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.

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.

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.

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.

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.

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.

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.

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.

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.

She is looking for women to participate in both the study group (those with cancer) and a control group (women without cancer). According to the announcement, you are eligible to participate in the study group if:

You are a female; are 18 years or order; live in U.S.; are in a relationship or married; read English; have experienced rectal cancer or gynecological cancer surgery for longer than three months; do not have a prior history of any other type of cancer; have finished postoperative chemotherapy and radiotherapy; had no postoperative complications, including wound infections, temporary bladder dysfunction, anastomosis leakage, bleeding, and ostomy complications; and are willing and able to provide information about the research questions.

You are eligible to participate in control group if:

You are a female; are 18 years or older; are in a relationship or married; read English; live in U.S.; not have a history of cancer; and are willing and able to provide information about the research questions.

Below is additional information on the study:

This study is not only for females with sexual dysfunction but also for females without any sexual dysfunction. You are encouraged to participate in this study if you feel interested in the study and are willing to provide information about the research questions.

Data will be collected by sending a packet consisting of an informed consent form, the set of questionnaires, and a $5 cash incentive and a tea bag of appreciation to your residence. If you are interested in the study, you can contact me by e-mail (chiachunli820@mail.utexas.edu) or phone (512-529-4527), and please tell me your mail address.

Your participation includes signing the informed consent form, completing the questionnaires, and returning them to me in the postage-paid envelope.

Risks to participants are considered minimal. All information about you will be kept confidential, and your name will not be connected with any information that you provide. Identification numbers associated with mail and e-mail addresses will be kept during the data collection phase for tracking purposes only.

Contact Information:
Chia-Chun Li, RN, MSN, Doctoral Candidate
The University of Texas at Austin, School of Nursing
4210 Red River #121
Austin, Texas 78751
E-mail address: chiachunli820@mail.utexas.edu
Telephone: 512-529-4527

Advisor: Lynn Rew, EdD, RN, AHN-BC, FAAN
The Denton & Louise Cooley and Family Centennial Professor
E-mail address: ellerew@mail.utexas.edu
Telephone: 512-471-7941