Wednesday, March 31, 2010

Don't ignore obstetrician liability concerns



Everyone agrees that the current C-section rate, at 33%, is a national scandal. How has it reached this level?

Obstetricians have been desperately trying to explain how liability concerns are driving the rising C-section rate, yet they are consistently ignored. That's rather surprising since obstetricians perform the C-sections and have much greater insight into their motivations than anyone else. But everyone from insurance company executives to health policy experts to "natural" childbirth advocates disparage and ignore doctors' explanations. How do they justify ignoring the very people whose behavior they wish to change?

Law professor Sandra Johnson offers insights into doctors' concerns and how they are ignored in, of all places, a law review article entitled, Regulating Physician Behavior: Taking Doctors' "Bad Law" Claims Seriously.

Doctors frequently claim that the very law intended to improve the lot of their patients is instead making the doctors provide poor care. These "bad law" claims are levied against malpractice litigation that makes doctors practice "defensive medicine"; ... against antitrust laws that prevent doctors from organizing themselves in ways that would produce more cost-effective and accessible care; and against regulations that impede important medical research. These “bad law” claims assert that the law's effort to promote patient health and well-being has actually caused significant harm.
And why have these concerns been ignored?
Medicine’s complaints ... [have come] to be characterized as the work of a self serving guild, rather than a profession motivated by altruism and armed with expertise, or at least as the work of the recalcitrant "bad apples" who continued to resist improvements that the more enlightened among them embraced. These narratives marginalized physicians' ... claims and diminished them as a source of legitimate information about the effectiveness of reform efforts.

Rather than addressing the substance of doctors' arguments, experts and lay people have denied that there the complaints are legitimate, ascribing them to greed and self interest. Yet in the case of medical liability, as in other areas of medical "reform," doctors are often right.
What if we take doctors' claims seriously? What can we learn about the impact of liability concerns on medical practices including Cesarean sections?

Professor Johnson explains that doctors' liability concerns are not simply ignored; even when they are directly addressed, they are often dismissed as irrelevant by those who don't or won't understand their impact on individual practitioners. She identifies a number of these dismissive behaviors.

All's not well that ends well

Policy experts and lay people alike often point to the fact that physicians win most malpractice suits as evidence that doctors shouldn't worry about being sued. But as Prof. Johnson notes:
The enforcement process itself [in this case, the lawsuit] also imposes significant penalties in the course of identifying violators. These penalties are distinct from formal penalties levied after a conclusive finding that a violation has occurred. These “penalties of the process” exert their own deterrent effect. When substantial, they will produce avoidance behaviors on the part of those who might fall within the investigative net even though the likelihood that they will be subject to formal sanctions is nil or close to it.
In other words, the risk of being sued has a deterrent effect, regardless of whether the doctor wins or loses. And who would know better than the doctors themselves?
The deterrence effect of these informal penalties may produce results that actually undermine the goals of the formal legal requirements. Yet, they are all but invisible—they make no appearance in the formal description of the standards and procedures incorporated in the law. The best information available concerning the operation of this shadow system of enforcement comes from the people who experience it, those doctors who claim that there is "bad law" causing them to avoid doing the right thing.
The interminacy of law

Lay people in particular like to claim that if the doctor "does the right thing," he or she has nothing to worry about. That is startlingly naive view.
... It is hardly ever the case that lawyers can tell doctors: "I assure you that you have nothing to be concerned about ... You are safe." ... So, instead, what doctors often hear lawyers say is: "Well, anyone with a filing fee can sue you, but they are not going to win." This consolation ... has to ring hollow to anyone who has been the defendant in any suit, even one that is eventually dismissed. Instead of reassurance, one could understand that this phrase would be heard as confirmation of the unpredictability of the legal hammer.
Asymmetrical legal risk
At times, legal risk is lined up entirely on one side as the doctor looks at the risks of particular decisions... [W]hen we began our work on pain management in 1995, only the doctor who prescribed opioids for his patients in pain faced investigation, sanctions, and liability claims. The doctor who used the less effective medications and neglected their patient’s pain faced no legal risk at all.
The same asymmetrical risk applies to C-sections. An obstetrician who fails to perform a C-section can be accused of negligence if there is anything wrong with the baby. An obstetrician who performs a C-section, even one that is not medical necessary, faces no legal risk at all.

Professor Johnson's most important message is that it is time to start taking physician liability concerns seriously instead of dismissing such complaints are motivated by greed and self interest:
[We] must accept that well-intentioned regulatory standards and enforcement systems can have negative outcomes as physicians react, and patients suffer as a result. Taking physicians' "bad law" complaints seriously brings physician behavior to the table as a credible and legitimate factor in evaluating the performance of the law... Taking “bad law” claims seriously appreciates that the behavior-inducing effects of the enforcement effort may thwart the goals of the regulation itself.
Ignore obstetricians liability concerns and the C-section rate will continue to rise.

Monday, March 29, 2010

Do vitamins cause cancer?



Among believers in alternative health, it is an article of faith that vitamin supplements prevent all manner of serious diseases including cancer. Yet the reality is almost exactly the opposite. According to Kristal and Lippman, writing in the Journal of the National Cancer Institute (Nutritional Prevention of Cancer: New Directions for an Increasingly Complex Challenge):

The prospects for cancer prevention through micronutrient supplementation have never looked worse. Several large, randomized cancer prevention trials have recently reported no reduced risk from micronutrient supplementation, and [there is] a growing body of evidence that micronutrient supplementation may be harmful...
The authors are commenting on a paper that appears in the same issue of JNCI that investigated whether folate supplementation decreased the risk of precancerous growths in the colon. Folate did not decrease the risk; it increased it by 67%. Further analysis revealed that folate supplementation increased the risk of prostate cancer by 167%.

The authors note:
... Among studies addressing micronutrient supplementation for the prevention of cancer, only a single randomized trial, testing 1200 mg of calcium for preventing the recurrence of colorectal polyps, has reported a statistically significant and positive result for its primary cancer outcome, whereas large trials testing supplementation with multivitamins, folate, selenium, β-carotene, and vitamins E, C, D, B 6 , and B 12 have found no benefits.
In fact:
... Even clinical trials designed to test agents that were found to reduce cancer risk in secondary analyses of previous trials, such as vitamin E and selenium for prevention of prostate cancer, have failed to find benefit from supplementation. The harmful effects of β-carotene supplementation in heavy smokers are well established, and it now appears that folate supplementation may increase cancer risk as well...
The scientific rationale for testing vitamin supplements for cancer prevention was sound. A variety of studies have shown that people who don't have cancer have higher levels of certain micronutrients. Unfortunately, the assumption that these vitamins and minerals prevent cancer was unjustified.
... the notion that some is good and therefore more is better has been proven wrong; it is more likely that for any given micronutrient, there is an optimal range of intake.
That's not surprising, considering how vitamins and minerals function within the body. Micronutrients are like nails in a house. Without enough nails to hold the various parts together, a house will fall apart. However, once the optimal number of nails has been reached, adding more will not increase the stability of the house and in large amounts, might even decrease stability.

That explains why vitamin supplements fail to prevent cancer. How would supplements act to cause cancer?
... using the folate supplementation trial as an example, it is not unreasonable to assume that optimal levels of folate are associated with more fidelity in DNA replication and thus a lower risk of spontaneous mutations, but high folate may also support more rapid cell growth and promote carcinogenesis in previously initiated cells.
Another possibility is that large quantities of specific vitamins or minerals may be consumed by particular types of cancer. In that case, low levels of that vitamin or mineral in cancer patients reflect the fact that the cancer needs the micronutrient. The level has dropped not because high levels of the vitamin or mineral prevent cancer, but because the cancer has used up what is available. Far from preventing cancer, supplements might actually feed the cancer and promote rapid growth.

Whatever the reason, it is clear that supplements do not represent the next frontier in cancer prevention. As the authors acknowledge:
... It is safe to conclude that cancer prevention is not going to be as simple as recommending high-dose micronutrient supplements for middle-aged and older adults.
In fact, the opposite may turn out to be true. Vitamin and mineral supplements may promote cancer growth.

Wednesday, March 24, 2010

Why is the Cesarean rate sky high?



The National Center for Health Statistics released a new report today, Recent Trends in Cesarean Delivery in the United States. The report is most notable for a startling statistic; the C-section rate has reached the astronomical level of 32%, an increase of more than 50% since 1996. This is disturbing news.

As the authors explain:

... Although there are often clear clinical indications for a cesarean delivery, the short- and long-term benefits and risks for both mother and infant have been the subject of intense debate for over 25 years. Cesarean delivery involves major abdominal surgery, and is associated with higher rates of surgical complications and maternal rehospitalization, as well as with complications requiring neonatal intensive care unit admission . In addition to health and safety risks for mothers and newborns, hospital charges for a cesarean delivery are almost double those for a vaginal delivery, imposing significant costs.
It's not surprising news, though, since it merely a continuation of a worrisome trend. As the graph demonstrates:



Why is the C-section rating sky high? The pervasive nature of the increase may hold some clues. The increase has been remarkably consistent across all possible variables. The C-section rate increased among all races. It increased in all maternal age groups. It increased at every gestational age, and it increased in all 50 states. The global nature of the increase suggests that it is due to a global factor, rather than the increase in a particular diagnosis a dramatic change in specific risk factors. Like many obstetricians, I suspect that the rising C-section rate is driven by liability concerns.

It's true that there is no correlation between numbers of lawsuits and the C-section rate. In addition, there is no correlation between the size of monetary awards and the C-section rate. There is a correlation between malpractice premiums and the C-section rate, but the association is not dramatic. So how could the C-section rate be tied to liability concerns?

The assumption behind searching for a correlation between C-section rate and malpractice lawsuits or monetary awards is that as the rate or payout of lawsuits rises, obstetricians will be reminded that they are at risk of being sued. However, if every obstetrician expects to be sued, the increasing rate of suits or payouts will be irrelevant. At this point, every obstetrician expects to be sued at least once in a professional lifetime.

According to Victoria Green, MD, JD author of the chapter Liability in Obstetrics and Gynecology in the textbook Legal Medicine:
Nearly 77% of obstetrician/gynecologists have been sued at least once in their career and almost half have been sued three or more times. Moreover, virtually one-third of residents will be sued during their residency. Fear of malpractice, in general, may cause physicians to order more tests than medically necessary, refer patients to specialists, and suggest invasive procedures to confirm diagnoses more often than needed. Nearly 40% may prescribe more medications than medically necessary due to concerns of legal liability. The public has responded by escalating the “punishment” associated with malpractice claims where multimillion-dollar jury awards are commonplace.
When obstetricians expect to be sued, it no longer matters how many other suits are filed, how high the monetary judgments are, or even whether malpractice premiums are rising. The only consideration when a lawsuit is inevitable is how to successfully defend oneself.

Consider the most common reasons for an obstetrics lawsuit. The paper Liability in High Risk Obstetrics explains the most common causes. Although the paper concentrates on high risk obstetrics (perinatology), the results appear to be generalizable to obstetrics as a whole. According to the paper's author James L. Schwayder, MD, JD, obstetric lawsuits center on errors of omission or commission. The most common alleged errors are:
1. Errors or omission in antenatal screening and diagnosis
2. Errors in ultrasound diagnosis
3. The neurologically impaired infant
4. Neonatal encephalopathy
5. Stillborn or neonatal death
6. Shoulder dystocia, with either brachial plexus injury or hypoxic injury
7. Vaginal birth after cesarean section
8. Operative vaginal delivery
9. Training programs (Resident supervision markedly impacts litigation exposure. Increased used of nurse midwives and nurse practitioners may increase ones liability exposure.)
Of the 9 most common reasons for obstetric malpractice suits, 6 (#3-#8) allege failure to perform a C-section or failure to perform a C-section sooner. In other words, performing a C-section when there is any doubt about the baby's health, or even before there is any doubt, will virtually eliminate the chance of being sued successfully in connection with the delivery; it might even make a lawsuit less likely if the plaintiff cannot argue that a C-section should have been performed.

Most of these potential complications are equally distributed across maternal age, maternal race, gestational age, and state of residence, leading to a rising C-section rate across all demographics. The skyrocketing rate is being driven by an attempt to defend or potentially avoid lawsuits, since the majority of lawsuits allege failure to perform a C-section or to perform a C-section sooner. An ever increasing C-section rate is the inevitable result.

The C-section rate is skyrocketing primarily for non-medical reasons. While doctors blame the tort system as the proximate cause, the fundamental cause rests with patients, not lawyers or insurance companies. The fundamental cause is an inability to tolerate any risk to a newborn. In the current legal climate, there is no possible justification for not doing a C-section, regardless of how tiny the risk posed by vaginal delivery may be. Unless and until people stop penalizing doctors for not doing C-sections, they will continue to do them in ever increasing numbers. They really have no choice. You cannot say to obstetricians, "Give me a perfect baby or I will sue you for failure to perform a C-section" and then express shock and dismay that obstetricians will perform C-sections in order to guarantee that you will have a perfect baby.

The sky high C-section rate all too predictable result of parental expectations. As long as parents continue to sue for failure to perform a C-section, the C-section rate will continue to rise.

Monday, March 22, 2010

The National Center for Health and Wishful Thinking



A consortium of chiropractors, herbalists and cancer quacks has petitioned the Federal government for creation of a National Center for Health and Wishful Thinking (NCHWT). The consortium believes that both "complementary medicine" and "integrative medicine" do not reflect the reality of alternative health. A spokeswoman for the consortium, Ima Frawde, explained that those descriptions do not accurately reflect the fundamental premise of alternative health, which is wishful thinking. According to the Ms. Frawde:

We don't merely believe in a mind-body connection. We are committed to the principle that health is determined by specific beliefs. Indeed, we feel strongly that the right beliefs can keep you healthy and the wrong beliefs can make you sick.
The consortium has published a working paper on what the National Center for Health and Wishful Thinking might look like, including plans for 6 specific departments. The following excerpts explain the departments.

Blame the Victim
A founding principle of the NCHWT is that anyone who is sick has brought it on themselves. They should have eaten better, exercised more, taken supplements and thought positive thoughts. Virtually all cases of cancer and heart disease are caused by the victim, who fully deserves the consequences including severe disability and death.

The Blame the Victim division will explore the ethical ramifications of withdrawing care from patients in order to divert the resulting savings to buy more preventive herbs and supplements for everyone else.

The "Nanny State" Department
This is the research arm of the NCHWT, though no actual research will be done. That's because all preventive care is good, and it is a waste of money to bother proving it. The "Nanny State" Department is charged with the promulgation and enforcement of laws determining just what foods are allowed and prohibited. Building on the groundbreaking ordinances in New York City, the department will expand far beyond restrictions on trans-fats and salt. Since all disease is determined by what people eat, some substances will be banned and others promoted. To ensure enforcement, stores and restaurants will be stripped of any products that do not receive the "Nanny State" Seal of Approval.
Childbirth Affirmations
Good health begins at birth. The bedrock principle of the Department of Childbirth Affirmations is that the key to health is for the mother to be empowered by her birth experience. Neonatal mortality and morbidity are sterile concepts and cannot capture the emotional significance of birth; therefore, such data will no longer be collected.

All births will be homebirths and only those with the least amount of education training will be allowed to attend births. The full transition to Certified Professional Midwives (who proudly have less education and training than any midwives in the industrialized world) must be completed within 5 years. In the meantime, any provider accused of "birth rape" will be sentence to death; no trial is necessary.
Vaccine Rejection
It's not merely physical health that begins in infancy, it is mental health as well. Since everyone knows that vaccines cause autism, vaccines will henceforth be banned. Moreover, closer monitoring of autism incidence will be funded by diverting money from previous efforts to track child mortality. Since infectious childhood diseases have disappeared spontaneously, there is no reason to anticipate that any children will die.
Mental Illness as a Social Construct
Obviously, mental illness is a category created to marginalize those challenge the norms of society and think outside the box. In recognition of the extreme creativity of those previously deemed "mentally ill" (e.g. Vincent Van Gogh), the use of psychotropic medications will henceforth be banned. Implementation will start by criminalizing the use of stimulant medications for ADHD since everyone knows that ADHD doesn't exist. It is merely a ruse used by upper middle class parents to turn B students into A students and simultaneously destroy their souls.
Department of Lying
It is axiomatic that the placebo effect helps more people with fewer side effects than any other treatments. Therefore, all future disease treatments will invoke the placebo effect by substituting any active ingredients with sugar. Since lying is an integral part of the placebo effect (i.e. patients need to be convinced by the doctor that the inactive medication will be effective) requirements for informed consent will be modified to emphasize that patients should not be given accurate information about their care.
Spokeswoman Ima Frawde cautions that the working paper represents only the most basic structure of the National Center for Health and Wishful Thinking. Further elaboration may yield more departments, greater contempt for victims and new methods of tricking patients. The consortium estimates that $1 trillion dollars should be diverted from conventional healthcare to the NCHWT, and more if any actual research is contemplated in the future. Close financial relationships between supplement manufacturers and the Center are contemplated to defray any additional costs.

As Ms. Frawde proudly points out:
The National Center for Health and Wishful Thinking will embody the latest advances in health. Knocking on wood or prayer may have been acceptable to previous generations, but the healthcare strategy of wishful thinking has advanced from those primitive methods. The cornerstone of future efforts will be the placebo effect, dietary restrictions and supplements. We estimate that by 2025, the US death rate will have dropped to zero; however, since our plans include ending actual monitoring of deaths we may unwittingly achieve our goal even sooner.

Thursday, March 18, 2010

Hold the hand wringing: is maternal mortality really rising?

In breathless language, the human rights organization Amnesty International urges the US to confront its "shocking maternal mortality rate." Entitled Deadly Delivery: The Maternal Healthcare Crisis in the USA, the Amnesty report lays its indictment:

The total amount spent on health care in the USA is greater than in any other country in the world. Hospitalization related to pregnancy and childbirth costs some US$86 billion a year; the highest hospitalization costs of any area of medicine. Despite this, women in the USA have a greater lifetime risk of dying of pregnancy-related complications than women in 40 other countries... More than two women die every day in the USA from pregnancy-related causes...
Amnesty International is sure that this increase in maternal mortality is due to lack of access to medical care.
The US government's failure to ensure that women have guaranteed lifelong access to quality health care, including reproductive health services, has a significant impact on the likelihood of having a healthy pregnancy and delivery.
"Natural" childbirth advocates are sure that the rising rate of C-sections and other interventions is contributing to the rising maternal mortality rate. Amnesty International appears to agree, citing a "lack of information and autonomy" as the cause.

Both decreased access and increased interventions are plausible causes of increased maternal mortality. However, it is far from clear that maternal mortality is even rising, let alone that it is rising because of decreased access to care or increases in the C-section rate or other interventions. A careful review of the data suggests that changes in the way that maternal mortality is assessed may be leading to a spurious "increase" in maternal mortality. Moreover, a detailed analysis of the causes of maternal mortality casts serious doubt on either access or interventions as the cause of any rise.

In the last two decades, there has been growing awareness that maternal mortality is under-reported. Vigorous efforts have been made to correct that problem, by both increasing surveillance and expanding categories included within maternal mortality. The CDC report Maternal Mortality and Related Concepts (2007) explains these changes:
In 1999, the coding guidelines used in the United States were expanded to cover additional categories ... Furthermore, if only indirect maternal causes of death (i.e., a previously existing disease or a disease that developed during pregnancy that was not due to direct obstetric causes but was aggravated by physiologic effects of pregnancy) were reported in Part I and pregnancy was reported in either Part I or II, the death was classified as a maternal death. [Previously] the pregnancy had to be reported in Part I for the death from indirect causes to be considered a maternal death.

Along with the new definitions, the [new coding guidelines] introduced new details and categories in the cause-of-death titles associated with pregnancy, childbirth, and the puerperium...
Furthermore, in 2003, the US Standard Certificate of Death was revised to ask explicitly whether any female death was associated with pregnancy, instead of relying on the person filling out the form to voluntarily provide that information.

The results of these changes are captured by the following graph.



It is clear that the 1999 and 2003 changes in reporting of maternal mortality resulted in large "increases" that are not increases at all. They reflect the more accurate measurement of maternal mortality just as they were designed to do.

Yet some of the increase may be real. What about possible causes?

Curiously, since Amnesty International bases its entire report on the claim that decreased access to healthcare has led to increased maternal mortality, the report contains no evidence that there has been a decrease in access to maternity services. While millions of people lack health insurance, almost all states provide public health insurance for the duration of pregnancy in any woman who needs it. Indeed, 99+% of births take place in hospitals, so there is certainly no decrease in access to hospital care.

If decreased access to healthcare were responsible for an increase in maternal mortality, we would expect that the increase would be spread evenly among all possible causes of maternal mortality, but that's not what we find. The following chart shows maternal death rates from pre-eclampsia/eclampsia, hemorrhage, embolism (the three most common causes of maternal death) as well as other direct causes (all other obstetric complications) and indirect causes (from other medical conditions).



As the graph shows, the purported increase in maternal mortality was not spread evenly across all categories. Indeed, the most common cause of maternal mortality remained flat. In contrast, the categories that were expanded in the new reporting guidelines were responsible for almost all of the purported increase. This suggests that the "increase" reflects more comprehensive reporting, not an actual increase in maternal mortality.

What about an association between the rising C-section rate and rising maternal mortality? A graph comparing the maternal mortality rate and the C-section rate certainly shows a correlation.



But correlation is not causation. If the rising C-section rate were leading to an increased maternal mortality rate, we would expect to see C-section complications, such as hemorrhage and embolism increasing disproportionately. But that's not what we see. As the following graph makes clear, both hemorrhage and embolism death rates did not change their contributions to overall maternal mortality.



The fact that hemorrhage and embolism were flat casts doubt on the idea that the increasing C-section rate is leading to increasing maternal mortality. Moreover, the C-section rate rose from 2005 to 2006, but the maternal mortality rate actually dropped.

So what can we conclude about the observed rise in maternal mortality? First, we can see that the 1999 coding revision and the 2003 birth certificate revision captured more maternal deaths just as they were designed to do. Those increases almost certainly reflecting changes in reporting and not increases in maternal mortality. Together they account for 80% of the observed increase since 1998 (5/100,000 out of a total change of 6.2/100,000). With that in mind, the Amnesty International report can be described as overwrought, to say the least.

And to the extent that there has been a real increase, is decreased access or the increased C-section rate the causes of this increase? That seems unlikely since the increase was not distributed evenly among all causes (as would be expected if decreased access were to blame) nor is the increase predominantly distributed among common C-section complications (if the increased C-section rate were to blame).

Despite the rhetoric of Amnesty International, it is unclear whether we are experiencing a crisis of any kind, let alone a "shocking" maternal mortality rate.

Wednesday, March 17, 2010

I'm a doctor and I'm afraid of preventive medicine



If there's one thing everyone agrees on, it's that preventive care is always a good thing. Well, I'm a doctor and I'm afraid of preventive medicine.

The theory behind preventive medicine is sound. It is better to treat prevent disease than to treat it. It is better to refrain from smoking and never get lung cancer than it is to treat lung cancer. It is better to refrain from alcohol abuse than to treat alcoholic cirrhosis of the liver. In each of those cases, avoiding a behavior known to cause the disease is highly effective in reducing the incidence of the disease.

But not all preventive medicine is about avoiding behaviors known to cause diseases. Preventive medicine has held out the possibility of avoiding naturally occurring diseases by correcting hormone, mineral or other imbalances through eating specific foods, taking supplements or using medication. Many of these preventive efforts have not only been unsuccessful, they have created problems of their own, sometimes the very problems they were meant to prevent.

The paradigmatic example is estrogen replacement therapy. Menopause, characterized by a lack of estrogen, is associated with increased risk of a variety of health problems including heart disease and osteoporosis. The reasoning behind estrogen replacement therapy was that if heart disease or osteoporosis are associated with decreased estrogen, replacing that estrogen will reduce heart disease and osteoporosis. There was some experimental evidence supporting that theory, but not a lot. Nonetheless, estrogen replacement therapy became the standard of care well before large scale, long term studies could be completed. It was preventive therapy; how could it cause any harm?

Merely replacing a missing hormone is not as simple as it sounds. Hormones, like many other substances in the body, are involved in more than one system. Indeed, lots of substances play multiple roles in multiple systems. Adding back the missing hormone can have an impact far beyond the system it was designed to protect and that impact can be harmful. The data is not final, but it appears that adding back estrogen increases the risk of breast cancer. And while estrogen replacement did have a beneficial effect on bone health, large scale, long term studies have not delivered the promised benefit of reducing the risk of heart disease. Routine postmenopausal estrogen replacement is no longer the standard of care; it is reserved only for specific situations in which the benefit is judged to be worth the risk.

With routine estrogen therapy contraindicated, the search continued for non-hormonal methods of preventing osteoporosis. Bisphosphonates appeared to promote bone health without the side effects of estrogen. Again, large scale, long term studies were lacking, but it was preventive therapy; how could it cause any harm? Unfortunately, it has turned out that biphosphonates may not promote bone health, but may weaken bones. The bisphosphonate Fosamax has already been linked to osteonecrosis (bone destruction) of the jaw, and now it appears that long term use of Fosamax may result in severe weakening of the femur bone (the thigh bone) leading to fractures that during activities as simple as walking.

Reversal of deficiencies associated with aging is not the only place where preventive medicine has gone wrong. Preventive medicine also rests on the premise that early diagnosis is better than late diagnosis, and that anything that increases the likelihood of early diagnosis must be beneficial. The most spectacular example of that faulty reasoning is the PSA (prostate specific antigen) test. Since increased PSA is associated with prostate cancer, doctors began recommending routine PSA screening, despite the fact that there were no large scale, long term studies demonstrating benefit. It was preventive medicine; how could it cause any harm?

Listen to what the test's inventor, Dr. Richard Ablin, has to say about its use: "I never dreamed that my discovery four decades ago would lead to such a profit-driven public health disaster."

According to Dr. Ablin:

... [T]he test is hardly more effective than a coin toss. As I’ve been trying to make clear for many years now, P.S.A. testing can’t detect prostate cancer and, more important, it can’t distinguish between the two types of prostate cancer — the one that will kill you and the one that won’t.

Instead, the test simply reveals how much of the prostate antigen a man has in his blood. Infections, over-the-counter drugs like ibuprofen, and benign swelling of the prostate can all elevate a man’s P.S.A. levels, but none of these factors signals cancer. Men with low readings might still harbor dangerous cancers, while those with high readings might be completely healthy.
Millions of men have been subjected to unnecessary biopsies, and harmful treatments, and billions of dollars have been wasted on this failed exercise in preventive care.

What can we learn from these and other similar debacles? We need to reexamine the basic premises of preventive medicine. Sure it is better to prevent disease than to treat it, but that does not mean that reversing the metabolic changes that accompany a disease will prevent it or will prevent it without causing serious unforeseen complications. Sure it is better to treat early stage cancer than late stage cancer, but a screening test that makes lots of mistakes can be worse than no screening test at all.

Most importantly, we must never forget that preventive medicine is a branch of medicine, in the exact same way that cardiology and neurology are branches of medicine. As such preventive medicine must be held to the same standards; any treatment, even a preventive treatment, must be tested in large scale, long term studies before being put into routine clinical use. Preventive medicine, like other branches of medicine, has the power to harm as well as to help. We ignore that fact at our own peril.

Thursday, March 11, 2010

VBAC activists aggressively ignoring reality



As predicted, VBAC activists are clinging to their resentment and aggressively ignoring reality.

Amy Romano on the Lamaze blog asks the bizarre question: Do women need to know the uterine rupture rate to make informed choices about VBAC? It's bizarre because she implies that this is a medical question and that the answer is unknown. However, this is a legal question and the answer has been clearly established by the courts. Not only is knowing the rupture rate required, it isn't even enough. Women must "understand" the rupture rate and many women have successfully argued that they are incapable of understanding.

Don't believe me? Consider what the "Syracuse NY Birth Injury Lawyers" have to say on the subject:

For an expectant mother to give meaningful and informed consent she must be specifically told and understand that "IF HER UTERUS RUPTURES DURING HER VBAC, THERE MAY NOT BE SUFFICIENT TIME TO OPERATE AND TO PREVENT THE DEATH OF, OR PERMANENT BRAIN INJURY TO, HER BABY." (emphasis in the original)
Courtmoom Mama, writing on the Unnecesarean, helpfully illustrates how VBAC activists desperately cling to their resentment. In her post NIH VBAC Consensus Development Conference: Gift Horse or Trojan Horse? she is most excited about the fact that an activist aggressively challenged a panel member, presumably "speaking truth to power." Courtroom Mama (a self described "law geek") utterly ignores the medico-legal issues that restrict availability of VBAC.

Most egregious, though, is the penchant of VBAC activists to invent rights that don't exist. Henci Goer's bemoans the "[f]ailure to recognize that VBAC is a right." Yet there is no legal right to VBAC. Indeed, there is no legal right to healthcare of any kind, let alone a right to a specific procedure. A "right" to VBAC implies an obligation on the part of doctors and hospitals to preside over VBACs, justifying resentment of obstetricians for depriving women of their "rights." However, since there is no "right" to VBAC, doctors and hospitals cannot be accused of violating anyone's rights.

Asserting a non-existent right is worse than pointless. It demonstrates an inability to understand and frame the real situation in favor of a make-believe world where evil obstetricians control everything. In the real world, women have only the right to refuse medical treatment, not a right to demand a specific treatment. Moreover, doctors and hospitals have no legal obligation to comply with patients who refuse medical advice or demand procedures that the doctors or hospitals do not provide.

And speaking of "procedures," activists who attended the conference impressed themselves with their clever observations on semantics. According to Goer:
VBAC ... is not a procedure. Labor is what inevitably happens at the end of pregnancy.
That point, currently bouncing its way around the Twitter universe, is simultaneously inane and irrelevant. Are doctors supposed to bang themselves upside the head and suddenly realize that VBACs don't pose additional risks because they aren't "procedures"? Are lawyers supposed to have a sudden epiphany that detailed consents aren't required for VBACs because they aren't "procedures"? Why don't VBAC activists notice that no one beside themselves is impressed with their "cleverness"?

VBACs have been dramatically restricted because of legal and insurance concerns. There's no one to "blame" because everyone involved is doing their job within medical and legal constraints that we all must acknowledge. Unfortunately, being deprived of the opportunity to blame obstetricians appears to be insupportable to VBAC activists. They demonstrate a greater commitment to made up reasons for resentment than to practical solutions for making VBAC more widely available. Indeed, they are so committed to resentment that they appear incapable of addressing reality.

Wednesday, March 10, 2010

NIH, VBAC and the politics of resentment



The NIH Consensus Conference on Vaginal Birth After Cesarean has just released its findings. Despite the fact that the conference statement offers strong support for a far more liberal VBAC policy, VBAC activists are currently parading before the panel during the public comment portion and attempting to outdo each other in their vilification of doctors. It's almost as if the panel findings are irrelevant. Their anger, self pity, and conspiracy theories are so important to activists, that they cannot let them go. In fact, they appear to be far more important to activists than the actual issue under discussion.

The NIH conference on VBAC was convened because doctors and policy makers (as well as patients) believe that the current VBAC policy is misguided and potentially harmful. As the statement explains:

Vaginal birth after cesarean (VBAC) describes vaginal delivery by a woman who has had a previous cesarean delivery... In 1980, a National Institutes of Health (NIH) Consensus Development Conference Panel questioned the necessity of routine repeat cesarean deliveries and outlined situations in which VBAC could be considered. The option for a woman with a previous cesarean delivery to attempt a trial of labor (TOL) was offered and exercised more often in the 1980s through 1996. Beginning in 1996, however, the number of VBACs has declined, contributing to the overall increase in cesarean delivery ...

Although the number of women ... faced with the question of whether to attempt TOL has markedly increased, there has been a concurrent, dramatic drop in VBAC. Yet cesarean and VBAC rates are identified as quality indicators for maternal health by policymakers, insurance providers, and health care quality monitoring groups. Success of TOL is consistently high (60 to 80 percent), whereas the risk of uterine rupture is low (less than 1 percent)...
In other words, in 1980, after reviewing the scientific literature, an NIH panel recommended offering a trial of labor to women who had had a previous C-section. As a result, VBAC became popular. Many women had successful vaginal deliveries. Only a very small proportion of women had serious complications, almost exactly what was predicted. Yet the VBAC rate peaked in 1997 and has declined precipitously since the, as the following graph shows.



Why did VBACs decline despite the fact that the benefits and risks were exactly as predicted? The answer can be summed up in one word: lawsuits. Although women offered VBAC were counseled about the small risk of uterine rupture (opening of the uterine scar during labor) and the attendant risk that the baby might die in the event of a rupture. Nonetheless, when a baby died after a uterine rupture, many mothers sued, and claimed that they had not "understood" the risks even though those risks were clearly explained. Juries were moved by these emotional appeals, and large judgments were paid out.

What did everyone learn from these lawsuits? Doctors learned that patients maintained that they could not "understand" risks no matter how carefully explained, patients learned that they did not have to take responsibility for their decisions, and lawyers learned that VBAC complications represented a bonanza.

The American College of Obstetricians (ACOG) stepped into the breach and, attempting to make things better, made them far worse. ACOG likes to remind its members that doctors have never lost a lawsuit in which they followed ACOG guidelines. Therefore, ACOG decided to promulgate guidelines that doctors could use in their legal defense. Unfortunately, the ACOG guidelines were so strict (unreasonably strict in the eyes of most obstetricians) that most obstetricians could not meet them. ACOG mandated that VBAC should only be attempted when both an anesthesiologist and obstetrician were present so that anyone who experienced a uterine rupture could be treated immediately. Most medium sized and small hospitals cannot afford to have an anesthesiologist in the hospital around the clock. Most obstetricians cannot afford to sit for hours while a patient labors. Therefore, many hospitals and anesthesiologists stopped offering VBAC.

The problem was compounded when malpractice insurers recognized that VBAC complications, though uncommon, represented an indefensible claim. If patients could claim that any consent for VBAC was essentially invalid, large payouts were inevitable. Many malpractice insurers told obstetricians that they should not preside over VBACs and, if they did, their entire malpractice policy would be voided. Obstetricians cannot practice without insurance; defying the insurer meant that an obstetrician would have to quit obstetrics altogether.

Simply put, liability concerns have sharply restricted the availability of VBAC. But that's not how VBAC activists tell the story. Like many advocates of alternative health, childbirth activists thrive on resentment. Any situation that they don't like is automatically ascribed to a conspiracy of evil doctors. VBAC activists insist, despite the copious evidence to the contrary, that doctors deliberately and maliciously chose to restrict VBAC. They have all sorts of purported "reasons" for this conspiracy. They claim that obstetricians make more for C-sections (for most doctors, and all doctors on salary, that is not the case), that doctors want to ruin women's birth "experiences," and that doctors are more concerned about protecting themselves (avoiding the loss of insurance) than about offering good medical care. They refuse to see that on the issue of VBAC, obstetricians are their allies.

The latest NIH panel reviewed the scientific literature and confirmed their earlier stance. VBAC should be offered to eligible women because the chance of success is high and the risk of complications is low. Furthermore, the conference report urged ACOG to re-evaluate their VBAC guidelines, presumably to eliminate the need for continuous presence of both anesthesiologist and obstetricians. In addition, the panel recommended that policy makers review the medico-legal strictures on VBAC, since liability concerns are driving the restriction of VBACs.

Despite all this, VBAC activists are still complaining about evil obstetricians. The public comment session immediately following presentation of the report was dominated by VBAC activists with inane demands for revision of the report. Chief among those demands was the insistence that doctors be blamed for the current situation. It makes me wonder whether these women even bothered to read the report. Or perhaps they read it but didn't care that it represents the most promising avenue for increasing access to VBAC. Resentment is such an integral part of VBAC activism that it appears to be more important than VBAC itself.

Monday, March 8, 2010

VBAC activists: what would you do?



I watched the web cast of the NIH Consensus Development Conference on Vaginal Birth After Cesarean: New Insights, which is occurring this week. Dr. Michael Socol, chief of OB-GYN at Northwestern, distilled the problem down to its essence. He said (I am paraphrasing) that if it were possible for women to sign a binding consent giving up their right to sue in the event of uterine rupture, there would be no need for the conference. Every doctor would be offering a VBAC to every eligible patient.It is liability that is driving the restriction of VBAC. Successful lawsuits have led malpractice insurers to void a doctors' malpractice policies for presiding over VBACs.

Unfortunately, the law does not allow patients to sign away their right to file malpractice suits. Since that is the case, doctors have stopped doing VBACs.

During the question and answer session, a woman (it looked like Henci Goer, but the lighting was too poor to be sure) made the typically sanctimonious comment that patients should be "informed" that doctors would putting their liability concerns ahead of the patients' well being. The comment accomplished nothing beyond demonstrating that the woman had no understanding of the issues involved.

Let me make it easier for VBAC activists to understand:

What would you do if your health insurance company made a rule that anyone who attempts a VBAC would automatically void their health insurance policy and lose all coverage forever. In other words, you’d be on the hook for your $15,000 hospital stay and your baby’s hospital stay. Not only that, your well baby visits to the pediatrician would no longer be covered. Your older child’s epilepsy medications would no longer be covered, nor would his occupational therapy. Your husband would have to pay for the medication used to control his blood pressure. You’d be out at least an additional $10,000 each and every year forever.

On the other hand, if you consented to an elective repeat C-section, everything would be covered and you would not lose any insurance benefits.

What would you do then? Would you be willing to void your health insurance policy and threaten the financial security of your family in order to have a vaginal delivery? Is a vaginal delivery worth paying $15,000 out of pocket AND all your health expenses for the rest of your life, totaling hundreds of thousands of dollars?

And if it’s not worth voiding your health insurance policy and being personally responsible for tens or even hundreds of thousands of dollars, why is it worth voiding a doctors' malpractice policy?

Thursday, March 4, 2010

The rate of US homebirths is not rising



Homebirths advocates are touting a reported increase in homebirths from 2004-2006. They ought to look at the actual numbers a bit more closely before they get excited. They don't seem to realize that the homebirth rate in 2006 is exactly the same as it was in 2000. Homebirths still represent only a minuscule proportion of births in the US.

According to Trends and Characteristics of Home and Other Out-of-Hospital Births in the United States, 1990–2006:

In 2006, there were 38,568 out-of-hospital births in the United States, including 24,970 home births and 10,781 births occurring in a freestanding birthing center. After a gradual decline from 1990 to 2004, the percentage of out-of-hospital births increased by 3% from 0.87% in 2004 to 0.90% in 2005 and 2006. A similar pattern was found for home births. After a gradual decline from 1990 to 2004, the percentage of home births increased by 5% to 0.59% in 2005 and remained steady in 2006... About 61% of home births were delivered by midwives. Among midwife-delivered home births, one-fourth (27%) were delivered by certified nurse midwives, and nearly three-fourths (73%) were delivered by other midwives.
In other words:

From 2004 to 2005 out of hospital births (planned plus unplanned) increased from 0.87% of births to 0.90% of births; there was no increase from 2005-2006. Among births at home from 2004-2005 (planned plus unplanned) there was an increase from 0.56% to 0.59%; there was no increase from 2005-2006. But the homebirth rate dropped from 2000-2004, so the purported "increased" homebirth rate in 2006 is actually unchanged from the homebirth rate in 2000.


addendum: This graph makes it easier to see what happened.

Wednesday, March 3, 2010

Snowplow parents



The helicopter parent is dead. Long live the snowplow parent!

We've all heard of helicopter parents, mothers and fathers who hovers over a child's every decision and action. Evidently helicopter parents have evolved into the snowplow parent s "who determinedly clears a path for their child and shove aside any obstacle they perceive in the way."

So says Craig Lambert in an article in this month's issue of Harvard Magazine. The article, Nonstop: Today's superhero undergraduates do 3,000 things at 150%, detailing the frenetic pace and relentless ambition of today's undergraduates is by turns horrifying and depressing.

Students today routinely sprint through jam-packed daily schedules, tackling big servings of academic work plus giant helpings of extracurricular activity in a frenetic tizzy of commitments. They gaze at their Blackberries ... to field the digital traffic: e-mail and text messages, phone calls, Web access, and their calendars. Going or gone are late-night bull sessions with roommates and leisurely two-hour lunches ...

There’s a wide consensus that today’s undergraduates make up the most talented, accomplished group of polymaths ever assembled in Harvard Yard: there’s nothing surprising about meeting a first-chair cellist in the Harvard-Radcliffe Orchestra who is also a formidable racer for the cycling club, or a student doing original research on interstellar dark matter who organized a relief effort in sub-Saharan Africa...

The paradox is that students now live in such a blur of activity that idle moments for such introspection are vanishing. The French film director Jean Renoir once declared, “The foundation of all civilization is loitering,” saluting those unstructured chunks of time that give rise to creative ideas. If Renoir is right, and if Harvard students are among the leaders of the future, then civilization is on the precipice ...
What's driving this frenetic activity? Relentless ambition that starts surprisingly early:
Busy parents book them into things constantly—violin lessons, ballet lessons, swimming teams. ... Dingman [dean of freshmen] notes that, “Starting at an earlier age, students feel that their free time should be taken up with purposeful activities...

Home life has changed in ways that would seem to undercut children’s development of autonomy. There was a time when children did their own homework. Now parents routinely “help” them with assignments ... Youngsters formerly played sports and games with other children on a sandlot or pickup basis, not in leagues organized, coached, and officiated by adults ... Once, college applicants typically wrote their own applications, including the essays; today, an army of high-paid consultants, coaches, and editors is available to orchestrate and massage the admissions effort.
Parents have created this culture. As Lambert explains, " The strategizing starts early; today’s parents groom their children for high achievement in ways that set in motion the culture of scheduled lives and nonstop activity... "

While "snowplow parents" seem to be a new phenomenon, I suspect that are just a variation on a phenomenon as old as recorded history: wealthy parents ensuring children's success by paving the way with money and social connections. The prep school has been replaced by the public high school with multiple AP courses, the European grand tour has been replaced by the summer trips to far off lands, the social clubs replaced with the National Honor Society as the reward for extensive tutoring, special courses and advanced summer programs. Money, copious amounts of it, is usually required.

Sure anyone can go to public school, but very few can afford to live in the communities with the best schools; schools are usually funded by property taxes and estate sized homes for wealthy families provide an excellent tax base. Those fabulous summer trips to work on a dig in Egypt or study intensive Italian in Florence cost a fortune. And tutors, special courses and advanced study at college programs designed for high school students don't come cheap.

It used to be that money and social connections assured a child's success. Now actual merit is required, but money and social connections pave the way just as they always did. An outstanding athlete requires talent, but talent can honed with private coaches and exclusive leagues. To become a brilliant scientist requires brilliance, but a summer working in the award winning lab of Dad's medical colleague gives a teen an undeniable advantage. And woe to the child who has not devoted serious time to "social action," time that children of modest means must spend at work in order to help their families make ends meet.

Not only do parents script their children's lives and pay for every possible advantage, they run roughshod over anyone and anything that dares to stand in the way. It's bad enough that they will not back teachers in ensuring good behavior in schools, but it is ridiculous that they expect to be able to call a college to "check up" on their sophomore, and it is downright harmful that some come along to job negotiations or try to amend grades in law school.

Snowplow parents forget that their principle job is not to make sure that a child is successful, but to make sure that a child becomes a competent adult; the success will follow if it is merited. Any parent who is calling their child's law school professor has no faith that the child can perform even the most basic tasks of adulthood, hardly surprising since the parents never taught them how.

Snowplow parents believe they are helping their children, but in many cases they are hurting them. They are depriving them of the opportunity of gaining competence by overcoming disappointment or by striving to reach goals instead of having the goals slid to within easy reach. How will these children make their way in the world when their parents are gone? How will these children learn to value themselves for who they are instead of what they achieve? And how will these children handle the disappointment of realizing that it may not always be possible to achieve what they desire?

Parents should be active and involved in their children's lives. And parents sometimes have to run interference for children, particularly when children are young and vulnerable to the whims of teachers and coaches who may be cruel or unfair. But that does not require a snowplow, it doesn't even require a shovel. It requires a more subtle tool such as a broom, one that gets smaller and smaller as the years pass until it finally fades away altogether.

A child in college should be competent enough to manage anything that comes along outside the realm of a true disaster like sexual harassment on the part of a professor, or a roommate who is mentally ill, in other words, very rare occurrences. If a parent cannot trust a child to manage on his own at college or beyond, then something is wrong, not with the child, but with the parent, who failed to ensure that the child gradually learned to handle the basic tasks of adulthood.

Tuesday, March 2, 2010

Your own germs at home



Homebirth advocates like to tout the many "advantages" of giving birth at home. High on the list is limiting exposure to hospital acquired infections, and since only your "own germs" are in your home, you are protected. Yes, you are protected from hospital acquired infections, but the most dangerous infectious agents are actually those that live inside the mother, not the ones in the hospital. Consider that for newborns both Group B strep and herpes virus represents potentially deadly threats. And both Group B strep and herpes virus are infectious agents carried by the mother. In other words, the most deadly infectious threat to the baby is the mother herself.

For mothers, the most common infectious risk is a uterine infection. Once again the infectious agent is usually a bacteria living in the vagina. Homebirth advocates like to fling accusations about women who contract life threatening sepsis at home and are fond of pointing out horror stories like the unfortunate woman in Florida who ended up losing parts of multiple limbs due to Group A strep ("flesh eating" bacteria) sepsis. But what they don't realize is that approximately 90% of cases of Group A strep sepsis are acquired outside the hospital because the bacteria lives in the community. Usually it is harmless, but when it invades a wound (like the raw surface of the inside of the uterus after birth), the results can be disastrous.

It appears that this has happened in a small Texas town. According to the local paper:

A few weeks ago, a perfectly healthy Katy gave birth to daughter Arielle, only to experience an intense and prolonged pain after the birth.

... Doctors at Kingwood Medical Center eventually discovered the new mom had a Streptococcal A infection that had aggressively invaded her body.

As a result, Katy has experienced multiple organ failure and is unconscious. Surgery last week involved the removal of several sepsis organs. She is currently on a ventilator and is receiving dialysis.
Katy had had an eight hour, drug-free, intervention free labor and delivered a 10 pound baby girl ... in a planned homebirth.

Of course, the result may not have been any different had Katy given birth in the hospital, since she would have brought the bacteria in with her. And that is the important point to keep in mind. While hospital acquired infections are a serious problem for the elderly and the immuno-compromised, they are far less common in obstetric care. During childbirth, the bacteria and viruses that pose the greatest threat to babies and mothers are those carried by the mother herself. Homebirth does not offer protection against serious neonatal and maternal infections, because the most dangerous "germs" are "your own germs at home."

Katy has no health insurance. A variety of events are being held to raise money for her and her family. Find out more here.