Archive for the ‘Reproductive Technology & Genetic Engineering’ Category

February 28, 2014

Stillbirths and Infant Health Risks Higher in California’s Artificially Conceived Infants

by Miriam Zoll

A new study published in the Journal of Perinatology online has found that in California from 2009-2011 there was a 24- to 27-fold increase in multiple births and significantly higher rates of preterm births, lower birth weights, fetal anomalies and stillbirth among infants born through assisted reproductive technologies (ART) or artificial insemination (AI) compared to babies conceived naturally.

The retrospective study was based on 2009-2011 data from the California Office of Statewide Health Planning and Development and conducted by researchers from the Loma Linda University School of Medicine.

The CDC’s Assisted Reproductive Technology Surveillance report for 2010 indicates that “ART-conceived births were highest in California, followed by Texas and New York,” and that nationwide that year, 46.4 percent of all ART births were multiples, compared to only three percent among naturally conceived infants.

While California has the most infertility clinics of any state in the country, the large increase in multiple births from ART/AI found in the study was higher than but not significantly different from those reported nationally. However, data from the Centers for Disease Control and Prevention (CDC) indicate that California’s rates of low- and very low-birth weight infants, as well as premature and very premature infants, exceed national averages.

According to the new Journal of Perinatology study, in 2009, 18,405 California women underwent ART cycles, which refers to procedures in which the egg and sperm are handled outside the body. Of the total number of women in California undergoing ART, only 3 percent of women underwent AI or intrauterine insemination.  A total of 15,953 embryos were transferred, resulting in 7,155 pregnancies and 5,710 live births. Roughly 1,718 of these births — or 30.1 percent — were multiple births consisting of twins, triplets or more.

The researchers found that when compared to naturally conceiving women, preterm labor and cesarean section were four times higher for women who underwent ART/AI, and their length of stay in hospital was twice as long. Compared to infants conceived naturally, among ART/AI pregnancies, there was a four- to five-fold increase in stillbirths, and a two to three-fold increase in fetal anomalies.

These findings align with those from another California study conducted by researchers at UCLA and published in 2013 in the Journal of Pediatric Surgery. Compared to naturally conceived babies, researchers found higher rates of congenital malformations among ART multiple babies — particularly of the eyes, neck, heart and urogenital tract.

In one case study highlighted in the Journal of Perinatology report, of 92 ART/AI infants born at Loma Linda Children’s Hospital over an 18-month period from 2012-2013, 10 very premature babies died on the first day. Seventeen were singleton births, with half requiring admission to the Neonatal Intensive Care Unit (NICU). Of the 27 pairs of ART/AI twins, one was stillborn, four deaths followed shortly after birth, and 22 sets were admitted to NICU. Three deaths occurred in two out of six sets of triplets and all surviving triplets required admission to the NICU. The average NICU hospitalization length of stay for these ART/AI babies averaged 38.4 days, with a range of anywhere from three to 138 days.

“We need to educate the public about these very serious risks,” Dr. Mitchell Goldstein of the Department of Pediatrics, Division of Neonatology, Loma Linda University School of Medicine,who co-authored the report, said in an interview. “If elective single embryo transfers became a higher priority among infertility specialists, we would likely see significant reductions in these severe health and stillbirth rates among ART/AI infants and reduced risks for mothers.”

Throughout the United States, the higher incidence of multiple and preterm births linked to ART/AI remains a significant public health concern, particularly for older women and their babies. A 2013 article in the New England Journal of Medicine estimated that 36 percent of twin births and 77 percent of triplet and higher-order multiple births in the U.S. were attributable to medically assisted conceptions.

The American Society for Assisted Reproductive Medicine recommends that reproductive endocrinologists transfer single embryos for most women, yet many doctors continue to transfer multiple embryos with the hope of procuring at least one live birth.

“Once a patient becomes pregnant through ART/AI,” explained Goldstein, “many reproductive endocrinologists lose touch with them and are then completely disconnected from any risks mother and infant may encounter. Neonatologists and infertility specialists must work together to reverse these trends and ensure the least harm.”

The findings from this study reflect one conducted by the University of Adelaide of roughly 300,000 patients in Southern Australia who had received assisted conception between January 1986 and December 2002. Published in January 2014 in PLOS ONE, the study also found higher rates of stillbirth, prematurity, low birth weight and neonatal deaths among ART infants.

But in this Australia study, even singletons from assisted conception were more likely to be stillborn or have low birth weight than babies born from spontaneous conceptions. Outcomes varied by type of assisted conception. For example, very low and low birth weight, very preterm and preterm birth, and neonatal death were markedly more common in singleton births from IVF, and to a lesser degree, in births from intra-cytoplasmic sperm injection (ICSI) where the one sperm is injected directly into the egg. Using frozen-embryos eliminated all significant adverse outcomes associated with ICSI but not with IVF.

In my next post, I’ll look more closely at the financial costs of babies born through assisted technology and what this might mean for insurance coverage.

Miriam Zoll is a member of the Our Bodies Ourselves board of directors, an independent journalist and the author of the new book, “Cracked Open: Liberty, Fertility and the Pursuit of High-Tech Babies.“ 

This blog was previously published on the USCAnneberg Reporting on Health Member Blog and is reposted with permission. Image by TipsTimesAdmin via Flickr.

February 20, 2014

New Data Shows IVF Use Has Steadily Grown

Photo: IVF Capillary Tube Insertion by ZEISS Microscopy licensed under CC BY-NC-ND 2.0

The Society for Assisted Reproductive Technology has released new data on in vitro fertilization (IVF) use in the United States during 2012, and the numbers are up — way up.

The organization, which represents IVF providers, reports that more than 165,000 cycles of IVF were performed in 2012, making it the biggest year ever in terms of both IVF procedures and the resulting babies born. By comparison, doctors performed about 113,000 cycles in 2003.

More than 61,000 babies were conceived using this technology in 2012, amounting to about 1.5 percent of the 3.9 million births that year.

Another number is on the decline: the number of high-risk multiple births from IVF.

“If we dig deeper into the data, there has been a marked reduction in triplets,” Charles Coddington III, an OB-GYN at the Mayo Clinic in Rochester and president of SART, told NPR. “Everyone is really attuned to reducing triplets.”

In 2003, women between the ages of 35 and 40 had about a 6 percent chance of having triplets during a successful IVF procedure. Now the odds have dropped to 0.7 percent.

The reason for the decline, Coddington says, is that couples and their doctors are choosing to use fewer embryos during each cycle. “It isn’t across the board,” Coddington says. “There are still outliers. But the trend is really good. So we’ve had a better year in terms of triplets.”

The chance for twins is also less than it was a decade ago. But the rate is still high, especially for women younger than 40. About a quarter of all successful IVF cycles for women in this age group resulted in twins during 2012, the study reported.

The problem with twins and triplets, Coddington says, is that they raise the health risks for both moms and babies.

Single embryo transfer is the most effective way to reduce riskier multiple births.

Unfortunately, as the newly released numbers show, many cycles of IVF never result in a baby.

Miriam Zoll, an Our Bodies Ourselves board member and author of “Cracked Open: Liberty, Fertility and the Pursuit of High Tech Babies,” noted in a Reuters article this week that women over age 35 have higher percentages of failures with IVF and that “these treatments have consistently failed two-thirds of the time since 1978,” when the first “test tube baby” was born.

For more information on IVF and related issues such as egg donation, surrogacy and related topics, read our blog posts on reproductive technology, including “What’s Wrong With Fertility Clinics and Online Advertising” and “Truth in Medicine: Vast Majority of Assisted Reproductive Technologies Fail.”

December 19, 2013

Cross-Border Surrogacy: How OBOS is Advancing Public Discourse and Action

Women's Rehabilitation Center facilitators in Kathmandu

Women’s Rehabilitation Center facilitators lead community discussions on cross-border surrogacy in Kathmandu / Photo courtesy of WOREC

by Ayesha Chatterjee & Sally Whelan

In an episode that aired on primetime television in 2007, America’s favorite talk show host portrayed cross-border surrogacy as a win for everyone.

Oprah Winfrey blazed her spotlight on an American couple that traveled to a fertility clinic in the Indian city of Anand to commission a baby. In front of an audience of millions, she extolled the benefits of the arrangement for the couple, who can finally have a baby, and for the woman who is paid to become their surrogate, who can finally send her child to school. Yes, many in the audience agreed, there seem to be benefits all around!

Cross-border surrogacy is a contract-based arrangement that uses assisted reproductive technologies, such as in vitro fertilization. It is a lucrative global industry — the heart of which beats in India — and part of a wider, multi-billion dollar market in assisted reproduction. Thousands of individuals, straight and gay, married and not, have hired surrogates to bear their children.

So who would rain on this parade? Why are there “concern trolls” raising difficult questions about a “solution” that seems a boon for everyone involved?

The answer demands a closer look at the supply side — at the lives, motivations, and vulnerabilities of the women who carry and deliver babies for others, most often to pull themselves and their families out of dire poverty. Their marginalized social and economic status creates a power imbalance that makes it impossible to negotiate dignified and fair “working” conditions and, in fact, allows recruiting agents and clinics to get away with exploitative practices.

Scratch the surface, and these arrangements are replete with health and human rights problems: gestational mothers, otherwise known as surrogates, unable to read the contractual obligations to which they consent; minimal compensation and unfair payment schedules; forced seclusion from family (including young children) and community, in dormitories with round-the-clock monitoring; high-risk medical procedures, including high doses of hormones for embryo transfer and mandated cesarean sections; and little or no postpartum follow up, even in cases of unexpected birth outcomes and health emergencies such as hemorrhage, which can occur days or weeks later with fatal results.

In the middle are the children born as a result of these arrangements. Without best practices and regulation, their rights as citizens in cross-border arrangements, their legal parentage and best interest in custody disputes, and their safety in the absence of adequate screening of commissioning parents, hang in limbo while the world catches up.

This is the untold story of cross-border surrogacy — one on which Oprah did not dwell, one that many of us – including many commissioning parents — know little about. In such a story, where the scales are tipped from the start, only one side wins. The other simply settles.

Here is another story. OBOS, with the Women’s Rehabilitation Centre (WOREC) and Sama Resource Group for Women and Health, is responding to ethical conundrums and human rights issues raised by the largely unregulated cross-border surrogacy market and its ability to adapt to lucrative regional niches.

Sama, based in India, uses action research to critically examine cross-border surrogacy practices, articulate the impact on the lives of women, and make policy recommendations. Sama and OBOS provide technical support to WOREC in Nepal as it builds awareness in its nationwide network of Women Human Rights Defenders, assesses the status of an emerging fertility sector — especially along the country’s border with India — and crafts a preemptive response.

Our goal is simple: develop evidence-based, objective and accessible information to ignite broader social dialogue and action on an issue that is layered, laden, and, most importantly, misrepresented by recruiting agents and fertility clinics.

This collaboration is a call for best practices and regulation of assisted reproduction, and a stepping stone to engaging with commissioning parents as allies who can hold the industry accountable. It embodies OBOS’s legacy of bringing important sexual and reproductive rights issues from the periphery to mainstream dialogue.

And, as policy lags behind technology and markets and the media continue to color public perception of a complex human rights dilemma, this collaboration positions us on the cutting edge to ensure cross-border surrogacy moves forward a an ethical option for growing our families and financial stability — making it a true win for everyone.

November 8, 2013

Here’s What ABC World News Did, and Did Not, Get Right in Report on Egg Donors

by Diane Tober / Associate Executive Director, Center for Genetics & Society

ABC World News joined other media this week in addressing the astonishing 74 percent rise over the past 10 years in young women providing their eggs so that other women can create families.

Correspondent Cynthia McFadden interviews egg “donors” and fertility practitioners to explore the risks of egg retrieval, and chats with anchor Diane Sawyer about the story. While the segment lets several misleading statements stand, it gets some important things right.

First, the report is clear about the point that young women, primarily college students, are recruited to become egg providers with offers of thousands of dollars (yet use of the term “egg donor” for what is a commercial transaction is misleading). Women who are considered better-looking are typically paid more, as are white and Asian women, and those who have higher SAT scores and/or athletic skills. More money also goes to “proven donors” — women whose eggs have been used by “intended parents” to achieve a successful pregnancy.

The story also correctly reports — and expresses appropriate surprise about — the lack of short- or long-term tracking of egg providers’ health and the fact that there is no national database for egg providers. As Dr. Jennifer Schneider points out in the segment, egg providers are “not considered patients — they’re considered more like vendors.” They essentially disappear as soon as the procedure is done.

Now let’s turn to the inaccuracies in the ABC World News story.

McFadden interviews Dr. Joel Batzofin, a reproductive endocrinologist, who states that although “nothing is risk free,” egg extraction is “essentially risk free.” He describes the short-term complication known as ovarian hyperstimulation syndrome or OHSS as “extremely rare” and says it occurs in less than 1 percent of cases.

Unfortunately, his claim remains unchallenged in the segment, despite emerging evidence that OHSS occurs much more frequently than that. One prospective study analyzed OHSS rates in 339 women who produced more than 20 ovarian follicles. 49 (14 percent) were hospitalized due to OHSS, 13 (3.8 percent) needed intravenous fluids, and 9 (2.7 percent) needed to have fluid drained from their abdomens.

Egg providers are commonly stimulated to produce more than 20 follicles, and therefore appear to be at much higher risk for OHSS than is currently being reported. A recent study in the Journal of the American Medical Association found that more than 21 eggs were retrieved in 40.3 percent of the retrieval cycles performed on “oocyte donors.”

Furthermore, preliminary collaborative research on egg provider experiences by CGS and We Are Egg Donors has found numerous cases of women experiencing OHSS to the point where they are bedridden for a week or more. Even though doctors and clinicians assure egg providers that OHSS is “rare,” no one is surprised when it occurs.

When donors are in pain and bloated to the point where they look six months pregnant — after their eggs have been retrieved — they are told that this is “normal,” and to rest and drink plenty of fluids. These cases are not even diagnosed as OHSS, let alone reported or tracked, so there is no data to substantiate that it only occurs in 1 percent of cases.

The ABC World News segment is equivocal in its discussion of links between egg retrieval and cancer. McFadden reports that “there are no known long-term medical issues for donors,” but goes on immediately to say that this is “a world of difference from saying [that there are] no long-term issues.”

In fact, some data does suggest that the synthetic hormones used in egg retrieval may increase risk of colon, ovarian, uterine and breast cancers, though it is difficult to prove the connection due to the delayed onset of cancers in former egg providers and infertility patients.

One Dutch study published in Human Reproduction by Dr. Flora van Leeuwen followed over 19,000 women for 15 years and found that those who had undergone at least one IVF cycle were approximately twice as likely to suffer ovarian malignancies as women who had not undergone IVF treatment.

So how does the ABC World News report rate overall? We recognize that it is not possible in a three-minute segment to cover the entire gamut of egg retrieval risks and experiences but would have liked to hear a mention of the side effects of Lupron (which is used off-label and has been known to cause strokes and a variety of dangerous side effects) and Clomid (which has been linked to increased cancer risk in women who don’t go on to become pregnant).

We would also have liked to see correspondent McFadden question the claims made by Dr. Batzofin, and point out that he and others in the infertility industry stand to profit from taking eggs from young women.

At the same time, we applaud ABC World News for its clear and explicit call for follow-up studies of egg providers and for a national database to track their short- and long-term health.

This post was originally published on Biopolitical Times, the blog of the Center for Genetics & Society.

Plus: Raquel Cool, co-founder of We Are Egg Donors, explains the need for a group that supports women considering or who have provided eggs for fertility purposes. Also check out this petition (started by OBOS, the Center for Genetics and Society, and other organizations), which calls for a human egg extraction health registry and for warnings on ads and notices seeking egg donors. And read one young woman’s experience as she contemplates donating her eggs.

September 5, 2013

California Governor Was Right to Veto Bill Allowing Researchers to Pay Women for Their Eggs

by Marcy Darnovsky, Ph.D. and Susan Berke Fogel, J.D.

OBOS is publishing a series of posts on egg donors and the ethical, legal, and health aspects of egg donation. Also read: one woman weighs the risks of donating her eggs to a friend, and a new group forms to share the perspectives of egg donors.

Last month, California Gov. Jerry Brown vetoed a bill that would have allowed researchers to pay women for having their eggs harvested and retrieved. His move was warmly welcomed by women’s health and public interest groups including Our Bodies Ourselves, National Women’s Health Network, Pro-Choice Alliance for Responsible Research, Alliance for Humane Biotechnology and Center for Genetics and Society. (Disclosure: see author affiliations.)

Echoing the longstanding concerns of many progressives about the serious risks of egg retrieval, Brown’s brief but eloquent veto message recognized that “in medical procedures of this kind, genuinely informed consent is difficult because the long term risks are not adequately known.” He also acknowledged that low-income women would face disproportionate temptations to discount the risks. “Putting thousands of dollars on the table only compounds the problem,” Brown wrote.

The vetoed bill, AB 926, was sponsored by the fertility industry’s trade organization, the American Society for Reproductive Medicine. It was supported by several mainstream women’s organizations, and breezed through the Democratic-dominated legislature. Ironically, as Brown noted, the law that this bill would have overturned was approved by near-unanimous votes in both houses.

That 2006 measure established protections for women who provide eggs for research and limited payments to reimbursement for expenses connected to the egg retrieval procedure. “After careful review of the materials which both supporters and opponents submitted, I do not find sufficient reason to change course,” Brown wrote.

The governor’s veto appears to have caught the bill’s supporters by surprise, and their response has been strongly negative, to the say the least. California NOW’s Facebook page asked “WTF Jerry Brown?” and went on to claim that Brown’s move was “consistent with his Jesuit Catholic Monk values” and that “he ignores science and women’s health in favor of the Catholic Conference’s beliefs that women getting compensated equally with male donors is high tech prostitution!”

Along similar lines, another supporter penned a rancorous Huffington Post piece with a headline that accused Brown of treating women like “children and the mentally handicapped.”

Oddly, most of the attacks on the governor — and some media accounts of his veto — have been silent about the existence of progressive and pro-choice opposition to AB 926. Some flatly mischaracterize the opposition as being solely religious and anti-choice. Others briefly acknowledge that pro-choice groups and individuals opposed the bill but describe them as part of a strange-bedfellows “coalition.”

There was indeed a coalition but it did not include any anti-choice groups. Rather it brought together diverse organizations including, besides our groups, Alliance for Humane Biotechnology, Black Women’s Health Imperative, Breast Cancer Action, and Friends of the Earth.

In addition to misrepresenting the nature of the opposition to the bill, its supporters largely failed to actually address the arguments against paying women to provide eggs for research. Although the state’s major newspapers published thoughtful op-eds raising questions about the issue (opinion pieces appeared in the Los Angeles TimesSan Francisco Chronicle and Sacramento Bee), proponents of paying women to provide eggs for research tended to repeat their talking points rather than answer the questions that were raised: Do we have sufficient information about the long-term effects of egg retrieval to ensure the health and future fertility of the women providing the eggs? Is there even enough information to permit “informed” consent? Might the payments for eggs be coercive to low-income women? Can researchers get the supply of eggs they need without resorting to financial incentives?

AB 926 supporters argued that paying for eggs for research is a matter of “equity for women,” which seems to mean several different things at once. One is that women should be paid for providing eggs because men are paid for providing sperm. UC Berkeley medical anthropologist Nancy Scheper-Hughes pointed out the fallacy of this analogy: Selling sperm and selling eggs are totally different matters, she wrote: “One is pleasurable and safe, the other is a complicated and invasive procedure.”

AB 926 supporters also argued that providing eggs for research should be compensated because it is analogous to enrolling in clinical trials, for which healthy people are paid. This too is misleading. In clinical trials, scientists study their subjects to determine the effects of a drug or procedure on the people taking the drug. But scientists do not study the effects of egg-harvesting drugs and procedures on the healthy young women whose eggs they want for their experiments. The object of their interest is only the eggs, not the women.

Finally, AB 926 supporters pointed out that people who need young women’s eggs for their own fertility treatments pay for them, and asked why researchers shouldn’t be permitted to do the same. That brings us to the core question: Should we expand the market in human eggs?

Given that many women who have undergone egg retrieval in the fertility context have experienced serious complications, and that the procedure’s risks are still grossly understudied, we believe that adequate safety data must be collected before we can have a sufficient evidence base on which to make that decision. A well-designed, multi-center prospective trial is long overdue.

AB 926 supporters claimed that they occupy the pro-science and pro-research camp, and that anyone who opposes them (including Gov. Brown) is “anti-science.” But they have had nothing to say about the well-documented short-term egg harvesting risk of ovarian hyper stimulation syndrome, which can cause organ damage, ovarian rupture, and in rare instances death. They also ignored evidence that the drugs used in egg retrieval may be associated with higher rates of cancer and infertility, and the lack of follow-up studies to ascertain what the risks really are.

In 2007, a report by the prestigious Institute of Medicine concluded that too little research had been done on egg retrieval. It noted that with “more data it will be possible to quantify the various risks of oocyte (egg) donation much better than can be done today and to put numbers to the risks that a donor may face.”

Not much has changed since then. But those who believe that it’s fine for women to “work” as egg providers seem indifferent to understanding the occupational hazards it entails, and to investigating what might be done to minimize the dangers.

Currently, New York is the only state that explicitly authorizes payments beyond reimbursement for women’s eggs for research. The practice is prohibited in far more countries than allow it.

We at the Center for Genetics and Society and the Pro-Choice Alliance for Responsible Research have been calling for years now for clinical studies that look at the long-term health effects of retrieving eggs, for both fertility and research. The American public assumes that medical procedures and drugs have undergone careful study and that treatments have been proven safe and effective before being widely used.

Let us be clear: To date, we do not have well-designed, prospective studies of the effects of egg retrieval. Let us start collecting that information and until we have it in hand, let’s rein in the market for eggs instead of expanding it. Doing so will benefit not just the young women who might provide researchers with eggs, but also the many women who undergo egg retrieval for their own or other people’s fertility treatments.

* * *

This guest column was originally published at Huffington Post and has been reprinted with permission.

Marcy Darnovsky, Ph.D., is Executive Director at the Center for Genetics and Society, a public affairs organization working to encourage responsible uses and effective societal governance of reproductive and genetic technologies. She speaks and writes widely on human biotechnologies, focusing on their social justice, human rights, health equity, and public-interest implications.

Susan Berke Fogel, J.D. is the co-founder of the Pro-Choice Alliance for Responsible Research (PCARR), working on cutting edge issues at the intersection of human genetic biotechnology and women’s health and rights. She is also the Director, Reproductive Health for the National Health Law Program, where she is a national expert on reproductive health law, low-income health programs and religious restrictions in health care.

Young women are increasingly being recruited to donate eggs for infertility and research purposes, though numerous health questions remain unanswered. Our Bodies Ourselves is calling for the creation of a mandatory health registry to facilitate long-term tracking and studies to better understand the risks of egg extraction. Please support the Petition for Human Egg Extraction Health Registry & for Warnings on Ads and Notices Seeking Egg Donors, started by OBOS, the Alliance for Humane Biotechnology, Pro-Choice Alliance for Responsible Research, and the Center for Genetics and Society, and endorsed by other organizations.

August 2, 2013

Racism, Mistrust in Medical System May Affect Black Women’s Use of Genetic Testing for Breast and Ovarian Cancers

Black women in the United States face many health disparities. The CDC recently provided data showing the average life expectancy for black women (at birth in 2010) is 78 — 3.3 years shorter than that for white women.

One of the many diseases for which there are unequal outcomes is breast cancer. Black women are less likely than white women to develop breast cancer, but are much more likely to die of the disease. One hypothesis to explain at least some of the disparity is that black women may be more likely to carry forms of the BRCA1/2 genes that increase their risk for breast and ovarian cancer.

Genetics alone, though, is probably not enough to explain the difference. A recently published study looks at how racism and mistrust in the medical system may also affect black women’s use of genetic testing to inform the monitoring and care they receive.

The authors studied 100 black women at high risk for breast cancer. They looked at whether the women knew how to get, pay for, and what to do with the results of BRCA gene testing, their knowledge of a U.S. law forbidding discrimination based on genetic findings, and their level of mistrust in the medical system, alongside whether the women knew about or had received genetic counseling and testing.

While it’s a small study, the researchers found that the more women knew about how to get and pay for the tests, and the more trust they had in the medical system, the more likely they were to have had BRCA testing.

It should come as no surprise that the more mistrust the women had in the medical system, the less likely they were to undergo genetic testing and counseling. In fact, some of the researchers on this study are affiliated with Johns Hopkins, which back in the 1950s oversaw the (now) widely publicized experiments using the cells of Henrietta Lacks for research.

There’s a long history of abuse — and resulting mistrust — between the medical and scientific establishment and the black community in the United States. Books such as “Bad Blood: The Tuskegee Syphilis Experiment” and “Killing the Black Body” review this history and are crucial to understanding how past injustices may contribute to ongoing disparities.

The study authors acknowledge this likelihood, and comment on how the era of “personalized medicine” may not benefit all patients equally due to this history of racism:

If minority communities have distrust of the medical system and have not benefited from traditional technologies, it is possible that disparities will persist or even widen in the pharmacogenomics era.

Despite being considered high risk, fewer than 1/3 of the women in the study had ever been referred for BRCA genetic testing by their healthcare provider.

Although the researchers didn’t measure it, the women in the study may have been more likely than many black women to have been referred for BRCA testing in general, as they were largely college-educated women and almost all of them had health insurance.

“Black women who are uninsured or those who have lower levels of education may have less genetic testing and counseling awareness and engagement than we found in our sample,” the study’s authors wrote.

The authors also note that women who are underinsured or uninsured may have trouble accessing these tests, which are expensive. Our Bodies Ourselves was a co-plaintiff in the recent lawsuit against Myriad Genetics, opposing the patenting of BRCA1/2 genes. We hope that the recent Supreme Court decision on those patents will lead to more available, affordable gene testing options for all women.

As an action item for potentially reducing disparities, the authors urge physicians and genetic counselors to “improve medical care by ensuring that risk assessment and risk reduction strategies include a clear presentation of the benefits, not just the risks of testing, and by addressing patient trust and concerns about the medical system.”

Read the full study, “Medical Mistrust and Self-efficacy Influence Black Women’s Level of Engagement in BRCA1/2 Genetic Counseling and Testing,” which is available online for free.

July 30, 2013

Egg Donors Create Support Group for Women and Push for More Safety Data

We Are Egg Donors website

by Raquel Cool
co-founder of We Are Egg Donors

I recently decided to retire as an egg donor.

This choice is clearly right for me, and although I speak for myself and note that the views expressed below are my own, I know that there are others who share my concerns.

Months ago, I viewed a slideshow by Dr. Jennifer Schneider in which she said that donors are treated more like vendors than patients [Ed note: Schneider's daughter, a three-time egg donor, died of colon cancer at age 31]. That statement has stayed with me. In my experience, the egg extraction process is streamlined, impersonal and automated.

Each busy specialist has a designated purpose and only stays in the room long enough to get what they need, whether it’s blood drawn, a cervical swab, a snapshot of my ovaries, etc. It can be a very draining process, and egg donors have no one to reach out to in these instances because we’re supposed to be “professional.” Even the psychologist is hired to assess — not counsel — the donor.

With the financial component, the donor’s role is more like a professional vendor. This furthers the likelihood that we won’t want to speak up about medical, psychological or health concerns, because the expectation is that we should defer to medical authorities and keep the process efficient.

I’m also troubled by the fact that most donors do not recognize a serious conflict of interest — relying on the advice of fertility doctors whose primary patients are the individuals seeking assisted reproductive technology (ART) services.

OBOS is publishing a series of posts on egg donors and the egg donation process. Previously, Ryann Summers weighs the pros and risks of donating her eggs to a friend.

Egg donors, when viewed as “instruments” for achieving other people’s fertility goals, may have their own important needs neglected, and the financial incentives now in place for medical professionals don’t require paying close attention to the health and well-being of egg donors. Everything is structured to first benefit the agency/fertility center, and then the patients seeking to have a baby. The considerations of the egg donor are last.

For example, I recently worked with an agency/broker that did not inform me that I had the right to choose my own lawyer — they simply told me that my lawyer (who is also the lawyer for the recipient couple using my eggs) would be contacting me.

That lawyer emailed me a document to sign that would waive the “inherent conflicts of interest” of having one legal group represent both parties. I ended up choosing my own lawyer, although the broker resisted (“Well, you can do that, but none of our egg donors ever have.”).

Ultimately, I ended up canceling the process. I realized that I no longer have it in me to participate in an industry that has resisted researching donor health for decades.

I recently spoke with a two-time egg donor who was diagnosed with an advanced case of endometriosis only six months after her last donation. When she reported her diagnosis to the egg donor agency, they invited her to use their services to treat her infertility. They said that many former egg donors have turned to them, years later, being diagnosed with infertility themselves. This saddens me deeply.

I would be open to donating if the health risks were better understood, and if the industry’s practices were designed to value the health and well-being of the egg donor.

The group I recently co-founded, We Are Egg Donors (WAED), has a mission to provide legal, emotional and advocacy support for women considering or providing eggs for fertility purposes. We offer a neutral space where women can engage in transparent conversations about their experiences — without the presence of a commercial or political agenda “guiding” their personal narratives.

Every donor’s perspective is different; this is mine. WAED doesn’t want to create a one-size-fits-all political voice for all egg donors, but we do share a passion for making sure that women who choose to do it are informed, supported, safe, and connected to agencies who will advocate for them.

We are compiling a digital library of information so women have access to more evidence-based information on the process. We are also promoting awareness of and participation in the only national voluntary registry that is tracking the long-term health of those involved in ART procedures: the Infertility Family Research Registry, based at Dartmouth Hitchcock Medical Center in Hanover, N.H.

We welcome the inclusion of additional resources for our website, and I hope to hear from those who share our mission. Please contact me (raquel AT To learn more about WAED, visit

Young women are increasingly being recruited to donate eggs for infertility and research purposes, though numerous health questions remain unanswered. Our Bodies Ourselves is calling for the creation of a mandatory health registry to facilitate long-term tracking and studies to better understand the risks of egg extraction.

Please support the Petition for Human Egg Extraction Health Registry & for Warnings on Ads and Notices Seeking Egg Donors, started by OBOS, the Alliance for Humane Biotechnology, Pro Choice Alliance for Responsible Research, and the Center for Genetics and Society, and endorsed by other organizations.

July 3, 2013

Egg Donation is Made to Look Easy, but Questions and Health Risks Remain

First in a series on egg donors and the egg donation process.

by Ryann Summers

Recently, a former co-worker and his romantic partner sent me a text message that left me reeling.

It essentially read: Hey, can I have ur eggs? Thx.

Few couples would be better equipped to raise a well-loved child than these two men, and I fully supported their decision to start a family. But I wondered how we had arrived at the point where this request has become so casual that it can be communicated in fewer than 140 characters. At least take me out to dinner.

I don’t fault my co-worker; his question mirrors how the issue is presented in our culture. As a woman in her early 20s, I am bombarded by advertisements seeking my eggs.

Recently when I was riding the T in Boston, I found myself staring at the face of a smiling baby, and a dollar amount. It seems, well, easy.

Egg donation payments range anywhere from $5,000 to $10,000; some solicitations offer amounts as high as $20,000, or even $100,000, for donors with specific characteristics. I could definitely benefit from thousands of dollars, and hey, I probably have eggs to spare, right?

These attractive compensation offers lack any balancing information about risks and hazards, creating a deus ex machina temptation: As far as I know, I have the potential to help create life for a deserving future parent — and make a staggering profit.

These two potential outcomes are, in fact, quite possible. It can be life-changing and rewarding to help others realize their dream of having children. The sky-high payment — sky-high, at least, to many college students, the prime demographic — is just gravy in this scenario.

But in a different light, it can be a bit like putting a price on the creation of life. Or, tilt again, and it’s simply reimbursement for the donor’s time, as well as the physical risk and discomfort.

So I dug a little deeper, and what I found is while the perspective may shift, there are some immutable realities that are rarely included in donor discussions.

Unlike the process men undergo to donate sperm, the preparation and procedure involved in egg donation require a longer-term commitment — a woman’s body is hormonally altered through the process, and she undergoes surgery.

I’d like to see ads note that fact, along with the known risks of egg donation. The ads don’t mention ovarian hyperstimulation syndrome (OHSS), a condition that causes the ovaries to swell and become painful in about one-fourth of women who use injectable fertility drugs. (OHSS generally goes away after a week or so, but in severe cases it can cause rapid weight gain, abdominal pain, vomiting and shortness of breath.)

Nor do they mention that the surgery to remove the eggs can sometimes lead to complications, including cramping, bleeding and infection.

Egg donors also need to be told that the long-term risks of egg donation remain largely unknown. There is little long-term safety data on the infertility drugs commonly used to stimulate egg production, and there have been no follow-up studies on women who have donated their eggs.

This lack of safety information has led Our Bodies Ourselves and other women’s health advocates to call for a mandatory egg donor registry that will allow researchers to track the long-term health of women who have donated eggs. The Infertility Family Research Registry, a voluntary registry, is based at the Dartmouth Hitchcock Medical Center (see below for more more information).

In addition to physical risks, there are the possible psychological reactions to consider. While donors generally undergo both physical and psychological testing before the process begins, it is impossible for donors to predict with certainty the emotional impact of this procedure.

A 2008 study on egg donors’ experiences published in Fertility and Sterility found that almost one in five women reported lasting psychological effects, some positive and some negative, including “concern for and/or attachment to their eggs and/or potential offspring, concern that the donor or resultant child might want a relationship with them in the future” and “stress resulting from the donation process as a whole.”

“Women need to look at the risk involved very carefully, and pay attention to what they’re being told about risks, not just to what they’re being offered to do it,” Nancy Kenney, co-author of the study, told HealthDay News.

As a member of the target demographic, I want complete and balanced information. With the prospect of such a permanent and life-altering decision, I need to know the risks and rewards.

Other women do, too. Three women who donated their eggs have begun collecting personal stories from fellow donors with the hope of creating a self-advocacy group.

“Some of us consider egg donation to be the best thing we’ve ever done. Others do not feel that way at all. Whatever her stance, each donor’s story is welcome here,” they write in the mission statement at

I personally decided against donating my eggs. I sympathized with the overwhelming process my former co-worker and his partner were experiencing, but I told them that I personally did not feel that egg donation was the right choice for me.

I knew very little about egg donation back then, but I did know enough not to match his casual request, delivered via text, with a casual promise that might worry me for years to come.

Plus: OBOS is actively encouraging infertility clinics and centers across the country to promote awareness of the Infertility Family Research Registry based at the Dartmouth Hitchcock Medical Center. Learn more about ongoing studies.

Read more about issues and concerns related to egg donation, particularly from a nursing perspective, in this article from MCN, The American Journal of Maternal/Child Nursing.

A Boston College alumna, Ryann Summers served for two years as a bilingual program advocate at Voices Against Violence, providing counseling and advocacy services to Spanish-speaking survivors of domestic violence. As an undergraduate, she founded and facilitated a support group for student survivors of sexual assault. An avid yogi and writer, Ryann aims to explore women’s public health themes regularly for OBOS.

June 13, 2013

Single Embryo Transfer Recommended in Most IVF Procedures

The process of in vitro fertilization – in which embryos are created outside a woman’s body and then implanted in her uterus — has become increasingly common in the United States. In 2010, 61,564 infants were born using an a form of assisted reproduction technology (ART), and almost all of those resulted from IVF.

A common IVF practice has involved transferring multiple embryos to a woman’s body in one cycle. This was thought to increase the likelihood that at least one embryo would successfully result in a live birth. The average number of embryos transferred at one time is two to three.

While this strategy makes sense theoretically, it is not risk free. Transferring more than one embryo creates a risk for multiple pregnancies, such as twins or triplets, which makes the pregnancy higher risk and increases the risk of premature birth and low birth weight. (Single pregnancies created via IVF are also thought to be at a higher risk for prematurity, low birth weight, and congenital anomalies, though researchers aren’t certain whether this is due to the IVF techniques or the underlying infertility problem.)

Recently, researchers have been studying whether single embryo transfer might be a better option. Some have suggested that birth rates might be similar when single embryos are transferred.

The research has been convincing. In a joint practice committee statement, the Society for Assisted Reproductive Technology and the American Society for Reproductive Medicine concludes that with improving technology, single embryo transfer (SET) is an increasingly better choice for achieving pregnancy while avoiding multiples.

The statement notes that SET may be particularly appropriate for women with the best chance of a good outcome, such as those who are under 35 or on their first or second treatment cycle, and that women ages 35 to 40 could also elect SET if they have “top quality” embryos of the proper stage available for transfer.

The authors also note that the United States has “lagged behind” the rest of the world in focusing on SET. For example, the National Institute for Health and Care Excellence (NICE) in the UK recommends single embryo transfer for most women and no more than two at a time for anyone.

For more on single-embryo transfers, read this excerpt from “Our Bodies, Ourselves.”

May 17, 2013

Angelina Jolie, Breast Cancer, and You: How to Make the Right Decisions for YOUR Health

Angelina Jolie on the cover of Time magazineAngelina Jolie certainly has good intentions in sharing her experience with breast cancer genetic testing and her decision to have a prophylactic mastectomy, and her announcement marks another welcomed example of well-known women coming forward about personal health issues.

But it is now up to women’s health advocates to ensure that the media coverage and public debate that follows does not offer false information or false hope — which I fear it will, if women are not fully informed about all the issues involved before imagining that Jolie’s decisions would be the right ones for them.

Already, women in the United States undergo a higher rate of mastectomies than women in other countries. “Breast cancer experts believe that many women undergoing mastectomies don’t need them and are getting them out of fear, not because of the real risks,” Diana Zuckerman, president of both the National Research Center for Women and Families and the Cancer Prevention and Treatment Fund, wrote this week.

First, women need to remember that BRCA1 and BRCA2 mutations occur in less than 1 percent of the population. To decide whether testing for breast cancer genetic mutations makes sense for them, it is important to speak with a knowledgeable health care provider. According to the National Cancer Institute:

The likelihood that a breast and/or ovarian cancer is associated with a harmful mutation in BRCA1 or BRCA2 is highest in families with a history of multiple cases of breast cancer, cases of both breast and ovarian cancer, one or more family members with two primary cancers (original tumors that develop at different sites in the body), or an Ashkenazi (Central and Eastern European) Jewish background. However, not every woman in such families carries a harmful BRCA1 or BRCA2 mutation, and not every cancer in such families is linked to a harmful mutation in one of these genes. Furthermore, not every woman who has a harmful BRCA1 or BRCA2 mutation will develop breast and/or ovarian cancer.

The steep price tag of testing, around $3,300, is of concern, though some women considered appropriate candidates for testing may be covered, all or in part, through their insurance. Under the Affordable Care Act, genetic counseling and BRCA testing, if appropriate, are considered preventive services and are covered without cost-sharing.

If a woman does seek testing, she needs to consider the pros and cons of all possible approaches to positive test results. While a bilateral mastectomy reduces the risk of getting the disease by 90 percent, about 10 out of 100 women who have their breasts removed will still get breast cancer in the underlying tissue. And there are numerous potential problems with such surgery that need to be fully discussed, such as infection and mobility impairment.

For those who choose this radical surgery, there is also the decision about whether to pursue breast reconstruction and, if so, what kind. Despite widespread assumptions to the contrary, there are major unresolved safety issues, especially for silicone breast implants.

Some women choose to forgo reconstruction entirely, though most media fail to mention this. The truth is, some women have no problems with their “breastless” bodies, nor do their sexual/intimate partners. Some women also find that modern prostheses are comfortable and offer a satisfying appearance.

Moreover, not all choices — even what might be ideal in a given circumstance — will be possible given financial constraints and lack of adequate medical coverage or support. As Cheryl Lemus, managing editor of Nursing Clio, a blog on gender and medicine, writes:

In order for all women to have the right to red carpet healthcare [...] then all women don’t just need money and insurance, but also the other resources Jolie highlighted in her op-ed, which include the supportive partner/spouse, family, an understanding employer, reliable transportation and childcare, and “time” in general.

Sadly, we know this is often not the case.

We also need to be honest about what we know and don’t know about breast cancer and risk. According to the NCI, women who have inherited a harmful mutation in BRCA1 or BRCA2 gene are approximately five times more likely to develop breast cancer than women who do not carry the mutation.

The way the numbers break down, about 12 percent of the general population — or about 120 women out of 1,000 — will develop breast cancer at some point during their lives, compared with about 60 percent — 600 out of 1,000 — who have inherited a harmful BRCA1 or BRCA2 gene mutation.

Yet there are other factors, such as environmental exposure, that influence breast cancer risk. Some women living in communities with high levels of toxic exposure may have elevated breast cancer risk for a non-heritable reason.

The NCI also notes that the risk factor for those carrying the mutated gene is based on research on large families in which many individuals have been affected by cancer. We still have many questions to answer about genetic and environmental influence:

Because family members share a proportion of their genes and, often, their environment, it is possible that the large number of cancer cases seen in these families may be due in part to other genetic or environmental factors. Therefore, risk estimates that are based on families with many affected members may not accurately reflect the levels of risk for BRCA1 and BRCA2 mutation carriers in the general population. In addition, no data are available from long-term studies of the general population comparing cancer risk in women who have harmful BRCA1 or BRCA2 mutations with women who do not have such mutations. Therefore, the percentages given above are estimates that may change as more data become available.

This heightened interest in breast cancer genetic testing caused an uptick in the stock of Myriad Genetics, which has a monopoly on BRCA1 and 2 testing. OBOS is a co-plaintiff in the lawsuit challenging Myriad Genetic’s patenting of human genes, along with the ACLUBreast Cancer Action, a number of scientific organizations and researchers, and Lisbeth Ceriani, a single mother whose circumstances led her to seek breast cancer genetic testing and who felt stymied by Myriad’s monopoly.

The Supreme Court heard arguments in the case last month and is expected to issue a ruling this summer. Its decision will have a major impact on whether or not scientists will be able to improve upon the current test as well as the future price tag for such testing. In the meantime, let’s hope that thousands of women don’t make hasty decisions about testing and treatment without careful consideration of all the issues involved.

As Zuckerman writes:

As an actress whose appeal has focused on her beauty, surgically removing both her breasts when she didn’t have cancer was a very gutsy thing to do. But if we care about women’s health, we need to stop thinking of mastectomy as the “brave” choice and understand that the risks and benefits of mastectomy are different for every woman with cancer or the risk of cancer. In breast cancer, any reasonable treatment choice is the brave choice.

May 16, 2013

Truth in Medicine: Vast Majority of Assisted Reproductive Technologies Fail

by Miriam Zoll

In an essay recently published in the Wall Street Journal, Sarah Elizabeth Richards, author of the new book “Motherhood Rescheduled,” encourages women to ward off age-related infertility by simply freezing their eggs — like she did.

Between the ages of 36 and 38, Richards spent $50,000 to freeze 70 eggs that she plans to thaw, fertilize, and insert into her uterus when she is 44 or 46.

“Egg freezing,” she said, “stopped the sadness that I was feeling at losing my chance to have the child I had dreamed about my entire life.” Still looking for a mate at almost 40, Richards says she now goes onto and has the confidence to tell men that she can “have kids whenever I want.”

While Richards’ decision appears to have provided her with a sense of hope and temporary emotional equilibrium, it may prove to be illusory. Sadly, as millions of women, including me, can attest, the vast majority of assisted reproductive technologies fail.

In 2012, of the 1.5 million treatments performed globally, 1.1 million failed: a 77 percent failure rate. In the United States, the overall failure rate was 68 percent. Once optimistic and hopeful about the promise of reproductive science, I endured four failed in vitro fertilization (IVF) cycles, one miscarriage, and two donor egg attempts in which both donors were diagnosed as being infertile.

But it is no wonder that Richards believes she will be able to bear children with her frozen eggs whenever she wants to. A $4 billion industry is driving the public discourse about often unproven discoveries through a lens that focuses attention on the minority of successes rather than the whole messy, complicated story.

Related: What’s Wrong With Fertility Clinics and Online Advertising

Growing up in a culture that reveres science, she has been bombarded with overly optimistic and one-sided media stories touting the miracles of creating babies in laboratories. The truth is, many women signing up for treatments do not realize until later the extent to which they are participating in a vast experiment, where evidence-based medicine has yet to establish a reasonable foothold.

The only current independent effort to track the health of all women going through treatments remains largely invisible to patients who might sign up to have their health — and that of their offspring — tracked over time.

The voluntary Infertility Family Research Registry is based at the Dartmouth Hitchcock Medical Center and is funded in part by the American Society for Reproductive Medicine (ASRM). To date, the vast majority of large fertility centers in the United States are not displaying the registry’s placard in their waiting rooms, greatly reducing the potential benefits such a long-term study would provide. [Ed note: Our Bodies Ourselves is actively encouraging infertility clinics and centers across the country to promote awareness of the Infertility Family Research Registry.]

Richards’ desire to protect her ability to bear a biological child is heartfelt, and her willingness to undergo egg freezing procedures that were considered experimental at the time speaks to her commitment — and her panic — to try anything to preserve that opportunity. But her statement that this decision was “the best investment” she ever made is premature, to say the least.

The general public knows virtually nothing about the failure and success rates of vitrification — a new flash-freezing technique that has been used to preserve the eggs of women younger than 30 who are facing life-threatening illnesses. While an estimated 1,000 babies have been born from this technology worldwide, there is virtually no data that tells us if these live births were the result of 3,000 or 10,000 trials.

We have no idea how many miscarriages or still births may have ensued, and there are few, if any, long-term infant health studies evaluating how flash freezing half of a child’s DNA might affect that child later in life. The one study Richards cites found that 900 babies exhibited no more risk of birth defects than babies conceived naturally by young mothers, but is one study really enough?

Apparently the ASRM believed it was proof enough for them to lift the “experimental” label from the still young procedure last fall. The ASRM Practice Committee said it was not yet ready to endorse widespread use of egg freezing for elective use. However, while randomized controlled studies were rare, the committee did find sufficient evidence to “demonstrate acceptable success rates in young, highly selected populations.”

Citing a lack of data on safety, efficacy, cost-effectiveness, and potential emotional risks, their report states, “Marketing this technology for the purpose of deferring childbearing may give women false hope and encourage them to delay childbearing. Patients who wish to pursue this technology should be carefully counseled.”

As would be expected, once the ASRM decision became public, their caution about women’s age and infant health was obscured and eventually obliterated by the dust kicked up by a stampede of panicked but hopeful 30- and 40-something women running to the nearest fertility clinic to have their eggs harvested for future use — for anywhere between $10,000 and $15,000 per harvest, or more.

One must wonder why the ASRM felt so compelled to provide a stamp of approval for a procedure still lacking in reliable safety and efficacy data. As legal scholars Debora Spar and Naomi Cahn have written in their books, “The Baby Business” and “Test Tube Babies,” respectively, in the context of an unregulated industry in the United States, it is virtually impossible to separate the medical and market forces at play when new techniques and procedures are advertised to potential clients.

The blurred boundaries between fertility clinics wanting to provide patients with safe, evidence-based procedures while also needing to generate business to meet their bottom lines puts that much more pressure on consumers to know what they are signing up for. But when evidence and information is scarce, biased, or non-existent, well-heeled consumers like Richards feel they have no choice but to close their eyes, write a check, and jump off that technological cliff called “hope.”

For Richards’ sake, I hope she succeeds. If not, she may well join the ranks of millions of men and women who, since the first IVF baby was born in Britain 35 years ago, have experienced involuntary biological childlessness as a result of delaying parenthood and relying on science for last-minute miracles.

Miriam Zoll is an award-winning writer and an international health and human rights advocate and educator. She is the author of “Cracked Open: Liberty, Fertility and the Pursuit of High Tech Babies” and is on the board of Our Bodies Ourselves. This article was originally published at RH Reality Check, and is reprinted with permission.

April 30, 2013

“Cracked Open”: New Book Looks at Fertility and Reproductive Technology

Our Bodies Ourselves board member Miriam Zoll has a new book coming out on May 1, “Cracked Open: Liberty, Fertility and the Pursuit of High Tech Babies.”

Zoll tells her own story of infertility and IVF treatments, and shares what she learned along the way about assisted reproductive technologies.

From the book description:

When things don’t progress as she had hoped, she and her husband enter a science-fiction world of medical seduction, capitalist conception and bioethical quagmires. Desperate to conceive, they turn to unproven treatments and procedures only to learn that the odds of becoming parents through reproductive medicine are far less than they and their generation had been led to believe.

OBOS Co-Founder and Executive Director Judy Norsigian contributed to the foreword with Michele Goodwin, a professor of law at the University of Minnesota. Learn more about Zoll and “Cracked Open” as she shares her story on the My Fertility Choices site.

Zoll is also collecting stories on infertility and reproductive technology via her website. Requests to have her come speak can also be made online.

April 18, 2013

Supreme Court Hears Case Against Myriad Genetics: Why Patents Hurt Women’s Health

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On Monday, the Supreme Court heard oral arguments in the lawsuit against Myriad Genetics, challenging the company’s right to hold patents on  two genes linked to increased risk of breast and ovarian cancer: BRCA1 an BRCA2.

The primary concern — which Our Bodies Ourselves, a co-plaintiff in the case, shares – is that human genes shouldn’t be patentable because they occur in nature. Allowing the patents restricts access to testing and research on these genes, and negatively affects women’s health.

Nina Totenberg, in her coverage for NPR, highlights the significance of the Court’s decision, expected later this year: “There is no way to overstate the importance of this case to the future of science and medicine.”

The oral arguments boiled down to two key opposing points. The attorney for the Association for Molecular Pathology and other plaintiffs in the case argued that the genes cannot be patented because they are found in nature. The attorney for Myriad Genetics essentially argued that because the company found and isolated the gene, it should be able to patent it. There was a great deal of discussion about this point, with analogies such as whether finding and removing a plant from the Amazon should entitle someone to patent that plant as an “invention.”

Major medical organizations have argued that the patents force people in the United States to “undergo tests that are inferior to and more costly than those available in other countries,” with the consequence that “no woman in America can get an independent second opinion about her condition before deciding to have her healthy breasts or ovaries removed in order to avoid cancer.”

In explaining the consequences of allowing the patents, the ACLU has written:

The patents on BRCA1 and BRCA2 are harmful to patients and create barriers to medical and scientific advancement. Myriad has a monopoly on BRCA genetic testing in the U.S. and therefore controls the type and price of testing. Thus, while genetic testing technologies have advanced to the point where all 23,000 human genes can be sequenced for $1000, Myriad has raised its price for BRCA genetic testing to over $4000 in the last few years and still does not capture all known BRCA mutations. Other laboratories cannot provide second opinions, and they cannot include the BRCA genes when offering testing of the multiple genes that are now associated with breast and ovarian cancer risk. Gene patents also have a chilling effect on research. Researchers must either obtain permission from the patentholder, or run the risk of being sued. And by virtue of its patents, Myriad controls most of the data about the BRCA genes and has refused to share that information with the scientific community.

Reporting from the courtroom, Breast Cancer Action praised those who made their voices heard in opposition to the patents:

It was a thrill to meet so many wonderful people working hard for women’s health, and it was incredibly moving to hear from the powerful women who stood up to tell their personal stories. We know that Myriad’s patents on our genes are wrong, and we hope that the Supreme Court will take this opportunity to come down on the right side of women’s health.

More coverage of the case:

For further information and resources, see OBOS’s previous posts:

April 17, 2013

“Can We See the Baby Bump, Please?”: Film on Commercial Surrogacy in India Screens in Boston

Can We See the Baby Bump, Please

Update: A second public event has been added, also co-sponsored by Our Bodies Ourselves: “Systemic Violence or Informed Consent? The Politics of New Reproductive Technologies and Medical Experimentation in India” is the theme of the program at MIT on Tuesday, April 23, which will include the film screening and remarks by Sama’s co-founder, Sarojini N. The event will take place in MIT Bldg. 5, Room 217, at 7 p.m.

The rise of commercial surrogacy has led to numerous concerns and conversations involving women’s health and medical ethics. On Monday, April 22, Our Bodies Ourselves will sponsor a screening of “Can We See the Baby Bump, Please?” — a documentary film about commercial surrogacy in India that explores the ethical challenges.

The screening will take place at Boston University’s Bakst Auditorium at 5 p.m. and is free and open to the public. Co-sponsors include the Health Law, Bioethics and Human Rights Department of the School of Public Health and the student-led Health and Human Rights Caucus.

From film director Surabhi Sharma’s website:

The global reach of medical tourism and commercial surrogacy spawns a range of clinics and practices across big cities and small towns in India. Anonymous, often with limited choice, woman’s labour is yet again pushed into the background. A whiff of immorality, the absence of regulation and the erasure of the surrogate’s experience collude to produce a climate of callousness. May we see the baby bump please? meets with surrogates, doctors, law firms,agents, and family in an attempt to understand the context of surrogacy in India.

The film was commissioned by the Sama Resource Group for Women and Health in New Delhi (view Sama’s blog for more on the film and a recent study on commercial surrogacy).

Sarojini N., the director and co-founder of Sama, will attend the screening and discuss her organization’s recent research on surrogacy practices, and strategies to address medical malpractice and the exploitation of women hired to be gestational mothers.

In 2012, Judy Norsigian, OBOS founder and executive director, traveled to Kathmandu to lead a workshop with Sarojini and Renu Rajbhandari, founder of the Women’s Rehabilitation Centre, OBOS’s Global Network partner in Nepal, on the growing popularity of cross-border surrogacy arrangements. Their presentation included effective strategies that could be used to educate and empower women.

“Already a booming business in India, where estimates suggest that 25,000 couples a year travel to arrange surrogacy contracts and there are about 1,000 surrogacy centers, this practice is soon expected to extend to Nepal, where poor women with limited economic opportunities will likely be attracted by the prospect of earning money by bearing children for others,” wrote Norsigian.

Read about her experience and learn more about the growing market in cross-border reproductive health care.

April 3, 2013

What’s Wrong With Fertility Clinics and Online Advertising

Did you know the United States and New Zealand are the only nations that permit direct-to-consumer (DTC) pharmaceutical ads?

A decade ago, Kaiser Family Foundation found that every $1 the pharmaceutical industry spends on direct-to-consumer (DTC) advertising yields $4.20 in drug sales, and that DTC ads were responsible for 12 percent ($2.6 billion) of the total growth in drug spending in 2000.

Groups such as Our Bodies Ourselves and the National Women’s Health Network have long argued for stricter regulation and elimination of DTC drug advertising, due to the tendency to overstate drug benefits and understate risks in order to increase pharmaceutical companies’ profits.

There is some minimal governmental regulation of traditional DTC ads (i.e., print, TV) with respect to the claims companies can make and information they must provide — although the level of oversight is insufficient to fully protect consumers from misleading and manipulative claims about drugs.

For web-based DTC advertisements, however, there is even less oversight and more mixing of advertising and information content, increasing the risk that consumers will be confused and misled.

This is the case with fertility clinic websites, which represent a multibillion dollar industry. Evidence suggests that fertility clinics’ approaches to online advertising present significant problems for consumers seeking objective information about success rates and clinic practices.

Since 1992, as a result of pressure by consumers and organizations, U.S. clinics have been required to report their success rates to the Centers for Disease Control and Prevention (CDC), which publishes this data (see reports on assisted reproductive technologies).

More than 146,000 cycles of assisted reproductive technologies (ART) are reported to the CDC each year (primarily in vitro fertilization attempts), meaning that there are many consumers who are having these procedures. But, consumers looking for fertility-related information and/or providers are more likely to visit fertility clinic websites than the CDC website.

Sadly, these clinic sites too often try to influence consumers with misleading information about their ability to create successful pregnancies. ART is expensive (averaging $12,400 per cycle, with many patients requiring two or more cycles) and often is not covered by insurance, so it is natural for patients to seek a provider who can maximize their chance of success.

Yet a recent analysis of web content from 372 U.S. fertility clinics (out of a total of 381 clinics) suggests that the success rates being promoted are not based on reputable practices and/or standards.

The analysis examined websites of the clinic members of the Society for Assisted Reproductive Technology (SART), which represents most U.S. fertility clinics. SART’s guidelines require clinics to compare their success rates only to the national average, but 46 percent of the clinics violated this policy.

Of those, 47 percent described their success rates as “superior” or “among the best,” without indicating what they were comparing themselves to (which is prohibited under SART guidelines). Over one-third (39 percent) of clinics that provided a success rate failed to describe how the rate was calculated (as SART requires), making it impossible for potential clients to gain a meaningful understanding of the rates.

Clinics also fail to meet the American Medical Association’s (AMA) guidance on website content; one study found the majority of fertility clinic websites failed to meet basic  guidelines such as describing how they protect patient’s privacy. The AMA does not investigate websites’ compliance or issue non-compliance penalties, however, and the only consequence for noncompliance with SART’s guidelines is for clinics to lose their membership (not a very significant penalty).

Consumers face challenges when trying to evaluate clinic performance in other areas as well. ART clinic sites frequently use non-medical and non-verifiable content and advertising tactics to entice potential patients. Many use words like “dream” (30 percent of websites) on their homepages. Many mention their excellent technology (84 percent), personal approach (75 percent), and high-quality doctors (70 percent) — factors that, while important, do not provide objective information by which to compare clinics.

An example of non-specific information is provided by a clinic that calls its prices “competitive” and says it “lacks hidden fees,” but does not provide an actual fee list.

Concerns about ART advertising date back to the field’s beginning in the late 1990s. Then, as now, concerns include the commercialization of medicine, inability to assess service quality, and a lack of accountability. Studies have found that clinics fail to provide objective measures of success; to note when their procedures are experimental (and may have lower success rates); and to generally comply with SART guidelines.

The only thing that’s new is that consumers now have ready access to misleading and poor information online, making it easier for consumer to access and, therefore, to be misled.

What can be done to help patients navigate the maze of on-line fertility clinic information? First, consumers should view these sites with a critical eye, recognizing that words like “miracle” and photos of smiling babies are intended to evoke specific feelings and encourage spending lots of money at a specific clinic. The sites should be considered to be advertisements rather than sources of accurate, verifiable medical information. Consumers should consult the CDC data (recognizing that comparisons may be difficult and clinics may select patients in ways that influence their rates).

Second, we need better oversight of clinic website content, including independent assessment and disclosure of how well clinic websites meet industry guidelines. SART and the American Society for Reproductive Medicine should establish new guidelines that reflect how clinics actually advertise (e.g., online), commit resources to member education, and impose significant consequences for non-compliance.

Any new guidelines should include the use of social media (like Facebook), used by about one-third of clinics already to reach potential customers. More broadly, Federal restrictions and regulations on DTC marketing should include web-based and social media, as well as TV ads and other forms of advertising.

A version of this article was originally published in The Women’s Health Activist, the newsletter of the National Women’s Health Network, and is adapted with permission. 

Related: Our Bodies Ourselves resources on infertility and assisted reproduction