Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, February 17, 2010

Thank you for the opportunity to testify about Senate Bill 213 on behalf of the National Research Center for Women & Families and our Cancer Prevention and Treatment Fund.

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, a resident of Maryland, and I was previously the chair of the Women’s Health Promotion Council for the state of Maryland, appointed by the Governor.

I was trained in epidemiology and public health at Yale Medical School; was on the faculty at Yale and Vassar; and directed a longitudinal research project at Harvard, and I bring that scientific perspective to my testimony today. I have worked on health policy issues in Congress, the White House, and for nonprofit organizations for 26 years.

Our Center strongly supports Senate Bill 213, which will help to ensure that Maryland’s children are better protected from the adverse health effects of BPA.

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-including infant formula cans.

We think of plastic as being solid, but research shows that BPA leaches out of the plastic or epoxy lining into the liquid or food in the container.  The Centers for Disease Control and Prevention found BPA in the bodies of more than 93 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 increase the risk of prostate cancer and breast cancer, cause early puberty, or affect the brain and behavior.[3]

There is research that claims that the levels of BPA in consumer products 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 and the FDA is working with companies to decrease or eliminate BPA in its area of jurisdiction (such as food and beverage containers).  The U.S. Department of Health and Human Services is also providing information to consumers on how to reduce exposure to BPA.

While the federal government is studying BPA, who is protecting Maryland’s children?  Parents shouldn’t need a PhD in chemistry when they shop for baby bottles, infant formula, and children’s products.  Most parents assume that potentially harmful chemicals are not allowed in products made for children.  If only that were true.

BPA levels are especially high in the bodies of infants and children,³ and children are especially vulnerable to BPA.  So it makes sense that this legislation focuses on children.

New Research Shows BPA Increases Health Risks

A study published last month based on a major government data set, the NHANES, found that adults with higher levels of BPA in their urine were more likely to have heart disease, even when other variables were statistically controlled.[4]  That study replicated the findings of an earlier study published in the Journal of the American Medical Association, which found a link between BPA levels and diabetes and heart disease, even when obesity was statistically controlled.[5] While this shows that BPA in adults is potentially very harmful, remember that these types of health problems can start in childhood.  That’s why this bill is so important.

 If a pregnant woman is exposed to BPA, then even before her child is born, he or she will be exposed to the chemical.  Pregnant women don’t have a special diet of canned foods and beverages-they eat the same food as everyone else.  That’s why we need to be concerned about BPA exposure from all containers for foods and beverages commonly consumed by adults.  And, of course, we need to remove BPA from liquid infant formula cans.

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.[6]  This means that BPA in all foods and beverages consumed by adults are potentially dangerous for chemotherapy patients.

Alternatives Available

Senate Bill 213 explicitly states that BPA may not be replaced with chemicals rated by the EPA as carcinogens or reproductive toxicants.  Safer alternatives to BPA are available.  Japan has reduced BPA in consumer products, such as canned beverages and plastic tableware. They are using different linings for beverage cans that are much safer, and plastic tableware that had BPA has been replaced with tableware that does not.[7]  Canada has designated BPA as the highest priority chemical in need of regulation and in effect 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.  However, given the numerous stalemates in the U.S. Congress, it is crucial that Maryland protects its children by passing Senate Bill 213.

Responsible retailers are not waiting for state or federal governments to act. Wal-Mart and Toys-R-Us have pledged to remove products containing BPA from their shelves.[8] 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.[9] Despite this progress, however, baby bottles and child care articles with BPA are still being sold and being used by our babies and children in Maryland and most other states.

Keeping Consumers Safe

The bottom line is that there is a growing body of scientific evidence that the cumulative exposures to BPA are endangering our children and probably also adults.  More than 100 well-designed scientific studies, many conducted by independent researchers without conflicts of interest, have raised doubts about the safety of BPA.  And, safer alternatives to BPA are available. If we want to protect our babies and children in Maryland, then it is important to ban BPA in infants’ and children’s products.

Thank you for your leadership by holding a hearing on Senate Bill 213.  We strongly urge you to support this important bill and join with us in finding ways to better protect Maryland’s children and adults from the risks of BPA.

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] 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

[5] 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.

[6] 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

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

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

[9] 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

February 1, 2010

The Honorable Andrea M. Boland
State Representative
Maine House of Representatives
2 State House Station
Augusta, ME 04333

Dear Representative Boland:

The Cancer Prevention and Treatment Fund of the National Research Center for Women & Families strongly supports the “Children’s Wireless Protection Act.”  We are very pleased that your legislation would require cell phones sold in Maine to have a prominent warning label on the phone and its packaging stating that the device may cause brain cancer and that cell phone users-especially pregnant women and children-should keep the phone away from their heads and bodies.

We have discussed cell phone radiation issues with many of the experts that are recommending that pregnant women and children limit their cell phone use, and are very concerned about the possible long-term risks for adults and children.  A study published in 2008 in Physics in Medicine and Biology revealed that the brains of children under 8 absorb twice as much radiation from cell phones as adult brains.^[1] According to Swedish researcher Lennart Hardell, people who begin using cell phones (and cordless landline phones) before the age of 20 are at an even higher risk of developing brain tumors than people who begin using these wireless phones as adults.^{[2], [3]}

While most cell phone studies have focused on cancer, a study published in the medical journal Epidemiology suggests that cell phone exposure could affect children’s behavior.^[4] The children in the study who were hyperactive or had emotional or behavioral problems, including trouble getting along with other kids, were much more likely to have mothers who used cell phones during pregnancy. The problems were even more pronounced for children whose mothers used cell phones both during pregnancy and during their children’s first seven years of life. These children were 80% more likely to have problems than children whose mothers rarely or did not use cell phones. While it is impossible to determine whether the problem is primarily from radiation exposure or if mothers who use cell phones frequently while caring for their children differ from other mothers in ways that affect their offsprings’ behavior, the research results have important implications that deserve further attention, and that parents would want to know about.

The extensive use of cell phones is a relatively recent phenomenon, and since cancers usually take at least 10-20 years to develop, it will be years before research is likely to conclude whether cell phones cause cancer or not. However, the growing body of evidence indicates cause for concern, and delaying warnings now could result in tragedies later.

A review of 18 studies of cell phones and brain tumors, published in Occupational and Environmental Medicine in 2007, concluded that studies of individuals using cell phones for more than 10 years “give a consistent pattern of an increased risk for acoustic neuroma and glioma,” with the risk being highest for a tumor on the same side of the head that the phone is used.^[5] Gliomas are the most common cancerous brain tumor and acoustic neuromas are benign tumors of the acoustic nerve that can cause deafness.   Gliomas are the type of cancer that killed Sen. Kennedy and columnist Robert Novak.

Neurosurgeon Vini Khurana, Lennart Hardell and other scientists, conducted a meta-analysis of 11 studies published in peer-reviewed journals on long-term cell phone use and the risk of developing brain tumors.  The authors concluded, in their article in Surgical Neurology in September 2009, that using a cell phone for ten or more years “approximately doubles the risk of being diagnosed with a brain tumor” on the side of the head where the cell phone user holds the phone.^[6]

Research also indicates that cell phone radiation (known as Radio Frequency-Electromagnetic Radiation or RF-EMR) harms sperm and may result in reduced fertility.^[7] The lead researcher on that study, Dr. John Aitken from the University of Newcastle in Australia, recommends that men of reproductive age who would like to have children should avoid carrying cell phones in their pockets or anywhere below the waist. It is noteworthy that this warning is based on the much lower level of radiation emitted while a phone is on in a pocket but not being used for a call. Cell phones emit a higher level of radiation during a phone conversation.

Cell phone companies insist that evidence shows their phones are safe, but the industry tends to focus on studies they fund themselves and that draw conclusions that will keep their business booming.   Generally, industry-funded studies do not evaluate on which side of the head the phone was used, have rarely included business customers with corporate accounts (who tend to be the heaviest cell phone users), and their studies measure regular cell phone use as at least one call per week, and most of the people in their studies have used cell phones for less than 9 years.^[8] These shortcomings almost ensure that the studies will not find a significant increase in cancers.

Prominent cancer researchers are not waiting for definitive studies, but are urging people to curb their cell phone use now.   For example, the director of the University of Pittsburgh Cancer Institute, Dr. Ronald Herberman, warned his staff in July 2008 that the risks from cell phone radiation justified precautions, such as using ear pieces and minimizing cell phone usage by children.^[9]

For the above reasons, the Cancer Prevention and Treatment Fund of the National Research Center for Women & Families strongly supports your pioneering, proactive legislation.  The “Children’s Wireless Protection Act” would help protect the health of Maine residents by making the state the first to require warning labels that radiation from cell phones may cause brain cancer.

Sincerely,

Diana Zuckerman, PhD

President

Cancer Prevention and Treatment Fund

National Research Center for Women & Families

References:

[1] Wiart J, Hadjem A, Wong MF, Bloch I. (2008) Analysis of RF exposure in the head tissues of children and adults. Physics in Medicine and Biology 53(13): 3681-3695 (15).

[2] Hardell L, Carlberg M, Hansson Mild K. (2009) Epidemiological evidence for an association between use of wireless phones and tumor diseases. Pathophysiology 16 (2-3): 113-122.

[3] Hardell L, Hansson Mild K, Carlberg M, Hallquist A. (2004) Cellular and cordless telephones and the association with brain tumours in different age group. Archives of Environmental Health 59 (3): 132-137.

[4] Divan HA, Kheifets L, Obel C, Olsen J. (2008) Prenatal and Postnatal Exposure to Cell Phone Use and Behavioral Problems in Children. Epidemiology 19(4): 523-529.

[5] Hardell L, Carlberg M, Soderqvist F, Hansson Mild K, Morgan LL (2007). Long-term use of cellular phones and brain tumours: increased risk associated with use for = 10 years. Occupational and Environmental Medicine 64(9):626-632.

[6] Khurana VG, Teo C, Kundi M, Hardell L, Carlberg M (2009) Cell phones and brain tumors: A review including the long-term epidemiologic data. Surgical Neurology 72(3): 205-214.

[7] De Iuliis GN, Newey RJ, King BV, Aitken RJ (2009) Mobile Phone Radiation Induces Reactive Oxygen Species Production and DNA Damage in Human Spermatozoa In Vitro. PLoS One 4(7):e6446.doi:10.1371/journal.pone.0006446. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0006446 (Accessed August 17, 2009).

[8] Schuz J, Jacobsen R, Olsen JH, et al. (2006) Cellular telephone use and cancer risk: Update of a nationwide Danish cohort. Journal of the National Cancer Institute 98: 1707-1713.

[9] “Researcher warns of brain cancer risk from cell phones. July 24, 2008. The New York Times. http://www.nytimes.com/2008/07/24/technology/24iht-cellphone.4.14767955.html

Complete warning from Herberman can be read at: http://www.upci.upmc.edu/news/pdf/The-Case-for-Precaution-in-Cell-Phone-Use.pdf

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

January 8, 2010

The Honorable Nancy Pelosi
Speaker
United States House of Representatives
Washington, DC 20515

Dear Speaker Pelosi:

Thank you for your tireless efforts to expand quality, affordable health care coverage to millions of Americans. In merging the House and Senate health care bills, members of the Patient and Consumer Coalition strongly urge you to include the House language on comparative effectiveness research.

The Senate language proposes the establishment of a non-profit “Patient-Centered Outcomes Research Institute,” and requires that the Governing Board include several members representing “pharmaceutical, device, and diagnostic manufacturers or developers.”

In a recent New England Journal of Medicine (NEJM ) article entitled, “Industry Influence on Comparative-Effectiveness Research Funded through Health Care Reform,” well-respected health policy experts Dr. Harry Selker and Dr. Alastair Wood noted that “Embedded in the Senate legislation are provisions ceding substantial influence to the medical products industries that have a major interest in the outcomes of such research.”

By proposing that the center for comparative effectiveness research be within the Agency for Healthcare Research and Quality (AHRQ), the House language avoids industry conflict-of-interest. AHRQ is well-established and well-respected, and comparative effectiveness research is consistent with AHRQ’s mission of improving “the quality, safety, efficiency and effectiveness of health care for all Americans.” The House language allows comparative effectiveness research to be done scientifically and objectively. Comparative effectiveness research done in this manner should save lives and improve medical care by reducing the use of ineffective treatments, including pharmaceuticals, medical devices, and inaccurate, unreliable, or potentially dangerous medical tests.

We realize that AHRQ has received some criticism for guidelines proposed by the U.S. Preventive Services Task Force. We want to point out that the Task Force is an independent entity and is not comprised of AHRQ employees, nor does AHRQ control their guidelines or how those guidelines are communicated. Whether you admire the Task Force for their work over the years or criticize them for their conclusions or communication skills, is irrelevant to the issue of whether AHRQ should be the entity entrusted with comparative effectiveness research. Clearly, AHRQ has the expertise and objectivity needed for the comparative effectiveness research that will provide patients and healthcare providers with the information they need to make the best possible medical decisions.

Objective comparative effectiveness research is urgently needed. In 2009, an Institute of Medicine report on the topic stated: “All too often, the information necessary to inform…medical decisions is incomplete or unavailable, resulting in more than half of the treatments delivered today without clear evidence of effectiveness.”

The goal of comparative effectiveness research should be to provide patients, physicians, and healthcare providers with the best available information to help assess the effectiveness of various treatments and therapeutics. This cannot be done if the studies are influenced by companies whose products are being evaluated or conducted by researchers with financial conflicts-of-interest. For this reason, we strongly urge you to include the House language on comparative effectiveness research in the final health care reform bill.

Sincerely,

Breast Cancer Action
Center for Medical Consumers
Community Access National Network
Consumers Union
Government Accountability Project
National Consumers League
National Physicians Alliance
National Research Center for Women & Families/Cancer Prevention and Treatment Fund
National Women’s Health Network
Reproductive Health Technologies Project
Steven E. Nissen, MD
THE TMJ Association
Union of Concerned Scientists
U.S. PIRG
Woodymatters

The Patient and Consumer Coalition includes nonprofit organizations that represent patients, consumers, health care providers, scientists, researchers, and other stakeholders who believe that our nation’s health care will improve if based on the best possible objective evidence to support sound medical decision-making.
For additional information, contact Paul Brown at the National Research Center for Women & Families, (202) 223-4000 or pb@center4research.org

Read the original letter here.

March 18, 2009

The Honorable Henry Waxman
Chairman
Energy and Commerce Committee
United States House of Representatives
Washington, DC 20515

Dear Chairman Waxman:

The above members of the Patient and Consumer Coalition strongly support H.R. 1523, the “Ban Poisonous Additives Act of 2009,” which will remove Bisphenol A (BPA) from food and beverage containers. The Centers for Disease Control and Prevention (CDC) found BPA in more than 90 percent of Americans tested for the chemical, and BPA is linked to numerous adverse health effects.

We are particularly concerned about BPA’s effects on pregnant women. Scientists have reported that BPA adversely affects the health of fetuses (along with infants and children) at currently exposed levels. Six major baby bottle manufacturers have recently announced that they will stop using BPA in bottles, but other manufacturers will continue to sell baby bottles with BPA. In addition, if a pregnant woman drinks or eats food stored in a container lined with BPA, her fetus would also be exposed to the chemical. H.R. 1523 addresses this issue by banning BPA in all food and beverage containers.

We are also gravely concerned about BPA’s effect on chemotherapy patients, especially those with breast cancer. A 2008 University of Cincinnati study concluded that “BPA at environmentally relevant doses” makes “chemotherapy significantly less effective.” This is particularly disturbing since studies have shown BPA can cause breast cancer in laboratory animals, and now a study shows that it interferes with chemotherapy-an important tool in treating breast cancer.

Numerous other scientific studies raise red flags about BPA. A recent study published in JAMA indicates that adults with higher levels of BPA in their bodies were more likely to be diagnosed with diabetes or heart disease, even when obesity was statistically controlled. Studies have also linked BPA to miscarriages, insulin resistance (a risk factor for Type II diabetes), and increased formation and growth of fat cells (which can lead to obesity). A 2008 Yale study linked BPA to brain and mood disorders in monkeys, which has implications for depression and learning in humans. Other studies state that BPA can affect the prostate and mammary glands and lead to early puberty in girls.4

Alternatives to BPA are available and several manufacturers and retailers have pledged to remove it from their products. BPA maker Sunoco recently announced that it will refuse to sell BPA to companies for use in food and beverage containers for children younger than 3.

However, a comprehensive ban, such as the “Ban Poisonous Additives Act of 2009” is needed to make sure that all manufacturers stop using BPA. It is not enough to ban BPA in products that directly affect infants and small children. The only way to protect pregnant women, all children and chemotherapy patients, is to ban BPA from products used by adults as well. We strongly support H.R. 1523, the Ban Poisonous Additives (BPA) Act, introduced by Rep. Ed Markey.

Sincerely,
Breast Cancer Action
Breast Cancer Fund
Community Access National Network (CANN)
Consumer Federation of America
Consumers Union
Government Accountability Project (GAP)
National Research Center for Women & Families/Cancer Prevention and Treatment Fund
Our Bodies Ourselves
U.S. PIRG
Woodymatters
For additional information, contact Paul Brown at the National Research Center for Women & Families at (202) 223-4000 or at pb@center4research.org