Born in the USA (12 page)

The general consensus now among perinatal scientists and obstetricians is that the ideal rate of episiotomy is 5 to 10 percent of all vaginal births. Episiotomies should be done only in urgent situations, such as cases of fetal distress due to a compressed umbilical cord, that require a hasty vacuum extraction.

Because obstetric interventions are introduced and disseminated in unsystematic, untested ways, it is no surprise that there is a big gap in the United States between what is being practiced in maternity care and what we know scientifically to be best. Perhaps even more frightening is the fact that there have been only a very few attempts to evaluate the long-term effects of interventions on the baby. As mentioned earlier, we know that there is a possible connection between a women having an epidural block during labor and reduced neurological functioning of the baby at one month of age. Two studies have shown that using drugs to manage pain during childbirth increases the chance that the baby will become addicted to drugs in adulthood.
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But there is much more that we do not know. For example, we have seen a rapid increase in the use of ultrasound to examine pregnant women in the last twenty years, but there has never been a large enough longitudinal, prospective, randomized trial to test the effects of ultrasound. So far research has suggested a connection between ultrasound of the fetus and later minimal neurological problems, but these findings have yet to be confirmed.
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Other studies suggest that miscarriages and preterm labors increase with ultrasound, but again we must wait for further research to confirm these findings.
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Finally, research now casts doubt on the efficacy of routine prenatal ultrasound. The author of a report on a large randomized
trial involving 15,151 pregnant women concluded, “The findings of this study clearly indicate that ultrasound screening does not improve perinatal outcome in current U.S. practice.”
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Another large randomized trial found no benefit from routine scanning and concluded, “It would seem prudent to limit ultrasound examinations of the fetus to those cases in which the information is likely to be of clinical importance.”
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This situation was well summarized by a radiologist: “The casual observer might be forgiven for wondering why the medical profession is now involved in the wholesale routine examination of pregnant patients with machines emanating vastly different powers of energy which is not proven to be harmless to obtain information which is not proven to be of any clinical value by operators who are not certified as competent to perform the operations.”
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Two decades later, we don't know much more about routine ultrasound scanning during pregnancy and must continue to wait for a scientifically valid study that will reveal both safety (risk levels) and efficacy.

Procedures used today, such as ultrasound scanning, may seem harmless, but it is important to remember the history of obstetric practices and the fact that, in the 1930s, taking X-rays of pregnant women seemed harmless as well. In 1937, a standard obstetric textbook stated: “It has been frequently asked whether there is any danger to the life of the child by the passage of X-rays through it; it can be said at once that there is none if the examination is carried out by a competent radiologist.”
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A later edition of the same textbook stated, “It is now known that the unrestricted use of X-rays is harmful to mother and child.”
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The reason for this change was the report in 1956 on the connection between fetal X-rays and later cancer in the child.
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Using the anti-precautionary approach and assuming the safety of any obstetric intervention is dangerous.

Today, there are essentially three approaches to “research” in obstetrics in the United States: non-science, false science, and valid science. The non-science approach, also known as “let's try it out,” is what the anesthesiologist from Boston described, and it is by far the most common way obstetricians go about determining if a new procedure or drug is a good idea. (In
chapter 4
, we will see that doctors took this approach with the drug Cytotec, and that this approach, based on the anti-precautionary principle, is widespread in obstetrics.) When doctors take this approach, I often hear them call what they are doing “fine-tuning,” as though they already know a lot about a new intervention and are just working out the last tiny details. But that is a euphemism, as there has been no primary research to fine-tune. “Trying it out” is not only unreliable, it's dangerous
and demonstrates the wisdom of Benjamin Franklin's aphorism—“Experience keeps a dear school, but fools will learn in no other.” I rarely hear doctors acknowledge that the women whose bodies are being used without their informed consent to “fine-tune” a new intervention sometimes die from the fine-tuning.

The second approach to obstetric research is false science, which is usually conducted by an obstetrician or group of obstetricians who have found an intervention they want to use, have been using it for a while on various patients, and then afterward decide to try to “prove” that it's a good idea. Medical schools do not usually train physicians in scientific methodology, so most practicing doctors who undertake studies have little or no scientific training and inevitably make mistakes, many of which stem from the fact that the “researcher” is biased and believes that he already knows what the study will find. This is the fundamental difference between a scientific approach and a clinical approach. To generate a hypothesis or a question, a scientist must believe that he does not know the answer; otherwise, his bias will contaminate the study. A practicing doctor, on the other hand, must believe with certainty that he
does
know, because he must have the confidence to make life-and-death decisions. Clinicians who do research must have the ability to change their mindsets quickly and frequently from clinician to scientist, and in my experience few have this ability.

Another common weakness in obstetric research is that once clinicians take on a study, they are usually in a hurry. They want answers immediately, and, as a result, studies are generally rushed and involve too few cases. In some situations, a small number of cases can prove efficacy—that is, show that a new drug or procedure works—but much larger numbers are needed to determine the level of risk involved with a reasonable degree of statistical certainty. This is because the most serious obstetric risks (e.g., uterine rupture, amniotic fluid embolism, brain damage, or death of the woman and/or the baby) occur infrequently.

So, without knowing enough about scientific methods, doctors start collecting data on their patients. They may or may not get hospital approval and they rarely get their patients' fully informed consent as participants in the study. They keep the study “low-profile.” Then, in spite of the fact that the research methodology is faulty and the results are mostly or completely invalid, the doctors may manage to get their study published in a “peer-reviewed” journal, that is, a journal where submissions are reviewed by other doctors who are also likely to lack adequate scientific training. Now the study is big news. The “researchers” are famous in their little world and
may even get promoted—and other obstetricians will use their study as justification for their own practices.

Here is a real-life story that illustrates many of the issues involved in physicians conducting and relying on what amounts to false science. A chief of obstetrics at a large hospital in a medium-sized city—we'll call him Dr. S—decided to mount a study to look at using a prostaglandin drug (not Pitocin) to induce labor in women who had previously had C-sections, even though the drug's label specifically says that the drug should not be used in this way. Clearly, not enough was known about the safety of using this drug for labor induction after a previous C-section, which is why the label warned against this use. Dr. S later admitted that one of the primary reasons for doing the study was that doctors in that hospital wanted to use the drug and wanted something that would protect them from litigation. If they ran into trouble, the existence of a study would at least allow them to say, “We're researching it.” As an afterthought, Dr. S decided that as long as they were going to do a study, they might as well have someone write a paper.

For the study to be official, Dr. S needed to have it approved by the hospital's institutional review board (IRB), and to be cleared by the IRB, certain research protocols must be followed. For example, the researchers must do a “review of the literature” to see what other studies have been published on the topic or related topics. Dr. S found a young obstetrician—we'll call her Dr. H—to join his study and do a lot of that scut work. Neither Dr. S nor Dr. H had any training in science, and they struggled to put together the IRB application.

Dr. H found only a few relevant previous studies. Naively, she put them together in a false “meta-analysis.” When there are a number of small studies, and each one is too small to get a scientific handle on outcomes such as risks, one solution is to combine the results of the small studies into a meta-analysis. This can be a useful method of study, but there are many pitfalls to avoid. Too often, as in this case, a meta-analysis combines findings that were the result of very different methodologies, which is like mixing apples, oranges, and bananas, and has no scientific validity.

By combining study results in this way, Dr. H ended up with just over three hundred total cases. Since the most serious risk of using the drug for induction after previous C-section was uterine rupture (which has a high mortality rate), it can be calculated that a study would have to include at least 3,957 women to determine the safety of the drug with a reasonable level of certainty. Since this hospital handled only about twenty-five pregnant women per year who had previously had C-sections and were attempting
VBAC, it would have taken the doctors 158 years to collect enough cases to prove that using the drug is safe. But this did not deter Dr. S. In fact, he later admitted that he knew from the start that he was not going to get a meaningful amount of data.

Working the system, Dr. S told various untrue stories about his study. He claimed that he told the women he recruited as subjects that they would be part of a study and further claimed that he told them they might be offered a drug that (to paraphrase) is not approved by the FDA, though he also told them that he and the other doctors at the hospital knew the drug to be safe and helpful. He told the hospital IRB something similar, though for their benefit, he did call the new drug “experimental” and indicated that the study would prove scientifically what doctors at the hospital already knew, that the drug is safe. Neither group was told the less palatable purposes of the study—that it was done to protect doctors using the drug from litigation, to advance the careers of Dr. S and Dr. H, and to promote the use of an obstetric intervention.

A hospital IRB is another example of the “peer-review” principle in medicine. The FDA mandates that an IRB of a hospital must include doctors from that hospital, as well as one administrator and one outsider from the community. The FDA also stipulates that it is the IRB's duty to guarantee that a study is scientifically valid and to protect the rights of the research subjects. A researcher must submit a research plan or protocol to the IRB for approval before starting. In this case, the doctors' research protocol was approved unanimously on the first try, despite the fact that it did not include an appropriate informed consent form and other essential elements. Any scientist reviewing this protocol would immediately have recognized the study as false science, but there were no scientists on the IRB.

Not long after the study began, a woman with a previous C-section came to Dr. S for maternity care. After a normal pregnancy, she was admitted to the hospital and, without her knowing it, she became part of Dr. S's study. (It appears that Dr. S's claim that all women were informed of the study was false.) Dr. S gave her the drug to induce labor, the drug led to overly strong contractions, a condition known as uterine hyperstimulation, and then to uterine rupture. As a result, the woman's baby was severely brain-damaged and died in infancy.

Several lessons can be learned from this example. First, “peer review” is not an effective method of quality control in approving obstetric research. When there are no trained scientists on an IRB, it is effectively a case of the blind reviewing the blind. Furthermore, today in American medical practice,
peer review
has become a catchword implying that this is a way of guaranteeing the validity of research papers and evidence. But the most respected leaders in medical scientific publishing warn us about peer review. An editorial in
The Lancet
comments: “ ‘Peer review, a process that research has shown to be an ineffective lottery prone to bias and abuse.' Richard Smith, former editor of the
BMJ
. Smith is not alone in his utterances.
The Lancet's
editor and two former editors of
The New England Journal of Medicine
have publicly expressed similar views. In addition, what evidence is available from systematic reviews points to similar systematic manipulation of evidence by the pharmaceutical industry and sometimes also by governments. Moreover, there is a lack of convincing evidence that the editorial system works.”
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We can also speculate that the IRB rubber-stamped the study application in this case because of hospital dynamics. Physicians generally dislike being regulated or controlled by their hospital administration, so the hospital administration must find ways to keep the physicians happy while also maintaining a reasonable system of quality assurance. One way to make physicians happy is to approve their study protocols. Published research also gives a hospital status and helps it attract doctors and patients. In addition, while the IRB is an agent of the administration in a hospital, most of the members are practicing physicians and are likely to want their own study protocols approved some day. So collusion among members is common—you approve my protocol and I'll approve yours. Finally, the physicians on the IRB were probably sympathetic when they heard the obstetricians in their hospital complaining that they needed to use this drug, but the FDA and the drug company said they shouldn't, because they had experienced similar frustrations.