Thursday, June 18, 2015

McCaskill Opens Inquiry into ‘Brain Armor’ and Other Dietary Supplements Targeting Seniors

 McCaskill Opens Inquiry into ‘Brain Armor’ and Other Dietary Supplements Targeting Seniors

 

 Senator seeks information from FDA, 15 major retailers on products marketed to those suffering from Alzheimer’s, dementia, memory loss

 

 Wednesday, June 17, 2015

 

 WASHINGTON – U.S. Senator Claire McCaskill, the top-ranking Democrat on the Senate Special Committee on Aging, today began an examination of products, regulations, and retailers in the dietary supplement industry that specifically market to seniors using claims about improving memory and treating dementia and Alzheimer’s disease. One of the supplements, sold by retailer Amazon, was recently pulled from the online retailer’s website after McCaskill alerted the Food and Drug Administration to claims it made about ‘protecting against Alzheimer’s, Dementia, (and) Stroke…’. While that product is no longer sold on Amazon.com, similar products remain on Amazon’s website and the websites of several other national retailers.

 

 “People looking online for cures or treatment for Alzheimer’s Disease and dementia are at their most desperate—and it’s clear from what we’ve found that many of these products prey on that desperation,” McCaskill said. “Right now it’s like the wild west when it comes to the production, marketing, distribution, and sale of these products. I want to figure out why that is and what we can do to better protect America’s seniors.”

 

 McCaskill has sent a letter to the Food and Drug Administration (FDA) asking about its obligation to prevent fraud and review new supplement ingredients. The letter also asks what enforcement actions FDA has taken against dietary supplement manufacturers and distributors that fail to comply with FDA regulations and for a detailed description of FDA’s process for evaluating medical and nutritional claims made by supplements already on the market.

 

 “While we understand that the FDA undertakes periodic reviews and targeted investigations of dietary supplements currently on the market, concerns have been raised that the FDA’s current regulatory authorities lack a systemic approach to preventing adulterated, mislabeled, and fraudulent products from entering the market,” the letter to FDA Commissioner Stephen Ostroff reads.

 

 McCaskill also sent letters to 15 retailers inquiring about their review policies for dietary supplements and what they had done to prevent sales of harmful or fraudulently marketed products in their stores and on their websites and shows. McCaskill sent inquiries to the retailers Amazon, QVC, Walgreens, Home Shopping Network, Walmart, Target, CVS, Vitamin Shoppe, Safeway, eBay, Kroger, Vitamin World, GNC, Google, and Yahoo—asking each about their policies relating to the sale and/or marketing of dietary supplements.

 

 In the letter to Amazon, McCaskill specifically referenced the Brain Armor product recently removed from the Amazon website, writing “While I appreciate Amazon’s efforts to work with the FDA to remove from the site this dietary supplement that made claims about prevision or treatment of a disease – a practice prohibited by law – I am concerned about how the product came to be sold…”

 

 “Customers, myself included, respect these businesses enough to shop at them, and it’s important that these companies respect their customers in turn by doing what they can to not sell products that are unsafe or misleading.”

 

 These letters follow briefings that the FDA and Federal Trade Commission had provided to McCaskill’s staff concerning their respective roles in ensuring consumer safety within the dietary supplement industry.

 

 As past Chairman of the Senate’s Consumer Protection Subcommittee, McCaskill held a hearing examining misleading and false claims made by makers of weight-loss products.

 

 A copy of McCaskill’s letter to the FDA is available online HERE. Letters to retailers are available HERE. An image of the Brain Armor product previously being sold on the Amazon website if available HERE.

 

 Visit mccaskill.senate.gov/consumers to learn more about McCaskill’s fight to strengthen protections for American consumers.

 

 ###

 


 

 A copy of McCaskill’s letter to the FDA is available online HERE.

 


 

 Letter to retailer

 


 

 

 

 Greetings Honorable Senator McCaskill,

 

 Thank you kindly for opening up an Inquiry about the validity of these Nutritional Supplements industry, and the dangers some can cause.

 

 You bring up suspect suspicious dubious claims aimed at the elderly, claiming all sorts of unsubstantiated claims of miracle treatment for Alzheimer’s Disease and dementia, but the bottom line, some of these Nutritional Supplements risk just the opposite, i.e. POTENTIALLY CAUSING THE Alzheimer’s and or Creutzfeldt-Jakob Disease CJD aka mad cow type disease.

 

 Back in 1997 I lost my mother to the hvCJD ‘confirmed’. Exactly one year to the day previously, my neighbor lost his mother to CJD ‘confirmed’. my neighbors mother had been taking a Nutritional Supplement called IPLEX. This was a BRAIN pill for the brain. the problem was, this pill contained Specified Risk Materials SRM, the most high risk tissues that carry the risk factors for mad cow disease. The FDA has been putting out a warning letter for decades about this, but it was all voluntary. I started investigating this in 1998, and then I was asked to make a submission to the BSE Inquiry about these Nutritional Supplements. Then later on, I made a submission to the OIG on this topic when metabolife went to court, and I did manage to get them to remove some of their more high risk animal tissues for the TSE prion aka mad cow type disease. later on, I was in my neurosurgeons office, I picked up a magazine, and it was a manufacturers magazine on the very pill my neighbor was taking i.e. Standard Processing Co. It must have been fate, because that magazine catalog had pill after pill of nothing more than a mad cow in a pill. they even had mad cow candy bars that contained high risk tissues. on my mothers grave, I am telling you the truth Ma’am. I still have the catalog somewhere. the mad cow epidemic in the U.K. was caused by nothing more than feeding all those cattle a small nutritional supplement, and that’s all some of these nutritional supplements for humans were, a mad cow in a pill. mad cow disease has been here, I said it back in 1997, I still say it today. NOW, sporadic CJD has been linked to mad cow disease and sheep scrapie, and concerns are growing in the scientific community for Chronic Wasting Disease CWD in deer and elk. There was even a warning about Nutritional Supplements and risk factors that deer antler velvet has to prions aka TSE mad cow type disease, and the CDC put out this risk warning. I am not sure what the ingredients Brain Armor has, but you might want to check on this risk factor I speak of in all products i.e. TSE Prion aka mad cow type disease and the tissues that cause the i.e. SRM Specified Risk Factors. I know there was some restrictions on some of the most high risk tissues, but they are still allowed to use animal tissues, and with a disease that incubates for up to 10, 20, 50 years, but once clinical is 100% fatal, plus the friendly fire threat of secondhand exposure, I think we have wasted enough time.

 

 I have followed the mad cow saga, blunder, fiasco, take your pick, since inception. I have made countless submissions to federal dockets, FOIA requests, and I have had a few things published in peer review journals on this matter. I kindly submit the following to you Ma’am.

 

 I have been trying to warn folks at the FDA of this for over a decade.

 

 what about specified risk materials and mad cow disease, or better yet, what about chronic wasting disease cwd tse prion. what are the risk factors there ? are there any ? 10 to 50 year incubation period? you bet there is a risk factor.

 

 I tried to get this information to you, but your staff would not allow it, due to you not allowing your email address to the public. this is a terrible practice to have, by not letting the public access you through email, except by form.

 

 oh well, I tried.

 

 the next best thing I guess is to post in a link. so here it is Ma’am ;

 


 
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.

 

 snip...

 

 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.

 


 

 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.

 

 also;

 
what about potential mad cow candy bars ?

 
see their potential mad cow candy bar list too...

 
THESE are just a few of MANY of just this ONE COMPANY...TSS

 
DEPARTMENT OF HEALTH AND HUMAN SERVICES

 
FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH 

 

 TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE

 

 Friday, January 19, 2001 snip...

 

 17 But I think that we could exhibit some quite

 

 18 reasonable concern about blood donors who are taking dietary

 

 19 supplements that contain a certain amount of unspecified-

 

 20 origin brain, brain-related, brain and pituitary material.

 

 21 If they have done this for more than a sniff or something

 

 22 like that, then, perhaps, they should be deferred as blood

 

 23 donors.

 

 24 That is probably worse than spending six months in

 

 25 the U.K.

 

 1/19/01

 

 3681t2.rtf(845) page 501

 


 

 Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7

 


 


 

 see full text ;

 


 

 2003 - 2004 Product Catalog

 
Standard Process Inc.

 
NATURAL COCOA STANDARDBAR (mad cow candy bar) (i will just list animal organs) bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...

 
NATURAL PEANUT BUTTER STANDARDBAR

 
bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...

 
USF (MAD COW) OINTMENT (RUB A DUB DUB, KURU ETC) ;

 
bovine orhic glandular extract

 
UTROPHIN PMG

 
bovine uterus PMG

 
VASCULIN

 
bovine heart PMG extract, veal bone PMG extract, bovine liever, porcine duodenum, bovine adrenal Cytosol extract, bovine spleen, ovine spleen

 
IPLEX (neighbors mom died from CJD while taking these pills for years) 

 
bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach, bovine adrenal, bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN, bovine bone, veal bone meal

 
MYO-PLUS

 
bovine heart PMG, bovine liver, porcine stomach, bovine orchic extract, bovine spleen, ovine spleen, bovine adrenal Cytosol extract, BOVINE BRAIN

 
NEUROPLEX

 
bovine orchic Cytosol extract, bovine spleen, BOVINE BRAIN PMG EXTRACT, BOVINE ANTERIOR PITUITARY, bovine liver, BOVINE PITUITARY PMG EXTRACT, AND MORE BOVINE BRAIN...

 
NEUROTROPHIN PMG

 
BOVINE BRAIN PMG

 
NIACINAMIDE B6 VM

 
bovine liver, porcine stomach, bovine spleen ovine spleen, BOVINE BRAIN 

 
OCULOTROPHIN PMG BOVINE EYE PMG

 
ORCHEX

 
bovine liver, bovine orchic Cytosol extract, porcine stomch, bovine spleen, ovine spleen, BOVINE BRAIN

 
OSTARPLEX

 
veal bone PMG extract, veal bone PMG extract, bovine liver, porcine stomach, bovine adrenal, bovine spleen, ovine spleen, BOVINE BRAIN

 
PARAPLEX

 
bovine pancreas PMG extract, porcine duodenum, bovine adrenal PMG, BOVINE PITUITARY PMG EXTRACT, bovine thyroid PMG extract

 
PITUITROPHIN PMG

 
RUMAPLEX

 
BOVINE BRAIN, veal bone PMG extract, bovine adrenal, bovine prostate Cytosol extract, veal bone meal, bovine liver PMG extract, bovine spleen, ovine spleen, bovine liver

 
SENAPLEX

 
bovine liver PMG extract, bovine adrenal, BOVNE BRAIN, veal bone meal, bovine kidney, bovine orchic extract, bovine spleen, ovine spleen .......... 

 
THESE are just a few of MANY of just this ONE COMPANY.

 
FOR the following reason, I implore that the FDA take serious action in further protecting the consumer from the TSE agent via nutritional supplements. 

 
Does all that e-mail spam promising sexual vitality actually hide serious risk of contracting MAD COW DISEASE?

 
Volume 361, Number 9368 03 May 2003

 
Correspondence

 
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 of dietary supplements 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 (e-mail nskinari at aol.com) 1 Palmer ME, Haller C, McKinney PE, et al. Adverse events associated with dietary supplements: an observational study. Lancet 2003; 361: 101-06. [Text ] 2 Cupp MJ. Herbal remedies: adverse effects and drug interactions. Am Fam Physician 1999; 59: 1239-45. [PubMed ] 3 Unites States Food and Drug Administration. Overview of dietary supplements. Jan 3, 2001.

 http://www.cfsan.fda.gov/~dms/ds-oview.html

(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 (accessed Feb 20, 2002).

 


 

 snip...end tss letter to fda.

 

 =================== 2013 ================

 

 my plight with Metabolife, the GAO et al, and my submission to the BSE inquiry, about mad cow in a pill ;

 

 Wednesday, March 20, 2013

 

 GAO-13-244, Mar 18, 2013 Dietary Supplements FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Product

 

 From: Terry S. Singeltary Sr.

 

 Sent: Tuesday, March 19, 2013 2:46 PM

 

 To: mailto:gomezj%40gao.gov Cc: mailto:siggerudk%40gao.gov ; mailto:youngc1%40gao.gov ; mailto:oighotline%40gao.gov

 


 

 Monday, February 01, 2010

 

 Import Alert 17-04 BSE CJD HIGH RISK TISSUES, Nutritional Supplements and Cosmetics Import Alert 17-04

 


 

 Thursday, March 19, 2009

 

 Chronic Wasting Disease Prions in Elk Antler Velvet (Nutritional Supplements and CJD)

 

 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]

 


 

 Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a

 

 Comment Number: EC –2

 

 Accepted - Volume 7

 


 

 Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7

 

 snip...

 

 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

 


 

 snip...

 
http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm

 

 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."

 

 > To: NelliganJ at gao.gov

 

 > > The General Accounting Office (GAO) today released the following reports

 

 > and testimonies: >

 

 > REPORTS >

 

 > 1. Dietary Supplements: Review of Health-Related Call Records for

 

 > Users of Metabolife 356. GAO-03-494, March 31.

 


 


 


> GREETINGS GAO:

 

 > i was suprised that i did not see any listing of bovine tissue in & gt; 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

 

 > > Dear Sir,

 

 > > 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

 

 > > Terry,

 

 > > 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 > & gt; this...............MADSON!!!!!1

 

 > > snip...

 

 > ===============================

 

 > Sender: "Patricia Cantos"

 

 > To: "Terry S Singeltary Sr. (E-mail)"

 

 > Subject: Your submission to the Inquiry

 

 > Date: Fri, 3 Jul 1998 10:10:05 +0100

 

 > > 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 >

 


 

 > > 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"

 

 > To:

 

 > CC: "Charles W Davenport" , "Carolyn Feis Korman" > > , "Martin Gahart" >

 

 > Mr. Singletary,

 

 > > 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."

 

 > To: Marcia G Crosse

 

 > CC: Charles W Davenport , Carolyn Feis Korman > > , Martin Gahart > References: > >

 

 > THANK YOU!

 

 > > MIRACLES DO HAPPEN! ;-)

 

 > > now all we need to do is; >

 

 > snip......

 

 > > one small step for man, one giant leap for mankind ;-)

 

 > > however; >

 

 > ''We did not independently verify the contents of the product''

 

 > > ???

 

 >

 

 > TSS >

 


 


 


 

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

 
http://www.organicconsumers.org/madcow/pill6101.cfm

 

The German Magazine Der Spiegel came out to the house here and interviewed me in 2001 (I think), about that token purina mad cow feed mill blunder, and they were very concerned about these type supplements that carried the SRMs that could very well carry the TSE prion agent. ...please see ;

 

 GERMAN DER SPIEGEL MAGAZINEDie

 

 BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehörden sind lax.

 


 

 DER SPIEGEL (9/2001) - 24.02.2001 (9397 Zeichen) USA: Loch in der Mauer Die BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehördensind lax.Link auf diesen Artikel im Archiv:

 


 

 "Löcher wie in einem Schweizer Käse" hat auch Terry Singeltary im Regelwerk der FDA ausgemacht. Der Texaner kam auf einem tragischen Umweg zu dem Thema: Nachdem seine Mutter 1997 binnen weniger Wochen an der Creutzfeldt-Jakob-Krankheit gestorben war, versuchte er, die Ursachen der Infektion aufzuspüren. Er klagte auf die Herausgabe von Regierungsdokumenten und arbeitete sich durch Fachliteratur; heute ist er überzeugt, dass seine Mutter durch die stetige Einnahme von angeblich kräftigenden Mitteln erkrankte, in denen - völlig legal - Anteile aus Rinderprodukten enthalten sind.

 

 Von der Fachwelt wurde Singeltary lange als versponnener Außenseiter belächelt. Doch mittlerweile sorgen sich auch Experten, dass ausgerechnet diese verschreibungsfreien Wundercocktails zur Stärkung von Intelligenz, Immunsystem oder Libido von den Importbeschränkungen ausgenommen sind. Dabei enthalten die Pillen und Ampullen, die in Supermärkten verkauft werden, exotische Mixturen aus Rinderaugen; dazu Extrakte von Hypophyse oder Kälberföten, Prostata, Lymphknoten und gefriergetrocknetem Schweinemagen. In die USA hereingelassen werden auch Blut, Fett, Gelatine und Samen. Diese Stoffe tauchen noch immer in US-Produkten auf, inklusive Medizin und Kosmetika. Selbst in Impfstoffen waren möglicherweise gefährliche Rinderprodukte enthalten. Zwar fordert die FDA schon seit acht Jahren die US-Pharmaindustrie auf, keine Stoffe aus Ländern zu benutzen, in denen die Gefahr einer BSE-Infizierung besteht. Aber erst kürzlich verpflichteten sich fünf Unternehmen, darunter Branchenführer wie GlaxoSmithKline, Aventis und American Home Products, ihre Seren nur noch aus unverdächtigem Material herzustellen.

 

 "Its as full of holes as Swiss Cheese" says Terry Singeltary of the FDA regulations. ...

 


 


 


 

Sunday, November 10, 2013

 
LARGE CJD TSE PRION POTENTIAL CASE STUDY AMONG HUMANS WHO TAKE DEER ANTLER VELVET WILL BE ONGOING FOR YEARS IF NOT DECADES, but who's cares $

 

 

 PRION 2015 ORAL AND POSTER CONGRESSIONAL ABSTRACTS

 

 THANK YOU PRION 2015 TAYLOR & FRANCIS, Professor Chernoff, and Professor Aguzzi et al, for making these PRION 2015 Congressional Poster and Oral Abstracts available freely to the public. ...Terry S. Singeltary Sr.

 

 O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations

 

 Emmanuel Comoy, Jacqueline Mikol, Val erie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France

 

 Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods. We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period, with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold longe incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014), is the third potentially zoonotic PD (with BSE and L-type BSE), ***thus questioning the origin of human sporadic cases. We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health.

 

 ===============

 

 ***thus questioning the origin of human sporadic cases...TSS

 

 ===============

 

 O.08: H-type bovine spongiform encephalopathy associated with E211K prion protein polymorphism: Clinical and pathologic features in wild-type and E211K cattle following intracranial inoculation

 

 S Jo Moore, M Heather West Greenlee, Jodi Smith, Eric Nicholson, Cathy Vrentas, and Justin Greenlee United States Department of Agriculture; Ames, IA USA

 

 In 2006 an H-type bovine spongiform encephalopathy (BSE) case was reported in an animal with an unusual polymorphism (E211K) in the prion protein gene. Although the prevalence of this polymorphism is low, cattle carrying the K211 allele are predisposed to rapid onset of H-type BSE when exposed. The purpose of this study was to investigate the phenotype of this BSE strain in wild-type (E211E) and E211K heterozygous cattle. One calf carrying the wild-type allele and one E211K calf were inoculated intracranially with H-type BSE brain homogenate from the US 2006 case that also carried one K211 allelle. In addition, one wild-type calf and one E211K calf were inoculated intracranially with brain homogenate from a US 2003 classical BSE case. All animals succumbed to clinical disease. Survival times for E211K H-type BSE inoculated catttle (10 and 18 months) were shorter than the classical BSE inoculated cattle (both 26 months). Significant changes in retinal function were observed in H-type BSE challenged cattle only. Animals challenged with the same inoculum showed similar severity and neuroanatomical distribution of vacuolation and disease-associated prion protein deposition in the brain, though differences in neuropathology were observed between E211K H-type BSE and classical BSE inoculated animals. Western blot results for brain tissue from challenged animals were consistent with the inoculum strains. ***This study demonstrates that the phenotype of E211K H-type BSE remains stable when transmitted to cattle without the E211K polymorphism, and exhibits a number of features that differ from classical BSE in both wild-type and E211K cattle.

 

 ==============

 

 ***This study demonstrates that the phenotype of E211K H-type BSE remains stable when transmitted to cattle without the E211K polymorphism, and exhibits a number of features that differ from classical BSE in both wild-type and E211K cattle.***

 

 PLEASE SEE ;

 

 Wednesday, May 27, 2015

 

 BSE Case Associated with Prion Protein Gene Mutation

 


 

 ==============

 

 P.108: Successful oral challenge of adult cattle with classical BSE

 

 Sandor Dudas1,*, Kristina Santiago-Mateo1, Tammy Pickles1, Catherine Graham2, and Stefanie Czub1 1Canadian Food Inspection Agency; NCAD Lethbridge; Lethbridge, Alberta, Canada; 2Nova Scotia Department of Agriculture; Pathology Laboratory; Truro, Nova Scotia, Canada

 

 Classical Bovine spongiform encephalopathy (C-type BSE) is a feed- and food-borne fatal neurological disease which can be orally transmitted to cattle and humans. Due to the presence of contaminated milk replacer, it is generally assumed that cattle become infected early in life as calves and then succumb to disease as adults.

 

 Here we challenged three 14 months old cattle per-orally with 100 grams of C-type BSE brain to investigate age-related susceptibility or resistance. During incubation, the animals were sampled monthly for blood and feces and subjected to standardized testing to identify changes related to neurological disease.

 

 At 53 months post exposure, progressive signs of central nervous system disease were observed in these 3 animals, and they were euthanized. Two of the C-BSE animals tested strongly positive using standard BSE rapid tests, however in 1 C-type challenged animal, Prion 2015 Poster Abstracts S67 PrPsc was not detected using rapid tests for BSE. Subsequent testing resulted in the detection of pathologic lesion in unusual brain location and PrPsc detection by PMCA only.

 

 Our study demonstrates susceptibility of adult cattle to oral transmission of classical BSE. We are further examining explanations for the unusual disease presentation in the third challenged animal.

 

 ========================

 

 ***Our study demonstrates susceptibility of adult cattle to oral transmission of classical BSE. ***

 

 P.86: Estimating the risk of transmission of BSE and scrapie to ruminants and humans by protein misfolding cyclic amplification

 

 Morikazu Imamura, Naoko Tabeta, Yoshifumi Iwamaru, and Yuichi Murayama National Institute of Animal Health; Tsukuba, Japan

 

 To assess the risk of the transmission of ruminant prions to ruminants and humans at the molecular level, we investigated the ability of abnormal prion protein (PrPSc) of typical and atypical BSEs (L-type and H-type) and typical scrapie to convert normal prion protein (PrPC) from bovine, ovine, and human to proteinase K-resistant PrPSc-like form (PrPres) using serial protein misfolding cyclic amplification (PMCA).

 

 Six rounds of serial PMCA was performed using 10% brain homogenates from transgenic mice expressing bovine, ovine or human PrPC in combination with PrPSc seed from typical and atypical BSE- or typical scrapie-infected brain homogenates from native host species. In the conventional PMCA, the conversion of PrPC to PrPres was observed only when the species of PrPC source and PrPSc seed matched. However, in the PMCA with supplements (digitonin, synthetic polyA and heparin), both bovine and ovine PrPC were converted by PrPSc from all tested prion strains. On the other hand, human PrPC was converted by PrPSc from typical and H-type BSE in this PMCA condition.

 

 Although these results were not compatible with the previous reports describing the lack of transmissibility of H-type BSE to ovine and human transgenic mice, ***our findings suggest that possible transmission risk of H-type BSE to sheep and human. Bioassay will be required to determine whether the PMCA products are infectious to these animals.

 

 ================

 

 ***our findings suggest that possible transmission risk of H-type BSE to sheep and human. ***

 

 ALSO, PLEASE SEE ;

 

 31 Jan 2015 at 20:14 GMT

 

 *** Ruminant feed ban for cervids in the United States? ***

 

 31 Jan 2015 at 20:14 GMT

 


 


 

 Saturday, May 30, 2015

 

 PRION 2015 ORAL AND POSTER CONGRESSIONAL ABSTRACTS

 


 


 

 Wednesday, June 10, 2015

 

 Zoonotic Potential of CWD Prions

 

 LATE-BREAKING ABSTRACTS

 


 

 please see attached pdf file, with references of breaches in the USA triple BSE mad cow firewalls, and recent science on the TSE prion disease. ...TSS No documents available. Attachments View All (1) Docket No. APHIS-2014-0107 Bovine Spongiform Encephalopathy; Importation of Animals and Animal Products Singeltary Submission View Attachment:

 


 

 COOL H.R. 2393 Agriculture Chairman K. Michael Conaway (R-TX) Fears of US imports infected with mad cow disease is emerging as an issue in trans-Pacific trade talks

 

 Posted by Terry S. Singeltary Sr. on May 20, 2015 at 9:00am

 


 

 strange how political science works is it not $

 

 strange how Ireland gets the green light to trade it’s mad cow beef around the globe now, and just a short time afterward, a highly suspected mad cow case emerges. I wonder how long Ireland kept that mad cow sitting up on a shelf before, final legislation was passed to open up Ireland mad cow beef trade to the world again? however, stranger things have happened. just take a look at the BSE Minimal Risk Region Policy i.e. the BSE MRR, that overtook the Geographical BSE Risk (GBR) assessments for every country. all the BSE MRR policy did, was make it legal to trade mad cow type TSE prion disease around the globe. the TSE prion disease is now a legal trading commodity. humans have become expendable for a long incubating disease, that once clinical, is a 100% fatal for humans and animals.

 

 lets start with the recent notice that beef from Ireland will be coming to America.

 

 Ireland confirmed around 1655 cases of mad cow disease. with the highest year confirming about 333 cases in 2002, with numbers of BSE confirmed cases dropping from that point on, to a documentation of 1 confirmed case in 2013, to date. a drastic decrease in the feeding of cows to cows i.e. the ruminant mad cow feed ban, and the enforcement of that ban, has drastically reduced the number of BSE cases in Europe, minus a few BABs or BARBs. a far cry from the USDA FDA triple BSE firewall, which was nothing more than ink on paper, where in 2007, in one week recall alone, some 10 MILLION POUNDS OF BANNED POTENTIAL MAD COW FEED WENT OUT INTO COMMERCE IN THE USA. this is 10 years post feed ban. in my honest opinion, due to the blatant cover up of BSE TSE prion aka mad cow disease in the USA, we still have no clue as to the true number of cases of BSE mad cow disease in the USA or North America as a whole. ...just saying.

 

 Number of reported cases of bovine spongiform encephalopathy (BSE) in farmed cattle worldwide* (excluding the United Kingdom)

 

 Country/Year

 

 snip...

 

 spontaneous atypical BSE $$$

 

 France is having one hell of an epidemic of atypical BSE, probably why they stopped testing for BSE, problem solved $$$ same as the USA, that’s why they stopped testing for BSE mad cow disease in numbers they could find any with, after those atypical BSE cases started showing up. shut down the testing to numbers set up by OIE that are so low, you could only by accident find a case of BSE aka mad cow disease. and this brilliant idea by the WHO et al, to change the name of mad cow disease, thinking that might change things is preposterous. it’s all about money now folks, when the OIE, USDA and everyone else went along and made the TSE prion disease aka mad cow type disease a legal trading commodity by the BSE MRR policy, I would say everyone bit off more then they can chew, and they will just have to digest those TSE Prions coming from North America, and like it, and just prey you don’t get a mad cow type disease i.e. Transmissible Spongiform Encephalopathy TSE prion disease in the decades to come, and or pass it to some other poor soul via the iatrogenic medical surgical tissue friendly fire mode of transmission i.e. second hand transmission. it’s real folks, just not documented much, due to lack of trace back efforts. all iatrogenic cjd is, is sporadic cjd, until the iatrogenic event is tracked down and documented, and put into the academic and public domain, which very seldom happens. ...

 

 As of December 2011, around 60 atypical BSE cases have currently been reported in 13 countries, *** with over one third in France.

 


 

 FRANCE STOPS TESTING FOR MAD COW DISEASE BSE, and here’s why, to many spontaneous events of mad cow disease $$$

 

 so 20 cases of atypical BSE in France, compared to the remaining 40 cases in the remaining 12 Countries, divided by the remaining 12 Countries, about 3+ cases per country, besides Frances 20 cases. you cannot explain this away with any spontaneous BSe. ...TSS

 

 Sunday, October 5, 2014

 

 France stops BSE testing for Mad Cow Disease

 


 

 *** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics of BSE in Canada Singeltary reply ;

 


 

 Thursday, June 11, 2015

 

 *** Ireland Department of Agriculture, Food and the Marine Identifies Suspected BSE Case

 


 

 Sunday, June 14, 2015

 

 Larry’s Custom Meats Inc. Recalls Beef Tongue Products That May Contain Specified Risk Materials BSE TSE Prion

 


 

 Tuesday, June 16, 2015

 

 Missouri MDC changes deer hunting regs to help slow CWD

 


 

 Self-Propagative Replication of Ab Oligomers Suggests Potential Transmissibility in Alzheimer Disease

 

 Received July 24, 2014; Accepted September 16, 2014; Published November 3, 2014

 


 

 *** Singeltary comment ***

 


 

 Saturday, March 21, 2015

 

 ***Canada and United States Creutzfeldt Jakob TSE Prion Disease Incidence Rates Increasing

 


 

 *** HUMAN MAD COW DISEASE nvCJD TEXAS CASE NOT LINKED TO EUROPEAN TRAVEL CDC ***

 

 Sunday, November 23, 2014

 

 *** Confirmed Variant Creutzfeldt-Jakob Disease (variant CJD) Case in Texas in June 2014 confirmed as USA case NOT European

 

 the patient had resided in Kuwait, Russia and Lebanon. The completed investigation did not support the patient's having had extended travel to European countries, including the United Kingdom, or travel to Saudi Arabia. The specific overseas country where this patient’s infection occurred is less clear largely because the investigation did not definitely link him to a country where other known vCJD cases likely had been infected.

 


 

 see more here ;

 


 

 Thursday, January 15, 2015

 

 41-year-old Navy Commander with sporadic Creutzfeldt–Jakob disease CJD TSE Prion: Case Report

 


 

 Subject: *** Becky Lockhart 46, Utah’s first female House speaker, dies diagnosed with the extremely rare Creutzfeldt-Jakob disease aka mad cow type disease

 

 what is CJD ? just ask USDA inc., and the OIE, they are still feeding the public and the media industry fed junk science that is 30 years old.

 

 why doesn’t some of you try reading the facts, instead of rubber stamping everything the USDA inc says.

 

 sporadic CJD has now been linked to BSE aka mad cow disease, Scrapie, and there is much concern now for CWD and risk factor for humans.

 

 My sincere condolences to the family and friends of the House Speaker Becky Lockhart. I am deeply saddened hear this.

 

 with that said, with great respect, I must ask each and every one of you Politicians that are so deeply saddened to hear of this needless death of the Honorable House Speaker Becky Lockhart, really, cry me a friggen river. I am seriously going to ask you all this...I have been diplomatic for about 17 years and it has got no where. people are still dying. so, are you all stupid or what??? how many more need to die ??? how much is global trade of beef and other meat products that are not tested for the TSE prion disease, how much and how many bodies is this market worth?

 

 Saturday, January 17, 2015

 

 *** Becky Lockhart 46, Utah’s first female House speaker, dies diagnosed with the extremely rare Creutzfeldt-Jakob disease

 


 

 *** ALERT new variant Creutzfeldt Jakob Disease nvCJD or vCJD, sporadic CJD strains, TSE prion aka Mad Cow Disease United States of America Update December 14, 2014 Report ***

 


 

 Tuesday, April 21, 2015

 

 Transmissible Spongiform Encephalopathy Advisory Committee TSEAC MEETING SCHEDULED FOR June 1, 2015

 


 

 Saturday, April 18, 2015

 

 *** vCJD TEXAS CDC Emerging Infectious Diseases May 2015 Baylor College of Medicine Neuroscience 2014 case of human form of “mad cow disease” highlights need for continued surveillance

 


 

 Saturday, May 09, 2015

 

 *** Psychiatric Symptoms in Patients With Sporadic Creutzfeldt-Jakob Disease ***

 


 

 Self-Propagative Replication of Ab Oligomers Suggests Potential Transmissibility in Alzheimer Disease

 

 Received July 24, 2014; Accepted September 16, 2014; Published November 3, 2014

 


 

 *** Singeltary comment ;

 

 *** IN STRICT CONFIDENCE ***

 


 

 Thursday, June 04, 2015

 

 Catholic Medical Center v. Civil No. 14-cv-180-JL Opinion No. 2015 DNH 110 Fireman’s Fund Insurance Company Creutzfeldt Jakob Disease TSE Prion tainted medical instruments

 

 UNITED STATES DISTRICT COURT DISTRICT OF NEW HAMPSHIRE

 


 

 Tuesday, May 26, 2015

 

 Minimise transmission risk of CJD and vCJD in healthcare settings Last updated 15 May 2015

 


 

 *** Creutzfeldt-Jakob Disease Public Health Crisis VIDEO

 


 


 


 


 

 Saturday, December 13, 2014

 

 Terry S. Singeltary Sr. Publications TSE prion disease

 

 Diagnosis and Reporting of Creutzfeldt-Jakob Disease

 

 Singeltary, Sr et al. JAMA.2001; 285: 733-734. Vol. 285 No. 6, February 14, 2001 JAMA

 

 snip...

 


 

 lost my mom to the Heidenhain Variant of Creutzfeldt Jakob Disease hvCJD 12/14/97 confirmed. I just made a promise to mom, never forget (I could never ever forget what I saw), and never let them forget...

 

 layperson

 

 Terry S. Singeltary Sr., P.O. Box 42, Bacliff, Texas USA 77518 flounder9@verizon.net

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