By Donald Collins, Jr. | 22 October 2019
President, ISAF
President Trump, your WGDP initiative for women of the world was courageous! Your major progress reforming immigration in the U.S. is impressive! You don’t shy away from big scary problems. So, Earth needs your help. Please direct the FDA to allow an expedited Phase III trial for (QS) quinacrine sterilization. Nice play on GDP with your WGDP name. Gross world product (GWP) now $88T, with an annual growth rate of 3%, will be $176T by 2043. Will more food, water, and nonrenewable resources sufficient to sustain this doubling in growth in 24 years come from technology?
Climate Change is a symptom of a bigger problem. Out of control population growth will take us to 9 billion humans by 2046. That’s why World Contraception Day, started in 2007, is the most important day of the year in this list of 73 environmental dates. Fewer people leads to higher quality of life for all.
Why is World Contraception Day our most important environmental day? Experts tell us contraception allows women to control their bodies to stop or delay having children, improving the quality of their family’s life, reducing human population growth; thus, giving the other species on Earth a chance. Women’s voices and influence is increased by contraception and this is critical to Earth’s survival.
Question: why isn’t world population sustainable by 2019? Answer: there’s little concerted effort.
I worked as an electrical engineer throughout most of the 30 doublings (1,000,000,000 times) transistor increase per chip shown in this chart. Much of that success occurred because consortiums of scientists, engineers, customers, manufacturers, experts, and regulators communicated with each other and laid down rules for progress that each contributor agreed to. Here is an example from IPC and JEDEC.
If I was a parent with a daughter, anywhere on Earth in 2019, why don’t I have a roadmap to give her?
| Phase of Life | 1st Choice | 2nd Choice | 3rd Choice |
|---|---|---|---|
| Puberty – 1st child | Pill | IUD | Implant |
| 1st child – 2nd child | IUD | Pill | Ring |
| 2nd child – Menopause | Sterilization | IUD | Patch |
And with global warming made worse every 12 years with the addition of another 1 billion humans, why doesn’t a leader (you) advise families that 2 children or fewer is optimal for the survival of humanity?
Guttmacher Institute, a leading research and policy organization committed to advancing sexual and reproductive health and rights in the United States and globally, says, “The pill and female sterilization have been the two most commonly used [contraception] methods since 1982.” See their chart below.
If you search for the best contraceptive (one that women like, which works, and is safe) you will find that there’s an infinite demand for better methods and education and there needs to be more research. Many women don’t use contraceptives. President Trump, if you made QS available to women now in the U.S. alone, it would save our economy $3.5B/year and reduce the number of abortions by a lot.
QS, quinacrine sterilization, has been available for more than four decades and safely used by 200,000 women in over 50 countries with no reported deaths or serious complications when administered with the approved pellet method. The Center for Disease Control (CDC) reports surgical tubal ligation (STL) has 3.76 deaths/100,000 women treated. QS is safer and 7 times cheaper than STL.
QS doesn’t require anesthesia
QS is safer than surgical tubal ligation
QS is as effective as surgical tubal ligation
QS doesn’t cause cancer any more than other methods
QS doesn’t cause tubal pregnancies any more than other methods
QS is more natural than other methods
QS is administered by healthcare pros not only doctors
QS is cheaper than other methods
QS is faster (during lunch break) than other methods
QS is the last contraceptive method a woman will need
QS may reduce maternal death in childbirth
QS may lead to higher quality of life for families
QS may reduce abortions performed worldwide
QS may lead to human population stabilization
In the nonsurgical QS procedure, a healthcare professional inserts 7 pellets, 36 milligrams each, of quinacrine into a woman’s uterus (without anesthesia) using a modified IUD inserter in two doses four weeks apart. That is a total of 504 milligrams compared to the 36,500 – 52,000 milligrams of quinacrine that millions of Americans have safely taken by mouth for a period of one year to combat giardiasis.
QS costs less than $1 per dose and has been administered by 1600 different trained healthcare professionals usually nurses or midwives. The procedure, most often recommended by word of mouth by women who’ve had it, has been in the public domain for decades so is not patentable. Tens of thousands of women have been studied over decades leading to scores of peer reviewed scientific articles that attest to the QS method’s safety and efficacy which can be found on our website.
ISAF spent over $8 million seeking FDA approval to conduct a Phase III trial (halted in 2007). FDA staff repeatedly ignored renowned expert scientists and after protracted negotiations and a rigged committee vote denied ISAF to conduct a Phase III trial the last time in December 2016.
FDA halted research of QS based on a 2-year rat study reported by Cancel et al.,(2010) in the pages of Regulatory Toxicology and Pharmacology (RTP) in 2010. The fundamental concept of maximum tolerated dose (MTD) defined by International Conference on Harmonization (ICH) Guidance for Industry S1C(R2) was ignored in this study. Cancel et al. used massive doses (up to 35 times the MTD) which killed many of the rats and destroyed the uterus of many survivors. Any tumors produced under such extreme conditions are of no relevance to humans. The evidence is overwhelming that the rat study reported in Cancel et al., (2010) is a product of scientific misconduct and is irrelevant.
Unfortunately, QS has been attacked by many others who recognize its safety, efficacy, and efficiency. QS must be only a voluntary procedure. Women are educated about QS, counselled in other contraceptive options, told QS is irreversible, told that 6% of women had regret after sterilization, and then after much deliberation, sign a consent form prior to having the QS procedure.
Here is what a few renowned doctors have said about QS.
Dr. Jack Lippes, has made fundamental contributions to the field of obstetrics and gynecology. In 1959, as a private practitioner, he invented the Lippes loop, an intrauterine contraception device.
“Much is now known about QS. It is nonsurgical, there is no need for anesthesia, and studies have shown that it is safe. With the improved Hieu insertion technique, and two treatments, QS effectiveness (failure rate of 1.2% after 2 years) compares favorably, with surgical tubal ligation (0.7% at 2 years). The cost is low, and QS can be performed by nonphysicians. It is time to reexamine the epidemiological and clinical data on the use of QS and reconsider its use in both developed and developing countries.”
“To put the risk of QS in perspective one must consider the risk of the alternative. At one time the Center for Disease Control (CDC) counted the deaths that occurred with Surgical Tubal Ligations. In one year, the CDC counted 21 deaths from complications due to STL. Unfortunately, the CDC no longer counts deaths from STL. However, the CDC developed a formula to measure the deaths from STL, which was 3.76/100,000 STL. I estimate that the cost of each QS procedure in the USA would likely be similar to the insertion of an intrauterine device (IUD) which is perhaps $500. There are approximately 700,000 STL’s performed annually in the U.S.A. Each STL costs between $1,500 and $7,000. Thus, STL adds approximately $3.5 billion to the United States health budget. If QS replaced STL’s in the United States, we would save billions of dollars and lives.”
Henry W. Foster, Jr., MD, FACOG, Professor Emeritus, former, Vice President for Medical Services & Dean School of Medicine Meharry Medical College & Clinical Professor, Obstetrics and Gynecology Vanderbilt University & President Bill Clinton’s nominee for US Surgeon General, 1995.
“This email is sent to (academic experts in the family planning field) share information with you regarding a nonsurgical method for permanent female sterilization utilizing, The Quinacrine Hydrochloride Pellet System (QS), which may be unfamiliar to some. Efforts to seek FDA approval for this nonsurgical permanent female sterilization procedure began in 2006; the process has been protracted, arduous and unsuccessful. Attached is a letter sent to Dr. Margaret Hamburg in 2012, who was Commissioner for the FDA. There was no reply.
The FDA’s decision for placing the QS application on hold in 2006 ostensibly resulted from their reliance on a study that reported carcinogenesis in a quinacrine rat study. That study was the reason given for placing the application on hold. The science presented in the hallmark publications by Haseman, et al and Jones, et al, overwhelmingly refutes the validity of the rat study. The dosage of quinacrine used in the rat study was many magnitudes higher than that used for women using QS, thus not comparable. Additionally, the mode of administration of quinacrine in the rat study was substantially different from that used with humans. Worldwide, more than 150,000 QS procedures have been conducted; the incidence of cancer found in those participants was no different from that seen in women receiving surgical tubal sterilization during the same time frame.
I have devoted much of my professional career to the realm of international family-planning and reproductive health. It has been my good fortune to have served as chairman of the Board of Directors for Pathfinder International, one of the nation’s preeminent organizations devoted to this cause. Also, having served as chairman of the Board of Directors for UNFPA (formerly the US Committee for the United Nations Population Fund) was another opportunity. I have evaluated family planning and reproductive health intervention projects on three continents, including a visit to Vietnam where more than 50,000 QS procedures have been done. There have been no known deaths and its effectiveness matches or exceeds that observed for surgical tubal ligation. The letter that was sent to Dr. Hamburg is being sent to, Dr. Scott Gottlieb, the current commissioner for the FDA. Hopefully on this occasion a response will be forthcoming. The population is increasing exponentially in countries least capable of coping with the demands for more food, clean water, clean air and better health outcome. Now there is a procedure that is safe, effective, economical, easily applied that has high patient acceptance. There now exists an unparalleled opportunity to address this burgeoning population challenge on a macro scale. When there are challenges that have inherent socio-political and cultural implications, I trust all government agencies, when rendering their decisions will always remain impervious to information that is neither scientific nor factual.”
Dr. D. T. Hieu, his teams performed tens of thousands of QS procedures in 33 provinces of Vietnam
“We were both surprised and disappointed by the treatment given by the scientific community with respect to our Lancet report. Scientific debate should be out in the open. Unsubstantiated opinions of unidentified WHO experts and FDA officials should not be accepted by the scientific community in this attempt to undermine our decision to proceed with this method; nor should these opinions be allowed to obstruct the international evaluation of this most promising family planning method.”
Dr. W. Lu, who performed tens of thousands of QS procedures in China.
“This study has shown that QS has many advantages over surgical sterilization. It is safe, reliable, simple to perform, does not use anesthesia. Health providers who perform IUD insertions can carry out this procedure. It is well suited for our frontier and underdeveloped areas. In short, QS helps implement the family planning policies set by our government.”
President Trump, our planet Earth needs your help. Humanity’s unbridled population growth is our most important problem (climate change and migration are symptoms of this problem) which will ruin life on Earth. It takes even more courage to stand up for population stabilization than as you have for women’s economic empowerment, immigration, and international trade tariffs. No other action will have a larger impact on Earth. Please direct the FDA to allow an expedited Phase III trial for QS now so it can be made available for sale in 2020.
REDUCING HUMAN POPULATION GROWTH REDUCES CLIMATE CHANGE.
So said Seth Wynes and Kimberly Nicholas in an article in Environmental Research Letters in July 2017:
“We have identified four recommended actions which we believe to be especially effective in reducing an individual’s greenhouse gas emissions: having one fewer child, living car-free, avoiding airplane travel, and eating a plant-based diet.”
In their article, Wynes and Nicholas published this graph showing the potential savings per year in a few countries by action.
CALL TO ACTION
Americans, people of Earth, please lend your voice to support a woman’s right to the contraceptive method she wants through QS on quinacrine.org so we can bring this cheap, safe, and effective method to all women of the world now. There’s plenty of evidence of QS safety and efficacy. Please demand QS be approved by the FDA in the U.S. now by executive order by calling President Trump 202-456-1111. Then Find your Senators and Find your Representatives in Congress and call them too (202) 224-3121.
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