Tuesday, August 1, 2017

Could Insulin be contaminated with and potentially spread, Transmissible Spongiform Encephalopathy TSE Prion, what if?

Could diabetes spread like mad cow disease?

OR

Could Insulin be contaminated with, and potentially spread, Transmissible Spongiform Encephalopathy TSE Prion, what if?

(iii.)    A wide variety of substances used as ingredients in the manufacture of medicinal products, including, for example, heparin and preparations of the pituitary when used as an ingredient in a medicinal product for parenteral injections, insulin, sera and vaccines;[70] and any substance wholly or partly derived from animals not specified elsewhere in the schedule to the relevant Order when used as an ingredient in a medicinal product for administration to animals

�6.�� Biological products were produced of bovine origin and this applied to a significant proportion of insulin despite genetically manufactured sources.� In addition, cell cultures for many vaccines used a bovine serum medium.� Dr Harris undertook to speak to the Director of NIBSC about biological products.

13.�� Mr Cruickshank thought it necessary to assess the risk in humans in order to justify the cost of any control measures taken by MAFF.� Although it would be possible to monitor diabetics, it could take 20 years or more before we would be able to assess whether any risk existed from bovine insulin.� In the meantime, with some 40 or so new cases in cattle a month, the disease would become newsworthy and it was important that both government departments arrange appropriate action before this happened.

7. Parenteral Products
I accept that there may be a different consideration of parenteral products. I presume that the major agents would be bovine insulin, and bovine serum albumen in vaccine production. If you were looking for a group of people to study, then I would have thought those who have received bovine insulin might be the most appropriate group. I suppose it might be possible to undertake a retrospective study comparing those who have received bovine insulin versus those who have received porcine or ideally human insulin. I presume the endpoint would have to be the development of an encephalopathic syndrome. The danger in constructing such a study would be the scientific risks of confounding, etc. and the political risk of worrying large numbers of diabetic patients.
233.         In his Statement to the Inquiry Dr Jefferys commented on his minute of 24 May 1988:
�In my minute, I set out some preliminary thoughts on the issues raised. I focused primarily on previously licensed products and said that with respect to them, we had no evidence of hazard, but I recognised that we could not provide reassurance given the timescale for possible incubation and infection. I thought that the risk from oral medicinal products would be very small in comparison to the risk from food. The major concern was with parenteral products, the major agents being bovine insulin and the use of foetal calf serum and bovine serum albumen in vaccine production (although neither foetal calf serum nor bovine serum albumen were used as active ingredients in vaccines). This reply reflected the consideration which had been given to this matter during the months of April and May.�

271.         The second part of the paper, entitled �Bovine Spongiform Encephalopathy � Action by Medicines Division�� states:
�1.Product Licence Situation
The computer list shows 53 product licences extant for preparations of bovine origin and of these 42 are for insulin.
It is not clear how complete this list is, particularly on the review side where there may be grounds for concern, especially with regard to products for cellular therapy.
There is no computer list showing the use of products such as bovine albumin and foetal calf serum in the process of manufacture. The latter is fairly widely used in tissue culture work.
For the purpose of recommended actions products will be divided into those for oral and parenteral use and those derived from brain, tissue, and blood.

3.1 Parenteral use
There are three products in this category:
������ i.��������� Insulin
������ ii.�������� Bovine collagen implants
������ iii.�������� Bovine fibrin implants.
The latter two are used in surgery and are the province of the CDSM.
3.2 Oral use
There are two products in this category:
i.���� Bovine fibrin powder used as a haemostatic
ii.���� A sugar coated tablets which are alleged to contain ox bile. (I note the comment from MAFF suggesting that bile is safe from transmission of BSE).
4. Products derived from Bovine Blood
4.1 For parenteral use
There are two H products for parenteral use which contain bovine immunoglobulines, these are:
B, ampoules and [redacted]
single plant preparation injection. (PLRs)
4.2 Oral
B pilules and single plant preparation pills, H.
C Vitamin B12 absorption test kit which contains bovine albumin.
5. New products
CSM through the Biologicals Sub-Committee have been asking companies who put in applications for bovine products to show the ability of their manufacturing procedures to inactivate scrapie and similar agents. No new licences for these products have been granted for some time.
6. Summary
6.1 Oral products
No action should be taken with regard to these products in view of the widespread consumption of beef by the population at large.
6.2 Parenteral products
The major problem here appears to be with insulin. The use of bovine insulin is rapidly declining and maybe restricted to those patients who have antibodies to the human preparation, or who cannot tolerate it. In this case bovine insulin is life saving, and the risk to benefit would currently be in favour of retaining its use. In addition to this for parenteral products in general:
i.���� All cattle used for the preparation of these products should come from certified healthy herds, and not to have been given food supplements containing material of animal origin.
ii.���� No brain or lymphoid tissue should be used in parenteral products.
iii.��� Manufacturers of parenteral products should show that their manufacturing procedure is capable of inactivating scrapie-like agents.
iv.��� While the agent of BSE is not known it is not possible to advise specific inactivation processes.
7. Recommendations for action
i.���� No licensing action should be taken against oral products.
ii.���� All bovine products should come from cattle from healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products.
iii.��� Manufacturers of parenteral products should show that their manufacturing processes are capable of inactivating scrapie-like agents.
iv.��� All licences for new products from bovine material should comply with the above.�
v.��� The Review/CDSM Sections should carry out a search for preparations containing bovine material.
vi.��� There should be an article in MAIL requesting manufacturers to identify bovine preparations used in the manufacturing process. Bovine albumin and foetal calf serum should come from healthy herds.
vii.�� The ADR database should be searched for ADRs to bovine products.
viii.� The Committee is asked to consider whether to take any action against bovine insulin or whether the risk/benefit ratio is appropriate.�[319]

7.��� Were pigs to be susceptible to BSE/scrapie, then this would have very serious impact on supply of insulins.

WHAT ABOUT CWD TSE PRION???


Research Project: TRANSMISSION, DIFFERENTIATION, AND PATHOBIOLOGY OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

Location: Virus and Prion Research

Title: Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease

Author item Moore, Sarah item Kunkle, Robert item Kondru, Naveen item Manne, Sireesha item Smith, Jodi item Kanthasamy, Anumantha item West Greenlee, M item Greenlee, Justin

Submitted to: Prion Publication Type: Abstract Only Publication Acceptance Date: 3/15/2017 Publication Date: N/A Citation: N/A Interpretive Summary:

Technical Abstract: Aims: Chronic wasting disease (CWD) is a naturally-occurring, fatal neurodegenerative disease of cervids. We previously demonstrated that disease-associated prion protein (PrPSc) can be detected in the brain and retina from pigs challenged intracranially or orally with the CWD agent. In that study, neurological signs consistent with prion disease were observed only in one pig: an intracranially challenged pig that was euthanized at 64 months post-challenge. The purpose of this study was to use an antigen-capture immunoassay (EIA) and real-time quaking-induced conversion (QuIC) to determine whether PrPSc is present in lymphoid tissues from pigs challenged with the CWD agent.

Methods: At two months of age, crossbred pigs were challenged by the intracranial route (n=20), oral route (n=19), or were left unchallenged (n=9). At approximately 6 months of age, the time at which commercial pigs reach market weight, half of the pigs in each group were culled (<6 challenge="" groups="" month="" pigs="" remaining="" the="">6 month challenge groups) were allowed to incubate for up to 73 months post challenge (mpc). The retropharyngeal lymph node (RPLN) was screened for the presence of PrPSc by EIA and immunohistochemistry (IHC). The RPLN, palatine tonsil, and mesenteric lymph node (MLN) from 6-7 pigs per challenge group were also tested using EIA and QuIC.
<6 challenge="" groups="" month="" pigs="" remaining="" the="">

Results: PrPSc was not detected by EIA and IHC in any RPLNs. All tonsils and MLNs were negative by IHC, though the MLN from one pig in the oral <6 5="" 6="" at="" by="" detected="" eia.="" examined="" group="" in="" intracranial="" least="" lymphoid="" month="" months="" of="" one="" pigs="" positive="" prpsc="" quic="" the="" tissues="" was="">6 months group, 5/6 pigs in the oral <6 4="" and="" group="" months="" oral="">6 months group. Overall, the MLN was positive in 14/19 (74%) of samples examined, the RPLN in 8/18 (44%), and the tonsil in 10/25 (40%). Conclusions:

This study demonstrates that PrPSc accumulates in lymphoid tissues from pigs challenged intracranially or orally with the CWD agent, and can be detected as early as 4 months after challenge.

CWD-infected pigs rarely develop clinical disease and if they do, they do so after a long incubation period. This raises the possibility that CWD-infected pigs could shed prions into their environment long before they develop clinical disease.

Furthermore, lymphoid tissues from CWD-infected pigs could present a potential source of CWD infectivity in the animal and human food chains.


CONFIDENTIAL

EXPERIMENTAL PORCINE SPONGIFORM ENCEPHALOPATHY

While this clearly is a cause for concern we should not jump to the conclusion that this means that pigs will necessarily be infected by bone and meat meal fed by the oral route as is the case with cattle. ...


we cannot rule out the possibility that unrecognised subclinical spongiform encephalopathy could be present in British pigs though there is no evidence for this: only with parenteral/implantable pharmaceuticals/devices is the theoretical risk to humans of sufficient concern to consider any action.


 Our records show that while some use is made of porcine materials in medicinal products, the only products which would appear to be in a hypothetically ''higher risk'' area are the adrenocorticotrophic hormone for which the source material comes from outside the United Kingdom, namely America China Sweden France and Germany. The products are manufactured by Ferring and Armour. A further product, ''Zenoderm Corium implant'' manufactured by Ethicon, makes use of porcine skin - which is not considered to be a ''high risk'' tissue, but one of its uses is described in the data sheet as ''in dural replacement''. This product is sourced from the United Kingdom.....


 snip...see much more here ;

WEDNESDAY, APRIL 05, 2017

Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease


*** U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL 

Jan. 9, 2001 

[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.

[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]

[host Richard] could you repeat the question?

[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

[not sure whom ask this] what group are you with?

[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.

[not sure who is speaking] could you please disconnect Mr. Singeltary

[TSS] you are not going to answer my question?

[not sure whom speaking] NO 

SNIP...read full transcript and history here;



311.         On 8 November 1988 a meeting was held between NOAH and MAFF.[365] The minutes record that the following points were raised at the meeting on the BSE situation:
�4. BSE situation � progress discussion
i)���� �There is also possibility that BSE exists in the USA following tests carried out in Wisconsin.
As a result of these tests bovine material from the US can no longer be recommended for inclusion in biological products.�
312.         Problems with supply of bovine material were identified together with the possibility of a change in production methods. The minute of the meeting records that:
��It was felt that the publication of the guidelines was required to protect the UK image and demonstrate to the Commission that we had a clear action policy. We remain the only MS to have admitted to recognising the disease so far�.[366]
http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1988/11/08005001.pdf

1989
341.         In January 1989 the Medicines Unit, MAFF, prepared a revised version of the guidelines for the VPC. The covering note said: �the document is presented to members essentially for information but it will be helpful to have comments on it, and suggestions from the Committee will whenever possible be incorporated�. The note also stated �it is important to progress the guideline as quickly as possible so that it can be distributed to appropriate organisations, and manufacturers using material of bovine origin in their products�. The guideline recommendations, which dealt with the �selection and treatment of material obtained from cattle in the UK and destined for use in the preparation of biological products�, provided:
�I)��� COLLECTION
1.��� No product from a BSE affected animal is acceptable for use.
2.��� Material should be obtained only from BSE-free herds.
3.��� Brain-penetrative stunning is unacceptable where tissues are collected post mortem.
4.��� Instruments used to collect samples and holding vessels should either be virgin�or be sterilised. After use reusable instruments should be sterilised after cleaning. Disposable materials should be incinerated.
II)��� TISSUES UNSUITABLE FOR COLLECTION
1.��� Primary cell structures.
2.��� Endocrine glands including placenta.
3.��� Spleen and lymphoid tissue.
4.��� Neural tissue
III)� TISSUES AND OTHER MATERIALS SUITABLE FOR USE
It is recommended that wherever possible source animals are calves.
1.��� Serum. All cellular components must be removed.
2.���� Fetal calf serum provided great care is taken to avoid contamination by placenta and fetal fluids. All cellular components must be removed.
3.���� Milk, or products derived from milk collected aseptically from individual cows under 3 years old.
4.��� Faeces collected from the rectum.
5.��� Bile collected aseptically.
6.��� Cell lines not derived from� neural or lymphoid tissues or cells.
7.��� Sterilised tissues excluding those listed in II.�[400]
Joint CSM/VPC Guidelines considered
342.         On 3 January 1989 Drs Adams, Jefferys and Purves, of the Medicines Division DH, met Dr Little, Mr Kidd and Mr Bradley of MAFF.[401]� A note, taken by Dr Adams, recorded the following:
�Subject: BSE and Medicines Licensing
1.��� MAFF stated that BSE had come before the veterinary Biologicals Sub-Committee in November 1987. With increased notifications of the disease, the implications for veterinary medicinal products were discussed with NOAH in July 1988 when draft guidelines were presented. A redraft of these guidelines, following discussions with MAFF and MD will be presented to VPC in January 1989.
2.        MAFF filled in background on trade implications, the Southwood Committee, inclusion of BSE on the Zoonosis Order and undertook to provide relevant documents for information.
3.        MD described the progress of Committee considerations and unresolved questions such as
a). Is there a problem to man � what about scrapie in sheep which has not been associated with any human disease?
b). What is a �healthy herd�?
c). How may manufacturers be expected to show that scrapie is inactivated by specific processes?
d). How many products should be implicated?
MD stated concerns re bovine insulins, heparin; also re vaccines, monoclonal products and others that have used foetal calf serum/bovine albumin/bovine broth in manufacture.
4.��� MAFF considered that no herd could be guaranteed healthy, all have had some contact with animal (sheep) protein in feed-stuffs: the problem is not necessarily exclusive to UK, there is a risk of spread to to (sic) Europe especially as feed-stuffs are exported and export of calves, embryo and semen from UK is increasing. The US have had Transmissible Mink Encephalopathy from downer cow feed. Ireland have had 2 x confirmed BSE cases.
5.��� MAFF considered that the safest source of bovine material was from Australia/New Zealand where animal/tissue imports are strictly controlled and where scrapie is absent.
6.��� Collection of foetal calf serum (FSC) (sic) may be critical. In the diseased sheep, the placenta is heavily contaminated with scrapie; present collection of FCS is not be [sic]an aseptic procedure and great skill is needed to avoid the placenta.
7.��� No farm or abattoir can approach surgical cleanliness and many may be contaminated already with BSE.
8.��� Although high pressure/high temperature sterilisation is possible, MAFF understood that the industry was not equipped with high pressure vessels for processing.
9.��� MD/MAFF agreed that it was essential to keep �in step� especially as MAFF concerns about animal vaccines would cause DH great difficulties of supply if current stock had to be lost.
10.�� MD/MAFF agreed to maintain official links regarding all developments. MAFF would put revised guidelines to VPC in January after which MD/MAFF would meet again with expert advisors (NIBSC & Biols) to produce joint guidelines for industry. These will be published in MAIL with a request for information on products.
381.         On 14 February 1989 a meeting was held between the Minister for Agriculture, Fisheries and Food, and Sir Richard Southwood �to discuss the recommendations in the Working Party report, timing of publication, and handling.�[447] Also present were Mr Thompson, the Permanent Secretary, Mr Meldrum, Mr Cruickshank, Mr Lawrence, Dr Watson, Sir Donald Acheson (CMO), Dr Pickles and Mr Smith. Sir Donald said that there would be a special Working Party meeting on 22 February 1989, comprising people knowledgeable in biological and pharmaceutical areas to consider the implications for medicinal products. The CMO continued that it was hoped that this meeting would offer some reassurance on this area. He said it would be wise to delay publishing the Report until after this meeting. Sir Richard said �we were dealing with �probabilities� rather than certainties� in this area, and that made it difficult. In his opinion, care should be taken when sourcing medicinal material from any country with a significant sheep population and where sheep material might be fed to cattle. Mr Meldrum pointed out that this issue was extremely complex: some countries might be ostensibly BSE-free while having an underlying problem with the disease in a sub-clinical form in their animals. It was agreed to await the outcome of the 22 February meeting to be clear on this issue.
382.         On 14 February 1989 Dr Adams attended a meeting with Drs Rotblat and Purves, Mr Hagger, Mr Sloggem, Mr Bewley and Mrs Alderman.[448] �The purpose of the meeting was to discuss the action agreed on vaccines at the internal Medicines Division meeting the previous day.
383.         On 14 February 1989 Dr Adams minuted Dr Harris about the information received on human vaccines in response to telephone inquiries. It stated:
�Vaccines
We have contacted all the major vaccine product licence holders whose products are likely to be used in children.� Many manufacturers use bovine material.� As can be seen, this information is diverse and incomplete.� Each company stressed that they could not give an accurate assessment without detailed researches, given the complexity of sourcing/purchasing arrangements.
All the licences are detailed in appendix 1; the overview is as follows:
1.��� D have polio, measles, mumps, rubella, rotavirus vaccines.� All use bovine serum from a UK source and bovine commercial product from unknown source.� Some agent comes from the USA and New Zealand.
2.��� I gave most information (see Appendix 2).� All their vaccines apart from yellow fever, cholera and typhoid contain bovine material:
Oral polio; up to 1988, foetal calf serum was used from UK and New Zealand (pooled); since 1988 foetal calf serum only from New Zealand.� Large� stocks are held.
Rubella; bulk was made before 1979 from foetal calf serum from UK and New Zealand.� None has been made as there are some 15 years stock.
Diphtheria; UK bovine beef muscle and ox heart is used but since the end of 1988 this has been sourced from Eire.� There are 1,250 litres of stock.
Tetanus; this involves bovine material from UK mainlyScottish.� There are 21,000 litres of stock.
Pertussis; uses bovine material fromthe UK.� There are 63,000 litres of stock.
They consider that to switch to a non-UK source will take a minimum of 6-18 months and to switch to a non-bovine source will take a minimum of five years.
3.��� E have measles, mumps, MMR, rubella vaccines.� These are sourced from the USA and the company believes that US material only is used.
4.��� J have a measles vaccine using bovine serum from the UK.� There are 440,000 units of stock.
-����� They have also got MMR using bovine serum from the UK.
5.���� K have influenza, rubella, measles, MMR vaccines likely to be used in children.� Of those they think that only MMR contains bovine material which is probably a French origin.
6.��� L have diphtheria/tetanus and pertussis on clinical trial [redacted]; These use veal material, some of which has come from the UK and has been made by I (see above).
7.��� M have influenza vaccines which are made up in egg medium.
8.��� The Secretary of State has a number of licences.� We understand that the inactivated polio vaccine is no longer being used.� There is a stock of smallpox vaccine.� We have not been able to determine the source material.� (Made in sheep very unlikely to certain bovine ingredients).
9.��� N have acellular triple vaccine in which I material of UK bovine source has been used.
As far as I can see I are the sole supplier of pertussis vaccine which uses bovine casein digest.
You should also be aware that DH has made arrangements for meningococal vaccine to be available, on a named patient basis, from D and K.� Both companies use bovine media in production.�[449]
Dr Adams also set out details of forthcoming� expert group meetings (VPC, Human and Veterinary Medicines Working Group, and CSM).
397.         On 22 February 1989 Miss Duncan minuted Dr Metters. Copies were sent to Drs Pickles, Sutton and Hoxey, Mr Luxton, Mr Allen and Mr Burton. This minute said, �As you will know from Dr Sutton we only became aware of the Southwood Report on Friday and it is clear that those compiling the report were unaware that there are a large range of unlicensed medical devices made from or containing material of bovine origin�, and that �from a public relations aspect the report does not draw attention to devices except for one reference to surgical implantation�. 

***She went on to say that the majority of such products were manufactured in the USA, and continued:

�3.�� Irrespective of what public reaction, [sic] we may anticipate it is clear that the Department needs to take action to complement that which w
ill be taken by Medicines Commission for licensed products.
4.        As soon as we were aware of the possible implications we prepared a provisional list of devices which from our Manufacturer Registration data and from individual specialist knowledge we know to contain animal origin material. A copy of that list will be made available as soon as possible.
5.        If you agree we would propose to follow whatever action CSM takes with a similar formal letter/questionnaire and consultative guidance (a) by facsimile to UK companies known to use bovine materials and (b) by post to all medical device companies making products which could conceivably include animal materials. The majority are in the USA.�[465]
398.         On 23 February 1989 Dr Richardson minuted Miss Duncan about Medical Devices of �Animal� origin. He noted that �Distinct types of areas appeared, eg �heparin� coated disposables, heart valves etc and have therefore been divided into categories as indicated.� The issue of sterilisation was also mentioned.[466]
399.         On 23 February 1989 Dr Metters replied to Miss Duncan�s minute of 22 February 1989, copies to all previous recipients. Dr Metters agreed that manufacturers of unlicensed medical devices with material of bovine origin should receive similar guidance and questionnaires to those the CSM were to give to manufacturers of licensed products. Dr Metters also noted the fact that sterilisation of products containing bovine material was one of the central uncertainties of BSE: nobody knew how infective it was, or of its potential to cross the species barrier. He advised that Dr Pickles should be kept closely informed on the subject of unlicensed medical devices.[467]
DFA 17

Subject: Re: 100 Diabetics warned about mad cow exposure tissue came from cattle in the U.S. 

From: "Terry S. Singeltary Sr." 

Reply-To: Bovine Spongiform Encephalopathy 

Date: Sat, 21 Apr 2007 20:46:06 -0500 Content-Type: text/plain Parts/Attachments: text/plain (2171 lines)

greetings,

i thougt some might want to read some old data on this topic ;

36. On 5 June 1989 I sent a minute to the CMO’s Private Secretary [169] (YB 89/06.05/3.1)

 BSE4I1 

A. 

Dr D Hcinnes PS/CHO . From: D D Hagger M31 Sate: 5 June 1989 Copies: Mr Rayner F?S/H Dr Harris Dcno 

,,Dr Ketters HEDSEB Dr K Jones RCA Mr Wilson RCA 3r Adams H338 Dr Jefferys MESA Dr Pickles HEDSEB Dr Rubery MEDIMCD Dr Rotblat MBBA 

, J Mr Cunningham CHP3 Hr Parker 854 Dr Purves HBSA Hr Bewley HBIC Hr Love M313 

Hr Sloggem MESA at Burton PD/STD/PGI Mr Armstrong MBlB~ Hr 5collen MAE? 

38E: HUHAR MEDICINES 

1. It might be helpful to provide an up-date on progress over the precautionary measures being taken by the HCA in respect of human medicines sourced from bovine materials - my earlier minutes of 23 February (addressed to you) and 24 February (to Mrs Goldhill) refer. - 

2. Over 4,000 letters were sent by the HCA (then Medicines Division) to all licence holders for human medicines on 9-10 Harch 1989, enclosing copies of the joint CSM/VPC guidelines and a questionnaire, for licence holders to return by 

1 Kay giving details of animal materials used in their products (annex A). 

3. Now that most licence holders have replied the preparations for a full professional analysis are nearing completion. The enquiry has produced a lot of material which will take time-to study before papers can be prepared for a meeting on 6 September of the special working group set up by the CSH to advise it (annex B). At this stage, a preliminary scan of the data has not identified any information which would appear to warrant immediate special action. The men is however taking account of the new guidelines in assessing applications for new licences and renewals. 

***4. In considering areas in which precautionary measures might usefully be taken,.mention has been made of insulin prepared from bovine material. This is being borne in mind but it may to some extent be reasurring to know that such insulin is used in the UK only for a very small group of mainly elderly patients for whom it is difficult to switch to either porcine or genetically engineered insulin. nevertheless, we are on the look out for any such products containing bovine brain or other possibly doubtful tissue. 

5. Further progress reports will be supplied from time to time, the next after completion of the full analysis unless there is any major finding in the meantime. 

http://www.bseinquiry.gov.uk/files/yb/1989/06/05003001.pdf

https://web.archive.org/web/20040626074844/http://www.bseinquiry.gov.uk/files/yb/1989/06/05003001.pdf

reporting on progress. This was unusual for me but I assume I did this I had minuted him previously and because of the degree of involvement the CMO had in the issues. The minute explained that most responses to questionnaires had been received and were currently being reviewed, and a preliminary scan of the data so far available had not identified any information requiring immediate special action. Further, the MCA were applying the new guidelines to licence applications and renewals. The use of bovine insulin in a small group of mainly elderly patients was noted and it was recognised that alternative products for this group were not considered satisfactory. (I seem to recall that later some of these patients did become quite ill when transferred to other forms of insulin.)

37. I received a copy of Dr Metters’ minute to Mr Clarke of 7 June 1989 on further measures MAFF were proposing to take to extend the offal ban [170-172] (YB 89/06.07/6.1-6.3).

http://www.bseinquiry.gov.uk/files/yb/1989/06/07006001.pdf

https://web.archive.org/web/20040626075457/http://www.bseinquiry.gov.uk:80/files/yb/1989/06/07006001.pdf

This advised of the effect this would have of drawing attention to the continued use of bovine material in medicines and brought to Mr Clarke’s attention my minute of 5 June 1989. The following day Dr Metters sent a minute to the CMO’s private secretary which he described as a follow up minute for officials only and it was copied widely to colleagues in the Medicines Division [173-174] (YB 89/06.08/7.1-7.2).

http://www.bseinquiry.gov.uk/files/yb/1989/06/08001001.pdf


http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1989/06/08007001.pdf

38. On 9 June Dr Metters similarly updated the CMO on developments [175-186] (YB 89/06.07/6.1-6.3 ; 89/06.07/7.1-7.2 ; 89/06.05/3.1 ; 89/06.09/5.1-5.4) .

http://www.bseinquiry.gov.uk/files/yb/1989/06/09005001.pdf









NOTE OF THE MCA MEETING ON BOVINE SPONGIFORM ENCEPHALOPATHY. 12 JUNE 1989

PRESENT.

Mr Love MB1B (Chairman)

Dr Jeffreys MB3A

Dr Adams MB3A

Dr Rotblat MB3A

Dr Raine MB3B

Dr Purves MB5A

Mr Burton PD/STD/PGlB

Mr Armstrong MB1B 

AGENDA

See Appendix A. The agenda as it appeared therein was followed. 

THE MEETING 

AGENDA ITEM 1. Mr Love gave a position statement:

MCA has had a 50 to 60% response to date. Approx. 1,000 companies having responded. listing approx. 1,500 products.

The mailshot used was based on the MAIL mailing list and may have included many companies who used no animal materials whatsoever.

The meeting agreed that those recipients known to have active PLs must be chased for a response.

The information is currently being transferred to a PC to make data manipulation easier. There are resource difficulties with this. 500 company responses are yet to be computerised.

The STD current position statement was also discussed (Appendix B).

Dr Jeffreys reported that Mr MacGregor (MAP? Minister) was due to ban all use of bovine brain and lymph tissue in human food (note: already banned in baby food.) It was understood that this would be announced tomorrow (13 June) and that a CMO meeting would follow. These events would undoubtedly raise the political profile of BSE once more.

AGENDA ITEM 2. The six agenda categories (2.1 to 2.6) are arranged in order of importance. The most serious being first. A detailed review of the pharmaceutical/medical implications of individual responses was not undertaken at this meeting, but much discussion took place on how to present the data and set the agenda for the September meeting of the Working Party on ESE.

ID1047/MV/l

8/06.12/14.1

Category 2.1 

Products with bovine brain/lymphoid tissue as ingredients and administered by injection.

3 such products known at present, but could be more. Action will need to be taken against these PLs in the light of MAFFs ban on bovine brain/lymphoid tissue in food.

2.2 Products with bovine ingredients (other than brain/lymphoid tissue) and administered by injection

This category includes those products containing foetal calf serum etc. and therefore covers injectable vaccines and other biologicals. Could be a very large category. A detailed breakdown required for the Working Party.

Category 2.3  Tissue implants. open wound dressing. surgical materials. dental and Ophthalmic products with bovine ingredients

***This MCA category matches those products of most - concern to STD.

***Sutures made from bovine material to be placed high on the agenda for the WorKing Party.

MCA have had discussions with : _____  who are producing a detailed submission on the subject.

Categories 2.4 to 2.6 Minimal emphasis and resource to be given to these categories at present. 

AGENDA ITEM 3. Several points were discussed:

a. The top priority was for MCA to arrange its response data into an easily manipulatable form as quickly as possible.

b. MAFF had diverged from MCA at the time the Guidelines were sent out and all matters relating to veterinary medicines were being handled directly by MAFF. Concern was expressed that MAFF could be developing independent policies in the face of pressure from their food sections. MCA to liaise more directly with MAFF in future.

c. MCA were still holding off from detailed consideration of oral products for the time being.

d. MCA were attempting to draw up a list of common animal—derived raw materials used in non—injectable products (eg. stearic acid, lanolin etc) in the hope that these could be submitted to the Working Party and then be dismissed from the enquiries.

ID1O47/MV/2

89/06.12/14.2

e. It was agreed that the agenda for the September Working Party on BSE meeting would follow the same category priority action as at Appendix A.

f. The authorities in Eire were understood to be considering similar BSE Guidelines since the 3 possible cases in that country had now been confirmed and more were suspected. The Dutch and French were also said to be concerned.

g. The case of ‘            " and other non-licensed injectables made from bovine brain and lymph tissue was discussed. It was agreed that STD would provide details of any such "named-patient" products to Mr Love for consideration by MCA.

R W BURTON 

PD/STD/PG1B

June 1989

ID1047/MV/3

89/06.12/14.3

APPENDIX B

PD/STD CURRENT POSITION STATEMENT WITH RESPECT TO BSE FOR MCA BSE MEETING OF 12 JUNE 1989

STATEMENT DATE 9 JUNE 1989.

1. Document package (letter, guidelines, questionnaires) on "BSE: Guidance on Good Manufacturing Practice and Request for Information relating to Surgical Implants and Blood Contact Medical Devices" sent to 338 MRS registered companies March 1989.

2. As at 9 June 1989 191 responses to the questionnaire had been received. Chasing of non-responders ongoing.

3. Responses up to 5 June 1989 have been reviewed. Data entered on a specially set up computer database. ****Printout obtained of all companies who have so far declared the use of animal derived materials. *** A total of 38 companies. 

4. An internal PD/STD preliminary review meeting was held on 2 May to:

a. Discuss implications of information received to that date.

b. Decide on chasing action for non—responders.

c. Discuss relationship with MCA on BSE. 

5. PD/STD has reported to MCA with respect to S o S PLs. 

6. A paper entitled “Inactivation of Scrapie—like Agents" has been produced by PGlA for DH use; It may he sent to Trade Associations after suitable editing.

June 1989 

R W BURTON PD/STD/PG1B

ID1047/MV/4

8/l06.12/14.4


French Bovine Sutures



I relayed the information about the proposed offal ban and also sought comments on the recommendations on pharmaceutical research issues that had been provided in draft by the Tyrrell Committee. (The report was submitted to Ministers on 13 June 1989.) On 7 September Dr Pickles sent me a minute regarding the Tyrrell report and its implication for medicinal products [196-197] (YB 89/09.07/3.1-3.2).

Subsequently there was a fair amount of correspondence between the Departments and their ministers about funding Tyrrell’s research proposals. I was not involved in this issue.

39. Questionnaire responses were analysed and outstanding replies were requested so that papers were ready for the BSE Working Party chaired by Professor Collee to consider them at a meeting on 6 September 1989 [188-195] (YB 89/09.06/10.1-10.8). I did not attend but I would have seen the minutes or the recommendations, which would have been available for the CSM’s meeting on 28 September 1989 [198-205] (YB

89/09.28/10.1-10.8). (I was not involved in the deliberations over the sourcing of bovine material for a particular licensed surgical suture because this was the remit of the CDSM which, at that time, fell outside my area of responsibility.) The recommendations of the BSE Working Party were:-

"1. That no licensing action is required at present in regard to products produced from bovine material or using prepared bovine brain in nutrient media and sourced from outside the United Kingdom, the Channel Isles and the Republic of Ireland provided that the country of origin is known to be free of BSE, has competent veterinary advisers and is known to practise good animal husbandry.

2. The Joint CSM/VPC guidelines should apply to all bovine material sourced from UK, Channel Islands and the Republic of Ireland and any other area known to have BSE. Companies which at present cannot comply should be encouraged to do so as soon as possible. The timescale should be agreed with the Licensing Authority for each individual product as appropriate.

3. No licensing action is required at present with respect to products containing material from animals other than cattle.

4. The Licensing Authority should continue to review scientific progress in

the field of BSE, so as to be in a position to take licensing action in the future should this be necessary."

The CSM endorsed these recommendations.

40. I discussed the action to be taken following the CSM meeting with Dr Jefferys, Dr Adams and Dr Purves around 13 October as documented in a memo from Dr Jefferys to Mr Love of that date [206] (YB 90/10.13/6.1). We agreed that the further advice of the BSE Working Group was needed and a meeting was planned for January 1990.

41. I later received a copy of a minute dated 14 November from Mr Robertson, who at that time was responsible for administrative issues relating to the CDSM (and therefore for products such as sutures which were considered by the CDSM) to Mr Davey, the private secretary to the Minister for Health and copied to the private secretaries to the other relevant ministers and to the CMO, regarding the possibility of media comment following a scientific conference on BSE to be held at the RSM the following day. The minute reiterated the advice of the Southwood report that the risk to man from medicinal products was theoretical and remote, referred to the CSM/VPC guidelines on manufacturing issued in March 1989 and confirmed that the CSM and MCA were continuing to monitor the position [207-209]. (YB 89/11.14/13.1-13.3)

1990

42. I did not attend the January 1990 meeting of the CSM BSE Working Group [210-233] (YB 90/01.10/7.1-7.7 ; 89/09.06/15.1-15.3) 221-233 (L2 Tab 3B) or the February CSM meeting [234-237] (YB 90/02.21/10.1-10.8); as a result of the MCA reorganisation (see below) my responsibilities had changed and these matters were no longer in my area. I cannot remember whether I would have seen the papers circulated for these meetings. By about February the new shadow businesses had been formed in the MCA, I had become co-ordinator for Business E (which was to take on responsibility for the Medicines Commission and the Medicines database but otherwise had no responsibilities for licensing matters, the CSM or other committees, or BSE) and Mr Bewley, the CSM Secretary, had become part of the management trio for Business A. In the Department's Distribution of Business, however, I continued to be shown as MB1 until October 1990 and so continued to receive some Departmental correspondence. Where I received material that was not for Business E or, later, B I would have passed it on to the appropriate person for action.

43. On 13 March the European Commission gave a decision regarding BSE, banning the export of certain bovine tissues and organs for human consumption and certain other bovine tissues and organs (including foetal calf serum, lymphoid tissue and cell cultures) for uses other than human consumption. Dr Metters subsequently sent a minute to Mr Bewley, copied to me, commenting on the possible effect of this decision on UK pharmaceuticals. He asked whether the CSM BSE Working Party had considered whether licensed products that still used bovine constituents should be asked to transfer to non-UK bovine source material [238] (YB 90/03.26/6.1). Mr Bewley (ex-MB1C but now Business A and Secretary to the CSM) responded to Dr Metters by a minute of 27 April 1990 (copied to various people including me) [244-254] (YB 90/04.27/5.1-5.4) which provided an update as to the current position on the few licensed medicines using bovine material sourced from the UK including stocks of vaccines; all new products were required to meet the guidelines. Dr Metters was also informed of the advice of the BSE Working Group. In a further minute of 1 May, Dr Metters indicated that he had noted the recommendations of the Working Group; he commented that even though any risk of transmissions of BSE through vaccination was remote, it would be desirable to replace existing vaccine stocks with New Zealand sourced products as soon as possible [255] (YB 90/5.1/8.1). He requested to be kept abreast of developments and would have discussed the issue with CMO if he had considered this appropriate.

44. On 26 April 1990 I attended a CSM meeting [239-243] (YB 90/04.26/9.1-9.5) at which a letter from the British Diabetic Association concerning the safety of bovine insulin was considered and a response approved confirming there was no insulin sourced from cattle in the UK or Ireland and that the situation in other countries was being monitored. By this time, I would have been aware of my impending appointment to Business B (Abridged Licensing) and that I would be establishing new links with the CSM.

https://web.archive.org/web/20090320181538/http://www.bseinquiry.gov.uk/files/ws/s476.pdf


On 26 April 1990 I attended a CSM meeting [239-243] (YB 90/04.26/9.1-9.5) at which a letter from the British Diabetic Association concerning the safety of bovine insulin was considered...

5 pages, 3 of which are blank...tss

http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1990/04/26009001.pdf

Bovine insulin

From: "Terry S. Singeltary Sr."

Hello , it might be beneficial for you to read the DFA 17. it has some valuable information in it, but some is outdated. there is disturbing news on the DOSE, and just how much infectivity it takes to infect an individual. i will post next. meanwhile, the url to DFA 17 is below the short article........

regards, Terry

--------------

207. On 17 March 1988 Dr Watson and Mr Alastair Cruickshank, Under Secretary of MAFF, attended a meeting with the CMO and senior medical officials at the DHSS to discuss BSE.[249] The minute of the meeting records:

6. Biological products were produced of bovine origin and this applied to a significant proportion of insulin despite genetically manufactured sources. In addition, cell cultures for many vaccines used a bovine serum medium. Dr Harris undertook to speak to the Director of NIBSC about biological products. 13. Mr Cruickshank thought it necessary to assess the risk in humans in order to justify the cost of any control measures taken by MAFF. Although it would be possible to monitor diabetics, it could take 20 years or more before we would be able to assess whether any risk existed from bovine insulin. In the meantime, with some 40 or so new cases in cattle a month, the disease would become newsworthy and it was important that both government departments arrange appropriate action before this happened. 14. In conclusion it was agreed that urgent advice was necessary on biological products and the disposal of sick animals. The options would be outlined to Ministers (of both government departments) and they would be asked to agree the setting up of an expert advisory group.

----------------

Medicines and medical devises;

----------------

235. On 2 June 1988, Dr Pickles responded to Mrs Alderman requesting a further database search and asking about bovine insulin, which was not on the list of products, although licensed. She also asked about the species used in the manufacture of any licensed rabies vaccines.[281] 236. Mrs Alderman replied on 3 June 1988, listing products containing bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282]

-----------------------

‘There has been one instance of inadvertant [sic] transmission of the scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and Wilson 1939). One of the three batches of vaccine made in 1935 at the Moredun Institute contained the scrapie agent resulting in 7% of the recipients of the 18, 000 doses in the batch developing scrapie. This vaccine was made from formalin-inactivated sheep brain, and brought to the attention of research workers that formalin, at a concentration of 0.35% for at least 3 months, which inactivated conventional viruses, did not totally inactivate the scrapie agent.

----------------------------

4. Questions we might want to have answered are: the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect (“natural” infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). ..........

Subject: Re: Bovine Insulin CJD/BSE $ Ignorant Doctors (Part 2) Date: December 6, 2000 at 8:05 am PST

In Reply to: Bovine Insulin CJD/BSE $ Ignorant Doctors posted by TSS on December 6, 2000 at 8:03 am:

4. Questions we might want to have answered are: the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect (“natural” infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). Are sterilisation processes adequate for the most resistant strain of scrapie agent or for CJD agent? Should companies be asked to include investigation for inclusion of scrapie agent (eg mouse innoculation [sic]) in at least some batches? If BSE behaves like scrapie, then we might expect other nervous tissue, spleen, lymph nodes and placenta to be contaminated. Infection has been described in other tissues too, eg gut wall, and we can not [sic] be sure blood is free. Do we know what bovine materials are used in which products, both as the active ingredient and in production? Bovine active ingredients in human products include insulin, vasopressin, bone, immune globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and fetal calf serum must be used in preparation of very many products. For each of these products would any “BSE agent” be destroyed or eliminated in processing? If not, and the product is administered parenterally or topically into an open wound, might there be a risk? [For oral products, there would only be a trivially increased load on top of that taken in food in omnivores/carnivores including man. But for some herbivores, this might allow the agent to be introduced into yet another species].

--------------------------

271. The second part of the paper, entitled ‘Bovine Spongiform Encephalopathy – Action by Medicines Division’ states: 1.Product Licence Situation The computer list shows 53 product licences extant for preparations of bovine origin and of these 42 are for insulin. It is not clear how complete this list is, particularly on the review side where there may be grounds for concern, especially with regard to products for cellular therapy.

-----------------------------

3.1 Parenteral use There are three products in this category: i. Insulin ii. Bovine collagen implants iii. Bovine fibrin implants. The latter two are used in surgery and are the province of the CDSM.

------------------------------

6.2 Parenteral products

The major problem here appears to be with insulin. The use of bovine insulin is rapidly declining and maybe restricted to those patients who have antibodies to the human preparation, or who cannot tolerate it. In this case bovine insulin is life saving, and the risk to benefit would currently be in favour of retaining its use.

In addition to this for parenteral products in general:

i. All cattle used for the preparation of these products should come from certified healthy herds, and not to have been given food supplements containing material of animal origin. ii. No brain or lymphoid tissue should be used in parenteral products. iii. Manufacturers of parenteral products should show that their manufacturing procedure is capable of inactivating scrapie-like agents. iv. While the agent of BSE is not known it is not possible to advise specific inactivation processes.

7. Recommendations for action

i. No licensing action should be taken against oral products. ii. All bovine products should come from cattle from healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products. iii. Manufacturers of parenteral products should show that their manufacturing processes are capable of inactivating scrapie-like agents. iv. All licences for new products from bovine material should comply with the above. v. The Review/CDSM Sections should carry out a search for preparations containing bovine material. vi. There should be an article in MAIL requesting manufacturers to identify bovine preparations used in the manufacturing process. Bovine albumin and foetal calf serum should come from healthy herds. vii. The ADR database should be searched for ADRs to bovine products. viii. The Committee is asked to consider whether to take any action against bovine insulin or whether the risk/benefit ratio is appropriate.’[319]

------------------------------

hope this helps out.

HUMAN/ANIMAL TSE's ARE A 'WORLD' PROBLEM.....

TSS

BSE Inquiry Draft Factual Account 17

http://www.bse.org.uk/dfa/dfa17.htm

Q-3. What are FDAs concerns regarding the importation of beef insulin for my personal use?

A. There is a possible threat of bovine spongiform encephalopathy (BSE) or "mad cow disease" transmission through the use of beef insulin if derived from tissue contaminated with BSE agent.

http://www.fda.gov/cder/drug/beefinsulin/default.htm#Q-3

http://www.bseinquiry.gov.uk/files/yb/1990/04/30006001.pdf

http://www.mad-cow.org/00/may00_news.html

Human vaccine prepared in animal brains

http://www.mad-cow.org/00/nov00_late_news.html#fff

http://www.whale.to/v/singeltary7.html

http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh

COMMERCIAL IN CONFIDENCE NOT FOR PUBLICATION SUB COMMITTEE ON BIOLOGICALS. COMMITTEE ON SAFETY OF MEDICINES

CSM/SEAR/88 10TH MEETING. BIOLS/88/6TH MEETING

This paper was discussed by the Biological Sub-Committee on 2 November 1988, when the following recommendations were made;

1. No immediate licensing action should be taken against oral products, in which bovine material has been used.

2. All bovine materials should come from cattle from appropriately certified healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products.'

3. Manufacturers of parenteral products should show that their manufacturing processes are capable of eliminating scrapie-like agents.

4. All licences for new products from bovine materials should comply with the above.

5. There should be an article in MAIL requesting manufacturers to identify products in which bovine materials have been used. Bovine albumin and foetal calf serum should come from appropriately certified healthy herds.

6. The above should be drawn to the attention of the review/CDSM sections along with the need to search for preparations containing bovine material.

7. The above should be drawn to the attention of the ADR Section and SEAR along with the need to search the ADR database for reactions to bovine products.

REMARK.

1. The Licensing Authority's attention was drawn to the need to give ongoing consideration to whether action was required on bovine insulin and heparin products.

88/11.02/5.1

http://www.bseinquiry.gov.uk/files/yb/1988/11/02005001.pdf

*** 'political risk of worrying large number of diabetic patients' ***

BSE3I1 0357 

CW {WI/“+0 Film 

To: Dr. Pickles From: Dr. Jefferys \\ Room A633 PMO, HB3A AFH Room 1527 Ext 3168 

Market Towers Date: 24th May, 1988 

c.c. Dr. Wood, M338 Dr. Jenkins, MB4 Dc hives

BOVIHE SPONGIFOEH EHCEPEALDPAIHY 

1. Your minute of the 20th May refers. 

2. 'I was aware of the joint MAFF-DHSS working group and it was in the light of this that I prepared my preliminary comments in my minute of the 13th April. 

3. The Biologicals sub-Committee have not formally discussed ESE, but they informally considered this at the last meeting during the course of the assessment of one application. For some months now the Sub—Committee have been requiring appropriate “spiking" studies to be undertaken with hardy viruses and these would include bovine products. The agents being used are from the Hanta virus and occasionally for studies with the scrapie agent. I think therefore that we can be reasonably confident about taking appropriate action for the new products. I would have thought that the major concern here is with the parenteral products 

4. With regard to previously licensed products, then we have no evidence of hazard, but clearly we cannot provide reassurance given the timescale for possible incubation and infection. 

5. As you will be aware from your previous work with the Review, many of the older products are PLRs (since many of the biological PLRs still have not been reviewed). I am therefore copying this minute to Dr. Wood since she will need to take account of this during the review of these products. 

6. Oral Products 

As I previously stated, I would have thought that the risk from oral medicinal products must be very small in comparison to the risk from food. I base this on the assumption that the infectious agent is probably not heat sensitive and therefore will not be removed by normal cooking. 

7. Parenteral Products 

I accept that there may be a different consideration of parenteral products. I presume that the major agents here would be bovine insulin and bovine serum albumen in vaccine production. If you were looking for a group of people to 

1 

88l5.24/3.1 

BSE3I1 0358 

\0 

study, then I would have thought that those who have received bovine insulin might be the most appropriate group. I suppose it might be possible to undertake a retrospective study comparing those who have received bovine insulin versus those who have received porcine or ideally human insulin. I presume the end point would have to be the development of an encephalopathic syndrome. The danger in constructing such a study would be the scientific risks of confounding, etc. and the political risk of worrying large numbers'of diabetic patients. 

These thoughts are very preliminary ones. It also occurs to me that this is more of a long term issue and that it may well involve william Jenkins since this is rather more an ADR problem than a New Drugs Group issue. I am therefore 'copying your minute to him. It may be appropriate perhaps for Sue Wood, William and I to have a discussion with you at a mutually convenient time. 

W 

DAVID JEFFERYS PHD, HB3A Room 1527 Ext 3168 Market Towers

88/5.24/3.2 

http://www.bseinquiry.gov.uk/files/yb/1988/05/24003001.pdf

http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1988/05/24003001.pdf

207. On 17 March 1988 Dr Watson and Mr Alastair Cruickshank, Under Secretary of MAFF, attended a meeting with the CMO and senior medical officials at the DHSS to discuss BSE.[249] The minute of the meeting records: 6. Biological products were produced of bovine origin and this applied to a significant proportion of insulin despite genetically manufactured sources. In addition, cell cultures for many vaccines used a bovine serum medium. Dr Harris undertook to speak to the Director of NIBSC about biological products. 13. Mr Cruickshank thought it necessary to assess the risk in humans in order to justify the cost of any control measures taken by MAFF. Although it would be possible to monitor diabetics, it could take 20 years or more before we would be able to assess whether any risk existed from bovine insulin. In the meantime, with some 40 or so new cases in cattle a month, the disease would become newsworthy and it was important that both government departments arrange appropriate action before this happened. 14. In conclusion it was agreed that urgent advice was necessary on biological products and the disposal of sick animals. The options would be outlined to Ministers (of both government departments) and they would be asked to agree the setting up of an expert advisory group.

----------------

Medicines and medical devises;

http://www.bse.org.uk/dfa/dfa17.htm

----------------

235. On 2 June 1988, Dr Pickles responded to Mrs Alderman requesting a further database search and asking about bovine insulin, which was not on the list of products, although licensed. She also asked about the species used in the manufacture of any licensed rabies vaccines.[281]

236. Mrs Alderman replied on 3 June 1988, listing products containing bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282]

-----------------------

‘There has been one instance of inadvertant [sic] transmission of the scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and Wilson 1939). One of the three batches of vaccine made in 1935 at the Moredun Institute contained the scrapie agent resulting in 7% of the recipients of the 18, 000 doses in the batch developing scrapie. This vaccine was made from formalin-inactivated sheep brain, and brought to the attention of research workers that formalin, at a concentration of 0.35% for at least 3 months, which inactivated conventional viruses, did not totally inactivate the scrapie agent.

----------------------------

4. Questions we might want to have answered are: the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect (“natural” infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). Are sterilisation processes adequate for the most resistant strain of scrapie agent or for CJD agent? Should companies be asked to include investigation for inclusion of scrapie agent (eg mouse innoculation [sic]) in at least some batches? If BSE behaves like scrapie, then we might expect other nervous tissue, spleen, lymph nodes and placenta to be contaminated. Infection has been described in other tissues too, eg gut wall, and we can not [sic] be sure blood is free. Do we know what bovine materials are used in which products, both as the active ingredient and in production? Bovine active ingredients in human products include insulin, vasopressin, bone, immune globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and fetal calf serum must be used in preparation of very many products. For each of these products would any “BSE agent” be destroyed or eliminated in processing? If not, and the product is administered parenterally or topically into an open wound, might there be a risk? [For oral products, there would only be a trivially increased load on top of that taken in food in omnivores/carnivores including man. But for some herbivores, this might allow the agent to be introduced into yet another species].

--------------------------

271. The second part of the paper, entitled ‘Bovine Spongiform Encephalopathy – Action by Medicines Division’ states: 1.Product Licence Situation The computer list shows 53 product licences extant for preparations of bovine origin and of these 42 are for insulin. It is not clear how complete this list is, particularly on the review side where there may be grounds for concern, especially with regard to products for cellular therapy.

-----------------------------

3.1 Parenteral use There are three products in this category: i. Insulin ii. Bovine collagen implants iii. Bovine fibrin implants. The latter two are used in surgery and are the province of the CDSM.

------------------------------

6.2 Parenteral products The major problem here appears to be with insulin. The use of bovine insulin is rapidly declining and maybe restricted to those patients who have antibodies to the human preparation, or who cannot tolerate it. In this case bovine insulin is life saving, and the risk to benefit would currently be in favour of retaining its use. In addition to this for parenteral products in general: i. All cattle used for the preparation of these products should come from certified healthy herds, and not to have been given food supplements containing material of animal origin. ii. No brain or lymphoid tissue should be used in parenteral products. iii. Manufacturers of parenteral products should show that their manufacturing procedure is capable of inactivating scrapie-like agents. iv. While the agent of BSE is not known it is not possible to advise specific inactivation processes. 7. Recommendations for action i. No licensing action should be taken against oral products. ii. All bovine products should come from cattle from healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products. iii. Manufacturers of parenteral products should show that their manufacturing processes are capable of inactivating scrapie-like agents. iv. All licences for new products from bovine material should comply with the above. v. The Review/CDSM Sections should carry out a search for preparations containing bovine material. vi. There should be an article in MAIL requesting manufacturers to identify bovine preparations used in the manufacturing process. Bovine albumin and foetal calf serum should come from healthy herds. vii. The ADR database should be searched for ADRs to bovine products. viii. The Committee is asked to consider whether to take any action against bovine insulin or whether the risk/benefit ratio is appropriate.’[319]

------------------------------

hope this helps out........TSS

Rick Wolf wrote:

From: "Rick Wolf"

My mother who died of CJD in 1998 was an diabetic requiring insulin

since the 1960s. She used a bovine based insulin for many years. I

read in the newpaper yesterday that blood banks are screening

people who may have used bovine base insulin before 1985 because of

potential risk of CJD/TSE.

Does anyone have any more info on this? For those that lost a loved

one to CJD, did they use bovine based insulin?

Robin

----------------------------------------------------------------------

Eileen MacArthur wrote:

From: Eileen MacArthur

Terry...

Just got your info on beef insulin..what a blow to read it in

print. Strange we always suspected a connection with it to Mom who died July

17/98. She took it for 27 years...now I really am wondering. I too take

insulin but not that one.

Eileen

Reading your emails about vaccines brought something to mind.

Although my mom was the one that died on Dec. 10, 98 from CJD....... my dad died on June 20, 83 from complications with diabeties. I remember dad saying insulin was made from pork. Is this still true?

Could diabetics be at a higher risk for CJD?

Terry, would you know anything about this? Just wondering......

Thanks, Suzanne riptss

Terry...

Just got your info on beef insulin..what a blow to read it in print. Strange we always suspected a connection with it to Mom who died July

17/98. She took it for 27 years...now I really am wondering. I too take insulin but not that one. Eileen

Greetings Voice members, after reading over Paul Brown statement to Robin, I find them most interesting, hope he is correct... Terry

____________________________________________________________

Another thing....I asked Dr. Brown about the Hep. B. shot and it being manufactured in the U.K. and Belgium and here was his reply......

Dear Robin:

Thanks for the name and address.

As for vaccines, I'm not an expert, but Hepatitis B can under some circumstances be transmitted from person to person without needle or sexual penetration, and so for public health purposes I suppose it is justified to require vaccination.

As for risk of CJD, you would not need to worry, even if the vaccine was stabilized with albumin from a cow with BSE! Blood from BSE-infected cattle is not infectious, and even if it were, the albumin extracted from it would not be infectious. Both of these statements are based on experimental evidence.

Hope this helps Paul

----------------------------------------------------------------oooops...........tss

9663 Re: [CJDVoice] Your help again [CJD QUESTIONNAIRE PART 3] ... date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. _ _ _ Prompt for hormone therapy or nutritional supplements including oral contraceptives and hormone replacement ... Terry S. Singeltary Sr. Nov 18, 2001 9:09 pm 19662 Re: [CJDVoice] Your help again [CJD QUESTIONNAIRE PART 2] ... the date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. _ _ _ Prompt for hormone therapy or nutritional supplements including oral contraceptives and hormone replacement therapy ... Terry S. Singeltary Sr. Nov 18, 2001 8:59 pm

http://health.groups.yahoo.com/group/cjdvoice/msearch?query=insulin&pos=100&cnt=10

http://health.groups.yahoo.com/group/cjdvoice/message/22712

http://health.groups.yahoo.com/group/cjdvoice/message/22711

http://health.groups.yahoo.com/group/cjdvoice/message/22695

22717 CJD QUESTIONNAIRE... updated version II...TSS ... date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. _ _ _ Prompt for hormone therapy or nutritional supplements including oral contraceptives and hormone replacement ... Terry S. Singeltary Sr. flounder@... madson1 Nov 5, 2002 12:51 pm 22716 RE: [CJDVoice] CJD QUESTIONNAIRE...TSS ... date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. No known routine medications to my knowledge._ _ _ Prompt for hormone therapy or nutritional supplements including ... Helen Severietti helen@... Nov 5, 2002 12:51 pm 22715 CJD QUESTIONNAIRE... updated version...TSS ... date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. _ _ _ Prompt for hormone therapy or nutritional supplements including oral contraceptives and hormone replacement ... Terry S. Singeltary Sr. flounder@... madson1 Nov 5, 2002 11:46 am

http://health.groups.yahoo.com/group/cjdvoice/msearch?query=insulin&pos=80&cnt=10

Tracie Kedzierski wrote:

Terry,

The only problem is that having it on our messageboard conflicts with the information I have on our home page about the surveillance project and the report form I send out to the families.-----it is confusing. In fact..I'm sorry but we (The Foundation) have to pull it off.

http://health.groups.yahoo.com/group/cjdvoice/message/22778

http://health.groups.yahoo.com/group/cjdvoice/message/36030

CWRU CJD QUESTIONNAIRE HISTORY

http://cjdquestionnaire.blogspot.com/

years ago, ARMOUR use to sell a BOVINE based thyroid drug. i don't believe they sell it anymore. i think it was called thylar or something. wonder how many women used that one ??? its documented in the voice archive years back somewhere. ...terry

Q. The Claim: Synthroid is the Best Thyroid Hormone Replacement Drug

If you are hypothyroid, your doctor will probably prescribe Synthroid. This levothyoxine (synthetic thyroxine) drug, made by Abbott Labs, is the top-selling thyroid drug in the U.S., commanding some two-thirds of the market for thyroid replacement. Synthroid is, however, often more costly than its competitors. Some doctors won't hear of prescribing anything but Synthroid however, and claim unequivocally that "Synthroid is the best." Is That So? A. Levothyroxine is the synthetic form of T4, one of the two main hormones the thyroid produces. The most widely prescribed levothyroxine product is the brand name Synthroid. Given that levothyroxine is the conventional medical world's accepted treatment for hypothyroidism, most patients will find themselves prescribed

levothyroxine, and usually Synthroid. Synthroid's manufacturer has at times claimed their drug to be better than its competitors, but research proved Synthroid to be merely bioequivalent -- or equal, in terms of what function they perform in the body -- to their competition, rather than better. This claim of superiority, therefore, actually has no merit. Many doctors, however, still erroneously believe that Synthroid is "better," after being subject to years of this misleading advertising message. All the major brandname levothyroxine products, Synthroid, Unithroid, Levoxyl and Levothroid, have different fillers and binders, so people may have different allergic responses to the different brands.

http://pagead2.googlesyndication.com/


So, if you react to one levothyroxine, your doctor might want to try other brands to see if you react to those brands as well.

Some people who are on levothyroxine also need the addition of the second key hormone, T3. Among that group, some people do best with the T3 drug Cytomel. Anecdotally, however, some patients have reported allergic reactions to Cytomel. The option, compounded or time-released compounded T3, has been used successfully by other patients, but there have been concerns about these products, due to inconsistent production. Other doctors and patients prefer a product known as Thyrolar, a synthetic combination of T4 and T3. Some patients do best on natural desiccated thyroid drugs, such as Armour thyroid, or, in some cases, people find the hypoallergenic formula of natural drug, Nature-throid, works best for them. (Pork allergies, however, may make these products problematic for some patients. There are some patients and practitioners who are also concerned about these products due to fears of prion-related diseases such as Mad Cow Disease, despite manufacturer assurances that these products are safe.) So is Synthroid, or any thyroid drug, better than the others? I think Dr. Richard Shames, a Boca Raton, Florida holistic practitioner and co-author of Thyroid Power and Fat, Fuzzy and Frazzled? -- who has treated thyroid conditions for a quarter century -- has the best advice for patients. "In 25 years of practice, I have found that it doesn't necessarily matter which kind of thyroid hormone you start with so much, as which kind you end up with after trying several different types to see which one works best for you. Initially, I typically recommend whatever type they have either heard about, have a "gut-feeling" about, know family members who have a good response to a particular kind of medicine, or have a philosophical inclination for one kind or another. Sometimes it it the combination of two or three of the above medicines that proves to be the magic solution for a particular person. If the initial item tried does not give 85-95% improvement, I then encourage the person to either add something to their first choice product or discontinue it and start something totally new. It is my firm belief that the state of the art in finding the optimal medicine is still trial and error." The answer is, the best drug is the drug which safely makes you feel your best. And there's no predetermined formula to tell which drug will be the best for you, until you try them, find optimal doses, and see how you do over time.

Mary Shomon, About.com's Thyroid Guide since 1997, is a nationally-known patient advocate and best-selling author of 10 books on health, including "The Thyroid Hormone Breakthrough: Overcoming Sexual and Hormonal Problems at Every Age," "The Thyroid Diet: Manage Your Metabolism for Lasting Weight Loss," "Living Well With Hypothyroidism: What Your Doctor Doesn't Tell You...That You Need to Know," "Living Well With Graves' Disease and Hyperthyroidism," "Living Well With Autoimmune Disease," and "Living Well With Chronic Fatigue Syndrome and Fibromyalgia." Click _here_


(http://thyroid.about.com/mbiopage.htm)


for more information on Mary Shomon.

From: Terry S. Singeltary Sr. (wt-d4-166.wt.net) Subject: Re: THYROID MEDICATION, PIGS , PIG FEED, AND MADCOW Date: August 16, 1998 at 14:14:48 EST

In Reply to: THYROID MEDICATION, PIGS , PIG FEED, AND MADCOW posted by Terry S. Singeltary Sr. on July 28, 1998 at 14:12:38:

I am having a hard time getting information on ingrediants of these drugs. Nobody wants to cooperate. Although I have found the names and ingrediants of some with DESICCATED ANIMAL (T4/T3). ARMOUR Thyroid tablets for oral use are natural preparations derived from porcine (Pork) thyroid glands. From the late 1890's until relatively recently, physicians worldwide have treated hypothroid patients with tablets containing desiccated (dried and powdered) animal thyroid glands. These tablets contained both levothyroxine (T4) and triiodothyronine (T3). In 1958, the first synthetic levothyroxine tablets were marketed in the United States. Because thyroid hormones were on the market before the Food and Drug Admimistration (FDA) laws were in place, manufacturers of these hormones were not required to meet the extensive testing requirements of safety and effectiveness required of all new drugs introduced after 1938. In other words, thyroid hormone replacements, such as synthetic levothyroxine, were "GRANDFATHERED" into the system, consequently, there are no FDA approved procedures or standards for testing these preparations other than specifying that each pill contain betwee 90% to 110% of the standard chemical content. Also Thyrolar contains synthetic T3. There is also Cytomel. I believe all these contain desiccated animal. I am still searching. Maybe the Thyroid Society could find time to list these drugs and their Ingrediants. None of the Drug company's will cooperate. You start talking about dessicated animals in these drugs and asking for ingrediants from people and they lose their tounge./

MADCOWDEADMOMMADSON/TERRY

PLUS, ARMOUR MADE A BOVINE THYROID MEDICATION SOME TIME BACK CALLED "THYRAR" MADE FROM DESSICATED BOVINE THYROID GLAND...

Subject: Mad Cow / Mad Pig and Thyroid Risks Date: November 10, 2000 at 2:24 pm PST Mad Cow / Mad Pig and Thyroid Risks

Could food supplements and medications be inadvertent media for the spread of prion based brain diseases? Multiple sources would suggest this is possible, even likely, due to the use of animal gelatins. This probability goes up even more when the medication itself is a glandular extract.

Importance

BSE / Mad Cow / TSE (Transmissible Spongiform Encephalopathies) are NOT a small topic!

Nobel Prize awarded to Carleton Gajdusek for Kuru/TSE research Nobel Prize awarded to Stanley Prusiner for TSE/Prion research Pulitzer prize winning author Richard Rhodes wrote "Deadly Feasts" on the controversy ISBN 0-684-84425-7 (Mentioned on 259 web pages) Oprah dedicated a show to BSE/Mad Cow, was sued by Texas cattlemen, Courts upheld her 1st Amendment right to Freedom of Speech! Cows, Sheep, Pigs, Mink, Humans have all caught and died of TSE's Prions can not be killed by mere boiling or cooking Over 200,000 deaths/year by 2015 predicted by Prof. Lacey (below) Over 30,700 web pages mention Mad Cow (AltaVista) Web pages on Chaperonins, chemicals possibly preventing the mis-folding of proteins which are the basis for TSE's and Alzheimer's, jumped from 2 to over 6,000 in one year!

Clearly, Transmissible Spongiform Encephalopathies, such as BSE and CJD (one human form,) are a topic of some controversy, one we should all become more aware of.

Mad Cow Censorship

Some questions were raised on the Thyroid mailing list out of StJohns.EDU regarding where the various natural thyroid supplements come from, and how safe they may be with respect to Mad Cow Disease. The basic text of this article was conveniently "discarded" by the moderator, as it seems are a number posts questioning the safety of natural thyroid extracts, or discussing non-prescription alternatives to them. Such pro-prescription medication biases are not new to certain moderated mailing lists... some of which may be rabidly pro something, others against, at the whims of biased or subsidized moderators. (The biases of that list are mild, compared to some other lists, such as an ozone list several years back.) Always look for biases when considering internet, and any other information sources.

Researchers on BSE / TSE say this kind of censorship is not new. Dr. Harash Narang, a British microbiologist and CJD researcher, says he first detected variant CJD in humans back in 1988. He claims that he was ordered to stop work on BSE in 1990, and subsequently "laid off". He believes that British authorities have blocked and undermined such research and detection efforts. (British press articles)

Thyroid Supplements and Mad Cow / BSE

There are natural thyroid extracts, such as Armour Thyroid, and synthetics such as Cytomel and Synthroid. The natural ones are taken from the thyroid glands of animals, such as pigs.

On page 220 of Rhodes' book, Nobel Price winner Dr. Carleton Gajdusek is quoted saying pigs are routinely slaughtered before the disease would become evident in them. Carleton Gajdusek is one of the foremost researchers of Kuru and other "Transmissible Spongiform Encephalopathies", TSE, of which Bovine Spongiform Encephalopathy, Scrapie, CJD, and Kuru are variants.

In the book, Dr. Gajdusek is quoted: "the disease hasn't turned up in pigs only because you don't keep pigs alive for seven or eight years; they're killed after two or three years at the most. When we kept pigs we'd inoculated in our laboratory for eight years, they came down with scrapie. [a TSE variant] Probably all the pigs in England are infected. And that means not only pork, it means your pigskin wallet. It means catgut surgical suture, because that's made of pig tissue. All the chickens fed on meat-and-bone meal; they're probably infected. You put that stuff in a chicken and it goes right through"... And in America, beef cattle are killed at or before age two, before they are likely to show outward symptoms. (Page 228)

Mad Cow in America

In America, chicken excreta is fed to cattle as a good source of nitrogen. (Page 258.) As for the American FDA's ban on feeding meat and animal by-products to cattle, Rhodes writes "That's a ban with exclusions big enough to drive a cortege of hearses through." Their own TSE advisory committee urged the FDA take stronger measures. (Page 257.)

According to the book, Bovine Spongiform Encephalopathy has been detected in America, and not just in cattle; the American form is yet another variant TSE, which does not cause the staggers and other behaviors found in British cattle, but results in a more "sedate" collapse of the victim, referred to as "downer cattle". The nature of the brain damage is also distinct; a spongiform with differently shaped and oriented vacancies. Other forms have been transmitted via eating wild squirrels, and wild bear. Some zoos have lost animals to TSE's.

Human Epidemic

Dr. John Pattison, Chairman of the British government's Spongiform Encephalopathy Advisory Committee (SEAC), Dean of the University College of London Medical School, believes 500,000 people may already be incubating CJD in Britain. [Dr. Alsleben.] Dr. Alsleben, in his excellent Mad Cow web site, states that prions can be found in white blood cells contaminating milk, and even in the animal grease used in lipstick. (URL at end) Professor Richard Lacey of the Microbiology Department of Chapel Allerton Hospital, Leeds, points out on page 222 of the book that "there was no certainty that the source of infection had been cut off."... "'If it seems that the incubation-period average for CJD in humans begins to be about twenty five years, maybe thirty years,' he told me grimly, 'then the peak human epidemic will come around the year 2015. If the current numbers of variant CJD cases [the main human TSE,] increases by fifty percent per year compound, as they well might, that would take it to about two hundred thousand cases a year by then'. Human cases, that is 200,000 deaths per year" (In Britain.)

Others suggest that 5% OR MORE of the Alzheimer's cases in America may be due to CJD and other TSE variants. If so, are we already seeing the beginning of a growing tide of TSE related deaths?

Limiting Factors

It is noted that amongst the Fore, the cannibals who got kuru, another TSE variant similar to CJD, only some one percent of the population seemed affected.

This one percent figure suggests a genetic bias, and some genetic biases have been detected. This may serve as a model for predicting human death rates. Evidence suggest a one in a million rate of spontaneous occurrence among susceptible species. Once inserted into a food chain that recycles animal protein, one in a hundred may get it.

In America, that one percent would translate to well over two and a half million slow, expensive deaths, a far worse epidemic

than AIDS! But... not the end of civilization as we know it.

One is reminded that there have been many plagues in human history; plagues like the Black Plague, the Justinian Plague, and many others. Humanity has thus far survived, even if reduced in numbers. No need to panic; just act wisely.

Prions and Counters

Several Prion variants have been found, some of which act quickly, some of which act far more slowly, so the 25 year estimate may be considerably off. There is also recent research on chaperonins, biochemicals that assist in folding proteins, which may be related to resistance to prion diseases. (Prion diseases are believed to involve folding of proteins, and what is similar to crystal growth of the mis-folded proteins.) See http://www.mad-cow.org/ and look up chaperonin at http://www.AltaVista.Digital.com , a term that only had two pages on the web last year, and now has over six thousand!

Will we find a cure for Spongiform Encephalopathy? Unlikely, since the spongiform phase is caused by massive death of neural tissue; tissue which can not regrow. That said, we might yet find ways of preventing the degeneration where it has not already occurred. So caution might be well advised.

Incubation

Twenty five years incubation time is a long time.... If one ends up with thyroid supplements in one's late thirties, it might be age 65 when some of the more noticeable effects begin to become evident. Those with less resistant genetics may display effects much sooner. Others may die of other dis-eases before the effects of TSE would become clearly visible. And most... may even avoid coming down with the disease.

And yet... Science News ran an article on Alzheimer's research in which some researchers claimed they could often detect the condition decades early simply by noting the manner of speech and writing of a person. People with pre-Alzheimer's conditions seem to rely more on lists and relationships, than logic and cause-and-effect reasoning about the world. They also tend to write shorter, simpler sentences long before clinical neurological deficits become evident. (Research was done using nuns, comparing their original statements of intent to become nuns, with their conditions decades later.)

Is Alzheimer's a form of TSE? Some would say yes, others would say no. And still others have suggested many cases of Alzheimer's are really TSE, but not all. The lesions in the brain are similar, but not identical.

Weigh the Risks

We must all weigh risks v.s. benefits ourselves. I am not a doctor, I can not advise you; you have to think for yourself. Like Oprah, I have stopped eating beef; as well as all other animal meats and animal products like gelatin. I dump the contents of all my gelatin capsules into a spoon, and discard the empty capsules. I also avoid "ranched" fish like catfish and salmon. Is that enough? I don't know. With luck, I may never find out.

A one percent rate sounds considerably better than other estimates I have run across. However, the real question I have is, what are the subtle effects long before the final destruction? If these prions are indeed the rod-like structures researcher Patricia Merz describes on page 156, then they would likely impede cellular machinery long before they became long enough to break cell membranes and kill the cells. Thus it is possible that long before that final break, subtle neurological effects could

become evident. Dr. Merz findings of prions in spleen tissue and elsewhere is quite disturbing, as it suggests prions may travel freely in the blood of these animals, and thus would imply that all tissue is likely to harbor some prions, not just brain tissue. Thus, over 25 million of us may be at grave risk to our health; and our relatives, at risk for extreme emotional and financial stresses as they contribute to our care as we slowly go mad and die of CJD.

Your health is your responsibility, not your doctor's. It is you who must decide what behaviors, and risks, are acceptable to you.

Books and Resources

"Deadly Feasts", by Pulitzer prize winner Richard Rhodes. ISBN0-684-84425-7. Worth reading! http://www.mad-cow.org/ Mentioned by Rhodes as a valuable current record on this developing topic. Dr. Harry Alsleben, a preventative medicine researcher, calls this "Our Greatest Biological Catastrophe", His excellent web site is dedicated to warning people about prion diseases; and exposing the policies that warn "officials", while attempting to minimize public concerns and short term financial impact to industry. What is more, he use to sell animal collagen products. He stopped and accepted the financial loss when he learned about BSE. I salute him for his responsible actions. Resources from PBS - Nova The Brain Eaters episode on Mad Cow disease. (Presumably, this site will not be up forever.)

http://www.mall-net.com/mcs/madcow.html

From: Terry S. Singeltary Sr. (wt-d4-166.wt.net) Subject: Re: THYROID MEDICATION, PIGS , PIG FEED, AND MADCOW Date: August 16, 1998 at 14:14:48 EST

In Reply to: THYROID MEDICATION, PIGS , PIG FEED, AND MADCOW posted by Terry S. Singeltary Sr. on July 28, 1998 at 14:12:38:

I am having a hard time getting information on ingrediants of these drugs. Nobody wants to cooperate. Although I have found the names and ingrediants of some with DESICCATED ANIMAL (T4/T3). ARMOUR Thyroid tablets for oral use are natural preparations derived from porcine (Pork) thyroid glands. From the late 1890's until relatively recently, physicians worldwide have treated hypothroid patients with tablets containing desiccated (dried and powdered) animal thyroid glands. These tablets contained both levothyroxine (T4) and triiodothyronine (T3). In 1958, the first synthetic levothyroxine tablets were marketed in the United States. Because thyroid hormones were on the market before the Food and Drug Admimistration (FDA) laws were in place, manufacturers of these hormones were not required to meet the extensive testing requirements of safety and effectiveness required of all new drugs introduced after 1938. In other words, thyroid hormone replacements, such as synthetic levothyroxine, were "GRANDFATHERED" into the system, consequently, there are no FDA approved procedures or standards for testing these preparations other than specifying that each pill contain betwee 90% to 110% of the standard chemical content. Also Thyrolar contains synthetic T3. There is also Cytomel. I believe all these contain desiccated animal. I am still searching. Maybe the Thyroid Society could find time to list these drugs and their Ingrediants. None of the Drug company's will cooperate. You start talking about dessicated animals in these drugs and asking for ingrediants from people and they lose their tounge./MADCOWDEADMOMMADSON/TERRY

PLUS, ARMOUR MADE A BOVINE THYROID MEDICATION SOME TIME BACK CALLED "THYRAR" MADE FROM DESSICATED BOVINE THYROID GLAND...

TSS

WONDER if any of our loved ones had taken "THYRAR" ??? (way back)

don't ask, don't find, cjd questionnaire. .............TSS

http://bseinquiry.blogspot.com/2008/05/bse-inquiry-draft-factual-account-dfa.html

TUESDAY, AUGUST 1, 2017 

BSE INQUIRY DFA 17 Medicines and medical devices


Research Project: TRANSMISSION, DIFFERENTIATION, AND PATHOBIOLOGY OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

Location: Virus and Prion Research

Title: Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease

Author item Moore, Sarah item Kunkle, Robert item Kondru, Naveen item Manne, Sireesha item Smith, Jodi item Kanthasamy, Anumantha item West Greenlee, M item Greenlee, Justin

Submitted to: Prion Publication Type: Abstract Only Publication Acceptance Date: 3/15/2017 Publication Date: N/A Citation: N/A Interpretive Summary:

Technical Abstract: Aims: Chronic wasting disease (CWD) is a naturally-occurring, fatal neurodegenerative disease of cervids. We previously demonstrated that disease-associated prion protein (PrPSc) can be detected in the brain and retina from pigs challenged intracranially or orally with the CWD agent. In that study, neurological signs consistent with prion disease were observed only in one pig: an intracranially challenged pig that was euthanized at 64 months post-challenge. The purpose of this study was to use an antigen-capture immunoassay (EIA) and real-time quaking-induced conversion (QuIC) to determine whether PrPSc is present in lymphoid tissues from pigs challenged with the CWD agent.


 Methods: At two months of age, crossbred pigs were challenged by the intracranial route (n=20), oral route (n=19), or were left unchallenged (n=9). At approximately 6 months of age, the time at which commercial pigs reach market weight, half of the pigs in each group were culled (<6 challenge="" groups="" month="" pigs="" remaining="" the="">6 month challenge groups) were allowed to incubate for up to 73 months post challenge (mpc). The retropharyngeal lymph node (RPLN) was screened for the presence of PrPSc by EIA and immunohistochemistry (IHC). The RPLN, palatine tonsil, and mesenteric lymph node (MLN) from 6-7 pigs per challenge group were also tested using EIA and QuIC.
<6 challenge="" groups="" month="" pigs="" remaining="" the="">

 Results: PrPSc was not detected by EIA and IHC in any RPLNs. All tonsils and MLNs were negative by IHC, though the MLN from one pig in the oral <6 5="" 6="" at="" by="" detected="" eia.="" examined="" group="" in="" intracranial="" least="" lymphoid="" month="" months="" of="" one="" pigs="" positive="" prpsc="" quic="" the="" tissues="" was="">6 months group, 5/6 pigs in the oral <6 4="" and="" group="" months="" oral="">6 months group. Overall, the MLN was positive in 14/19 (74%) of samples examined, the RPLN in 8/18 (44%), and the tonsil in 10/25 (40%). 
<6 5="" 6="" at="" by="" detected="" eia.="" examined="" group="" in="" intracranial="" least="" lymphoid="" month="" months="" of="" one="" pigs="" positive="" prpsc="" quic="" the="" tissues="" was=""><6 4="" and="" group="" months="" oral="">
<6 5="" 6="" at="" by="" detected="" eia.="" examined="" group="" in="" intracranial="" least="" lymphoid="" month="" months="" of="" one="" pigs="" positive="" prpsc="" quic="" the="" tissues="" was=""><6 4="" and="" group="" months="" oral="">
 <6 5="" 6="" at="" by="" detected="" eia.="" examined="" group="" in="" intracranial="" least="" lymphoid="" month="" months="" of="" one="" pigs="" positive="" prpsc="" quic="" the="" tissues="" was=""><6 4="" and="" group="" months="" oral="">Conclusions: This study demonstrates that PrPSc accumulates in lymphoid tissues from pigs challenged intracranially or orally with the CWD agent, and can be detected as early as 4 months after challenge.
CWD-infected pigs rarely develop clinical disease and if they do, they do so after a long incubation period. 

Conclusions: This study demonstrates that PrPSc accumulates in lymphoid tissues from pigs challenged intracranially or orally with the CWD agent, and can be detected as early as 4 months after challenge.

CWD-infected pigs rarely develop clinical disease and if they do, they do so after a long incubation period. 

***This raises the possibility that CWD-infected pigs could shed prions into their environment long before they develop clinical disease.

***Furthermore, lymphoid tissues from CWD-infected pigs could present a potential source of CWD infectivity in the animal and human food chains.
CONFIDENTIAL

 EXPERIMENTAL PORCINE SPONGIFORM ENCEPHALOPATHY
While this clearly is a cause for concern we should not jump to the conclusion that this means that pigs will necessarily be infected by bone and meat meal fed by the oral route as is the case with cattle. ...
we cannot rule out the possibility that unrecognised subclinical spongiform encephalopathy could be present in British pigs though there is no evidence for this: only with parenteral/implantable pharmaceuticals/devices is the theoretical risk to humans of sufficient concern to consider any action.

 Our records show that while some use is made of porcine materials in medicinal products, the only products which would appear to be in a hypothetically ''higher risk'' area are the adrenocorticotrophic hormone for which the source material comes from outside the United Kingdom, namely America China Sweden France and Germany. The products are manufactured by Ferring and Armour. A further product, ''Zenoderm Corium implant'' manufactured by Ethicon, makes use of porcine skin - which is not considered to be a ''high risk'' tissue, but one of its uses is described in the data sheet as ''in dural replacement''. This product is sourced from the United Kingdom.....

 snip...see much more here ;

WEDNESDAY, APRIL 05, 2017

Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease
TUESDAY, APRIL 18, 2017 
*** EXTREME USA FDA PART 589 TSE PRION FEED LOOP HOLE STILL EXIST, AND PRICE OF POKER GOES UP ***



SATURDAY, JULY 29, 2017

Risk Advisory Opinion: Potential Human Health Risks from Chronic Wasting Disease CFIA, PHAC, HC (HPFB and FNIHB), INAC, Parks Canada, ECCC and AAFC



PRION 2017 DECIPHERING NEURODEGENERATIVE DISORDERS 

 Subject: PRION 2017 CONFERENCE DECIPHERING NEURODEGENERATIVE DISORDERS VIDEO

PRION 2017 CONFERENCE DECIPHERING NEURODEGENERATIVE DISORDERS

PRION 2017 CONFERENCE VIDEO




Chronic Wasting Disease CWD TSE Prion to Humans, who makes that final call, when, or, has it already happened?

TUESDAY, JUNE 13, 2017

PRION 2017 CONFERENCE ABSTRACT First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress


TUESDAY, JULY 04, 2017

*** PRION 2017 CONFERENCE ABSTRACTS ON CHRONIC WASTING DISEASE CWD TSE PRION ***


TUESDAY, JUNE 13, 2017

PRION 2017 CONFERENCE ABSTRACT Chronic Wasting Disease in European moose is associated with PrPSc features different from North American CWD


URINE

SUNDAY, JULY 16, 2017

*** Temporal patterns of chronic wasting disease prion excretion in three cervid species ***


WEDNESDAY, JULY 26, 2017

Chronic wasting disease continues to spread Disease of cervids causing local population declines


TUESDAY, JULY 18, 2017 

USDA announces Alabama case of Bovine Spongiform Encephalopathy Alabama


THURSDAY, JULY 20, 2017 

USDA OIE Alabama Atypical L-type BASE Bovine Spongiform Encephalopathy BSE animal feeds for ruminants rule, 21 CFR 589.200


SUNDAY, JULY 30, 2017 

Do we need to explain the occurrence of atypical scrapie?


TUESDAY, JULY 18, 2017 

MINK FARMING USA TRANSMISSIBLE MINK ENCEPHALOPATHY TSE PRION DISEASE SURVEILLANCE AND TESTING



WEDNESDAY, APRIL 05, 2017 

Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease 


TUESDAY, APRIL 18, 2017 

*** EXTREME USA FDA PART 589 TSE PRION FEED LOOP HOLE STILL EXIST, AND PRICE OF POKER GOES UP *** 


WEDNESDAY, JULY 26, 2017 

APHIS USDA Emerging Animal Disease Preparedness and Response Plan July 2017




Article 

Induction of IAPP amyloid deposition and associated diabetic abnormalities by a prion-like mechanism

 View ORCID ProfileAbhisek Mukherjee, Diego Morales-Scheihing, Natalia Salvadores, Ines Moreno-Gonzalez, Cesar Gonzalez, View ORCID ProfileKathleen Taylor-Presse, View ORCID ProfileNicolas Mendez, Mohammad Shahnawaz, View ORCID ProfileA. Osama Gaber, View ORCID ProfileOmaima M. Sabek, View ORCID ProfileDaniel W. Fraga, View ORCID ProfileClaudio Soto DOI: 10.1084/jem.20161134 | Published August 1, 2017

ArticleFigures & DataInfoMetrics Preview PDF Abstract

Although a large proportion of patients with type 2 diabetes (T2D) accumulate misfolded aggregates composed of the islet amyloid polypeptide (IAPP), its role in the disease is unknown. Here, we show that pancreatic IAPP aggregates can promote the misfolding and aggregation of endogenous IAPP in islet cultures obtained from transgenic mouse or healthy human pancreas. Islet homogenates immunodepleted with anti-IAPP–specific antibodies were not able to induce IAPP aggregation. Importantly, intraperitoneal inoculation of pancreatic homogenates containing IAPP aggregates into transgenic mice expressing human IAPP dramatically accelerates IAPP amyloid deposition, which was accompanied by clinical abnormalities typical of T2D, including hyperglycemia, impaired glucose tolerance, and a substantial reduction on β cell number and mass. Finally, induction of IAPP deposition and diabetic abnormalities were also induced in vivo by administration of IAPP aggregates prepared in vitro using pure, synthetic IAPP. Our findings suggest that some of the pathologic and clinical alterations of T2D might be transmissible through a similar mechanism by which prions propagate in prion diseases.

Submitted: 19 July 2016 Revision received 24 March 2017 Accepted: 19 June 2017 http://www.rupress.org/terms/https://creativecommons.org/licenses/by-nc-sa/4.0/ This article is distributed under the terms of an Attribution–Noncommercial–Share Alike–No Mirror Sites license for the first six months after the publication date (see http://www.rupress.org/terms/). After six months it is available under a Creative Commons License (Attribution–Noncommercial–Share Alike 4.0 International license, as described at https://creativecommons.org/licenses/by-nc-sa/4.0/).

View Full Text © 2017 Mukherjee et al.


TUESDAY, AUGUST 1, 2017 

Could diabetes spread like mad cow disease?




Terry S. Singeltary Sr.

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