All posts by Amy Tuteur, MD

“Evidence based maternity care” is not evidence based

The Childbirth Connection is an advocacy organization for the “natural” childbirth industry. In an ongoing effort to promote the socially constructed values of a small subgroup of women, it publishes papers that purport to show that “natural” childbirth is supported by the weight of scientific evidence, and is desired by the majority of American women. There’s just one problem; it’s not supported by the weight of scientific evidence and it does not represent the desires and values of American women.

It’s widely publicized Listening to Mothers Survey II (2006) is a case in point. The report concludes that obstetric technology is overused, there are too many interventions, there are too many C-sections and women are not appropriately informed of the risks of interventions. Yet the conclusions are completely belied by the evidence in the report.

Mothers generally gave high ratings to the quality of the United States health care system and even higher ratings to the quality of maternity care in the U.S… [M]ost felt that the malpractice environment caused providers to take better care of their patients.

By law … women are entitled to full informed consent or informed refusal before expriencing any test or treatment. Most mothers stated that they had fully understood that they had a right to full and complete information … and to accept or refuse any offered care…

A small proportion of mothers reported experiencing pressure froma health professional to have labor induction (11%), epidural anesthesia (7%) and cesarean section (9%)… Despite the very broad array of interventions presented and experienced … just a small proportion (10%) had refused anything …

The Childbirth Connection wrote a report about listening to mothers, and then proceeded to ignore that mothers were pleased with American obstetric care. Why did they ignore their own evidence? They ignored it because it did not match the predetermined conclusion that the socially constructed values of the “natural” childbirth industry represent the “ideal” way to give birth.

Yesterday they published their latest effort to substitute their personal values for the scientific evidence and for the values of the majority of women in the US. As usual, they start with the conclusions and work backward. As usual, they present no evidence to support their claims. You can read the entire 128 page report here. I cannot summarize all 128 pages, but I will offer three specific examples of the way in which the Childbirth Connection attempts to pass off personal opinions as scientific evidence.

First, the title of the report is truly Orwellian, Evidence Based Maternity Care: What Is It and What Can It Achieve. The title is Orwellian because virtually none of the conclusions are supported by evidence in the paper or any evidence at all. The fundamental claim, that “natural” childbirth with minimal intervention is better, safer and healthier is not supported by scientific evidence. This is a classic example of using “scientese” to trick people. Obstetrics is evidence based medicine. “Natural” childbirth is values based opinion. Trying to hide that fact does not fool anyone who is familiar with the actual scientific evidence.

Second, the willingness to place personal opinion above scientific evidence is best exemplified by the section of the report on epidurals.

… Labor epidurals alter the physiology of labor and increase risk for numerous adverse effects. Undesirable maternal effects include immobility, voiding difficulty, sedation, fever, hypotension, itching, longer length of the pushing phase of labor, and serious perineal tears.

The authors provide no references to back up these claims. The central claim, that epidurals alter the physiology of labor is flat out false. The scientific evidence shows the opposite.

The authors have simply fabricated several of the so called “undesirable” maternal effects including immobility, and sedation. That begs the larger question: undesirable to whom? The answer is that the side effects (the real ones, not the made up ones) are undesirable to the members of Childbirth Connection. The authors provide no evidence that the patients consider these side effects to outweigh the benefits of effective relief.

Indeed, the authors acknowledge that the majority of women do not share their disdain for epidurals, but in the classic manner of “natural” childbirth advocates, they ascribed it to ignorance without offering any proof.

Many laboring women welcome the pain relief of epidural anesthesia, but they do not appear to be well-informed about the side effects.

Once again the authors present no evidence for their implication that women would forgo pain relief if they were “better” informed.

Third, the report, like virtually all “natural” childbirth and homebirth advocacy is filled with deliberate distortions. The authors compare neonatal mortality rates among countries, and fail to compare the more accurate measurement of perinatal mortality. The authors discuss the “charges” for obstetric procedures instead of the actual reimbursements. The authors claim that systematic reviews “give the most trustworthy knowledge about beneficial and harmful effects of specific health interventions,” but that is flat out false. Systematic reviews are completely dependent on the quality of the studies that the authors choose to include and whether those studies are representative of the existing scientific literature. Systematic reviews are a good starting point for evaluating obstetric procedures, but they are hardly the “most trustworthy” sources of scientific information.

This report from the Childbirth Connection is not consistent with the scientific evidence, and is not consistent with the desires and values of the majority of American women. It is nothing more than an extended attempt to promote the personal opinions of a small group of “natural” childbirth advocates.

Cutting HIV by cutting

Yesterday’s Journal of the American Medical Association (JAMA) included an important new study on the effect of circumcision on transmission of HIV, the virus that causes AIDS (Circumcision Status and Risk of HIV and Sexually Transmitted Infections Among Men Who Have Sex With Men A Meta-analysis, Gregorio A. Millett; Stephen A. Flores; Gary Marks; et al. JAMA. 2008;300(14):1674-1684 ). The study adds information to our understanding of how HIV is transmitted and what we can do to reduce the spread of the virus. Unfortunately, lay publications misrepresented the findings of the study, calling the value of circumcision into question.

 The new study does not change what we already know: circumcision dramatically reduces the risk of transmitting HIV. The new study merely shows that the protective effect, which is quite strong among heterosexual men, does not extend to gay men having certain forms of sex.

 The protective effect of circumcision was discovered by epidemiological data. Studies of the incidence and prevalence of HIV among heterosexual African men revealed that circumcision is associated with a statistically significant protective effect against HIV. However, correlation is not causation, and large scale controlled studies were done to determine if circumcision really does prevent the transmission of HIV. The accompanying editorial in JAMA explains:

Adult male circumcision reduced HIV acquisition among … heterosexual men in South Africa, Kenya, and Uganda with effect sizes that were remarkably consistent and similar to those predicted by the earlier observational studies. The biological plausibility of HIV protection resulting from male circumcision has been supported further by … studies indicating the susceptibility of the inner foreskin for virus-target cell contact… [C]ircumcision was determined to protect against HIV in high-quality, well powered clinical trials in 3 different nations of Africa. Based on the biological, histopathological, epidemiologic, and clinical trials evidence, global health leaders now promote circumcision for reducing HIV risk in heterosexual men.

 The new study sought to answer a different question. Does circumcision protect against HIV transmission in among men who have sex with men (MSM)? We know that circumcision prevents transmission of HIV in vaginal intercourse, but does it offer the same protective effects in other forms of sex? Unfortunately, to date there have been no studies that specifically address this issue. Therefore, the authors of the JAMA study reviewed studies done for other purposes from 1989-2008 to see if they could find any information about circumcision and gay sex.

 The authors reviewed thousands of studies on circumcision but were only able to find 15 that had recruited gay men, used circumcision as a study variable, and tested for HIV status. Keep in mind though that none of the studies were focused on the effect of circumcision on the transmission of HIV among gay men. The authors describe the studies:

The 15 studies were conducted between 1989 and 2007… The average quality of the studies … was moderate. Five studies that met 5 or more study quality criteria were considered the highest quality; the remaining studies fulfilled fewer than 5 of the scale’s 8 study criteria… A total of 53 567 MSM were included in our analytical sample, 52% of whom were circumcised.

 When the authors pooled the data from these 15 studies, they found:

… a protective, albeit statistically nonsignificant, association of circumcision with HIV infection in our metaanalysis of MSM observational studies …Our data revealed that male circumcision conferred a significant protective effect from HIV infection among MSM in studies conducted before [retroviral drug therapy] but not after, possibly due to documented increases in sexual risk behavior during the era since the availability of [retroviral drug therapy].

 In other words, the review of these 15 studies could not answer the question of whether circumcision is as effective in preventing the transmission of HIV in gay men as it is in heterosexual men. Where does that leave us? According to the accompanying editorial:

… [I]s further research warranted to evaluate the effect of circumcision on HIV incidence in MSM? Most scientists and policy makers will argue a vigorous yes, because MSM continue to be disproportionately over represented in new HIV cases …There is a global need to know whether male circumcision should be considered a tool in the fight against HIV transmission among MSM…

Infant and adult circumcision are recommended in regions with high HIV prevalence as in sub-Saharan Africa. But the question as to whether MSM should be circumcised to reduce their HIV risk, particularly men who preferentially practice insertive sex, is one that only future research can answer.

 Circumcision is still one of the most effective tools in limiting the transmission of HIV. It remains to be seen whether the benefits observed in heterosexual sex will extend to gay sex as well.

Never events: Medicare won’t pay, but you will

Medicare, like all health insurers, is constantly looking for way to avoid paying for medical care. The latest attempt sounds perfectly reasonable, until you consider who will bear the burden.

As of October 1, 2008, Medicare will no longer pay for what it claims are “never events,” events that should never happen. The purported rationale of this new rule is that by refusing to pay for “mistakes,” Medicare will reduce the number of medical mistakes that occur. There’s precisely zero evidence that refusing to pay reduces mistakes, and there is reason to believe that refusal to pay will hurt patients in ways that have not truly been considered. Don’t have Medicare? This still affects you, since Medicare payment rules are usually adopted in short order by private insurers.

What is a “never event”? Medicare claims that a “never event” is a mistake so easy to prevent that it never should occur. Which events are “never events”? According to the Center for Medicare and Medicaid Services, these seven conditions are in the initial group characterized as “never events”:

•  pressure ulcer stages III and IV;

•  falls and trauma;

•  surgical site infection after surgery for obesity, certain orthopedic procedures, and heart bypass surgery;

•  intravenous-catheter associated infection;

•  bladder catheter-associated urinary tract infection;

•  administration of incompatible blood;

•  air embolism; and

•  foreign object unintentionally retained after surgery.

The first problem is that of the eight stated “never events,” only three are medical mistakes. No instruments or sponges should ever be left behind after surgery, no one should ever receive blood that has not been properly typed and cross-matched, and no one should ever have air introduced into the bloodstream by way of injection or IV. Instituting appropriate hospital procedures can and should be able to prevent all incidents of foreign objects left behind, incompatible blood transfusions and air embolus.

The other five events are not “never events.” They are known complications of hospitalization or illness. They are going to happen anyway, despite best efforts to prevent them. Since they cannot be prevented 100% of the time, Medicare plans to save money by simply refusing to pay for them. That’s not where it ends, though. Someone is going to pay and that someone is going to be the patient.

The burden on patients is going to be far greater than simply being forced to pay for the treatment and extended hospitalizations that result from infections, pressure sores or falls. Consider the case of falls. Elderly people are prone to falling. Often, they are in the hospital because of a fall. Nothing can be done to make those individuals less likely to fall, so the only recourse of the hospital is to prevent the falls from occurring. The most reliable way to do this is to prevent them from getting out of bed without supervision. In the case of the incapacitated elderly, the most reliable way to prevent them from getting out of bed is to tie them into it.

How about procedure related infections? We know that those are who most ill or most frail are more likely to suffer infections. If the hospital knows it will not be reimbursed for infections that are impossible to prevent, it will simply refuse to care for patients most likely to get infections. It will accomplish this by refusing to admit those patients, by denying them the procedures, or by transferring them to other facilities. If all else fails, it will simply bill the patient personally for the treatment that is needed to cure the infection.

Considering pressure sores as a “never event” creates a Catch-22 situation for the hospital. Pressure sores occur when patients are so sick or so weak that they can no longer move themselves in bed. They lie for long periods of time in one position, and the skin in areas under constant pressure begins to break down.

There is one and only one way to prevent pressure sores, and that is by constantly changing the position of the patient in bed. The repeated cutbacks in Medicare reimbursement have made it impossible to staff hospitals with enough people to provide the level of care that prevents pressure sores. Now Medicare is insisting that it will not pay for the unintended results of its own cost cutting measures. The hospital will have only one choice, and that is to refuse to admit patients who might develop pressure sores.

As Roy Poses, MD, president of the Foundation for Integrity and Responsibility in Medicine writes:

“Thus is appears that the surest way to avoid incurring CMS’s proposed financial penalty … it to avoid admitting sicker patients… This, of course, is a perverse incentive that could make care less accessible for those who need it most, and would violate hospitals’ fundamental mission to care for the sick…

Paying physicians for the time it takes to gather information, think about it and thoughtfully come up with the best possible plan for each individual patient would do a whole lot more to improve quality and patients’ outcomes than penalizing hospitals … for events that they could not have prevented.”

The ER doctor who blogs at WhiteCoat Rants predicts:

1 You’ll get diagnosed with a lot more illnesses so that it is very difficult to determine what care is for a “never event” and what care is for the “never event.” Then when you have to stay in a hospital longer because of a “never event,” the hospital can allege that the extended stay was really due to a problem that was not a never event. That will mean more testing, more procedures, and higher costs.

2. If you develop a “never event,” you’ll be more likely to get transferred to another hospital. CMS won’t pay for never events if they develop in a hospital, but they will pay for treatment if you present with a pre-existing never event. Hospitals will develop unwritten agreements that certain specialists at each other’s facilities are better suited to treat a certain patient’s “never event.” More transfers mean more redundant testing, higher costs, and more complications from the testing.

3. Testing and diagnosis of never-event conditions will diminish where feasible. That bedsore isn’t a Grade 3 – it’s only Grade 2. CMS will pay for those.

4. Say hello to the Advance Beneficiary Notices. Medicare won’t cover preventative care, so you are going to have to pay for it out of your pocket. If you’re prone to falls or bedsores, you’ll have to pay for a personal nurse to wait on you hand and foot so you don’t develop these never events. If you don’t pay for a personal nurse 24 hours around the clock to keep a never event from happening, you’re personally responsible for paying the costs of treatment if the “never events” occur. You had the opportunity to prevent the events but you were just too cheap to pay for it. I think that ABNs are less likely to catch on, but eventually I think they will become commonplace.

Medicare’s refusal to pay for “never events” is simply the latest iteration of paying for performance (P4P). However, by refusing to pay for complications that cannot be prevented, Medicare will merely shift the burden to the patients themselves, in particular, the oldest and sickest among us.

All natural Cheetos

Sometimes, the most mundane practices can give us insight into our deepest beliefs. Such is the case with marketing of products. For example, the current obsession with “green” products may or may not improve the environment, but it does tell us what ideas have captured the attention of the American public.

Marketing involves various tactics. The best tactic is to market based on the true virtues of the product. So, for example, if a laundry detergent is the best at removing grass stains, you can market it as “best at removing grass stains” and that will attract certain buyers.

Of course, not every product has virtues that are worth marketing. So often times marketers resort to other strategies, appealing to instincts and preconceived ideas of potential buyers. Take Cheetos for example. There is absolutely nothing nutritionally redeeming about Cheetos. No one is going to be able to market them as “good for you”. So the marketers did the next best thing. Appealing to an inate belief among buyers that “natural” is better, they’ve now brought out a product called “All Natural Cheetos”. Cheetos are just as bad for you as they ever were, but the marketers have blunted this perception by appealing to unconscious beliefs about natural products.

How did the marketers of All Natural Cheetos hit upon this strategy? In Packaging as a Vehicle for Mythologizing the Brand in the journal Consumption, Markets and Culture, Knaizeva and Belk identify “Myths of the World in the Past” that influence the “stories” found on packaging.

Packaging narratives depict the modern world as a deeply distorted reflection of what it originally was – the garden before agro-chemical technology. While the values of the past include family, tradition, authenticity, peace, and simplicity, the current era is associated with broken family ties that need to be restored, scientific “advances” that pose threats, constant pressure on the well-being of humans, and unnecessary complexity in everyday life.

The authors pay particular attention to the concept of “naturalness”:

Naturalness appears as a rich emotional construct that connects with positive contemporary images of nature… People do not want to remember that nature can also be destructive as in deadly hurricanes and poisonous mushrooms … In a natural health context, Thompson also finds nature to be a positively framed powerful mythic construction; and his informants attribute magical, regenerative powers to nature. They firmly believe that aligning with what nature has to offer for one’s health lets them assert control over their lives and bodies versus losing control by being complicit in a scientized medical system.

We can see here the spiritual treatment of nature that … pervades alternative medicine, vegetarianism, voluntary simplicity philosophies, the natural childbirth movement, and dietary beliefs linking food to health with a resulting reverence for magical, harmonious, whole, natural foods free of herbicides, pesticides, and genetic modification. These beliefs are in turn linked to puritanical American beliefs that we must take responsibility for our bodies, work hard to perfect our health, cleanse our environment and system of pollutants, and choose the foods that will make us healthy…

Ultimately, these myths are joined in service of the over-arching myth, that of the “enobled and empowered”

consumer:

… [A]ll the significance attached by storytellers to the products transforms otherwise powerless consumers into the powerful marketplace players. As a result, newly empowered consumers can temporarily escape imposed world conditions by shaping their personal myths and servicing their individual lives. Thus, myths of the past are meaningfully used to serve the present.

Marketers exploit these myths precisely because they have so much resonance for consumers. It is these same myths that undergird contemporary health fads such as “alternative” medicine, “natural” childbirth, and fears of an obesity epidemic.

 the myth of idealized nature
the myth of the idealized past
the myth that are health choices will necessarily make us healthy
the myth that making the prescribed choices empowers people

Unfortunately, those myths are nothing more than wishful thinking. There is no such thing as “alternative” health, “natural” childbirth bears no resemblance to childbirth in nature, and healthy choices like eating and exercising to be thin do not necessarily make us healthy.

Whether we choose to respond to these marketing ploys is far less important than examining the assumptions that underlie them. Sometimes our most accepted beliefs, the ones we take for granted, have no basis in fact.

Paying doctors for performance

There’s a new wrinkle in the healthcare debate. It’s called “paying doctors for performance” commonly abbreviated as P4P.

On the face of it, who could object to P4P? A doctor will be paid based on his performance. The better the quality of medicine he practices, the more patients he saves and improves, the more he will be paid. Oh, wait, that’s not what P4P really means. According to proponents, in P4P, the physicians who will be most highly compensated are “physicians who are perceived to be delivering higher quality for lower cost ….”

Therefore, P4P  is fundamentally unethical.

Let’s look at an example:

If an oncologist treats 10 patients at a cost of $1,000 each, and 9 survive, he has saved 9 lives for $10,000.

Now imagine that a second oncologist treats 10 similar patients. The first 9 respond to the $1,000 treatment, but, again, the 10th patient does not. However, this oncologist refuses to give up and creates a new treatment regimen. This regimen fails, too, and the patient is hospitalized with multiple complications of his disease. On the next try, the oncologist comes up with a life saving regimen, and patient #10 lives. Of course, between the first failed attempt, the second failed attempt, the hospitalizations and the third successful attempt, an additional $10,000 has been spent. The second oncologist has saved 10 lives for $20,000.

Whose “performance” is better? Who should be paid more, the doctor who managed to save 9 people at a total cost of $10,000 or the doctor who saved everyone by refusing to give up and creatively designing new treatment regimens at a cost of $20,000?

Obviously, the second oncologist is the “better” doctor. However, I suspect that a P4P system would consider him less cost effective and would penalize him accordingly. In fact, they might penalize the doctor quite severely since he cost the insurance company double the “average” amount spent by the first oncologist.

The example above shows the perverse results of a P4P system which uses “higher quality for lower cost” as its benchmark. It is not surprising that such a system would deliver perverse results because such a system is unethical on its face.

The fundamental relationship in medicine is the doctor-patient relationship. Society and the law recognize this by privileging this relationship in comparison to other types of relationship. The doctor has a moral and and legal obligation to put the patient’s interests and well-being above his own. Obviously, not every doctor will do that. There are some doctors who might recommend expensive treatments purely to enrich themselves. However, we understand those doctors to be unethical, and they may even be subject to legal action.

In dramatic contrast, however, P4P attempts to inject the insurer into the relationship. Even more objectionable, the insurer asks the doctor explicitly to balance the patient’s interests against the doctor’s financial interest. This is fundamentally unethical and should be banned as a result.

American democracy is a rights based system, not a utilitarian one. Ethically and legally, you are not allowed to violate a person’s rights even if it will increase overall happiness or utility. Each person in a democracy is shielded from the power of others and the power of government by these rights.

Similarly, the sanctity of the doctor patient relationship is a moral right. Insurers are not free to violate it simply because it may free up money to care for others (or more likely to profit the insurance company). Furthermore, it is unethical for an insurance company to ask doctors to violate this patient right.

There are many ethical ways to save money in the current healthcare crisis, but P4P is not one of them. 

Breastfeeding and the cult of total motherhood

I am a passionate advocate of breastfeeding and breastfed my four children. Nonetheless, I am disturbed at the way that breastfeeding is wielded by breastfeeding activists (lactivists)  to criticize other women. New studies confirm that many of the purported benefits of breastfeeding have been grossly overstated. The scientific literature shows that while breastfeeding has real benefits, the benefits are actually quite small.

Lactivism is just one aspect of the growing cult of “total motherhood”.  The article Is Breast Really Best? Risk and Total Motherhood in the National Breastfeeding Awareness Campaign by Joan Wolf describes how lactivism is a  facet of a new moralism that has redefined the role of the mother to promote the personal preferences of a select group of women.

… [T]otal motherhood obligates mothers to be experts in everything their children might encounter, to become lay pediatricians, psychologists, consumer products – safety inspectors, toxicologists, educators, and more. Mothers are expected not only to protect their children from immediate threats but also to predict and prevent any circumstance that might interfere with putatively normal development. Total motherhood is a moral code in which mothers are exhorted to optimize every dimension of children’s lives, beginning with the womb, and its practice is frequently cast as a trade-off between what mothers might like and what babies and children must have. When mothers have wants, such as a sense of bodily, emotional, and psychological autonomy, but children have needs, such as an environment in which anything less than optimal is framed as perilous, good mothering is construed as behavior that reduces even minuscule or poorly understood risks to offspring, regardless of potential cost to the mother. (my emphasis)

Breastfeeding has particular significance within this newly defined moral universe:

Breast-feeding is an integral part of the total motherhood discourse. Dubbed “America’s pediatrician” and credited with coining the term “attachment parenting” — which promotes mothers’ constant physical and emotional attachment to their babies — Dr. William Sears is perhaps the country’s best-known breast-feeding advocate. Virtually all of his advice to women takes as its point of departure babies’ needs and the necessity of breast-feeding, and mothers’ well-being is addressed largely through these demands… Sears contends that breast-feeding is better for a baby’s brain, eyes, ears, mouth, throat, kidneys, appendix, urinary tract, joints and muscles, skin, growth, and bowels as well as its respiratory, heart, circulatory, digestive, immune, and endocrine system. The benefits he attributes to breast-feeding are both more extensive and less scientifically defensible than those of the NBAC. “You are doing the most important job in the world,” he tells mothers. “Nothing matters more than this.”

The corrosive nature of such moralizing is on display in public health campaigns designed to promote breastfeeding and in the way that lactivists talk about and treat other women.

… [W]omen’s needs — to work, control their bodies, or sustain an identity independent of their children — become “weaknesses in individual maternal character, to be corrected through educational messages”. This kind of reasoning, which implies that either ignorance, cowardice, or selfishness is behind a mother’s decision not to do what is best for her baby, rests firmly on assumptions about total motherhood in a risk society…

Any woman is free to choose the principles of “total motherhood” for herself and her family. The problem occurs when these women and their supporters assert that what is best for themselves and their families is objectively required either for health reasons or emotional reasons. Lactivists need to understand that their way of looking at the world, and the role of mothers in the world, is only one of many possible ways. While it might currently be a popular view, particularly among Western, white, relatively well educated and relatively well off women, that does not privilege it above other possible ways of understanding the role and obligations of mothers. The “risk society”, “total motherhood” and the view of breastfeeding as a proxy for good mothering are cultural fads, no different than the cultural fads that once considered breastfeeding primitive and ignorant. Lactivists have no right to lie to women about the risks and benefits of breastfeeding, and they have no right to present their view of mothering as superior to anyone else’s view.

 

What’s the right C-section rate? Higher than you think.

Anti-cesarean activists love to point out that the World Health Organization has recommended that the C-section rate should be 10-15%. Unfortunately, the WHO appears to have pulled those numbers out of thin air. Its own data shows that a 15% C-section rate does not result in the lowest possible levels of either neonatal mortality or maternal mortality. Indeed, Dr. Marsden Wagner, who has probably done more than anyone to promote the idea of a 15% C-section rate as ideal, is a co-author of a study that actually demonstrates the opposite.

The paper is Rates of caesarean section: analysis of global, regional and
national estimates
(Paediatric and Perinatal Epidemiology, 2007; 21:98–113.) The article explicitly acknowledges that the 15% C-section rate recommendation was made without any data to support it. This paper is actually the first paper that attempts to compare international C-section rates with maternal and neonatal mortality.

Since publication of the WHO consensus statement in 1985, debate regarding desirable levels of CS has continued; nevertheless, this paper represents the first attempt to provide a global and regional comparative analysis of national rates of caesarean delivery and their ecological correlation with other indicators of reproductive health.

The data regarding C-section rates below 10% is stark:

…[T]he majority of countries with high mortality rates have CS rates well below the recommended range of 10–15%, and in these countries there appears to be a strong ecological association between increasing CS rates and decreasing mortality.

How about the data on C-section rates above 15%? The authors claim:

Interpretation of the relationship between CS rates and mortality in countries with low mortality rates is more ambiguous; nevertheless, the sum total of the evidence presented here supports the hypothesis that, as has been argued previously, when CS rates rise substantially above 15%, risks to reproductive health outcomes may begin to outweigh benefits.

Not exactly. Indeed, not even close. The data show that low maternal mortality and low neonatal mortality are associated almost exclusively with high and very high C-section rates.

The article contains a variety of charts that make this clear. Of note, the charts are of an unusual kind. Rather than graphing C-section rates against mortality rates, the authors chose to graph the log (logarithm) of C-section rates against the log of mortality rates. A log-log graph has the advantage of exposing tiny differences when all the values are bunched close together, but all the values are not bunched together in this situation. C-section rates occur along a broad range, and mortality rates occur along a broad range. As a consequence, the log-log graph magnifies the effect of tiny differences and minimizes the effect of large differences. Therefore, you need to be very careful in interpreting the graphs.

This is an adaptation of the chart that appears in the paper comparing C-section rate to maternal mortality (the authors claim that graphing C-section rate against neonatal mortality produces a similar result). The area representing a C-section rate of 10-15% has been highlighted in yellow. The horizontal blue line represents a mortality rate of 15%. Lower mortality rates are below the blue line and higher mortality rates are above the blue line.

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The data themselves are quite clear. There are only 2 countries in the world that have C-section rates of less than 15% AND low rates of maternal and neonatal mortality. Those countries are Croatia (14%) and Kuwait (12%). Neither country is noted for the accuracy of its health statistics. In contrast, EVERY other country in the world with a C-section rate of less than 15% has higher than acceptable levels of maternal and neonatal mortality. There nothing ambiguous about that.

The authors claim:

Although below 15% higher CS rates are unambiguously
correlated with lower maternal mortality; above this range, higher CS rates are predominantly correlated with higher maternal mortality.

No, that’s not what it shows at all. It shows that only countries with  high C-section rates have low levels of maternal and neonatal mortality. A high C-section rate does not guarantee low maternal and neonatal mortality because C-section rate is not the only factor. For example, Latin America (represented on the chart by open diamonds) has a high rate of C-sections performed for social reasons, but does not have a low level of maternal mortality.

The bottom line is this: The only countries with low rates of maternal and neonatal mortality have HIGH C-section rates (except Croatia and Kuwait). The average C-section rate for countries with low maternal and neonatal mortality is 22%, although rates as high as 36% are consistent with low rates of maternal and neonatal mortality.

The authors claims are not supported by their own data. There is simply no support for a C-section rate of 15%, since virtually none of the countries with low rates of maternal and neonatal mortality have a C-section rate of 15% or below, and most have rates that are far higher. There is also no support for the claim that “the sum total of the evidence presented here supports the hypothesis that … when CS rates rise substantially above 15%, risks to reproductive health outcomes may begin to outweigh benefits”. When C-sections are performed for medical indications, there is no evidence that rising C-section rates lead to rising rates of maternal or neonatal mortality.

The authors own data indicate that a C-section rate of 15% is unacceptably low, and that the average should be at least 22%, with rates as high as 36% yielding low levels of maternal and neonatal mortality.

Are C-section mothers less responsive to their babies’ cry

You may have read recently about the widely publicized study by Swain and colleagues claiming that mothers who had C-sections respond to their baby’s cry differently than mothers who had vaginal deliveries (Maternal brain response to own baby-cry is affected by cesarean section delivery, Swain et al., Journal of Child Psychology and Psychiatry, 2008). The study shows nothing of the kind, and the authors have been utterly irresponsible in the way that they have publicized their findings.

The study itself suffers from so many serious problems that it is hard to know where to begin. The study is too small to draw any conclusions, let alone the conclusions drawn by the authors. We don’t know if there is any validity to the image of brain activity that the authors were looking at. There is no evidence that this image is correlatedin any way with maternal care taking.

These problems are easier to under stand in the following thought experiment:

Suppose I asked my children to toss coins. My son tossed a coin 6 times and got 6 heads, and my daughter tossed a coin 6 times and got 6 tails. Then suppose I wrote a study claiming that gender determines whether a coin lands heads or tails. Wait a minute, you’d say, your study doesn’t prove anything, and you’d be right. My study would prove nothing for the exact same reasons that the Swain study proves nothing.

First, my study, like the Swain study, is underpowered. I haven’t included enough coin tosses for my son or my daughter. We know from probability theory that if I repeated the experiment with my son tossing the coin 6000 times and my daughter tossing the coin 6000 times, they would get the exact same proportion of heads to tails; they would both get 50:50. My results are not valid because I didn’t include enough coin tosses.

Swain and his co-authors looked at the brain imaging patterns of 6 women who had vaginal deliveries and found that they were different from the 6 women who had C-sections. Just like the heads-tails study, the results could simply reflect the fact that the study is far too small.

Second, drawing the conclusion in my coin experiment that gender determines the result of a coin toss rests on the assumption that correlation equals causation. However, we know from the rules of statistics that correlation does not demonstrate causation. Correlation means that two events appear to be related. Causation means that one event caused the other. In my coin toss experiment, gender and coin toss result appeared to be correlated, but that does not mean that gender caused the coins to land heads or tails. It was just a coincidence.

Similarly, in the Swain study, the two different modes of birth appeared to be correlated with brain image, but that does not mean that the mode of birth cause the specific brain image pattern. It could just have easily been coincidence.

Third, my study claiming that gender determines the result of a coin toss would have rest on another flawed assumption, that there is something fundamentally different, beyond appearance, between a coin landing heads and a coin landing tails. In reality, though, there is no difference; it’s just a matter of chance whether a coin lands heads or tails.

Similarly, Swain and colleagues have made a seriously flawed assumption that the two different brain image patterns they observed reflect a fundamental difference in the actual reaction of the mother, not just a matter of chance. In reality, the authors present no evidence that the brain image pattern has anything to do with the mother’s response to her baby’s cry.

This study shows nothing. It could potentially represent an interesting finding that deserves more investigation, or it could be entirely the result of chance. It is extremely irresponsible for the authors to claim that they showed that mode of delivery determines a mother’s response to an infant. It is no better than a coin toss study claiming that gender determines the result of a coin toss.

Was Gardasil overhyped?

The New York Times carried an article in the August 29, 2008 edition asking if the media should be blamed for Gardasil hype. Gardasil, the vaccine that it touted as preventing cervical cancer, has progressed through three stages of media frenzy. First, there was the initial burst of publicity surrounding its introduction, then there was the burst of publicity surrounding efforts of conservatives to discourage its use, now there is the all too predictable burst of publicity asking whether early reports on Gardasil were overly optimistic.

The irony is that nothing about Gardasil or its use has changed. We have the same information now that we possessed when the vaccine was introduced. Did the media overhype the introduction of Gardasil? Yes, it did, but that’s because it appears that no one read the scientific literature before writing about it.

Were the media improperly influenced by the Gardasil marketing campaign? The marketing campaign made claims that, thus far, are only extrapolations from existing data. The manufacturer did not lie, but the manufacturer does not yet know what the long term protective effect of the vaccine will be. The fact that the media looked to the marketing campaign for information was improper. Scientific claims can only be evaluated by looking at the scientific evidence. A marketing campaign does not provide a complete view of the scientific evidence.

Cervical cancer is caused by certain strains of the human papilloma virus. The virus also causes genital warts and pre-cancerous changes in the cervix. The vaccine causes the body to produce antibodies against the virus. Initial testing has been very promising; women who received the vaccine did not develop genital warts and did not have detectable levels of virus on testing. In contrast, some women who received the placebo did develop genital warts, and the virus could be detected on tests.

So far, so good. The vaccine appears to offer excellent protection against the HPV virus, and appears to prevent the development of genital warts. Does the vaccine prevent cervical cancer? No one knows, because it takes many years for cervical cancer to develop after exposure to HPV, and the vaccine has not been around for many years. Theoretically, it will prevent cervical cancer, but only if the strains in the vaccine are the only strains that can cause cancer, and only if protection is long lasting. We have little or no information on these issues.

Did the media overhype Gardasil? Of course it did. The media, like the manufacturer, claimed that Gardasil will prevent cervical cancer, but no one actually knows if that is true. It will take years to determine whether Gardasil prevents cervical cancer.

But wait; does that mean that the manufacturer should be prohibited from claiming that Gardasil can prevent cervical cancer? Does that mean that girls should not receive the vaccine? Those are difficult ethical questions. Gardasil probably does prevent cervical cancer, but we won’t know definitively for a decade or more. In the meantime young women who forgo the vaccine because it hasn’t been proven to prevent cervical cancer might be forgoing protection against a deadly disease. We know the virus causes cancer. We know that the vaccine helps the body fight off the virus. Logically, we expect that the vaccine will prevent cervical cancer.

How sure do we need to be before we should recommend widespread use of the vaccine? The government decided that given all the available evidence, the projected benefits appear to outweigh any risks, and they are probably right. However, the truth is that no one really knows if Gardasil prevents cervical cancer.

“The mother is the factory”

Who said: “the mother is the factory, and by education and care she can be made more efficient in the art of motherhood”?

That was written in 1942 by Grantly Dick-Read, widely considered to be the father of modern natural childbirth. Most people don’t realize that natural childbirth was invented by a man to convince middle and upper class women that childbirth pain is in their minds, thereby encouraging them to have more children. Read’s central claim was that “primitive” women do not have pain in childbirth. In contrast, women of the upper classes were “overcivilized” and had been socialized to believe that childbirth is painful.

Grantly Dick-Read’s theory of natural childbirth grew out of his belief in eugenics. He was concerned that “inferior” people were having more children than their “betters” portending “race suicide” of the white middle and upper classes. Read believed that women’s emancipation led them away from the natural profession of motherhood toward totally unsuitable activities. Since their fear of pain in childbirth might also be discouraging them, so they must be taught that the pain was due to their false cultural beliefs. In this way, women could be educated to have more children.

According to Read: “Woman fails when she ceases to desire the children for which she was primarily made. Her true emancipation lies in freedom to fulfil her biological purposes”..

The comparisons between “overcivilized” white women and “primitive” women who gave birth easily was not merely the product of racism, but reflected the anxiety that men felt about women’s emancipation. This anxiety was expressed in medicine generally, and in obstetrics and gynecology particularly, by the fabrication of claims about the “disease” of hysteria and the degeneration of women’s natural capabilities in fertility and childbirth compared to her “savage” peers. Simply put, the result of women insisting on increased education, enlarged roles outside the home and greater political participation was that their ovaries shriveled, they suddenly began to experience painful childbirth and they developed the brand new disease of “hysteria”, located in the uterus itself.

Pain in childbirth served a very important function in this racist and sexist discourse: it was the punishment that befell women who became too educated, too independent and left the home. The idea that “primitive” women had painless childbirth was fabricated to contrast with the painful childbirth of “overcivilized” women.

Grantly Dick-Read was issuing a warning to women of a certain social class: if you step beyond the roles prescribed for women, you will be punished with painful labor. And if you have had painful labor, you should understand it as a punishment for ignoring your “natural” duty to stay home and procreate.

In light of this, the contemporary popularity of natural childbirth is more than a bit ironic. The central claims of natural childbirth, that childbirth is not inherently painful, and that if you “prepare” properly, your birth will be painless, too, were utter fabrications. Read would be delighted that these fabrications have been embraced by many women and that his philosophy has been propagated so successfully that most women don’t even realize that the central tenets of natural childbirth are racist and sexist lies.