sexual and reproductive health

May 13, 2023

How a medication abortion, also known as an ‘abortion pill,’ works | CNN

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CNN
—

While legal battles over access to mifepristone, one of two drugs used for medication abortions, play out in court, the drug continues to be available in states which consider abortion legal.

“While many women obtain medication abortion from a clinic or their OB-GYN, others obtain the pills on their own to self-induce or self-manage their abortion,” said Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco.

“A growing body of research indicates that self-managed abortion is safe and effective,” he said.

Mifepristone blocks the hormone progesterone, which is needed for a pregnancy to continue. The drug is approved to end a pregnancy through 10 weeks’ gestation, which is “70 days or less since the first day of the last menstrual period,” according to the FDA.

In a medication abortion, a second drug, misoprostol, is taken within the next 24 to 48 hours. Misoprostol causes the uterus to contract, creating cramping and bleeding. Approved for use in other conditions, such as preventing stomach ulcers, the drug has been available at pharmacies for decades.

Together, the two drugs are commonly known as the “abortion pill,” which is now used in more than half of the abortions in the United States, according to the Guttmacher Institute, a research group that supports abortion rights.

“Some people do this because they cannot access a clinic — particularly in states with legal restrictions on abortion — or because they have a preference for self-care,” said Grossman, who is also the director of Advancing New Standards in Reproductive Health, a research group that evaluates the pros and cons of reproductive health policies and publishes studies on how abortion affects a woman’s health.

What happens during a medication abortion? To find out, CNN spoke with Grossman. The conversation has been edited for clarity.

CNN: What is the difference between a first-trimester medication abortion and a vacuum aspiration in terms of what a woman experiences?

Dr. Daniel Grossman: A vacuum aspiration is most commonly performed under a combination of local anesthetic and oral pain medications or local anesthetic together with intravenous sedation, or what is called conscious sedation.

An injection of local anesthetic is given to the area around the cervix, and the cervix is gently dilated or opened up. Once the cervix is opened, a small straw-like tube is inserted into the uterus, and a gentle vacuum is used to remove the pregnancy tissue. Contrary to what some say, if the procedure is done before nine weeks or so, there’s nothing in the tissue that would be recognizable as a part of an embryo.

The aspiration procedure takes just a couple of minutes; then the person is observed for one to two hours until any sedation has worn off. We also monitor each patient for very rare complications, such as heavy bleeding.

Grossman: A medication abortion is a more prolonged process. After taking the pills, bleeding and cramping can occur over a period of days. Bleeding is typically heaviest when the actual pregnancy is expelled, but that bleeding usually eases within a few hours. On average people continue to have some mild bleeding for about two weeks or so, which is a bit longer than after a vacuum aspiration.

Nausea, vomiting, fever, chills, diarrhea and headache can occur after using the abortion pill, and everyone who has a successful medication abortion usually reports some pain.

In fact, the pain of medication abortion can be quite intense. In the studies that have looked at it, the average maximum level of pain that people report is about a seven to eight out of 10, with 10 being the highest. However, people also say that the pain can be brief, peaking just as the pregnancy is being expelled.

The level of cramping and pain can depend on the length of the pregnancy as well as whether or not someone has given birth before. For example, a medical abortion at six weeks or less gestation typically has less pain and cramping than one performed at nine weeks. People who have given birth generally have less pain.

CNN: What can be done to help with the pain of a medication abortion?

Grossman: There are definitely things that can be used to help with the pain. Research has shown that ibuprofen is better than acetaminophen for treating the pain of medication abortion. We typically advise people to take 600 milligrams every six hours or so as needed.

Some people take tramadol, a narcotic analgesic, or Vicodin, which is a combination of acetaminophen and hydrocodone. Recent research I was involved in found medications like tramadol can be helpful if taken prophylactically before the pain starts.

Another successful regimen that we studied combined ibuprofen with a nausea medicine called metoclopramide that also helped with pain. Other than ibuprofen, these medications require a prescription.

Another study found that a TENS device, which stands for transcutaneous electrical nerve stimulator, helps with the pain of medication abortion. It works through pads put on the abdomen that stimulate the nerves through mild electrical shocks, thus interfering with the pain signals. That’s something people could get without a prescription.

Pain can be an overlooked issue with medication abortion because, quite honestly, as clinicians, we’re not there with patients when they are in their homes going through this. But as we’ve been doing more research on people’s experiences with medication abortion, it’s become quite clear that pain control is really important. I think we need to do a better job of treating the pain and making these options available to patients.

CNN: Are there health conditions that make the use of a medication abortion unwise?

Grossman: Undergoing a medication abortion can be dangerous if the pregnancy is ectopic, meaning the embryo is developing outside of the uterus. It’s rare, happening in about two out of every 100 pregnancies — and it appears to be even rarer among people seeking medication abortion.

People who have undergone previous pelvic, fallopian tube or abdominal surgery are at higher risk of an ectopic pregnancy, as are those with a history of pelvic inflammatory disease. Certain sexually transmitted infections can raise risk, as does smoking, a history of infertility and use of infertility treatments such as in vitro fertilization (IVF).

If a person is on anticoagulant or blood thinning drugs or has a bleeding disorder, a medication abortion is not advised. The long-term use of steroids is another contraindication for using the abortion pill.

Anyone using an intrauterine device, or IUD, must have it removed before taking mifepristone because it may be partially expelled during the process, which can be painful.

People with chronic adrenal failure or who have inherited a rare disorder called porphyria are not good candidates.

CNN: Are there any signs of trouble a woman should watch for after undergoing a medication abortion?

Grossman: It can be common to have a low-grade fever in the first few hours after taking misoprostol, the second drug in a medication abortion. If someone has a low-grade fever — 100.4 degrees to 101 degrees Fahrenheit — that lasts more than four hours, or has a high fever of over 101 degrees Fahrenheit after taking the medications, they do need to be evaluated by a health care provider.

Heavy bleeding, which would be soaking two or more thick full-size pads an hour for two consecutive hours, or a foul-smelling vaginal discharge should be evaluated as well.

One of the warning signs of an ectopic pregnancy is severe pelvic pain, particularly on one side of the abdomen. The pain can also radiate to the back. Another sign is getting dizzy or fainting, which could indicate internal bleeding. These are all very rare complications, but it’s wise to be on the lookout.

We usually recommend that someone having a medication abortion have someone with them during the first 24 hours after taking misoprostol or until the pregnancy has passed. Many people specifically choose to have a medication abortion because they can be surrounded by a partner, family or friends.

Most people know that the abortion is complete because they stop feeling pregnant, and symptoms such as nausea and breast tenderness disappear, usually within a week of passing the pregnancy. A home urine pregnancy test may remain positive even four to five weeks after a successful medication abortion, just because it takes that long for the pregnancy hormone to disappear from the bloodstream.

If someone still feels pregnant, isn’t sure if the pregnancy fully passed or has a positive pregnancy test five weeks after taking mifepristone, they need to be evaluated by a clinician.

People should know that they can ovulate as soon as two weeks after a medication abortion. Most birth control options can be started immediately after a medication abortion.

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May 12, 2023

FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN

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CNN
—

Advisers for the US Food and Drug Administration voted unanimously on Wednesday in support of making the birth-control pill Opill available over-the-counter, saying the benefits outweigh the risks.

Two FDA advisory panels agreed that people would use Opill safely and effectively and said groups such as adolescents and those with limited literacy would be able to take the pill at the same time every day without help from a health care worker.

The advisers were asked to vote on whether people were likely to use the tablet properly so that the benefits would exceed the risks. Seventeen voted yes. Zero voted no or abstained.

Opill manufacturer Perrigo hailed the vote as a “groundbreaking” move for women’s health.

“Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.,” Murray Kessler, Perrigo’s president and CEO, said in a statement. “We are motivated by the millions of people who need easy access to safe and effective contraception.”

The FDA doesn’t have to follow its advisers’ advice, but it often does. It is expected to decide whether to approve the over-the-counter pill this summer.

If it’s approved, this will be the first birth-control pill available over the counter in the United States. Opill is a “mini-pill” that uses only the hormone progestin.

At Wednesday’s meeting, Dr. Margery Gass of the University of Cincinnati College of Medicine thanked the FDA for its consideration of switching Opill to an over-the-counter product.

“I think this represents a landmark in our history of women’s health. Unwanted pregnancies can really derail a woman’s life, and especially an adolescent’s life,” she said.

The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.

Unwanted pregnancies are a public health issue in the US, where almost half of all pregnancies are unintended, and rates are especially high among lower-income women, Black women and those who haven’t completed high school.

In March 2022, 59 members of Congress wrote a letter to FDA Commissioner Dr. Robert Califf about OTC contraception.

“This is a critical issue for reproductive health, rights, and justice. Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system,” the lawmakers wrote.

A recent study showed that it’s become harder for women to access reproductive health care services more broadly – such as routine screenings and birth control – in recent years.

About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.

Increasing reproductive access for women and adolescents was a resounding theme among the FDA advisers.

“We can take this opportunity to increase access, reduce disparities and, most importantly, increase the reproductive autonomy of the women of our nation,” said Dr. Jolie Haun of the James A. Haley Veterans’ Hospital and the University of Utah.

Dr. Karen Murray, deputy director of the FDA’s Office of Nonprescription Drugs, said the agency understands the importance of “increased access to effective contraception” but hinted that the FDA would need more data from the manufacturer.

Some of the advisers and FDA scientists expressed concern that some of Perrigo’s data was unreliable due to overreporting of “improbable dosing.”

Murray said the lack of sufficient information from the study poses challenges for approval.

“It would have been a much easier time for the agency if the applicant had submitted a development program and an actual use study that was very easy to interpret and did not have so many challenges. But that was not what happened for us. And so the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting,” she said. “But I wanted to again emphasize that FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for US women.”

Ultimately, the advisers said, they don’t want further studies of Opill to delay the availability of the product in an over-the-counter setting.

“I just wanted to say that the improbable dosing issue is important, and I don’t think it’s been adequately addressed and certainly leads to some uncertainty in the findings. But despite this, I would not recommend another actual use study this time, and I think we can make a decision on the totality of the evidence,” said Kate Curtis of the US Centers for Disease Control and Prevention.

Curtis said she voted yes because “Opill has the potential to have a huge positive public health impact.”

Earlier in the discussion, Dr. Leslie Walker-Harding of the University of Washington and Seattle Children’s Hospital said the pill is just as safe as many other medications available on store shelves.

“The safety profile is so good that we would need to take every other medicine off the market like Benadryl, ibuprofen, Tylenol, which causes deaths and people can get any amount of that without any oversight. And this is extremely safe, much safer than all three of those medications, and incorrect use still doesn’t appear to have problematic issues,” she said.

Dr. Katalin Roth of the George Washington University School of Medicine and Health Sciences also emphasized the safety of the pill over the 50 years it has been approved as a prescription drug in the US.

“The risks to women of an unintended pregnancy are much greater than any of the things we were discussing as risks of putting this pill out out over-the-counter,” she said. “The history of women’s contraception is a struggle for women’s control over their reproduction, and we need to trust women.”

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April 30, 2023

How to support your loved one during the infertility journey | CNN

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Editor’s Note: Chloe Melas is a reporter for CNN, covering all things entertainment for the network across platforms. After nearly two years of fertility treatments, she and husband Brian Mazza now have two sons. Melas was a recipient of Resolve’s 2020 Hope Award for Advocacy.

CNN
—

“Bobby and Sara are having twins!”

I remember my husband coming into the bathroom where I was taking a bath to tell me about his childhood best friend’s happy news.

We had been trying to get pregnant for several months at that point, and we were going through rounds of intrauterine insemination, better known as IUI.

I wanted to genuinely give a nice response, but I just sank down further in the tub, my eyes welled up with tears. I felt nauseous and angry. I let out a mumble: “Great.” But what I wanted to do was scream, “Why them and not us?!”

I carried around such bitterness and resentment throughout our yearslong struggle to start a family.

As it turns out, we were in the same boat as millions of people all over the world.

Infertility affects about 1 in 6 people, according to a recent report from the World Health Organization previously covered by CNN. Rates of infertility — meaning the inability to conceive after 12 months of having sex without protection — are similar across all countries and regions, according to the WHO report.

During our fertility treatments to get pregnant with our first child, Leo, I kept our fertility treatments a secret from my family and friends. I didn’t want to have to deal with answering any questions or let anyone down if the procedures didn’t result in a baby.

But it was difficult to mask my overwhelming despair. At one point during my first round of in vitro fertilization, or IVF, I finally saw a psychologist. I’m not sure if it had to do with the copious amounts of fertility drugs, the daily injections or the months of failed treatments — but it was a perfect emotional storm. I needed validation that what I was feeling was, in fact, normal.

As it turns out, lots of people feel this way. Receiving a psychiatric diagnosis, most commonly anxiety or depression, is something up to 40% of women affected by infertility face, according to the American Psychiatric Association.

“During the journey, there are often long wait times with appointments or providers. Waiting to get test results, waiting to hear something was effective, waiting for next steps. All that waiting can really put us in a non-ideal mental health space,” psychologist Dr. Heather Tahler told CNN. She is the mental health services lead at women and family telemedicine startup Maven Clinic in New York City.

“I think another big stressor people feel is the societal pressure for family building to look a certain way. We don’t talk enough about all the different paths that people go through to build their family.”

This kind of distress can be severe. Dr. Elizabeth A. Grill, associate professor of psychology at the Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine at Weill Medical College of Cornell University, equates the stress of an infertility diagnosis to that of a terminal illness.

“The research shows that the distress levels of those going through infertility are equal to patients diagnosed with heart disease, cancer and HIV,” Grill said.

Part of my sadness was how isolating it all felt. When my husband and I initially began tracking my ovulation and good old-fashioned sex wasn’t working, I would talk to my girlfriends and certain family members, who would brush my worries aside and tell me the key to getting pregnant was to lower my stress levels. “Just have a glass of wine before sex,” one friend said. “Take a trip,” a relative suggested. They were trying to be helpful, but it was hurtful.

To find out what could be helpful for others, I talked to several people for their advice on what to do and not do when supporting a loved one going through infertility.

Talk less and listen more, advised Grace Bastidas, the editor-in-chief of Parents. She regularly covers the topic of infertility and recently published a piece about how to help people going through infertility.

“If a friend or a relative tells you they’re having a tough time conceiving, try not to minimize it by saying, ‘Just try to relax.’ That’s really not helpful,” Bastidas said.

“It really doesn’t validate how they are feeling in the moment,” she said. “If you don’t know what to say, sometimes just listening and being that ear or that shoulder and letting them know they can count on you is what you can do.”

It sounds awful but for more than a year, I found it very difficult to be happy for anyone becoming pregnant. I’d get invites to baby showers and dread having to go. I’d see pregnant women in the checkout aisle at the grocery store and feel pangs of sadness.

It felt like every woman on the planet was pregnant, except me.

Elizabeth Angell, editor-in-chief of Romper, a website for millennial moms, advises people not to hide your happy news but have grace and understanding for the ones around you who are struggling.

“Events like baby showers and christenings can be minefields for anyone going through infertility. I would take your cues from them,” said Angell, who has a section at Romper dedicated to trying to conceive.

“You should invite your good friends to any such celebration, but don’t be offended if they choose not to come. It doesn’t mean they aren’t happy for you. Give them the space to grieve and reassure them that you’re there for them when they’re ready to talk about it.”

Stepping up for your loved one, whether that means taking them to doctor’s appointments or sending a small gift can go a long way, Grill told me.

“If the person you are trying to support is open to ideas, try to think of what you would do for a friend diagnosed with any other illness,” Grill said. “Call or text to ask how they are doing, bring them dinner, offer to take them to appointments.

“Let them know you love them and are there for them. Learn to listen, support and show trust more than offering advice. Most importantly, validate their experience and learn to sit with them in the discomfort of their pain.”

Angell agreed. “Infertility treatments are often physically taxing. If that’s something your friend is going through, send food or a nice bathrobe or pajamas — something they can use when they’re resting and recuperating.”

Although well intended, “seemingly innocuous questions of curiosity … can trigger feelings of devastation and anxiety for those trying to conceive,” Grill told CNN.

Nora DeBora, who hosts The Ultimate Pregnancy Prep Podcast, has been open about how her desire to start a family hasn’t happened yet.

“As a single woman in my late 30s who deeply desires a family, it can be off-putting and uncomfortable when people ask ‘when are you going to have a baby?’ There is a lot of pressure that women put on themselves already while feeling like their biological clock is ticking with each passing year.”

Some days you might be handing your loved one a tissue, and others they may seem closed off.

“Being present for someone on their journey means meeting them where they are at,” Tahler said. “Some days it could be talking, some days it could be a hug. There are a variety of emotional responses day-to-day. It is best to remind yourself of this, so you don’t take it personally.”

It has been liberating but sometimes incredibly vulnerable ever since my husband and I first began sharing our story in 2018.

CNN's Melas with her husband, Mazza, and their two sons.

Recently, I went on the Pregnantish podcast with host Andrea Syrtash, who told me that the stigma around infertility is still very prevalent. That’s why she is compelled to feature stories of people who go the distance to create their families and how their relationships are impacted.

“‘First comes love, then comes marriage, then comes a baby carriage’ is an outdated narrative for millions of people,” she told me.

“Modern family building and infertility impact every relationship we have. With our partners, friends, family, workplace and most importantly, the relationship we have with our bodies and ourselves.”

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April 26, 2023

Amid contradictory laws, hospitals in one state were unable to explain policies on emergency abortion care, study finds | CNN

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CNN
—

Oklahoma’s laws restricting abortions have created a confusing, contradictory environment that may have a chilling effect on health care, new research says.

After the US Supreme Court overturned the right to an abortion last year with the Dobbs v. Jackson Women’s Health Organization decision, several states quickly passed laws that restricted such procedures. A report released Tuesday and described in the medical journal the Lancet finds that the laws in at least one state left workers at many hospitals confused about how to proceed.

When the court made its decision, the Oklahoma law that criminalized abortion in 1910 went back into effect, according to the state’s attorney general. Lawmakers then created multiple overlapping laws that further criminalized abortion and increased penalties for those who performed or assisted in an abortion procedure, according to the new report from Physicians for Human Rights, Oklahoma Call for Reproductive Justice and the Center for Reproductive Rights.

The Oklahoma laws allow abortion in the case of a medical emergency, but one doesn’t define a medical emergency. Another says it allows for the “preservation of life in a medical emergency,” defined as causing “substantial and irreversible body of bodily impairment” – which is not a medical term, experts say.

To understand exactly how well Oklahoma hospitals understood the laws, the researchers used a “secret shopper method,” study co-author Dr. Michele Heisler said.

Researchers posed as prospective patients and called 34 hospitals to ask about the emergency pregnancy care they offered.

Heisler said that when the researchers designed the study, she expected the hospitals to tell the patients that they could get help in an emergency but that a second provider might have to sign off on an abortion or that a doctor would have to get the decision past an “onerous” hospital oversight committee.

“What we weren’t expecting is that there would be so much confusion and contradictory information and really not clear information,” said Heisler, who is medical director at Physicians for Human Rights and a professor of internal medicine and public health at the University of Michigan.

The researchers said that none of the hospitals they contacted in Oklahoma was totally able to articulate clear, consistent policies for emergency obstetric care to potential patients.

Specifically, 65% – 22 of the 34 hospitals – were unable to provide information about policies, procedures or the support provided to doctors when it is clinically necessary to terminate a pregnancy to save the life of a pregnant patient.

In 14 of the 22 cases, hospital representatives provided unclear and/or incomplete answers about whether doctors require approval to perform a medically necessary abortion.

Three of the hospitals said they do not provide abortions at all, even though it remains legal in the case of a medical emergency or to “preserve the life” of the pregnant person. Four others provided information that was factually wrong, the report says.

Four hospitals said they had formal approval processes that clinicians must go through if they have a situation in which it is medically necessary to terminate a pregnancy; they cannot make that decision on their own.

Three hospitals indicated that they have policies for these situations but refused to share any information about them.

“Unfortunately, it is being just left up to individual health systems and clinicians to try to make sense of these laws and provide guidance and support,” Heisler said.

The Oklahoma Hospital Association said it has been in conversations with Oklahoma’s medical licensure boards to seek clarity about the state’s conflicting abortion laws.

The association sent guidance to its members in September to explain what it interpreted as “saving the life of a pregnant woman” and what the laws would mean for a person made pregnant through rape or incest, among other issues. The guidance explains that the state’s criminal laws do not make an exception for these circumstances unless it is to save the life of someone who is pregnant in a medical emergency.

The guidance also warns that a person convicted of “administering, prescribing, advising, or procuring a woman to take any medicine drug or substance, or a person convicted of using or employing any instruction or ‘other means whatever,’ with the intent to procure an abortion, shall be guilty of a felony punishable by two (2) to (5) years imprisonment. From August 27, 2022, forward, a person convicted of performing or attempting to perform an abortion shall be guilty of a felony punishable by a fine not to exceed One Hundred Thousand ($100,000.00) and/or imprisonment not to exceed ten (10) years.”

The guidance says the “persons potentially liable” are the provider, not the pregnant person.

Study co-author Rabia Muqaddam, a senior staff attorney at the Center for Reproductive Rights who is working on multiple cases challenging the abortion bans in Oklahoma, called the overlapping laws a “bizarre” situation.

“Aside from the fact that there are so many of them is that they all conflict,” she said. “All of the laws have inconsistent definitions, which is where a lot of the confusion comes from for health care providers. What’s most dangerous for patients is the fact that the definitions of medical emergency and life-preserving abortions is unclear and inconsistent.”

“If I was the hospital general counsel and I was looking at these laws, I have absolutely no idea what my physician could or could not do in any particular circumstance,” she said.

When there is a lack of clarity and when penalties are involved, “what you get is massive chill.”

“Physicians are terrified. They’re terrified that if they make the wrong decision, they’re going to go to jail. They’re going to lose their license. And at the other end of that is that patients are being seriously harmed,” Muqaddam said.

Sonia M. Suter, a professor of law at George Washington University who was not involved in the new research, said recent abortion laws have created “such a mess.”

“You are telling physicians that they have two conflicting obligations,” said Suter, whose scholarship focuses on issues at the intersection of law, medicine and bioethics, with a particular focus on reproductive rights.

There is an obligation to stabilize patients in emergencies that may not always qualify as “life-threatening,” but doctors and hospitals could also risk being sued because the doctors are not following the standard of care, “which you can’t do with how some of these exceptions are worded.”

She said hospitals also don’t know how the laws will be applied. Lawyers typically will instruct institutions to interpret the law as conservatively as possible, and physicians may be equally conservative because they don’t want to risk their licenses or face stiff penalties.

“It’s just devastating for everybody,” Suter said. “It’s just cruel.”

Molly Meegan, general counsel for the American College of Obstetricians and Gynecologists, said state laws to restrict abortion with emergency exceptions are not comprehensive.

“They can’t be applied in a medical situation. They just aren’t practical,” she said. “They have an ethical and personal duty to their patients to do what is best for their patients. It can at times be in direct conflict with whatever the laws are, especially if they’re vague, and most of the ob/gyns throughout the country, including in Oklahoma, are in an impossible situation.”

Meegan and Suter both believe the confusion will lead to the deaths of more women. Those who survive may be left with dire health problems, including losing the ability to have children in the future.

“They already have horrific maternal mortality and infant mortality rates,” Suter said. “It feels like the end of evidence-based medicine.”

According to the US Centers for Disease Control and Prevention, Oklahoma persistently ranks among the states with the worst rates of maternal deaths, even before the new abortion laws went into effect. The state had a maternal mortality rate of 25.2 deaths per 100,000 live births for 2018-20, well above the national average.

For communities of color, the rate is significantly worse, according to the Oklahoma Health Department.

White women had 23.2 maternal deaths per 100,000 live births for 2018-20, the lowest rate overall in Oklahoma. The rates for Black women and Native American women were about twice as high: 49.4 and 44.4, respectively.

Oklahoma is not alone. The 13 states where most abortions are banned generally have some of the highest infant and maternal mortality rates in the country, Heisler said. Even more states could be restricting abortion access soon, the experts believe, with potentially more problems to come.

“The hostile climate many states are creating for the health care field by enacting criminal and other penalties for abortion care is an outcome whose reverberations we are only just beginning to see,” said Kelly Baden, vice president for public policy at the reproductive health nonprofit Guttmacher Institute.

Heisler noted that the researchers don’t blame the hospitals or the doctors for this confusion. Overall, she said, the staffers who talked to the researchers “were wonderful,” despite the circumstances.

“They were empathetic. They said, ‘I completely understand.’ They tried to give answers. They acted in good faith. But really, none of the hospitals were really able to say what we were hoping for, which is to unequivocally state that they would stand behind their clinicians and that clinicians at their facilities would be able to use their best clinical judgment for the individual case and that it would be made as medical decisions should be in collaboration with the patient, taking into account to their needs, their preferences and their values,” she said.

“We are recognizing that hospitals and clinicians are in an untenable situation,” Heisler added.

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April 26, 2023

These women ran an underground abortion network in the 1960s. Here’s what they fear might happen today | CNN

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CNN
—

The voice on the phone in 1966 was gruff and abrupt: “Do you want the Chevy, the Cadillac or the Rolls Royce?”

A Chevy abortion would cost about $200, cash in hand, the voice explained. A Cadillac was around $500, and the Rolls Royce was $1,000.

“You can’t afford more than the Chevy? Fine,” the voice growled. “Go to this address at this time. Don’t be late and don’t forget the cash.” The voice disappeared.

Dorie Barron told CNN she recalls staring blankly at the phone in her hand, startled by the sudden empty tone. Then it hit her: She had just arranged an illegal abortion with the Chicago Mafia.

The motel Barron was sent to was in an unfamiliar part of Chicago, a scary “middle of nowhere,” she said. She was told to go to a specific room, sit on the bed and wait. Suddenly three men and a woman came in the door.

“I was petrified. They spoke all of three sentences to me the entire time: ‘Where’s the money?’ ‘Lie back and do as I tell you.’ And finally ‘Get in the bathroom,’” when the abortion was over, Barron said. “Then all of a sudden they were gone.”

Bleeding profusely, Barron managed to find a cab to take her home. When the bleeding didn’t stop, her bed-ridden mother made her go to the hospital.

At 24, Barron was taking care of her ailing mother and her 2-year-old daughter when she discovered she was pregnant. Her boyfriend, who had no job and lived with his parents, “freaked,” said Barron, who appears in a recent HBO documentary. The boyfriend suggested she get an abortion. She had never considered that option.

“But what was I to do? My mom was taking care of my daughter from her bed while I worked — they would read and play games until I got home,” Barron said.”How was either of us going to cope with a baby?

“Looking back, I realize I was taking my life in my hands,” said Barron, now an 81-year-old grandmother. “To this day it gives me chills. If I had died, what in God’s green earth would have happened to my mom and daughter?”

Women in the 1960s endured restrictions relatively unknown to women today. The so-called “fairer sex” could not serve on juries and often could not get an Ivy League education. Women earned about half as much as a man doing the same job and were seldom promoted.

Women could not get a credit card unless they were married — and then only if their husband co-signed. The same applied to birth control — only the married need apply. More experienced women shared a workaround with the uninitiated: “Go to Woolworth, buy a cheap wedding-type ring and wear it to your doctor’s appointment. And don’t forget to smile.”

Marital rape wasn’t legally considered rape. And, of course, women had no legal right to terminate a pregnancy until four states — Alaska, Hawaii, New York and Washington — legalized abortion in 1970, three years before Roe v. Wade became the law of the land.

Illinois had no such protection, said Heather Booth, a lifelong feminist activist and political strategist: “Three people discussing having an abortion in Chicago in 1965 was a conspiracy to commit felony murder.”

Despite that danger, a courageous band of young women — most in their 20’s, some in college, some married with children — banded together in Chicago to create an underground abortion network. The group was officially created in 1969 as the “Abortion Counseling Service of Women’s Liberation.”

But after running ads in an underground newspaper: “Pregnant? Don’t want to be? Call Jane,” each member of the group answered the phone as “Jane.”

Despite their youth, members of Jane managed to run an illegal abortion service dedicated to each woman's needs.
From left: Martha Scott, Jeanne Galatzer-Levy, Abby Pariser, Sheila Smith and Madeline Schwenk.

“We were co-conspirators with the women who called us,” said 75-year-old Laura Kaplan, who published a book about the service in 1997 entitled “The Story of Jane: The Legendary Underground Feminist Abortion Service.”

“We’ll protect you; we hope you’ll protect us,” Kaplan said. “We’ll take care of you; we hope you’ll take care of us.”

What started as referrals to legitimate abortion providers changed to personalized service when some members of Jane learned to safely do the abortions themselves. Between the late 1960s and 1973, the year that the Supreme Court decided Roe v. Wade, Jane had arranged or performed over 11,000 abortions.

“Our culture is always searching for heroes,” said Kaplan. “But you don’t have to be a hero to do extraordinary things. Jane was just ordinary people working together — and look what we could accomplish, which is amazing, right?”

Even after several members were caught and arrested, the group continued to provide abortions for women too poor to travel to states where abortion had been legalized.

“I prayed a lot. I didn’t want to go to jail,” said 80-year-old Marie Learner, who allowed the Janes to perform abortions at her apartment.

“Some of us had little children. Some were the sole breadwinners in their home,” Learner said. “It was fearlessness in the face of overwhelming odds.”

Marie Learner opened her home to women undergoing abortions. Her neighbors knew, she said, but did not tell police.

The story of Jane has been immortalized in Kaplan’s book, numerous print articles, a 2022 movie, “Call Jane,” starring Elizabeth Banks and Sigourney Weaver, and a documentary on HBO (which, like CNN, is owned by Warner Bros. Discovery).

Today the historical tale of Jane has taken on a new significance. After the 2022 Supreme Court reversal of Roe v. Wade and the mid-term takeover of the US House of Representatives by Republicans, emboldened conservative lawmakers and judges have acted on their anti-abortion beliefs.

Currently more than a dozen states have banned or imposed severe restrictions on abortion. Georgia has banned abortions after six weeks, even though women are typically unaware they are pregnant at that stage. In mid-April, Florida Governor Ron DeSantis signed a bill that would ban most abortions after six weeks. It won’t go into effect until the state Supreme Court overturns its previous precedent on abortion. Several other states are considering similar legislation. In other states, judicial battles are underway to protect abortion access.

“It’s a horrific situation right now. People will be harmed, some may even die,” said Booth, who helped birth the Jane movement while in college.

“Women without family support, without the information they need, may be isolated and either harm themselves looking to end an unwanted pregnancy or will be harmed because they went to an unscrupulous and illegal provider,” said Booth, now 77.

A key difference between the 60s and today is medication abortion, which 54% of people in the United States used to end a pregnancy in 2022. Available via prescription and through the mail, use of the drugs is two-fold: A person takes a first pill, mifepristone, to block the hormone needed for a pregnancy to continue.  A day or two later, the patient takes a second drug, misoprostol, which causes the uterus to contract, creating the cramping and bleeding of labor.

In early April a Texas judge, US District Judge Matthew Kacsmaryk – a Trump appointee who has been vocal about his anti-abortion stance — suspended the US Food and Drug Administration’s approval of mifepristone despite 23 years of data showing the drug is safe to use, safer even than penicillin or Viagra.

On Friday, the Supreme Court froze the ruling and a subsequent decision by the Fifth US Circuit Court of Appeals at the request of the Justice Department and the drug manufacturer. The action allows access to mifepristone in states where it’s legal until appeals play out over the months to come.

However, 15 states currently restrict access to medication abortion, even by mail.

The actions of anti-abortion activists, who have been accused of “judge shopping” to get the decisions they want, is “an unprecedented attack on democracy meant to undermine the will of the vast majority of Americans who want this pill — mifepristone — to remain legal and available,” Heather Booth told CNN.

“This is a further weaponization of the courts to brazenly advance the end goal of banning abortion entirely,” she added.

If women in her day could have had access to medications that could be used safely in their homes, they would not have been forced to risk their lives, said Dorie Barron, thinking back to her own terrifying abortion in a sketchy Chicago motel.

“I’m depressed as hell, watching stupid, indifferent men control and destroy women’s lives all over again,” she said. “I really fear getting an abortion could soon be like 1965.”

Chicago college student Heather Booth had just finished a summer working with civil rights activists in Mississippi when she was asked to help with a different kind of injustice.

Heather Booth, 18, with civil rights heroine Fannie Lou Hamer during

A girl in another dorm was considering suicide because she was pregnant. Booth, who excelled at both organization and chutzpah, found a local doctor and negotiated an abortion for the girl. Word spread quickly.

“There were about 100 women a week calling for help, much more than one person could handle,” Booth said. “I recruited about 12 other people and began training them how to do the counseling.”

Counseling was a key part of the new service. This was a time when people “barely spoke about sex, how women’s bodies functioned or even how people got pregnant,” Booth said. To help each woman understand what was going to happen to them, Booth quizzed the abortion provider about every aspect of the procedure.

“What do you do in advance? Will it be painful? How painful? Can you walk afterwards? Do you need someone to be with you to take you home?” The questions continued: “What amount of bleeding is expected, and can a woman handle it on their own? If there’s a problem is there an urgent number they can call?”

Armed with details few if any physicians provided, the counselors at Jane could fully inform each caller about the abortion experience. The group even published a flyer describing the procedure, long before the groundbreaking 1970 book “Our Bodies, Ourselves” began to educate women about their sexuality and health.

“I don’t particularly like doctors because I always feel dissatisfied with the experience,” said Marie Learner, who spoke to many of the women who underwent an abortion at her home.

“But after their abortion at Jane, women told me, ‘Wow, that was the best experience I’ve ever had with people helping me with a medical issue.’”

Eileen Smith, now 73, was one of those women. “Jane made you feel like you were part of this bigger picture, like we were all in this together,” she said. “They helped me do this illegal thing and then they’re calling to make sure I’m OK? Wow!

“For me, it helped battle the feeling that I was a bad person, that ‘What’s wrong with me? Why did I get pregnant? I should know better’ voice in my head,” said Smith. “It was priceless.”

Like many young women in the 60s, Heather Booth often protested for civil and women's rights.

Many of the women who joined Jane had never experienced an abortion. Some viewed the work as political, a part of the burgeoning feminist movement. Others considered the service as simply humanitarian health care. All saw the work as an opportunity to respect each woman’s choice.

“I was a stay-at-home mom with four kids,” said Martha Scott, who is now in her 80s. “We knew the woman needed to feel as though she was in control of what was happening to her. We were making it happen for her, but it was not about us. It was about her.”

Some volunteers, like Dorie Barron, experienced the Jane difference firsthand when she found herself pregnant a few years after her abortion at the hands of the Mafia.

“It was a 100% total reversal — I had never experienced such kindness,” Barron said. Not only did a Jane hold each woman’s hand and explain every step of the process, “they gave each of us a giant supply of maternity sanitary pads, and a nice big handful of antibiotics,” she said. “And for the next week, I got a phone call every other day to see how I was.”

Barron soon began volunteering for Jane by providing pregnancy testing for women in the back of a church in Chicago’s Hyde Park.

“It wasn’t just abortion,” Barron explained. “We also said, ‘You could consider adoption,’ and gave adoption referrals. And if the woman wanted to continue with her pregnancy, we said, ‘Fine, please by all that is holy make sure you get prenatal care, take your vitamins, and eat as best you can.’ It was women helping women with whatever they needed.”

Most of the women who contacted Jane were unable to support themselves, in unhealthy relationships, or already had children at home, so the service was a way of “helping them get back on track,” said Smith, who, like Barron, had begun working for Jane after her abortion.

“We were telling them ‘This isn’t the end of the world. You can continue to leave your boyfriend or your husband or continue to just take care of those kids you have.’ We were there to help them get through this,” said Smith, who later became a homecare nurse.

From left: Eileen Smith, Diane Stevens and Benita Greenfield were three of the dozens of women who volunteered for Jane.

Diane Stevens says she came to work for Jane after experiencing an abortion in 1968 at the age of 19. She was living in California at the time, which provided “therapeutic abortions” if approved in advance by physicians.

“I’d had a birth control failure, and I was coached by Planned Parenthood on how to do this,” said Stevens, now 74. “I had to see two psychiatrists and one doctor and tell them I was not able to go through with the pregnancy because it would a danger to both my physical and mental health.

“I was admitted to the psychiatric ward, although I didn’t really know that — I thought I was just in a hospital bed. But oh no, ‘I was mentally ill,’ so that’s where they put me,” said Stevens, who later went to nursing school with Smith. “Then they wheeled me off for the abortion. I had general anesthesia, was there for two days, and then I was discharged. Isn’t that crazy?”

Sakinah Ahad Shannon, now 75, was one of the few Black women who volunteered as a counselor at Jane. She joined after accompanying a friend who was charged a mere $50 for her abortion. At that time, Jane’s fee was between $1 and $100, based on what the woman could afford to pay, Shannon said.

“When I walked in, I said, ‘Oh my God, here we go again. It’s a room of White women, archangels who are going to save the world,’” said Shannon, a social worker and member of the Congress of Racial Equality, an interracial group of non-violent activists who pioneered “Freedom Rides” and helped organize the March on Washington in 1963.

What she heard and saw at her friend’s counseling session was so impressive it “changed my life,” Shannon said. She and her family later opened and operated three Chicago abortion clinics for over 25 years, all using the Jane philosophy of communication and respect.

“It was a profoundly amazing experience for me,” she said. “I call the Janes my sisters. The color line didn’t matter. We were all taking the same risk.”

Sakinah Ahad Shannon and her daughters went on to open and run three abortion clinics in Chicago.

It wasn’t long before the women discovered a “doctor” performing abortions for Jane had been lying about his credentials. There was no medical degree — in the HBO documentary, he admitted he had honed his skills by assisting an abortion provider.

The group imploded. A number of members quit in horror and dismay. For the women who stayed, it was an epiphany, said Martha Scott. Like her, several of the Janes had been assisting this fake doctor for years, learning the procedures step by step.

“You’d learn how to insert a speculum, then how to swap out the vagina with an antiseptic, then how to give numbing shots around the cervix and then how to dilate the cervix. You learned and mastered each step before you moved on to the next,” said Laura Kaplan, who chronicled the procedure in her book.

By now, several of the Janes were quite experienced and willing to do the work. Why not perform the abortions themselves?

“Clearly, this was an intense responsibility,” said Judith Acana, a 27-year-old high school teacher who joined Jane in 1970. She started her training by helping “long terms,” women who were four or five months along in the pregnancy.

“Remember, abortion was illegal (in Illinois) so it could take weeks for a woman to find help,” said Arcana, now 80. “Frequently women who wanted an abortion at 8 or 10 weeks wound up being 16 or 18 weeks or more by the time they found Jane.”

The miscarriage could happen quickly, but it rarely did, she said. It usually took anywhere from one to two days.

“Women who had no one to help them would come back when contractions started,” Arcana said. “One of my strongest memories is of a teenage girl who had an appointment to have her miscarriage on my living room floor.”

The group also paid two Janes to live in an apartment and be on call 24/7 to assist women who had no one to help them miscarry at home, said Arcana, a lifelong educator, author and poet. “But many women took care of it on their own, in very amazing and impressive and powerful ways,” she said.

Judith Arcana learned how to do abortions herself and wrote about the Jane experience in poems, stories, essays and books.

Any woman who had concerns or questions while miscarrying alone could always call Jane for advice any time of the day or night.

“People would call in a panic: ‘The bleeding won’t stop,’” Smith recalled. “I would tell them, ‘Get some ice, put it on your stomach, elevate your legs, relax.’ And they would say ‘Oh my gosh, thank you!’ because they were so scared.”

For women who were in their first trimester, Jane offered traditional D&C abortions — the same dilation and curettage used by hospitals then and today, said Scott, who performed many of the abortions for Jane. Later the group used vacuum aspiration, which was over in a mere five to 10 minutes.

“Vacuum aspiration was much easier to do, and I think it’s less difficult for the woman,” Scott said. “Abortion is exactly like any other medical procedure. It’s the decision that’s an issue — the doing is very straightforward. This was something a competent, trained person could do.”

It was May 3, 1972. Judith Arcana was the driver that day, responsible for relocating women waiting at what was called “the front” to a separate apartment or house where the abortions were done, known as “the place.”

On this day, a Wednesday, the “place” was a South Shore high-rise apartment. Arcana was escorting a woman who had completed her abortion when they were stopped by police at the elevator.

“They asked us, ‘Which apartment did you come out of?’ And the poor woman burst into tears and blurted out the apartment number,” Arcana said. “They took me downstairs, put cuffs on me and hooked me to a steel hook inside of the police van.”

Inside the apartment on the 11th floor, Martha Scott said she was setting up the bedroom for the next abortion when she heard a knock at the door, followed by screaming: “You can’t come in!”

“I shut the bedroom door and locked it,” Scott said, then hid the instruments and sat on the bed to wait. It wasn’t long until a cop kicked the door in and made her join the other women in the living room.

“We tell this joke about how the cops came in, saw all these women and said, ‘Where’s the abortionist?’ You know, assuming that it would be a man,” Scott said.

By day’s end, seven members of Jane were behind bars: Martha Scott, Diane Stevens, Judy Arcana, Jeanne Galatzer-Levy, Abby Pariser, Sheila Smith and Madeleine Schwenk. Suddenly what had been an underground effort for years was front page headlines.

“Had we not gotten arrested, I think no one would ever have known about Jane other than the women we served,” Scott said.

Top: Sheila Smith and Martha Scott.
Bottom: Diane Stevens and Judith Arcana.

An emergency meeting of Jane was called. The turnout was massive — even women who had not been active in months showed up, anxious to know the extent of the police probe, according to the women with whom CNN spoke.

Despite widespread fear and worry, the group immediately began making alternate plans for women scheduled for abortions at Jane in the next few days to weeks. The group even paid for transportation to other cities where abortion had already been legalized, they said.

News reports over the next few days gave further details of the bust: There was no widespread investigation by the police. It was a single incident, triggered by a call from a sister-in-law who was upset with her relative’s decision to have an abortion, they said.

“It wasn’t long after I was arrested that I came back and worked for quite a few months,” said Scott, one of the few fully trained to do abortions.

“I like to think I was a good soldier,” Scott said. “I like to think what did made a difference not only to a whole bunch of people, but also to ourselves. It gave us a sense of empowerment that comes when you do something that is hard to do and also right.”

As paranoia eased, women began to come back to work at Jane, determined to carry on.

“After the bust, we had a meeting and were told ‘Everybody needs to start assisting and learn how to do abortions.’ I was like, ‘Whoa, whoa, whoa!’” said Eileen Smith, who had not been arrested. “But you felt like you really didn’t have much of a choice. We had to keep the service running.”

Laura Kaplan volunteered for the Janes, later immortalizing the group in her book,

The preliminary hearing for the arrested seven was in August. Several of the women in the apartment waiting for abortions the day of the arrest suddenly developed amnesia and refused to testify. According to Kaplan’s book, one of the women later said, “The cops tried to push me around, but f**k them. I wasn’t going to tell on you.”

It didn’t matter. Each Jane was charged with 11 counts of abortion and conspiracy to commit abortion, with a possible sentence of up to 110 years in prison.

As they waited for trial, the lawyer for the seven, Jo-Anne Wolfson, adopted delaying tactics, Kaplan said. A case representing a Texas woman, cited as “Jane Roe” to protect her privacy, was being considered by the US Supreme Court. If the Court ruled in Roe’s favor, the case against the Jane’s might be thrown out.

That’s exactly what happened. On March 9, 1973, three months after the Supreme Court had legalized abortion in the US, the case against the seven women was dropped and their arrest records were expunged.

Later that spring, a majority of Janes, burned out by the intensity of the work over the last few years, voted to close shop. An end of Jane party was held on May 20. According to Kaplan’s book, the invitation read:

“You are cordially invited to attend The First, Last and Only Curette Caper; the Grand Finale of the Abortion Counseling Service. RSVP: Call Jane.”

Today, most of the surviving members of Jane are in their 70s and 80s, shocked but somehow not surprised by the actions of abortion opponents.

“This is a country of ill-educated politicos who know nothing about women’s bodies, nor do they care,” said Dorie Barron. “It will take generations to even begin to undo the devastating harm to women’s rights.”

In the meantime, women should research all available options, keep that information confidential, seek support from groups working for abortion rights, and “share your education with as many women as you can,” Barron added.

As more and more reproductive freedoms have been rolled back over the past year, many of the Janes are angry and fearful for the future.

Abortion rights demonstrators walk across the Brooklyn Bridge in New York nearly two weeks after the leak of a draft Supreme Court opinion that would overturn Roe v. Wade.

“This is about the most intimate decision of our lives — when, whether and with whom we have a child. Everyone should have the ability to make decisions about our own lives, bodies, and futures without political interference,” said Heather Booth, who has spent her life after leaving Jane fighting for civil and women’s rights.

“We need to organize, raise our voices and our votes, and overturn this attack on our freedom and our lives. I have seen that when we take action and organize we can change the world.”

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April 16, 2023

Texas abortion drug ruling could create ‘slippery slope’ for FDA approvals, drug research and patients, experts say | CNN

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CNN
—

What happened in one judge’s courtroom in Texas could have drastic effects for the United States’ entire drug approval process, experts warn.

US District Judge Matthew Kacsmaryk’s ruling that suspended the US Food and Drug Administration’s approval of the medication abortion drug mifepristone was an unprecedented one, the first time a court has bypassed the federal system set up to determine what drugs should be allowed on the market.

Regardless of whether the ruling – or a part of it – is ultimately allowed to stand, legal scholars, scientists and drugmakers are concerned that the decision could start a trend of drugs being targeted in courts, creating a chilling effect on drug development in the US and hurting patients in the process.

Vaccines, including the Covid-19 shots, antidepressants and psychotropic medicines could be at risk, some said.

“Well, one does not want to be Chicken Little,” former FDA Commissioner Dr. Jane Henney said Wednesday, but “I can’t imagine that it wouldn’t have implications for other products.

“The approval process will be at risk, and it’s not just an approval process that patients rely on and providers rely on, it’s one that has been considered the gold standard, really, for the world,” said Henney, who was the head of the FDA when mifepristone was approved.

Since the dawn of the 20th century, the FDA has had the sole authority in the United States to regulate drugs. In 1906, the federal government created the agency to enforce the Pure Food and Drug Act, which was instituted to ensure that medicine, food and cosmetics were safe.

Over the years, that authority became more defined.

After elixir of sulfanilamide, a drug used to treat streptococcal infections, killed 107 people in 1937, Congress created the Food, Drug, and Cosmetic Act. Signed into law in 1938 by President Franklin D. Roosevelt, it required manufacturers to conduct pharmacological studies to prove that their drugs were safe before they could be sold or advertised. In 1962, drug manufacturers were also required to prove to the FDA that their products were effective.

Modern drug approval in the US is a careful and conscientious process. Before any drug goes to market, there are countless hours of research, the work and expertise of multiple scientists, and several layers of oversight for approval.

Until now, the courts have been deferential to the FDA’s process and have never overturned an FDA decision on the grounds that the agency misjudged the science, said William Schultz, a former deputy commissioner at the FDA and former general counsel for the Department of Health and Human Services.

“Any FDA drug approval involves hundreds of judgments by the agency. And if a court feels free just to kind of take a fresh look at each of those, there’s a chance that a court will find one of those FDA judgments wrong,” Schultz said in an online discussion Monday about the impact of the Texas court’s ruling that was hosted by Protect Our Care, an organization that advocates for equitable and affordable health care.

Hundreds of well-known biotech and pharmaceutical company leaders, concerned about the effects of Kacsmaryk’s ruling on other drug approvals, signed an open letter Monday in support of the FDA’s authority “to approve and regulate safe, effective medicines for every American.”

The letter also advocated a reversal of the mifepristone decision from a judge with “no scientific training,” saying it “set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry.”

In a separate statement, the biotech industry group BIO’s interim president and CEO, Rachel King, emphasized the “dangerous precedent” the decision sets.

“The preliminary ruling by a federal judge in Texas is an assault on science and the FDA’s long-standing role as the authority to make decisions on the safety and efficacy of medicines. For a court to invalidate the approval of a drug that was reviewed and approved more than two decades ago is without precedent. As legal scholars have noted, the courts do not have the medical expertise to make these types of scientific determinations,” King said.

The main lobbying group for the pharmaceutical industry, PhRMA, criticized Kacsmaryk’s ruling as undermining the regulatory process.

“PhRMA has serious concerns with any court substituting its opinion for the FDA’s expert approval decision-making,” said James C. Stansel, the association’s executive vice president, general counsel and corporate secretary. Stansel added that such a decision could have a “chilling effect on the research and development ecosystem.”

The pharmacutical sector is a huge part of the American economy. Of the world’s 25 largest phamacutical companies, 10 are based in the US, and most of the others have a large base of operations in the country.

Often, the US market is the first to get access to new drugs, but that could change if lawsuits undermine the regulatory integrity of the FDA process, said Susan Lee, partner in the law firm Goodwin’s Life Sciences group and Life Sciences Regulatory & Compliance practice, who works with companies to get drugs approved by the FDA.

“If there do tend to be more lawsuits like this, I wonder if there might be a little bit of a tendency to not always look at the US as the first market,” Lee said. “Some manufacturers may say ‘we’d rather go to Europe, where we’re not going to be sued on a jurisdiction-by-jurisdiction basis.’ “

Lee also wonders whether manufacturers will abandon efforts to develop drugs that could be considered unappealing to some, such as those that help women’s health or work to prevent HIV.

“I think there are just certain sectors that are already kind of thinking about whether they might also have a target on their back. I’ve definitely heard that discussed,” Lee said.

The groups at the heart of the Texas case have not disclosed any further plans regarding lawsuits over medications, but experts say they are already hearing concern.

“I’ve already been getting questions from lawmakers and other people about ‘could the Covid vaccine be next?’ or other things that may have stigma around it,” said Dr. Kristyn Brandi, an ob/gyn and abortion provider in New Jersey and a spokesperson for the American College of Obstetricians and Gynecologists.

The Covid-19 vaccines have been thoroughly tested and found to be safe and effective, but they’re the subject of conspiracy theories and misunderstanding about how mRNA vaccines were tested. Beliefs that the vaccines were tested on recently harvested aborted fetal cells made some people decidedly anti-vaccine.

Dr. Lynn R. Goldman, professor and dean of the Milken Institute School of Public Health at George Washington University, is also concerned that mRNA vaccines could be targeted soon.

“There might be people who disagree with some of the technologies that are used by vaccine makers, like the mRNA vaccines, but feeling uncomfortable about a technology is not the same thing as identifying that there is risk,” she said in the Protect Our Care conversation.

Members of the LGBTQ+ community may also be vulnerable, experts say, as activists could target puberty blockers or hormones used in gender-affirming therapy.

“I don’t like to do slippery slope, but I’m also very worried about things like gender-affirming care, since there’s already been so many laws about that recently in other states,” Brandi said.

There is political pressure against other vaccines, antidepressants and psychotropic medicines, among others, former FDA Commissioner Margaret Hamburg and former Principal Deputy Commissioner Joshua Sharfstein wrote in an editorial published Thursday in the journal Science.

“If judges begin to dictate the terms of medication access, then others will seek to use ideology and influence to advance their agendas,” they warn.

Goldman said that any legal decision that could undermine the FDA drug approval process would ultimately hurt the doctors who prescribe them and the people who use them.

Doctors don’t have time to vet all the studies used to prove that a drug is safe and effective, so they rely on the FDA for this work, she said. Court interference could confuse this process.

“I think that this is, for doctors, an incredibly serious moment, because up to now, we have been able to trust that an approval by the FDA is a science-based decision and that we can say that if the FDA has approved a drug, that it is safe for us to use,” Goldman said.

A lack of confidence in the drug approval process will ultimately hurt people far beyond the most recent decision, Protect Our Care Chair Leslie Dach says.

“Confidence that the FDA can do its work is essential for clinicians and patients who depend on it in its decision-making for matters of life and death,” Dach said.

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April 16, 2023

When children are told they were born via assisted reproduction can affect outcomes, study finds | CNN

Post By zittrexstore Health biology, brand safety-nsf health issues, brand safety-nsf mature, brand safety-nsf sensitive, children, continents and regions, demographic groups, domestic alerts, domestic-health and science, domestic-international news, Europe, families and children, family members and relatives, fertility and infertility, genetics, health and medical, iab-biological sciences, iab-diseases and conditions, iab-family and relationships, iab-genetics, iab-infertility, iab-medical health, iab-parenting, iab-reproductive health, iab-science, iab-sexual health, international alerts, international-health and science, medical fields and specialties, northern europe, parents and parenting, population and demographics, reproductive technology, science, sexual and reproductive health, society, sperm banks, surrogate motherhood, United Kingdom No Comments

CNN
—

At age 14, Helen wasn’t bothered by the fact she was born via surrogacy.

“My mum is still my mum. My dad is still my dad,” she told UK researchers conducting a study on the mental health and well-being of children born through egg donation, sperm donation and surrogacy. Helen is not her real name.

“I was talking to someone at school and they said they were an accident,” 14-year-old Simon (also not his real name) told the researchers. “I know I was no accident, I was really wanted, and it makes me feel special.”

Parents worried their children may experience difficulties as a result of learning they were conceived by assisted reproduction can stop fretting — the kids are just fine, according to the study published this week after two decades in the making.

“When we began this study more than 20 years ago, there was concern the absence of a biological link between the child and the parents could have a damaging effect on their relationship and on the well-being of the child,” said lead author Susan Golombok, professor emerita of family research and former director of the Centre for Family Research at the University of Cambridge in the UK.

However, at age 20, children born via egg or sperm donation and surrogacy were psychologically well-adjusted, the study found, especially if parents told the children about their birth history before age 7.

“What this research means is that having children in different or new ways doesn’t actually interfere with how families function. Really wanting children seems to trump everything — that’s what really matters,” Golombok said.

Clinical psychologist Mary Riddle, an associate professor of psychology at Pennsylvania State University called the study “important, in that it represents research conducted over a long period of time.”

However, Riddle, who was not involved in the study, said the results aren’t completely applicable to the United States because surrogacy can be practiced differently in the UK in several ways.

Called “tummy mummies” by some of the children, surrogates in the UK may become part of the family, participating in the upbringing of the child they helped bring into the world, according to Golombok’s 2020 book, “We Are Family: The Modern Transformation of Parents and Children.”

“In the UK, intended parents often know their surrogate prior to the surrogate pregnancy whereas in the US, commercial surrogates are often matched through agencies and don’t have prior relationships with the families for whom they carry babies,” Riddle said.

It’s also more common in the UK to use “partial” surrogacy, in which surrogates are impregnated with the sperm of the intended father and are therefore the biological mother of the child, Riddle said.

“Here in the US, gestational surrogacy, where the surrogate mother has no genetic connection to the child she is carrying, is far more common and thought to be potentially less fraught with psychological and legal pitfalls,” she added.

The study, published Wednesday in the journal Developmental Psychology, followed 65 children — 22 born by surrogacy, 17 by egg donation and 26 by sperm donation — from infancy until age 20. Another 52 families who did not use any assistance were also followed. Researchers spoke to the families when the children were 1, 2, 3, 7, 10 and 14.

Young adults who learned about their biological origins before age 7 reported better relationships with their mothers, and their mothers had lower levels of anxiety and depression, the study found.

However, children born through surrogacy had some relationship issues around age 7, “which seemed to be related to their increased understanding of surrogacy at that age,” Golombok said.

“We visited the families when the children were 10, and these difficulties had disappeared,” she said. “Interestingly, the same phenomenon has been found among internationally adopted children. It may have to do with having to confront issues of identity at a younger age than other children.”

Developmentally, children begin to notice and ask questions about pregnancy between the ages of 3 and 4, said clinical psychologist Rebecca Berry, an adjunct faculty member in the department of child and adolescent psychiatry at New York University’s Grossman School of Medicine.

“To satisfy their curiosity they’ll begin to ask questions about babies and where they came from as a way of trying to understand why they are here,” said Berry, who was not involved with the study.

Children as young as 7 will already have a basic understanding of genetics, and can be surprised when they learn they aren’t genetically connected to one or both parents, said Lauri Pasch, a psychology professor at the University of California San Francisco, who specializes in infertility and family building.

“Our current thinking is that it is best for parents to share the story of donor conception with their children at a very early age, so that if I were to ask their child when they are an adult when they learned that they were donor conceived, they would respond that they ‘always knew,’” said Pasch, who was also not involved in the study, via email.

“This allows the child to grow up with the information, as opposed to learning it later in life, when it comes as a surprise or shock and can hurt their trust in their parents and their identity development,” she added.

When it came to maternal anxiety and depression, there were no differences between families formed by surrogacy and egg or sperm donation and families with children born without assisted conception. Nor were they any differences in the mothers’ relationships with their partners at home, the study found.

However, mothers who had babies via donor eggs reported less positive family relationships than mothers who used sperm donation, likely due to insecurities about lack of a genetic connection to their children, Golombok said.

Young adults conceived by sperm donation reported poorer family communication than those conceived by egg donation, the study found. That’s perhaps due to a greater reluctance on the part of fathers to disclose they are not a genetic parent, Golombok said.

Only 42% of parents who had conceived via sperm donor had revealed the child’s birth history by the time their children were age 20, compared to 88% of egg donation parents and 100% of parents who used surrogacy.

When asked, many of the children said they weren’t concerned about how they were conceived.

“A lot of the children said ‘It’s not a big deal. I’ve got more interesting things going on in my life,’ while others said ‘Actually it’s something a bit special about me. I like talking about it,’ Golombok said. “I think it’s really nice to hear from the children themselves and I don’t think any other study has done this.”

Once told, a child needs to revisit the birth history from time to time, so parents should be sure any conversation is an ongoing one, Golombok said.

“There is this idea parents will tell the child and that is it. But you need to keep having these conversations to give the child a chance to ask questions in an age appropriate way as they grow older,” she said.

“Many of the parents in our study use children’s books that were specifically designed for this purpose,” Golombok added. “Then they could bring the child’s own story into the narrative.”

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April 14, 2023

Clinics and doctors brace for more restrictions on women’s health care after court ruling on abortion drug | CNN

Post By zittrexstore Health abortion, Abortion rights, brand safety-nsf health issues, brand safety-nsf mature, brand safety-nsf other, brand safety-nsf sensitive, business, business and industry sectors, clinics and outpatient services, continents and regions, decisions and rulings, demographic groups, domestic alerts, domestic-health and science, domestic-us news, economy and trade, females (demographic group), health and health care (by demographic group), health and medical, Health Care, health care facilities, health care professionals, iab-business and finance, iab-diseases and conditions, iab-healthcare industry, iab-healthy living, iab-industries, iab-law, iab-medical health, iab-non-profit organizations, iab-pharmaceutical drugs, iab-pharmaceutical industry, iab-pregnancy, iab-reproductive health, iab-sexual health, iab-women's health, international alerts, international-health and science, international-us news, law and legal system, maternal and child health, medical fields and specialties, medical treatments and procedures, non-profit and ngo organizations, North America, obstetrics and gynecology, pharmaceutical industry, pharmaceuticals, pharmaceuticals and prescription drugs, physicians and surgeons, Planned Parenthood, population and demographics, pregnancy and childbirth, reproductive health clinics, sexual and reproductive health, societal issues, society, the americas, trial and procedure, United States, womens health No Comments

CNN
—

Less than a year after the US Supreme Court ended legal protection for abortions nationwide, clinics that provide reproductive health care across the United States are bracing for more restrictions on the care they provide to women.

If a judge’s ruling takes effect Friday, it may soon be illegal for doctors to prescribe mifepristone, the first in a two-drug regimen that can help women terminate a pregnancy at home – and that has other uses.

At Northeast Ohio Women’s Center, staffers are calling patients who expected to get medication abortions next week, telling them to change their plans.

“They’re scrambling to change their schedules to get in to see us earlier,” said Dr. David Burkons, the physician who runs the clinics.

About half of abortions in the US use mifepristone, which is sold under the brand name Mifeprex.

Mifeprex blocks the hormone progesterone, which effectively stops a pregnancy from continuing. For an abortion, women take mifepristone first, followed one or two days later by misoprostol, a drug that causes the uterus to contract, cramp and bleed, similar to a heavy period. It empties out the uterus, ending the pregnancy. It can be used up to 10 weeks of pregnancy.

But the uses of mifepristone go beyond abortion.

The drug helps soften and open the cervix, the neck of the uterus, and doctors depend on it to help when women are having a miscarriage and when a pregnancy needs to be terminated quickly if the life of the mother is at stake.

In certain situations, when a pregnancy has become too risky, time is of the essence, says Dr. Alison Edelman, who directs the division of Complex Family Planning at Oregon Health and Sciences University.

“The more expediently that we can have somebody not be pregnant, the better, and mifepristone helps us speed that process up and make it safer for patients,” she said.

Doctors also use mifepristone before procedures in which they need to go into the uterus, such as to remove bleeding polyps. Studies have shown that the drug helps reduce the amount of force needed to open the cervix and reduces the amount of blood loss associated with the procedure.

Studies also show that mifepristone has moderate to strong benefits for inducing labor and treating uterine fibroids and endometriosis, sometimes helping avoid surgery, according to the American Society of Health Systems Pharmacists.

It can be used to prevent bleeding between periods and to control hyperstimulation of the ovaries during in-vitro fertilization, the society said in a statement.

Doctors say they still have other ways to treat those problems, but when considering the needs of individual patients, they will be missing a valuable tool.

“We have our gold standard of what we provide – the safest, most effective regimen – and then if it’s not available, we use the next best one. And that’s what we would be left with,” Edelman said.

Mifepristone has been approved by the US Food and Drug Administration for 23 years, and it has been used by over 5 million women in the United States. FDA data shows that less than 1% of women who take it have significant adverse events. A CNN analysis of FDA data found that mifepristone was even less risky than some other common medications, including Viagra and penicillin.

Medication abortions have become an increasingly important option for women in states that restricted abortion access after the Supreme Court’s ruling last year that ended legal protections for abortions in every state. They are also sometimes the only kind of abortion many women can get in rural areas that have lost abortion providers.

This ease of access has also made the medication regimen a target for abortion opponents.

“They want to see a national ban, and this is in fact what they are going for in this case,” said Kristen Moore, director of the EMAA Project, a nonprofit that is seeking to make it easier to get abortion medications in the US.

What will happen next is far from settled. Appeals have been filed to stop the ruling in Texas from taking hold, and higher courts will have to weigh in.

Even if the court does take mifepristone off the market in the US, doctors say, they will still be able to provide medication abortions using misoprostol alone.

In fact, some abortion providers have been planning on using misoprostol by itself in case mifepristone is isn’t available.

Carafem, which provides telehealth abortion care, has been offering a misoprostol-only regimen since the Covid-19 pandemic began, Chief Operating Officer Melissa Grant says.

“In 2020, we started to use misoprostol alone as an option,” she said. Workers have since been tweaking the regimen and gathering data.

“We now feel confident that, even though we would much prefer to use both, that we can use misoprostol alone effectively and are ready to switch gears to have a higher percentage of our clients or even 100% of our colleagues use that option if necessary,” Grant said.

Still, some providers said it’s not ideal.

The misoprostol-only regimen is slightly less effective than the one that uses both drugs, and it causes more cramping and bleeding, which can mean more complications.

“We’re more likely to see failures and therefore more likely to need surgical intervention after misoprostol alone,” said Dr. Erika Werner, chair of the Department of Obstetrics and Gynecology at Tufts Medical Center.

Still, doctors want women to know that medication abortions and miscarriage care will still be available even if mifepristone isn’t. And they hope that higher courts will intervene to keep this medication on pharmacy shelves.

“The clinicians would have to use these other options instead of choosing based on their own expertise, knowledge and judgment when rendering such care,” Dr. Iffath Hoskins, president of the American Congress of Obstetricians and Gynecologists, said Monday. “Frankly, as a clinician, I do not want to be in that position.”

Correction: This story has been updated to include the correct name of Tufts Medical Center.

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April 13, 2023

Concerned about the courts, some states and universities are stockpiling abortion drugs | CNN

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CNN
—

With an eye on the courts, a growing number of Democratic-led states are stockpiling the pills that can be used for a medication abortion, the most common form of the procedure in the US.

The officials want to be prepared, in case US District Judge Matthew Kacsmaryk’s decision to suspend the US Food and Drug Administration’s approval of mifepristone goes through, so medication abortions would still be available in their states for some period of time. But they’re taking different approaches to the idea.

New York Gov. Kathy Hochul announced Tuesday that her state’s Department of Health would buy 150,000 doses of misoprostol, the other of the two drugs typically used in a medication abortion.

Misoprostol can be used off-label for an abortion, without mifepristone, but patients often have to use more of it. It would not be covered by the court case, and if Kacsmaryk’s decision stands, the New York City’s Health Department tweeted, it will change to using this medication only.

“Medication abortion continues to be available at our Sexual Health Clinics and NYC Health + Hospitals locations. Should mifepristone become unavailable, we will continue to make medication abortion accessible to all in NYC by shifting to a misoprostol-only treatment regimen,” the tweet said.

The state says the 150,000 doses should represent a five-year supply of pills.

“Anti-choice extremists have shown that they are not stopping at overturning Roe, and they are working to entirely dismantle our country’s reproductive health care system, including medication abortion and contraception,” Hochul said. “New York will always be a safe harbor for abortion care, and I am taking action to protect abortion access in our State and continue to lead the nation in defending the right to reproductive autonomy.”

California is also stocking up on misoprostol.

“While California still believes Mifepristone is central to the preferred regimen for medication abortion, the State negotiated and purchased an emergency stockpile of Misoprostol in anticipation of Friday’s ruling by far-right federal judge Matthew Kacsmaryk to ensure that California remains a safe haven for safe, affordable, and accessible reproductive care,” Gov. Gavin Newsom’s office said in a release Monday.

California plans to purchase up to 2 million pills through CalRx, a state initiative set up to make drugs more affordable.

The governor’s office said the state now has more than 250,000 pills on hand, which it purchased for about $100,000.

California said it shared the terms of its purchase agreement with other members of the Reproductive Freedom Alliance, a nonpartisan coalition of 21 governors who are committed to protecting reproductive rights, and who might also be interested in taking such action.

Another member of that alliance, Washington Gov. Jay Inslee, announced last week that his state bought a three year-supply of mifepristone, the drug at the center of Kacsmaryk’s ruling.

Inslee directed the state Department of Corrections – which has a pharmacy license and is legally able to buy medications – to buy the drug last month, he said, and the shipment was delivered March 31. The University of Washington also purchased 10,000 doses.

Lawmakers are introducing a bill to authorize officials to distribute or sell the medication to licensed providers throughout the state.

“This Texas lawsuit is a clear and present danger to patients and providers all across the country. Washington will not sit by idly and risk the devastating consequences of inaction,” Inslee said. “Washington is a pro-choice state, and no Texas judge will order us otherwise.”

In the meantime, its attorney general, Bob Ferguson, is helping lead a multistate lawsuit to protect access to mifepristone.

On Friday, the same day Kacsmaryk’s ruling came down, a federal judge in Washington ordered the US not to make any changes that would restrict access to mifepristone in the territories that brought the lawsuit: 17 states and the District of Columbia.

On Monday, Massachusetts Gov. Maura T. Healey announced that at her request, the University of Massachusetts and health care providers have also taken action to stockpile doses of mifepristone.

The governor’s office said last week that the university bought about 15,000 doses of mifepristone, enough to cover the commonwealth for about a year, and the pills are expected to arrive this week. Local health care providers have agreed to buy more, and the government agreed to set aside $1 million to pay for those doses.

The Massachusetts governor also signed an executive order confirming protections for medication abortion under existing law.

“Here in Massachusetts, we are not going to let one extremist judge in Texas turn back the clock on this proven medication and restrict access to care in our state,” Healey said. “The action we are taking today protects access to mifepristone in Massachusetts and protects patients and providers from liability. In Massachusetts, we stand for civil rights and freedom. We will always protect access to reproductive health care, including medication abortion.”

Danco Laboratories, the manufacturer of the brand-name version of mifepristone, says that orders for the drug have increased substantially in recent months and are significantly higher than they were at this time last year.

Demand for mifepristone is up across all types of customers, including clinics, pharmacies and individual providers, said Abby Long, Danco’s director of public affairs. But Massachusetts is the only state that has requested an especially large number of pills from the company.

Maine Gov. Janet Mills, who called the Texas decision “reckless” and a “fundamental assault on women’s rights,” said Monday that her administration is evaluating its options, “including procuring mifepristone if needed, to protect access to medication abortion for Maine women.”

The Connecticut governor’s office said Wednesday that it is also monitoring the situation.

Oregon Gov. Tina Kotek’s office said in an email Wednesday that she has directed the Oregon Health Authority to “explore all available avenues for ensuring Oregon is prepared should Mifepristone become less available. That includes evaluating the supply of Mifepristone and Misoprostol and consulting with providers to better understand the potential impact on the provision of abortion and reproductive health care and what additional support might be necessary.”

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April 12, 2023

‘It just didn’t enter my mind to initiate sex;’ Low sex drive in men linked to chemical imbalance | CNN

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CNN
—

While hanging out with his college roommates, Peter (not his real name) realized he felt differently about sex than other heterosexual men.

“I’ve never been somebody who was interested in pornography, but I’d laugh along with their jokes,” said Peter, now 44, who is British. “Of course I never mentioned that … as a man, you’d be kicked out of the herd.”

As he developed “proper, serious relationships” with women, Peter discovered he didn’t have the sexual drive many of his partners did.

“I would make excuses around getting tired or feeling stressed, that kind of thing,” he said. “It wasn’t an issue with attraction to my partner. It just didn’t enter my mind to initiate sex.”

In 2021, Peter saw an ad recruiting male volunteers for a new study on hypoactive sexual desire disorder, or HSDD. Researchers planned to inject the study’s participants with kisspeptin —a naturally occurring sexual hormone — to see if it increased their sex drive. Kisspeptin plays a key role in reproduction; without adequate levels of the hormone children do not go through puberty, for example.

In a long-term, committed relationship with a woman he says has a higher sexual appetite, Peter signed up, intrigued by the thought that a biological imbalance might help explain his behavior.

In the week after the final session, Peter said, something amazing occurred.

“All of a sudden, I wanted to initiate intimacy. I can only presume it was driven not by my mind remembering something, but my body wanting something,” he said. “I did initiate sex more and it improved things with my partner incredibly.”

Experts believe HSDD affects at least 10% of women and up to 8% of men, although those numbers may be low, said Stanley Althof, a professor emeritus of psychology at Case Western Reserve University School of Medicine in Cleveland, Ohio and executive director of the Center for Marital and Sexual Health of South Florida.

“Men are embarrassed to go to the doctor to begin with, and you’re supposed to be a macho guy,” said Althof, who was not involved in the kisspeptin study.

“So it’s difficult for men to say, ‘Hey, I’ve got a problem with my sex drive.’ That’s why the majority of male patients I see with HSDD are sent in by their partners.”

To be diagnosed with the disorder, a person must have no other issues that might cause a change in libido, such as erectile dysfunction or premature ejaculation.

“Losing interest due to performance issues is common, but HSDD is its own thing,” Althof said. “It’s an absence of erotic thoughts and a lack of desire for sex that has to be present for six months. It also cannot be better explained by another disorder or other stressors: It can’t be due to depression. It can’t be due to a bad relationship. It can’t be due to taking an antidepressant.”

One more key point: A man or woman must have clinically significant distress to have HSDD, said clinical psychologist Dr. Sheryl Kingsberg, a professor in reproductive biology and psychiatry at Case Western Reserve University, who was also not involved in the kisspeptin study.

“Some people aren’t bothered by their lack of interest in sex, so we wouldn’t treat them for HSDD,” said Kingsberg, who is also chief of behavioral medicine at MacDonald Women’s Hospital and University Hospitals Cleveland Medical Center.

“The women coming into my office are deeply distressed,” she said. “They tell me ‘I used to have desire but it’s gone. I could be on a desert island with no pressures, but I just don’t have the appetite. I want it back.’ Those women have HSDD.”

Dr. Waljit Dhillo, a professor in endocrinology and metabolism at Imperial College London, has been studying the relationship between low sexual desire and the hormone kisspeptin for years, first in animals, then in people.

Prior studies by Dhillo of healthy men with no libido problems found giving them kisspeptin boosted levels of testosterone and luteinizing hormone, which is important for gonad function.

His newest study, published in the journal JAMA Network Open in February, enrolled 32 men with verified HSDD. Peter was one of them.

“So many people say to themselves, ‘It’s just me. I’ve got a problem.’ But actually, HSDD may be how your brain is wired,” said Dhillo, who is a dean at the United Kingdom’s National Institute for Health and Care Research Academy in Newcastle upon Tyne.

“The biology is telling us there’s increased activation of inhibitory areas in the brain — the same areas that tell us it’s not OK to walk around in public naked — and those areas are switching off sexual desire. How can we tackle that? We give a hormone that would naturally give you increased sexual desire, essentially hijacking the normal system.”

The men participating in the new study visited Dhillo’s lab twice. On each occasion, they were fitted with a device to objectively measure arousal, given an injection and asked to watch pornography while their brains were scanned via functional magnetic resonance imaging (fMRI).

Neither the subjects or the researchers knew if that day’s injection was kisspeptin or a placebo.

“It was extraordinarily surreal, lying there with something resembling a hangman’s noose around your bits and watching a mixture of ’70s to modern-day pornographic images and videos,” Peter said. “You’d get about five or six seconds of one type of image or video, rate your arousal for the researchers, and then move on to the next.”

Brain scans showed a significant dual effect after the kisspeptin injection, Dhillo said. Activity in the areas of the brain that inhibit behavior slowed, while areas of the brain connected to sexual interest lit up.

“As a group, the men had a 56% higher sexual response to sexual images after the kisspeptin than the placebo,” Dhillo said. “And we found no side effects at the very, very small dose that we are using.”

Peter noticed a difference immediately after finishing the treatments. His sex life was so robust, in fact, that it wasn’t long before his partner was pregnant with their first child.

As published, the study did not follow the men long-term to see if the effects of kisspeptin lasted. For Peter, however, its impact has been life-changing.

“I have found there’s been a lasting effect for me,” he said. “I do find I have a much better sexual appetite even now some years after the treatment.”

Even the arrival of a baby boy didn’t deter his new interest in sex.

“The cliche is when you have kids, your sex life takes a bit of a hit,” he told CNN. “But that hasn’t been the case for us. In fact, we’re pregnant with our second child, due in July.”

While Peter had a positive long-term result, it’s too soon to say kisspeptin injections were the reason, Althof said.

“When you hear dramatic results like Peter’s, I would be cautious in saying that is the typical outcome. While it’s wonderful that it happened for him, these fMRI studies are difficult to interpret and not conclusive,” he said.

“Sexual desire is very complicated — I say it’s a combination of brain function, hormones and love, wine and roses,” Althof added. “This study is promising, but it needs replication in larger groups.”

And even if future research does confirm kisspeptin’s benefits, medical treatment is not a substitution for healthy communication about sex between partners and with health care providers, Dhillo said.

“These are society’s taboos, but actually, the more we talk about real (sexual) issues that affect real people, the more we find it’s actually quite common,” he said.”If you’re not troubled by low libido, it’s not an issue at all, but if you are troubled by it, this can lead to marital breakdown, unhappiness and reduced quality of life.”

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Tag: sexual and reproductive health

How a medication abortion, also known as an ‘abortion pill,’ works | CNN

FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN

How to support your loved one during the infertility journey | CNN

Amid contradictory laws, hospitals in one state were unable to explain policies on emergency abortion care, study finds | CNN

These women ran an underground abortion network in the 1960s. Here’s what they fear might happen today | CNN

Texas abortion drug ruling could create ‘slippery slope’ for FDA approvals, drug research and patients, experts say | CNN

When children are told they were born via assisted reproduction can affect outcomes, study finds | CNN

Clinics and doctors brace for more restrictions on women’s health care after court ruling on abortion drug | CNN

Concerned about the courts, some states and universities are stockpiling abortion drugs | CNN

‘It just didn’t enter my mind to initiate sex;’ Low sex drive in men linked to chemical imbalance | CNN