On Friday, former FDA official Susan Wood issued her response to the move in the Washington Post, rejecting Sebelius’s claim that more data is needed on safety and label comprehension for the youngest of possible emergency contraception users:

…this type of age restriction, and worries about the use of medicines by teenagers, have not been applied to other products…Indeed, for no other over-the-counter medication has the FDA ever required extra data for a particular age group. (This extra data on younger teenagers was provided to the FDA in the latest application by the company.)

But somehow, the prescription requirement for Plan B — which is very safe and impossible to overdose on — remains in place for those younger teens who are in the unfortunate situation of being at risk of pregnancy and who need emergency contraception immediately.

Wood also notes that because the age restriction remains, access for older women remains restricted – emergency contraception is available without a prescription for those over 17, but is still behind a pharmacy counter.

Wood previously served as assistant FDA commissioner for women’s health and director of the Office of Women’s Health. She resigned in 2005 because of past politically motivated delays in emergency contraception approval, stating at that time:

I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled.

Now, Wood calls out Obama for breaking his promise to the American people by allowing this overruling:

In his scientific integrity memo, the president stated: “When scientific or technological information is considered in policy decisions, the information should be subject to well-established scientific processes, including peer review where appropriate, and each agency should appropriately and accurately reflect that information in complying with and applying relevant statutory standards.”

In overturning the well-considered, scientifically based decision of the FDA, Sebelius and the Department of Health and Human Services certainly did not “appropriately and accurately reflect” the available scientific information…The president should stand by the principles of scientific integrity and restore science to its rightful place. He should support the FDA commissioner and direct the secretary to allow the agency to do its job. By doing so he will fulfill the promise of that beautiful day in March 2009 when he pledged that science would trump politics, not the other way around.

If you would like to write President Obama to object to Sebelius’s action and remind him to remember his promise about scientific integrity, you can contact the White House directly via this online form.

The HealthCentral website has just published an interview on on spontaneous femur fractures with Dr. Jennifer Schneider, a physician who had been taking a bisphosphonate for several years when her thigh bone fractured as she stood on a New York City subway. In it, Dr. Schneider tells her story and explains the controversy over widespread use of bisphosphonates for osteoporosis prevention, the recovery process from drug-associated fractures, her testimony to the FDA, and other information about the drugs.

The new issue of the National Women’s Health Network’s newsletter, The Women’s Health Activist, also includes an article on this topic by Cindy Pearson. She writes about other women who told their stories of broken thigh bones to the FDA:

“They talked about turning to put a piece of paper in the trash can, stepping away from the kitchen sink, or walking down the sidewalk — and suddenly collapsing in agonizing pain as their leg gave way. All of these women had been healthy and active before their leg broke.”

The organization is working to get the FDA to make changes in how drug companies are allowed to market the drugs to healthy women. NWHN also recommends that healthy women under 65 with no risk factors for fragile bones avoid bone density scans because of concerns about accuracy and overtreatment; the US Preventive Services Task Force also focuses their recommendation for screening in women under 65 on those women who have risk factors.

On a related topic, I also have an article in this issue of NWHN’s newsletter about confusion over the risks and benefits of calcium supplements.

Nitrous oxide (N2O) is a gas that a laboring woman can breathe in through a mask.  It works very quickly, taking effect in about a minute, and wears off quickly.  Because it is administered by the laboring woman herself, it allows her to obtain a short burst of relief only when needed, as an alternative to an epidural. It is the most commonly used form of analgesia in the United Kingdom.

However nitrous oxide is not widely available in the U.S., despite the endorsement of various childbirth advocacy organizations, including the American College of Nurse Midwives.

In her article, Rooks reviews the research and literature on the safety and risks of nitrous use. She discusses questions around high and low doses of the gas, labor progress, maternal and fetal/newborn effects, and occupational hazards.  She notes that:

Because N2O/O2 labor analgesia does not have adverse effects that could threaten the safety of the mother or fetus, laboring women who use it do not need routine intravenous access, continuous electronic fetal monitoring, or other procedures that are intrusive and restrict the mother’s freedom of movement during labor. Nitrous oxide labor analgesia is safe for the mother, fetus, and neonate and can be made safe for caregivers.

The review points out several health concerns,  including that women who have had recent ear surgery (because of potential vomiting and inner ear pressure issues) and women who at increased risk of vitamin B12 deficiency may need special review before using nitrous, and that workplaces should take care to make sure the appropriate safety measures are taken to limit birth workers’ exposure. She also points to the need for additional research on issues like brain effects and occupational exposure in birth settings.

Although it’s only available to members, the American College of Nurse-Midwives also covered nitrous oxide in their recent Quickening newsletter. In it, they speak to Michelle Collins, CNM at Vanderbilt, who was instrumental in pushing for nitrous to be an option there. Collins explains several reasons women might choose nitrous: to take the edge off contractions, reduce anxiety, relieve discomfort while waiting on an epidural or during other procedures, or simply to delay epidural and keep more time available when the woman can be mobile.

Collins shares that in one month this summer, “35 women used the nitrous during labor at Vanderbilt, and of those, 22 used it as their sole analgesia. The remain­ing 13 used it and later had an epidural.”

For more on this topic, see this previous post with further discussion from Judith Rooks.

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.

Last fall, the FDA requested changes to bisphosphonate labels to warn of the fracture risk, explain that the optimal amount of time to take the drug is not known, and recommend that patients and their doctors periodically reevaluate whether the drug should be continued.

Recently, FDA committees on reproductive health drugs and drug safety/risk management met to discuss long-term (>3-5 years) use of bisphosphonates and these potential complications.

In a briefing document prepared for the meeting, the FDA reviewed evidence on these relatively rare but concerning effects, and concluded, “The safety of long-term bisphosphonate therapy continues to be unclear as study results are conflicting as to whether or not ONJ [jaw osteonecrosis], atypical femoral fractures or esophageal cancer are associated with use of bisphosphonates for the prevention and treatment of osteoporosis.”

The agency further concluded that the evidence suggests an increased prevalence of jaw osteonecrosis with longer use, especially of 4 or more years, but that larger studies are needed. It also writes that “Atypical fractures…appear to have a strong association with bisphosphonates but there is no current consensus on the extent to which cumulative use of bisphosphonates increases the risk of this rare type of fracture. Finally, no definitive evidence is available to support an association between esophageal cancer and long-term use of bisphosphonates.”

In discussing whether long-term use of bisphosphonates would have a benefit of reducing osteoporosis-related fractures, the agency found no clear benefit of continuing, stating, “These results suggest no significant advantage of continuing drug therapy beyond 5 years.”

The New York Times also has coverage of the recent FDA meeting, and notes: “The committee also called for more study of the overall effectiveness of the drugs in their desired goal of preventing fractures. And the advisers recommended that the F.D.A. take a close look at why the drugs are prescribed as preventive medicine for women who do not even have osteoporosis.”

For more on this topic, see our previous posts, and the National Women’s Health Network, which also raises the issue of whether these drugs should be marketed and prescribed for prevention to healthy women.

The Safe Cosmetics Act of 2011, introduced by Janice Schakowsky (IL-D), is intended to help close some of these gaps in cosmetics regulation.

The Act would give the government the power to recall unsafe cosmetics, require better disclosure of ingredients, establish additional safety standards and require manufacturers to submit data on the safety of their products, mandate reporting of adverse health effects, allow the banning of ingredients found to have reproductive or cancer-causing effects, encourage alternatives to animal testing, address worker safety, along with other measures.

The Campaign for Safe Cosmetics, which promotes the legislation and greater consumer awareness of cosmetic safety concerns, has more information at http://www.safecosmetics.org/section.php?id=74.

More info:

• More information on the FDA’s current role in regulating cosmetics
• Rep. Schakowsky’s press release on the Act
• Additional coverage at Good and Forbes

Patients Before Profits: What You Should Know About the FDA, Big Pharma, and Breast Cancer
June 21, 2011 10:00AM – 11:00 AM Pacific (1:00 pm – 2:00 PM Eastern)

Featuring Miriam Hidalgo, BCAction Volunteer Program Coordinator and Jane Zones, Medical Sociologist and Former BCAction Board Member

We will focus on how the competing interests of pharmaceutical companies and regulatory governmental bodies can fail to deliver safe and effective drugs that patients need. If you sign up, you will learn about power players at the FDA, the origins of the accelerated approval process, and more.

You will need to register online for this webinar and then will receive an email with instructions on how to join in on the 21st.

Forty years ago, the New England Journal of Medicine published an article about the synthetic estrogen DES that is now recognized as a watershed in the annals of medicine.

The authors of the study, physicians at Massachusetts General Hospital, reported an association between DES – a prescription “wonder drug” intended to prevent miscarriages – and vaginal cancer in women who were just 15 to 22 years old. From the 1940s to the 1970s, between 5 and 10 million pregnant women and their sons and daughters were exposed to DES during pregnancy. When the daughters became teenagers and some of them developed reproductive tract cancer, the MGH physicians identified DES as the first transplacental carcinogen, and the daughters took on the new identity of “DES daughters.”

When DES daughters had trouble becoming pregnant and giving birth to healthy babies, DES was connected with miscarriage and other problems during pregnancy. These characteristics – crossing the placenta, disrupting the developing fetus, and affecting the bodies of DES daughters in multiple ways that often do not appear for many years – are those that identify DES as the first endocrine disruptor.

Much has been written in the past few weeks about DES. There have been reports of current research about damaging effects of DES: of its possible effects on the children of DES daughters, of its significance for understanding how human reproductive organs develop, and of the dangers of too much haste and too little prudence in adopting medical technologies.

Physicians writing in the New England Journal of Medicine use the words “humble” and “trauma” and “unanswered questions” in looking back and looking ahead to the future of DES. All of this is wise and good. Yet there is more that must be said in this time of remembering.

The DES story is about more than a tragedy that occurred to a population in the mid-20th century and more than a humbling experience for medicine. It is also about a women’s health movement that questioned whether doctors always know best. These women were among the first to judge science based on their intimate, firsthand knowledge of their own bodies, and joined together in collective action for social change.

Thank goodness for one “DES mother” whose daughter developed vaginal cancer during the 1960s and for her doctor who worried too. This mother asked her daughter’s physician—who was also puzzled about the cause of her daughter’s very rare cancer and was searching for answers—whether it could have been caused by the DES she took during the pregnancy.

Her physician was Dr. Howard Ulfelder, who listened to her, took her question seriously and researched the possibilities. We should celebrate this mother for voicing her hunch and this physician for listening to her. Ulfelder became one of the authors of the NEJM article; the mother remains anonymous.

DES mothers and DES daughters began the grassroots organizations DES Action (in 1975) and the DES Cancer Network (in 1982). Among other things, we should be grateful to these organizations for their efforts in bringing about an interdisciplinary, international “workshop” about DES in 1992 – a watershed in DES research, legislation and funding. Lines of research and practice initiated at that 1992 workshop have transformed the doing of science by incorporating activists in the conceptualization and conduct of DES science.

Thirty years ago, I began a research project to understand DES daughters’ experiences. I interviewed DES daughters, read their letters to the editor of these grassroots organizations, and traced their participation in the DES workshop. The results, published in my book, trace story by story their individual and collective efforts that galvanized the watershed DES research, legislation and funding.

One DES daughter who had vaginal cancer in her early 20s was devastated when her surgeon told her she would need a complete hysterectomy. Years later, after she had returned to see him many times for examinations she told me, “I was one of the wonders of medical science,” a woman whose surgeon had saved her life and rebuilt her body. For her surgeon – one of the pioneers in surgery for DES cancer – her body was “the most wonderful thing in the world.”

By the time she told me her story, “it was nothing abnormal to have five or six guys standing around” watching and learning as her surgeon examined her during follow-ups. They learned both from him and from her. As she put it, during those exams, “I used to tease him a lot you know, ‘Oh yeah, I know what to do now.’” The repeated examinations and displays of her body had educated her as well as doctors. She too, became a bearer of knowledge about the clinical contours of DES.

In taking care of themselves these patients and their mothers created new pathways, transformed relations of power and knowledge, and contributed to making new spaces and bringing world wide attention to DES. So on this 40th anniversary of that publication, let us celebrate the courage and the unique contribution of women’s health activism to the DES story.

Susan E. Bell is Professor of Sociology and A. Myrick Freeman Professor of Social Sciences at Bowdoin College in Brunswick, Maine. She is the author of “DES Daughters: Embodied Knowledge and the Transformation of Women’s Health Politics” (Temple University Press, 2009).

Researchers used data on women and their children from the Slone Epidemiology Center Birth Defects Study and the CDC’s National Birth Defects Prevention Study. For these studies, mothers of children with and without birth defects reported what prescription and over-the-counter medicines they remembered taking while pregnant. They excluded vitamins, blood, oxygen, and topical and IV medicines.

Among the findings:

• In 2008, 93.9% of pregnant women took at least one medicine; 82.3% used at least one medicine during their first trimester.
• The average number of medicines used at any time during pregnancy increased from 2.5 medicines in 1976-1978 to 4.2 in 2006-2008.
• The percentage of women taking 4 or more medicines during pregnancy increased from 23.3% in the early years to 50.1% in the most recent years.
• Antidepressant use increased the most, with less than 1% women taking any antidepressant during pregnancy through 1988-1990, climbing to 7.5% of women in the most recent years.
• The top 20 mostly commonly used medicines (in the first trimester) were identified, an include examples of antibiotics, the flu vaccine, allergy and asthma drugs, thyroid drugs, antidepressants, hormones, and a diabetes drug.

The researchers note that of course women’s recall of medication use may be imperfect. However, they conclude that the most commonly used medicines should have their risks and safety in pregnancy evaluated, and ongoing monitoring should be done to better inform women and their providers of potential risks of the medicines they use.

We’ve discussed concerns about direct-to-consumer pharmaceutical advertising previously, but this program is intended more to monitor inappropriate claims about drugs made directly to providers (rather than directly to consumers).

According to the webinar website, “The pharmaceutical industry spends nearly three times as much on advertising to health care professionals as it does on advertising to consumers.” Problematic examples of these promotions to healthcare providers include presentations that describe a drug’s benefits while omitting the risks, sales reps pushing a drug for a non-FDA-approved purpose, misrepresentation of study data and outcomes, or other incomplete or misleading claims.

The FDA has asked that healthcare providers “monitor drug companies’ promotional messages for fair balance and truthfulness.” To learn more about the “Bad Ads” program, see the webinar information page. It will take place at noon (presumably Eastern time) on Thursday April 28.

For more information, see “Direct to Consumer Advertising” on the Our Bodies Ourselves website.

[hat tip to Siobhan]