Archive for the ‘Legal’ Category

March 28, 2014

Why Contraception is a Health Issue for Everyone

Photo “ritual” by Monik Markus used under CC BY-2.0 from https://flic.kr/p/8YaubV

Some of the media coverage of Tuesday’s arguments before the Supreme Courton the contraception mandate tended to pit women’s rights activists against social conservatives, making contraception seem like a lifestyle choice that only benefits some women — you know, the ones who have sex.

What often gets lost in the debate is why contraception is considered a preventive health issue — and why treating it as such is beneficial for everyone.

During the healthcare debate, the Department of Health and Human Services charged the Institute of Medicine (IOM) with reviewing preventive services that are important to public health and well-being, and recommending which ones should be considered in the development of comprehensive guidelines.

IOM came up with this evidence-based list of preventive services for adults and children, all of which are now covered by insurers with no required co-payment. Take a look at the IOM report, which explains the selection process.

For women, this includes annual well-woman visits, testing for STIs and HIV, support for breastfeeding, and screening and counseling for domestic violence.

It also includes FDA-approved contraception methods, as well as patient education and counseling on contraception. What makes contraception a health issue? Well, with all due respect to Mike Huckabee, it’s not about women’s libidos.

Here’s the deal: When women use contraception, they can avoid unwanted pregnancies and space planned pregnancies to promote optimal birth outcomes.

When a pregnancy is planned, women can start prenatal care, including increasing their intake of folic acid; work with their healthcare providers to address relevant medical conditions, as well as substance abuse; and take other steps that lead to healthier outcomes for both the mother and the infant.

Pregnancies that are unplanned are more likely to be affected by delayed prenatal care, maternal depression, low birth weight, poorer childhood physical and mental health, and other complications. Breastfeeding rates are also lower after unintended pregnancies.

Social conservatives should also take note that 40 percent of unintended pregnancies end in abortion. And there is an economic cost: Two-thirds of unintended pregnancies are paid for by publicly funded insurance programs, usually Medicaid. For more information, Guttmacher Institute has a terrific fact sheet on unintended pregnancies that explains the incidence rate, demographics, outcomes and costs.

When you look at the facts, contraception is smart public health policy.

Of course, for some women, birth control is essential for other health reasons, including acne, fibroids, endometriosis and to reduce problems associated with irregular or very heavy periods.

Despite the proven health benefits — and the benefits to society as a whole — Hobby Lobby and Conestoga Wood claim that the requirement to provide health insurance that includes no-cost contraception violates their religious freedom.

Not surprisingly, the Court’s three female justices were most skeptical of their position. As Jeffrey Toobin writes in The New Yorker:

After Paul Clement, the lawyer for Hobby Lobby, began his argument, twenty-eight of the first thirty-two questions to him came from Ruth Bader Ginsburg (four questions), Sonia Sotomayor (eleven), and Elena Kagan (thirteen). The queries varied, of course, but they were all variations on a theme. The trio saw the case from the perspective of the women employees. They regarded the employer as the party in the case with the money and the power. Sotomayor asked, “Is your claim limited to sensitive materials like contraceptives, or does it include items like blood transfusion, vaccines? For some religions, products made of pork? Is any claim under your theory that has a religious basis, could an employer preclude the use of those items as well?” Clement hedged in response. When Clement asserted that Hobby Lobby’s owners, because of their Christian values, did care about making sure that their employees had health insurance, Kagan shot back:

“I’m sure they want to be good employers. But again, that’s a different thing than saying that their religious beliefs mandate them to provide health insurance, because here Congress has said that the health insurance that they’re providing is not adequate, it’s not the full package.”

At Talking Points Memo, Sahil Kapur wrote:

The most forceful was Justice Elena Kagan, who repeatedly asked aggressive questions throughout the 90-minute argument about the legal dangers of exempting certain entities from laws on the basis of religion.

“There are quite a number of medical treatments that religious groups object to,” she said, positing that a ruling against the Obama administration could empower business owners to seek exemptions from laws about sex discrimination, family leave and the minimum wage. “You’d see religious objectors come out of the woodwork,” Kagan warned, arguing that it’s problematic for judges to test the centrality of a belief to a religion or the sincerity of beliefs that are invoked in court.

Much of the argument also centers around whether companies really have religious freedom, or if that really only applies to people — whether corporations count as “people” has been a major issue before the Court in the recent past. In “The Hobby Lobby Case Represents The Worst Kind Of Anti-Choice Arrogance,” Sarah Erdreich writes:

But even if the owners do have a religious commitment, Hobby Lobby is not pretending that it is a religion. It is a business. That any business should have power over what can literally be the life-and-death health decisions of its employees, well, that’s another issue for another day. But as long as Hobby Lobby sells its supplies to saints and sinners alike, it has no business questioning what its employees do when they go to see the doctor.

Access to birth control is important for everyone — for preventing pregnancies, and to allow women and families to best time and plan healthy pregnancies. Hopefully the male members of the Supreme Court will see it that way, too.

To catch up on the issue, check out this coverage:


December 3, 2013

Science Says: Emergency Contraception Does Not Block Implantation of a Fertilized Egg

Last week, in a post about how some types of emergency contraception are less effective or ineffective in women weighing more than 165 pounds, we mentioned that the European equivalent to Plan B One-Step was getting a new label that will note the problem.

Let’s take a look at the other reason for the label change: European health officials have determined — and want to make clear — that the drug “cannot stop a fertilized egg from attaching to the womb.”

This is a big issue, as abortion opponents have long opposed EC on the grounds that it might prevent a fertilized egg from implanting in the uterus. U.S. labels of levonorgestrel-containing emergency contraceptive pills, such as Plan B, don’t directly refute the possibility.

But as The New York Times noted last year, recent science suggests that this is not the case; the pills work only by preventing ovulation and fertilization.

Last week, NYT reporter Pam Belluck noted how the FDA and other health agencies responded to the scientific studies:

References to the possibility of blocking implantation were then removed from the websites of the National Institutes of Health and the Mayo Clinic. And an F.D.A. spokeswoman, Erica Jefferson, said that “the emerging data on Plan B suggest that it does not inhibit implantation.”

On Tuesday, Ms. Jefferson reiterated that view. The drug agency has not moved to change the label, saying manufacturers must request a change. Plan B One-Step’s manufacturer, Teva Pharmaceuticals, declined to comment. It had previously said scientific evidence suggested that the pill did not disrupt implantation.

Although pregnancy is not medically considered to have begun until a fertilized egg has successfully implanted in the lining of the uterus, media coverage around this topic has often obscured this distinction and promoted a false idea that emergency contraception is the same thing as the abortion pill (RU-486) or abortion in general. Medical professionals generally assert that “emergency contraception is not effective after implantation; therefore, it is not an abortifacient.”

Effect on Lawsuits
Hobby Lobby is one for-profit corporation that filed suit to avoid complying with Obamacare coverage for contraception, claiming that forms of contraception that could interfere with the implantation of a fertilized egg are tantamount to abortion. The Supreme Court will hear the case, focusing on whether for-profit companies can be required to provide coverage that may conflict with the private religious beliefs of the business owners.

As Linda Greenhouse wrote in an op-ed about challenges to the contraception mandate under the Affordable Care Act, a coalition of medical groups, led by Physicians for Reproductive Health, filed a brief in the case, noting in part that “the weight of the scientific evidence establishes that the FDA-approved contraceptives and emergency contraceptive are not abortifacients.”

Read Greenhouse’s column for an excellent look at how the religious-based challenges represent a culture war on “modernity.” For more on the lawsuits, SCOTUSblog is a smart resource.

And we highly recommend the Emergency Contraception website for easy-to-understand fact sheets, such as this one: “Does emergency contraception cause an abortion?


November 4, 2013

The Ultimate Guide to the Legal Battle Over OTC Access to Emergency Contraception

In the October issue of the journal Contraception, authors from Harvard Law School and Brown University’s medical school trace the legal and political battles over non-prescription access to emergency contraception.

The authors date the legal dispute back to Jan. 21, 2005, when a coalition of organizations in favor of emergency contraception filed a lawsuit accusing the FDA of ignoring the science and safety and applying different standards to Plan B, a type of EC under review at that time, than the FDA applied to other drugs.

Of course, concern about access and the FDA’s process actually goes back further. Organizations had filed a Citizen Petition four years earlier asking the FDA to approve over-the-counter access. The FDA’s failure to respond to that petition, and rejection of the drug company’s application for OTC status, are what ultimately led to the 2005 lawsuit.

The article in Contraception covers the legal battles and notes the various ways the U.S. government interfered in the FDA’s decision-making. You might recall that politically motivated delays under the Bush administration led Susan Wood, a former assistant FDA commissioner for women’s health and director of the Office of Women’s Health, to resign in 2005.

“I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled,” she said at the time of her decision.

After President Obama took office, and amid hopes that sound policy would prevail over politics, HHS Secretary Kathleen Sebelius overruled the agency’s 2011 decision that Plan B could be made available without a prescription or age restrictions. Noting this and subsequent political interference, the authors comment:

The final resolution of this controversy offers an ideal vantage point to examine the vulnerability of the FDA to political influence. While the FDA has “consistently been named or identified as one of the most popular and well-respected agencies in government”, the ability of the FDA to resist political influence is more precarious than its apparent reputation might suggest. After all, the FDA is not an independent agency. Indeed, the FDA Commissioner serves at the pleasure of the President. What is more, the idealized notion that the science-driven decision-making process of the FDA is insulated from and resistant to the political discourse is incommensurate with precedent.

Yes, that’s lawyer speak, but what it translates to is this: The Plan B drama has shown us that the FDA cannot be relied upon to make purely evidence-based decisions. At any time, a presidential appointee (like Sebelius) might step in to overrule evidence-based decisions. And as we’ve seen with Plan B, the resulting legal battle and limited access to a needed drug can stretch on for years.

Without a doubt, as the authors note, “there can be little questioning the foot dragging and active role played by two successive presidential administrations in shaping the emergency contraception debate.”

Plus: For more on the history of the fight for OTC emergency contraception, view a timeline from the Center for Reproductive Rights, and the original Citizen’s Petition, and check out coverage at Our Bodies, Our Blog. Important posts for context include this item on  Sebelius overriding the FDA’s decision, Susan Wood’s response at the time, and more history of the battle for increased access to EC.


July 31, 2013

The Medical (and Political) Problem with 20-Week Abortion Bans

July 15 protest rally in Austin against anti-abortion legislation

July 15 protest rally in Austin against anti-abortion legislation / Photo by Mirsasha

The recent wave of anti-abortion legislation has caused much confusion and concern over what the future of reproductive healthcare might look like in a few years.

Texas recently enacted a 20-week abortion ban, and 13 states have passed similar bans. In Congress, Republican senators are pushing to bring a 20-week abortion ban up for a vote after the August recess, reports The New York Times.

Let’s first look at the language in these bills, which usually reference “20 weeks post-fertilization.” Aside from the restrictive issues, these post-fertilization bans present a major problem — that’s not how pregnancy is measured.

When a doctor or midwife indicates that someone is “20 weeks pregnant,” what they mean is that it has been 20 weeks since the first day of the last menstrual period (or LMP). This can be a bit confusing, because the first day of the last period is not when ovulation followed by fertilization actually occur.

This LMP method is used because it’s the easiest to measure. While ovulation is often estimated at about two weeks after the start of the last menstrual period, it can occur at different times for different people, making it impossible to know exactly when ovulation — or fertilization or implantation, for that matter — occurred.

LMP, however, is something we can point to on a calendar and is easily knowable. That’s why healthcare providers ask the question.

To recap the terms:

  • 20 weeks “pregnant” = 20 weeks after the first day of the last menstrual period (LMP); used by medical providers to date pregnancies.
  • 20 weeks “gestational age” = usually the same as above, measured since the first day of the last menstrual period; used by medical providers to date pregnancies.
  • 20 weeks “post-fertilization” = may be approximately 22 weeks “pregnant” by the normal method of measuring; used by politicians to promote 20-week abortion bans.

In other words, nobody but politicians uses fertilization as a way of dating a pregnancy. For the record, a pregnancy does not start at fertilization; implantation must occur for the pregnancy to progress.

So why are politicians using “post-fertilization”? For one, politicians may simply have very little understanding of pregnancy. This would not surprise us in the anti-science era of “legitimate rape.” (Though we really wish members of Congress would read their copies of “Our Bodies, Ourselves.”)

More cynically, politicians may be deliberately fostering confusion in order to make it more difficult for women to determine whether they are within their legal right to obtain an abortion.

For example, a woman told she is “22 weeks pregnant” by a healthcare provider may assume she’s past the cutoff and no longer able to obtain an abortion. In reality, she may be just 20 weeks post-fertilization and still eligible for a short period of time.

Anti-abortion advocates justify 20-week post-fertilization limits based on the widely disputed idea that fetuses may feel pain at that point. The so-called “Pain-Capable Unborn Child Protection Act” (HR 1797) that the House passed in June specifically referred to 20 weeks after fertilization as the cutoff for legal abortion, based on the widely disputed idea that fetuses can feel pain at this point.

However, a 2005 systematic review on the topic concluded that “pain perception probably does not function before the third trimester.” Similarly, a 2010 report by the Royal College of Obstetricians and Gynaecologists (UK) concluded: “Interpretation of existing data indicates that cortical processing of pain perception, and therefore the ability of the fetus to feel pain, cannot occur before 24 weeks of gestation.”

For all the supposed concern about pain, it’s almost unheard of for anti-abortion activists to discuss the counterbalancing notion of pain, illness, injury and potential death that a woman may face carrying a pregnancy to term — see Jessica Valenti’s most recent column in The Nation for more from this perspective.

It’s also important to remember, as Paul Waldman points out, that these bills contain provisions that aim to shut down abortion clinics, including onerous Targeted Regulation of Abortion Providers (TRAP) laws that are costly and do nothing to increase safety:

Abortion clinics often require doctors from out of state to travel to the clinic, because of the harassment, threats, and even assassinations that local doctors have been subject to? Then we’ll require that every doctor have admitting privileges at a hospital within a certain number of miles, which out-of-state doctors won’t have. And we’ll throw in some rules on how wide your hallways need to be (not kidding), meaning in order to stay open you’d have to do hundreds of thousands of dollars of remodeling. Failing that, we’ll make sure that women who need abortions will have to suffer as much inconvenience, expense, and humiliation as possible.

Ultimately, the GOP’s concern is not so much about minimizing human suffering, but about advancing strategies for keeping women from exercising their right to safe, legal abortion. Writing at RH Reality Check, Imani Gandy does a  good job explaining the anti-choice litigation strategy, noting in part:

The push for 20-week abortion bans is part of a national strategy implemented by anti-choice advocates to create exactly the sort of legal mess that will force the Supreme Court to reconsider Roe v. Wade and Planned Parenthood v. Casey, and to revisit the viability standard that has served as the constitutional foundation for abortion rights for 40 years.

An analysis by RH Reality Check suggests that the strategy deployed by anti-choicers is deeply subversive. It capitalizes on personal feelings and anti-abortion hostilities by enticing judges and legislatures to abandon empirical science in favor of biased, agenda-driven science or, as it is sometimes called, “junk science.” Proponents of junk science, which has become a cottage industry among anti-abortion advocates, confuse the issue of fetal viability, invent claims about fetuses feeling pain (or masturbating in utero), and call into question established medical standards.

The strategy is a smart one, to be sure. Anti-choicers understand that once junk science has been incorporated into legislation, courts are not inclined to question those scientific findings—no matter how agenda-driven they are—and will simply apply the law to those “facts.” In cases when junk science is presented to a court, a judge (or justice) hostile to abortion rights requires only the flimsiest reasoning to ground their legal opinion in fact, even if those “facts” are anything but factual.

As the American Congress of Obstetricians and Gynecologists wrote when addressing political attempts to limit abortion based on ideas about fetal, pain: “Facts are important.”

Let’s hope the courts think so, too.


June 25, 2013

HIV/AIDS Policy and Prevention Cannot Succeed if Sex Workers Are Stigmatized

by Anna Forbes

In a ruling praised by organizations working on HIV/AIDS policy and prevention, the U.S. Supreme Court last week struck down a decade-old law forcing groups that receive government money in a global anti-AIDS program to embrace a policy opposing prostitution.

By a vote of 6-2, the Court ruled that the Anti-Prostitution Pledge in the President’s Emergency Plan for AIDS (PEPFAR) violated the First Amendment rights of U.S.-based organizations and was therefore unconstitutional.

PEPFAR funding is allocated to implement the 2003 United States Leadership Act against HIV and AIDS, Tuberculosis, and Malaria. While a major step forward in terms of overall investment in global health (and particularly in the HIV/AIDS response), the Act contains some insidious provisions, one of which is the Anti-Prostitution Pledge (APP), which states that “no funds, “may be used to provide assistance to any group or organization that does not have a policy explicitly opposing prostitution and sex trafficking,” and that “[N]o funds…may be used to promote, support, or advocate the legalization or practice of prostitution.”

The APP required, as a condition of funding, that all PEPFAR grantees write and adopt an explicit agency policy condemning sex work. Under this policy, grantees could not use any of their funding (including money received from other sources) on activities in any way related to sex workers’ rights. This resulted in the reduction or complete elimination of HIV prevention and treatment services for sex workers in numerous countries — including the de-funding of USAID-identified best practices programs.

Legal challenges to the constitutionality of the APP were brought by the Alliance for Open Society International (AOSI) and Pathfinders International in 2004; InterAction and the Global Health Council later joined the case.

Chief Justice John G. Roberts wrote in the majority opinion: “This case is not about the government’s ability to enlist the assistance of those with whom it already agrees. It is about compelling a grant recipient to adopt a particular belief as a condition of funding. By demanding that funding recipients adopt — as their own — the Government’s view on an issue of public concern, the condition by its very nature affects ‘protected conduct outside the scope of the federally funded program.’”

He added that although the government has a legitimate interest in controlling how PEPFAR funds are spent, it cannot require grantees to “pledge allegiance to the government’s policy of eradicating prostitution.”

The majority opinion was supported by Justices Samuel Alito, Stephen G. Breyer, Ruth Bader Ginsberg, Anthony Kennedy, and Sonia Sotomayor, with Justices Antonin Scalia and Clarence Thomas dissenting. Justice Elena Kagen, who had worked on the case while Solicitor General, recused herself.

It remains to be seen whether the Supreme Court decision will enable funded organizations based outside of the United States to abandon compliance with the APP without risk. The Court’s decision affirmed that U.S.-based agencies are protected under the Constitution but was not clear on whether agencies based outside of the United States, without the Constitution’s First Amendment purview, were similarly protected.

Despite this ambiguity, the decision is a clear win for those who uphold the human rights of sex workers and support access to the peer-based programming that has been shown to effectively reduce their vulnerability to HIV, as well as other health risks and human right violations.

Globally, sex workers are identified by UNAIDS and others as one the three “most at risk populations” (MARPS). In its 2011 report “Guidance for the Prevention of Sexually Transmitted Infections,” USAID wrote that countries receiving PEPFAR funding “should take steps to ensure that scale-up of prevention programs for MARPs is accompanied by appropriate protections of their rights, including the review of policies and regulations that criminalize or deter MARPs seeking services and training for service providers to reduce stigma and discrimination.”

Grantees’ ability to follow this guidance, however, was directly impeded by the APP requirement that grantees not only adopt an anti-prostitution policy but also distance themselves from any “organization that engages in activities inconsistent with the recipient’s opposition to prostitution and sex trafficking.”

Rather than risk funding loss, many grantees simply eliminated any sex worker-related services they had been providing. In a survey of staff in PEPFAR-recipient agencies, the Center for Health and Gender Equity (CHANGE) found that “19 of the 31 people interviewed in the field reported that they censored themselves or their organizations as a result of the pledge. Almost all contracting agencies reported that they have cleared their websites of references to sex workers or rights.”

In Bangladesh, for example, a drop-in center program recognized as a UNAIDS “best practices” model was defunded (losing 16 of its 20 centers) after the international NGO funding them decided to err on the side of caution in compliance with the APP. These drop-in centers provided homeless street-based sex workers with sanitation facilities, a place to sleep, temporary safety, condom counselling and promotion, and skills-building opportunities to facilitate transitioning out of sex work for those wishing to do so.

Hazera Bagum, director of the Bangladesh program, told CHANGE, “They came in and rested, educated themselves and talked to each other about effective HIV prevention … The monthly condom distribution rate used to be very high, but since the closings, there is less access, so sex workers are not using as many condoms. They distribute fewer every month.”

It is impossible for the U.S. government, or any government, to stigmatize people on one hand and simultaneously help them to reduce their HIV risk on the other. Gay men know the truth of this, as do women, as do people of color, as do sex workers, as do we all.

Now, at least, the Supreme Court has stopped Congress from insisting that its U.S.-based grantees attempt the impossible in this particular case. We have a long way to go, but this is progress.

Plus: For a broader view of how this fits into advocacy for sex workers rights, particularly with regard to HIV, read “Solidarity with Sex Workers: On the Agenda or Under the Bus?

An advocate, organizer and writer, Anna Forbes has worked on HIV/AIDS policy since 1985 and on women’s health and rights since 1977. Now an independent consultant with an international client base, her work centers around women, HIV, gender, health and rights.


June 11, 2013

Obama Administration Will Stop Trying To Block Some Emergency Contraception Access

Best news all day: ”The Obama administration has decided to stop trying to block over-the-counter availability of the best-known morning-after contraceptive pill for all women and girls.”

The administration is withdrawing its appeal of a ruling that requires emergency contraception pills to be made available without prescription, regardless of age. This is good news for access to the one-pill form of emergency contraception.

In not-so-good news, the administration may still interfere with over-the-counter access to the two-dose form of the drug.

Although the previous ruling required that the two-pill form be made available even before the intended appeal was heard, the Justice Department’s letter indicates that it may still try to require additional data specific to safety of the often more affordable, generic two-dose form in younger adolescents before approving the change.

As SCOTUSblog explains, “the FDA is interpreting Judge Korman’s April order as giving it permission to choose between Plan B One-Step and the two-pill version so that just one of them would be open without restrictions to women of all ages.”

The Center for Reproductive rights, which has been heavily involved in the court cases around this issue, responded:

Now that the appeals court has forced the federal government’s hand, the FDA is finally taking a significant step forward by making Plan B One-Step available over the counter for women of all ages. But the Obama Administration continues to unjustifiably deny the same wide availability for generic, more affordable brands of emergency contraception.

Congratulations and thanks to everyone who has worked for more than a decade to call attention to this important issue. While more work is still needed to make emergency contraception fully accessible to women and girls when they most need it, this recent news puts us much closer to that goal.


June 7, 2013

New Developments in OTC Emergency Contraception Court Case

First, a quick refresher:

A couple of months ago a judge ordered that emergency contraception pills (like Plan B) be made available over the counter (OTC) without age restrictions. The U.S. Justice Department appealed that ruling, and asked for a stay so that OTC access wouldn’t take effect during the appeals process.

Around the same time, the FDA approved Plan B One-Step emergency contraception pills for purchase without a prescription for teens ages 15 and older.

On Wednesday, the Second Circuit Court of Appeals denied the stay for two-pill types of emergency contraception. This means that two-pill regimens should become available without prescription to women and girls of all ages even before the government’s appeal is resolved. The Court allowed the stay for one-pill variants of emergency contraception (e.g. Plan B One Step), and stated that the appeal process would be expedited.

Women’s health advocates have been fighting for more than a decade to make OTC emergency contraception a reality.

Nancy Northup of the Center for Reproductive Rights called Wednesday’s order “a historic day for women’s health,” adding: “Expanding access to this safe and effective way of preventing pregnancy after failed birth control or unprotected sex is the among the very best decisions our federal government can make for women’s health.”

Marcia Greenberger of the National Women’s Law Center remarked, “The Center applauds today’s decision, which underscores the simple fact that there is no reasonable basis for restricting access to this safe and effective birth control.”

The American Academy of Pediatrics, American College of Obstetricians and Gynecologists, and Society for Adolescent Health and Medicine have collectively denounced the administration’s decision to appeal the ruling at all, and issued a strong statement rejecting limited access: “There is no scientific justification for a continued age restriction on emergency contraception. The Administration’s decision puts the health of adolescent girls at risk and is inconsistent with what we know about the safety and benefits of emergency contraception.”

It’s unclear what will happen next in the fight for more accessible emergency contraception. The Justice Department has stated only that they are reviewing the order. According to SCOTUSblog, the administration has the option of asking the Supreme Court to delay all parts of that initial order for OTC access without age restriction. NPR’s Shots explains that “some lawyers say the government might be able to appeal to the full 2nd Circuit. But more likely, if they insist on fighting, government attorneys would have to seek relief from the Supreme Court justice who oversees the 2nd Circuit — Ruth Bader Ginsburg.”


April 18, 2013

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

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

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

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

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

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

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

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

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

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

More coverage of the case:

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


April 12, 2013

The Long Political History of Increasing Access to Emergency Contraception

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:

Background information from Our Bodies Ourselves:


March 15, 2013

Rally at the Supreme Court – Breast Cancer Gene Case to be Heard Next Month

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:


January 16, 2013

When Pregnancy is a Crime: Arrests, Forced Interventions in the Name of Public Health

Although this January marks the 40th anniversary of the landmark Supreme Court decision legalizing abortion, we know that there is still much work to be done to ensure reproductive justice for all women.

The Guttmacher Institute reports that 2012 saw the second highest number of abortion restrictions enacted in a single year; the Center for Reproductive Justice addresses each state in this report.

Among the provisions ultimately defeated were “fetal personhood” bills in Mississippi and Oklahoma. But the notion that fetuses should be protected from the women carrying them has resulted in the restriction and punishment of women across America.

Lynn Paltrow, executive director of National Advocates for Pregnant Women, and Jeanne Flavin, a professor of sociology at Fordham University and chair of NAPW’s board, have put together an extremely interesting and important study: “Arrests of and Forced Interventions on Pregnant Women in the United States, 1973–2005: Implications for Women’s Legal Status and Public Health.”

Paltrow and Flavin (who is also the author of the 2008 book “Our Bodies, Our Crimes: The Policing of Women’s Reproduction in America“) tried to identify and examine U.S. cases from 1973, the year of Roe v. Wade, through 2005, in which a medical or government authority tried or succeeded in stripping a woman’s autonomy because of pregnancy. The study appears in the Journal of Health Politics, Policy and Law.

These cases could have involved threat of or actual arrest, incarceration, or increased prison/jail time; detention in a hospital, treatment program, or mental institution; or forced medical intervention. Descriptive detail of several cases is provided, along with summary statistics on the findings.

Looking at legal, medical and other sources, Paltrow and Flavin analyzed 413 cases, which they speculate are “a substantial undercount,” because cases were difficult to identify and some sources referred to additional cases.

The data reveals substantial racial, income and geographic disparities. While almost every state had multiple cases, the regions with the most were the south (56 percent) and midwest (22 percent). These cases disproportionately targeted black women (52 percent of cases overall, and 72 percent of cases in the south), and 71 percent involved low-income women (enough so that they qualified for indigent defense).

Most women who faced criminal charges were charged with felonies; a greater percentage of black women (85 percent) were charged with felonies than white women (71 percent).

The authors explore how these disparities are interlinked with disparities in drug laws, disproportionate application of criminal laws, and outdated stereotypes about cocaine use (such as the “crack baby” myth).

The vast majority of the cases — 84 percent — involved allegations of illegal drug use. In the remaining cases, “women were deprived of their liberty based on claims that they had not obtained prenatal care, had mental illness, or had gestational diabetes, or because they had suffered a pregnancy loss.”

Although concern for the health of the fetus/infant is typically offered as a reason for increased scrutiny or detainment of pregnant women, in 64 percent of the cases there was no reported health issue cited in the allegation.

Chillingly, most cases were reported by people in so-called “helping professions”: health care providers (41 percent), social workers (12 percent), and hospital, child protective services, or police personnel (17 percent). Health care providers reported black women at a higher rate (48 percent) than white women (27 percent).

As the authors point out:

Due in part, no doubt, to the strong public health opposition to such measures, no state legislature has ever passed a law making it a crime for a woman to go to term in spite of a drug problem, nor has any state passed a law that would make women liable for the outcome of their pregnancies. Similarly, no state legislature has amended its criminal laws to make its child abuse laws applicable to pregnant women in relationship to the eggs, embryos, or fetuses that women carry, nurture, and sustain. No state has rewritten its drug delivery or distribution laws to apply to the transfer of drugs through the umbilical cord. To date no state has adopted a personhood measure, and no law exists at the state or federal level that generally exempts pregnant women from the full protection afforded by federal and state constitutions.

In other words, nothing about existing law should make women subject to such persecution. They also note that public health groups have observed that targeting pregnant women may lead to women avoiding medical care or having unwanted abortions to avoid increased and punitive scrutiny.

Paltrow and Flavin also highlight these cases in the context of proposed personhood laws, which would give fetuses individual rights and potentially could lead to increased prosecutions of women. They authors note that they have identified “more than two hundred cases initiated against pregnant women since 2005 that also overwhelmingly rest on the claim of separate rights for fertilized eggs, embryos, and fetuses.”

Opponents to personhood laws have cautioned that such measures could lead to forced medical interventions on pregnant women along with possible punishment for miscarriages and stillbirths. While personhood proponents often dismiss these warnings as scare tactics, the research shows there is good reason to be concerned.

Paltrow and Flavin conclude with a call for change:

In light of these continued efforts and our findings, we challenge health care providers, law enforcement and child welfare officials, social workers, judges, and policy makers to examine the role they play in the arrests and detentions of and forced interventions on pregnant women. We call on these same people to develop and support only those policies that are grounded in empirical evidence, that in practice will actually advance the health, rights, and dignity of pregnant women and their children, and that will not perpetuate or exacerbate America’s long and continuing history of institutionalized racism.

Finally, our study provides compelling reasons for people who value pregnant women, whether they support or oppose abortion, to work together against personhood and related measures so women can be assured that on becoming pregnant they will retain their civil and human rights.

The whole article is well worth a read if you can get a copy. The abstract is freely available online.


November 7, 2012

Our Bodies, Our Votes: Election 2012 Highlights

Last night, the War on Women suffered a setback — due largely to women voters who used the ballot to re-elect President Barack Obama and to push back against absurd, insulting and just plain offensive comments about rape and women’s bodies.

As Veronica Arreola posted on Facebook:

Two of the biggest losers last night were the gentlemen who claimed that women have magic wombs that stop pregnancy from occurring during legitimate rape and if it does happen, it was a gift from God. The magic was in our votes, ladies. We’ve had it all along.

Erin Gloria Ryan’s post at Jezebel is succinctly titled “Team Rape Lost Big Last Night.” Read it for a complete look at races around the country.

Some highlights …

Missouri Rep. Todd Akin failed to unseat incumbent Sen. Claire McCaskill, causing Twitter to explode with a new round of Akin-related humor, like “Claire McCaskill legitimately wins and shuts that whole Akin thing down!”

John Koster was defeated by Suzan DelBene in Washington state — Koster famously referred to “the rape thing” and confused one woman’s choice with controlling all women’s choices: “I know a woman who was raped and kept the child, gave it up for adoption and doesn’t regret it.”

And in Illinois, Rep. Joe Walsh, who doesn’t believe abortion is ever necessary to save the life or health of a mother, lost to challenger Tammy Duckworth, an Iraq War veteran who lost both legs in combat.

For more analysis, Bryce Covert at The Nation examines the impact of politicians’ misogyny on the election outcomes, and concludes: “Score one for women’s rights, zero for attempts to control their bodies.”

***

Our Bodies, Our Votes …

“Our Bodies, Ourselves” turned up in a number of tweets last night. Anne Elizabeth Moore, who led The Ladydrawers on the road trip to deliver “Our Bodies, Ourselves” to the offices of Akin and McCaskill, posted this upon news of Akin’s defeat:

hey @RepToddAkin, now maybe you’ll finally have time to get crackin at all those books @oboshealth and @TheLadydrawers dropped off!

We heartily second that recommendation.

Following the defeat of Indiana Senate candidate Richard Mourdock — who recently said, “I think even when life begins in that horrible situation of rape, that it is something that God intended to happen” — Jason Lefkowitz tweeted: ”And in Indiana, Mourdock has officially been buried under a massive pile of hardback copies of ‘Our Bodies, Ourselves.’”

Jason Cherkis also took note of the upsets, tweeting: ”GOP furiously buying ‘Our Bodies, Ourselves’ on Amazon.”

No need; with the public’s help, we’ll deliver the book to each and every member of Congress (41 days left to make this happen!).

***

Big gains for women and marriage equality …

binders full of women headed for the u.s. senateWe now have a record number of women in Senate, with 20 women Senators elected.

Rep. Tammy Baldwin became the first openly gay senator, and the first woman senator from Wisconsin. Rep. Mazie Hirono became the first woman senator from Hawaii as well as the first Japan-born immigrant to be elected to the Senate and the first Buddhist.

Another big success last night was the passage of ballot measures in Maine and Maryland approving same-sex marriage, the first time it has been made legal through a popular vote. An amendment to ban same-sex marriage was defeated in Minnesota.

We’re still waiting to hear for sure about Washington state, but early returns are promising. Same-sex marriage is now legal in eight states as well as in Washington, D.C.

More good news: Iowa Supreme Court Justice David Wiggins is staying on the bench – he had been targeted for removal because of his role in the legalization of gay marriage in that state.

***

Mixed results on abortion-related measures …

Abortion-related measures were considered in two states. In Florida, voters defeated Amendment 6, which would have prevented state employees from using their healthcare coverage for most abortions, and would have affected privacy rights in a way that could have led to further restrictions.

In Montana, voters approved a parental notification measure requiring girls under age 16 to notify a parent or seek judicial bypass prior to terminating a pregnancy.

 ***

Lessons learned and work to be done …

Akiba Solomon at Colorlines shares “Five Race and Gender Justice Lessons Learned from This Marathon Election Cycle,” including this important point: “The Republican-led war on abortion, Title X-funded reproductive health care and contraceptive access was—and still is—a war on poor women of color and their families.”

And if anyone needs a reminder of the work we still have before us, On the Issues magazine has appropriately titled its fall issue “The Day After.”

From the editor’s note: “On wide-ranging issues — the economy to the environment, reproductive freedom to voting freedom, sexuality to media representation — our writers, artists and thinkers in The Day After remind us to extend our vision beyond the ballot box to where we need to place our energies, build our muscles and put our feet on the ground every day of the year.”

In other words, it’s time to get busy — again.


September 21, 2012

Pregnant Workers Fairness Act Introduced in Senate

Senators Bob Casey (D-Penn.) and Jeanne Shaheen (D-N.H.) this week introduced the Pregnant Workers Fairness Act to provide pregnant workers with legal protection against discrimination, similar to protections provided by the existing Americans with Disabilities Act (which does not cover pregnancy).

Many women need simple accommodations like being allowed to sit while working or additional bathroom breaks, and these are not protected under existing laws. As an example, one pregnant worker was reportedly fired for carrying a water bottle and drinking from it while working, as it was against store policy prohibiting eating or drinking while working.

Casey remarked:

Pregnant workers face discrimination in the workplace every day, which is an inexcusable detriment to women and working families in Pennsylvania and across the country. This legislation will finally extend fairness to pregnant women so that they can continue to contribute to a productive economy while progressing through pregnancy in good health.

The bill was also introduced in the House earlier this summer by Rep. Jerry Nadler (D-N.Y.) and has more than 100 cosponsors. Not much has happened on it, though, except referrals to various committees — prompting RH Reality Check’s Sheila Bapat to remark that the bill was “going nowhere fast.”

Bapat also clarifies why the the Pregnant Workers Fairness Act matters, even though a Pregnancy Discrimination Act has existed since 1978:

There are laws that protect pregnant women from discrimination, but they have not been interpreted to protect women seeking adjustments to their work responsibilities. The Pregnancy Discrimination Act (PDA) was passed over 30 years ago and prevents discrimination “on the basis of pregnancy, childbirth and related medical conditions.” But the PDA is interpreted to only protect women who are pregnant but not hindered in job performance due to pregnancy or women who cannot work at all and need leave.

National Advocates for Pregnant Women has an online guide to laws affecting pregnancy discrimination in employment, which is a great starting point for understanding existing protections and the gaps in current laws, such as the ADA and the Family and Medical Leave Act.

The National Women’s Law Center has been working to promote passage of the Act, and has a number of useful posts at their blog for learning more. Excellent posts in the series include “It Shouldn’t Be A Heavy Lift: Pregnant Workers Fairness Act Introduced in Senate,” and “The Pregnant Workers Fairness Act: What It Means for Low-Wage Working Women.”


September 21, 2012

Ley de Equidad para Trabajadoras Embarazadas Presentado en el Senado

Escrito por Rachel. Traducido del orginial en inglés Sept. 21, 2012.

Los senadores Bob Casey (Demócrata, Pennsylvania) y Jean Shaheen (Demócrata, New Hampshire) presentaron introdujeron la Ley de Equidad para Trabajadoras Embarazadas esta semana para extender protecciones legales a trabajadoras embarazadas contra la discriminación, protecciones a las que provee el Acta de Americanos con Descapacidades (que no cubre el embarazo) .

Muchas mujeres embarazadas necesitan arreglos sencillos en el trabajo: el permiso de trabajar sentadas, o descansos de baño mas frecuentes. Pero estos arreglos no están protegidos bajo las leyes actuales. Como ejemplo, una trabajadora fue despedida después de cargar y beber agua de una botella, ya que el negocio donde trabajaba tenia una regla prohibiendo empleados de comer y beber durante el trabajo.

Dijo Casey:

Trabajadoras embarazadas enfrentan discriminación en el trabajo todo los días, lo que es un detrimento sin excusa a las mujeres y familias trabajadoras de Pennsylvania y por toda la nación.  Esta ley finalmente extenderá equidad a las mujeres embarazadas para que puedan continuar a contribuir a una economía productiva mientras que progresan con un embarazo sano.

La ley se presentó en la Cámara de Representantes previamente en este verano por el Rep. Jerry Nadler (Demócrata Nueva York) y tiene más de 100 copatrocinantes. Sin embargo, no ha progresado mucho, menos ser referida a varios comités– provocando el comentario de Sheila Bapat de RH Reality Check, “ la ley no estaba yendo a ningún lugar.”

Bapat también nos clarifica las razones por la cuales la Ley de Equidad para Trabajadoras Embarazadas tiene importancia, aunque una Acta contra Discriminación en el Embarazo ha existido desde 1978:

Ya existen leyes que protegen mujeres embarazadas contra la discriminación, pero no han sido interpretado en términos de proteger mujeres que buscan modificaciones a sus responsabilidades en el trabajo. El Acta contra Discriminación en el Embarazo (PDA) se aprobó hace 20 años, y previene la discriminación “a base de embarazo, parto, y condiciones médicas relacionadas.” Pero esta ley ha sido interpretada a proteger solamente a las mujeres que están embarazadas pero que no necesitan modificaciones en su trabajo para continuar, o mujeres embarazadas que ya no pueden seguir trabajando y que necesitan baja por maternidad.

Defensores Nacionales para Mujeres Embarazadas tiene una guía a las leyes que afectan la discriminación contra las mujeres embarazadas en el trabajo en la red  un buen punto de partida para comprender las protecciones que ya existen y los huecos en las leyes actuales, como el Acta de Americanos con Descapacidades y el Acta de Baja Médica y de Familia (“ADA” y “FMLA” en sus siglas ingleses”.

El Centro Nacional de Ley de Mujeres (National Women’s Law Center) está promoviendo la aprobación de la ley, y tiene varias entradas útiles en su blog para profundizar conocimiento sobre el tema. Entradas excelentes incluyen “It Shouldn’t Be A Heavy Lift: Pregnant Workers Fairness Act Introduced in Senate,” y “The Pregnant Workers Fairness Act: What It Means for Low-Wage Working Women.”


July 3, 2012

Reactions to the Supreme Court’s Affordable Care Act Decision

Last Thursday, the Supreme Court ruled to largely uphold the Patient Protection and Affordable Care Act, or health care reform. The Act should help women access a number of preventive services and help them access healthcare more easily.

The National Latina Institute for Reproductive Health issued a press release, Supreme Court decision means health care access for Latinas, calling the decision “a significant victory for Latinas, who are more likely than other groups to face structural barriers that prevent them from accessing health care and preventive services.” They also note, however, that works remains to be done and many immigrants still lack access to essential care.

Physicians for Reproductive Choice and Health’s board chair Douglas Laube released a statement for the organization, writing:

Thanks to today’s ruling, we can move closer to the day when our patients won’t go without basic medical care because they can’t pay for it. The Affordable Care Act has already begun to change health insurance in the United States for the better, doing away with pre-existing conditions, gender-rating (making insurance more expensive for women than men), and other practices that have hurt women’s health.

The Planned Parenthood Federation of America calls the decision a victory, and lists several benefits for women:

• More than 45 million women have already received coverage for preventive health screenings at no cost since August 2010 thanks to the Affordable Care Act – including mammograms and Pap tests – and millions more will be able to get free screenings in the coming years.
• 3.1 million young adults have already been able to stay on their parents’ insurance because of the Affordable Care Act. In the next year, millions more who would have otherwise lost coverage will continue to be insured under their parents’ plan.
• Women are guaranteed direct access to ob/gyn providers without a referral, as a result of the Affordable Care Act.
• Starting in August, birth control will be treated like any other preventive prescription under the Affordable Care Act, and will be available without co-pays or deductibles.

The National Women’s Health Network called the decision “historic and thrilling,” and is currently running a “Countdown to Coverage” campaign to highlight ways the Act will benefit women’s health.

At RH Reality Check, Jodi Jacobson writes of some women’s group’s reactions to the Supreme Court Decision. Amanda Marcotte, also at RH Reality Check, has some questions for opponents of the Affordable Care Act. Also there, an author from MADRE writes about the international and human rights context for the decision.

Raising Women’s Voices has a ton of coverage and links, including information on what women can expect out of health care reform.