November 22, 1982

C. Everett Yqop, M.D.
The Surgeon.ceneral
U.S. Public Health Service
5600 Fishers Lane
Rockville, Maryland   20857

Dear Dr. Koop:

   As you are aware, the Food and Drug Administration ap-
proved the public sale of the vaccine Heptavax B produced by
Merck, Sharp and Dohme last spring or summer.  The clinical
use of the vaccine was recommended by the Immunizations
Practices Advisory Committee.  My husband, Dr. Saul J.
Schweber, an oral surgeon in Silver Spring, Maryland, re-
ceived the first of the three innoculations of Heptavax B
vaccine.  Approximately three weeks later, Dr. Schweber was
admitted to Holy Cross Hospital and diagnosed as having
Guillian-Barre syndrome.  At this writing, my husband is
still in the hospital and we look forward to his release
within the next few weeks as well as to his recovery through
next spring at which time we hope he will be able to return
to hi; practice.

  My husband suffered no symptoms of any physical dis-
order before innoculation with the vaccine or after until
the symptoms of GBS appeared.

   I am writing to you because my husband and I are con-
cerned that the public excitement surrounding this vaccine
as a long-awaited medical breakthrough to fight the dreaded
hepatitis disease may be overshadowing the possible need for
additional laboratory study and safety testing.   We have
read medical literature promoting the vaccine for mass
immunization of medical, dental and laboratory personnel (at
high risk to HBV infection) in hospitals, clinics, some
schools, etc.  Some professional organizations are pre-
senting the conservative position that more study may be
needed on the use of this vaccine.  We agree with this
latter point of view.

   We are in communication with the Center for Disease
Control in Phoenix (the hepatitis lab).   Our concern is that
my husband's case with which they are familiar may not be
reported to the public by them or by Merck, Sharp and Dohme.
The only reaction stated in the literature to date are of a
minor nature relating to tenderness in the area of innocu-
lation.  This is not the case in the incident concerning my
husband and may not be fair to the public with regard to
public health and safety practices.


C. Everett Koop, M.D.
November 22, 1982
Page Two

  My husbgnd made a conscious decision to protect himself
and his patients by receiving a vaccine approved by FDA,
promoted by the Department of Health and Human Services and
which showed virtually no risk to the recipient in any
literature which he investigated.  Previously, my husband,
Dr. Schweber, has not taken any influenza vaccine because
medical literature clearly shows some risk to the group of
susceptible recipients.  In our opinion,  under the circum-
stances,  there has not been a sufficient study of all the
facts surrounding the use of Heptavax B vaccine to provide a
basis for a professional decision by the Immunizations
Practices Advisory Commitee and FDA.

   We hope that this matter will receive your serious
attention.

Sincerely,

14200 Catamount Court
Silver Spring, Maryland   20906