10.3201/eid1505.081458 Suggested citation for this article: Angers RC, Seward TS, Napier D, Green M, Hoover E, Spraker T, et al. Chronic wasting disease prions in elk antler velvet. Emerg Infect Dis. 2009 May; [Epub ahead of print]
Chronic Wasting Disease Prions in Elk Antler Velvet
Rachel C. Angers,1 Tanya S. Seward, Dana Napier, Michael Green, Edward Hoover, Terry Spraker, Katherine O’Rourke, Aru Balachandran, and Glenn C. Telling Author affiliations: University of Kentucky Medical Center, Lexington, Kentucky, USA (R.C. Angers, T.S. Seward, D. Napier, M. Green, G.C. Telling); Colorado State University, Fort Collins, Colorado, USA (E. Hoover, T. Spraker); US Department of Agriculture, Pullman, Washington, USA (K. O’Rourke); and Canadian Food Inspection Agency, Ottawa, Ontario, Canada (A. Balachandran) 1Current affiliation: MRC Laboratory of Molecular Biology, Cambridge, UK.
Chronic wasting disease (CWD) is a contagious, fatal prion disease of deer and elk that continues to emerge in new locations. To explore the means by which prions are transmitted with high efficiency among cervids, we examined prion infectivity in the apical skin layer covering the growing antler (antler velvet) by using CWD-susceptible transgenic mice and protein misfolding cyclic amplification. Our finding of prions in antler velvet of CWD-affected elk suggests that this tissue may play a role in disease transmission among cervids. Humans who consume antler velvet as a nutritional supplement are at risk for exposure to prions. The fact that CWD prion incubation times in transgenic mice expressing elk prion protein are consistently more rapid raises the possibility that residue 226, the sole primary structural difference between deer and elk prion protein, may be a major determinant of CWD pathogenesis.
The transmission of CWD prions in antler velvet from 2 naturally affected elk to mice in 2 Tg models demonstrates that this tissue contains low, but detectable, amounts of CWD prions. In addition, serial PMCA amplified otherwise undetectable levels of PrPSc in antler velvet. We characterized CWD prion infectivity by end-point titration. The .6 log i.c.ID50/g CWD prion titer estimated by this method contrasts with .9 log i.c.ID50/g titers of mouse-adapted scrapie prions in rodent brains (9) and .7.7.7 log i.c.ID50/g titers of BSE prions estimated by bioassay in transgenic mice (10,11). The linear relationship between dose and incubation time (12) provides an opportunity to estimate the level of prions in materials containing an unknown amount of infectivity. The attack rates of <100% after inoculation with antler velvet preparations from elk 01-0306 and 03-0306 and the failure to transmit disease from the remaining antler velvet samples suggest that CWD prion titers are close to, or at, the end point of the Tg(CerPrP)1536+/. bioassay. Although we are aware of the limitations of comparing levels of prions in tissues from different CWD-affected cervids, we estimate the end point of the CWD prion titration using D92 to be <3.5 log i.c.ID50 units. Other factors could also influence levels of infectivity in the 4 tested samples, e.g., the portion of the antler processed and the age of the antler when harvested. Histologic evaluation indicated that the velvet samples used in these transmission studies came from elk antlers in the early stages of seasonal growth (data not shown). Whether CWD prion titers in antler velvet vary according to the state of antler growth remains to be determined. Whether prion infectivity is derived from nervous system tissue, blood (13), or another component of velvet, is also unclear. Implications for Horizontal CWD Transmission and Human Exposure Our studies indicate that antler velvet represents a previously unrecognized source of CWD prions in the environment. Whereas oral transmission of rodent-adapted scrapie prions is known to be .5 orders of magnitude less efficient than transmission by intracerebral inoculation (14,15), the relative efficiency of oral CWD prion transmission is unknown. Multiple exposures
Page 7 of 17
to low levels of CWD prions in the environment (16,17), as well as increased infectivity when prions are bound to soil minerals (18), are factors that may influence transmission. The appearance of variant Creutzfeldt-Jakob disease in humans exposed to bovine spongiform encephalopathy (BSE) (19,20) and the demonstration of CWD prions in muscle (3) placed the human species barrier to CWD prions at the forefront of public health concerns. Our studies indicate that antler velvet represents an additional source for human exposure to CWD prions. Widely used in traditional Asian medicine to treat a variety of ailments including impotence, arthritis and high blood pressure, antler velvet can be readily purchased in caplet form and its usage has increased worldwide. Fortunately, to date there is no epidemiologic evidence for increased rates of CJD in the CWD-endemic region (Colorado, USA) (21,22). Also reassuring is the inefficient in vitro conversion of human PrP to protease-resistant PrP by CWD (23). Two studies have shown that CWD prions failed to induce disease in Tg mice expressing human PrP (24,25). However, the failure of BSE to be transmitted to Tg mice expressing human prion protein (HuPrP) was cited as early evidence for a BSE transmission barrier in humans (26); subsequent studies demonstrated a strong effect of the codon 129 polymorphism on transmissibility of BSE prions (27). To date, only mice expressing HuPrP with methionine at 129 have been challenged with CWD. In support of the argument that humans might be susceptible to CWD, intracerebral inoculation of squirrel monkeys produced disease after >30 months (28). Prion strain properties are also critical when considering the potential for interspecies transmission. The existence of multiple CWD strains has been suggested by several studies (4,25,29,30), but strain isolation and host range characterization have not been reported. Finally, it is worth considering that if CWD were to cross the species barrier into humans, this transmission source might not be recognized if the disease profile overlapped with one of the forms of sporadic CJD reported in North America.
Possible Role for Residue 226 in CWD Pathogenesis
Previous studies that demonstrated more rapid CWD prion incubation times in Tg mice expressing elk PrP (24,29) than in Tg(CerPrP)1536+/. mice (4) raised the possibility that the single amino acid difference at residue 226 between elk and deer PrP (5) may influence CWD pathogenesis (29). However, when the transmission characteristics of CWD isolates were directly compared in Tg mice expressing differing levels of deer or elk PrP, Tamguney et al.
Page 8 of 17
concluded that CWD incubation times were related solely to the level of PrP transgene expression (25). We compared CWD transmission in Tg(CerPrP-E226)5037+/. and Tg(CerPrP)1536+/. mice, which express PrP at levels .5-fold higher than PrP in wild type mouse brain (Figure 1A), and found that CWD transmission was consistently and substantially more rapid in Tg(CerPrP-E226)5037+/. mice. Our results appear compatible with more efficient CWD prion propagation by elk cellular prion protein (CerPrPC) containing E at residue 226 than by deer CerPrPC containing Q at this position. Consistent with this interpretation, despite 5-fold lower levels of transgene expression in Tg(CerPrP-E226)5029+/. than in Tg(CerPrP)1536+/. mice, mean incubation times of the D92 isolate were equivalent in these 2 lines (Table). Nonetheless, undetected differences in CerPrPC expression, for example in particular cell types, might result in more rapid disease and/or altered pathologic changes. The generation of transgenic mice expressing elk and deer coding sequences using gene replacement strategies would seem to be an excellent approach for resolving this issue. The different responses to CWD in Tg mice also appear to recapitulate aspects of CWD pathogenesis in the natural hosts. Previous limited comparative transmission studies indicated that CWD developed .25% more rapidly in orally challenged elk than deer (31). Although plaques were not detected in brains of CWD-affected elk, florid plaques have been observed in the brains of diseased deer (32,33). Similar differences in pathologic changes were observed in Tg(CerPrP-E226)5037+/. and Tg(CerPrP)1536+/. mice (Figure 4). Structural analyses suggest that residue 226 is located within a region of PrPC proposed to interact with a factor (34), possibly equivalent to the postulated protein X (35). Although mutation of the equivalent residue from Q to lysine (K) in epitope-tagged mouse PrP had no effect on PrPSc formation in transfected chronically infected ScN2A cells, the effects of the Q-to-E substitution were not assessed (36).
Acknowledgments We thank Dongyue Zhuang for excellent technical assistance. This work was supported by grants 2RO1NS040334-04 from the National Institute
old news. ...
Terry S. Singeltary Sr. [email@example.com] ... CJDIBSE (aka madcow) Human/Animal TSE’s--U.S.--Submission .... such as 'nutritional supplements' containing various extracts ... US cattle/sheep/cervids. ("antler velvet" extracts!) should be forbidden ... suggest that CWD transmissions to humans would be as limited ...
Volume 361, Number 9368 03 May 2003
Tighter regulation needed for dietary supplements in USA
Sir--Mary Palmer and colleagues (Jan 11, p 101)1 found that dietary supplements have the potential to cause serious adverse effects. The investigators state that research on the hazards and risks ofdietarysupplements should be a priority. The safety of individuals who consume these products is important, and organisations such as the US Food and Drug Administration (FDA) need to take initiative by enforcing stricter regulations on supplements. Several commonly used products--for example ginkgo biloba, St John's Wort, and ephedrine--can have serious adverse effects.2 Although the FDA requires multiple studies on the safety and efficacy for pharmaceutical products before placing them on the market, standards are less robust for dietary supplements. In the USA, under the Dietary Supplement Health and Education Act (DSHEA) of 1994, supplements are subject to the same regulatory requirements as food. There are no provisions that require FDA approval for the safety or effectiveness of supplements,3 which leaves consumers and manufacturers essentially responsible for the health effects of these products. The DSHEA of 1994 needs to be revised so that dietary supplements are subject to the same regulations as pharmacological drugs. The FDA needs to review clinical studies on the safety and efficacy of dietary supplements. Organisations such as Public Citizen and the American Medical Association are already taking steps to achieve these changes. However, they face immense opposition from groups such as the National Nutritional Foods Association, the American Herbal Association, and the Council for Responsible Nutrition. To overcome such resistance, consumer organisations, health-care providers, and government agencies need to approach this subject in unison. The public needs to be able to assess the risks and benefits of dietary supplements before consuming them. Health-care providers and the more than 100 million Americans who consume these products4 should encourage the FDA to treat supplements with the stringent regulations it enforces on pharmaceutical products.
Nipa Kinariwala ------------------------------------------------------------------------ 700 Bolinwood Drive, Apartment 12A, Chapel Hill, NC 27514, USA 1 Palmer ME, Haller C, McKinney PE, et al. Adverse events associated with dietary supplements: an observational study. Lancet 2003; 361: 101-06. [Text < http://www.thelancet.com/journal/vol361/iss9368/full/llan.361.9352.original_rese >] 2 Cupp MJ. Herbal remedies: adverse effects and drug interactions. Am Fam Physician 1999; 59: 1239-45. [PubMed < http://www.ncbi.nlm.nih.gov/htbin-post/PubMed/wgetcit?journal=Am+Fam+Physician+& >] 3 Unites States Food and Drug Administration. Overview of dietary supplements. Jan 3, 2001. http://www.cfsan.fda.gov/~dms/ds-oview.html < http://www.cfsan.fda.gov/%7Edms/ds-oview.html%20>(accessed Feb 20, 2002). 4 Pear R. Feds call for tighter control over nutritional supplements. Organic Consumers Association, April 17, 2001. http://www.organicconsumers.org/Organic/dietsupp.cfm < http://www.organicconsumers.org/Organic/dietsupp.cfm%20>(accessed Feb 20, 2002). http://www.thelancet.com/journals/lancet/article/PIIS0140673603132072/fulltext
TSEs i.e. mad cow disease's BSE/BASE and NUTRITIONAL SUPPLEMENTS
IPLEX, mad by standard process;
vacuum dried bovine BRAIN, bone meal, bovine EYE, veal Bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.
i will only list animal ingredients of the following Nutritional Supplements by only ONE company;
Standard Process Co.
IPLEX; bovine EYE PMG Extract, veal bone PMG Extract, bovine liver powder, vaccuum dried porcine stomach, vacuum dried bovine adrenal, vacuum dried bovine kidney, bovine adrenal, vacuum dried BOVINE BRAIN, bone meal, vacuum dried veal bone.
A-FBetafood R vacuum dried bovine prostate, bovine liver powder, vacuum dried bovine kidney, bovine orchic glandular extract, bovine liver fat extract.
Arginex R bovine liver powder.
Adrenal, Desiccated TM Vacuum dried bovine adrenal.
Albaplex R bovine liver PMG Extract, vacuum dried bovine adrenal, bovine kidney PMF Extract, bovine thymus Cytosol Extract, bovine liver powder, bone meal, vacuum dried bovine kidney, veal bone meal.
Allerplex TM bovine lung PMF Extract, bovine adrenal PMF Extract, bovine liver fat extract (yakriton), bone meal, vacuum dried bovine kidney, vacuum dried veal bone.
Immuplex R Bovine liver PMG Extract, bovine liver powder, veal bone PMF Extract, bovine spleen PMF Extract, vacuum dried bovine and ovine spleen, bovine thymus PMF Extract, bovine thymus Cytosol Extract.
Vasculin R Bovine Heart PMG Extract, veal bone PMF Extract, bovine liver powder, vacuum dried porcine duodenum, bovine adrenal Cytosol Extract, vacuum dried bovine and ovine spleen.
Zypan R bovine pancreas Cytosol Extract, vacuum dried bovine and ovine spleen.
last i heard, they were getting sued;
Suit Filed Over Mad Cow Disclaimer
By Jason Hoppin The Recorder March 23, 2001
A small San Francisco litigation firm has teamed up with Milberg, Weiss, Bershad, Hynes & Lerach to sue a health supplements manufacturer, alleging the company misrepresents the danger of acquiring mad cow disease through its products.
The suit, filed under California's unfair business practices statute, alleges that Wisconsin's Standard Process Inc. uses, in part, crackpot science to allay customers' fears about the transmission of bovine spongiform encephalopathy, also known as mad cow disease.
"Standard Process either knowingly or recklessly has omitted a material fact by failing to inform consumers that the overwhelming majority of reputable scientists and physicians have concluded that mad-cow disease is transmitted to humans by prions in bovine meat and/or bovine organs," Bushnell, Caplan & Fielding's Alan Caplan wrote.
The complaint points to a statement by the company about the safety of its products which suggests that pesticides may be to blame for mad cow outbreaks, not the consumption of meat.
"It's probably loosely referred to as research," deadpanned Jan Novakofski, a University of Illinois researcher who studies thedisease. "The evidence for that kind of concept [versus the consumption theory] is about an ounce to a pound."
No cases of mad cow have ever been reported in the United States, and the plaintiff in the case, James Gorman, does not suffer from the disease. Instead, he is seeking damages for misrepresentation, fraud, unfair advertising and unfair business practices.
The case was filed in San Francisco Superior Court.
The product, a vitamin supplement called Iplex 5100, is sold through licensed health professionals, including acupuncturists, nutritionists and the like.
Iplex 5100 is made in part, with cow parts: eyes, kidneys, livers, bonesand brains, where BSE is most highly concentrated.
Standard Process did not return a phone call seeking comment, but the company's Web site says it purchases bovine products only from U.S.government-inspected facilities.
"Standard Process has never used any glandular substances or bovine tissue derivatives from animals in any BSE-infected country," the company states.
The human manifestation of BSE -- variant Creutzfeld-Jakob disease --has killed more than 80 people in Great Britain, and new outbreaks have recently been reported in several European countries.
U.S. officials have worried that dietary supplements may provide an entry point for the disease, which has been detected here in animals other than cows.
"The health food industry is totally unregulated," Novakofski said. "You go to the health food store and no one's ever tested anything."
However, Standard Process says its Wisconsin production facility is regulated by the U.S. Food and Drug Administration, and that its cow products are certified by the government.
© 2001 law.com Inc. ======================= Supplements Association Moves to Eliminate Bovine Parts From Products
WASHINGTON (Reuters Health) Mar 16 - The nation's largest dietary supplements industry group has issued new guidance to manufacturers amid concerns that some alternative health products containing bovine materials pose a risk of transmitting bovine spongiform encephalopathy (BSE) to humans.
The guidance, published by the National Nutritional Foods Association (NNFA), encourages manufacturers to eliminate all neurological bovine materials from their products. Consumption of brains and spinal cords from cows infected with BSE are widely believed to be the source of new variant Creutzfeldt-Jakob disease (vCJD) in humans........
snip... full text at;
Letter to Manufacturers of Biological Products - Recommendations Regarding Bovine Spongiform Encephalopathy (BSE)
Department of Health and Human Services Public Health Service Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448
April 19, 2000
To Manufacturers of Biological Products
The Food and Drug Administration (FDA) has issued letters (date May 3, 1991, December 17, 1993, and May 9, 1996) and a guidance document (September 1997) requesting that materials derived from ruminants which have resided in or originated from countries where Bovine Spongiform Encephalopathy (BSE) has been diagnosed not be used in the manufacture of FDA-regulated products intended for administration to humans. The United States Department of Agriculture (USDA) also issued an interim rule on January 6, 1998, restricting the importation of ruminants, meat and meat products from ruminants, and certain ruminant products and byproducts from all countries of Europe. Because of the serious nature of this issue, the Center for Biologics Evaluation and Research (CBER) believes it critical to update the current recommendations.
CBER strongly recommends that manufacturers take whatever steps are necessary to assure that materials derived from all species of ruminant animals born, raised or slaughtered in countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist, are not used in the manufacture of FDA-regulated products intended for administration to humans. The Agency has previously recommended that manufacturers take the following steps to prevent this occurrence:
1.Identify all ruminant-derived materials (e.g., culture medium, transferrin, albumin, enzymes, lipids) used in the manufacture of regulated products. FDA considers the manufacture of biological products to include the preparation of master (including the original cell line) and working cell banks, as well as materials used in fermentation, harvesting, purification and formulation of the products.
2.Document the country of origin and all countries where the live animal source has resided for each ruminant-derived material used in the manufacture of the regulated product. The regulated-product manufacturer should obtain this information from the supplier of the ruminant-derived product. The regulated-product manufacturer should also obtain the appropriate veterinary regulatory inspection certification of slaughter, as required by the country of origin of live animals, from the supplier. Documentation should be maintained for any new or in-process lots of licensed, cleared or approved products; products pending clearance or approval; and investigational products intended to be administered to humans.
3.Maintain traceable records for each lot of ruminant material and each lot of FDA-regulated product manufactured using these materials. These records should be part of the product batch records and available for FDA inspection. Such records should be maintained for products manufactured at foreign as well as domestic facilities.
It is the responsibility of the manufacturer to obtain up-to-date information regarding countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist. This information is available from the USDA's Animal and Plant Health Inspection Service (APHIS) at telephonenumber 301-734-8364, website addresshttp://www.aphis.usda.gov/ncie, and codified at 9 CFR 94.18 (see attached).
Specific product-related questions should be directed to the appropriate application division within CBER's product offices. The phone numbers are:
Dr. David Asher, Office of Blood Research and Review 301-827-3524 Dr. Paul Richman, Office of Vaccines Research and Review 301-827-3070 James Crim, Office of Therapeutics Research and Review 301-827-5101
Thank you for your attention to this matter.
Kathryn C. Zoon, Ph.D. Director Center for Biologics Evaluation And Research
better late than never, but leaving regulation up to the industry, will be like telling the wolf to guard the hen house. allowing that to happen with some pathogens is one thing, but we better think twice about human/animal TSE's. This same letter has been around for ten years with nobody taking heed to the potential dangers...TSS
How serious is this bit of deregulation? Here's what Dr. Lurie told the Senators:"For BSE (mad cow disease), this means that an unscrupulous manufacturer could literally take a British cow brain, crush it, dry it out, formulate it into a dietary supplement and export it to the U.S."
another fine example;
In fact, the salesman now tells us he doesn't sell the machines anymore. But the quest for youth goes beyond facial creams and exotic contraptions, anti-agers are also ingesting some pretty wild-sounding dietary supplements. "Live proteins from sheep and pig from France, processed," says a representative.
Life-Cell Technologies touts the benefits of supplements that contain processed pig and sheep organs. "I have a lot of body builders and professional athletes that use these products because they strengthen and stimulate the different glands and organs,"says one woman. The idea, she implied, often is that ingesting ground up animal organs will strengthen human organs or even cure thyroid and adrenal diseases. "To my knowledge you can't just take pulverzied organs and feed them to somebody and think they're not going to have thyroid disease anymore or hypo-adrenalism," says Dr. Wexler. It would be kind of a medical miracle, wouldn't it? "It would be amazing, truly amazing," says Dr. Wexler. "Dateline" attended another anti-aging conference and expo in Chicago -- this time with ourcameras in plain view. Remember the exhibitor selling processed pig and sheep organs? We pressed her for scientific documentation. We asked, what is the science behind the idea? The woman tells us, "You would have to go on the Internet and get information, scientific studies."But this is her company, isn't it? "Yes it is," she says. "And if you don't mind, I don't want to be interviewed. I don't.""Dateline" tells her, "They are simple questions that any consumer would ask." Everywhere "Dateline" went at the anti-aging expo we heard a lot about so-called "scientific studies." "Well, it comes from 3,000 studies," a man at the expo tells us.
At one booth the product is called transfer factor, and theactive ingredient is colostrum -- the potent pre-milk fluid in a lactating mother's breast.
"We actually filtrate the transfer factor out of the colostrum," says one man. From where, mothers? "No," the man tells us. "From bovine colostrum, from cows."
http://www.msnbc.com/news/550100.asp?cp1=1 (url now dead...tss)
AS you can see below, i was trying to warn the public of this potential and highly likely route of TSE via nutritional supplements years before the above people were. THESE folks have PhDs, so maybe someone will listen now, maybe not $$$
Could you get mad cow from a pill ? Some doctors say a class of pills that promise smarts, energy, and sexual vitality may cause mad-cow disease. The government isn't worried. Should you be?
June 1, 2001 Health Magazine by Susan Freinkel
GERMAN DER SPIEGEL MAGAZINE
Die BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehörden sind lax.
MAD COW DISEASE AND NUTRITIONAL SUPPLEMENTS...
Subj: cjd/bse aka MADCOW DISEASE in the U.S.A., please let me count the ways...
Date: 31/07/00 17:51:30 GMT Daylight Time
SOMETHING TO CHEW ON
In reading the recent article in the BMJ about the potential BSE tests being developed in the U.S. and Bart Van Everbroeck reply. It does not surprize me, that the U.S. has been concealing vCJD. There have been people dying from CJD, with all the symptoms and pathological findings that resemble U.K. vCJD for some time. It just seems that when there is one found, they seem to change the clerical classification of the disease, to fit their agenda. I have several autopsies, stating kuru type amyloid plaques, one of the victims was 41 years of age. Also, my Mom died a most hideous death, Heidenhain Variant Creutzfeldt Jakob disease. Her symptoms resemble that of all the U.K. vCJD victims. She would jerk so bad at times, it would take 3 of us to hold her down, while she screamed "God, what's wrong with me, why can't I stop this." 1st of symptoms to death, 10 weeks, she went blind in the first few weeks. But, then they told me that this was just another strain of sporadic CJD. They can call it what ever they want, but I know what I saw, and what she went through.
Sporadic, simply means, they do not know. My neighbors Mom also died from CJD. She had been taking a nutritional supplement which contained the following; vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach. As I said, this woman taking these nutritional supplements, died from CJD. The particular batch of pills that was located, in which she was taking, was tested. From what I have heard, they came up negative, for the prion protein. But, in the same breath, they said their testing, may not have been strong enough to pick up the infectivity. Plus, she had been taking these type pills for years, so, could it have come from another batch?
Evidence Of CJD/BSE Transmission Via Supplements From Terry S. Singeltary Sr. firstname.lastname@example.org 1-26-3
Scrapie (Mad Sheep Disease) May Pose a Risk to Humans From New Scientist magazine (UK) Online News March 28, 2001
What if you can catch old-fashioned CJD by eating meat from a sheep infected with scrapie?
Exclusive from New Scientist magazine
Singeltary suspected an environmental cause in his mother's demise, a feeling reinforced a year later when a neighbor died of sporadic CJD. For years, the neighbor had been taking nutritional supp- lements that contained cow brain extracts.
"The FDA needs to review clinical studies on the safety and efficacy of dietary supplements. Organisations such as Public Citizen and the American Medical Assoc- iation are already taking steps to achieve these changes.
"However, they face immense opposition from groups such as the National Nutritional Foods Association, the American Herbal Association, and the Council for Responsible Nutrition.
"To overcome such resistance, consumer organisations, health-care providers, and government agencies need to approach this subject in unison. The public needs to be able to assess the risks and benefits of dietary supp- lements before consuming them.
Health-care providers and the more than 100 million Americans who consume these products should encourage the FDA to treat supplements with the stringent regulations it enforces on pharmaceutical products."
Animal ingredients of Nutritional Supplements by only ONE company;
Standard Process Co.
bovine EYE PMG Extract, veal bone PMG Extract, bovine liver powder, vaccuum dried porcine stomach, vacuum dried bovine adrenal, vacuum dried bovine kidney, bovine adrenal, vacuum dried BOVINE BRAIN, bone meal,vacuum dried veal bone.
vacuum dried bovine prostate, bovine liver powder, vacuum dried bovine kidney, bovine orchic glandular extract, bovine liver fat extract.
bovine liver powder, Adrenal, Desiccated TM, Vacuum dried bovine adrenal.
bovine liver PMG Extract, vacuum dried bovine adrenal, bovine kidney
PMF Extract, bovine thymus Cytosol Extract, bovine liver powder, bone meal, vacuum dried bovine kidney, veal bone meal.
bovine lung PMF Extract, bovine adrenal PMF Extract, bovine liver fat extract (yakriton), bone meal, vacuum dried bovine kidney, vacuum dried veal bone.
Bovine liver PMG Extract, bovine liver powder, veal bone PMF Extract, bovine spleen PMF Extract, vacuum dried bovine and ovine spleen, bovine thymus PMF Extract, bovine thymus Cytosol Extract.
Bovine Heart PMG Extract, veal bone PMF Extract, bovine liver powder, vacuum dried porcine duodenum, bovine adrenal Cytosol Extract, vacuum dried bovine and ovine spleen.
WASHINGTON (Reuters Health) Mar 16 2001 - The nation's largest dietary supplements industry group has issued new guidance to manufacturers amid concerns that some alternative health products containing bovine mate- rials pose a risk of transmitting bovine spongiform encephalopathy (BSE) to humans.
The guidance, published by the National Nutritional Foods Association (NNFA), encourages manufacturers to eliminate all neuro- logical bovinematerials from their products. Consumption of brains and spinal cords from cows infected with BSE are widely believed to be the source of new variant Creutzfeldt-Jakob disease (vCJD) in humans.
We hope that the above data informs, but not overwhelms, the reader. For the technically literate there are numerous articles and links available via. www.google.com ( http://www.google.com ) searching for mad cow disease. If you have any questions for
Terry Singeltary write or e-mail email@example.com and we will forward them to him.
Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7
what did Paul Brown say about this previously;
i bring your attention to (page 500) Dr. Paul Brown statements;
253 1 DR. BOLTON: I have an additional question about 2 that. What is the assurance that additional locally sourced 3 tracheas are not added into that manufacturing process, thus 4 boosting the yield, if you will, but being returned to the 5 U.S. as being produced from U.S.-sourced raw material? 6 DR. McCURDY: Are there data to indicate how many 7 grams, or whatever, of infected brain are likely to infect 8 an organism, either animal or man, when taken orally? 9 DR. BROWN: If I am not mistaken, and I can be 10 corrected, I think a half a gram is enough in a cow, orally; [FULL TEXT ABOUT 600 PAGES] 3681t2.rtf
Unregulated "foods" such as 'nutritional supplements' containing various extracts from ruminants, whether imported or derived from 3 US cattle/sheep/cervids ("antler velvet" extracts!) should be forbidden or at least very seriously regulated.
(neighbors Mom, whom also died from CJD, had been taking bovine based supplement, which contained brain, eye, and many other bovine/ovine tissues for years, 'IPLEX').
my plight with metabolife and there 'bovine complex' about risk factors of TSE in there product ;
Terry S. Singeltary Sr. wrote:
######## Bovine Spongiform Encephalopathy
1. Dietary Supplements: Review of Health-Related Call Records for Users of Metabolife 356. GAO-03-494, March 31.
-------- Original Message --------
Subject: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA'' Date: Thu, 01 May 2003 11:23:01 -0500 From: "Terry S. Singeltary Sr."
The General Accounting Office (GAO) today released the following reports and testimonies:
1. Dietary Supplements: Review of Health-Related Call Records for Users of Metabolife 356. GAO-03-494, March 31.
i was suprised that i did not see any listing of bovine tissue in metabolife on it's label. have they ceased using these desiccated tissues???
i see that the lable on this product METABOLIFE 356, does not state that it has any tissues of desiccated bovine organs? i no the product use to, so i am curious if they have ceased the use of the tissues of cattle they _use_ to use (see below)???
METABOLIFE 356 BOVINE COMPLEX/GLANDULAR SYSTEM OVARIES, PROSTATE, SCROTUM AND ADRENAL USDA SOURCE CATTLE
i tried warning them years ago of this potential threat of CJD/TSEs;
From: Randy Smith To: "'flounder at wt.net'" Subject: Metabolife Date: Mon, 7 Dec 1998 14:21:35 -0800
We are looking at reformulation. I agree that slow virus diseases present a problem in some areas of the world.
Our product uses healthy USDA inspected cattle for the glandular extract.
If you have any links to more information on this subject I would like to examine them.
Thank you for your interest and concern,
Dr. Smith ============
From: Randy Smith To: "'flounder at wt.net'" Subject: RE: [Fwd: Your submission to the Inquiry] Date: Wed, 9 Dec 1998 10:37:07 -0800
Thank you for your note and the information links you forwarded to me. I am new to Metabolife International, however hopefully as my role here enlarges I well have a greater impact on formulation and product development.
Metabolife International does believe in placing safety first. And I am going to do my best to see that we continue to do so.
Sincerely, Dr. Smith ============ -----Original Message----- From: Terry S. Singeltary Sr. [mailto:flounder at wt.net] Sent: Wednesday, December 09, 1998 5:49 PM To: rsmith at metabolife.com Subject: [Fwd: Your submission to the Inquiry]
Dr. Smith, I am truly impressed with you honesty, THANKS.....I am not just spouting off about the potential dangers, here. THEY ARE REAL.....I have forwarded an e-mail from the BSE Inquiry, in which I made a statement about them........You might want to go to the site and read through it........IT WILL TAKE A WHILE........ THINGS ARE HAPPENING HERE SIR, THAT YOU ARE NOT AWARE OF, AND AS MOST PEOPLE ARE NOT...............I JUST HOPE, THAT THE REFORMULATION YOU SPEAK OF, IS IN FACT GOING TO TAKE PLACE. The Department of Health, here in the U.S., is also worried about the potential dangers involved hear............Terry/MADSON
From: Randy Smith To: "'flounder at wt.net'" Subject: RE: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!] Date: Fri, 18 Dec 1998 09:55:17 -0800 Return-Receipt-To: Randy Smith
Thanks very much for the info. I appreciate all these articles I can get. It does sound very familiar - just follow the green ($) trail.
-----Original Message----- From: Terry S. Singeltary Sr. [mailto:flounder at wt.net] Sent: Friday, December 18, 1998 5:15 PM To: rsmith at metabolife.com Subject: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!]
Randy, thought you might be interested in this...............MADSON!!!!!1
Sender: "Patricia Cantos"
3 July 1998 Mr Terry S Singeltary Sr. E-Mail: Flounder at wt.net Ref: E2979
Dear Mr Singeltary,
Thank you for your E-mail message of the 30th of June 1998 providing the Inquiry with your further comments. Thank you for offering to provide the Inquiry with any test results on the nutritional supplements your mother was taking before she died.
As requested I am sending you our general Information Pack and a copy of the Chairman's letter. Please contact me if your system cannot read the attachments.
Regarding your question, the Inquiry is looking into many aspects of the scientific evidence on BSE and nvCJD. I would refer you to the transcripts of evidence we have already heard which are found on our internet site at http://www.bse.org.uk. Could you please provide the Inquiry with a copy of the press article you refer to in your e-mail? If not an approximate date for the article so that we can locate it? In the meantime, thank you for you comments. Please do not hesitate to contact me on 0171 261 8332 should you have any queries.
Yours sincerely Patricia Cantos Families Team Leader Attachments TSS
-------- Original Message --------
Subject: re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA'' Date: Thu, 01 May 2003 16:04:35 -0400 From: "Marcia G Crosse"
We were informed by representatives of Metabolife, Inc. that Metabolife 356 was reformulated to remove bovine complex as an ingredient in the product, approximately September 2001. We did not independently verify the contents of the product.
Sincerely, Marcia Crosse Acting Director Health CarePublic Health and Science Issues U.S. General Accounting Office 441 G Street, N.W. Washington, D.C. 20548
-------- Original Message -------- Subject: Re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA'' Date: Thu, 01 May 2003 15:48:52 -0500 From: "Terry S. Singeltary Sr."
MIRACLES DO HAPPEN! ;-)
now all we need to do is;
one small step for man, one giant leap for mankind ;-)
''We did not independently verify the contents of the product''
####### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ########
-------- Original Message --------
Subject: DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of Material From Deer and Elk in Animal Feed; Availability Date: Fri, 16 May 2003 11:47:37 -0500 From: "Terry S. Singeltary Sr." < firstname.lastname@example.org > To: email@example.com
i would kindly like to comment on; Docket 03D-0186FDA Issues Draft Guidance on Use of Material From Deer and Elk in Animal Feed; Availability Several factors on this apparent voluntary proposal disturbs me greatly, please allow me to point them out;
Oral transmission and early lymphoid tropism of chronic wasting diseasePrPres in mule deer fawns (Odocoileus hemionus ) These results indicate that CWD PrP res can be detected in lymphoid tissues draining the alimentary tract within a few weeks after oral exposure to infectious prions and may reflect the initial pathway of CWD infection in deer. The rapid infection of deer fawns following exposure by the most plausible natural route is consistent with the efficient horizontal transmission of CWD in nature and enables accelerated studies of transmission and pathogenesis in the native species.
now, just what is in that deer feed? _ANIMAL PROTEIN_
Subject: MAD DEER/ELK DISEASE AND POTENTIAL SOURCES
Date: Sat, 25 May 2002 18:41:46 -0700 From: "Terry S. Singeltary Sr." Reply-To: BSE-LTo: BSE-L
8420-20.5% Antler DeveloperFor Deer and Game in the wildGuaranteed Analysis Ingredients / Products Feeding Directions
DEPARTMENT OF HEALTH & HUMAN SERVICESPUBLIC HEALTH SERVICEFOOD AND DRUG ADMINISTRATIONApril 9, 2001 WARNING LETTER01-PHI-12CERTIFIED MAILRETURN RECEIPT REQUESTED
Brian J. Raymond, Owner Sandy Lake Mills 26 Mill Street P.O. Box 117 Sandy Lake, PA 16145
Dear Mr. Raymond:Food and Drug Administration Investigator Gregory E. Beichner conducted an inspection of your animal feed manufacturing operation, located in Sandy Lake, Pennsylvania, on March 23,2001, and determined that your firm manufactures animal feeds including feeds containing prohibited materials. The inspection found significant deviations from the requirements set forth in Title 21, code of Federal Regulations, part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE) . Such deviations cause products being manufactured at this facility to be misbranded within the meaning of Section 403(f), of the Federal Food, Drug, and Cosmetic Act (the Act).Our investigation found failure to label your swine feed with the required cautionary statement "Do Not Feed to cattleor other Ruminants" The FDA suggests that the statement be distinguished by different type-size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.
In addition, we note that you are using approximately 140 pounds of cracked corn to flush your mixer used in the manufacture of animal feeds containing prohibited material. This flushed material is fed to wild game including deer, a ruminant animal.Feed material which may potentially contain prohibited material should not be fed to ruminant animals which may become part of the food chain.The above is not intended to be an all-inclusive list of deviations fromthe regulations. As a manufacturer of materials intended for animalfeed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance withthe law. We have enclosed a copy of FDA's Small Entity Compliance Guideto assist you with complying with the regulation... blah, blah, blah...
snip...end...full text ;
2003D-0186 Guidance for Industry: Use of Material From Deer and Elk In Animal Feed
EMC 1 Terry S. Singeltary Sr. Vol #: 1
see my full text submission here ;
Saturday, January 24, 2009
Research Project: Detection of TSE Agents in Livestock, Wildlife, Agricultural Products, and the Environment Location: 2008 Annual Report
Friday, November 30, 2007
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION
*** NOTE ***
please include venison/sheep/lamb and the bovine to any of the above questions.
example=brain tanning deer/elk hide or any other topics that pertain to transmission of TSEs
example=antler velvet nutritional supplements
_any_ nutritional supplements??? name/ingredients
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518