$75 million offered to further non-surgical sterilization

[Guest guest]

From ANIMAL PEOPLE, October 2008:

(Actual publication date 11-5-08.)

 

 

$75 million offered to further non-surgical sterilization

 

CHICAGO--For $75 million, can someone invent a vaccine

against canine and feline pregnancy? Or a chemosterilant that will

be widely accepted by the humane and veterinary communities?

If an effective immunocontraceptive or chemosterilant for

dogs and cats existed, would it be used where most needed?

Might the money be more productively used in extending high

volume, low cost, best practice dog and cat sterilization surgery to

all parts of the world--and in keeping existing low-cost

sterilization programs operating, at a time of plummeting donations?

The headline item at the mid-October 2008 Spay USA national

conference was the $75 million incentive package offered by Found

Animal Foundation founder Gary K. Michelson, M.D., to encourage

the development of nonsurgical dog and cat contraception.

Representatives of the Found Animal Foundation at an October

16 pre-Spay USA conference reception announced that Michelson is

offering a prize of $25 million to the inventor of a successful

single-injection sterilization method for dogs and cats. The

claimant may be either an individual or an organization. Of more

immediate help to researchers who have promising ideas but lack

financial backing, Michelson is also offering up to $50 million in

grant funding for nonsurgical sterilization research.

" Researchers have been on the verge of discovering pet

contraceptives and non-surgical steriliants for years, " said Found

Animals director of communications Michael Gilman, " but a lack of

funding has kept these ideas stalled in the early stages of research.

New scientific breakthroughs in other health care fields may offer

promise when applied to this goal. "

Michelson, 59, has put comparable money into promoting

medical breakthroughs on behalf of human beings. A practicing

orthopedic surgeon for more than 25 years, Michelson eventually

turned to surgical invention, chiefly associated with treating back

pain. According to the Found Animal Foundation web site, Michelson

" has over 900 issued or pending patents worldwide related to

instruments, operative procedures, and medical devices. In 2005

Michelson assigned ownership of much of his spine-related

intellectual property to Medtronic for a price in excess of $1

billion, catapulting him onto the Forbes 400 where he has since

remained. "

Medtronic announced in April 2005 that it would pay Michelson

$550 million to settle five years of litigation between Michelson and

Medtronic, as directed in 2004 by a federal grand jury, and would

pay Michelson $800 million for the rights to " over 100 issued U.S.

patents, over 110 pending U.S. applications and approximately 500

foreign counterparts. "

The Medtronic settlement was actually Michelson's second big

payday through litigation. " In 1995, " recounts his Forbes 400

profile, " he sued a subsidiary of U.S. Surgical (now Covidien) for

infringing his patents on a fusion technology. The case won a large

settlement that he is not allowed to talk about, although he

confirms it was nine figures. His licensing revenue grew to $40

million annually. In 2001, when his dispute with Medtronic began,

Michelson had a net worth, he says, of $300 million. "

The Michelson initative " is without doubt the biggest thing

to happen in our field, " said Alliance for Contraception in Cats and

Dogs executive director Joyce Briggs. " ACC & D has long seen the need

for an infusion of funding to attract researchers. Dr. Michelson has

risen to that challenge, and we are delighted to be working closely

with the Found Animal Foundation on this initiative. "

" We're completely agnostic regarding the approach, " said

Found Animals Foundation executive director Aimee Gilbreath, who was

hired in March 2008 from a background in business consulting and

animal shelter volunteer work. " We'll consider anything. We really

believe if cutting-edge technologies are applied we can solve this. "

But the idea is actually to replace " cutting-edge "

technologies, which involve invasive surgery and are as old in

concept as castrating male animals--or human slaves-- and sewing shut

the vaginas of females, practiced in some parts of the world since

early Biblical times.

The basic methods of sterilizing dogs and cats remain

castration of males and ovariohysterectomy of females, 75 years afer

the American Veterinary Medical Association first formally endorsed

the procedures. The surgical techniques have been expedited and

refined, enabling top sterilization surgeons to operate on more than

twice as many animals per hour with hundreds of times less risk to

the animals than when sterilization surgery became commonplace, in

the 1970s.

Yet despire the improvements, sterilizing animals remains

markedly more costly and complicated than vaccinating them. The

prevailing belief in the animal advocacy, veterinary, and animal

care and control communities has for decades been that sterilizing

animals must become almost as easy and inexpensive as vaccination,

in order for the procedures to become universal enough to prevent dog

and cat overpopulation.

The need for a cheap, quick, safe and effective

non-surgical sterilization method is believed to be especially acute

in the developing world, where the veterinary shortage afflicting

the U.S. since the early 1990s is much more intense, and pressure to

reduce the numbers of street dogs and feral cats is omnipresent,

especially in regions where rabies remains endemic.

 

Hormones

 

The oldest approach to non-surgical dog and cat population

control involves regulating hormone levels, as in human birth

control, and has been researched without a breakthrough to finding a

safe, practical, single-shot method for approximately 50 years.

Among the first researchers in the field was Wolfgang Jochle,

originally from Germany, now a senior advisor to ACC & D. Jochle

began his studies when street dogs were re-emerging as a problem in

western Europe, then recovering from World War II. While colleagues

developed birth control pills for humans, Jochle anticipated a

future when dogs and cats would no longer be killed to control their

numbers. Several times he thought he was close to finding the magic

elixir that would make this possible. Eventually much of western

Europe, including Germany, reduced dog and cat overpopulation to

the point of becoming almost no-kill nations. But Jochle by then had

emigrated to the U.S. His discoveries, while achieving limited use

with pets in Europe, never proved practical for use with street dogs

or feral cats, except in some closely supervised colonies, and

never gained popularity in the U.S.

Several hormone-based contraceptive products have been

marketed in the U.S. for use by prescription, primarily in show

animals. One of them, Ovaban, reached the U.S. market in 1975,

and is still sold, but has not become popular because of the

severity of the side effects frequently associated with it.

The Connecticut sterilization service provider Tait's Every

Animal Matters, headed by John Caltibiano, DVM, in mid-2008 began

marketing a similar product for feral cats, called FeralStat. The

two TEAM mobile units have performed conventional sterilization

surgery on more than 117,000 cats since 1997, but noting that " it is

difficult for those who are managing feral cat colonies or feeding

homeless cats to trap each cat for sterilization before they

reproduce, " Caltibiano " began prescribing this oral contraceptive to

feral cat caretakers in Connecticut, Oregon, Texas, California,

Florida, and Canada seven years ago, " according to the TEAM

advertisements.

" By all accounts, " the ads claim, FeralStat " is safe,

effective, convenient--it works. The active ingredient, a

synthetic progestin, was patented and approved by the U.S. Food &

Drug Administration in the early 1950s. It is used extensively in

human medicine, and has been prescribed by veterinarians for over 30

years for cats with skin, urinary tract, and behavioral disorders.

It also has FDA approval for off-label use as a feline oral

contraceptive to postpone estrus in cats. "

According to the ads, FeralStat can be mixed with food once

per week and fed to all of the cats in a feral colony, without

harmful effects on male cats, pregnant females, and kittens who

share the meals.

" The recommended daily dosage for treating cancer in humans, "

the FeralStat ads say, " will prevent 20,000 cats from coming into

heat. "

But FeralStat is unlikely to share in the Michelson prize,

because it does not actually sterilize the cats who ingest it, and

is not a single-shot method.

The Alliance for Contraception in Cats & Dogs is also

skeptical of Caltibiano's safety cliams. " The active ingredient in

FeralStat is megestrol acetate, " points out Joyce Briggs. " This is

the same active ingredient which is in Ovaban. In numerous studies

over three decades, this drug, like other progestins, has been

found to pose serious health risks in cats, including diabetes

mellitus, mammary swelling and tumors, uterine disease, pyometra,

and skin disorders. Megestrol acetate is not now, nor has it ever

been, approved by the FDA for use in cats, " Briggs asserts, though

it is approved for contraceptive use in dogs.

" There do not appear to be any controlled studies of

FeralStat that show that it is either safe or fully effective at the

dose used, " Briggs continued in a July 24, 2008 media statement.

" We have no information that FeralStat has gone through any formal

review process. Because FeralStat is given as a food additive for

outdoor cat colonies, there is no way to control the amount of the

drug each cat ingests, or to prevent wildlife or owned pets from

consuming the drug. While we continue our thorough review, " Briggs

said, " ACC & D cannot recommend the use of FeralStat. "

 

Chemosterilants

 

Chemosterilants use chemical substances to reduce fecundity.

No effective chemosterilant for female animals has been developed.

Several chemosterilants for male dogs and cats have been

experimentally introduced. Most notably, a chemosterilant called

Talsur failed in field trials in India in 1991. A similar product

called Neutersol has long been used successfully in Mexico, a

comparable product is used in Thailand, and another is reportedly

close to introduction in Brazil, but Neutersol was rejected in India

after a field trial initially appeared to be producing some of the

same problems as Talsur. Limited use by nonprofit organizations in

eastern Europe was thwarted by veterinary opposition.

Efforts to market Neuterol in the U.S. were not commercially

successful.

" Neutersol was originally introduced in the U.S. in 2003,

and was available until the patent holder and the original

distributor severed ties in early 2005, " ACC & D executive director

Joyce Briggs recounted in introducing Michelson's incentive package.

" A reintroduction plan was introduced in 2005, " Briggs added.

" ACC & D worked in partnership with the new marketing company to

develop plans for a shelter advisory board and programs to aid the

reintroduction. "

However, Briggs said, " ACC & D recently learned that the

reintroduction of Neutersol into the U.S. has been cancelled, with

the termination of a contract between the company that was going to

distribute the product and the patent holder. ACC & D will shift our

focus to the use of this product internationally, " Briggs said,

" where the largest potential for saving lives exists, and where, in

developing nations, veterinary surgery is a scarce commodity. "

Briggs mentioned that the product called Neutersol in the

U.S. is now sold in Mexico as Esterilsol.

 

Immunocontraception

 

Immunocontraception attempts to trick a female animal's body

into rejecting the male animal's sperm and destroying it just as the

immune system destroys viruses and bacteria. Immunocontraceptives

have been developed for many mammal species, and are now widely used

to control reproduction of hooved animals. The first

immunocontraceptive for horses, for example, was tested by

ZooMontana director Jay Kirkpatrick in 1990, and has recently been

used with some success among wild horses.

Leading researchers in July 2000 told a Spay USA conference

in Waltham, Massachusetts that they expected to have one or more

immunocontraceptives for dogs and cats ready for general use within

just a few years, based on porcine zona pellucida, the same

byproduct of pork production that worked in horses. By 2004,

however, when the first ACC & D conference was held in Breckenridge,

Colorado, the pZP researchers' optimism had waned. Cat and dog

reproductive systems were not tricked by pZP.

A second immunocontraceptive approach, using

anti-gonadotropin-releasing hormones, has been researched here and

there for at least 18 years, but several major pharmaceutical

manufacturers have abandoned work on anti-GnRH methods.

That leaves several other possibilities. One idea, still

completely untested, would be to use gene therapy to modify the

fecundity of animals. The idea would be to introduce altered genes

into the animals, which would take over control of their

reproductive systems. Similar techniques are now experimentally used

in fighting many severe human illnesses with a genetic component.

The gene therapy approach might be used in dogs and cats to

restrict litter sizes or reduce the frequency of ovulation cycles,

so as to reduce fecundity to the level needed to replace pets, or to

maintain the population of street dogs and feral cats needed in a

developing world situation to control rodents and prevent monkey

invasions.

Whether this could be accomplished with a single-shot

injectible product, or could be done at all, is as yet not known

because no one is known to have researched it. But cats and dogs are

known to have relatively recently evolved greater fecundity in

response to the pressures of living in proximity to humans, where

more food is available but there is also risk of persecution much

more intense than the risk of predation in the wild.

The fecundity of feral and domestic cats today is roughly

four times greater than that of their closest wild relative, the

African desert cat, and is about double the fecundity of pregnant

cats who were mummified thousands of years ago by the ancient

Egyptians. The fecundity of dogs is also believed to have markedly

increased since domestication.

This means, in theory, that genetic selection for smaller

and less frequent litters could be done by switching on recessive

genes that were dominant among cat and dog ancestors just a blink ago

in evolutionary time.

--by Merritt Clifton

 

 

 

 

--

Merritt Clifton

Editor, ANIMAL PEOPLE

P.O. Box 960

Clinton, WA 98236

 

Telephone: 360-579-2505

Fax: 360-579-2575

E-mail: anmlpepl

Web: www.animalpeoplenews.org

 

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