The Common Factor, no. 8

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The Common Factor

issue 8.20 The Common Factor issue 8

Alpha Therapeutics (Venoglobulin I).
The HCV transmissions in Britain occurred after the FDA ordered HCV
antibody screening of plasma. However, the contaminated IVIG was
produced before the FDA's policy
change. U.S. companies were allowed to continue marketing their
existing stocks of IVIG produced
from unscreened plasma. These
unscreened products were used in
the U.S. as well as exported to countries such as Great Britain.
The FDA decision to not recall
existing supplies of unscreened IVIG
from the market was devastating for
those bone-marrow transplantees. It
also represented a repeat of FDA
mistakes of the early to mid-1980s.
At that time the agency refused to
recall existing stocks of factor concentrates which had a high probability of being contaminated with HIV.
The consequences of that error were
the continuing infection of persons
with hemophilia by HIV.
The FDA should have learned
from the HIV catastrophe of the
1980s, yet the usage and export of
IVIG produced from unscreened
plasma indicates just the opposite.
Nothing has changed and the FDA
is not about to take action that could
substantially impact drug company
profits, even in the face of serious
health risks to users of blood products.

not undergo any viral inactivation
step after fractionation. Some of the
other companies with IVIG products
had further inactivation steps in
place (see box on page 19).
The Gammagard transmissions
demonstrate that further viral inactivation or sterilization steps are necessary as well as antibody screening.
The process of Baxter's voluntary
recall of Gammagard did not effectively notify all prescribing physicians of the recall. Bill Mutert of
Baxter stated that they did their best
to contact physicians around the
country. Yet we have found instances where doctors prescribing
Gammagard have not yet been
alerted. As of late March, an Infec
tious Disease doctor and a family
practitioner in Central California had
not yet been notified of the Gammagard/Polygam recall. Even when the
recall is voluntary and initiated by
the manufacturer, the FDA should
be involved in the notification procedure to ensure that it is complete.
The FDA responds that it is not their
job.
Regulation??
Was hepatitis C always present
in immune globulins? Did the
change in administration lead to a
greater risk of transmission? This
certainly is not the first time that
changes in products that were
thought to be great improvements

Problems with Gammagard a with Haya
The HCV transmissions by is used
Gammagard began shortly after the 4 o
products screened for HCV antibod- - o
ies became available. Dr. Ed
Gomperts, Baxter's Medical Director, h tha t n
speculated that even if HCV antibodies don't neutralize the virus, they 4
might be able to form a complex with w IVIG. One alvs e
the virus that is washed out during d ant CD4benefit in ioo*
fractionation.i G
The circumstantial evidence n y used dose
around these transmissions lends of is mg per kilogram of
plausibility to Gomperts's argument, body weiht once every four weeks. found
but the fact that HCV was transmit- A special IVIG preparation ciated with a decase in *
ted via a single company's product that contains high lev. dence o
indicates the HCV screening cannot - esis crretly
be the sole explanation for the prod- stzded asa way to prevent mrer
uct failure. Baxter's Gammagard did thWtansmission of HIV infection thanin