Blog of the Society for Menstrual Cycle Research

How do mothers pass on knowledge about menstruation to their daughters?

September 21st, 2015 by Editor

Guest Post by Sheryl Mendlinger, PhD

The impetus of my research on menstruation started many years ago when my daughter Yael was in her teens in the 1990s, and came home from school and told me that her friends said, “If you use tampons you could lose your virginity.” Therefore, none of them were using tampons. We lived in a diverse community and many of her friends’ parents had immigrated from North Africa, Iraq and Europe to Israel. I started thinking that what we learn from our mothers, especially about menstruation, can impact our lives in so many ways. Years later when I chose my topic for my PhD, I examined mother-daughter dyads from North Africa, Ethiopia, Europe, North America, the Former Soviet Union, and Israeli born, in order to better understand how mothers transmit knowledge about health behaviors, specifically about  menstruation, to their daughters.

Photo of a menstrual hut provided by Sheryl Mendlinger

A model of knowledge acquisition for learning about menstruation was developed that included:

  • Traditional knowledge—informal knowledge passed through the generations
  • Embodied knowledge—observing others or experiencing oneself
  • Technical knowledge—the products used, and
  • Authoritative knowledge—learning from books, professionals, etc.

One of the most interesting aspects of this research is the stories the women shared about their menarche experiences. Certain celebrations that have continued through the generations may give either a positive or negative valence to the way women view menstruation. Traditional knowledge and rituals often provide strong emotional support for daughters allowing a comfortable transition through this key developmental stage. Several women whose origins were from Europe spoke about “the slap.” One mother told the story that when she got her first period her mother slapped her across the face, which she did to both of her daughters. The mother said the reason was something about the blood coming back and the daughter said it was something about the blood not going to your mind. The actual historical reasons for the slap vary and include: the manner in which it was performed could determine the duration of menstruation; it was necessary for a girl when she becomes a woman as protection against disgrace; and the rush of blood will make the girl have a wonderful color of her life. Often the rituals continue, but the rationale for the tradition has been lost.

The older Ethiopian women talked about their experiences at menarche which included special foods that their mother’s prepared, and then the young girl would go to the menstruation hut where she would stay until the completion of her period and be pampered by other women of the community. Women often looked forward to that time as a fun week away from chores and a brief vacation from everyday life, and a time to be with their women friends. As one woman said “In Ethiopia there is no rest until you go to the hut; only during menstruation does the woman rest.” The mothers however did not continue these traditions, even preparing special foods, following immigration to Israel.

The older women born in North Africa spoke with joy and excitement when they reminisced about getting their periods for the first time and the celebrations that surrounded this event. Their mothers were an integral part of this transition in life from child to woman. Some of the traditions included: mothers giving their daughters pieces of jewelry and preparing special foods; performing the ritual of putting three of the daughters’ fingers in flour so that they should only get their period for three days; and the oil ceremony. Mothers told their daughters to look and smile at their reflection in a bowl of olive oil, and then their faces were rubbed with oil. These girls were told that the image they saw on that day should continue and they should enjoy a happy life. The women noted that the oil would smooth a woman’s passage into womanhood. This oil ceremony was accompanied by a festive meal with traditional foods including honey-dipped, oil-fried cakes. When these women, the elders, were asked if they continued this tradition with their daughters, they all answered an emphatic no, of course not.

These special traditions and ceremonies that were so important from the past were often not continued into the next generation. It appears that the change and adaptation to the new culture and environment took precedence and provides an explanation for why these mothers did not continue these traditions with their daughters.

Recently however, there has been a movement to find positive and meaningful ways for young adolescent girls to celebrate the onset of menstruation in the western modern society. In my study there was an example of the daughter of an American immigrant who grew up on a Kibbutz, an agricultural collective community in which children grow up together in children’s homes.  She spoke with enthusiasm, excitement and had positive memories when remembering how each time a girl in her age group got their period, they would celebrate with gifts. These celebrations took place together with the girls in their age cohort rather than with their mothers.

Through this research we gained a better understanding of the influences and attitudes related to menarche that a mother passes on to her daughter, and the changes that take place following immigration and acculturation to the new society.

A poignant first period story from the book Schlopping

September 16th, 2015 by Editor


From the book Schlopping: Developing Relationships, Self-Image & Memories comes another unique mother-daughter menarche story as follow up to Monday’s post by A daughter raised with body literacy. Though completely different in many respects, both these stories convey the love and good intentions two mothers had for their daughters upon the occasion of their first menstrual period.

Sheryl Menlinger and Yael Magen are the authors of Schlopping explained as: (noun) schlep + love + shopping, a ritual of schlepping with someone you love while shopping. What’s it about? “Two completely different people,” the book’s back cover states, “who happen to be mother and daughter, find answers to life’s challenges through their invented world of schlopping.”

This duo’s differences are apparent in the tale they tell together of Yael’s first period. It unfolds in the second chapter of the book, but on this post you can watch and listen to Sheryl and Yael read this story as they took part in the Menstrual Poetry Open Mic conference-closing event at the Society for Menstrual Cycle Research conference in Boston, on June 6th, 2015.




Sheryl and Yael read from Schlopping:

Dahlia Lithwick, Senior Editor at Slate, says about the book:

Schlopping is a beautiful dialogue that is only nominally about families and shopping. What it truly captures is all the spaces in between: the love, the pressure, the body image, questions, illness, money, terrorism, parenting, beauty, materialism, and womanhood.”

A portion of sales of Schlopping will go to research and wellness for endometriosis and breast cancer. The book includes stories of Yael’s and Sheryl’s experiences with both.

Sheryl E. Mendlinger, PhD, is an author, advocate for women’s health, daughter, wife, mother, and grandmother. Sheryl’s expertise is inter-generational transmission of knowledge and health behaviors in mother-daughter dyads from multicultural populations with a focus on menstruation.  

Yael Magen, Esq., is a lawyer, author, public speaker, entrepreneur and mother of two young children. Yael worked in government and non-profit, and was a mayoral candidate at the beginning of her career. Today she focuses on her general law practice Multigenerational Family Law and Taxes LP where she helps families who have financial, physical, and emotional obligations to two or more generations with their finances and estate planning. 

A daughter raised with body literacy

September 14th, 2015 by Lisa Leger

Adapted from A Baby Born to Body Literacy, Femme Fertile, Winter, 2006, p. 6

Lisa Leger, a Justisse Method fertility awareness educator, with her daughter.

My daughter was born at home with midwives. Not because I was brave, but because I was chicken. Working in health care, I had heard too many maternity-ward horror stories. My studies in fertility awareness and charting my own cycles gave me confidence in my own body to do what it was supposed to do. I also trusted my baby to do her part, and felt safe with my husband and midwives by my side. She came straight to my breast and grew up nursing on demand without ear infections, fevers, constipation, or sniffles.

Her dad and I taught her how to live by explaining everything, how food was fuel, why we wash our hands and wipe our bums. We modelled a casual intimacy in the bathroom; she saw my mucus and menstrual blood. As a toddler she loved pulling the strip off my disposable pads; as a tween she wanted more privacy. The early rituals of puberty were all dealt with straightforwardly and I was full of information and eager to go into detail so my daughter was well-informed about sex and fertility compared to her peers.

When my daughter’s first period arrived shortly after her 12th birthday, the first thing I did was get a blank menstrual cycle chart and have her fill in the date of her first Day One. Since then, I have been revealing more details about the adult world, welcoming her into the “blood mysteries” with stories both mythical and personal. She learned about the back stories related to puberty and sexuality for Little Red Riding Hood, that cherries represent virginity. We watched the 1976 movie Carrie, and she was appalled that Carrie’s mother didn’t tell her daughter anything about what to expect before her periods began.

At first I helped my daughter chart her cycles, complete with mucus observations, abdominal pains, cramps and clots. I remember charting during story time as part of our evening routine. She reported sensations and mucus observations, but her main interest was in knowing when to expect her periods in relation to swimming trips or sleep-overs.

When she decided to have sex at 17, my daughter went to the public health unit and got some birth control pills from the nurse. This was probably thanks to the sex education she got in high school as much as from the human tendency to reject whatever one’s mom does.  I kept my mouth shut with difficulty until side effects appeared. She then tried the Nuvaring, unsuccessfully, and eventually settled on condoms as her birth control method. This process was more difficult for me than for her, because I had to watch as she developed gall bladder symptoms, nausea, and mood swings that interfered with her relationships until she arrived at her own decision to ditch the synthetic hormones.

My daughter has a good foundation of body literacy: she trusts that her body functions are normal, she understands charting, and she is grounded by this knowledge as a young woman of 22 years old. My colleagues will point out that few girls have the good fortune to grow up with a fertility awareness educator for a mother, but I am optimistic that every girl can learn to be aware of her fertility cycles and benefit from even a rudimentary understanding of ovulation. This is why I implored sexual health educators in another blog post–Sex Ed. for Teens: Where’s The Mucus?–to explain the role of cervical mucus in identifying the fertile time.

Research evidence suggests that fertility awareness education leads to delayed sexual activity, reduced teen pregnancy, and lower risky behaviour. I have observed this in my daughter’s life; she has been discerning in her relationships, aware of her worth, and careful with her health. I expect that the body literacy she acquired as a child and teen will serve her well in all reproductive health events throughout her life.

Lisa Leger, B.A., is a Holistic Reproductive Health Practitioner on Vancouver Island. She teaches the Justisse Method of fertility awareness in a pharmacy setting where she works as the Natural Health Consultant. 

Save the Date! The Next Great Menstrual Health Con

June 16th, 2014 by Chris Bobel

No Snack, Just Tampons

April 24th, 2014 by Heather Dillaway

I was flipping through the May 2014 issue of Working Mother Magazine the other day and landed upon a small article about a working mother’s recent “faux pas”: on a “crazed morning” she accidentally packed her bag of tampons in her 7-year-old son’s camp bag and took her son’s snack to work with her. Not only did this mistake leave her son without a snack for the day but also with an “inappropriate” item in his camp bag. The article, titled “The Big Switch,” told of this mother’s horror when she realized that she packed tampons in her son’s camp bag. It told of the constant agony and mortification she felt in just thinking about what might happen at school if anyone found the tampons in her son’s bag. She called her friends and they laughed, offering no advice. She braced herself for the end of the day but, when the end of the day came, she found out that her son had received a special treat of Oreos at school because he had no snack. Her son arrived home happy and unphased. The story ends without us finding out whether the son ever even realized that he had tampons in his school bag. We are also left to think, “Phew, disaster averted.”

Mothers naturally make mistakes all of the time (indeed, it’s maybe one of the things we do best!). However, this mistake was high stakes because it challenged an important social norm: a concealment norm. Women should not let anyone know that they menstruate and they should definitely not involve and/or show kids the evidence. This mother worried for her son’s potential willingness to “share” his knowledge of the tampons in his bag among his friends. She envisioned moments within which everyone at camp would know that she had packed tampons in her son’s bag and was concerned about potential repercussions. This mother worried that camp counselors might even call Protective Services if they found out about the tampons in her son’s bag, and that other parents might find out and complain as well. She knew there could be real consequences….but there weren’t consequences. In fact, in the end, this mistake seemed trivial. Perhaps the son saw the tampons and didn’t think they were a big deal, or perhaps he never saw them.

When we go against concealment norms and “show” to others that women/moms menstruate, we realize exactly how powerful those concealment norms are. This mother spent an entire day on the edge of her seat, unable to engage in her paid work, worried about what would happen to her son and to her because of this mistake. She thought about all of the possible problems and solutions, and engaged in quite a bit of emotional work trying to deal with the fact that she had made this mistake. This illustrates exactly how much work women invest in the concealment of menstruation, how much time and energy it entails yet also how fragile concealment is over time. Women must continually engage in concealment (and also be ready to do damage control) to make certain that menstruation can remain hidden.

This is also a story about how working mothers are constantly negotiating whether they are “good” mothers. This mother provides lots of excuses for why the “big switch” happened – everything from having deadlines at work to being a single mother. Thus we see another set of social norms at work as well in this story: social norms about who is a “good” mother. According to our social norms, there is only one kind of good mother at the end of the day: the mother who does not make mistakes. How silly is that? The ending of the story even seems to suggest how silly these motherhood norms might be, because the son turned out just fine — tampons didn’t hurt him, nor did his lack of snack.

In the end, this small story is just one more representation of the tightropes that women walk, and the impossible demands that social norms place on women. Let it be known that women menstruate and that mothers make mistakes. No social norm has the power to discount those facts.

Choice, Fertility, and Menstrual Cycle Awareness

April 2nd, 2014 by Laura Wershler

Guest Post by Lisa Leger

Photos courtesy Lisa Leger

Posing while pregnant in my pro-choice T-shirt in 1993 was a political statement, one I made with a huge sassy grin on my face. When I recreated the pose recently on my daughter’s 21st birthday, I found it easy to reprise the grin. First take, in fact. My choice tee is well worn; it’s a house/jammy shirt that my daughter has seen me in her whole life. Little does she know that she’s had her nose wiped by a piece of Canadian history.

I bought the choice tee at a fundraiser in Toronto when the Ontario Coalition for Abortion Clinics was helping Canadian abortion rights crusader Dr. Henry Morgentaler with legal expenses when he was forced to defend in court his practice of providing safe abortions in a free-standing clinic. At the time, abortion was legal in Canada, but only if approved by a Therapeutic Abortion Committee and performed in a hospital. I was 27 years old, fresh from university, and a legal abortion had allowed me to finish my degree unburdened by an unplanned pregnancy, but I supported fewer restrictions to access.

Like most twenty-somethings, I had a long history of contraceptive use. I’d tried the pill, an IUD, and even the rhythm method, a fuzzy grasp of which I probably had picked up in a public school health class. I had a rotten attitude about my fertility, saw it as a huge hassle, and had no interest whatsoever in becoming a mother. My social and political opinions about the right to reproductive choice were fully formed when I bought this T-shirt for the cause I so ardently supported.

I was 32 years old when I posed in it while pregnant. By then I’d been charting my menstrual cycles for enough years to have improved my attitude about fertility dramatically. I’d met Geraldine Matus in the late 80s and learned to use the Justisse Method for Fertility Awareness that she developed. It changed my life forever; not only did I gain body literacy, develop a healthy relationship with my cycling body, and break free from contraceptive drugs and devices forever, I also gained a cherished mentor in Geraldine, and a career path as a Justisse fertility awareness educator that has sustained and gratified me for the past 25 years.

I took that picture in my choice T-shirt in 1993 because, for me, it says “I’m choosing to be pregnant.” I grinned because it was my choice to have Clair; I wasn’t scared or forced or coerced into that pregnancy. It was entirely my free will to lend my body to the great task of having a child and I made that choice because of the healing that had gone on over the years of charting, coming into relationship with my body, and learning to appreciate the awesomeness of my pro-creative power. Now that my daughter is 21 years old, I think about the freedom and choices she has as a Canadian woman in 2014, and feel sadness for those who don’t have that choice. I reflect on what a shame it is that these battles over reproductive choice, human rights, access to birth control, stigma, and power seem never to be put to rest. On Clair’s birthday, I posed in my choice T-shirt for my family archives and for those who still do not have choice.

Lisa Leger is a Holistic Reproductive Health Practitioner (HRHP) and women’s health activist on Vancouver Island. She serves on the board of the Society for Menstrual Cycle Research.

A Letter to My Mom: I am Sorry I Was A Brat

February 17th, 2014 by Chris Bobel

Photo courtesy

Dear Mom,

I owe you an apology.

Remember when you were perimenopausal (or as we called it, “going through menopause”)? Remember when you experienced hot flashes? And remember when you did, how we, your loving family, either 1) ignored 2) trivialized or 3) mocked you? Your hot flashes were a constant source of humor around our house and I recall you joining the fun.

But I am betting that while you were yukking it up, you felt lonely and misunderstood. I think you were just ‘being a good sport’ because what choice did you have?

You deserved better.

I admit that until recently, until I began hotflashing myself, I forgot about your transition and how we responded to it. But now that I am living with my own body thermostat on the fritz, I get it.

Now that I am consumed by cycles of heat and chill with no warning, I am having a major A HA ! moment. Now that I find myself waking in the night, my pillow wet, my face wetter, my sleep disrupted, I am time traveling to our sunny kitchen on 2nd Street—you: flapping your blouse, face flushed. Me: rolling my eyes.

I feel badly that I did not appreciate that this process is HARD. I feel badly that I made fun of you, thinking you just a silly old woman whining about something meaningless.

In short, I was a total brat.

Sure. I did not have models for compassionate support. It seems that the discourse of peri/menopausel has two nodes 1) joking  2) patholgizing—another distorted binary that fails to capture the complexity of human experience.

I know that today, struggling through my own perimenopause, I need some simple understanding. I am normal. This is normal. AND this normal reproductive transition can suck to high heaven.

While, we don’t need to stop the clocks or call the midwife, I would like some acknowledgement (minus the sexist aging jokes, please) that doesn’t make me  (or my body) the butt of a joke.

You deserved better when it was your time, Mom, and I am so sorry you didn’t get it.

Love, Chrisi

Making Room for Menstrual Shame

January 20th, 2014 by Chris Bobel

This fall, our family TV indulgence was Master Chef Junior. My 10 year old, a master of scrambled eggs, pancakes and experimental smoothies, was into it, her enthusiasm contagious. So once a week, we sat on the couch– Mom, Dad, and Kid—and watched a dwindling number of freakishly talented miniature chefs slice, dice and sauté their way into our hearts.

Photo credit: Stuart Miles

I enjoyed this respite and low-output family time,  but, there was a price.

The commercials. Oh! Damn those commercials. Because we watched the show online (we don’t have TV), the commercial breaks typically repeated a small set of ads. Over and over again.

In a single episode, we screened some combination of ads for these products a dozen times. According to my crude math, by the time the Master Chef Junior (Alexander, in case you are a fan) was handed his trophy, we watched around 100 different glossy messages that pointed out just how inadequate we are, or would be, soon enough.

I began calling our ritual of watching Master Chef Junior “Self-Consciousness Hour.”

Here is a short list of what’s wrong with me:

My eyelashes are stumpy, thus, my eyes are ugly. 

My teeth are yellow. Yellow teeth are gross. Why bother to dress nice when my teeth are so unsightly? 

My skin is flawed and if I fix it, I will have more friends and a happier life. 

My deodorant is embarrassing me. I might have my disgusting animal smell under control but white powder under my arms can make me the laughing stock of the nightclub. 

Obviously these messages unnerved me (I am not immune to feeling inadequate in spite of my fierce feminism, let’s be honest).

But I really worried about was my daughter. I watched her watch those commercials, her brain processing how she measured up to the standards.

Of course we offered our own critical voice overs at every turn (e.g., You know, human teeth naturally yellow with age. Teeth are not supposed to be pearly white.). We mocked the commercials, trying to expose their absurdity. We initiated more serious discussions of the industry and its nefarious methods, and she engaged these critiques, to some degree. We did what we could (excepting refusing to watch the show, which we could have done, I know). But in spite of our efforts, we doubted our power to counter the power of marketing to manufacture “problems” and sweep in with “lifesaving solutions” all in one (minty fresh) breath.

When all was said and done, between lessons on how to perfectly boil an egg or debone a chicken, my impressionable kid was fed heaping spoonfuls of body shame.

And here’s the menstrual link.

This body shame is the context for her menstrual experiences-to-be. The menstrual taboo, the Grandmother of Body Shame, will slink into her life soon enough, directing her to hide, deny, and likely, detest a natural (and healthy body process). And thanks to  noisy, flashy persistent messages like these, the door is swung open, the lights on, and the pillows fluffed. Come on in, Menstrual Shame! We have been waiting for You! Puleeeze…make yourself at home! Have you met ‘Fat Shame’ sitting here with a throw pillow in her lap? 

I know it is impossible to censor everything my kid sees, hears, reads. I have some experience with this. She is our 3rd kid; we’ve been down this road before and we’ve learned. We tried to do somethings differently this time. Namely, we send her to a crunchy school with an explicit low tech policy (which we observe, on good days). But then the other day, I overheard one of her classmates look down at her feet and exclaim, with horror: “Ewww…My feet look fat in these shoes!” I remind you; she is 10.

Recognizing the ubiquitousness of media messages, our  aim is to teach our kid to responsibly consume what surrounds her. If we equip her with good media literacy skills, she can see commercials through a critical lens. And maybe when her friend complains her feet are fat, she will not take the bait. This is the best we can do, I think.

But “Self Consciousness Hour” really discouraged me. We are outnumbered by the barrage of highly polished and market tested images of “you are not good enough the way you are.” And I fear that Miss Menstrual Shame is already on her way, bags in hand, ready to move in and make herself comfortable.

If you see her, can you tell her we moved?

KHORAI: Women’s Reproductive & Maternal Mental Health & Well-being at the Public Library

November 12th, 2013 by Saniya Lee Ghanoui

Image courtesy of KHORAI

Guest Post by Marie Hansen

November 23rd will mark the third session of KHORAI: a scientific & scholarly reading & discussion group about women’s maternal & reproductive mental health.

I decided to take this opportunity to write a blog post to let you all about what we have been doing at KHORAI and how you can start your own KHORAI group at your local library (or other public space).

What is KHORAI?

KHORAI is a new initiative started by the Maternal Psychology Laboratory at Teachers College, Columbia University in partnership with the New York Public Library. The idea is to translate scientific and scholarly articles about women’s health & psychology to the general public. It works pretty much like your typical book discussion group; only instead of books we read & discuss journal articles. Each session is led by a member of the Maternal Psychology Laboratory using a journal article of their choice. The purpose of the groups are to take our knowledge of women’s health research out from behind university walls and into the greater community as well as  foster conversations about topics that might not be otherwise talked about — including menstruation & gender. Our goal is body literacy and, importantly, since most of us come from a clinical psychology background, we are interested in promoting psychological literacy and exploring the ways in which women’s experiences of their bodies and reproductive life impact their inner life.

So far we have discussed:

It’s not all bad: Women’s construction and lived experience of positive premenstrual change by Marlee King and Jane Ussher

The Pervasiveness and Persistence of the Feminine Beauty Ideal in Children’s Fairy Tales by Lori Baker-Sperry and Liz Grauerholz

Our next article is:

Motherhood as Opportunity to Learn Spiritual Values: Experiences and Insights of New Mothers by Aurélie Athan and Lisa Miller

The groups so far have been a really wonderful experience. People from all walks of life have attended, from fashion designers to schools teachers to new mothers! Tasha Muresan, the lab member who ran the session on fairy tales, wrote up a great little piece about our last discussion.

Why the public library?

Public libraries have long been known as “the People’s University”—their purpose is to enhance public education, literacy, and community—basically, the perfect place to introduce women’s reproductive & maternal mental health! As free & open public spaces, they make for great locations to host discussion groups. Plus, most libraries have access to databases where you can retrieve the scholarly articles to use for discussions.

How do I start a KHORAI group?

Starting a KHORAI group is really simple. Just contact your local librarian and ask him/her if they would be interested in hosting a KHORAI group. If you live close to a university, you can ask other students or professors in psychology, sociology, or women’s studies departments if they would be interested in leading a group discussion (or if you are feeling brave, try leading one yourself). You canalso ask women’s health professionals such as nurses, midwives, or doulas. Plan a day for your group, make a flyer, & put it up in coffee shops, hair salons, & bookstores—any place you think people will find them. Give out the journal article through e-mail (or hard-copy at the library) at least a week in advance to give people time to read it.

If you are running the discussion yourself, take notes while you read the article and highlight the parts that you find interesting. What did you think of the methodology used? What ideas or thoughts did you have while reading the article? Do you see any limitations to the study? Why is the research important for women’s health?

The day of the discussion, relax! We have found that people are excited to talk about women’s reproductive health & psychology, and it generally feels like having a great conversation with friends. If there seems to be a lull in the conversation, you can always bring up something that you noted while you were reading the article to get things going again. We also discovered thatcapping the audience to 10-13 people has been really helpful to keep thingscoherent & flowing.

Also, be sure to e-mail us ( so we can list your group on our website & hear about what articles you are discussing. We’d love to build a network of community women’s health discussion groups!

And if you are in New York, come join our third session.

Ethics in Wonderland: The SUPPORT Study

June 24th, 2013 by Paula Derry

Arthur Caplan is a well-known ethicist, the head of the Division of Medical Ethics at New York University’s Langone Medical Center. On June 11, 2013, Caplan posted an article called “Get real: No need to overdo risk disclosure” on the medical website Medscape. According to basic ethical standards, subjects in research projects are supposed to give written informed consent, which means among other things that they are informed of possible risks that a decision to participate in the study might cause. The Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services criticized researchers in a large project called SUPPORT for failing to clearly disclose the study’s risks. In his Medscape article, Caplan disagreed with OHRP and argued that strict, inappropriate requirements for consent discourage important research. His sentiments were echoed in a recent editorial in the New England Journal of Medicine, a major respected journal. In contrast, SUPPORT is criticized in a New York Times editorial entitled “An Ethical Breakdown” and by watchdog organizations like the Alliance for Human Research Protection and Public Citizen (many of the critical documents are on the Alliance for Human Research Protection website).

Here’s some background: SUPPORT was a large study of how best to treat very premature babies. These babies often need to be given oxygen to help them breathe. However, if too little oxygen is given, there is a risk of death or brain damage; if there is too much, the babies may develop an eye problem called ROP or blindness. Enter SUPPORT. According to the researchers, their goal was to determine the best oxygen level to get lowest risk of blindness without increased risk of death. This amount had already been narrowed to 85% to 92% oxygen saturation (a measure of the oxygenation of blood) in medical practice; the researchers wanted to find out where within this range is best. Infants in the research were randomly assigned to experimental conditions; in one condition, babies were given enough oxygen to bring the oxygen saturation measure to the lower end of the range (averaging 85%); in the other condition, the higher end (averaging 92%). The researchers found that infants receiving less oxygen did, indeed, have fewer eye problems than did infants given the higher amount, but more of them died.

The critical letter from OHRP stated that the consent forms that the mothers of the babies signed should have clearly stated, but did not, that an increased risk of blindness (for babies in the higher oxygen condition) or death (for babies in the lower oxygen condition) was possible. The ethicist Caplan objected to this. He argued that the researchers were comparing two standard medical practices, since 85% to 92% is the standard range used by doctors. In his view, the current way that doctors decide how much oxygen to use within that range is “a coin flip”; randomly assigning babies to the experimental groups was simply comparing two treatment approaches currently in use to see which one is best and involved no increased risk than the babies would otherwise face. He distinguished this from studies that introduce a new treatment, where informed consent about risks is a different matter. Caplan stated: “I believe that this research is highly ethical” and expressed concern that overly strict rules will hinder needed research. The New England Journal of Medicine editorial also objects to the OHRP letter. The editorial states that the OHRP’s finding that subjects should have been informed of an increased risk of death was based on hindsight. The editorial quotes the researchers, who state that “there was no evidence to suggest an increased risk of death” for infants receiving the lower levels of oxygen before their study was done. The editorial states that OHRP has “cast a pall over the conduct of clinical research” and “strongly disagree[s]” with their letter. SUPPORT, in the editorial’s view is “a model of how to make medical progress.”

What is the controversy? First, with regard to the idea that what was being compared were two versions of standard care, although Caplan does not state this in his article, the OHRP letter specifically addressed this point. In real clinical practice, a range of 85% to 95% exists, but in this study only the extremes were used. As the letter states:

According to the study design, on average, infants assigned to the upper range received more oxygen than average infants receiving standard care, and infants assigned to the lower range received less. Thus the anticipated risks and potential benefits of being in the study were not the same as the risks and potential benefits of receiving standard of care.

Further, in real clinical practice, physicians would be making decisions about where within this range to aim, and how much oxygen a particular infant needed. Caplan assumes that random assignment in the experiment was no different than a physician making a decision. In my view, this is a pretty big assumption. Since the researchers compared infants receiving higher vs. lower levels of oxygen, but did not compare either group with a control group of infants getting real standard care, we do not have evidence whether the babies did better, the same, or worse, than babies given genuine standard care. We know that babies receiving less oxygen in the experiment had fewer eye problems than did babies receiving higher amounts, but we do not have definitive evidence of whether they did better or worse than babies receiving usual care.

Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.