US CUSTOMS IN CHULA VISTA HAS SEIZED A SHIPMENT OF NTZ (A PROMISING
TREATMENT FOR CRYPTO DIARRHEA).  PEOPLE WITH HIV/AIDS NEED THIS DRUG
TODAY.  WHAT FOLLOWS IS BACKGROUND INFORMATION AND A LETTER TO DR.
DAVID
KESSLER, THE FDA COMMISSIONER, WRITTEN BY SALLY COOPER OF THE PWA
HEALTH
GROUP IN NEW YORK.  PLEASE CIRCULATE WHAT FOLLOWS, POST ANYWHERE
HELPFUL
AND FAX DR. KESSLER EMPHASIZING THAT PEOPLE WITH CRYPTO NEED ACCESS TO
THIS DRUG NOW. THANK YOU.

WHAT IS NITAZOXANIDE?
Nitazoxanide (NTZ) is the first drug to have ever shown a significant
effect against Cryptosporidium parvum infection in people living with
HIV/AIDS.  The Taber's Cyclopedic Medical Dictionary defines
cryptosporidiosis as,

"A diarrheal disease caused by a protozoa...The typical infection
causes
explosive diarrhea and abdominal cramps...In immunocompromised patients
the disease often causes death...the only effective therapy is reversal
of the immunologic defect."

We do not yet have any therapy that can reverse the 'immunologic
defect'
in people living with HIV/AIDS.  What does exist is a drug,
manufactured
in Mexico, that has been reported to resolve up to 98% of AIDS
patients'
cryptosporidium-caused diarrhea.

WHY IS NTZ CRITICAL FOR PEOPLE LIVING WITH HIV/AIDS?
In the human studies completed thus far, NTZ has shown itself to be the
most effective treatment ever studied for crypto.  At the present time
there is no effective standard of care approved in the US for crypto
infections in people living with HIV/AIDS.  In a phase III study
recently
completed in Mexico, 98% of HIV-infected patients with crypto-caused
diarrhea were able to resolve their diarrhea within the two week study.

Many of these patients' diarrhea resolved within twenty-four hours,
more
within three days.  This type of anti-crypto activity has never, ever
been seen before.  There was a recurrence of diarrhea in a quarter of
the
patients studied in Mexico, but it is unclear whether these patients
did
not respond to therapy or were reinfected with the bug.

WHAT DO THE STUDIES SAY?
The results of the phase I dose-ranging study completed at Cornell
Medical Center were not as shockingly good, but still much better than
Humatin (paromomycin) monotherapy. Dr. Soave, of Cornell, reports a
65-75% diarrhea resolution with NTZ therapy within the one month study
period.  NTZ is the only drug available in the world that has been
shown
to be effective in more than half the patients treated for
cyptosporidiosis.  Humatin monotherapy has been approved by the FDA for
the treatment of crypto, but is only ever effective up to 20% of the
time.  There are a few other {*filter*} being studied in the US, but none
are
approved with a cryptosporidiosis indication, nor is the off-label
standard of care, the combination of Humatin and Zithromax
(azithromycin).

WHAT ARE WE TRYING TO DO HERE?
The PWA Health Group, a AIDS buyers' club in New York, has worked for
many months to help people with AIDS import NTZ from Mexico.  The
Mexican
Ministry of Health approved NTZ with a broad 'anti-parasitic'
indication,
as NTZ is also active against amoebas, trichomonas, giardia, and worms.

Only last week was the Mexican manufacturer able to complete the supply
of the NTZ that will be for sale in Mexican pharmacies on July 1. The
PWA
Health Group arranged the purchase of NTZ from the manufacturer, but on
Friday, June 21, half of the supply, worth $7000, was taken by US
Customs
at the Tijuana-San Diego border.  Please help the PWA Health Group get
this drug out of Customs purgatory. Many, many, many people living with
crypto will be able to thank you later.

FAX FDA COMMISSIONER, DR. DAVID KESSLER: 301-443-3100

June 24, 1996

David Kessler, MD
Commissioner
FDA - 5600 Fishers Lane
Rockville, MD
BY FAX:301/443-3100

Dear Dr. Kessler,

Last Friday night, 6/21/96, US Customs in Chula Vista, California
seized
an incoming shipment of nitazoxanide, or NTZ.  Nitazoxanide is the
first
promising treatment found for cryptosporidiosis, showing incredible
results in early trials.  Cryptosporidiosis is a devastating source of
unrelenting diarrhea that has resulted in the death of thousands of
people with AIDS over the past fif{*filter*} years.  Standard treatments fail
in 60-80% of people diagnosed with cryptosporidiosis.

In response to widespread demand from physicians treating people with
AIDS, the PWA Health Group began following nitazoxanide last fall,
working closely with researchers running the dose-ranging trial at
Cornell.  Callers were referred to Unimed's small emergency release
program, but it closed early this spring.  The program has just
re-opened, but enrollment is limited to 150 people nationwide.

Recently, as Mexican approval approached, we started calling our long
list of people waiting for nitazoxanide.  Over half the list had died
in
the few months since they had signed up.

We are asking you to intervene on behalf of hundreds of PWAs with
severe
cryptosporidiosis, for whom NTZ represents their only hope.  The
shipment
was accompanied by prescriptions, as per the Personal Use Import
Guidance
 of 1989, and will be distributed in a nonprofit manner according to
our
charter and public practice of the past nine years.  In the past year,
shipments have been held up for as long as four months.  People with
cryptosporidosis rarely have four months.  Without your intervention,
the
whole shipment could be lost, which would be an unnecessary
bureaucratic
nightmare, resulting in a loss of life.

People with cryptosporidiosis fight a daily nightmare.  Early access to
this drug may save their lives.  Please expedite the release of this
shipment.  Thank you.

Sincerely,

Sally Cooper
Executive Director

Subject: Action Alert: NTZ Seized
Date: 24 Jun 1996 22:28:25 -0500