Refer Feminist Research: Corea, Gena. The Invisble Epidemic: The Story of Women and AIDS (New York: Harper Collins Publishers Inc., 1992, and at the time widely acknowledged as the female equivalent of Randy Stilts' classic, And the Band Played On .... , plus in December of 1992 was listed in The New York Times Book Review "Notable Books of the Year".
In other words, a decade-plus of neglect which largely accounts for research into the highly promising protective measure of microbicides still being in its infancy in 2005, even as the feminized face of HIV/AIDS becomes more and more obvious. Under which rock have the the below mentioned "experts" been hiding since 1992? =========================== Pakistan Saturday June 11 2005-- Jamadi Al Awwal 03, 1426 A.H.
Women: more vulnerable to HIV
HIV/AIDS is rapidly becoming a woman's epidemic. Approximately 14,000 people become infected with HIV every day, half of them women Bobby Ramakant
Global HIV data -- tragically -- confirms what women's health, rights, and social justice advocates have said for a decade. The social, economic, and sexual vulnerability of women -- particularly young women and girls -- harms their health and increases their risk of HIV and other sexually transmitted diseases (STDs). Existing prevention strategies have largely failed to address this vulnerability, focusing on abstinence, mutual monogamy and male condom use -- none of which are easily controlled by women. The faces of HIV and AIDS in the world today are increasingly those of young women, many of whom are married, many of whom contracted the virus during adolescence.
Predictably, HIV/AIDS is rapidly becoming a woman's epidemic. Approximately 14,000 people become infected with HIV everyday. Half of them are women. A vast majority of women had only one mode of exposure to HIV -- sex with their male partners. Women are biologically more vulnerable to STD including HIV/AIDS. Women are twice as likely as men to contract HIV from unprotected intercourse. Vaginal membranes are exposed to infectious fluids for hours after sex; younger women are at greater risk because the immature cervix is more vulnerable to damage and infection. STDs often go undetected, and therefore untreated, in women. They increase women's vulnerability to HIV and if untreated, can lead to infertility, ectopic pregnancy, infant mortality and cervical cancer.
Gender inequalities prevent many women from being able to protect themselves. Millions of women lack the social and economic power to insist on HIV prevention measures, such as condoms, abstinence or mutual monogamy. Male and female condom use requires the tacit cooperation, if not outright participation, of the male partner. HIV risk escalates among adolescent girls because of their physical vulnerability and susceptibility to rape, forced marriage, trafficking, economic dependence and coercion. Violence, coercion, and economic dependency render millions of women of all ages unable to "negotiate" condom use or to abandon partners who put them at risk. Millions live in societies that permit them no role in sexual decision-making, condone male infidelity and assign to women the burden of shame and stigma associated with infectious disease.
But there is always hope that not only gender inequity might change for the better, and women and men will recognise, appreciate and respect the rights of each other, but women will have more meaningful roles to play in decision-making, and will be empowered enough to access, afford, use and negotiate the use of STD/HIV prevention options with their partners. This struggle will indeed be a long one.
Some dedicated advocates, scientists and donors are working to develop microbicides -- gels, tablets, or other intra-vaginal products a woman could use to reduce the risk of getting HIV through sex. Microbicides are substances that can substantially reduce the transmission of HIV and other sexually transmitted infections (STIs) when applied vaginally and, possibly, rectally. Epidemiological models suggest that a microbicide with 60 percent efficacy could avert 2.54 million HIV infections worldwide over three years.
However, microbicides are still being researched; it will require significant political will, public investment and popular demand before they become available. Microbicides are at different stages of research in a number of countries. They could be produced in a variety of forms: gel, cream, film, suppository, sponge or vaginal ring. Some would enable women to become pregnant without risking infection, while others would also be contraceptives, offering women a dual protection method.
Many studies have reported that women who perceive themselves at risk for HIV had little success in asking their husbands to use condoms. While condom promotion has encouraged men to use this protection with sex workers and casual partners, most men still refuse to use condoms with wives or regular partners. No wonder HIV cases are increasing rapidly among married, monogamous women in countries like India. Microbicides will certainly help these women to protect themselves from STI/HIV.
Many women want to get pregnant -- for their own reasons and/or to achieve the status and security that, in many societies, they can only attain through motherhood. Since condoms are contraceptive, women now have to choose between childbearing and HIV prevention. Microbicides offer a ray of hope here too, being developed into two variants: contraceptive and non-contraceptive, which will make it possible for a woman to conceive without exposing herself to the risk of HIV transmission.
Microbicides must be safe for all potential users -- women and men, pregnant women, HIV-positive women, adolescents. They must also be compatible with condoms and other barrier methods. Potential mechanisms of microbicide action include: killing or inactivating the virus by disrupting the surface membrane (surfactants), boosting the vagina's natural defences (acidifying agents), or preventing the virus from binding to its target cells (adsorption inhibitors), blocking replication of the virus once it has entered cells.
There are about 60 possible microbicides in the pipeline. Six potential products are likely to enter the phase of large-scale multi-centric clinical trials soon to assess effectiveness in prevention of vaginal transmission of HIV. These products include the surfactant (Savvy), the acidifying agent (buffer gel), and the adsorption inhibitors (PRO 2000, dextrin sulphate, carageenan and cellulose sulphate).
There are also some barriers to widespread support for microbicides. Morally conservative and patriarchal social norms make it difficult to confront the reality of a sexually transmitted epidemic. A culture of silence around women's sexuality enhances the stigma associated with seeking information or interventions about self-protection.
Much progress has been made on microbicides, but many challenges remain. Badly needed is a significant increase in investment from both the public and private sectors.
Another challenge is to involve men and try to address the unequal power equation between a man and a woman, thereby increasing the understanding of each other's need, and collectively demand: HIV prevention must address women's needs and vulnerabilities. Women need education, economic opportunity and social support, and gender equality in order to protect their health and rights. Women need HIV and STI prevention tools they can control. Women need microbicides.
The writer is a key correspondent for Health and Development Networks, Thailand, and volunteers as AIDS Care Watch campaign coordinator for South Asia
DifferenTakes is an investigative series of issue papers, published by the Population and Development Program at Hampshire College, providing alternative information and analysis on a wide range of reproductive rights, population, environment and social justice issues. This spring we are launching a special series of DifferenTakes focusing on 'Reviving Reproductive Safety' in movements for women's health and reproductive justice.
We are pleased to send you the fourth fifth in the series, "Quinacrine Sterilization in India: Women's Health and Medical Ethics Still at Risk" by Rajashri Dasgupta. This issue explores health risks and ethical controversies associated with the use of quinacrine sterilization, a method banned in India in 1998 but which is still being used by medical practitioners in in the country to sterilize women.
- Betsy Hartmann and Amy Oliver Co-editors, DifferenTakes Download .pdf format here ^^^^^^^^^^^^^^
Quinacrine Sterilization in India:Women’s Health and Medical Ethics Still at Risk
Women’s groups in India are only too aware that the “real battles” are fought outside the court room. In 1998, when the Supreme Court of India banned quinacrine sterilization (QS) because its long-term effects on women are unknown and are potentially harmful, activists knew they had to continue the struggle outside the courts. Their fears proved true when a group of medical practitioners violated the ban on the use of the drug for female sterilization.
A study conducted in 2003 found that five years after the ban, medical practitioners in India were still using quinacrine to sterilize women.1 None of the women interviewed knew that QS was an unauthorized method, with potential health hazards. Most of the women who underwent QS said that the provider never asked them to sign or give their thumb-print on any consent form or other document. The few who did sign forms said that they were not aware why they were asked to do so. "It calls into question any claim that informed consent was given by these women, thus violating their human rights," stated Shree Mulay, Director, Centre for Research and Teaching on Women, McGill University, Canada, who led the team of researchers based in Kolkata, the capital city of West Bengal, the Indian state bordering Bangladesh.2
QS is a non-surgical, permanent method of sterilization by the synthetic anti-malarial chemical quinacrine. When quinacrine pellets are inserted into the uterus through an intra-uterine device, they dissolve, form scars and block the fallopian tube to prevent fertilization.
In 1997, women's health advocates around the world were alarmed to discover that large-scale clinical trials had been conducted with QS on over 100,000 women in 25 countries. An ardent proponent of QS, Dr. Ashi Sarin, claimed in a telephone interview that at least one-fifth of the QS cases in the world were done in 26 centers in India before the ban. Sarin herself has conducted 134 QS procedures among ‘high-risk’ women and found it to be effective. "In most countries like India the trials were covert. We are concerned that women are being targets of unethical drug trials," said Mohan Rao of the Public Health faculty of Jawaharlal Nehru University (JNU) in Delhi.
It was this concern that led to intense campaigns by women’s groups in several parts of the country. Protest demonstrations were held in front of clinics of doctors practicing QS in the cities of Delhi and Kolkata. Saheli, a prominent women’s rights group, published an in-depth study that countered the arguments put forward by QS advocates and media reports questioned the government’s failures in regulating and monitoring illegal drug trials. To further strengthen the growing movement, the faculty of Public Health at JNU joined hands with the All India Democratic Women’s Association to file a public interest litigation that finally led to the Supreme Court ban on QS.
Two years later in a workshop in Kolkata, a study with a feminist perspective was developed to document women’s experiences of QS, determine if there are any deleterious effects, investigate whether QS is being used after the ban and find out whether women were aware that QS was an experimental method. The workshop participants were women’s health advocates, academics and media personnel, many of whom had been involved in the movement against QS in India, Bangladesh, the USA and Canada; they supported the study team with ideas and advice during the entire research period.
Given limited resources, a larger population-based study was not possible. Instead the study in West Bengal would conduct in-depth interviews with 32 women in one region who had undergone quinacrine sterilization, followed by medical examination offered to those who wanted one. An equal number of women who had undergone surgical sterilization (SS) were selected using parity parameters such as socio-economic status, current age, age during the sterilization procedure, and reproductive history at the time of the study.
In 2003, the study was released in Kolkata with the support of women’s activists and the Women’s Commission of West Bengal, a statutory body. It found the striking difference between the QS and SS women was that the former had several cases of cervical erosion and inflammation, requiring long-term follow up. Thirteen of the 32 QS women “bled on touch” during internal examination, and the cervices of 13 were diagnosed as "clinically unhealthy” and “ulcerated,” and had “growth,” therefore requiring further microscopic investigations, according to Dr Sanjeev Mukherjee, a Kolkata-based gynecologist who conducted the medical examination.
In the last decade worldwide unethical QS trials received a series of setbacks. In 1998, the U.S. Food and Drug Administration (FDA) asked the two Americans, Dr. Elton Kessel and Stephen Mumford, the spirit behind the trials, to halt immediately the distribution, import, manufacture and export of quinacrine pellets for female sterilization. Earlier in 1994, the World Health Organization (WHO) had cautioned researchers to stop all human trials until laboratory and animal testing was complete, the first essential steps in the development of any new drug. But it was the Indian ban that was an “enormous setback” for QS worldwide, said Dr. Mumford, as it “undermined the efforts of individuals in numerous other governments to have their own governments undertake national clinical trials.”
QS is promoted in countries like India by a network of doctors (like Sarin) in urban areas, who in turn train rural practitioners and supply them with pellets. In West Bengal, gynecologist Biral Mullick claimed to have done 10,000 QS procedures; he trained hundreds of rural practitioners and set up the Indian Rural Medical Association (IRMA) that claims a membership of 40,000. The rural practitioners have a smattering knowledge of allopathic drugs and combine it with traditional medicine and homeopathy.
"The doctors are my friends and I only teach them the technical know-how and provide them with pellets," admitted Kessel when he was in Kolkata in 1998 to convince doctors to appeal to the Indian government to rescind the ban. “I do not do anything illegal, I do not do trials in your country.”
What drives Kessel, founder of the International Federation for Family Health, and Mumford, director of the US-based Center for Research on Population and Security (CRPS), is their life-long devotion to fighting population growth in developing countries and increased immigration to developed countries. They promote QS as the answer to maternal deaths in poor countries while simultaneously promoting the need for sterilization by playing on upper-class fears of the “population problem.”
"The explosion of numbers will come from the immigrants and their offspring and will dominate our lives. There will be chaos and anarchy. It's even more serious than the nuclear threat," said Kessel. “The threat of immigrants invading and taking over is real, they are swarming all over and draining the resources. Look at the chaos in India’s eastern region with thousands coming in from Bangladesh and in the USA, Mexicans and Caribbeans are pouring in. No civilized government can allow this.”
By exploiting fear of the “population explosion,” Mumford and Kessel shift attention away from pressing issues of hunger, unemployment and rising costs of health care and education, according to economist Navsharan Singh, who co-authored the West Bengal study. Like national governments and the international population lobby, the duo do not take into account the impoverished lifestyles and gender inequality that rob most women of their choice on issues of marriage or repeated pregnancies.
The West Bengal study, for the first time, documented the actual experiences of women who have undergone QS. Apart from the health impact, it probes deeply the socio-economic context in which women are choosing to be sterilized and the issue of easy availability of QS from private medical practitioners in the context of deteriorating public health services. Rural medical practitioners who provide QS were interviewed to understand their informal networks and to provide a contrast to the information given by the women.
A major factor that influenced women's decision-making was that the rural medical practitioners who provide QS are locals and trusted members of the community. Moreover, they have a personal relationship with the women and their families since over the years they have treated them for various ailments. As one woman sterilized with quinacrine put it, "He (the provider) guaranteed that there would be no side-effects. And his medicines really work. He has treated me many times; I have faith in him." In contrast, surgical sterilizations are done in impersonal camps by unknown doctors with hundreds of women sterilized on one day with makeshift facilities and little counseling.
In the absence of adequate public health services, particularly in rural areas, the easy availability and accessibility of these providers make the community dependent on them. The IRMA of unregistered ‘doctors’ also provide essential services like abortion and thus endear themselves to women. In such a scenario, women who are desperate for birth control need little convincing to try QS after hearing positive things about these ‘doctors’ from relatives or neighbors who have undergone the procedure.
According to women's rights activist Laxmi Murthy, "The non-governmental organizations (NGOs) like IRMA providing QS tend to be better-behaved and have better services than the government-run clinics. So when NGOs use these banned procedures, people unfortunately tend to trust them more than the government, which they are more suspicious of. Since government services are almost non-existent especially in villages, NGOs fill the gap and are welcomed."
The use of banned drugs and procedures in India is possible because of weak regulations and lack of monitoring and enforcement. Two years ago, members of IRMA conducted trials on 700 women in Bengal by inserting crushed erythromycin tablets through an intra-uterine device to sterilize them. Last year, doctors experimented with chord blood on HIV/AIDS patients without their consent or following research protocols. "It's the lure of fame, foreign travel and the glamour of seminars that encourage doctors to pursue these so-called trials," said gynecologist Mukherjee.
Health and women's rights networks have used various opportunities to raise awareness about the campaign against quinacrine sterilization in India. They have suggested to the state drug controller that medical professional bodies should be informed repeatedly and warned against its use. Following the public hue and cry, the rampant use of QS seems to have weakened among qualified doctors in the cities.
However, some doctors have appealed to the Drug Controller of India to rescind the QS ban. Last year Dr. Sarin filed a legal petition in the Punjab High Court to lift the ban on quinacrine. For the last six years, said Mumford, Dr. Kessel and he have “personally” talked to perhaps 20,000 American clinicians about QS, including physicians, nurse practitioners and nurse midwives. Since without FDA approval, there is little chance of QS being approved by any governments, least of all India, the International Federation for Family Health and CRPS have encouraged FDA-approved trials initiated by Dr Jack Lippes in the U.S. “We are now preparing to apply to the FDA for approval to undertake a much larger national trial,” said Mumford.
If so, the struggle against QS is far from over. In India, the QS ban, the study to document the experiences of QS women, and the coalition of health activists and academics are a step forward in the campaign. However, while women continue to be sterilized with quinacrine, thousands of QS women are left without health follow-up, medical practitioners conducting the unapproved trials go scot-free and governments remain indifferent.
With the unholy alliance of right wing groups keen to stop the ‘invasion’ of third world immigrants and a group of dubious medical practitioners quick-fixing medical ethics, only a sustained campaign with a stronger and wider network of international solidarity backed by more feminist research can highlight how quinacrine sterilization exploits and harms women. The stakes are high not only for women’s health, but for the ethical practice of medicine. QS threatens to be another infamous chapter in an ongoing saga of unethical medical experimentation on human beings.
Rajashri Dasgupta is a journalist with a special interest in issues relating to gender, health, development and politics. She is active in the women’s and peace movements.
Mulay, Shree; Singh, Navsharan; Dasgupta, Rajashri (2003) “Quinacrine Non-Surgical Sterilisation In West Bengal: What We Have Learned From The Women On The Ground,” A report presented in a workshop to discuss the research findings, Kolkata, India, November 28.
The interviews quoted in the text were conducted by the author either on phone or through email. Interview with Elton Kessel was conducted personally in November 1998 when he was in Kolkata to attend a medical conference. In March 2005 Dr Mumford replied to the set of questions I sent to April Mayberry referred to by Dr. A. Sarin. He said she was out of the office traveling.
DifferenTakes is an investigative series of issue papers, published by thePopulation and Development Program at Hampshire College, providing alternative information and analysis on a wide range of reproductive rights, population, environment and social justice issues. This spring we are launching a special series of DifferenTakes focusing on 'Reviving Reproductive Safety' in movements for women's health and reproductive justice.
We are pleased to send you the fourth issue in the series, "Egg Donation for IVF and Stem Cell Research: Time to Weigh the Risks to Women's Health" by Judy Norsigian, co-author of Our Bodies, Ourselves and co-founder of the Boston Women's Health Book Collective. This issue critically examines the process by which women donate their eggs both for IVF (in-vitro fertilization) and stem cell research purposes, and its implications for women's health.
- Betsy Hartmann and Amy Oliver Co-editors, DifferenTakes
Also available in pdf format ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
Egg Donation for IVF and Stem Cell Research: Time to Weigh the Risks to Women’s Health
By Judy Norsigian A Publication of the Population and Development Program at Hampshire College • No. 33 • Spring 2005
Last year, Barbara Seaman’s article, “Is This Any Way to Have a Baby?” in O (Oprah) Magazine (February 2004) caused quite a stir among infertility experts as well as women dealing with infertility. It explored women’s experiences with fertility drugs and underscored the paucity of long term safety data as well as the serious, occasionally irreversible problems experienced by some women using these drugs. In response, members of the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART) posted an unusual rebuttal at the ASRM website, and the controversies continue.
Because there is now significant debate about embryo stem cell research, and because one type of embryo stem cell research (“somatic cell nuclear transfer” or SCNT) requires women volunteers to undergo egg extraction to produce eggs for research purposes, there is renewed attention to the larger question of risks to women’s health from egg extraction procedures. These procedures are the same whether performed for reproductive purposes — as is the case in an infertility clinic where women undergo “in vitro fertilization” (IVF) procedures — or performed for research purposes, as is now being proposed in a number of states pursuing embryo cloning as part of a larger plan to expand stem cell research.
What are the risks of multiple egg extraction? The drug most often used to shut down a woman’s ovaries (before stimulating them with other drugs to produce multiple follicles) is Lupron™ (leuprolide acetate), which has caused a range of problems reported to the Food and Drug Administration (FDA), including rash, vasodilation (dilation of blood vessels causing a “hot flash”), paresthesia (sensation of burning), tingling, pruritis (itching), headache and migraine, dizziness, urticaria (hives), alopecia (hair loss), arthralgia (severe joint pain, not inflammatory in character), dyspnea (difficulty breathing), chest pain, nausea, depression, emotional instability, loss of libido (sex drive), amblyopia (dimness of vision), syncope (fainting), asthenia (weakness), asthenia gravis hypophyseogenea (severe weakness due to loss of pituitary function), amnesia (disturbance in memory), hypertension (high arterial blood pressure), tachycardia (rapid beating of the heart), muscular pain, bone pain, nausea/vomiting, asthma, abdominal pain, insomnia, swelling of hands, general edema, chronic enlargement of the thyroid, liver function abnormality, vision abnormality, anxiety, myasthenia (muscle weakness), and vertigo. Although approved for several specific uses, 1 Lupron is NOT approved for use in procedures for multiple egg extraction — something not well understood by many women. (It is legal to use a drug for a non-approved use, as long as it is on the market for at least one approved use, and Lupron is just one of many drugs used “off-label” in this fashion. But proper studies justifying this use for egg extraction have never been formally submitted to the FDA).
The drugs used to “hyperstimulate” the ovaries also have negative effects, most notably a condition called Ovarian Hyperstimulation Syndrome (OHSS). Serious cases of this syndrome involve the development of many cysts and enlargement of the ovaries, along with massive fluid build-up in the body. As noted in an article about OHSS, “the reported prevalence of the severe form of OHSS is small, ranging from .5 to 5%. Nevertheless, as this is an iatrogenic complication of a non-vital treatment with a potentially fatal outcome, the syndrome remains a serious problem for specialists dealing with infertility.” 2 Also, as noted by Dr. Suzanne Parisian, a former Chief Medical Officer at the FDA: “OHSS carries an increased risk of clotting disorders, kidney damage, and ovarian twisting. Ovarian stimulation in general has been associated with serious life threatening pulmonary conditions in FDA trials including thromboembolic events, pulmonary embolism, pulmonary infarction, cerebral vascular accident (stroke) and arterial occlusion with loss of a limb and death.” 3
So why is multiple egg extraction the norm in IVF clinics? With such risks involved, why don’t specialists just try to extract the single egg that women normally release each month? If only one egg is “harvested” using so-called “natural” cycling, there is a good possibility that it will not be successfully fertilized, or if fertilized, it may not develop into an embryo that could be successfully implanted into a woman’s uterus, thus requiring repeated surgical procedures to extract more eggs. Extracting multiple eggs obviously increases the likelihood of success with each IVF procedure.
The same reasoning can be applied to the research context, as it would be better to have more eggs with which to conduct research rather than fewer eggs. But given the early stages of embryo stem cell research, with only very hypothetical benefits at hand, it may be far wiser to protect women from the risks of multiple egg extraction solely for SCNT research purposes and to permit only surgical extraction of the usually single egg produced each month. Others argue that whatever the risks are — known and unknown — a woman should have the choice nonetheless to take these risks, especially if she has a strong personal investment in seeing certain therapies developed, even if they are only a distant promise.
Those who oversee the ethical conduct of research, especially members of Institutional Review Boards (IRBs), are supposed to think carefully about the matter of “risk/benefit” ratio when making decisions about whether to approve a research protocol. Embryo cloning research (SCNT) poses significant challenges in this regard. One IRB for Advanced Cell Technology in Massachusetts did approve a protocol for somatic cell nuclear transfer several years ago and included in the informed consent document the following language: “Severe lung and blood clot events have resulted in death.” 4 They clearly decided that it was ethical to ask women to take such a risk, though others might argue just the opposite.
Reading the stories of young women who agreed to be multiple egg donors for IVF clinics and ended up with tragic consequences should give us all reason to think carefully about whether these risks are justifiable in the research context. Many advocates believe that such risk-taking would not be ethical, partly because true informed consent is not possible in the absence of better data regarding Lupron in particular. 5
One of the more serious issues needing far greater attention is the absence of any good quality long term safety data on the infertility drugs commonly used. There are hundreds if not thousands of anecdotal reports, where complications were NOT short-lived. As noted in a three-part series in the Boston Herald:
“Seven of the women interviewed for this story say they suffered memory loss and bone aches while on Lupron, and that the problems continue years after stopping the drug. Some say seizures and serious vision problems that started while on Lupron also haven’t gone away.
One woman, Linda Abend in southern New Jersey, started a National Lupron Victims Network after her 34-year-old sister was hospitalized with seizures while taking Lupron in 1991 for a benign fibroid. Abend says her sister continues to suffer daily seizures, plus debilitating bone and muscle pain eight years later. And Abend said she has heard from more than 1,000 people nationwide — mostly women — who also report serious side effects that continue after stopping Lupron.
The FDA says it has not tracked claims of such long-term effects.…” 6
In a report submitted by TAP Pharmaceuticals to the FDA in April 1998, researchers wrote that they were “concerned” because more than one-third of the women they studied who took Lupron did not “demonstrate either partial reversibility” or “a trend toward return” of bone mass in the six months after they stopped taking the drug. Further, the researchers noted some women lost as much as 7.3 percent of their bone density during treatment — more than twice the amount the drug’s packaging lists in its warnings. The researchers concluded, “A more complete assessment of the effects of Lupron on (bone density) can only be made with longer term follow-up of these patients.” 7
Some women’s health advocates argue that it is premature to conduct SCNT, especially when it involves multiple egg extraction, because the substantial risks involved are not offset by any clear benefit. In the case of IVF, the best infertility clinics can now offer 30- 40% success rates, so that women undergoing multiple egg extraction — whether to achieve a pregnancy themselves, or to be an egg donor for another woman — do know that there is a clear potential benefit, and one that is of inestimable value: a baby.
The risk/benefit ratio is vastly different in the case of SCNT, where the possible benefits of such research are quite hypothetical at this stage. It is far from clear that SCNT will lead to any viable therapies, and much of what we need to learn in this realm of research can result from studying embryo stem cells derived from “conventional” embryos that would otherwise be discarded by couples who are no longer pursuing IVF at an infertility clinic. (Thousands of such embryos are now available for embryo stem cell research being conducted around the country.) It is conceivable that, over time, when embryo stem cell research has demonstrated that viable therapies are possible, a stronger case can be made for pursuing SCNT. (SCNT theoretically will make it possible to develop therapies that will be immuno-compatible, thus avoiding the problem of tissue rejection, which is more likely to occur with stem cell therapies that have a different genetic make-up.)
Although SCNT does provide an opportunity to study the progression of certain rarer diseases, some of this research can be done with embryos that were rejected during the process of preimplantation genetic diagnosis (PGD). Again, these are embryos that will not be used for reproduction purposes, because problems were detected, and thus would likely be discarded if not used for research.
Some women’s health advocates urge that multiple egg extraction for research cloning purposes not be pursued at this time, and that any eggs for such research be obtained only via “natural cycling” — where a woman would not use fertility drugs but simply have the (typically) one follicle per month that she releases surgically collected. Given that South Korean researchers had to extract 242 eggs from 16 women to create one clonal embryo from which they developed a line of embryo stem cells to study further, there will certainly be pressures to accelerate the collection of eggs through more widespread use of multiple egg extraction procedures. Ads for egg donors are already commonplace on many college campuses, where young women are motivated to undergo egg extraction for much-needed income ($4-7,000 in most cases) as well as for altruistic reasons. Both of these motivations could influence thousands more young women and economically disadvantaged women to undergo risky egg extraction procedures solely for research, and under circumstances where the benefits are far less clear and mostly still hypothetical. This will be another arena where we will see the mantra of “reproductive choice” once again co-opted and falsely applied.
Given that there may be new techniques developed soon that would obviate the need for multiple egg extraction, there is even more justification for a cautious approach. As noted in the New York Times, a technique called “in vitro maturation,” or I.V.M., may make it possible to obtain multiple eggs without using hormone injections. “Doctors have found that a few days before ovulation, as many as 30 to 50 egg follicles have begun to mature. Normally, only one will fully ripen for ovulation, and the rest are lost. But if the eggs are removed before ovulation, many of them can be matured in the laboratory.” 8
The push for SCNT (also called research cloning or “therapeutic” cloning) will be strong in the coming years. Because the most vocal critics of this research are from the anti-abortion community, many prochoice advocates are reluctant to get involved with this debate for fear of lending support to a larger anti-choice agenda. Although there are those who have deliberately confused this issue, sometimes conflating embryo cloning research with ALL embryo stem cell research, it is important to keep the two separate and to insist that health concerns for women don’t take a back seat.
Judy Norsigian is a co-author of Our Bodies, Ourselves and co-founder of the Boston Women’s Health Book Collective, now called Our Bodies Ourselves. She serves as the organization’s Executive Director and is involved with numerous women’s health initiatives nationally and internationally.
Endnotes 1 For example, the treatment of endometriosis and fibroid-associated anemia. 2 Delvigne, Annick and Rozenberg, Serge. “Epidemiology and prevention of ovarian hyperstimulation syndrome (OHSS): a review” Human Reproduction Update, vol. 8, no. 6, 2002, pp 559-577. 3 From Dr. Parisian’s February 2005 memo now posted at www.ourbodiesourselves.org 4 Other language from this document, titled “Consent to Participate in a Study Involving Egg Donation for Stem Cell Research”:
Complications associated with being an egg donor include unpredictable response to the hormones provided to you, surgical complications during the egg collection, and unknown long-term side effects from the hormones. If any of these complications arise the reproductive biologists involved in this research may choose, at their discretion, to terminate your continued participation in this research.
Risks and side effects associated with hormones (gonadotropins, hCG and GnRH agonists). The gonadotropins will be used in order to stimulate your ovaries. Adverse reactions reported in women treated with gonadotropins include ovarian hyperstimulation. This is a condition in which the ovaries continue to enlarge even after the eggs have been collected. In addition to enlarged ovaries, fluid begins to be retained in the abdomen and becomes very difficult to control, resulting in fluid imbalance. Rare, but serious, consequences of this imbalance include lung and circulation problems such as collapse of a lung, acute respiratory distress syndrome, blood clot which may lead to inflammation of the veins, obstruction of blood vessels in the lungs, damage to the lung tissues, stroke, obstruction of an artery resulting in the loss of limb(s); blood in the abdominal cavity; kidney damage; large ovaries; increased heart rate; shortness of breath; rapid breathing; flu-like symptoms of fever, chills, musculoskeletal aches, joint pain, nausea, headache and tiredness; breast tenderness; and skin reactions such as dry skin, blood rash, hair loss and hives. Severe lung and blood clot events have resulted in death.
The following adverse reactions have been reported in patients receiving human chorionic gonadotropin therapy: headache, irritability, restlessness, depression, fatigue, edema, and pain at the injection site.
Adverse reactions regarding GnRH agonists include anemia; changes in various heart problems; high blood pressure; fluid accumulation in the limbs; formation of blood clots which potentially could be dislodged from the involved vein or artery causing damage to vital organs such as lungs, heart or brain; intestinal problems such as decreased appetite, constipation; nausea and vomiting, diarrhea, difficulty in swallowing; intestinal bleeding, intestinal ulcers and polyps; thyroid enlargement; breast tenderness; hot flashes; bone, muscle and joint pain; anxiety; depression; blurred vision; mood swings; nervousness; numbness; taste changes; memory problems; lightheadedness; blackouts; and headaches. 5 See “Risks to women in embryo cloning,” op ed by Judy Norsigian, February 25, 2005, Boston Globe. 6 Lazar, Kay “Wonder drug for men alleged to cause harm in women,” Boston Herald, August 22, 23, 24, 1999. 7 Ibid. 8 Duenwald, Mary “After 25 Years, New Ideas in the Prenatal Test Tube,” New York Times, July 15, 2003.
DifferenTakes is an investigative series of issue papers, published by the Population and Development Program at Hampshire College, providing alternative information and analysis on a wide range of reproductive rights, population, environment and social justice issues. This spring we are launching a special series of DifferenTakes focusing on 'Reviving Reproductive Safety' in movements for women's health and reproductive justice.
We are pleased to send you the third issue in the series, "Depo-Provera: Old Concerns, New Risks" by Amy Oliver and Diana Dukhanova. This issue discusses the ramifications of new research suggesting a link between Depo and increased susceptibility to several Sexually Transmitted Infections (STI's).
- Betsy Hartmann and Amy Oliver Co-editors, DifferenTakes
By Amy Oliver and Diana Dukhanova A Publication of the Population and Development Program at Hampshire College • No. 32 • Spring 2005
The Summer 2000 issue of DifferenTakes provided an introductory glance at the injectable contraceptive Depo-Provera (or DMPA), and why many women's health advocates are concerned with its use and misuse around the world. 1 Approved for use in the U.S. in 1992, Depo has only become more controversial as its image as a hassle-free contraceptive clashes with the reality of possible side effects such as irregular bleeding, weakness, depression, weight gain, nausea, loss of libido, darkening of skin, abdominal pain, headaches and hair loss. 2 Side effects can be so numerous and severe that over 70% of American women who have ever used Depo discontinued their use within the first year. 3 Injected into the arm or buttock, Depo's effects last for three months and its effectiveness rate is an impressive 99.7%. 4 But with alarming new risks added to these worrisome side effects, the contraceptive deserves closer scrutiny.
Depo-Provera Receives "Black-Box" Warning
The Food and Drug Administration (FDA) recently mandated that Depo carry the "black box" warning label, the agency's most severe warning. Based on new data from Pfizer, Depo's manufacturer, the new label will inform users of recent findings that Depo causes a loss in bone mineral density that may not be completely reversible. The warning also suggests that Depo use should be limited to two years unless other forms of birth control are insufficient, and in this case women should be evaluated while taking the drug long-term.
These findings have special relevance to young women who are in the critical period of bone growth. Studies are conflicting as to whether or not bone loss can be completely recovered once use of the drug is discontinued. 5 Clearly, the FDA black box label poses a red flag that more research is needed on Depo's long-term effects on women's bone loss and future risk of osteoporosis.
Increasing Risks of STI's and HIV/AIDS
Other recent studies show that Depo-Provera users are at an additional risk of contracting Sexually Transmitted Infections (STI's). A joint study funded by the National Institute of Child Health and Human Development (NICHD) and the U.S. Agency for International Development (USAID) recently found a strong correlation between Depo use and a woman's chances of contracting chlamydia and gonorrhea. The study, published in the journal Sexually Transmitted Diseases , followed over 800 women in Baltimore, MD, who had the choice of using Depo-Provera, oral contraceptives, or a non-hormonal contraceptive.The study found no correlation between taking oral contraceptives and contracting the infections, and did not conclude why Depo users were more likely than women using other hormonal contraceptives to contract these STI's, indicating further research is needed on the subject. 6
The findings clearly have important implications for women's reproductive health and call into question the widespread promotion of Depo-Provera in family planning programs in the U.S. and overseas. Yet there is already an attempt by some agencies to downplay them. Family Health International's (FHI) August 2004 report on the findings states that "while of concern...this new research does not call for changes in the provision or use of DMPA." 7 The report goes on to assert that women in monogamous relationships are at no additional risk of infection, and that the results of the study "are of little concern for DMPA users who use condoms consistently and correctly, since such condom use only rarely fails to provide protection..." 8 The fact that the report virtually ignores such significant findings is alarming. The results clearly state that the use of Depo-Provera only , not hormonal contraceptives in general, increases the risk three-fold of contracting chlamydia and gonorrhea. 9 In lieu of an in-depth look at the implications of these findings, FHI quickly puts the responsibility on correct and consistent condom use and monogamous relationships to prevent the spread of STI's.
Encouraging condom use is of course important, but as a consumer choosing a safe, reliable method of birth control in addition to condoms, one might think twice about choosing Depo given that condoms can fail or one's partner might be unwilling to use them. Moreover, many women who are at risk for contracting STI's because of their partner's promiscuity most likely believe (or would like to believe) that their partner is faithful. The point at which a woman finds out her partner isn't faithful is far too late to decide to switch birth control methods, particularly if she just received her three-month shot. Meanwhile, she could have been putting herself at an addition risk of contracting STI's from her partner simply because she used Depo .
New studies show conflicting evidence over whether Depo-Provera increases the risk of contracting HIV, transmitting it to others, and increasing the rate at which the virus progresses once in the body. A study published in January 2004 in The Journal of Infectious Diseases found a correlation between taking hormonal contraceptives (both injectable and oral) and acquiring HIV. 10 The study further concluded that the use of Depo at the time of HIV transmittal hastened the rate of disease progression. 11 In terms of contracting HIV, skeptics point out that the research yielding these results used sex workers in Kenya, who would have more frequent exposure to HIV than the average person. 12 Only a handful of prospective studies have addressed injectable hormonal contraceptives in particular and their effect on HIV, and findings are mixed. 13 Some found no correlation between Depo use and HIV, and suggest further research is needed. The National Institute for Child Health and Human Development (NICHD) is currently conducting a larger study inclusive of subjects who are at a lower risk of HIV infection, and results are expected some time this year.
Although Depo's manufacturer was mandated to add the "black-box" label concerning bone loss, it seems less concerned with adequately informing women of other new risks. While promoting their product as ultra-convenient and period-free, Depo's current distributor, Pfizer, claims "There is no proof from clinical studies that shows Depo-Provera increases your risk of acquiring a sexually transmitted disease, or STD." 14 This claim was found on the official Depo-Provera website seven months after the findings were released (and reported in popular U.S. news sources) 15 concerning women's increased risk of contracting STI's. While Pfizer does remind women that Depo does not protect from STI's and HIV/AIDS, it thus far ignores this recent finding.
In informational materials (mainly targeting college-age women) put out by Depo's former distributor, Pharmacia, sweeping statements are made that "while most sexually active young women use condoms to protect themselves against sexually transmitted diseases, they don't often think to protect themselves against pregnancy as well." 16 Pharmacia's materials go on to claim that the condom's failure rate is as high as 14%, compared to Depo's 99.7% effectiveness. 17 The materials neglect to mention that condoms, used with withdrawal, can be up to 98% effective, as reported by Planned Parenthood. 18
With the rate of HIV infection rising to pandemic levels among the youth population -- half of all HIV infections in the U.S. occur in people under 25 19 -- promoting a birth control method to youth that downplays condoms as ineffective will only contribute to the crisis. In light of the recent findings that Depo increases the risks of contracting STI's and possibly HIV, it is critical that women receive accurate information regarding the risks of solely relying on hormonal contraceptives.
At What Risk?
Because of the particular circumstances in which Depo-Provera is used in the U.S. and abroad, new risks associated with Depo should not be taken lightly. Long-acting contraceptives such as Depo and Norplant (a contraceptive placed under the upper arm) have a history of being coercively targeted at poor women and women of color, often without informed consent, despite the current promotion of Depo as a white, college woman's contraceptive. 20 Anecdotal evidence shows that Depo is disproportionately promoted to women on welfare as a population control measure, 21 and there is a pressing need for more research in this area. New risks associated with bone loss, contracting STI's and possibly HIV pose great concern for women who are already less likely to have access to basic services such as healthcare.
With many questions left unanswered, widespread research is needed on the safety of Depo-Provera. A study conducted in India in 2003 explored women's experiences with obtaining and using Depo (banned in 2002 from India's Family Welfare Program after much pressure from women's groups). The study profiled a sample of 50 women, most between the ages of 21 and 30, who received Depo from a public hospital. Goals were to measure how informed the choice was to take the drug, women's knowledge of risks and benefits, medical screening tactics, personal health risk factors, and physical setting of medical facilities. The study found some alarming results: over half of the women were given no other contraceptive options besides Depo, 42 out of 50 were not informed of the probable side effects, and more than half received no screening. 22 The study made women's first-hand experiences a central focus of the research, an approach severely needed in the U.S.
Depo has for years served as both a subtle and blatant tool for population control in developing countries despite the fact that risks are aggravated in places where medical monitoring is difficult or impossible. 23 Under apartheid in South Africa, Depo was typically given to women without adequate screening and health services, which were virtually inaccessible to rural populations. Many black South African women were coerced into using Depo and were sometimes forced to use it in order to keep their jobs. 24 Although this does not mean Depo is always misused in developing countries, its vast history of abuse by population control programs and potential for further misuse (particularly in areas of high HIV risk such as South Africa) call into question its ultimate safety for women.
Despite recent concerns about a link between Depo-Provera and HIV/AIDS, there is little evidence that new risks will be taken seriously by those who consider reducing Third World birth rates a higher priority than women's health. In a report on the recent findings concerning Depo and HIV risk, Timothy Wilkin, M.D., M.P.H., (Instructor of Medicine at Cornell University and writer for a popular website on AIDS research), states "It is difficult to say what this means for women's reproductive health. Because women in developing countries such as Kenya are much more at risk for dying during childbirth...it is unclear whether this increase in HIV infection is more important than the risk of unwanted pregnancies." 25
While it is true that because of poor living conditions and lack of prenatal care, a woman's chance of dying during childbirth is generally higher in developing than in developed countries, it is a cruel trade-off to pit the risks of an unwanted pregnancy and childbirth against using Depo (with possible increased risk of contracting HIV) as a woman's only two options. If we are really concerned with reducing death rates related to childbirth, we instead should focus on improving overall standards of living and prenatal care for women in Kenya and elsewhere. Further, the risk of contracting HIV can greatly be reduced by increased condom use and there are other contraceptives women can use besides Depo. Indeed, given present concerns about Depo causing increased risk of acquiring STI's and possibly HIV/AIDS, it is questionable whether Depo should be used at all in vulnerable populations. We may be witnessing the beginning of a major public health crisis.
A Broader Vision for Contraceptive Choice
Despite the new FDA black box warning about bone loss, evidence of increased risk of contracting STI's among Depo users, and concern that Depo may be linked to increased HIV infection, Depo-Provera continues to be used by many of the most vulnerable populations in the world. Seen at first as a hassle-free contraceptive that would answer women's prayers, new findings raise serious questions of the usefulness of this drug as a safe option for women. While many advocates for reproductive choice argue that more contraceptive options automatically empower women, we must raise the question of how important a choice is if the safety of the method is in serious doubt. A broader movement for reproductive health looks beyond a narrow definition of choice to the assurance that available options are safe as well as effective. Moreover, women need to be completely informed of the array of contraceptive options available to them, and the risks associated with their use.
Amy Oliver is the Program Coordinator for the Population and Development Program at Hampshire College, an organization dedicated to promoting reproductive rights, economic justice, and social equality for women. Diana Dukhanova is a fourth-year student at Hampshire College concentrating in Russian literature. She has been working for the Civil Liberties and Public Policy Program and Population and Development Program since her first year and her primary activist interests lie in reproductive rights.
1 Littlecrow-Russell, Sarah. “Time to Take a Critical Look at Depo-Provera,” DifferenTakes, Population and Development Program at Hampshire College, No. 5, Summer 2000. 2 Unveiled Realities: A study on women’s experiences with Depo-Provera, and injectable contraceptive, Sama Resource Group for Women and Health, New Delhi, India, 2003. 3 Ibid. 4 “Different Needs at Different Times,” Pharmacia Corporation, 2001. 5 “Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection,” http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01325.html, Last visited February 17, 2005. 6 “Depo-Provera Appears to Increase Risk for Chlamydial and Gonococcal Infections,” http://www.nichd.nih.gov/new/releases/depo-provera-risk.cfm, Last visited February 22, 2005. 7 “Depo study USAID Guidance,” FHI News email:
, August 31, 2004.
8 Ibid. 9 “Depo-Provera Appears to Increase Risk for Chlamydial and Gonococcal Infections,” http://www.nichd.nih.gov/new/releases/depo-provera-risk.cfm, Last visited February 22, 2005. 10 “Hormonal Contraception and HIV: an Update by Dr. Charles Morrison and Kim Best,” August, 2004. http://www.fhi.org/NR/Shared/enFHI/PrinterFriendly.asp, Last visited February 16, 2005. 11 Ibid. 12 Ibid. 13 Ibid. 14 http://www.depoprovera.com/vc-prospect-user.asp, Last visited March 7, 2005. 15 Rubin, Rita. “Contraceptive is Linked to High STD Risk,” USA Today, Gannett Company, Inc., August 23, 2004. 16 “Different Needs at Different Times,” Pharmacia Corporation, 2001. 17 Ibid. 18 http://www.plannedparenthood.org/pp2/portal/files/portal/medicalinfo/birthcontrol/pub-contraception-choices-5.xml, Last visited February 23, 2005. 19 “Adolescents and HIV/AIDS,” http://www.advocatesforyouth.org/publications/factsheet/fshivaid.htm, Last visited March 2, 2005. 20 “Beyond Pro-Choice Versus Pro-Life: Women of Color and Reproductive Justice,” Smith, Andrea. NWSA Journal, Vol. 17 No.1 Spring 2005. 21 Littlecrow-Russell, Sarah. “Time to Take a Critical Look at Depo-Provera,” DifferenTakes, Population and Development Program at Hampshire College, No. 5, Summer 2000. 22 Unveiled Realities: A study on women’s experiences with Depo-Provera, and injectable contraceptive, Sama Resource Group for Women and Health, New Delhi, India, 2003. 23 “Depo-Provera Deadly Attempt At Population Control,” Reproductive Rights Newsletter, Reproductive Rights National Network, Summer 1981. 24 Hartmann, Betsy. Reproductive Rights and Wrongs, Hartmann, Betsy. South End Press, Boston, MA, 1995. 25 “Hormonal Contraceptives Increase HIV Risk; Vitamin A Levels Unrelated to Viral Load,” http://www.thebody.com/confs/retro2003/wilkin2.html Last visited February 9, 2005.
Reproductive Health and the FDA: Buffeted by Political Battles
By Amy Allina
Since its inception, the Food and Drug Administration (FDA), the U.S. government’s main watchdog agency over the pharmaceutical industry, has been subject to political pressures that undermine its mission to ensure drug safety and protect consumer health. In the last several years, these pressures have intensified as the FDA is buffeted by the Bush administration’s right-wing agenda and an ever more powerful pharmaceutical industry. More often than not, women’s reproductive health and safety are caught in the crossfire of these political and economic agendas.
The Religious Right and the Battle over Emergency Contraception In 2002, the Bush administration set off a powerful reaction when it tried to install W. David Hager as chair of the reproductive health drugs advisory committee responsible for advising the FDA on questions relating to contraception and abortion. The outrage of women around the country – expressed by more than 10,000 protest email messages to the FDA – led to a close public scrutiny of Hager’s record. Hager had been the lead spokesperson for the Christian Medical Association’s petition for a ban on mifepristone,1 the drug approved by the FDA for abortion. He had spoken publicly of his reluctance to prescribe contraception to patients who are not married.2 And as headlines across the country proclaimed, he was co-author of a book recommending prayer as treatment for PMS.3
In the face of this storm of public opposition, the Bush administration backed off from the original plan of putting Hager in charge of the committee, but they did make him a member. And they provided him with like-minded colleagues, appointing Joseph Stanford (who has written that he is unwilling to prescribe contraception even to married patients because of his belief that any interference between sexuality and fertility is detrimental to marriage4) and Susan Crockett (a board member of the American Association of Pro-Life Obstetricians and Gynecologists) to the committee as well.
Reproductive rights advocates and FDA watchers saw these appointments as a sign of the Bush administration’s allegiance to the religious right and pointed out that they set the stage for a fight over the pending FDA decision on whether to make emergency contraception (EC) available over-the-counter. Following that discouraging development, feminist activists and reproductive health advocates cheered the triumph of science a year later when the committee voted unanimously that emergency contraception was safe for use in an over-the-counter setting. In the face of overwhelming scientific evidence, even the three staunch opponents of reproductive rights on the committee had to acknowledge that this after-the-fact contraceptive method could be used safely without a prescription requirement. Among the doctors, scientists and activists who had been working for years to expand women’s access to EC, most had expected far worse from the committee.
The victory was short-lived, however. Despite the overwhelming recommendation from FDA’s science advisors, opponents of contraception prevailed and the FDA denied the EC over-the-counter application.*
Scientists and medical experts joined reproductive rights advocates in criticizing that decision, pointing out that by bowing to anti-choice political pressure, the FDA has denied women access to a safe and effective contraceptive and has undermined its own credibility as a scientific agency around the world. An editorial in the New England Journal of Medicine lamented the loss of FDA’s “enviable international reputation” and pointed out that the decision was “likely to mean that both physicians and patients will wonder whether future drug-approval decisions are based on the evidence with regard to efficacy and safety or, rather, on political considerations.”5 Mission in Flux The EC controversy was not a typical, everyday occurrence at FDA. The FDA usually operates behind-the-scenes, unnoticed by most people – even those concerned about health. Yet, despite being out of the public eye, the FDA is still under constant pressure from political forces of a different kind than the very public battles that take place over reproductive rights. The standard battle at the agency is between the interests of the companies that make the drugs and devices it regulates and consumer advocates concerned about the safety of those products.
Since the FDA was first created early in the twentieth century, there have been struggles between businesses, determined to fight off government interference, and consumers and their advocates, working to establish a role for the federal government in protecting the public health.6 At its start the FDA was made up of a handful of scientists who worked in an obscure bureau of the Department of Agriculture; as the scope of drugs and medical devices in the world has expanded, the FDA has grown as well, now responsible for regulating over a trillion dollars worth of food, drugs and medical devices, more than a fifth of the U.S. economy.
This growth has taken place in spite of industry resistance. It has taken fierce fights between consumer advocates and industry, and all too often, national and international tragedies to expand the scope of FDA regulation. Sadly, many of the events that have persuaded Congress of the need for better regulation of drugs and medical devices have specifically involved damage to the life and health of women. Only after thalidomide, given to pregnant women to reduce morning sickness, was found to have caused nerve damage in the women who took it and sometimes fatal birth defects in their children, did Congress mandate that FDA must review evidence of a drug’s safety and efficacy before a company could begin to sell it. And pre-market review of medical devices came even later. In the United States alone, 17 women died and thousands more had emergency hysterectomies to save their lives as a result of using the unsafe Dalkon Shield IUD before the FDA was given the authority to require those reviews.
In the last decade, however, the trend has gone in the opposite direction. When conservative lawmakers won control of Congress in 1994, they went to work on a broad reform agenda that reflected the wish lists of industries from financial services to pharmaceuticals. The FDA Modernization Act of 1997 reshaped the agency in response to the drug industry’s long-held desires. The new law speeded up drug approvals, scaling back safety requirements, and even redefined the agency’s mission statement to commit it to working in consultation with “manufacturers, importers, packers, distributors, and retailers of regulated products.”7
Recent news about drug safety problems with widely prescribed pain relievers, however, has led to a growing public understanding that FDA’s ability to protect the public has been eroded. Public outrage has already translated into Congressional interest, and these developments may lead to drug safety reform legislation to restore some of FDA’s capacity to ensure drug safety.
The False Choice Between Speed and Safety Over the years as these trends have evolved, drug companies have not always been alone in criticizing FDA for its slow approval process. Patient activists have sometimes made common cause with industry, pushing for faster drug approvals even at the expense of rigorous safety testing. Early AIDS activists, in particular, urged FDA to dispense with stringent safety requirements to give dying patients access to new treatment drugs. Later, as more AIDS drugs became available, many of these same activists responded to the changed circumstances and urged the FDA to reprioritize the need for evidence of long-term effectiveness and safety in its consideration of AIDS drugs.
Women’s health advocates similarly urged faster approval for the female condom and other barrier methods of contraception that hold the potential to protect women from HIV infection and other sexually transmitted diseases. The question of how to balance safety concerns with the urgent need for a product will again be at center stage when FDA eventually considers approval of microbicides now in development – topically applied products that help prevent the transmission of HIV and other infections. Drug companies and device manufacturers have watched these developments carefully and learned from them. Industry-funded patient groups now often play a very public role in companies’ plans for obtaining FDA approval; in some cases these patient groups have been found to be wholly created by the companies whose products they are demanding access to. But activists who are accountable to real-life patients suffering from illness are learning as well. They have learned to reject the false choice between faster approval and safer products. The demand for efficient consideration of urgently needed products does not have to result in the elimination of safeguards for the public health.
Addressing Safety Concerns and Overcoming Division When it comes to contraception, the political battles sometimes converge, subjecting these critical women’s health products to the complicated tensions of the safety/access balance as well as the bruising assaults of the anti-choice, anti-family planning right wing. In the past, this convergence has created division within the reproductive health community, as was seen with Depo Provera, the contraceptive injection, and Norplant, the contraceptive implant. Women’s health advocates who asked the FDA not to approve a contraceptive because of safety concerns have been seen by family planning advocates as unwitting accomplices to anti-choice efforts to block access to products that improve women’s ability to control fertility. Family planning advocates who have urged approval of new contraceptive products in spite of unanswered questions about safety have been seen by consumer health advocates as unwitting accomplices to an industry agenda that promotes fast approval without adequate safeguards for women’s health.
These controversies (as well as the fact that the Baby Boomers, who drive so many marketing choices in the United States, need less and less contraception as they age) have sometimes led major companies to shy away from contraceptive products, except in cases where they expect very high levels of profitability to counterbalance their concerns about political controversy. Both mifepristone and EC fell into this category, failing to attract the interest of the big pharmaceutical companies and only advancing to FDA approval with the support of smaller companies committed to providing women access to these products.
It is interesting to note that in the case of both mifepristone and EC, the companies involved worked closely with the reproductive rights and women’s health communities to make sure that women’s safety concerns were seriously addressed. This cooperative approach headed off the potential for internal controversy and created a united front of women’s advocates to face the anti-choice opposition which was thus effectively marginalized. Lack of Credibility Undermines FDA’s Ability to Protect Women’s Health Last fall, a new development in the regulation of Depo Provera proved the truth of the New England Journal of Medicine editorial warning that FDA’s motivation for future decisions would be called into question.
Women’s health advocates have raised concerns about the safety of Depo Provera for decades. Over time, research has laid to rest some but not all of the questions about the effects of this drug. One uncertainty that had remained was about Depo’s effect on the strength of the bones of women using it; some preliminary research indicated that women using Depo experienced a loss of bone density.8 Health advocates have continually called for better information on this and other possible risks of long-term use of the method. The kind of cooperative approach that created unity among women’s advocates on EC and mifepristone has not yet evolved with respect to Depo Provera. Meanwhile, the FDA – its credibility weakened by the Bush administration’s appointment of unqualified candidates like David Hager and by denying women improved access to safe and effective EC – announced labeling changes for Depo Provera that revealed the fault lines in the women’s community.
Based on new data, submitted by the company that makes Depo, the FDA has instructed the company to add information to the drug label about bone loss and to recommend that clinicians limit use of Depo to two consecutive years. This new information is being conveyed in the form of a black box warning on the label – FDA’s most severe label warning, commonly although not exclusively, used for life-threatening conditions. Many women’s health advocates have been pleased to see the FDA requiring that the bone loss information be provided to women.9 But at the same time, the agency’s recent history of manipulating and suppressing scientific data for political ends and the Bush administration’s track record of attacks on family planning cannot help but raise questions about what is really behind this label change. Is it a genuine effort to protect women’s health by sharing new scientific evidence? Or is it a politically motivated attack on contraception, using science as a smokescreen for an anti-choice agenda? Just as the editorial warned, FDA’s distorted decision on EC has undermined the agency’s credibility and led even those who support its role as a protector of the public health to question the motivations behind these actions.
Amy Allina is Program Director of the National Women’s Health Network, a national organization that is committed to ensuring that women have self-determination in all aspects of their reproductive and sexual health. Prior to joining the NWHN in 1999, she worked on women's health policy issues at the consulting firm of Bass and Howes and as the Political Organizer for the Maryland affiliate of NARAL. She serves on the board of directors of the Reproductive Health Technologies Project and the Alan Guttmacher Institute.
* While this is being written, a revised application to make EC available over-the-counter is still pending and may eventually be approved, but it’s been seriously weakened by a plan to restrict over-the-counter access to women 16 and older, setting up a two-tiered system of access based on age and denying improved access to younger women.