Born in the USA (13 page)

This story is also an example of the way research can be abused and may be conducted for the wrong reasons, such as to advance physicians' careers or to protect physicians who are unwilling to adhere to regulations. It is extraordinary that in obstetrics, where most doctors have little or no training in scientific methodology, doing scientific research is nevertheless one of the important steps to climbing the career ladder.

The most important thing this story illustrates, however, is that the human rights of research subjects are being abused. The FDA has a list of eight kinds of information that must be given to a patient who is used as a research subject, so that the patient can make an informed choice about whether or not to participate in the study. Everyone who does research or approves research should know these eight FDA requirements by heart.
And yet the FDA has found it necessary to publish a list of the most common problems found when evaluating consent forms.
⁶⁹
The forms (1) fail to include all eight required elements; (2) fail to state that the drug or procedure is experimental; (3) fail to state all the purposes of the research (i.e., they include only those purposes that the subject would consider most beneficial); (4) overstate facts or are overly optimistic in tone or wording; (5) fail to adequately describe the treatment alternatives available to the woman or the risks and benefits of the alternatives; or (6) fail to provide a contact for answers to questions about the research.

When the woman in Dr. S's study had a uterine rupture and lost her baby, the FDA sent someone to the hospital to investigate. They found a lot of inadequacies in the work performed by the hospital's IRB and found that the consent form used in Dr. S's study contained the first four of the six most common failures listed in the previous paragraph.

According to the federal government, the case presented here is not exceptional in obstetric research in the United States. So much of our medical research lacks adequate protection for “human subjects” that there is a special federal office set up to monitor research and deal with abuse cases. A document published by this special office says, “Despite their intentions to ensure compliance, it is not uncommon for federally funded research institutions to discover that their own policies for protecting human subjects are misunderstood, poorly implemented, or simply disregarded by their own clinicians and IRBs.”
⁷⁰

Another related issue is “checkbook science,” in which studies are conducted and papers are published that are intended not to expand knowledge or to benefit humanity, but rather to sell products.
⁷¹
Pharmaceutical companies and other health care industry interests hire public relations firms, which, in turn, hire medical writers to ghostwrite academic-style articles for medical school professors, who submit the articles to respected medical journals. When the paper is published, the headline refers to the new study as the “Harvard study,” ensuring that the results will be taken seriously. For his part, the Harvard professor will receive a generous honorarium, such an all-expense-paid trip to another country, where the professor will play the role of the prestigious expert and speak on behalf of the new product at a major conference. In effect, the professor is a paid spokesperson, but he can honestly say that he is not paid by the company because the money comes from the public relations firm (which in turn is paid by the company).

In addition to these problems with how obstetric research is conducted
in the United States, there are also many problems with the ways obstetricians interpret and use research. There are many examples in this book of obstetricians who have drawn false conclusions, used misleading language to manipulate research findings, acknowledged only the studies that support their position (and ignored the rest), and so on.

The third type of obstetric research—valid science—takes the form of randomized controlled experimental trials in which there is a sufficient number of cases to draw conclusions about serious risks, proper methodology is used, and researchers obtain proper informed consent from subjects. To examine this type of research, take a look at the Cochrane database (
www.cochrane.org
). The Cochrane database is assembled by a group of top-notch perinatal scientists from around the world who review the world's scientific literature and make recommendations on obstetric practices based on their reviews. This is valid science, and tragically there is far too little of it.

Several members of the Cochrane group published a textbook titled
A Guide to Effective Care in Pregnancy and Childbirth
, which focuses on valid science (findings from randomized controlled trials) and discusses their recommendations. At the back of the book are six tables that list obstetric practices.
Table 1
includes practices for which effectiveness was demonstrated “by clear evidence from controlled trials,”
tables 2
through
5
show practices backed up by decreasing levels of valid science, and, finally, in
table 6
, we see practices for which “ineffectiveness or harm was demonstrated by clear evidence.”
⁷²
Of the 458 practices in the six tables, we can say that 260 practices (those in
tables 4
,
5
, and
6
) are not supported by adequate scientific evidence or scientific evidence indicates that they should not be done. It is extraordinary to note that among these 260 unsupported or harmful practices are a number of practices that are common in American obstetrics.
Table 4
(on the next two pages) contains a partial list. As you read through the list, reflect on how many of these practices you have seen or experienced. (The statements, from
A Guide to Effective Care in Pregnancy and Childbirth
, of ineffective or harmful practices are in quotation marks. My comments are in italics following the statements.)

Compared to other medical specialties, the state of obstetric research is the worst by far. The Cochrane group has given the field of obstetrics an award called the “Wooden Spoon,” which symbolizes its unique place as the medical specialty with the poorest quality of research and the least evidence-based practice.

Meanwhile, the rate of women dying around the time of birth in the United States is going up. It is difficult to draw conclusions from death certificate data because only the immediate cause of death is listed, not the underlying causes. But if we look at the six leading causes of pregnancy-related death in the United States, three of them (hemorrhage, anesthesia, and infection) are likely to be the result of obstetric interventions. For example, the immediate cause of death is frequently given as hemorrhage, but we can speculate that in many cases the hemorrhage, as in the case in Iowa cited earlier, is associated with C-section. Research done in the United States and in Great Britain shows that the maternal mortality rate for C-section—combining emergency and elective—is four times higher than the maternal mortality rate for vaginal birth.
⁷³
And the rate of women dying is still nearly three times higher when it is a routine or “elective” C-section without any emergency. Given that well over half of the C-sections performed in the United States these days are unnecessary, we must conclude that unnecessary C-sections are contributing to our increasing maternal mortality rates.
⁷⁴
It is proven that using epidural block for normal labor pain carries an increased risk that a woman will die, and “anesthesia complications” is documented as one of the leading causes of maternal mortality in the United States.
⁷⁵
So unnecessary epidural blocks are also contributing to the increase in deaths. There is good reason to believe that other obstetric technologies, such as drugs used to induce labor, contribute to the rising number of women dying during childbirth in the United States as well, and we will look closely at that in
chapter 4
.