(Slow) Progress Towards Uncovering Sex-Linked Differences in Drug and Device Safety and Efficacy

In 2000, the General Accounting Office (since re-named the Government Accountability Office) reported that more women than ever were being included in clinical trials funded by the National Institutes of Health.  In fact, the GAO noted, over 50% of the participants in the trials that NIH funded in fiscal year 1997 were women.  At the same time, the NIH had made much less progress implementing the requirement that certain clinical trials it funds be designed to reveal sex-linked differences in a treatment’s safety and efficacy.  In 2012, sex-linked differences in responses to treatments are still not being studied in research funded by the government or by the private sector.  In a summary released last month of an Institute of Medicine workshop on the problem, Theresa Wizemann reports that “[e]ven when women are included in clinical trials, the results are often not analyzed by sex” despite “growing acknowledgement that men and women have substantial and widespread biologic differences.”

As its title — “Sex-Specific Reporting of Scientific Research” — suggests, a focus of the IOM Workshop was whether medical journals could drive reform in this area by requiring that authors report sex-specific data.  Wizemann writes that because “[r]esearchers are eager to have their papers published in high-profile journals[,]” “editorial policies implemented by those journals can be effective in modifying behavior.”  But several participants in the IOM Workshop noted that studying population subgroups poses “methodologic and analytic” challenges.  In many cases, Wizemann reports, “achieving statistical significance for subgroup analyses would require unattainable or unjustifiable numbers of participants.”  Workshop participant Gregory Curfman, who is the Executive Editor of the New England Journal of Medicine, “cautioned against editorial policies that require trials to be designed to reach valid statistical conclusions for males and females separately[,]” because “[s]uch editorial policies would create a ’steep mountain to climb for investigators and for funding agencies[.]‘”

The participants in the Workshop seemed to be largely in agreement that journals could not, acting alone, re-shape “research culture to embrace consideration of sex differences as part of sound study design.”  There are steps that journals could (and should, I think) take short of dictating study design, though, including requiring study authors to tabulate and make available raw sex-specific data to facilitate future studies that draw on data from multiple trials.

Government agencies and other funders have a role to play too.  The NIH should more stringently enforce the statutory requirement that certain later-stage trials it funds be designed to evaluate sex-linked differences, and the FDA should take similar action with regard to trials funded by drug and device companies.

A study published last year by Sanket Dhruva, Lisa Bero, and Rita Redberg in the journal Circulation highlighted how little progress the FDA made on the device side over the last decade.  In 1994, the FDA issued a directive requiring that every time it makes a decision on an application for approval to market a new device, it issue a Summary of Safety and Effectiveness Data (SSED) that includes, among other things, a “gender bias” statement addressing the following two questions: (1) Did the proportion of men and women in the clinical trial reflect the distribution of the disease? and (2) Were there any sex-linked differences in safety or effectiveness?  Dhruva and colleagues reviewed all of the of the SSEDs for all of the cardiovascular premarket approval applications submitted and approved between 2000 to 2007 and found (1) that women were underrepresented in the underlying clinical trials and (2) that less than half (41%) of the SSEDs included the required “gender bias comment or analysis.”  Nearly a third (28%) did not even report the percentages of men and women enrolled in the studies supporting the application.  And, there was no improvement over time; “[t]here was no change in the presence of gender bias comments or analyses over the 8-year period” studied.

The FDA has been working for several years to address the problem and in December of 2011 it released a draft guidance in which it “strongly recommends” that device companies work closely with the agency to “investigate and report differences in study outcomes of treatment by sex.”

The Guidance provides clear direction for companies regarding (1) increasing the percentage of enrollees in device trials who are women, (2) designing studies to allow for the “consideration of sex and associated covariates” such as body size, (3) analyzing study data for sex-linked differences, and (4) “reporting sex-specific information in summaries and labeling for approved devices.”  Whether these strong recommendations translate into strong and consistent agency action remains to be seen, but the Guidance is an excellent start.  As Carolyn Clancy, the Director of the Agency for Healthcare Research and Quality, who participated in the IOM Workshop, emphasized, “[b]etter data on women would be better data for everyone,” allowing for more specific clinical practice guidelines and better-tailored care of individual patients.

A Call for Improved Guidance on Research with Pregnant Women

This month, the thoughts of Christians around the world turn to a laboring mother in “a stable at midnight in Bethlehem in the piercing cold.” It seems an appropriate time to direct your attention to the work of the Second Wave Initiative, “a collaborative academic effort to advocate for, and help find, ethically and scientifically responsible solutions for increasing our knowledge base for the treatment of pregnant women who face medical illness.”

At the end of October, the Initiative submitted comments on the Department of Health and Human Services’ Advance Notice of Proposed Rulemaking (ANPRM) regarding revisions to the regulations governing human participation in federally-funded research, known as the Common Rule.  The Initiative’s comments, of which I am a co-signatory, call attention to the fact that the ANPRM fails to address “vagaries and constraints” in the current regulations “that make it difficult for researchers to feel comfortable understanding the parameters of responsible research with pregnant women.”

The Initiative recommends that HHS take the following five steps.

First, amend the Common Rule to allow for research in pregnant women, fetuses, and neonates that creates a minor increase over a minimal risk of harm, as is already permitted in children. The Initiative’s comments explain that the regulations currently provide that “any research that does not carry the potential for direct health benefit to pregnant woman or fetus is disallowed unless it involves ‘no more than minimal risk.’”  Some government officials have concluded from this that even pharmacokinetic studies — which involve nothing more risky than drawing blood and which are vital to determining dosing in pregnancy — are ruled out.

Second, eliminate the requirement that, with certain delineated exceptions, fathers must consent to research that “holds out the prospect of direct benefit solely to the fetus.” The current regulations do not require paternal consent where there is a prospect of direct benefit to the pregnant woman or, oddly, where there is no prospect of direct benefit to the pregnant woman or the fetus.  The regulations governing pediatric research seem more sensible, requiring that both parents give consent where the research involves greater than minimal risk and holds out no prospect of directly benefitting the child.

Third, amend the regulations so that they no longer label pregnant women as “vulnerable.” As Seton Hall Law’s Carl Coleman has explained, the Common Rule does not define vulnerability and the examples it gives of vulnerable populations are diverse.  With regard to pregnant women, “it is not clear why any special issues related to capacity or coercion would necessarily arise.”  The Initiative recommends changing the word “vulnerable” to “population meriting special regulation.”

Fourth, confirm that HHS’ proposed changes with regard to research that is excused from ethics review and research that is eligible for expedited review encompass research with pregnant women. The Initiative contends that explicit confirmation is necessary “to avoid inappropriate exceptionalism about pregnancy on the part of researchers and institutional review boards.”

Finally, “establish and formally charge a working group to propose new model language for the special regulation of clinical research with pregnant women that strikes a more appropriate and more just balance of rights, needs, and interests.” As I explained here, “[w]e lack data on the efficacy or safety or both of most drugs when used by pregnant women. … Without denying or dismissing the real moral conundrums that arise in maternal-fetal medicine, the information gap is deeper and wider than that.”  To the extent that the Common Rule creates unjustified barriers to desperately-needed, ethically-appropriate research, revisions must be made.

The Global Burden of Stillbirth

As a teenager in the late 1980s, I was a huge fan of the model Christy Turlington Burns.  As I’ve blogged about before, in 2011 there’s much more to admire about her than her enduring beauty.  Over the weekend, Turlington Burns and others representing her advocacy organization, Every Mother Counts, ran the ING New York City Marathon to, in her words, “make the vital connection for people that so many pregnant women live far from health services around the world and that distance does make a difference [in the prevention of maternal mortality]. Simply put, we want to run so that others don’t have to…”

Just as distance makes a difference in the prevention of maternal mortality, it also makes a difference in the prevention of stillbirth.[1] In the introduction to a special series of articles that ran in The Lancet in April of this year, Zoe Mullan and Richard Horton note that 98% of the estimated 2.64 million stillbirths each year, “occur in low-income and middle-income countries, and in places such as south Asia and sub-Saharan Africa, at least half of them take place during labour or birth.”  In addition to reducing maternal and newborn mortality rates, then, closing the literal and figurative distance between pregnant women and childbirth care would prevent many stillbirths from occurring.

In a pair of important articles - Stillbirths: What Difference Can We Make and At What Cost? and Stillbirths: How Can Health Systems Deliver for Mothers and Babies — The Lancet’s Stillbirths Series Steering Committee delves into the prevention question in detail.  The Steering Committee systematically assessed 35 potential interventions to determine (1) whether they were effective at reducing the stillbirth rate and (2) “whether they are affordable and implementable in low-income and middle-income countries.”   The following ten interventions passed the Committee’s test and were strongly recommended for implementation: “periconceptional folic acid fortification, insecticide-treated bednets or intermittent preventive treatment for malaria prevention, syphilis detection and treatment, detection and management of hypertensive disease of pregnancy, detection and management of diabetes of pregnancy, detection and management of fetal growth restriction, routine induction to prevent post-term pregnancies, skilled care at birth, basic emergency obstetric care, and comprehensive emergency obstetric care.”  Of these, the Committee recommended that skilled care at birth and emergency obstetric care take priority, both because they were the most effective at reducing the number of stillbirths and because they additionally benefit women and newborn babies.

The Stillbirths Series Committee estimated that “[i]n 68 countries accounting for 92% of the worldwide burden of stillbirths in 2008, universal coverage of care (99%) with intervention packages in 2015 could save up to 1.1 million (45%) third-trimester stillbirths, 201,000 (54%) maternal deaths, and 1.4 million (43%) neonatal deaths at an additional cost of US $2.32 per person, which is well below the WHO and World Bank criteria for cost-effectiveness.”  While it seems only fair to consider this “triple return for every dollar invested” in determining funding priorities, the tragedy of stillbirth does not always “count.”

The World Health Organization’s Global Burden of Disease analysis, for example, which aims to “provide[] a comprehensive and comparable assessment of mortality and loss of health due to diseases, injuries and risk factors for all regions of the world[,]” does not factor in stillbirths.  The WHO explains on its website that “[p]erinatal mortality, defined as number of stillbirths and deaths in the first week of life per 1,000 live births, is a useful additional indicator, and work is ongoing to improve estimates of stillbirth rates, a major component of perinatal mortality.”  The United Nations’ Millennium Development Goals similarly fail to include reducing the rate of stillbirths.  This should change.  In the words of Mullan and Horton in The Lancet, “stillbirths matter to people” and “stillbirth prevention should be placed as highly on global and national health agendas as prevention of maternal and neonatal deaths.”

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[1] I thank Catherine Finizio, the Administrator of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, for keeping me focused on this important issue.  (My prior posts are here and here.)  Cathy’s grandson, Colin Joseph Mahoney, was stillborn at 39 weeks gestation on November 10, 2008.

Mother’s Day Maternal Health Update

Inspired to act to reduce maternal mortality after she survived a postpartum hemorrhage, renaissance woman Christy Turlington has been making the rounds promoting her documentary No Woman No Cry, which tells the stories of at-risk pregnant women in Bangladesh, Guatemala, Tanzania, and the United States.  If you have been in a Starbucks lately you may have seen the compilation compact disc of the same name, the proceeds of which support the advocacy organization Turlington founded, Every Mother Counts.  As Turlington writes, “almost all of the hundreds of thousands of maternal deaths that occur each year are preventable. Yes, 90 percent!”

While the developing world bears the brunt of the global burden of maternal mortality and morbidity, the United States is not immune.  Women in 49 other countries have a better chance of surviving childbirth.  Passage of the Maternal Health Accountability Act of 2011, which was introduced by Representative John Conyers (D-MI) on March 3, 2011 and is currently pending in the House Committee on Energy and Commerce’s Subcommittee on Health, would be an important step towards redressing the problem of maternal mortality and morbidity here at home.

Among other things, the Act would provide funds to states to improve the reporting and tracking of pregnancy-related deaths.  In a recently-released report, the Council of State and Territorial Epidemiologists noted that maternal & child health “is the one program area in which overall state-level epidemiology and surveillance capacity increased progressively from 2004 to 2009, bucking the trend of an overall decrease in state-level epidemiology capacity.”  On the other hand, “the MCH epidemiology capacity glass is only half full: nearly half of all states lack even substantial MCH epidemiology and surveillance capacity, and in only a minority of jurisdictions do MCH epidemiologists participate substantially in policy development; have access to important data sets; and work with colleagues in substance abuse, mental health, and occupational health.”

The Maternal Health Accountability Act would also direct the National Institutes of Health to “organize a national workshop to identify definitions for severe maternal morbidity and make recommendations for a research plan to identify and monitor such morbidity in the United States.”  As the Act’s findings section explains, “[s]evere complications that result in women nearly dying, known as a ‘near miss’ or severe morbidity, according to some estimates, increased by 25 percent between 1998 and 2005, to approximately 34,000 cases a year. However, there is no scientific consensus on uniform definitions of severe maternal morbidity and best practices for data collection, making it difficult to measure the full extent of severe morbidity and developing evidence-based interventions.”  Finally, the Act would direct the Secretary of Health and Human Services to conduct research and establish demonstration projects targeting the stark geographic, racial, and socioeconomic disparities in maternal health outcomes.  According to Amnesty International’s Spring 2011 Deadly Delivery report, “[n]ew government data shows that for 2005-2007, the maternal mortality ratio (deaths per 100,000 live births) was highest among non-Hispanic black women (34.0), followed by American Indian/Alaska Native women (16.9), Asian/Pacific Islanders (11.0), non-Hispanic whites (10.4), and Hispanics (9.6).”

Importantly, tackling the problem of maternal mortality and morbidity need not wait until Congress acts.  In an article in the April issue of the American Journal of Obstetrics & Gynecology, Hospital Corporation of America, a chain of 114 inpatient facilities that claims to be the “largest obstetrical health care delivery system in the United States,” reported on its highly-successful obstetric patient safety program.  Among other things, HCA expanded the number of free, online programs it offers on topics such as fetal heart rate monitoring, postpartum hemorrhage, and shoulder dystocia, with the goal of educating providers and ensuring that they use “common terminology and thus avoid potentially hazardous miscommunication.”  In addition, HCA engaged in process standardization efforts including the development of checklist-based protocols and supported the development of national quality metrics to facilitate benchmarking.  HCA has been effective at reducing elective delivery before 39 weeks gestation and it “instituted a policy of universal perioperative pneumatic compression device use in all patients undergoing cesarean delivery.”  (I discussed the latter intervention here.)  HCA reports that its efforts have paid off, not just in outstanding perinatal outcomes, but also in reductions in litigation, as reflected by reported claims.  In 2009, the company’s losses due to “accidents on hospital grounds” exceeded its losses due to maternal mortality and morbidity.  Even more impressive, its “perinatal loss (in dollars) … is rapidly approaching the level of loss seen in the category ‘occupational therapy.’”

HCA opines “that adoption of our approach on a national level could, within 5 years, both dramatically reduce adverse perinatal outcomes and to a large extent eliminate the current national obstetric malpractice crisis.  In reality, a relatively small number of repeated errors lead to most preventable adverse outcomes, and may be reduced by the approaches outlined above.”  The company is not optimistic that its approach will be widely adopted, however, because it believes that efforts to improve perinatal outcomes have been hindered by “an alternative culture in which physician autonomy and anecdotal experience trump available data and the recommendations of the Institute of Medicine, contributing to a ‘normalization of deviance’ at odds with a safety-based culture.”  I wonder how physicians would respond to this interesting and provocative claim.  Might they argue that hospital policies and practices are at least in part to blame for our stalled efforts to reduce maternal mortality and morbidity?

Stillbirth: A “Largely Unstudied” Problem

While the ubiquitous pink ribbons (and pink everything else) ensure that everyone knows that October is Breast Cancer Awareness Month, less well known is that it is also Pregnancy and Infant Loss Awareness Month[1], proclaimed so by President Ronald Reagan in 1988.  As I wrote last October, about 1 in every 160 deliveries in this country ends in a stillbirth, and all too frequently no one can say why.  Stillbirth is a “largely unstudied …  problem in obstetrics.”

Encouragingly, the work of the physicians and scientists participating in the National Institute of Health’s Stillbirth Collaborative Research Network (SCRN) is beginning to bear fruit.  The August 2010 issue of the journal Obstetrics & Gynecology included an important article in which the SCRN investigators presented their “standardized method to assign probable and possible causes of death of stillbirths based on information routinely collected during prenatal care and the clinical evaluation of fetal death.”  Rigorously defining and more accurately determining causes of fetal death will both facilitate research and have useful clinical implications.  As the authors note, “[a]ccurately assigning a cause of fetal death is critically important for counseling grieving families.”

There will be much more to come from the SCRN, which has completed data collection on three distinct studies conducted between March 2006 and December 2009.  The first is a surveillance study designed “to assess the completeness of two reports of stillbirths: hospital labor and delivery logs and state vital statistics records. The data from the two sources will be linked statistically to determine incidence of stillbirth, the extent of under- or over-reporting, and factors associated with reporting.”  The second study entails a complete evaluation of 500 women and their 512 stillborn babies; the study also includes a control group of 1,932 women with live births.  The goal of this study was to develop and apply the method for determining cause of fetal death discussed above, with the ultimate goal of “determin[ing] maternal and fetal risk factors associated with increased risk of stillbirth.”  Finally, the SCRN conducted a follow-up study of the participants in the second study who experienced stillbirths, “to determine how many of the women have had subsequent pregnancies and subsequent pregnancy complications; how well women with a loss have resolved their grief and whether grief resolution is associated with the course and care of the pregnancy; and whether life-course stresses and environmental factors are associated with an increased risk of stillbirth.”

Research of the sort conducted by the SCRN is expensive and time consuming.  The SCRN investigators collected and are now analyzing 130,000 forms containing information provided by study participants and 120,000 maternal, fetal, and placental samples.  Stillbirth is an important public health problem but one that private sector actors lack the incentive or wherewithal or both to tackle.  Government support for research into what causes it and what can be done to prevent it is crucial — something for advocates to bear in mind as the struggle unfolds over funding for the National Institutes of Health for Fiscal Year 2011.

Photo Credit: I Should Be Doing Laundry via Flickr.

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[1] I thank Catherine Finizio, the Administrator of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, for keeping me focused on this important issue.  Cathy’s first and only grandson, Colin Joseph Mahoney, was stillborn at 39 weeks gestation on November 10, 2008.

A Breastfeeding Report Card

This week, the CDC released its 2010 Breastfeeding Report Card and, on some measures at least, we passed.  Most notably, the Healthy People 2010 target for the early postpartum period has been met.  Three out of four American newborns now begin life breastfeeding.  For older babies, the news is not so good, with “rates of breastfeeding at 6 and 12 months, as well as rates of exclusive breastfeeding at 3 and 6 months remain[ing] stagnant and low.”

The reasons for the drop off are not hard to guess.  In her recent article Respecting Working Mothers with Infant Children: The Need for Federal Intervention to Develop, Protect and Support a Breastfeeding Culture in the United States, Barry Law School professor Heather M. Kolinsky explains that “[i]f a woman does not have flexibility in her schedule and a place to pump, then the desire to breastfeed is often squelched by the demands and realities of the workplace.”

As Katherine Matos noted here, Section 4207 of The Patient Protection and Affordable Care Act, which is captioned Reasonable Break Time for Nursing Mothers, is an attempt to smooth the way for new mothers to continue breastfeeding after they return to work.  Section 4207, which went into effect with the passage of PPACA, requires that employers provide “a reasonable [uncompensated] break time for an employee to express breast milk for her nursing child for 1 year after the child’s birth each time such employee has need to express the milk; and … a place, other than a bathroom, that is shielded from view and free from intrusion from coworkers and the public, which may be used by an employee to express breast milk.”  Smaller employers (i.e., those with less than 50 employees) are exempt to the extent that “such requirements would impose an undue hardship by causing the employer significant difficulty or expense when considered in relation to the size, financial resources, nature, or structure of the employer’s business.”

It will be interesting to see whether the passage of Section 4207 will lead to an increase in the rates of breastfeeding at 6 and 12 months.  If it does, the gains may exacerbate existing inequalities.  Older, more highly educated, higher income mothers are already more likely to breastfeed past the newborn stage.  They may also be more likely to work for large employers subject to Section 4207, in positions with the flexibility necessary to take regular breaks to pump breastmilk.  As Hanna Rosin put it in The Case Against Breastfeeding, her highly controversial 2009 article in The Atlantic, “[e]xplain to your employer that while you’re away from your baby, ‘you will need to take breaks throughout the day to pump your milk,’ suggest the materials from the awareness campaign.  Demand a ‘clean, quiet place’ to pump, and a place to store the milk.  A clean, quiet place.  So peaceful, so spa-like.  Leave aside the preposterousness of this advice if you are, say, a waitress or a bus driver.”

The Downfall of Mammography?

Mammography’s reputation as gold standard in breast cancer screening took another hit this past month.  As the New York Times reported last week, research studies demonstrate that the radiation emitted by mammography can actually increase the incidence of cancer. Two nuclear technologies, breast-specific gamma imaging (B.S.G.I.) and positron emission mammography (P.E.M.), expose “patients to a risk of radiation-induced cancer that is comparable to the risk from an entire lifetime of yearly mammograms starting at 40.”

While digital mammography has an average lifetime risk of inducing 1.3 fatal breast cancers per 100,000 women aged 40 at exposure, a single B.S.G.I. exam was estimated to involve a lifetime risk 20 to 30 times greater in women aged 40, and the lifetime risk of a single P.E.M. was 23 times greater.

Moreover, mammography only increases a woman’s risk for breast cancer while B.S.G.I. and P.E.M. increase the risk of cancer in other organs, such as the intestines, kidneys, bladder, gallbladder, uterus, ovaries and colon, the study said.

That’s right, the risk of breast cancer is greater in those women that regularly receive mammograms.  At a November 30, 2009 conference, researchers reported that “for young women who have a high risk of breast cancer because of genetic mutations or family history, the radiation from yearly mammograms may make the risk even higher.”  Meta-analysis of prior research pertaining to high-risk women (0.5 - 1% of the population) with a median age of 45 found that “those women who had had mammograms or chest X-rays (which use a lower radiation dose than mammography) were more likely to have breast cancer.”

Researchers Question the Value of Mammography

The great mammogram debate began on October 21, 2009, when a Journal of the American Medical Association article stated that mammography is not as effective as anticipated:

[S]creening may be increasing the burden of low-risk cancers without significantly reducing the burden of more aggressively growing cancers and therefore not resulting in the anticipated reduction in cancer mortality… There are several reasons that may help to explain why screening has not led to a more significant reduction in deaths from these 2 diseases in the United States. First, screening increases the detection of indolent cancers. Second, screening likely misses the most aggressive cancers.

The “increasing burden of low-risk cancers” can be characterized by the high rate of false positive tests, resulting in over-treatment. As a prior HealthReformWatch post reported:

The recent analysis of all the available evidence from multiple studies published in the British Medical Journal shows that if 2,000 women are screened with mammograms regularly for ten years, only one single woman’s life will be prolonged, but 500 will have at least one false positive and ten will be diagnosed with a “cancer” that would never have become a real disease if it had been left alone.

The New York Times reports that since the mammograms became widely used in the 1980s, the diagnosis of ductal carcinoma in situ (D.C.I.S.), what many believe to be a breast cancer precursor, has increased significantly with more to more than 50,000 women in the U.S. each year.  However, the diagnosis of these borderline breast legions has raised concerns that 17 percent of diagnoses are false positives.

Researchers at Dartmouth College succinctly summed up the deficits of mammography.  In addition to the discomfort of x-ray mammography:

• The rate of false negatives from x-ray mammography range from 4% to 34%
• X-ray mammography is less sensitive in women with dense breast tissue (a common among trait among young women who are at high-risk for developing the most aggressive breast cancers)
• Seventy-five percent of biopsied lesions resulting from suspicious mammogram findings turn out to be benign (a false-positive)

It would be surprising if the Food and Drug Administration (FDA) approved an imaging modality with such poor results today.  However, the FDA never approved x-ray mammography for the diagnosis of breast cancer; it was grandfathered by the Medical Device Amendments of 1976 because it was already in clinical use.  The mammogram does not detect cancer directly, but is a measurement of tissue abnormalities such as microcalcifications, architectural distortions, masses, and asymmetrical densities.

The only mammography device to pass the pre-market approval (PMA) process is the T-Scan 2000 ED by Mirabel Medical Systems, a form of impedance imaging.  Research into impedance imaging has received attention because it does not emit radiation, can more accurately image dense breast tissue, and can differentiate between tissue types without biopsy.  Despite producing greater sensitivity in clinical trials than x-ray mammography or ultrasound, it has not become a primary imaging method.

So When Should Mammography Be Used?

The rumblings of debate turned into a roar when the U.S. Preventive Services Task Force (USPSTF) changed its breast cancer screening recommendations.  The Task Force listed many of the foregoing problems, including false positives, overdiagnosis, and radiation exposure, in support of its decision.  Despite the evidence that more effective screening measures are needed, the response in support of x-ray mammography was overwhelming.  As HealthReformWatch reported:

A number of professional and advocacy groups have responded to the Task Force’s November 16 recommendation.   The ACS continues to recommend annual screening using mammography and clinical breast examination for all women beginning at age 40.  The American College of Radiology issued a frankly titled statement, “USPSTF Mammography Recommendations Will Result in Countless Unnecessary Breast Cancer Deaths Each Year” and labeled the recommendations “cost cutting.”  And the American Congress of Obstetricians and Gynecologists continues to recommend a screening mammography every 1-2 years for women aged 40-49 years and every year for women 50 and over, as well as to recommend BSE.

The editors of Annals of Internal Medicine, which published the Task Force recommendations, responded in an editorial titled, When Evidence Collides With Anecdote, Politics, and Emotion: Breast Cancer Screening.  ”Although prevention is vital to public health, none of the previous guidelines grabbed the public’s attention as much as the Task Force’s recommendation against “routine screening mammography in women aged 40 to 49 years.”  Results of an Annals‘ website survey suggested that clinicians are more likely than the general public to be influenced by the Task Force recommendations.  In response, the editors took a position in support of the new recommendations:

Unfortunately, only a fraction of abnormalities initially detected on mammography and subsequently treated truly represents a life saved rather than unnecessary or premature treatment. Sadly, it is also true that many women who have cancer detected by screening die of the disease despite early detection and treatment… Breast cancer prematurely claims the lives of many, but it is wrong to mislead women about the effectiveness of current screening methods. Women deserve to make decisions about screening for breast cancer armed with the best available information about potential benefits and harms.

One survey respondent wrote, “This Task Force has performed a vital service for years. It brings a welcome dose of science to the politics of screening.” The editors heartily agree… Because the USPSTF issued recommendations that were politically unpopular among some constituents, there have been calls to curtail this independent body’s work. If the USPSTF sinks in turbulent waters whipped up by emotion, anecdotes, and politics, Americans should mourn its loss.

Politics and Science in the Breast Cancer Screening Debate

But what role do politics actually play in breast cancer screening?  According to Dr. Barron Lerner of Columbia University College of Physicians & Surgeons, a big one. In an interview with Kaiser Health News, he recounted:

In the late 1990s, Congress passed a bill that mandated that women who had a mastectomy would have their reconstructive surgery paid for. If you think about this, this really doesn’t happen in most areas except for breast cancer, where Congress would act, and say, “This is something we’re forcing insurance companies to do.” But it speaks to the powerful nature of the breast-cancer lobby.

One other time a report came out criticizing mammograms… the House voted 430 to nothing [ed. note: it was 424-0] — to rebuke that scientific report. So, politics is always intruding into the world of breast cancer….

In the early 1990s, there was some suggestion that if you did something called a bone marrow transplant, or stem cell transplant — which was a very aggressive treatment for metastatic breast cancer — that women live longer… The power of that lobby was so strong that insurance companies began to pay for the procedure, even though it was still experimental and its value hadn’t been proven….

It turns out that when the randomized studies came through and we got good data — at the end of the 1990s — that treatment was, in fact, no better than standard chemotherapy and caused more harm along the way. So it was not indicated at all. But, again, this was an example of Congress, or the government, sort of sticking its foot where it shouldn’t — trying to do the right thing, trying to insure access for all women who have a serious disease. But if you don’t look at the data and you’re acting based on your heart, or your gut instinct, you often make the wrong decision.

In supporting some breast cancer treatments, some lobby groups divert important resources away from important goals (e.g., development of an x-ray mammography alternative) and waste them on every promise of hope (e.g., extensive x-ray screening despite evidence of its negative effects).  The most recent example involves the new drug Avastin.

As the Fiscal Times reports, the FDA gave “accelerated approval” for the marketing of Avastin in 2008.  Two confirmatory trials submitted earlier this year led an FDA advisory committee decision to withdraw agency approval.  The first study showed that Avastin did not delay patient death and a second study indicated that patients on Avastin actually died more quickly than those on chemotherapy alone.  In spite of these findings, Susan B. Komen for the Cure chief Nancy G. Brinker and Sen David Vitter, R-La, have called upon the FDA to continue its approval of Avastin.  The FDA has yet to issue a decision.

How Much Does PPACA Really Benefit Women?

A recent article by the Commonwealth Fund entitled Realizing Health Reform’s Potential: Women and the Affordable Care Act of 2010¸forecast that “over the next decade, the Affordable Care Act (ACA) is likely to stabilize and reverse women’s growing exposure to health care costs.”  However, a review of the claimed benefits shows that many are equally important to men and women.

Such claims of gender-specific benefits without statistical support are also available from the White house.  That being said, there are some provisions that will greatly benefit women — and to supporters’ detriment — have not received the focus that they should.

Intended Benefits

Several portions of PPACA are intended to benefit women.  The prohibitions against gender-based insurance denials or premium pricing are aimed at combating blatant gender-discrimination in the insurance market.  7.3 million women (38%) in the individual insurance market reported that they were turned down, charged a higher price, or had a preexisting condition excluded from coverage (see graphic below).  As the White House reports, “Right now, a healthy 22-year-old woman can be charged premiums 150 percent higher than a 22-year-old man.”  Such gender-based rating is allowed in 42 states, with some plans charging women as much as 84% more than men for the same age group.  As Secretary Sebelius phrased it, “[b]eing a woman is no longer a pre-existing condition!”

S. Collins, S. Rustgi, and M. Doty, Realizing Health Reform’s Potential: Women and the Affordable Care Act of 2010, The Commonwealth Fund, July 2010.

The essential benefits standards require insurers to cover maternity care, eliminating previously reported pregnancy-discrimination.  Only 13 percent of plans sold in the individual market provide maternity benefits and “in 22 states, no plan covered costs related to pregnancy.”  Other plans impede access to maternity benefits by placing severe limits on costs covered or implementing long waiting periods before coverage begins.

Other services that must be covered by all non-grandfathered health plans beginning September 2010 include:

• Breast cancer screening every one to two years for women age 40 and older
• Cervical cancer screening
• Genetic counseling for the breast cancer (BRCA) gene
• Osteoporosis screening for all women 65 and older, and 60 and older for those at high risk
• Aspirin to prevent cardiovascular disease in women ages 55 to 79

PPACA has several other provisions focused on breast cancer–including, “a special provision directed at raising awareness of, and increasing screening for, breast cancer in young women,” and a directive to pursue breast cancer prevention research in younger women.

Section 4207 of PPACA amends Section 7 of the Fair Labor Standards Act (”FLSA”) by requiring employers to provide “reasonable break time for an employee to express breast milk for her nursing child for 1 year after the child’s birth each time such employee has need to express the milk… [in] a place, other than a bathroom, that is shielded from view and free from intrusion from coworkers and the public…”  The Department of Labor Fact Sheet #73 further explains that a space temporarily converted or made available will be sufficient.

Unintended Benefits

The ban on pre-existing conditions exclusions will remedy a number of  unfair and discriminatory insurance industry practices. It will benefit women in the eight states and District of Columbia where insurers may legally reject a woman’s application on the basis of her prior experience as a victim of domestic violence.  It will also benefit women who would have been previously denied, on the basis of a previous cesarean section, either future C-sections or health insurance as a whole.

Also, the phase-out of the “doughnut hole” coverage gap in the Medicare prescription drug benefit )Part D) will incidentally help more women than men.  Of the 16% of Medicare beneficiaries that reach the doughnut hole each year, women (along with Alzheimer’s and diabetes patients) are the most likely to reach the gap in coverage.

Benefits for Men

So how do men benefit from PPACA?  For starters more men will benefit from the extended health insurance coverage mandated by PPACA.  Although women comprise 60% of adult Medicaid beneficiaries (in 2006), 54.6% of all uninsured are men (in 2007-2008).  The Medicaid safety net has caught more women than men.  However, that is a completely different social discussion to be had another day.

*Note: uncited statistics can be found in the Commonwealth Fund article, S. Collins, S. Rustgi, and M. Doty, Realizing Health Reform’s Potential: Women and the Affordable Care Act of 2010, The Commonwealth Fund, July 2010.

Recent Empirical Research Suggests Rise in Cesarean Section Rates Not Caused by Malpractice Liability Pressure

In my recent post on the NIH’s consensus development conference on vaginal birth after cesarean, I noted that one of the recommendations coming out of the conference was that “medico-legal” reforms “be developed, implemented, and evaluated” to determine their effect on cesarean section rates.  Recent empirical research indicates that such reforms are likely to have little impact.

Prior work suggested that medico-legal reforms could play a significant, if supporting, role in efforts to reduce the number of unnecessary cesarean sections.  For example, the authors of a 2006 study published in Health Affairs analyzed the disturbingly large disparities in cesarean rates from county to county and concluded that, for normal weight births, 14.5 percent of the variance in rates was attributable to variance in malpractice premiums and the number and size of malpractice payouts.  Another study published in the journal Medical Care in 2009 found, among other things, a small negative association between cesarean section rates and two types of tort reforms — caps on noneconomic damages and pre-trial screening panels.

In an article in the latest volume of American Law and Economics Review, Influence and Deterrence: How Obstetricians Respond to Litigation Against Themselves and Their Colleagues, Northwestern University researchers David Dranove and Yasutora Watanabe move beyond “macro measures of the malpractice environment” and “tak[e] a micro look at the data, examining on a quarterly basis how physicians respond to claims lodged against themselves and their immediate colleagues.”  Using two rich data sets from Florida, one of all hospital births between 1994-2000 and another of every resolved malpractice claim from that state from 1979-2003, Dranove and Watanabe generate answers to three provocative questions:  Do obstetricians perform proportionally more cesarean sections after they have been sued?  Do their cesarean section rates increase in the wake of suits against other obstetricians at their hospital?  What about when the number of lawsuits filed against non-obstetricians in their county goes up?  The answer to the first two questions is yes, but the “effects are both small in magnitude and very short-lived.”  Moreover, the effect disappears after an obstetrician has been sued once; subsequent suits have no effect.  The answer to the third question is no.

Dranove and Watanabe theorize that “[t]he fact that [the effect of a physician's own history] is short-lived and limited to obstetricians with no previous contacts may indicate that obstetricians overreact to their first contact.  It is possible, for example, that they rapidly discover that the litigation process is neither costly nor particularly painful.  For example, physicians rarely make a financial payment to the plaintiff and do not appear to lose any income as a result of being sued (Danzon et al. 1990; Zeiler et al., 2008).”  They conclude that “[w]hatever has caused the pronounced upswing in [c]esareans, it is not due to the influence of individual, hospital-wide, or regional contacts with the legal system.”  This, of course, causes one to wonder what has caused the “pronounced upswing;” in a subsequent post, I will look at other possible explanations, including reasons related to health care finance and organization.

Solving the Mysteries of Pregnancy

In last week’s JAMA, the Pandemic H1N1 Influenza in Pregnancy Working Group reported that their analysis of nationwide data on 2009 influenza A (H1N1) in pregnant women revealed that “early antiviral treatment appeared to be associated with fewer admissions to an ICU and fewer deaths.”  Pregnant women who were not treated with antiviral medication until 3-4 days after they began experiencing flu symptoms were more likely to die than those who were treated within 2 days of symptom onset.  Women who were first treated with medication more than 4 days after symptom onset were 54 times more likely to die than those who were treated within 2 days.

The authors speculate that the “reasons for delayed treatment … could include reluctance of pregnant women or clinicians to use antiviral medication because of concern for risk to the fetus, despite available evidence suggesting that treatment benefit likely outweighs the potential risk.”  Given the shocking 54-fold increased risk of death associated with late initiation of antiviral medication, the authors’ use of the qualifiers “suggesting” and “likely” is noteworthy.  They are forced to hedge because, as a group of experts convened by the CDC acknowledged in late 2009, “[l]ittle is known about the effects of the four currently available influenza medications on the fetus.”

In my article The Mysteries of Pregnancy: The Role of Law in Solving the Problem of Unknown But Knowable Maternal-Fetal Medication Risk (forthcoming in the University of Cincinnati Law Review), I point out that this information gap is not unique to antivirals.  We lack data on the efficacy or safety or both of most drugs when used by pregnant women.  A frequent shorthand explanation for the dearth of information is that you cannot test drugs on pregnant women because of ethical concerns.  Without denying or dismissing the real moral conundrums that arise in maternal-fetal medicine, the information gap is deeper and wider than that.  As Ruth Faden puts it: “Everyone thinks, Oh, my God, research on pregnant women!  All kinds of ethical flags go up.  We don’t have to start with high drama.  [There's enough] low-hanging fruit that we could keep lots of medical researchers busy for a long time.”

Two FDA-led efforts promise to begin connecting the dots: the Medication Exposure in Pregnancy Risk Evaluation Program, which will conduct epidemiological research using data on approximately 1 million births gathered by the 11 participating research sites, and the Sentinel Initiative, which is creating a national electronic system with the goal of, among other things, allowing for prompt investigation of the safety of newly-approved drugs in pregnant women.  Other government agencies also have roles to play.  For example, the house committee report accompanying the Departments of Labor, Health and Human Services and Education Fiscal 2010 Appropriations measure encouraged the NIH “to  expand research on pregnant women with the goals of better understanding the long-term health effects on women of disease states in pregnancy, the proper therapeutics for pharmacologic treatments for pregnant women who face illness, and the safety and efficacy of medications administered to pregnant women and fetuses.”   Finally, industry can and should do more.  Congress should empower FDA to require pharmaceutical companies to sponsor maternal-fetal medication research in appropriate cases, authority the agency already has in the pediatric arena.

Health Reform, Women Helped Make It Happen

As I watched C-SPAN last Sunday afternoon, I found it inspiring that the health care legislation was being voted on in the House during Women’s History Month.  And to see the fight to passage being led by two amazingly powerful women, Speaker of the House Nancy Pelosi, and her right-hand woman Representative Louise Slaughter of New York, the milestone of health care reform became even more monumental for me. The commitment to health care reform by women leaders such as Pelosi and Slaughter led to the reconciliation bill’s passage on Sunday.

Nancy Pelosi, who is now being called “Lyndon Johnson in a skirt,” was vital in rallying needed Democratic votes last Sunday.  Pelosi held individual meetings with many of the swing-voters, reminding them of the importance of the bill.  In addition, many cite her persuasive skills in keeping the Obama Administration from ceding more to Republican demands.  Meanwhile on the floor of Capitol Hill, Louise Slaughter, a Congresswoman whose district serves Rochester, Niagara Falls, and Buffalo, NY, added a personal element of to reform as she called on other representatives to share stories of their constituents’ everyday issues with the current health care system.

Though some were said to be uncomfortable with the executive order which essentially reiterated the Hyde Amendment, there are a number of wins that women can point to, regardless of their stance regarding the executive order.  Women will have cheaper premiums since insurance companies can no longer practice gender rating.  They will have coverage for needed preventive care like mammograms and Pap smears.  In 2014, insurance companies will be required to cover maternity care, newborn care, and certain mental health care.  Also by 2014, health insurance companies will no longer be able to discriminate based on pre-existing conditions such as C-sections and past domestic abuse.  Women who are small business owners also stand to gain from the reform.  By 2014, small firms will be allowed to pool together in exchanges to purchase health insurance.

Though neither side was fully satisfied with the final bill, the fact that uninsured Americans will be guaranteed access to quality, affordable health care warrants an applause for those leaders who worked to make health care for all a reality.

NIH Panel Recommends Medico-Legal Reform to Reduce Elective Repeat Cesarean Delivery Rate

In December 2009, an Arizona woman made the news when, in her ninth month of pregnancy, she left her husband and three sons behind and traveled to Phoenix, six hours away from her home, to await the birth of her fourth child.  She took these drastic measures because she wanted to give birth vaginally but her local hospital did not allow women who have had a cesarean section to attempt a vaginal delivery.

Last week, the NIH held a consensus development conference on vaginal birth after cesarean (”VBAC”) to evaluate, among other things, the sharp increase in elective repeat cesarean deliveries in the United States and the medical and non-medical factors that have caused it.  The panel convened by the NIH found that both a trial of labor in women who have had a prior cesarean and an elective repeat cesarean delivery have “important risks and benefits” that “differ for the woman and her fetus.”  A trial of labor is associated with a statistically significant increase in risk of uterine rupture and in risk of perinatal death.  Elective repeat cesarean delivery, on the other hand, is associated with a statistically significant increase in risk of maternal death.  Moreover, as the number of prior cesareans goes up, the risk of serious harm to both mother and baby does too, which is of particular concern to women who hope to have large families.  As the panel notes, these facts and figures pose “a profound ethical dilemma for the woman as well as her caregivers, because benefit for the woman may come at the price of increased risk for the fetus and vice versa.”

The panel concluded that for certain women — those with a “prior low transverse uterine incision” — a trial of labor is a reasonable choice, albeit one that it increasingly constrained by difficulty accessing clinicians and facilities able and willing to offer it. Among the non-medical barriers to VBAC is a recommendation made by the American College of Obstetricians and Gynecologists and the American Society of Anesthesiologists that women with a prior cesarean not be permitted to attempt a vaginal delivery unless the hospital has “immediately available” surgical and anesthesia personnel.  The panel concluded that this recommendation should be reassessed in light of “other obstetrical complications of comparable risk, risk stratification, and in light of limited physician and nursing resources.”

The panel also found that “medico-legal considerations add to, as well as exacerbate” barriers to VBAC.  Midwife Amy Romano, who writes the Science & Sensibility blog for Lamaze International, explains that because “lawsuits focus entirely on the counseling around [uterine] rupture rates, and doctors are sued if that counseling isn’t done or documented effectively, then the doctor has a financial incentive to focus on rupture likelihood[.]“  This steers women toward elective repeat cesarean delivery and exacerbates the already formidable liability barrier to VBAC.  The panel predicted that “caps on noneconomic damages and reductions in physician malpractice premiums would result in fewer cesarean deliveries” and recommended that these and other interventions to reduce the liability barrier be developed, implemented, and evaluated to determine their efficacy.

Rising Maternal Death Rate: A Sentinel Event

California Watch, a project of the Center for Investigative Reporting, reported earlier this month that the rate of maternal deaths directly related to pregnancy and birth nearly tripled in California between 1996 and 2006– from 5.6 maternal deaths per 100,000 live births to 16.9 per 100,000.  Even after accounting for improved information gathering, the rate has more than doubled and “[c]hanges in the population — obese mothers, older mothers and fertility treatments — cannot completely account for the rise … said Dr. Elliott Main, the principal investigator for the task force” that prepared the report.  While the reason or reasons for the rise in deaths are not yet understood, Dr. Main notes that the rate of Cesarean sections increased by 50 percent over the 1996-2006 time period.

Sadly, California is unlikely to be unique in this regard.  Maternal death rates have probably increased in other states and in the country as a whole as well.  On January 26th, the Joint Commission issued a Sentinel Event Alert to hospitals, notifying them that “current trends and evidence suggest that maternal mortality rates may be increasing in the U.S.”  The Commission acknowledged that that incidence of maternal death remains low — at an estimated 13.3 deaths per 100,000 live births — and that a possible reason for the increases seen is better identification of women who die during or shortly after pregnancy.  Still, the Commission quoted the CDC’s Dr. William M. Callaghan as follows: “[T]here clearly has been no decrease in maternal mortality in recent years, and we are not moving toward the U.S. government’s Healthy People 2010 target of no more than 3.3 maternal deaths per 100,000 live births[].”  Moreover, “[m]aternal deaths are the tip of the iceberg for they are a signal that there are likely bigger problems beneath — some of which are preventable,” says Dr. Callaghan. “It is important to consider the women who get very, very sick and do not die, because for every woman who dies, there are 50 who are very ill, suffering significant complications of pregnancy, labor and delivery.”

Not all maternal deaths are preventable, of course.  To reduce the rate of those that are, the Joint Commission suggests a number of actions for hospitals and physicians to take, including participating in state-level maternal mortality reviews and developing protocols (and holding drills to train staff on the protocols) for responding to conditions such as hemorrhage and pre-eclampsia.  More concretely, the Commission quotes Dr. Steven L. Clark of the Hospital Corporation of America who argues that the “only cause of maternal death amenable to nationwide systematic prevention efforts is pulmonary embolism [a blood clot in the lung].”  Disappointingly, while nearly all adult patients undergoing major surgery receive prophylactic measures for the prevention of venous thromboembolism (VTE) — even patients with no risk factors for the condition — pregnant women undergoing Cesarean delivery traditionally do not, despite the fact that they are at increased risk.   In light of the Commission’s Sentinel Event Alert, it seems to me that hospitals would be well-advised to adopt VTE prophylactic measures for all pregnant women undergoing Cesarean sections at once.  Is there a downside I am missing?

New Breast Cancer Screening Recommendations Cause Controversy

Rarely do medical recommendations or clinical guidelines receive such immediate and passionate attention as those released this month by the U.S. Preventive Services Task Force (USPSTF), an independent panel of doctors and scientists who make recommendations to the Department of Health & Human Services.  In a striking detour from prior recommendations by the Task Force and those of the American Cancer Society (ACS) that women over 40 receive a mammogram every one to two years, the Task Force now recommends:

• “against routine screening mammography in women aged 40 to 49 years”;
• “biennial screening mammography for women aged 50 to 74 years”;
• “against teaching breast self-examination (BSE)” (emphasis added).

In a radio interview on the new guidance, Dr. Bruce Calonge, chair of the Task Force, was asked about the USPSTF recommendation against routine screening for women in their 40’s and “the possibility that some women may die as a
result of not having routine mammograms.”  Calonge’s astonishing answer:

“what women really need to understand in that decade is that overall reduction in mortality, which is for all comers in that age group, only about 15%, because breast cancer is relatively rare in that age group, that benefit is really quite small…”

Although he claimed that cost analysis had no place in the Task Force’s recommendations, later, focusing on early detection generally, he repeated,

“I think one of the things that is important to say… that mammography’s benefit is only a 15% reduction in mortality.”

Kathleen Sebelius, HHS Secretary, has clarified that the federal policy on breast cancer screening has not changed, despite the Task Force’s recommendations.   In response to concerns that patients who seek mammograms before the age of 50 would not be covered by health insurance, Sebelius stated that she “would be very surprised if any private insurance company changed its mammography coverage decisions as a result of this action.”  Despite such assurances, if past experience is a guide insurance companies will use these criteria to determine coverage.

A number of professional and advocacy groups have responded to the Task Force’s November 16 recommendation.   The ACS continues to recommend annual screening using mammography and clinical breast examination for all women beginning at age 40.  The American College of Radiology issued a frankly titled statement, “USPSTF Mammography Recommendations Will Result in Countless Unnecessary Breast Cancer Deaths Each Year” and labeled the recommendations “cost cutting.”  And the American Congress of Obstetricians and Gynecologists continues to recommend a screening mammography every 1-2 years for women aged 40-49 years and every year for women 50 and over, as well as to recommend BSE.

So what would the task force’s mammography recommendations mean for patients?  The changes to the recommendations extend beyond the age at which they recommend beginning mammography screening.  For example, the 2002 USPSTF recommendations explained, “[t]he precise age at which the benefits from screening mammography justify the potential harms is a subjective judgment and should take into account patient preferences” (emphasis added).  The elimination of the term “preferences” and the focus on “patient context” and the “patient’s values regarding specific benefits and harms” indicates a move toward evidence-based medicine, whereby a patient’s inclinations and personality are taken less into consideration or play a less significant role in predicting outcomes.  In a November 17 New York Times article, the author asks,

Are you the sort for whom shivering in a paper gown, enduring discomfort and waiting a week for results is so unnerving that you are thrilled for a decade-long reprieve? Or are you that woman who gets an extra breast sonogram with your gynecologist even when it is not medically indicated? Do you trust scientists or prefer your own gut?

These concerns seem more like preferences than medically-supported decision-making factors.   The 2009 recommendations instruct that “the patient’s values regarding specific benefits and harms” be taken into account — but do not explain how far “patient context” be considered.  The recommendations do not apply to women with “known underlying genetic mutation or a history of chest radiation.”  Beyond these two exceptions, how will doctors and patients make individual decisions to start regular, biennial screening mammography?  The recommendations should be appreciated for confirming — to an extent — that the decision to begin regular screening mammography is individual.  The doctor and patient, in collaboration, should consider the patient’s risk tolerance, family history, and any other applicable factors.  Sebelius recommends that patients “[k]eep doing what you have been doing for years — talk to your doctor about your individual history, ask questions, and make the decision that is right for you.”  It is unclear how the Task Force’s recommendations could affect the decision to begin mammography in an educated and reasoned way.

The Task Force’s self-examination recommendation is also worrisome.  The USPSTF states that “there is moderate or high certainty that [BSE] has no net benefit or that the harms outweigh the benefits.”  However, discouraging the use of self-examination — a short, free, easy, and non-invasive process — might seem astonishing to many, particularly those who have known someone for whom a BSE has been the means by which breast cancer was first discovered.  Appreciating the concern about BSE leading to higher incidences of biopsies, additional screenings, and false-positive test results, with the increasing focus on disease prevention, this recommendation seems, at best, counter-intuitive, particularly when taking into account those who are uninsured and may not pursue other methods of breast cancer screening.

The House Democrats’ Health Care Plan Unveiled, Questions on Women’s Access to Health Care Remain

Last Thursday, October 29^th, House Democrats announced their bill for health care reform, the Affordable Health Care for America Act.  The House bill includes provisions such as a public option and employer mandates.  For women, the House bill has been a controversial issue; though the bill contains provisions that will expand women’s access to certain areas of health care, other areas have been neglected.

On the plus side is the bill’s prohibition of domestic violence being categorized as a pre-existing condition for health insurance purposes.  Ms. Pelosi was able to follow through on her promise to women that such a discriminative practice would be ended through the House bill.  Meanwhile, U.S. News attributes the inclusion of women’s health needs in the bill to the widespread women-led activism for health care reform.  Still, as significant aspects of women’s access to health are yet left unaddressed, some advocates wonder if we should have asked for more.

One issue of contention is that an amendment to the the bill allows for 12 years of exlcusivity for biologic drugs– some of which have been found particularly efficacious in the treatment of breast cancer. In addition to the 12 year exculsivity period, manufacturers will also be able still to engage in the process known as “evergreening,” the practice of changing a drug slightly–such as altering the time release mechanism– and thereby garnering additional periods of exclusivity. These periods of exclusivity prohibit cheaper generic versions of the drug– known as “follow-on biologics” or “biosimilars” from entering the marketplace. (To read more about the biologic exclusivity debate read here and here.) The end result would seem to point– if money matters (and when does it not?),  to a decrease in the availability of breast cancer biosimilars and thus a decrease in available efficacious treatment.  One of the bill’s sponsors, Anna Eschew of California, defends the proposal on the grounds that it does not interfere with women’s access to breast cancer treatment, and that it only curbs the ability of bio-pharmaceutical generic competitors to freely utilize the costly, extensive research and development of the original bio-pharmaceutical innovators.  Eschew believes that lesser periods of exclusivity will have a chilling effect on biologic research and development– as lesser exclusivity would make it more difficult for the original developers of the drugs to recoup the large expenses associated with such development.

Reproductive health care issues have also come to the forefront of the debate, but with a clear consensus yet to have emerged on what the bill does or does not cover within the various exchanges, options and subsidies within the bill.

While political groups are preparing to battle out these issues, one thing remains constant, women are a force that both democrats and republicans want on their side.  The House Democrats were paying attention when drafting their health plan, but the holes still left in women’s health care access might mean that women need to make themselves heard again–and this time, maybe a little louder.

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