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 Match.com 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.

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

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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.

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.

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.

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

In early October, I had the honor of co-leading a workshop in Kathmandu on the growing popularity of cross-border surrogacy arrangements with two colleagues from the New Delhi-based Sama Resource Group for Women and Health and Dr. Renu Rajbhandari, founder of the Women’s Rehabilitation Centre (WOREC).

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.

In some parts of India, women are now offered fees ranging from $5,000 to $7,000, amounts that represent up to 10 years of earnings for people in rural areas.

The workshop, hosted by WOREC, OBOS’s global partner in Nepal, brought together women’s right activists from across the country to better understand the growing market in cross-border reproductive health care, its implications for Nepal, and the most effective strategies to educate and empower women.

Surrogacy Legislation in India
Participants included two nurses from the Kathmandu-based IUI (intrauterine insemination) clinic, several health counselors, a psychosocial counselor for women with fistulas, a family planning coordinator, the editor of a quarterly women’s magazine, several members of Women’s Human Rights Defenders, a nursing professor, an advocate with Save the Children, and a staff person from a rural women’s radio station in eastern Nepal. Languages used during the workshop were primarily Hindi and Nepali, with English translation offered as needed.

Sarojini and Preeti, our colleagues at Sama, provided an excellent overview of surrogacy in India, including a description of assisted reproductive technology (ART) legislation now being hotly debated in Parliament. One provision in the controversial bill would require that a woman entering into a contract surrogacy agreement undergo an embryo transfer rather than be inseminated with the intended father’s sperm.

Since insemination would be much safer, many workshop participants felt that a choice should be offered. An embryo transfer places the woman at greater risk by exposing her to powerful hormones that prepare her body for the pregnancy and to surgical procedures required to physically transplant the embryo into her uterus.

The proposed law assumes that a woman using her own eggs will be more likely to change her mind at birth and decide she wants to keep the baby than a woman who becomes pregnant with an embryo created with another woman’s eggs. There is poor evidence to support this assumption.

Preparation in Nepal
By their very nature, commercial surrogacy arrangements are created by contracting couples and agencies whose primary interests typically do not reflect the needs and concerns of women recruited as gestational mothers.

This is why groups like Sama and WOREC are advocating for public policies that will protect gestational mothers and ensure they receive evidence-based information about risks and benefits in a manner they fully understand. Policies must also ensure follow-up care and effective recourse if things go wrong.

The women at the workshop want to be better prepared in case a similar bill is introduced in Nepal. Sarojini, Preeti and I shared practical information about the various ART techniques involved in surrogacy and explored, with our Nepali colleagues, ways to preserve the health and rights of women agreeing to be surrogates. Most participants were quite unfamiliar with the whole topic of ARTs and asked many questions about the medical, social and economic impacts.

Why Language Matters
We also screened two documentary films about surrogacy – Made in India, by New York City-based filmmakers Vaishali Sinha and Rebecca Haimowitz, and Would Like to See Baby Bump Please, a new film just released in India by Sama — and discussed the importance of using language sensitive to all the parties involved in a surrogacy arrangement.

For example, the term “reproductive tourism” carries the image of couples vacationing in their pursuit of parenthood. In most cases, these trips are stressful and a far cry from the typical tourist experience. Using alternative language such as “cross-border commercial surrogacy” is one way to avoid such innuendo.

Similarly, referring to a gestational mother as a “surrogate mother” or “gestational carrier” can belittle and objectify her central role as the woman carrying a pregnancy for nine months and then giving birth. Many at the workshop preferred the descriptive, less diminishing term “gestational mother.”

At the end of the workshop, we developed a number of recommendations for moving forward.

Meeting Local Activists
After the workshop, I traveled with Renu to Udaipur in eastern Nepal, where she introduced me to many younger women at the WOREC center, including some who contributed to WOREC’s set of six Nepali health booklets, recently adapted from Our Bodies, Ourselves.

I also visited a group of young women who are the sole staff for a radio station in Udaipur, where egg cartons provide the sound proofing in their recording studio. They frequently address women’s health topics in their programming and invite community conversations about sexuality, domestic violence and the environment.

Although I had met Renu briefly when she traveled to Boston for OBOS’s 40th anniversary symposium in 2011, the many hours of chatting while we drove over mountainous terrain cemented a special friendship I now treasure. I have a new appreciation of her remarkable leadership over the past several decades and was deeply impressed by her efforts to pass the torch to a younger generation.

A trip to a fairly remote mountain village was particularly inspiring. The women had successfully lobbied for village development council funds to create a small multipurpose women’s center. Though a bit run-down, it was getting a lot of use and clearly a sign of how effective some women’s groups have been over the past decade.

The provisional constitution for the country still has not passed, but its contents – including funding for legal abortion – offer great hope for the future of women’s reproductive rights and justice in Nepal.

This article was originally published in the winter 2012/2013 Our Bodies Ourselves newsletter. View the full newsletter.

The American Civil Liberties Union has launched the “Take Back Our Genes” campaign to fight against issuing patents issued human genes. The ACLU believes that allowing one company to own the patent for a particular gene limits research on genetic health conditions and also limits patient options for genetic testing.

As the organization explains:

Myriad Genetics, which controls the patents on the genes, is able to exclude others from testing and conducting research on the patented genes. Patients who want to obtain genetic testing to determine whether they are at risk for hereditary breast and ovarian cancer have only one option for full genetic sequencing: Myriad Genetics. Myriad decides what tests are offered, which mutations are included, at what cost, and what research can be conducted without fear of patent infringement liability.

The ACLU is asking individuals to send their photos or videos explaining their opposition to gene patenting. The video below provides a great example of how gene patenting can affect patients and their access to affordable, reliable testing.

Our Bodies Ourselves is one plaintiff in the lawsuit filed by the ACLU and the Public Patent Foundation against the U.S. Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation to challenge the patents they hold on BRCA1 and BRCA2 genes.

See our previous posts on this topic:
OBOS Joins ACLU Lawsuit Challenging Breast and Ovarian Cancer Gene Patents
Breast Cancer Gene Patents Invalidated (see later update from the appeals court)

These two recent pieces also provide good explanation of why gene patents are an important issue for patients and researchers to consider.

You may have seen recent news coverage along the lines of “BRCA variants not tied to worse cancer outcomes.” This story refers to a recently published study about changes in the BRCA1 and BRCA2 genes that affect breast and ovarian cancer. Women with mutated versions of the genes have greater risks of breast and ovarian cancer than women with typical versions of the genes.

In the new study in the Journal of Clinical Oncology, researchers tried to figure out whether women with BRCA1 or BRCA2 mutations who do develop cancer have worse outcomes than women without the mutations. They compared records for women with breast cancer and one of the mutations with those of women with breast cancer who did not have these gene changes.

Overall, they found that women with BRCA1 mutations had similar rates of metastatic (“distant”) cancer recurrence and death as women without it. Women with BRCA2 mutations had higher risks of recurrence and death, although the risk was similar when the women got adjuvant therapy (additional treatment to help prevent recurrences). Other factors like age and stage of the cancer also made a difference.

However, this study should be interpreted with caution. Bigger studies are probably still needed to properly understand any effects of these genes on women’s cancer therapy outcomes. The similarity of outcomes between women with and without the mutations may have to do, in part, with what we have learned about therapies for women with those mutated genes – which therapies don’t work as well for them, and which therapies might be added on for better outcomes. The researchers for the current study do say that women with mutated BRCA1/2 genes were more likely to have received adjuvant therapy, and the authors were unable to look at women’s results by how much chemotherapy they received.

While women who have BRCA1/2 mutations may be advised to have earlier or more frequent cancer screenings than other women, it’s not yet completely clear who should get tested for these mutations or if women should be tested once they’re diagnosed with breast or ovarian cancer.

As we learn more about how our genes affect our cancer risks and therapy outcomes, I expect we’ll see more and more news on these topics, and it may take some time to figure out how to assess risk, guide cancer therapies, and how our outcomes change based on this knowledge. Here are a few helpful resources for this growing area of study:

• Genetics Home Reference – Cancers – information from the National Library of Medicine on genes related to a number of cancers
• General Cancer Genetics Information – information from the National Cancer Institute on genetic (hereditary) risks for cancer, gene testing, a dictionary of genetics terms, and other resources
• My Cancer Genome – information intended to help inform physicians about tumor (not hereditary) genes and their effect on cancer therapy. Disclosure: I work with the team that produces this site.

Many of us have at least heard of controversies over open vs. closed adoption laws, and the efforts by many to make adoption more open so children can find out about their biological parents. One of many arguments for open adoptions relates to health – children may want or need to find out about their family history and risk for medical conditions that may affect them.

Until recently, I hadn’t heard that the same debate is raging with regards to “donor offspring” – people conceived as the result of sperm, egg, or embryo donation. It makes sense – many of the same issues are raised in a donor situation, including what hereditary medical issues are important to watch out for.

Last week, the Supreme Court of British Columbia (Canada) ruled in favor of journalist Olivia Pratten, who was conceived using sperm from an anonymous donor and filed suit against the BC government after finding out that the records had been destroyed. The Pratten case centered around two claims – that protecting the rights of adoptees but not donor offspring to learn about their biological parents is discrimination, and that the right to liberty and security of the person guarantees a constitutional right to know one’s origins and genetic heritage.

Pratten won the case, with the judge ruling that donor offspring are entitled to the same rights as adoptees and granting a permanent injunction in British Columbia prohibiting the destruction of donor records including those for anonymous donations of sperm, eggs and embryos. This is the first such North American ruling banning donor anonymity; reportedly 11 jurisdictions elsewhere already banned anonymous gamete donation, including seven in Europe, three in Australia, and one in New Zealand.

A few related resources that may be of interest:

• Feb 2011 Newsweek coverage of Pratten’s story and the case
• International Donor Offspring Alliance, which advocates for rights of donor-conceived persons
• Anonymous US, focused on “reproductive technologies and family fragmentation”
• The Donor Sibling Registry, which helps connect genetically related persons conceived through donations

Last summer, we shared that OBOS had joined an ACLU lawsuit challenging breast and ovarian cancer gene patents.

Briefly, the ACLU and the Public Patent Foundation (with plaintiffs including OBOS, pathology associations, and individuals) filed a lawsuit against the U.S Patent and Trademark Office, Myriad Genetics and the University of Utah Research Foundation, “charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid.” The suit focused on the BRCA1 and BRCA2 genes, mutations of which are related to increased risk of breast and/or ovarian cancers, and for which Myriad Genetics controlled the patents (effectively controlling the available testing for important mutations).

As Breast Cancer Action explained, “When one company controls all the testing, less information and resources are available to both patients and researchers.” The New York Times story on the ruling also explains that “Some doctors and researchers contend that this monopoly has long held up not only competing, cheaper tests but has also hindered gene-based research.”

Last Monday, a U.S. judge ruling in the case invalidated the patents, arguing that “the company deserved praise for what is ‘unquestionably a valuable scientific achievement,’ but not a patent because the ‘isolated DNA is not markedly different from native DNA as it exists in nature.’” Essentially, the relevant genes are found in nature and thus aren’t novel enough to qualify for patent protection.

The judge dismissed the claim that the U.S. Patent and Trademark Office’s issuing of the patents was unconstitutional. The complete ruling can be found here [PDF]. The ruling has the potential to make the study of and testing for important genetic variations cheaper and more readily available.

Genomics Law Report has a good overview of the ruling, and several ScienceBlogs authors are also talking about the case, with one calling the ruling “a monumental step towards bringing sanity to biotech patents.”

This Sunday, CBS aired an episode of 60 Minutes that prominently featured the case. As OBOS was a plaintiff to the suit, we also got a chuckle out of the title of this editorial at the NYDailyTimes: Our bodies, ourselves: Judge rightly rules that no one can patent human genes

The ACLU itself also has commentary on the ruling, calling it “a huge victory for women’s health and scientific freedom,” and NPR’s Richard Knox has an interview with an attorney who explains the ruling and its implications.

The November issue of the journal Fertility & Sterility includes an article that attempts to determine whether assisted reproductive technology (ART, or AHR for “assisted human reproduction”) may be associated with a higher risk of birth impairments.

The authors reviewed data from records in an Ontario birth database for which information about reproductive assistance was reported, and compared outcomes for the 790 infants conceived via assisted means (including ovulation induction, intra-uterine insemination, in vitro fertilization, and intracytoplasmic sperm injection) to the outcomes of 43,462 infants conceived without assisted methods.

After adjusting for factors such as maternal age and smoking, the authors found that 2.91% of infants conceived by ART were diagnosed with a major birth impairment compared with 1.86% in the control group, with significantly greater odds of all anomalies and cardiovascular and gastrointestinal impairments; risks were highest for the IVF group as compared with other methods examined.

The authors explain that some other research has shown various levels of increased risk, but that it is not clear what might explain the findings. They speculate that “Elements that may contribute to increasing birth defects include the advanced age of one or both partners of the infertile couple, the essential cause of infertility, or the medications used to induce ovulation or to maintain the luteal phase.” They suggest that “The potential risk of anomalies associated with AHR may be considered in the counseling that is offered to infertile couples.”

In November of last year, the CDC released a study on the same topic and concluded, “Infants conceived with Assisted Reproductive Technology (ART) are two to four times more likely to have certain types of birth defects than children conceived naturally, according to a study by the CDC.”

The study found higher risks of some heart defects, cleft lip, and some gastrointestinal impairments associated with ART in singleton births as compared to babies conceived without fertility treatments.

The agency explained, however, that the absolute risk of any birth impairment is low, and provided the following example for context: “In the United States, cleft lip with or without palate affects approximately 1 in every 950 births; doubling the risk among infants conceived by ART would result in approximately 1 in every 425 infants being affected by cleft lip with or without palate.”

Reaching a similar conclusion as the current article, the authors of the CDC study state that “Although the mechanism is not clear, couples considering ART should be informed of all potential risks and benefits.”

A number of other studies have investigated this issue, although the body of literature on the topic has been criticized as being inadequate due to methodologic problems such as “inadequate population sizes, inappropriate control groups, missing adjustments, and unclear descriptions of the methods used to screen malformation,” according to one author.

However, most reviews of the topic seem to come to a similar conclusion: that further research is needed, and what is known should be discussed with those seeking ART so they may make informed choices about potential risks.

Earlier this month, California Governor Arnold Schwarzenegger signed into a law a bill, AB 1317, which requires advertisements seeking egg donors for fertility treatment to include a notice about the possible adverse health effects of egg donation.

Such advertisements must contain standard warning language that there may be risks associated with human egg donation, and advise potential donors that they are required to receive specifics on the known risks before signing a legally binding contract. The required language also recommends consulting with one’s physician prior to donation.

The state already had a law requiring such a warning summary be provided to women donating eggs for research purposes. That existing law also sets out the specifics of the warning to be provided to women prior to signing a contract for donation. The warning needs to consist of “medically accurate disclosures” concerning the potential risks associated with the surgical procedure for egg retrieval as well as the “drugs, medications, and hormones” prescribed for ovarian stimulation during the process.

Relatedly, one publisher of classroom materials has recently released a book on the topic of egg donation intended for a young audience. Egg Donation: The Reasons and the Risks is listed as being intended for grades 7-12, and at a 6th grade reading level. The book seems focused on egg donation for fertility (not research) purposes, with the description noting that it “explains the current controversy” as well as “the basic science behind egg harvesting and in vitro fertilization and describing the process donors go through to help other women conceive.” Potential health risks and ethical issues are also apparently covered.

For more on the potential health concerns associated with egg donation, see Christine’s previous post on the topic, and Egg Donation for IVF and Stem Cell Research: Time to Weigh the Risks to Women’s Health.

Last year, in an article published at Our Bodies Ourselves, freelance writer and registered nurse Jen Dozer wrote about the emotional effects of pregnancy after infertility or loss. She later spoke with Our Bodies Our Blog about her own experience with infertility and the anxiety and distrust she felt toward her own body when she did become pregnant.

After Dozer’s article was published, she asked readers of her blog, Mrs. Spock, to share their own stories about infertility and pregnancy loss. Nine of those stories are now published at Our Bodies Ourselves.

With unflinching honesty, the writers describe what it’s like to undergo test after test; to commit to infertilty drugs only to see hopes rise and fall with each cycle; or to conceive after infertility, with no clear understanding of why the pregnancy suddenly happened — and whether it will last.

Kathleen O’Grady sums up the anguish that comes with realizing a pregnancy cannot be willed by love and desire alone: ”Pregnancy was not supposed to happen like this — with the cold medical hands of specialists leading me through an intricate web of possible bodily malfunctions.  But through a spontaneous moment of grace, a sacred orgasmic moment when one plus one makes three.”

In another story, the writer walks readers through her discovery, at her 20-week scan, that her son no longer has a heartbeat; his sister still does.  ”I began to think about the flu I had come down with last week and the antibiotics I had taken for the resulting sinus and ear infection, the accidental diet Sprite I had, the Tylenol I had taken to help with the misery of the flu symptoms. I thought of all the things that I thought I had done wrong and asked Ajay, “Did I do this? Is this my fault? [...] How is this happening?”

Read their stories here. Personal experiences of loss and doubt are rarely included in books about pregnancy. But they are essential. As Dozer writes at her own site:

I’ve often thought that birth, to us in the infertility trenches, is more denouement than climax, because we do all our laboring on the front end. All of our blood, sweat, and tears, all of our anticipation, all of our hard work, is spent on conceiving our children, or navigating the adoption process. And just like a labor, no two experiences are alike. I liked the idea of sharing our stories of infertility and loss, and pulling back the veil on the many paths to parenthood- or to childfree living as the case may be. [...]

It is only by sharing our stories that the ten percent of us that have “tubeless” or “unicornate” or “incompetent cervix” or “anovulatory” stamped on our foreheads look more like the daughters, sisters, friends, and neighbors we are, than the kooky Octomom looking for a reality show deal the fertile world thinks we are.

This Week’s Super Fun Health Reform Graphic: The award goes to The New York Times for the multi-tab Key Challenges in the Healthcare Debate. Below is the view from the section on “Getting Through Congress.”

 

Cuts to Medicare Drug Costs: The AARP has endorsed an offer by drug manufacturers to discount the price of some Medicare prescriptions by $80 billion over the next decade. The announcement was made today at the White House; a transcript of President Obama’s remarks is available here.

“The unusual offer by the Pharmaceutical Research and Manufacturers of America (PhRMA) is part of its effort to convince skeptical lawmakers that it backs major health-care legislation,” writes Ceci Connolly of the Washington Post. “Though the agreement represents a fraction of the total cost of health-care reform, it has been managed for maximum public relations exposure.”

Connolly explains how the deal would work:

When the Medicare prescription drug benefit approved by Congress went into effect in 2006, it left a coverage gap that charges seniors the full cost of medications once a patient has received $2,700 worth of drugs, until the total reaches about $6,100. At that point, “catastrophic” coverage kicks in and covers nearly all drug expenses.

“The existence of this gap in coverage has been a continuing injustice that has placed a great burden on many seniors,” Obama said over the weekend.

Under the proposal, seniors who fall into the coverage gap known as the “doughnut hole,” would pay half price for all brand-name medicines. The discounts could save 3.5 million retirees up to $1,700 a year, according to AARP. In addition, the full price of the drug would count toward a person’s out-of-pocket total, thus maximizing the insurance benefit.

Connolly also wrote a good Sunday Outlook piece on Obama’s strategic approach to health reform, and this morning she participated in an online discussion about the article.

Study Time: It’s a busy week for Congress, as three House committees — Ways and Means, Energy and Commerce and Education and Labor — take up health-reform legislation. Here’s the draft bill released Friday by House Democrats.

Kaiser Health News’ Mary Agnes Carey discusses the highlights of the bill, which includes an individual mandate for coverage, with some exclusions, and an employer mandate – called “pay or play.” As for how it will be paid for:

They stressed that everything is on the table. They have some ideas. They want major Medicare and Medicaid system reform such as ‘accountable care’ organizations that really try to coordinate medical care to make sure it’s the best possible care for the patient and reducing hospital re-admissions.

But of course, they’re always talking about taxes as well. And these are some of the ideas that will be discussed in the coming weeks: a tax on the benefits that an employer provides, a payroll tax, a tax on sugary drinks, taxes on alcohol, value added taxes (also called VAT) on some goods and services.

Igor Volsky at The Wonk Room notes that the Tri-Committee proposal “seems to contain a fairly robust public insurance option.” The Times published a poll Sunday showing overwhelming support for a government-funded public option that would compete with private insurance plans.

“On the whole,” adds Volsky, “the bill’s affordability measures are impressive.” His post includes a comparison of the HELP bill, the Senate Finance Committee draft and the Tri-Committee bill.

Raising Women’s Voices notes that the new House bill includes a statement on meeting women’s health care needs. Two points in particular stand out:

• Include coverage of maternity services as a benefit category in the new basic benefit package. All plans in the Exchange would be required to maternity services and over time plans outside the Exchange would be required to do so as well.
• Prohibit plans in the Exchange from charging women more than men by banning gender rating. This protection will extend to all health plans outside the Exchange over time as well.

Pus: The Senate debate kicked off Wednesday, and it was a rocky start. Jeffrey Young at The Hill has more.

Here are six senators to watch for their involvement in crafting a bipartisan health-care bill, via The Fix. Three former Senate majority leaders — Democrat Tom Daschle, and Republicans Bob Dole and Howard Baker — have reemerged with their own plan. They must be missing the excitement.

Dan Balz writes that Obama is soon going to have to “make clear what he’ll accept and what he won’t” when it comes to “cost and coverage, revenue and savings, a public option or not, and the cost vs. the desirability of bipartisan agreement.”

Cost and coverage suddenly became a more central issue after the Congressional Budget Office issued new estimates last week. The goal of reform advocates long has been a plan that moves the country to universal coverage. Earlier assumptions put the price tag in the neighborhood of $1 trillion over 10 years. The CBO shattered those assumptions, though their numbers were based on incomplete plans.

A preliminary estimate of the Senate Finance Committee’s draft bill put the price tag of universal coverage at $1.6 trillion over 10 years. That was considerably more than anyone anticipated and forced the committee to delay work on the bill. The cost of the incomplete plan drafted by the Senate Health, Education, Labor and Pensions Committee was pegged at about $1 trillion over 10 years, but the CBO said that would still leave 30 million (rather than the current 46 million) people without coverage.

Talking Points: Media Matters notes that during a Sunday morning interview with members of the Obama administration’s health care team, Good Morning America’s Diane Sawyer didn’t include any questions that reflected the concerns or positions of progressives.

Meanwhile, single-payer advocates continue to make news. The Boston Globe has a Q&A with Dr. Steffie Woolhandler, a Cambridge Health Alliance internist and Harvard Medical School professor who co-founded Physicians for a National Health Program. And MinnPost.com interviews PNHP’s president, Dr. Oliver Fein, who notes how popular single payer has become, despite its unpopularity:

What I think is really interesting is that although Sen. [Max] Baucus says that single payer is off the table, at the minimum, we’re the elephant under the table. Everybody is referring to us.

So, you have someone like [Health and Human Services Secretary Kathleen] Sebelius now saying we’ll create a public option that will not go to single payer. You have Republicans saying that the thing they fear is single payer; you have a whole variety of discussion that’s going on that keeps referring to this thing called single payer. Probably one of the real problems is there’s not enough of a definition for the public to make an assessment about what that really is.

Plus: Here’s Sebelius’s no-single-payer interview with NPR.

In other political news …

So About That All-Important Sounding Council …: Linda Lowen, About.com Guide to Women’s Issues, is waiting to hear what the White House Council on Women and Girls is doing. And she doesn’t like waiting. Via Feminist Peace Network (she doesn’t like waiting, either).

Did You Hear the One About the Republican Senator Who Wouldn’t Condemn Clinic Violence?: Sadly, it’s true. Jodi Jacobson reports at RH Reality Check that an anonymous Republican senator used his (it’s presumed, with good reason, that the Republican in question is male) power “to put a ‘hold’ on a Senate Resolution originally introduced by U.S. Senators Jeanne Shaheen (D-NH), Barbara Boxer (D-CA), and Amy Klobuchar (D-MN) condemning violence against women’s health providers, thereby blocking any vote on the resolution.”

Bush Bioethics Panel No More: The New York Times reports: “Members of the President’s Council on Bioethics were told by the White House last week that their services were no longer needed and were asked to cancel a planned meeting, a council staff member said Wednesday.”

Reid Cherlin, a White House press officer, told the NYT the panel was designed to a “a philosophically leaning advisory group” that was more about discussion than consensus-building.  that favored discussion over developing a shared consensus. Obama will appoint a new panel charged with offering “practical policy options,” said Cherlin.

The FDA’s Full Plate: FDA Commissioner Margaret Hamburg told USA TOday there’s no truth to the rumors that the FDA will split in two, with one half overseeing food safety and tobacco and the other responsible for oversight of medical products.

Drug safety, tobacco regulation and direct-to-consumer advertising top Hamburg’s agenda. On the subject of advertising, Hamburg said, “There certainly have been concerns about the quality and authenticity of some of the messages … We have a dedicated staff working on the issue.”

We’ve written previously about the ACLU’s concern about gene patents, especially regarding the possibility that “high licensing and diagnostic testing fees that some biotech companies charge for use of ‘their’ genes are inhibiting biomedical research and interfering with patient care.”

On May 12, the ACLU and the Public Patent Foundation filed a lawsuit against the U.S Patent and Trademark Office, Myriad Genetics and the University of Utah Research Foundation, “charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid.” The suit focuses on the BRCA1 and BRCA2 genes, mutations of which are related to increased risk of breast and/or ovarian cancers.

In explaining the rationale for the lawsuit, ACLU Executive Director Anthony D. Romero wrote:

Knowledge about our own bodies and the ability to make decisions about our health care are some of our most personal and fundamental rights. The government should not be granting private entities control over something as personal and basic to who we are as our genes. Moreover, granting patents that limit scientific research, learning and the free flow of information violates the First Amendment.

The following video provides an excellent overview of concerns about BRCA gene patenting, with additional commentary from ACLU representatives and women concerned about how the patents affect their own health:

Our Bodies Ourselves has joined the suit as a plaintiff, along with the Association for Molecular Pathology, American College of Medical Genetics, American Society for Clinical Pathology, and the College of American Pathologists, several prominent individuals in genetics and pathology, genetic counselors, and individual women patients who have been affected by the patents.

Breast Cancer Action has also joined the suit as a plaintiff, explaining that:

When one company controls all the testing, less information and resources are available to both patients and researchers. Women unable to afford the $3,500 fee are prevented from access to the test; women seeking second opinions on any results they might receive have nowhere to go; and women of African, Hispanic, or Asian descent are at a significant disadvantage because they disproportionately receive ambiguous results when tested by Myriad.

BCA Executive Director Barbara Brenner notes the importance of the landmark case:

There are so many injustices and inequities in breast cancer. The time has come to address them in all their forms—as they affect genetic risk, as well as social, political, and economic realities. This case is an important first step.

OBOS Executive Director Judy Norsigian will appear in a segment on the issue produced by Ivanhoe Broadcast News’s “Smart Woman” team — we’ll post an update when the piece airs.

The suit itself, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., was filed in the United States District Court for the Southern District of New York in Manhattan and can be accessed online via this ACLU webpage.

The ACLU is also providing answers to frequently asked questions about the issue, and a number of background resources and fact sheets. Individuals may also sign a statement of support for the plaintiffs.

More than 50 years ago, network censors prevented Lucille Ball from using the word “pregnant” to describe her, um, pregnancy on “I Love Lucy.” She instead had to say she was “expecting.”

Fast forward to 2009, where the leading home pregnancy test, First Response, appears on TV shows like “Gossip Girls” and in the movie “Juno.”

Andrew Adam Newman reports in The New York Times that in addition to nifty product placement, First Response has rolled out a new advertising campaign built around three pregnancy-related products, including its newest one: an at-home fertility test that measures FSH (follicle stimulating hormone). FSH stimulates the growth of ovarian follicles in the ovary, so measuring it and finding a healthy level shows that one sign of fertility is present.

The test, performed on the third day of the menstrual cycle, is sold at major retailers such as CVS and Wal-Mart. It is not without its critics, however, who note that it has some obvious limitations — the test can’t gauge if there are problems with the uterus, cervix or fallopian tubes, or the man’s sperm. And yet the packaging seems to gloss over this:

In capital letters in large type, it says, “Are You Able to Get Pregnant?*” with the asterisk referring to smaller type that specifies that the product will not really answer that question, saying, “This test detects F.S.H. This test does not detect all fertility issues.” (Instructions inside the package emphasize that even women within the normal F.S.H. range who are under 35 and who have been trying to conceive more than a year, or over 35 and trying for six months, should consult a doctor).

First Response also makes a daily ovulation test. Ads featuring all three products ask: “Am I …” followed by “fertile?” “ovulating?” and “pregnant?”

“We really believe First Response can and should be the brand that helps women in the whole reproductive cycle,” Stacey Feldman, a marketing vice president at Church & Dwight, maker of First Response, tells the NYT. “It’s not really about one product — it’s about the system.”

First Response started running ads this week on AccentHealth, a CNN-produced program shown in waiting rooms, including 1,500 obstetrics and gynecology offices, and print ads will appear in the fertility magazine Conceive and on the magazine’s website.

Plus: Writing about a new study that shows children born to older dads have, on average, lower IQ scores, than to children born to younger dads, Lisa Belkin sees the potential for reconsidering our cultural attitudes toward gender and aging:

The push and pull between timetables and dreams, between our bodies and our babies, is at the core of many women’s worldview, which also means it is at the core of relationships between the sexes. This tension feeds the stereotype of woman as eager to settle down and men as reluctant, and it’s the crux of why we see women as “old” and men as “distinguished.”

If those underlying assumptions were to change, would all that follows from them change as well?

Read the whole piece.