ISU veterinary researchers study retinal scans as early
detection method for mad cow disease
ISU veterinary researchers study retinal scans as early detection method
for mad cow disease
Posted Apr 9, 2015 4:18 pm
Heather Greenlee's research shows that scanning the retinas of cattle can
lead to faster detection of mad cow disease. Photo by Christopher Gannon. Larger
image.
AMES, Iowa – New research from Iowa State University shows that a fatal
neurological disease in cows can be detected earlier by examining the animal’s
retinas.
Bovine spongiform encephalopathy (BSE), known more commonly as mad cow
disease, is an untreatable neurodegenerative disorder caused by misfolded brain
proteins known as prions. Classic BSE incubates for years before producers or
veterinarians notice symptoms, usually discovered when the animal can no longer
stand on its own.
But Heather Greenlee, an associate professor of biomedical sciences in Iowa
State’s College of Veterinary Medicine, said studying the retinas of cattle can
identify infected animals up to 11 months before they show signs of illness.
“The retina is part of the central nervous system,” Greenlee said.
“Essentially, it’s the part of the brain closest to the outside world, and we
know the retina is changed in animals that have prion diseases.”
In collaboration with Justin Greenlee’s group at the U.S. Department of
Agriculture’s National Animal Disease Center, she recently published findings in
the peer-reviewed academic journal PLOS ONE. She began studying how the retina
relates to prion diseases in 2006, and the experiments that led to her most
recent publication began in 2010.
The experiments utilize electroretinography and optical coherence
tomography, noninvasive technologies commonly used to assess the retina.
Greenlee said cows infected with BSE showed marked changes in retinal function
and thickness.
The results have implications for food safety, and Greenlee said the
screening methods used in her research could be adopted for animals tagged for
import or export as a means of identifying BSE sooner than conventional methods.
Greenlee said she’s also looking at how similar diseases in other species
affect the retina. For instance, she’s conducting experiments to find out if
retinal tissue may be a valid means of surveillance for chronic wasting disease
in deer.
She said she isn’t ready to publish her results, but the data gathered so
far looks promising.
The research also may contribute to faster diagnosis of Alzheimer’s disease
and Parkinson’s disease in humans, both of which are caused by proteins folding
incorrectly.
“Our goal is to develop our understanding of the retina to monitor disease
progression and to move diagnoses up earlier,” Greenlee said. “We think this
research has the potential to improve diagnosis for a range of species and a
range of diseases.”
-30- -
See more at:
see study ;
Wednesday, March 18, 2015
Changes in Retinal Function and Morphology Are Early Clinical Signs of
Disease in Cattle with Bovine Spongiform Encephalopathy
see more here ;
it’s all getting very interesting now with the TSE prion disease, all it’s
routes and sources and species, and now the risk factor for Alzheimer’s and is
Alzheimer’s a TSE prion disease, and what are the risk factors from the many
potential IATROGENIC ROUTES ???
what about the infamous VPSPR ??? price of prion poker went up for sure
with that.
and just what is SPORADIC GSS AND SPORADIC FFI, both familial type prion
disease, but yet NOT link to any genetic family ???
could it be IATROGENIC TRANSMISSION OF THE sGSS and sFFI ???
many questions still unanswered...
1999
The Eyes have it/CJD * and they could be stealing them from YOUR loved one,
hence the spread of CJD (aka MADCOW DISEASE) will spread...
From: Terry S. Singeltary Sr. (216-119-138-142.ipset18.wt.net)
Subject: The Eyes have it/CJD * and they could be stealing them from YOUR
loved one, hence the spread of CJD (aka MADCOW DISEASE) will spread...
Date: February 10, 2000 at 9:10 am PST
############ Creutzfeldt-Jakob Disease #############
Greetings list members, I was impressed that someone is listening,
considering the timing of when I broke the story in Nov. and this was posted in
Dec., what a coincidence. Thanks for listening. I find it rather frightening of
the fact sporadic CJD as well as vCJD can transmit infectivity this way. Makes
me wonder about blood?
Kind Regards, Terry S. Singeltary Sr., Bacliff, Texas USA
Vol. 282 No. 23, December 15, 1999 Preventing Prion Transmission in Corneal
Transplants
To the Editor: We agree with the Council on Scientific Affairs'
recommendation that "physicians become knowledgeable about BSE [bovine
spongiform encephalopathy] so they can appropriately advise their patients about
routes and rates of BSE transmission."1 Unfortunately, there is only passing
mention of prion transmission by corneal transplantation, which is performed on
40,000 to 50,000 patients each year in the United States.2 In addition to the
1974 US case,3 2 additional cases of probable and possible transmission,
respectively, have been reported in Germany and Japan,3 but the major new
concern relative to prion transmission via corneas occurred recently in Great
Britain. In February 1997, the corneal transplant and sclera from a 53-year-old
woman who had died of presumed metastatic lung cancer were transplanted to 3
recipients.4 In November 1997, the donor's brain revealed sporadic
Creutzfeldt-Jakob disease (CJD), confirmed by the United Kingdom CJD
Surveillance Unit.4 Although transplanted tissues were subsequently removed,
these 3 cases raise particular concern since infectivity of ocular tissue in
scrapie was reported as 5.4 log U/mL median infective dose (cornea) compared
with 8.9 log U/mL (brain) and 8.5 log U/mL (retina).3
The demonstrated possibility of further CJD or potential new variant-CJD
(nv-CJD) corneal transmission has created heightened medical and public scrutiny
of US eye donor screening standards; recently tightened criteria were approved
by the Eye Bank Association of America.5 Fortunately, no additional corneal
transmission has been reported in the United States since 1974, and additional
safeguards in place should further ensure the highest standards of continued
tissue safety in this country.
H. Dwight Cavanagh, MD, PhD R. Nick Hogan, MD, PhD University of Texas
Southwestern Medical Center at Dallas
1. Tan T, Williams MA, Khan MK, et al. Risk of transmission of spongiform
encephalopathy to humans in the United States: report of the Council on
Scientific Affairs. JAMA. 1999;281:2330-2339. ABSTRACT | FULL TEXT | PDF |
MEDLINE
2. Eye Bank Association of America. Eye banking statistical report.
Washington, DC: Eye Bank Association of America; 1997.
3. Hogan RN, Brown P, Heck E, Cavanagh HD. Risk of prion disease
transmission from ocular tissue transplantation. Cornea. 1999;18:2-11. MEDLINE
4. Royal College of Ophthalmologists. CJD and the Eye. London, England:
Royal College of Ophthalmologists; 1998. Monograph 7.
5. http://www.fda.gov/cber/rules/suitdonor.txt.
Accessed November 29, 1999.
In Reply: The transmission of classic CJD via corneal transplantation has
been demonstrated, and the potential possibility of transmission of nv-CJD via
corneal transplantation should be taken into consideration. With ongoing
national efforts to increase organ and tissue donation, we are pleased to hear
from Drs Cavanagh and Hogan that the additional safeguards introduced in the new
eye donor screening standards and recently approved by the Eye Bank Association
of America will ensure the highest standards of safety in this tissue.
Litjen Tan, PhD Michael A. Williams, MD Council on Scientific Affairs
American Medical Association Chicago, Ill
_______________________________________________________________________
Cadaver corneal transplants -- without family permission
Houston, Texas channel 11 news 28 Nov 99 Repoorted by Terry S. Singeltary
Sr.son of CJD victim
"It was a story about how the Lions eye bank were harvesting corneas from
victims in the Morgue, without their consent. Under Texas law, this appears to
be legal (remember Texas has the Veggie liable law). Even if Family says no,
this appears to happen, from what the news story said.
They said the only way to prevent this, is to fill out a form, stating not
to have this done. So if you don't fill out the form, they can do this. How many
people don't know about the form?
This is not only disgusting and appalling, it could be highly infectious.
Without proper background checking of the donors, on their physical history,
checking on past dementia, and/or family history, some of these unfortunate
victims, could be passing a human TSE.
Response Jill Spitler Clevelland Eye Bank:
"No, we are not stealing.........Yes, you do have such a law in the state
of Texas, but not all your state Eye Banks utilize the law. The Eye Bank that
you're speaking of is only one of 43 certified Eye Bank throughout the USA.
And there are measure taken per the Medical Standards of the Eye Bank
Association of America, the certifying body for eye banks and per FDA
regulations to address those concerns that you speak of.
I would suggest that those interested/concern with transplant contact their
local agencies. The Eye Bank Association of America has a web. site . Further if
anyone has problems contacting or finding out about their local organization(s),
call me or e-mail me I would be glad to help. My e-mail address is
jill@clevelandeyebank.org"
Terry Singeltary responds:
"Explain this to the family in Houston who went to their loved ones
funeral, only to find out that the loved one that was in the casket, had their
corneas removed without their permission, without the consent of the victim or
it's family. They would not have known it, only for the funny look the victim
had. So, they questioned, only to find out, the corneas, had in fact, been
removed without consent.
I call that stealing, regardless what the law states. This type of legal
grave robbing is not a logical thing to do without knowing any type of
background of the victims medical past, which really will not prove anything due
to the incubation period. Eye tissue being potentially a highly infective
source, there are risks here.
Should they not at least know of the potential ramifications of TSE's (the
person receiving the corneas)?
Should there not be some sort of screening?
Should there be some sort of moral issue here? If this is the case, and in
fact, they can come take your corneas, without your consent, then what will they
start taking next, without your consent?
Lets look at a hypothetical situation: What would happen if my Mom (DOD
12-14-97 hvCJD) would have gotten into a car wreck and died, before the symptoms
of CJD appeared. Not much money, so there was no autopsy. What would have
happened to that recipient of those infecting corneas?"
Comment (webmaster): Actual transmission of CJD by means of corneal
transplant may or may not be rare. The incidence of infectivity in older people
could be fairly high; this is not to be confused with the lower incidence of
symptomatic (clinical) CJD. It is very unlikely that familial CJD would have
been diagnosed in earlier generations; however, without interviewing the family
even known kindreds would not be excluded.
In blood donation, a much stricter policy is followed, even though corneal
transplant may be far more dangerous (being a direct link to the brain and not
going through purification steps).
Since highly sensitive tests for pre-clinical CJD are now available, it
would make sense to screen corneas for CJD, just as they are screened for AIDS,
hepatitus, and a host of other conditions.
############ http://mailhost.rz.uni-karlsruhe.de/warc/cjd-l.html
############
From: TSS (216-119-130-114.ipset10.wt.net)
Subject: re-The Eyes Have It (cjd) and they could be stealing them from
your loved one...
Date: September 17, 2000 at 10:06 am PST
Subject: RE-The Eyes Have It (cjd) and they could be stealing them from
your loved one... "pay back time" Date: Sat, 16 Sep 2000 10:04:26 -0700 From:
"Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L
Greetings List Members,
I hate to keep kicking a madcow, but this still is very disturbing to me.
Not only for the recipient of the cornea's, but as well, for the people whom
would be operated on, using the same tools that were used to put those stolen
cornea's in the recipient with. No history of this donor or his family (re-ffi),
or anything would be known, using stolen organs and or tissue's. I just think
this is not only wrong, but very dangerous to a great many other people, as this
is one of the most infectious tissues of TSE's. It seems that this practice of
stealing organ/tissue happens more than we think. Anyway, the family of the
victim which had their cornea's stolen, are now suing. In the example I used
with my Mother, if 3 months before, she would have been in a catastrophic
accident (car wreck, whatever), no autopsy (for whatever reason), no family (for
whatever reason), she lay in the morgue, and after 4 hours, they come steal the
cornea's, lot of people could have been infected, just because of lack of
medical history of donor/family. It may be hypothetical, but very real. We need
to stop the spread of this disease.
kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA
===========================================
Previous story--
Cadaver corneal transplants -- without family permission... http://www.mad-cow.org/~tom/dec99_news.html#bbb
===============================================
Sept. 15, 2000, 11:39PM
Slain woman's family sues over missing eyes
By BILL MURPHY Copyright 2000 Houston Chronicle
The family of a woman who was stabbed to death last year has filed a
lawsuit accusing the Lions Eye Bank of Houston of removing the woman's eyes
without permission and inserting plastic discs in their place.
Daisy Diaz's relatives were horrified when they saw her body and noticed
her eyes were missing, said their lawyer, Duncan Neblett III.
"They're a Catholic family," Neblett said. "They have strong beliefs about
the body and burial. They were really upset by this."
Dorey Zidrow, the eye bank's spokeswoman, said she could not specifically
discuss the Diaz case because it was in litigation. But Zidrow said a state law
allows doctors to remove corneas -- the dime-sized lens near the eye's surface
-- from a corpse without the family's permission.
The eye bank's usual procedure calls for removing the corneas, Zidrow said,
but not the entire eyes.
"There are an awful lot of people who benefit from this program in the
state of Texas," she said.
Diaz, 25, was stabbed to death in her apartment in the 400 block of
Thornton in October. Her brother-in-law, 30-year-old Raudel Quiroz, is charged
in the killing but has not been caught.
Neblett said authorities have told him Quiroz may have returned to his
native Guatemala.
Neither Diaz nor her family had given permission to donate any of her
organs, Neblett said.
Although state law allows corneas to be removed from corpses without first
gaining the family's permission, they cannot be removed over the family's stated
objection.
The eye bank is located at, and staffed by, the Baylor College of Medicine,
and receives part of its funding from the Lions Club.
The Diaz lawsuit is the second such suit to be filed against the eye bank
in recent years.
The family of Levi Perry Jr., a Houston teacher shot to death in MacGregor
Park in 1994, also alleged in their suit that Perry's eyes were removed. The
family was awarded $345,000 from the eye bank in April 1999.
==========================================================
THE LEGALITY OF STEALING ORGAN/TISSUE...
TEXAS STATUTES
Sec. 693.012. Removal of Corneal Tissue Permitted Under Certain
Circumstances.
On a request from an authorized official of an eye bank for corneal tissue,
a justice of the peace or medical examiner may permit the removal of corneal
tissue if:
(1) the decedent from whom the tissue is to be removed died under
circumstances requiring an inquest by the justice of the peace or medical
examiner;
(2) no objection by a person listed in Section 693.013 is known by the
justice of the peace or medical examiner; and
(3) the removal of the corneal tissue will not interfere with the
subsequent course of an investigation or autopsy or alter the decedent's
postmortem facial appearance.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Note: This information includes legislation enacted through the 75th
Congress. The 76th session of the Texas Legislature has concluded. The State of
Texas has not yet made the new codes available to the public. Until they do,
search the bill text for any changes or amendments.
Search 1999 Legislation for: 693.012
--------------------------------------------------------
TEXAS STATUTES Sec. 693.003. Consent Required in Certain Circumstances.
(a) A medical examiner or a person acting on the authority of a medical
examiner may not remove a visceral organ unless the medical examiner or person
obtains the consent of a person listed in Section 693.004.
(b) If a person listed in Section 693.004 is known and available within
four hours after death is pronounced, a medical examiner or a person acting on
the authority of a medical examiner may not remove a nonvisceral organ or tissue
unless the medical examiner or person obtains that person's consent.
(c) If a person listed in Section 693.004 cannot be identified and
contacted within four hours after death is pronounced and the medical examiner
determines that no reasonable likelihood exists that a person can be identified
and contacted during the four-hour period, the medical examiner may permit the
removal of a nonvisceral organ or tissue.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Note: This information includes legislation enacted through the 75th
Congress. The 76th session of the Texas Legislature has concluded. The State of
Texas has not yet made the new codes available to the public. Until they do,
search the bill text for any changes or amendments.
Search 1999 Legislation for: 693.003
--------------------------------------------------------
PLEASE NOTE; the bottom would only pertain to those who know of the law. if
you don't know about it, you cannot dispute, so in four hours, they can legally
remove body organs, as long as they don't disfigure. and who is to know the
difference? makes me wonder of some of my dead relatives, and if they were
burried with their eye's and or any of their organs. This is very disturbing, if
not for moral reasons, but for the risk of dangerous pathogens (human TSE's,
etc.) to be transmitted. only time will tell, but i am very disturbed. these
laws are not morally correct. They should be re-written as to they cannot so
easily take your organs, with no one knowing. The Family or Victim, must
consent. There should be some kind of research on donor/family medical
history...TSS
--------------------------------------------------------
Sec. 693.013. Persons Who May Object to Removal.
The following persons may object to the removal of corneal tissue:
(1) the decedent's spouse;
(2) the decedent's adult children, if there is no spouse;
(3) the decedent's parents, if there is no spouse or adult child; or
(4) the decedent's brothers or sisters, if there is no spouse, adult child,
or parent.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Note: This information includes legislation enacted through the 75th
Congress. The 76th session of the Texas Legislature has concluded. The State of
Texas has not yet made the new codes available to the public. Until they do,
search the bill text for any changes or amendments.
Search 1999 Legislation for: 693.013
-------------------------------------------------------
to cover one's butt....
Sec. 693.014. Immunity From Damages in Civil Action.
(a) In a civil action brought by a person listed in Section 693.013 who did
not object before the removal of corneal tissue, a medical examiner, justice of
the peace, or eye bank official is not liable for damages on a theory of civil
recovery based on a contention that the person's consent was required before the
corneal tissue could be removed.
(b) Chapter 104, Civil Practice and Remedies Code, applies to a justice of
the peace, medical examiner, and their personnel who remove, permit removal, or
deny removal of corneal tissue under this subchapter as if the justice of the
peace, medical examiner, and their personnel were state officers or employees.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Note: This information includes legislation enacted through the 75th
Congress. The 76th session of the Texas Legislature has concluded. The State of
Texas has not yet made the new codes available to the public. Until they do,
search the bill text for any changes or amendments.
Search 1999 Legislation for: 693.014
[[[as you can see, they knew it was wrong when they wrote the laws. or they
would not have covered the rear-ends so well...TSS]]]
Testimony of Bess Believeaux, Lions Eye Bank of Central Texas (Submission
to the Jan. 18/19 meeting of the TSE Advisory Committee)
TSS Submission to the same Committee; http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
Tissue Banks International (TBI), Gerald J Cole http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_13.pdf
TSS
########### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############
From: TSS (216-119-162-15.ipset44.wt.net)
Subject: re-The Eyes Have It (CJD) and they could be stealing them from
YOUR LOVED ONE !!!
Date: June 9, 2002 at 11:27 am PST
######## Bovine Spongiform Encephalopathy #########
June 8, 2002, 9:12PM Family seeks redress in cornea harvesting case By
JANET ELLIOTT Copyright 2002 Houston Chronicle Austin Bureau
AUSTIN -- Unless the Texas Supreme Court reverses course and decides to
review a case filed by the family of a Houston murder victim, there might be no
legal remedy for the wrongful harvesting of organs.
"As it stands now, people whose loved ones have their organs removed
without consent and against the express wishes of the family do not have a cause
of action," said Cletus Ernster III, lawyer for the parents of Levi Perry Jr.
Perry, a 38-year-old schoolteacher, was shot while jogging in MacGregor
Park in 1994. Four gang members who participated in the killing were convicted.
In 1999, Perry's parents and two of his siblings won a $345,000 judgment
after a Harris County jury found that Lions Eye Bank of Texas removed Perry's
eyes despite the fact that Perry's father signed a form denying approval for any
organ or tissue removal.
Houston's 14th Court of Appeals last September reversed the judgment. In a
2-1 decision, a panel of the court found that state law doesn't allow the Perrys
to recover mental anguish damages on their negligence claim.
In a dissent, Justice Charles Seymore said that Texas courts have
consistently allowed recovery of mental anguish damages for the negligent
handling of a dead body.
In March, and again in May, the Supreme Court denied review of the lower
court ruling.
Ernster said he is planning one more attempt to get the high court to hear
the case.
Kevin Yankowsky, a Houston lawyer who represents the eye bank, said the
appeals court opinion did not make new law. He said it doesn't close the
courthouse door to future claims that raise different legal and factual issues.
Evidence that Perry did not want to be an organ donor was particularly
strong.
Perry was the oldest of 10 children of Levi Perry Sr. and Eula Perry. The
elder Perrys were pioneering African-American doctors in the Fifth Ward.
Seven of the children followed their parents into medicine, including
Angela Perry, who became an opthalmologist.
About four years before Levi's murder, Angela Perry asked him to be an
organ donor. He declined, saying, "I want to leave this world with everything
God gave me," according to testimony Angela Perry gave in 1999.
When the family received word of Perry's murder, they went to Ben Taub
Hospital to identify the body. That is when Dr. Perry, a cardiologist, signed
the form consenting to an autopsy as required for a homicide, but denying any
organ or tissue donations.
"They felt like that was the last thing they could do for their son,"
Ernster said.
Under state law, corneas can be removed from dead people without the
permission of the family. Other organs, including eyeballs, need the permission
of the deceased or family members to be removed. But corneas cannot be removed
if the family files an objection such as the Perrys did.
The dime-sized corneas, which are the eye's main focusing element, can be
collected and transplanted after a person's death. Transplanted corneas can help
patients recover sight lost to injury, disease or infections.
According to the Eye Bank Association of America, in 2000 there were 47,000
corneal grafts. There are no waiting lists for corneas and, in fact, the U.S.
exports corneas to other countries.
Donated eyeballs are used for research.
An eye bank employee who testified in the trial in the Perrys' lawsuit
denied he removed the eyeballs.
But Angela Perry testified that the family was attending a private rosary
when she noticed her brother's eyes appeared to be sunken. She said she opened
his eyelids and saw the eyeballs were not there.
The jury was so incensed about the evidence that they found the eye bank
grossly negligent and awarded $200,000 in punitive damages.
Officials with the eye bank were not available for comment, said Heather
Russell, a spokeswoman with Baylor College of Medicine. The eye bank is
affiliated with the medical school.
In 2000, the eye bank was named in another lawsuit filed by the family of a
woman who was allegedly stabbed to death by her brother-in-law.
Daisy Diaz's relatives said they were horrified when they saw her body and
noticed her eyes were missing. Duncan Neblett III, who represents the family,
said pictures taken by a doctor show Diaz's face was badly damaged and bruised.
The family had not signed a form consenting to removal of the eyeballs nor
were they contacted by workers at the morgue, Neblett said.
After a television report aired on the lawsuit, Neblett said, he received
calls from several families who related similar experiences. He said all of the
callers were minorities.
"I've never talked to a wealthy white person this has happened to," Neblett
said.
He said the Perry case could have an impact on the lawsuit he filed,
although he alleged some causes of action that were not included in the Perrys'
lawsuit.
In April, the parents of a 15-year-old Central Texas girl who died after a
car wreck filed a lawsuit against several defendants, including the Lions Eye
Bank of Central Texas.
The parents of Jenna Mae Spene declined when they were asked at Austin's
Brackenridge Hospital whether they wanted to donate her organs and tissues.
The lawsuit says a family friend who went to the funeral home to dress the
body discovered that Jenna's corneas, part of her right breast and part of her
left foot had been removed.
Daniel Richards, an Austin lawyer who represents Teresa and Chris Spene,
said the parents hope their lawsuit might prompt legislators to consider
changing the law that allows cornea harvesting without the consent of relatives.
Michigan's law allowing coroners to harvest corneas without the consent of
relatives was ruled unconstitutional by a state court. The U.S. Supreme Court in
1995 refused to reverse the ruling.
Subject: Re: The Eyes have it (CJD), and they could be stealing them from
your loved one...
Date: Sat, 14 Oct 2000 16:58:28 –0700
From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy #########
Greetings everyone,
I am sure most of you remember this thread, and the concern I raised of
this potential threat of transmission of TSE, not only to another victim from
the donor, but my most concern, was all the other patients that may have been
operated on, with the same instruments that was used to transplant those
potentially infected corneas', which were stolen. I listed a hypothetical using
my mother as an example, etc. So instead of reposting, for those of you not
familiar with this thread, i posted urls below to go to, plus url to this
document/docket that just literally floored me, from the ignorance of it all. I
shall pass it on to you, so you may share the ignorance of it all with
me...
thank you, Terry S. Singeltary Sr., Bacliff, Texas USA
===========================================
Medical Eye Bank of Maryland 815 Park Avenue Baltimore, MD 21201
410-752-2020 FAX: 410-545-4455
1177 99 DEC 27 A9:39
Medical Board Directors Walter J. Stark, MD, Medical Director John C. Baer,
MD. Assoc. Medical Director John D. Gottsch. M.D Assoc. Medical Director
Verinder Nirankari, M.D. Assoc. Medical Director
Medical Eye Bank of Maryland Advisory Board Robert C. Davis, Jr
Chairman
Executive Director Patricia A. Murphy
Technical Program Manager Bernard E. Madison
Donor Development Coordinator Carol Miller
December 23, 1999
Docket Management Branch (HFA - 305) Food and Drug Administration 5630
Fishers Lance, Rm. 1061 Rockville, Maryland 208.52
Re: 21 CFR Parts 210, 211, 820 and 1271 [Docket No. 97N484S]
Proposed Rule: Suitability Determination for Donors of Human Cellular and
Tissue-Based Products
Dear Sir or Madame:
As the Executive Director of the Medical Eye Bank of Maryland and a member
organization of Tissue Banks International, I would like to state my agreement
to our organization's objection to the current proposed rule.
The Medical Eye Bank of Maryland has safely and efficiently operated since
1962 providing needed corneal transplants to the citizens in Maryland. Part of
the successful elimination of our corneal waiting list is due to the recovery of
corneas obtained under the Maryland legislative consent through the State of
Maryland Medical Examiner Office. This program has been in place for several
decades. I disagree with the FDA's contention that requiring a donor medical
history interview for corneas obtained under legislative consent is necessary to
ensure the risk of communicable disease transmission and would urge the FDA to
reassess this proposal.
As indicated in the Tissue Banks International chart, there is little
likelihood that a potential CJD case would even be brought into the Medical
Examiners Office for an autopsy and even less likely that CJD case would not be
screen out under our current medical standards for recovery. I believe that the
medical/social history that we perform on all cases obtained under legislative
consent are just as comprehensive as those cases obtained with a next-of-kin
consent and a medical/social history questionnaire.
I urge the FDA to reassess this proposed rule and the affect that it would
have on the public that we serve. The Medical Eye Bank of Maryland has been able
to serve the citizens of our state effectively by continuing to meet scheduled
surgery dates for potential corneal transplant recipients, The proposed
legislation may dramatically change how we can provide this service to our
citizens.
I would be available for any questions that you may have about my
comments.
Sincerely,
Patricia A. Murphy Executive Director
OFFICE OF THE CHIEF MEDICAL EXAMINER (MEO) Baltimore, Maryland 1998
Statistics for the State of Maryland
The following is an analysis of the total caseload of the Chief Medical
Examiner of the State of Maryland for the ywr 1998.
Reported Autopsied
Total Cases Reported: 8003 Total Cases Autopsied: 3184
*Total cases Nervous System Diseases 43 (0.5%) (NSD):
Total NSD cases autopsied: 4 (0.1%)
Total # of Eye Donors from NSD cases: o (0%) o (0%)
Total CJD Cases: Reported to MEO : 0 Autopsied by MEO: 0 Cornea Donors to
Eye Bank: 0
*Where a CJD case would be classified per MEO
Discussion:
The scientific literature indicates one case of CJD per million in general
population
The 1998 population of the State of Maryland is 5.1 million thus; it could
be expected that five cases CJD cases might occur in one year. (1988)
The total number of deaths (all causes) in Maryland is approximately 40,000
annually (1998 data) thus; it could be expected that one case might be a MEO
case in one year (1998) (MEO cases equal 20% of total annual deaths) if MEO
cases were representative of the general population (of deaths).
MEO cases are a distinct sub set of the general death population primarily
including accident; suicide and homicide
CJD cases are generally not reported to MEO CJD cases are generally not
autopsied by MEO CJD cases (as an infectious disease case) would not be
available to the eye bank by definition CJD cases would be screened out under
current medical standards as would any other case with unknown neurological
disorders.
SUMMARY
The likelihood of a potential CJD case being made available to the eye bank
by the MEO is nil by definition and category as determined by the MEO. The
likelihood of the eye bank recovering tissue from a MEO CJD case is nil because
by definition unknown nervous system disorders are ruled out.
==============================================================
TBI/TISSUE BANKS INTERNATIONAL
December 23, 1999
Docket Management Branch (HFA - 30.5) Food and Drug Administration 5630
Fishers Lane, rm. 1061 Rockville, MD 20852
Re: 21 CFR Parts 210, 211, 820 and 1271 pocket No. 97N - 484S]
Proposed Rule: Suitability Determination for Donors of Human Cellular and
Tissue-Based Products
Dear Sir or Madame:
Tissue Banks International (TBI) has commented on the FDA's "proposed
document" and "proposed registration rule" whereby TBI communicated our
objection to a comprehensive regulatory system for all tissue based products.
Unlike the December 1993 Interim Final Rule where there was concern about unsafe
imported tissue and potentially inadequate donor screening, the FDA's proposed
new system of regulation for human cellular and tissue based products is not
accompanied by a demonstrated need for additional regulation. Similarly, the
proposed role cited above is not based on a demonstrated need to modify the
screening and testing regulations for the human allograft tissue currently
regulated under the FDA's "'tissue final rule".
TBI's objection to the current proposed rule is consistent with our
previously communicated objections. There is mention of "concern" about
communicable disease in the FDA commentary. To our knowledge, under the current
regulation there have been no problems with transmission of communicable disease
through the use of human tissue for the diseases currently listed or for those
proposed to be added. The eye and tissue banking community has not been informed
of the FDA's safety and effectiveness concerns.
Additionally, the FDA has not yet addressed the concerns expressed by TBI
and many others in the eye and tissue banking community over the definition,
specific interpretation and scope of certain concepts within the "proposed
approach document" such as "homologous use", "minimal manipulation" and
"systemic effect". The current proposed rule only
[skip to page 3, full text url below...tss]
Tissue Banks International FDA [Docket No. 97N - 484S] Page 3 of 6
The FDA already deemed relevant TSE/CJD and treponema pallidum in addition
to HIV and hepatitis (for non leukocyte-rich tissue) contained in the "tissue
final rule" requiring screening for former and testing for the later. The tissue
and eye banking commtmity already screens for many diseases and disease risks
including CJD. TBI does not believe the FDA has sufficiently demonstrated
(quantitatively or scientifically) relevant risk for expanding its oversight to
include other diseases in addition to HIV and hepatitis. As previously
expressed, the application of "relevant" is subject to FDA's sole determination
which is further complicated by the FDA's interpretation of the terms
"sufficiently prevalent", "risk" and "appropriate screening". These terms are
not sufficiently defined. Additionally, relevant risk is broadly applied and
does not sufficiently address risk by specific tissue that TBI will comment on
in the following subtitle.
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AND CREUTZFELDT-JACOB DISEASE
(CJD): The FDA seems to be particularly concerned about the transmission of CJD
through dura mater and cornea transplants. Yet, apparently based on these
reports, the FDA proposes to apply the screening Lo all tissue. Of particular
concern to TBI is if the FDA would require the tissue and eye banking community
to screen for and reject donors who exhibit changes in speech and gait. Changes
in speech and gait are symptoms that might apply to many medically suitable
donors most likely not associated with TSE / CJD.
TBI would like to stress that the reports of the transmissions of disease
for both dura mater and corneal tissue occurred outside of the United States
except for one reported case of CJD via cornea transplant in the U.S. The cornea
is this case was never evaluated or screened by the local eye bank and occurred
before the promulgation of any organized screening standards.
TBI is working with the Eye Bank Association of America to review the
adequacy of the screening of eye donors for CJD. Walter Stark, M.D., head of the
Cornea Service at the Wilmer Eye Institute at Johns Hopkins University Medical
Center and TBI's National Medical Director is participating with Richard
Johnson, M.D., also from Johns Hopkins and author of many publications on prion
disease along with others on a special ad hoc committee investigating this
issue. TBI recommends the FDA take no action regarding the screening for TSE /
CJD until further evaluation by this EBAA ad hoc committee can be completed and
the results can be shared with the FDA.
TBI knows of no currently available method to test for TSE except for a
brain biopsy. TBI agrees with the FDA that testing for TSE through a brain
biopsy is not feasible because the test results would not be available before
corneal tissue is optimally utilized for transplantation. This would not be in
the best interest of the patient receiving the cornea. There is also a
significant question on the impact upon the rate of corneal donation if consent
for a brain autopsy was also needed. A reduction in donors and a return to
waiting lists is also not in the best interest of the patient or patient
outcomes.
[pages 4 and 5 skipped, you can read full text at below URL...tss]
Sincerely,
Richard L. Fuller President/CEO Tissue Banks International
Monday, August 31, 2009
HUMAN BODY PARTS FOR SALE TO THE HIGHEST BIDDER Inside a Creepy Global Body
Parts Business
Subject: New guidance on decontamination of trial contact lenses and other
contact devices has been revealed for CJD AND vCJD
From: "Terry S. Singeltary Sr."
Reply-To: Creutzfeldt-Jakob Disease
Date: Fri, 4 Dec 2009 15:59:48 +0000
Content-Type: text/plain
Parts/Attachments: Parts/Attachments text/plain (1009 lines) Reply Reply
New DoH guidance on decontaminating lenses
December 4th, 2009
New guidance on decontamination of trial contact lenses and other contact
devices has been revealed.
The latest recommendations from the Department of Health’s Advisory
Committee on Dangerous Pathogens (ACDP) replace previous guidance issued amid
fears that Creutzfeldt-Jakob Disease (CJD) and variant CJD (vCJD), the human
form of bovine spongiform encephalopathy (BSE, ‘mad cow disease’), could
theoretically be transmitted from person to person by contact lenses and other
devices such as tonometer heads and diagnostic lenses.
Details were discussed at the British Contact Lens Association’s Pioneers’
Conference in London late in November.
Professor Roger Buckley (pictured), a member of the ophthalmology subgroup
of the ACDP’s Transmissible Spongiform Encephalopathy Working Group established
to review this advice, told BCLA members at the Royal Society of Medicine that
there had been no known cases of transmission of CJD/vCJD resulting from contact
lens wear or diagnostic examination, and there was now thought to be a low level
of risk of infectivity of the cornea and ocular surface.
Under the new guidance, six steps are required to minimise the risk of
transmission via re-used contact devices. The lens or device should be:
decontaminated immediately after contact with the eye surface; rinsed in Water
for Irrigation BP (not tap water) for not less than 30 seconds; cleaned on all
surfaces with a liquid soap or detergent, then rinsed in Water for Irrigation BP
for a further 30 seconds; immersed in a freshly-prepared solution of sodium
hypochlorite providing 10,000ppm of available chlorine for ten minutes; rinsed
in three changes of Water for Irrigation BP for a total of not less than ten
minutes; shaken to remove excess water, dried with a disposable tissue, and
stored dry in a suitable container.
Any further measure (such as autoclaving) can then be carried out, if this
is necessary and if the device is designed to withstand such a process.
Otherwise, it is ready for immediate re-use.
Transmissible Spongiform Encephalopathy Agents: Safe Working and the
Prevention of Infection: Annex C ANNEX C General principles of decontamination
and waste disposal
Alert to Urological Surgeons TRANSRECTAL PROSTATIC BIOPSY IN MEN AT RISK OF
VARIANT CJD
Ophthalmology The Ophthalmology subgroup met twice in 2008 on 7th April and
20th June to discuss issues relating to CJD infection control in ophthalmology.
The following topic groups were identified: 17 • Anterior eye • Posterior eye •
Assessment tool • Decontamination of ophthalmic surgical instruments •
Examination, diagnostic equipment and contact lenses • CJD incident management
Members were assigned to relevant topic groups, and discussions and research
were coordinated by a topic group lead. The topic groups then produced draft
guidance on their particular areas of expertise towards the end of 2008.
Pathology (Annex K) The Working Group drafted guidelines for pathologists and
pathology laboratories for the handling of tissues from patients with, or at
risk of, CJD. This document (Annex K of the Working Group guidance) is aimed at
pathologists and individuals working in pathology laboratories who handle
tissues from patients. It aims to ensure that laboratory staff are aware of risk
factors for CJD prior to carrying out procedures on tissues. The draft annex was
sent out for a limited consultation with representatives from the Royal College
of Pathologists, the Institute for Biomedical Sciences, the British
Neuropathological Society and the Health and Safety Executive. The Annex was
approved by the Working Group at their December 2008 meeting. Annex K has since
been published at:
Pre-surgery assessment (Annex J) The updates to Annex J were approved for
publication by the Working Group at their February 2008 meeting, subject to some
minor adjustments. The Annex was then signed off by the ACDP Chairman and
published on 1st May 2008 at:
see full text ;
Friday, July 17, 2009 Revision to pre-surgical assessment of risk for vCJD
in neurosurgery and eye surgery units Volume 3 No 28; 17 July 2009
Wednesday, August 20, 2008 Tonometer disinfection practice in the United
Kingdom: A national survey
CJD Human Cornea Tissue, Recall END OF ENFORCEMENT REPORT FOR AUGUST 5,
2009 Posted Aug 07 2009 6:32pm
From: TSS
Subject: Tonometer prism sterilisation: A local and UK national survey
(TSE)
Date: August 24, 2007 at 1:24 pm PST
1: Cont Lens Anterior Eye. 2007 Aug 17; [Epub ahead of print]
Tonometer prism sterilisation: A local and UK national survey.
Chandra A, Barsam A, Hammond CJ. West Kent Eye Centre, Princess Royal
University Hospital, Orpington, Kent BR6 8ND, UK.
PURPOSE: First to audit local adherence to a protocol of use of an alcohol
wipe for each tonometry, and secondly to assess current practice nationally in
the UK. METHOD: The audit was carried out at two units: The West Kent Eye Centre
at the Princess Royal University Hospital (Orpington, UK) and Queen Mary's
Hospital (Sidcup, UK). The standard set for this audit was 100% sterilisation.
During a 1-week period in November 2005, the number of alcohol wipes was counted
in each consultation room after outpatient clinics, with the doctors being
assessed blind to the survey. The number of Goldman applanation tonometry
intra-ocular pressures recorded by each clinician was counted by inspection of
the medical records of patients seen. Secondly, departments listed in the UK
Directory of Training Posts were contacted by telephone and the senior nurse was
interviewed. They were asked directly about their department's tonometer prism
sterilisation and management. RESULTS: The local audit showed only 54% of
tonometry measurements were associated with sterilisation using an
alcohol-impregnated wipe. The national survey included 140 of the 152 UK
training departments. Thirty-three (23.6%) departments used disposable tonometer
prisms routinely. The remaining 107 (76.4%) used non-disposable prisms.
Eighty-five (60.7%) departments provided sodium hypochlorite for prism
sterilisation, with 69 (81.2%) of these departments providing more than one
prism/clinician to allow full exposure to the disinfectant. Twenty-two (15.7%)
departments used alcohol wipes. Only 8 (7.5%) of the 107 departments using
non-disposable prisms tracked these prisms, despite Royal College of
Ophthalmologists guidelines that they should be. These same 8 (7.5%) departments
replaced the non-disposable prisms as per manufacturer guidelines. 19.3% of
charge nurses were aware of a policy for tonometry in patients with, or at risk
of, prion disease. CONCLUSIONS: This study highlights that sterilisation of
tonometer prisms was inconsistent in a local audit. Nationally, practices were
varied. The majority of ophthalmology departments continued to use
non-disposable tonometer prisms, but few seemed aware of the Royal College of
Ophthalmologists' recommendation that disposable prisms are used in patients at
risk of prion disease, and few track tonometer heads or replace them according
to manufacturers guidelines. Use of disposable tonometer prisms would seem to
reduce concerns about sterilisation, as well as prevent spread of common
pathogens.
PMID: 17703987 [PubMed - as supplied by publisher]
PA-34
SPORADIC CREUTZFELDT-JAKOB DISEASE: PRPRES IS CONSTANTLY PRESENT IN THE
RETINA, AND RARELY IN THE OPTIC NERVE
M. Mangieri1, G. Giaccone1, L. Limido1, G. Di Fede1, S. Suardi1, R.
Capobianco1, P. Fociani2, O. Bugiani1, F. Tagliavini1 1 Istituto Nazionale
Neurologico Carlo Besta, Division of Neuropathology and Neurology 5, Milano,
Italy and 2 Ospedale Luigi Sacco, Division of Pathology, Università di Milano,
Milano, Italy
e-mail: mmangieri@istituto-besta.it
Creutzfeldt-Jakob disease (CJD) is marked by the presence of the protease-
resistant prion protein (PrPres) in the brain. Studies of the retina and optic
nerve in patients with CJD are scanty and on very small series of patients. We
analysed ocular tissues of sporadic CJD patients (retina of 58 and optic nerve
of 51), representing all combinations of PRNP codon 129 polymorphisms and PrPres
types by Parchi, except VV1. Ocular tissue from 24 patients with other
neurological diseases were used as controls. The ocular tissue was collected at
autopsy and the samples were fixed in Carnoy solution or frozen. Before
immunohistochemistry with 3F4 antibody, the sections were pretreated with
proteinase K and guanidine thiocyanate. In all cases of sCJD the retina showed
immunoreactivity for PrPres localized in the inner and outer plexiform layers,
with a synaptic type of labelling. No difference in the pattern of labeling was
detected between CJD patients with different PRNP codon 129 polymorphisms and
PrPres types in the brain. In all cases with frozen retinal tissue available (n
= 18), the immunoblot was positive for PrPres . Two out of the 51 sCJD showed
the deposition of PrPres also in the optic nerve, corresponding to an
immunostaining delineating stellate cells and associated with the presence of
numerous CD68- and CD45-positive cells. Our results demonstrate the presence of
the pathological form of prion protein not only in the retina of all sCJD cases
analysed, but also in optic nerve in a small subset of sCJD patients, a finding
previously described only in variant CJD and in experimental animal models.
Moreover, our data suggest a correlation between the deposition of PrPres and
inflammatory changes in the optic nerve in sCJD.
143
----- Original Message -----
From: "Terry S. Singeltary Sr." <[log in to unmask]>
To: <[log in to unmask]>
Sent: Thursday, December 28, 2006 10:23 AM
Subject: Ophthalmic Surgery in Prion Diseases
Volume 13, Number 1–January 2007 Dispatch Ophthalmic Surgery in Prion
Diseases Tsuyoshi Hamaguchi,*1 Moeko Noguchi-Shinohara,* Yosikazu Nakamura,†2
Takeshi Sato,‡2 Tetsuyuki Kitamoto,§2 Hidehiro Mizusawa,¶2 and Masahito Yamada*2
*Kanazawa University Graduate School of Medical Science, Kanazawa, Japan; †Jichi
Medical University, Shimotsuke, Japan ‡National Center for Neurology and
Psychiatry, Ichikawa, Japan; §Tohoku University Graduate School of Medicine,
Sendai, Japan; and ¶Tokyo Medical and Dental University, Tokyo, Japan
Suggested citation for this article
Abstract Eleven (1.8%) of 597 patients underwent ophthalmic surgery within
1 month before the onset of prion disease or after the onset. All
ophthalmologists reused surgical instruments that had been incompletely
sterilized to eliminate infectious prion protein. Ophthalmologists should be
aware of prion diseases as a possible cause of visual symptoms and use
disposable instruments whenever possible.
Visual impairment occurs in 10% to 20% of patients with sporadic
Creutzfeldt- Jakob disease (sCJD) during an early stage of the disease
(Heidenhain variant) (1,2). Some patients with prion diseases may visit
ophthalmologists with visual impairment due to prion diseases or with coexisting
age-related eye diseases (3,4).
Infectious prion protein (PrPSc) was identified in the retina and optic
nerve in patients with variant CJD (vCJD) and sCJD (5,6), and CJD has been
transmitted by corneal transplantation (7,8). In the World Health Organization
(WHO) guidelines, eyes were classified as highly infectious tissues (9).
Secondary transmission of PrPSc through ophthalmic surgery could possibly
be prevented around the onset of prion diseases, although surgery that is
performed long before the onset of prion diseases would not have that potential.
It is important to understand the current status of ophthalmic surgery for
patients with prion diseases and to clarify the clinical features of the
patients with prion diseases who undergo ophthalmic surgery. Here, we describe
the relevant data from CJD surveillance in Japan.
The Study.....snip full text ;
----- Original Message -----
From: "Terry S. Singeltary Sr." <[log in to unmask]>
To: <[log in to unmask]>
Sent: Wednesday, December 27, 2006 12:21 PM
Subject: ABNORMAL PRION ACCUMULATION ASSOCIATED WITH RETINAL PATHOLOGY IN
EXPERIMENTALLY INOCULATED SCRAPIE-AFFECTED SHEEP
Eye procedure raises CJD concerns
November 19, 2004 United Press International by STEVE MITCHELL
A New York man who died from a rare brain disorder similar to mad cow
disease in May underwent an eye procedure prior to his death that raises
concerns about the possibility of transmitting the fatal disease to others,
United Press International has learned. The development comes on the heels of
the announcement Thursday by U.S. Department of Agriculture officials of a
possible second case of mad cow disease in U.S. herds.
Richard Da Silva, 58, of Orange County, N.Y., died from Creutzfeldt Jakob
disease, an incurable brain-wasting illness that strikes about one person per
million.
Richard's wife Ann Marie Da Silva told UPI he underwent a check for the eye
disease glaucoma in 2003, approximately a year before his death. The procedure
involves the use of a tonometer, which contacts the cornea -- an eye tissue that
can contain prions, the infectious agent thought to cause CJD.
Ann Marie's concern is that others who had the tonometer used on them could
have gotten infected.
A 2003 study by British researchers suggests her concerns may be justified.
A team led by J.W. Ironside from the National Creutzfeldt-Jakob Disease
Surveillance Unit at the University of Edinburgh examined tonometer heads and
found they can retain cornea tissue that could infect other people -- even after
cleaning and decontaminating the instrument.
"Retained corneal epithelial cells, following the standard decontamination
routine of tonometer prisms, may represent potential prion infectivity," the
researchers wrote in the British Journal of Ophthalmology last year. "Once the
infectious agent is on the cornea, it could theoretically infect the
brain."
Prions, misfolded proteins thought to be the cause of mad cow, CJD and
similar diseases, are notoriously difficult to destroy and are capable of
withstanding most sterilization procedures.
Laura Manuelidis, an expert on these diseases and section chief of surgery
in the neuropathology department at Yale University, agreed with the British
researchers that tonometers represent a potential risk of passing CJD to other
people.
Manuelidis told UPI she has been voicing her concern about the risks of
corneas since 1977 when her own study, published in the New England Journal of
Medicine, showed the eye tissue, if infected, could transmit CJD.
At the time the procedure was done on Richard Da Silva, about a year before
he died, she said it was "absolutely" possible he was infectious.
The CJD Incidents Panel, a body of experts set up by the U.K. Department of
Health, noted in a 2001 report that procedures involving the cornea are
considered medium risk for transmitting CJD. The first two patients who have a
contaminated eye instrument used on them have the highest risk of contracting
the disease, the panel said.
In 1999, the U.K. Department of Health banned opticians from reusing
equipment that came in contact with patients' eyes out of concern it could
result in the transmission of variant CJD, the form of the disease humans can
contract from consuming infected beef products.
Richard Da Silva was associated with a cluster of five other cases of CJD
in southern New York that raised concerns about vCJD.
None of the cases have been determined to stem from mad cow disease, but
concerns about the cattle illness in the United States could increase in light
of the USDA announcement Thursday that a cow tested positive on initial tests
for the disease. If confirmed, this would be the second U.S. case of the
illness; the first was detected in a Washington cow last December. The USDA said
the suspect animal disclosed Thursday did not enter the food chain. The USDA did
not release further details about the cow, but said results from further lab
tests to confirm the initial tests were expected within seven days.
Ann Marie Da Silva said she informed the New York Health Department and
later the eye doctor who performed the procedure about her husband's illness and
her concerns about the risk of transmitting CJD via the tonometer.
The optometrist -- whom she declined to name because she did not want to
jeopardize his career -- "didn't even know what this disease was," she
said.
"He said the health department never called him and I called them (the
health department) back and they didn't seem concerned about it," she added. "I
just kept getting angrier and angrier when I felt I was being dismissed."
She said the state health department "seems to have an attitude of don't
ask, don't tell" about CJD.
"There's a stigma attached to it," she said. "Is it because they're so
afraid the public will panic? I don't know, but I don't think that the answer is
to push things under the rug."
New York State Department of Health spokeswoman Claire Pospisil told UPI
she would look into whether the agency was concerned about the possibility of
transmitting CJD via tonometers, but she had not called back prior to story
publication.
Disposable tonometers are readily available and could avoid the risk of
transmitting the disease, Ironside and colleagues noted in their study. Ann
Marie Da Silva said she asked the optometrist whether he used disposable
tonometers and "he said 'No, it's a reusable one.'"
Ironside's team also noted other ophthalmic instruments come into contact
with the cornea and could represent a source of infection as they are either
difficult to decontaminate or cannot withstand the harsh procedures necessary to
inactivate prions. These include corneal burrs, diagnostic and therapeutic
contact lenses and other coated lenses.
Terry Singletary, whose mother died from a type of CJD called Heidenhain
Variant, told UPI health officials were not doing enough to prevent people from
being infected by contaminated medical equipment.
"They've got to start taking this disease seriously and they simply aren't
doing it," said Singletary, who is a member of CJD Watch and CJD Voice --
advocacy groups for CJD patients and their families.
U.S. Centers for Disease Control and Prevention spokeswoman Christine
Pearson did not return a phone call from UPI seeking comment. The agency's Web
site states the eye is one of three tissues, along with the brain and spinal
cord, that are considered to have "high infectivity."
The Web site said more than 250 people worldwide have contracted CJD
through contaminated surgical instruments and tissue transplants. This includes
as many as four who were infected by corneal grafts. The agency noted no such
cases have been reported since 1976, when sterilization procedures were
instituted in healthcare facilities.
Ironside and colleagues noted in their study, however, many disinfection
procedures used on optical instruments, such as tonometers, fail. They wrote
their finding of cornea tissue on tonometers indicates that "no current cleaning
and disinfection strategy is fully effective."
Singletary said CDC's assertion that no CJD cases from infected equipment
or tissues have been detected since 1976 is misleading.
"They have absolutely no idea" whether any cases have occurred in this
manner, he said, because CJD cases often aren't investigated and the agency has
not required physicians nationwide report all casesof CJD.
"There's no national surveillance unit for CJD in the United States; people
are dying who aren't autopsied, the CDC has no way of knowing" whether people
have been infected via infected equipment or tissues, he said.
Ann Marie Da Silva said she has contacted several members of her state's
congressional delegation about her concerns, including Rep. Sue Kelly, R-N.Y.,
and Sen. Charles Schumer, D-N.Y.
"Basically, what I want is to be a positive force in this, but I also want
more of a dialogue going on with the public and the health department," she
said.
From: Terry S. Singeltary Sr. (216-119-138-149.ipset18.wt.net)
Subject: Trial Contact Lenses and RE-USE in the U.S. & CJD, no threat
says FDA???
Date: October 7, 2000 at 9:19 am PST
Subject: Trial Contact Lenses and RE-USE in the U.S. & CJD, no threat
says FDA???
Date: Sat, 7 Oct 2000 10:27:03 –0700
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy #########
Greetings List Members,
It just never ceases to amaze me, that the FDA and the rest of the
different political governmental bodies that are suppose to protect us, but
instead, choose to protect their best interest$ the corporate industries that
donate all the cash$ there has been plenty of warning and tests to prove of some
sort of infectivity in the eyes. the fda speaks of no test for the tears, well
hell, there is no test that will detect it period, but yet you still die from
it. does not mean it is not there. when will they wake up? sporadic CJD is
coming from somewhere and they had better start looking as to where it is coming
from. this is just more typical B.S.eee. please read the ignorance,
below....
thank you, Terry S. Singeltary Sr., Bacliff, Texas USA
Subject: 09-018 - gsc - flounder@wt.net - concern of CJD transmission with
trial contact lenses
Date: Fri, 06 Oct 2000 14:49:24 –0400
From: "Clark, Geoffrey S."
To: 'flounder@wt.net'
CC: "Warburton, Karen" , "CDRH Small Manu. Assistance"
Terry S. Singeltary Sr.:
I have discussed your concerns with our Device Evaluation staff who have
provided the following information:
The risk of CJD transmission through the use of trial (fitting) contact
lenses is extremely low and at present unmeasureable. There have been no
documented cases of CJD transmission via a contact lens or contact lens
solution. It is highly unlikely that the CJD agent would be present on the
surface of the cornea or present in the tears of an infected person.
Additionally, the use of trial lens sets has been declining in the US over the
past 10 years as the soft contact lens market has shifted to lenses dispensed in
non-reusable blister packs. Therefore, a formal recommendation against the use
of trial lenses because of potential CJD transmission is not appropriate at this
time.
Please feel free to contact me if I can be of additional assistance.
=|<: 130h="" 5074275="" cdrh.fda.gov="" clark="" eoff="" from="" gsc="" pc="" room="">
(HFZ- 220) 1350 Piccard Dr., Rockville, MD 20850-4307 800.638.2041x122
fax.301.443.8818
==========================================================
From: Winston, F. Blix
Sent: Tuesday, September 05, 2000 5:00 PM
To: Clark, Geoffrey S.
Subject: 09-018 - flounder@wt.net Geoff,
This came into the DSMA account. Would you please respond?
Thanks, Blix
-----Original Message-----
From: WEBO@CDRH.FDA.GOV [SMTP:WEBO@CDRH.FDA.GOV]
Sent: Friday, September 01, 2000 9:27 AM
To: DSMA@CDRH.FDA.GOV
Subject: DSMA Email Form Response
Name: Terry S. Singeltary Sr. Phone Number: Na Fax Number: Na Email
Address: flounder@wt.net Mailing Address: P.O. Box 42 Bacliff, Texas USA
77518
Questions/Comments: P990072 *In relation to human Transmissible Spongiform
Encephalopathy and Contact Lens
i think it would be to everyone's best interest, "IF" the practice of
"RE-USING" _display_ contact lens in the commercial aspect takes place in the
U.S., this practice must be stopped. Please allow me to explain. In the U.K.,
the practice of having display of different colors of contact lens on display,
for the consumer to try on, and see how they look with the different colors.
These contact lens were then re-used over and over. No standard cleaning
cleaning solution and or auto-claving procedure will kill the TSE agent. This is
known fact. Plus, the U.K. has 'BANNED' this practice due to vCJD and sCJD (if i
am not mistaken), but regardless, both can transmit the TSE agent. I will not
waste my time trying to explain this in this box, will post a few URLS and you
will see what i speak of if you care. But the eyes, brain, pituitary are the
most infectious parts, of an infective species. Trust me, i know what i speak
of.......
thank you, Terry S. Singeltary SR. ======================= ISSUE 1490
Thursday 24 June 1999
CJD alert over contact lenses By David Brown, Agriculture Editor
PEOPLE risk catching the human form of mad cow disease from re-used contact
lenses, scientists warned the Government yesterday. They urged the Department of
Health to stop opticians re-using trial lenses among their clients to help
prevent further outbreaks of the new variant Creutzfeldt-Jakob disease which has
killed 41 people so far.
The warning came from the Spongiform Encephalopathies Advisory Committee,
the independent team of scientists advising the Government on BSE and CJD.
Ministers are expected to ban the re-use of these lenses as a precaution, which
could mean higher prices for consumers.
In a statement, the committee said: "Any potential risk is probably very
low, but the committee felt strongly that the Department of Health should
encourage opticians to adopt, as a matter of best practice, the single use of
trial lenses followed by safe disposal." Sir John Pattison, the committee's
chairman, said it was surprised to learn that it was common practice among
opticians to try the same contact lenses on several clients.
It was known that the classical variety of CJD, the kind which was known
before the new variant (vCJD) was announced in 1996 and linked to BSE, had been
spread in the past by transplants of infected corneas.
The committee noted that the eyes are directly connected to the brain, the
main seat of BSE and CJD. The warning applied to vCJD and the classical variety
of the fatal brain disease.
JOURNAL OF NEUROLOGY
MARCH 26, 2003
RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease
in the United States
Email Terry S. Singeltary:
flounder@wt.net
I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment
on the CDC's attempts to monitor the occurrence of emerging forms of CJD.
Asante, Collinge et al [1] have reported that BSE transmission to the 129-
methionine genotype can lead to an alternate phenotype that is indistinguishable
from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs
are not reportable nationally. CJD and all human TSEs must be made reportable in
every state and internationally. I hope that the CDC does not continue to expect
us to still believe that the 85%+ of all CJD cases which are sporadic are all
spontaneous, without route/source. We have many TSEs in the USA in both animal
and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink,
ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known
incubation periods in other TSEs, oral transmission studies of CWD may take much
longer. Every victim/family of CJD/TSEs should be asked about route and source
of this agent. To prolong this will only spread the agent and needlessly expose
others. In light of the findings of Asante and Collinge et al, there should be
drastic measures to safeguard the medical and surgical arena from sporadic CJDs
and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2
PrPSc?
Monday, December 31, 2007
Risk Assessment of Transmission of Sporadic Creutzfeldt-Jakob Disease in
Endodontic Practice in Absence of Adequate Prion Inactivation
Subject: CJD: update for dental staff
Date: November 12, 2006 at 3:25 pm PST
1: Dent Update. 2006 Oct;33(8):454-6, 458-60.
CJD: update for dental staff.
Wednesday, August 20, 2008
*** Tonometer disinfection practice in the United Kingdom: A national
survey ***
Tuesday, August 12, 2008
Biosafety in Microbiological and Biomedical Laboratories Fifth Edition 2007
(occupational exposure to prion diseases)
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in
the United States 2003 revisited 2009
August 10, 2009
Greetings,
I would like to submit a review of past CJD surveillance in the USA, and
the urgent need to make all human TSE in the USA a reportable disease, in every
state, of every age group, and to make this mandatory immediately without
further delay. The ramifications of not doing so will only allow this agent to
spread further in the medical, dental, surgical arena's. North America seems to
have the most species with documented Transmissible Spongiform Encephalopathy's,
most all of which have been rendered and fed back to food producing animals and
to humans for years. If you look at the statistics, sporadic CJD seems to be
rising in the USA, and has been, with atypical cases of the sCJD. I find deeply
disturbing in the year of 2009, that Human Transmissible Spongiform
Encephalopathy of any strain and or phenotype, of all age groups, and I stress
all age groups, because human TSE's do not know age, and they do not know
borders. someone 56 years old, that has a human TSE, that has surgery, can pass
this TSE agent on i.e. friendly fire, and or passing it forward, and there have
been documented nvCJD in a 74 year old. Remembering also that only sporadic CJD
has been documented to transmit via iatrogenic routes, until recently with the 4
cases of blood related transmission, of which the origin is thought to be nvCJD
donors. However most Iatrogenic CJD cases are nothing more than sporadic CJD,
until the source is proven, then it becomes Iatrogenic. An oxymoron of sorts,
because all sporadic CJD is, are multiple forms, or strains, or phenotypes of
Creutzfeldt Jakob Disease, that the route and source and species have not been
confirmed and or documented. When will the myth of the UKBSEnvCJD only theory be
put to bed for good. This theory in my opinion, and the following there from, as
the GOLD STANDARD, has done nothing more than help spread this agent around the
globe. Politics and money have caused the terrible consequences to date, and the
fact that TSEs are a slow incubating death, but a death that is 100% certain for
those that are exposed and live long enough to go clinical. once clinical, there
is no recourse, to date. But, while sub-clinical, how many can one exposed human
infect? Can humans exposed to CWD and scrapie strains pass it forward as some
form of sporadic CJD in the surgical and medical arenas? why must we wait
decades and decades to prove this point, only to expose millions needlessly,
only for the sake of the industries involved? would it not have been prudent
from the beginning to just include all TSE's, and rule them out from there with
transmission studies and change policies there from, as opposed to doing just
the opposite? The science of TSE's have been nothing more than a political
circus since the beginning, and for anyone to still believe in this one strain,
one group of bovines, in one geographical location, with only one age group of
human TSE i.e. nvCJD myth, for anyone to believe this today only enhances to
spreading of these human and animal TSE's. This is exactly why we have been in
this quagmire.
The ones that believe that there is a spontaneous CJD in 85%+ of all cases
of human TSE, and the ones that do not believe that cattle can have this same
phenomenon, are two of the same, the industry, and so goes the political science
aspect of this tobacco and or asbestos scenario i.e. follow the money. I could
go into all angles of this man made nightmare, the real facts and science, for
instance, the continuing rendering technology and slow cooking with low temps
that brewed this stew up, and the fact that THE USA HAD THIS TECHNOLOGY FIRST
AND SHIPPED IT TO THE U.K. SOME 5 YEARS BEFORE THE U.S. STARTED USING THE SAME
TECHNOLOGY, to save on fuel cost. This is what supposedly amplified the TSE
agent via sheep scrapie, and spread via feed in the U.K. bovine, and other
countries exporting the tainted product. BUT most everyone ignores this fact,
and the fact that the U.S. has been recycling more TSE, from more species with
TSEs, than any other country documented, but yet, it's all spontaneous, and the
rise in sporadic CJD in the U.S. is a happenstance of bad luck ??? I
respectfully disagree. To top that all off, the infamous BSE-FIREWALL that the
USDA always brags about was nothing more than ink on paper, and I can prove
this. YOU can ignore it, but this is FACT (see source, as late as 2007, in one
recall alone, some 10,000,000 MILLION POUNDS OF BANNED MAD COW FEED WENT OUT
INTO COMMERCE TO BE FED OUT, and most was never recovered. This was banned blood
laced, meat and bone meal. 2006 was a banner year for banned mad cow protein
going into commerce in the U.S. (see source of FDA feed ban warning letter
below). I stress that the August 4, 1997 USA mad cow feed ban and this infamous
BSE firewall, was nothing more than ink on paper, it was never
enforceable.
I propose that the current diagnostic criteria for human TSEs only enhances
and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD
only theory in 2009. With all the science to date refuting it, to continue to
validate this old myth, will only spread this TSE agent through a multitude of
potential routes and sources i.e. consumption, medical i.e., surgical, blood,
dental, endoscopy, optical, nutritional supplements, cosmetics etc. I propose as
with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek,
Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE
Transmissible Spongiform Encephalopathy is far from an exact science, but there
is enough proven science to date that this myth should be put to rest once and
for all, and that we move forward with a new classification for human and animal
TSE that would properly identify the infected species, the source species, and
then the route. This would further have to be broken down to strain of species
and then the route of transmission would further have to be broken down.
Accumulation and Transmission are key to the threshold from sub- clinical to
clinical disease, and key to all this, is to stop the amplification and
transmission of this agent, the spreading of, no matter what strain. In my
opinion, to continue with this myth that the U.K. strain of BSE one strain TSE
in cows, and the nv/v CJD one strain TSE humans, and the one geographical
location source i.e. U.K., and that all the rest of human TSE are just one
single strain i.e. sporadic CJD, a happenstance of bad luck that just happens
due to a twisted protein that just twisted the wrong way, IN 85%+ OF ALL HUMAN
TSEs, when to date there are 6 different phenotypes of sCJD, and growing per
Gambetti et al, and that no other animal TSE transmits to humans ??? With all
due respect to all Scientist that believe this, I beg to differ. To continue
with this masquerade will only continue to spread, expose, and kill, who knows
how many more in the years and decades to come. ONE was enough for me, My Mom,
hvCJD i.e. Heidenhain Variant CJD, DOD 12/14/97 confirmed, which is nothing more
than another mans name added to CJD, like CJD itself, Jakob and Creutzfeldt, or
Gerstmann-Straussler-Scheinker syndrome, just another CJD or human TSE, named
after another human. WE are only kidding ourselves with the current diagnostic
criteria for human and animal TSE, especially differentiating between the nvCJD
vs the sporadic CJD strains and then the GSS strains and also the FFI fatal
familial insomnia strains or the ones that mimics one or the other of those TSE?
Tissue infectivity and strain typing of the many variants of the human and
animal TSEs are paramount in all variants of all TSE. There must be a proper
classification that will differentiate between all these human TSE in order to
do this. With the CDI and other more sensitive testing coming about, I only hope
that my proposal will some day be taken seriously. ...
please see history, and the ever evolving TSE science to date ;
Saturday, June 13, 2009
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in
the United States 2003 revisited 2009
Thursday, November 05, 2009
Incidence and spectrum of sporadic Creutzfeldt-Jakob disease variants with
mixed phenotype and co-occurrence of PrPSc types: an updated
classification
Tuesday, August 11, 2009
Characteristics of Established and Proposed Sporadic Creutzfeldt-Jakob
Disease Variants
Brian S. Appleby, MD; Kristin K. Appleby, MD; Barbara J. Crain, MD, PhD;
Chiadi U. Onyike, MD, MHS; Mitchell T. Wallin, MD, MPH; Peter V. Rabins, MD,
MPH
Background: The classic Creutzfeldt-Jakob disease (CJD), Heidenhain, and
Oppenheimer-Brownell variants are sporadic CJD (sCJD) phenotypes frequently
described in the literature, but many cases present with neuropsychiatric
symptoms, suggesting that there may be additional sCJD phenotypes.
Objective: To characterize clinical, diagnostic, and molecular features of
5 sCJD variants.
Design: Retrospective analysis.
Setting: The Johns Hopkins and Veterans Administration health care
systems.
Participants: Eighty-eight patients with definite or probable sCJD.
Main Outcome Measures: Differences in age at onset, illness progression,
diagnostic test results, and molecular subtype.
Results: The age at onset differed among sCJD variants (P=.03); the
affective variant had the youngest mean age at onset (59.7 years). Survival time
(P .001) and the time to clinical presentation (P=.003) differed among groups.
Patients with the classic CJD phenotype had the shortest median survival time
from symptom onset (66 days) and those who met criteria for the affective sCJD
variant had the longest (421 days) and presented to clinicians significantly
later (median time from onset to presentation, 92 days; P=.004). Cerebrospinal
fluid analyses were positive for 14-3-3 protein in all of the affective
variants, regardless of illness duration. Periodic sharp-wave complexes were not
detected on any of the electroencephalography tracings in the
Oppenheimer-Brownell group; basal ganglia hyperintensity was not detected on
brain magnetic resonance imaging in this group either. All of the Heidenhain
variants were of the methionine/ methionine type 1 molecular subtype.
Conclusions: The classic CJD phenotype and the Heidenhain, Oppenheimer-
Brownell, cognitive, and affective sCJD variants differ by age at disease onset,
survival time, and diagnostic test results. Characteristics of these 5
phenotypes are provided to facilitate further clinicopathologic investigation
that may lead to more reliable and timely diagnoses of sCJD.
Arch Neurol. 2009;66(2):208-215
snip...
COMMENT
snip...see full text ;
Sunday, May 10, 2009
Meeting of the Transmissible Spongiform Encephalopathies Committee On June
12, 2009 (Singeltary submission)
Thursday, January 29, 2009
Medical Procedures and Risk for Sporadic Creutzfeldt-Jakob Disease, Japan,
1999-2008 (WARNING TO Neurosurgeons and Ophthalmologists) Volume 15, Number
2-February 2009 Research
Friday, December 04, 2009
New guidance on decontamination of trial contact lenses and other contact
devices has been revealed for CJD AND vCJD
Saturday, January 16, 2010
Evidence For CJD TSE Transmission Via Endoscopes 1-24-3 re-Singeltary to
Bramble et al
Evidence For CJD/TSE Transmission Via Endoscopes
From Terry S. Singletary, Sr flounder@wt.net 1-24-3
Terry S. Singeltary Sr., P.O. BOX 42, Bacliff, Texas 77518 USA
Professor Michael Farthing wrote:
Louise Send this to Bramble (author) for a comment before we post. Michael
Thursday, July 08, 2010
GLOBAL CLUSTERS OF CREUTZFELDT JAKOB DISEASE - A REVIEW 2010
Saturday, February 12, 2011
Another Pathologists dies from CJD, another potential occupational death ?
another happenstance of bad luck, a spontaneous event from nothing, or
friendly fire ???
Tuesday, July 31, 2012
11 patients may have been exposed to fatal disease Creutzfeldt-Jakob
Disease CJD Greenville Memorial Hospital
Thursday, August 02, 2012
CJD case in Saint John prompts letter to patients Canada CJD case in Saint
John prompts letter to patients
Thursday, October 25, 2012
Current limitations about the cleaning of luminal endoscopes and TSE prion
risk factors there from
Article in Press
Thursday, April 12, 2012
Health professions and risk of sporadic Creutzfeldt–Jakob disease, 1965 to
2010
Eurosurveillance, Volume 17, Issue 15, 12 April 2012
Research articles
Tuesday, May 28, 2013
Late-in-life surgery associated with Creutzfeldt-Jakob disease: a
methodological outline for evidence-based guidance
Sunday, June 9, 2013
TSEAC March 14, 2013: Transmissible Spongiform Encephalopathies Advisory
Committee Meeting Webcast
Tuesday, May 21, 2013
CJD, TSE, PRION, BLOOD Abstracts of the 23rd Regional Congress of the
International Society of Blood Transfusion, Amsterdam, The Netherlands, June
2-5, 2013
Tuesday, March 5, 2013
Use of Materials Derived From Cattle in Human Food and Cosmetics; Reopening
of the Comment Period FDA-2004-N-0188-0051 (TSS SUBMISSION)
FDA believes current regulation protects the public from BSE but reopens
comment period due to new studies
Tuesday, May 28, 2013
Late-in-life surgery associated with Creutzfeldt-Jakob disease: a
methodological outline for evidence-based guidance
Monday, October 14, 2013
Researchers estimate one in 2,000 people in the UK carry variant CJD
proteins
However, I think that the specific confusion there is that people talk
about sporadic CJD occurring at 1 per million. That is not your individual risk.
Your risk is 1 per million every year. Actually, it is nearer 2 per million per
year of the population will develop sporadic CJD, but your lifetime risk of
developing sporadic CJD is about 1 in 30,000. So that has not really changed.
When people talk about 1 per million, often they interpret that as thinking it
is incredibly rare. They think they have a 1-in-a-million chance of developing
this disease. You haven’t. You’ve got about a 1-in-30,000 chance of developing
it.
Cases of vCJD peaked in 2000, leading some scientists to speculate that the
disease has an incubation period of about a decade. Yet studies of different
forms of CJD suggest that the incubation time of vCJD could be much longer,
indicating that many people in Britain could be carrying the infection without
symptoms.
Saturday, October 19, 2013
***A comparative study of modified confirmatory techniques and additional
immuno-based methods for non-conclusive autolytic Bovine spongiform
encephalopathy cases
Sunday, October 27, 2013
A Kiss of a Prion: New Implications for Oral Transmissibility
Wednesday, December 11, 2013
*** Detection of Infectivity in Blood of Persons with Variant and Sporadic
Creutzfeldt-Jakob Disease ***
Friday, July 19, 2013
Beaumont Hospital in Dublin assessing patients for CJD
Saturday, September 21, 2013
CJD CONFIRMED in patient at New Hampshire Department of Health and Human
Services (DHHS), Catholic Medical Center (CMC), and the Manchester Health
Department (MHD)
Thursday, September 26, 2013
Minimise transmission risk of CJD and vCJD in healthcare settings Guidance
Saturday, November 16, 2013
Management of neurosurgical instruments and patients exposed to
creutzfeldt-jakob disease 2013 December
Infect Control Hosp Epidemiol.
Wednesday, November 27, 2013
NHS failed to sterilise surgical instruments contaminated with 'mad cow'
disease
Wednesday, January 15, 2014
*** INFECTION PREVENTION AND CONTROL OF CJD, VCJD AND OTHER HUMAN PRION
DISEASES IN HEALTHCARE AND COMMUNITY SETTINGS Variably Protease-Sensitive
Prionopathy (VPSPr) January 15, 2014
http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/infection-prevention-and-control-of-cjd.html
Friday, January 10, 2014
*** vpspr, sgss, sffi, TSE, an iatrogenic by-product of gss, ffi, familial
type prion disease, what it ???
Thursday, January 23, 2014
Medical Devices Containing Materials Derived from Animal Sources (Except
for In Vitro Diagnostic Devices) [Docket No. FDA–2013–D–1574]
Sunday, April 06, 2014
SPORADIC CJD and the potential for zoonotic transmission there from, either
directly or indirectly via friendly fire iatrogenic mode, evidence to date
“Cases of vCJD peaked in 2000, leading some scientists to speculate that
the disease has an incubation period of about a decade. Yet studies of different
forms of CJD suggest that the incubation time of vCJD could be much longer,
indicating that many people in Britain could be carrying the infection without
symptoms.”
Tuesday, April 01, 2014
Questions linger in U.S. CJD cases 2005, and still do in 2014
Monday, March 10, 2014
Investigators study silent variant of mad cow disease Galveston Daily News
March 4, 2014
Wednesday, April 02, 2014
Distinct origins of dura mater graft-associated Creutzfeldt-Jakob disease:
past and future problems
Saturday, April 19, 2014
Human prion diseases and the risk of their transmission during anatomical
dissection
Sunday, January 19, 2014
*** National Prion Disease Pathology Surveillance Center Cases Examined1 as
of January 8, 2014 ***
Saturday, April 19, 2014
Exploring the zoonotic potential of animal prion diseases: In vivo and in
vitro approaches
Thursday, January 22, 2015 Transmission properties of atypical
Creutzfeldt-Jakob disease: a clue to disease etiology?
Wednesday, April 08, 2015
Sporadic Creutzfeldt-Jakob Disease MM1+2C and MM1 Are Identical in
Transmission Properties
Thursday, March 26, 2015
Variant CJD and blood transfusion: are there additional cases?
Vox Sanguinis (2014) 107, 220–225 ORIGINAL PAPER © 2014 International
Society of Blood Transfusion DOI: 10.1111/vox.12161
Sunday, March 29, 2015
Uncommon prion disease induced in macaque ten years after scrapie
inoculation
*** The potential impact of prion diseases on human health was greatly
magnified by the recognition that interspecies transfer of BSE to humans by beef
ingestion resulted in vCJD. While changes in animal feed constituents and
slaughter practices appear to have curtailed vCJD, there is concern that CWD of
free-ranging deer and elk in the U.S. might also cross the species barrier.
Thus, consuming venison could be a source of human prion disease. Whether BSE
and CWD represent interspecies scrapie transfer or are newly arisen prion
diseases is unknown. Therefore, the possibility of transmission of prion disease
through other food animals cannot be ruled out. There is evidence that vCJD can
be transmitted through blood transfusion. There is likely a pool of unknown size
of asymptomatic individuals infected with vCJD, and there may be asymptomatic
individuals infected with the CWD equivalent. These circumstances represent a
potential threat to blood, blood products, and plasma supplies.
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 ;
Comment from Terry Singeltary
This is a Comment on the Food and Drug Administration (FDA) Notice: Draft
Guidance for Industry on Ensuring Safety of Animal Feed Maintained and Fed
On-Farm; Availability
For related information, Open Docket Folder Docket folder icon
--------------------------------------------------------------------------------
Show agency attachment(s)
Attachments
View All (0)
--------------------------------------------------------------------------------
Comment
View document:
Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed
On-Farm Draft Guidance FDA-2014-D-1180 Singeltary Comment
Greetings FDA et al,
I wish to comment on Guidance for Industry Ensuring Safety of Animal Feed
Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180.
Once again, I wish to kindly bring up the failed attempt of the FDA and the
ruminant to ruminant mad cow feed ban of August 4, 1997. This feed ban is still
failing today, as we speak. Even more worrisome, is the fact it is still legal
to feed cervids to cervids in the USA, in fact, the FDA only _recommends_ that
deer and elk considered to be of _high_ risk for CWD do not enter the animal
food chain, but there is NO law, its only voluntary, a recipe for a TSE prion
disaster, as we have seen with the ruminant to ruminant feed ban for cattle,
where in 2007, one decade post August 1997 mad cow feed ban, where in 2007
10,000,000 POUNDS OF BANNED BLOOD LACED MEAT AND BONE MEAL WHEN OUT INTO
COMMERCE, TO BE FED OUT. Since 2007, these BSE feed ban rules have been breached
time and time again. tons and tons of mad cow feed went out in Alabama as well,
where one of the mad cows were documented, just the year before in 2006, and in
2013 and 2014, breaches so bad (OAI) Official Action Indicated were issued.
those are like the one issued where 10 million pounds of banned blood laced meat
and bone meal were fed out.
What is the use of having a Guidance for Industry Ensuring Safety of Animal
Feed Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180, if it cannot be
enforced, as we have seen with a mandatory ruminant to ruminant feed ban?
I strenuously once again urge the FDA and its industry constituents, to
make it MANDATORY that all ruminant feed be banned to all ruminants, and this
should include all cervids as soon as possible for the following
reasons...
======
In the USA, under the Food and Drug Administrations BSE Feed Regulation (21
CFR 589.2000) most material (exceptions include milk, tallow, and gelatin) from
deer and elk is prohibited for use in feed for ruminant animals. With regards to
feed for non-ruminant animals, under FDA law, CWD positive deer may not be used
for any animal feed or feed ingredients. For elk and deer considered at high
risk for CWD, the FDA recommends that these animals do not enter the animal feed
system.
***However, this recommendation is guidance and not a requirement by law.
======
31 Jan 2015 at 20:14 GMT
*** Ruminant feed ban for cervids in the United States? ***
31 Jan 2015 at 20:14 GMT
19 May 2010 at 21:21 GMT
*** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics
of BSE in Canada Singeltary reply ;
Tuesday, December 23, 2014
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2014 BSE TSE PRION
2013
Sunday, December 15, 2013
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2013 UPDATE
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
EMC 1 Terry S. Singeltary Sr. Vol #: 1
PLEASE SEE FULL TEXT SUBMISSION ;
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN
COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
REASON
Blood meal used to make cattle feed was recalled because it was cross-
contaminated with prohibited bovine meat and bone meal that had been
manufactured on common equipment and labeling did not bear cautionary BSE
statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
REASON
Products manufactured from bulk feed containing blood meal that was cross
contaminated with prohibited meat and bone meal and the labeling did not bear
cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
Terry S. Singeltary Sr.
*** See attached file(s)
No documents available.
Attachments
View All (1)
Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed
On-Farm Terry Singeltary Comment
View Attachment:
Sunday, April 5, 2015
*** Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed
On-Farm Draft Guidance FDA-2014-D-1180 ***
TSS
all iatrogenic CJD TSE prion disease is, is sporadic cjd TSE prion disease,
until the iatrogenic event is discovered, documented, and put in the public
domain. this very seldom happens due to trace back efforts, and the very
industry that refuses to do any trace back for CJD, or any TSE prion disease.
...
kind regards, terry
layperson
MOM DOD 12/14/97 confirmed hvCJD. just made a promise to mom, never forget,
never let them forget...
wasted days and wasted nights...Freddy Fender
stupid is, as stupid does, and some times you just can’t fix stupid $$$
TSS
Terry S. Singeltary Sr.
