FDA SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION BOVINE HEPARIN BSE CJD TSE PRION Wednesday, June 4, 2014
FDA SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION BOVINE HEPARIN
Wednesday, June 4, 2014
SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION
Wednesday, June 4, 2014
FDA White Oak Campus
Building 31, Room 1503
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
The meeting was convened at 8:32 a.m., Russ ALTMAN,
snip...
So it has been shown -- so how would you -- there is a risk, though. There
is a theoretical risk of any herd or whatever having contamination. So how can
you mitigate even that very small risk? It has been shown that the existing
manufacturing processes could remove or inactive BSE agents if present. This is
because they're an extremely robust extraction under very harsh
conditions.SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION
The FDA has guidelines regarding TSEs that can be applied to heparin, and
these generally were developed by CBER and include control of animal sources,
which obviously is critical, selection of the type of tissue used, incorporation
of risk-reduction steps into the production process. And, of course, this is
typical for any animal source material or even human source material that we use
in other people, and so that's what we'd like to talk about today.
UNIDENTIFIED SPEAKER: Janet, what's a TSE?
DR. WOODCOCK: Pardon me?
UNIDENTIFIED SPEAKER: What is a TSE?
===========================================
I friggen give up...tss
===========================================
SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION
Wednesday, June 4, 2014
FDA White Oak Campus
Building 31, Room 1503
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
The meeting was convened at 8:32 a.m., Russ ALTMAN,
M.D., Ph.D., Chair, presiding.
MEMBERS PRESENT:
RUSS ALTMAN, M.D., Ph.D., Chair, presiding
MARIA FREIRE, Ph.D., Co-Chair
LYNN GOLDMAN, M.D., M.P.H.
JEFFREY BENDER, D.V.M., M.S.
PAUL BILLINGS, M.D., Ph.D.
MEMBERS PRESENT (CONTINUED)
BARBARA KOWALCYK, Ph.D.
MICHAEL GIBBONS, M.D., M.P.H.
WILLIAM HAIT, M.D., Ph.D.
FREDERICK KUSHNER, M.D.
MARK MCLELLAN, Ph.D.
LISA NOLAN, D.V.M., M.S., Ph.D.
BRUCE PSATY, MD., Ph.D., M.P.H.
DAN RODEN, M.D.
ALAN RUSSELL, Ph.D.
MICHAEL YASZEMSKI, M.D., Ph.D.
INVITED EXPERTS FOR HEPARIN SOURCING
LINDA A. DETWILER, D.V.M., Clinical Professor,
Department of Pathobiology and Population Medicine, College of Veterinary
Medicine, Mississippi State University
DEAN E. GOELDNER, D.V.M., Senior Staff Veterinarian,
USDA/APHIS
CHRISTINA SIGURDSON, D.V.M., Ph.D., Associate Professor,
Department of Pathology, University of California -
San
Diego
ROBERT ROHWER, Ph.D., Rohwer Technical Consulting
Designated Federal Officer:
MARTHA MONSER, Office of the Chief Scientist, Office of
the Commissioner, FDA
FDA Participants:
MARGARET A. HAMBURG, M.D., Commissioner, Food and Drug
Administration
STEVE OSTROFF, M.D., Acting Chief Scientist, Office of
the Chief Scientist, FDA
DAN ACOSTA, Ph.D., Deputy Director for Research,
National Center for Toxicological Research
DAVID ASHLEY, Ph.D., Director, Office of Science, Center
for Tobacco Products
BERNADETTE DUNHAM, D.V.M., Director, Center for
Veterinary Medicine
JAN JOHANNESSEN, Ph.D., Deputy Director for Science,
Office of Translational Sciences, Center for Drugs and
Evaluation Research
MICHELLE MCMURRY-HEATH, Ph.D., Associate Director for
Science, Center for Devices and Radiological Health
STEVE SOLOMON, Deputy Associate Commissioner for
Regulatory Affairs, Office of Regulatory Affairs
DAVID WHITE, Ph.D., Chief Science Officer, Office of
Foods and Veterinary Medicine
CAROLYN WILSON, Ph.D., Associate Director for Science,
Center for Biologics Evaluation and Research
ALSO PRESENT (CONTINUED)
DONALD L. ZINK, PH.D., Senior Science Advisor, FDA
DANIEL TADESSE, D.V.M., Ph.D., Division of Animal and
Food Microbiology, Office of Research, CVM
LESLIE, WHEELOCK, M.S., R.N., Director, Office of
Scientific Professional Development, Office of the Chief
Scientist,
ANN FARRELL, M.D., Director, Office of Pharmaceutical
Science, CDER
DAVID ASHER, M.D., Director, Laboratory of Bacterial and
Transmissible Spongiform Agents, Office of Blood
Research and Review, CBER
LAWRENCE YU, Ph.D., Acting Director, Office of
Pharmaceutical Science, CDER
JANET WOODCOCK, M.D., Director, Center for Drugs
Evaluation and Research
STEVE ANDERSON, Ph.D., Director, Office of Biostatistics
and Epidemiology, CBER
JONCA BULL, M.D., Director, Office of Minority Health
P R O C E E D I N G S
MS. MONSER:
Good morning, everyone.
Good morning. I would like to go ahead. It's about 8:30, if everybody can
take their seats I'm Martha Monser, the Designated Federal Official for the
meeting, and I would like to keep the meeting on track. So if everyone
could--everyone can hear me, right?
UNIDENTIFIED SPEAKER:
No, you have to be a little louder.
UNIDENTIFIED SPEAKER:
Get closer.
MS. MONSER: Hello?
UNIDENTIFIED SPEAKER: That's better.
MS. MONSER: Good morning. This is Martha Monser. I'm the Designated Federal
Official for the meeting. Since it is past 8:30 --we're kicking off two minutes
late -- I would like to go ahead and get started.
Our chair, Russ Altman, sent me an email about an hour or two ago and said
that his plane was an hour late, and he had taken a red eye, so I'm actually
wondering if he fell asleep after the plane had landed for an hour. But I would
like to introduce Dr. Maria Freire. She is our new Co-Chair, so she is going to
kick off our meeting for us and get us started. And we will -- when Russ gets
here, we'll let him take over maybe.
INTRODUCTIONS
SNIP...
Now, what about bovine heparin? Is that some unknown? Well, no. The first
application for bovine heparin was approved in 1939. It is what we call a very
old drug. And this was at a time, of course, where we just had safety testing.
That was before you had to show the drug worked for anything, but you did have
to show it was safe.
Multiple applications were subsequently approved. Those of you who are
clinicians know how ubiquitous this drug is in healthcare. The bovine heparins,
though, were voluntarily removed in the 1990s by the manufacturers because of
the BSE concern. And they were able to do this because we also had co-existing
porcine heparin out there, and actually they were, I think, interchangeable --
Ann, you're going to talk about that --in the applications.
And those of you who, again, are clinically oriented remember that we had
bovine and porcine in all kinds of insulins a long time ago, and those were
used. As people got allergies and so forth, you switched people to different
insulins. And again, they were treated at the time relatively interchangeable.
So we have more than 50 years of manufacturing experience in clinical use with
heparin obtained from bovine sources, and Ann is going to tell you more about
this.
Now, are there differences that would be more germane now than it was
treated back in the time it was introduced up to the 90s. Bovine heparin, like
porcine heparin, is associated with a life-threatening adverse event called
heparin-induced thrombocytopenia, or HIT. There have been a few studies
comparing the relative risk for HIT in patients receiving either bovine or
porcine heparin, and they're contradictory and inconclusive.
This is not a super rare event actually, and it can be very catastrophic,
but, you know, it has not been studied very much. And so, we actually don't know
whether one type of approved heparin is associated with greater incidence of HIT
than the other. The fractionated heparins have a lower -- are known to have a
lower incidence of the side effect. However, it still happens.
But interestingly, much of the clinical data that we do have regarding the
safety and efficacy of unfractionated heparin -- the heparin we're talking about
today -- was, in fact, derived from the bovine sources. So when we switched over
in the 90s, we were dealing with a known quantity, the porcine. But much of the
data that the clinicians had in their mind about how heparin performed in the
clinic was actually from bovine heparin.
Now, bovine spongiform encephalopathy. They removed bovine heparin products
from the U.S. market because of the concerns of this transmission of this
disorder obviously. And I think the members of the Science Board are well aware
of this and familiar with it. This market removal did not occur in Brazil where
bovine heparin, which is the intestinal heparin, though, is an approved product
on the market. And that was because, I think, Brazil didn't feel they had a risk
of BSE because they didn't have the agricultural or whatever you call them,
animal practices that other countries had. And that came to pass. In fact, they
did not have these problems.
And so, now the risk of BSE, how to inactivate products that are bovine
products and so forth are better understood 20 years into this episode that
occurred. And so, I think we have several lines of data understanding the
incident of BSE in various countries related to their agricultural practices,
and also how to inactivate the agent. And we'll have some more discussion about
that.
So in 2013, we got a -- the CDC put out a report over the outbreak that
occurred in the UK, and it peaked in '93 at a thousand new cases per week, and,
you know, dropped off after correction of the practices. I don't know since 2010
what the reports have been, but the amount of cases in the UK has dropped very
precipitously, but, of course, that was a desperate situation for a long time.
But I think people are pretty clear about the ideology, the practices that led
to this and how to avoid them.
And in North America, you know, people said we'd never have a case in the
U.S. And the orange shows cases that occurred in the U.S., and we have had a few
cases. Some of them have been imported to us and originated elsewhere, from
Canada, for example. And some --Bernadette would have more of an idea about what
the causes are of these. But anyway, there's very, very few cases reported in
the U.S. ever during this whole outbreak in the UK and elsewhere.
So it has been shown -- so how would you -- there is a risk, though. There
is a theoretical risk of any herd or whatever having contamination. So how can
you mitigate even that very small risk? It has been shown that the existing
manufacturing processes could remove or inactive BSE agents if present. This is
because they're an extremely robust extraction under very harsh conditions.
The FDA has guidelines regarding TSEs that can be applied to heparin, and
these generally were developed by CBER and include control of animal sources,
which obviously is critical, selection of the type of tissue used, incorporation
of risk-reduction steps into the production process. And, of course, this is
typical for any animal source material or even human source material that we use
in other people, and so that's what we'd like to talk about today.
UNIDENTIFIED SPEAKER: Janet, what's a TSE?
DR. WOODCOCK: Pardon me?
UNIDENTIFIED SPEAKER: What is a TSE?
So as Dr. Woodcock mentioned, bovine spongiform encephalopathy is a concern
in the heparin products, and it led to the request by the FDA for the voluntary
withdrawal of bovine heparin from the U.S. market. However, there have been no
case reports reported to the FDA or to the CDC linking exposure to a TSE or
transmission of spongiform encephalopathy, whether it's variant
Creutzfeldt-Jakob disease with the use of heparin, bovine sourced. Thank you
very much.
CHAIRMAN ALTMAN: Thank you very much, and we'll continue holding questions.
Actually we're probably going to hold questions until after lunch, so write your
questions down. And now I welcome Dr. Asher.
UNDERSTANDING THE RISK OF IATROGENC BSE
DR. ASHER: Thank you. I'm David Asher from the Office of Blood in CBER, the
Center for Biologics.
I'd like to start with two housekeeping remarks. There are also a few typos
for which I am responsible in the last handout, the one right before that big
re-print from the Federal Register. Most of them are trivial, but the one on
page 3 in the first full paragraph, 10th line, is not trivial. Where it says
"proximal ileum," it should say "distal ileum." I'm responsible for that. I
don't know how I did it, but it is an important mistake.
The other thing I would like to say is that with me today is Luisa Gregori,
who was, as you've heard earlier today, the recipient of one of the Chief
Scientist Challenge Grants for a process validation study looking at clearance
of a TSE agent. We hope it will be the agent of BSE itself in the Biosafety
Level 3 facility in this building is certified, and if USDA approves.
Finally, I'd like to ask Martha to give me a sign when you want me to stop
in five minutes because, as usual, I've prepared too many slides. I'm going to
start with a very brief introduction to transmissible spongiform
encephalopathies called TSEs or prion diseases, review iatrogenic transmissions
of TSEs, both veterinary and medical, discuss BSE and variant CJD, and then
address possible approaches to mitigating the risk for bovine-derived
products.
First let me point out that although the talk has been cleared,
particularly for those people from the public, this is not a final position of
the Food and Drug Administration. The purpose of the talk is to open the topic
of BSE risk and mitigations for discussion. But I will say now that in addition
to the mitigations already in place, which are the prohibition of the feeding of
ruminant proteins, to ruminants and USDA import controls, there are a number of
other possible mitigations that would reduce the risk even further. One would be
to use low-risk animals, low-risk tissues from those animals, and then potential
effective manufacturing processes.
And I'll close, if I get that far, with a couple of examples in which
partial solutions that might not have been effective, nonetheless were very
effective in reducing or even eliminating a spongiform encephalopathy.
Scrapie is the oldest of the best known of the animal TSEs, still present
in this country. Chronic wasting disease mainly in the U.S. and Canada. The
fastest-spreading spongiform encephalopathy, transmissible mink encephalopathy,
essentially gone. BSE is our concern today. It's infected not only bovines, but
zoo ungulates, house cats, zoo cats, and unfortunately since 1994, a number of
human beings in which the disease is called variant Creutzfeldt-Jakob disease...
snip...
please see full text 265 pages (I suggest you download it) ;
Wednesday, June 4, 2014
FDA White Oak Campus
Building 31, Room 1503
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
The meeting was convened at 8:32 a.m., Russ ALTMAN,
SEE MUCH MORE ON HISTORY OF TSE AND HEPARIN HERE ;
Wednesday, January 28, 2015
BOVINE HEPARIN POSITION STATEMENT ON THE REINTRODUCTION and POTENTIAL BSE
TSE PRION RISK FACTORS THEREFROM
by the Grace of God, we have not had a Louping-ill vaccine type blunder
that happened with sheep scrapie and the Louping-ill vaccine, in humans. we are
one mutated TSE prion strain away from that, in my opinion. ...tss
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
nvCJD CONFIRMED TEXAS USA 2014
‘’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.’’
Confirmed Variant Creutzfeldt-Jakob Disease (variant CJD) Case in
Texas
Updated: October 7, 2014
CDC and the Texas Department of State Health Services (DSHS) have completed
the investigation of the recently reported fourth vCJD case in the United
States. It confirmed that the case was in a US citizen born outside the Americas
and indicated that the patient's exposure to the BSE/vCJD agent most likely
occurred before he moved to the United States; 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.
Sunday, November 23, 2014
Confirmed Variant Creutzfeldt-Jakob Disease (variant CJD) Case in Texas in
June 2014 confirmed as USA case NOT European
Monday, November 3, 2014
USA CJD TSE PRION UNIT, TEXAS, SURVEILLANCE UPDATE NOVEMBER 2014
National Prion Disease Pathology Surveillance Center Cases Examined1
(October 7, 2014)
***6 Includes 11 cases in which the diagnosis is pending, and 19
inconclusive cases;
***7 Includes 12 (11 from 2014) cases with type determination pending in
which the diagnosis of vCJD has been excluded.
***The sporadic cases include 2660 cases of sporadic Creutzfeldt-Jakob
disease (sCJD),
***50 cases of Variably Protease-Sensitive Prionopathy (VPSPr)
***and 21 cases of sporadic Fatal Insomnia (sFI).
Monday, November 3, 2014
The prion protein protease sensitivity, stability and seeding activity in
variably protease sensitive prionopathy brain tissue suggests molecular overlaps
with sporadic Creutzfeldt-Jakob disease
Tuesday, November 04, 2014
The pathological and molecular but not clinical phenotypes are maintained
after second passage of experimental atypical bovine spongiform encephalopathy
in cattle
*** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics
of BSE in Canada Singeltary reply ;
Saturday, January 24, 2015
Bovine Spongiform Encephalopathy: Atypical Pros and Cons
ruminant feed ban for cervids in the United States ? 31 Jan 2015 at 20:14
GMT http://www.plosone.org/annotation/listThread.action?root=85351
Saturday, January 31, 2015
RAPID ADVICE 17-2014 : Evaluation of the risk for public health of casings
in countries with a “negligible risk status for BSE” and on the risk of
modification of the list of specified risk materials (SRM) with regard to BSE
Sunday, January 11, 2015
Docket No. APHIS-2014-0107 Bovine Spongiform Encephalopathy; Importation of
Animals and Animal Products Singeltary Submission
Thursday, January 22, 2015
Transmission properties of atypical Creutzfeldt-Jakob disease: a clue to
disease etiology?
Saturday, January 31, 2015
European red deer (Cervus elaphus elaphus) are susceptible to Bovine
Spongiform Encephalopathy BSE by Oral Alimentary route
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 ***
BSE INQUIRY DFAs
Sunday, May 18, 2008
BSE Inquiry DRAFT FACTUAL ACCOUNTS DFA's
Sunday, May 18, 2008
BSE, CJD, and Baby foods (the great debate 1999 to 2005)
Sunday, May 18, 2008
MAD COW DISEASE BSE CJD CHILDREN VACCINES
‘’I shall not forget the profound effect on my emotions when I visited
these farms and was warmly welcomed because of the great benefits resulting from
the application of louping-ill vaccine, wheras the chief purpose of my visit was
to determine if scrapie was appearing in the inoculated sheep. The enquiry made
the position clear. Scrapie was developing in the sheep vaccinated in 1935 and
it was only in a few instances that the owner was associating the occurrence
with louping-ill vaccination. The disease was affecting all breeds and it was
confined to the animals vaccinated with batch 2.’’
SOME OTHER HISTORY HERE PITUITARY HORMONES AND TSE PRION ;
In 1993 the Allar’s inquiry into the use of cadaver-derived pituitary
hormones under The Australian Human Pituitary Hormone Program and the
association with four medically acquired (iatrogenic) Creutzfeldt-Jakob disease
(CJD) deaths recommended the formation of an Australian surveillance unit to
monitor further cases of iatrogenic CJD in Australia.1 The Australian National
Creutzfeldt-Jakob disease Registry (ANCJDR) was established in October 1993 at
the Department of Pathology at the University of Melbourne. The monitoring of
further Australian iatrogenic CJD cases related to pituitary hormone treatment
for infertility or short stature and contaminated dura mater grafts remains one
of the core objectives of the ANCJDR. However, the ANCJDR’s activities have
changed to encompass the surveillance of all types of CJD including sporadic,
genetic and variant CJD and other transmissible spongiform encephalopathies
(TSEs) such as Gerstmann Sträussler-Sheinker Syndrome (GSS) and fatal familial
insomnia (FFI).
see more here ;
Saturday, November 09, 2013
Surveillance for creutzfeldt-Jakob disease in Australia: update to December
2012
Background of Australian Human Pituitary Hormone Program From 1967 until
1985 2,100 Australians were treated with human pituitary hormones under the
Australian Human Pituitary Hormone Program (AHPHP).
In similar programs in overseas countries the majority of recipients of
human pituitary hormones (hPH) were treated with human growth hormone (hGH) for
short statue. In Australia the Australian Human Pituitary Hormone Program
(AHPHP) treated approximately 1570 woman and about 60 men for infertility using
human pituitary gonadotrophin (hPG). Approximately 660 Australian children were
treated for short statue with human growth hormone (hGH).
Five Australians may so far have developed and died from health-care
associated (iatrogenic) Creutzfeldt-Jakob disease (CJD) after hPH treatment .
The program was suspended in 1985 following CJD deaths of recipients of hGH in
the United States and England.
All those treated with hPH are at low risk of developing CJD. There is no
way of knowing if batches received by recipients were contaminated. To date
there is no test to show if recipients are incubating CJD.
The AHPHP was run under the auspices of the Commonwealth Department of
Health. The hormones were manufactured by the then government-owned Commonwealth
Serum Laboratories in Melbourne.
The AHPHP was conceived and operated by the Human Pituitary Advisory
Committee (HPAC) until its activities ceased in 1985 and the committee was
disbanded.
From 1992 intense media and political pressure followed news of the first
two deaths from iatrogenic CJD as the families demanded an explanation. The then
Minister for Health, Senator Graham Richardson, ordered an independent
inquiry.
Associate Professor Margaret Allars, an administrative law expert from the
University of Sydney conducted the inquiry into the use of Pituitary Derived
Hormones in Australia and Creutzfeldt-Jakob Disease, which reported in June
1994.
The inquiry report made a number of recommendations concerning the care of
recipients, the establishment of support services and the formation of a
ministerial advisory council.
Recipients of hPH now live with a health status of being at “low risk” of
CJD. Current infection control guidelines refer to “low risk” patients.
Recipients and their families also live with anxiety linked to the threat of
contracting a disease which can lie dormant for decades and for which there is
no test, treatment or cure.
Tuesday, November 23, 2010
Prosecutors call for prison terms for CJD growth hormone doctors
Tuesday, May 04, 2010
Review of the Human Pituitary Trust Account and CJD Issue 20 January
2010
Creutzfeldt-Jakob Disease, CJD Support Group for short statured children of
the 1970's and 1980's. Recommendations for Unapproved/Unregistered recipiants
wonder how Michael is doing today ??? hope is all well...
Mr. Michael O'Meara
Senator Bernardi Senator for South Australia Michael O’Meara 120 Port Road
P.O. Box 250 Hindmarsh SA 5007 Kinglake 3763 24th February 24, 2009
Dear Senator Bernardi
Re; Senate Committee Inquiry on Men’s Health
It is with regret that the 60 page submission I was preparing for this
inquiry was lost in the recent Kinglake Bushfire, along with all other property
and possessions of mine, and I now submit an abbreviated submission. Under such
personal adversity, I believe this submission falls within the Terms of
Reference.
Its is with pleasure that this submission be accepted in accordance with
your Notice Of Motion (276) published in November 2008, some 5 months after a
Private Member Motion was read in the House of Representatives. The Member for
McEwen (Ms Fran Bailey) read a very emotional speech in the House (Committee
Room) on 16th June 2008, supported by the Member for Moore, (Dr Mal Washer) and
further with bipartisan support by the Rudd Government - expressed by the
Members of Page, (Ms Janelle Saffin) and Dobell, (Mr. Craig Thomson)
It is with my pleasure that I submit the following Submission on behalf of
myself and all other (then) boys and men treated with Human Pituitary Hormones,
unofficially, and not recorded, under the Australian Human Pituitary Hormone
Program, and who have suffered, with both short term and long term side effects
to the male endocrine system as a result of such Human Experimentation, and with
such side effects that are irreversible.
Approved Recipients of Human Growth Hormone or Human Pituitary
Gonadotrohpin were subjected to a Senate Inquiry in 1993, known as “The Allars
Inquiry”, however – unapproved and/or “Off Program” recipients who were not
included in the Allars Inquiry, and whom were not disclosed to the Department of
Health and Aging, who are at the same risk of CJD, and were never advised of
their risk, particularly unrecorded recipients of hPG at Prince Henry’s Hospital
in Melbourne – hundreds of males. The Senate now records (1998) the “Allars
Inquiry” was misled.
It is these Males who were “overtreated” with Human Pituitary
Gonadotrophin1, who were “overstimulated” through invivo experimentation, with
batches varying2 and causing dire consequences to physical, mental and
reproductive health - those who were exposed to anabolic steroids (a
carcinogenic) as a Growth Promotant with severe side effects. Particular
Recommendations were presented and submitted to The Minister for Heath by
Professor Margaret Allars in 1994, and further explored by the Senate Affairs
Reference Committee in 1998. Of these numerous recommendations, I draw
particular reference to Recommendation 5 m stating
That the settlement offer should not preclude a plaintiff making any future
claim in relation to: (a) Other physical illnesses contracted by recipients
which may be related to long term side effects of HPH treatment3 This submission
is dedicated to the Infant boys, Toddlers boys, Prepubescent boys, Teenage boys,
Young, Middle Aged and Elderly Men aged 2 to 101 – who were treated under such
experimental Programs, exposed to Endocrine Disruptors during the 1970’s,
particularly those whom were castrated and sterilized by the Australian
Government and/or representatives engaged under the Health Act 1958. Such
Section with the Act has since been repealed so that the “experimental nature”
of “The Program” cannot happen again - following the “Allars Inquiry”. This does
not repeal or repair the ongoing side effects. In particular, I dedicate this
submission to the memory of the child who lost his life under these experimental
programs at Prince Henry’s Hospital during the 1970’s4.
Please accept my gratitude with appreciation with your efforts in this
forthcoming Inquiry.
Yours Faithfully
Michael O’Meara
PDF 159KB
see also ;
Michael was recruited into the growth hormone clinic at Prince Henry's
Hospital in 1972 when he was just 10 years old. He was subjected to deep sleep
therapy in April 1972. At this time he was administered the human growth hormone
using products from cadavers. It has since been found that some of this material
was contaminated, with a number of young recipients subsequently contracting and
dying of the deadly Creutzfeldt-Jakob disease, or CJD.
also, I always remember this old study here, fascinating to me, just how
little, and how long, yet still deadly for some, why ?
J Neurol Neurosurg Psychiatry 2002;72:792-793 doi:10.1136/jnnp.72.6.792
Short report
Creutzfeldt-Jakob disease 38 years after diagnostic use of human growth
hormone
E A Croes1, G Roks1,*, G H Jansen3, P C G Nijssen2, C M van Duijn1
+ Author Affiliations 1Genetic Epidemiology Unit, Department of
Epidemiology and Biostatistics, Erasmus University Medical Centre Rotterdam, PO
Box 1738, 3000 DR Rotterdam, Netherlands 2Department of Neurology, St Elisabeth
Hospital, PO Box 90151, 5000 LC Tilburg, Netherlands 3Department of Pathology,
University Medical Centre Utrecht, Heidelberglaan 100, 3584 CX Utrecht,
Netherlands
Correspondence to: Professor C M van Duijn, Genetic Epidemiology Unit,
Department of Epidemiology and Biostatistics, Erasmus University Medical Centre
Rotterdam, PO Box 1738, 3000 DR Rotterdam, Netherlands; vanduijn@epib.fgg.eur.nl
Received 27 December 2001 Accepted 12 March 2002 Revised 1 March 2002
Abstract
A 47 year old man is described who developed pathology proven
Creutzfeldt-Jakob disease (CJD) 38 years after receiving a low dose of human
derived growth hormone (hGH) as part of a diagnostic procedure. The patient
presented with a cerebellar syndrome, which is compatible with iatrogenic CJD.
This is the longest incubation period described so far for iatrogenic CJD.
Furthermore, this is the first report of CJD after diagnostic use of hGH. Since
the patient was one of the first in the world to receive hGH, other cases of
iatrogenic CJD can be expected in the coming years.
snip...
An incubation period as long as 38 years had never been reported for
iatrogenic CJD. Huillard d'Aignaux et al7 studied the incubation period in 55
patients with hGH related CJD in a cohort of 1361 French hGH recipients. The
median incubation period was between 9 and 10 years. Under the most pessimistic
model, the upper limit of the 95% confidence interval varied between 17 and 20
years. Although the infecting dose cannot be quantified, it can be speculated
that the long incubation period in our patient is partly explained by the
administration of a limited amount of hGH. This hypothesis is supported by
experimental models, in which higher infecting doses usually produce shorter
incubation periods.6 Since our patient was one of the first in the world to
receive hGH, this case indicates that still more patients with iatrogenic CJD
can be expected in the coming years. Another implication of our study is that
CJD can develop even after a low dose of hGH. This case once more testifies that
worldwide close monitoring of any form of iatrogenic CJD is mandatory.
SHORT REPORT
Creutzfeldt-Jakob disease 38 years after diagnostic use of human growth
hormone
the warning shots fired over the bow of the boat that were never heard ;
PITUITARY EXTRACT
This was used to help cows super ovulate. This tissue was considered to be
of greatest risk of containing BSE and consequently transmitting the
disease...
NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE
snip...
I was quite prepared to believe in unofficial pituitary hormones, also in
the 1970's, whether as described by Dr. Little, or in other circumstances, for
animal use.
snip...
The fact that there were jars of pituitaries (or extract) around on shelves
is attested by the still potent 1943 pituitaries, described in Stockell Hartree
et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the
trouble to collect them, they were not lightly thrown out...
Saturday, February 07, 2015
Annual report Creutzfeldt-Jakob disease surveillance in Australia,
2013
kind regards, terry
posted by Terry S. Singeltary Sr. at
10:18 AM
