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

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 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.

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.

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.

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.”

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.

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.

Although somewhat technical, this Human Genome Project Information page from the Oak Ridge National Laboratory provides an overview of the topic, including some of the arguments for and against gene patenting, with lots of links to related information.

A freely available article from Nature Reviews Genetics, Patenting human genetic material: refocusing the debate, also provides good background reading on this issue, including a discussion of concerns about patenting from “adversely affecting the research environment to hampering the distribution of useful technologies.” A number of other articles on this topic are also freely available through PubMed Central.

The ACLU is specifically focused on patents related to the BRCA1 and BRCA2 genes relevant to breast and ovarian cancer, explaining that:

“…the Utah-based company Myriad Genetics has patented two genes – BRCA1 and BRCA2 – and certain mutations along these genes that have been associated with an increased risk of certain forms of breast and ovarian cancer. The high licensing and diagnostic testing fees charged by Myriad have forced some researchers to discontinue research on breast cancer and have prevented women from having access to screening for mutations.”

The organization is currently conducting a survey to gather information on women’s experiences with BRCA testing:

We are interested in hearing from you if you have been advised to get the BRCA genetic test and fall into one of the following categories:

1) You were tested, and had problems with or concerns about the testing process (for example, your results were uncertain or incorrect, or you were advised you needed to be tested a second time); or

2) You were tested, and want to be tested again through another lab for verification; or

3) You wanted to be tested, but had financial problems getting the test (for example, you could not afford it or your insurance did not cover it); or

4) You want to determine the BRCA status of a deceased relative.

If your answer is YES to even one of these questions, please take the ACLU’s survey: www.aclu.org/brcasurvey. The ACLU is looking into the legality of patenting human genes, including the BRCA1 and BRCA2 genes, and the effects of gene patenting on research and testing.

For additional information on genetic testing and breast cancer in general, see our related content and this page from the National Cancer Institute.

The issue has become more urgent as more women are showing an interest in egg donation as a way to make ends meet. Some fertility clinics say that the number of applicants has increased as much as 55 percent in the past four months compared to the same period last year.

Catherine Elton writes:

Doctors say there is no biological reason that donating eggs would cause infertility, but they also cannot say for sure that it doesn’t. The long-term health effects of egg donation have never actually been studied, in large part because the high cost of studies doesn’t “seem justified in terms of what the possible risks [of the procedure] might be,” according to Sean Tipton, spokesman for the American Society for Reproductive Medicine (ASRM). He points out that egg donors undergo the same drug treatment as IVF patients — hormone injections and other drugs that stimulate follicles, promote egg maturation and prevent the release of eggs before they can be retrieved — and that studies of the latter population show it is safe.

But some women’s health advocates say that evidence isn’t strong enough, calling for further study and a national, trackable registry of egg donors. While the Centers for Disease Control and Prevention (CDC) logs the number of donated eggs transferred to infertile women each year — there were some 15,500 in 2006, the most recent year for which data are available — no one knows how many individual donors those eggs came from, who they were or whether they were exceeding industry guidelines of six donations in a lifetime. (The guidelines are intended to limit the number of offspring from a particular donor and to prevent overexposure to fertility drugs, but they are not based on scientific data.)

“Right now egg donors are treated like vendors, not as patients. Patients need to be followed up,” says internist Jennifer Schneider, who has been advocating for the government to track egg donors since 2007, a few years after her daughter, a three-time egg donor, died of colon cancer at age 31. “After the first few days of being discharged from the IVF clinic and seeing that there were no immediate consequences, they are never contacted again.”

Short-term risks include ovarian hyperstimulation syndrome, ovarian torsion or ruptured ovarian cysts. Our Bodies Ourselves Executive Director Judy Norsigian, who also supports a national registry of egg donors, tells Time that women she speaks to on college campuses are generally uninformed about the risks. Elton writes:

A recent study of past donors seems to support Norsigian’s impressions. In an article published in Fertility and Sterility in November 2008, researchers found, for example, that 34% of former egg donors didn’t recall being aware at the time of donation of the risk of ovarian hyperstimulation syndrome, the most common side effect. The majority of donors experience at least the mild or moderate form of this syndrome, which involves discomfort, bloating or nausea and usually resolves itself on its own. The severe version of this syndrome is rare — only 100 to 200 for every 100,000 women — but its consequences can include kidney failure and death. And then there are other side effects, such as bleeding, infection and death, which are associated with any surgery performed under general anesthesia. But fully 20% of the 80 donors interviewed said they didn’t know there were any physical risks to egg donation at all.

“There is a clear problem about informed consent here,” Norsigian says.

It’s a comprehensive story that raises a number of important issues — please share it.

Related: Egg Donation for IVF and Stem Cell Research: Time to Weigh the Risks to Women’s Health