Neutersol hits the market; Third World seeks a price break

From ANIMAL PEOPLE,  July/August 2003:

COLUMBIA,  Missouri–Globally anticipated for more than 12
years,  approved by the U.S. Food and Drug Administration in March
2003,  and officially introduced to the U.S. veterinary drug market
in May 2003,  the injectible sterilant Neuterol is finally here–but
not there yet,  overseas,  in the impoverished nations where
uncontrolled reproduction of street dogs is most problematic.
As marketed so far by Addison Biolog-ical Laboratories,
Neutersol is only for American puppies,  and then only for those
puppies whose caretakers are willing to pay almost as much for
sterilization by injection as for a conventional surgical castration
or vasectomy.
“Work is continuing with the FDA toward a clearance for cats
and older dogs,”  Addison president Bruce Addison told Vet Practice
News.

The initial price of Neutersol is reportedly $49.95 per dose,
in packages of five doses.
“There will be no discounts for volume.  Thus this does not
look like the silver bullet for animal shelters,”  PETsMART Charities
consultant Carol Moulton told ANIMAL PEOPLE,  after speaking with
Addison representatives.
Previously director of companion animal welfare programs for the
American Humane Association,  Moulton followed the development of
Neutersol from the earliest stages.
“The Addison goal is to have this embraced by veterinarians,”
Moulton explained.  “In fact,  they are telling vets that there is no
reason to charge clients less for Neutersol than for surgery.  The
selling points are the benefits of avoiding anesthesia,  overnight
stays,  and surgical risk.  It is a conflicting situation,”  Moulton
continued.  “The high price will keep the product from saving
hundreds of thousands of animals that it probably could,  but if it
does well in the marketplace and makes money for vets and Addison,
other pharmaceutical companies will be more motivated to invest in
other forms of non-surgical sterilant,”  especially the
immunocontraceptives that are the most promising product for use in
female animals.
The mid-May 2003 Addison announcement of the availability of
Neutersol came a week after the Fresno Bee erroneously asserted that
the Madera County Animal Shelter in Central California would soon
begin clinical trials of an immunocontraceptive for female cats
developed by Julie Levy,  DVM,  of the University of Florida at
Gainesville.
Responded Levy,  “There is no clinical trial.  This was made
up by an overeager county librarian and a reporter who failed to
check the facts.  There is no product advanced enough for use by the
public yet,”  Levy added,  but offered “I have a lot of enthusiasm
for this technology,  and hopefully will have some good news soon.”

Overseas prospects

Neutersol was developed primarily by the late Dr. Mostafa S.
Fahim,  who was director until his death in December 1995 of the
Center of Reproductive Science and Technology at the Columbia campus
of the University of Missouri.
Fahim was familiar with both animal and human population issues
worldwide,  and is reportedly still the only researcher to seriously
investigate ultrasonic surgical sterilization.  During the FDA
approval process Fahim and colleagues tested Neutersol in small
numbers of dogs from the Arizona Humane Society,  Humane Society of
Missouri,  and North Shore Animal League America,  and tested it more
extensively in Mexico and Romania,  working with the Humane Society
International division of the Humane Society of the U.S.
Hopes were high that Neutersol would be priced in a manner making it
available for high-volume overseas use–even if,  of political
necessity,  the U.S. price was kept competitive with other methods of
sterilizing male dogs.
“The concept of two-tier markets is well established with
human drugs and biologicals,”  an international public health expert
involved in negotiations with pharmaceutical makers told ANIMAL
PEOPLE,  on condition of anonymity.
“For example,”  the expert said,  “AIDS patients can be
treated with state-of-the-art drugs for a fraction of the cost in
Thailand,  Brazil,  or India that would be charged in the US or
Europe.  Many companies have two price levels for pharmaceuticals.
Addison Biological Laboratory,  so far,  seems uninterested.
However,”  the expert hinted,  “the chemistry of Neutersol is rather
simple and the Indians have little difficulty in reverse-engineering
a needed product.”
In fact,  while Fahim was still in the early stages of
seeking approval of Neutersol,  Beauty Without Cruelty/India in 1990
sponsored the introduction of a chemically similar injectible
sterilant called Talsur.  It was withdrawn from use after two months
because under street conditions many of the dogs who received the
injections developed painful scrotal swelling.  With Neutersol
showing how to avoid that problem,  Indian researchers might now be
able to re-engineer Talsur to work without painful side effects–and
without infringing the Addison Biological patents.
Thus the choice for Addison Biological may soon be between
accepting two-tier pricing and losing overseas markets,  either to
knock-offs or to other sterilants  using parallel technology.