Mammalian Sterilizing Pharmaceuticals mission statement ...

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Mammalian Sterilizing Pharmaceuticals
mission statement formulation guidelines
for Biotechnology Pharmaceutical Corporations.
A. W. Morrow
V 0.5
March 2011
Glossary
SPL – Species Population Level
USP – Unsustainable SPL
SSP – Sustainable SPL
BPC – Biotechnology Pharmaceutical Corporation
MSP – Mammalian Sterilizing Pharmaceuticals
PMS – Perinatal Mammalian Sterilization
Executive Summary
There is a potential new market for the biotechnology pharmaceutical corporation (BPC) in helping to

preserve the planet's biosphere from the dangers of Unsustainable Species Population (USP). What is

required is a well-crafted mission statement for such a product that should provide a guide in its

development and be provided as a part of the documentation to accompany each package or more

likely, every single dose. A BPC might start with a specialist in perinatal bioethics and take an approach

that leads to a product with a range of applications for a variety of mammalian species.
This emerging market is an opportunity to develop and market an innovative type of pharmaceutical to

appropriate governments or licensed agencies that could be a part of a modern management program.

As an example, the document proposes Perinatal Mammalian Sterilization (PLS) where the BPC would

produce a range of Mammalian Sterilizing Pharmaceuticals (MSP). Such a product might be a

controlled substance. Sustainability and the numerical value of Sustainable Species Population (SSP) is

a number that only individual management agencies can determine and is thus beyond the scope of this

document, but many scholars indicate that even present SPL values might prove to be not sustainable

for the foreseeable future either in sustainable development and quality of life for the average mammal.

Species-specific MSP of acceptable quality would find markets with municipal Animal Control

Departments and veterinarians as a preferred humane alternative to surgery for specific species of

mammals. While at first perhaps counter-intuitive, an ambitious goal for a MSP is the ability to safely

sterilizing mammalian fetuses
in utero
as early as possible in gestation.
The effort for companion mammals is already underway. In 2008, Found Animals Foundation

announced the Michelson Prize and Grants in Reproductive Biology

(
http://michelson.foundanimals.org/
) funded at $75 million as an international competition the

challenge of non-surgical single-dose pet sterilization.

Alliance for Contraception in Cats and Dogs (ACC&D) (
http://www.acc-d.org/
)
Perinatal Mammalian Sterilization
Managers of wildlife, companion mammals (strays and pets) seeking a non-surgical form of

sterilization would be the target applications. The goal is to be able to achieve permanent infertility

with a single dose and minimal side-effects. The optimal time to sterilize is as early in the perinatal

period as possible, perhaps even
in utero
.
For mammals, the traditional irreversible surgical procedures

is gonadectomy. This includes bilateral orchiectomy (castration) or bilateral oophorectomy. More

modern procedures include the surgical procedures of vasectomy/salpingectomy or tubal ligation but

there is no major role for the BPC. The BPC should be able to develop an improved MSP that would

target and permanently disable the Sertoli cells (the gamete generating cells) of the male and the

approximately two million primordial oocytes of the female with pinpoint specificity. It will be

necessary to disable of the structures that allow Sertoli cells to proliferate and de novo primordial

oocytes production in postnatal life. In early version of the drug, it may be acceptable to allow for very

small amounts of sperm may be produced (oligospermia), but the ultimate goal is for there to be no

detectable sperm in the semen (azoospermia). Research can ramp up to grades of pharmaceutical until a

human-grade product is available: An appropriate human-grade MSP might require special controls to

avoid possible misuse. This is an opportunity for BPCs to deliver a safe product that will be in the best

interests of mammals and eventually for humans who prefer a non-surgical form of sterilization for

themselves.
Modern efforts that provide the BPC with new opportunities include:

Darting female wildlife using immunocontraception using porcine zona pellucida provides for

multi-year contraception . Some experimental work on human females with cloned zona

pellucida cDNA or human chorionic gonadotropin. A surgical procedure for females involves

using a catheter to placing objects akin to stents into both fallopian tubes which prompt enough

scar tissue to occlude the lumen of each tube. This this procedure is intended to be permanent, it

has been shown that with skilled surgery, this procedure can be reversed. An alternative

approach is inserting quinacrine pellets through the cervix into a woman's uterine cavity, and

lodging them at the utero-tubal junctions, causing scaring. For quinacrine, the insertions are

performed during day 6-12 of two sequential menstrual cycles.

For captive mammalian males, intratesticular injection of zinc gluconate has been shown to be

effective at imposing untreatable infertility, but the testis shrink and hormone production is

reduced.

Humans who prefer a non-surgical form of sterilization for themselves will represent a long-
term market for a high-quality product with few side effects.
It is possible for some types of chemotherapy to cause sterility in humans. It is possible for the damage

to the lining of the testicles to reverse; however the process may take several years. In some cases, the

effect may be permanent. Drugs which may cause infertility in men and women include: alkylating

agents- such as busulfan, cisplatin, cyclophosphamide, ifosfamide and melphalan. For female adults,

cyclophosphamide or combination treatments including alkylating agents can sometimes induce

menopausal symptoms, but those might not be permanent. In humans, busulfan causes a high incidence

of sterility in males, and has been known to cause sterility in females as well. In rodents, a10 mg/kg of

busulfan treatment results in female mice in the complete loss of the primordial pool in 20 days.
Immunology-based female mammal work would be based on primordial oocytes antigens . One recent

example of such work is:
Proliferating cell nuclear antigen (PCNA) regulates primordial follicle assembly by promoting

apoptosis of oocytes in fetal and neonatal mouse ovaries.
Xu B, et al.
PLoS One. 2011 Jan 6;6(1):e16046.
doi: 10.1371/journal.pone.0016046.
PMID: 21253613 PMCID: PMC3017099
http://www.quinacrine.com/