All posts by CPTFeditor

Faster Drug Approval: Winners and Losers

In the News, News Stories & Editorials
Kristen Fischer, HealthZette: June 28, 2016

By the time a drug is approved by the Federal Drug Administration, it’s been through extensive human clinical trials. There are so many obstacles to greenlighting any new medication or treatment, in fact, that it seems like it can take forever — with countless lives lost in the meantime.

Recently, due to calls for novel treatments that move faster from the (lab) bench to the bedside, a legislative effort is attempting to speed up that process. The 21st Century Cures Act would allow companies to submit evidence of safety based on patient stories instead of actual clinical trials.

The House already passed its own version; the Senate is expected to review it in the coming weeks, STAT reported.

While the measure could speed up the process, some people fear it would also remove a lot of quality control. And when it comes to health, it’s good to know that the medications you take have been tested extensively and are backed by reliable data.

Another concern is any new fast-track process would enable pharmaceutical companies, for the most part, to dictate the efficacy of a drug instead of the FDA as a third party. […]

In a Washington Post editorial, Susan F. Wood, an associate professor at George Washington University’s Milken Institute School of Public Health and a former FDA assistant commissioner, explained that the 21st Century Cures Act is based on an assumption that there will be more cures if drugs and devices are studied more quickly on fewer patients.

She, along with Diana Zuckerman, president of the National Center for Health Research, believes the studies would be too small to allow safety and effectiveness findings to be broken down into subgroups such as male and female.

“This embrace of smaller, more preliminary studies could drastically lower scientific standards. When fewer people are studied, it is more likely that a drug will seem safe and effective even if it has dangerous side effects for many patients — who may not have been included in those small studies,” they wrote. […]

To see original article, click here.

Women’s Health Bills Are Now in Committee

In the News, News Stories & Editorials, Uncategorized
Jay W. Bell Isle, Legal Reader: June 28, 2016

Three important pieces of legislation, one introduced last year and two introduced this month, could change the way certain women’s health issues are handled. These women’s health bills are now in Committee. The bills were introduced by Rep. Mike Fitzpatrick (R-PA), a long-time supporter of women’s health causes and champion of the move to reform the FDA’s broken processes for medical device approval.

The bill introduced last year is the E-Free Act, legislation that if passed, would strip Bayer of the FDA-issued Pre-Market Approval (PMA) status on its “permanent” birth control device, Essure. It would also force the product off the market. To date, tens of thousands of women have been harmed by this device, some irreparably so. However, the PMA status of the Essure device prevents injured women from suing except on a few points, such as negligent misrepresentation, negligent failure to warn, negligent training of doctors, negligent risk management and negligent manufacture. The E-Free Act would open the gates barring injured women from suing on several other counts, offering them full access to the justice system.

One of the bills introduced earlier in June also takes aim at the PMA protection, but not just for Essure. Despite being named for a victim of the Essure device, Ariel Grace’s Law would allow anyone harmed by a medical device with PMA protection to pursue legal action to address their injuries. […]

Rep. Fitzpatrick is not alone in his advocacy for change. Along with tens of thousands of injured women and their supporters, the recently introduced bills also have the support of Dr. Diana Zuckerman, president of the National Center for Health Research.

The NCHR, according to its website, “is a nonprofit, nonpartisan think tank focused on research that can improve the lives of adults and children. Throughout our country, there are programs and policies that have the potential to save lives and improve the quality of life for many adults and children. Unfortunately, these programs and policies do not always live up to their potential. The National Center for Health Research conducts and analyzes research that is then used to encourage new, more effective programs, policies, and medical treatments.”

In short, the NCHR is committed to finding ways to better address such issues as Essure and a broken FDA approval process. Dr. Zuckerman said, “We think both bills would be very important ways to protect patients from harmful devices.”[…]

To see original article, click here.

Could a Common and Inexpensive Heart Medicine (Beta-Blockers) Help Cancer Patients Live Longer?

Breast Cancer, General Treatment Issues, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
Jessica Cote, Cancer Prevention & Treatment Fund

Beta-blockers are drugs that are usually prescribed for high blood pressure (hypertension), irregularities in heart beat (arrhythmias), and to prevent heart attacks after a first heart attack has already occurred. Beta-blockers work by stopping adrenaline and noradrenaline from triggering the body’s “fight or flight” response to stress or danger.  Beta blockers help the body feel more relaxed, lowering blood pressure and increasing blood flow.

Beta-blockers are taken by so many Americans that they are the fifth most widely prescribed class of drugs.[1]  Since they are safe and inexpensive, wouldn’t it be great if they were effective for treating cancer, too?

Doctors and researchers noticed that when cancer patients took beta-blockers because of their heart disease, they tended to live longer than other cancer patients. They decided to study whether beta-blockers significantly improve survival for several different types of cancer.

How Beta-Blockers Affect Different Types of Cancer

Non-Small Cell Lung Cancer

In a study published in Annals of Oncology in 2013, Hong-Mei Wang and colleagues at the MD Anderson Center in Texas reviewed data from 722 patients with non-small cell lung cancer, the most common type of lung cancer.[2] All patients received radiation therapy to treat their lung cancer, but only some took beta-blockers for heart conditions. Almost all the patients in the study had stage III cancer.

The 155 patients taking beta-blockers survived for an average of almost 24 months while the 567 patients not taking beta-blockers survived for an average of about 18.5 months. In addition to living longer, patients taking beta-blockers lived longer without their lung cancer returning (disease-free survival) and without it spreading to other parts of their body (distant metastasis-free survival). The researchers statistically controlled for other factors that could affect survival, such as the patient’s age, the stage of the cancer, the use of aspirin, and use of chemotherapy, to be sure that the beta-blockers were truly helping slow down the cancer.

Breast Cancer

Six studies published since 2010 have examined how beta-blockers affected breast cancer patients who had been treated with beta blockers for heart disease at the same time they were treated for cancer.[3] All six studies found that breast cancer patients lived longer if they were taking beta-blockers.

A new clinical trial is currently underway to find out what happens to women who take beta-blockers specifically as a breast cancer treatment. However, the results are not yet available.

Ovarian Cancer

Elena Diaz and colleagues at Cedars-Sinai Medical Center published a study in 2012 of 248 women who were treated with surgery and chemotherapy for their ovarian cancer.[4] Twenty-three patients took beta-blockers for high blood pressure or other heart conditions during their cancer treatment. The results showed that women who took beta-blockers were more likely to remain free of ovarian cancer after treatment than women who didn’t take beta-blockers (progression-free survival) and less likely to die from ovarian cancer (disease-specific survival). Women taking beta-blocker lived an average of 56 months after cancer treatment while those not taking beta blocker lived an average of 48 months after treatment. In addition, women who took beta-blockers were 54% less likely to die during the more than 12 years that researchers tracked their health, compared to the women who did not take beta blockers.

Pancreatic Cancer

Hussein Al-Wadei and colleagues at the University of Tennessee published a study in 2009 that showed how beta-blockers were able to halt the progression of pancreatic cancer in animals.[5]  Research is needed to determine if beta-blockers is effective for pancreatic cancer in humans.

Why Might Beta-Blockers Help Cancer Patients?

Adrenaline and noradrenaline, the two neurotransmitters that stimulate the “fight or flight” response, probably trigger tumor growth. When beta-blockers halt the activity of these neurotransmitters, they may therefore help reduce the growth of cancerous tumors.

When the FDA makes a decision to approve a drug, it is always for specific symptoms or diseases, and the risks and benefits for that specific treatment is what the FDA considers. Although generally safe, beta-blockers can cause fatigue, headache, upset stomach, constipation, diarrhea, dizziness, cold hands, shortness of breath, and trouble sleeping.   For that reason, it is not a good idea to use beta-blockers to treat cancer unless there is clear evidence that they are likely to work — that the benefits outweigh those risks.  And, that is the reason that the breast cancer study that is now underway only includes beta blockers for 2 days before and 3 days after the cancer surgery.

In addition to being approved by the FDA to control blood pressure and heart disease, beta-blockers are also approved for preventing migraines, treating essential tremor (ET) in the head, arms and legs, and, as eye drops to treat glaucoma.  Doctors prescribe beta blockers for other reasons , but  taking medicines for non-approved uses can be risky. If a use is not approved, it often means that there is no conclusive evidence showing that the benefits outweigh the risks.  However, it sometimes means that the companies making the drug don’t think FDA approval for the new use will benefit the company financially.  The latter is especially true for drugs that are already on the market and inexpensive, such as beta-blockers.

The Bottom Line

  • Beta-blockers are usually used to treat heart conditions like high blood pressure and an irregular heart beat. New research has shown that these inexpensive drugs may help cancer patients live longer.
  • More research is needed to know which beta-blockers work best when added to cancer surgery, radiation, or chemotherapy, and for which cancers.
  • If you already take beta-blockers for a heart condition, they may provide keep taking them if you are also diagnosed with cancer. If you don’t take beta-blockers but are diagnosed with non-small cell lung cancer or early breast cancer, you may want to ask your doctor whether to take beta-blockers for two days before and three days after your cancer surgery.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. Consumer Reports, Best Buy Drugs: “Using Beta-blockers to treat: High Blood Pressure and Heart Disease.” Updated March 2011. https://www.consumerreports.org/health/resources/pdf/best-buy-drugs/CU-Betablockers-FIN060109.pdf
  2. Wang HM, Liao ZX, Komaki R et al. Improved survival outcomes with the incidental use of beta-blockers among patients with non-small-cell lung cancer treated with definitive radiation therapy. Annals of Oncology 2013.
  3. Barron TI, Sharp L, Visvanathan K. Beta-adrenergic blocking drugs in breast cancer: a perspective review. Therapeutic Advances in Medical Oncology 2012; 4(3):113-125.
  4. Diaz ES, Karlan BY, Andrew JL. Impact of beta blockers on epithelial ovarian cancer survival. Gynecologic Oncology 2012; 127(2):375-378.
  5. Al-Wadei HAN, Al-Wadei  MH, Schuller HM. Prevention of pancreatic cancer by the beta-blocker propranolol. Anticancer Drugs 2009; 20(6):477-482.

Should Women Undergo Mammograms? YES.

Breast Cancer
Diana Zuckerman, PhD, Brandel France de Bravo, MPH, Jae Hong Lee, MD, MPH, and Sophia Lee, Cancer Prevention & Treatment Fund

For several decades, women have been told that regularly scheduled mammograms for midlife women can help detect breast cancer early and save lives. However, there have been controversies; for example, two Danish scientists concluded in 2001 that using mammograms to screen for breast cancer did not save lives.[1][2] One of those scientists has continued to publish articles questioning the benefits of mammogram screening for breast cancer and arguing that women are not sufficiently warned about the negative effects of screening.[3][4][5][6][7][8] As a result of the media attention to those concerns, some women are wondering whether they should undergo regularly scheduled mammograms. While the Danish researchers have highlighted some important issues, we say the answer to “Should midlife women undergo mammograms?” is YES.

First, it is important to understand that mammograms serve two different purposes: Screening mammograms are the ones regularly scheduled (usually every year or two) regardless of whether there are any lumps or other symptoms. Diagnostic mammograms are the type that are scheduled specifically to learn more about any potential lumps or other signs or symptoms.

There is no controversy about diagnostic mammograms: Experts agree they are important. The controversy is about screening mammograms.

What evidence is there that mammograms save lives? Six large clinical studies performed by researchers over several decades, incorporating data from hundreds of thousands of women in three countries, have shown that using mammograms to screen for breast cancer helps to prevent deaths from breast cancer-with decreases in the number of breast cancer deaths ranging from 13% to 45%.[9][10]  Only one large study, performed in Canada, showed no difference in the number of breast cancer deaths with the use of mammograms.[11][12] Some scientists have criticized the design of the Canadian study because it compared mammography plus a physical examination by a doctor to physical examinations alone. This study design would tend to dilute the benefits of mammography since physical exams and mammograms will detect some of the same cancers.[13] However, numerous studies show that regularly scheduled mammograms help to catch breast cancer in earlier stages, when the chances of a cure are much better and when treatment might require less extensive surgery that conserves the breast.[14] That last point is important, because even if the Danish study were correct and mammograms do not save lives compared to physical exams, earlier detection combined with less extensive surgery would be a significant quality-of-life benefit.[15]

The bottom line is that either mammograms or physical exams will help detect breast cancer, but mammograms can detect much smaller, earlier cancers, and many women have mammograms more often than they would have physical exams. Overall, the research cited above indicates that the benefits of mammography generally outweigh the risks, as long as mammograms are performed in accordance with federal regulations (as outlined under the Mammography Quality Standards Act[16]). In 2021, FDA warned women that several mammography centers were found to have inaccurate results.[17][18]

What kind of a study did the Danish researchers conduct to come up with results so different from six out of seven clinical studies? For their 2001 study, Ole Olsen and Peter Gotzsche performed what is known as a meta-analysis. This type of study does not produce any new data, but instead reanalyzes previously published data-in this case, data from the seven large clinical studies already mentioned above. Meta-analyses have become increasingly popular, in part because they are inexpensive and relatively easy to perform: all that is needed are paper copies of previously published studies, a computer, and software. However, performing a meta-analysis also requires many subjective decisions by the scientists that can bias the results. For example, many researchers disagree with the decision by Olsen and Gotzsche to label certain studies “unreliable” because of small differences in average age between the groups of women receiving and not receiving mammograms.[19][20] Those researchers argue that differences of a few months in average age between patient groups are not relevant in judging the validity of a study. As you can see, it is very possible for two different teams of researchers performing a meta-analysis of the same data to reach completely different conclusions.

In a 2009 article, Gotzsche and his colleagues propose revising patient information materials about mammography screening to make the risks clearer to women.  Although he acknowledges that mammograms can save lives, he again emphasizes that it is “not clear whether screening does more good than harm” because mammography screening results in “overdiagnosis” and “overtreatment.”[21] False positives cause emotional distress and may result in additional unnecessary exposure to radiation. In addition, women with non-invasive breast conditions, such as Ductal Carcinoma in Situ (DCIS), may undergo medically unnecessary mastectomies. He concludes that instead of decreasing mastectomies, breast cancer screening with mammography leads to more mastectomies.

If six out of seven large-scale clinical studies show that mammography screening saves lives, could Gotzsche be correct that the risks outweigh the benefits? His articles have received a great deal of attention because he has worked with the prestigious Cochrane Collaboration and because the articles were published in two prestigious British medical journals: The Lancet and the British Medical Journal. Publication in such journals tends to lend weight to a scientific report, but that does not guarantee the quality or true importance of the work. In the case of the meta-analysis, some journalists could not critically evaluate the results from this type of study. Most journalists, including those who report on health issues, are not scientists and do not have extensive medical research experience. That may explain why the news media overemphasized the importance of the Danish meta-analysis, causing concerns among thousands of patients around the world.

How Overtreatment Affects the Risk to Benefit Ratio

Although the importance of the Danish meta-analysis may have been overemphasized, the authors did raise very important potential problems with breast cancer screening using mammograms: unnecessary biopsies or overaggressive treatment.[12] The use of mammograms to screen for breast cancer does result in more biopsies for lesions that look suspicious on mammograms but are not cancer. However, better training of radiologists and improved technology could reduce the number of unnecessary biopsies.[22] Overly aggressive treatment is a well-documented problem, and not only because of mammograms. Many breast cancer patients undergo mastectomies when they are eligible for less extensive breast-conserving surgery.[23][24][25] Women who have pre-cancerous conditions are often urged to have surgery even when experts believe “watchful waiting” or “active surveillance” is the more appropriate choice.[26][27] It is important for patients to carefully discuss diagnostic and treatment options with their physicians. A second opinion is always a wise option, especially if any type of surgery is recommended.

A final important issue is that at the same time that mammograms improve the chances of early diagnosis, they also expose women to radiation, which certainly can increase the risk of getting breast cancer. For example, the radiation from digital mammography screening is estimated to cause 2 to 11 deaths per 100,000 women. This estimate depends on factors like the woman’s age and how frequently she undergoes mammography.[28] For this reason, it makes sense to avoid unnecessary mammography, rather than assume that more mammograms are better than fewer. Women should not undergo mammograms more often than is necessary, and they should make sure that their exposure to radiation from mammography is as low as possible.

When considering whether the benefits of mammography outweigh the risks, it is important to weigh the risks and benefits of mammography as a technology separately from the risks of overtreatment. Overtreatment can be reduced if physicians are more cautious in their treatment recommendations and do a better job of communicating with their patients.

Should women younger than 50 and older than 75 get mammograms?  Every year or every 2 years?

The risks and benefits of mammography vary depending on a woman’s age.  In November 2009, the U.S. Preventative Services Task Force (Task Force) changed their recommendations for mammography.  The new recommendations raised the year of regular screening for most women from 40 to 50, and changed the frequency from every year to every two years through the age of 74. In 2019, the American College of Physicians also recommended screening mammography every 2 years for average-risk women between the ages of 50 and 74.[29]  For more information on the most recent mammography screening guidelines, click here.

Over the past decade, the recommendations for mammography screening have changed several times.   Prior to 2002, the Task Force screening mammograms recommendations were similar to current recommendations: women under 50 were not recommended for regular screening, because cancer is less common in that age group, and mammograms are less accurate for younger women because their breast tissue tends to be denser. Screening mammography was not recommended for women over 69 either, because the costs appeared to outweigh the benefits: older women tend to face many life-threatening illnesses other than breast cancer. A study funded by the National Institute of Health (NIH) followed Medicare patients for eight years to see if there was a difference in breast cancer mortality between women who underwent annual mammography screenings and those who did not. In women over the age of 75, researchers found that annual screenings did not make a statistically significant difference in the percentage of women dying of breast cancer.[30]

Consistent with these research results and the recommendations of the U.S. Preventive Services Task Force, the American College of Physicians also recommends that mammography should be discontinued in average-risk women aged 75 years or older, or in women with a life expectancy of 10 years or less.[30]

Between 2002 to 2009, the U.S. Preventive Services Task Force issued mammography screening recommendations that broadened the age range beyond women 50-69,[31] even though 50-69 is still the age group for which the evidence of benefits and reduced mortality is greatest. These guidelines recommended that women 40 and older undergo a mammogram every 1-2 years. The Task Force made this change based on evidence that screening women 40 and older could possibly reduce breast cancer deaths by 20-25% over a ten-year period; however, they also point out that on average, the risks and benefits of screening mammography between the ages of 40-49 are relatively even.

In 2009, the Task Force retracted these guidelines as further evidence revealed that screening mammograms before 50 has little benefit for most women, and may even be harmful.  At this point, there is a general consensus supporting regular screening with mammography for women 50 and older, but some debate still exists as to whether women 40 to 49 should routinely be screened. The associated risks of screening-false positives, unnecessary anxiety, biopsies, and exposure to radiation-outweigh the benefits for some women, but for others the risk of cancer is great enough to override those risks.  It is important to note that both the Task Force and the American College of Physicians acknowledge that certain women would benefit from earlier screenings (such as women who have a high risk for breast cancer).  Both groups encourage an individualized approach to determining whether a woman’s risk of cancer between the ages of 40-49 justifies regular mammograms.[31][32]

An alternative to mammograms is magnetic resonance imaging (MRI). Breast MRIs are, on average, more than 10 times as expensive as mammograms, but they are more accurate at detecting breast cancer in high risk women and do not expose patients to radiation. Research suggests that they may be an especially good option for young women who carry the BRCA1 or BRCA 2 gene mutation, which puts them at very high risk for breast cancer. For women under 35 years of age with BRCA1 or BRCA2, the harms of annual mammograms outweigh the benefits.[34] MRIs show great promise but because of the expense and high number of false positives, they are not likely to be used for regular screening anytime soon, except among those women at greatest risk. A 2012 study of women under 30 years old with BRCA1 and BRCA2 mutations showed that the radiation they were exposed to from early mammography increased their risk of breast cancer. Women with the most radiation exposure had the highest risk of breast cancer. This research indicates that young women who carry these genes should be screened using methods that don’t use radiation, including magnetic resonance imaging (MRI) techniques. According to a 2004 article in the Journal of the American Medical Association, “…MRI-based screening is likely to become the cornerstone of breast cancer surveillance for BRCA1 and BRCA2 mutation carriers, but it is necessary to demonstrate that this surveillance tool lowers breast cancer mortality before it can be recommended for general use.”[35]

The Danish study stirred controversy more than a decade ago and some experts continue to be highly critical of mammography screening, but scientific evidence still supports the use of mammograms every 2 years for women ages 50 and over. Similarly, there is widespread agreement that women younger than 50 who are at a higher risk of breast cancer because of gene mutations or other risk factors should be screened regularly, but the risk of mammography can be reduced for them by using screening devices with reduced radiation, or with MRIs.  We now know that women who are carriers of the BRCA genetic mutation are likely to be harmed more than helped by yearly mammograms starting at age 25-30, because the higher exposure to radiation over their lifetime increases their chance of getting radiation-induced breast cancer that they may not have gotten otherwise.[34]

For women between the ages of 40-49 who are not at high risk, the benefits and risks of mammogram screening are close to even, which is why there are differences of opinion among health care providers. On average, for women between 50 and 74, mammograms every other year contribute to early detection, which can translate into less aggressive treatment and fewer deaths from breast cancer.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. Gotzsche PC, Olsen O. Is screening for breast cancer with mammography justifiable?Lancet. Jan 8 2000;355(9198):129-134.
  2. Olsen O, Gotzsche PC. Cochrane Review on Screening for Breast Cancer with Mammography. Lancet. 2001;358:1340-1342.
  3. Jorgensen KJ, Gotzsche PC. Content of invitations to publicly funded screening mammography. BMJ 2006;332:538-41.
  4. Gotzsche PC, Hartling OJ, Nielsen M, Brodersen J, Jorgensen KJ. Breast screening: the facts-or maybe not. BMJ 2009;338:b86.
  5. Bjurstam N, Bjorneld L, Duffy SW, et al. The Gothenburg breast screening trial: first results on mortality, incidence, and mode of detection for women ages 39-49 years at randomization. Cancer. Dec 1 1997;80(11):2091-2099.
  6. Chu KC, Smart CR, Tarone RE. Analysis of breast cancer mortality and stage distribution by age for the Health Insurance Plan clinical trial. J Natl Cancer Inst. Sep 21 1988;80(14):1125-1132.
  7. Frisell J, Lidbrink E, Hellstrom L, Rutqvist LE. Followup after 11 years-update of mortality results in the Stockholm mammographic screening trial. Breast Cancer Res Treat. Sep 1997;45(3):263-270.
  8. Tabar L, Fagerberg G, Chen HH, et al. Efficacy of breast cancer screening by age. New results from the Swedish Two-County Trial. Cancer. May 15 1995;75(10):2507-2517.
  9. Andersson I, Janzon L. Reduced breast cancer mortality in women under age 50: updated results from the Malmo Mammographic Screening Program. J Natl Cancer Inst Monogr. 1997(22):63-67.
  10. Alexander FE, Anderson TJ, Brown HK, et al. 14 years of follow-up from the Edinburgh randomised trial of breast-cancer screening. Lancet. Jun 5 1999;353(9168):1903-1908.
  11. Miller AB, To T, Baines CJ, Wall C. The Canadian National Breast Screening Study: update on breast cancer mortality. J Natl Cancer Inst Monogr. 1997(22):37-41.
  12. Miller AB, Baines CJ, To T, Wall C. Canadian National Breast Screening Study: 1. Breast cancer detection and death rates among women aged 40 to 49 years. Cmaj. Nov 15 1992;147(10):1459-1476.
  13. Law M, Hackshaw A, Wald N. Screening mammography re-evaluated. Lancet. Feb 26 2000;355(9205):749-750; discussion 752.
  14. Solin LJ, Legorreta A, Schultz DJ, Zatz S, Goodman RL. The importance of mammographic screening relative to the treatment of women with carcinoma of the breast.Arch Intern Med. Apr 11 1994; 154(7): 745-752.
  15. Lee JH, Zuckerman D. Screening for breast cancer with mammography. Lancet. Dec 22-29 2001;358(9299):2164-2165.
  16. Monsees BS. The Mammography Quality Standards Act. An overview of the regulations and guidance. Radiol Clin North Am. Jul 2000;38(4):759-772.
  17. FDA. Mammography problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA safety communication. FDA.gov. https://www.fda.gov/medical-devices/safety-communications/mammography-problems-capitol-radiology-llc-doing-business-laurel-radiology-services-laurel-maryland?utm_medium=email&utm_source=govdelivery. May 20, 2021.
  18. FDA. Mammography problems at Advanced Women Imaging in Guttenberg, NJ. FDA.gov. https://www.fda.gov/medical-devices/safety-communications/mammography-problems-advanced-women-imaging-guttenberg-nj?utm_medium=email&utm_source=govdelivery. May 21, 2021.
  19. Duffy SW, Tabar L. Screening mammography re-evaluated. Lancet. Feb 26 2000;355(9205):747-748; discussion 752.
  20. Hayes C, Fitzpatrick P, Daly L, Buttimer J. Screening mammography re-evaluated.Lancet. Feb 26 2000;355(9205):749; discussion 752.
  21. Gøtzsche PC, Nielsen M. Screening for breast cancer with mammography. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD001877. DOI: 10.1002/14651858.CD001877.pub3.
  22. Lehman CD, Miller L, Rutter CM, Tsu V. Effect of training with the American College of Radiology breast imaging reporting and data system lexicon on mammographic interpretation skills in developing countries. Acad Radiol. Jul 2001;8(7):647-650.
  23. Zuckerman DM. The need to improve informed consent for breast cancer patients. J Am Med Womens Assoc. Fall 2000;55(5):285-289.
  24. Dolan JT, Granchi TS. Low rate of breast conservation surgery in large urban hospital serving the medically indigent. Am J Surg. Dec 1998;176(6):520-524.
  25. Kotwall CA, Covington DL, Rutledge R, Churchill MP, Meyer AA. Patient, hospital, and surgeon factors associated with breast conservation surgery. A statewide analysis in North Carolina. Ann Surg. Oct 1996;224(4):419-426; discussion 426-419.
  26. National Center for Policy Research for Women & Families. Improving Information About Treatment Options for Women with Stage Zero Breast Cancer. Proceedings of September 2003 National Meeting. http://www.center4research.org/pdf/dcis-lcis_10-04.pdf.
  27. Kerlikowske, K (2009). Epidemiology of Ductal Carcinoma in Situ [Abstract]. NIH State-of-the-Science Conference: Diagnosis and Management of Ductal Carcinoma in Situ (DCIS), September 22-24, 2009. Online version of conference abstracts available athttp://consensus.nih.gov/2009/dcis.htm.
  28. Nelson HD, Cantor A, Humphrey L, et al. Screening for Breast Cancer: A Systematic Review to Update the 2009 U.S. Preventive Services Task Force Recommendation. Rockville (MD): Agency for Healthcare Research and Quality (US); January 2016.
  29. Qaseem A, Lin JS, Mustafa RA, Horwitch CA, Wilt TJ; Clinical Guidelines Committee of the American College of Physicians. Screening for Breast Cancer in Average-Risk Women: A Guidance Statement From the American College of Physicians. Ann Intern Med. 2019 Apr 16;170(8):547-560. doi: 10.7326/M18-2147. Epub 2019 Apr 9. PMID: 30959525.
  30. 30. García-Albéniz X, Hernán MA, Logan RW, Price M, Armstrong K, Hsu J. Continuation of Annual Screening Mammography and Breast Cancer Mortality in Women Older Than 70 Years. Ann Intern Med. 2020;172(6):381-389. doi:10.7326/M18-1199
  31. Screening for breast cancer. Feb 2002. Agency for Healthcare Research and Quality Web site.
  32. Qaseem A, Snow V, Sherif, K, Aronson, M, Weiss KB, Owens DK, for the Clinical Assessment Subcommittee of the American College of Physicians. Screening Mammography for Women 40 to 49 Years of Age: A Clinical Practice Guideline from the American College of Physicians. Annals of Internal Medicine. April 2007;146 (7):511-515.
  33. U.S. Preventive Services Task Force, Screening for Breast Cancer: Recommendation Statement, http://www.ahrq.gov/clinic/uspstf09/breastcancer/brcanrs.htm#update.
  34. Berrington de Gonzalez A, Berg CD, Robson M, Visvanathan K. Estimated risk of radiation-induced breast cancer from mammographic screening for young BRCA mutation carriers. J Natl Cancer Inst. Feb 2009;101(3):205-209.
  35. Causer PA, Cutrara MR, DeBoer G, Hill KA, Jong RA, Meschino WS, Messner SJ, Narod SA, Piron CA, Plewes DB, Warner E, Yaffe MJ, Zubovits JT. Surveillance of BRCA1 and BRCA2 mutation carriers with magnetic resonance imaging, ultrasound, mammography, and clinical breast examination. JAMA,2004; 292(11):1317-1325.

 

DCIS, LCIS, Pre-Cancer and Other “Stage Zero”; Breast Conditions: What Kind of Treatment – If Any – Is Needed?

Breast Cancer, Breast Cancer
Susan Dudley, PhD and Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

Thanks to the widespread use of screening mammography, many women are being diagnosed with breast cancer.  However, that has also resulted in what some experts consider an epidemic of women diagnosed with abnormal breast conditions that are not cancer or may never develop into invasive cancer. Some of these conditions are not at all dangerous, and others have survival rates near 99%; nevertheless, these diagnoses often sound very frightening. In fact, research shows that these women are often just as worried about whether they will survive as women with the much more dangerous, invasive forms of breast cancer.

There is a wide range of treatment for women with these “stage zero” conditions. Although mastectomies are almost never necessary or recommended by experts, many women undergo mastectomies nevertheless. Research suggests that this is especially likely in the South, Midwest, and Southwest parts of the United States, in certain types of medical facilities, and with older doctors.

Knowing the Facts Will Reduce the Fear

It can be extremely upsetting for a woman to learn that she has any condition that increases her breast cancer risk. Too often, such news leaves women feeling that they must rush into surgery. They agree to – or even insist upon – undergoing mastectomies that they do not really need, in hopes that it will increase their chances of survival. In fact, their chances of survival are already very high, and having a mastectomy will not make it higher.

The good news is that most women with “pre-cancerous” conditions or other non-cancerous breast conditions will never get invasive breast cancer. For example, only 1 in 12 breast lumps is cancerous, and 1 in 5 cases of micro-calcification (white spots seen on mammograms that alert doctors that follow-up diagnosis is needed) are related to cancer, so most women get good news after a breast biopsy. For many women, however, anxiety levels soar when they learn that they might possibly be at risk for breast cancer because of abnormal changes in their breasts.

This issue brief will describe two conditions that are often referred to as “stage zero breast cancer” as well as other non-cancerous abnormal breast conditions.

Ductal Carcinoma In Situ (DCIS)

In recent years, ductal carcinoma in situ (DCIS) has become one of the most commonly diagnosed breast conditions. It is often referred to as “stage zero breast cancer” or a “pre-cancer.” It is a non-invasive breast condition that is usually diagnosed on a mammogram when it is so small that it has not formed a lump. In DCIS, some of the cells lining the ducts (the parts of the breast that secrete milk) have developed abnormally, but the abnormality has not spread to other breast cells. DCIS is not painful or dangerous, but it sometimes develops into breast cancer in the future if it is not treated, and that breast cancer can spread and is therefore dangerous. That is why surgical removal of the abnormal cells, followed by radiation, is usually recommended.

What makes most cancers dangerous is that they are invasive, which means they are not restricted to one spot, but have spread to other cells within the organ where they arose. Once that happens, cancer can metastasize, which means that it spreads to other organs in the body.  Experts disagree on whether DCIS should be called “cancer” or “pre-cancer” but everyone agrees that it is not an invasive type of cancer and that DCIS cannot metastasize unless it first develops into invasive cancer.

The goal of treating invasive cancer while it is still confined to the breast is to prevent it from spreading to the lungs, bones, brain, or other parts of the body, where it can be fatal. Since DCIS is not an invasive cancer, it is even less of a threat than Stage 1 or Stage 2 breast cancer, which are the earliest types of invasive cancer.

Having DCIS means that a woman has an increased risk for developing invasive breast cancer in the future, unless she has treatment. Most women with DCIS will never develop invasive cancer whether they are treated or not, but it is impossible to predict which women with DCIS will develop cancer and which ones won’t.  That’s why treatment is recommended.  A woman with DCIS does not need all the same treatment as a woman diagnosed with invasive breast cancer, but she does need surgery to remove the DCIS, and radiation to ensure that any stray, abnormal cells are destroyed. This lowers the risk that the DCIS will recur or that invasive breast cancer will develop.  Some women also try hormone therapy such as tamoxifen or aromatase inhibitors to reduce their risk even further.

DCIS does not need to be treated immediately. A woman can spend a few weeks after her diagnosis to talk with her doctors, learn the facts about her treatment choices, and think about what is important to her before she chooses which kind of treatment to have.

For more information about DCIS, see our booklet.

Treatment Choices for DCIS

DCIS patients have three surgery choices. They are 1) lumpectomy 2) mastectomy or 3) mastectomy with breast reconstruction surgery. Most women with DCIS can choose lumpectomy.

Lumpectomy means that the surgeon removes only the cancer and some normal tissue around it. This kind of surgery keeps a woman’s breast intact – looking a lot like it did before surgery. Under most circumstances, mastectomy does not increase survival time for women with DCIS, and would only be considered under unusual circumstances, such as cases where the breast is very small or the area of DCIS is very large. For women who undergo mastectomy, reconstruction can replace the breast lost to cancer. However, there is some evidence that women with DCIS who undergo mastectomy do not live as long as those who undergo lumpectomy.

Radiation therapy is often recommended for many women with DCIS after lumpectomy. This type of treatment could prevent more DCIS or invasive cancer from developing in the same breast. However, DCIS patients who choose lumpectomy live just as long whether they undergo radiation or not. DCIS patients who undergo a single mastectomy or double mastectomy do not live any longer than DCIS patients who undergo lumpectomy.

Tamoxifen or another hormonal therapy is recommended for some women with DCIS to help prevent breast cancer. The benefit is that it can further decrease the risk of recurrence of DCIS or the development of invasive breast cancer. In the last few years, tamoxifen is sometimes recommended instead of surgery. However, these hormonal medicines can have potentially dangerous side effects, such as increased risk of endometrial cancer, severe circulatory problems, or stroke. In addition, hot flashes, vaginal dryness, abnormal vaginal bleeding, and a possibility of premature menopause are common for women who were not yet menopausal when they started treatment.

Active surveillance is gaining attention as an option for women with DCIS.  Active surveillance consists of regular mammography screening to make sure the DCIS does not develop into breast cancer.[1]

Unlike women with invasive breast cancer, women with DCIS do not usually undergo chemotherapy and they usually do not need to have their lymph nodes tested or removed. Since most DCIS will never become cancer, you should consider getting a second opinion if a doctor recommends either chemotherapy or lymph node removal for DCIS.

Experts now believe that most women with DCIS will never develop invasive breast cancer even if they receive no treatment for DCIS. But, if a woman with DCIS is relatively young and healthy, she is likely to choose lumpectomy with or without radiation so that she can put fears of breast cancer behind her.

Lobular Carcinoma In Situ (LCIS)

Lobular carcinoma in situ (LCIS) is also sometimes referred to as stage zero breast cancer. But we shouldn’t let the words “carcinoma” or “cancer” scare women. LCIS got its name many years ago, before doctors realized that it is not breast cancer at all.

Unlike breast cancer, LCIS does not form a tumor. Unlike DCIS, it does not form abnormal cells that can develop into invasive cancer. That is why no surgery is needed to remove LCIS. Instead, LCIS is one of several conditions that may indicate an increased risk for a woman to develop breast cancer in the future. Even though most women who have LCIS never develop breast cancer, a woman with LCIS should talk to her physician to evaluate all her risk factors and to set up a plan to monitor her breast health, such as regular mammograms. This will ensure that any changes in her breast health can be detected and evaluated very early.

How Is LCIS Different from Breast Cancer?

In LCIS, some of the cells lining the lobules (the parts of the breast that can make milk) have developed abnormally. LCIS is not cancer. It does not cause pain or produce a lump. In fact, by itself, LCIS is not a dangerous condition.

How Does LCIS Affect Breast Cancer Risk?

There is no way for doctors to predict whether a woman with LCIS will develop breast cancer in the future. Most won’t, but if they do, it could be in either breast (not just the one where the LCIS was found) and in any part of the breast (not just in the area near where the LCIS was discovered).

What Is the Treatment for LCIS?

LCIS has no symptoms, and is first suspected because of an abnormal mammogram. A biopsy is needed to confirm the diagnosis. After a diagnosis is made, no more surgery or other treatment is needed, even if the affected area is large.

The abnormally developing cells that make up LCIS are often spread around in more than one location in the breast. It may even be in several areas and both breasts. If LCIS is diagnosed in one breast, it is not necessary to search for it or biopsy the second breast or to try to locate each area of affected lobules. That’s because no treatment is necessary regardless of the spread or location.

Women diagnosed with LCIS may question why no treatment is necessary, but experts agree that LCIS is a condition that should be managed rather than a disease to be treated. You can think of it like being overweight, which is a condition that puts a person at risk for heart disease but is not itself heart disease – and people who are overweight do not always develop heart disease.

Women with LCIS who are especially worried and want to “do something” can consider a low calorie or low-fat diet, as well as an increase in fresh fruits and vegetables to reduce their risk of future breast cancer. Although the research is not conclusive, those kinds of dietary changes may reduce the risk of breast cancer, and also have the potential to prevent other diseases. Hormonal therapy (with a drug such as tamoxifen) is also sometimes recommended to reduce the risk of future breast cancer, although it has the potentially dangerous side effects mentioned earlier, such as increasing the risk of stroke and endometrial cancer, and can cause unpleasant symptoms such as hot flashes and vaginal dryness. However, if a woman is very worried and does not feel comfortable without treatment, hormonal therapy is a less radical prevention method than bilateral mastectomies.

Other Non-Cancerous Breast Conditions

Many women who find lumps on their breasts do not have cancer, DCIS, or LCIS. Non-cancerous lumps can be cysts that are filled with fluid, or fibroadenomas, which are smooth, and hard, often feeling like a marble under the skin. Thickened but harmless areas called pseudo-lumps also fall into this category. Cysts are sometimes but not always drained, but otherwise, these conditions usually require no further treatment. Fibrocystic breasts (also called mammary dysplasia, benign breast disease, or diffuse cystic mastopathy) feel bumpy or lumpy and sometimes painful. This condition used to be considered a pre-cancerous disease, but experts now realize that it is not a disease and does not increase the risk of breast cancer.

What About Mastectomy to Prevent Future Breast Cancer?

More than 20 years ago, when breast conditions like these were diagnosed, they were often treated with mastectomy, surgery which completely removes the affected breast. Sometimes a healthy second breast was also removed (prophylactic mastectomy), even when there was no sign of cancer or other abnormalities in the other breast.

Today, thanks to advances in scientists’ understanding of breast cancer and of these other conditions, along with the development of better diagnostic, surgical, and treatment techniques, mastectomy is often unnecessary. In fact, we now know that a less radical treatment (lumpectomy followed by radiation therapy for most DCIS or Stage 1 or Stage 2 cancers) or no treatment (for cysts, fibroadenomas, fibrocystic breasts, and LCIS) is just as effective.  The latest research indicates that women who undergo lumpectomy and radiation rather than mastectomy tend to live longer.[2] Except in unusual circumstances, mastectomy does not increase survival time for these conditions, and the risks of mastectomy usually outweigh any benefits.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

Related Content:
DCIS: Mostly good news
Vitamin D and breast cancer
BRCA1 and BRCA2 mutations: when your genes increase your cancer risk
Radiation Therapy for Ductal Carcinoma In Situ (DCIS)
Hormonal Therapy for Ductal Carcinoma In Situ (DCIS)

References

  1. Esserman L, “When Less is Better, but Physicians are Afraid not to Intervene.” Journal of the American Medical Association: Internal Medicine 2016 May 31; doi: 10.1001/jamainternmed.2016.2257
  2. Hwang ES, Lichtensztajn DY, Gomez SL, Fowble B, Clarke CA.Survival after lumpectomy and mastectomy for early stage invasive breast cancer: the effect of age and hormone receptor status. Cancer 2013 Apr 1;119(7):1402-11. doi: 10.1002/cncr.27795

Colon Cancer: Who Is at Risk, and How Can It Be Prevented?

Colon Cancer, Prevention
Noy Birger, Brandel France de Bravo, MPH, Alea Sabry, and Melissa Stoner,  Cancer Prevention & Treatment Fund

When cancer begins in the colon (large intestine) or rectum, it is called colorectal cancer or colon cancer.

 

In the early stages, this cancer begins with small polyps, which are shaped like little mushrooms growing on the wall of the colon. Polyps are very common, especially as people get older. Not all polyps develop into cancer, but all colorectal cancer begins with polyps. Certain kinds of polyps are more likely to lead to cancer than others, but the doctor can’t tell if a polyp is precancerous just by looking at it. This is why doctors prefer to remove and analyze any polyps found during screening. Polyps can be identified and removed by colonoscopy, in which a small camera on a flexible tube is inserted into the rectum.[1]

 

Despite the number of people diagnosed with colon cancer decreasing in recent years, it is still the third most common cancer for both men and women.[2][4] In recent years, there has been concern about the number of younger adults getting diagnosed, including some in their 20’s or 30’s. For people diagnosed at any age, the death rate can be reduced by the early detection of disease and by timely and appropriate treatment. Overall screening rates have increased for adults aged 50-75, but could be higher. Experts recently recommended lowering screening ages to start at 45, but screening for adults aged 45-49 remains low. [3][4]

 

A study published in February 2012 in New England Journal of Medicine found that patients who received colonoscopies and had noncancerous or pre-cancerous growths (polyps) removed, were half as likely to die from colon cancer than people in the general population who were not screened or used less effective screening methods. [5]

 

Men and women are equally likely to die from colon cancer, but men are more likely to be diagnosed with colon cancer than women of the same age.[6][7]. Non-Hispanic American Indian and Alaska Native men and women are at a higher risk for developing colorectal cancer. Black men and Black women continue to have a higher risk of dying from colorectal cancer compared to white men and white women of the same age.[8][9][10] Being overweight or obese increases men’s risk of colon cancer more than it does women’s (see Weight and Cancer: What You Should Know).

 

Risk Factors for Developing Colon Cancer

In addition to your sex and race, your age and genes are important risk factors you can’t do anything about. Your chances of developing colon cancer increase as you get older: 80% of cases are in people 55 and over.[10] Having a family member be diagnosed with colon cancer also slightly increases your chances of developing it, especially if they developed colorectal cancer at an earlier age. [11]

 

In addition to people with pre-cancerous polyps, people who suffer from ulcerative colitis or Crohn’s disease are more likely to develop colon cancer.[12] Ulcerative colitis and Crohn’s disease cause inflammation of the colon, which is why they are both also referred to as Inflammatory Bowel Disease (IBD). Chronic inflammation in the body seems to increase the risk of various types of cancer.

 

Less is known about what you can do to prevent colon cancer. People who eat too much fat in their diet or too little fiber or too little calcium, smoke, drink alcohol, don’t exercise enough, or are overweight are more likely to be diagnosed with colon cancer. However, scientists do not know whether people can lower their risks of getting colon cancer if they change one or more of those behaviors. Several recent meta analyses suggest that high-fiber diets can help prevent colorectal cancer. [13][14][15] Of course, there is very clear evidence that calcium, exercising, maintaining a healthy weight, and avoiding smoking and alcohol is generally good for your health, whether it reduces your chances of colorectal cancer or not.   

So, What Can You Do to Lower Your Risk?
  • Get screened regularly from age 45 to 75.[16] If you have a relative with colon cancer, your doctor may want to screen you earlier than age 40. The recommended screening tests are:
  • High Sensitivity Fecal Occult Blood Test (FOBT), which involves providing stool samples and should be done once every year
  • Colonoscopy (mentioned above) requires emptying out your colon using powerful laxatives that require being near a toilet for many hours. Most people consider this the worst part of a colonoscopy, although it is also an invasive procedure requiring anesthesia. If polyps are found, the doctor can remove them during the procedure. It is only needed every 10 years, or every 5 years if a close relative developed colon cancer.
  • Flexible sigmoidoscopy is similar to a colonoscopy. It can be used to find polyps but not to remove them. It is recommended every 5 years
  • Cologuard — A non-invasive multitarget stool DNA test designed to detect DNA mutations and methylations that can show the presence of cancer. However, its low specificity causes false-positive results, resulting in many unnecessary colonoscopies.[17]
  • CT Colonography (virtual colonoscopy) is less invasive than a traditional colonoscopy because it uses x-ray images of your colon and rectum. However, the preparation for a virtual colonoscopy is like that of a traditional colonoscopy, which involves the powerful laxatives described above. If abnormal growths or polyps are detected during a virtual colonoscopy, the patient will need to undergo a standard colonoscopy to remove them. Sometimes a virtual colonoscopy scan will find abnormalities outside of your colon. Additional screenings and expenses may be necessary to determine if those abnormalities are a potential health issue. [18] [19] As with any CT scan, a virtual colonoscopy exposes you to relatively high levels of radiation (see Everything You Ever Wanted to Know about Radiation and cancer, But Were Afraid to Ask).

 

Each screening method has pros and cons. A regular colonoscopy (not a virtual one) has the advantage of allowing doctors to remove polyps right away during the screening procedure. The downside of both types of colonoscopy is that you need to take a day off from work, fast for about 12 hours, and purge with large quantities of an unpleasant laxative drink or pills taken with lots of liquid. The Fecal Occult Blood Test is easier and less expensive, and like the CT colonography scan, it can detect potential problems or polyps. But, if anything unusual is found, you would still need a colonoscopy to have polyps removed. [20]

  • Quit smoking. Cigarette smoking doubles your chances of getting polyps and long-term smoking increases the risk of colon cancer. It also increases your chances of dying from colon cancer.[21][22][23]
  • Maintain a healthy weight. Extra pounds mean extra risk for all kinds of cancer, including colorectal cancer. Fat cells appear to trigger chronic inflammation of the body, which stresses the immune system.[24]
  • Do more physical exercise. Research suggests that moderate physical activity, like walking, gardening, or swimming, can help lower your risk of some cancers, including colorectal cancer. [25] [26] [27]. Current guidelines state that adults who want to stay healthy should be getting at least 150 minutes of moderate-intensity aerobic physical activity a week. [27] 
  • Eat a balanced diet. Be sure to include plenty of fruits and vegetables (especially ones from the cabbage family, like broccoli, cauliflower, cabbage, Brussels sprouts, and collard greens), and limit the amount of red meat you eat (particularly well-done). This strategy may lower your chances of developing cancer, and it definitely can help people live longer. So, why not try it? [28][29]
  • Fiber in your diet. High fiber diets can also reduce your likelihood of getting colorectal cancer. Fiber in your diet helps protect your colon by interfering with the processes that start cancer, balancing the gut microbiome, and providing a good source of antioxidants. [30][31]
  • Get more Vitamin D. While the U.S. Preventive Services Task Force doesn’t currently recommend the use of multivitamin supplements to prevent cancer, some studies suggest that low vitamin D levels may increase the chances of developing colorectal cancer, especially for women. [32] Since vitamin D has many health benefits (see more here), you should discuss vitamin D levels with your doctor if you are concerned about colon cancer, and especially if you are likely to have inadequate vitamin D.[33] This can include older individuals, people with dark skin, and those with limited access to sunlight [25].
  • Low-dose aspirin. Experts no longer recommend the use of low-dose aspirin to prevent colorectal cancer. Whether taking low-dose aspirin could help you to prevent cardiovascular disease depends on your medical history and should be discussed with your doctor. [34]
  • Avoid taking unnecessary antibiotics. Overusing antibiotics may increase your chances of colorectal cancer by disrupting the balance of healthy gut bacteria, but more research is needed to study the long-term effects of antibiotics on gut health.[35] Only take antibiotics when your physician agrees that it is necessary.

All articles on our website are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

 

References:

  1. Basic Information About Colorectal Cancer. Centers for Disease Control and Prevention. https://www.cdc.gov/colorectal-cancer/about/index.html.
  2. American Cancer Society. Key Statistics for Colorectal Cancer. https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html. January 12, 2021.
  3. Zauber AG. The impact of screening on colorectal cancer mortality and incidence: Has it really made a difference? Digestive Diseases and Sciences. 2015;60(3):681-691. doi:10.1007/s10620-015-3600-5
  4. Star J, Siegel RL, Minihan AK, Smith RA, Jemal A, Bandi P. Colorectal cancer screening test exposure patterns in US adults 45 to 49 years of age, 2019-2021. JNCI Journal of the National Cancer Institute. 2024;116(4):613-617. doi:10.1093/jnci/djae003
  5. Zauber AG, Winawer SJ, O’Brien M.J, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, et al. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. New  EnglandJournal of Medicine. 2012;366(8), 687-696.
  6. Fuchs CS, Giovannucci EL, Colditz GA, et al. Dietary Fiber and the Risk of Colorectal Cancer and Adenoma in Women. New England Journal of Medicine. 1999; 340:169-176.
  7. Jemal A, Siegal R, Ward E, Hoa Y, Xu J, Thun MJ. Cancer Statistics 2009.  CA:A Cancer Journal for Clinicians.. 2009;59:225-249.
  8. USCS Data visualizations. CDC. https://gis.cdc.gov/Cancer/USCS/#/Demographics/
  9. Carethers JM. Racial and ethnic disparities in colorectal cancer incidence and mortality. Advances in Cancer Research. Published online January 1, 2021:197-229. doi:10.1016/bs.acr.2021.02.007
  10. American Cancer Society. Colorectal Cancer Facts & Figures 2023-2025.; 2023.https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2023.pdf
  11. Colorectal cancer risk factors | Hereditary colorectal risk factors. American Cancer Society. https://www.cancer.org/cancer/types/colon-rectal-cancer/causes-risks-prevention/risk-factors.html
  12. Jia Q, Lupton JR, Smith R, Weeks BR, Callaway E, Davidson LA, et al. Reduced Colitis-Associated Colon Cancer in Fat-1 (n-3 Fatty Acid Desaturase) Transgenic Mice. Cancer Research. 2008; 68: (10).
  13. Arayici ME, Mert-Ozupek N, Yalcin F, Basbinar Y, Ellidokuz H. Soluble and Insoluble Dietary Fiber Consumption and Colorectal Cancer Risk: A Systematic Review and Meta-Analysis. Nutrition and Cancer. 2021;74(7):2412-2425. doi:10.1080/01635581.2021.2008990
  14. Gianfredi V, Salvatori T, Villarini M, Moretti M, Nucci D, Realdon S. Is dietary fibre truly protective against colon cancer? A systematic review and meta-analysis. International Journal of Food Sciences and Nutrition. 2018;69(8):904-915. doi:10.1080/09637486.2018.1446917
  15. Arayici ME, Basbinar Y, Ellidokuz H. High and low dietary fiber consumption and cancer risk: a comprehensive umbrella review with meta-meta-analysis involving meta-analyses of observational epidemiological studies. Critical Reviews in Food Science and Nutrition. Published online December 28, 2023:1-14. doi:10.1080/10408398.2023.2298772
  16. Davidson KW, Barry MJ, Mangione CM, et al. Screening for colorectal cancer. JAMA. 2021;325(19):1965. doi:10.1001/jama.2021.6238
  17. Clebak KT, Nickolich S, Mendez-Miller M, Penn State Health Milton S. Hershey Medical Center. Multitarget stool DNA testing (Cologuard) for colorectal cancer screening. American Family Physician. 2022;105(2):198-199.https://www.aafp.org/pubs/afp/issues/2022/0200/p198.pdf
  18. Halligan S, Wooldrage K, Dadswell E, et al. Identification of extracolonic pathologies by computed tomographic colonography in colorectal cancer symptomatic patients. Gastroenterology. 2015;149(1):89-101.e5. doi:10.1053/j.gastro.2015.03.011
  19. Screening tests to detect colorectal cancer and polyps. Cancer.gov. Published October 29, 2024. https://www.cancer.gov/types/colorectal/screening-fact-sheet
  20. Edwards BK, Ward E, Kohler BA, Eheman C, Zauber AG, Anderson RN, Jemal A, Schymura MJ, Lansdorp-Vogelaar I, Seeff LC, van Ballegooijen M, Goede SL, Ries LA. Annual report to the nation on the status of cancer, 1975-2006, featuring colorectal cancer trends and impact of interventions (risk factors, screening, and treatment) to reduce future rates.Cancer 2010;116(3):544-573.
  21. Botteri E, Iodice S, Raimondi D, Maisonneuve P, Lowenfels AB. Smoking and Adenomatous Polyps: a Meta-analysis. Gastroenterology. 2008;134(2):388-395.e3
  22. Hannan LM, Jacobds EJ, Thun MJ. The association between cigarette smoking and risk of colorectal cancer in a large prospective cohort from the United States. Cancer Epidemiology, Biomarkers & Prevention.2009;18(12):3362-3367.
  23. Botteri E, Iodice S, Bagnard V, Raimondi S, Lowenfels AB, Maisonneuve P. Smoking and colorectal cancer: a meta-analysis. Journal of American Medical Association.2008;300(23):2765-2778.
  24. American Institute for Cancer Research. Researchers present data linking obesity/overweight to higher cancer risk, poorer cancer survival. November 2009. www.aicr.org.
  25. Orange ST. What is the optimal type and dose of physical activity for colorectal cancer prevention? Best Practice & Research Clinical Gastroenterology. 2023;66:101841. doi:10.1016/j.bpg.2023.101841
  26. Amirsasan R, Akbarzadeh M, Akbarzadeh S. Exercise and colorectal cancer: prevention and molecular mechanisms. Cancer Cell International. 2022;22(1). doi:10.1186/s12935-022-02670-3
  27. Current guidelines | odphp.health.gov.https://odphp.health.gov/our-work/nutrition-physical-activity/physical-activity-guidelines/current-guidelines
  28. Cotterchio M, Boucher BA, Manno M, Gallinger S, Okey AB, Harper PA. Red meat intake, doneness, polymorphisms in genes that encode carcinogen-metabolizing enzymes, and colorectal cancer risk.Cancer Epidemiology, Biomarkers & Prevention. 2008;17:3098-3107.
  29. Cheng J, Ogawa K, Kuriki K, Yokoyama Y, Kamiya T, Seno K. Increased intake of n-3 polyunsaturated fatty acids elevates the level of apoptosis in the normal sigmoid colon of patients polypectomized for adenomas/tumors. Cancer Letters, Volume 193, Issue 1,10 April 2003; 1: 17-24
  30. Hu J, Wang J, Li Y, Xue K, Kan J. Use of dietary fibers in reducing the risk of several cancer types: an umbrella review. Nutrients. 2023;15(11):2545. doi:10.3390/nu15112545
  31. Celiberto F, Aloisio A, Girardi B, et al. Fibres and colorectal cancer: clinical and molecular evidence. International Journal of Molecular Sciences. 2023;24(17):13501. doi:10.3390/ijms241713501
  32. McCullough ML, Zoltick ES, Weinstein SJ, et al. Circulating vitamin D and colorectal Cancer risk: an international pooling project of 17 cohorts. JNCI Journal of the National Cancer Institute. 2018;111(2):158-169. doi:10.1093/jnci/djy087
  33. “Dietary Supplement Fact Sheet: Vitamin D.” National Institutes of Health. Office of Dietary Supplements. https://ods.od.nih.gov/factsheets/VitaminD-Consumer/
  34. Vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer: Preventive medication. Published June 21, 2022. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/vitamin-supplementation-to-prevent-cvd-and-cancer-preventive-medication
  35. Bassett, M. Are Antibiotics Linked to Early-Onset Colorectal Cancer?. Medpage Today. July 2021. https://www.medpagetoday.com/meetingcoverage/additionalmeetings/93412?xid=nl_mpt_DHE_2021-07-05&eun=g1146420d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202021-07-05&utm_term=NL_Daily_DHE_dual-gmail-definition

Phthalates and Children’s Products

Environmental Exposures, Other Cancers, Prevention
Paul Brown, Keris Krenn Hrubec, Dana Casciotti, PhD, Brandel France de Bravo, MPH, Stephanie Fox-Rawlings, PhD, Cancer Prevention & Treatment Fund

Phthalates are synthetic chemicals found in every home, in plastic toys, personal care products such as shampoos and lotions, vinyl floors, and shower curtains. They are also found in some medical products, such as saline bags, feeding tubes and catheters. They are used to make plastic flexible and to add fragrances to soap and other personal products.  Unfortunately, these chemicals don’t stay inside the products. Based on recent research on ants, scientists have concluded that the high levels of phthalates in the bodies of insects around the world are the result of phthalates in the air.[1] Because phthalates are released into the air and dust around us, they are found in human urine, blood, and breast milk.[2] Levels are highest in women and children ages 6 to 11. Young children may have higher levels of phthalates in their bodies because their hands find their way into their mouths more frequently: they touch objects made with phthalates and surfaces covered with phthalate dust, and then their hands touch their mouths.

Phthalates are called “endocrine disruptors” because they affect the body’s hormones by mimicking them or blocking them. They interfere with the body’s natural levels of estrogen, testosterone, and other hormones, which is why they are called “disruptors.” Endocrine disruptors are hard to study for several reasons: 1) we are exposed to very small quantities from many different sources every day, 2) researchers have proved that, unlike other chemicals, these appear to have more serious effects at lower levels than at higher levels.[3] Usually, we assume that the higher the dose or exposure, the greater the harm, but endocrine disruptors play by different rules. The director of the National Institute of Environmental Health Sciences, Linda Birnbaum, says that chemical manufacturers are asking “old questions” when they test for safety even though “science has moved on.”[4]

Hormones can increase the risk of some cancers, whether those hormones are natural or synthetic. Too much or too little of a hormone can be harmful. Is a child who is exposed to phthalates more likely to develop cancer as an adult?  No one knows for sure but animals exposed to phthalates are more likely to develop liver cancer, kidney cancer, and male reproductive organ damage.[5]

Phthalates are believed to also affect girls’ hormones, but the health impact is not yet known. Studies also show associations between children’s exposure to phthalates and the risk of asthma, allergies and bronchial obstruction.[6][7][8]

Researchers at Mount Sinai also found a link between obesity and phthalates.[9] They found that among overweight girls ages 6 to 8, the higher the concentration of certain phthalates (including low molecular weight phthalates) in their urine, the higher their body mass index (BMI).  BMI takes height and weight into account when determining if someone is overweight. A study among Danish children ages 4 to 9 found that the higher the concentration of phthalates (all of them), the shorter the child. This was true for girls and boys.[10] More research is needed to determine the impact of phthalates on height and BMI.

Even short-term exposure has now been linked to developmental deficits.[11] Researchers found that children in intensive care units were exposed to the phthalate DEHP through plastic tubing and catheters. The children had 18 times (!)  as much DEHP in their blood compared to children who had not spent time in the ICU. Four years later, the children who had been exposed to DEHP had more problems with attention and motor coordination. The researchers found that the DEHP caused these problems regardless of medical complications or treatments.

Prenatal Exposure to Phthalates

Childhood exposure to phthalates begins in the womb. Several studies that have tested phthalate levels in women in their third trimester of pregnancy have found health effects in the infants, toddlers, and older children of the mothers with the highest levels. There are many different types of phthalates. Most studies look at several types, and the effects tend to vary by type.  A 2011 study found that six-month-old boys whose mothers had the highest phthalate levels scored lower on brain and motor development tests.[12] The same effect was not true for female infants.

Research indicates that boys exposed to phthalates while in the womb may be more likely to develop smaller genitals and incomplete descent of the testicles.[13] Boys who are born with undescended testicles are 2-8 times more likely to develop testicular cancer later on than men born with both testicles descended[14] (their risk is lessened if they get corrective surgery before age 13.[15]). Studies by Harvard researchers have shown phthalates may alter human sperm DNA and semen quality.[16][17][18][19]

Columbia University researchers discovered that three-year olds with high prenatal exposure to two types of phthalates were more likely to have motor delays.[20] They also reported that three phthalates were linked to certain behavior problems in three-year olds, such as social withdrawal.  One phthalate in the study was linked to lower mental development in girls.

Other studies have also linked increased prenatal phthalate exposure to behavior problems. Researchers in Taiwan found an association with aggressive and disobedient behaviors in eight-year-olds of both sexes.[21][22] Similarly, researchers from Icahn School of Medicine at Mount Sinai found that higher levels of exposure to phthalates during gestation were associated with aggression, rule-breaking, and conduct problems for males only.[23]

Researchers at Mount Sinai School of Medicine studied the impact of prenatal exposure to “low molecular weight” phthalates—the kind often found in personal care products and the coatings of some medications—on the social behavior of children ages 7 to 9. Children who were exposed to higher levels of these phthalates, which include DEP and DBP, had worse scores for social learning, communication, and awareness.  This means they were less able to interpret social cues, use language to communicate, and engage in social interactions.[24]

What Is Being Done to Limit Children’s Exposure?

As of February, 2009, children’s toys and child care products sold in the U.S (such as teething rings and plastic books) cannot contain certain phthalates.  The ban on those phthalates is the result of a law passed in 2008, the Consumer Product Safety Improvement Act.  The law permanently bans certain kinds of phthalates (BBP, DBP and DEHP) from toys and child care products, and temporarily bans other phthalates (DIDP, DINP and DnOP) until a scientific board (the Chronic Hazard Advisory Panel) determines for the Consumer Product Safety Commission (CPSC) whether or not they are safe. In 2014 the Chronic Hazard Advisory Panel determined that stricter regulations were appropriate.[25] It stated that the permeant bans should remain on BBP, DBP and DEHP, and that DINP should be added to this list. Furthermore, because a large component of exposure to these chemicals comes from food and other products, it recommended increased regulation. The panel was less concerned about DIDP and DnOP, but recommended additional study. Finally, the panel recommended permanently banning DIBP, DPENP, DHEXP, and DCHP, and putting an interim ban on DIOP.

A few months before the 2008 bill passed, major retailers such as Wal-Mart, Target, and Babies “R” Us promised to remove or severely restrict children’s products containing phthalates by the end of 2008.[26] That provided added incentives for major companies making teething rings and other soft plastic products to stop using phthalates.

The ban in the U.S.followed similar bans in other countries.  In 2006, the European Union banned the use of 6 phthalates in toys that may be placed in the mouth by children younger than 3 years old.[27] The banned phthalates are DINP, DEHP, DBP, DIDP, DNOP, and BBzP.  Fourteen other countries, including Japan, Argentina, and Mexico, had also banned phthalates from children’s toys prior to the U.S.

Phthalate Exposure Continues

A 2014 study looking at data over a ten-year period (2001– 2010) found that exposures to some phthalates have declined while others have increased. Americans’ exposure to three substances permanently banned in toys and children’s products—DEHP, DBP and BBP—has declined. But exposure to other phthalates such as DiNP and DiBP, as measured in urine, has increased. The higher  levels of DiBP and other phthalates “suggest that manufacturers may be using them as substitutes for other phthalates even though the US EPA has expressed concern about their use.”[28] It is surprising that DiNP exposure has gone up since it was banned on an interim basis from children’s toys and children’s products.  Additionally, in 2013, California declared DiNP a carcinogen.[29]

Even with the ban on phthalates in children’s toys, children, and adults, too, continue to be exposed because these chemicals are in many products, including food packaging, pharmaceuticals, medical devices and tubing, soap, lotions, and shampoos.[30] Johnson & Johnson recently reformulated its baby shampoo to remove harmful chemicals,[31] and Proctor & Gamble has promised to eliminate the phthalate DEP from fragrances used in its products by the end of 2014.[32] DEP is used in personal care products  and “reductions in DEP exposures have been the most pronounced,” according to the 2014 study.[33] Ten years ago, more than a thousand companies pledged to remove “chemicals of concern from personal care products,” however, it is unclear how many have done so. The U.S. Food and Drug Administration (FDA) regulates many of these products, including baby shampoo and baby lotion.  If the FDA does not decide to ban phthalates from these products, legislation would be required to do so.

The U.S. Environmental Protection Agency (EPA) developed an “action plan” in 2010 for eight phthalates “because of their toxicity and the evidence of pervasive human and environmental exposure.” [34] The phthalates are being studied for health effects and for alternatives. The EPA developed two new rules for these chemicals. However, the rules were delayed and then withdrawn in 2013.[35] In 2014, seven of these phthalates were included in the Toxic Substances Control Act work plan, because of their potential for harm and the frequency of exposure.[36] The eighth phthalate (DnPP) was not included because it is no longer being used in new products. The chemicals on the work plan are to be assessed for additional study or regulation, but it is unclear when that assessment will occur.

While other government agencies are concerned about phthalates in specific products, the EPA’s job is to focus on the chemicals for use in any kind of product and establish safety standards for each phthalate.  A challenge for the EPA is to set safety standards that make sense given that people may be exposed to several phthalates from many different sources. Teenage girls, for instance, have been found to use up to 17 personal care products a day.[37] Setting safety standards for phthalates individually or for individual products without considering their interactions and cumulative effects could underestimate the real-world risks of phthalates to the health of children and adults.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. 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.
  2. 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.
  3. Vandenberg et al. (2012). Hormones and Endocrine Disrupting Chemicals: Low-dose Effects and Nonmonotonic Dose Responses. Endocrine Reviews.  First published ahead of print March 14, 2012 as doi:10.1210/er.2011-1050.
  4. Cone, Marla and Environmental Health News. Low Doses of Hormone-Like Chemicals May Have Big Effects. Scientific American.march 15, 2012. http://www.scientificamerican.com/article.cfm?id=low-doses-hormone-like-chemicals-may-have-big-effects.
  5. Vastag, B., (2001). CDC Unveils First Report on Toxins in People, JAMA 285(14): 1827-1828.
  6. 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.
  7. Kanazawa A, Kishi R (2009 May). Potential risk of indoor semivolatile organic compounds indoors to human health. Nippon Eiseigaku Zasshi, 64(3): 672-82.
  8. Hsu NY, Lee CC, Wang JY, et al. (2012). Predicted risk of childhood allergy, asthma, and reported symptoms using measured phthalate exposure in dust and urine. Indoor Air. 22(3): 189-99.
  9. Teitelbaum SL, Mervish N, L Moshier E, Vangeepuram N, Galvez MP, Calafat AM, Silva MJ, L Brenner B, Wolff MS. (2012, January).Associations between phthalate metabolite urinary concentrations and body size measures in New York City children. Environmental Research 112:186-193.
  10. Boas M, Frederiksen H, Feldt-Rasmussen U, Skakkebaek NE, Hegedus L, Hilsted L, et al. (2010). Childhood exposure to phthalates: associations with thyroid function, insulin-like growth factor I, and growth. Environmental Health Perspectives 118:1458-1464.
  11. Verstraete S, Vanhorebeek I, Covaci A, Güiza F, Malarvannan G, Jorens PG, Van den Berghe G. (2016). Circulating phthalates during critical illness in children are associated with long-term attention deficit: a study of a development and a validation cohort. Intensive Care Med 42(3):379-92.
  12. Yeni Kim Y, Eun-Hee Ha, Eui-Jung Kim, et al. (2011). Prenatal Exposure to Phthalates and Infant Development at Six Months: Prospective Mothers and Children’s Environmental Health (MOCEH) Study, Environmental Health Perspectives. 119(10): 1495-500.
  13. Main KM, Skakkebaek NE, Virtanen HE, Toppari J (2010). Genital anomalies in boys and the environment. Best Pract Res Clin Endocrinol Metab.Apr;24(2):279-89.
  14. Toppari J, Kaleva M. Maldescendus testis. Horm Res 1999;51:261-9.
  15. Pettersson A et al. (2007) Age at surgery for undescended testis and risk of testicular cancer. New England Journal of Medicine 356:1835-41.
  16. Duty, S. M., M. J. Silva, et al., (2003). Phthalate exposure and human semen parameters. Epidemiology 14(3): 269-77.
  17. 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.
  18. 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.
  19. Duty, S. M., A. M. Calafat, et al., (2005). Phthalate exposure and reproductive hormones in adult men. Hum Reprod 20(3): 604-10.
  20. Whyatt RM, Liu X, Rauh, VA, Calafat AM, Just AC, Hoepner L, Diaz D, et al. (2012). Maternal prenatal urinary phthalate metabolite concentrations and child mental, psychomotor and behavioral development at age three years.  Environmental Health Perspectives 120(2):290-5.
  21. Lien YJ, Ku HY, Su PH, Chen SJ, Chen HY, Liao PC, Chen WJ, & Want SL (2015). Prenatal Exposure to Phthalate Esters and Behavioral Syndromes in Children at 8 Years of Age: Taiwan Maternal and Infant Cohort Study. Environ Health Perspect 123(1): 95–100.
  22. Prenatal Phthalate Exposures and Neurobehavioral Development Scores in Boys and Girls at 6–10 Years of Age. Environ Health Perspect 122(5): 521–528.
  23. Kobrosly RW, Evans S, Miodovnik A, Barrett ES, Thurston SW, Calafat AM, & Swan SH (2014).
  24. Miodovnik A, Engel SM, Zhu C, et al. (2011). Endocrine disruptors and childhood social impairment.  Neurotoxicology Mar;32(2):261-7.
  25. CPSC. Chronic Hazard Advisory Panel on Phthalates and Phthalate Alternatives. 2014. http://www.cpsc.gov/PageFiles/169902/CHAP-REPORT-With-Appendices.pdf
  26. Pereira, J. and Stecklow, S. (2008, May). Wal-Mart Raises Bar on Toy-Safety Standards, The Wall Street Journal.
  27. Sathyanarayana S, Swan SH et al., (2008, February). Baby Care Products: Possible Sources of Infant Phthalate Exposure, Pediatrics, Vol. 121, No. 2.
  28. Zota AR, Calafat AM, & Woodruff TJ (Advance on-line publication January 15, 2014) Temporal Trends in Phthalate Exposures: Findings from the National Health and Nutrition Examination Survey, 2001-2010.
  29. Lee SM, (January 15, 2014). Banned chemicals replaced by worrisome ones, UCSF study shows. SFgate.com (San Francisco Chronicle).
  30. U.S. Food and Drug Administration (2008). Phthalates and Cosmetic Products. Retrieved November 4, 2009 at http://www.fda.gov/Cosmetics/ProductandIngredientSafety/SelectedCosmeticIngredients/ucm128250.htm
  31. Thomas K (January 17, 2014). The ‘No More Tears’ Shampoo, Now With No Formaldehyde. The New York Times. http://www.nytimes.com/2014/01/18/business/johnson-johnson-takes-first-step-in-removal-of-questionable-chemicals-from-products.html.
  32. Prcoter & Gamble Web site: What are Phthalates?  Accessed January 22, 2014. http://www.pg.com/en_US/sustainability/safety/ingredients/phthalates.shtml.
  33. Zota AR, Calafat AM, & Woodruff TJ (Advance on-line publication January 15, 2014) Temporal Trends in Phthalate Exposures: Findings from the National Health and Nutrition Examination Survey, 2001-2010.
  34. EPA. Phthalates Action Plan Summary. http://www.epa.gov/assessing-and-managing-chemicals-under-tsca/phthalates.
  35. Sheppard Kate (September 6, 2013). EPA Quietly Withdraws Two Proposed Chemical Safety Rules. Huffington Post. http://www.huffingtonpost.com/2013/09/06/epa-chemical-safety_n_3882262.html.
  36. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update. https://www.epa.gov/sites/production/files/2015-01/documents/tsca_work_plan_chemicals_2014_update-final.pdf
  37. Environmental Working Group. 2008. Sutton R. Adolescent exposures to cosmetic chemicals of concern. http://www.ewg.org/research/teen-girls-body-burden-hormone-altering-cosmetics-chemicals.

Why We Shouldn’t Trade a Weakened FDA for More Medical Research Funds

News Stories & Editorials
Ed Silverman, STAT: May 17, 2016

In a quest to bring new medical products to Americans, Congress is considering a grand bargain.

Legislation passed last year by the House would provide billions more dollars for medical research and encourage faster approval of prescription drugs and devices. The Senate is currently working on a set of companion bills in hopes of crafting a compromise measure.

“If we succeed, this will be the most important bill signed into law this year,” Senate health committee chairman Lamar Alexander, a Tennessee Republican, said at a committee meeting last month.

This sounds promising. After all, adding $9 billion to the National Institutes of Health’s budget over the next five years to underwrite new cures is a good idea. And in an era when desperately ill patients are clamoring for new medicines, giving the Food and Drug Administration extra tools also makes sense.

But there’s a catch. By linking the extra funds to speedier approvals, Congress appears ready to undermine regulatory standards. This is a misguided notion that, unfortunately, is more likely to help companies than patients. […]

“This is a harsh way of putting it, but this is why I call it the 19th Century Fraud Act,” said Harvard University political scientist Daniel Carpenter, who studies the FDA. “This is a part of the bill that threatens to take us back more than a century.”

The final details of the Senate bill remain uncertain, but some proposals are also prompting objections. As an example, one suggestion for speeding approvals of medical devices is to label certain products as “breakthroughs,” a designation that would offer an expedited review pathway. To qualify as a breakthrough, though, a company need only argue its product is either a significant advance over existing devices or is in the best interest of patients.

The use of the word “or” is problematic, because it creates wiggle room for unproven claims. “It’s very vague and only encourages companies to seek breakthrough status,” said Diana Zuckerman, who heads the National Center for Health Research, a nonprofit think tank. […]

There is no question that more research funding is necessary and that finding legitimate ways to get medicines to patients faster is crucial. But Congress ought to separate the debate over research funding from the rest of the legislation. Loosening regulatory standards would only create problems for which real cures will be needed.

Read the full article here.

Less Radical Surgery Is a Healthier Choice for Women with Breast Cancer

Breast Cancer, news-you-can-use,
Brandel France de Bravo, MPH and Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

Experts have long advised that lumpectomy patients live as long as mastectomy patients.  But the latest research, based on hundreds of thousands of women, indicates that women with DCIS or early-stage breast cancer are more likely to live longer, healthier lives if they choose less radical surgery. And their quality of life will also be better.

Five enormous studies indicate that lumpectomy patients live longer.

In a 2021 study of almost 49,000 Swedish women followed for 6 years after surgery for early-stage breast cancer, the women who underwent lumpectomy with radiation therapy lived longer on average than those who underwent mastectomy with or without radiation therapy. The benefit of lumpectomy was true when diagnosis, other medical problems, social class, and other demographic factors were statistically controlled. [1]

In a study of almost half a million women with breast cancer in one breast, Harvard cancer surgeon Dr Mehra Golshan reported in 2016 that those undergoing double mastectomies did not live longer than women undergoing a mastectomy in only one breast.[2] On average, women who underwent a lumpectomy instead of mastectomy lived longer than women undergoing either a single or double mastectomy for cancer in only one breast.

Similarly, a study of more than 37,000 women, also published in 2016, women with early-stage breast cancer who underwent lumpectomy with radiation were more likely to be alive 10 years later, compared to women who underwent mastectomies.[3] They were also less likely to have died of breast cancer or of other causes. This was true even when age and factors that could influence survival were taken into account.

Dr. Shelly Hwang and her colleagues found similar results in a 2013 study of more than 112,000 California women who had lumpectomies to remove their early-stage breast cancer were more likely to be alive and free of breast cancer 5 years after surgery than women who had mastectomies.[4] The women had been diagnosed between 1990 and 2004 with either Stage 1 or 2 breast cancer. All of them had either a lumpectomy with radiation or a mastectomy. After surgery, their health was monitored for an average of 9 years (the women were all studied for 5-14 years). The women who had a lumpectomy and radiation tended to live longer than the women who had mastectomies, when controlling for age at diagnosis, race, income, education levels, tumor grade or the number of lymph nodes with cancer. Lumpectomy with radiation was especially effective for women who were 50 years and older with hormone-receptor positive tumors: they were 19% less likely to die of any cause during the study than women just like them who had mastectomies. Perhaps more surprising, they were 13% less likely to die of breast cancer than women just like them who had mastectomies.

What about bilateral mastectomies rather than single mastectomies? In a study published in 2014, Dr Allison Kurian and her colleagues at Stanford studied 189,734 California patients diagnosed from 1998 to 2011 with early-stage breast cancer in one breast, ranging from Stage 0 (DCIS) to Stage 3.[5] The study showed that the percentage of women having both breasts when only one breast had cancer (called bilateral mastectomies) increased dramatically, but there was no advantage to that more radical approach.  Instead, the women who underwent lumpectomies (removing only the cancer, not the entire breast) lived longer and were more likely to be alive 10 years after diagnosis compared to women undergoing a mastectomy.  Women who had both breasts surgically removed did not live longer than those undergoing a mastectomy on one breast.

Compared to women in other countries, women in the U.S. who are diagnosed with early-stage breast cancer are more likely to remove both breasts even if only one has cancer. It is not known why bilateral mastectomy provides no medical advantage, but a study of more than 4,000 cancer patients by Dr. Fahima Osman at the University of Toronto indicates that having a healthy breast removed in addition to the breast with cancer increases the chances of medical complications.[7] Removing the healthy breast (“contralateral breast”) doubled the chances of having wound complications in the first month after surgery: from about 3% for women who had only the breast with cancer removed to about 6% for women who also had the healthy breast removed. About 4% of women who had a single mastectomy experienced some kind of complication (not necessarily wound-related) in the 30 days after surgery, compared to 8% of women who had both breasts removed. The risk of cancer in that healthy breast was already less than 1% per year unless the woman has a BRCA gene or some other very high risk factor.[7] Hormone therapy that blocks estrogen, such as aromatase inhibitors or other pills, can further reduce that already low risk.

Quality of Life

The above studies show that women undergoing lumpectomy live longer than those undergoing mastectomy.  But what about their quality of life?  A study of 560 young women with early-stage (stage 0-3) breast cancer published in JAMA Surgery in 2021, found that women who underwent lumpectomies had a better quality of life than women who underwent mastectomies, regardless of whether they had reconstructive surgery. The women were all 40 years old or younger when they were diagnosed, and their quality of life was evaluated an average of 5-6 years after surgery.  Women’s quality of life tended to be lowest for women who had undergone mastectomy with radiation therapy. [6]

Women who are diagnosed with breast cancer sometimes choose more radical treatments than they need in an effort to “do everything possible” to fight the cancer. It is important to know that research on hundreds of thousands of breast cancer patients who completed their treatment show that being physically active, eating healthy foods, and maintaining a healthy weight all are effective ways to help breast cancer patients live longer. [9]

The Bottom Line: These enormous studies of women in the U.S. and other countries make it clear that women with DCIS or early-stage breast cancer (stages 1-3) should undergo surgery to remove only the DCIS lesion or the cancer, not the entire breast. The women who undergo lumpectomy with radiation usually live longer than those who undergo single mastectomy or bilateral mastectomy, with or without radiation. The one study of young women with breast cancer found that although many undergo mastectomy with reconstruction, their quality of life would be better if they underwent lumpectomy instead. In addition, mastectomy patients who have breast implants are more likely to kill themselves compared to mastectomy patients without implants. Unfortunately, the fear of breast cancer and desire to “get rid of the problem” has resulted in too many women undergoing medically unnecessary mastectomies that do more harm than good. Physicians and breast cancer advocacy groups need to make sure that patients understand why lumpectomy with radiation is a better idea.

For a free booklet on treatment options for DCIS, click here.  For a free booklet on treatment options for early-stage breast cancer, click here.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References 

    1. de Boniface J, Szulkin R, Johansson ALV. Survival After Breast Conservation vs Mastectomy Adjusted for Comorbidity and Socioeconomic Status: A Swedish National 6-Year Follow-up of 48 986 Women. JAMA Surg. 2021;156(7):628–637. doi:10.1001/jamasurg.2021.1438
    2. Wong, S., Freedman, R., Sagara, Y., Aydogan, F., Barry, W., & Golshan, M. Growing Use of Contralateral Prophylactic Mastectomy Despite no Improvement in Long-term Survival for Invasive Breast Cancer. Annals of Surgery. 2016 March; doi:10.1097/SLA.0000000000001698
    3. Marissa C. van Maaren, et al, “10 year survival after breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer in the Netherlands: a population-based study”. Lancet Oncol. 2016 Aug; 17(8): 1158–1170. Published online 2016 Jun 22. doi: 10.1016/S1470-2045(16)30067-5
    4. Hwang ES, et al “Survival after lumpectomy and mastectomy for early stage invasive breast cancer: The effect of age and hormone receptor status” Cancer2013 April 1; 119(7); DOI: 10.1002/cncr.27795.
    5. Kurian, Allison W., Daphne Y. Lichtensztajn, Theresa H. M. Keegan, David O. Nelson, Christina A. Clarke, and Scarlett L. Gomez. “Use of and Mortality After Bilateral Mastectomy Compared With Other Surgical Treatments for Breast Cancer in California, 1998-2011.” The Journal of the American Medical Association2014; 312(9): 902-914. DOI:10.1001/jama.2014.10707
    6. Dominici L, Hu J, Zheng Y, et al. Association of Local Therapy With Quality-of-Life Outcomes in Young Women With Breast Cancer. JAMA Surg. Published online September 01, 2021. doi:10.1001/jamasurg.2021.3758
    7. Osman, Fahima, et al “Increased postoperative complications in bilateral mastectomy patients compared to unilateral mastectomy: an analysis of the NSQIP database.” 2013 Oct; 20(10): 3212–3217. Published online 2013 Jul 12. doi: 10.1245/s10434-013-3116-1
    8. National Cancer Institute. Breast Cancer Treatment (PDQ®). http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessional/page1
    9. Brooks, M (2022) “Lifestyle changes can reduce risk of death after breast cancer.” Medscape. https://www.medscape.com/viewarticle/983131?src=mkm_ret_221113_mscpmrk_BC_monthly&uac=140425SY&impID=4853207

Stomach Cancer and Diet: Can Certain Foods Increase Your Risk?

Diet, Habits, & Other Behaviors, Other Cancers, Prevention
Laura Gottschalk, PhD, Cancer Prevention & Treatment Fund

There is growing evidence that the foods we eat can increase the chances of developing certain types of cancer. A report by the World Cancer Research Fund International says that stomach cancer is one of them.

Stomach cancer is the fifth most common cancer worldwide and the third most common cause of death from cancer.[1] Older adults are more at risk to develop stomach cancer with most people in the U.S. being diagnosed over the age of 70.[2] Men are twice as likely to develop stomach cancer compared to women.[2]

You can’t control how old you are or whether you are a man or woman, but what you eat can either increase or decrease your chances of developing stomach cancer. The World Cancer Research Fund looked at all the scientific research that was available discussing diet, weight, physical activity, and the risk of stomach cancer.[3] After looking at 89 studies that examined nearly 77,000 cases of stomach cancer, the report concluded that each of the following can increase a person’s risk for developing stomach cancer.

  • Drinking three or more alcoholic drinks per day.
  • Eating foods preserved by salting, such as pickled vegetables and salted or dried fish, as traditionally prepared in East Asia.
  • Eating processed meats that have been preserved by smoking, curing or salting, or by the addition of preservatives. Examples: ham, bacon, pastrami, salami, hot dogs, and some sausages
  • Being overweight or obese, as measured by body mass index (BMI).

Based on their findings, the WCFR has made several recommendations to reduce your risk of stomach cancer:

  • Maintain a healthy weight
  • Be physically active
  • Eat a healthy diet that avoids processed meat and limits salt
  • Limit your alcohol consumption

These recommendations are good ones for preventing cancer in general, not just stomach cancer.

Still not convinced to give up your 6-packs, kimchi, and bacon just yet? This is just the latest of many studies showing that being overweight and eating processed meats increases your risk of cancer. And, previous research has also shown that drinking more alcohol increases your chances of developing cancer.[4] However, this is probably the most comprehensive study showing the link between a range of eating and drinking habits and stomach cancer.

In addition to what you eat, there are other aspects of your life that increase the risk of stomach cancer.

  • Smoking: It is estimated that 11% of stomach cancer cases are due to smoking.
  • Infection: A bacteria called pylori is known to cause chronic inflammation of the stomach which can lead to stomach cancer. Fortunately, food sanitation in developed countries dramatically cuts down on risk of infection.
  • Industrial chemicals: Exposure to dust and high-temperature environments in the workplace increases the risk of stomach cancer.

If you can’t reduce the risks of smoking, infection or industrial chemicals, changing your diet is the best option for reducing your chances of stomach cancer. Eating fresh vegetables and meats is better than preserved and processed ones. That doesn’t mean you should never eat another hot dog or slice of bacon, but it does mean trying to eat them only rarely. As with most things, moderation is key. Try and balance your diet:  don’t just decrease the amount of unhealthy foods you eat, but also increase the amount of healthy foods. Studies have shown that eating lots of fresh fruits and vegetables, especially citrus fruit,[5] may even reduce your chances of developing stomach cancer![3]

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. end Centers for Disease Control and Prevention. “Global Cancer Statistics.”  Department of Health and Human Services. 02 Feb. 2015. Accessed: 05/04/2016. http://www.cdc.gov/cancer/international/statistics.htm
  2. end National Cancer Institute. “What you need to know about stomach cancer.” NIH Publication No. 09-1554. Printed September 2009. Brochure.
  3. end World Cancer Research Fund International/American Institute for Cancer Research. Continuous “Update Project Report: Diet, Nutrition, Physical Activity and Stomach Cancer.” 2016. Available at: wcrf.org/stomach-cancer-2016.
  4. end IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. “Personal habits and indoor combustions. Volume 100 E. A review of human carcinogens. Exit Disclaimer.” IARC Monographs on the Evaluation of Carcinogenic Risks in Humans. 2012: 100(Pt E):373-472.
  5. end Bae JM, Lee EJ, et al. “Citrus fruit intake and stomach cancer risk: a quantitative systematic review.” Gastric Cancer. 2008;11(1):23-32.