Archive for the ‘Research & Studies’ Category

August 31, 2012

Dear Researchers, Your Gender Bias is Showing

Yesterday I came across a press release that nearly gave me an eyeroll injury. It covered a paper that looks at data on the differing amounts of time women with and without paid jobs spend doing various activities related to food and their children, such as grocery shopping, cooking, eating with children, playing or exercising with children, and supervising or caring for children (inexplicably two separate categories).

From the release:
“When it comes to cooking, grocery shopping and playing with children, American moms with full-time jobs spend roughly three-and-half fewer hours per day on these and other chores related to their children’s diet and exercise compared to stay-at-home and unemployed mothers.” Overall, according to the full paper, they found that “The average number of total minutes per day spent with children is 410 min for non-working mothers and 277 min for working mothers.”

Now for the eyeroll.

As the second paragraph explains, “Employed fathers devote just 13 minutes daily to [chores related to children's diet and exercise] and non-working fathers contribute 41 minutes.”

So what’s the headline? “Fathers providing very little help in child care activities, regardless of employment status?” How about, “Fathers neglecting duties related to childhood obesity?”

Nope. Predictably, moms get the focus, and the blame, with “Working moms spend less time daily on kids’ diet, exercise, study finds.” The authors state prominently in the  paper’s abstract that these findings “suggest plausible mechanisms for the association between maternal employment and childhood obesity.”

The author actually did concede in a quote that maternal supports are needed and he’s not encouraging women to exit the workforce:

“It’s inaccurate to pin rising childhood obesity rates on women, given that husbands pick up so little of the slack,” cautioned lead author John Cawley, professor of policy analysis and management and of economics at Cornell’s College of Human Ecology.

This is a “what you said vs. what you did” problem. When your research indicates that the time fathers – working or not – spend on activities related to kids’ eating and exercise is in the tens of minutes, while the time mothers – working or not – spend is in the hundreds of minutes, suggesting that moms are to blame shows clear gender bias about expected household activities and contributions to childcare. The whole focus on women’s activities — with men’s as an afterthought — reeks of blaming working women.

So where are the fathers in this study (which focuses only on female/male partnerships)? In a section on “offsetting behavior by husbands/partners,” the researchers concede: “Time allocation decisions may be made jointly to maximize the household’s objective function, implying that some of the decreases in time by mothers may be offset by increases in time by fathers.” They provide multiple citations for the idea that household decisions are made jointly, suggesting that readers need evidence that this is actually true.

Framing the participation of fathers as “offsetting” behavior just emphasizes the biased notion that fathers are naturally secondary players in child care. Yes, we may know from the data that fathers spend less time than mothers on household work and child care. But the researchers’ interpretation of the data suggests and accepts that any potentially adverse events in the children’s health are the result of how working mothers are spending their time. They fail to point to another possible conclusion: that perhaps fathers lack of participation in children’s eating and exercise activities may affect the children’s health.

The authors also find that women tend to spend the most time on these activities when their children are young and less able to do things for themselves. (Note the lack of framing the issue as “women invest considerable effort to ensure care of youngest children,” or “younger children create greater time pressures on working women.”)

Look, I know the study is called “Maternal employment and childhood obesity: A search for mechanisms in time use data.” The researchers intended from the outset to focus on how much women’s working outside the home might be to blame for children’s obesity. But what they found is actually pretty minimal, in terms of the difference between working and non-working mothers, even if it’s statistically significant – 17 fewer minutes cooking, 10 fewer minutes eating with children, and 12 fewer minutes playing with children per day.

And, more importantly, they didn’t actually look at ANY health outcomes for the children involved. The researchers simply propose that these fewer minutes of motherly focus might contribute to childhood obesity.

Have you seen similar examples of gender bias in health research and related media coverage? Share your examples in the comments!


June 22, 2012

Hormonal Contraception and Heart Risks

Hormonal birth control (like the Pill), especially modern lower dose medicines, are generally safe for most women. Like all medicines, though, there is the potential for adverse effects for some users. The potential for cardiovascular effects from using hormonal contraceptives has been known for some time; women who smoke cigarettes or who have severe high blood pressure are advised not to take the Pill, and hypertension, heart attack, and blood clots are rare but possible serious side effects.

As a new study in the New England Journal of Medicine points out, though, most research on adverse effects of hormonal contraceptives has focused on blood clots (deep vein thrombosis and pulmonary embolism), with little research focusing on heart attack or clot-related stroke.

The authors of the new study set out to figure out just how common stroke or heart attack are among a group of more than a million Danish women who used oral or other hormonal contraceptives. They looked at the medical records for contraceptive prescriptions and cardiovascular events, and excluded women who had cancers or during pregnancy – both factors that would increase women’s risk of stroke on their own.

The good news is that the study found that blood clots related to hormonal contraception are rare. They did, however, find that women who used combined (estrogen plus progestin) methods showed an increased risk of heart attack and stroke. The amount of increase varied by estrogen dose and other factors. As expected, smoking raised women’s risk of heart attack and stroke. Women who had diabetes, high blood pressure, or high cholesterol were also at an increased risk.

Risk of stroke was elevated among users of the patch and vaginal ring, but was only statistically significant for the ring. Women who used progestin-only methods did not have increased risks. The researchers also found that among women who had stopped using hormonal contraceptives, their risks were similar to women who had never used them.

The authors summarize the risks:

…the risk was increased by a factor of 0.9 to 1.7 with oral contraceptives that included ethinyl estradiol at a doseof 20 μg and by a factor of 1.3 to 2.3 with those that included ethinyl estradiol at a dose of 30 to 40 μg, with relatively small differences in risk according to progestin type.

They also point out that “the absolute risks of thrombotic stroke and myocardial infarction associated with the use of hormonal contraception were low,” meaning that while the increase seems high, very few women will actually experience these outcomes compared to how many women use these methods of birth control. As an accompanying editorial explains:

Considering the absolute risks of cerebral thrombosis and myocardial infarction among nonusers of hormonal contraceptives and the relative risks among users, the number of “extra” arterial thrombotic events attributable to hormonal contraceptives is about 1 to 2 per 10,000 women per year or, equivalently, 10 to 20 per 100,000 women per year for the combined estrogen–progestin formulations that might cause arterial events. These are small numbers. For an individual woman, the probability of an event is quite small.

They also say that “Although hormonal contraception is not risk-free, the evidence is convincing that the low and very low doses of ethinyl estradiol <50 μg) in the combined estrogen–progestin contraceptives studied by Lidegaard and colleagues — whatever the progestin and whether delivered orally or by means of the patch or the ring — are safe enough.”

Although estimates vary, rates of pregnancy-related stroke (during or immediately after pregnancy) are thought to generally be higher than those associated with hormonal contraceptives.


June 14, 2012

New AHRQ Info for Consumers and Public Comment

The federal Agency for Healthcare Research and Quality (AHRQ) has released a draft report for public comment, Vaginal Birth After Cesarean: Developing and Prioritizing a Future Research Agenda.

Through interviews with clinicians, consumer advocates, research funders, and others, and review of the evidence gaps identified in the 2010 VBAC conference, the report team came up with a lot of ideas for future research on VBAC. They then prioritized them, to highlight what they think are the top 10 most important questions for future research. These priorities are meant to guide researchers in focusing their projects and also may influence funding for such projects.

The ten priorities include: examining how institutional and other policies affect availability and safety of trial of labor after cesarean; barriers to providing safe trial of labor; maternal and infant outcomes; the effect of legal liability on practices; long-term complications, and other issues. The complete list with explanations is available in the report PDF.

An opportunity for public comment is available before the report and its priorities are finalized. To submit your comments, use this online form to enter your comments on each section or upload a document with all of them. The deadline for submitting comments is Jun. 22.

AHRQ has also released a new summary for consumers on treating chronic pelvic pain. These summaries present an overview of the condition and options, and what the researchers found from looking at the available evidence on treatment methods, with guidance for making decisions about therapy. Unfortunately, the findings were that “very little is known” about effective ways to treat chronic pelvic pain, with there being very little evidence that either medicines or surgeries really help.


May 31, 2012

Media Coverage of Health News

If you’ve ever questioned the accuracy of media coverage of medical news, Health News Review is a great go-to resource. The site has excellent resources to help people critically read health news articles and learn what to look for in news reports, which often overstate or misstate the potential impact of the newest test or treatment.

You can also go to HRN to find reviews, written by the site’s medical experts, of specific medical news stories.

Medical news stories are reviewed for a number of criteria, like whether the costs and potential harms of any treatments are explained, if the story medicalizes normal variations and states (like menopause or wrinkles), whether conflicts of interest are identified, and whether a story discusses the quality of the evidence.

For example, HNR recently reviewed a Wall Street Journal article on long-lasting birth control.  The study found that methods such as the IUD and hormonal implants, which don’t require action on the part of the user once the method is in place, are far more effective than methods like the Pill, which require a woman to take a pill daily. HRN notes that while benefits and availability of these methods are covered, the article doesn’t address costs or side effects, especially in comparison to other methods.

The site also provides tips for understanding studies and a blog for additional topics and discussion.


April 2, 2012

“Pervasive” Problems in Studies Linking Abortion to Mental Health Issues

Earlier this month, an editor-in-chief of the Journal of Psychiatric Research, along with a co-author, published a commentary critical of a 2009 article  in the journal claiming that women who had an abortion were more likely than women who did not have an abortion to experience panic attacks, alcohol and drug abuse, major depression, bipolar disorder, and other negative mental health outcomes.

The author of the 2009 article,  Priscilla Coleman, suggested the results showed that abortion had more impact on mental health problems than did childhood sexual or physical abuse, physical assault in adulthood, or rape. While Coleman does not explicitly state “abortion causes mental health problems,” she uses language like “abortion…made a significant independent contribution to…mental health outcomes” which suggests not only an association between the two, but a direct causal link.

In 2011, Coleman released a correction to the article, stating that the data had been analyzed incorrectly. The new analysis led to the author dropping panic disorder, panic attacks, new mania and bipolar disorder from the list of conditions she associated with abortion.

Other researchers (Steinberg and Finer) published their own reanalysis of the data Coleman used and were unable to replicate the results of any association between abortions and mood, anxiety, or substance use disorders, with the exception of an association between multiple abortions and substance use disorders. Steinberg and Finer also criticized Coleman for including women who may have already had mental health concerns prior to their abortions, because her analysis relied on women’s mental health diagnoses over their lifetimes rather than specifically after abortion.

The new commentary in the Journal of Psychiatric Research addresses both Coleman’s and Steinberg and Finer analyses. The editor notes that Steinberg and Finer are not the final word on the topic, and future research could do a better job of ensuring comparable groups of women and better understand how responses vary between groups of women in very different life circumstances.

About Coleman’s article, though, they write:

Based on our joint review and discussion of the debate, we conclude that the Steinberg-Finer critique has considerable merit and that the Coleman et al. (2009) analysis does not support their assertions that abortions led to psychopathology….

The fact that the evidence for adverse mental health effects of abortion was weaker in the Steinberg-Finer analysis than the Coleman et al. (2009) analysis is consistent with the conclusions of two recent reviews of the literature, both of which found that evidence for adverse effects of abortion on mental disorders is much less pronounced in higher quality than lower quality studies.

The American Psychological Association in 2008 released a report after reviewing the available evidence (through 2007) on abortion and mental health, and concluded that “the most methodologically sound research indicates that among women who have a single, legal, first-trimester abortion of an unplanned pregnancy for nontherapeutic reasons, the relative risks of mental health problems are no greater than the risks among women who deliver an unplanned pregnancy.” The APA also called methodology problems in the literature “pervasive,” and included criticisms of Coleman’s methods in many of her previous studies, such as their inclusion criteria and failure to control for prior mental health issues or other confounding factors.

With regards to past criticisms of her work published in the British Journal of Psychiatry, Coleman claimed [link goes to LifeSiteNews, an anti-choice website]: “The paper is being published in a very prestigious journal, the British Journal of Psychiatry, which is considered one of the top psychiatry journals in the world. This means the paper has been extensively scrutinized by well-respected scientists and the results of studies are trusted by practitioners throughout the world.”

Unfortunately, even “prestigious” journals are not immune to publishing inappropriately conducted studies, as a look at the site Retraction Watch will illustrate. The 2011 article in the BJP by Coleman reviewed 22 studies of abortion and mental health and drew a number of comments including criticisms of Coleman’s methods, and prompted the Royal College of Obstetricians and Gynaecologists to issue a statement that “What this research does not fully examine is if these women had pre-existing mental health complications such as dependency issues and mood disorders before the abortion.”

Coleman has claimed [link goes to National Right to Life page] that criticisms of her research are just media bias, and “efforts to deny” a link between abortion and mental health problems “will become even less effective, because we all likely know at least one person, who has had trouble coming to terms with an abortion experience.” This statement again refuses to acknowledge the many factors (including pre-abortion mental health, and social stigma around abortion) that may contribute to a woman’s feelings after abortion, and confuses the distinction between what happens with some women and what can actually be attributed to abortion itself.

Why does all of this wrangling about details in studies of abortion and mental health matter? Because research like this is rarely used simply to allow women to make the most well-informed choices for their own lives – it is often part of an agenda of restricting choice. It matters if research suggesting a causal link between abortion and mental health problems is well done because that research is going to end up a tool for restricting women’s choices. We have seen many attempts to restrict abortion across the United States over the last couple of years. New laws requiring hospital admitting privileges for providers, requiring additional regulation and reporting by clinics, and “informed consent” laws that require providers to state false information about breast cancer risks are all enacted under the guise of “protecting” women, but the underlying agenda is prevent women from being able to readily choose abortion. That’s why these informed consent laws *never* contain information on how carrying a pregnancy to term and delivering a baby is statistically *more* dangerous for women than early abortions.

Further Reading:
Guttmacher: Abortion and Mental Health – quick facts about studies on this topic
Reuters, Journal disavows study touted by U.S. abortion foes – good overview of the current discussion
National Women’s Health Network, APA Releases New Report: Abortion No Threat to Women’s Mental Health – 2008 piece I wrote for the NWHN newsletter when the APA released their report on this topic


March 22, 2012

New Recommendations for Cervical Cancer Screening

The U.S. Preventive Services Task Force has released a new recommendation statement on when and how often women should get cervical cancer screening.

Changes from the old recommendations include:

  • Pap test screening every 3 years among women age 21 to 65 years. Other organizations and previous recommendations have suggested waiting until age 30 to wait longer than a year between screenings, or suggested screening “at least every 3 years.” The evidence indicates that screening more often offers little benefit while creating a large increase in harms related to additional procedures and overtreatment.
  • A new recommendation that women younger than 21 not be screened, even if they are sexually active. Based on the available evidence, screening before age 21 does not appear to reduce the rates of cervical cancer or death.
  • A recommendation based on new evidence that HPV testing combined with Pap testing is okay for women age 30 to 65 years who want to do testing every 5 years instead of every 3 years.

The agency continues to recommend that these groups do not need screening: 1) women without a cervix and who don’t have a history of serious pre-cancer lesions or cervical cancer; 2) women older than 65 with a good record of previous screening who are not at a high risk for cervical cancer.

The USPSTF also recommends against HPV testing in women younger than age 30, because the potential harms are thought to outweigh the benefits in younger women. Rates of HPV are high in this age group while rates of cervical cancer are low, so younger women may experience false positives and unnecessary invasive interventions, such as colposcopy and cervical biopsy.

These procedures in turn sometimes can result in vaginal bleeding, pain, and infection. Some procedures, including cold-knife conization and loop excision, are associated with outcomes like preterm delivery, which can create additional risks for a newborn. The report recommendation also notes that women who get abnormal results may also experience short-term psychological harms like increased anxiety, and that overdiagnosis of HPV or lesions that may not really affect a woman’s health can create additional stresses.

The recommendations do not apply to women who have an increased risk of cervical cancer because of HIV infection, a compromised immune system, in utero exposure to diethylstilbestrol (DES), or previous treatment for a high-grade precancerous lesion or cervical cancer.

The new recommendations are freely available online. Note that they will often say “cytology” screening – this means Pap tests (or “smears”). The agency has also released a three-page guide to understanding the recommendations.

To understand how the harms of more frequent screening can outweigh the good, see What the New Cervical Cancer Screening Guidelines Mean for Women on the Our Bodies Ourselves website.


January 31, 2012

Lesbian and Bisexual Women With Breast Cancer History Sought for Study

Via Susan Love’s Army of Women project, we learned about a breast cancer research study headed by Boston University researchers that is currently recruiting lesbian and bisexual women. The goal of the study is to learn more about quality of life and well-being issues for lesbian and bisexual women who have been diagnosed with breast cancer, and to use that information to inform services and reduce health disparities.

From the email announcement:

It is widely known that a breast cancer diagnosis can have far reaching effects both socially and emotionally. Less well understood are the ways in which a breast cancer diagnosis impacts the well-being and quality of life of women who have historically been underserved by the medical community. Lesbian and bisexual women are one of these underserved populations, and little research has been done to assess their health and well-being as women with breast cancer. Identifying their unique needs by asking some questions in a survey will help researchers to develop culturally appropriate programs for these women.

The researchers are interested in hearing from all lesbian and bisexual women who have had a breast cancer diagnosis. They have a particular interest in women who have metastatic disease, recurrent disease, or an additional invasive cancer diagnosis, or are currently undergoing cancer treatment. If you have ever been diagnosed with breast cancer, please read on to learn more about what’s involved and who can participate.

Women have been diagnosed with breast cancer at some point their lives and identify as lesbian, bisexual, or as a woman who partners with women are eligible to participate. Participants will complete a 45 minute phone survey about their health, medical history, demographics, and sexual orientation.

Visit this page at Army of Women to learn more or sign up online to participate.


January 3, 2012

FDA Seeking Public Comment on Ensuring Inclusion of Women in Medical Device Studies

The U.S. Food and Drug Administration (FDA) is seeking public comment on a draft guidance intended to define expectations about inclusion of women* in medical device research, including making sure women are represented in clinical trials and that data on women’s outcomes with devices should be collected and reported. Medical devices include products like contact lenses, coronary stents and pacemakers, breast and hip implants, prostheses, and other equipment for diagnosis and therapy.

The FDA is the agency that approves medical devices for use/marketing in the United States, so we would expect them to ask about these issues and data when companies propose that a device be approved.

This is meant to improve how risks and benefits of medical devices can be understood and communicated to women, and to encourage researchers to consider how sex-related differences may affect women’s outcomes when using medical devices.

For example, according to an evaluation of studies used to seek approval for heart-related devices, there was “persistent underrepresentation” of women – only about 1/3 of the study participants were women. Studies of certain existing heart devices have already found increased risks of adverse effects in women for some products, and possible better outcomes for women using some other devices.

Comments are due before midnight (Eastern time) on March 12, 2012. They can be submitted online, or via mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. If you write a paper letter, you should include the docket number: FDA-2011-D-0817.

*Note: the language used in the FDA documents defines female sex “according to their reproductive organs and functions assigned by chromosomal complement,” and gender as provided by patient/participant self-report.


December 21, 2011

BRCA Genes and Cancer Outcomes

You may have seen recent news coverage along the lines of “BRCA variants not tied to worse cancer outcomes.” This story refers to a recently published study about changes in the BRCA1 and BRCA2 genes that affect breast and ovarian cancer. Women with mutated versions of the genes have greater risks of breast and ovarian cancer than women with typical versions of the genes.

In the new study in the Journal of Clinical Oncology, researchers tried to figure out whether women with BRCA1 or BRCA2 mutations who do develop cancer have worse outcomes than women without the mutations. They compared records for women with breast cancer and one of the mutations with those of women with breast cancer who did not have these gene changes.

Overall, they found that women with BRCA1 mutations had similar rates of metastatic (“distant”) cancer recurrence and death as women without it. Women with BRCA2 mutations had higher risks of recurrence and death, although the risk was similar when the women got adjuvant therapy (additional treatment to help prevent recurrences). Other factors like age and stage of the cancer also made a difference.

However, this study should be interpreted with caution. Bigger studies are probably still needed to properly understand any effects of these genes on women’s cancer therapy outcomes. The similarity of outcomes between women with and without the mutations may have to do, in part, with what we have learned about therapies for women with those mutated genes – which therapies don’t work as well for them, and which therapies might be added on for better outcomes. The researchers for the current study do say that women with mutated BRCA1/2 genes were more likely to have received adjuvant therapy, and the authors were unable to look at women’s results by how much chemotherapy they received.

While women who have BRCA1/2 mutations may be advised to have earlier or more frequent cancer screenings than other women, it’s not yet completely clear who should get tested for these mutations or if women should be tested once they’re diagnosed with breast or ovarian cancer.

As we learn more about how our genes affect our cancer risks and therapy outcomes, I expect we’ll see more and more news on these topics, and it may take some time to figure out how to assess risk, guide cancer therapies, and how our outcomes change based on this knowledge. Here are a few helpful resources for this growing area of study:

  • Genetics Home Reference – Cancers – information from the National Library of Medicine on genes related to a number of cancers
  • General Cancer Genetics Information – information from the National Cancer Institute on genetic (hereditary) risks for cancer, gene testing, a dictionary of genetics terms, and other resources
  • My Cancer Genome – information intended to help inform physicians about tumor (not hereditary) genes and their effect on cancer therapy. Disclosure: I work with the team that produces this site.


December 15, 2011

Participate in a Study of Body Image and Well-Being

A Doctor of Psychology candidate at Deakin University in Australia who is working on her thesis about the connection between a woman’s body image and her sense of well-being contacted us with a request to share a link to the online questionnaire where women 18 and older can participate in her research.

The questionnaire will ask you about how you feel about your body, behaviors related to your body, and how you feel about yourself in general. You can complete it online and they estimate that it should take no more than 20-30 minutes to complete.

The survey includes some questions about sexual orientation, height, and weight, as well as your satisfaction with specific parts and areas of your body and how much you think you resemble your “ideal” body. The researchers do mention that “The completion of this study may result in increased self-awareness regarding your attitudes and feelings about your body, yourself, and your life. For some individuals, this self-awareness may produce…discomfort.” Information about how your responses will be kept private is also provided on the website.


November 7, 2011

Understanding In Vitro Fertilization and Ovarian Cancer Risk

A recent article in the journal Human Reproduction has attracted a fair bit of attention because it suggests a possible link between in vitro fertilization (IVF) and later increased risk of ovarian cancer.

Certain factors increase a woman’s risk of getting ovarian cancer, including a family history of reproductive cancers, personal history of cancer, certain gene mutations, increasing age, hormone replacement therapy, and infertility itself.  Right now, it’s still very hard to determine how much fertility treatments – such as the ovarian stimulation used in IVF – may contribute to increased risk.

For the current study, researchers in the Netherlands identified about nineteen thousand women with fertility problems who received in vitro fertilization, and about six thousand women who had fertility problems before IVF was in common use and so did not receive it. The researchers used questionnaires and medical and cancer records to follow the women for fourteen to sixteen years, from the time of their first IVF treatment or first infertility diagnosis.

The authors found a two-fold risk of ovarian cancer in women who had IVF. Most of this increased risk, however, was for “borderline ovarian tumors,” a noninvasive type that may require surgery but typically has a good prognosis. There was no significant difference in rates of invasive ovarian cancer between the two groups. The authors also note that even larger studies are needed to confirm or refute their findings and to examine any possible relationship between the dose of ovarian stimulation treatments and increased ovarian cancer risk.

They also make this important point:

Knowledge about the magnitude of the risks associated with ovarian stimulation is important for women considering starting or continuing IVF treatment, as well as their treating physicians.

A 2006 review of existing literature on the topic also observed “a stronger association…between fertility drug use and borderline tumors of the ovary,” but called the finding “not consistent among the available studies to date.”

See also: The Politics of Women’s Health: Egg Donation for IVF and Stem Cell Research: Time to Weigh the Risks to Women’s Health.


September 26, 2011

La FDA Reevalúa los Riesgos de los Medicamentos para la Osteoporosis

Escrito por Rachel; traducido del orginial en inglés Sept. 20, 2011.

OBOS has received funding to make blog entries available in Spanish. We hope to expand outreach efforts in the coming year.

Los bisfosfonatos (p.e. Fosamax, Boniva, etc.) son medicamentos para el tratamiento y la prevención de la osteoporosis en mujeres postmenopáusicas, pero hay preocupación por los posibles efectos secundarios causados por el uso de estos medicamentos por periodos largos.  Entre los posibles efectos secundarios se incluyen: fracturas atípicas de fémur (muslo), osteonecrosis (muerte de la mandíbula), y cáncer de esófago.

El otoño pasado, la FDA pidió cambios en las etiquetas de los bisfosfonatos para incluir advertencias sobre riesgos de fracturas, para explicar que no se sabe exactamente el tiempo que se debe consumir el medicamento, y recomendar que pacientes y doctores reevalúen periódicamente el uso del medicamento.

Recientemente, algunos comités de la FDA encargados de los medicamentos para la salud reproductiva y del manejo de la seguridad/riesgo de las medicinas, se reunieron para discutir el consumo extendido (>3-5 años) de bisfosfonatos, y sus posibles complicaciones.

En un documento informativo preparado para la reunión, la FDA revisó evidencias sobre estos relativamente raros pero preocupantes efectos, y concluyó: “La seguridad para el consumo prolongado de  bisfosfonatos aún no es clara, por cuanto los resultados de los estudios sobre la posible relación entre la osteonecrosis de la mandíbula, las fracturas atípicas de fémur, o el cáncer del esófago, y el uso de bisfosfonatos para la prevención y el tratamiento de la osteoporosis son conflictivos.”

La agencia concluyó que la evidencia sugiere un aumento en la incidencia de osteonecrosis de la mandíbula con un uso prolongado, especialmente de 4 años o más, pero que se necesitan estudios más profundos.  También dice, “Las fracturas atípicas….parecen tener una asociación importante con los bisfosfonatos, pero no hay actualmente consenso en cuanto a la manera como el uso acumulado de bisfosfonatos aumenta los riesgos de este tipo de fractura poco común.  Finalmente, no hay evidencia definitiva para apoyar la relación entre el cáncer de esófago y el uso prolongado de bisfosfonatos.”

En cuanto a los posibles beneficios resultantes del uso prolongado de bisfosfonatos para reducir fracturas relacionadas con la osteoporosis, la agencia no encontró beneficios evidentes.  “Los resultados sugieren que no hay ventajas de importancia en continuar usando esta medicina por más de 5 años.”

El New York Times también informa acerca de las recientes reuniones de la FDA, y destaca: “El comité convocó a más estudios para establecer la eficacia del medicamento en la meta deseada de prevenir fracturas.  Así mismo, los asesores recomendaron que la FDA examine la razón por la que el medicamento es recetado como medicina preventiva a mujeres que nunca han tenido osteoporosis.”

Para más información sobre este tema, vea nuestras previas entradas de blog, y la Red Nacional de la Salud de la Mujer (the National Women’s Health Network), la cual también pregunta si este producto debe ser comercializado y recetado como medicina preventiva para mujeres con buena salud.


July 18, 2011

Share Your Thoughts: What Do Women Need to Know About Egg Donation?

Women are being sought to complete an online survey about egg donation to help inform the creation of a website to answer women’s question about the egg donation process, including medical and legal concerns.

The survey is being conducted by the organization Generations Ahead and the Health Equity Institute at San Francisco State University. Questions address work, family, and money issues, as well as what you know about egg donation.

From the organizations:

The survey only takes 15-20 minutes and it is completely anonymous. We are looking for women with all kinds of experiences to fill out this survey. They do not need to have been a donor, or even have thought about donating to participate. We would love to hear from any woman who has been even curious about the process or the money involved.

We will use the information we collect here to make sure women’s voices are inserted into this debate and to design a website to give women comprehensive, unbiased information so that they can make the best decision for themselves.

If you have any questions, or want to learn more about, please contact Sujatha Jesudason (sjesudason@generations-ahead.org) or Laura Mamo (lmamo@sfsu.edu). You can also see a description of this project at http://www.generations-ahead.org/projects/egg-donation.

For more discussion of issues related to egg donation and women’s health, see our online companion materials.


June 27, 2011

Are Doctors Using the HPV Test Appropriately?

The current issue of Obstetrics and Gynecology includes a paper that examines how doctors are making use of HPV tests, including whether they are using them appropriately to assess women’s cervical cancer risk.

HPV tests are sometimes done as part of pelvic exams because of the connection between HPV and cervical cancer. Guidelines generally recommend screening for high-risk forms of HPV be done in women over age 30, and in women with abnormal pap results. HPV screening is not recommended in women 21 years old and younger because younger women are likely to get and fight off the virus without any resulting health problems.

An earlier article in a less high-profile journal, Journal of Pathology Informatics, reported similar concerns after reviewing data on HPV tests ordered from 2003-2009. Those authors found that while tests on younger women had declined, but about one in four tests were inappropriate according to the American Society for Colposcopy and Cervical Pathology guidelines.

For the current study, the authors used CDC survey data on what providers do for cervical cancer screening, including their use of HPV tests. They compared those responses to guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American Society for Colposcopy and Cervical Pathology to find out whether the providers were inappropriately testing.

Almost 60 percent of providers reported using HPV tests for “cotesting” in women younger than 30, meaning that the test was done as part of routine screening along with the pap, a use that is not recommended in that age group. For women under 30, “a positive HPV test more likely signifies a transient HPV infection that will resolve spontaneously without needing further intervention.” With a positive test result, however, these women are likely to undergo additional unnecessary testing or treatment.

Survey takers also reported doing HPV tests because women asked for them in order to know their HPV status, and explain that because HPV is so common, such screening should not be done outside of cervical cancer screening. It does not appear that providers were asked whether they talk with the patients in these cases about why an HPV test might not be useful for their care, but are encouraged to do so by the authors.

The authors also found that 31 percent of office-based health care providers and 25 percent of hospital clinics reported testing for low-risk forms of HPV which are not considered relevant to cervical cancer screening. They put it quite bluntly: “There is simply no role for low-risk HPV testing in cervical cancer screening nor any other clinical scenarios to justify its use.” Almost 13 percent of survey takers reported not being aware that there was a difference between the high and low risk tests.

They go on to write:

The continued use of low-risk HPV testing by health care providers in the United States may be driven by a combination of financial gain, test marketing, and health care provider confusion on the difference between the low-risk and high-risk tests. Eliminating the availability of the low-risk HPV test, which has no clinical indications, should be considered…

Both the study and editorial authors mention the need to address payment for the unnecessary tests, such as the additional costs/reimbursement received for adding a low-risk test to the more useful high-risk test.

In an accompanying editorial, Abuses in Human Papillomavirus DNA Testing, Dr. Phillip Castle writes about the negative effects of undergoing unnecessary testing, including anxiety, distress, and a decreased sense of sexual well-being, unnecessary procedures such as colposcopies, and the costs of extra tests and procedures. He asks:

Who is to blame, clinicians, laboratories, or the manufacturer? I suggest that they all share in the blame—the clinicians order it, the laboratories provide it, and the manufacturer makes it (ie, the low-risk HPV test). Unfortunately, it is the patient who has to live with the consequences of payment or copayments and being labeled as HPV-positive.


May 2, 2011

“Skin Deep” Database Provides Details on Safety of Skin Care and Cosmetic Products

The Skin Deep Cosmetics Database, a free online database maintained by the Environmental Working Group, provides information on the safety and potential harms of ingredients in make-up, sunscreen, facial cleansers and moisturizers, contact lens solutions, shampoo, nail polish and remover, baby wipes, soaps, and creams, toothpaste, fragrances, and other cosmetic and skin care products.

You can browse by cosmetic category or search for the name of your favorite product to find out about possible hazards in terms of cancer risk, reproductive toxicities, and allergies. Information is also provided on companies’ animal testing policies. The directions and ingredients listed on each product label is listed, and links are provided to other similar product types and products from the same manufacturer. You can also read others comments and leave your own on specific product pages.

Because in some cases there may not be much testing data on particular ingredients, the amount of available data is labeled, such as none, limited, fair, or robust. Information is provided on whether the data come from a single or multiple animal studies (which may be of limited value for humans), or if there is strong evidence of potential harm in humans.

Sources of data used for the assessments and the methods for computing scores are provided at http://www.ewg.org/skindeep/site/about.php. Thus, you can see how the assessments and ratings are derived in a pretty transparent way. For the fellow librarian readers, yes, I sent them a suggestion about the Hazardous Substance Data Bank!

I love the idea of a database like this, because it’s often difficult to know how “safe” any particular product is. I personally don’t have the appropriate background in toxicology to assess how accurately the potential risks of common ingredients are described, so I’d love to hear from readers with that expertise. I’ll also leave it to commenters to talk about why it was necessary for the “men’s” products to be in their own segregated section of the site. ;)