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.

Time magazine has a story about growing concerns over the long-term health effects of donating eggs, especially cancer and infertility.

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

Last year, a measure passed that requires researchers who receive federal funding from the National Institutes of Health to abide by a public access policy and make their research papers available through PubMed Central, a free online archive of life and biomedical science journal literature.

As a result, much more literature medical research is expected to become available to the public (although much of it will become available only after 12 months have passed since publication). Librarians and consumer advocates have been among the champions of this policy because it will increase access to scientific and medical knowledge.

Last week, it was announced that this policy of access no longer needs to be renewed every year, making it more likely to succeed in providing the public with access to medical research funded by their tax dollars. Supporters of the policy, however, are currently fighting a legislative challenge from Rep. John Conyers (D-MI); it has been suggested that his and others’ opposition the public access policy may be related to political donations received from the publishing industry.

In addition to the individual articles to be made available through the public access policy, a number of journals are already available in full online as “open access” journals — journals which are freely available to the public “without financial or other barrier other than access to the internet itself.” In other words, you or your library do not need to pay for a subscription to access these titles.

Currently, BioMed Central seems to be the biggest publisher of open access medical journals. A complete list of BioMed Central journals is available online. A few that might be of particular interest to our readers:

• BMC Pregnancy and Childbirth
• BMC Women’s Health
• Breast Cancer Research
• Conflict and Health
• Globalization and Health
• International Breastfeeding Journal
• Reproductive Health

For more information on open access publishing (which is distinct from the NIH public access policy), check out this introduction and the fairly detailed Wikipedia entry.

Obama’s Feminist Mystique: What a week for women in the new adminstration. President Obama named Melanie Verveer, chair and CEO of the Vital Voices Global Partnership for emerging women leaders, to a newly created State Department position: special ambassador for global women’s issues. Veveer was once Hillary Clinton’s White House chief of staff.

Then on Wednesday Obama signed an executive order creating a White House Council on Women and Girls. (Read about the event through the eyes of basketball star Lisa Leslie.) Lynn Sweet has photos and a full list of the attendees.

The council will be led by longtime Obama adviser Valerie Jarrett, who talked with NPR’s Linda Wertheimer about what the group will focus on. Director of Public Liaison Tina Tchen will oversee day-to-day operations.

Its mission, according to the White House memo, is to “provide a coordinated federal response to the challenges confronted by women and girls to ensure that all Cabinet and Cabinet-level agencies consider how their policies and programs impact women and families.”

In his remarks, Obama emphasized that women are not the only ones hurt by gender inequality:

“These issues are not just women’s issues. When women make less than men for the same work, it hurts families who find themselves with less income, and have to work harder just to get by. When a job doesn’t offer family leave, that also hurts men who want to help care for a new baby or an ailing parent. When there’s no affordable child care, that hurts children who wind up in second-rate care, or spending afternoons alone in front of the television set. And when any of our citizens cannot fulfill their potential because of factors that have nothing to do with their talent, their character, their work ethic, that says something about the state of our democracy.”

New York Times columnist Nicholas Kristof summed up the powerful message that the White House is sending.

“For decades, the ’serious’ foreign policy issues were the likes of non-proliferation or trade rules, but a new agenda is emerging and the treatment of women around the world is high on it,” writes Kristof.

“But this isn’t just a justice issue. It’s also a matter of economic development. One of the things we’ve learned over the last 15 years is that you can’t fight poverty effectively unless you educate, emancipate and empower women, and bring them into the formal economy. So, with these new positions, onward!”

New FDA Commissioner Named: Filling a key vacancy, Obama today said in his weekly radio address that he would nominate Margaret A. Hamburg, a physician and former New York City health commissioner, to lead the Food and Drug Administration. Joshua Sharfstein, Baltimore’s health commissioner, will serve as Hamburg’s chief deputy.

The address, which focused on food safety, confirmed Hamburg’s nomination, which was made public earlier this week.

“The pair, both outsiders, would take on an agency in crisis,” wrote Rob Stein and Lyndsey Layton in the Washington Post. “Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel — and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.”

The dismal news continues:

The agency has been lambasted on Capitol Hill for a series of food-borne illnesses, the most recent of which is an ongoing salmonella illness outbreak that has sickened 700 people and killed nine. It has been slammed by its own scientists for approving medical devices without proper vetting. And it has been unable to ensure the safety of imported goods pouring into the United States from around the world, including food, drugs and raw materials.

Other than that, I’m sure things are just swell.

Plus: Over at the Wall Street Journal, Alicia Mundy has a good story about how political lobbying drove the FDA approval process of Menaflex, a medical device designed to treat a common knee injury. The story includes a paper trail of memos.

And here’s an interesting fact about Hamburg’s mother, Beatrix; She was the first African American woman to attend Vassar College and to earn a degree from the Yale University School of Medicine.

Spending Bill Passes; Includes Funding for Reproductive Health: Congress finally passed the 2009 omnibus spending bill this week. Michele Goldberg, writing at RH Reality Check, discusses the $50 million the bill includes for the United Nations Population Fund (UNFPA), which was de-funded under the Bush administration.

“Now that Democrats are running things, we’re seeing a return to reality-based policymaking on women’s health,” she writes, but warns that conservatives will continue to find ways to attack the UNFPA.

Jodi Jacobson has more analysis of the spending bill and its funding for domestic and international reproductive health programs.

Science Trumps Ideology: Last week we previewed Obama’s decision to overturn the Bush administration’s restrictions on stem cell research. But Obama went a step further on Monday, outlining how his administration would continue to  value the expertise of science advisers. From The New York Times:

The document orders Mr. Obama’s top science adviser to help draft guidelines that will apply to every federal agency. Agencies will be expected to pick science advisers based on expertise, not political ideology, the memorandum said, and will offer whistle-blower protections to employees who expose the misuse or suppression of scientific information.

The idea, the president said in remarks before an audience of lawmakers, scientists, patients advocates and patients in the East Room, is to ensure that “we make scientific decisions based on facts, not ideology”: a line that drew more applause than any other. Irv Weissman, who directs an institute at Stanford University devoted to studying stem cells, called the declaration “of even greater importance” than the stem cell announcement itself.

After noting that “Congressional Democrats and scientists themselves issued report after report asserting that the White House had distorted or suppressed scientific information,” the Times turned to Bush political strategist Karl Rove and counselor Ed Gillespie to defend their boss and his supposedly rigorous application of science — which makes for a very subjective ending.

Take Action
*Email President Obama at president@whitehouse.gov or call the White House at 202-456-1111 and thank the president for his commitment to promoting sound science based on fact not ideology and for not letting religion be used as a barrier to access safe and effective drugs. (National Women’s Health Network)

*As Rachel reported, the first step in rescinding the Bush administration’s so-called concscience-provide rule is the 30-day public comment period. Here are some sample comments for your review and inclusion. (National Partnership for Women and Families)

Stem Cell Funding: “President Obama’s decision to lift restrictions on federal funding of human embryonic stem cell research, scheduled to be announced Monday, is expected to provide a major boost to one of the most promising but controversial fields of biomedical research in generations,” reports the Washington Post in what will be a page-one story on Saturday.

Congress Hits Spending Roadblock: Congress on Friday passed a stop-gap bill to keep the government running for another five days. The legislation was needed because Republicans on Thursday unexpectedly forced a postponement on a vote on the government’s so-called omnibus bill.

Jodi Jacobson covers the Republican attacks on sexual and reproductive health programs contained in the spending bill — such as the Affordable Birth Control Act, a correction to earlier legislation that is not an earmark (learn more), and U.S. funding for the United Nations Population Fund.

“[F]or the far right, apparently no ideological position is too shallow and no misrepresentation too outrageous to prevent them from wreaking havoc on this country or to mitigate against their purely political shenanigans,” writes Jacobson.

Fortunately, Republican Sen. Roger Wicker’s amendment to limit UNFPA funding failed.

Fox News Misrepresents Provider Conscience Rule: This one is a doozy. From Media Matters:

In separate reports, Fox News’ Bret Baier and Megyn Kelly misrepresented the reported plans of the Obama administration to rescind a December 2008 Bush administration regulation to falsely assert that the Obama administration’s decision could result in doctors’ being prosecuted or discriminated against for refusing to perform abortions. In fact, federal law — which the Obama administration cannot “repeal[]” — prohibits public officials from requiring recipients of public funds to perform abortions or sterilizations in violation of their religious or moral beliefs.

Read more at Media Matters, along with our coverage of how some media outlets last week mis-characterized the Bush administration policy.

Plus: This is essential: Rachel explains how to comment on the rule to rescind the Bush rule. The  30-day public comment period starts on Tuesday.

Health Care Summit: Health care reform was the topic of the week as more than 150 lawmakers, insurers, doctors and advocates converged on Washington. You can watch the forum on C-SPAN’s website and read the White House’s live blog.

“While the participants were extremely diverse, there was real, across-the-board consensus that the course we’re on right now is neither sustainable nor responsible, and that it’s not working for businesses, state governments, the federal government, individuals or families,” Debra Ness, president of the National Partnership for Women & Families, said in statement.

Over at Womenstake, the blog of the National Women’s Law Center, NWLC president Marcia Greenberger wrote: “What was striking was that a positive tone existed, not only in front of the cameras but in private conversations throughout the day. Wanting to read it tonight, one Republican member of the House asked me for my own copy of the Center’s report on the outrageous practice of many insurance companies to charge women more than men when they buy insurance directly — even with maternity coverage excluded!”

The New York Times notes that a “wide variety” of the speakers “expressed support for an individual obligation.”

Speakers who endorsed such a requirement included Representative John D. Dingell, Democrat of Michigan; Representative Jo Ann Emerson, Republican of Missouri; Kendall J. Powell, the chief executive of General Mills and a member of the Business Roundtable, which represents large companies; Representative Allyson Y. Schwartz, Democrat of Pennsylvania; and Scott P. Serota, the president of the Blue Cross and Blue Shield Association.

Ms. Emerson said it was essential to “get the entire population in an insurance pool and spread the risk.”

Likewise, Mr. Serota said, “an enforceable mandate is the cornerstone to getting everybody covered.” Health insurance will not work if people can buy it when they are sick and drop it when they are healthy, he said.

Richard J. Umbdenstock, the president of the American Hospital Association, said the word “mandate” seemed to alarm some people, so he suggested using a term like “responsibility.”

Insurance should be viewed as “a responsibility on every individual, every institution and every enterprise in our society,” Mr. Umbdenstock said.

Plus: Today’s “Morning Edition” on NPR looked at how Obama plans to pay for expanding health care coverage.

Health Forums Hit the Road: The White House will hold regional forums on health care in key states, but Obama probably won’t attend.

“The White House, in a statement, indicated that people from around the country — experts, health care professionals and providers as well as everyday citizens — would be invited to attend the sessions in these states: California, Iowa, Michigan, North Carolina and Vermont. The forums are to be held later this month and next, although no specific dates were announced,” writes Kate Phillips.

More Health Care Reform Suggestions: Democratic Sen. Max Baucus of Montana said this week he will introduce comprehensive health-care legislation in June, reports the Philadelphia Inquirer. Baucus is looking to introduce a bipartisan bill with Sen. Charles E. Grassley (R.-Iowa), and he hopes to get the support of 70 senators.

“We need to come up with a uniquely American solution, which is a combination of public and private,” Baucus said. “I think we’d be spending capital inefficiently to pursue single-payer. I think there should be choice, flexibility, in our reform package. This is not a single-pay country.”

Watch the full video of Baucus’ remarks at Kaiser Family Foundation.

And Another Thing: This isn’t directly health-related, but the fact that Obama suspended a Bush administration rule on endangered species is cool.

Action Items
Help Save Affordable Birth Control
Last week regulations to restore affordable birth control were included in the 2009 Appropriations bill. This week, Sen. DeMint tried to strip affordable birth control from the bill, characterizing the Affordable Birth Control Provision as “an earmark for Planned Parenthood,” even though it is of no-cost to the government. Call your senators and encourage them keep in the Affordable Birth Control Provision. (Planned Parenthood)

Searching for Common Ground: Robert Pear of The New York Times reports on an apparent consensus emerging among key players in the health care debate:

Many of the parties, from big insurance companies to lobbyists for consumers, doctors, hospitals and pharmaceutical companies, are embracing the idea that comprehensive health care legislation should include a requirement that every American carry insurance.

While not all industry groups are in complete agreement, there is enough of a consensus, according to people who have attended the meetings, that they have begun to tackle the next steps: how to enforce the requirement for everyone to have health insurance; how to make insurance affordable to the uninsured; and whether to require employers to help buy coverage for their employees.

Health Care “Reform” is Not Enough: “Most current health care reform initiatives, including those of Barack Obama, focus on providing wider access to health insurance. They do little to address the underlying problems with our health care system,” writes Susan Yanow in On The Issues magazine. Yanow identifies the top five problem areas for women with our insurance-driven health system.

Plus: This list of 10 ways to spend less on health care during a recession is well-meaning, but the list assumes a level of privilege that leaves out millions. I keep thinking of this story from last week.

“Is Your Daughter Safe at Work?”: The PBS program NOW has collaborated with the Schuster Institute for Investigative Journalism at Brandeis University on an unprecedented broadcast investigation of teen sexual harassment in the workplace. Check your local PBS station schedule for air dates.

The NOW website has a terrific collection of useful links and resources, as does the Schuster Institute, including an interactive map with links to information about specific teen sexual harassment cases gone to court. Keep in mind the map reflects a tiny proportion of probable cases. Kudos to EJ Graff for kicking off this project with her article, “Is Your Daughter Safe at Work?,” published in Good Housekeeping in June 2007.

The Trouble With Repeat Cesareans: “Much ado has been made recently of women who choose to have cesareans, but little attention has been paid to the vast number of moms who are forced to have them,” writes Pamela Paul at Time magazine. “More than 9 out of 10 births following a C-section are now surgical deliveries, proving that ‘once a cesarean, always a cesarean’ — an axiom thought to be outmoded in the 1990s — is alive and kicking.” A good look at the VBAC-lash.

North Dakota House Passes Egg-as-Person Bill: “On Tuesday, one body of North Dakota’s state legislature voted, 51-41, not only to ban abortion, but to define life as beginning at conception. Such a measure, considered extreme even by pro-life standards, would have far-reaching consequences on women’s health,” writes Kay Steiger at RH Reality Check.

Understandably, Rachel Has Some Concerns …: About a proposed Tennessee bill that calls for testing some pregnant for alcohol and drugs.

Gone Daddy Gone: I couldn’t agree more with Creativity magazine editor Teressa Lezzi, who writes at AdAge.com:

After this year’s Super Bowl, I just couldn’t do it anymore. As it was, any time I had to log on to Go Daddy I felt some combination of embarrassment and annoyance at the registrar’s approach to women and marketing. But after its execrable ad efforts around this year’s game, I found that I just couldn’t stomach contributing anything to this organization any longer. I’m transferring my domains and my insignificant little piece of business elsewhere.

GoDaddy turned me off years ago because of its super lame ads, though I sometimes have to deal with the company for other clients. If sexist advertising isn’t reason enough to stay away, GoDaddy’s user interface sucks.

Cervical Cancer Vaccine Usage in California: A study by UCLA’s Center for Health Policy Research found that one in four teenage girls in California  — about 378,000 out of 1.5 million — received at least one dose of the Gardasil vaccine in 2007, its first full year of distribution, reports the L.A. Times.

Truth Catches Up: Remember the eye-catching “truth” anti-smoking ads? Researchers at the Johns Hopkins Bloomberg School of Public Health and the American Legacy Foundation estimate that the nations’ largest youth smoking prevention campaign saved $1.9 billion or more in health care costs associated with tobacco use. The findings appear in the Feb. 12 online edition of the American Journal of Preventive Medicine. The American Legacy Foundation, which launched the ads in 2000, spent $324 million to implement and evaluate the truth campaign.

Plus: Cigarette-maker Philip Morris was ordered to pay $8 million in damages to the widow of a smoker who died of lung cancer in a case that could set the standard for 8,000 similar Florida lawsuits, reports NPR.

Obama Closer to Nominating HHS Secretary: Kansas Gov. Kathleen Sebelius appears to be President Obama’s leading choice for secretary of Health and Human Services. In a front-page story on Thursday, Peter Baker and Rober Pear of The New York Times write:

With his economic recovery plan signed into law, Mr. Obama plans to turn his attention more to health care next week with a fiscal blueprint that will begin to advance his ideas about covering the uninsured, advisers said. He may also make health care a theme of his prime-time address to a joint session of Congress on Tuesday night, they said.

It remained unclear whether the White House would finish vetting Ms. Sebelius in time to nominate her by next week. Advisers described her as “the leading candidate,” although they said other names were still in discussion and emphasized that no final decision had been made.

We previously noted Sebelius’ frontrunner status, along with other names reportedly under discussion. The Washington Post’s Al Kamen this week mentioned another would-be contender: “Obama transition chief John D. Podesta, whose name has been out there as perhaps most ready to handle the difficult job, has told co-workers and friends that he’s staying put at his think tank, the Center for American Progress. But he’s been observing that perhaps Bill Novelli, the outgoing head of AARP, the seniors lobby, might be a possible candidate.”

The More Things Change …: In that same column, Kamen notes that Obama’s first 56 selections for Senate-confirmed jobs reflect, well, the status quo — white men still rule, though they’re not quite the majority. At this early stage, 32 percent of the appointees are women.

By way of comparison on a few of these statistics, 39 of Bill Clinton’s first 48 nominees (81 percent) were white and seven (15 percent) were African American; 75 percent were men. Of George W. Bush’s 28 first nominees, 22 were white (79 percent) and only 14 percent were women, according to data compiled by the Presidential Transition Project at New York University’s Wagner School of Public Service.

It should be noted that this snapshot is of the Cabinet and topmost officials in the new administration and may change significantly over time. For example, the average age could be expected to drop a bit as lower-level positions — assistant secretaries and such — get filled, probably with a younger cohort of appointees.

Obama Signs Stimulus Bill: President Obama on Tuesday signed into law the $787-billion economic stimulus bill. Ann at Feministing looks at who’s getting stimulated — or, to be more specific, how will the law expand job opportunities for women?

Over at The New York Times, Robert Pear reports that the bill provides “substantial amounts of money for the federal government to compare the effectiveness of different treatments for the same illness.”

Under the legislation, researchers will receive $1.1 billion to compare drugs, medical devices, surgery and other ways of treating specific conditions. The bill creates a council of up to 15 federal employees to coordinate the research and to advise President Obama and Congress on how to spend the money.

The program responds to a growing concern that doctors have little or no solid evidence of the value of many treatments. Supporters of the research hope it will eventually save money by discouraging the use of costly, ineffective treatments.

Meanwhile, NPR reports on a new study that shows even head-to-head comparisons don’t provide easy answers.

Scientists Await Action on Stem Cells: Sure the economy has demanded a lot of attention, but some scientists are wondering when Obama is going to lift restrictions on stem cell research.

“Everyone is waiting with bated breath,” George Daley, a leading stem cell scientist at Children’s Hospital in Boston. tells the Washington Post. “We’re all waiting to breathe a huge sigh of relief.”

Know How to Fix Health Care?: If you have a plan — and if you’re an undergraduate or graduate student — Kaiser Family Foundation wants to hear from you. Below is your essay assignment — and unlike the last paper you wrote, this one could net you $1,000:

President Obama has stated that reforming the health care system is one of his top priorities, and there is broad interest from policymakers and the public in making a change. During the campaign, he outlined a framework for reforming health care. The essay should cover: what elements of his plan should be prioritized given the current economic crisis, what elements are most likely to garner support and which ones will be most challenging and why?

Action Alert
* Ask Obama to End Abstinence-Only Funding
President Obama is putting together his proposed budget for 2010, and as he has assured the nation, he will be on the lookout for failed programs that deserve to be eliminated. We have an easy cut to suggest: End federal funding for the failed abstinence-only-until-marriage experiment.
Email the White House (Chicago Foundation for Women)

The Barnard Center for Research on Women is sponsoring a day-long conference Saturday, Feb. 28, on ”The Politics of Reproduction: New Technologies of Life.” I wish I could get to New York — the topic and the questions raised couldn’t be more timely. Just look at today’s New York Times, which considers whether in vitro fertilization causes changes in gene expression or in developmental patterns — changes that may not be obvious at birth.

Here’s the conference description:

“The Politics of Reproduction” will focus on the global social, economic and political repercussions of new forms of reproduction, including assisted reproductive technology (ART) and transnational adoption. These new technologies have created a “baby business” that is largely unregulated and that raises a number of important social and ethical questions.

Do these new technologies place women and children at risk? Should there be limits on how reproductive technologies are used? How should we respond ethically to the ability of these technologies to test for genetic illnesses? And how can we ensure that marginalized individuals, for example, people with disabilities, women of color, and low-income women, have equal access to these new technologies and adoption practices?

The conference will feature numerous experts in the field of reproductive rights and reproductive justice, including Wendy Chavkin, professor of clinical population and family health at Columbia University’s Mailman School of Public Health; Michele Goodwin, Everett Fraser Professor in Law at the University of Minnesota and founder of the Center for the Study of Race and Bioethics at DePaul College of Law; Iris Lopez, associate professor of Latin American and Latino Studies at the City University of New York and author of “Matters of Choice: Puerto Rican Women’s Struggle for Reproductive Freedom”; and Loretta Ross, national coordinator and founding member of SisterSong, a reproductive justice collective.

View the full speakers’ list here, along with the program. Would love to hear from folks who are able to attend. If anyone wants to guest blog, let me know.

Chemicals in Toyland: The Consumer Product Safety Improvement Act (CPSIA) took effect this week, mandating stricter enforcement of lead and phtalates in children’s products and toys.

“While the ban was hailed as a victory for children’s health, it’s no guarantee that the products are safe,” reports NPR’s “Morning Edition.” “That’s because companies currently aren’t required to publicly disclose the chemicals they use in place of phthalates — and little is known about the health effects of one of the most widely used alternatives.”

Pthalates have been shown to affect the development of the male reproductive system in lab animals. They’re also present in some cosmetics, personal care products, pharmaceuticals, food packaging and cleaning and building materials — making them almost impossible to avoid. Check out NPR’s timeline of phthalate regulation and an interactive look at chemicals in the home.

IVF – New Lab for Studies: “In addition to helping thousands of infertile couples have children, ‘test tube’ babies are offering scientists a novel laboratory for resolving one of the most vexing debates in science: nature vs. nurture,” writes Rob Stein in the Washington Post.

In the first study of its kind, British researchers have studied children conceived through in vitro fertilization (IVF) to examine whether children whose mothers smoked during pregnancy were more likely to develop behavioral problems because of the toxic effects of smoking — as has been suspected — or because their mothers passed on a genetic predisposition to antisocial behavior.

The study, which appears to debunk the notion that smoking’s effects on the brain of a developing fetus result in antisocial tendencies, could be the first in a series of attempts to use the approach to disentangle whether genes or various prenatal exposures are responsible for later behavioral problems.

Friends Don’t Let Friends Get “Booty” Injections: And definitely not from a woman who administers shots without a medical license. Two women are now hospitalized in critical condition in Tampa, Fla. “It almost is bootleg cosmetology here,” said sheriff’s office spokesman JD Callaway.

Plus: The economy is having some effect on cosmetic enhancements, reports The New York Times. Natasha Singer writes that doctors and pharmaceutical executives thought antiwrinkle shots like Botox would be resistant to the downturn, but the latest earnings report from Allergan, the maker of Botox, fell almost 9 percent compared with a year earlier. Allergan’s sales of breast implants were down 12 percent.

“You could forecast that with implants, but the bigger question was, ‘How have injectables been holding up?’” said Gary Nachman, an analyst with Leerink Swann, a health care investment bank. “Now, even the injectables have been impacted significantly.”

Maternal & Child Health in the Obama Administration: “[...] President Obama has lauded and pledged to expand presidential initiatives to fight HIV/AIDS, TB and malaria — recognizing the sizeable effect they have had not only in saving hundreds of thousands of lives, but also in improving U.S. foreign policy. Now is the time for President Obama to elevate the issue of global family health to that high level,” argues Maurice Middleberg, vice president for public policy at the Global Health Council.

Council members, including global maternal health, child health and family planning organizations, are developing a framework for a Global Family Health Action Plan.

On Their Own Terms: “[B]etween the clinic demonstrations, the political discussions and the imprecations from the pulpit, too many American women have come to feel that their pelvis is public property. Slowly, quietly, a new abortion method has become part of the landscape, and it’s no accident that those women who have chosen it often cite reclaiming privacy and control as the reason,” writes Anna Quindlen at Newsweek, describing how RU-486 has allowed women to keep abortion private and personal.

Plus: Glamour magazine recently featured a whole section on abortion, acknowledging that one in three women will have at least one abortion by age 45. Eight women share their personal stories.

Salma Hayek Sparks Breastfeeding Discussions: By now you’ve probably heard about Salma Hayek breastfeeding an infant in Sierra Leone. ABC’s “Nightline” filmed Hayek during a trip to Africa to spotlight efforts to eliminate tetanus through vaccinations. The infant’s mother had no milk, so Hayek did what came naturally. Tracy Clark Flory nicely sums up some of the respectful and sophmoric public reactions.

Hayek, who is still breastfeeding her 1-year-old daughter, said, “I actually think my baby would be very proud to share her milk. And when she grows up I’m going to make sure she continues to be a generous, caring person.” Read more reactions and more about Hayek’s journey. The full “Nightline” episode is quite moving.

Happy Valentine’s Day: Some feminist advice from RH Reality Check. Plus, researchers at the University of Iowa report on what college-age men and women are looking for in a mate and how priorities have changed since the 1930s. While it’s nice to see that “chastity” is no longer an important characteristic, I’m surprised “similar political background” is considered unimportant as well.

And here’s the best act of defiance I’ve seen mentioned for Valentine’s Day — members of the Facebook group “A Consortium of Pub-going, Loose and Forward Women” are encouraged to “Join us on Feb. 14, Valentine’s Day, the day on which Indian women’s virginity and honor will self-destruct unless they marry or tie a rakhi. Walk to the nearest pub and buy a drink. Raise a toast to the Sri Ram Sene.” Swati Prasad explains the rebellion against the right-wing Sri Ram Sene.

Ever since the Women’s Health Initiative study found that women taking supplemental hormones had an increased risk of breast cancer, heart disease, and stroke, women struggling with menopausal symptoms have searched for safer alternatives. Companies that make bioidentical hormones (also called natural or compounded hormones) have been quick to jump into the void, often claiming that their products are safer and more effective than traditional “synthetic” hormones.

Unfortunately, there is no evidence to suggest that this is true. Yesterday, the American College of Obstetricians and Gynecologists (ACOG) issued a press release on such hormones.

ACOG expressed concern about the lack of testing of these products and also criticized the salivary testing that is often done in bioidentical hormone users under the assumption that it provides information needed for selecting a dosage:

“Despite celebrity testimonials touting scientifically unfounded benefits of compounded bioidentical hormones, the bottom line is that most have not undergone rigorous clinical testing for safety or efficacy, nor are they approved by the FDA. ACOG also stresses that salivary testing of a woman’s hormone levels is not useful because they vary within each woman depending on her diet, time of day, the specific hormone being tested, and other variables. Although monitoring salivary hormone levels is promoted by some as a means of ‘tailoring’ a hormone treatment to an individual, hormone therapy does not require customized dosing. “

The organization previously released a committee opinion in 2005 stating that “There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies,” but indicated that recent media attention to the topic led to yesterday’s statement.

The FDA has also set up a page for consumers of myths vs. facts about compounded “bioidentical” hormones, and expressed concern that “claims like these [about the effects of the hormones] mislead women and health care professionals, giving them a false sense of assurance about using potentially dangerous hormone products.”

Related Posts: Outrage Over FDA Crackdown on Biodentical Hormones? Not So Fast, says National Women’s Health Network

OBOS Web Content: Natural Products: Phytoestrogens and Bioidentical Hormones; The Medicalization of Menopause