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Old 02-06-2004, 04:02 AM
Bill Oliver
 
Posts: n/a
Default Bone/ Blood Meal and Mad Cow Disease

In article ,
Ermalina wrote:
Bill Oliver wrote:

In article ,
Janet Baraclough.. wrote:

Or via blood donations. In the UK, people who recieved a transfusion
during the early 80s are banned from donating blood. Some countries no
longer import any human blood products from the UK.

Janet


Even the FDA has admitted there is no scientific basis for this
decision in the US -- it was purely political, in order to
"reassure" the population.

In fact, this is one example of the BSE hysteria *costing* lives.
The FDA allows fewer and fewer people to donate blood for political
reasons while the demand for blood rises, leading to severe
blood shortages. BSE has cost lives in the US -- because of the
over-reaction to a very small risk.

billo


Please provide a citation for your claim that "Even the FDA has admitted
there is no scientific basis for this decision in the US -- it was
purely political, in order to 'reassure' the population".


The fact that this is a "theoretical" risk is openly noted by the
FDA -- if you look at its labeling guidance the FDA demands the
following warning (see:

http://www.aabb.org/members_only/arc...dcoi101001.htm

)

WARNING: Because whole blood and blood components are made from human blood,
they may carry a risk of transmitting infectious agents, eg viruses, and theoretically
the Creutzfeldt-Jakob disease (CJD) agent.?


Note that "theoretically." In other words, they don't know what the
risk actually is.

In fact, here's the FDA position as described by the AABB:

(see
http://www.aabb.org/members_only/arc...ins/ab99-8.htm
)

So far, there is no evidence that anyone who has traveled to the UK has
become infected with nvCJD. The AABB does not believe that people who
have traveled there should be concerned about their health. To date,
there is also no evidence that nvCJD can be transmitted by blood
transfusions, or by any type of person-to-person contact. However,
until more research is done and conclusive evidence can be found
regarding how nvCJD is transmitted, the FDA is requiring this
precautionary donor deferral to safeguard against the unproven
possibility that nvCJD could be spread by blood transfusion.

***** end excerpt ****

Ah yes, a precaution to safeguard against the unproven possibility.

That's rock solid science, yessirree.


As noted by the American Red Cross in

http://my.webmd.com/content/article/...177_2417_00_07

************************************
begin excerpt

In 2001, in an attempt to protect the nation's blood supply from mad
cow disease, the FDA banned blood donation from people who had
previously lived in Europe. But blood industry representatives are
appealing to the agency to lift the ban, saying that it exacts a
tremendous toll on our blood supply.

Currently, donations are banned from:

* Anyone who has lived in the U.K. for three months or longer since 1980
* Anyone who has lived anywhere in Europe for six months since 1980
* Anyone who has received a blood transfusion in the U.K.

Mad cow disease is a degenerative brain disease in animals. Infected
animals act crazy, or "mad," displaying changes in mood such as
nervousness or agitation and having difficulty standing up, and usually
die within two weeks to six months. Mad cow disease seems to spread to
people through eating infected beef. Some animal studies suggest that
it may be possible to transmit the disease through blood transfusion,
prompting concerns among blood bank and FDA officials about
safeguarding the blood supply.

Scientists still don't know a lot about mad cow disease and how it is
transmitted, nor do doctors have a test to screen for it.

In humans, mad cow disease is called new variant Creutzfeldt-Jakob
disease, or vCJD. Most of the 140 vCJD cases identified so far have
occurred in the U.K. The first U.S. case occurred in October 2002, but
it is believed the patient contracted it while in the U.K.

Still, there is no evidence to suggest that the disease has spread
through blood or blood products. "(But) the concern is that the
incubation period can be quite long. Even if the risk is quite small,
you might not see it in a hundred or so cases. After the experience in
the '80s (with HIV transmission through the blood supply), the public
expects us to do too much too soon rather than too little too late,"
said Peter L. Page, MD, senior medical officer at the American Red
Cross.
***** end excerpt *****

Yes, Virginia, political. That's what "the public expects us
to do too much too soon" means.


The AABB notes the effect this policy of "too much too soon" has
on the blood supply. See

http://www.aabb.org/pressroom/press_...rtse062701.htm

begin excerpt

*********

The AABB acknowledges the FDA's need to reach a compromise on whether
to implement any new donor deferral policies while at the same time
carefully balancing patient welfare against all relevant risks and
benefits to patient health.

Currently, an individual will be deferred or disqualified as a blood
donor if he or she has lived in the United Kingdom for a cumulative
period of six months or more from 1980-1996. This policy was
established by the FDA in order to prevent a possible but not confirmed
risk of transmitting vCJD through blood transfusion.

However, stricter criteria currently are being debated, which could
adversely affect the availability of blood. Although it is difficult to
measure precisely the effect of a stricter deferral, best estimates
suggest that anywhere between five and ten percent of potential blood
donors could be eliminated.

"We recognize that a theoretical risk of transmission of TSE through
blood transfusion exists," said Klein. "At the same time, availability
of blood is also a safety issue and we must balance this risk against
the potential risk of TSE transmission through blood."

********
end excerpt


Here's what are to tell people who are deferred:

IF YOU WERE DEFERRED AS A BLOOD DONOR BECAUSE OF TRAVEL TO THE UNITED KINGDOM?

* The deferral is a result of a Food and Drug Administration (FDA)
recommendation that anyone who spent more than six months in the
United Kingdom (UK) between 1980 and 1996 be deferred from donating
blood. We would like to reassure you, however, that you should not
be alarmed about your health, and we do not believe that it is
necessary for you to see your doctor as a result of this deferral.

* The FDA is taking a very conservative approach to make sure that
an unusual and rare brain disease called "new variant
Creutzfeldt-Jakob disease" (nvCJD) does not affect the US blood
supply. In fact, this travel deferral is an addition to other CJD
deferrals that have been in place for many years.

* New variant CJD is extremely rare, and has infected only a very
small number of people, mostly from England or other parts of the UK (England,
Scotland, Wales, Northern Ireland, Channel Islands and Isle of
Mann). It is likely, but not yet proven, that there is a connection
between eating beef from cattle infected with a similar disease.

* There is no evidence that travelers to the UK, even those who may
have eaten beef while traveling there, have become infected with
nvCJD. Scientists do not believe that nvCJD can be transmitted
through casual or even intimate (sexual) contact with an infected
person. To date, there is no evidence that nvCJD can be spread
person-to-person by blood transfusions. However, until more
research is done and conclusive evidence can be found regarding how
nvCJD is transmitted, the FDA is requiring this precaution.

* Your deferral period is (institution's deferral period here). We share
your disappointment, but please know that as new information about
nvCJD, or even a blood test, becomes available, it may be possible
someday to reinstate you as a donor.

* Thank you for your generous spirit. Your desire to save lives by
donating blood makes all the difference for patients in need, and
we are grateful to you.

(http://www.aabb.org/members_only/arc...ins/ab99-8.htm)

So, it is a theoretical risk in which there is no actual evidence that
travellers to the UK are at risk and they are doing it to be extremely
cautious and do "too much too soon." And in doing so, they are decreasing
the blood supply by 10 - 15% at a time with blood demand is increasing.

As noted by Celso Bianco, MD in his review for Hematology:

(see http://www.aabb.org/members_only/arc...ins/ab96-4.htm )

The theoretical possibility of CJD transmission by transfusion has been
examined by other investigators. A study of transfusion histories of
202 definite and probable cases of CJD which had been part of
prospective studies performed in England and Wales between 1980-84 and
1990-92, showed that 21 of the patients had received blood transfusions
and 29 had donated blood (8). The frequency of blood transfusions or
donations did not differ between CJD cases and matched controls,
leading the investigators to conclude that the evidence did not suggest
that transfusion was a major risk factor for development of CJD (8). No
cases of CJD among hemophiliacs have been reported in the medical
literature. The Medline database contains 1,485 references on CJD and
6,385 references on hemophilia between January 1976 and October 1994.
None of these references links CJD and hemophilia. An extensive review
of mortality data performed by L. Schonberger from the CDC did not
identify a single CJD death in individuals with a clott

On December 15, 1994, the issue of CJD and transfusion was reviewed by
the FDA Blood Products Advisory Committee. After extensive discussion,
the Committee recommended that in-date cellular products of blood from
donors who later develop CJD should be withdrawn from distribution. In
case these products were transfused, the Committee recommended that
physicians and recipients be notified. In the case of plasma pooled for
further manufacture, the Committee recommended against recall of
manufactured products, because of the lack of evidence for
transmission. The hemophilia community appeared to be quite
dissatisfied with this recommendation, leading the FDA to convene a new
Advisory Committee to review the possibility of transmission of CJD by
plasma derivatives. The Special Advisory Committee met on June 22,
1995, and recommended that all plasma products containing plasma from
individuals who later died of CJD, including albumin, should be
withdrawn from the market, despite the lack of evidence for transmissib

Lookback studies have been organized around blood donors who later
developed CJD. These studies involve identification of recipients and
review of their health status. So far, review of the cause of death of
35 recipients of these units indicated that none had developed CJD or
other central nervous system disease. Once case of potential
transmission to a liver transplant recipient who also received
transfusions of albumin has recently been reported. One of the albumin
donors died three years later from a dementia clinically characterized
as CJD (9). Obviously, the liver transplant recipient was exposed to a
variety of drugs and biologics, making it difficult to determine the
exact source of disease. Unfortunately, because of the very low
incidence of CJD and the long incubation period, there will be a long
period of time before more definitive answers become available. In the
interim, CJD is being approached as a disease which can theoretically
be transmitted by blood and blood products.

***** end excerpt ****


The risk is small. Period.






billo