Archive for the ‘Research & Studies’ Category

December 12, 2012

The Benefits and Harms of Routine Mammograms

The topic of routine screening mammography has become extremely controversial in recent years, especially following publication of a 2009 evidence review and subsequent U.S. Preventive Services Task Force recommendation that mammography be considered on an individual basis for women in their 40s, rather than automatically recommending mammograms for all women in that age group.

A new study published in the New England Journal of Medicine adds to the questioning of routine mammograms, concluding that “whatever the mortality benefit, breast-cancer screening involved a substantial harm of excess detection of additional early-stage cancers that was not matched by a reduction in late-stage cancers.”

The authors looked at data on how many women age 40 or older had screening mammograms and the incidence of early and late stage breast cancers. The assumption is that if widespread mammography is really helping to catch cancers at earlier, presumably more treatable stages, we’ll see fewer of those late stage breast cancers.

What they actually found was a large increase in detection of early cases (122 per 100,000 women), but a much smaller decrease (8 per 100,000 women) in late cases.

If mammograms were simply shifting diagnosis earlier, they should have seen about the same number for the increase in early cases and decrease in later cases. Instead, it resulted in diagnosis of numerous extra early cases that might not have progressed to more serious disease and would be considered over-diagnosis (with the corresponding over-treatment).

The researchers conclude that “the excess detection attributable to mammography in the United States involved more than 1.3 million women in the past 30 years.”

The authors did find that the death rate attributable to breast cancer had decreased over the last three decades, but they suggest that improvements in treatment over the last few decades may be primarily responsible.

As Dr. Diana Petiti, former vice chair of the USPSTF, explained in an email exchange:

Not all breast cancers detected by mammography would have caused a lump. Some breast cancers detected by mammography (we don’t know how many) revert to normal. Some breast cancers detected by mammography (we don’t know how many) don’t grow to the size of a lump. Some breast cancers detected by mammography (we don’t know how many) grow so slowly, they would not cause a lump in the forseeable lifespan of a woman.

Further not all lumps found by a woman (without mammography) would have caused death from breast cancer. Some breast cancers found as lumps (without mammography) are cured by treatment. Some breast cancers found as lumps (without mammography) grow so slowly that they never cause death due to breast cancer (which occurs because the cancer spreads). Some breast cancers found as lumps (with or without mammography) occur so late in life that something else causes death before the breast cancer spreads and causes death.

The newest data suggests that a not-small percentage of the breast cancers detected by mammography (without a lump) would not have killed the woman from breast cancer had it not been found.

While this is a complicated topic, this New York Times op-ed by Dr. H. Gilbert Welch, one of the authors of study published in NEJM, does a reasonable job of explaining it clearly. Welch, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice and an author of “Overdiagnosed: Making People Sick in the Pursuit of Health,” includes this call for change:

What should be done? First and foremost, tell the truth: woman really do have a choice. While no one can dismiss the possibility that screening may help a tiny number of women, there’s no doubt that it leads many, many more to be treated for breast cancer unnecessarily. Women have to decide for themselves about the benefit and harms.

But health care providers can also do better. They can look less hard for tiny cancers and precancers and put more effort into differentiating between consequential and inconsequential cancers. We must redesign screening protocols to reduce overdiagnosis or stop population-wide screening completely.

Dr. David Newman, an emergency room physician in New York City and author of the book “Hippocrates Shadow: Secrets from the House of Medicine,” tackles the controversy head-on in a column titled ”Ignoring the Science on Mammograms“:

For years now, doctors like myself have known that screening mammography doesn’t save lives, or else saves so few that the harms far outweigh the benefits. Neither I nor my colleagues have a crystal ball, and we are not smarter than others who have looked at this issue. We simply read the results of the many mammography trials that have been conducted over the years. But the trial results were unpopular and did not fit with a broadly accepted ideology—early detection—which has, ironically, failed (ovarian, prostate cancer) as often as it has succeeded (cervical cancer, perhaps colon cancer).

More bluntly, the trial results threatened a mammogram economy, a marketplace sustained by invasive therapies to vanquish microscopic clumps of questionable threat, and by an endless parade of procedures and pictures to investigate the falsely positive results that more than half of women endure. And inexplicably, since the publication of these trial results challenging the value of screening mammograms, hundreds of millions of public dollars have been dedicated to ensuring mammogram access, and the test has become a war cry for cancer advocacy. Why? Because experience deludes: radiologists diagnose, surgeons cut, pathologists examine, oncologists treat, and women survive.

Newman also notes that mammography is not the only area of medicine ripe for questioning:

It is normally troubling to see an observational study posing questions asked and answered by higher science. But in this case the research may help society to emerge from a fog that has clouded not just the approach to data on screening mammography, but also the approach to health care in the United States. In a system drowning in costs, and at enormous expense, we have systematically ignored virtually identical data challenging the effectiveness of cardiac stents, robot surgeries, prostate cancer screening, back operations, countless prescription medicines, and more.

To further explore this topic, listen to this WBUR Boston (NPR) segment with Dr. Welch, Judy Norsigian, OBOS founder and executive director, and Dr. Otis Brawley, chief medical officer at the American Cancer Society. Norsigian also wrote a column for WBUR’s Cognoscenti section, “Do Screening Mammograms Do More Harm Than Good?


December 12, 2012

Do Screening Mammograms Do More Harm Than Good?

A sweeping U.S. study published on Nov. 22, 2012 in the New England Journal of Medicine shows that mammograms have done surprisingly little to catch deadly cancers before they spread. At the same time, they have led more than a million women to be treated for growths that never would have threatened their lives. 

Women over 40 are routinely advised to have yearly mammograms, and it’s widely believed that having one is key to protecting a woman’s health.

Although experts agree that diagnostic mammograms are beneficial (cases where there is a breast lump or other symptoms), there is much controversy about screening mammograms, which are performed on women with no signs of cancer. Mammograms detect breast cancer, although many people believe mistakenly that they prevent breast cancer. We now know that the mortality benefits remain quite small.

Eight trials performed in the United States, Canada and Europe have evaluated the ability of screening mammograms to decrease the death rate from breast cancer, as well as overall mortality. Looking at the overall death rate, not just death from breast cancer, is essential, because this approach also evaluates whether the screening test and any subsequent treatment may be causing other harms.

Overall, the early studies showed a 30 percent reduction in the risk of dying from breast cancer in women who were screened by mammography. In 2001, a critical review of all eight trials by the Cochrane Collaboration found that six of them were sufficiently flawed to invalidate their results. The Cochrane Collaboration then pooled the results of the two remaining studies and found no evidence to support the use of screening mammography.

The U.S. Preventive Services Task Force (USPSTF) evaluated the trials also. Although recognizing many of the same flaws, the USPSTF felt only one trial was sufficiently flawed to be invalidated. They pooled the results of the remaining trials and found a 16 percent reduction in the risk of dying of breast cancer in the women in the screened group.

The meta-analysis published in 2006 by the Cochrane Collaboration confirmed that screening does slightly reduce breast cancer mortality, but that it also leads to over-diagnosis and overtreatment of breast cancer. They concluded:

(F)or every 2000 women invited for screening throughout 10 years, one will have her life prolonged. In addition, 10 healthy women, who would not have been diagnosed if there had not been screening, will be diagnosed as breast cancer patients and will be treated unnecessarily. It is thus not clear whether screening does more good than harm.

In a recent issue of the New England Journal of Medicine, Dr. Archie Bleyer and Dr. Gilbert Welch summarized the latest analyses as follows:

Despite substantial increases in the number of cases of early-stage breast cancer detected, screening mammography has only marginally reduced the rate at which women present with advanced cancer.

And this is the key to meaningful breast cancer screening — that we reduce the rate at which women have to be treated for late stage cancer.

When the data for women under 40 were studied (these are women who generally don’t get regular mammograms), Dr. Welch and Bleyer wrote:

There was a larger relative reduction in mortality among women who were not exposed to screening mammography than among those who were exposed. We are left to conclude, as others have, that the good news in breast cancer — decreasing mortality — must largely be the result of improved treatment, not screening.

Dr. Susan Love, a long time clinician and researcher, would like to see less emphasis on screening and more focus on cancer prevention and treatment for the most aggressive cancers. (Roughly 15 percent to 20 percent of breast cancers are deadly.)

“There are still 40,000 women dying every year,” Dr. Love notes. “Even with screening, the bad cancers are still bad.”

As Donald Berry, a biostatistician at M.D. Anderson Cancer Center in Houston, has pointed out:

Most breast cancers are not lethal, however found. Screening mammograms preferentially find cancers that are slowly growing, and those are the ones that are seldom deadly. Getting something noxious out of the body as soon as possible leads women to think screening saved their lives. That is most unlikely.

The challenge now is to make more widespread the use of techniques that help clinicians identify biological markers that will distinguish between the lethal and benign types of tumors. This appears to be the next big advance in reducing mortality from breast cancer.

Mammography, like other detection tools, is imperfect (it misses about 20 percent of lumps due to dense breasts and other factors). Some would consider it a very weak detection tool, and given the harms of overtreatment (for example, unnecessary chemotherapy and radiation treatments), it is not surprising that some women will want to forego screening mammography.

Women need to carefully consider these factors and decide for themselves what would be best, although friends, caregivers, and even commercial interests may tell them that having routine mammograms is the only rational choice. What really helps is knowledgeable and supportive counseling.

This article was originally posted at Cognoscenti, WBUR Boston’s ideas and opinions section, and is re-posted with permission.


November 28, 2012

CDC Releases New Data on U.S. Abortions

Each year, the Centers for Disease Control and Prevention (CDC) releases information on the number of abortions in the United States. Newly published data from 2009 shows that rates of abortion overall have decreased 5 percent since 2008 to the lowest levels since 2000. In general, rates of abortion were highest right after legalization, fell steadily in the 1980s and 1990s, and started to level off in the past decade.

It is not clear why rates have fallen. Possible contributors range from the expanded use of contraceptives and better sex education to the declining number of abortion providers and increases in restrictive abortion laws. Unintended pregnancy rates have not changed in decades – about half of all U.S. pregnancies are unintended — so that is not responsible for any decline.

As we know, many myths persist about who gets abortions and why. The following details shed some light on the topic:

  • Women in their 20s have the highest rates of abortion (ages 20–24: 27.4 abortions per 1,000 women / ages 25–29: 20.4 abortions per 1,000 women), and account for 57.1 percent of all abortions.

This doesn’t seem terribly surprising given that women in their 20s are more likely to be fertile. In addition, they are more frequently uninsured. The insurance factor likely decreases their use of the most effective birth control methods –IUDs and implants –as those methods require a visit to a health care provider.

  • The majority of women (55.3 percent) having abortions have not had a previous abortion. About 25 percent have had one previous abortion, and about 11 percent have had two previous abortions. Only about 8 percent have had three or more abortions, suggesting that the overwhelming majority of women having abortions do not fit the “using it as birth control” myth.
  • Six out of every 10 women having abortions have already had one or more children. Women very frequently say that they chose abortion in order to best be able to care for their existing families.
  • Abortions are usually performed early in pregnancy, with 64 percent done at less than eight weeks gestation, and about 92 percent done by or before 13 weeks.

There has been a clear shift to earlier abortions, with an almost 50 percent increase in abortions done at less than six weeks’ gestation. The CDC report is not able to address the reasons why; the increase may be caused by the greater availability of medication abortion (medication abortions are performed only up to 9 weeks) or an increased number of abortion laws that make later abortions more difficult to obtain.

Other points of interest:

  • Use of medication abortion continues to increase; 16.5 percent of abortions in 2009 were done medically instead of surgically, a 10 percent increase from 2008.
  • Abortion ratios (the number of abortions for every 1,000 women) decreased among non-Hispanic white women but not among women in any other racial/ethnic group.

Poor women, young women, and women of color are less likely to have access to reproductive health care services, more likely to have an unintended pregnancy, and more likely to have an abortion.

The CDC concludes its report with public health recommendations, including support for no-cost birth control. The Affordable Care Act comes close by eliminating co-pays for insured women (though employers who oppose reproductive rights are still fighting this provision), making birth control available without a co-pay for an estimated 47 million women. Here’s what the CDC has to say:

Moreover, although use of the most effective forms of reversible contraception (i.e., intrauterine devices and hormonal implants, which are as effective as sterilization at preventing unintended pregnancy ) has increased, use of these methods in the United States remains among the lowest of any developed country, and no additional progress has been made toward reducing unintended pregnancy. Research has shown that providing no-cost contraception increases use of the most effective methods and can reduce abortion rates. Removing cost as one barrier to the use of the most effective contraceptive methods might therefore be an important way to reduce the number of unintended pregnancies and consequently the number of abortions that are performed in the United States.

See our analysis of a recent study on unintended pregnancies in St. Louis for further discussion of how improved access to free birth control reduces abortions. The study is important for its role in dismantling persistent myths about contraception and abortion.

Plus: Though some members of Congress with less-than-accurate ideas about women’s bodies lost re-election, that doesn’t mean Congress is apt to back smarter policy. Let’s remind all members about the importance of access to contraception and reproductive health services. Join the Educate Congress campaign to send “Our Bodies, Ourselves” to every elected senator and representative. You’ll receive an “I Educated Congress” button (and other perks) showing you did your part!


October 16, 2012

Study: No Link Between HPV Vaccine and Girls’ Sexual Activity

In 2006, when the FDA approved the first HPV vaccine for girls and women ages 9 to 26, one of the concerns opponents expressed was that it might make young girls think it’s OK to have sex.

That’s because the HPV vaccine protects against a virus that is contracted during sexual contact; specifically, four strains of the human papillomavirus, or HPV, which can cause cervical cancer and some vaginal, vulvar, penile and throat cancers.

In Nashville, where I live, one religious leader claimed, “What we are encouraging is abstinence and sexual purity. If they have a relationship with the Lord, they will recognize that they don’t need that vaccine.”

Others made claims along the same lines — that girls who “come from good homes” don’t need the vaccine, or that it would otherwise somehow promote promiscuity.

We’ve heard a lot less of this rhetoric lately, now that the novelty of the vaccine has worn off and the initial controversy has subsided. It always seemed like a bit of a ridiculous objection, since girls who become sexually active are probably not weighing the risk of some far-off consequence like cervical cancer. 

Heck, even the notoriously conservative Family Research Council has come around to acknowledging that either through abuse or by marrying someone who is a carrier of the virus, “it is possible that even someone practicing abstinence and fidelity could benefit” from the vaccine.

Still, opponents should be pleased with this news: The journal Pediatrics published a new study this week that shows the HPV vaccination is not associated with increased sexual activity among girls.

The researchers looked back at records for almost 500 girls who received the vaccine at ages 11 or 12 compared to about 900 girls who did not get the vaccine. Then they looked at whether the girls, over the next several years, had any record of being counseled about birth control, received contraception (specifically for birth control, not for acne or irregular periods), or had a diagnosis of pregnancy or certain STIs — all markers that imply sexual activity.

The researchers found no significant difference between girls who did and did not receive the vaccine.

Of course there are some limitations to the study, such as that some girls considered unvaccinated could have been vaccinated elsewhere, and girls could have received reproductive health care at places that weren’t counted in the study. A more conclusive set of results could come from following girls in real time over the years and collecting more detail about their health care and behavior.

However, this study provides important initial information that refutes concerns about HPV leading to increased sexual activity. Future research on concerns about the vaccine, then, might be better focused on learning more about long-term safety and effectiveness questions, rather than behavioral concerns.

Now we’ll just have to wait to see if there’s equal worry over whether boys who get the HPV vaccine are more likely to be more sexually active. I wouldn’t count on it.


October 10, 2012

Birth Control Reduces Unintended Pregnancies and Abortions, So Why Do Myths Persist?

Today in “Yeah, no kidding!”: A new article in the journal Obstetrics & Gynecology reports on a study that found when women are provided with free birth control, women choose more effective long-term methods, and unintended pregnancies and abortion rates drop.

Here are the essential details from the study’s abstract (emphasis below is mine):

OBJECTIVE: To promote the use of long-acting reversible contraceptive (LARC) methods (intrauterine devices [IUDs] and implants) and provide contraception at no cost to a large cohort of participants in an effort to reduce unintended pregnancies in our region.

METHODS: We enrolled 9,256 adolescents and women at risk for unintended pregnancy into the Contraceptive CHOICE Project, a prospective cohort study of adolescents and women desiring reversible contraceptive methods. Participants were recruited from the two abortion facilities in the St. Louis region and through provider referral, advertisements, and word of mouth. Contraceptive counseling included all reversible methods but emphasized the superior effectiveness of LARC methods (IUDs and implants). All participants received the reversible contraceptive method of their choice at no cost. We analyzed abortion rates, the percentage of abortions that were repeat abortions, and teenage births.

RESULTS: We observed a significant reduction in the percentage of abortions that were repeat abortions in the St. Louis region compared with Kansas City and nonmetropolitan Missouri (P<.001). Abortion rates in the CHOICE cohort were less than half the regional and national rates (P<.001). The rate of teenage birth within the CHOICE cohort was 6.3 per 1,000, compared with the U.S. rate of 34.3 per 1,000.

CONCLUSION: We noted a clinically and statistically significant reduction in abortion rates, repeat abortions, and teenage birth rates. Unintended pregnancies may be reduced by providing no-cost contraception and promoting the most effective contraceptive methods.

The study’s researchers have set up an excellent website, The Contraceptive Choice Project, along with a YouTube video (see above) on what would happen if women had access to birth control methods that worked best for them, and the project is on Facebook. You can also read more about the findings at Women’s Health Policy Report.

While the study seems pretty intuitive — removing a major obstacle to birth control use (cost) means that more women use it and the rate of unintended pregnancies goes down — strangely enough, this argument rarely seems to convince abortion foes to support contraception.

Why is that? For starters, some conservatives are unwilling to concede that contraception lowers the rate of unintended pregnancies. As Amanda Marcotte smartly explains, their real opposition is to sex, not to reducing the number of abortions.

Anti-abortion groups have also promoted a specious argument attempting to redefine how contraception works. One provision of the Affordable Care Act requires coverage of women’s preventive services, including contraception, without cost sharing in new health plans. This provision has been decried by those who have religious objections to birth control in general, and by a segment of the anti-reproductive rights crowd that believes contraception is equivalent to abortion.

The conservative group Focus on the Family, for example, sent an alert to its supporters claiming that “the federal government is requiring both religious and secular employers to fund possible abortion-inducing drugs.” The email was sent in response to a federal judge in Missouri’s recent dismissal of a lawsuit challenging the contraception mandate of the federal health care law.

It would take you about two seconds of Googling to find many, many other examples of anti-abortion groups and individuals claiming that contraception is a form of abortion, especially if there is even the remotest possibility that the method may interfere with the implantation of a fertilized egg, which they have insisted is the case with emergency contraception.

But as The New York Times recently reported, emergency contraception (also known as the morning-after pill and marketed under the brand names of Plan B and Ella) doesn’t prevent fertilized eggs from implanting in the womb:

Rather, the pills delay ovulation, the release of eggs from ovaries that occurs before eggs are fertilized, and some pills also thicken cervical mucus so sperm have trouble swimming.

It turns out that the politically charged debate over morning-after pills and abortion, a divisive issue in this election year, is probably rooted in outdated or incorrect scientific guesses about how the pills work. Because they block creation of fertilized eggs, they would not meet abortion opponents’ definition of abortion-inducing drugs.

Medically, women aren’t considered pregnant until a fertilized egg implants, and it’s not possible to carry a pregnancy to term without successful implantation. Despite these medical definitions and standards, the belief that contraception equals abortion persists.

So, where does that leave us? Certainly findings like the St. Louis study provide important evidence of what works to reduce abortion rates, and the study bolsters our arguments for contraception access. What’s less clear, though, is what works to counter the notion that birth control = abortion.

If opponents sincerely believe this, how well do fact-based arguments work to change their minds? Have we seen any evidence of other fact-based appeals resulting in shifts in opinion? Share your thoughts in the comments.


September 26, 2012

Conversations We Shouldn’t Still Be Having: Pelvic Exams Under Anesthesia

In the October issue of the journal Obstetrics and Gynecology, a medical student writes of his discomfort with a practice many people may be surprised to learn still occurs — medical students practicing pelvic exams, without explicit consent, on women who are under anesthesia for surgery.

The student, Shawn Barnes, writes that the practice left him “ashamed.”

“For 3 weeks, four to five times a day, I was asked to, and did, perform pelvic examinations on anesthetized women, without specific consent, solely for the purpose of my education,” writes Barnes. “To my shame, I obeyed.”

He continues:

As a medical student, I am all too aware of the hierarchy that exists during training. My medical education experience has reinforced the notion that the medical student should not question the practices of those above him or her. I was very conflicted about performing an act that I felt was unethical, but owing to both the culture of medicine and my own lack of courage, I did not immediately speak out against what I was asked to do by residents and attendings.

His commentary, titled “Practicing Pelvic Examinations by Medical Students on Women Under Anesthesia: Why Not Ask First?,” is available only by subscription/purchase, or through a library, as is a related editorial in the same issue, “Pelvic Examinations Under Anesthesia: A Teachable Moment.”

Carey M.York-Best and Jeffrey L. Ecker, authors of the editorial, remark that no one knows how often these exams occur, and they point out that teaching hospitals, which are expected to train students, do ask patients for general consent for students to be involved in their care. However, they rightly note that blanket consent is inadequate when it comes to pelvic exams:

After all, consent forms at many teaching hospitals include a statement outlining the involvement of students in patient care. Yet we believe that, even if such phrases may meet the letter of recommended conduct, they often are overlooked and a few words on an already too-long form do not represent true informed consent.

Barnes also calls these forms inadequate, and he also doesn’t buy the argument that women should expect such things when they go to a teaching hospital:

We first must remember that patients tend to seek care at facilities that are geographically nearby, where their regular physician has privileges, or where their insurance is accepted. Consent forms at teaching hospitals tend to use language stating that medical students and residents may be involved in that case. That involvement is not specified.

Practicing pelvic exams on women under anesthesia purely for teaching purposes — not for the women’s medical benefit — is not a new practice. However, many may have assumed it had largely stopped, particularly after a 2003 study (which I discussed several years ago) drew a lot of attention to the issue, causing many medical schools to clarify their policies and/or seek women’s explicit consent. Several professional medical organizations have also denounced the practice.

The study was based on a 1995 survey of students at five U.S. medical schools. The researchers found that only about a third of the students thought it was “very important” to get consent prior to doing a pelvic exam. Students who had actually done an ob/gyn clerkship were even less likely to think consent was important. Almost 10 percent of those students actually responded that explicit consent was “very unimportant.” The overwhelming majority (90 percent) of the ob/gyn clerkship students had performed pelvic exams on women under anesthesia.

Back to 2012 — Barnes informs readers that as a result of a bill signed into law this past June, Hawaii (where he studies) will join California, Illinois, and Virginia in making “unconsented” pelvic examinations against the law. For those interested in learning more, his testimony is included among these documents supporting the Hawaii bill.

This may be an opportunity for advocacy in other states, where it may be possible to get similar laws passed.


September 14, 2012

Task Force Update: Routine Ovarian Cancer Screening Not Recommended for Most Women

Earlier this month, the U.S. Preventive Services Task Force reaffirmed its previous recommendation that most women don’t need routine ovarian cancer screening.

The agency looked at recent evidence to see if anything new has been published that might alter its 2004 recommendation and concluded, once again, that annual screening is likely to do more harm than good in women who do not have any symptoms, genetic markers, or other increased ovarian cancer risk factors.

The reason? Studies have shown that the current methods for regular screening — transvaginal ultrasonography or serum CA-125 testing — are not effective in reducing ovarian cancer deaths in women without increased risk.

For many women, these tests will produce incorrect results suggesting cancer, causing women to undergo unnecessary surgery in order to get confirmation. Surgery can include the removal of a healthy ovary and associated harms such as infections or blood clots.

The recommendation does not apply to women with known genetic mutations that increase their risk for ovarian cancer. The Taskforce has also produced this fact sheet that explains the rationale for the recommendation and includes information to help you decide if you should be screened.

Groups Agree with Recommendation, But Screening Still Common

The Taskforce is not alone in its findings. The American Congress of Obstetricians and Gynecologists does not recommend screening for ovarian cancer in asymptomatic women. And the American Cancer Society has stated that there is no screening test proven to be effective and accurate in early detection.

Despite the USPSTF’s 2004 recommendation against routine screening, many physicians still provide it, likely misunderstanding its utility. According to the The New York Times, based on a 2008 survey:

But some doctors continue to recommend screening anyway, and patients request it, clinging to the mistaken belief that the tests can somehow find the disease early enough to save lives. A report published in February in Annals of Internal Medicine, based on a survey of 1,088 doctors, said that about a third of them believed the screening was effective and that many routinely offered it to patients.

Research on Screening Continues

In addition to finding no new evidence supporting annual screening, and additional evidence on harms, the Task Force also notes that research continues on specific methods of screening and screening in general.

“The main gap in our knowledge,” write Taskforce members, “remains the uncertain ability to offer effective treatment of cancer at an early stage to improve the ultimate outcome.”

The recommendation, then, might change in the future if better evidence is found that screening can reduce deaths or if forms of screening are devised that can be shown to affect survival rates.

Cara Tenenbaum of the Ovarian Cancer National Alliance emphasizes that more research is needed to find better methods of screening: “The task force’s recommendation underscores how badly we need an effective screening test for ovarian cancer. Ovarian cancer is the deadliest gynecologic cancer because it often isn’t detected until the disease is in an advanced state.”

CDC Campaign Advises Women to Pay Attention to Physical Changes

The most common symptoms of ovarian cancer include bloating, pelvic or abdominal pain, trouble eating or feeling full quickly, and urinary symptoms, such as frequent or urgent urination. These symptoms could apply to a range of health issues — most of the time, they’re caused by other, less serious health issues.

The Centers for Disease Control  has created an Inside Knowledge campaign to raise awareness about gynecologic cancers. The campaigns includes fact sheets and posters in Spanish and English, and radio and television public service ads featuring women discussing the symptoms that led them to visit their health care provider. The ad below features writer and performer Jenny Allen.

CDC Inside Knowledge Campaign

 Plus: For more links to news stories and analysis, read the Women’s Health Policy Report.


August 31, 2012

Dear Researchers, Your Gender Bias is Showing

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

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

Now for the eyeroll.

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

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

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

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

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

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

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

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

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

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

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

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


June 22, 2012

Hormonal Contraception and Heart Risks

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

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

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

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

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

The authors summarize the risks:

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

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

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

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

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


June 14, 2012

New AHRQ Info for Consumers and Public Comment

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

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

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

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

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


May 31, 2012

Media Coverage of Health News

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

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

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

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

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


April 2, 2012

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

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

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

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

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

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

About Coleman’s article, though, they write:

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

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

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

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

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

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

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

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


March 22, 2012

New Recommendations for Cervical Cancer Screening

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

Changes from the old recommendations include:

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

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

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

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

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

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

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


January 31, 2012

Lesbian and Bisexual Women With Breast Cancer History Sought for Study

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

From the email announcement:

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

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

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

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


January 3, 2012

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

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

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

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

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

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

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