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JULY-AUGUST 2003

Neutersol hits the market; Third World seeks a price break

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 Neutersol 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. ³Work is continuing with the FDA toward a clearance for cats and older dogs,² Addison president Bruce Addison told Vet Practice News. The initial price of Neutersol is reportedly $49.95 per dose, in packages of five doses. ³There will be no discounts for volume. Thus this does not look like the silver bullet for animal shelters,² 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. ³The Addison goal is to have this embraced by veterinarians,² Moulton explained. ³In 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,² Moulton continued. ³The 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,² 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, ³There 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,² Levy added, but offered ³I have a lot of enthusiasm for this technology, and hopefully will have some good news soon.²

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.

 

³The concept of two-tier markets is well established with human drugs and biologicals,² an international public health expert involved in negotiations with pharmaceutical makers told ANIMAL PEOPLE, on condition of anonymity. ³For example,² the expert said, ³AIDS 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,² the expert hinted, ³the chemistry of Neutersol is rather simple and the Indians have little difficulty in reverse-engineering a needed product.² 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.