GERON RECEIVES FDA CLEARANCE TO BEGINWORLD'S FIRST HUMAN CLINICAL TRIALOF EMBRYONIC STEM CELL-BASED THERAPY
Geron to Study GRNOPC1 in Patients with Acute Spinal Cord Injury
MENLO PARK, Calif., January 23, 2009 - Geron Corporation (Nasdaq: GERN) announced today that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury. The clearance enables Geron to move forward with the world's first study of a human embryonic stem cell (hESC)-based therapy in man. Geron plans to initiate a Phase I multi-center trial that is designed to establish the safety of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries. "The FDA's clearance of our GRNOPC1 IND is one of Geron's most significant accomplishments to date," said Thomas B. Okarma, Ph.D., M.D., Geron's president and CEO. "This marks the beginning of what is potentially a new chapter in medical therapeutics - one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord." GRNOPC1, Geron's lead hESC-based therapeutic candidate, contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury (Journal of Neuroscience, Vol. 25, 2005). "The neurosurgical community is very excited by this new approach to treating devastating spinal cord injury," said Richard Fessler, M.D., Ph.D., professor of neurological surgery at the Feinberg School of Medicine at Northwestern University. "Demyelination is central to the pathology of the injury, and its reversal by means of injecting oligodendrocyte progenitor cells would be revolutionary for the field. If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year." The GRNOPC1 Clinical Program Patients eligible for the Phase I trial must have documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T10 spinal segments and agree to have GRNOPC1 injected into the lesion sites between seven and 14 days after injury. Geron has selected up to seven U.S. medical centers as candidates to participate in this study and in planned protocol extensions. The sites will be identified as they come online and are ready to enroll subjects into the study. Although the primary endpoint of the trial is safety, the protocol includes secondary endpoints to assess efficacy, such as improved neuromuscular control or sensation in the trunk or lower extremities. Once safety in this patient population has been established and the FDA reviews clinical data in conjunction with additional data from ongoing animal studies, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1, enroll subjects with complete cervical injuries and expand the trial to include patients with severe incomplete (ASIA grade B or C) injuries to enable access to the therapy for as broad a population of severe spinal cord-injured patients as is medically appropriate. Preclinical Evidence of Safety, Tolerability and Efficacy Geron submitted evidence of the safety, tolerability and efficacy of GRNOPC1 to the FDA in a 21,000-page IND application that described 24 separate animal studies requiring the production of more than five billion GRNOPC1 cells. Included in the safety package were studies that showed no evidence of teratoma formation 12 months after injection of clinical grade GRNOPC1 into the injured spinal cord of rats and mice. Other studies documented the absence of significant migration of the injected cells outside the spinal cord, allodynia induction (increased neuropathic pain due to the injected cells), systemic toxicity or increased mortality in animals receiving GRNOPC1. In vitro studies have shown that GRNOPC1 is minimally recognized by the human immune system. GRNOPC1 is not recognized in vitro by allogeneic sera, NK cells or T cells (Journal of Neuroimmunology, Vol. 192, 2007). These immune-privileged characteristics of the hESC-derived cells allow a clinical trial design that incorporates a limited course of low-dose immunosuppression and provide the rationale for an off-the-shelf, allogeneic cell therapy. Also included in the IND application were published studies supporting the utility of GRNOPC1 for the treatment of spinal cord injury. Those studies showed that administration of GRNOPC1 significantly improved locomotor activity and kinematic scores of animals with spinal cord injuries when injected seven days after the injury (Journal of Neuroscience, Vol. 25, 2005). Histological examination of the injured spinal cords treated with GRNOPC1 showed improved axon survival and extensive remyelination surrounding the rat axons. These effects of GRNOPC1 were present nine months after a single injection of cells. In these nine-month studies, the cells were shown to migrate and fill the lesion cavity, with bundles of myelinated axons crossing the injury site. Production and Qualification of GRNOPC1 GRNOPC1 is produced using current Good Manufacturing Practices (cGMP) in Geron's manufacturing facilities. Geron's GRNOPC1 production process and clean-room suites have been inspected and licensed by the state of California. The cells are derived from the H1 human embryonic stem cell line, which was created before August 9, 2001. Studies using this line qualify for U.S. federal research funding, although no federal funding was received for the development of the product or to support the clinical trial. Geron's H1 hESC master cell bank is fully qualified for human use and was shown to be karyotypically normal and free of measurable contaminants of human or animal origin. Production of GRNOPC1 from undifferentiated hESCs in the master cell bank uses qualified reagents and a standardized protocol developed at Geron over the past three years. Each manufacturing run of GRNOPC1 is subjected to standardized quality control testing to ensure viability, sterility and appropriate cellular composition before release for clinical use. GRNOPC1 product that has passed all such specifications and has been released is available for the approved clinical trial. The current production scale can supply product needs through pivotal clinical trials. The existing master cell bank could potentially supply sufficient starting material for GRNOPC1 to commercially supply the U.S. acute spinal cord injury market for more than 20 years. Intellectual Property The production and commercialization of GRNOPC1 is protected by a portfolio of patent rights owned by or exclusively licensed to Geron. Patent rights owned by Geron protect key technologies developed at Geron for the scalable manufacturing of hESCs, as well as the production of neural cells by differentiation of hESCs. The fundamental patents covering hESCs are exclusively licensed to Geron from the Wisconsin Alumni Research Foundation (WARF) for the production of neural cells, cardiomyocytes and pancreatic islets for therapeutic applications. The validity of these patents was recently confirmed by the U.S. Patent and Trademark Office in a re-examination proceeding. Geron funded the original research at the University of Wisconsin-Madison that led to the first isolation of hESCs. The production of oligodendrocytes from hESCs is covered by patent rights exclusively licensed to Geron from the University of California. These patent rights cover technology developed in a research collaboration between Geron and University of California scientists. Conference Call and Video Webcast Thomas B. Okarma, Ph.D., M.D., will host a conference call and video Webcast presentation for investors and the media at 6:00 a.m. PST/9:00 a.m. EST today. Participants can access the conference call via telephone by dialing 866-783-2145 (U.S.) or 857-350-1604 (international). The passcode is 89631672. The video Webcast presentation is available at http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=67323&eventID=2077348. All participants are encouraged to view Dr. Okarma's presentation on the Internet. The video Webcast will also be accessible through a link that is posted on the home page of Geron's Web site at www.geron.com. Participants are encouraged to log on at least 15 minutes prior to the beginning of the presentation in order to download any necessary software. The video Webcast will be available for replay through February 23, 2009. About Geron Geron is developing first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. The company is advancing an anti-cancer drug and a cancer vaccine that target the enzyme telomerase through multiple clinical trials. Geron is also the world leader in the development of human embryonic stem (hESC) cell-based therapeutics. The company has received FDA clearance to begin the world's first human clinical trial of a hESC-based therapy: GRNOPC1 for acute spinal cord injury. For more information, visit www.geron.com. This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding potential applications of Geron's human embryonic stem cell technology constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Geron's periodic reports, including the quarterly report on Form 10-Q for the quarter ended September 30, 2008.
Many women say they have been pressured into abortions they did not want, according to research conducted by the Elliot Institute, a nonprofit specializing in the effects of abortion on women and families. For years, the pro-choice movement has circulated horrid tales of back-alley abortions performed before Roe v. Wade legalized abortion on demand in 1973. Yet the opposite phenomenon, which has occurred across the nation, is even more disturbing. In a society in which abortion is legal, many women and teens are pressured to abort their child. So how much choice do American women really have over their reproductive capacities?
Women are coerced to abort a fetus by either husbands or boyfriends who do not want the additional responsibility or expense of a child; by parents who are ashamed of a teen pregnancy or who seek to conceal incest or rape; or by counselors, pastors and health professionals who insist this is in a woman's best interest even when she doesn't think so. Consider the pressures women face to abort a child: 45 percent of men interviewed at abortion clinics said they urged abortion, including 37 percent of married men, according to the report "Forced Abortion in America" that compiled much of the research on this topic. Women are often threatened by male companions who take them to their abortion appointment, according to eyewitness accounts at abortion clinics. And women are also encouraged to abort their fetus by the staff at these clinics who have a vested interest in selling the procedure.
Pressure to abort can consist of badgering a pregnant woman until she concedes, intimidation, blackmail and even violence. An astounding 64 percent of women say they were intensely pressured to abort their fetus, according to a 2004 study published in the Medical Science Monitor. Hundreds of women have come forward to tell their tale - and some of these stories have led to convictions of coercers.
In Florida, Glenda Dowis brought her pregnant daughter at gunpoint to an abortion clinic, where the staff called police. To cover up her son's rape of a 12-year-old, Pennsylvania mother Joyce Farley took the pregnant girl out of state for an abortion - her parents were not notified. Nine women held in a juvenile detention center in Chalkville, Alabama accused the male guards of repeatedly raping them and then forcing the girls to have abortions when they became pregnant. Augencia Jasso of New Mexico was charged after hitting his pregnant, young, sexually abused victim in the stomach, deliberately inducing a miscarriage.
In other instances, coercion was less intense, but nonetheless played a vital role. A homeless woman, Shontrese Otry, was coerced to get an abortion by Emergency Shelters Inc., whose staff would not give her shelter unless she aborted the baby; she later won a $25,000 settlement. Actress Hunter Tylo was told by producers of "Melrose Place" to "just go out and get an abortion" when she became pregnant; she was fired - and later won a pregnancy discrimination suit. Assistant women's basketball coach Sharrona Alexander was told by a head coach at the University of California- Berkeley to quit or have an abortion; she gave birth and then won a $115,000 settlement.
Elliott Institute founder David Reardon says that Americans need to think about the man by ways women feel pressured to abort, and then suffer severe emotional and psychological consequences. In one instance, a pregnant teen he interviewed said she was asked by her mother: "Where will you live?"According to Mr. Reardon, "The withdrawal of social and economic support by parents is among one of the most common forms of coercion." Yet, despite the growing body of evidence on the issue of forced abortions, little headway has been made in protecting women. "I have been disappointed in the pro-life camp for not raising the level of urgency on this,"said Dr. Reardon. A simple solution is for states to pass a bill such as "The Prevention of Coerced and Unsafe Abortions Act" featured in the report.
This would require health professionals to screen for coercion and to counsel against an abortion in instances where there is a high risk that the woman is not freely consenting or that she will suffer severe depression - and possibly even attempt suicide - as a result of the procedure. Introducing a legal liability for psychological damage is one possible way to combat these practices. There is an ugly - and underreported - underside to the abortion industry: "Choice" is sometimes turned into coercion. The back alleys are gone, but the dangers for both mother and child are ever-present.
Apparently, if thousands of Chinese women are forced to abort their unborn children--and baby girls, in particular, are targeted for death--well that's just collateral damage in the cause of "women's rights", in the view of groups like NOW. Of course, to be fair, feminists claim that UNFPA does not directly support forced abortions in China. I'm skeptical that UNFPA equipment and funds do not aid some of the doctors performing forced abortions, but it's indisputable that that the Communist party gives local bureaucrats population control goals to meet. When number of births exceeds the desired limit, the bureaucrats sometimes decide to round up women and abort their children. For example, in April 2007 in Guangxi province, "61 pregnant women were injected with an abortive drug after being dragged to local hospitals". If Obama funds China's population control program without requiring China to prosecute those performing forced abortions--or, ideally, requiring China to do away with its one-child policy altogether--there will be a lot more horrifyingstories coming out of China--brought to you, in part, by the American taxpayer.
Robin was sitting in the classroom, giving me an exact account of the Russian Revolution. It was his specialist subject and he knew every date, every manoeuvre, the names of the Bolshevik leaders, and where they were when the Winter Palace was stormed. Robin was 16.
“So, what do you think of Lenin?” I asked. He looked at me blankly. “I don't think anything of Lenin,” he said. Robin was autistic.
He had an extraordinary grasp of facts, meticulously arranged in his mind. He had no concept of analysis or interpretation. The idea of forming an opinion was alien to him. With that incapacity came social isolation, an inability to form friendships or any lasting relationship. He was stranded, with his brilliant but disabled mind. Bringing him up had been a constant strain for his parents.
Quite how he would fare in the wider world was not yet clear.
Robin, and thousands like him, are at the centre of an ethical debate with far-reaching consequences. Within a few years it may become possible for expectant mothers to have prenatal tests to determine if their child is likely to be autistic.
These may be genetic, to see whether the characteristics of autism have been inherited, or tests of amniotic fluid in the womb to detect high levels of testosterone that have been found to be associated with the condition - mainly in boys.
As the parents of the first British baby screened to be free of a breast cancer gene celebrate the birth of a healthy daughter, this must seem yet another miraculous step in the advance of science. For any family that has experienced the anguish of living with an autistic child, the prospect of being able to determine if another is about to be born would be invaluable. It would offer that most precious commodity - a choice.
Just as with Down's syndrome, cystic fibrosis or spina bifida, a mother-to-be could decide whether she can cope with the strain of bringing up a disabled child. With an autistic child, it may mean a lifetime of rejection - living with someone unlikely ever to fit into the family, who responds with blank incomprehension to affection, whose behaviour may be erratic and disturbing, whose condition is permanent. Autism, and its associated condition, Asperger's syndrome, can range from virtual incapacity at one end of the spectrum to the merely strange at the other. To bring up one autistic child is a challenge to the sanity of an entire family. To bring up two might destroy it.
The evidence of Down's syndrome suggests that very high numbers of mothers-to-be opt for an abortion if pre-natal tests show that their child has the condition. In America it is as a high as 90 per cent. In Britain, it is not so high and may be reversing - as knowledge grows, perhaps more mothers elect to keep their babies. There is, however, a critical difference between Down's and autism, highlighted by Professor Simon Baron-Cohen, director of the Autism Research Centre at Cambridge. He points out that autistic males often turn out to be skilled at mathematics and engineering - some reaching near-genius level. Almost all the mathematical giants of the past have been male. He says that Newton and Einstein were almost certainly autistic, finding relationships difficult. Artists, too, have suffered from autism or Asperger's - including the blind pianist Derek Paravicini, the artist Peter Howson and, reportedly, the film director Steven Spielberg. So if we found a test for autism, and gave parents the opportunity of aborting the foetus, we might eliminate not just an unwanted and difficult child but a potential genius.
Here lies the dilemma. Should medical science offer the opportunity to eliminate a child who may turn out to be, not only a valuable member of society, but an important contributor to its future? And here lies a further twist in the moral maze. If that were the decision, what would be the justification for deciding that only the most intelligent members of society should be protected, while the less able were judged expendable. Does not that come close to Nazi-style eugenics, the one aspect of genetic engineering we have all determined will never again be contemplated?
Professor Baron-Cohen says that we must debate these matters now, before even the possibility of a test becomes a reality. I have no doubt he is right. But I am far from clear which side we should be on.
Every human instinct must surely be against some form of national screening that would offer the opportunity to breed out the wild, the eccentric, the sometimes weird, crazed individualists who break free of routine constraints and offer the diversity on which we thrive. Can we afford to lose a future Einstein?
There is a deeper strain to the debate. Who is to judge where lies the dividing line between madness and norm? As Kamran Nazeer so brilliantly described in Prospect magazine last year, it is possible to convert the apparent drawbacks of autism into an ideal - to learn the art of conversation, for instance, and to become as adept at it as a “normal” member of society.
As the father of a bipolar son, whose understanding of his own condition and whose empathy with his fellow human beings far surpasses my own, I claim no superiority of intelligence when it comes to deciding who is rational and who not. So I shrink instinctively from any notion that we should be given the opportunity of discarding a future human being simply because he or she may be an inconvenience.
If that means holding back science or our knowledge of genetics, even at the expense of suffering families, I think it a price worth paying. To interfere with the natural diversity of the human race runs the risk of impeding natural selection itself. And that, in Darwin's bicentenary, would be a backward step.
I am pleased to extend this invitation from the March for Life Fund Board of Directors and from thousands of prolife Americans as we look forward to the memorable occasion of your inauguration. We request that you come to speak to us at the 36th annual March for Life Rally on Thursday, Noon, January 22, 2009 at the Mall and 4th Street NW. Why? Because America needs your strong leadership as President of all of the people to stop the intentional killing of an estimated 3,000 preborn boys and girls each day and the brutalizing of mind, heart and body of pregnant mothers. This evil continues because some public officials and other citizens are indifferent to the fatal errors of Roe v. Wade and the critical need to overturn the illicit Roe v. Wade. So, on January 22, 2009, we prolifers will again peacefully March for Life in our Nation’s capital with the theme: "REMEMBER — The Life Principles mean ‘Equal Care’ with No Exception!"
What Are the Life Principles? The March for Life drew up and adopted the principles in 1974 as a positive response to Roe v. Wade errors. The Life Principles are summarized immediately below. They focus on the fact that each human life begins at fertilization, and society must provide equal care for the right to life of each born and preborn human. The Life Principles are based on law of God and Man: Thou Shalt Not Kill, and begin with a sentence adapted from our Declaration of Independence:
"We hold these truths to be self-evident: That all human beings are created equal and are endowed by their Creator with certain unalienable rights, among which is the right to life . . .."
The Life Principles then set the duty of every human in society and of society as a whole to preserve and protect the right to life from each human’s beginning at fertilization and throughout the natural continuum of life without regard to age, health, or condition of dependency.
The Life Principles conclude with an equal care provision: "When two or more human beings are in a situation in which their lives are mutually endangered, all available ordinary means and reasonable efforts shall be used to preserve and to protect the life of each and every human so endangered."
We know that a doctor may not be able to save the life of each patient. An innocent human may die, but must never be killed. Thus, rather than using an "exception clause" to try to authorize anyone intentionally to kill an innocent preborn, America must provide equal care for both a pregnant mother and her preborn child.
No Exception! No Compromise! What does this mean? It means that a government or a person does not own the unalienable right to life of another human, and does not have capacity to authorize anyone intentionally to kill an innocent human with impunity. We can correct Roe v. Wade errors with education focused on 1) the fact that a human is in existence at fertilization, and 2) society’s duty is to provide equal care for both a pregnant mother and her preborn child. This theme calls each American – prolife and pro-abortion alike – to free ourselves from the evils of abortion. Moral and civil laws are based on sanctity of human life and command each human not to shed innocent blood. Each American has a personal duty to God, Self, Neighbor and Country to defend by word and deed against abortion evils, because it is the inescapable right thing to do.
History tells us that this duty to protect the right to life of each human in existence at fertilization was not always carried out as it should have been. Our own country suffers the evils of slavery, the Nazi era, and more. Both church and state officials often apologize today for past errors when heinous things were done and when necessary proper things were not done. Abortion evil in America is error which officials and citizenry of both church and state have a duty to stop and can unite to stop. The dreadful killing goes on because abortionists and media keep the innocent blood of preborns out-of-sight, which keeps many Americans so passive to the evil of killing that they tolerate or even support a choice to murder preborns. Killing innocents is a crime against humanity as we learn from principles used by Americans in judging at the Nuremberg Trials. There is no common ground or "moderate" position between "to kill or not to kill.
"It is an anomaly for an American to enjoy personal civil rights and then participate directly or indirectly in the intentional killing of even one preborn human – or, for public and private officials to favor legislation, persons, or positions which make exceptions to the Life Principles and approve of murdering a preborn human with impunity. Americans must not shirk their duty to protect preborns today and force Americans to apologize tomorrow for the massacre of innocents which we can stop today. The offense of innocent blood wreaks havoc on the moral, political, economic and social fiber of both individual citizens and our country. By abortion, a pregnant mother is hurt and a preborn is a torn-apart corpse. Each prolifer is repulsed that America tolerates this home-grown violence to humans. It is equally as heinous intentionally to kill a tiny preborn human at fertilization as to kill a larger preborn or an innocent born human.
Mr. Obama, we hear about genocide in far-off lands, and America is asked to help stop that evil. Certainly America wants to help stop all genocide evil – foreign and domestic. Since the illicit Roe v. Wade, America suffers genocide of an estimated 50,000,000 preborn boys and girls. And, since the March for Life Rally last year, an estimated 1,300,000 preborn humans have been intentionally killed out-of-sight – without coverage by media or a celebrity. An abortion killing site is within walking distance of the White House. As President of all the people, please join us prolifers as we March for Life for love of God, of our born and preborn Neighbors, including abortionists, and of our Country.
NEW YORK - The advent of the Obama administration is rousing enthusiasm among abortion-rights supporters and deep anxiety among opponents as both sides mark Thursday's anniversary of Roe v. Wade.Abortion-rights groups view President Barack Obama - and the Democratic leadership in Congress - as allies who are likely to ease restrictions on federal funding, broaden family-planning programs, and install federal judges who support the Supreme Court's landmark 1973 decision that legalized abortion.Anti-abortion activists fear multiple political setbacks and are urging the Republican minority in the Senate to filibuster if necessary."The alignment of a hard-core pro-abortion president with pro-abortion Democratic majorities in Congress means that many existing pro-life policies are now in great jeopardy,"
Douglas Johnson of the National Right to Life Committee wrote in a memo this month."Some damage is inevitable," Johnson added. "But the extent to which the Obama abortion agenda will be achieved will depend on the perception of elected policy-makers as to how the public is responding to the proposed changes."Obama can take some steps without Congress. Abortion-rights supporters hope he will quickly repeal the so-called "global gag rule," which bans overseas family planning groups that receive U.S. funds from providing any abortion-related services or information."He could move right away," said Nancy Keenan, president of NARAL Pro-Choice America. "It would make a big, big difference in the lives of poor women abroad."The president of the U.S. Conference of Catholic Bishops, Cardinal Francis George, wrote Obama last week urging him to keep the funding ban, arguing that "a shift toward promoting abortion in developing nations would also increase distrust of the United States."In the U.S., abortion-rights groups are backing what they call a "common-ground, commonsense" agenda in Congress aimed at reducing the number of unintended pregnancies. The Prevention First Act, already endorsed by Obama, would increase federal funding for family planning, promote comprehensive sex education, and expand women's access to contraceptives.Other proposals, supported by moderates and conservatives, would provide incentives for pregnant women to carry their fetuses to term. But there would likely be bitter debate, largely along partisan lines, if Democrats try to repeal the 33-year-old Hyde Amendment and other laws that ban federal funding for abortions under almost all circumstances.Abortion-rights activists would like these bans lifted so that poor women could access abortion through Medicaid and servicewomen could get abortions through military health programs.
Conservatives have mounted a petition drive aimed at pressuring House Appropriations Chairman David Obey, D-Wis., to preserve the bans.Rep. Diana DeGette, D-Colo., a lead sponsor of the Prevention First Act, says she opposes the Hyde Amendment but would not make it a priority to repeal it this year."Our efforts should be focused on finding common ground to prevent unwanted pregnancies so you won't have to worry about abortions in the first place," she said in a telephone interview Wednesday.While on the defensive in Washington, anti-abortion groups are on the attack against the Planned Parenthood Federation of America, which provides family-planning and reproductive-health services - including abortions - at its nationwide network of clinics.Planned Parenthood receives extensive public funding for its non-abortion services, and anti-abortion activists contend this amounts to an indirect subsidy of abortion that should be halted, especially during an economic crisis.Last fall, several anti-abortion groups formed a coalition to hinder the opening of new Planned Parenthood clinics and reducing the funding it receives from corporate and government sources.The economic crisis and the Bernard Madoff investment scandal already have affected donations to Planned Parenthood, which recently laid off some employees. Its president, Cecile Richards, wouldn't specify the number of layoffs, but expressed confidence that her organization would thrive under Obama."We're excited to have a president who understands and supports women's health needs, who will be partner," she said.Several of Obama's high-level appointments reflect his ties to the abortion-rights movement.
The White House communications director, Ellen Moran, was executive director of EMILY's List - which raises funds for female Democratic candidates who support abortion rights. Domestic policy adviser Melody Barnes served on the board of EMILY's List, and Dawn Johnsen, appointed as assistant attorney general for the office of legal counsel, was once an abortion-rights lawyer for NARAL.Across the country, rallies, vigils and other events are planned Thursday to mark the Roe v. Wade anniversary. Activities in Washington include the annual March for Life, an anti-abortion service at the new U.S. Capitol Visitor Center, a "Blogs for Life" conference featuring Sen. Sam Brownback, R-Kan., and a vigil outside the Supreme Court building in support of abortion rights, organized by the National Organization for Women.But this year, March for Life participants won't be hearing a presidential message of support from George W. Bush. Bush remained popular among anti-abortion activists, who felt their views were reflected in his appointments to the U.S. Supreme Court and other federal judgeships.
THIS week news of an important report was published in L'Osservatore Romano which, if you will excuse the painful pun, should have been a godsend to eager environmentalists. After all these people are great doomsayers and the contents of the report was the stuff of science fiction horror stories.
According to the International Federation of Catholic Medical Associations, an alarming rise in male infertility in developed nations is possibly caused by the quantities of synthetic female hormones, particularly estrogen, in the food chain and water. These quantities are directly attributable to increased use of the contraceptive pill and hormone replacement therapy. The original report published in German has been widely publicised but mysteriously, the only response to this terrible scenario, which seems to be with us just as surely as global warming, were a couple of letters in this publication and in The Sydney Morning Herald that could have come straight from a 19th-century Old Bigot's handbook of insults. They hysterically decried the whole thing as a Vatican misogynistic plot. Never mind that it didn't come from the Vatican. But apparently, in some people's minds, any taint of Catholicism is enough to justify screaming "ignorant, stupid, unscientific" and of course predictably "misogyny".
Strange then that in 1998 women's groups and environmentalists formed an alliance in Japan against the legalisation of the contraceptive pill. Apparently some Japanese women and environmentalists, including the Women's Network for Ecology, were worried enough about the effect of introducing synthetic hormones in a country that relies on very intensive agriculture and aquaculture to campaign against its legalisation. That is aside from widespread suspicion among Japanese women that there is a definite link between the use of the pill and breast cancer in their Western sisters.
The evidence that synthetic hormones can have grotesque environmental effects has actually been around for a long time and it is mounting. As long ago as the 1980s, studies were done in the US which showed the effects of estrogen pollution on wildlife, famously alligators in Florida with deformed genitals. But more recently, in February 2008, the University of Cardiff published a study that claimed a link between sexual deformities in birds around sewerage outlets of large British cities and the increased amount of estrogen finding its way into rivers and estuaries.
Recently during research for a story on the viability of using recycled water in Canberra, I came across several papers that pointed to the problem of estrogen in recycled water. Indeed, according to Canberra Hospital professor Peter Collignon, an opponent of recycling sewage water into the potable supply, estrogen can be more of a problem in recycled water than microbes because it cannot be filtered out and we simply do not know how well it breaks down. Just as the Romans drinking from lead cups unwittingly caused infertility in themselves, perhaps we are seeing after 30 years of contraceptive pill use the long-term effects of introducing artificial estrogen into our wider environment. So you see this is not just a preoccupation of the misogynistic old Vatican.
But how can it be misogynistic to point out that artificial hormones can have a bad effect on men as well as women? And who exactly are the misogynists? Is it the people warning of the possible dangers of long-term exposure to artificial estrogen for both sexes, or the hysterical letter writers and doctors who seem to be saying, "There dear, just go ahead and take your pill and everything will be all right?"
As a woman I think Australian women ought to think again about this great biochemical boon to the human race, or perhaps I should say to men. Australian women have one of the highest rates of contraceptive pill use in the world. Most women feel obliged to use it as soon as they become sexually active and the average time women stay on the pill is 10 years. That is 10 years of suppressing one's normal hormonal cycle and replacing it with artificial hormones with all the physical and psychological ramifications, including the decline of libido.
However, even though we have the highest rate of breast cancer in the world, and there is a lot of research pointing to the pill as at least a partially causative factor, many doctors (even some of my own acquaintance) have no compunction in prescribing it to girls who have just reached puberty. In fact one doctor I know told me she feels legally obliged to give it to any sexually active girl, no matter what age. Furthermore, not only is long-term pill use implicated in infertility and sexually transmitted disease, what is worse is it has not prevented our abortion rate from being one of the world's highest.
There are so many reasons for being wary of the contraceptive pill. Why are we not questioning its prevalence?
The reason is, of course, that it is the sacred cow of the sexual revolution. One imaginative letter writer claimed the Catholic view of the pill was that it was "the great Satan", and actually that is not a bad description. It was marketed as an instrument of sexual freedom, and it has provided that, particularly for men. But one might ask if for women it has been the means of sexual liberation or just a way of turning us into empty vessels for sex? Is it like the sexual revolution itself: a pretty and alluring package that turns out to be - for both sexes - like a series of empty boxes, one inside the other. At the end, there is nothing but an empty box.
The environmental effects of the pill on men may in fact gradually reveal the extent of the damage to our whole society, something that Francis Fukuyama points out in his essay, The Great Disruption: that we can't just introduce something such as this for 30 years and not expect unforeseen consequences, moral, social and, of course, physical. But tragically it will be young men and boys who suffer before women will also free themselves of this burden.
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