[Letter to Bob Nugent, Jack Moye, Anne Willouby, George Nemo, Elaine Sloand, Harvey Shifrin, Dacia Clayton from Lynne Mofenson]

TO: Bob Nugent PhD, Jack Moye MD, Anne Willoughby MD, NICHD
George Nemo PhD, Elaine Sloand MD, NHLBI
Harvey Shifrin, NICHD
Dacia Clayton, NIH
FROM: Lynne Mofenson MD, NICHD
5571095.0281.007
DATE: July 8, 1992
RE: Abbott statement re: HIVIG contract
In the context of a follow-up call from John Cohen (Science) regarding
the HIVIG trial, he related to me the following statement issued by the Abbott
press staff to him regarding the trial:
"Abbott is continuing to work toward execution of the NIH contract for
the HIVIG study. Throughout the discussions, Abbott has sought assurances
that NIH will waive Abbott's liability for use of HIVIG in clinical studies.
This issue has been raised because the risk exists, although small, that an
infant could become infected with the HIV virus by infusion of HIVIG, a drug
containing concentrated antibodies to HIV, into the mother and infant. Abbott
continues to expect that this waiver for product liability will be granted.
Abbott will begin to supply the product for clinical trials once the waiver is
granted."
I bring this to your attention because I am concerned regarding some
inconsistencies in Abbott's statement and my perception of these issues. I
would like to clarify my perceptions, as summarized below:
1) Abbott is stating that these issues were never resolved; my understanding was that there had been general agreement on each of their issues,
including agreed-upon changes to the protocol informed consent at their
request, and that once I approved a late delivery date in October, we were led
to expect the contract would be signed during the week of June 22.
2) On our 185 protocol team conference call on Monday, July 6, Mr.
Shafer of Abbott stated that their concerns was "if the product doesn't work,
Abbott could get sued", and that NIH could easily get the issue resolved "by
having Congress adding an indemnification statement to the NIH authorization".
He also stated that Abbott has "no commercial interest" in HIVIG; however, I
recall that patent issues were a significant concern during the course of
negotiations, and that Abbott wanted to have "the Government agree to grant
Abbott Laboratories a non-exclusive, perpetual, world-wide, royalty-free
license...". This seems inconsistent with the statements regarding "no
commercial interest".
3) Issues of "enhancement" of infection by antibody were extensively

discussed by the protocol team, are also discussed in the protocol text itself
and are additionally outlined in the informed consent (which was reviewed by
community constituency members for content and readability). Additionally,
enhancement is an in vitro phenomenon that only occurs in certain cell culture

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