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Physician Groups Make Recommendations to Reduce Healthcare Costs

Nyedra W. Booker, PharmD, MPH, Cancer Prevention and Treatment Fund

  • Does an 18-year-old girl need a pap smear?
  • Should a patient with a mild sinus infection be given antibiotics?

You might be surprised that the answer to both questions is NO according to leading physicians.

In an effort to improve medical care in the U.S. and save healthcare dollars at the same time, each of nine U.S. medical groups recently proposed a list of Five Things Physicians and Patients Should Question. This is a bold move by medical groups who collectively represent almost 375,000 physicians.  Currently, doctors are paid more for ordering more tests and diagnostic procedures, so these recommendations  are not financially beneficial to the physicians involved, but have the potential for reducing the cost of medical care for patients, health insurance companies, and government health programs such as Medicare, Medicaid, and Veterans healthcare.

The medical groups represent a wide range of medical care.  The nine groups include the American Academy of Allergy, Asthma & Immunology; American Academy of Family Physicians; American College of Cardiology; American College of Physicians; American College of Radiology; American Gastroenterological Association; American Society of Clinical Oncology; American Society of Nephrology and the American Society of Nuclear Cardiology.

Recommendations

Here are just a few of the groups’ recommendations:

Hives – Routine diagnostic testing (such as immunoglobulin E (IgE), a skin prick or blood test for allergies) is not recommended for patients with chronic hives, because such testing is usually ineffective at identifying the cause. [American Academy of Allergy, Asthma & Immunology]

Pap Smears – Routine pap smears to screen for cervical cancer are not recommended for women under the age of 21. [American Academy of Family Physicians]

Cardiac Stress Test – Cardiac stress test imaging (a procedure where dye is inserted into the blood stream and images show how well the blood is flowing through the heart) is not recommended for cardiac patients at their annual check-ups unless symptoms are present. [American College of Cardiology]

X-Rays and MRIs for Back Pain – Imaging (X-rays, MRIs) is not recommended for a patient with lower back pain unless a specific cause has been identified. [American College of Physicians]

MRIs and CCTs of the Brain – Imaging of the brain, including MRIs and CCTs (cranial computed tomography), is not recommended for a patient with a headache unless specific risk factors have been identified. [American College of Radiology]

Colorectal Cancer Screening– Colorectal cancer screening by any method (including flexible sigmoidoscopy, computed tomography colonography, double-contrast barium enema test) should be repeated every 10 years in low to average-risk patients who received a normal result at their last colonoscopy screening.  This is less frequently than previous recommendations.  It is recommended that people get their first colonoscopy at age 50. [American Gastroenterological Association]

Breast Cancer Testing – Imaging (PET, CT and radionuclide bone scans) is not recommended for patients with early-stage breast cancer at low risk for metastasis (cancer spreading to other parts of the body). [American Society of Clinical Oncology]

Cancer Screening – Routine cancer screenings (including colonoscopy, mammography and pap smears) are not recommended for patients on dialysis who have a short life expectancy, unless specific signs and symptoms are present. [American Society of Nephrology]

Chest Pains – Routine cardiac imaging including a stress echocardiogram (which  uses ultrasound to show how well the heart is pumping blood) is not recommended for a patient with chest pains who is at low risk for a heart attack or cardiac-related death, is able to exercise, and has a normal electrocardiogram (EKG).[American Society of Nuclear Cardiology][1]

A complete list of all 45 recommendations is available at: http://choosingwisely.org

How Will This Help?

Healthcare spending in the United States reached almost $2.6 trillion in 2010 and is expected to rise to around $4.6 trillion by 2020 unless major changes are made to eliminate unnecessary procedures, according to the Centers for Medicare & Medicaid Services.[2] An increase in the number of people living with chronic illnesses, rising prescription drug prices, and the high administrative costs of managing healthcare programs will contribute to increasing costs. While many continue to debate the exact reasons why healthcare spending is out of control, most agree that something needs to be done immediately.

In 2011, the American Board of Internal Medicine Foundation (ABIM) announced the Choosing Wisely campaign, and the National Physicians Alliance helped develop a multi-year initiative that would promote discussion among physicians, patients and consumer groups, aimed at decreasing healthcare costs by reducing unnecessary tests and procedures. Each participating group of physicians was asked to develop a list of five recommendations based on evidence from research findings. These recommendations were specific to their respective medical fields.

While many doctors and health experts understand that more medical care, and more expensive medical care, is not necessarily better medical care, studies show that the American public is wary of health care guidelines, even when they’re based on strong evidence. Patients and consumers tend to assume that running more tests and relying on newer, more costly technologies translate into health improvements (see Is Newer and More Expensive Care Better?).  As for doctors, the need to pay for expensive new imaging devices by charging for their use, the desire to give patients a clear diagnosis, and concerns about harming a patient by missing a diagnosis can all contribute to ordering unnecessary imaging and other tests.

Given this divide, it’s not surprising that Choosing Wisely has generated praise and concern. While many are praising the initiative as a step in the right direction to reduce the staggering cost of healthcare in the U.S., others question whether these cost-cutting strategies will come at the expense of good patient care.

Next Steps

The American Board of Internal Medicine Foundation and the National Physicians Alliance will continue to work with the nine medical specialty groups and several partnering organizations, including Consumer Reports and the American Association of Retired Persons (AARP), to develop tools and resources to help physicians discuss healthcare decisions with their patients. There will also be at least eight additional medical specialty groups joining the initiative and releasing their recommendations in the fall of 2012.

References:

  1. Choosing Wisely: An Initiative of the ABIM Foundation. Accessed April 04, 2012. http://choosingwisely.org/?page_id=13.
  2. Centers for Medicare & Medicaid Services. “National Health Expenditure Projections 2010-2020.” Accessed April 09, 2012. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/proj2010.pdf

 

Are Bisphenol A (BPA) Plastic Products Safe?

Diana Zuckerman, PhD, Paul Brown, Brandel France de Bravo, MPH, Sonia Nagda, MD, MPH, and Stephanie Fox-Rawlings, PhD, Cancer Prevention and Treatment Fund


Studying the Effects in Animals
Studying How BPA Affects Humans
The FDA Drags Its Feet As Other Countries Take Action
Legislation to Ban BPA in the U.S.
BPA in Plastics
BPA in Cans
Are BPA Any Substitutes Safer Than BPA?
Individual Efforts to Reduce Exposure to BPA
References

Bisphenol A (BPA) is a chemical used to make plastics. It is frequently used in sports equipment, water bottles, medical devices, as a coating or lining in food and beverage cans, and in credit card receipts. It leaches out of plastic into liquids and foods, and the Centers for Disease Control and Prevention found measurable amounts of BPA in the bodies of 93% of the U.S.population studied.[1]

Infants and children are estimated to have the highest daily intake of BPA because “they eat, drink, and breathe more than adults on a pound for pound basis,” according to the U.S. National Toxicology Program.[2] Until a few years ago, most plastic baby bottles contained BPA. The chemical is especially likely to leach out of plastic when it is heated, such as when a baby bottle is warmed in the microwave, thereby allowing the BPA to be ingested and enter the bloodstream.[2]  On any given day, several times a day, a baby might drink liquid formula that was sold in a can lined with BPA and then warmed in a plastic baby bottle containing BPA.

If BPA is in so many different items that we use every day, it must have been proven safe, right?  Unfortunately not. BPA was developed as a synthetic estrogen, and it mimics and interferes with the action of that hormone, which helps regulate development and reproduction.[3] It is called an “endocrine disruptor” because it affects the body’s own hormones (its endocrine system) in ways that could be potentially harmful.

It is difficult to determine just how much BPA, or how much of any hormone-disrupting chemical, is unsafe. Toxicologists test chemicals at very high doses in animals to see if they die or if their health is harmed. After establishing the dangerous dose, much lower doses are then allowed in products used or consumed by humans. These products are labeled safe, despite the fact that the chemicals in them have rarely been tested at low doses in animals, and were never tested in humans at all. Furthermore, recent research shows a paradoxical phenomenon with BPA and other chemicals that affect the endocrine system: their impact on health is sometimes greater at low doses than at high doses.[4]

While early concerns about BPA’s health effects were based primarily on animal studies and research on cells, there is increasing evidence from studies in humans that BPA can cause serious harm, such as increased risk of heart disease, diabetes, obesity, sexual dysfunction, and behavior problems in children.[5,6,7,8,9]

Studying the Effects of BPA in Animals

Before studies were conducted on humans, dozens of studies were conducted and are still being conducted in the lab. The American Chemical Society, the national professional association for chemists, reported that 153 government-funded BPA experiments on lab animals and tissues found harmful effects while only 14 did not.[1]

BPA experiments on rats linked the chemical to precancerous lesions in the prostate and mammary glands, and to early puberty in females at BPA dosages similar to human exposures, according to a 2008 report on BPA by the National Institutes of Health’s National Toxicology Program.[2]  Another study on rats showed that exposure to BPA, as well as exposure to fungicides and pesticides, appears to cause ovarian cysts and fewer eggs in offspring—as many as three generations down the line (a rat’s great “grandchildren”).[10]

Studies of mice exposed to BPA in the womb found that these mice tended to put on more body fat after birth.[11,12] However, as adults the BPA-exposed mice were the same size and weight as mice that were not exposed to BPA in the womb. Another study, published in 2012, found that adult mice given low doses of BPA twice a day for eight days did not gain weight, but they did develop problems with their metabolism that would lead to type 2 diabetes.[13]

Studies have linked the hormonal effects of BPA from canned cat food to the epidemic of hyperthyroidism in cats, especially females.[14] Studies of rats and mice have linked BPA to hyperactivity and various brain and behavioral changes, including increased anxiety and impaired cognition.[15,16,17,18] In 2008, the first study of nonhuman primates found that BPA levels were associated with cognitive problems that could affect learning and memory.[19]

The National Toxicology Program’s 2008 report recommended that more studies be conducted on BPA’s health effects on humans, and the report stated: “The possibility that bisphenol A may alter human development cannot be dismissed.”

Studying How BPA Affects Humans

Since 2008, studies of humans have added greatly to concerns about the health risks of BPA. A major study published in January 2010, 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.  The NHANES data also showed a separate link between levels of BPA in urine and high blood pressure, a major contributor to heart disease.[20] These findings were similar to a study published in the Journal of the American Medical Association in 2008, which found a link between BPA levels and diabetes and heart disease, even when obesity was statistically controlled.  A study published in Circulation in 2012 based on research in the UK supported these findings.[21] At least two other articles published in 2012 conclude that BPA exposure puts humans at risk for metabolic disorders and obesity.  One of the articles (a review) focused on in utero exposure to BPA, which Dr. Frederick vom Saal and his co-authors say appears to program the fetus to develop into an overweight adult.

As a weak estrogen, BPA has been shown to cause pre-cancerous growths in the mammary glands of rodents, so an important question is whether it could increase a woman’s chances of developing breast cancer, since breast cancer can feed on estrogen.[22] Laboratory studies where scientists look at cells taken from the body suggest that BPA may cause breast cells to change and become cancerous.[23] Not only does regular BPA exposure potentially increase a woman’s chances of developing breast cancer, but it appears to also interfere with chemotherapy for breast cancer patients, possibly reducing its efficacy.[24,25]

There is also evidence of harm to fertility and sexual activity.  In one stucy, men who were exposed to very high levels of BPA at work were four times as likely to experience erectile dysfunction and reduced sexual desire compared to men who did not work with BPA.[26]  BPA-exposed workers were also seven times as likely to have problems with ejaculation. Although the men in that study had much higher levels of BPA exposure than the average man, this study demonstrates BPA’s potential to harm men’s sexual and reproductive health at high levels and it raises questions about lower levels of exposure.  Research is needed to study the effects of more typical BPA exposures (non-occupational exposures) on men’s sexual health.

BPA can also affect a woman’s fertility and has been linked to miscarriages.[27] Studies have shown that women undergoing in vitro fertilization (IVF) who have higher levels of BPA have more difficulty becoming pregnant due to the lower quality of their eggs, fewer fertilized eggs, and reduced levels of estrogen.[28,29,30]

Recent research links prenatal and early childhood BPA exposure to mildly increased anxiety, depression, hyperactivity, and aggression in children.[31,32,33,34,35] However, the extent to which BPA seems to affect behaviors varies in different studies, potentially due to differences in how long the child was exposed to BPA, age of the child when exposed or when behavior was examined, the child’s sex, and family factors such as parents’ education levels. Better studies are needed to clarify to what extent BPA exposure affects behavior.

The FDA Drags Its Feet As Other Countries Take Action

After a Food and Drug Administration (FDA) analysis concluded that BPA was safe in 2008, the FDA Science Board, which consists of independent scientists who do not work for the FDA, recommended in October 2008 that the FDA analyze the research literature again, relying less on two industry-funded studies of rats and taking into account the best independent studies. It also recommended that new research be conducted to examine BPA safety concerns.

Meanwhile, Canada announced in 2008 that it intended to reduce infant and newborn exposure to BPA by banning its use in baby bottles, setting stringent standards for the amount of BPA allowed to migrate from the can into infant formula, and working with industry to develop alternative food packaging.[36] In October 2010, Canada became the first government in the world to add BPA to its list of toxic substances, in preparation for regulating its use.[37] France and Denmark joined Canada in banning BPA from baby bottles in 2010, and the European Commission voted that same year to ban European Union countries from making and selling baby bottles with BPA, beginning in 2011.[38] In December 2012, the French parliament voted to ban BPA from all baby food packaging in 2013 and from all food containers in 2015.[39]

In January 2010, the FDA announced that its National Center for Toxicological Research in cooperation with the National Toxicology Program is “carrying out in-depth studies to answer key questions and clarify uncertainties about the risks of BPA.” The FDA said that it “shares the perspective of the National Toxicology Program that recent studies provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children.” The FDA also recognized “substantial uncertainties” with the interpretation of BPA studies and how BPA may affect human health.  Despite those uncertainties, the FDA said it supported “a more robust regulatory framework for oversight of BPA to be able to respond quickly, if necessary, to protect the public.” However, the agency said at that time that it was “not recommending that families change the use of infant formula for foods, as the benefit of a stable source of good nutrition outweighs the potential risk of BPA exposure.”[40]

In March 2012, the FDA finally responded to a 2008 petition from the Natural Resources Defense Council (NRDC).  The petition had asked the FDA to ban BPA’s use in food and beverage packaging, based on the studies at the time. After ignoring NRDC’s petition for years, the FDA—under pressure of a law suit—responded that there was insufficient evidence to remove the chemical from the products in which it is currently being used, and that the Agency would continue to review studies of BPA.[41] It is important to note that the FDA’s rejection of the petition was based on the studies that the NRDC had submitted with the petition in 2008, not on the more recent studies.

Legislation to Ban BPA in the U.S.

In March 2009, Suffolk County in New York became the first county in the U.S. to ban BPA in baby bottles and “sippy” cups, and in May of 2009, Chicago and Minnesota followed.[42,43,44]  Also in 2009, Connecticut passed a law banning BPA in children’s reusable bottles and cups as well as infant formula and baby food containers, which went into effect in October 2012.[45] Between 2009 and 2013, 12 states and the District of Columbia have passed bans on BPA in either infant formula containers or other food-related products for children.[46] By July 2013, the industry had stopped using BPA-based packaging for infant formula.  It was not until the industry had voluntarily stopped using BPA that the FDA amended its rules to prevent BPA from use in these packages.[47]

Members of the U.S. Congress have introduced BPA-related legislation since 2009 without success. In the Spring of 2015, Senator Dianne Feinstein (D-CA) introduced a bill in the Senate (S. 821) that would require any food packaging that contains BPA to state “This food packaging contains BPA, an endocrine-disrupting chemical, according to the National Institutes of Health.” [48]

BPA in Plastics

BPA is found in polycarbonate (PC) plastics, which are typically clear and hard, marked with the recycle symbol “7” or may contain the letters “PC” near the recycle symbol.[49] To avoid the risks of baby bottles with BPA or other questionable chemicals, look for packages that say “BPA-free” and also consider alternatives such as glass bottles. And to avoid warming up food in plastic containers with these chemicals, use only stoneware, china, or glass dishes and containers in your microwave.

In 2008, manufacturers such as Playtex and Nalgene and retailers such as Wal-Mart pledged to remove BPA from their products and stores by the end of the year.[50] In March 2009, the six major manufacturers of baby bottles in the United States announced that they would no longer sell baby bottles made with BPA in the U.S.[51] A few days later, SUNOCO, a BPA manufacturer, announced that it would require companies using BPA in their products to confirm that none of those products would be used to hold food or water for children under 3 years of age.[52] These voluntary efforts were a result of negative publicity and consumer concerns about BPA.

BPA in Cans

BPA is still in most canned food and beverages sold to people and pets in the U.S. and other countries. Some companies are not waiting for a ban and are voluntarily removing BPA from their food packaging. Eden Foods began using BPA-free cans in 1999 and now uses BPA-free cans for everything except highly acidic tomato products.[53] According to Eden, it costs the company $300,000 more a year to produce BPA-free cans, which are 14% more expensive than industry standard cans; this translates into about 2 cents more per can.[54] Vital Choice introduced new cans and pouches for its fish products at the end of 2008.[55] In 2015, the Environmental Working Group released a market survey of the company reported use of BPA in their cans for 252 food brands. Of the 143 brands from which they were able to obtain information, 31 stated that they used only BPA-free cans (e.g. Health Valley and Tysons) and 78 used cans containing BPA for all products (e.g. Chef Boyardee, Green Giant, Hormel, and Ocean Spray). The rest used BPA-lined cans for some products but not others (e.g.,StarKist, Libby’s, and 365 Everyday Value).[56]

Are BPA Any Substitutes Safer Than BPA?

In response to new laws, regulations, and consumer concerns about BPA, many products are being made with two new chemicals, bisphenol S (BPS) and bisphenol F (BPF). These chemicals were not well studied prior to use, however in the past few years they have been shown to have endocrine disrupting similar effects to BPA in laboratory tests.[57] BPA alternatives also enter the human body just as easily as BPA.[58] This new research suggests that substituting BPA with new compounds that have not been adequately tested for safety is unlikely to provide any health benefits. What is needed is to test the safety of potential BPA substitutes before they can be sold.

Individual Efforts to Reduce Exposure to BPA

While we wait for more research to be conducted, is it possible to avoid BPA and substitutes that may be just as worrisome? One study suggests that we can significantly lower our levels of BPA by strictly avoiding many packaged foods and beverages and also changing how we prepare and store food.

In 2012, Ruthann Rudel from the Silent Spring Institute and her co-authors published a study showing how BPA levels in the body are affected by consuming foods and beverages that have come into contact with BPA. Twenty participants in 5 families switched from their normal diet, including canned and packaged items, to a diet consisting of only fresh, unprocessed foods for 3 days. Their BPA levels were tested before the switch, during the 3 days of BPA-free eating and drinking, and again after they had returned to their normal diet. The researchers found that BPA levels went down significantly when people ate foods and drank beverages that had never spent time in cans, plastic bottles, or plastic food storage containers made with BPA and had never come into contact with plastic or nonstick pans during preparation or while eating.[59]

References:

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  2.  “NTP-CEHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A.” National Toxicology Program. U.S. Department of Health and Human Services (HHS). Sept. 2008. Web.3 Apr. 2009.
  3. Schierow, L. and Lister, S.A. “Bisphenol A (BPA) in Plastics and Possible Human Health Effects.” May 2008. Congressional Research Service Report for Congress, The Library of Congress.
  4. Vandenberg LN, Colborn T, Hayes TB, et al. “Hormones and Endocrine-disrupting Chemicals: Low-Dose Effects and Nonmonotonic Dose Responses.” Endocrine Reviews. March 2012. Web.16 Apr. 2012.
  5. Melzer, D., Rice, N.E., Lewis, C., Henley, W.E., and Galloway, T.S. “Association of Urinary Bisphenol A Concentration with Heart Disease:  Evidence from NHANES 2003/06.”  PLoS ONE2012; 5(1). Web. Retrieved January 13, 2010 http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0008673
  6. Lang, I.A., Galloway, T.S., Scarlett, A., et al. “ Association of Urinary Bisphenol A Concentration With Medical Disorders and Laboratory Abnormalities in Adults.” Journal of American Medical Association 2008; 300(11): 1303-1310.
  7. Vom Saal FS, Nagel SC, Coe BL, Angle BM, Taylor JA. The estrogenic endocrine disrupting chemical bisphenol A (BPA) and obesity. Mol Cell Endocrinol. 2012 May 6;354(1-2):74-84. Epub 2012 Jan 10
  8. Li, D., Zhou, Z, Qing, D., et al. “Occupational Exposure to Bisphenol-A (BPA) and the Risk of Self-Reported Male Sexual Dysfunction.” Human Reproduction. Web. 2009 November 10.
  9. Findlay LC, Kohen DE. “Bisphenol A and child and youth behaviour: Canadian Health Measures Survey 2007 to 2011.” Health Reports. Aug, 2015. 26(8): 3-9.
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  12.  Ryan KK, Haller AM, Sorrell JE, Woods SC, Jandacek RJ, Seeley RJ; Perinatal exposure to bisphenol-a and the development of metabolic syndrome in CD-1 mice. Endocrinology. 2010, 151(6):2603-12.
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  33. Evans SF, Kobrosly RW, Barrett ES, Thurston SW, Calafat, AM, Weiss B, Stahlhut R, Yolton K, Swan SH. “Prenatal Bishpeol A Exposure and maternally reported behavior in boys and girls.” Neurotoxicology. 2014 Dec; 45: 91-99.
  34. Harley KG, Gunier RB, Kogut K,  Johnson C, Bradman A, Calafat AM, Eskenazi B. “Prenatal and early childhood Bisphenol A concentrations and behavior in school-aged children.” Environ Res. Oct, 2013; 126: 43-50.
  35. Perera F, Vishnevetsky J, Herbstman JB, Calafat AM, Xiong W, Rauh V Want S. “Prenatal Bisphenol A exposure an child behavior in an inner-city cohort.” Environ Health Perspect. Aug, 2012; 120(8): 1190-1194.
  36. “Government of Canada Takes Action on Another Chemical of Concern: Bisphenol A.” Health Canada. April 18, 2008. Web. April 3, 2009.
  37. Reuters. Canada declares BPA toxic, sets stage for more bans. October 14, 2012. http://www.reuters.com/article/2010/10/14/us-bpa-idUSTRE69D4MT20101014
  38. USA Today.Europe votes to ban chemical from baby bottles. Updated November 29, 2012.
  39. Agence France Presse. France bans contested chemical BPA in food packaging. December 13, 2012.
  40. “Update on Bisphenol A for Use in Food Contract Applications.” U.S. Food and Drug Administration. January 2010. Web. May 4, 2010, www.fda.gov/food/ingredientspackaginglabeling/foodadditivesingredients/ucm064437.htm
  41. “FDA Rejects NRDC Call to Eliminate BPA from Food Packaging.” Natural Resources Defense Council. March 30 2012. Web. Apr. 6 2012.
  42. Kindall J. “Suffolk’s Ban on BPA Hailed in Some Quarters.” The New York Times. March 13, 2009. Web. May 4, 2010 http://www.nytimes.com/2009/03/15/nyregion/long-island/15cupsli.html
  43. Hawthorne M, Mihalopoulos D. “Chicago BPA ban: Chicago bans sale of baby bottles, sippy cups with dangerous chemical.” Chicago Tribune. May 14 2009. Web. May 4, blocked::http://articles.chicagotribune.com/2009-05-14/news/0905131100_1_baby-bottles-ban-sippy-cups.
  44. Von Sternberg B. (8, May 2009). “State bans chemicals in baby bottles: Bisphenol-A is found in many plastics, but Minnesota becomes the first state to outlaw sale of items containing it.” Start Tribune. May 8, 2009. Web.
  45. State of Connecticut. “An Act Concerning Banning Bispehnol-A in Children’s Products and Food Products.” Substitute House Bill No.6572. June 3, 2009. Web. May 4, 2010 blocked::http://www.cga.ct.gov/2009/ACT/PA/2009PA-00103-R00HB-06572-PA.htm
  46. National Conference of State Legislatures. “NCSL policy update: state restrictions on bisphenol a (BPA) in consumer products.” Feb 2015. Web. http://www.ncsl.org/research/environment-and-natural-resources/policy-update-on-state-restrictions-on-bisphenol-a.aspx#me
  47. US Food and Drug Administration. “FDA Regulations No Longer Authorize the Use of BPA in Infant Formula Packaging Based on Abandonment; Decision Not Based on Safety.” July 11, 2013. Web. http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm360147.htm
  48. US Congress. “S.821 – BPA in Food Packaging Right to Know Act.” Web Jan 14, 2016. https://www.congress.gov/bill/114th-congress/senate-bill/821
  49. Parker-Pope, T. “A Hard Plastic is Raising Hard Questions.” The New York Times. April 22, 2008. Web. April 3, 2009. http://www.nytimes.com/2008/04/22/health/22well.html
  50. Gunther, M. “Wal-Mart: the new FDA.” Fortune Magazine. July 16, 2008. Web. http://archive.fortune.com/2008/07/15/magazines/fortune/gunther_bpa.fortune/index.htm
  51. Layton, L. “No BPA for Baby Bottles in U.S.” The Washington Post. March 6, 2009. Web. April 3, 2009 http://www.washingtonpost.com/wp-dyn/content/article/2009/03/05/AR2009030503285.html
  52. Rust S, Kissinger M. “Maker acknowledges BPA worries.” JSOnline. Milwaukee Wisconsin Journal Sentinel. March 12, 2009. Web. April 3, 2009 http://www.jsonline.com/watchdog/watchdogreports/41186522.html
  53. Eden Foods. “Eden Foods Bisphenol-A (BPA) Free Pioneer.” Web. January 2016 http://www.edenfoods.com/articles/view.php?articles_id=178
  54. Deardoff  J. “Where to find BPA free cans. Julie’s Health Club. June 30, 2008. Web. April 6, 2009 http://featuresblogs.chicagotribune.com/features_julieshealthclub/2008/06/where-to-find-b.html
  55. “Vital Choice Goes BPA-Free.” Vital Choice Newsletter. Dec. 29, 2008. Web. April 6, 2009.
  56. Environmental Working Group. “BPA in Canned Food.” Web. June 3, 2015. http://www.ewg.org/research/bpa-canned-food.
  57. Rochester JR, Bolden AL. Bisphenol S and F: A Systematic Review and Comparison of the Hormonal Activity of Bisphenol A Substitutes. Environmental Health Perspectives. July 2015; 123(7):643-650.
  58. National Conference of State Legislatures. “NCSL policy update: state restrictions on bisphenol a (BPA) in consumer products.” Feb 2015. Web. http://www.ncsl.org/research/environment-and-natural-resources/policy-update-on-state-restrictions-on-bisphenol-a.aspx#me
  59. Rudel RA, Gray JM, Engel CL, Rawsthorne TW, Dodson RE, et al. “2011 Food Packaging and Bisphenol A and Bis(2-Ethyhexyl) Phthalate Exposure: Findings from a Dietary Intervention.” Environ Health Perspect March 30, 2011; 119(7).

Cervical Cancer Screening: The Key to Prevention

Padma Ravichandran, Danielle Pavliv and Brandel France de Bravo, MPH, Cancer Prevention and Treatment Fund

Cervical cancer and the Human Papilloma Virus (HPV)

The cervix is the lowest part of a woman’s uterus, connecting the uterus to the vagina. During childbirth, the baby leaves the uterus where he or she has been growing and squeezes past the cervix to pass through the vagina or birth canal.

Cancer of the cervix (cervical cancer) is the third most common form of cancer among women worldwide after breast cancer. In the initial stages of the disease, there often aren’t any symptoms, and the symptoms that do appear can be mistaken for other health conditions. These symptoms include: continuous vaginal discharge, vaginal bleeding between periods or after intercourse, vaginal bleeding after menopause, or heavier and longer periods. In the later stages of the cancer, a woman might have any of the following symptoms: weight loss, loss of appetite, fatigue, pelvic pain, back pain, leg pain, one swollen leg, heavy vaginal bleeding, urine or feces leaking from the vagina, or bone fractures.[1]

Almost all cervical cancer is caused by infection with the Human Papilloma Virus (HPV).[2] It is very easy to get infected with HPV because it spreads by skin to skin contact of the genitals or genital contact with mucous membranes (such as in the vagina, anus, or mouth). At least half of all sexually active men and women have been infected with HPV at some point in their lives.[3]

Although about 95 % of women diagnosed with cervical cancer show evidence of HPV infection, the vast majority of women who have been infected with HPV do not develop cervical cancer.[4] There are at least 40 strains of sexually transmitted HPV that affect the genitals, but HPV strains 16 and 18 cause approximately 70% of all cases of cervical cancer.[5]

Women exposed to HPV in their twenties or earlier are able to clear the virus more quickly than women exposed later in life. As women get older, it takes longer for their body to get rid of the infection, which increases their chance of developing cervical cancer.[6] Our bodies clear most HPV infections within 1-2 years, but the longer an infection lingers, especially strains 16 and 18, the more likely it will progress to pre-cancer. HPV can cause the cells of the cervix to grow abnormally, and abnormal cells can sometimes become pre-cancerous.[7]

Abnormal or precancerous cells often go away on their own (becoming normal cells again) without treatment. Since it is impossible to predict whether treatment is needed or not, the Pap smear test screens for abnormal and precancerous cells on the cervix.

About 6% of all Pap smears find abnormal cells or pre-cancers requiring follow-up, and those are surgically removed so that they won’t become cancerous.[8]

Cancers take years to develop, but cervical cancer tends to develop earlier in life than other cancers because HPV exposure often happens in late adolescence or early adulthood when people are most likely to have more than one sexual partner. Doctors have diagnosed precancerous growths or lesions on the cervix in women as young as 25 years old, but cervical cancer is usually diagnosed in women between the ages of 35-55.

Although HPV is the main cause of cervical cancer, smoking, having multiple births, and long-term use of oral contraceptives each increase the risk.[9]

Screening Tests

In order to identify any precancerous or cancerous cells before they become life-threatening, doctors encourage women to get routine Papanicolaou (Pap Smear) tests. Depending on a woman’s age, the doctor may also recommend one of the HPV tests.[10]

Pap Smear

The Pap smear, also known as cytology screening, is done in a doctor’s office, along with a pelvic exam. The gynecologist will take a sample of the cervical mucus and cervical cells and send them to the lab for testing. There, they look for abnormal cells or precancerous cells that might eventually become cancerous.[11] The Pap smear has long been used to screen for cervical cancer. In countries where this screening test is widely available, the number of cases of cervical cancer and the number of deaths from the disease have dropped dramatically.[12] In the United States, there has been a 70% reduction in cervical cancer incidence and mortality since the introduction of Pap smears.[13]

Researchers have found that women who have never gotten a Pap smear are three to ten times more likely to develop invasive cervical cancer than women who get routine screening.[14] Though precancerous cells can sometimes progress to cancer in as little as a year, that is rare and expert guidelines do not recommend annual screening for most women.

How Often Should You get a Pap Smear?

Not everyone agrees on when a woman should first get screened for cervical cancer and how often she should get screened. Recommendations given by different organizations over the years have varied. The one thing everyone seems to agree on is that there should be a minimum age and that beginning to screen too early is ineffective and even harmful. Young women often have abnormal cells on the cervix that the body can get rid of naturally. Positive Pap smear results, indicating the presence of abnormal cells, may lead a woman to undergo unnecessary treatment procedures that could cause emotional distress and physical discomfort.[15] Also, as a result of unnecessary treatment, these young women are more likely to have premature babies and babies with low-birth-weight.[16]

In 2012, the United States Preventive Services Task Force and a coalition consisting of the American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology released guidelines for screening for cervical cancer. [17,18] While the two sets of guidelines were created separately, they are consistent with one another. The chart below lists the newest recommendations for women as developed by these agencies and organizations. Cervical cancer screening guidelines are different if you have HIV/AIDS or have a suppressed immune system, if your mother took DES (diethylstilbestrol) when she was pregnant with you, or if you have already been told you have, or have been treated for, abnormal cells, precancerous cells, or cervical cancer.

Age group USPSTF and ACS/ASCCP/ASCP guidelines
Under 21 years Should not be screened regardless of the age of sexual initiation or other risk factors
21-29 years Recommends screening with cytology alone every 3 years
30-65 years Screening with cytology and HPV testing (known as “co-testing”) every 5 years is preferred, but cytology screening alone every 3 years is acceptable
Older than 65 years Women who have had negative screenings for the past 20 years and are not otherwise at high risk for cervical cancer should not be screened.*ACS/ASCCP/ASCP adds that screening should not be resumed for any reason, even if a woman reports a new sexual partner
After hysterectomy(surgery to remove the uterus) Women of any age who have had a hysterectomy   with removal of the cervix and who do not have a history of a high-grade precancerous lesion or cervical cancer should not be screened.

HPV Tests

The HPV test is done on the same sample of cervical cells and cervical mucus. When checking for abnormal or cancerous cells, the laboratory specialist can also check the cells for the HPV virus. There are two types of high risk HPV tests:  the Digene hc2 High Risk HPV Test and Cervista HPV HR test. The company that makes the Cervista HPV HR test recently developed a test that specifically looks for strains 16 and 18.

The Digene hc2 High Risk HPV Test has been around for some years and checks for thirteen high risk strains of HPV, including HPV 16 and 18. While this test can determine if a woman is infected with a high risk strain, it is not that effective at identifying which high risk HPV strain she has.[19] The second high risk HPV test, Cervista HPV HR is similar to the Digene hc2 High Risk HPV Test in that it screens for high risk strains of HPV. The difference between these two tests is that the Cervista HPV HR screens for fourteen strains compared to the thirteen that the Digene hc2 High Risk HPV Test screens for. Both tests are approved by the Food and Drug Administration (FDA) to screen for high risk strains of HPV in women over the age of 30. This means that the test is not approved for women under 30, even if they have an abnormal Pap smear. Women under 30 who are given this HPV test have a good chance of getting a false positive reading [20] (the test falsely says that she has HPV), which is why it is not approved for this age group.

The newest test, Cervista HPV 16/18, is a test that checks specifically for HPV 16 and 18, which are the strains responsible for most cases of cervical cancer. The drawback to this particular test is that it must be administered together with the Cervista HPV HR test.   Similar to the high risk HPV tests, the Cervista HPV 16/18 can only be administered on women above the age of 30. [21]

The HPV tests are helpful to physicians whose patients over 30 have had Pap smears with abnormal or precancerous cells. A woman who has precancerous cells and a positive HPV test is more likely to develop cervical cancer. The HPV test confirms that the woman has strains of HPV that could cause cancer. [22] The doctors are more likely to recommend immediate follow-up or treatment for these women than women with precancerous cells and no evidence of a high risk strain of HPV.

Women under 30 must rely exclusively on Pap smears once every three years for detecting and keeping a watchful eye on changes in cervical cells. The HPV test is of no use for women in this age group, because even if they are infected with one or more types of HPV most will be able to rid themselves of infection relatively quickly. If young women with abnormal Pap smears were given the HPV test, they would be likely to receive unnecessary treatment which could harm their reproductive system. [23]

The Bottom Line

Cervical cancer screening is simple, low-cost, and saves lives. Women should start getting Pap smears at 3-year intervals at age 21, and women over 30 whose Pap smear showed abnormal cells or pre-cancers may want to also get one of the HPV tests.

References:

  1. U.S. National Library of Medicine and National Institutes of Health. (2008). Cervical Cancer. Retrieved 18 February 2010, from the MedLine Plus Web Site:     http://www.nlm.nih.gov/medlineplus/ency/article/000893.htm
  2. zur Hausen, H. (2009). Papillomaviruses in the causation of human cancers-a brief historical account.  Virology, (384). 260-265.
  3. Center for Disease Control and Prevention. (2009). Genital HPV Infection-CDC Fact Sheet. Retrieved 9 February 2010 from the Center for Disease Control and Prevention Web Site: http://www.cdc.gov/STD/HPV/STDFact-HPV.htm
  4. National Cancer Institute. (2009). PDQ cancer information summaries: Cervical cancer. Retrieved 2 February 2010, from the National Cancer Institute Web Site:                 http://www.cancer.gov/cancertopics/pdq/screening/cervical/healthprofessional/allpages
  5. National Cancer Institute. (2008). Human papillomaviruses and cancer: Questions and answers. Retrieved 3 February 2010, from the National Cancer Institute Web Site:  http://www.cancer.gov/cancertopics/factsheet/Risk/HPV
  6. chiffman, M., Castle, P.E., Jeronimo, J., Rodriguez, A.C. & Wacholder, S. (2007). Human papillomavirus and cervical cancer. Lancet (370). 890-907.
  7. Schiffman, M., Castle, P.E., Jeronimo, J., Rodriguez, A.C. & Wacholder, S. (2007). Human papillomavirus and cervical cancer. Lancet (370). 890-907.
  8. National Cancer Insitute. Pap Test Fact Sheet. http://www.cancer.gov/cancertopics/factsheet/Detection/Pap-test . Retrieved 17 February, 2010.
  9. Schiffman, M., Castle, P.E., Jeronimo, J., Rodriguez, A.C. & Wacholder, S. (2007). Human papillomavirus and cervical cancer. Lancet (370). 890-907.
  10. Center for Disease Control and Prevention. (2009). Cervical cancer screening. Retrieved 1 Feb 2010  from the Center for Diseases Control and Prevention Web Site:   http://www.cdc.gov/cancer/cervical/basic_info/screening.htm
  11. Center for Disease Control and Prevention. (2009). Cervical cancer screening. Retrieved 1 Feb 2010, from the Center for Diseases Control and Prevention Web Site:   http://www.cdc.gov/cancer/cervical/basic_info/screening.htm
  12. National Cancer Institute. (2009). PDQ cancer information summaries: Cervical cancer. Retrieved 2 February 2010, from the National Cancer Institute Web Site:                 http://www.cancer.gov/cancertopics/pdq/screening/cervical/healthprofessional/allpages
  13. Baseman, J.G., Kulasingam, S.L., Harris, T.G., Hughes, J.P., Kivat, N.B., Mao, C., Koutsky, L.A. (2008). Evaluation of primary cervical cancer screening with an oncogenic human papillomavirus DNA test and cervical cytologic findings among women who attended family planning clinics in the United States. American Journal of Obstetrics and Gynecology(26). E1-E8.
  14. National Cancer Institute. (2009). PDQ cancer information summaries: Cervical cancer. Retrieved 2 February 2010, from the National Cancer Institute Web Site:                 http://www.cancer.gov/cancertopics/pdq/screening/cervical/healthprofessional/allpages
  15. National Cancer Institute. (2009). PDQ cancer information summaries: Cervical cancer. Retrieved 2 February 2010, from the National Cancer Institute Web Site:                 http://www.cancer.gov/cancertopics/pdq/screening/cervical/healthprofessional/allpages
  16. Samya, G.F. (2009). Cervical cancer screening-New guidelines and the balance between benefits and harms. New England Journal of Medicine (361). 2503-2505.
  17. Saslow D, Solomon D, Lawson HW, Killackey M, Kulasingam SL, Cain J,…Myers E. (2012). American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. American Journal of Clinical Pathology. (137).516-542.
  18. Whitlock EP, Vesco KK, Eder M, Lin JS, Senger CA, Burda BU. (2011). U.S. Preventive Services Task Force. Liquid -based cytology and human papillomavirus testing to screen for cervical cancer. Retrieved 4 June 2012 at: http://www.uspreventiveservicestaskforce.org/uspstf11/cervcancer/cervcancerupd.htm
  19. National Cancer Institute. (2009). PDQ cancer information summaries: Cervical cancer. Retrieved 2 February 2010, from the National Cancer Institute Web Site:                 http://www.cancer.gov/cancertopics/pdq/screening/cervical/healthprofessional/allpages
  20. Food and Drug Administration. (2003). Summary of safety and effectiveness data: Digene hybrid capture 2 high-risk HPV DNA test. Retrieved 8 Feb 2010, from the Food and Drug Administration Web Site: http://www.accessdata.fda.gov/cdrh_docs/pdf/P890064S009b.pdf
  21. Food and Drug Administration. (2009). Summary of safety and effectiveness data: Cervista HPV 16/18. Retrieved 8 February 2010, from the Food and Drug Administration Web Site:               http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080015b.pdf
  22. Naucler, p. et al. (2009). Efficacy of HPV DNA testing with cytology triage and/or repeat HPV DNA  testing in primary cervical cancer screening. Journal of the National Cancer Institute (101). 88-99.
  23. National Cancer Institute. (2009). PDQ cancer information summaries: Cervical cancer. Retrieved 2 February 2010, from the National Cancer Institute Web Site: http://www.cancer.gov/cancertopics/pdq/screening/cervical/healthprofessional/allpages

Testimony of Dr. Diana Zuckerman, PhD at the Senate Special Committee on Aging Hearing on Medical Devices

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, May 4, 2012

Thank you for the privilege of testifying at this important hearing. I am president of the National Research Center for Women & Families, a think tank dedicated to improving the health of adults and children.  I am also testifying on behalf of our Cancer Prevention and Treatment Fund.

I was trained in epidemiology at Yale Med School, was a faculty member at Vassar and Yale, and a researcher at Harvard.  I am a fellow at the University of Pennsylvania Center for Bioethics.  My FDA expertise began as a committee staffer in Congress.

Today I will talk about our recently published study in the prestigious Archives of Internal Medicine.

We studied the recalls from 2005 to 2009 that FDA designated as the highest risk to patients because they can kill or permanently harm them.  We found that most of those devices were not approved through the PMA process.  They were cleared through the 510(k) process or exempt from review because they were thought to be such low risk.

GAO explained that FDA is ignoring the law when they clear high-risk devices through the 510(k) process.

I will explain how that harms patients.

There are 3 essential safeguards missing from the 510(k) process – that are in PMAs:

  1. There are no clinical trials-testing on human patients.
  2. Pre-market inspections are not required to make sure the device is made correctly
  3. Post-market clinical trials or epidemiological studies are not required as a condition of approval.

Defenders of the status quo have said that what’s important is that less than 1% of device applications are later subject to a high-risk recall.

That might make sense from a business point of view, but not from the public health or policy points of view.

Americans are dying and being harmed because their devices were not tested in patients or inspected prior to sale.

As a scientist and logical person, I believe that if a device can kill you, it is not low-risk or moderate-risk. I’m not talking about lightning striking out of the blue.  I’m talking about an implant that deteriorates inside the human body.  Or a diagnostic test that is inaccurate. Those predictable life-threatening problems could be reduced.

We don’t celebrate every time we eat a meal that doesn’t poison us.  We expect all our food to be safe, meal after meal, day after day.  That’s why Congress improved food safety even though most foods were already safe.  That will save lives.  Improving how medical devices are tested will also save lives.

Devices are common.  Those of us who wear contact lenses or hearing aids, or have a replacement hip or knee, or had LASIK or Botox, or use test strips for diabetes rely on medical devices every day.

More than 430 million devices were subject to high-risk recalls in just the first 6 months of 2010-more than one device for every man, woman, and child in the U.S.

It doesn’t make sense that standards for even the most innocuous drug-for constipation, for example-are more rigorous than for life-saving medical devices.

Mr. Hall’s analysis would not meet the standards of a peer-reviewed medical journal or even of the research methods course I’ve taught.  I won’t go into details, which are in my written statement, but feel free to ask me about the flaws in his analysis.

There were almost 8,000 moderate risk recalls in the last 5 years – such as Katie’s hip.  If you add those to 113 high-risk recalls, and divide by Mr. Hall’s estimated 20,000 submissions, devices would not have a 99% safety record-it would be 60%.  If we use GAO’s lower number of recalls-almost 3,500-the safety record is still only about 82%. Moderate-risk recalled devices can result in death during surgery, and add billions to Medicare costs.   That’s why we should include those recalls when we evaluate the safety record of the medical device approval and clearance processes.

We don’t know how many people die every year from unsafe medical devices.  Hospitals are required to report deaths that might have resulted from medical devices, but doctors are not required to report them.

Even so, there were almost 5,000 reported deaths from medical devices in 2009, and hundreds of thousands of serious complications.  These are the tip of the iceberg, because most doctors don’t report these adverse reactions to the FDA, even though medical facilities are required to do so.

In conclusion, lives could be saved and patients would spend less time in the hospital if FDA implemented the law as required.  Billions of Medicare dollars could be saved.

The 510(k) process may be acceptable for devices that are truly low or moderate risk, but not for implanted devices or those that diagnose or treat potentially deadly diseases.

How Does the FDA Monitor Your Medical Implants? It Doesn’t, Really.

Lena Groeger, ProPublica: May 3, 2012

Each prescription drug you take has a unique code that the government can use to track problems. But artificial hips and pacemakers? They are implanted without identification, along with many other medical devices. In fact, the FDA doesn’t know how many devices are implanted into patients each year – it simply doesn’t track that data.

The past decade has seen numerous high profile cases of malfunctioning medical devices, which have led to injury or even death. Critics say the FDA’s minimal monitoring of devices contributes to these problems.

“If you’re lucky, you might find a sticker on the operating room note that was left over from the product,” said Richard Platt, who runs the Harvard Pilgrim Health Care Institute. Otherwise, there is little way of knowing what device was used.

Right now, the FDA depends mostly on voluntary reports from doctors, patients, manufacturers and hospitals to notify them of problems with devices already on the market. The agency does have some power to require manufacturers to conduct further studies or track a particular device once it is sold. But many devices don’t get that level of surveillance.

“It’s much like a patchwork of streams of information getting to the FDA,” said cardiologist Frederic Resnic of Brigham and Women’s Hospital, who has worked with the FDA on medical device safety monitoring. “The FDA is relying on anecdotal and very variable information about the safety of medical devices.”

If manufacturers get word from a doctor or hospital about a death or injury that occurred as a result of their product, they are legally obligated to investigate the event and report it to the FDA. But the process isn’t straightforward, as has become clear in the recent controversy over the malfunctioning St. Jude’s Riata defibrillator leads (wires that connect a defibrillator to the heart). The FDA said an individual doctor’s report helped alert them to the problem, but it was months before the device was recalled.

According to attorney William Vodra, a regulatory law expert and member of the Institute of Medicine panel that published a report on medical device safety last year, the number of doctors who actually contact manufacturers is small.

And after being notified of patient harm, manufacturers can minimize their own responsibility if they point the blame elsewhere, said health policy expert Diana Zuckerman, president of the National Research Center for Women & Families.

For example, if someone dies from complications in a surgery to remove an implant, the manufacturer may argue that it was the surgery – not the implant – that killed the patient.

“You have a system that is not rigorous, the standards are not always understood, and they are interpreted differently by different people,” Zuckerman said.

The FDA responds to the criticism by pointing out that while every medical device carries a potential risk, the vast majority of devices perform well and improve patient health. An FDA spokeswoman emphasized that the agency must evaluate thousands of medical devices each year, and is constantly looking for ways to better and more quickly identify problems.

While the FDA makes the adverse event reports publically available in a searchable database, it doesn’t have a standardized system for reviewing reports once they are sent in, said Vodra, the attorney. A disclaimer on the site specifically states that the data is “not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.”

“What you would normally consider the simplest kind of data analysis is not done,” said Zuckerman. Often, doctors catch a malfunctioning device before the FDA ever notices.

In one case, a group of Pennsylvania doctors noticed that several patients were showing severe complications a few years after getting an IVC filter – a device designed to capture blood clots. Bits of the filter were breaking off, causing chest pain and a dangerous build-up of fluid and pressure around the heart. In 2010 the doctors conducted their own study and found that the filter broke in a quarter of all patients who used it.

On the day that study was published, the FDA issued a warning saying it had received over 900 reports of problems with IVC filters since 2006, and that the device was meant to be removed after a few months, not left in permanently.

There have been numerous attempts at reform. Five years ago Congress ordered the FDA to set up a post-market surveillance system to track the safety of all medical projects, but a system hasn’t yet been set up for medical devices.

A year later the FDA announced the Sentinel Initiative, which would combine existing data from electronic health records and medicalclaims to track drugs, vaccines, and devices. Some groups of hospitals or other organizations have voluntarily set up registries to collect information about the make and model of devices.

While the FDA has made significant progress on tracking drugs, it’s not yet in a position to do the same thing for devices, according to Harvard’s Platt, who is the principal investigator of Mini-Sentinel, the FDA’s pilot program for the national system. The data isn’t there.

The FDA has long acknowledged the need for a unique device identifier system, and got permission from Congress to set one up five years ago. No such system of ID-tags exists yet, but after several recent high profile medical device failures, the issue getting some attention from Congress. A proposed Senate bill, which cleared the Health, Education, Labor and Pensions Committee last week, sets a timeframe for implementing a unique identification system, among other reforms.

“If UDI’s were used in a consistent way, we could use the same kinds of techniques we’ve developed for drugs for devices,” said Platt. “It would be a huge breakthrough.”

Radiation and Thyroid Cancer

Sonia Nagda, MD, MPH, Cancer Prevention and Treatment Fund

Recent media reports have raised fears that radiation from dental x-rays and mammograms increase the risk of thyroid cancer.  Thyroid cancer rates have been increasing over the past 30 years, and this cancer affects women three times as often as men.[1] Is it true that dental x-rays and mammograms are to blame for the increase in thyroid cancer?  Can a simple thyroid shield (an optional extension of the lead apron that blocks x-rays from reaching the neck) reduce the risk and put fears to rest?

Radiation in many forms-including x-rays, CT scans, sunlight, nuclear fallout (from atomic warfare or nuclear accidents such as Chernobyl) and even the radiation therapy that is used to treat cancer-can harm the DNA in the body and cause cancer. For more on this, see:  Everything You Ever Wanted to Know About Radiation and Cancer but Were Afraid to Ask.

The thyroid gland is one of the organs most sensitive to the risk of radiation. Located in the neck directly over the trachea (the tube that brings air from the nose and mouth into the lungs)¸the thyroid gland makes two different hormones, known as T3 and T4, which are responsible for regulating energy and the body’s metabolism.

Background Radiation vs. X-Rays

We are all exposed to small amounts of radiation all the time. This is called “background” radiation. People who live in areas where radon gas is common or at high altitude have higher levels of background radiation.

For radiation to affect your thyroid and cause cancer, it has to reach your thyroid gland in sufficiently high doses-either from a big one-time dose (as from a nuclear disaster) or through many smaller doses. The closer the area being x-rayed is to the thyroid, the greater the amount of scattered rays that will reach it.  Since the mouth is closer to the thyroid than the breasts, it makes sense that dental x-rays are more likely to affect the thyroid gland than mammograms, which are x-rays of the breast. On the other hand, dental x-rays expose patients to much less radiation than a mammogram: 0.005 millisieverts (mSv) for a dental x-ray, which is comparable to one day of natural background radiation, as compared with 0.4 mSv for a mammogram, which is comparable to 7 weeks of background radiation.[2]

Besides the dose, the age of the person being x-rayed or scanned is important. The thyroid gland is particularly sensitive to radiation during childhood and adolescence-when the gland is most active and a person’s body grows the most. As we age, the thyroid gland doesn’t work as hard, and the amount of radiation that it takes in becomes much smaller.

Dental X-Rays: a Risk for Thyroid Cancer or Not?

A study by Sara Schonfield and colleagues at the National Cancer Institute, published in 2011, compared the number of dental x-rays received by a group of thyroid cancer patients prior to their diagnosis with the number received by a group of similar individuals without thyroid cancer. Overall, those who had dental x-rays were twice as likely to develop thyroid cancer.  More than 75% of the thyroid cancer patients were diagnosed before the age of 44. The more dental x-rays that a patient received, the more likely he or she was to develop thyroid cancer: the patients who received more than 10 x-rays had more than 5 times the risk of developing cancer than someone who had not had any dental x-rays.[1]

Mammograms: a Risk for Thyroid Cancer or Not?

The radiation that scatters from the breast to the thyroid gland is so negligible that the risk of developing thyroid cancer in a 40-year-old woman getting a mammogram is 6 in a billion.[3] This is similar to the amount of radiation your thyroid would get by standing outside for 30 minutes. Even if you got mammograms every year from the ages of 40 to 80, your risk of developing thyroid cancer would still only be 1 in 17.8 million, so there’s really no need to use a thyroid shield. In fact, using a thyroid shield during a mammogram makes the image blurry and more difficult for the radiologist to read. And, the thyroid shield can slip out of place and get in the way of the x-ray image, making a repeat exam (potentially exposing you to more radiation!) necessary.[4]

So, if mammograms don’t increase the risk of thyroid cancer, why are women three times as likely as men to be diagnosed with this cancer? Unfortunately, researchers have not yet found the answer to this question. Some believe that it could be related to better detection, and others think it could be a combination of diet, genetics, and the environment.[5]

Other Forms of Imaging

While CT scans of the head and neck are not as common as mammograms or dental x-rays, these can produce a lot of scattered radiation that can be absorbed by the thyroid. Studies have shown that wearing a thyroid shield during CT scans of the head and neck significantly limits radiation exposure to the thyroid gland.[6,7]

What You Need to Know to Keep You and Your Family Safe

  • Wear a thyroid guard during dental x-rays and CT scans.
  • You do not need to wear a thyroid guard during your mammogram. Continue regular mammography as recommended based on your breast cancer risk and age. Click here to learn about the latest mammography guidelines.
  • Try to keep x-rays of all kinds to a minimum, especially in children. Make sure that a scan (x-ray, CT, etc.) is being done only when needed, and that repeat exams are not done more frequently than absolutely necessary. Request that medical records and images be sent to all of the doctors treating you so that they don’t ask you to undergo scans that have already been done.

References:

  1. Schonfeld SJ. Lee C. Berrington de Gonzalez A. “Medical Exposure to Radiation and Thyroid Cancer.” Clinical Oncology 2011; 23:244-250.
  2. “Patient Safety: Radiation Exposure in X-ray and CT Examinations.” RadiologyInfo.org. Accessed April 23, 2012. Available at: http://www.radiologyinfo.org/en/pdf/sfty_xray.pdf.
  3. Sechopoulos I, Hendrick RE. “Mammography and the Risk of Thyroid Cancer.” AJR 2012; 198:705-707.
  4. Kopans DB. “Mammograms and thyroid cancer: The facts about breast-cancer screening” Accessed April 20, 2012. Found at: http://www.massgeneral.org/imaging/about/newsarticle.aspx?id=2720.
  5. Chen AY, Jemal A, Ward EM. “Increasing Incidence of Differentiated Thyroid Cancer in the United States, 1988-2005.” Cancer 2009; 115(16): 3801-3807.
  6. Williams L, Adams C. “Computed tomography of the head: An experimental study to investigate the effectiveness of lead shielding during three scanning protocols.” Radiography 2006; 12: 143-152.
  7. Lee YH, Park E, Cho PK, et.al. “Comparative Analysis of Radiation Dose and Image Quality Between Thyroid Shielding and Unshielding During CT Examination of the Neck.” AJR 2011; 196:611-615.

Red Meat: The News is Not Good

Langan Denhard, Cancer Prevention and Treatment Fund

Americans love red meat, but a March 2012 study of over 170,000 men and women may change that. The study found that eating just one 3-ounce portion a day of pork, beef, or lamb may significantly increase your risk of dying early.[1] And, unfortunately, a 3-ounce portion is much smaller than a typical American portion – it is about the size of a bar of soap. A double quarter pounder would be almost 3 day’s worth of meat,

The research team, led by doctors An Pan and Frank Hu of Harvard University, tracked a group of 51,529 male health professionals and 121,700 female nurses for over 20 years, beginning in the 1980s. Men and women with a history of cardiovascular disease or cancer were excluded from the study. Every four years, the researchers sent the participants detailed surveys asking them about their dietary habits. The researcher kept track of deaths and determined the cause of death. By the end of the study in 2008, 23,926 of the participants had died, 5,910 of them due to cardiovascular disease and 9,464 due to cancer.

The participants were analyzed by comparing 5 groups that were designated according to their daily consumption of red meat. The group that consumed the lowest amount of meat—Group 1—ate on average a quarter serving of red meat a day, or about 2 standard-size servings (3 ounces) weekly. Group 3, the group in the middle, ate about one standard-size serving of red meat per day. Group 5, with the highest level of consumption, ate on average 2 servings a day—or 14 servings of red meat each week.

The people who ate the most red meat were also the people least likely to exercise regularly, mostly likely to smoke and drink, and had the highest body mass index—an index which uses height and weight to calculate if you are overweight.But by controlling for age, body mass index, level of physical activity, smoking status, and family history, the researchers were able to determine to what degree red meat alone played a role in people’s death. They found that the men who belonged to the one serving a day group—Group 3—were 20% more likely to have died in the course of the study than were the men in Group 1 who only ate a quarter serving every day. Meanwhile, the “hard core” red meat eaters in Group 5 were 37% more likely to have died than Group 1.

Eating larger or more servings of meat did not affect women as dramatically as it did men. Women in the moderate meat-eating group (Group 3) were 11% more likely to have died than women in Group 1, whereas Group 5 women were 24% more likely to have died than women in Group 1.

Combining the data for men and women, the researchers were able to evaluate the dangers of eating unprocessed and processed red meat: an additional serving per day of unprocessed red meat increased the risk of dying early by 13%. An additional serving per day of processed red meat (such as 2 slices of bacon, 1 hot dog, or 1 slice of lunch meat), increased the chances of dying prematurely by 20%.

A one-serving-per-day increase of unprocessed red meat increased the risk of dying from cardiovascular disease by 18%, and it increases the risk of dying from cancer by 10%. And if the red meat is processed, your risk of dying from cardiovascular disease goes up by 21% and your risk of dying from cancer by 16%.

The researchers determined that 9.3% of deaths in male participants and 7.6% in females would have been prevented had they limited themselves to an average of one half serving of red meat per day (1.5 ounces.)

If by this point you’re considering cutting down on red meat, you may be wondering what to eat instead. The research team used substitution analysis to determine how much people could lower their risk of premature death by eating one serving per day of fish, poultry, nuts, legumes, low-fat dairy products, or whole grains instead of a daily serving of red meat. They found that for each serving consumed in place of one serving of red meat daily, the risk of premature death decreased as follows: 7% for fish, 14% for poultry, 19% for nuts, 10% for legumes, 10% for dairy, and 14% for whole grains.[1] It is impossible to know why fish was not as beneficial as the other alternatives, but perhaps it is because the most popular fish meals in the U.S. tend to be tuna salad or fried fish, both of which have high fat content.

How Worried Should I Be?

This study does not confirm a “cause and effect” relationship between red meat consumption and premature death. All it shows is that when meat-eating goes up, death is more likely. This study relied on food records that were updated by the participants once every four years, and while this is standard for a study of this immense size, it isn’t always that reliable. Try remembering how and what you ate four years ago!

Although meat is a popular protein source, it is not the healthiest. Red meat tends to be higher in saturated fat, which raises cholesterol in the blood. High cholesterol levels can result in cardiovascular disease. While processed and unprocessed read meats are both high in saturated fat, the high sodium content of processed red meat makes it even more harmful. When the body gets more sodium than the kidneys can handle or can be excreted through urine, sodium begins to build up in the bloodstream. This makes it harder to pump blood through blood vessels, which increases the pressure on the arteries. Americans consume about 3400 mg of sodium day, on average—much more than the USDA’s recommended limit of 2300 mg a day. Processed red meats generally have four times the amount of sodium and 50% more preservatives than unprocessed red meats.[2] You can read more about the differences between processed and unprocessed red meats here.

This study suggested a higher rate in cancer deaths among red meat eaters; however, the connection remains vague and poorly understood. It is not known why red meat could cause cancer, or whether it is only certain types, but studies indicate that people who eat a lot of red meat—regardless of whether it’s grilled (charred) or not—are at higher risk for various cancers, including colon,[3] breast,[4] and prostate cancer.[5]

Cutting Back on Red Meat

Giving up meat entirely would be tough for many, but the mounting evidence against regular meat consumption is hard to ignore. Try eating chicken or fish (but not fried!) as your protein source, rather than hamburgers, pork chops, or deli meats. Dr. Frank Hu, the lead author of the study, suggests eating unprocessed red meats no more than 3 times a week—that’s nine ounces of beef, lamb or pork over seven days. Bacon, hot dogs, bologna and other processed meats, although tasty, should only be eaten occasionally—at a baseball game or picnic.

Remember that a healthy diet combined with regular physical activity is the best way to improve the quality and length of your life! Check out our 10 easy steps to get your family eating healthy!

References:

  1. An, Pan, Qi Sun, Adam M. Bernstein, Matthias B. Schulze, JoAnn E. Manson, Meir J. Stampfer, Walter C. Willett, and Frank B. Hu. “Red Meat Consumption and Mortality.” Archives of Internal Medicine (2012). Web. 15 Mar. 2012.
  2. Cole, Megan. “Are Processed Meats More Dangerous than Other Red Meats? Yes and No!” Center for Research. National Research Center for Women and Families. Web. 3. Apr. 2012.
  3. Biger, Noy; France De Bravo, Brandel. “Colon Cancer: Who is at Risk and How Can it Be Prevented?” Stop Cancer Fund. Cancer Prevention and Treatment Fund. Web. 3, April. 2012.
  4. “Does Red Meat Cause Breast Cancer?” Center For Research. National Research Center for Women and Families.December 2006.Web.3, April 2012.
  5. Porte-Antoine, Stephanie; France De Bravo, Brandel. “Prostate Cancer: Diet and Dietary Supplements.” Stop Cancer Fund. Cancer Prevention and Treatment Fund. August 2009. Web. 3, Apr. 2012.

Surgery after Lumpectomy: Is it Possible to get All the Cancer out on the First Try?

Amrita Ford, MA, Cancer Prevention and Treatment Fund

Lumpectomy, or partial mastectomy, is the most common surgery for invasive breast cancer.[1]   It is performed in 60-75% of new breast cancer cases each year and has been in use for 30 years. Also called breast-conserving surgery, lumpectomy removes the cancerous tumor while preserving as much of the breast as possible.[2]  In an attempt to preserve the size of the breast, however, a doctor may accidentally leave behind a small amount of cancer. That’s why almost one in every four lumpectomies is followed by additional surgery, according to a February 2012 study published in the Journal of the American Medical Association.[1]

These repeat surgeries (also known as re-excisions) include women with ductal carcinoma in situ (DCIS), an early noninvasive form of breast cancer that if left untreated can develop into invasive breast cancer.

Experts believe that some women are having additional operations they may not need and others are missing out on surgery that could help prevent a recurrence of breast cancer.

During a lumpectomy, surgeons remove the cancer, along with some surrounding normal breast tissue. They then send the surgically removed tumor and surrounding rim of healthy tissue to a pathology lab. A pathologist will examine the tumor and breast tissue under a microscope, and if no cancer cells are found near the edges of the healthy tissue, it is called a clear margin.[2]

However, surgeons differ widely in their interpretation of the pathology results and disagree on how big of a margin there should be between the cancer and the healthy tissue. This results in re-operation rates for individual surgeons that range from 0 to 70%.[1] Some surgeons consider a lumpectomy successful as long as there is a clear margin between the cancer and normal tissue. Other surgeons prefer a wider margin, sometimes up to 5-10 millimeters, and if there is less, they will operate again. Differences in surgical training or a surgeon’s confidence in removing tumors may explain why surgeons treat margin sizes so differently and why there is a lack of standardization. Rates of repeat surgery also vary from one hospital to another, ranging from 1.7% to 20.9%. That means the number of surgeries a patient will undergo depends in part on her surgeon and the hospital where she receives treatment. The variation between hospitals may be explained by differences in the operating technique of surgeons, or the way in which different pathology teams analyze tissue specimens.

In the study, almost half of the repeat surgeries were done in women with clear but less than 1 millimeter margins, indicating that the surgeries may not have been necessary.[1]
Additional surgeries can be emotionally and physically taxing for patients, as well as an added financial burden. Many women who have repeat surgery subsequently undergo total mastectomy (removal of the entire breast), so the decision to operate again is a significant one. For patients who had a clear margin between tumor cells and healthy tissue, the factors that influenced the decision to operate again were the particular hospital, an unknown cancer diagnosis prior to initial surgery (versus a preoperative diagnosis like invasive ductal carcinoma, for example), and tumor size (very small and very large tumors were more likely to be re-operated).

On the other hand, 14% of patients in the study without clear margins did not undergo an additional surgery, despite being at an increased risk for breast cancer recurrence later on.1 Patients who had evidence of cancer left behind were more likely to be operated on again if their final diagnosis (based on the pathology report after the first surgery) was lobular cancer or if cancer cells were found in their blood or lymphatic vessels. Also, patients who had a lumpectomy based on an unknown cancer diagnosis were more likely to have additional surgery. Other factors may have played a role in the decision not to operate again, such as specific pathological features of the tumor, clinical characteristics of the breast cancer, and the patient’s wishes, but this study did not look at those factors.

The study suggests that whether breast cancer patients undergo repeat surgery following a lumpectomy depends not only on their clinical condition but also on their surgeon and where they receive treatment. While it suggests some patients are having too many surgeries, having a high rate of repeat surgery is not necessarily a bad thing and could mean a surgeon is especially diligent about removing all cancer cells. Similarly, a low re-operation rate could mean the surgeon usually performs lumpectomies correctly the first time, but it could also mean that he or she performs more mastectomies over lumpectomies initially or fails to provide additional surgery when it is needed. [3]

What Other Studies are Saying

The purpose of additional surgery following a lumpectomy is to reduce the chances of breast cancer recurrence or death from breast cancer. However, the long-term benefits of additional surgery are unclear. Some studies have shown that very small margins (less than 2 millimeters) between the cancerous area and healthy breast tissue lead to an increased risk of recurrence, so a second surgery would be a good idea. [4,5,6] A meta-analysis, which is a combined analysis of several different studies, concluded that wide margins of at least 10 millimeters are important for patients with ductal carcinoma in situ (DCIS) to lower the risk of recurrence.[7] However, other studies have found that larger margins (2 millimeters or greater) don’t reduce recurrence and are, therefore, usually unnecessary. [8,9] Even larger margins (5-10 millimeters) have not been conclusively linked to a reduction in breast cancer recurrence, especially if the patient undergoes radiation or other therapies following surgery to further decrease the chance of recurrence.

Meanwhile, other methods to reduce the number of repeat surgeries are being investigated. Physicians at the University of Michigan Comprehensive Cancer Center were able to reduce the number of repeat surgeries by having an on-site pathologist present in the operating room during lumpectomy surgeries. [10] The pathologist would examine the tumor and surrounding tissue immediately after their removal and give the results back to the waiting surgeon, who could at that point continue with additional surgery if necessary. Having an on-site pathologist reduced the percentage of patients requiring additional surgery from 25% to 11%. The on-site pathology lab, however, required a different approach for analyzing tumor and tissue samples called frozen section analysis. Frozen section allows samples to be analyzed in a short amount of time and involves freezing the specimen, cutting it, and staining it so it can be viewed under a microscope. The study found that frozen section analysis was just as accurate as traditional methods; however another study found it was slightly less accurate for analyzing the margins of patients with DCIS. [11] Although the approach increases surgical time for a lumpectomy and requires an investment from the medical center, both time and money will be saved in the long run if women are operated on fewer times.

The Bottom Line

There is no clear evidence whether a second surgery is a good thing for patients because it means the surgeon is being cautious, or a bad thing because women are undergoing two surgeries instead of one. Maybe surgeons could simply ask patients what they would prefer: Would they rather have more of their breast tissue, a bigger “lump,” removed during the first lumpectomy surgery in order to reduce the chance of a second operation, or would they prefer taking out as little breast tissue as possible (preserving the breast’s appearance more), knowing that if the margins aren’t clear, the surgeon will have to perform a second surgery? Judging from the available research, it seems likely that a woman will be more satisfied with the outcome of her lumpectomy if she has a say in whether to remove more or less breast tissue at the initial surgery.

References:

  1. McCahill LE, Single RM, Aiello Bowles EJ, et al. Variability in reexcision following breast conservation surgery. JAMA. 2012;307(5):467-475.
  2. Breast Lump Removal. http://www.nlm.nih.gov/medlineplus/ency/article/002918.htm. Accessed February 13, 2012.
  3. Morrow M, Katz SJ. The challenge of developing quality measures for breast cancer surgery. JAMA. 2012;307(5):509-510.
  4. Dillon MF, McDermott EW, O’Doherty A, Quinn CM, Hill AD, O’Higgins N. Factors affecting successful breast conservation for ductal carcinoma in situ. Ann Surg Oncol. 2007;14(5):1618-1628.
  5. Kunos C, Latson L, Overmoyer B, et al. Breast conservation surgery achieving >or=2mm tumor-free margins results in decreased local-regional recurrence rates. Breast J. 2006;12(1):28-36.
  6. Chan KC, Knox WF, Sinha G, et al. Extent of excision margin width required in breast conserving surgery for ductal carcinoma in situ. Cancer. 2001;91(1):9-16.
  7. Wang S-Y, et al. Network meta-analysis of margin threshold for women with ductal carcinoma in situ. J Natl Cancer Inst. 2012;507-516.
  8. Singletary SE. Surgical margins in patients with early-stage breast cancer treated with breast conservation therapy. Am J Surg. 2002;184(5):383-393.
  9. Houssami N, Macaskill P, Marinovich ML, et al. Meta-analysis of the impact of surgical margins on local recurrence in women with early-stage invasive breast cancer treated with breast-conserving therapy. Eur J Cancer. 2010;46(18):3219-3232.
  10. Sabel MS, et al. Development of an intraoperative pathology consultation service at a free-standing ambulatory surgical center: clinical and economic impact for patients undergoing breast cancer surgery. Am J Surg. 2011.
  11. Cendán JC, Coco D, Copeland EM 3rd. Accuracy of intraoperative frozen-section analysis of breast cancer lumpectomy-bed margins. J Am Coll Surg. 2005;201(2):194-198.

Consumer Reports: Unsafe Medical Devices

Consumer Reports: May, 2012

Most Medical Implants Have Never Been Tested for Safety

Tens of millions of Americans live with medical devices implanted in their bodies-artificial joints, heart defibrillators, surgical mesh. And it’s a safe bet that most of them assume that someone, somewhere, tested the devices for safety and effectiveness.

But that is rarely the case. For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue. Often, the only safety “testing” that occurs is in the bodies of unsuspecting patients-including two of the three people whose stories are told in this report.

As for the smaller number of high-risk products for which advance safety studies are required, government rules allow them to be sold based on studies that are smaller and less rigorous than those required for prescription drugs.

“Standards for devices exist, they just don’t make sense,” says Diana Zuckerman, Ph.D., a vocal critic of the current system and president of the National Research Center for Women & Families, a nonprofit advocacy organization.

To read the entire article, click here: http://www.consumerreports.org/cro/consumer-reports-magazine/May-2012/medical-devices.htm

2012 Foremother Awards & Health Policy Hero Luncheon

banner-cancer-prevention-fund

Cordially Invites You to Our

2012 Foremothers Awards and
Health Policy Hero Luncheon

Friday, May 11, 2012 at Noon
The Cosmos Club of Washington, D.C.
2121 Massachusetts Avenue, NW

Join us on May 11th, the Friday before Mother’s Day, at the elegant Cosmos Club of Washington, D.C. as we honor our 2012 Foremothers and Health Policy Hero.   The Foremother Awards are for lifetime achievement for Washington area women whose lives have touched adults and children across the country.Description: https://mail.google.com/mail/images/cleardot.gif

Katharine Weymouth, publisher of The Washington Post, will emcee.

  • Joan Claybrookis a nationally respected consumer advocate whose work has saved lives and improved public policies that affect all of us. She was president of Public Citizen from 1982 until 2009, fighting for safer cars, food, and medicines as well as campaign finance reform.
  • Dr. Beatrix Hamburgwas the first African-American to graduate from Vassar and the first African-American woman to graduate from Yale Medical School. She has dedicated her life to improving the lives of our nation’s children, as past president of the William T. Grant Foundation and as a faculty member and leader at the nation’s top medical schools.
  • Alice Rivlinwas the founding director of the Congressional Budget Office from 1975-1983, and the first woman Director of the White House Office of Management and Budget. She served as Vice Chair of the Federal Reserve Board, and has also been credited with saving the District of Columbia from financial disaster as chair of the DC Financial Management Assistance Authority from 1998-2001.

Linda Birnbaum, Director of NIH’s National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program, will be honored as our 2012 Health Policy Hero for her outstanding research on the health effects of environmental pollutants and chemicals. Thanks to her leadership, NIEHS is carrying out groundbreaking research, prevention, and intervention efforts that are making our homes and communities safer across the country.

Take advantage of this great opportunity to meet these four inspiring women, previous Foremother honorees, and many of D.C.’s other movers and shakers.  Help us honor the newest inductees into this special society for remarkable women.  Lunch is from noon to 1:30, preceded by a champagne reception for honorees and patron guests.

Donations must be made by April 15 to guarantee a seat.

Prices below are valid through April 15.

Regular lunch tickets are available for a donation of $90 per ticket.  A table for 10 is $850.

Patron Tickets ($150 per ticket) include a champagne reception with the current and former honorees just before lunch, priority seating, listing in the program, and free valet parking.

Corporate sponsorships are also available, from $1,000-$10,000.

The National Research Center for Women & Families is the leading national organization dedicated to improving the health and safety of all adults and children. Our goal is to prevent diseases and help families get the most effective medical treatments, regardless of the disease or illness.  Our Cancer Prevention and Treatment Fund focuses on reducing cancer risks in our homes and communities, educating adults and children about harmful cancer-causing exposures, and helping patients, with their doctors, make the best choices for their medical care.

 

Proceeds from the luncheon will support our Cancer Prevention and Treatment Fund, which has been designated as one of America’s best charities by the Independent Charities of America.

 

 

Please contact Emily Moore at em@center4research.org

or (202) 223-4000.

Payment: Please donate online here.

(Write “Foremothers Luncheon” in the comments box and be sure to provide contact information) or mail a check made payable to “Cancer Prevention and Treatment Fund” to 1001 Connecticut Ave, Suite 1100, Washington, DC 20036.