Plan B on a drugstore shelf in Canada. Photo / Cory Doctorow

What a frustrating week in the ongoing battle over evidence-based health policy.

To the surprise and disappointment of women’s health advocates, the U.S. Justice Department on Wednesday filed an appeal to prevent girls under age 15 from gaining over-the-counter access to emergency contraception.

Approaching the date U.S. District Judge Edward Korman’s order making levonorgestrel-based emergency contraceptive pills (such as Plan B and Next Choice) available without restrictions would go into effect, the Obama administration also requested a stay pending appeal, meaning the judge’s order would not be implemented according to schedule.

The judge’s ruling last month was in response to the Center for Reproductive Rights’ renewed lawsuit seeking over-the-counter access to the morning-after pill.

Responding to the appeal, Nancy Northrup, CRR president and CEO, said in a statement:

Women who urgently need emergency contraception have been delayed in getting it or denied access entirely for more than a decade because of the political maneuverings of the last two presidential administrations. The federal court has made clear that these stalling tactics were based purely on politics, not science.

We are deeply disappointed that just days after President Obama proclaimed his commitment to women’s reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions.

In the appeal documents, the administration argues that the court overstepped its authority and improperly interfered with the rulemaking process; the judge should have instead sent the issue back to the FDA for further action.

“We aren’t focused in this appeal on the merits of the secretary’s decision,” a Justice Department official, who spoke on condition of anonymity, told The New York Times. “What we’re focused on is that the remedies that the judge ordered were beyond his authority.”

Ironically, overstepping is what many would argue the administration did in 2011 when HHS Secretary Kathleen Sebelius overturned a decision by FDA scientists to make the contraceptive pills available without restriction.

The administration also argues that since the actual plaintiffs in the case are all over age 15, and it’s not a class action suit, that no harm is done to the plaintiffs by granting the stay (see below). By making this argument, the administration avoids addressing the potential harm to girls who are prevented from accessing a drug both FDA scientists, and the judge, said should be available.

The administration claims that the public would suffer irreparable harm if the stay is not granted; if the ruling is allowed to go forward and later overturned, it would create confusion for women, who might “mistakenly believe that they can obtain the drug without a prescription or at certain locations where it used to be available, but is no longer.”

We’re also supposed to believe the appeal has nothing to do with politics. A Justice Department official told The New York Times: “This is a decision that the Justice Department is making in representing our client: FDA. This is not a political decision. It’s not had White House intervention or involvement. This in our judgment is the right legal step to take in this case.”

Meanwhile, FDA Approves Making Plan B Available to Teens Age 15 and Up
The decision to appeal came just one day after the FDA announced its approval of Plan B One-Step emergency contraception pills without a prescription for teens age 15 and older. The drug was previously only available without a prescription to women 17 and older.

It’s a great step forward; however, younger women, for whom access to a healthcare provider may be most difficult, are still left without prescription-free access to the drug, which must be used within a limited window.

The FDA adds to the burden by specifically requiring proof of age. From the FDA’s press release:

The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.

In addition, Teva will make the product available in retail outlets with an onsite pharmacy, where it generally, will be available in the family planning or female health aisles. The product will be available for sale during the retailer’s normal operating hours whether the pharmacy is open or not.

The ID/proof of age requirement is a big hurdle for many teens. Many states set an age requirement of 16 for a driver’s license or learner’s permit. Obtaining a state ID (related to driving or not) costs money, and hours for doing so are often limited. And undocumented teenagers are unable to obtain a legal ID at any age.

“While welcomed by some as an acceptable compromise,” said Nancy Stanwood, Physicians for Reproductive Health board chair-elect, the “FDA decision to approve the sale of emergency contraceptive Plan B One-Step to those 15 years and older with government-issued identification does little to improve real access for already-vulnerable women and young teens. Plan B has a time limit, and too many women in the U.S. have gone without it because of unfair, unnecessary, and medically unjustified barriers to access.”

Writing at ThinkProgress, Tara Culp-Ressler explains other reasons why the policy shift is still problematic, noting in part that it simply isn’t based on science, and the high cost remains a barrier.

The FDA’s ruling was in response to an amended application request by Teva Women’s Health, the company that makes Plan B One-Step, to make the drug available without a prescription to women age 15 and older. The FDA in 2011 denied Teva’s application to make Plan B One-Step available for all females of reproductive age. And still the debate goes on.

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

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

From the book description:

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

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

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

Although there is a fair amount of information and research available on postpartum depression in general, very little of it seems to focus specifically on the needs or care of teen mothers.

A pilot study published in the American Journal of Obstetrics and Gynecology in March attempts to fill in this gap — and it shows some promising results.

First, the authors explain why the risks of PPD in teens are important:

PPD puts adolescent mothers and their children at risk during an already challenging time in their lives, and this hardship may be a major determinant of poor outcomes for these young mothers and their children. Untreated, depression is associated with school dropout, suicide, and substance use. Among adolescent mothers, evidence suggests that depression may prevent them from engaging in health-promoting behaviors for their infants and themselves.

The study is based on a randomized controlled trial of the REACH program (Relax, Encourage, Appreciate, Communicate, Help), which is designed to help expectant mothers develop stress management and other skills. The program was offered as structured therapy during pregnancy, followed by a postpartum “booster” session.

Participants in the therapy group used interpersonal therapy to work on effective communication skills, conflict management, improving their social support systems and building healthy relationships, and goal setting. They, as well as the control group, received a handbook of typical pregnancy and postpartum/newborn health information. A total of 106 teens age 17 or younger and without pre-existing mental health issues were randomized to the therapy or control groups.

The researchers looked for major depressive episodes within the six months after birth. Although only 12.5 percent of the REACH teens developed postpartum depression, compared with 25 percent of the control teens, the results were not statistically significant, as the study was fairly small and very few teens (19) overall developed postpartum depression. A larger study may be needed to better determine the utility of the program.

Despite a lack of clear effect, the study highlights a need for further investigation into the postpartum mental health needs of teens. As the authors explain:

Although validated treatments for adolescent depression exist and include interpersonal therapy, cognitive behavioral therapy, and antidepressant medication, teen mothers with mental health problems are mostly under treated. To date, only one published report of 2 small open-trial pilot studies addressed treatment for depression in pregnant adolescents. Despite the potentially high burden of depression to young women and their families, studies on the prevention of PPD in pregnant adolescents are virtually nonexistent.

Another lesson learned in this study was that teens preferred individual therapy sessions over the planned group sessions, so sessions were adjusted to be one-on-one. The researchers also took care to specifically design the REACH program to be culturally appropriate for a diverse group of racial and ethnic backgrounds.

Intrauterine devices (IUDs) are a fairly safe, long-acting form of contraception, but many myths about the devices persist. For example, it’s somewhat common to hear that women who haven’t already had a baby, and especially teenagers, are not good candidates for IUDs; neither of these is true.

For a new study published in the journal Obstetrics & Gynecology, researchers reviewed data from health insurance records of more than 90,000 women who had IUDs inserted (including both hormonal and copper IUDs). They looked specifically at how many records indicated a IUD-related complication, discontinuation, or pregnancy.

When the researchers looked at the data by age group, they found that women ages 15-19 did not discontinue using IUDs any more frequently than older women. Teens were slightly more likely than older women to experience dysmenorrhea (menstrual cramps) or absence of menstruation within one year of insertion, or failure of the IUD to prevent a normal pregnancy, but rates for both of these were very low. Only 1.8 percent of teens using a levonestrogel-releasing IUD experienced a pregnancy (3.6 percent for copper), and 2.4 percent experienced cramping (6.2 percent for copper).

Pelvic inflammatory disease occurred in less than half a percent of teens. Women of all ages using a copper IUD were much more likely to stop using it than women using the hormone-releasing IUD, and this was most true for teens, although it’s not completely clear why. Rates of removal within 30 days for any complication were estimated to be very low for teens (2.9 percent for hormone IUD, 5.2 percent for copper) as well as older women.

The researchers conclude:

Overall, these data indicate that the IUD is an appropriate contraceptive for younger women and is not likely to cause serious side effects among teenagers. Physician recommendations play an important role in their patients’ decision-making, and their recommendation of the IUD could increase the use of this cost-effective and safe method of birth control among teenagers. Thus, physicians should include information about this highly effective method when they counsel young patients on their contraceptive options to help reduce the unintended pregnancy rate among teenagers in the United States.

The authors cite evidence that teens may indeed face clinician education barriers when seeking an IUD. One survey found that “only 19% of obstetrician–gynecologists surveyed in a 2010 study stated that they would offer an IUD to an unmarried 17 year old who had never been pregnant.”

With more evidence like the current study on hand, we hope it will become easier for teens to access this long-acting, effective form of contraception.

Related: Revisiting the IUD for Contraception – Pros and Cons for Women looks at the rise in IUD use and the safety record.

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

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

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

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

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

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

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

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

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

More coverage of the case:

• SCOTUSblog: First Myriad reactions; Argument recap: Analogies to the rescue; Justices debate gene patenting issues: In Plain English
• More from Nina Totenberg at NPR: Justices Appear Skeptical Of Patenting Human Genes
• PBS NewsHour: Supreme Court Tackles Case of Patent Law, Human Genetics
• The ACLU provides an overview of the case, timeline, and other background on their website.

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

• OBOS Joins ACLU Lawsuit Challenging Breast and Ovarian Cancer Gene Patents
• Breast Cancer Gene Patents Invalidated
• Take Back Our Genes Campaign Fights Restrictive Gene Patenting
• ACLU Survey for Women Who Have Been Advised to Get BRCA Genetic Testing

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

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

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

From film director Surabhi Sharma’s website:

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

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

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

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

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

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

Last week, a judge ordered the FDA to make emergency contraception pills available over the counter, with no age restrictions, capping a long and frustrating legal battle to increase access.

Versions of levonorgestrel-based emergency contraceptive pills (such as Plan B and Next Choice) are expected to be made available without restriction within 30 days, but it’s not clear whether there will be some administrative interference. The FDA might decide on new labeling or to limit the forms of emergency contraception made available. There is also the possibility that the decision will be appealed.

OTC access for all ages is essential because most emergency contraception pills are most effective when used as soon as possible, and time, distance, money, and privacy can be serious barriers, especially for teenagers, to obtaining and filling a prescription in time to prevent pregnancy.

The push to make emergency contraception pills (also known as morning-after pills) available to all ages without a prescription suffered a major setback in 2011, when HHS Sec. Kathleen Sebelius blocked the FDA’s decision to remove the age barrier. Since 2009, emergency contraception has been available without a prescription for anyone age 17 and older.

Sebelius’s objections focused on the idea that young girls would use EC in unsafe ways. Susan Wood, A former director of the FDA’s Office of Women’s Health who in 2005 resigned over political delays around emergency contraception, rejected Sebelius’s claim that more data was needed on safety and label comprehension, noting that “this type of age restriction, and worries about the use of medicines by teenagers, have not been applied to other products.”

U.S. District Judge Edward R. Korman, in reversing the FDA’s decision to deny a citizen petition for all-ages access, seems to agree that the “What about 11-year-olds?” objection is merely a smokescreen. From the memorandum:

This case is not about the potential misuse of Plan B by 11-year-olds. These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year-olds using these drugs is likely to be miniscule, the FDA permits drugs that it has found to be unsafe for the pediatric population to be sold over-the-counter subject only to labeling restrictions, and its point-of-sale restriction on this safe drug is likewise inconsistent with its policy and the Food, Drug, and Cosmetic Act as it has been construed.

Instead, the invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.

Korman characterized Sebelius’s actions as “obviously political” and “arbitrary, capricious, and unreasonable,” and wrote:

Nevertheless, even with eyes shut to the motivation for the Secretary’s decision, the reasons she provided are so unpersuasive as to call into question her good faith. While the Secretary has strung together three factual statements in her memorandum to Commissioner Hamburg, she has failed to offer a coherent justification for denying the over-the-counter sale of levonorgestrel-based emergency contraceptives to the overwhelming majority of women of all ages who may have need for those drugs and who are capable of understanding their correct use.

While we’re celebrating the judge’s ruling, we should also keep in mind the fact that President Obama is still praising Sebelius’s unprecedented, access-denying interference and overriding of the FDA’s scientific review process.

More coverage:

• The Top 11 Zingers From the Emergency Contraception Decision – Sharona Coutts at RH Reality Check
• Emergency Contraception and Moral Panic: Dissecting the Newest Misinformation Campaign – Sidra Zaidi at RH Reality Check
• Doctors Celebrate Plan B Ruling – Physicians for Reproductive Choice
• Federal EC Ruling will Benefit Immigrant and Young Latinas – Press release from the National Latina Institute for Reproductive Health
• Federal Judge Orders FDA to Broaden Access to Emergency Contraception – Center for Reproductive Rights; includes a great timeline showing milestones in the struggle for OTC access for more than a decade.

Background information from Our Bodies Ourselves:

• Emergency Contraception Still Not Easily Available to Young Women
• Newly Appointed Acting Surgeon General Played Role in Holding Up OTC Sale of Emergency Contraception
• Information on emergency contraception from “Our Bodies, Ourselves,” including both pills and IUDs

Despite the prevalence of eating disorders in adolescent girls, it’s difficult to find information about longer term health consequences in adults, as little follow-up has been done. A new article in the journal Maturitas on the long-term health consequences of the female athlete triad, a syndrome that may include eating disorders, is an important contribution to the research.

First defined in the early 1990s, female athlete triad used to be defined as the combination of an eating disorder, amenorrhea (lack of a menstrual period), and osteoporosis.

The definition was adjusted in 2007 to focus more on a spectrum of health and now includes low energy (with or without an eating disorder), menstrual function, and bone mineral density. These are interrelated; it is thought that the lack of energy due to excessive exercise or disordered eating leads to changes in menstrual cycles and loss of bone mineral density.

While it’s not original research, the new review by Jill Thein-Nissenbaum of the University of Wisconsin-Madison’s physical therapy program points out some important health issues for women beyond the teen years.

Of major concern, based on a review of the literature, are the long-term effects of decreased bone mineral density associated with the triad. Women who restricted their energy intake may have missed crucial bone mass building time, and this bone density may not be made up even with eating disorder recovery.

Thus, as women age, they are losing additional bone mass from an already depleted system. Thein-Nissenbaum notes that women with the triad may also be at greater risk of musculoskeletal injury, and these injuries may have negative effects throughout life.

Thein-Nissenbaum suggests that women who currently have or have recovered from female athlete triad discuss with their healthcare provider their history of eating behaviors and menstrual history, dating back to adolescence, and review details from previous bone scans.

She also cites the need for bone mineral density assessment in women who have had a history of disordered eating behaviors, menstrual irregularity, or more than one stress fracture.

The National Eating Disorders Association provides a toolkit for coaches and athletic trainers that includes a section on the female athlete triad, including causes, treatment, and behaviors to look out for. The guide also has information on other types of eating disorders and the role of coaches and trainers in prevention and early intervention.

Plus: Eating disorders are most commonly associated with adolescents, but adults are also susceptible to anorexia, bulimia, binge eating and other disorders, and they face a unique set of challenges, says Cynthia M. Bulik, author of the new book ”Midlife Eating Disorders.” Women’s eNews recently published an excerpt.

“If we look at the numbers,” writes Bulik, “the most common profile of someone with an eating disorder is a woman in her 30s or 40s who struggles with weight control and suffers from binge eating disorder. But countless women and men in midlife and beyond — from all racial, ethnic and socioeconomic backgrounds — wake up each morning to an ongoing battle with eating and body image, with many suffering from anorexia nervosa, bulimia nervosa, purging disorder, binge eating disorder and night eating syndrome.”

In the United States, 87 percent of counties have no abortion provider, forcing some women to travel potentially long distances for reproductive health services, while others delay making a decision until later in the pregnancy, when an abortion is more costly and restrictions are more severe.

One way to increase access is to increase the range of providers who are permitted to do abortions, such as nurse practitioners, nurse midwives, and physician assistants.

Currently, non-physician clinicians can perform surgical (aspiration) abortions legally only in Montana, Oregon, New Hampshire and Vermont. In some states, these providers can oversee medication abortions, though that, too, has become a contentious issue as more legislatures seek to restrict women’s access to abortion.

Are laws requiring physicians to perform surgical abortions necessary, from a patient-safety perspective? Not according to a recently published study.

Tracy Weitz, director of Advancing New Standards in Reproductive Health, a collaborative research group and think tank at University of California, San Francisco, and Diana Taylor, ANSIRH’s director of research and evaluation, primary care initiative, set out to answer the question of healthcare outcomes and applied for a waiver of California legal statutes that limit surgical abortion to physicians. They note:

In 2008, 1.21 million abortions took place in the United States, with more 200,000 (18%) in the State of California. Nationally, 92% of abortions take place in the first trimester, but Black, uninsured, and low-income women have less access to this care. In California, only 87% of women using state Medicaid insurance obtain abortions in the first trimester. Because the average cost of a second-trimester abortion is substantially higher than that of a first-trimester procedure, shifting the population distribution of abortions to earlier gestations would result in safer, less costly care. Increasing the types of health care professionals involved in abortion care is one way to reduce this health care disparity.

For the purpose of the study, 40 certified nurse midwives, nurse practitioners and physician assistants in ANSIRH’s Health Workforce Pilot Project, who already had experience with medication abortions, were trained to perform surgical abortions. (ANSIRH’s Early Abortion Training Workbook, which is used in medical schools around the world, is also available online.)

The authors compared the outcomes of abortions performed by those medical professionals to outcomes of abortions performed by 96 physicians. Patients were not randomized to a provider type; they were asked if they would agree to have the non-MD provider on duty perform their first trimester abortion.

Complications were rare in general, with only 1.3 percent of the 11,487 abortions resulting in any type of complication. While the newly trained CNM/NP/PA group had slightly more complications than the group with abortions performed by more clinically experienced MDs, the difference was not considered significant.

The authors conclude that “only 1 additional complication would occur for every 120 procedures as a consequence of having an NP, CNM, or PA as the abortion provider,” and these would largely be minor complications, such as a low-level infection or bleeding that could be treated at home or at an out-patient clinic.

The study was published in the American Journal of Public Health. Based on the findings, the authors argue in favor of expanding the types of providers who can perform abortions:

The benefits of expanding access to abortion for California’s women outweigh the small initial difference in risk, particularly because it would likely move many second-trimester abortions into the first trimester, significantly decreasing the overall risk of complications, which increases with gestational age. Expanded access is also likely to afford more women the opportunity to obtain care without the additional indirect costs associated with traveling to a geographically distant abortion provider.

We would hope, after reading this study, that more state legislatures would consider removing restrictions on non-physician clinicians, but we know such a move would require great amounts of political will, as the trend in recent years has been to restrict rather than increase access.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Related: Our Bodies Ourselves resources on infertility and assisted reproduction

The Guttmacher Institute recently published a report examining how access to and the use of effective birth control affects women’s lives.

“The Social and Economic Benefits of Women’s Ability to Determine Whether and When To Have Children“ reviews more than 66 studies over the past 30 years. According to researchers, access to contraception and avoidance of unplanned pregnancy have led to:

• increases in young women obtaining at least some college education
• increases in college-educated women pursuing advanced professional degrees
• increased participation in the workforce by women
• increases in women’s earning power and decreases in the gender gap in pay

The researchers identify several gaps in the literature as well as areas where additional research is needed, such as how contraception benefits older women and women with low incomes, of racial and ethnic minorities, single mothers, and women with other sociodemographic factors that might prevent them from getting the full benefits of contraception.

The authors conclude with an important call for ongoing efforts to enhance access to contraception:

Clearly, access to reproductive health care and the recognition of reproductive rights cannot be addressed in isolation from the rest of an individual’s life, or from the rest of society’s inequities. Rather, policies and programs that advance contraceptive access and those that affect whether a woman is still able to achieve her life goals if and when she becomes a mother should be considered as part of a greater whole.

By helping women and couples, regardless of background or income, determine and exercise their own reproductive choices, government and organizational policies can help advance broader economic equality and social justice for individual women, families and society.

The report is available online as a PDF; a summary with links to more information is also provided. Also check out OBOS’s Brief History of Birth Control and discussion of Global Access to Birth Control.

While cesarean rates (which reached an all-time high in 2007) are known to vary widely by state, they also vary quite a bit by hospital. One common explanation for this has been that different hospitals have different c-section rates because they see different types of patients – patients who are sicker or healthier, or more likely to have complications requiring cesarean.

In an article published in PLOS ONE, researchers report findings from a study designed to look at other factors that influence cesarean rates. The authors looked at birth certificate and hospital discharge data in Massachusetts to determine which factors were linked to cesarean rates at each hospital.

The researchers focused on first births of single, non-breech births in Massachusetts hospitals from the beginning of 2004 through the end of 2006. They report that at the hospital level, the percent of cesarean deliveries varied between 14.0 percent and 38.3 percent (average of 26.4 percent). Then they adjusted for health and sociodemographic factors, like labor induction and maternal age, that are linked to higher rates of cesarean.

They found, predictably, that individual risk for cesarean varied by demographic, socioeconomic, pregnancy, and preexisting medical conditions. After they adjusted for these factors, though, there was still significant variation in rates between hospitals that could not be explained by those medical and personal risk factors.

While the authors did not set out to explain why this variation occurred, they note that it has been observed in other studies (such as in Arizona, and in military hospitals), and that contributing factors may include liability- and insurance-related factors, whether a woman delivers at a teaching hospital, the provider’s approach to delivery, hospital practices related to labor induction and augmentation, and others. They conclude that additional research is needed on hospital characteristics to figure out what is driving variability between hospitals and reduce the influence of non-clinical factors on women’s risk of cesarean delivery.

Finding out the rate of cesarean sections at any given hospital can be difficult, as is understanding why the rates are high in any given situation. At her  website, CesareanRates.com, consumer advocate Jill Arnolds attempts to bring together the available statistics, allowing users to compare cesarean rates by state and by individual hospital.

If you’re interested in finding out more about what you can do increase your chances of having a vaginal birth, see this tip sheet from Childbirth Connection.

There’s been much discussion lately about routine mammogram screening for breast cancer, including, according a new study, the very real psychological harm connected to false positive readings.

Complicating this information further is the issue of breast density. Dense breasts have less fat and more glandular and connective tissue. While some women’s breasts become less dense and more fatty as they age, other women’s breasts remain relatively dense.

Why does this matter? Having dense breast tissue makes it harder to obtain an accurate reading of mammograms. It also increases a woman’s risk of developing breast cancer.

However, questions remain about what women should do with that information. In fact, recent research suggests that actual risk of death from breast cancer is not increased for women with denser breast tissue.

Despite a lack of certainty about how dense breast tissue affects health outcomes, a handful of states have mandated that providers discuss breast density with women. On April 1, California will become the fifth state with a breast density notification law in place. Similar bills have been introduced in other states.

At the federal level, the Breast Density and Mammography Reporting Act was introduced in Congress in 2011, but never made it out of committee. It, too, would require that women be told about breast density, the correlation with cancer, and that they might benefit from supplemental screening tests.

It’s not clear, however, if additional tests would even help.

The authors of a recent commentary in the medical journal Radiology note that while explaining the increased risk of cancer to women with dense breasts “seems ethical, reasonable, and appropriate,” there is little known about what additional follow-up might help those women.

They conclude that “the advocacy push to legislate mandatory reporting of breast density and possible adjunct screening for all women with heterogeneously or extremely dense breasts is far outpacing the reporting of evidence that supplemental screening may provide better outcomes for these patients.”

They also raise concerns about invasive procedures: “Because some cancers detected at screening may not go on to cause symptoms or death, additional interventions performed on these excess cancers would only increase morbidity for these patients.”

These concerns are similar to those raised about routine mammography in younger women — that more testing may increase harm to women from extra procedures, while not actually increasing survival rates.

Breast Cancer Action addressed mandatory notification laws in late 2012, coming down against such legislation:

Unfortunately, the importance of breast density is still not well understood and as a result there is no clear action for women who receive this information. Breast Cancer Action believes that medical practitioners should discuss all aspects of a woman’s health with her and we do not believe legislation is the appropriate way to address the issue of breast density. We believe resources and energy are better spent on working for better medical care and understanding the ways to prevent breast cancer in the first place.

Laura Newman, a medical journalist, has also looked at this issue. Her Patient POV blog has a couple of clear, useful posts, including “Are Dense-Breast, Right-to-Know Laws Helpful?” and “Is the Bar High Enough for Screening Breast Ultrasounds for Dense Breasts?”

Where does this leave women, especially those who may be told they have dense breast tissue as a result of one of these new laws? Unfortunately, there is no clear answer right now.

Arguments are scheduled to be heard by the Supreme Court on April 15 on the Myriad Genetics case, which will challenge patents held on human genes, especially the BRCA1 and BRCA2 genes known to increase breast cancer risk.

The suit charges that leaving human genes in the hands of corporations limits diagnostic testing and research that could lead to cures, and limit women’s options for medical care.

Breast Cancer Action is holding a rally on April 15, the day the case is heard, to stand up for women’s health and against corporate control of our genes. It begins at 9:30a.m and will take place on the steps of the Supreme Court. To find out more, follow @BCAction on Twitter.

Our Bodies Ourselves is a co-plaintiff in the lawsuit challenging these gene patents. For further information and resources, see these previous posts:

• OBOS Joins ACLU Lawsuit Challenging Breast and Ovarian Cancer Gene Patents
• Breast Cancer Gene Patents Invalidated
• Take Back Our Genes Campaign Fights Restrictive Gene Patenting
• ACLU Survey for Women Who Have Been Advised to Get BRCA Genetic Testing

While most birth control pills currently available in the United States are safe for most women, some newer pills that contain the progestin drospirenone have come under scrutiny because of an increased risk of blood clots. Birth control pills containing drospirenone include Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz and Zarah.

The European Medicines Agency (EMA) announced late last month that it would take another look at so-called third and fourth generation oral contraceptives, including those with drospirenone, and consider whether use of these drugs should be limited.

The agency also plans to review whether current product information is enough to properly inform women and their health care providers of the risks. The agency has also said, though, “There is no reason for any woman to stop taking her contraceptive” — a rather confusing message for women wondering if they should switch to other types of pills.

The EMA previously reviewed whether this type of drug (specifically Yaz) could be marketed for use in preventing acne, but decided it could not based on concerns about the clot risk; it factored in that if women who no longer needed contraception or no longer needed the acne treatment continued on the drug, they would be exposed to unnecessary additional risk.

The U.S. FDA also did a review of pills with drospirenone, and is requiring language about the higher risk of blood clots to be added to the labels. As we noted last year, women’s health experts, including OBOS, have concerns about that review, and about leaving these pills on the market when safer alternatives exist.

That’s a key point in considering pills with drospirenone. While the risk of clots is small, we know the risk is higher with these pills than with other oral contraceptives. As one expert testified before the FDA, “I don’t usually vote against choices, but this time I did. And the reason is because on the benefit side, I didn’t see any improved benefit over the existing available choices.”

In the Women’s Health Activist newsletter in spring of 2012, Amy Allina, program and policy director of the National Women’s Health Network, wrote:

The question for a woman is, what should she weigh these risks against? As some have pointed out, the blood clot risks of pregnancy are greater than those of drospirenone pills. Is that the right basis of comparison? The Network does not believe it is. There are other, safer, ways women can avoid the risks of pregnancy – including contraceptive pills that don’t contain drospirenone. Drospirenone pills don’t provide a unique benefit over other available contraceptive pills. We’re also concerned that most women using drospirenone pills are unaware that other contraceptive pills are safer.

The NWHN has asked the FDA to remove these pills from the market. Allina wrote: “We believe that women who are looking for contraceptive options to help them postpone or prevent pregnancy should not be unnecessarily exposed to a higher risk of blood clots when there are safer alternatives with the same benefits available.”