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This bill promises to speed up drug approvals so much that it’s making people uncomfortable

News Stories & Editorials
By Carolyn Johnson, The Washington Post
July 8, 2015

The bill slated to land on the House floor on Thursday seems unassailable on its face – the 21st Century Cures legislation promises to modernize medicine and speed the development of lifesaving treatments.

But a vocal chorus of physicians and pharmaceutical industry watchdogs warn that the bill is full of stealth provisions that could actually put sick people in harm’s way, by speeding the development of treatments that are neither safe nor effective.

It’s not exactly easy to oppose a widely-supported bipartisan bill that is often referred to as just “Cures.” But opponents say the proposed law is full of flaws, starting with its name and its key premise: that bottlenecks in the regulatory process are a big reason we haven’t cured cancer, Alzheimer’s, and a panoply of rare diseases.

To drug companies and patient advocates, expedited access to drugs and devices might seem like a huge boon. But critics are worried that the law will relax America’s standards for evaluating new drugs and devices, which are approved based on careful review of evidence — including rigorously designed clinical trials. The bill offers up a slew of new ways to evaluate drugs: for example, allowing antibiotics to be approved based on what would today be considered preliminary evidence — animal and test tube studies and very small trials in people. New medical devices could be approved based on “case histories” — potentially of just a handful of patients.

“The irony is calling this 21st Century Cures, when they’re talking about standards that were left behind in the 20th century, because they were found to not be good,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit, non-partisan think tank that does not accept money from drug or medical device companies.

Here are a few of the provisions that have sparked debate:

-The bill would allow antibiotics to be approved based on laboratory and animal tests and small, early clinical trials.

-The bill allows companies to seek expedited drug approval based on so-called “surrogate endpoints” — early indicators that a drug is working, such as whether a tumor has stopped growing in cancer.

A study published last month in the journal JAMA Internal Medicine found that efforts to expedite cancer drug approval by using such criteria has resulted in the approval of many cancer drugs that do not extend life, but do have side effects.

-The bill also threatens disclosure requirements that are intended to limit pharmaceutical companies’ influence on physicians. The bill would allow physicians to receive speaking fees and gifts from companies without disclosing them, as long as they were for medical education.

Read full story here.

NCHR Comment on the USPSTF’s Draft Recommendations for Cervical Cancer Screening

Cervical Cancer & HPV, Policy
2015

The National Center for Health Research is dedicated to improving the health and safety of adults and children by scrutinizing medical and scientific research. Based on our detailed analysis of currently available data, the Center strongly supports the existing USPSTF guidelines on cervical cancer screening which recommend Pap smears every 3 years starting at age 21, with the option of replacing that regimen starting at age 30 with a combination of a Pap smear and HPV test.

In response to the key systematic question regarding “the effectiveness of HPV testing, with or without cytology, as a primary screening strategy for reducing cancer mortality and incidence,” we strongly believe that this critical question must be divided into four questions: Is HPV testing effective with or without cytology (Pap smear) for women below 30 and for women above 30? Based on current data, the answers to those four questions seem to differ dramatically and more research will help answer those questions for different racial and ethnic groups.

Based on the research to date, HPV test without cytology should not be used as a screening tool. The HPV test by itself isn’t useful for women under 30 because many young women have HPV that will disappear without any treatment. Being objectively correct about whether HPV is present does not accurately predict whether infection with HPV will lead to cervical cancer.  On the contrary, the vast majority of women with HPV will never develop cervical cancer.   The only question is the extent to which HPV screening is useful for women over 30 and whether that is related to marital status or other measures associated with the number of sexual partners.

Positive results of an HPV test performed instead of a Pap smear, especially for women under 30, will add anxiety and lead to additional testing, as physicians follow a positive result on the HPV test with a colposcopy, an expensive and invasive procedure that could result in much lower compliance. Undergoing an HPV test without Pap smear is going to scare many women who are not at high or even moderate risk of cervical cancer.

The HPV test can only detect the presence of the virus, which in many cases will not result in cervical cancer; it cannot identify abnormal cells and it also cannot detect cancers of the cervix  that are not caused by HPV.

Although the FDA approved the use of the HPV test without cytology in 2014, it did not recommend replacing the safe and effective, well-established Pap screening regimen that has successfully prevented cervical cancer in the U.S.  FDA approval does not mean the HPV test is as good as the Pap smear, it only means it is better than placebo.

There has been little comparative effectiveness data comparing HPV-alone screening with HPV and cytology tests, known as co-testing. A new study published last month, conducted by scientists from the Quest Diagnostics laboratory and Magee-Women’s Hospital, analyzed data for over 256,000 women over 30[end Blatt AJ, Kennedy R, Luff RD, Austin RM, Rabin DS. Comparison of cervical cancer screening results among 256,648 women in multiple clinical practices. Cancer Cytopathol. 2015 May;123(5):282-8. Epub 2015 Apr 10.], and found that “approximately 19% of women with cervical cancer may be misdiagnosed by an HPV-only cervical screen.”  We urge the USPSTF to carefully review those data, and compare them to co-testing for women under 30 and those over 30.

The study data support co-testing in women ages 30 to 65 years as more effective at detecting pre-cancers and cancers. In addition, the study states that, “Co-testing performed better than HPV-alone or Pap-alone for cervical adenocarcinoma, a form of cervical cancer that is known to be harder to detect”.  It is important to consider and carefully scrutinize these data as the guidelines for cervical cancer screening undergo revision. We ask that USPSTF includes this study in its Proposed Research Approach — Evidence Review.

Current data indicate that HPV testing alone is likely to be much less accurate on women under 30, making the benefits of co-testing less likely for that age group.

In conclusion, based on current data and an excellent track record in the U.S., we believe Pap smear is an important screening tool, and that women should continue to rely on it every 3 years starting at age 21. Pap smears identify abnormalities in the cervix, which is useful by itself or together with an HPV test for women over 30. Most U.S. women who get cervical cancer did not have Pap smears within the last 5 years. In fact, some never had Pap smears. For that reason, women should continue to rely on Pap smears to screen for cervical cancer.  At the age of 30 or older, women may want to also be tested for HPV at the same time.

Startling link between pregnant mother’s exposure to DDT and daughter’s risk of breast cancer

In the News, New Cancer Research, Uncategorized
by Ariana Eunjung Cha, Washington Post
June 17, 2015

Banned by the United States in 1972, the insecticide DDT is best known as the impetus for the modern environmental movement. Since Rachel Carson’s bestseller “Silent Spring” sounded the alarm about the poisonous effects of the chemical on wildlife, the environment and human health, numerous studies have linked it to birth defects, miscarriage and reduced fertility.

Its role in cancer has been less clear. The Environmental Protection Agency classifies DDT as a “probable” carcinogen. Roughly three dozen studies have been published about DDT and breast cancer risk for women who lived during its peak use in the 1950s, but a 2014 meta-analysis of that research found that there was no significant association between exposure and breast cancer risk.

They may have been looking at the wrong generation of women.

A new study published Tuesday in the Journal of Clinical Endocrinology and Metabolism found a startling link between pregnant women exposed to DDT and the breast cancer risk to their daughters.

The study tracked the daughters of women who were part of a study at the Kaiser Foundation Health Plan from 1959 to 1967 near the city of Oakland, Calif. During that time DDT was widely used and accumulated in the fat of animals that we eat and was found in milk, butter, cheese and other products in the food supply. It was also in a number of consumer products, including some wallpaper.

During that period the participants gave birth to 9,300 daughters. Every mother had some measurable level of DDT in her blood. Researchers determined the level of exposure to DDT in utero by analyzing stored blood samples that were taken from the mothers during pregnancy or shortly after they delivered their babies. By using state records and surveying the daughters, who are now in their late 40s and early 50s, they were able to figure out which ones developed breast cancer.

The researchers found that elevated levels of DDT in the mother’s blood were associated with almost a four-fold increase in her daughter’s risk of breast cancer and that this was independent of the mother’s history of breast cancer. They also determined that those with higher levels of exposure were diagnosed with more advanced breast cancer.

About 83 percent of those who got breast cancer had estrogen-receptor positive breast cancer and were more likely to develop HER2-positive breast cancer in which a genetic mutation produces an excess of a protein. In previous studies, DDT has been found to interfere with the function of estrogen and, separately, to activate the HER2 protein, which may explain the link.

Barbara A. Cohn, one of the study’s authors and the director of Child Health and Development Studies at the Public Health Institute in Berkeley, Calif., said the 54-year study is “the first to provide direct evidence that chemical exposures for pregnant women may have lifelong consequences for their daughters’ breast cancer risk.”

Elizabeth Ward, senior vice president of intramural research for the American Cancer Society, said the group of mothers and daughters the researchers are studying is a “unique resource” for studying potential associations between maternal blood levels of chemicals and risk to their children.

“What makes this study interesting is its analysis of in-utero exposure,” she said. However, she said that the number of breast cancer cases was small — 103 — so “the results should be interpreted cautiously.”

In an interview, Cohn said the paper is part of a series of studies on chemicals and their effects on hormones or  development during gestation. Earlier studies she led have looked at the effects of DDT on the time of pregnancy of the daughters of women exposed (they found it could slow their ability to become pregnant or shorten it depending on level of exposure) and on incidence of testicular cancer among the male children (those exposed to the highest levels had an almost three-fold risk  compared with those with lower exposure). She is also studying the effect of other chemicals used for stain control on carpeting and waterproofing for food containers.

“We are looking at a vulnerable period in utero,” she said. “In some ways it is not surprising that early in life is a time when some of these chemicals can have a strong effect.”

Earlier work by Cohn also supports the idea that timing of the exposure matters. In a 2007 paper, she found that DDT affected breast cancer only for women who were exposed before age 14.  The meta-analysis that didn’t find any association between DDT and exposure looked at studies of women who were exposed later in life.

DDT is still widely used in other parts of the world, including regions of Africa and Asia, where it is used to control the spread of malaria.

“Our findings don’t change the perception of benefits, but they do change the perception of risks,” Cohn said. “We are hoping that policymakers will use this information as they continue to debate the use of DDT around the world.”

 

See original article here.

Kids Talk About Healthy Eating

Diet, Habits, & Other Behaviors
Cancer Prevention and Treatment Fund

Energy In-Energy Out. (Manuel, age 11)

I don’t feel like walking when my backpack is really full. Sometimes it gets so heavy because I forget to clean it out. I just keep putting things in without taking out books I’ve already read, old homework assignments, food wrappers and other stuff that I don’t need to be hauling around. My mom keeps telling me, “Just carry what you need.”  I’m starting to think about food that way. I eat the foods my body really needs, and when I forget or have a craving to eat the ones it doesn’t need-like cookies and chips-I try to take the stairs instead of the elevator, or walk the last five blocks home instead of staying on the bus.

I like to Pick my Own Sneakers and Dress a Certain Way. My Mom Says That Eating Right Means Making Sure Your Plate is Wearing the Right Colors. (Alex, age 9)

When I dress, I like to stick to my favorite colors-blue and yellow. But when I serve myself food, I try to get as many colors on my plate as I can because each color has its own “magical powers” (Okay, they’re really just vitamins and nutrients). It turns out that orange and dark green are some of the most powerful. And one way I keep from eating too many of the wrong foods is by making sure that half my plate is covered with colorful fruits or vegetables.

The One Time I Don’t Want to be Multi-Tasking: When I’m Eating. (Alisha, age 13)

My parents don’t understand how I can be checking text messages, doing homework, IMing, and listening to music all at the same time. I can, though.  Really.  But one thing I’ve learned recently: if I’m eating while watching TV or YouTube videos, I don’t pay attention to how much I’m eating.  All of sudden I’m like, I just ate a whole box of crackers.  Everyone eats stuff on the go sometimes, but now I’m trying to eat my meals and snacks on a plate or in a bowl and not do anything else while I’m eating except enjoy my food.  Being focused on my food lets me see how much I’m eating and be sure that most of what I’m eating really is fuel.  Put the wrong thing in your gas tank and your car won’t run.

Let’s Move (Chris, age 15)

It’s true that I spend a lot of time sitting-too much time: in class, in front of the television or the computer, or in the car to and from school. Mrs. Obama has been telling kids (and their parents) that they need to get moving to stay healthy.  So now I’ve made myself some rules that I stick to pretty regularly: for every 30 minutes I am sitting down, I do 30 jumping jacks or 30 sit-ups. I call it “doing my 30s.” I can’t do 30 push ups yet, but you know what? I’m working on it! The funny thing is that instead of feeling tired after my “30s,” I feel like I have more energy.

Saving Calories is Like Saving Money to Buy Something Special (Jesse, age 10)

I don’t like to use up my spending money on stuff I don’t need.  And nothing makes me more upset than losing money, like sometimes I’ll pull something out of my pocket and drop a dollar bill without noticing.  It’s all right to drink a soda when you really feel like it or when you’re at a party, but drinking soft drinks, sugary ice tea, and sports drinks just because you’re thirsty is like throwing money away-not just because of what they cost, but because they’re a waste of calories.  Water has no calories, and at home and school you can usually get it for free.  If you want to stay healthy, save up your calories for foods and beverages that keep you feeling full and satisfied-food and beverages that give you the vitamins and nutrients you need.  When I’m thirsty I stick to water or 1% milk.

I’m Down With Brown (Keesha, 16)

Bread, spaghetti, rice.  Whatever it is, I ask for it “brown,” because that means it’s whole grain.  Nothing has been taken away-none of the nutrition and none of the flavor.  And when I drink milk or eat yogurt or ice cream, I get reduced fat or fat-free. I get all the taste without the calories or saturated fat (that’s the kind of fat you don’t want to eat too much of-it’s in food that comes from animals, like meat, cheese, butter, and other stuff made from milk).  Remember this: low fat is all that!

Reading for a Reason (Khalil, age 14)

Reading can save your life. We all need to be able to read the directions on a medicine bottle because medicine can make you feel better and even cure you-if you use it right. Too much medicine can poison you. Too much of the wrong foods and the wrong ingredients can poison your body. That’s why I’ve started looking at the writing on food packages. I don’t read everything but I at least look at how much sodium, how much sugar, and how much fat is in those crackers or cookies.  I don’t want to eat half of the fat I’m supposed to eat in one day in just one snack!  Even fast food restaurants have that kind of information available, and if it’s not posted, you can ask where to find out how much fat is in those fries.  We all have a right to know-that’s what getting an education is about.

How Do I Get My Child to Eat Healthier Foods?

Diet, Habits, & Other Behaviors
Cancer Prevention and Treatment Fund

A Guide for Parents of On-The-Go Kids and Picky Eaters

Between parents’ work schedules, after school activities, homework, and chores, you may find it impossible to make time for healthy meals that your kids actually want to eat.  The challenge is even greater when kids get hooked on the pizza, soda, and chips provided at friends’ houses, activities, and parties.  Even the most conscientious parent may find it hard to avoid the temptation of fast food and favorite snacks.  But there are solutions!

  • Have easy foods on hand for last minute meals.  Keep healthy food on hand for quick and easy meals-frozen food can be an easy and healthy choice, especially all-in-one bag frozen family meals that are low on calories and fat (check out the many combinations of grilled chicken, rice or pasta, and vegetables in one bag).  If those family meals aren’t quite large enough for your family, you can easily add more fresh or frozen peas, green beans, or corn to make it more filling.
  • Plan meals in advance.  This is hard for most families, but if you cook on the weekend you can freeze meals (or at least one major ingredient, such as cooked beans or rice) that you can use to make several meals during the week.  You can even look online for Once a Month Cooking (OAMC) plans that designate one day each month as “cooking day” and free up the rest of your time for other things.  Ask your kids to help you select and even help prepare the dishes-that way they are more likely to eat them when they are served.
  • Out of sight, out of mind.  Don’t keep cake, candy, cookies, or chips (the 4 Cs!) in the house.  If you want to splurge occasionally, buy a small bag or individual portion as a treat.  Keep healthy snacks where kids can reach them.  You can “disguise” healthy foods by combining them with favorites-for example, try apple slices with low-fat peanut butter, baby carrots with veggie dip, or make your own trail mix with a combination of nuts, seeds, and dried fruit.
  • Shopping Tips.  When you buy groceries, try to buy “whole foods” instead of processed foods – for example, buy fish, chicken, turkey, whole grain breads and cereals, brown rice, and fresh fruits and vegetables.  If fresh fruits and vegetables are too expensive or inconvenient, look for frozen ones without sauces, salt, sugar, or additives.  Whole foods are preferable because they have all their nutrients and they don’t have added chemicals, sugars, salt, or fat.  Experts call these foods “nutrition dense” because you get more nutrients per calorie than you do with processed foods.  Try to pick foods that look good together because they have different colors and textures.  It sounds funny-like you’re trying to have a “fashion forward” plate-but this is a great way to maximize taste and nutrition!
  • Avoid misleading “health” claims.  Grilled chicken or fish are great choices, but fried chicken or fried fish are no healthier than hamburgers.  Remember that how food is prepared (fried, grilled, baked) is almost as important as what is in the food.  Most “juice drinks” have more sugar than the fruit they are made from, and contain little or no fiber, and many vegetable soups have more salt than vitamins.  If a salad has ham, eggs, cheese, and lots of salad dressing, it may be more fattening than a cheeseburger.  Remember that just because a label says “low calorie” or “sugar-free,” doesn’t mean the food or beverage is healthy.  Check food and beverage labels for nutrients like vitamins, protein, fiber, and minerals, not just for “bad” things like fat, calories, and salt.
  • Transition slowly.  If you and your family are used to eating a lot of fast food and prepared meals, your kids will need to slowly get used to other foods.  For example, try adding some extra fruits and vegetables to your usual meals, gradually decreasing the portion size of other items on the plate.  Start using whole grain bread, lean meat, low-fat cheese in a sandwich.  Try applesauce for dessert.  Our taste buds adjust over time, so cravings for very sweet or salty foods will decrease if you gradually take those foods out of your children’s diets.
  • Get young children involved in the kitchen.  The more kids are involved in making meals and snacks, the more they will enjoy eating healthy food.  Ask your kids to help you wash fruits and vegetables or do simple tasks like snapping the stems off of green beans, or making a salad.  Give children a few healthy choices for their sandwich or salad, so that they are involved and interested in eating healthy.  You can also teach kids where their food comes from by helping them start a small garden-even if all you have is a windowsill or fire escape.

All articles have been reviewed by Dr. Diana Zuckerman and senior staff.

References:

  1. Diana Zuckerman & Brandel France de Bravo, The Survival Guide for Working Moms (and Other Stressed-Out Adults), 2009.
  2. United States Department of Agriculture and Department of Health and Human Services, Dietary Guidelines for Healthy Americans 2010, available at: http://www.health.gov/dietaryguidelines/.

The Cost of Obesity: a Higher Price for Women—and Not Just in Terms of Health

Diet, Habits, & Other Behaviors
Margaret Aker and Brandel France de Bravo, MPH, Cancer Prevention and Treatment Fund

By now nearly everyone knows that being obese is bad for your health, but did you know that it is also bad for your wallet? This is especially true for women.

Obesity is usually defined as being 20% over ideal weight or as having a body mass index of 30 or higher (body mass index or BMI is calculated using height and weight). Obese people are more likely to suffer from chronic health problems, such as diabetes and heart disease, and they don’t usually live as long as people who are not overweight. The latest research indicates that obese men and women are at higher risk of colon cancer, and obese women are also more likely to get breast cancer and endometrial cancer (cancer of the womb). Obese people also experience a diminished quality of life because of physical difficulties and discrimination. While many reports have discussed the “cost to society” of obesity, none have looked at the additional costs in dollars for an obese woman or man.

A 2010 study by Avi Dor and his colleagues at the School of Public Health at George Washington University found that it costs an obese woman $4,870 more per year to live in America than a woman of healthy weight. Obesity costs less for men — an additional $2,646 per year.[1] Some of those costs are paid directly by the obese person and part by employers and the government.

How did the Researchers Come Up with Those Figures?

They looked at all the data available on direct medical costs, work-related costs, and personal costs. Direct medical costs include out-of-pocket as well as insurance-covered expenses related to doctor visits, hospital care, and medications; work-related costs include differences in wages, missed work days and disability payments. Personal costs refer to the yearly dollar amount spent on transportation and life insurance.

The researchers believe that their estimates are on the low side because they did not take into account other expenses that typically are higher for obese people, such as clothing, air travel, or furniture.

Lower Wages

Most surprising, the researchers discovered that obese women do not earn as much as normal-weight female employees. No such wage differential was found for obese men who earn the same as normal-weight men. While no one knows for sure why it is that obese women have lower wages, one likely explanation is a double standard that places greater emphasis on women’s physical appearance than men’s. If obese women’s lower wages were the result of something else, like lower productivity or more missed days of work, wouldn’t that  be true for obese men as well?

The chart below shows the breakdown in obesity costs for men and women. For men, direct medical costs account for over half of their additional “cost of living,” whereas for women, reduced wages are the biggest contributor.

TOTAL COST OF OBESITY FOR AN INDIVIDUAL

cost-of-obesity-for-men-and-women1 

Overweight vs. Obese: Do Costs go Down When Weight goes Down?

This study also found that there is an added cost for being overweight (BMI of 25 to 29.9), although not as high as for being obese. It costs an overweight woman an extra $524 per year to live in the United States, compared to $432 extra per year for men. So, how overweight you are matters. If a person is only overweight by a few pounds, losing those pounds could potentially save quite a bit.

The economic downturn has affected nearly all of us in one way or another, but this study reveals that its impact may be even greater for people who are overweight or obese. If health concerns aren’t enough incentive to change eating and exercise habits, knowing the economic costs might be.

Lastly, while many of us need to lose weight, all of us should be finding ways to fight discrimination. This study draws needed attention to another way obese people — particularly women — are discriminated against.

All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff. 

  1. Dor, A., Ferguson, C., Langwith, C., Tan, E.: A Heavy Burdern: The Individual Costs of Being Overweight and Obese in the United States. The George Washington University School of Public Health and Health Services 2010.

Statement of Dr. Diana Zuckerman before the DC Committee on Government Operations and the Environment regarding bisphenol A and phthalates, January 20, 2010

Legislation
Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, January 20, 2010

Thank you for the opportunity to testify about BPA and phthalates as president of the Cancer Prevention and Treatment Fund of the National Research Center for Women & Families.

Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific health and safety issues.

In addition, I am a fellow at the University of Pennsylvania Center for Bioethics, and a board member for two nonprofit organizations that work to improve resources for the FDA: the Alliance for a Stronger FDA, and the Reagan Udall Foundation.

I was trained in epidemiology at Yale Medical School; was on the faculty at Yale and Vassar; and directed a longitudinal research project at Harvard. I have worked on health policy issues in Congress, the White House, and for nonprofit organizations for 25 years.

The Cancer Prevention and Treatment Fund of the National Research Center for Women & Families strongly supports Bill 18-521, the “Human and Environmental Health Protection Amendment Act of 2009,” which will help to ensure that children and residents of the District of Columbia are better protected from the adverse health affects of a variety of chemicals. Due to time constraints, I will address only Sections 2 and 3 of the bill-the sections on Bisphenol A (BPA) and Phthalates.

Bisphenol A (BPA) is a chemical used to make plastics, and is frequently used in baby bottles, water bottles, and medical devices. It is also used in an epoxy coating on the inside of almost all food and beverage cans.

We think of plastic as being solid, but BPA leaches out of plastic and epoxy linings into liquids and foods. The Centers for Disease Control and Prevention found measurable amounts of BPA in the bodies of more than 90 percent of the U.S. population studied.[1]

BPA mimics and interferes with estrogen-an important hormone in reproduction and development.[2] Scientists are concerned about BPA’s behavioral effects on fetuses, infants, and children at current exposure levels, and whether it can affect the prostate gland, brain, and behavior.[3] There is also considerable concern about the impact of BPA on the mammary gland and its ability to trigger early puberty in girls, as well as the long-term risk of breast cancer.

There is research that claims that the levels of BPA in food containers are not harmful, but that research is funded by companies with financial ties to BPA. It is not objective research, and it is not credible research. That is why the FDA has finally admitted their concerns about BPA and is funding new research to better understand the risks. Meanwhile, the FDA is working with companies to decrease or eliminate BPA in food containers, and they are providing information to consumers on how to reduce exposure to BPA.

Phthalates are chemicals that are used to make plastic flexible and to add fragrances to soap and other personal products. Unfortunately, these chemicals don’t stay only in the products, and phthalates have been found in indoor air and dust,[4] and in human urine, blood, and breast milk.[5] Levels are highest in women and children ages 6 to 11. African Americans have been shown to have higher levels of phthalates than whites.[6]

Research indicates that boys exposed to phthalates may be more likely to develop smaller genitals and incomplete descent of the testicles. Boys who are born with undescended testicles are more than twice as likely to develop testicular cancer as teenagers or young men. Phthalates are believed to also affect girls’ hormones, but the health impact is not yet known. Recent studies also show associations between children’s exposure to phthalates and the risk of asthma, allergies and bronchial obstruction.[7], [8] Studies by Harvard researchers have shown phthalates may alter human sperm DNA and semen quality.[9]

Thanks to a Federal law passed in 2008, children’s toys and child care products for children under the age of 3 that are sold in the U.S (such as teething rings and plastic books) can not contain phthalates. However, testing to ensure these products are actually phthalate-free does not even begin until next year in order to give small businesses time to comply with the new law.

What about protecting our children while BPA is being studied? And what about phthalates in plastic products for children older than 3, and shampoos and creams for babies and young children? We don’t think parents should need a PhD in chemistry when they shop for baby bottles, infant formula, and baby creams.

BPA levels are especially high in the bodies of infants and children3 and children are especially vulnerable to BPA and phthalates. So it makes sense that Sections 2 and 3 ban BPA and phthalates in products intended for use by children under the age of 6. This is an excellent first step. But, what about prenatal exposures to BPA and phthalates?

Pregnancy and Chemical Exposures

If a pregnant woman is exposed to BPA or phthalates, then even before her child is born he or she will be exposed to BPA and phthalates. Pregnant women don’t have a special diet of canned foods and beverages-they eat the same food as everyone else. Pregnant women are encouraged to eat fish and fruits and vegetables, and if that is in the form of canned foods, such as canned tuna, they will get even more BPA in their bodies and the bodies of their babies. And, they use the same shampoos and creams that other adults use. That’s why we need to be concerned about BPA exposure from all containers for foods and beverages commonly consumed by adults and phthalates in all personal care products used by women.

Chemotherapy Patients

BPA may interfere with chemotherapy, especially for breast cancer patients. A study published in Environmental Health Perspectives in February 2009 found that the effectiveness of chemotherapy could be undermined by exposure to BPA among breast cancer patients.[10] This means that BPA levels in all foods and beverages consumed by adults are potentially dangerous.

BPA and Heart Disease

A study published this month based on a major government data set, the NHANES, “consistently associated [BPA] with reported heart disease in the general adult population of the USA.”[11] That study replicated the findings of an earlier study published in the Journal of the American Medical Association, which found a like to diabetes and heart disease.[12]

Because of these serious health risks, we believe that companies should have labels on all food containers that contain BPA. That will help our residents make informed decisions and it will provide an incentive for companies to find alternatives to BPA.

Alternatives Available

Safer alternatives to BPA and phthalates are available. Japan has reduced BPA in consumer products, such as canned beverages and plastic tableware. They are using different linings for beverage cans, which leach only a small amount of BPA, and plastic tableware that had BPA has been replaced with tableware that does not.[13] Canada has designated BPA as the highest priority chemical in need of regulation and has banned its use in infant products.

Several cities and states across the U.S. have weighed the scientific evidence and are seeking to implement bans. Suffolk County in New York became the first in the U.S. to ban BPA in baby bottles and sippy cups, in March, 2009. In Congress, bills were introduced in the U.S. Senate and House of Representatives (S. 593/H.R. 1523) to ban BPA in children’s products.

Responsible retailers are not waiting for local or federal governments to act. Wal-Mart and Toys-R-Us have pledged to remove products containing BPA from their shelves.[14] Bottle manufacturers such as Playtex and Nalgene are using non-BPA materials for their products. SUNOCO, a BPA manufacturer, announced last year that it would require customers to confirm that no BPA would be used in food or water containers for children under 3 years of age.[15] Despite this progress, however, baby bottles, infant formula cans, and other children’s products with BPA are still being sold and being used by D.C. residents.

Keeping Consumers Safe

The bottom line is that there is a growing body of evidence that the cumulative exposures to BPA and phthalates are endangering our children and possibly also adults. More than 100 studies, many conducted by independent researchers without conflicts of interest, have raised doubts about the safety of BPA and phthalates. And, safer alternatives to BPA and phthalates are available. If the Council wants to protect consumers in the District, then it should ban BPA and phthalates in infants’ and children’s products. And to protect pregnant and nursing women and their babies, chemotherapy patients, and other adults, the DC government should consider what it could do to encourage companies to ensure that food and beverage containers that use BPA are labeled as such. Similarly, phthalates in personal care products meant for adults should also be labeled. As I mentioned, that would make it possible for our residents to make informed decisions and it will provide an incentive for companies to find alternatives to these chemicals.

We thank you for considering the “Human and Environmental Health Protection Amendment Act, and strongly urge you to support it and join with us in finding ways to better protect children and adults from the risks of BPA and phthalates.

 

References:

[1] Hileman, B. (2007, April). Bisphenol A on Trial. Chemical & Engineering News Government & Policy, Vol. 85, Number 16. Retrieved April 3, 2009 from http://pubs.acs.org/cen/government/85/8516gov2.html

[2] Schierow, L., Lister, S.A. (2008, May). Bisphenol A (BPA) in Plastics and Possible Human Health Effects.

Congressional Research Service Report for Congress, The Library of Congress.

[3] National Toxicology Program. U.S. Department of Health and Human Services (HHS). (2008, September). NTP-CEHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. Retrieved April 3, 2009 from http://cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.pdf

[4] Rudel RA, Brody JG, Spengler JD,Vallarino J, Geno PW, Sun G, Yau A (2001). Identification of selected hormonally active agents and animal mammary carcinogens in commercial and residential air and dust samples. Journal of Air and Waste Management Association 51(4):499-513.

[5] Kato K, Silva MJ, Reidy JA, Hurtz D, Malek NA, Needham LL, Nakazawa H, Barr DB, Calafat AM(2003). Mono(2-ethyl-5-hydroxyhexyl) phthalate and mono-(2-ethyl-5-oxhexyl) phthalate as biomarkers for human exposure assessment to di-(2-ethylhexyl) phthalate. Environmental Health Perspectives 112: 327-330.

[6] CDC (2005). Third National Report on Human Exposure to Environmental Chemicals. Atlanta: Centers for Disease Control and Prevention.

[7] Jaakkola JJ, Knight TL (2008 July). The Role of exposure to phthalates from polyvinyl chloride products in the development of asthma and allergies: a systematic review and meta-analysis. Environ Health Perspect, 116(7): 845-53.

[8] Kanazawa A, Kishi R (2009 May). Potential risk of indoor semivolatile organic compounds indoors to human health. Nippon Eiseigaku Zasshi, 64(3): 672-82.

[9] Duty, S. M., M. J. Silva, et al., (2003). Phthalate exposure and human semen parameters. Epidemiology 14(3): 269-77. Duty, S. M., N. P. Singh, et al., (2003). The relationship between environmental exposures to phthalates and DNA damage in human sperm using the neutral comet assay. Environ Health Perspect 111(9): 1164-9. Duty, S. M., A. M. Calafat, et al., (2004). The relationship between environmental exposure to phthalates and computer-aided sperm analysis motion parameters. J Androl 25(2): 293-302. Duty, S. M., A. M. Calafat, et al., (2005). Phthalate exposure and reproductive hormones in adult men. Hum Reprod 20(3): 604-10.

[10] Barrett JR 2009. Trumped Treatment?: BPA Blocks Effects of Breast Cancer Chemotherapy Drugs. Environ Health Perspect 117:A75-A75. doi:10.1289/ehp.117-a75. Retrieved January 13, 2010 from http://ehsehplp03.niehs.nih.gov/article/fetchArticle.action?articleURI=info%3Adoi%2F10.1289%2Fehp.117-a75

[11] Melzer, D., Rice, N.E., Lewis, C., Henley, W.E., and Galloway, T.S. (2010, January). Association of Urinary Bisphenol A Concentration with Heart Disease: Evidence from NHANES 2003/06. PLoS ONE, 5(1), e8673. Retrieved January 13, 2010 from http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0008673

[12] Lang I.A., Galloway T.S., Scarlett A. et al. (2008). Association of Urinary Bisphenol A Concentration With Medical Disorders and Laboratory Abnormalities in Adults. Journal of American Medical Association 300(11),1303-1310.

[13] Advanced Industrial Science and Technology. (2007). Risk Assessment Document: Bisphenol A.

[14] Parker-Pope, T., (2008, April 22). A Hard Plastic is Raising Hard Questions, The New York Times.

[15] Rust, S. and Kissinger, M. (2009, March 12). Maker acknowledges BPA worries. JSOnline. Milwaukee Wisconsin Journal Sentinel. Retrieved on April 3, 2009 from http://www.jsonline.com/watchdog/watchdogreports/41186522.html