E mail sent 12/23/02

Date: 12/23/02

FROM: Claudia French

180 Preston Hollow Dr.

Spring Hill, Florida 34609

Ph 357-544-2741

E-Mail ** [Caf180mom@aol.com]{.underline}**

TO: [Dockets Management Branch (HFA-305)]{.underline}

Food and Drug Administration

5630 Fishers Lane, rm. 1061

Rockville, MD 20852.

or

**[Fdadockets@oc.fda.gov ]{.underline}**

include docket \# in message ask for a notice of reciept

RE1: Comments & Suggestions to change the Guidance for Industry

[Docket #02D-0266, ]{.underline}

CBER document #150

Federal Register notice #02-15898

FR Notice Availability to 12/23/2002

RE2: Concerning preventing the transmission of CJD/vCJD by HCT/Ps
through

deferral of diabetics that have injected beef insulin from the UK

RE3; Clips from Guidance For Industry and request for change(s)
addressed in the order that the *Guidance For Industry, *that is open
for change, is laid out.

**"GUIDANCE FOR INDUSTRY**

Preventive Measures To Reduce The Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease
(vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products
(HCT/Ps)

Draft - Not for Implementation

"Under our Good Guidance Practices (GGPs), we may reconsider our
recommendations after reviewing comments and information submitted to
the docket, and the effect of donor deferrals on the availability of
HCT/Ps or **[other relevant information]{.underline}**."

[There are three proposed rules]{.underline}:

#1 "[Has been finalized. ]{.underline}"Human Cells, Tissues, and
Cellular and Tissue-Based Products; Establishment Registration and
Listing; Final Rule"

**#2 "[Suitability of Donors of Human Cellular and Tissue-Based
Products]{.underline};"**

#3 "Current Good Tissue Practice for Manufacturers of Human Cellular and
Tissue-Based Products; Inspection and Enforcement;"

**[INTRODUCTION]{.underline}**

[Warnings concerning a 'possibility' of beef/bovine insulin injection
carrying BSE should be eliminated from this and all guidance documents.
It is causing an undue restraint of trade of this life source thus
causing much pain and suffering and even death to the needy
diabetics.]{.underline}

I will be responding to and requesting changes to Item #2 above. I will
also be addressing the FDA's concern about the deferred donors potential
for transmission of classic Creutzfeldt-Jakob disease (CJD) and variant
CJD (vCJD) by transplantation, implantation, infusion, or transfer of
Human Cells, Tissues, cellular and tissue-based Products (HCT/Ps) as it
concerns Beef/Bovine Insulin.

My main emphasis will be on the transfer of CJD and vCJD via Bovine/beef
insulin from the UK or anywhere. Addressing the lack of possibility that
said diabetics might harbor CJD or vCJD from the UK's bovine insulin.
Addressing also the confounding lack of evidence that Bovine/beef
insulin could cause CJD or vCJD. Thus proving that the undue deferral
criteria of said diabetic donors is based on unreasonable possibilities
and unproved theory/hypothesis. I will prove that said criteria should
be stricken from all FDA guidelines and web sites.

Also, the hardships caused to the insulin dependent diabetics because of
inability to purchase Beef/bovine insulin in the United States because
of the guidelines that inaccurately infer said insulin **'might
possibly' **cause CJD/vCJD. The words 'might' and or 'possibly' is
inappropriate especially in light of the damage caused to many
diabetics.

I will point out the references that must be stricken from the current
Guidance which is at this time open for correction.

You have asked for my comments stating that you[ "are especially
interested in receiving information about the effect that these
recommendations might have on availability of HCT/Ps]{.underline}."

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

**[PROOFS]{.underline}**[ and
]{.underline}**[RECOMMENDATIONS]{.underline}**

The committee did not recommend specific deferral criteria because of
the scarcity of information available about the transmission of vCJD/CJD
in tissues. Yet, still lacking information about the likelihood of
transmission or any indication of possibility, Beef Insulin was used by
the FDA as an unsupported reason to ban donors who had injected bovine
insulin from the UK 1980-96.

These incorrect guidance(s) have also caused the FDA to turn down CP
Pharmaceutical's, application from Wales, UK. Asking permission to
market

their 25 year proven bovine insulin here in the US. Because their
stainless steel

equipment used to manufacture bovine insulin 'MIGHT' have BSE prions
stuck to their equipment, their application was rejected. If you would
like the reason this is impossible, read on.

Asking CP to clean the nonexistent prions off of their equipment would
damage their life saving equipment and is not necessary. Read on for
reasons why.

There has been no prudent reason found for advising that UK Beef Insulin
injection by diabetics '*might possibly*' carry and or spread the CJD
virus. NONE! Such warnings concerning beef/bovine insulin injection
should be eliminated from this and all guidance documents. It is causing
an undue restraint of trade of this life source thus causing much pain
and suffering and even death to a large minority of the insulin
dependent diabetic population.

There have been no cases of CJD or vCJD caused by BSE in beef insulin.
There has never been found any BSE prions in bovine/beef insulin. It is
not possible to find what isn't there. With odds of \*1 in 100,000,000
years that one 'might' catch CJD from Bovine insulin even if said bovine
sources were infected with BSE. (Re III)

"We recognize that we may need to revise this draft guidance." It is one
of many that needs to be revised in all reference to bovine/beef
insulins from all countries. **All warnings in any and all guidelines
referring to Beef/bovine Insulin's hypothetical ability to cause CJD or
vCJD or BSE should be deleted.**

"CJD is a rare but invariably fatal degenerative disease of the central
nervous system, associated with **[a poorly understood transmissible
agent ]{.underline}**(Refs. 8, 9). Sporadic CJD cases occur at a low
frequency by an unknown mechanism."

"vCJD is an emerging disease with unique clinical and pathological
characteristics."

BSE, CJD and or vCJD are NOT valid reasons to keep the restrictive
guidelines on beef insulin. The FDA's statement(s) of 'possibility' that
Bovine Insulin 'might' carrying BSE is unfounded.

BSE[ has never been found in Beef pancreas nor beef
insulin.]{.underline}

III\) ** BASIS FOR vCJD RECOMMENDATIONS **

There are five currently recognized risks of exposure to the BSE agent.

The **[5]{.underline}^[th]{.underline}^[ one is the one that should be
removed ]{.underline}**from the Guidance for Industry that is now under
consideration for change. As well as from all other guidance documents.

*["]{.underline}[#5 ]{.underline}****[Theoretical exposure to BSE agent
through]{.underline}****[ ]{.underline}****[bovine insulin produced from
cattle in the U.K.]{.underline}****" *

Several facts are available to support the validity of my request.

**a.** CP Pharmaceuticals in Wales does not use UK cattle pancreas to
make their insulin. The source of their beef insulin crystals is from
US. cattle (born, bred & slaughtered in the US).

**b. **No one has ever found any BSE in beef insulin.

**c. **No one has ever contacted CJD or vCJD from beef insulin

d\) I will quote 3 scientists from the TSEAC meeting 7/27/2000 stating
there is no BSE in Beef Pancreas. And Common Reasons #4-6. There is no
foundation for a suspicion that beef insulin carries BSE or causes CJD
or vCJD.

\* 1 \* DR. RAY BRADLEY, CBER, no BSE in pancreas

\* 2 \* DR. Gerald Wells, no infectivity

\* 3 \* DR. David BOLTON, Ph.D, TSEAC, propagating BSE prions in
\[pancreas\] ...doesn't seem to work.

\* 4 \* Filtration 14 times

\* 5 \* Australia, 1 in 100,000,000 years 'maybe'

\* 6 \* CP only uses insulin crystals from the US

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**\* 1 \***

DR. Ray Bradley, [CBER]{.underline}, Speaker for SmithKline Beecham,
head of the pathology at The Central Veterinary Laboratory, now called
the Veterinary Laboratory Agency, in the** **U.K.'s Ministry of
Agriculture, and BSE coordinator for MAFF '91 to '95,
[independent]{.underline} [BSE consultant]{.underline} to **[WHO, OIE,
EC, U.K]{.underline}**[.,]{.underline} Argentine and the U.S.
governments' committees and expert committees and expert consultation
Fisheries and Food, or MAFF, from 1983-91

"I now pass to muscle and pancreas. To summarize these two issues which
have been part of the concern, skeletal muscle and
***[pancreas]{.underline}***[ from cattle affected with natural BSE
have]{.underline} [shown no detectable infectivity]{.underline} after
bioassay in susceptible [mice]{.underline}. Furthermore, [BSE
infectivity has not been detected in ]{.underline}skeletal muscle or
**[pancreas]{.underline}** at any stage of incubation of **experimental
BSE**, also following bioassay in susceptible **mice**."

"So the **conclusions **from this are [that no BSE infectivity has been
detected in]{.underline} skeletal muscle**,
[pancreas]{.underline}**[,]{.underline} spleen, blood or any component
of blood **[of cattle]{.underline}** or bovine fetuses in
[na]{.underline}tural or [exp]{.underline}erimental BSE"...

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**\* 2 \***

DR. Gerald Wells, Studies of BSE Infectivity in Tissues of Cattle:
United Kingdom

"There I'd like to leave it and just to say that, clearly, from these
experiments [there is no evidence as yet of infectivity]{.underline} in
any of the tissues that we are concerned with in this session today.
Thank you."

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**

\* 3 \*

DR. David BOLTON, Ph.D, **[TSEAC]{.underline}**, head of the Laboratory
of Molecular Structure and Function, New York State Institute for Basic
Research, ,one of the people who helped discovered PrP(prion protein),
current researcher & overviewer.

"There's somewhat of maybe a dichotomy here. If you look in the normal
animal**, [PrPC is made in many different tissues]{.underline}**,
[including heart and skeletal muscle and lymphocytes
]{.underline}\[white blood cells including b & t cells\] and **[a lot of
different tissues besides the brain]{.underline}**. But it's [a curious
fact]{.underline} that when you **[try to propagate prions in these
other tissues, it doesn]{.underline}[']{.underline}[t seem to
work]{.underline}**."

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

**\* 4 \***

Common Knowledge:

\> **FILTRATION: ** There are 51 amino acids in insulin except for
Lantus which has 53 amino acids (it has other problems that I don't wish
to address here).

BSE prions have 254 amino acids (5 times the size of an insulin
molecule).

Beef insulin is filtered 14 times.

If there were BSE prions they would be filtered out by the 5^th^
filtration leaving no BSE to be included in the insulin composition.
Keep in mind, however, that Beef pancreas does not carry BSE. SEE items
1-3.

It is unreasonable that *The Guidelines For Industry* infer that BSE
might be in beef insulin. Mentioning a 'possibility' of BSE in beef
insulin, which has been proven to not even have an ability to exist or
spread through manufactured beef insulin, is improper.

The filters block all but the 51 amino acids. BSE has 254 amino acids
but they have never been found to be present in the pancreas of a cow.

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**\* 5 \***

[COMMON KNOWLEDGE]{.underline}

\>**AUSTRALIA REPORTS, 22nd March 2001, ** **INFORMATION RELEASED FOR
PEOPLE WHO USE BOVINE INSULIN: **

**[Professor Smallwood said]{.underline}**.

\"It is clear that the potential risk from this product is
[infinitesimally small]{.underline}.

**[Nowhere in the world is there any direct evidence to link bovine
insulin to vCJD]{.underline}**. On a theoretical basis, the risk of
contracting variant Creutzfeldt Jakob Disease (vCJD) from this insulin
is estimated at **[one in a 100 million years of treatment in the worst
possible case]{.underline}...**

** Professor Smallwood said, that on the other hand [there is a very
real risk to the health of people if]{.underline} their current
treatment using bovine insulin is disrupted." \[ALSO RISKS to MANY NEWLY
DIAGNOSED WITH IDDM\]**

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**\* 6 \***

[COMMON KNOWLEDGE]{.underline}

CP Pharmaceuticals in Wales, UK certifies that their bovine insulin Is
sourced from a BSE free country. The USA.

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-

e\. The mention of Bovine Insulin as a possible carrier of BSE should be
removed from this *Guidance For Industry *and all other inference to the
possibility in other guidance documents should be removed immediately.
Including the FDA site of *'FREQUENTLY ASKED QUESTIONS ABOUT IMPORTING
BEEF INSULIN FOR PERSONAL USE' *
**[http://www.fda.gov/cder/drug/beefinsulin/default.htm]{.underline} **

Reason.: There has never been a possibility that beef insulin crystals
could carry BSE. FDA's guidance(s) that beef insulin could possibly
carry BSE is placing undue guides on those who might otherwise be
approved as beef insulin suppliers to the US open market. Said
guidance(s) carrying the FDA's BSE warning of a possibility that Beef
Insulin might cause BSE is scaring people from acquiring this life
source and many have become very sick having lost their quality of life
because beef insulin is no longer sold or recommended in the US. Many
have already died from the lack of availability. The *Guidelines For
Industry* creates undue mandates on UK beef insulin suppliers.

The various BSE guidelines, printed concerning this product, have guided
and caused incorrect and unnecessary recommendations in The *Guidance
For Industry* and other similar guidance documents and FDA reference
sites such as
**[http://www.fda.gov/cder/drug/beefinsulin/default.htm]{.underline} **
These references throughout the FDA literature (including the *Guidance
For Industry*) should be removed thus correcting this misinformation and
mishandling of applications to market beef insulin in the United States.

The Guidance For Industry itself states:

**III. E. "Exposure to Bovine Insulin **

"No cases of transmission of vCJD have been reported in recipients of
bovine

insulin or other injectable products manufactured in BSE- countries.
However, as a safeguard, we have recommended that **material from cattle
in BSE - countries should not be used in the manufacture of FDA
regulated products** (Ref. 41)... Therefore, **[as a preventive
measure]{.underline}**, you should**[ indefinitely defer HCT/P donors
who have injected bovine insulin since 1980,]{.underline}** unless you
can confirm that the product was not manufactured after 1980 from cattle
in the UK"(RE III)

Item III. E. in the *Guidance For Industry* should be eliminated.

**"IV. RECOMMENDATIONS FOR DONOR ELIGIBILITY" **

There are 8 items listed in this guidance

I wish to bring your attention to item 8.

"You should determine to be ineligible any donor who: **...**

8\. has injected bovine insulin since 1980, unless you can confirm that
the product was not manufactured after 1980 from **cattle in the U.K."
**

Item 8 should be removed from all guidance documents including the
current one which I am commenting on. It is not appropriate. (see III)

Not only is #8. not appropriate for it's own sake. It has caused
interference with a needed life source and needless agony to many of the
unsuspecting insulin taking population.

On a minor note but the subject of this guidance that I am referring to.
Said item III. E. and IV 8. do in addition to scaring and pushing away
beef insulin suppliers and users these restrictions also unnecessarily
eliminate many would be diabetic donors. Thus, in the end harming many
Insulin Dependent Diabetics and also needlessly differing this group of
possible donors.

[Many insulin dependent diabetics have an urgent medical need for beef
insulin. What is available in the US market is not satisfactory to many
Insulin Dependent Diabetics. Beef insulin is an 81 year old proven drug
and is desperately needed by many]{.underline}. [Also, an appropriate
match with a recipient needlessly differed outweighs the unlikely/non
existent risks of BSE. (see III and the second purposed rule open for
comment to 12/23/2002)]{.underline}

**"V. NON-CLINICAL SCIENTIFIC OR EDUCATIONAL USE" **

There are 3 items. I will emphasize the 3^rd^ item that directs,**
"**label an HCT/P from an ineligible donor as follows:"

3\. ..."Collected from a donor with a [potential risk of
vCJD]{.underline},"

As I have shown, just because an individual has injected Beef Insulin
does

not put him/her at risk for CJD or vCJD and should not be considered
differed.

**"VI. ASSESSING THE IMPACT OF THESE RECOMMENDATIONS ON THE HCT/P
SUPPLY" **

[Assessing one impact is "the effect that implementation of these
recommendations could have on the HCT/P supply." By unnecessarily
deferring as donors, people who have injected UK beef
insulin.]{.underline}

[Addressing another ]{.underline}***[major]{.underline}***[ impact is
the effect that parts of the ]{.underline}*[Guidelines For
Industry]{.underline}[']{.underline}[s]{.underline}*[ recommendations
have on people needing beef insulin from the UK. (see III & IV
specifically)]{.underline}

**"VII. IMPLEMENTATION OF RECOMMENDATIONS **

We are publishing this draft guidance for public comment to present our
current thinking about preventing the transmission of CJD/vCJD by HCT/Ps
through deferral of donors." Please give my report serious consideration
in your reviewal process and report back to me your intentions.

Summary:

**["]{.underline}[The benefits of the use of beef insulin outweigh the
risks of BSE.]{.underline}["]{.underline}[ ]{.underline}**

1\) It is not reasonable that the FDA should defer people because they
have injected bovine insulin from the UK.

2\) There is no BSE in beef insulin. Thus, transmission of BSE, CJD or
vCJD is impossible (re: III) from Beef/Bovine Insulin.

3\) The current guidelines should be changed by deleting all references
that Beef/Bovine insulin 'might or possibly could' cause CJD or vCJD or
harbor BSE.

4\. **All warnings in any and all guidelines referring to Beef/bovine
Insulin's hypothetical ability to cause BSE, CJD or vCJD should be
deleted.**

*** **[Warnings concerning a
]{.underline}**[']{.underline}**[possibility]{.underline}**[']{.underline}**[
of beef/bovine insulin injection carrying BSE should be eliminated from
this and all guidance documents. It is causing an undue restraint of
trade of this life source thus causing much pain and suffering and even
death to the needy diabetics and an undue restraint of possible
donors.]{.underline}***

Note: Quotes " " refer to the Guidance For Industry document that is
open for comment.

By: Marjorie A. Baker

Claudia French

E-mail **[floridacracker@ij.net]{.underline}** Phone 727-938-6572