Our Bodies, Ourselves (171 page)

Microbicides, substances that when inserted in the vagina or rectum could substantially reduce the risk of getting or transmitting STIs, including HIV, have been under study for many years, often with disappointing results. More recent work with topical antiretrovirals used in gel form has shown promise in reducing the risk of viral transmission.

In July 2010, South African scientists who led the CAPRISA 004 trial announced that 1 percent tenofovir gel reduced women's risk of acquiring HIV from their male partners by 39 percent.
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The researchers found that women who used the gel 80 percent or more of the times they had sex had reduced their HIV risk by 54 percent. Women who used the gel less than half the times, however, reduced their HIV risk by only 28 percent, indicating, not surprisingly, that the more consistently the microbicide gel was used, the less likely its user was to become HIV positive. What was surprising, however, was that tenofovir gel also showed 51 percent effectiveness against herpes (HSV-2) infection; this was important in itself—and also because people infected with herpes are more likely to acquire and transmit HIV.

Still, it will probably be three to four years before tenofovir gel becomes publicly available, as more studies are needed to confirm its effectiveness and safety. Another large study involving tenofovir gel is under way, with results expected in 2012 or 2013, and smaller key studies are being readied for rapid start-up. Confirmation from these studies that the gel has a protective effect would be likely to expedite efforts to bring it to market. Several other potential microbicides are also in clinical trials, with a larger number in development.

This new antiretroviral-based class of candidates may be more potent and offer greater protection against HIV infection than any of those tested to date. Like any drug, they will raise different kinds of questions. Antiretroviral-based microbicides are likely to be available only by
prescription (at least initially, until more is known about them) and may raise questions of drug resistance. They may not protect against other STIs, since they target HIV specifically. Still, tenofovir's activity against herpes was a fine surprise, and some ARV-based candidates may lend themselves to combination with other anti-infectives, contraceptives, and new delivery systems.

Owing to the many years of work by advocates around the world, millions of people have now heard about microbicides and agree on the need for them. Now it is up to us as advocates to ensure that funding is available and public demand for microbicides is maintained so that these candidates continue to move through the product pipeline as efficiently and as rapidly as possible.

We are well into what some have termed the biotech century, and a range of new reproductive and genetic technologies and practices are under development and being brought to market. Many offer significant benefits, including advanced tools for biomedical research, improved medical treatments, and new options for forming families. But many also pose unique safety challenges and raise questions about their social consequences and ethical meanings.

Assisted reproductive technologies are an obvious area of interest for those concerned with women's health (see
“The Ethics of Fertility Treatments,”
). Other issues raised by human biotechnologies and related technologies include the patenting of human genes; the appropriate use of genetic testing; the questionable marketing of direct-to-consumer tests to determine your (or your children's) genetic makeup; the civil liberties and racial justice implications of forensic DNA databases; the use of synthetic biology techniques to create novel forms of life; and the prospect of extreme practices such as creating cloned or genetically redesigned human beings.

Advocates for women's health are among the growing number of civil society leaders, scholars, and policy experts who are concerned about the societal implications of these technologies and who want to ensure that their introduction will be grounded in values of social justice, human rights, ecological integrity, and the common good.

An informal network of organizations and individuals concerned about new reproductive and genetic technologies gathered in summer 2010 for the first of three planned annual meetings, now collectively known as the Tarrytown Meetings. The Center for Genetics and Society is the lead organization, and Our Bodies Ourselves is proud to be centrally involved in planning and implementation. These meetings focus on the policies, practices, and other societal changes needed to ensure responsible use and accountable governance of these technologies, both nationally and globally, and to promote a fuller awareness of their benefits and risks among the public, opinion leaders, policy makers, and others. For more information, see geneticsandsociety.org.

Since human embryonic stem cells were first isolated in 1998, some scientists, biotechnology companies, and research advocates have made dramatic claims about their medical potential, promising treatments and cures for a wide range of chronic, degenerative, and acute diseases—including diabetes, Parkinson's disease, cancer, and Alzheimer's disease.

Their predictions have won impassioned support from many patient advocacy groups and stirred hopes in all who want to alleviate the suffering that these diseases inflict. Although some of these claims have been exaggerated, and although no treatments based on embryonic stem cells have been produced so far, many researchers believe that significant breakthroughs may be close at hand.

In addition to building excitement, embryonic stem cell research has also generated heated controversy. The critical voices most often heard during debates are those with strong moral objections to
all
embryonic stem cell work, on the grounds that it uses and then destroys human embryos for the sole purpose of harvesting stem cells. Yet a number of reproductive rights advocates have concerns, too—specifically about a type of stem cell research known as research cloning.

The crucial distinction between embryonic stem cell research and research cloning is often blurred in the public debate. Embryonic stem cell research uses embryos initially produced in fertility clinics to help women become pregnant. So long as those embryos are donated with informed consent, which some people wish to do when they no longer need them for reproductive purposes, most women's health advocates have no objections to their use in research.

Research cloning—also called somatic cell nuclear transfer, embryo cloning, and therapeutic cloning—requires young women to undergo invasive and risky egg extraction procedures solely for the purpose of research. If it were to be perfected, research cloning would open a gateway not just to therapeutic applications but to efforts to clone a human being or to engineer the traits of future
children (see
“Genetic Modification of on Future Generations”
). Unlike dozens of countries around the world, the United States has not yet established a federal prohibition on reproductive cloning, making it more likely that unethical researchers would use cloned embryos to attempt to produce a cloned baby.

Still, some reproductive rights advocates have hesitated to speak out against research cloning out of apprehension that their concerns will be used by anti–abortion rights activists to elevate the legal and moral status of embryos in efforts to deny access to abortion.

With new developments such as induced pluripotent stem cells (iPS cells)—specially treated cells that can be processed to behave somewhat like embryonic stem cells—research cloning may not even be necessary for generating patient-specific and disease-specific stem cell lines that could be used for medical therapies.

Many feminists and social justice activists are concerned about research cloning and the egg extraction required for it. The envisioned treatments could require many thousands of donated eggs, requiring thousands of women to undergo the substantial risks of multiple egg extraction, which uses high doses of potent drugs. Although women already undergo these procedures in infertility clinics, the risks—even as inadequately defined as they are—may be justified because there is a demonstrated possibility that a baby will result. It is unwarranted to ask women to undergo these risks solely for research cloning. Not only are the benefits unclear, but there are not yet sufficient data on health risks to make true informed consent possible.

In addition, many women's health advocates are concerned about the creation of a larger market in human eggs. Women providing eggs for other people's fertility treatments generally receive reimbursements that range from $5,000 to $10,000, and some ads on college campuses have offered as much as $50,000 to $100,000 for eggs from women with desired traits (so-called Ivy League eggs).

It is unlikely that many women would provide eggs for research without reimbursement, and economically disadvantaged and young women would be most vulnerable to such incentives. Whether eggs are for research or helping others to have a baby, all women have the right to be informed about the potential risks. For this reason, advocacy groups are now calling for a national registry that would track the long-term effects of these procedures on women who donate eggs.

New developments in assisted reproductive technologies (ART) have enabled many people to have biologically related children who previously could not. At the same time, these technologies continue to raise complicated ethical questions that are often difficult for individuals and society to resolve.

Drawing the line with ARTs is both an individual and a social concern. In countries such as Canada, the United Kingdom, South Korea, and Australia, public policies have already been established to ensure greater safety for everyone involved with fertility procedures—parents, children, women who donate eggs, and gestational, or surrogate, mothers. These countries have prioritized the need for public discourse to ensure that these technologies—powerful enough to create human life outside a woman's body and to alter the species—are used in ways that society deems ethically acceptable.

Procedures that enable women to have a gestational—but not genetic—tie to a child, or that result in children with several sets of parents, pose new social and logistical dilemmas. Other procedures that test the genes of fetuses or embryos for genetic conditions open the way to further stigmatize people with disabilities; every day, more conditions are classified as diseases requiring intervention. A small but vocal group of scientists and others envision a future in which parents routinely choose their offspring's sex, physical traits, and even intelligence, prospects that would alter family and social relationships in disturbing ways.

As assisted reproduction technologies have mushroomed into a multibillion-dollar fertility industry, ethical and social challenges multiply. And as people seek to avoid policies in one country by traveling to another country to seek the services of a gestational mother, or to obtain embryos or donated eggs not available in their own countries, a rapidly growing phenomenon of cross-border reproductive tourism—also called fertility tourism—has magnified these problems.

For example, because the services of gestational mothers are less expensive in India than in the United States, India has become the leading go-to source of such services. Women with few other economic options are becoming gestational mothers with little assurance that contracts specifying particular payments will be honored, and with little protection for their own well-being and autonomy. These women are sometimes required to leave their own children for part or all of the duration of the pregnancy, live in dormitories attached to fertility clinics, and deliver by C-section even when that is not medically indicated.