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Archive for the ‘Critical Health Information’ Category

President’s Cancer Panel Annual Report 2008 – 2009 Reducing Environmental Cancer Risk – What We Can Do Now

What Individuals Can Do: Recommendations regarding Children

It is vitally important to recognize that children are far more susceptible to damage from environmental carcinogens and endocrine-disrupting compounds than adults. To the extent possible, parents and childcare providers should choose foods, house and garden products, play spaces, toys medicines, and medical tests that will minimize children’s exposures to toxics. Ideally, both mothers and fathers should avoid exposure to endocrine-disrupting chemicals and known or suspected carcinogens prior to a child’s conception and throughout pregnancy and early life, when risk of damage is greatest. Page 27 of the report

Please check out the Organizations Providing Critical Information Category. There are many organizations providing resources for parents to limit and reduce exposures to toxic chemicals.

To review the complete report click on the link below.

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Decline in Semen Quality among Fertile Men in Paris during the Past 20 Years by Jacques Auger, M.D., Ph.D., Jean Marie Kunstmann, M.D., Françoise Czyglik, M.D., and Pierre Jouannet, M.D

Jacques Auger, M.D., Ph.D embarked on this analysis because he simply didn’t believe Skakkebaek’s theory that sperm counts were falling. In the hopes to disprove the Danish study, the French team instead provided the strongest evidence of support that sperm counts were falling. There were other studies in New York , Minneapolis, and Los Angeles that contradicted this but the press coverage for these studies ignored methodological differences and failed to note a fundamental weakness in the US studies. The studies were based on men who volunteered for vasectomies — a group known from other studies to show higher than average sperm counts and to be unrepresentative of the population at large. The French findings are particularly persuasive because the data allowed the researchers to correct two important confounding variables that might call sperm count results into question: age and abstinence. A man’s sperm count generally declines as he gets older, and it drops immediately after sex, recovering within a few days.

 

Taken from Our Stolen Future

This study addresses both variables.

The New England Journal of Medicine

Volume 332:281-285 February 2, 1995 Number 5

ABSTRACT

Background Several studies have suggested a population-wide decline in the quality of semen over the past 50 years, but clear evidence of decreasing semen quality in recent decades is lacking.

Methods From 1973 through 1992 we measured the volume of seminal fluid, the sperm concentration, and the percentages of motile and morphologically normal spermatozoa in 1351 healthy fertile men. The data on the semen samples were collected at one sperm bank in Paris. The data in each calendar year were analyzed as a function of the year of donation, the age of each patient, the year of birth, and the duration of sexual abstinence before semen collection.

Results There was no change in semen volume during the study period. The mean concentration of sperm decreased by 2.1 percent per year, from 89 x106 per milliliter in 1973 to 60×106 per milliliter in 1992 (P<0.001). During the same period the percentages of motile and normal spermatozoa decreased by 0.6 percent and 0.5 percent per year, respectively (both P<0.001). After adjustment in multiple regression analyses for age and the duration of sexual abstinence, each successive calendar year of birth accounted for 2.6 percent of the yearly decline in the sperm concentration and for 0.3 percent and 0.7 percent, respectively, of the yearly declines in the percentages of motile and normal spermatozoa (all P<0.001).

Conclusions During the past 20 years, there has been a decline in the concentration and motility of sperm and in the percentage of morphologically normal spermatozoa in fertile men that is independent of the age of the men.

During the past three decades, several reports have suggested that the quality of semen in normal men is declining.1,2,3,4 Recently, in a meta-analysis of 61 studies worldwide, Carlsen et al. found a trend toward decreasing sperm count and volume of seminal fluid over the past 50 years.5 The studies included in the meta-analysis were conducted in different countries at different times, and bias in the recruitment of men or in methods of semen analysis may have affected the findings.6 It is important, therefore, to assess this finding and to determine whether there has been a parallel decline in male fertility.
The Centre d’Etude et de Conservation des Oeufs et du Sperme Humains is a sperm bank created in 1973 in a university hospital. All the donors are fathers, and the mode of recruitment of men and the method of semen analysis have remained the same during the past 20 years. In an analysis of data from this bank, we found that there have been significant declines in sperm concentration, the percentage of motile sperm, and the percentage of normal sperm over the past 20 years.

Methods

Study Subjects

We analyzed the first ejaculate donated at the center between 1973 and 1992 by each of 1750 men to help infertile couples become parents. The donors were all healthy, unpaid volunteers who had previously fathered at least one child. Ninety-six percent were white, and 85 percent lived in the Paris area. One percent were farmers; 16 percent were manual workers; 40 percent were technicians, teachers, or tradesmen; 38 percent were executives; and the remaining 5 percent had other occupations. We divided the donors into three groups. One group was composed of 314 men requesting cryopreservation of their semen before vasectomy who agreed to provide additional specimens for use in artificial insemination. The second group was composed of 85 men who were brothers of infertile men who requested artificial insemination of their partners with donor semen. The third group was composed of 1351 men who were referred by unrelated infertile couples or by physicians or who appeared spontaneously.

The mean concentration of sperm, the percentage of motile spermatozoa, and the percentage of normal spermatozoa in the second group of fertile men (those whose brothers were infertile and requested artificial insemination of their partners) were significantly lower than those of the 1351 donors in the third group (Table 1). The values for mean concentration and motility were higher in the first group (the men studied before vasectomy) than in the third group (Table 1), since candidates for vasectomy were recruited for semen donation only if the motility of their sperm was relatively unaffected by freezing and thawing. As a result, the first two groups were excluded from the study. In the remaining group of 1351 men, the mean (±SD) age at the time of donation was 34±6 years (range, 19 to 59). Among these men, the mean age of those donating semen in a calendar year increased throughout the study from 32 years in 1973 to 36 years in 1992 (P<0.001) (Figure 1).

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Table 1. Characteristics of Semen Samples from 1750 Fertile Donors.

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Figure 1. Change in the Mean Age of the Men Donating Semen in a Given Calendar Year, 1973 –1992.
Linear regression analysis showed that the mean age of the donors increased significantly, from 32 years in 1973 to 36 years in 1992 (P<0.001). A total of 1351 men were studied.

Analysis of Semen Samples

All the semen samples were collected by masturbation at the laboratory after a recommended period of sexual abstinence of three to five days. Each sample was incubated at 37°C and analyzed within one hour. The volume of seminal fluid was determined by weighing, assuming that 1 g of semen is equivalent to a volume of 1 ml. The concentration of sperm per milliliter of sample was determined with a hemocytometer; the sperm were counted in the two chambers at a final magnification of 400, and the mean value was calculated.7 The total sperm count was then calculated. To determine the percentage of motile sperm, a 20-µl drop of gently mixed semen was placed on a glass slide under a coverslip. The slide was placed on the heating stage of a microscope (37°C) and observed at magnifications of 100 and 400 with phase optics. The slide was scanned, and at least 100 spermatozoa in all were counted and classified in four to six fields chosen at random. The percentage of motile spermatozoa was calculated from the ratio of the number of rapidly and slowly moving sperm (grades a and b, according to the classification system of the World Health Organization7) to the total number of sperm counted. The percentage of morphologically normal spermatozoa was evaluated at a final magnification of 1000, after Shorr staining as described by David et al.8

During the 20 years of the study, 11 technicians worked in the laboratory, 4 for 1 to 4 years, 3 for 5 years, and 4 for 9 to 14 years. We determined coefficients of variation with respect to measurements of semen characteristics for the three technicians working in the laboratory at the conclusion of the study, who had been there for 14, 5, and 2 years. For each technician, coefficients of variation for sperm concentration and morphologic features were determined from triplicate analyses of three different semen samples. Coefficients of variation between technicians were determined from the first analysis of each of the three samples. For each technician, the coefficient of variation for sperm motility was determined from triplicate measurements of 4 semen samples; the coefficient of variation between technicians was determined from 15 samples.

The coefficients of variation for the three technicians with respect to the measurement of sperm concentrations were 1.3, 3.1, and 4.2 percent; the coefficient of variation between technicians was 4.6 percent. In the assessment of the morphologic features of sperm, the coefficients of variation for the three technicians were 2.0, 3.7, and 7.1 percent; the coefficient of variation between technicians was 9.9 percent. In the assessment of motility, the coefficients of variation for the three technicians were 0, 7.7, and 8.3 percent; the coefficient of variation between technicians was 7.3 percent.

Statistical Analysis

BMDP statistical software was used in all the statistical analyses.9 Sperm concentrations and total sperm counts do not have normal distributions in large groups of fertile men,2,10 and this was the case among the 1351 men studied (as determined by Wilk’s test). Age at donation and the donor’s year of birth had normal distributions, but the duration of sexual abstinence was skewed. The best transformation of the data that yielded normal distributions for each of the three variables without normal distributions was the logarithmic (base 10) transformation. The relations between each characteristic of the semen samples and the year of semen donation were studied by linear regression analysis. The variable for the year of semen donation was composite because it combined each man’s age at the time of donation with his year of birth. The relation of each semen characteristic to these independent variables (age at donation and year of birth) was tested with multiple regression analysis. The duration of sexual abstinence before the collection of semen was also included, since it affects the semen characteristics,11 had a wide range in this study, and increased significantly (P = 0.02) with the advancing age of the men.

Results

The mean volume of seminal fluid was 3.8 ml, and this value did not change during the study period. In contrast, the mean sperm concentration decreased by 2.1 percent per year (Figure 2A), from 89×106 per milliliter in 1973 to 60×106 per milliliter in 1992. During the same period, the percentages of motile and normal spermatozoa decreased by 0.6 and 0.5 percent per year, respectively (P<0.001 for both) (Figure 2B and Figure 2C).

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Figure 2. Changes in the Sperm Concentration (Panel A), the Percentage of Motile Sperm (Panel B), and the Percentage of Morphologically Normal Sperm (Panel C) in 1351 Fertile Men, 1973 –1992.
Linear regression analysis revealed a decrease of 2.1 percent per year in the mean sperm concentration, from 89×106 per milliliter in 1973 to 60×106 per milliliter in 1992. The concomitant decreases in the mean percentages of motile and normal spermatozoa were 0.6 and 0.5 percent per year, respectively.

A man’s age and the duration of his sexual abstinence before the collection of semen influence the characteristics of the semen.11,12 We therefore assessed the contribution of these two factors to the declines measured. Age, duration of abstinence, and year of birth were included as independent variables in a multiple regression analysis of the data. Greater sexual abstinence was associated with an increase in the sperm concentration and a decrease in the percentage of motile spermatozoa (Table 2); it thus contributed to the observed decline in motility. Older age contributed significantly to the decreases in the sperm concentration, the percentage of motile sperm, and the percentage of normal spermatozoa. Multiple regression analyses after adjustment for age and the duration of sexual abstinence revealed that 2.6 percent of the yearly decline in the sperm concentration and 0.3 percent and 0.7 percent of the yearly decline in the percentages of motile and normal spermatozoa, respectively, were associated with each successive calendar year of birth (all P<0.001) (Table 2).

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Table 2. Effects of Age, Year of Birth, and Duration of Sexual Abstinence before the Collection of Semen on Changes in Characteristics of Semen Samples from 1351 Fertile Men Studied by Multiple Regression Analysis.

A preliminary analysis (data not shown) indicated that to eliminate the confounding effects of the duration of sexual abstinence, a subgroup of men with a narrower age range (28 to 37 years) and comparatively similar durations of abstinence (three or four days) should be studied. In this restricted group of 382 men, age and the duration of sexual abstinence were not significantly correlated. Linear regression analysis of the data for this subgroup revealed that the mean sperm concentration decreased by 3.7 percent per year, from 101×106 per milliliter in 1973 to 50×106 per milliliter in 1992 (P<0.001), whereas the percentage of normal spermatozoa declined by 0.7 percent per year (P<0.001). After adjustment for age, the yearly decline in the sperm concentration with each successive year of birth was more pronounced in this subgroup than in the entire group (Table 3). For example, the predicted sperm concentration of men 30 years old who were born in 1945 was 102×106 per milliliter, as compared with 51×106 per milliliter for 30-year-olds born in 1962.

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Table 3. Effect of Age and Year of Birth on Changes in Characteristics of Semen Samples from 382 Fertile Men 28 to 37 Years of Age Who Were Sexually Abstinent for Three to Four Days before the Collection of Semen.

Discussion

We found a decline in the concentration and motility of sperm and in the percentage of morphologically normal sperm in fertile men studied in Paris over a 20-year period, but unlike Carlsen et al.,5 we found no decline in the volume of semen. We doubt that the decline in the quality of semen between 1973 and 1992 could be attributed to changes in personnel, techniques, or equipment. During the 20 years of the study, there were few changes in staff. All the technicians had the same training, the method of study did not change and was regularly verified, and no new equipment was introduced. In our laboratory, the coefficients of variation for each technician and between technicians in the assessment of the percentage of motile sperm were less than 10 percent in the 1970s,13 and the results were similar for the staff members working at the end of the study. Although the coefficients of variation in the assessment of semen characteristics were less than 10 percent, the evaluations by technicians may have differed with regard to characteristics assessed subjectively, particularly those pertaining to morphologic features of sperm.14 However, there was no change in the procedure used to evaluate these features over the 20-year period.

Our study confirms that both the duration of sexual abstinence before the collection of semen and the age of the donor influence the characteristics of semen.11,12,15 Thus, these factors should be considered and recorded accurately in all studies of the characteristics of semen in fertile men. In most studies of these characteristics, the subjects are asked to remain abstinent for three to five days before donating the sample. We made the same request, but only 66 percent of the men adhered to it. After the duration of abstinence was taken into account, there were still significant declines in the concentration of sperm and in the percentages of motile and normal spermatozoa with each successive year of birth. Thus, we conclude that there has been a true decline in the quality of semen during the past 20 years, since the characteristics of semen from a fertile man of a given age in 1992 were significantly poorer than those of a fertile man of the same age in 1973. This decline is unexplained. If this trend concerns not only the population of fertile men we studied but also all the men in the population, the proportion of men with fertility problems will increase.

The decline in the sperm concentration may reflect impaired spermatogenesis and may be linked to a decrease in the number of Sertoli cells.16,17 The fact that not only the concentration of sperm but also the percentage of normal spermatozoa declined indicates a qualitative impairment of spermatogenesis and perhaps of the Sertoli cells. Such modifications have been reported in experiments involving heat-induced inhibition of spermatogenesis and Sertoli-cell function.18,19 The decline in the quality of semen coincides with an increasing incidence of abnormalities of the male genital tract, including testicular cancer and cryptorchidism, in various countries.20,21 In some regions of France, the incidence of testicular cancer increased from 1975 to 1992,22 but no data are available for the Paris area. Whether there has been an increase in cryptorchidism in France, as in the United Kingdom,23 is unknown, but the incidence of postpubertal cryptorchidism may have increased.24,25

The decline in semen quality and the increasing incidence of genital abnormalities in a geographic area may have a common origin.5 Estrogens or compounds with estrogen-like activity taken by pregnant women have been suggested to affect the testicular function of male offspring adversely.16,17 Diethylstilbestrol is thought to be responsible for an increase in abnormalities of the reproductive tract and for reductions in the output and fertilizing potential of sperm of male offspring.26,27 However, the number of donors at our center who may have been exposed in utero to diethylstilbestrol is probably very low. Other routes of estrogen exposure may be involved if the hypothesis of an estrogen effect is true.17

If the finding of a decline in semen quality with the advancing year of a donor’s birth suggests prenatal alterations of testicular function, it may also be related to changes in diet or lifestyle after birth or puberty. However, the significant decline in the concentration of sperm and the quality of semen during the past 20 years in the Paris area may be related to an interaction of the age of the donors and the chronologic period that in turn could implicate factors affecting all the inhabitants of an area, such as the water supply28 or environmental pollution.29


Decline in Semen Quality among Fertile Men in Paris during the Past 20 Years Complete Article

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Poisoned For Profit – The Toxic Assault on Our Children by Philip Shabecoff & Alice Shabecoff

The environmental assault

We and our children are exposed to toxins invisibly, stealthily, without our knowledge.

The U.S. now makes or imports 42 billion pounds of chemicals per day (not even counting pesticides, drugs, food additives or polymers).

Causing harm

POISONED PROFITS, based on more than five years of investigative research and reporting, reveals the cumulative scientific evidence connecting the massive increase in environmental poisons to the epidemic of disability, disease, and dysfunction among our nation´s children.

The manufacturers and their defense team

The authors conclude that the poisoning of the environment is as grave a threat to the future as any problem confronting our nation.

Yet even as individual parents and pediatricians struggle to fight illness, one child at a time, the public remains in the dark about the enormity of this crisis. Why? because corporations control the system, molding laws to their liking. The book shines a light on the motives and means of corporate-paid lawyers, “product defense” companies, fake grassroots groups, research centers and scientists, including one paid $600 an hour to watch a movie.

The Victims

POISONED PROFITS, cast as a crime story, relates what happens to the victims—the families and communities polluted by different toxic substances—by pesticides, nuclear waste, industrial chemicals, air pollutants. Here are the stories of Dickson, Tennessee, where an extraordinary number of babies were born with cleft lips and palates after landfill chemicals seeped into the water; and Port Neches, Texas, where so many graduates of a high school near a petrochemical plant contracted cancer that it was nicknamed “Leukemia High”; and a small brother and sister in Indiana who, exposed to pesticides, slipped into severe retardation.

Genes + the environment

In layman´s language, the book explains how genes and the environment act upon each other, how mental and behavioral illnesses can be environmentally-triggered, affecting both the body and mind. And it explains the ways in which the fetus and young child are much more vulnerable than adults.

Our nation picks up the tab for these illnesses—POISONED PROFITS gives the dollar figures for reduced productivity on one hand, the staggering cost of care for sick children on the other.

Solutions

Instead of fighting against disability and disease with cures, a never–ending struggle, the authors affirm that we now have the knowledge to prevent harm and they describe the solutions. POISONED PROFITS demonstrates how people are fighting back, whether through grassroots parents´ groups, the rise of “ecotheology” or the new “green chemistry” that replaces bad elements with harmless ones.

The Shabecoffs also include a guide for parents on how to reduce toxic risks to their children in their everyday lives.

POISONED PROFITS was researched and written with support from the Ford, V. Kann Rasmussen, Heinz Family and Rockefeller foundations, under the sponsorship of Greater Boston Physicians for Social Responsibility. Physicians for Social Responsibility and the Institute for Children´s Environmental Health are current sponsors. Some of the nation´s leading environmental health scientists served as advisors to the book.


THE VICTIMS

Sarah

Sarah Sauer at age seven fell ill with a brain tumor. The Sauers at that time lived near the Dresden 2 nuclear power plant in Grundy County, Illinois run by Exelon, the nation’s largest nuclear energy producer. The Dresden plant and another Exelon-owned plant nearby had leaked millions of gallons of water contaminated with tritium, a radioactive isotope of hydrogen, into the surrounding environment. Some of it seeped into water supplies used by the Sauers and other local residents for drinking, bathing and cooking. Since the leaks, childhood leukemia has increased 49% and childhood brain cancer has increased 104%.

Exelon hadn’t informed the community of the leak. After it became public, Exelon repaired the leak with duct tape.

Cindy, Sarah’s mother, describes herself as a devout Christian. She thinks that the pollution that affects her child and other children is a right to life issue of great importance. “I don’t want my government allowing corporations and industries to put toxins in my environment that could be dangerous to my family. It’s always economics vs health, and economics always wins.”

Justin

Justin was diagnosed with glioma, a very rare brain cancer, when he was 12 years old,” explains his grandmother, Ann Tillery. “They said it was inoperable; he would be dead in six months. I took him straight to Ronald McDonald House and he had six weeks of radiation. Then I took him to his home, gave him herbal remedies, music and touch therapy. I learned how to play pool with him. I stayed at his house every day; I slept on the floor. I asked God, ‘Where is my miracle?’ He lasted 42 months. I suppose that was my miracle.”

Their community in Texas is home to synthetic rubber manufacturing facilities. Justin told Ann: “Grandma you have to find out what is doing this to me. I don’t want other children going through this.”

Lauren

Lauren Woods was born with a cleft lip and palate; now 11, Lauren has undergone five surgeries—lip closure, palate closure, inserting tubes in her ears, and removing a piece from the middle of her palate—and has at least 13 more to endure. The Shriners facility for children with birth defects did her surgery pro bono. Down the road, lives Peyton, born with a cleft lip and palate and a deformed heart.

In all, nineteen children within a two year period were born in Dickson, TN, with clefts (the national average for a town of this size is three), as well as brain, heart and penile defects, and cancer. Their mothers while pregnant had all drunk water laced with the solvent TCE leaking from a nearby landfill. The polluter was a company which subsequently deserted the town, leaving behind a bankrupt shell. TCE is one of the most common pollutants of water in the U.S.

Their community in Texas is home to synthetic rubber manufacturing facilities. Justin told Ann: “Grandma you have to find out what is doing this to me. I don’t want other children going through this.”

Sean

Sean Behm went through bouts of destructive behavior in his early school years, driven by his dyslexia and other learning problems. He once spoke of ‘jumping off the (Golden Gate) bridge,” and asked his parents if he was mentally retarded. Bullies at school kept taunting him. His mother, JoAnn, an RN with a masters in nursing, left a job she loved to spend time attending to her son’s needs and to advocate for environmental health for children in California. With his parents’ advocacy and care and finally finding the right school, he’s made it to young adulthood and college where he’s studying chemistry and industrial technology.

Jo, looking for possible causes, volunteered for a study in California that looked for industrial chemicals in adults’ bodies. “Every pollutant I was tested for, I have. That includes heavy metals, industrial compounds, pesticides, phthalates, flame retardants, and DDT. What did I as just Jo Citizen do to deserve this, why am I carrying around all these products? How about young people and the fetus and the embryo and breastfeeding milk?”


Christina & AJ

Christina Ebling and her brother A.J. were normal, attractive little children when in 1994 their family moved into an apartment in a nice-looking garden complex in Indiana. Soon both children began to be convulsed by seizures. Today they are both tragically retarded. Christina, now 16, slack-jawed and vacant-eyed, has the capacity of about a three year old. She is incontinent, her speech is barely intelligible. She cannot even brush her own teeth. A.J. has an IQ of 44.

The parents subsequently discovered that their apartment had been repeatedly sprayed with Dursban, a pesticide made by Dow Chemical Company, and another chemical of similar make-up. These chemicals are related (in diluted form) to the nerve gas Sarin which Japanese terrorists piped into Tokyo subways in 1995, and the poison gas that Iraq’s Sadam Hussein used to murder 5,000 Kurds. Residues show up in the urine of nearly every American child.

Jobori

Two year-old Jobori Montgomery lives with his mother Latisha in an apartment complex in Port Arthur, TX, that is separated only by a playground and wire fence from vast areas of oil and chemical production facilities. Enveloped in air pollution from before birth on, Jobori suffers from a severe case of asthma, as do almost all the other children.

Latisha lives in a neighborhood where Hilton Kelley is organizing the parents. Hilton had grown up in Port Arthur but moved to California where he was enjoying a successful career as an actor and stunt man. One year, upon his return to Port Arthur for a visit, he was dismayed to see the havoc wreaked on the health of the people in the city by the dense warren of oil refineries and chemical plants that crowd around it. On the plane back to California he experienced a religious epiphany that convinced him to return to his home town and work to help the people there. He is still there in Port Arthur, running the community organization, trying to get industry there to clean up its act.

From the 1980s to now, the incidence of asthma in children has increased from 3.6% to 8.7%, more than doubled.

Michael

Michael Gillick developed brain cancer as an infant and was not expected to live to see his first birthday. He is now nearly 30 years old but he has been in pain all his life and has grown to only about three feet tall.

Michael lives in Toms River, New Jersey, where two chemical companies, Union Carbide and Ciba-Geigy, had operated for years and emitted or spilled large amounts of toxic chemicals into the environment. He is one of over 100 children in the area who have developed leukemia or brain cancer in recent years. But the local and state government did not investigate until Michael’s mother Linda organized parents into a mutual self-help and advocacy organization, Oceans of Love, and began raising hell. Toms River is one of only two federal investigations that concluded a cancer cluster existed, but even here the exact cause remains in contention.

Sheila

Sheila Holt-0rsted comes from one of the few African-American families in Dickson, TN. Her family has long owned and worked farmland only 500 feet away from the county landfill. Sheila sees what happened to her family and herself as a ‘poster child’ case of environmental injustice. She found evidence indicating that Tennessee environmental and water officials had concerns as early as 1988 about the possibility of TCE appearing in the Holt’s well water but left their water untested for nine years while TCE problems in the wells of white families were tended to.

Sheila, 45, a physical trainer, had breast cancer and continues to suffer skin rashes. Her father died of cancer at 67; her mother has breast cancer. Their cows died en masse, their chickens were born with three legs. Sheila has had cervical polyps; her sister has had colon polyps. Her aunt next door and three of her cousins have had cancer. Her aunt across the street has had chemotherapy for a bone disease. Her uncle died of Hodgkin’s disease. Her daughter, 12-year-old Jasmine, has a speech defect.


THE PERPETRATORS

Dow Chemical

What happened to turn Christina and A.J. from normal to tragically retarded children? Their decline began after the family moved to a new apartment, which, their parents subsequently discovered, had been repeatedly sprayed with Dursban, a pesticide made by Dow Chemical Company, and another chemical of similar make-up. These chemicals are related (in diluted form) to the nerve gas Sarin, which Japanese terrorists piped into Tokyo subways in 1995, and the poison gas that Iraq’s Sadam Hussein used to murder 5,000 Kurds. Residues show up in the urine of nearly every American child.

In 1995, the EPA discovered that for ten years Dow had been hiding from federal regulators no fewer than 302 lawsuits and other claims for money damages alleging Dursban poisoning. The EPA’s response was to fine Dow $876,000, a relatively insignificant amount to a company as large as Dow. Under threat of an EPA ban, Dow finally withdrew Dursban from home use in 2000, but it remains in use in agriculture and on golf courses.

Syngenta (formerly Novartis)

The Swiss company Syngenta (formerly Novartis), the world’s largest agrochemical manufacturer, makes the herbicide atrazine. Atrazine is the most widely-used weed killer in the Corn Belt of America; it is found in over 90 percent of water samples in farming communities, and in at least 23 states. Its use was never allowed in Switzerland, and it was banned by the European Union in 2003. Despite evidence that atrazine can turn male frogs into hermaphrodites, the EPA, after 50 private meetings with Syngenta and with two advisory committees composed of only Syngenta and EPA representatives, decided to keep it on the U.S. market with no new restrictions.

Syngenta interfered with the publication of a hired researcher’s study that had found exposure to atrazine during frogs’ fetal stage, even at levels 30 times lower than currently permitted in water, converted male frogs’ hormones to female, that the frogs had in essence been chemically castrated. New researchers were hired, who found no risk from atrazine at the EPA-allowed levels.

DuPont

DuPont has long been one of the largest producers of toxic substances. One of DuPont’s products is Teflon, manufactured in plants in Parkersburg, West Virginia …and contaminating the water supplies in West Virginia and Ohio. In secret tests conducted as long ago as 1984, DuPont found a Teflon-related contaminant in the area’s tap water but the company never told the community, its water utility or state regulators, a violation of federal law. This indestructible chemical, found in the blood of over 95 percent of Americans, causes cancer, birth defects and other serious health problems in animals.

Twenty years later, EPA fined the company $16.5 million for two decades’ worth of cover-up (less than half of one percent of DuPont’s after-tax annual profits from the Teflon product over that period). For many years, DuPont was a major producer of the tetraethyl lead used in gasoline.

Monsanto

For almost 40 years, the Monsanto Company manufactured PCBs (fire-resistant chemicals once used in electrical equipment) in an Alabama town called Anniston, in a section of the city populated largely by African-Americans. The company “routinely” dumped millions of pounds of toxic wastes, including mercury and other hazardous substances but chiefly PCBs, into streams and open landfills in and around Anniston. Internal documents show that Monsanto knew it was poisoning the community with potentially devastating health effects. Thousands of Anniston citizens filed damage claims against Monsanto on behalf of themselves and their children; those who won were awarded small sums. PCBs, a probable carcinogen which also harm the brain and nervous system and damage the body’s hormones, were finally banned 1978.

Monsanto also manufactures Bovine Growth Hormone (BGH), which is injected into cows to increase milk production, as well as the Agent Orange herbicide used in the Vietnam war and the pesticide 2,4-D, whose manufacture leaves a residue of the highly toxic by-product dioxin.


(Side note – August 20, 2008 – Under the terms of the agreement, Lilly will purchase assets and liabilities of Monsanto associated with the POSILAC brand and related business for an upfront payment of $300 million, plus additional contingent consideration. The transaction will be completed as soon as practical. Additional terms of the agreement were not disclosed. Elanco has been marketing recombinant bovine somatotropin for Monsanto over the last decade outside the United States under a licensing agreement.) – Eli Lilly/Elanco was the last manufacturer of DES until 1996. They are quite familiar with synthetic estrogen chemicals.

General Electric

General Electric was one of the two U.S. companies that made the greatest use of PCBs in its manufacturing. Over the years, the company buried tons of PCBs on its huge site in Pittsfield, MA, and also released the chemicals into the river near their plant, which then spread throughout the town, and into the Housatonic River. They also gave tons of PCB-contaminated soil to town residents. A small mountain of PCB-contaminated waste lies right behind an elementary school.

GE similarly polluted the Hudson River with PCBs. Internal company documents indicate that GE, despite protesting no harm occurred, was aware for many years that its dumping of PCBs might cause health problems and liabilities for the company.

Co-Conspirators

If perchlorate, a chemical used in rocket fuel, finds its way into a person’s body, through drinking water for example, it knocks out the thyroid gland’s ability to use iodine and that disrupts the body’s major systems. In an adult, that could be harmful. In a fetus or infant, even in small amounts, it can destroy the brain.

For decades, perchlorate has been leaking from military dumpsites into surrounding areas. For decades, the Pentagon and its aerospace contractors have known about the leaks. By now, perchlorate contaminates the public drinking water sources that supply 40 states, the entire Colorado River and the water for farms in California growing berries and lettuce for the nation. But the Pentagon and Lockheed Martin and Kerr-McGee, among others, have colluded, spending millions of dollars to block the EPA from requiring any clean up. The corporations have contracted with “science-for-hire” laboratories to generate study after study over the years to muddy the debate and to keep fighting with EPA over ‘safe’ levels.


SOLUTIONS

Appendix A of POISONED PROFITS is a comprehensive summary of actions you can take to reduce the toxic assault on your children.
This guide starts with advice specifically for pregnant women and pregnancy-planning couples, then discusses choosing a neighborhood, and then removing harmful substances from

your home,
water,
food,
furnishings,
cosmetics and other personal care products,
household cleaning and laundry products,
your car and
your child’s school.
The guide addresses the question of the pediatrician you chose and encourages readers to take action as citizens.


TAKE ACTION

Our nation needs an active citizenry. It is the American way. Repairing our children’s health requires all parents ot take on some active role. Throughout the book, POISONED PROFITS identifies non-governmental organizations which are changing public policy for the benefit of our children and ourselves.
Research and Public Policy

Beyond Pesticides provides a wealth of information in a variety of formats about the risks of insecticides, herbicides, fungicides and other toxic pesticides to human health and suggests alternatives to their use. It also provides insights into pesticide policies of government and industry. http://www.beyondpesticides.org

The Center for Children’s Health and the Environment at Mt. Sinai Hospital in New York City does research into environmental sources of childhood illness and ways to combat such illness through science and public policy. It offers a variety of practical information for parents and physicians. http://www.childenvironment.org

The Center for Health, Environment and Justice offers information on toxic substances and technical and organizational support to help communities deal with environmental threats to health. http://www.chej.org

Children’s Environmental Health Network is a national organization of physicians, scientists, environmentalists, community organizers and other citizens. It monitors the science and public policy aspects of children’s environmental health and proposes courses of action for individual citizens and communities, as well as national policy initiatives. http://www.cehn.org

Healthy Child Healthy World (formerly called Children’s Health Environmental Coalition), a national group formed by parents of sick kids, provides information about preventable childhood illness caused by exposure to toxics in the home, school and community, and what parents can do. Its HealthEHouse is an interactive website displaying the various rooms of a typical home, the possible contaminants lurking in each, and advice about simple ways to avoid or minimize risk. http://www.healthychild.org

The Collaborative on Health and the Environment, a leader in the emerging environmental health movement, is an international network of individuals and organizations working together to collect and advance knowledge about links between health and the environment. It pays special attention to children. http://www.healthandenvironment.org

The Columbia Center for Children’s Environmental Health does research to study the effects of environmental pollutants and their impact on infant and child health. The results help communities improve environmental health through science and public policy. http://www.ccceh.org

Environmental Health Sciences is a non-profit group that publishes free of charge Environmental Health News and Above the Fold online, both valuable summaries of new research articles and media stories with hyperlinks to the original sources. Users can go to stories about children’s health with a click. http://www.environmentalhealthnews.org

The Environmental Working Group is a Washington, D.C. based non-profit that investigates and publicizes environmental contamination, who is doing it, and what the consequences are. It collects and publishes online and in print a trove of information about how children are exposed to toxic substances and offers practical advice about what parents might do about such things as chemicals in cosmetics, flame retardants, playground equipment, food, and frying pans. http://www.ewg.org

Institute for Children’s Environmental Health works to create networks of organizations and individuals to promote a safer environment for children. It presses for precautionary action to remove products and processes that harm kids. Its website offers much useful information and links to many other sites. http://www.iceh.org

The Natural Resources Defense Council, a national non-profit research, lobbying and litigation group, maintains a very usable website devoted to the health of children. It monitors toxic dangers to kids and also keeps track of what the government is doing or not doing to protect children. http://www.nrdc.org/health/kids

Physicians for Social Responsibility, founded in the 1960s to address the medical consequences of nuclear warfare, now produces research, policy reports, and training materials to address other serious environmental threats. Its Boston chapter holds seminars across the nation to train pediatricians in children’s environmental health. http://www.psr.org

Science & Environmental Health Network is a consortium of North American environmental organizations and a leading proponent of the Precautionary Principle as a new basis for environmental and public health policy, to protect and prevent illness.
http://www.sehn.org

TCE Network, For families who discover the toxic solvent TCE in their water supply, contact http://www.cpeo.org, a network of families and scientists to share information and fight to remove the chemical from use.

Organizations Advocating for Solutions to Specific Childhood Illnesses

The Learning Disabilities Center of America provides support to children, teachers, and physicians who help children with learning problems. Its Healthy Children Project (www.healthychildrenproject.org/exposures) offers information about the link between toxics in the environment and those problems. http://www.ldanatl.org

Autism Research Institute, founded to conduct and sponsor scientific research, collaborates with the Autism Society of America, a parent advocacy organization, following the theory that autism is a whole body condition that is treatable. They offer the Defeat Autism Now project for parents and physicians. ARI maintains a website which offers advice and support to parents and information for physicians; and has published a manual for use by doctors for helping kids with autism. http://www.AutismResearchInstitute.com

Birth Defects Research for Children, a national nonprofit organization founded by a parent of a child with birth defects, offers free information, parent networking and birth defect research. It operates the only National Birth Defect Registry, which collects information on all categories of structural and functional birth defects as well as the health, genetic and environmental exposure histories of the mothers and fathers of the affected child. http://www.birthdefects.org

Families Against Cancer and Toxics (FACT), founded by parents of children with cancer, is both a network and a source of information and research news. http://www.familiesagainstcancer.org

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Milwaukee Journal Sentinel’s Watchdog Series “Chemical Fallout”

This is an outstanding series. Here are some of the latest articles in the series. The link below will direct you to the series

Chemical Fallout

Warning: Dangerous chemicals are common in every day products, including food containers. And government has been slow to protect consumers from those dangers. Indeed, in the case of Bisphenol A, federal government regulators long sided with the chemical industry in declaring BPA safe – despite independent studies that repeatedly documented danger to children and adults. The government about-face in January of 2010 came only after years of investigations by the Journal Sentinel. Read original series: Part 1 | 2

Impact
The following stories highlight action taken as a result of the Journal Sentinel’s investigation.

FDA does about-face on exposure to BPA
The U.S. Food and Drug Administration on Friday reversed its position on bisphenol A, saying it was concerned about the chemical’s effects on fetuses, infants and children. However, the agency stopped short of a ban, saying more studies are needed. »Read Full Article

REACTION: Most welcome FDA’s decision
TIMELINE: FDA reverses ruling after evidence, pressure mounted

More Headlines
Doyle signs bill limiting BPA use (20)
Assembly backs limits on BPA in baby bottles (26)
Regulator waffles on bisphenol A (24)
EPA official says agency will act soon on BPA
It’s best to avoid BPA, federal official says

Featured Investigations

BPA industry fights back with public relations blitz
The chemical industry is under attack over bisphenol A, a key ingredient in hard, clear plastic products. Now, the industry is pushing back with an unprecedented public relations blitz.

FDA relied heavily on BPA lobby
As federal regulators hold fast to their claim that a chemical in baby bottles is safe, e-mails obtained by the Journal Sentinel show that they relied on chemical industry lobbyists to examine bisphenol A’s risks, track legislation to ban it and even monitor press coverage.

Use of plastic bottles increases BPA in study

EPA veils hazardous substances
The U.S. Environmental Protection Agency routinely allows companies to keep new information about their chemicals secret, including compounds that have been shown to cause cancer and respiratory problems, the Journal Sentinel has found.

BPA leaches from ‘microwave safe’ products
Products marketed for infants or billed as “microwave safe” release toxic doses of the chemical bisphenol A when heated, an analysis by the Journal Sentinel has found.

Plastics industry behind FDA research, study finds
A government report claiming that bisphenol A is safe was written largely by the plastics industry and others with a financial stake in the controversial chemical, the Journal Sentinel found.

Donation raises questions for head of FDA’s bisphenol A panel
A retired medical supply manufacturer who considers bisphenol A to be “perfectly safe” gave $5 million to the research center of Martin Philbert, chairman of the Food and Drug Administration panel about to make a pivotal ruling on the chemical’s safety.

EPA fails to collect chemical safety data
A few blocks from St. Josaphat Basilica on Milwaukee’s near south side, a company called Milport Enterprises makes more than a million pounds a year of a chemical that no one knows much about, not even the company executives. This is despite a decade of promises by the federal government to provide safety information about just such chemicals.

Hazardous flame retardant found in household objects
A flame retardant that was taken out of children’s pajamas more than 30 years ago after it was found to cause cancer is being used with increasing regularity in furniture, paint – even baby carriers and bassinets – and manufacturers are under no obligation to let the public know about it.

EPA drops ball on danger of chemicals to children
The Environmental Protection Agency is supposed to evaluate compounds in products such as flame retardants in mattresses and car seats to see if they are especially harmful to children. But it doesn’t.

Warning: Bisphenol A is in you
The federal government’s assurances that a common chemical is safe are based on outdated U.S. government studies and research heavily funded by the chemical industry.

GUIDE: What you can do to minimize your chemical exposure

Are your products safe? You can’t tell.
Congress ordered the federal government in 1996 to begin testing and regulating certain chemicals suspected of causing cancer and a host of developmental problems. Eleven years later, not a single compound has been put to that test.

AUDIO SLIDESHOW: A chemical home audit
GRAPHIC: Room by room chemicals abound (pdf)

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The following review by the American Academy of Pediatrics is critical to understanding the risks taken when our children are prescribed medications. If your child falls into the percentage of children that have adverse reactions to prescription medication excipients, it could cost your child’s life or cause significant unnecessary suffering. The following review examines 187 studies of adverse reactions to pharmaceutical excipients (An “excipient” or “inert” is considered an “inactive” ingredient in pharmaceutical formulations). These ingredients are no longer just water or table sugar. In some children, these ingredients cause death. Despite the repeated lobbying by the American Academy of Pediatrics to make mandatory labeling of all “inactive” or “excipents” in children’s pharmaceuticals, the FDA has sided with the pharmaceutical industry. The labeling of excipients continues to remain voluntary. It begs to ask the question, “If all ingredients are not labeled due to “trade secret” laws then how can the FDA ensure its safety?” The following report fully illustrates the negative impacts on our children’s health due to this reckless policy. I have pasted the document but you may also access it through the link.

PEDIATRICS Vol. 99 No. 2 February 1997, pp. 268-278


AMERICAN ACADEMY OF PEDIATRICS:
“Inactive” Ingredients in Pharmaceutical Products: Update (Subject Review)

Committee on Drugs

Abstract

Because of an increasing number of reports of adverse reactions associated with pharmaceutical excipients, in 1985 the Committee on Drugs issued a position statement1 recommending that the Food and Drug Administration mandate labeling of over-the-counter and prescription formulations to include a qualitative list of inactive ingredients. However, labeling of inactive ingredients remains voluntary. Adverse reactions continue to be reported, although some are no longer considered clinically significant, and other new reactions have emerged. The original statement, therefore, has been updated and its information expanded.


Full Report

INTRODUCTION
Top
Abstract
Introduction
Recommendation
References

Pharmaceutical products often contain agents that have a variety of purposes, including improvement of the appearance, bioavailability, stability, and palatability of the product. Excipients (substances added to confer a suitable consistency or form to a drug, such as the vehicle, preservatives, or stabilizers) frequently make up the majority of the mass or volume of oral and parenteral drug products. These pharmaceutical adjuvants are usually considered to be inert and do not add to or affect the intended action of the therapeutically active ingredients.

Some 773 chemical agents have been approved by the Food and Drug Administration (FDA) for use as inactive ingredients in drug products.2 Inasmuch as these compounds are classified as “inactive,” no regulatory statutes require listing on product labeling. Pharmacopeial guidelines, enforceable under the Food, Drug, and Cosmetic Act, do require labeling of inactive ingredients for topical, ophthalmic, and parenteral preparations; orally administered products are currently exempt. Because of pressure from professional and consumer organizations asking the FDA to require complete disclosure of all ingredients, voluntary labeling was adopted by the two major pharmaceutical industry trade associations. These voluntary guidelines contain an exemption for “trade secret” components and do not require complete disclosure of all fragrance and flavoring ingredients.

Current problems encountered with “inactive” ingredients include benzalkonium chloride-induced bronchospasm from antiasthmatic drugs, aspartame-induced headache and seizures, saccharin-induced cross-sensitivity reactions in children with sulfonamide allergy, benzyl alcohol toxicity in neonates receiving high-dose continuous infusion with preserved medications, dye-related cross-reactions in children with aspirin intolerance, lactose-induced diarrhea, and propylene glycol-induced hyperosmolality and lactic acidosis. Although many other excipients have been implicated in causing adverse reactions, these are the most significant in the pediatric population.

ANTIASTHMATIC MEDICATIONS
It is readily appreciated that some percentage of asthmatic children will develop a “paradoxical” bronchospasm after they inhale their medication. Because many of these reactions were attributed to sulfite, which had been highly publicized as a causative agent, it was often first suspected. During the past 10 years, however, the active ingredient in sulfite-containing preparations, the nonselective 2-agonists isoproterenol, isoetharine, and metaproterenol, have been replaced as drugs of choice by more selective agents, primarily albuterol, that do not contain sulfites. Paradoxical reactions continue to be reported, in some cases resulting in product reformulation because of excessive adverse reactions. Inactive ingredients that have been implicated in causing these reactions include benzalkonium chloride, oleic acid, chlorofluorocarbons, soya lecithin, and sorbitan trioleate.

Sulfites

Sulfiting agents are widely used as antioxidants. Six sulfite compounds (sulfur dioxide, sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite, and potassium metabisulfite) have been categorized as “Generally Recognized as Safe” for use in foods and drugs. This status was revoked for raw fruits and vegetables (excluding potatoes) in 1986 after the FDA received reports of more than 250 cases of adverse reactions, including six deaths associated with the ingestion of sulfites in foods.3,4 Although primary exposure in children is through foods, serious reactions have also occurred after oral, inhalational, parenteral, and ophthalmic administration of sulfite-containing drugs.

Signs and symptoms most frequently reported include wheezing, dyspnea, and chest tightness in patients with known reactive airway disease.5-9 Nonimmunologic anaphylactoid reactions have also occurred.7,8,10,11 Reactions to sulfites rarely occur in patients without reactive airway disease.12 Metabisulfite hypersensitivity was demonstrated in 19 (66%) of 29 children with a history of chronic moderately severe asthma.13 The incidence of sulfite sensitivity increases with age in severely asthmatic children (31% of children up to 10 years of age and 71% of older children).14

The presence of sulfites in antiasthmatic medications has been a concern, but many of these medications have been reformulated or replaced in clinical practice by more -selective agents, which do not contain sulfites. Metered-dose aerosol bronchodilators do not contain sulfites. Nonsulfite-containing products used to treat asthma are presented in Table 1. Parenteral drugs, such as corticosteroids, aminoglycosides, and epinephrine, may contain sulfites (Table 2) but rarely produce reactions because of the small amounts present. Patients who react to oral challenges with small amounts (5 to 10 mg) are at risk for similar reactions from these parenteral agents.15 Local dermal reactions accompanied by eosinophilia have been reported after continuous infusion with dobutamine.16 Sulfite-preserved amino acids contained in most mixtures of total parenteral nutrition are a less commonly appreciated source. Nevertheless, life-threatening situations requiring the administration of epinephrine should be treated with sulfite-preserved epinephrine if no preservative-free product is available, even in very sensitive patients. The diagnosis of sulfite sensitivity is made by history and through challenge testing.7 Avoidance of foods containing sulfites through careful reading of packaged food labels and inquiry at restaurants as to the use of agents that contain sulfites may prevent reactions. A commercial sulfite-detection strip was found to be unreliable, especially when used on acidic foods or foods removed from their original containers.17 Drug manufacturers must disclose the presence of sulfites in product labeling.

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TABLE 1
Some Medications Used by Asthmatics That Do Not Contain Sulfites

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TABLE 2
Some Sulfite-containing Medications Used by Asthmatics

Benzalkonium Chloride

Benzalkonium chloride is a commonly used bactericidal preservative in albuterol and metaproterenol nebulizer solutions in the United States and in beclomethasone and ipratropium bromide nebulizer solutions in other countries. Inhalation of pure benzalkonium chloride causes reproducible, dose-related, cumulative bronchoconstriction, with a rapid onset and prolonged duration compared with sulfites. It is frequently accompanied by a cough and burning sensation and, occasionally, by facial flushing and pruritus. Bronchoconstriction is inhibited by concurrent treatment or pretreatment with 2-agonists and cromolyn sodium and partially by histamine1 antagonists.18-20 The mechanism appears to be non-IgE-mediated release of mast cell mediators, with atopic patients being more susceptible.21

Because the reaction is dose-related and cumulative and may be masked by the active agent in many patients, few clear-cut cases of paradoxical bronchoconstriction have been attributed to benzalkonium, primarily in patients using more than one agent containing this excipient or in those receiving frequent dosing.22-26 Unit-dose vials deliver five times as much benzalkonium as the same dose given from a multiple-dose vial, which resulted in one case of bronchoconstriction.26 Other potential sources of benzalkonium in children with asthma and concurrent sinusitis include nasal saline, nasal corticosteroid, and nasal decongestant solutions.

In several studies of adult asthmatics, the lowest dose of pure benzalkonium chloride that produced a 20% decrease in forced expiratory volume in 1 second ranged from 124 to 159 µg. Albuterol (from a multidose vial) contains 50 µg per 0.5 mL of solution18,19; thus, a single dose is unlikely to cause a reaction. Even in patients without overt deterioration after the use of benzalkonium-preserved antiasthmatic agents, some evidence exists that benzalkonium-free solutions may have improved efficacy.21,27 Thus, although the presence of benzalkonium probably has a minimal effect in most patients using single, infrequent doses of a preserved bronchodilator, development of a unit-dose, nonpreserved preparation may significantly benefit the severely ill, hospitalized patient in whom disease-related deterioration in pulmonary function may be difficult to distinguish from preservative toxicity.

Metered-dose Inhalers (MDIs)

Paradoxical bronchoconstriction has been reported in up to 6.9% of asthmatic patients after inhalation of pure MDI vehicle.28 When combined with an active ingredient, this incidence decreases to approximately 1.5% to 4%.29 Most studies of MDI-related bronchoconstriction have been confounded by the lack of testing of individual vehicle components, inherent irritability of some active ingredients (corticosteroids), or concurrent use of potent active ingredients (bronchodilators). Inactive ingredients that have been implicated in the deterioration of pulmonary function attributable to hypersensitivity or irritant effects include chlorofluorocarbons,30-33 sorbitan trioleate,30,34 oleic acid,28,35 and soya lecithin (H. G. Wilms, written communication, October 27, 1989).28,36 One metaproterenol product, reformulated to contain soya lecithin, was withdrawn from the market after 1 month because of escalating reports of coughing, gagging, and asthma exacerbation (H. G. Wilms, written communication, October 27, 1989).

ARTIFICIAL SWEETENERS
Aspartame

Aspartame, a dipeptide of aspartic acid and a methyl ester of phenylalanine, is approved for use in pharmaceutical products and is being used increasingly in chewable tablet and sugar-free formulations. Labels for both prescription and nonprescription products must include the phenylalanine content. The major consideration in the use of aspartame in children is in patients with autosomal recessive phenylketonuria. Although heterozygotes do not appear to have clinically significant increases in phenylalanine after ingestion of even large amounts (equivalent to 24 12-oz cans of diet beverages), homozygotes with strict dietary restrictions should avoid aspartame. Children without dietary restrictions could safely ingest 10 mg/kg/d.37-40 Dietary consumption of aspartame is typically less than 5 mg/kg/d41; young children, however, could ingest considerably more. For example, a 2-year-old child weighing 12 kg consumes 17 mg/kg from drinking one 12-oz can of diet soda and one serving of a sweetened product (eg, cereal, pudding, gelatin, or frozen dessert).42

Headache is the most common adverse effect attributed to aspartame but is seldom confirmed by single-dose double-blind challenge. Up to 11% of patients with chronic migraine headaches reported headaches triggered by aspartame43; however, a double-blind challenge with three doses of 10 mg/kg given every 2 hours triggered no more headaches than did placebos in patients with vascular headaches believed to be exacerbated by aspartame.44 A small, double-blind 4-week trial showed an increase in frequency of headaches after ingestion of 1200 mg/d, indicating that a longer challenge period may be necessary.45

In anecdotal reports, aspartame has been linked to various neuropsychiatric disorders, including panic attacks, mood changes, visual hallucinations, manic episodes, and isolated dizziness.46-49 A small, double-blind crossover study of patients with major depression revealed a higher incidence of reactions in these patients compared with nondepressed volunteers after administration of 30 mg/kg for 7 days; symptoms included headache, nervousness, dizziness, memory impairment, nausea, temper outbursts, and depression.50 None of these conditions has been rigorously proven to be caused by aspartame, but carefully conducted double-blind challenges may be indicated in patients with histories that suggest aspartame as a cause. Patients with underlying mitral valve prolapse or affective disorders may be at increased risk for neuropsychiatric effects51; several studies have shown that individuals without psychiatric or seizure disorders do not demonstrate these effects.50,52

Seizures have been reported via passive surveillance data collected by the FDA and in a few case reports.47,48,53 A recent analysis of FDA reports showed 41 cases of rechallenge with a temporal relationship to aspartame consumption. Most seizures occurred in patients who had an acceptable dietary intake, except for a 16-year-old who ingested up to 57 mg/kg of aspartame.54 Aspartame is generally considered safe for children with epilepsy. One study found increased spike-wave discharges in children with untreated absence seizures after a high dose of aspartame and suggested that children with poorly controlled absence seizures avoid aspartame.55

Several studies have shown no relationship between aspartame and aggressive or hyperactive behaviors or cognitive function in children; thus, children with attention deficit disorder, with or without hyperactivity,56,57 do not need to avoid this sweetener.

Isolated confirmed hypersensitivity reactions resulting from ingestion of aspartame have been reported, including two patients who developed subcutaneous nodules or granulomas resembling erythema nodosum.58,59 Other reported reactions include orofacial granulomatosis, erythema, pruritus, urticaria, and angioedema.60-62 A meticulous workup with double-blind challenge usually fails to confirm the purported reaction; hypersensitivity reactions appear to be rare.63,64 These reactions may be related to breakdown products formed during the storage of liquid products, such as diketopiperazine derivatives, especially after exposures to higher temperatures.62 If so, rechallenge with fresh encapsulated powder could produce a false-negative reaction.

Saccharin

Many oral drugs, including both solid and liquid dosage forms, contain saccharin as a sweetening agent. Saccharin is not included in drug labeling. The most frequent use of saccharin is in foods and beverages, accounting for 70% of the total consumption. A British survey found that conventional soft drinks were the predominant source of saccharin in children aged 2 to 9 years, replaced by diet soft drinks in adolescents. The median intake of saccharin was 0.2 to 0.9 mg/kg/d in the general population and 0.6 to 2.3 mg/kg/d in diabetics.65 Foods containing saccharin must carry a label stating that the “use of this product may be hazardous to your health . . . contains saccharin which has been determined to cause cancer in laboratory animals.”

Saccharin may be present in drugs in substantial amounts. Ingestion of the recommended daily dosage of chewable aspirin or acetaminophen tablets in a school-age child would provide approximately the same amount of saccharin contained in one can of a diet soft drink. This amount, relative to the body weight of a child younger than 9 or 10 years, ingested for prolonged periods would be considered as “heavy use,” as defined in a major large-scale FDA/National Cancer Institute epidemiologic study.66 In this study, heavy use of artificial sweeteners was associated with a significantly increased risk for the development of bladder cancer. An independent review of this study concluded that there was no association.67 An investigation of saccharin performed by the American Medical Association in 1985 concluded that bladder changes were species-specific, were confined to the second generation of male rats, and occurred in association with large doses (equivalent to several hundred cans of diet soft drink per day). The no-effect level was equivalent to 500 mg/kg/d.68,69 Saccharin is not genotoxic; the presumed mechanism of toxicity is the binding of saccharin to urinary proteins (not normally found in humans), creating a nidus for the formation of silicate crystals, which are cytotoxic to bladder epithelium.70

Saccharin is an O-toluene sulfonamide derivative and causes similar dermatologic reactions. Cross-sensitivity with sulfonamides has been demonstrated; therefore, children with “sulfa” allergy should also avoid saccharin. Hypersensitivity can usually be confirmed by a radioallergosorbent test for saccharin.71 In a series of 42 patients with adverse effects resulting from consumption of saccharin in pharmaceutical agents, pruritus and urticaria were the most common reactions, followed by eczema, photosensitivity, and prurigo.72 Other reactions include wheezing, nausea, diarrhea, tongue blisters, tachycardia, fixed eruptions, headache, diuresis, and sensory neuropathy.73-77

Ingestion of saccharin-adulterated milk formula by infants was associated with irritability, hypertonia, insomnia, opisthotonos, and strabismus, which resolved within 36 hours after ingestion. Two anecdotal reports of an accidental overdose in an adult and a child discussed reactions of generalized edema, oliguria, and persistent albuminuria.75 Because of the paucity of data on the toxicity of saccharin in children, the American Medical Association has recommended limiting the intake of saccharin in young children and pregnant women.68

BENZYL ALCOHOL
Benzyl alcohol is commonly used as a preservative in many injectable drugs and solutions. A number of neonatal deaths and severe respiratory and metabolic complications in low-birth-weight premature infants have been associated with use of this agent in bacteriostatic saline intravascular flush and endotracheal tube lavage solutions.78-80 In a controlled study, intraventricular hemorrhage, metabolic acidosis, and increased mortality were positively correlated with substantial benzoic acid and benzyl alcohol levels in neonates.81 The incidence of premature infant mortality, kernicterus, and intraventricular hemorrhage decreased markedly after discontinuation of preserved flush solutions.82-84 In surviving infants, exposure to benzyl alcohol was also found to be associated with morbidity, including cerebral palsy and developmental delay.83

Most therapeutic agents, other than large-volume fluids, contain amounts of benzyl alcohol smaller than those associated with neonatal death. The effects of lower amounts, however, have not been adequately studied (Table 3). Toxicity has been described in one infant weighing 3350 g who received 32 to 105 mg/kg/d.80 Continuous infusions of high doses of some medications containing benzyl alcohol, such as doxapram, may reach the range of benzyl alcohol dosage associated with toxicity in this case report. Premature infants receiving low doses in medications were found to have peak benzoic acid levels 10 times higher than those in term infants but without evidence of toxicity.85 Two studies noting the striking decrease in kernicterus after removal of benzyl alcohol did not reveal a dose-response relationship and could not exclude the possibility that other advances in therapy were responsible.84,86

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TABLE 3
Parenteral Medications That Contain Benzyl Alcohol

The US Pharmacopeia requires labeling of bacteriostatic water and saline for injection with the phrase, “Not for use in newborns.” The FDA declined similar labeling for multidose parenteral medications, because serious toxic effects from benzyl alcohol had virtually disappeared.87 The toxic effects in newborns relate primarily to the use of preservative-containing flush solutions, which clearly are to be avoided in newborns. At low doses, such as those present when medications preserved with benzyl alcohol are administered, benzyl alcohol is safe for newborns.

Bacteriostatic saline solution containing benzyl alcohol was associated with severe bronchitis and hemoptysis when used to dilute albuterol for nebulization in an adult man.88 Nonpreserved saline solution should be used in children to dilute nebulized bronchodilators.

Benzyl alcohol may also rarely cause hypersensitivity reactions. Contact dermatitis,89 as well as more generalized allergic symptoms including nausea, fatigue, fever, maculopapular rash, or angioedema, may occur after parenteral administration of products containing benzyl alcohol as a preservative.90-92

COLORING AGENTS
Numerous dyes are used in pharmaceutical manufacturing. These dyes give products a distinctive, identifiable appearance, and they impart a uniform and attractive color to products that might otherwise be drab and unappealing or exhibit color variation among batches.

Several groups of dyes have been associated with serious adverse effects. The azo dye tartrazine (FD&C Yellow No. 5) is known to be potentially dangerous in aspirin-intolerant individuals. Approximately 2% to 20% of asthmatics are sensitive to aspirin. The incidence of cross-reaction to tartrazine was previously believed to be as high as 10%,93,94 but more recent carefully blinded studies have shown the incidence to be less than 2.4%.95-98 Unlike aspirin, tartrazine does not alter prostaglandin synthesis and does not, therefore, exert anti-inflammatory actions. Nonetheless, reactions to tartrazine are similar to those produced by aspirin, occur in patients both with and without a history of aspirin intolerance, and include acute bronchospasm, nonimmunologic urticaria, eosinophilia, and angioedema.94,99-107 Rarely, nonimmunologic anaphylactoid reactions occur.108,109 The most likely mechanism for these reactions is dose-related histamine release from mast cells.110,111 Patients with recurrent allergic vascular purpura may experience exacerbations after exposure to azo dyes, such as tartrazine, sunset yellow, and new coccine.112-114 Because of both the seriousness of these reactions and the widespread use of tartrazine in foods and over-the-counter and prescription drugs, since 1980 the FDA has required that all products containing tartrazine be labeled so that these substances can be avoided.115

Patients with the classic aspirin triad reaction (asthma, urticaria, and rhinitis) or anaphylactoid reactions may also develop similar reactions from dyes other than tartrazine, including amaranth,116-118 erythrosine,118,119 indigo carmine (FD&C Blue No. 2),103 ponceau,106,116,118 new coccine,113,117 sunset yellow,103,106,108,113,117,118 Brilliant Blue (FD&C Blue No. 1),106,118 methyl blue,120 quinolone yellow,121 and FD&C Red No. 40.122

Gastrointestinal intolerance, with abdominal pain, vomiting, and indigestion, has been associated with sunset yellow; in one case, eosinophilia and hives were also present.123,124 Other dermatologic reactions, including photosensitivity, erythroderma, and desquamation,125 have been attributed to erythrosine, an iodine-containing dye. By mandate, erythrosine has been removed from topical products and is being voluntarily removed from many oral drug products because of concerns about carcinogenicity.

Contact dermatitis has been associated with neutral red,126,127 D&C Yellow No. 11,128,129 indigo carmine (FD&C Blue No. 2),130 quinoline yellow,129 and gentian violet (CI Basic Violet No. 3).131,132

Dyes and other food additives have also been suggested as a cause or aggravating factor in some cases of hyperactivity in children116; carefully controlled trials133-136 and current opinion137-139 generally refute a possible association.

Because carefully controlled double-blind challenges often fail to confirm suspected reactions in children with atopic eczema,140 a controlled challenge is recommended before dyes are eliminated from the diet. Hypersensitive individuals should avoid dyes; liquid medications and nutritional supplements that do not contain dyes are listed in Table 4. These listings were originally compiled from voluntary responses to personal communications received from 56 US drug manufacturers and updated with a repeat mailing in December 1992. Until complete ingredient labeling is mandated, these lists will provide a tool to prevent reactions through avoidance in sensitive children using liquid dosage forms. Because inactive ingredients may change without changes in labeling, information in these tables should be verified.

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TABLE 4
Examples of Dye-free Orally Administered Liquid Medications

LACTOSE
Lactose (milk sugar) is widely used as a filler or diluent in tablets and capsules and to give bulk to powders. Lactase deficiency, occurring either as a rare congenital disorder or more commonly as an acquired lack of intestinal brush border disaccharidase, may lead to diarrhea, abdominal cramping, bloating, and flatulence after ingestion of milk products or lactose. These effects are produced either by lactic acid formed in the intestine by bacteria from undigested lactose or by a high intestinal osmotic load caused by unabsorbed carbohydrate with production of carbon dioxide and hydrogen gas by bacterial fermentation.141 Lactose intolerance in infants and young children may be associated with severe, prolonged diarrhea complicated by bacterial proliferation in the small bowel, dehydration, and metabolic acidosis.142 Lactose may be detrimental to the galactose-intolerant infant.

Late-onset lactase deficiency (adult hypolactasia) is a common disorder. Approximately 90% of adult American blacks and 60% to 80% of Mexican-Americans, Native Americans, Asians, and most Middle Eastern and Mediterranean populations have abnormal findings on lactose tolerance tests.143-148 Approximately 10% of the white population with Scandinavian or European ancestry is affected.148 Lactase deficiency may develop sporadically in otherwise tolerant individuals while they are suffering from an intestinal disease, such as tropical sprue or acute gastroenteritis.149

Sensitivity to lactose varies widely in severity, although some individuals (adults and children) may experience diarrhea, gaseousness, or cramping after ingestion of as little as 3 g or less of lactose.150,151 Such symptoms can occur in sensitive individuals after ingestion of drugs containing lactose.152-154 Two adult asthmatics who developed bronchospasm from lactose-containing medications had positive double-blind challenges with 300 and 500 mg of lactose.155,156

PROPYLENE GLYCOL
Propylene glycol is commonly used as a drug solubilizer in topical, oral, and injectable medications.

Absorption of the agent from creams applied to burns157,158 and injection of multivitamin products or enoximone (a phosphodiesterase inhibitor) in infants has resulted in serum hyperosmolality,159,160 which was associated with cardiorespiratory arrest in one case.160 Neonates have a longer propylene glycol half-life (16.9 hours) compared with adults (5 hours).158,159 Although the use of a multivitamin containing propylene glycol correlated strongly with serum osmolality in very low-birth-weight premature infants,161 propylene glycol from phenobarbital injection contributed an insignificant amount to the osmolar gap in another study.162 The higher amount of propylene glycol contained in an intravenous multivitamin product delivering 3 g/d was associated with a higher incidence of seizures in these infants compared with those receiving lower doses from an alternative product delivering 300 mg/d.163 Hyperosmolality related to topical propylene glycol occurred in 9 of 262 hospitalized burn patients.164

Because propylene glycol is metabolized to lactic acid, lactic acidosis may occur.165 Hemolysis, central nervous system depression, hyperosmolality, and lactic acidosis have been reported after intravenous administration.165-168 Hyperlactemia is associated with high propylene glycol levels, usually in patients with renal insufficiency, and is generally of minor clinical importance.169 Rapid infusion of concentrated propylene glycol-containing drugs has also been associated with respiratory depression, arrhythmias, hypotension, and seizures.170 Inadvertent administration of a highly concentrated solution can occur during manual push infusions; a piggyback infusion is preferred.171 Seizures and respiratory depression have also occurred in children who have ingested oral liquid medications containing propylene glycol.172,173

Several cases of localized contact dermatitis from the application of propylene glycol as a vehicle to skin or mucous membranes have been reported.174-180 In a series of 487 patients with eczematous contact dermatitis, 4.5% were found to be sensitive to propylene glycol.181 Oral or parenteral administration may exacerbate dermatitis in sensitized patients.182,183 The high concentration of propylene glycol contained in certain drug products, such as phenytoin, diazepam, digoxin, and etomidate, may induce thrombophlebitis when administered intravenously.184,185 In one study, 22% of patients experienced venous reactions to etomidate in propylene glycol, with no reactions to etomidate lipid emulsion.186

RECOMMENDATIONS

In a previous review of inactive ingredients, the American Academy of Pediatrics recommended mandatory labeling of inactive ingredients for all prescription and over-the-counter products. Since voluntary labeling was adopted, the legislative push for mandatory labeling has been abandoned, other than for nutritional supplements. A recently published survey of labeling on 102 chewable and liquid pediatric preparations found that only 90% labeled sweeteners, 80% labeled dyes and coloring agents, and 65% labeled preservatives. Although 90% of the preparations labeled flavorings, few provided the specific ingredient, in accordance with the voluntary guidelines.187 Therefore, the voluntary system is clearly inadequate. Again, the American Academy of Pediatrics recommends mandatory labeling for all prescription and over-the-counter drugs.

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Endocrine-Disrupting Chemicals: An Endocrine Society Scientific Statement

There is growing interest in the possible health threat posed by endocrine-disrupting chemicals (EDCs), which are substances in our environment, food, and consumer products that interfere with hormone biosynthesis, metabolism, or action resulting in a deviation from normal homeostatic control or reproduction. In this first Scientific Statement of The Endocrine Society, we present the evidence that endocrine disruptors have effects on male and female reproduction, breast development and cancer, prostate cancer, neuroendocrinology, thyroid, metabolism and obesity, and cardiovascular endocrinology. Results from animal models, human clinical observations, and epidemiological studies converge to implicate EDCs as a significant concern to public health. The mechanisms of EDCs involve divergent pathways including (but not limited to) estrogenic, antiandrogenic, thyroid, peroxisome proliferator-activated receptor , retinoid, and actions through other nuclear receptors; steroidogenic enzymes; neurotransmitter receptors and systems; and many other pathways that are highly conserved in wildlife and humans, and which can be modeled in laboratory in vitro and in vivo models. Furthermore, EDCs represent a broad class of molecules such as organochlorinated pesticides and industrial chemicals, plastics and plasticizers, fuels, and many other chemicals that are present in the environment or are in widespread use. We make a number of recommendations to increase understanding of effects of EDCs, including enhancing increased basic and clinical research, invoking the precautionary principle, and advocating involvement of individual and scientific society stakeholders in communicating and implementing changes in public policy and awareness.

The complete report can be accessed here

Click to access edc_scientific_statement.pdf

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