HICN243 News Part 3/3 
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 HICN243 News Part 3/3

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not cause discomfort,  and there are not aphtous stomatitis, must be ruled out
syphilis, trough serologic tests, specially in Aids patients.  Third, the {*filter*}
syphilitic lesions were alone.  Commonly the mucous  membrane  lesions  appear
coincidentall  with  cutaneous  manifesttions  (macular  rash on the palms and
soles, systemic symptoms, condylomata lata,  ulcerating skin lesion),  but may
also appear alone (4) as in this case.

There  are  some factors that contribute tho the clinical development of Aids.
These factors include genetic predisposition,  environmental  responses,  drug
use  or  abuse,  infections  with cytomegalovirus,  Epstein-Bar,  Hepatitis B,
Treponema pallidum or intestinal parasites,  and malnutrition (7).  Since  our
patient  presented  secondary  syphilis,  and  the  past  medical  history was
negative for another previous infections,  the treponema  could  be  important
factor  in  the  evolution  of  the  disease.  In  early epidemiologic studies
conducted by the Centers for Disease Control (CDC),  {*filter*} patients  with
Aids  more  commonly  (68%)  reported a history of syphilis,  as compared with
{*filter*} controls (36%) (8).  This,  initially suggested a possible role for
syphilis  in  the  development  of  Aids,  but  also  is  consistent  with the
hypothesis that  Adis  patients  are  more  {*filter*}ly  active.  The  latter  is
supported  by  the fact that among less {*filter*}ly actrive hetero{*filter*} patients
with Aids,  only 6% of 31 patients  studied  by  CDC  reported  a  history  of
Syphilis (8).

Some  investigators  have suggested that early (primary or secondary) syphilis
infection suppresses the immune response, particularly cellular immunity. This
is based on antigen- and mitogen-induced  lymphocyte-transformation  responses
an   on   macrophage   migration-inhibition  studies  using  peripheral  {*filter*}
lymphocytes from syphilitic humans or rabbits,  but  that  results  are  quite
contradictory,   and   one  investigator  may  demostrate  reduced  lymphocyte
function,  another shows increased responsiveness,  and a third may demostrate
no change in lymphocyte function during syphilis (9).


1.  Silverman  S.,  et  al.  {*filter*}findings in people with or at high risk from
AIDS. A study of 375 {*filter*} males. J Am Dent Assoc 1986:112: 187-192.

2.  Jaffe HW.,  et al.  National case-control study of  Kaposi's  Sarcoma  and
pneumocystis  carinii  pneumonia  in  {*filter*}  men:  Part 1.  Epidemiologic
Results. Ann Intern Med 1983:99:145-151.

3.  Pindborg JJ.  Classifation of {*filter*}lesions associated with HIV  infection.
{*filter*}Surg {*filter*}Med {*filter*}Path 1989:67:292-295.

4.  Fiumura NJ. Venereal Diseases of the {*filter*}cavity. J {*filter*}Med. 1976:31: 51-

5.  Schulten EAJM.,  et al.  {*filter*}manifestations of HIV infection in 75  Dutch
Patients. J {*filter*}Pathol Med 1989:18:42-46.

6.  Phelan JA., et al {*filter*}findings in patients with acquired immnode-ficiency
syndrome. {*filter*}Surg {*filter*}Med {*filter*}Path 1987:64:50-56.

7.  Haverkos HW.  Factors associated with the pathogenensis of AIDS.  J Infect
Dis 1987:156:251-257.

Health InfoCom Network News                                             Page 22
Volume  2, Number 43                                      November 20, 1989

8.  Guinan  ME.  et  al.  Hetero{*filter*}  and  {*filter*} patients with acquired
immunedeficiency  syndrome.  A  comparision  of  surveillance,  interview  and
laboratory data. Ann Intern Med 1984:100:213-218.

9.  Schell  RF.  Musher  DM.  Eds.  Pathogenesis  and immunology of treponemal
infection. New York: Marcel Dekker 1983:271-364.

Health InfoCom Network News                                             Page 23
Volume  2, Number 43                                      November 20, 1989

                        cooking.net">food & Drug Administration News

                              L-tryptophan recall

     P89-49                                   cooking.net">food and Drug Administration
  FOR IMMEDIATE RELEASE                    Jeff Nesbit (703) 273-1043 (home)
November 17, 1989                        Donald McLearn (301) 926-6909 (home)
                             (301) 443-3285 Office

    The cooking.net">food and Drug Administration today said that it will seek a nationwide
recall of all over-the-counter dietary supplements in which  L-tryptophan,  an
amino  acid,  is  the  sole  or  major component of the product because of the
rising number of patients taking the product diagnosed as having eosinophilia-
myalgia syndrome, a rare {*filter*} disorder.
    Consumers are urged to stop using the L-tryptophan supplements,  which are
widely available in health cooking.net">food stores as well as in such major retail outlets
as supermarkets and drug stores.
    Starting Monday,  FDA field offices in the U.S.  will be asked to identify
and mail letters  to  all  manufacturers  of  the  food  supplement  in  their
respective   jurisdictions   asking  them  to  recall  these  products.   Each
manufacturer  would  be  expected  to  contact   its   clients   (wholesalers,
distributors and retailers) to remove the products from the marketplace.
    While  the  investigation  continues,  the  FDA,  the  Centers for Disease
Control and state health officials have now concluded that there is a "strong,
virtually unequivocal link between  consumption  of  L-tryptophan  tablets  or
capsules  and  the  syndrome."  What  has  not  been established by government
scientists is the reason why ingesting L-tryptophan  is  associated  with  the
syndrome.  Most,  but not all,  of the affected patients have been individuals
who were taking L-tryptophan tablets, caplets or capsules before becoming ill.
The syndrome nearly always involves severe muscle and joint pain,  swelling of
the  arms  and  legs,  skin  rash  and possible fever.  It is characterized by
intense eosinophilia,  a {*filter*} abnormality in which white {*filter*} cells increase
to abnormally high levels.
    FDA issued its first alert to consumers to discontinue use of L-tryptophan
supplements  on  Nov.  11.  That  action  was based on reports of more than 30
cases of the {*filter*} disorder in six states.  As  of  today,  CDC  has  received
reports  of  287  cases  in  37  states  plus  the  District of Columbia.  And
according to CDC, there has been at least one death that is most likely due to
consumption of L-tryptophan.
    Based on all available information,  FDA officials stated today  that  the
disease  posed  a  "moderate  to severe and perhaps life-threatening hazard to
certain individuals" and that some victims may suffer chronic after-effects in
the future.
    The dietary supplement is sold under the  name  L-tryptophan  as  well  as
under a wide variety of other brand names in which L-tryptophan is the sole or
major  ingredient.  FDA's  warning  applies  only to those products.  To date,
none of  the  cases  investigated  appear  to  involve  multi-ingredient  food
supplements, some of which may have L-tryptophan as a minor ingredient.
    L-tryptophan   is   reportedly  used  by  some  individuals  for  sleeping
difficulties, premenstrual syndrome,  stress,  depression and {*filter*} and drug
abuse.  FDA has not approved L-tryptophan as a medicinal drug.

Health InfoCom Network News                                             Page 24
Volume  2, Number 43                                      November 20, 1989

    On Nov.  14,  the Council for Responsible Nutrition,  a Washington, D.  C.
based  industry  group  whose  membership  is  comprised   of   manufacturers,
distributors and other marketers of nutritional supplement products, urged its
members to temporarily suspend the wholesale,  distribution and retail sale of
single entity L-tryptophan products.
    Another  industry  group,  the  National  Nutritional  Foods  Association,
advised  its  membership on Nov.  15 that it would be "prudent" to voluntarily
curtail manufacture and distribution of "single active ingredient L-tryptophan
    FDA and other public health investigators have been analyzing  samples  of
L-tryptophan  supplements  obtained  from  victims  and  from retail and other
outlets.  The investigation includes evaluation  of  the  raw  materials--most
tryptophan  is  produced  by  four  companies  in Japan--and the manufacturing
processes employed.  FDA is now inspecting the Japanese plants.


                      Fraudulant Immunization Kit Warning

   P89-48                                      Food and Drug Administration
    FOR IMMEDIATE RELEASE                       Brad Stone - (301) 443-3285
     Nov. l5, 1989                               (Home) -- (703) 892-0468

    The cooking.net">food and Drug Administration warned today that an  Idaho  naturopath's
"immunization  kits"  sold  widely  through the mails to protect children from
common diseases consisted of {*filter*} and water solutions and sugar pills.
    The immunization kits may have been sold as protection from polio, scarlet
fever,  smallpox,  measles,  typhoid,  mumps,  tetanus,   whooping  cough  and
    FDA  said  copies  of  letters of immunization signed "Dr.  James Solomon,
N.D." were found.  The agency said such letters signed  by  Solomon  or  other
naturopaths  may  have  been  sent  to  kit purchasers so they could get their
children into schools,  most of which require vaccination  against  contagious
    "FDA  has  never  approved  immunization  kits  or vaccines for use in the
home," FDA Commissioner Frank E.  Young, M.D., Ph.D.,  said.  "Parents who may
have bought and used such unapproved kits should have their children immunized
as soon as possible.  These kits and pills offer no protection."
    The  kits  were  discovered  when  a  team led by the Idaho State Attorney
General's Office executed search and seizure warrants Oct.  25 and 26  at  the
Twin  Falls  office,  laboratory  and  health  food  store of J.S.  Inc.,  the
distribution company of James D. Solomon, and at the E. F. Skilling Company of
Buhl,  Idaho,  a device manufacturer.  Solomon has referred to  himself  as  a
"naturopath,"  a  term  sometimes  used  by  people  who  recommend  "natural"
therapies.   Some  of  the  products  are  also  labeled  "Homeopathic."   FDA
participated in the investigation.
    Records  of  distribution  of  J.S.  Inc.  products were in disarray.  But
distribution was apparently to naturopaths and parents  as  well  as  regional
distributors.  While  the kits may have been sold in every state,  the records
reviewed so  far  establish  sales  to  Florida,  Utah,  Ohio,  Kansas,  South
Carolina, Washington and Wyoming.
    FDA  warned that Solomon also appears to have promoted tinctures,  pellets
and unapproved medical devices as treatments for  AIDS,  angina,  bone  marrow
suppression,   cancer,   Down's  syndrome,  epilepsy,  cataracts,  hemophilia,
diabetes, multiple sclerosis,  Parkinson's disease,  rabies,  tuberculosis and

Health InfoCom Network News                                             Page 25
Volume  2, Number 43                                      November 20, 1989

various tumors.
    Idaho  authorities  said  that Solomon has been arrested on state charges.
FDA  will  continue  to  investigate  the  distribution  of  these  unapproved
    While most of the products sold in the immunization kits have counterparts
in medicine, there is no valid vaccine for scarlet fever, and smallpox vaccine
is no longer given since that disease has been eradicated worldwide.


                             L-tryptophan warning

   P89-47                                      Food and Drug Administration
  FOR IMMEDIATE RELEASE                       Donald McLearn - (301) 443-3285
     November 11, 1989                           (Home) -- (301) 926-6909

    The  Food  and  Drug  Administration  today  alerted  consumers  taking L-
tryptophan,  an over-the-counter cooking.net">food supplement sold in  tablet  and  capsule
form   that  has  been  used  by  some  people  for  sleeping  difficulty  and
premenstrual syndrome, to temporarily discontinue use of the product.
    The alert is being issued because  doctors  in  the  past  few  days  have
reported  more than 30 cases nationwide of a syndrome characterized by intense
eosinophilia,  a {*filter*} condition.  The syndrome nearly always involves  severe
muscle pain with some patients also exhibiting weakness,  joint pain, swelling
of the arms and legs,  fever and skin rash.  Health departments in the  states
involved  are  cooperating  with the Centers for Disease Control and FDA in an
investigation of the cases.  While the syndrome has  an  association  with  L-
tryptophan  use,  the investigation to date has not progressed sufficiently to
determine a cause and effect association with the product  or  any  particular
component of the product.
    Affected  persons  in  most of the cases have reported taking L-tryptophan
products before becoming ill.  L-tryptophan tablets are sold under the name L-
tryptophan and also under a variety of other brand names.
    While the FDA and CDC investigate the cases,  they recommend the following

    --  Persons  with  recent onset of an illness that may fit the description
given above should consult their physicians.

    -- Persons taking L-tryptophan for over-the-counter  uses  such  as  sleep
disorder or premenstrual syndrome should temporarily discontinue use.


                                 AZT for Kids

      P89-44                                               Brad Stone/FDA
      FOR IMMEDIATE RELEASE                                (301) 443-4177
   Oct. 26, 1989                                        Elaine Baldwin/NIAID
                                (301) 496-5717

         HHS Secretary Louis W.  Sullivan, M.D., today announced that the cooking.net">food

Health InfoCom Network News                                             Page 26
Volume  2, Number 43                                      November 20, 1989

and Drug Administration has granted permission for distribution of zidovudine,
commonly called AZT, for use in treating children under the age of 13 who have
AIDS or who are suffering from symptoms of advanced infection  with  the  AIDS
         "Today's action is a significant advance in extending AIDS therapy to
children.  It  will  give  many  sick  children  access  to a drug that offers
promise for improving or even extending their lives," Dr. Sullivan said.
         Zidovudine will be distributed free of charge to children  with  AIDS
or  at  advanced  stages  of  AIDS  virus  infection  under  a  Treatment  IND
(investigational new drug) program sponsored by the Burroughs Wellcome Company
of Research Triangle Park, N.C.,  with medical and technical assistance by the
National Institute of Allergy and Infectious Diseases (NIAID),  a component of
the National Institutes of Health (NIH).
         This Treatment IND program is based on clinical  data  that  indicate
that  the  drug  may  prolong  survival  and  relieve  severe AIDS symptoms in
children,  as it does in {*filter*}s.  These data were  obtained  through  clinical
trials  sponsored  by  Burroughs  Wellcome and conducted by researchers at the
National Cancer Institute and  through  NIAID's  AIDS  Clinical  Trials  Group
network.  The  pediatric  trials began in 1986 and have involved more than 200
  "The need for providing effective AIDS therapy for children has been a major
concern for some time,  and I commend FDA,  NIAID,  NCI and Burroughs Wellcome
for  their  work  in  helping  to  fill this need," said Dr.  James O.  Mason,
Assistant Secretary for Health.
         The Treatment IND mechanism was established by FDA to allow  patients
suffering  from  serious or life-threatening conditions for which there are no
satisfactory treatments to  obtain  promising  experimental  {*filter*}  that  have
undergone sufficient clinical testing to show they may be safe and effective.
         Under  this Treatment IND protocol,  physicians caring for children 3
months to 12 years of age who have symptoms of  advanced  infection  with  the
AIDS  virus  will  be  eligible to receive the drug at no cost in this program
sponsored by  Burroughs  Wellcome.  A  recently  approved  strawberry-flavored
syrup  form  of zidovudine will be used,  since it is more easily swallowed by
children and the doses can be more easily adjusted to their body size than the
capsule form of the drug.
         Zidovudine has been approved since March 1987.  It is  indicated  and
labeled  for  the  treatment  of  patients,  age 13 or older,  who have severe
symptoms  of  AIDS  virus  infection.   Label  indications  do  not   restrict
physicians   from   prescribing  zidovudine  for  other  patient  populations,
including children under  13  years  of  age.  However,  many  physicians  and
hospitals have been reluctant to use zidovudine for children because it is not
labeled  for  this  use,  and  because of concerns that the drug's known side-
effects in {*filter*}s might be even more severe in  children.  Clinical  data  now
indicate that children receiving zidovudine experience side-effects similar to
those occurring in {*filter*}s.
         Although  zidovudine  is  the  only  drug  that  has been shown to be
effective in prolonging the lives of people with AIDS,  it is  also  known  to
have  significant  side-effects.  The  drug  can inhibit the production of red
{*filter*} cells,  which may result in severe anemia requiring {*filter*}  transfusions.
Zidovudine  can  also  reduce  white  {*filter*} cell counts to the point where the
drug's use has to be discontinued, to avoid infections.
         Using data accrued from the pediatric clinical trials of  zidovudine,
the  Treatment  IND  has  been  designed  to minimize the risks of these side-
effects.  Patients enrolled in this Treatment IND program  will  be  carefully
monitored for any adverse reactions.

Health InfoCom Network News                                             Page 27
Volume  2, Number 43                                      November 20, 1989

         Physicians  interested  in  enrolling  patients  in the Treatment IND
protocol can call the Burroughs Wellcome toll-free number at  1-800  829  PEDS
from  8  a.m.  to  7  p.m.,  Eastern Time.  The company will immediately begin
processing applications from physicians for their pediatric patients.
         Those interested in this Treatment IND or in other AIDS  studies  can
call  1-800  TRIALS-A,  a  toll-free  service  offering information about AIDS
clinical trials from 9 a.m. to 7 p.m., Eastern Time, Monday through Friday.


Health InfoCom Network News                                             Page 28

--- end part 3 of 3 cut here ---

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