Companion Drug to RU-486 Could Be Dangerous If Not Taken Properly

Alexa Stanard

Researchers in Michigan say misoprostol, the drug most commonly used with RU-486 to induce an abortion, may have dangerous consequences if taken vaginally but is completely safe when taken orally.

Misoprostol, a companion drug to RU-486 that is used during medication abortions, is safe when taken orally but could reduce the body’s immune response when used vaginally, according to a study released Monday by researchers at the University of Michigan.

Vaginal use of the drug may be responsible for the deaths by rare infection of eight women since 2000, the study’s authors said.

Misoprostol is approved by the U.S. Food and Drug Administration to be taken orally along with RU-486 to end an early-term pregnancy. RU-486 stops the pregnancy, while misoprostol allows the uterus to contract and the cervix to dilate so that a woman will expel the embryo. More than a half-million women in the United States have used the two drugs safely since the FDA approved the method in 2000.

But many women have used the drug vaginally, a delivery method the FDA has not evaluated.

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Misoprostol is a synthetic version of a natural prostaglandin called E2. Prostaglandins are compounds that regulate the body’s immune response, and E2 can be a potent suppressor of that response, said Dr. David Aronoff, an infectious disease specialist who led the study.

His immunology lab began its study after the U.S. Centers for Disease Control reported in 2005 on four of the deaths, all of healthy women who died after medication abortions. Another had died as well.

"What struck me in those five cases is the women had previously been healthy, then died after taking fairly high doses of synthetic prostaglandin E2, which is misoprostol," Aranoff said.

"Vaginal application seems to be more effective, and women tolerate it better. It became quite popular," he added. "But in Europe they don’t use misoprostol vaginally, and no deaths had been reported there. We wondered if maybe high concentrations of this stable prostaglandin in the vaginal tract might lower a women’s ability to fight bacterial infections."

In animal and cell culture studies, the researchers found that when used vaginally, misoprostol can allow Clostridium sordellii, a normally non-threatening bacterium, to flourish and cause deadly infection. When absorbed through the stomach, however, the drug did not compromise immune defenses or cause illness.

Women rarely harbor the infection vaginally in the first place, Aranoff said, indicating an additional risk factor must exist in order for the infection to occur.

"It needs to be emphasized that the termination of pregnancy with these is drugs very safe," he said. "What our research does is maybe make a safe procedure even safer. These infections are very rare."

When taken orally, misoprostol gets absorbed into the bloodstream and distributed throughout the body. Vaginal use forces the drug to be absorbed initially in the soft tissue, leading to high concentration in one area before the subsequent absorption into the bloodstream.

Misoprostol is occasionally used as an immunosuppressant for organ transplant patients and most commonly as prevention against stomach ulcers by those taking high doses of aspirinlike compounds.

"Those patients show no immunosuppressant problems," Aranoff said. "That further substantiates how safe this drug is when taken by mouth."

In 2006 Planned Parenthood, the nation’s largest provider of abortions, stopped offering misoprostol vaginally as a precaution. The study supports that decision, Aranoff said.

It appears online ahead of print in the Journal of Immunology.

Roundups Sexual Health

This Year in Sex: It’s Time to Take Action

Martha Kempner

We have the tools to work against sexually transmitted infections, harmful "conversion therapy" for LGBTQ teens, and sexual assault on college campuses. Now, we just have to use them.

This Year in Sex takes a look back at the news and research related to sexual behavior, sexuality education, contraception, sexually transmitted infections, and other topics that captured our attention in 2015.

STIs Are on the Rise in Every Group

This year, it seemed like every week there was a new headline about a rise in sexually transmitted infections or diseases among a specific group, in a certain geographic area, or even among the general population. When states released their 2014 STI data, we learned that Minnesota’s rates hit a record high and that the rate of gonorrhea nearly doubled in Montana between 2013 and 2014. Counties across the country reported rising rates of chlamydia, gonorrhea, and syphilis. California’s Humboldt County, for example, noted a tenfold increase in gonorrhea since 2010, and Clark County, Nevada—home of Las Vegas—reported a 50 percent increase from 2014 in the number of cases of primary and secondary syphilis.

In fact, many of the headlines this year involved syphilis—a curable disease that the United States was once close to eliminating because rates were so low has continued its resurgence. A Department of Defense report, for example, points to a 41 percent increase in the rate of this disease among men in the military. Another disturbing report showed a dramatic rise in the number of babies born with syphilis; congenital syphilis can cause miscarriage, stillbirth, severe illness in the infant, and even early infant death. This reflects both an increase in cases of the disease among women and a lack of prenatal testing that could catch and treat syphilis during pregnancy. This year, there was also an outbreak of ocular syphilis on the West Coast that led to blindness in at least one patient.

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While syphilis is on the rise in both men and women, 90 percent of cases are in men, 83 percent of which are those who have sex with men in cases where the gender of the partner is known.

Young people are also disproportionately impacted by STIs, specifically chlamydia and gonorrhea—54 percent of the cases of gonorrhea and 66 percent of cases of chlamydia reported to the CDC occurred in those younger than 25. Though if detected early and treated, those STIs can be cured, they can also cause future health problems, including infertility.

Perhaps the ultimate headline about STIs this year, however, was the one in which we learned that almost everyone has herpes. A report by the World Health Organization estimated that 3.7 billion people worldwide—or about two out of every three adults across the globe—are infected with herpes simplex virus 1.

All of this news should remind us that sexually transmitted diseases and infections are a public health crisis and we have to up a fight. We need to prevent the spread by educating young people and adults and making condoms readily available. We need to invest in testing that can help people detect STIs before they face many potential health consequences and prevent them from spreading further. And, we need, of course, to provide access to treatment and combat stigma-based fear.

We Know How to Prevent HIV (Now We Just Have to Keep Doing It)

There was a lot of good news this year when it comes to preventing HIV, much of which focused on how well pre-exposure prophylaxis (PrEP) can work. PrEP is a combination of two antiretroviral drugs—tenofovir and emtricitabine—used to treat people who have HIV. When taken daily by people who are HIV-negative, these drugs have been shown to prevent transmission of the virus. In fact, a study by Kaiser Permanente found that since the approval of PrEP in 2012, none of the patients who were using it became infected with HIV. This was actually better than the researchers expected given the findings in clinical trials.

Incorporating PrEP into a multifaceted HIV-prevention program can work, and San Francisco—once a hotbed of the national HIV and AIDS epidemic—proved that, with just 302 new HIV diagnoses in 2014. Getting those HIV-negative residents who are at high risk of contracting the virus onto PrEP is one of the strategies the city uses. In addition, the city provides rapid treatment for the newly diagnosed and continued follow-up appointments to make sure that patients stay on their treatment plan. This can not only help them stay healthy but can prevent the further spread of the virus, as people who adhere to an antiretroviral drug protocol can suppress the virus to the point that they cannot transmit it to others. In San Francisco, 82 percent of residents with HIV are in care and 72 percent are suppressed. This is significantly higher than national statistics, which show that 39 percent of those with HIV are in treatment and only 30 are taking their drug regimen regularly enough to be considered suppressed.

While it will be difficult for many places to adopt a system as expensive as the one in San Francisco, its success shows us that we have the tools we need to prevent HIV. And, in fact, diagnoses of HIV are down in the United States by 19 percent, though the success was not evenly spread: some groups, such as Latino and Black men who have sex with men, are actually seeing increases. It’s time to renew our investment in ending this epidemic for everyone.

Vaccines (Including the HPV Vaccine) Are Not Dangerous, But Skipping Them Is

The year started with a massive outbreak of the measles on the West Coast, so it’s not surprising that there was a lot of conversation about the value of inoculations and what happens when too many people in a certain area are not vaccinated. In the midst of the epidemic and the debate, some schools asked unvaccinated children to stay home, and some states tried to close loopholes that make it easy for parents to opt of required vaccines because of “personal beliefs.”

Unfortunately, many of these personal beliefs are based on false reports and misinformation suggesting that certain vaccines cause autism. A study of anti-vaccine websites found that this misinformation is abundant on the Internet. Of 480 sites dedicated to the anti-vaccine movement, about 65 percent claimed that vaccines are dangerous, about 62 percent claimed vaccines cause autism, and roughly 40 percent claimed vaccines caused “brain injury.” Many of these facts lacked citations, but some were based on misinterpretation of legitimate research.

The scientific truth is that vaccines are safe and have no connection to autism. If there was any doubt, yet another study was released this year confirming it. In fact, the only study that has ever found a connection was proven to be falsified by an unethical researcher who stood to make a profit.

Of course, that didn’t stop the field of Republican presidential hopefuls—which includes two medical doctors—from trying to score political points by suggesting the government may “push” “unnecessary” vaccines.

Though not mentioned by name, they may have been referring to the HPV vaccine, which has always been controversial because of its connection to sex. There seems to be a sense that because HPV is sexually transmitted, vaccinating against it is less important or will give teens permission to have sex. Numerous studies have shown this to be false. One study published this year even found that girls who have gotten the HPV vaccine take fewer sexual risks.

But the fear and misinformation continues, and it turns out doctors might not be helping matters. One study showed doctors may be discouraging the HPV vaccine by not strongly recommending it, not doing so in a timely manner (the CDC advises that vaccinations should start at age 11), and only suggesting it to young people they perceive to be at risk. This could be part of why HPV vaccination rates still lag behind those of other recommended vaccines.

We need to remember that this vaccine prevents cancer. The newest protects against nine strains of the virus and has the potential to prevent 90 percent of cervical, vulvar, vaginal, and anal cancer. And there is reason to believe it will also prevent oral cancer. That’s five cancers prevented by one series of shots.

Of course, like the others, it can only work if our children obtain it. Hopefully, it will not take another outbreak of a preventable disease like measles for us to realize how lucky we are to live in an age in which we know how to stop so many of the diseases that disabled and killed generations before us.

Government Weighs in on ‘Conversion Therapy’

This year saw many positive developments in the struggle for LGBTQ rights, one of which was a willingness of both the White House and many senators to come out against “conversion therapy” for young people. Sometimes called reparative therapy, this is the practice of trying to change a person’s sexual orientation or “cure” their homosexuality. While no legitimate medical organizations sanction such a practice, some young people are subjected to it because their parents or their religion disapprove of same-sex relationships.

Conversion therapy can include anything from Bible study to forced heterosexual dating to aversion therapy, in which patients are shown homosexual erotica and shocked every time they display arousal. Research has found not only that it does not work to change an individual’s sexual orientation, but that it can be harmful and lead to depression, shame, and suicidal thoughts.

In April, the White House released a report condemning the practice for teenagers and asking states to ban it for minors. In an accompanying letter President Obama wrote: “Tonight, somewhere in America, a young person, let’s say a young man, will struggle to fall to sleep, wrestling alone with a secret he’s held as long as he can remember. Soon, perhaps, he will decide it’s time to let that secret out. What happens next depends on him, his family, as well as his friends and his teachers and his community. But it also depends on us—on the kind of society we engender, the kind of future we build.” Two Democratic legislators echoed this sentiment when they offered a resolution asking the Senate to condemn the practice as well, and a report from the Substance Abuse and Mental Health Services Administration attempted to offer parents alternatives that can support LGBTQ young people.

This year Oregon joined those states—including New Jersey, California, and the District of Columbia—that do ban the practice. Furthermore, a challenge to New Jersey’s ban failed when the U.S. Supreme Court turned the case away.

Doing away with harmful practices is a step in the right direction for LGBTQ adolescents, but there is still much more to do in order to protect and educate all of our young people.

We All Continued Talking About Consent

The problem of sexual assault on college campuses was pervasive in the news in 2015. At the end of last year, California became the first state to pass a law mandating affirmative consent on college campuses, also known as “yes means yes.” This year, New York joined it, and other states are considering doing the same.

Affirmative consent has its critics, who say that the standard is unclear and unrealistic in real-life settings. A poll by the Kaiser Family Foundation found that most college students (83 percent) had heard of affirmative consent and many (69 percent) felt it was very or at least somewhat realistic. But when asked whether different scenarios met the standard, students showed a variety of opinions, proving that putting the standard into practice might be tricky.

Still, I believe the conversations about affirmative consent have been useful. They have given us a platform to talk more about the role of alcohol in sexual behavior and sexual assault, and what happens when one is not passed out but clearly very drunk—and therefore incapable of giving consent. We’ve made college students more clearly establish their own boundaries. And educators have been able to both reiterate and go beyond the “no means no” message to talk about what good, consensual sex might look like.

Affirmative consent is not the end-all solution to sexual assault—it won’t, for example, prevent some perpetrators intent on raping. But if we talk about it enough and start before college—California, for example, mandated affirmative consent message in high school—we might have a generation who can think critically about their own behavior and the behavior of others, a generation that is prepared for healthy sexual relationships and knows that, at the bare minimum, a sexual encounter must include consent.

Investigations Sexual Health

The Right’s Answer to Gutting Planned Parenthood? Elementary Schools, Homeless Shelters, Jails

Sharona Coutts, Zoe Greenberg & Brie Shea

Most people would consider it unusual to pick a corrections facility if they were in the market for a breast exam. But that’s exactly what is suggested by a new website launched last month by 17 of the nation’s most prominent anti-choice groups.

The receptionist at the clinic at Washington D.C.’s Correctional Treatment Facility seemed baffled to receive a call last week from a reporter asking whether she could schedule a breast exam at the facility.

“This is a jail,” the receptionist said. The reporter asked whether people from the community could nonetheless make appointments at the facility for a breast exam, a Pap smear, or a test for sexually transmitted infections. “Ma’am, this is a jail,” she said again, before suggesting that the reporter contact doctors’ offices nearby.

Indeed, most people would consider it unusual to pick a corrections facility if they were in the market for a breast exam. But that’s exactly what is suggested by a new website launched last month by some of the nation’s most prominent anti-choice groups.

The site, GetYourCare.org, is registered to the Alliance Defense Fund, a deep-pocketed fundamentalist Christian group based in Phoenix, Arizona, now known as the Alliance Defending Freedom. Other sponsors of the site include Concerned Women for America, the Susan B. Anthony List and the Family Research Council. Together, these groups have played leading roles in either promoting or bankrolling some of the most significant anti-choice, anti-LGBTQ campaigns and lawsuits of the last few years.

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The new site was launched on September 28, the day before Cecile Richards, president of Planned Parenthood Federation of America, testified before Congress about the discredited claims that her organization profits from fetal tissue donation. The claims were made in a series of surreptitiously recorded and deceptively edited videos. Though they were the focus of a media frenzy over the summer, no evidence has been found to substantiate them, despite multiple hearings and both state and federal investigations.

Planned Parenthood serves an estimated 2.7 million people throughout the United States per year, many of them students, parents, and low-income individuals reliant on Medicaid for health care. GetYourCare.org is a not-so-subtle effort by anti-choice groups to double down on their repeated claims in Congress and the media that women’s health care would be largely unaffected if federal and state governments stripped Planned Parenthood of public funding. The site features a green map of the United States, covered in a spray of thousands of yellow dots, each of which is supposed to represent a health-care facility that could ostensibly fill the vacuum left by Planned Parenthood’s absence. The site says it draws its information “primarily from two separate lists: Federally Qualified Health Centers (FQHC) and Rural Health Centers (RHC).”

“GetYourCare.org was created to show that women have real choices when it comes to health care,” the site says. “All across America, thousands of low-cost health centers offer women and their families high-quality health care.”

A press release from the Alliance Defending Freedom claimed that the facilities listed on the map “typically offer the full range of women’s health services without all the scandal of Planned Parenthood.”

But in an investigation into the facilities, Rewire has found that these “real choices” include hundreds of elementary, middle, and high schools; clinics that provide care for homeless people; nursing homes; pediatrics centers; and even the D.C. jail. Rewire called and emailed hundreds of the facilities listed on the map, and discovered that many of their spokespeople were bewildered by the notion that women would be directed to their facilities for reproductive health services.

School officials, in particular, were confused that they would be asked to provide reproductive and sexual health services to the general population. The GetYourCare site explains that there are over 600 schools listed because they “have been identified as providing girls’ and women’s health care services at ‘school-based health centers’ on location. Thus, the school serves as a very real option for girls and young women in the area who need healthcare.”

In fact, virtually none of the 60 schools Rewire contacted from the list said they provide health care to girls and women in the community.

That includes Wearwood Elementary School, which sits nestled at the foot of the Great Smoky Mountains in Wears Valley, Tennessee. Wearwood, which teaches students from kindergarten through eighth grade, is part of a rural farming community—and not the first place you might think to go for an STI screening.

Instead, the clinic is like many other elementary school nurse’s offices, where a full-time school nurse provides limited care to the 190 students in attendance.

The nurse primarily tends to the school’s one diabetic student, the principal, Jon Manning, told Rewire in a phone interview. She can also treat scrapes, fevers, and headaches, although the district has a telemedicine program for more serious ailments.

Principal Manning described the school as “remote;” the nearest commercial district is nine miles away in Pigeon Forge, Tennessee. If women need to make an appointment for a breast exam or a birth control prescription, Wearwood Elementary is certainly not the place to go.

“We just don’t have the equipment or the staff,” Principal Manning said, when asked if women from the community could make check-up appointments there.  “What we have to offer really wouldn’t be feasible. One thing is, normally, we don’t allow strangers in during the school day for security reasons.”

Of the 60 elementary, middle, and high schools Rewire contacted across six different states, only two said they provided health services to women in the community. Both were based in Sneedville, Tennessee, and are funded by the East Tennessee State University’s college of nursing, according to a receptionist at the clinic. She said the school-based clinics provide care to students during school hours, but are open to the general public after hours and on weekends. They do provide Pap smears, breast exams and STI screenings, and they accept Medicaid patients, she said.

But many respondents at the schools were mystified by the question of providing sexual and reproductive health care.

“You called an elementary school,” a receptionist at the Heritage Hill School in Springdale, Ohio, said.

“To women?” asked a receptionist at the Delhi Charter School in Delhi, Louisiana. “No ma’am, we just do the children here that go to this school.”

“We don’t have a school-based clinic and we never have,” the receptionist at the Abiquiu Elementary School in Abiquiu, New Mexico, told Rewire.

Other types of centers explained that they did not provide services to the general population.

Rewire attempted to contact more than 20 clinics that provide health care for homeless people listed on the map. Many facilities that we contacted did not return calls or emails seeking information about the care they offered. Of those that did answer calls, several said that they did provide some type of primary health care, but in some cases those services were available only to people who met their criteria for homelessness. For a facility in El Paso, Texas, that meant providing a referral letter from a homeless shelter. For the Jessie Trice Community Health Center in Miami, Florida, a receptionist said that treatment consisted mainly of primary care for residential drug treatment patients, and not for the general public.

Similarly, the pediatrics centers we contacted were puzzled by the notion that they could offer comprehensive reproductive and sexual health services to women and girls. For instance, the receptionist at the pediatrics clinic on Marco Island in Florida—the only facility listed by the map in the area of Marco Island—confirmed that they could see girls for general pediatric complaints, but for anything involving reproductive or sexual health issues, they would need to refer patients out. She told us that the closest facility was in Naples, some 30 miles away.

It should come as no surprise that so many of these facilities do not offer comprehensive sexual and reproductive care. The official government document that explains what is included in the list that the anti-choice groups used to populate the map does not specifically mention sexual or reproductive care. Rather, it enumerates some more general forms of care—such as physician services, “other ambulatory services,” and some screening treatments—that could potentially encompass sexual and reproductive care. But the list also explicitly includes services that seem to be unrelated, such as nursing home care and diabetes self-management.

When informed of our findings, the Alliance Defending Freedom was unperturbed.

GetYourCare.org includes clinics serving different populations and demonstrates that Planned Parenthood is very rarely the only option even for the very limited services Planned Parenthood actually provides,” wrote spokesman Bob Trent in an email. “Even if Planned Parenthood were to stop providing these services, it would hardly be a blip.”

The notion that shuttering Planned Parenthood could be done without affecting access to care for those patients has been widely rejected by academics, experts, and the nonpartisan Congressional Budget Office, which concluded that 15 percent of current patients would immediately “face reduced access to care” should Planned Parenthood cease providing family planning services. That conclusion focused on “services that help women avert pregnancies,” and not the many other services, such as cancer screenings and STI testing, that Planned Parenthood provides. The CBO also concluded that the move would result in more births, and therefore greater costs to Medicaid.

But that hasn’t stopped prominent anti-choice politicians and groups from sticking to the claim.

Louisiana Gov. Bobby Jindal, who is running for the Republican presidential nomination, made that argument in court filings over his state’s efforts to strip Planned Parenthood of state reimbursements for services it provides to some 5,200 patients. When the federal judge hearing the case questioned why Jindal and his lawyers had included dentists and ophthalmologists in their list of facilities that could pick up the slack, Jindal’s administration had to back down and acknowledge that a dentist’s office is probably not the right place to go if you’re in need of a Pap smear or other reproductive health service.

The groups backing GetYourCare.org are no small-bit players. The Alliance Defending Freedom is a key architect behind legal strategies to frame anti-LGBTQ laws as protections for religious liberty. It had $35.5 million in assets, according to its 2014 public tax filings. The Family Research Council has been designated as a hate group by the Southern Poverty Law Center for its homophobic vitriol. It reported assets of more than $4 million and revenue of $13.7 million in the fiscal year ending in 2014. Concerned Women for America and the Susan B. Anthony List both clock in with around $4 million in revenue according to their most recent tax filings. Each of these groups actively campaign to end access to safe and legal abortion in the United States, as well as to restrict access to contraception. Another sponsor, Americans United for Life, generates hundreds of the model laws that have been used by state and federal legislators to further the same goal.

Based on efforts to contact hundreds of the roughly 11,000 facilities that appear to be included on the map, Rewire found that many locations did say they could provide the services we requested. Facilities in Arizona and Ohio were more likely than those in Nevada, Oklahoma, northern California, or Oregon to be able to make appointments within the next week. For those other states, wait times were typically until late December or early January. A receptionist at a facility in the northwest quadrant of Washington, D.C., said that since the clinic wasn’t taking any new patients until January, she wasn’t able to schedule appointments at this time. In Kansas and Nevada, receptionists suggested looking to facilities nearby, often more than an hour away, to schedule well-woman visits. Many voicemails and emails simply went without a reply.

Insurance coverage was also patchy. Some facilities said they accepted Medicaid and others said they charged on a sliding scale, depending on ability to pay. However, other facilities said they did not accept the types of insurance that a reporter cited.

Rewire’s reporting, though not a scientific study, strongly supported the conclusions of numerous experts who found that closing or limiting Planned Parenthood services would have a dramatic impact on women and girls—especially those in low-income communities and communities of color.

Writing in the Health Affairs Blog last month, Sara Rosenbaum, a professor and founding chair of the Department of Health Policy at George Washington University School of Public Health and Health Services, argued that defunding Planned Parenthood would be a disaster for women and girls: “Unable to access the contraceptive care they need, women would be left to pay the price, as more unintended pregnancies and abortions result.”

Rosenbaum, who is also a commissioner on the Medicaid and CHIP (Children’s Health Insurance Program) Payment and Access Commission, concluded:

[A] claim that community health centers readily can absorb the loss of Planned Parenthood clinics amounts to a gross misrepresentation of what even the best community health centers in the country would be able to do were Planned Parenthood to lose over 40 percent of its operating revenues overnight as the result of a ban on federal funding.

Based on Rewire’s reporting, not even the nation’s elementary schools, homeless shelters, and nursing homes could fill that gap.