Archive for the ‘Drugs & Pharmaceutical Companies’ Category

December 17, 2013

When Off-Label is Safer for Women: The Politics of Medication Abortion

Among the numerous tactics used to restrict abortion access, several states have proposed or implemented laws that impose unnecessary restrictions on medication abortion. These restrictions interfere with evidence-based practices that are considered safer for women’s health.

Some states are requiring that medication abortions follow the exact regimen approved by the FDA back in 2000, though research has since proven that lower doses are safer and just as effective. (The FDA has approved updated labeling since 2000, but these updates have not addressed the commonly used lower-dose regimen; it is not clear whether the drug company plans to submit new data and request these changes.)

The FDA protocol calls for a clinician to provide 600 mg of the first drug, mifepristone, for the patient to take orally, followed 48 hours later by 400 mcg of oral misoprostol. More modern, evidence-based regimens call for only 200 mg of mifepristone, followed later by 800 mcg of misoprostol that is held in the cheek until it dissolves instead of swallowed. The newer regimen also allows for the misoprostol dose to be taken at home.

Guttmacher Institute: State Policies on Medication AbortionBut states looking to make abortions more difficult for women to obtain are requiring physicians to administer the second dose in person. This mean women are forced to make an additional clinic visit — a significant hardship for many patients.

It’s common practice for doctors to prescribe drugs “off-label,” which means in a different way or for a different purpose than what the FDA has specifically approved. This allows doctors to use the most current evidence and their own judgment. Indeed, a new study accepted for publication in the journal Contraception illustrates how the practice of medicine can change to improve patient safety after a drug has been approved by the FDA.

The researchers reviewed Planned Parenthood data from the five years prior to 2006 — the year Planned Parenthood clinics changed their protocol for medication abortion from vaginal to oral administration of misoprostol, and added additional steps (such as STI testing and routine antibiotics) to reduce infection risk — and the five years after.

They found three deaths out of 218,928 abortions before the change, and no deaths among 711,556 abortions after the change. The Planned Parenthood study used the common reduced dose regimen of 200 mg mifepristone followed by 800 mcg of misoprostol. Other studies have also demonstrated the safety and effectiveness of the reduced mifepristone dose.

When politicians insist on the outdated FDA-approved regimen, they are prohibiting the use of the safer approaches.

The outdated FDA regimen, says Rachael Phelps, medical director for Planned Parenthood in Rochester and Syracuse, is “dramatically less effective, has more side effects, is harder for women to use, and increases the likelihood of an additional invasive procedure compared to the evidence based regimen. Mandating the FDA regimen forces doctors to provide substandard medical care and is just plain bad medicine.”

A case challenging such a law in Oklahoma had been set to go before the Supreme Court, but was dismissed following a state Supreme Court ruling that the law would effectively ban all medication abortion in the state. Texas’s controversial HB 2 law also requires adherence to the outdated FDA-approved regimen.

For a quick guide to additional states with restrictions requiring the old regimen or barring remote doctors from supervising medication abortion via telemedicine, view this fact sheet from Guttmacher Institute.

The federal Women’s Health Protection Act (S1696 / HR 3471) introduced this year would prohibit such restrictions. Among provisions addressing telemedicine abortion, hospital admitting privileges, and other targets of recent legislation, the bill would forbid any “limitation on an abortion provider’s ability to prescribe or dispense drugs based on her or his good-faith medical judgment, other than a limitation generally applicable to the medical profession.” Contact your senator or representative to support this Act.

November 22, 2013

Top Hospitals Putting an End to Formula Marketing to New Moms

Despite a wealth of evidence that breastfeeding provides the most health benefits for infants, many barriers — including rigid work conditions and lack of family or community support — can interfere with a woman’s ability to start breastfeeding, or to keep breastfeeding for at least six months.

Health advocates have long criticized the popular hospital practice of distributing infant formula to new mothers, because doing so descreases the length of time that women breastfeed — even when they have indicated a desire to try breastfeeding, and sometimes instead of providing lactation support (read this previous post, which discusses a report on Chicago hospitals in low-income neighborhoods).

According to the Centers for Disease Control, 77 percent of infants in the United States start out being breastfed, which is an increase over recent years, yet fewer than half are still breastfeeding at the six-month mark.

Many hospitals have banned pharmaceutical or other industries from providing marketing materials directly to doctors, in order to avoid conflicts of interest, but many hospitals still provide free formula samples directly to patients.

A new report from Public Citizen, however, suggests that more of the top hospitals in the country are agreeing to limit distribution.

The consumer advocacy organization looked at the top hospitals in the U.S. News and World Report rankings, both those with the gynecology specialty and maternal/newborn services and those on the general Honor Roll. It then surveyed those hospitals about their policies and practices, and checked against data from the national Ban the Bags campaign, which grew out of a Massachusetts effort to stop aggressive formula marketing.

Some of Public Citizen’s key findings:

  • Sixty-seven percent of top gynecology hospitals in gynecology reported not giving out bags sponsored by formula companies, formula samples, or other formula-related promotional materials
  • An additional 11 percent (5 of 45) limited samples and sponsored bags to those who request them, moms who are already planning to formula feed, or to Neonatal Intensive Care Unit patients
  • Eighty-two percent (14 of 17) of the best overall hospitals reported having a policy or practice against distributing these materials

Public Citizen recommends that the remaining hospitals on these lists also ban formula distribution, and discuss other interventions that public health departments and state legislatures can take to restrict the practice. As the report notes:

Numerous studies show that women are likely to breastfeed less, and for shorter durations, if they receive formula samples and promotional materials in hospital discharge packs. Formula bag distribution effectively influences new mothers to use formula because it sends a powerful message that hospitals endorse formula feeding, even where breastfeeding in hospitals is promoted.

One major effort to improve the support for breastfeeding in hospitals is the Baby-Friendly Hospital Initiative, endorsed by several major medical organizations. The Initiative sets standards for baby-friendliness, including breastfeeding support. The Initiative’s guidelines and evaluation criteria states that in baby-friendly hospitals, staff members should not receive donations from breast milk substitute providers, and mothers and their families should not be given marketing materials for formula or gift packs containing formula. The Baby-Friendly principles have been endorsed by several major medical organizations.

Ban the Bags provides a toolkit for advocating against these formula sample bags, which can be downloaded from its website, as a resource for taking action in your own community. As Ban the Bags puts it: “Hospitals should market health, and nothing else.”

June 28, 2013

Emergency Contraception Can Be Free, But it Takes Planning – And a Prescription

By Michelle Andrews, Kaiser Health News

Women of all ages will soon be able to pick up emergency contraceptive pills at pharmacies and other stores without a prescription or proof of age. What many may not realize, however, is that they can get the pricey pills free under the Affordable Care Act. Doing so, however, may take time and forethought.

“Women may be faced with a tradeoff between timeliness and coverage/cost,” says Adam Sonfield, a senior public policy associate at the Guttmacher Institute, a reproductive health research and policy organization.

When it comes to emergency contraception, timing is important. The pills, which delay or inhibit ovulation, generally need to be taken within three days of unprotected sex or they lose their effectiveness. (One prescription-only pill now available is effective for up to five days after a sexual encounter.)

Like other types of birth control, emergency contraceptives are required to be covered as a preventive benefit without cost sharing in health plans that aren’t grandfathered under the health law or don’t meet certain religious exclusions. But consumers can only receive reimbursement from their insurer for over-the-counter products if they get them through a prescription from a medical provider.

Since it can be difficult to get a prescription immediately, women’s health advocates suggest that women may want to get a prescription ahead of time, perhaps at an annual well-woman visit.

“Then you have it in hand, and you can just go to the pharmacy and fill it when you need it,” says Gretchen Borchelt, senior counsel at the National Women’s Law Center.

This month, the Obama administration announced it will no longer fight a judge’s order to make emergency contraceptives available to women of all ages over the counter without a prescription. Officials, including President Barack Obama, had argued that parents should be involved in their minor daughters’ health care, but the court disagreed. The decision was applauded by women’s health advocates.

There are a number of one- and two-pill brand name and generic emergency contraceptives on the market. The FDA last week approved an application for Plan B One-Step to make the drug available without restrictions over the counter.

Plan B One-Step, a popular emergency contraceptive, isn’t cheap. The product generally costs between $35 and $60, say advocates.

About half of all pregnancies in the United States are unplanned. Use of emergency contraception has increased markedly in recent years. Between 2006 and 2010, 11 percent of women between the ages of 15 and 44 said they had used emergency contraception, according to the Centers for Disease Control and Prevention. In 2002, the figure was 4.2 percent.

Young adult women between 20 and 24 were most likely to report that they had used emergency contraception; 23 percent said they had done so.

The administration’s decision to allow over-the-counter emergency contraceptive sales without age restrictions may have the most profound impact on teenagers. But even though they can least afford a $50 pill, privacy worries may stop young women who are on their parents’ health plans from trying to get reimbursed for it.

“They’d rather not go that extra step,” says Allison Guarino, 19, who finished her freshman year at Boston University this spring and volunteers in a program that teaches pregnancy prevention in Boston high schools. “They’ll just go to the pharmacy and purchase it, keep it a little hush hush.”

That’s not surprising, say experts. The number one reason teenagers give for not using contraception in the first place is that they’re afraid their parents will find out, says Bill Albert, the chief program officer for the National Campaign to Prevent Teen and Unplanned Pregnancy.

Even though these young women can consent to receive contraceptive services on their own, health insurers frequently send insurance “Explanation of Benefits” forms to their parents, the policyholders, describing the medical services covered family members have received.

Cost barriers will continue to be a problem for the forseeable future, but advocates suggest that will change.

Even if Plan B One-Step is the only product on the shelves for a time, “We know it’s part of a longer path to get more of these products available, and that the cost will come down eventually,” says Susannah Baruch, interim president of the Reproductive Health Technologies Project.

Plus: Read about efforts to encourage the FDA to make lower-cost, generic versions of emergency contraception available without age restriction, and view OBOS’s full coverage of emergency contraception.

Provided by Kaiser Health News, an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente. 

June 28, 2013

Ask the FDA to Approve *All* Emergency Contraception Pills for OTC Access

Many readers are already aware of the developments over the past few months regarding prescription-free access to emergency contraception,  including the FDA’s recent approval of Plan B One Step with no age restrictions.

While unrestricted access to Plan B One-Step is great news for women and girls needing timely access to emergency contraception, there are concerns that the cost — between $35 and $60 — puts it out of reach for many users. Unfortunately, the FDA’s approval focused specifically on that one product, and left out generic two-pill versions that would likely cost less.

In his response to the FDA’s plan, U.S. District Judge Edward R. Korman noted that he “did not order the defendants to make the brand-name Plan B One-Step available over-the-counter without age or point-of-sale restrictions,” but instead instructed the FDA “to make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions.”

Korman had allowed, however, that if the FDA believed there was a real difference between the newer one-pill and two-pill products, it could limit its approval to the one-pill form. The FDA did just that, citing the need for additional studies to determine whether women under age 17 could read a two-pill label and correctly take the pills 12 hours apart.

In his initial ruling, Korman said that such data was already available and there is very little risk in varying the 12-hour timing, but added that “if the FDA actually believes there is any significant difference,” it could just approve the one pill version. In his more recent response, Korman called the FDA’s claims “far fetched.”

Our Bodies Ourselves and other women’s health advocates disagree with the FDA’s finding, noting that there is a lack of scientific evidence for the distinction between the one-pill and the two-pill versions.

The National Women’s Health Network has posted a letter, which we encourage you to sign, asking FDA Commissioner Peggy Hamburg to remove  barriers to more affordable, generic EC products. It reads in part:

The FDA’s own scientists concluded that age restrictions were unnecessary for all EC products, and the medical community consensus supports that as well. We urge you to allow the makers of generic EC products to revise their labels to make them available without age or point of sale restrictions.

Leaving lower-cost generics behind the pharmacy counter will disproportionately affect low-income women, racial minorities, and younger women for whom cost is a greater barrier. Withholding more affordable generic options from women could contribute to persistently high unintended pregnancy rates in the United States as compared to other developed countries and to adverse health outcomes among vulnerable populations.

All women deserve access to emergency contraception. Please add your name to the FDA letter today!

Plus: For tips on saving money on the cost of OTC emergency contraception, visit the Emergency Contraception website, a project of the Office of Population Research at Princeton University and by the Association of Reproductive Health Professionals.

And, if you have health insurance coverage, learn more about getting a prescription for emergency contraception, which may reduce the cost to nothing.

June 11, 2013

Obama Administration Will Stop Trying To Block Some Emergency Contraception Access

Best news all day: ”The Obama administration has decided to stop trying to block over-the-counter availability of the best-known morning-after contraceptive pill for all women and girls.”

The administration is withdrawing its appeal of a ruling that requires emergency contraception pills to be made available without prescription, regardless of age. This is good news for access to the one-pill form of emergency contraception.

In not-so-good news, the administration may still interfere with over-the-counter access to the two-dose form of the drug.

Although the previous ruling required that the two-pill form be made available even before the intended appeal was heard, the Justice Department’s letter indicates that it may still try to require additional data specific to safety of the often more affordable, generic two-dose form in younger adolescents before approving the change.

As SCOTUSblog explains, “the FDA is interpreting Judge Korman’s April order as giving it permission to choose between Plan B One-Step and the two-pill version so that just one of them would be open without restrictions to women of all ages.”

The Center for Reproductive rights, which has been heavily involved in the court cases around this issue, responded:

Now that the appeals court has forced the federal government’s hand, the FDA is finally taking a significant step forward by making Plan B One-Step available over the counter for women of all ages. But the Obama Administration continues to unjustifiably deny the same wide availability for generic, more affordable brands of emergency contraception.

Congratulations and thanks to everyone who has worked for more than a decade to call attention to this important issue. While more work is still needed to make emergency contraception fully accessible to women and girls when they most need it, this recent news puts us much closer to that goal.

June 7, 2013

New Developments in OTC Emergency Contraception Court Case

First, a quick refresher:

A couple of months ago a judge ordered that emergency contraception pills (like Plan B) be made available over the counter (OTC) without age restrictions. The U.S. Justice Department appealed that ruling, and asked for a stay so that OTC access wouldn’t take effect during the appeals process.

Around the same time, the FDA approved Plan B One-Step emergency contraception pills for purchase without a prescription for teens ages 15 and older.

On Wednesday, the Second Circuit Court of Appeals denied the stay for two-pill types of emergency contraception. This means that two-pill regimens should become available without prescription to women and girls of all ages even before the government’s appeal is resolved. The Court allowed the stay for one-pill variants of emergency contraception (e.g. Plan B One Step), and stated that the appeal process would be expedited.

Women’s health advocates have been fighting for more than a decade to make OTC emergency contraception a reality.

Nancy Northup of the Center for Reproductive Rights called Wednesday’s order “a historic day for women’s health,” adding: “Expanding access to this safe and effective way of preventing pregnancy after failed birth control or unprotected sex is the among the very best decisions our federal government can make for women’s health.”

Marcia Greenberger of the National Women’s Law Center remarked, “The Center applauds today’s decision, which underscores the simple fact that there is no reasonable basis for restricting access to this safe and effective birth control.”

The American Academy of Pediatrics, American College of Obstetricians and Gynecologists, and Society for Adolescent Health and Medicine have collectively denounced the administration’s decision to appeal the ruling at all, and issued a strong statement rejecting limited access: “There is no scientific justification for a continued age restriction on emergency contraception. The Administration’s decision puts the health of adolescent girls at risk and is inconsistent with what we know about the safety and benefits of emergency contraception.”

It’s unclear what will happen next in the fight for more accessible emergency contraception. The Justice Department has stated only that they are reviewing the order. According to SCOTUSblog, the administration has the option of asking the Supreme Court to delay all parts of that initial order for OTC access without age restriction. NPR’s Shots explains that “some lawyers say the government might be able to appeal to the full 2nd Circuit. But more likely, if they insist on fighting, government attorneys would have to seek relief from the Supreme Court justice who oversees the 2nd Circuit — Ruth Bader Ginsburg.”

May 2, 2013

One Step Forward, Two Steps Back: The Week in Over-the-Counter Emergency Contraception

Plan B on a drugstore shelf in Canada.

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.

March 15, 2013

Rally at the Supreme Court – Breast Cancer Gene Case to be Heard Next Month

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:

November 9, 2012

Questions Remain about Osteoporosis Drugs and Unusual Fractures

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.

July 31, 2012

The Women’s Health Initiative Studies, Ten Years Later

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.

June 7, 2012

Some Vaginal Meshes for Prolapse Coming Off the Market; FDA Expresses Safety Concerns About These Devices

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.

June 5, 2012

Hormone Therapy and Chronic Disease Prevention

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.


May 16, 2012

Congrats to Our Friends at the National Women’s Health Network!

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.

May 15, 2012

Long-term Use of Bisphosphonates Not Helpful for Most Women

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.

May 4, 2012

Progesterone-Alone for Hot Flashes and Night Sweats?

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.