Plan B on a drugstore shelf in Canada. Photo / Cory Doctorow

What a frustrating week in the ongoing battle over evidence-based health policy.

To the surprise and disappointment of women’s health advocates, the U.S. Justice Department on Wednesday filed an appeal to prevent girls under age 15 from gaining over-the-counter access to emergency contraception.

Approaching the date U.S. District Judge Edward Korman’s order making levonorgestrel-based emergency contraceptive pills (such as Plan B and Next Choice) available without restrictions would go into effect, the Obama administration also requested a stay pending appeal, meaning the judge’s order would not be implemented according to schedule.

The judge’s ruling last month was in response to the Center for Reproductive Rights’ renewed lawsuit seeking over-the-counter access to the morning-after pill.

Responding to the appeal, Nancy Northrup, CRR president and CEO, said in a statement:

Women who urgently need emergency contraception have been delayed in getting it or denied access entirely for more than a decade because of the political maneuverings of the last two presidential administrations. The federal court has made clear that these stalling tactics were based purely on politics, not science.

We are deeply disappointed that just days after President Obama proclaimed his commitment to women’s reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions.

In the appeal documents, the administration argues that the court overstepped its authority and improperly interfered with the rulemaking process; the judge should have instead sent the issue back to the FDA for further action.

“We aren’t focused in this appeal on the merits of the secretary’s decision,” a Justice Department official, who spoke on condition of anonymity, told The New York Times. “What we’re focused on is that the remedies that the judge ordered were beyond his authority.”

Ironically, overstepping is what many would argue the administration did in 2011 when HHS Secretary Kathleen Sebelius overturned a decision by FDA scientists to make the contraceptive pills available without restriction.

The administration also argues that since the actual plaintiffs in the case are all over age 15, and it’s not a class action suit, that no harm is done to the plaintiffs by granting the stay (see below). By making this argument, the administration avoids addressing the potential harm to girls who are prevented from accessing a drug both FDA scientists, and the judge, said should be available.

The administration claims that the public would suffer irreparable harm if the stay is not granted; if the ruling is allowed to go forward and later overturned, it would create confusion for women, who might “mistakenly believe that they can obtain the drug without a prescription or at certain locations where it used to be available, but is no longer.”

We’re also supposed to believe the appeal has nothing to do with politics. A Justice Department official told The New York Times: “This is a decision that the Justice Department is making in representing our client: FDA. This is not a political decision. It’s not had White House intervention or involvement. This in our judgment is the right legal step to take in this case.”

Meanwhile, FDA Approves Making Plan B Available to Teens Age 15 and Up
The decision to appeal came just one day after the FDA announced its approval of Plan B One-Step emergency contraception pills without a prescription for teens age 15 and older. The drug was previously only available without a prescription to women 17 and older.

It’s a great step forward; however, younger women, for whom access to a healthcare provider may be most difficult, are still left without prescription-free access to the drug, which must be used within a limited window.

The FDA adds to the burden by specifically requiring proof of age. From the FDA’s press release:

The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.

In addition, Teva will make the product available in retail outlets with an onsite pharmacy, where it generally, will be available in the family planning or female health aisles. The product will be available for sale during the retailer’s normal operating hours whether the pharmacy is open or not.

The ID/proof of age requirement is a big hurdle for many teens. Many states set an age requirement of 16 for a driver’s license or learner’s permit. Obtaining a state ID (related to driving or not) costs money, and hours for doing so are often limited. And undocumented teenagers are unable to obtain a legal ID at any age.

“While welcomed by some as an acceptable compromise,” said Nancy Stanwood, Physicians for Reproductive Health board chair-elect, the “FDA decision to approve the sale of emergency contraceptive Plan B One-Step to those 15 years and older with government-issued identification does little to improve real access for already-vulnerable women and young teens. Plan B has a time limit, and too many women in the U.S. have gone without it because of unfair, unnecessary, and medically unjustified barriers to access.”

Writing at ThinkProgress, Tara Culp-Ressler explains other reasons why the policy shift is still problematic, noting in part that it simply isn’t based on science, and the high cost remains a barrier.

The FDA’s ruling was in response to an amended application request by Teva Women’s Health, the company that makes Plan B One-Step, to make the drug available without a prescription to women age 15 and older. The FDA in 2011 denied Teva’s application to make Plan B One-Step available for all females of reproductive age. And still the debate goes on.

Arguments are scheduled to be heard by the Supreme Court on April 15 on the Myriad Genetics case, which will challenge patents held on human genes, especially the BRCA1 and BRCA2 genes known to increase breast cancer risk.

The suit charges that leaving human genes in the hands of corporations limits diagnostic testing and research that could lead to cures, and limit women’s options for medical care.

Breast Cancer Action is holding a rally on April 15, the day the case is heard, to stand up for women’s health and against corporate control of our genes. It begins at 9:30a.m and will take place on the steps of the Supreme Court. To find out more, follow @BCAction on Twitter.

Our Bodies Ourselves is a co-plaintiff in the lawsuit challenging these gene patents. For further information and resources, see these previous posts:

• OBOS Joins ACLU Lawsuit Challenging Breast and Ovarian Cancer Gene Patents
• Breast Cancer Gene Patents Invalidated
• Take Back Our Genes Campaign Fights Restrictive Gene Patenting
• ACLU Survey for Women Who Have Been Advised to Get BRCA Genetic Testing

Bisphosphonates, a category of drugs that includes Fosamax and Boniva, are commonly prescribed to treat and prevent osteoporosis. Unfortunately, concerns have been raised about possible adverse effects of these drugs when used for longer than 3 – 5 years.

There are many unanswered questions about the long-term use of bisphosphonates.  A 2012 New England Journal of Medicine perspective piece notes that it is unclear how long most people should take the drugs, whether certain groups of patients are more likely to benefit from longer term use of the drugs, how long benefits of the drugs last after stopping them, and whether there are reliable measures to help make that decision in individual patients.

One of the concerns regarding long-term use is the potentially higher risk of unusual thigh bone fractures (often called “atypical femur fractures”).

A new study published in the The Journal of Clinical Endocrinology & Metabolism attempts to shed more light on the potentially higher risk of these fractures. The researchers collected the stories of 78 women and 3 men who suffered an atypical femur fracture after taking a bisphosophonate for treatment or prevention of osteoporosis. Medical histories were collected to see how long people had been on the drugs, if they experienced another fracture in the other leg, how long they were in pain before the fractures were actually diagnosed, and other factors.

They found that 77% of the patients were in pain before they were initially diagnosed with a fracture, and they were in that pain for an average of about 9 months (ranging from 1 to 24 months). The authors write, “Sixty-one patients had sought treatment for persistent thigh, leg, or hip pain and had multiple studies and procedures that did not discover the problem.” Almost 40% of the patients ended up with another fracture on the other side. About a third of the patients also had metatarsal (foot) fractures, while 2.5% had a pelvic fracture and 3.7% experienced jaw osteonecrosis. Despite the lack of certainty about long-term safety of these drugs, the patients on average had been taking them for more than 9 years.

The authors note that while patient reports may sometimes be inaccurate or incomplete, they hoped the reports would provide more complete information than that found in bits and pieces across medical charts. Although additional rigorous study is still needed, the authors raise important questions about whether we should also be concerned about foot fractures with these drugs, and whether patients receive timely diagnosis when they do experience bad outcomes.

A systematic review on the risk of fracture was reportedly discussed at a recent American College of Rheumatology meeting – we’ll keep an eye out for those findings being published.

Although the Women’s Health Initiative trials, which studied different aspects of postmenopausal women’s health, began in 1991, the real game-changing results from the trials happened 10 years ago, in 2002, when the trial of estrogen plus progestin hormone therapy was stopped early. The trial was stopped because those responsible for monitoring trial safety found an increased risk of breast cancer, along with risks for heart attacks, strokes and blood clots to the lungs and legs.

This was major news at the time, because many, many women had been prescribed this combination hormone therapy under the assumption that it might actually protect them from heart disease, cancer, and stroke.

Today, both consumer advocate organizations like the National Women’s Health Network and the federal U.S. Preventive Services Task Force seem to agree that hormone therapy should not be used for the prevention of these diseases.

Earlier this month, in honor of the 10 year anniversary of the halting of the trials, the National Women’s Health Network hosted a blog carnival about hormone therapy. Among the posts:

• Dr. Sharima Rasanayagam of the Breast Cancer Fund writes about hormone therapy, chemical exposures, and breast cancer risk. (full post here)
• Karuna Jaggar of Breast Cancer Action on the importance of independently funded research, including the WHI (full post here)
• Cindy Pearson, Executive Director of the National Women’s Health Network, on the importance of the WHI and the need for ongoing research and “protections against misleading promotion of unproven and unsafe drugs.”
• Amy Allina, also of NWHN, writes about “challenging unproven medicine and saving lives.”
• Also, an interview with Dr. Vivian Pinn, former Director of the NIH’s Office of Research on Women’s Health, NIH, on the importance and impact of the WHI trials.

You can find these and other posts on NWHN’s blog.

The NWHN is also collecting stories from women took or were offered hormone therapy before the WHI; who refused it because of the study’s findings; were involved in the study as researchers or participants; and other health care providers, advocates, and individuals affected by the WHI.

Earlier this week, Johnson & Johnson stated in federal court that it would no longer sell several of its vaginal mesh products. The company is being sued by hundreds of women who claim it caused them injuries. According to reports, earlier this year the FDA said the company had sold one of the implants, the Gynecare Prolift, for three years without proper regulatory approval.

Vaginal (or transvaginal) mesh has been one surgical approach to pelvic organ prolapse – when organs like the uterus or bladder may protrude into the vagina. This often has to do with weakness of the muscles and tissues that support these organs, and can cause pain, urinary incontinence, sexual issues, and other problems for women. Treatment options include Kegel exercises or other physical therapy, various types of surgery, and other approaches.

Last July, the FDA issued a safety communication on transvaginal placement of these surgical meshes for pelvic organ prolapse (POP), explicitly stating that:

• “serious complications associated with surgical mesh for transvaginal repair of POP are not rare;” and
• “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

The complications of the mesh described in that communication are quite serious:

…the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

Despite this information, a Johnson & Johnson spokesperson, commenting on the decision to stop selling the products, claimed, “We continue to have confidence in the safety and efficacy of these products.”

Also in 2011, the American College of Obstetricians and Gynecologists and the American Urogynecologic Society issued a joint recommendation on the procedures, stating that it should be reserved “for high-risk individuals in whom the benefit of mesh placement may justify the risk, such as individuals with recurrent prolapse.”

In January of this year, the FDA announced that it was considering changing transvaginal mesh for pelvic organ prolapse repair from a Class II to Class III device. Class III devices are those that are considered riskiest, and require specific premarket approval from the agency, supported by scientific evidence to assure that the device is safe and effective for its intended use. The FDA also ordered more than 30 manufacturers of the mesh to submit postmarket study plans to address specific safety and effectiveness concerns.

This month, the U.S. Preventive Services Task Force released a new report which is informing their updated recommendations on hormone therapy for chronic disease prevention in menopausal women. Bone fractures, dementia, stroke, and urinary incontinence were among the chronic conditions they examined.

In the 2005 recommendations, USPSTF recommended against routine use of combined estrogen and progestin for the prevention of chronic conditions in postmenopausal women, and against estrogen alone for the prevention of chronic conditions in postmenopausal women who have had a hysterectomy. The new research looked at 9 newer studies – mostly from the Women’s Health Initiative – in order to review and update those recommendations.

Based on their review of the evidence, the authors concluded that both regimens – estrogen plus progestin, and estrogen alone – decrease risk of bone fracture but increase risk for stroke, thromboembolic events (blood clots in the legs or lungs), gallbladder disease, and urinary incontinence. Estrogen plus progestin was found to increase risk for breast cancer and probably dementia, while estrogen alone may slightly decrease risk for breast cancer.

The draft new recommendations are very similar to the 2005 ones. The USPSTF “concludes with high certainty that there is zero to negative net benefit for the use of combined estrogen and progestin therapy for the prevention of chronic conditions, and concludes with moderate certainty that there is no net benefit for the use of estrogen alone.” They also explain that the recommendations do not apply to women younger than age 50 who have undergone surgical menopause, and they don’t address use of hormone therapy for the management of menopausal symptoms like hot flashes or vaginal dryness.

There were some limitations of this research described by the authors, like the small number of new studies, variations in the studies that make it hard to combine their findings, and lots of study participants who dropped out before the trials were finished. In addition, most of the women in the studies were 60 to 69 years old. Additional research is needed that looks at women who are transitioning through menopause or immediately postmenopausal.

A Washington Post article puts the findings in context, explaining:

One form of hormone replacement therapy — estrogen alone — did appear to slightly reduce the incidence of breast cancer. Invasive breast cancer looms large as a concern to many women, but affects just 11 percent of them past menopause.

That possible protective effect became less consequential when weighed against hormone therapy’s impact on far more likely risks to women’s health…It fails to reduce the risk of heart disease, which will affect 30 percent of women who live past menopause. It slightly increased the likelihood of dementia, which will affect 22 percent of all post-menopausal women. It was linked to a higher likelihood of stroke, affecting 21 percent of these women.

Earlier this month, the National Women’s Health Network received the Grassroots Activism Award from the National Breast Cancer Coalition for its years of work challenging the wisdom of widespread use of menopausal hormone replacement therapy, especially estrogen/progestin therapy known to raise women’s risk of breast cancer.

NWHN Director Cindy Pearson, in response to the award, reminds us of how widespread HRT was in the recent past, and how little was really known at that time about the potential harms of the therapy:

You remember what she was talking about: until just about 10 years ago, it was routine practice to prescribe hormone therapy to women during menopause. This was justified by claims that it would keep us young and healthy, despite the lack of evidence supporting those claims and despite evidence suggesting that hormone therapy might increase the risk of breast cancer. But the Network knew that what the medical establishment believed had not been proven by science. And we wouldn’t stop saying that – even when the response was rolled eyes and smug looks.

Kudos to the NWHN for their persistence, getting the message out to women who needed it, and this much-deserved recognition.

Last week, the U.S. Food & Drug Administration (FDA) published a perspective piece on the long-term use of bisphosphonates for reducing bone fracture risk in the New England Journal of Medicine, describing findings from the agency’s September 2011 review of these drugs. The agency had reviewed data from a few studies on longer term (>3 years) use of the drugs, including whether they increased bone mineral density and decreased bone fractures.

We wrote about that review in more detail here. Essentially, the agency reported that long-term safety of these drugs was still something of a mystery, but there was concern about rare but serious complications – jaw osteonecrosis, atypical femoral fractures, and esophageal cancer. The agency has also previously stated that there was no apparent benefit of continuing the drug beyond 5 years for fracture prevention.

In the NEJM piece, agency authors reiterated both these concerns and the reality that more research and information is still needed on questions such as how long most people really should take the drugs, whether certain groups of patients are more likely to benefit from longer term use of the drugs, how long benefits of the drugs last after stopping them, and whether there are reliable measures to help make that decision in individual patients. While they don’t focus on it, there is also considerable concern and controversy about whether women who do not actually have osteoporosis (or who are classified as having “osteopenia”) should be getting these drugs in an attempt to prevent it.

The NEJM piece is likely to draw more attention to this issue than the previous FDA documents alone, and bolster advocates’ push to reconsider practices and get the information gaps filled. The National Women’s Health Network, a longtime advocate of looking closely at these issues, writes in response:

NWHN agrees with the FDA that long-term use of bisphosphonates isn’t helpful for most women, and urges women and their clinicians to seriously consider stopping these drugs after 3-5 years. Are there some women who should continue bisphosphonates beyond 3-5 years?…We will advocate for more studies to answer this important question.

Now that the FDA has acknowledged the problems of long-term use of these drugs, it should take the next step and address the important question – Which women should start taking bisphosphonates in the first place? We have urged the agency to change its recommendations to end the practice of prescribing bisphosphonates to healthy women for prevention. Too many women are handed a prescription for bisphosphonates after getting a bone density scan that shows normal age-related bone loss, even though they have no other risk factors for fracture. Those women are very unlikely to have a serious fracture in the next few years – and taking bisphosphonates isn’t likely to do them any good.

The NWHN has also recently sent a letter to FDA Commissioner Margaret Hamburg urging the agency “to remove the prevention indication for bisphosphonates and to take steps to alert women and their health care providers that these drugs are no longer recommended for prevention of osteoporosis.”

See also: our previous posts on bisphosphonates and osteoporosis.

Many women going through perimenopause and in menopause either don’t have have flashes and night sweats that bother them or are able to ease them with self-help approaches.  However, between 7 and 9 percent of women have symptoms severe enough to interfere with their quality of life.

In the past, the primary treatment for hot flashes and night sweats (called vasomotor symptoms) was estrogen-plus-progestin or estrogen-alone hormone therapy—both effective therapies. But as the Women’s Health Initiative (WHI) trials demonstrated, these hormone regimens unfortunately increase the risk of heart disease, stroke, blood clots and breast cancer.

Because of these risks, new treatment options for vasomotor symptoms are needed. A new study published in the journal Menopause by the Centre for Menstrual Cycle and Ovulation Research looks at the safety and effectiveness of progesterone-only therapy for alleviating hot flashes and night sweats. (Progesterone is a hormone produced in the body, while progestin, which was used in the WHI, is a synthetic form of progesterone).

In this trial, the researchers randomized 133 healthy, postmenopausal women with vasomotor symptoms to Prometrium, a brand of oral micronized progesterone, or placebo, and had them report on the frequency and severity of their night sweats and hot flashes over three months.

The researchers (one of whom, Jerilynn Prior, co-wrote the menopause chapter in the 2011 edition of Our Bodies, Ourselves) found that symptoms improved in both the progesterone and placebo groups over the course of the study. Scores, however, improved significantly more in the progesterone group, suggesting that the hormone provided greater relief of symptoms than placebo. There were few adverse effects reported in this brief trial, none of which were considered serious.

It is not clear what the breast cancer implications of progesterone-alone therapy might be – the Women’s Health Initiative trials found an increased risk of breast cancer with estrogen-plus-progestin therapy but not with estrogen-alone. In their article, the authors briefly address this issue, noting varying findings in other studies and remarking that:

Although there is reason to believe that progesterone has a more favorable safety profile than medroxyprogesterone [used in the WHI study], large safety trials of progesterone as postmenopausal monotherapy are lacking.

OBOS contacted researcher Jerilynn Prior to ask her if she had any additional comments about the potential increased risk of breast cancer. Prior answered that a large observational study in France called E3N found that estrogen with progesterone was not associated with increased breast cancer risk, while estrogen alone and estrogen with progestin were. “This suggests that progesterone alone would be safe in terms of breast cancer risk,” Prior noted.

In the published study, the researchers address certain limitations of their work, including the racial/ethnic makeup of their study population (primarily white), and participants being overall leaner and healthier than the general population. Additionally, while the placebo was identical to the active drug and neither the researchers or women could guess by the look or feel of the pill which they were taking, over time 54% of those receiving progesterone and 60% of those getting placebo were able to correctly guess their group assignment. In correspondence with OBOS, Prior said that this was likely due to the fact that many of those taking progesterone experienced improvement in their sleep.

The researchers also note that their population were postmenopausal, having not menstruated for 1-10 years, so their findings are not applicable to women transitioning into menopause.

The bottom line is that progesterone-alone may be a useful treatment for relieving hot flash and night sweat symptoms of menopause, although more investigation is needed. Many of the benefit and harms of hormone therapy may turn out to depend on the type of hormone, who’s using it, in what form, when and for how long. I hope to see more studies on this in coming years.

DES Action, an organization that provides information, education, and support related to DES exposure, is conducting a health history survey to learn more about the health issues faced by women who took DES and the daughters and granddaughters and sons and grandsons of those women.

DES (diethylstilbestrol) is a drug that used to be prescribed to women to prevent miscarriages and preterm births, and is now known to increase the risk of certain cancers and other adverse effects in the sons and daughters of women who took the drug. Researchers are now starting to look for possible effects in the women’s granddaughters and grandsons.

June 15th is the deadline for all surveys to be completed and returned. The survey is not a formal scientific study, so there is not the usual informed consent process with privacy information. DES Action hopes the collecting these surveys will help them to identify some trends and concerns to share with researchers who may be able to follow-up with further study.

Related information on DES:
DES: 40 Years of Research with More to Learn – recent article in the newsletter of the National Women’s Health Network
The DES Follow-up Study – DES timeline, health risks, and information in the National Cancer Institute’s “Linkage” newsletter.

Our 2009 post on side effects of stopping the injectable birth control Depo-Provera (depot medroxyprogesterone acetate, or DMPA) continues to generate important discussion — more than 100 women have shared their stories of adverse effects after stopping the drug.

Although a quick internet search finds many women complaining of or asking about post-Depo symptoms, there isn’t much published scientific evidence on the topic. Frustratingly, there is really not much new on the topic in the 2 1/2 years since we first posted on this. There don’t appear to be ongoing or upcoming studies on the concerns we’ve heard, either. A few studies here and there report some effects, like how long it took for menstruation to return, how long periods lasted, and how long it took to become pregnant after stopping.

Most of the existing research on women who stop using Depo-Provera seems to focus on bone mineral density. The drug comes with a “black box” warning that it may cause significant bone density losses, although research suggests that it’s possible that these losses may be made up after women stop taking the drug. The Society for Adolescent Medicine has said that “The data from all of these studies [of bone density in adolescent users] are encouraging, although it is unknown whether girls ultimately achieved the same peak bone mass as they would have in the absence of DMPA.” They also suggest that the advantages of preventing pregnancy may outweigh the risk for bone loss, but that patients should be informed of the potential for bone loss. Because of this concern, though, research on what happens when women stop using this birth control method tends to focus on understanding changes in their bone density.

Studies of “discontinuation” of birth control methods also tend to focus on the side effects of taking a drug and the reasons women stop using them, rather than what happens – aside from pregnancies – after they make that decision. It is thought that about half of women who quit Depo in order to get pregnant are able to do so by 10 months later, but that some women have longer waits before they are fertile. According to the drug label, “it is expected that 68% of women who do become pregnant may conceive within 12 months, 83% may conceive within 15 months, and 93% may conceive within 18 months from the last injection.” It also notes, though, that almost 40% of who discontinued the drug to become pregnant could not be followed up on, so they are not represented in those percentages.

What would you like to know about stopping Depo-Provera? What should researchers be examining? If you would like to share your own story of stopping Depo, please add them to the previous post.

Last December, a joint meeting of the FDA’s Reproductive Health Drugs and Drug Safety and Risk Management advisory committees met to discuss the safety of birth control pills containing drospirenone, such as Yasmin and YAZ (both Bayer products). Concerns have been raised about the increased risk from the drugs of venous thromboembolism – blood clots in the legs or that travel to the lungs, which can be fatal.

The committees were asked to consider, among other things, the conflicting evidence on these risks in reported studies, whether the benefits of using drospirenone-containing drugs for pregnancy prevention outweigh the risks, and whether users of these drugs are at an increased risk of clots (VTE) compared to users of other oral contraceptives.

According to the background documents for the advisory committee meeting, the studies funded by the drug company did not find any difference in the risk of VTE between women taking dropsirenone-containing drugs (Yasmin) compared to women taking other combined oral contraceptives.

The FDA funded a separate study combaring Yasmin to other oral contraceptives, and this study did find an increased risk of VTE with Yasmin, especially in women younger than 35 years old. They explain that because of the different designs of the different studies, and because the different results can’t be reconciled just by looking at these different study designs, “none of the studies to date provides a definitive answer” about the safety of drugs like Yasmin in terms of VTE risks.

The FDA also noted that all of the studies examined focused on Yasmin or its equivalent (3 mg drospirenone and .03 mg estrogen), while none of the studies reviewed by the committees examined YAZ (3mg drospirenone and .02 mg estrogen).

Former OBOS board member Pamela Bridgewater testified at the meeting, urging the committee to consider why “the studies that had the closest ties to Bayer show no evidence of an increase in blood clots.” Cindy Pearson of the National Women’s Health Network also testified, asking the agency to “take these more dangerous and no-more-beneficial products off the market, and get back to the arc of history and progress that protects women while supporting their contraceptive choices.”

While the committee members voted 15 to 11 that the benefits of drugs like Yasmin outweigh their risks, the transcript of the meeting provides illuminating comments they made as they voted. Many of those who voted yes said they believed that the risks of unwanted pregnancy are greater, and that the absolute risk of VTE is small. Others, however, expressed concerns about the conflicting data, and suggested that they’d change their vote to no if the standard was how the drug compared to other types of oral contraceptives. Many of the members voting no also expressed concerns that these drugs may be no better and may be more harmful that other oral contraceptives on the market.

For example, Dr. Jacqueline Gardner explained:

I don’t usually vote against choices, but this time I did. And the reason is because on the benefit side, I didn’t see any improved benefit over the existing available choices; and there are so many of them, I believe that as far as oral contraceptives are concerned, women could find alternatives. I don’t see that the alternative to this product is necessarily unintended pregnancy. That’s not the balance, but rather, other safer alternatives. And I, too, believe that when all of the studies are analyzed adequately, that we may find that the risk is even higher, and that translates to a large number of women, in public health terms.

Our Bodies Ourselves has signed onto a letter to FDA Commissioner Margaret Hamburg expressing concerns about the composition of the panel and the focus on comparison of risks and benefits of these oral contraceptives compared to pregnancy, rather than on whether the risks and benefits of drugs like Yasmin outweigh the risks and benefits compared to other oral contraceptives.

Bayer was previously required by the FDA to run corrective ads because their television commercials for the drug were found by the agency to be “misleading because they broaden the drug’s indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug.” There have also been reports that Bayer previously withheld harms information about Yasmin and blood clots from the FDA.

Related reading:

• Group Seeks New FDA Vote on Birth Control Safety Risks After Industry Ties Surface – National Partnership for Women and Families
• Yaz Panel Was Filled With ‘Irregularities’: Advocates – Pharmalot
• A Conflicted FDA Panel, Bayer & Birth Control Pills – Pharmalot
• With Doubts, FDA Panel Votes For Yaz And Related Contraceptives – Shots, NPR’s health blog
• Group seeks re-vote on birth control clot risk – Reuters coverage
• Just How Safe is Yaz? Women Need to Know! – Ms. Blog

The American Civil Liberties Union has launched the “Take Back Our Genes” campaign to fight against issuing patents issued human genes. The ACLU believes that allowing one company to own the patent for a particular gene limits research on genetic health conditions and also limits patient options for genetic testing.

As the organization explains:

Myriad Genetics, which controls the patents on the genes, is able to exclude others from testing and conducting research on the patented genes. Patients who want to obtain genetic testing to determine whether they are at risk for hereditary breast and ovarian cancer have only one option for full genetic sequencing: Myriad Genetics. Myriad decides what tests are offered, which mutations are included, at what cost, and what research can be conducted without fear of patent infringement liability.

The ACLU is asking individuals to send their photos or videos explaining their opposition to gene patenting. The video below provides a great example of how gene patenting can affect patients and their access to affordable, reliable testing.

Our Bodies Ourselves is one plaintiff in the lawsuit filed by the ACLU and the Public Patent Foundation against the U.S. Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation to challenge the patents they hold on BRCA1 and BRCA2 genes.

See our previous posts on this topic:
OBOS Joins ACLU Lawsuit Challenging Breast and Ovarian Cancer Gene Patents
Breast Cancer Gene Patents Invalidated (see later update from the appeals court)

These two recent pieces also provide good explanation of why gene patents are an important issue for patients and researchers to consider.

Last week, we wrote about a controversial decision by HHS Secretary Kathleen Sebelius, who overruled the FDA’s decision that emergency contraception should be made available over the counter to women of all ages.

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.

We have written several times here about concerns about bisphosphonates – a drug intended to prevent bone fractures – and the possibility that these drugs increase the risk of a type of femur fracture. While these fractures are relatively rare and not well understood, the FDA has said that patients should be made aware of the potential risk, especially with long-term use of the drugs. There is also debate over how much these drugs actually help prevent fractures and whether they should be used for prevention in people with “lower than normal” bone density who do not have osteoporosis.

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.