“Defective premises tend to recur in new settings”

A new experimental program at a nonconventional “lifestyle medicine” center is targeting pregnant women who are Black and Hispanic minority, poor and fat. These women are being enrolled into a free health program which tells them it will benefit them and their unborn babies and make their babies healthier.

No mention is made in the patient literature that, by the soundest clinical evidence to date, compared to the standard of care, the program’s alternative interventions have been shown to lead to poorer chances of survival for babies, higher rates of spontaneous preterm births, and to put babies at greater risk for serious physical and neurological health problems and learning disabilities. There is no indication that these underprivileged minority women are giving their informed consent or are aware they are participants in human experiments that could endanger their unborn babies.

Why has no one cared to notice? The answer to that question is even more disquieting….

In the news

A press release was issued earlier this month by Northwestern University, which the media published with embellishment and without question. The articles publicized a new program at the Northwestern Comprehensive Center on Obesity in Chicago that was said to help babies “beat obesity odds” by keeping expectant mothers’ pregnancy weight gain in check.

Dr. Alan Peaceman, M.D., co-director of the program, told the media that “obesity in pregnancy may be contributing to the epidemic of childhood obesity and diabetes that we are seeing today.” An appropriate weight gain for some women who are overweight is no weight gain at all, he said.

As Reuters reported:

It is based on new research suggesting that excessive weight gain in pregnancy hurts both the mother and her fetus, raising the risk of complications during pregnancy and putting the child at risk for obesity and diabetes later in life… "We've known for a long time that children of overweight mothers are more likely to be overweight themselves," said Dr. Robert Kushner, who directs the Northwestern Comprehensive Center on Obesity. But he said researchers had assumed that was simply because the mother passed along her bad eating and lifestyle habits to her child after birth. Now, animal studies suggest … “The whole idea is, as that child comes out of the birth canal, you've already imprinted that child's vulnerability to be overweight," Kushner said. "It's like being born with handcuffs on. In this environment, how do they have a fighting chance?" said Kushner, referring to the growing obesity epidemic…

This may sell among the public, many of whom have come to believe the myth that type 2 diabetes, like obesity, is caused by overeating or eating too much sugar or junk, but medical professionals know otherwise. Research has documented for years that not only are obesity and type 2 diabetes primarily hereditary, if there even is a link between nutrition in utero and genetic changes that contribute to later diabetes or insulin resistance in a baby, it’s more likely that children born to mothers who’ve had restricted diets, eaten too little, or endured famine (intentional, such as dieting, or imposed, such as the Dutch famine during World War II) during pregnancy may be more likely to develop type 2 diabetes, perhaps especially those with a hereditary tendency to being larger. And low birthweight babies whose mother’s may have not eaten enough during their pregnancies, are more likely to develop impaired glucose regulation and diabetes later in life, independent of obesity or any risk factor (as shown in a recent China study). In other words, based on the clinical research to date, restricting a mother’s diet so that she gains little or no weight during pregnancy could likely have the opposite effect this story suggests, and put babies’ health at greater risk.

The news went on to say that experimenting on pregnant women has been considered unethical because it imposes risks to the most innocent of all — a growing baby. Dr. Kushner was quoted saying that “pregnant women have often been considered hands off because of fear of harming the developing baby [but] it’s time to be more aggressive with fat pregnant women.”

The program has “a special emphasis on treating low-income minority women,” said the nurse coordinator, but several women in the program have also had gastric bypass surgery and fear gaining too much weight. They want to “maintain a normal weight gain in pregnancy, which is no more than 15 pounds because these women are obese,” she said. A young pregnant woman profiled in the news story said she hopes the program will help give her ammunition to resist the pressure she’s getting to gain weight… from her obstetrician.

As the media reported, the program hopes someday to gather data to see if it helped give babies “a better shot at having a healthy weight.” In other words, as the news failed to explain, this program is not part of a study — a randomized, controlled clinical trial, which would be the only “fair test” of the effectiveness of such a medical intervention. This is not research designed to credibly advance scientific knowledge. Also not reported to women and their referring physicians is that this experiment has not released a clinical trial protocol or been registered at clinicaltrials.gov.

Background

The public didn’t hear that this experimental program is through the Center for Lifestyle Medicine, which offers a variety of services for weight loss and “healthy lifestyles” — including dietary and behavioral counseling for weight loss, bariatric surgery, and disease management.* Lifestyle medicine, reviewed here, is the latest popular alternative modality. It is not conventional medicine. It advocates that most chronic diseases of aging are our own fault and caused by the wrong diets and lifestyles, and can be prevented with “healthy lifestyles,” weight loss and special diets. Even as clinical trial evidence is steadily failing to support these beliefs behind lifestyle medicine, this modality is increasingly finding its way into mainstream medicine, academia and public health policies. Lifestyle medicine has become such big business and so widely and heavily promoted, that the fact that most of it isn’t sound, evidence-based mainstream medical care isn’t widely realized among lay people.

JFS readers will remember Dr. Kushner from 2007, when obesity interests rallied to re-interpret the findings from senior research scientists at the CDC National Center for Health Statistics, who had conducted years of investigations into claims that hundreds of thousands of people were dying every year from overweight and obesity. Using data from actual physical examinations on a nationally-representative cross section of the population and U.S. vital statistics, the CDC scientists found that most fat people actually had lower risks of premature death than “normal” weight people — those with BMIs of 30 to 35, for example, were associated with a 23 percent lower risk of premature death.

At that time, Dr. Kushner was the Director of the Wellness Institute at Northwestern Memorial Hospital. He had authored the American Medical Association’s Assessment and Management of Obesity, funded by $50 million from Robert Wood Johnson Foundation. A prolific author, he also wrote Fitness Unleashed: A Dog and Owner’s Guide to Losing Weight and Gaining Health Together and the Personality Type Diet book series. His personality diet suggests that obesity is due to emotional issues with foods, sedentary behaviors, and eating bad foods and at the wrong times of day. It offers a personality test and a weight loss diet for your personality, focused on plant-based, soy, low-fat, high-fiber, “super foods.” There has yet to be a published study showing any long-term effectiveness for weight loss or improved health outcomes of a personality diet. Last fall, on October 21, 2008, the Obesity Society, the largest lobbying organization of obesity stakeholders, announced it had made Dr. Kushner its new president.

Northwestern’s Comprehensive Center on Obesity, located in its new Center for Lifestyle Medicine, opened last November. It was founded, according to the director, to address the global epidemic of obesity by focusing research on fat pregnant women, minorities and children; developing public policies and lobbying for obesity prevention programs; and educating medical students and professionals on the causes and treatment of obesity. It tells consumers that it can help them:

● manage your weight;

● determine if bariatric surgery would be a good option and then, if so, guide you through the surgery, follow-up care, and adjustment period;

● evaluate your risk factors for major life-threatening chronic diseases such as heart disease, diabetes, stroke; and

● counsel you using specific test results and recommend ways to change your behavior that suits your needs and personality

Healthy for 2

The Center for Lifestyle Medicine’s program for minority, poor fat pregnant women is called: Healthy for You, Healthy for 2. The online patient literature tells the women that their obstetrician referred them to the program because they met the criteria by being fat, gained “too much weight” in a previous pregnancy or had gestational diabetes, or had bariatric surgery. Clearly equating weight with health, it says a fat mother passes along the tendency of being fat to her unborn baby, so that by keeping her weight gain in check, her baby may be healthier, too. The women are told that the program has unique interventions that will benefit them and help their baby be healthier, and visits will extend after their baby is born to help them reach their goals (presumably for weight loss).

Participants in this experimental program won’t find that there is no evidence that mothers who try to restrict their pregnancy weight gain to 0-15 pounds can do so safely and that it will help their babies be healthier or prevent the hereditary tendency for obesity in their children. Nor does it appear that these minority, disadvantaged mothers are even being made aware that the evidence, for more than half a century, suggests that such restrictions could increase risks for their babies.

The idea of lowering the weight recommendations for expectant mothers to address the obesity epidemic has been floated by RWJF-funded entities for several years. RWJF-supported anti-obesity initiatives have been promoting weight loss before and between pregnancies, and it commissioned the Institute of Medicine to propose changing the clinical guidelines to recommend more restrictive weight gain during pregnancy. This 22-month initiative has been previously reviewed, along with the reasons why the weight guidelines are as they are today.

Knowing about this research is important for women who want a healthy baby. There is no clinical evidence to support that pregnancy weight gain is to blame for the obesity epidemic or childhood obesity. Studies following women through their pregnancies and their children for years thereafter, found that mothers gaining “too much” weight during pregnancy had little correlation to children’s later weight status.

In contrast, low pre-pregnancy weight or low weight gain during pregnancy is well-recognized as a strong predictor for both preterm deliveries and a doubled risk of retarded fetal growth. Low weight gain by mothers during pregnancy, including women trying to watch their figures, is one of the factors shown to play a role in babies of low birthweight, which is associated with a range of health problems for newborn babies.

A mother’s caloric and fat intake, more so than even recommendations for specific micronutrients, has been shown to play a critical role in ensuring optimal fetal growth and development — something all babies deserve regardless of their mother’s size. Cholesterol, for instance, is essential for the developing embryo, just as dietary fats are critical for growing babies and children. It is common sense that babies not growing normally during pregnancy are at risk, but the risks for intrauterine growth retarded babies just for surviving infancy are staggering. IUGR is responsible for about half of normal-formed stillbirths and babies weighing less than 5 1/2 pounds at birth have mortality rates 5 to 30 times higher than average birth weights. Babies under 3 1/3 pounds have mortality rates 70 to 100 times greater. Babies suffering from undernutrition during pregnancy are also at increased risk for neurological, respiratory, intestinal and circulatory problems during the neonatal period.

The evidence suggesting life-long ramifications for children who suffer IUGR far exceeds any potential harms associated with being a fat child. Low birth weight babies are also associated with earlier and higher prevalence of hypertension, coronary heart disease, adult onset diabetes, chronic respiratory disease, autoimmune thyroid disease and some forms of cancer later in life.

This notion of restricting pregnancy weight gain has been tried before… and proved detrimental for babies. In the 1950s, it became standard practice for public health officials in the United States to recommend restricting weight gain during pregnancy to less than 20 pounds, out of fears that gaining more could risk toxemia and birth complications. But medical professionals recognized that this advice was ill-founded and endangering babies. Among mothers following their weight gain restrictions, their babies had poorer chances for survival and more health problems. The facts finally led to a reversal in the 1970s and the clinical guidelines we have today. The research has continued to show these recommendations help to ensure a safe pregnancy, optimal fetal growth and healthy babies.

JFS recently examined the fact that fat pregnant women are more likely to carry babies to term. They have lower risks for spontaneously delivering premature babies. Obstetricians with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal–Fetal Medicine Units Network (MFMU), a network of fourteen university medical centers that have been involved in clinical research on mothers and babies for more than two decades, have documented that the body of evidence clearly shows that not only is being fat protective, but thinner women and inadequate weight gain during pregnancy are also independent risk factors for premature births. Authors from the Division of Reproductive Health at the Centers for Disease Control and Prevention noted that at least a dozen studies published prior to 2000 had documented this well-established fact.

These experts recognized more than a decade ago that preterm deliveries are also responsible for about eight out of ten perinatal deaths in the United States.

Fat women have far fewer premature babies, with the risks of having a preemie decreasing with increasing maternal weights. More stunning, researchers who had hoped to show that women losing weight before getting pregnant could reduce rates of preterm births, instead found the opposite. Examining all the women who had delivered at one major medical center between 1996 and 2004, for instance, revealed that the more weight the women lost between pregnancies, the greater their risks for subsequently having a preterm baby. A single BMI unit drop (about 6 pounds for a woman of average height) doubled her risks of having a spontaneous preterm delivery. Losing more than 5 kg/m² BMI was associated with nearly triple the risk of having a preemie (28% to 80%).

The Healthy for 2 experimental program targets minority, poor, fat women.

Recommendations that women gain little or no weight during pregnancy to have healthier babies are clearly not supported by sound evidence. Such recommendations are a public health message that might help sell weight loss and “healthy lifestyle” programs, but could have devastating effects for millions of innocent babies and their families.

The soul-searching part

Look again at the website of the Healthy for 2 program. Do you see any patient information for the women referred to this program that explains any of the potential risks to their babies?

No, they are told only how this program will benefit them and their unborn babies. The women referred to this clinical program are told where to go, with no indication that they have a choice. There is not even an indication that this is an experimental program — it’s listed under “Clinical Care” on their website, and not even linked to the center’s research. Nowhere is it explained that the “unique interventions” of this program mean they are not traditional medical practice and that they depart from standards of clinical practice.

Do you feel that the underprivileged minority fat women being targeted in this program are being given information to enable them to freely give their informed consent to an experimental intervention?

The core principles that guide medical professionals around the world in the ethical practice of medicine and human experimentation were born of the 1946 Nuremberg doctor’s trial in Germany. It's become part of every clinical trial protocol and consent process. Essential is the ability of each person to be in the position to freely give their voluntary, informed consent to participate in experimental interventions. That means no “element of force, fraud, deceit, duress, overreaching or other ulterior form of constraint or coercion,” according to the Nuremberg Code. This is why especially vulnerable populations in dependent positions receive special consideration. It also dictates that any human experimentation must weight the risks against the expected benefits for the patients.

FDA guidelines on the elements of an informed consent further states that study participants must be given a full explanation of any reasonably foreseeable risks and a full disclosure of appropriate alternative treatments that might help them, so that they can make a reasoned decision for themselves. The Declaration of Helsinki, adopted worldwide in 1964, adds additional safeguards, calling upon all research on human subjects to conform to accepted scientific principles and be based on adequately performed laboratory and animal experimentation and a thorough knowledge of the scientific literature.

It isn’t known if this experimental program has undergone review by an Institutional Review Board (IRB) to ensure that the rights and welfare of human subjects have been protected. IRBs also review study participant recruitment literature and news releases to make sure that they don’t promise free healthcare or imply a certainty of favorable outcomes or benefits beyond that outlined in the consent document.

In the week since this story first appeared, a multitude of media stories have reinforced the unsubstantiated, and potentially harmful, public health message that gaining weight during pregnancy could lead to obese children and that restricting weight gain might prevent obesity. Medical and public health professionals have been silent.

Every day brings us closer to the frightening parallels by Dr. Edmund D. Pellegrino, M.D., Professor Emeritus of Medicine and Medical Ethics and Adjunct Professor of Philosophy and Director of the Center for Bioethics at Georgetown University, in his sobering assessment of medical ethics today. In describing what he saw happening in medicine, he cautioned that medicine was increasingly being used for purposes other than the good of the sick, and failing to be stewards of sound medical knowledge. “Clearly, the major lesson of the Nuremberg Trials has not been learned,” he wrote. The oppression and violation of human rights has repeatedly felt justified for what's considered to be moral and right reasons.

At its deepest soul, the practice of medicine is founded on the moral commitment to heal and protect patients, especially the most vulnerable. Medical ethics calls upon us to not engage in human experimentation without the voluntary, informed consent of the patient; to ensure that the research conforms to accepted scientific principles and a thorough knowledge of the science; and to particularly safeguard the rights and welfare of vulnerable populations such as pregnant women, babies and children, institutionalized people, the handicapped or economically-socially disadvantaged.

Moral lessons are quickly forgotten. Medical ethics is more fragile than we think. Moral reasoning based on defective premises tends to recur in new settings.— Dr. Edmund D. Pellegrino, M.D., “The Nazi Doctors and Nuremberg: Some moral lessons revisited,” 1997.

© 2009 Sandy Szwarc

* JFS has covered the research on the lack of efficacy or effectiveness of these interventions at length. Newer readers, you’ll find a Google search tool to the right, to read about studies you may have missed.

Thanks Anita!