physician initially found nothing wrong with the woman and thought the symptoms were related to menopause. With no specific diagnosis or treatment recommendations, the patient started taking a variety of herbal therapies, including a kelp supplement, fish oil, ginkgo biloba and grape seed extract. The kelp supplement was the only herbal therapy she took regularly throughout the course of her illness.
Over a period of several months, the woman's short- and long-term memory became so impaired that she could no longer remember her home address. She also reported having a rash, nausea and vomiting, which made it very difficult to work and forced her to leave a full-time job. The woman actually increased her dosage of kelp from two to four pills a day after her doctors still could not find a clear diagnosis.
Bad move, because this is why the woman was having problems:
A study of herbal kelp supplements led by UC Davis public health expert Marc Schenker concludes that its medicinal use may cause inadvertent arsenic poisoning and health dangers for consumers, especially when overused.Schenker and two researchers evaluated nine over-the-counter herbal kelp products purchased at Davis stores and found higher-than-acceptable arsenic levels in eight of them.
Names of the brands and stores were not released. Schenker said the samples were tested in a blind study, meaning the samples were not labeled so researchers did not know which brand or store each sample was from.
Further, Schenker said the arsenic levels appear to vary from batch to batch. So, a brand that appears safe in one batch may have high arsenic levels in another.
Why the hell didn't they release the brand names of the kelp supplements with the excessively high levels of arsenic in them? In a blinded study, even a blinded clinical study, there is an investigator who can break the code and unblind the experimental groups to reveal which one is which. The specific brands and lots that were contaminated should have been published in the paper! The only reason I can think of for not publishing them is fear of legal action by the manufacturers. Be that as it may, the woman's kelp supplements contained 8.5 ppm arsenic, with FDA recommendations being no more than 0.5-2.0 ppm for certain food products. Here are the symptoms of chronic arsenic poisoning, as described in the article:
Chronic arsenic toxicity may cause peripheral neuropathies, parasthesia, ataxia, cognitive deficits, fatigue, and muscular weakness. GI complaints include anorexia, hepatomegaly, jaundice, nausea, and vomiting. Skin afflictions may include erythema, eczema, pigmentation (arsenic melanosis), diffuse alopecia, keratosis (especially of palms and soles), scaling and desquamation, brittle nails, white lines or bands in the nails (Mees lines), and localized subcutaneous edema. White striae in the fingernails are consistent with a diagnosis of arsenical polyneuritis, even though urine and hair arsenic concentrations may be within normal limits (Heyman et al. 1956).
Manifestations of chronic arsenic ingestion depend on both the intensity and duration of exposure. Our case had a more severe presentation than would be expected with an elevated urinary arsenic concentration of 83.6 μg/g creatinine. The intensity of her symptoms may have been the result of her lengthy duration of exposure or perhaps of an undiagnosed underlying condition. Also, that a single spot urine may not be as accurate as a 24-hr urine sample, despite adjustment for creatinine concentration.
And this is far from the only example of such problems:
A number of published studies have highlighted cases in which homeopathic remedies cause clinical arsenic toxicity. One such study describes 74 patients in Singapore who were victims of chronic arsenic poisoning caused by local antiasthmatic herbal preparations (Tay and Seah 1975). Systemic involvement mainly affected the patients' skin (hyperpigmentation, hyperkeratosis), nervous system (polyneuropathy, tremors, headache), and GI system (gastroenteritis, toxic hepatitis). Of the 74 patients studied, 10 presented with malignancies. Of the 29 herbal preparations analyzed in this study, 16 contained inorganic arsenic in concentrations of 25-1,000 ppm, and 10 contained 1,001-50,000 ppm.
Mitchell-Heggs et al. (1990) reported on a 33-year-old Korean woman who presented with malaise, difficulty walking, arthralgia, and diarrhea. Her elevated urine and blood arsenic levels were linked to an herbal treatment for hemorrhoids, which contained 10,000 ppm arsenic. The patient recovered completely after ceasing her usual dosage of 90 pills/day (50 mg/day).
Espinoza et al. (1995) analyzed traditional Chinese herbal balls, which are taken for a variety of conditions, including rheumatism and cataracts. The herbal balls were found to contain up to 36.6 mg arsenic per ball. The authors concluded that with a "recommended dose" of two herbal balls daily, the preparation "poses a potentially serious health risk to consumers." They advised that "health professionals should be aware that patients who consume traditional Chinese remedies may be exposed to potentially toxic substances" (Espinoza et al. 1995).
Fortunately, the story that prompted this study has a happy ending:
At her physician's suggestion, the patient discontinued the kelp supplement. Within weeks, her symptoms disappeared, and within several months arsenic was no longer detected in her urine and its levels had dropped significantly in her blood.
She later was referred to the UCD Occupational Medicine Clinic as a follow-up to her primary care.
When I say that I want to see "alternative" medicines treated the same way as "conventional" medicines, cases like this one are another reason why.
Why the hell do you have to do a blinded study when determining arsenic contamination? This makes no sense to me. I understand that in certain types of assays (perhaps a cell counting assay) with some sort of human judgement on calls would definitely require some sort of blinding, but an analytical assay, where the machine certainly doesn't know the difference between samples, this strikes me as somewhat ridiculous.
"A number of published studies have highlighted cases in which homeopathic remedies cause clinical arsenic toxicity."
If homepathic medicines are supposed to be pure water with a trace of almost nothing how to they get to have enough arsenic in them to be toxic? Totally sloppy production methods?
Yes, where is the arsenic coming from, or did I miss it somewhere in the various quotes?
The article seems to be confusing "homeopathic remedies" with "herbal remedies." While I realize that the general public often doesn't know the difference, one would think the writers here would be more careful.
There can be some "memory" effects when analyzing samples for trace metals (in some machines), so the order that samples are delivered to the machine can make a difference. That is a common effect in AA and ICP type analyzers. But usually the differences are small, and in the modern equipment that UC Davis has, likely not an issue at all.
I think you are right that in this case, the "blinding" was to protect the researchers from legal liability, or from the need to hire a lawyer, or waste time defending their study from legal attack, which would most likely cost more than the entire study.
I think in fairness to them, people might take a low arsenic value in the brand that they use as "proof" that it is safe even though because of lot differences it might not be. The prudent default would be to assume it is contaminated unless proven otherwise.
If you look at the problems the dog food industry is having right now, quality control is just not an issue that the suppliers of these products and raw materials have as a priority.
Daedalus2u: Pet food industry. It's not just dogs; most of the confirmed fatalities were cats. I'm just glad that my cats don't eat any of the affected brands, and my renal failure kitty had problems long before the contaminated food hit the market. CRF kitty died last December.
Umm.. Orac, do you know of any veterinary blogs that provide skeptical coverage of alternative medicine? Evolution Diet is pushing a vegetarian diet for pets, and has a link to a paper pushing fringe pet nutrition and yelping about a pet food industry/big pharma conspiracty. The paper references several names, of which I recognized two: Dean Ornish and Lorraine Day. I'd really like someone qualified to have at it.
The answer to why this has, does and will happen lies here:
Dietary Supplement Health and Education Act of 1994 (DSHEA)
http://www.cfsan.fda.gov/~dms/dietsupp.html
"For decades, the Food and Drug Administration regulated dietary supplements as foods, in most circumstances, to ensure that they were safe and wholesome, and that their labeling was truthful and not misleading. An important facet of ensuring safety was FDA's evaluation of the safety of all new ingredients, including those used in dietary supplements, under the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, with passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress amended the FD&C Act to include several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. As a result of these provisions, dietary ingredients used in dietary supplements are no longer subject to the premarket safety evaluations required of other new food ingredients or for new uses of old food ingredients."
Essentially, these are the doings of Orin Hatch, Senator from Utah:
Scorin' with Orrin: How the gentleman from Utah made it easier for kids to buy steroids, speed, and Spanish fly.
By Stephanie Mencimer, 9/01
http://www.washingtonmonthly.com/features/2001/0109.mencimer2.html
Executive Interview: Q&A with Senator Orrin Hatch
2006-02-16 - By Suzanne Shelton
http://www.npicenter.com/anm/templates/Exec_Series.aspx?articleid=14911…
"I am adamantly opposed to pre-market approval for supplements. Consumers would be hurt, and it would be the death knell of this industry. FDA approval is an extremely costly, lengthy process. The majority of supplements cannot be patented, and there would be no financial incentive for manufacturers to undergo that approval process. In addition, all recognize that the vast majority of supplements are safe, and have been used safely for centuries if not millennia. That is why DSHEA "grandfathered" supplements on the market as of the date of enactment, and set up a process for FDA pre-notification (as opposed to pre-clearance) for those products."
NPIcenter
http://www.npicenter.com/default.aspx
His son is a lobbyist for the industry - from the bottom of this page.
http://www.sourcewatch.org/index.php?title=Scott_D._Hatch
"Althealth News (UK), April 19, 2005: "Sen. Orrin Hatch (R-Utah) is seen as the key legislator behind the exemption for DHEA: Many dietary-supplement makers are based in Utah, and Hatch lobbied to keep DHEA on the market when Congress was drafting anti-steroid legislation last year. Scott Hatch, the senator's son, is a lobbying for a trade association for the supplement industry.""
This industry has a major presence in Utah:
http://www.edcutah.org/datacenter/publications/documents/TopDietarysupp…
Part of this dance is passing enabling legislature, which allows legislators to beat their chests about all they are doing on an issue, but not funding the regulatory mandate, forcing the agency to prioritize it's efforts behind the scenes. My definite impression from people more directly involved in this issue is that Hatch's real message to the FDA was and is "hands off", despite his public statements to the contrary.
FDA Dietary Supplements
http://www.cfsan.fda.gov/~dms/supplmnt.html
FWIW.
Even in an analytical study, there is the potential for bias. If a sample doesn't come out the way you expected it to, you may wonder if you screwed it up (maybe you spilled some of it, or got the vials mixed up, or the assay was incorrectly calibrated) and re-run the sample. But you don't rerun the samples where the result is what you expected, so you are more apt to catch errors that reinforce your expectations than errors that are contrary to expectation. This introduces a bias that could affect your conclusions.
Of course, that's still no reason not to break the code and publish the identify of the samples once the study is over.
Interesting article on the kelp supplements. There are no problems with these alternative supplements, it's the people who take them. If prescription medicine didn't have a doctor's advisement of how many pills to take, it would be the same thing said about those medicine's too. And, it should be mentioned that those who take prescription medicines, do sometimes overdose by not following directions.
Should alternative supplements, homeopathic remedies, be regulated by doctors? Perhaps at one time in the history of medicine, herbs and foods were the preferred method of wellness, dating back hundreds if not thousands of years (hippocrates?) until pharmaceutical companies got a hold of medicine.
the lesson? Be informed. Do your research, don't get caught up in the latest health fad.
Who the heck would down that much kelp anyway?
Jill, it's a strong statement that there are no problems with these supplements, one which seems at odds with the evidence. In the linked article, Schenker is quoted stating:
How is that not a problem? This arsenic is not a beneficial additive, but a potentially dangerous contaminant and, unless I misinterpret this statement, one unknown to the consumer. Although you are correct in stating that prescription drugs can be dangerous when misused, that's the very reason why they are regulated. The requirements for safety and efficacy, although not perfect, are greatly preferable to the laissez-faire treatment of "herbal supplements".
Quoted from Jill:
Why should that be mentioned, unless you're seeking to take a defensive jab at "big pharma" because you're feeling threatened by criticism of supplements? Those who take prescription medicines can generally expect not to have dangerous amounts of arsenic in them!
Perhaps at one time herbs and foods were indeed preferred, but so what? At one time in the history of medicine, many illnesses that are now eminently treatable were often deadly. Personally, I'd much rather take advantage of the new understanding brought to us by scientists and the great achievements of doctors than trust in fairy tales about the wisdom of the ancients. Frankly, I'd be disappointed in Hippocrates if he had a chance to live in our time yet disregarded modern knowledge.
Speaking of doing research, you'd probably do better to have done some of your own than to point vaguely at Hippocrates, "hundreds if not thousands of years ago", if you really intend to convince us that "herbs and foods" are a valid alternative to modern medicine. You seem to be hinting that the current importance placed on pharmaceuticals is due to some plot of the industry against good medicine, but you don't provide any evidence of this. Sure, pharmaceutical companies can be as greedy as any other business, but that doesn't mean that their products aren't useful. Big altie is often at least as corrupt as big pharma, but largely exempt from proper regulation.
All this isn't to say that herbs are never helpful. As Orac says at the end of this piece, it would be good if "alternative" treatments were treated like "conventional" ones. If a herb does good, great! Let's do the science to determine what it does and how safely, treating it like any other medicine. Leaving consumers to do their own "research" in supplements is hardly better than asking them to sort through the claims of the old nostrum vendors.
Who the heck would down that much kelp anyway?
Somebody who believes the sales hype that it contains lots of concentrated natural minerals taken up from sea-water; all these healthy, natural minerals that are totally lacking in our depleted modern diet mean that kelp can cure all sorts of things, like weight gain, tiredness, hair loss et al (according to said sales hype).
Unfortunately, kelp can't tell the difference between 'good' minerals, like iodine, and 'bad' minerals, like arsenic.
anon,
You are correct to assign blame to Sen. Orrin Hatch (R. Utah) for the 1994 law exempting "nitritional supplements" from FDA oversight. Another major player was Rep. Dan Burton (R. Indiana), whom Orac probably recognizes as an anti-vaxer - which is why I'm supporting his primary opponent, John McGroff, MD.
However, it is important to recognize that this was passed when the Democratic party controlled both houses of congress. Representaive Waxman could have just let the bill die in committee, as could the Senate committee chair (who I believe was Kennedy, but I could be very wrong.)
Which is a long-winded way to point out that it won't be easy to get this repealed.
fusilier
James 2:24
Check the following. Another issue.
www.cfsan.fda.gov/seafood1.html