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From the Townsend Letter
April 2011

briefed by Jule Klotter

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Researching Genetically Modified Crops
What are the health risks of genetically modified foods? The short answer is, we don't know. Compared with other foreign substances that we ingest, such as pharmaceuticals, GM foods have undergone few safety studies. As GM crops entered the market, regulators decided to treat them as if they were the same as other food crops because the new crops were expected to have proteins, fats and oils, and carbohydrates "substantially similar" to those found in non-GM crops. This policy of "substantial equivalence" has been criticized. As French researcher Jöel Spiroux de Vendômois and colleagues state, "Such a concept … is based on a simplistic view of living cells. In particular, it overlooks all the interactions between genes, and the direct or indirect potential metabolic consequences of insertional mutagenesis [inserting foreign genes into a crop's DNA]." Animal studies show that GM crops currently in the food supply have negative effects on the liver, pancreas, kidneys, gastrointestinal tract, and reproduction as well as affecting blood, biochemical, and immunologic measurements. A 2010 hamster study, conducted by Russian biologist Alexey V. Surov, showed high rates of sterility and infant death within three generations among hamsters with GM soy in their diet. The hypothesis of "substantial equivalence" needs to be rigorously tested, since GM crops have infiltrated the diets of every human and domesticated animal eating manufactured food.

At this point, soy and canola (rapeseed oil) modified to tolerate Monsanto's pesticide Roundup and corn (maize) modified to produce its own pesticide in the form of mutated Bt (Bacillus thuringiensis) toxins are the primary edible GMOs in the marketplace. Some researchers believe that GM crops should undergo the same safety testing as pharmaceuticals. Long-term, generational studies involving statistically sufficient numbers of a variety of animal species would help resolve many questions about GM safety. Right now, most information about GM health effects come from short, manufacturer studies involving young adult laboratory animals. When a court order required Monsanto to release its safety data on MON 863 Bt maize, the most detailed trial was a three-month-long rat study. A French research team performed its own analysis of the data and found: "… a significant increase in blood glucose of 10% in GM-fed females, in triglycerides of 24-40%, overweight livers and enhanced liver/brain ratios (7%), small but significant body weight gain (3.7%), and disturbed kidney parameters."

Monsanto, the largest maker and seller of GM seeds, along with Dow Agrosciences, Syngenta, and Dupont claim that GM crops are more productive, need fewer pesticides, and lessen soil erosion because the crops require less tilling. "Unfortunately, it is impossible to verify that genetically modified crops perform as advertised," write the editors of Scientific American in their August 13, 2009, editorial. "That is because agritech companies have given themselves veto power over the work of independent researchers." User agreements attached to the sale of GM seeds "explicitly [forbid] the use of the seeds for any independent research." The editors continue, "Under the threat of litigation, scientists cannot test a seed to explore the different conditions under which it thrives or fails. They cannot compare seeds from one company against those from another company. And perhaps most important, they cannot examine whether the genetically modified crops lead to unintended environmental side effects." In the past, researchers who found negative health effects on test animals have lost company permission to print the study. Those who have publicized negative results, including Dr. Arpad Pusztal, have lost jobs and had their reputations attacked. Scientific American editors state, "… when scientists are prevented from examining the raw ingredients in our nation's food supply or from testing the plant material that covers a large portion of the country's agricultural land, the restrictions on free inquiry become dangerous." In addition to company restriction on independent laboratory research, epidemiological studies are virtually impossible because most countries – including the US – do not track GM crops. GM food labeling legislation has never been passed in the US, allowing these crops to be used throughout the food supply without consumer knowledge.

Failure to Yield, a recent report from the Union of Concerned Scientists, challenges the GM industry's claim that genetic modification increases crop yield and allows the use of less herbicide. With the exception of Bt corn, crop yield on farmland sown with GM seed has not substantially increased. The use of Roundup herbicide, however, has. As Mary Budinger reported in the Townsend Letter (October 2010), "… GE crops have been responsible for an increase of 383 million pounds of herbicide use in the US between 1996 and 2008." Roundup, like other synthetic herbicides, has negative effects including the inhibition of estrogen synthesis. The Union of Concerned Scientists refutes industry's claim that GM crops are the best solution to food shortage and world hunger. Recommendations from the International Assessment of Agricultural Knowledge, Science and Technology for Development (IAASTD), an organization supported by the World Bank and United Nations, give priority to funding of agroecology farming methods (e.g., organic) and to roadways that improve market access, not to patented GMO seeds. "A recent peer-reviewed summary of world-wide organic production found that organic and near-organic methods in developing countries increased yields more than industrial production methods," according to the Union of Concerned Scientists website.

The ascendancy of GM crops is a clear case of the power that lies in propaganda while working to keep the population ignorant of facts.

Budinger M. Whoops! the legacy of genetically engineered food. Townsend Lett. October 2010;327:50–55.
Dona A, Arvanitoyannis IS. Health risks of genetically modified foods. Crit Rev Food Sci Nutr. 2009;49(2):164–175. Available at: Accessed January 16, 2011.
Do seed companies control GM crop research? [editorial]. Sci Am. August 13, 2009. Available at: Accessed January 20, 2011.
Séralini G-E, Spiroux de Vendômois, J, Cellier D, Sultan C, et al. How subchronic and chronic health effects can be neglected for GMOs, pesticides or chemicals. Int J Biol Sci. 2009;5(5):438–443. Available at: Accessed January 16, 2011.
Smith J. Genetically modified soy linked to sterility, infant mortality in hamsters [online article]. Huffington Post. April 20, 2010. Available at: Accessed August 18, 2010.
Spiroux de Vendômois J, Cellier D, Vélot C, et al. Debate on GMOs health risks after statistical findings in regulatory tests. Nt J Biol Sci. 2010;6:590–598. Available at: Accessed January 19, 2011.
Union of Concerned Scientists. Failure to Yield: frequently asked questions [Web page]. April 14, 2009. Available at: Accessed January 20, 2011.

Evidence of Flu Vaccine During Pregnancy
By the time you read this, the 2010–2011 influenza season in the US will be ending. Health agencies' drive to vaccinate women who are more than 14 weeks pregnant for flu will have eased. As fall approaches, however, you can expect to hear a renewed call to vaccinate women who are in their second and third trimesters during flu season. While most people survive that beastly, weeklong combination of fever, chills, sore throat, muscle aches, and cough that characterizes influenza, people with respiratory problems (including asthma) and depressed immune response can develop serious complications from the infection. To prevent complications during pregnancy (a time of depressed immunity), authorities recommend inactivated flu vaccine. (The US Centers for Disease Control [CDC] does not recommend activated vaccine, administered via nasal spray, for pregnant women.) Authorities say that the benefits of vaccination outweigh the risks. What is the evidence?

Conducting good studies on flu vaccine efficacy is problematic. "The incidence and circulation of seasonal influenza and other respiratory viruses vary greatly each year, each season, and even in each setting," explains Tom Jefferson in a 2006 article for the British Medical Journal. For this reason, he says that studies that track several flu seasons are the only ones that provide useful information. Using data from just one or two seasons or using too few participants invites erroneous conclusions. Moreover, the studies must document the prevailing flu strain for the year as well as the flu antigens in the given vaccine to ensure that they match. Given that not all respiratory illness during flu season is caused by the flu virus, a good study should also test participants for the presence of the influenza virus. The CDC says that about 36,000 Americans, mostly in the high-risk groups, die from flu complications each year. However, the agency does not require testing for the presence of influenza, so no one knows how many of this number are actually infected with bacteria or other viruses instead. Tom Jefferson says, "In general the most powerful and reliable studies are those that 'average' out several years and perform subanalyses by setting, population, viral circulation, and viral-vaccine antigenic match-variables that affect interpretation of the effects of a vaccine. Systematic reviews are the best way to perform such analyses. …"

When Jefferson examined systematic reviews of inactivated vaccines, he found that most did not follow the basic guideline of identifying flu strains and vaccine antigens. Moreover, many of the reviewed studies were nonrandomized, cohort studies whose results could be easily skewed by selection bias (consciously or unconsciously). Despite the prevailing belief that annual flu vaccination is an effective preventive of hospitalization and death, Jefferson says, "Evidence from systematic reviews shows that inactivated vaccines have little or no effect on the effects measured."

Jefferson was also surprised to find little data on the safety of inactivated vaccines in the medical literature: "A Cochrane Database Systematic Review found only one old trial with data from 35 participants aged 12-28 months. In the general population of elderly people, despite a dataset of several million observations, safety was only reported in five randomized controlled trials (2963 observations in total) on local and systemic adverse events seen within a week of giving parenteral inactivated vaccine." Jefferson calls for large, randomized, placebo-controlled studies with good methodological designs to establish whether influenza vaccines are truly effective. He suspects that policymakers push flu vaccines simply because they are available: "… A similar philosophy is the 'we have to make decisions and cannot wait to have perfect data' approach."

A 2008 article by Tippi K. Mak and colleagues concerning the use of influenza vaccination during pregnancy found limited data on disease burden due to flu in healthy pregnant women. One of the few studies involving disease burden, a CDC study published in JAMA, reported 56 maternal deaths attributed to H1N1. The actual cause of most of these deaths was not verified with testing. Mak and colleagues also found that little safety data exists regarding the effect on the fetus. Safety questions arise because manufacturers' package inserts for flu vaccines – "the most reliable information about vaccine side effects," according to the CDC – state that they are not recommended for pregnant women. (See Some flu vaccines have undergone animal reproduction studies, but none of the inserts claim that these vaccines are safe during pregnancy. (Such a claim would be very difficult to prove.) Instead, the inserts say, "give to pregnant women only if clearly needed." How can women or practitioners know if the vaccine is needed when vaccine research is so sloppy?

Tracking risk is difficult. The Vaccine Adverse Event Reporting System (VAERS) gives only shadow figures – enough to show that vaccines are not 100% safe but not reliable enough to give an accurate incidence of adverse events. Patients and family members as well as physicians can make a report to VAERS; but the system is voluntary, and underreporting is likely. Nonetheless, VAERS can indicate safety problems. The National Coalition of Organized Women collected data from VAERS and from pregnant women who received a 2009 A-HN1 flu vaccine. The organization reported a total of 241 vaccine-related fetal deaths (miscarriages and stillbirths).

Can flu cause death? Yes. Can influenza vaccine cause death? Yes. Researchers and policymakers need to get serious about investigating the efficacy and safety of influenza vaccines, so that an accurate risk/benefit can be determined. Then, women will be able to make an informed choice.

Centers for Disease Control and Prevention. Vaccine safety: summary of adverse events in pregnant women following administration of TIV and LAIV in VAERS, 1990-2009 [Web document]. Available at: Accessed January 17, 2011.
Dannemann E, King PG, Goldman GS. A comparison: probable 2009-A-H1N1-flu-shot-related fetal losses and maternal deaths in pregnant women attributed to unverified H1N1-infection-related complications [Web document]. correction Exhibit4.pdf. Accessed January 3, 2011.
Jefferson T. Influenza vaccination: policy versus evidence. BMJ. 2006;333:912. doi:10.1136/bmj.38995.531701.80. Available at: Accessed January 10, 2011.
Mak TK, Mangtani P, Leese J, Watson JM, Pfeifer D. Influenza vaccination in pregnancy: current evidence and selected national policies. Lancet Infect Dis. January 2008;8:44–52.
National Coalition of Organized Women. CDC allegedly falsifies reports – ignoring up to 3,587 miscarriages from H1N1 vaccine [online press release]. Accessed January 17, 2011.

Grandmother Hypothesis of Menopause
Why do female orcas (killer whales), pilot whales, and humans – unlike females of other species – continue to live long after their ability to reproduce ends? The theory of evolution says that their extended lifespan should contribute to the species' survival. Evolutionary biologists have proposed two hypotheses to explain this deviation. George William's 50-year-old "grandmother hypothesis" says the presence of older, nonbreeding females benefits survival by helping the next generation raise children. A 2002 Japanese study lends some support to this idea. The study indicates that households that include the mother's mother are less likely to experience the death of a child than other households. (Results failed to reach statistical significance because of the small number of homes with maternal grandmothers.) While the presence of grandmothers (at least maternal grandmothers) may give a survival advantage to their grandchildren, biologists believe that the advantage is too small to explain why women and their whale counterparts stop reproducing midway through life.

In 2008, Drs. Michael Cant and Rufus Johnstone hypothesized "… that menopause is an adaptation to minimize reproductive competition between generations of females in the same family unit." In societies without access to medical technology, women usually have their first babies around age 19 (on average) and their last children at age 38, the age at which their own children are beginning to have babies themselves. Some societies in Asia and Africa actually have taboos that discourage women from having children after the birth of the first grandchild. Cant says, "'Women everywhere experience a rapid decline in fertility after the age of forty, culminating in menopause around ten years later. Our study helps to explain why this phase of rapid 'senescence' of the reproductive system starts when it does, and why women, on average, stop having children a full ten years before the onset of menopause.'" Curiously, as postmenopausal whale and human females age, they become increasingly attached to infants, according to more recent research by Cant and Johnstone.

Do hormones play a role in this renewed maternal behavior? Peter B. Gray and Maureen Samms-Vaughan conducted a study with 25 caregiving postmenopausal grandmothers and 20 women of comparable age (50–65 years) and socioeconomic status who did not live with a biological grandchild aged 5 or less. The researchers wanted to see if active grandmothering corresponded to increases in oxytocin and prolactin (hormones associated with mothering). They also tested vasopressin and cortisol levels. "Hormonal data revealed that grandmothers had significantly higher vasopressin levels than control women, but did not exhibit differences in cortisol, oxytocin, and prolactin compared with control women," they reported. The act of caregiving itself did not produce short-term changes in vasopressin levels. A woman's vasopressin measurement taken within four hours of doing child care compared to measurements taken without child care in the preceding four hours did not differ. Since the study did not show an effect on oxytocin and prolactin levels, the researchers question their study's design. The elevated vasopressin level, however, supports other observations about this hormone.

Vasopressin has been long recognized as the regulator of water absorption by the kidneys and salt content in the blood. It also has a role in social behavior. Vasopressin promotes sociability, monogamy, and offspring care in both males and females, according to animal research. "Vasopressin and oxytocin differ chemically by only two amino acids and can bind to each other's receptors," explains Virginia Hughes. "… Both hormones are released during stress, and their actions seem inextricably tied: vasopressin elicits an active fight-or-flight response, whereas oxytocin dials down the resulting anxiety." Fight or flight. Maybe grandmothers are hormonally geared to protect the young in ways that science does not yet understand.

Bosch OJ, Neumann ID. Brain vasopressin is an important regulator of maternal behavior independent of dams' trait anxiety. PNAS. November 4, 2008;105(44):17139–17144. Available at: Accessed January 10, 2011.
Emory University Health Sciences Center. Social behavior transformed with one new gene [online article]. ScienceDaily. August 19, 1999. Accessed January 10, 2011.
Gill V. Orca grandmothers develop close ties to infants in their pods [online article]. BBC News. Accessed January 10, 2011.
Gray PB, Samms-Vaughan M. Investigating potential hormonal associations of grandmaternal care in Jamaica [online article]. Internet J Biol Anthrop. August 24, 2010;4(1). Available at: Accessed January 5, 2011.
Hughes V. Rat study sniffs out vasopressin's role in social behavior [online article]. Simons Foundation. Accessed January 10, 2011.
Jamison CS, Cornell LL, Jamison PL, Nakazato H. Are all grandmothers equal? A review and a preliminary test of the 'grandmother hypothesis' in Tokugawa Japan [abstract]. Am J Phys Anthrop. September 2002;119(1):67–76. Available at: Accessed January 10, 2011.
Grandmother hypothesis of menopause [online press release]. Medical News Today. April 1, 2008. Available at Accessed January 10, 2011.

The Grandmother Project
In Western industrialized societies, people tend to accept advice from experts in media (a top-down, transmission-persuasion model); but in many traditional societies, grandmothers are the experts. They are the health advisors, the authorities on child care, and the supervisors of younger women. Western health-care workers tend to see older women in traditional societies as opponents incapable of and uninterested in releasing their old beliefs and practices that block health-care improvements. Since 1997, the Grandmother Project (GMP) has incorporated medical anthropology in programs that encourage Western-trained health-care workers to work with the older generation for the greater good. Instead of relying on a top-down-transmission-persuasion approach, GMP "encourages learning and communal decisionmaking through open discussions about problems facing the community." Such cooperation is only possible when outside health-care workers acknowledge and respect the role of the traditional health advisors – the grandmothers – and seek their involvement in improving their communities' health and nutrition. The Grandmother Project, an international organization, has sponsored health and nutrition programs in Laos, Senegal, Mali, Uzbekistan, Albania, and other traditional communities in Africa, Asia, and South America.

The GMP model had a significant impact on a maternal and child nutrition education program in rural Senegal in 2002. Traditional beliefs encouraged women to work hard to remain strong for the delivery and not eat too much during pregnancy so that the baby would be small enough to deliver easily. Even before getting pregnant, about 29% of reproductive-age women in the study locale were malnourished (BMI<18.6). Food restrictions during pregnancy did not help matters. The other primary factor affecting childhood nutrition was the area's breast-feeding practice. Traditionally, breast-feeding is highly valued in Senegal: "… rural women breastfeed for an average of 22 months." Unfortunately, the traditional practice encouraged women to give their infants water for the first days after birth until breast milk was available. As a result, these babies missed out on the beneficial immune factors in their mothers' colostrum and were exposed to possible pathogens in the drinking water. Exclusive breast-feeding (without water or other food) for the first four to five months of life was rare – only 8% – even after 10 years of top-down education programs from the country's Ministry of Health.

Before trying to intervene, GMP had interviewers talk to local grandmothers. The interviews revealed that area grandmothers "greatly value[d] breastfeeding," but most had never heard of breast-feeding without also giving the baby water. They viewed water as necessary because Senegal is so hot and the babies' throats and mouths would dry out without it. To the interviewers' surprise, the grandmothers also voiced "regret that they are never invited to attend the health education sessions and that they are interested in knowing about the 'new ideas' on [maternal child health]. In all grandmother focus groups the idea was expressed that, 'The world is changing and our knowledge is not up to date.'"

After the interviews, staff recommended that the pilot project's health-care facilitators acknowledge grandmothers' role in maternal child health and view them "as resource persons and partners rather than as obstacles and competitors." GMP recommended using a problem-posing approach, building on shared values and practices, to strengthen the grandmothers' role in the community and to work toward specific improvement in maternal-child nutrition. "For field workers steeped in 'message delivery' approaches," write GMP founder Judi Aubel and colleagues, "it is not easy for them to establish genuine, horizontal communication relationships and to adopt a posture of co-learners rather than expert, message disseminators."

Twelve months after the field work, a woman with a 2-month-old baby reported: "'Now the advice the grandmothers give us includes both traditional and modern ideas. Now when you are pregnant they tell you to eat more and to work less. Before there were certain foods they told us not to eat and they forbid us from snacking between meals. Now they tell us to eat more and especially green leafy vegetables, beans and small dried fish so we'll be strong when we deliver. Before each woman did her own work. Now, when a woman is pregnant they ask other women in the family to help out, or they do some of your work themselves.'" Clearly, community bonds had strengthened. In addition, over 90% of infants were being breast-fed exclusively.

The Grandmother Project is also involved in ending female genital mutilation (cutting/circumcision). The practice has been difficult to stop because of the cultural belief that it prevents adultery and men prefer to marry girls who have undergone the procedure. Rather than directly addressing the problem of female genital cutting, GMP is working with community grandmothers to provide an alternative rite of passage based on positive cultural traditions and "holistic upbringing of girls' intellectual, spiritual, physical, moral, and psychological well-being." An October 2009, preliminary review of the project's effects revealed that community attitudes are shifting away from female genital cutting, early marriage for girls, and violence against women. Moreover, the review found "a greater appreciation for grandmothers' roles in disseminating positive cultural values. …"

The Grandmother Project has shown that respecting and collaborating with a traditional culture's grandmothers to solve problems "leads to increased community involvement in solving local problems in a culturally appropriate and sustainable way, greater collaboration between community members and organizational agents, strengthened intergenerational communication, and ultimately greater community cohesion." Involvement, problem solving, sustainability, collaboration, intergenerational communication, cohesion … sounds good, doesn't it?

Aubel J. Senegalese grandmothers promote improved maternal and child nutrition practices: the guardians of tradition are not averse to change. Soc Sci Med. 2004;59:945–959. Available at: Accessed January 12, 2011.
Mossaad N. Grandmother Project: a new approach to ending harmful traditional practices [online article]. Interagency Gender Working Group. February 2010. Accessed January 12, 2011.

Focused Ultrasound for Fibroids
An ongoing study conducted by Gina K. Hesley, MD, and colleagues at Mayo Clinic is assessing the use of focused ultrasound, guided by magnetic resonance, to treat uterine fibroids. At this time, hysterectomy is the only permanent cure for the pain and heavy bleeding associated with fibroids. This less-invasive treatment uses focused ultrasound waves to heat the benign tumor(s) until the MRI shows a specific color change in the tissue that indicates the targeted temperature. Heating the tumor changes the tissue's consistency and destroys the blood supply. When the procedure is performed correctly, the tissue "shrivels up" and dies. Mild discomfort that responds to acetaminophen is the most common side effect of the procedure, according to the Mayo research team.

In their first report presented at a Society of Interventional Radiology conference, the Mayo researchers said that about 90% of 100 patients "reported considerable or excellent pain relief" one year after treatment. Eight of the 100 who received ultrasound treatment underwent a hysterectomy or myomectomy during the year follow-up. Mayo researchers will continue to gather data on fibroid-related symptoms and symptom relief from the women in order to determine two- and three-year outcomes.

Focused ultrasound is not available to every woman with uterine fibroids. Although it is FDA-approved, few medical centers offer it; and not all insurers cover it. The procedure can cost over $10,000, according to a 2007
New York Times article. Moreover, the location, size, and/or number of fibroids can make a woman ineligible for focused ultrasound. This treatment is contraindicated in pregnant women. Like other surgical procedures, the likelihood that ultrasound treatment is successful correlates to the amount of experience the practitioner has. High-intensity focused ultrasound ablation has been used in China for over a decade to treat uterine fibroids and other solid tumors including liver cancers, breast cancers, pancreatic cancers, bone tumors, and renal cancers.

Fiore K. SIR: focused ultrasound for fibroids effective long-term [online article].
MedPage Today. March 15, 2010. Accessed March 16, 2010.
Okada A, Morita Y, Fukunishi H, Takeichi K, Murakami T. Non-invasive magnetic resonance-guided focused ultrasound treatment of uterine fibroids in a large Japanese population: impact of the learning curve on patient outcome [abstract].
Ultrasound Obstet Gynecol. November 2009;34(5):5795–83. Available at Accessed January 12, 2011.
Rabin RC. It banishes uterine fibroids, but for how long?
New York Times. August 7, 2007. Available at Accessed January 12, 2011.
Zhang L, Wang ZB. High-intensity focused ultrasound tumor ablation: Review of ten years of clinical experience [abstract].
Front Med China. September 2010;4(3):294–302. Available at: Accessed January 12, 2011.

The Home Birth Debate
A September 2010 meta-analysis involving 12 studies, conducted by Joseph R. Wax and colleagues, added fuel to the ongoing debate about the safety of home birth. The authors made the controversial decision to look at neonatal mortality, defined as death within 28 days, in addition to perinatal mortality and maternal interventions and complications surrounding delivery. None of the studies in the meta-analysis were designed to determine neonatal mortality. In addition, the meta-analysis's definition for "perinatal" – "stillbirth of at least 20 weeks or 500 g or death of liveborn within 28 days of birth" – overlaps the definition for "neonatal." Using all 12 studies, the perinatal death rate between planned home births and planned hospital births was statistically the same. Perinatal mortality is the primary monitor for delivery safety. Neonatal deaths, however, showed a "three fold increase" in planned home births: 23 babies (without a congenital deformity) out of 15,633 planned home births died within 28 days compared to 14 out of 31,999 planned hospital births. The authors suggest that this increased neonatal mortality is due to "decreased obstetric intervention" in the form of ultrasound, electronic fetal heart rate monitoring, fetal acid-base assessment, labor induction, and cesarean delivery. The meta-analysis offers no evidence to support this supposition, nor does it consider confounding socioeconomic and environmental factors such as poverty that could contribute to death in the first month of life.

Not surprisingly, proponents of home birth and midwifery criticized the quality of this meta-analysis. According to the Coalition for Improving Maternity Services (CIMS) chair Michelle Kendell, "'CIMS found that the authors of the study included confounding data, such as outdated and low-quality studies, low-risk and high-risk mothers, babies born preterm, babies unintentionally born at home, births attended by unqualified providers and data from birth certificates that researchers have found to be notoriously inaccurate.'" Critics of the meta-analysis also questioned the exclusion of a 2005 study by Johnson and Daviss, "the only high-quality study of planned homebirths in the U.S." The Johnson and Daviss study "showed excellent health outcomes for infants and their mothers when attended by certified professional midwives."

Gill Gyte and Mary Newburn at the UK's National Childbirth Trust and Alison Macfarlane, a professor of prenatal health at London's City University, reviewed the studies used to determine neonatal mortality. They found that "not all the included studies used the same definitions and some gave no definition of perinatal or neonatal deaths." In addition, the meta-analysis identifies six studies used to determine the neonatal mortality rate, but Table 3 says that seven were used. Byte, Newburn, and Macfarlane say that "careful scrutiny of the primary research papers that have been included in the meta-analysis suggests that there are eight studies that contribute to [perinatal mortality] and – with some overlap and some differences – eight studies that contribute to [neonatal mortality] … missing data and absence of clear definitions in some papers means that further work is needed to ascertain for sure which studies contribute data for each of the two different outcomes measures. …" In addition, most studies used to determine mortality rates did not adjust for confounding risk factors. The study that contributed the most data to mortality was retrospective (the least reliable type of study) based on birth registry data (Pang JWY et al. Outcomes of planned home births in Washington State: 1989-1996. Obstet Gynecol. 2002;100:253–259).

Gyte, Newburn, and Macfarlane also criticize the meta-analysis for its failure to report quality assessments for the included studies and its failure to discuss the limitations of the small numbers involved in the neonatal analysis. Despite these flaws, the American College of Obstetricians and Gynecologists, a strong opponent of home births, labeled the Wax meta-analysis "Editors Choice." Ironically, ACOG opposes home birth because of "safety concerns and lack of rigorous scientific study."

The slight (and questionable) increase in neonatal deaths is the only negative finding against planned home birth in this meta-analysis. Wax and colleagues report that women who had a planned home birth had fewer medical interventions (e.g., epidurals, electronic fetal heart monitoring, episiotomy, and cesarean) and fewer complications (i.e., infections, third-degree or greater lacerations, hemorrhages, and retained placentas). Home birth babies were less likely to be premature, have a low birth weight, or need assisted newborn ventilation.

In her response to the Wax meta-analysis, Melissa Cheyney, assistant professor of medical anthropology at Oregon State University, wrote: "In Oregon, where we have both licensed and unlicensed midwives working in home and in birth center settings, research has shown deep mistrust between doctors [who believe that only hospital deliveries are safe] and some midwives. … Such studies [like this meta-analysis] only deepen this mistrust and have the potential to increase hostility during encounters when midwives and their clients have to seek hospital care for complications. The end result is a system that can be detrimental to women and their babies because of the impaired ability to communicate. …" She points out that 99% of US women give birth in hospitals, but the US perinatal death rate is 6.3 deaths per 1000 babies – one of the highest rates among developed countries. In comparison, the Netherlands has 4.73 deaths per 1000 even though one-third of all deliveries are midwife-assisted home births. "There is something to be learned from the centuries-old traditions of midwifery," Cheyney writes, "and I believe that if doctors and midwives, including those who work in the home setting, could be willing to learn from and respect one another, women and babies in our country would benefit. After all, we are all working for the same end result: a happy and healthy mother and baby. …"

Cheyney M. Why home births are worth considering [online article]. Huffington Post. September 9, 2010. Accessed January 10, 2011.
Coalition for Improving Maternity Services. CIMS responds to the publication of an extremely skewed study on the safety of homebirth [press release]. July 9, 2010. Available at: Accessed January 12, 2011.
Gyte G, Newburn M, Macfarlane A. Critique of a meta-analysis by Wax and colleagues which has claimed that there is a three-times greater risk of neonatal death among babies without congenital anomalies planned to be born at home. Available at: Accessed January 31, 2011.
Wax JR, Lucas FL, Lamont M, Pinette MG, Cartin A, Blackstone J. Maternal and newborn outcomes in planned home birth vs planned hospital births: a metaanalysis. Am J Obstet Gynecol. September 2010. Available at: Accessed January 12, 2011.

Maitake SX-Fraction and Polycystic Ovary Syndrome
Maitake SX-Fraction, a proprietary extract made by Mushroom Wisdom Inc., induced ovulation in women with polycystic ovary syndrome (PCOS) in a 2010 study. Polycystic ovary syndrome, an endocrine disorder, affects an estimated 7% to 8% of reproductive women. Symptoms include absence of menstruation and/or scanty flow, presence of ovarian follicular cysts, and hyperandrogenism indicated by elevated basal LH (luteinizing hormone) and normal basal FSH (follicle-stimulating hormone), and possibly hirsutism. Insulin resistance and high insulin blood levels, which accompany PCOS, contribute to hyperandrogenism by increasing production of ovarian androgen and decreasing the synthesis of sex hormone binding globulin.

Maitake mushroom (Grifola frondosa) – specifically a bioactive fraction called "SX-fraction" – reduces elevated blood glucose levels and improves insulin resistance. This mushroom can also reduce blood pressure, modulate serum lipids, and stimulate immune response. (Maitake D-fraction, also produced by Mushroom Wisdom, contains an immune-stimulating maitake extract.)

The recent PCOS open trial, conducted by Jui-Tung Chen, MD, PhD, and colleagues, involved 72 PCOS patients, aged 18 to 35, from three Japanese clinics. (Eighteen dropped out over the course of the study.) The women were randomly assigned to take clomiphene citrate (CC), a standard medication for inducing ovulation, or Maitake SX-Fraction (MSX) for 12 weeks or three cycles. Those in the MSX group took three MSX tablets, three times a day between meals. Each tablet of this product is standardized to have at least 18 mg of the insulin-reducing extract and 250 mg of dried maitake mushroom powder. Participants were assessed every two weeks for ovulation with ultrasound.

By the end of 12 weeks, 20 of 26 subjects (76.9%) in the MSX group had ovulated, compared with 29 of 31 subjects (93.5%) in the CC group. However, significantly more ovulated cycles occurred in the CC group (58 ovulated cycles in 83 cycles [69.9%]) in contrast to the MSX group (30 ovulated cycles out of 72 cycles [41.7%]). The 41.7% rate is comparable to other insulin sensitizers that have been tested on PCOS patients, according to the study authors. Seven women in the MSX group and 8 in the CC group did not ovulate. These women were given CC-MSX combination therapy for up to 16 weeks or four cycles. With combination therapy, all 7 from the MSX group and 6 of the 8 CC patients ovulated. As an aside, the researchers note that 3 of 11 women who wished to become pregnant conceived during the treatment period; two with MSX only and one with combination treatment.

While the ovulation-stimulant clomiphene citrate is more effective than MSX, CC can have more negative side effects, including hot flashes, abdominal discomfort, weight gain, mood swings, nausea, and dizziness. CC may increase ovarian cancer risks, so it is not usually recommended for more than six cycles. Researchers say that only two MSX subjects in this study reported an adverse effect: mild upper stomach pain that eventually stopped over the course of treatment.

Chen J-T, Tominaga K, Sato Y, Anzai H, Matsuoka R. Maitake mushroom (Grifola frondosa) extract induces ovulation in patients with polycystic ovary syndrome: a possible monotherapy and a combination therapy after failure with first line clomiphene citrate. J Altern Complement Med. 2010;16(12):1–5.
Mushroom Wisdom, Inc. infertility treatment breakthrough: extensive clinical study confirms that Maitake SC-Fraction® (MSX) induces ovulation in PCOS patients [press release]. December 29, 2010.

Teenage Menstrual Cycle and Bone Health
Health urgings for bone mass density testing and drug advertising for Boniva are usually aimed at menopause-age women and older, making us view osteoporosis as a problem for mature women. In reality, true prevention begins during the teen years, the primary time for building bone mass. Lawrence M. Nelson, MD, writes, "… osteoporosis is a pediatric disease with geriatric consequences. … Bone density can be compared to a bank account: We need to take care of it when we are young so it is there to take care of us in our old age." Young women who miss the window for bone growth are more susceptible to developing osteoporosis at menopause.

An important and early signal that a woman has a higher risk of osteoporosis is menstrual irregularity as a young woman. Menstrual irregularity with more than 90 days between periods is a sign that the body is not producing enough of the bone-building estrogen estradiol. Menstrual irregularity can have many causes, including too much exercise, emotional stress, eating too few calories, radiation or chemotherapy, androgen excess, and medical conditions like hyperprolactinemia and primary ovarian insufficiency. The longer estrogen deficiency persists, the more likely a young woman will have osteoporosis later in life.

Nelson tells practitioners, "At every medical encounter involving adolescent girls, two questions need to be asked: 1) 'When was your last menstrual period?' and 2) 'Are your periods coming regularly?'" (Practitioners may need to define what they mean by "regularly.") Nelson says to chart these answers along with other vital signs and investigate any abnormalities. By assuming that irregularities are just a part of the early teen years, practitioners can miss an opportunity to prevent the occurrence of osteoporosis later in life.

Nelson LM. The menstrual cycle in adolescents – a vital sign of bone health.
Contemp Ob Gyn. March 2010;55(3):32–37.

Jule Klotter


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