Toxicology: September 2008 Archives
The latest in the investigation of melamine in Chinese milk and milk-containing products is the revelation that Cadbury chocolates may contain the contaminant. According to the AP, the British candy maker is recalling 11 of its products made at a Beijing plant, which were distributed in Taiwan, Hong Kong, and Australia.
The Xinhua News Agency reports that 22 people in Hebei Province—including managers of pastures, breeding farms, and milk-purchasing stations—have been detained under the suspicion of making or selling melamine and putting the contaminant into milk. Police seized nearly 500 pounds of the toxin in connected raids.
Last year, melamine (along with cyanuric acid) caused renal dysfunction or failure in unknown numbers of domestic cats and dogs as a result of pet food made with contaminated Chinese wheat gluten. In the September 1 issue of the Journal of the American Veterinary Medical Association, investigators reported their findings in 70 cats from a single, commercial cattery* that were inadvertently fed tainted pet food.
Forty-three cats developed clinical signs of disease, including lethargy, poor eating, vomiting, polydipsia, and polyuria. More than half of the cats (38 of 68) that were biochemically analyzed developed azotemia, and 1 cat died. Among the 13 cats that were euthanized, kidney specimens revealed crystal-associated tubular necrosis and perivascular inflammation.
Cyanuric acid, which is produced by the hydrolysis of melamine, forms insoluble (or poorly soluble) crystals when combined with melamine. According to the FDA, cyanuric acid may be generated in the production of melamine or by its degradation.
There are no news reports, as yet, regarding the content of cyanuric acid in the currently tainted Chinese milk products.
* Cats were used to assess the "routine palatability and acceptability" of commercial cat foods.
Photomicrograph of cat renal tubule containing gold-brown circular crystals of melamine and cyanuric acid (arrow); bar = 50 microns. Source: Ciancolo RE et al. J Am Vet Med Assoc. 2008;233:729-737.
The Federal Trade Commission has sued 5 companies, alleging their deceptive advertising of bogus cancer cures, according to a government press release on Thursday. The suits are the culmination of an extended investigation,* in concert with the US FDA and the Competition Bureau Canada, to crack down on the online sale of unproven and potentially harmful products that are intended for the prevention, treatment, and/or cure of cancer. (See here for additional background.)
The 5 defendant companies (and associated individuals) are the following.
Alexander Heckman doing business as (d/b/a) Omega Supply and Eric Del Rio (San Diego, CA) through the website laetrilesupply.com: In addition to bogusly marketing cyanide-containing laetrile (aka "amygdalin" aka "vitamin B17") as a cancer cure, Heckman and Del Rio are charged with making false claims regarding the benefits of hydrazine sulphate (a potential carcinogen) and cloracesium (aka cesium chloride).
Mark J. and Marianne Hershiser d/b/a Native Essence Herb Company (El Prado, NM) through various websites: The FTC cites the company's marketing of the chaparral shrub (associated with "acute toxic hepatitis" per the FDA), various herbal concoctions, and maitake mushroom extracts.
James Feijo d/b/a Daniel Chapter One (Portsmith, RI) through the website danielchapterone.com: The company sells shark cartilage and herbal formulations. According to the FTC, Feijo claims that one of his formulations mitigates the adverse effects of radiation and chemotherapy.
William H. Iseley, owner of Gemtronics, Inc (Franklin, NC): Iseley's company markets Chrysobalanus icaco (aka the Florida evergreen shrub cocoplum) and Agaricus, the most widely consumed genus of mushroom.
Mary T. Spohn d/b/a Herbs for Cancer (Surprise, AZ): Spohn markets a whole slew of Chinese herbal teas, according to the FTC's complaint, which are advertised to treat at least 16 types of cancer.
The 5 suits will be litigated before administrative law judges at the FTC. The FTC also reports complaints against 6 other companies that have been settled. The proposed settlements stipulate that the cited individuals and/or companies will pay sizable judgments (in some cases, several hundred thousand dollars) and will be barred from representing their products as preventing, treating, or curing cancer without the support of "reliable scientific evidence." The settlements, however, do not constitute an admission of guilt by the defendants.
* Between August 2007 and January 2008, the FTC sent warning letters via e-mail to 112 websites. Among these, nearly 30% closed their sites or removed cancer-treatment claims.
There's no reason to assess the removal of a substance when there's no evidence that the substance causes the disease in question.
That's pretty much the thought process of the NIMH, when it decided Wednesday to suspend a planned phase 2 study to assess mercury chelation in autism spectrum disorders (ASD). The study would have assessed the efficacy of DMSA, an oral chelating agent, or placebo to alleviate ASD symptoms in children aged 4-10 years during a 12-week period, despite the fact that mercury (from vaccines or otherwise) has not been associated epidemiologically with autism.
Also chelation is not without its hazards, owing to its ability to remove essential minerals, in addition to toxic heavy metals like mercury and lead, from the body. Moreover, in a study published last year, DMSA in rats that were not exposed to lead "produced lasting and pervasive cognitive and affective dysfunction," which was comparable to that seen with high lead exposure. Enrollees in the NIMH study would have had detectable, but not toxic, levels of mercury and lead.
Melamine-tainted infant formula is now linked to more than 6240 cases of renal stones as of Wednesday, reports WHO. Melamine has been found in products of at least 22 dairy manufacturers in China, with levels ranging from 0.09 to 2.560 mg/kg.
There is also a concern that melamine may turn up in other dairy products, like ice cream. The possible extent of the contamination has caused a nationwide panic among parents, reports the Chinese news agency Xinhua. Today's report also increases the number of melamine-related deaths to 4.
WHO reports that Sanlu, an original source of the tainted formula, received a complaint of illness as early as March of this year and, according to Forbes, Sanlu was urged in early August by its majority owner, New Zealand's Fonterra Cooperative Group, to initiate a product recall. However, Sanlu (in possible collusion with Chinese government officials) delayed the recall to avoid a PR scandal during the upcoming Olympic Games in Beijing.
Sanlu claims that one of its raw milk suppliers used melamine to artificially boost the product's protein content, wrote Scientific American on Tuesday.
Depiction of melamine chemical structure from Wikipedia.
9/22/08 update: Melamine-tainted infant formula has now sickened 52,857 Chinese children and resulted in the hospitalization of 12,892, reports the AP. More than 80% of those hospitalized were or are 2 years of age or younger, and 104 were or are in serious condition. The latest news report also confirms 4 related deaths. The uptick in ill children may be due to the review of earlier hospital records, from May through August. In addition, the head of the Chinese agency that monitors food and product safety, who had held the position since 2001, resigned.
With the options of 1) pushing its inane "expose" of trace pharmaceuticals in drinking water and 2) letting its dumb story slip quietly into the ether, the AP makes the wrong decision.
On Friday, writer Martha Mendoza stubbornly updated the AP's idiotic article from March, by reporting that at least 46 million Americans are now exposed to parts per billion or trillion of a scattered number of prescription drugs, like so much fairy dust, in the nation's tap water. Wow. That's 5 million more, likely unaffected individuals to add to the original 41 million, likely unaffected individuals who must drink water to maintain existence. All thanks to the unnecessary testing prompted by the AP's unthinking reportage.*
Despite pressure to examine city water supplies by the AP's moronic investigation, some environmental officials remain rational, including those at NYC's Department of Environmental Protection, who refuse to test for the presence of drugs at infinitesimal levels—probably given, at least in part, the fact that serious macroscopic vermin issues deserve ongoing attention.
* And are measurements of drugs even accurate at that level?
Addendum: Just to get an idea of the dilution we're talking about here, the value of 1 part per billion (ppb) is 10–9, which is equivalent to 1 microgram (µg) per liter (L) of water or 1 g diluted in 1 million L of water. One part per trillion is 10–12 or 1 nanogram per L of water or 1 g diluted in 1 billion L of water (400 Olympic-size swimming pools, per Wikipedia). The EPA's action levels for lead and mercury (which are not FDA approved for consumption) in water are 15 and 2 ppb (15 and 2 µg/L), respectively.
Melamine is back. This time, the suspected renal toxin has been found in Chinese-made infant formula, alerts the FDA. The agency is working to inform Asian and ethnic markets in the United States that illegally imported Chinese formula may be contaminated with the fake protein additive. But the FDA is also reassuring consumers that infant formula approved for sale in the United States, which is not made with Chinese ingredients, is safe.
The Xinhua news agency reports an ongoing police investigation into the contamination of Sanlu brand powdered formula in Shijiazhuang, China, where the product was manufactured. The investigation was prompted by reports of kidney dysfunction in at least 50 Chinese infants who consumed the product. One infant reportedly died as a consequence.
Melamine was found last year in Chinese-imported wheat gluten, which was used to produce domestic pet food. Melamine in the contaminated pet food, along with another contaminant, cyanuric acid, are believed to have led to innumerable cases of renal dysfunction or failure in American pets. The event led to the largest recall of pet food in the United States.
In February, the federal government indicted Sally Qing Miller and her husband Stephen S. Miller, from the Las Vegas-based ChemNutra, for importing 800 metric tons of tainted Chinese wheat gluten into the United States, while conspiring to bypass mandatory Chinese inspections.
Primary news source: USA Today
Depiction of melamine chemical structure from Wikipedia.
Update: In a press release, the FDA reports that the following manufacturers have met the necessary FDA requirements for marketing milk-based infant formulas in the United States—Abbott Nutritionals, Mead Johnson Nutritionals, Nestle USA, PBM Nutritionals, and Solus Products LLC. An English-based manufacturer, SHS/Nutricia, sells an amino-acid-based, nondiary infant formula.
9/15/08 update: The AP reports that 2 brothers, who ran a "milk-collection center" (whatever that is) in Hebei province, were arrested on suspicion of adding melamine to the infant formula. The AP also indicates that Chinese officials were slow to initiate a formula recall, after being alerted to the contamination by Fonterra, a New Zealand dairy farmers' cooperative that owns 43% of Sanlu, the manufacturer of the tainted formula. Complaints were reportedly received by Sanlu as early as March, and company tests of formula revealed the presence of the contaminant in August. The AP story does not reveal how the milk-collection center is connected to Sanlu. The latest casualty numbers: 1253 infants possibly sickened, 340 currently hospitalized (53 in "severe" condition), 2 dead.
9/17/08 update: According to the AP, melamine-tainted baby formula has now sickened 6244 Chinese infants, with 1327 hospitalized and 158 experiencing acute renal failure. Three children are now dead as a result. Four milk suppliers have been arrested in China, and the general manager of Sanlu, the manufacturer of the tainted formula, was detained by Chinese police yesterday, wrote the news service. At the center of the investigation is whether Sanlu or the company's local government stalled a public recall of the tainted formula in August. Other Chinese dairy companies are recalling their possibly tainted products, including 2 Chinese exporters, which have sent formula to parts of Asia and Africa.