All posts by CPTFeditor

Cancer of the Immune System (ALCL) and Breast Implants: Plastic Surgeons Study 173 Women

Other Cancers
Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

In 2015, plastic surgeons who have been well known for defending the safety of breast implants published a study of 173 women with cancer of the immune system caused by breast implants. [1]   The study was paid for by a plastic surgery medical association and written by plastic surgeons who have defended the safety of breast implants for decades.

ALCL (Anaplastic Large Cell Lymphoma) develops near a breast implant but is not breast cancer – it is a cancer of the immune system.  The authors of this study point out that the first silicone breast implant was implanted in 1962 and the first publicly reported case of ALCL in a woman with silicone breast implants was in 1997. The authors reviewed 37 medical articles reporting on 79 patients and collected information about an additional 94 women with ALCL caused by breast implants.

Results

Physicians first identified these 173 women with ALCL based on either seromas (a collection of fluid under the skin), a mass attached to the scar capsule surrounding the implant, a tumor that eroded through the skin, in a lymph node near the breast, or discovered during surgery to replace a breast implant. Whether the women had silicone gel or saline breast implants didn’t seem to make a difference, but many of the women had at least one textured breast implant.  Cosmetic augmentation patients and women who had breast implants to reconstruct their breasts after undergoing a mastectomy were both at risk of developing ALCL because of their implants.  Of the women whose ALCL spread outside of their scar capsule surrounding the implant, about half died from ALCL.

The authors pointed out that ALCL can be difficult to diagnose.  Although the fluid and scar capsule usually appear abnormal, they sometimes look normal. The authors recommend “that all fluid and capsule tissue from patients with seromas” should be tested for ALCL.  They point out that if the tumor is inside the capsule, removing both implants and the capsules may be the only treatment necessary.  However, if the tumor has developed just outside the capsule, chemotherapy with or without radiation is needed and usually effective.  Unfortunately, aggressive ALCL that has spread beyond the scar capsule area is usually fatal, regardless of treatment.

2017 Update

In March 2017, the U.S. Food and Drug Administration (FDA) reported that it had received 359 reports of ALCL among women with breast implants. Unfortunately, many cases of ALCL are not reported to the FDA.  The FDA’s announcement came after the World Health Organization (WHO) officially named the disease “breast implant associated ALCL (BIA-ALCL)” in 2016. In 2014, the National Comprehensive Cancer Network (NCCN) has also released a worldwide oncology standard for surgeons and oncologists to test for and diagnose the disease.

To read the official summary of this article, click here: http://www.ncbi.nlm.nih.gov/pubmed/25490535

To read about another study on ALCL, click here.

To read more about what you need to know about ALCL, click here.

Reference

  1.  Brody GS, Deapen D, Taylor CR, Pinter-Brown L, House-Lightner SR, Andersen JS, Carlson G, Lechner MG, Epstein AL. Anaplastic Large Cell Lymphoma Occurring in Women with Breast Implants: Analysis of 173 Cases. Plastic and Reconstructive Surgery. Vol 135: 695, 2015.

Breast Implants and Cancer of the Immune System (ALCL): A History of Who Knew What When

Other Cancers
Maura Duffy, Cancer Prevention & Treatment Fund

Experts now agree that breast implants can cause a type of cancer of the immune system.  The FDA finally admitted this risk of cancer in 2017, but other experts – including plastic surgeons — were aware of the risk years before.  Why did it take so long for FDA, the media, and women with implants to find out that choosing breast implants could increase their chances of developing a potentially fatal disease?

Anaplastic large cell lymphoma (ALCL) is a rare type of cancer of the immune system that usually develops in the lymph nodes, skin, lungs, or liver. However, ALCL sometimes develops in the breast area of women with breast implants.

In 2008 Dutch researchers published a report of 11 women with breast implants and ALCL, and concluded that the implants seemed to be associated with ALCL.[3]  Although published in the Journal of the American Medical Association (JAMA), this information was not widely reported.

The link between ALCL and breast implants was first reported by the FDA in January of 2011. In 2013, researchers at MD Anderson Cancer Center studied 60 women with breast implants who were diagnosed with ALCL in the breast. Since ALCL was thought to be diagnosed in only 1 woman in half a million, this was much higher than would be expected.[4]  In 2016, the World Health Organization (WHO) officially recognized BIA-ALCL.[5]  In 2017, the National Comprehensive Cancer Network (NCCN), a nonprofit network of cancer experts, released a worldwide oncology standard for surgeons and oncologists to test for and diagnose “breast implant associated ALCL (BIA-ALCL).” NCCN includes a guided algorithm for surgeons and oncologists to test for and diagnose the disease.  They concluded that any abnormal accumulation of fluid or a mass that develops near the breasts in women with breast implants must be evaluated.

And yet, it was not until March 2017 that the FDA finally updated its website to officially report that breast implants could cause ALCL. At the time of the FDA announcement, the agency reported that they had received 359 reports of ALCL among women with breast implants. Reports to the FDA of problems from medical devices are acknowledged to be the “tip of the iceberg” since surgeons frequently do not do these online reports.

How did women find out they had ALCL before the official announcement of BIA-ALCL was made? Most of them approached their doctors with symptoms such as pain, lumps, swelling, or asymmetry in their breasts years after getting implants.  Since breast implants are a “foreign body,” the body forms scar tissue around the implant to protect their body from this “foreign invader.”  The scar tissue surrounding the implant is known as the scar capsule. It is natural for the body to form scar tissue, and the scar tissue is only a problem if it tightens or hardens around the implants, causing pain and hardness known as “capsular contracture.”  Breast implant-associated ALCL is almost always found in the scar capsule surrounding the implant, not the breast tissue itself. It has been reported in women both with and without capsular contracture, as well as women with silicone gel or saline breast implants.[4]

ALCL is diagnosed by testing the fluid that collects around the implant, called a seroma.[5] Seroma is usually not caused by ALCL.  It is important to understand that even when ALCL is in the breast, it is not breast cancer, but rather a cancer of the immune system.  Most breast implant-associated ALCL has cancer cells within the fluid inside the scar capsule. That ALCL can be treated by removing the implant and the surrounding scar tissue. This surgery is known as a capsulectomy.

One study of nine women who had a capsulectomy after being diagnosed with BIA-ALCL found that all nine were disease free when they were studied 3.5 years later, and they did not require chemotherapy nor radiation treatment. However, some types of ALCL are more aggressive and need to be treated with chemotherapy or radiation. [6]

In December 2013, the study of 60 patients with breast implants and ALCL reported that the ALCL was more likely to be fatal for women who had a solid ALCL tumor than for women who had ALCL cancer cells in the surrounding fluid (known as effusion ALCL). All of the patients with effusion-type ALCL were still alive 5 years after their diagnosis, compared to only 75% of the patients with solid ALCL tumors. ALCL returned in only 14% of patients with effusion-type ALCL. Patients with solid ALCL tumors had a 50% recurrence rate.[7]

Longer studies with more patients are needed to determine if certain kinds of breast implants are more likely to cause ALCL.  Preliminary data indicate that most, but not all, women with BIA-ALCL had textured breast implants at some point.  Meanwhile, women with all types of implants should have routine follow-ups and should immediately see a doctor if one or both of their breasts become swollen.

For women with silicone implants, FDA recommends getting a breast coil MRI three years after getting the implants, and every two years after that.[8]

Although plastic surgeons and breast implant manufacturers admit that breast implants can cause ALCL, they claimed it was very rare.  For example, Allergan, a manufacturer of many different types of breast implants, claimed that “A woman is more likely to be struck by lightning than to get this condition.”[9]   However, 400 people are injured or killed by lightning every year,[10] which is why most people avoid situations where lightening can harm them.

In fact, the Australian version of the FDA now estimates that 1 in 1,000 women with breast implants will develop BIA-ALCL, [11] which is not nearly as rare as plastic surgeons and manufacturers have claimed.

Many women would not want to take the chance of developing cancer as a result of breast implants, and this is especially true for women who underwent mastectomies that were not medically necessary in an effort to reduce their chances of cancer returning.

It is also important to note that the link between breast implants and autoimmune diseases has been hotly debated for two decades, with many women reporting serious autoimmune symptoms that went away when their implants were removed.[11]  The scientific evidence regarding ALCL and implants once again raises questions about the possible impact of breast implants on autoimmune disease or symptoms such as joint pain, body pain, memory loss, and chronic fatigue.

For many years, women with breast implants were assured by implant companies, plastic surgeons, and the FDA that breast implants did not cause breast cancer or any other type of cancer. Evidence of a link to some types of cancer and to autoimmune diseases, including studies conducted by researchers at FDA and the National Cancer Institute, was dismissed. However, as everyone knows from data on lung cancer and smoking, it can take decades to determine if an exposure causes cancer or other serious diseases. Even a very strong carcinogen, such as tobacco, is very unlikely to cause lung cancer for at least 30 years.  For this reason, it is essential that physicians and researchers take a closer look at the link between breast implants and cancer of the immune system, as well as other immune disorders.

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

References

  1. Mazzucco, AE. Next Steps for Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol, 2014. Early release publication. June 16, 2014.
  2. S. Food and Drug Administration. 26 January 2011. Web. June 25, 2012, <http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm241090.htm>
  3. “Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses.” January 2011. Center for Devices and Radiological Health. U.S. Food and Drug Administration. Web. June 25, 2012, <http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm>
  4. “FDA Questions and Answers about Anaplastic Large Cell Lymphoma (ALCL).” U.S. Food and Drug Administration. 26 January 2011. Web. June 25, 2012, <http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm241086.htm>
  5. Kim B, Roth C, Young VL, Chung KC, van Busum K, et al. Anaplastic large cell lymphoma and breast implants: results from a structured expert consultation process. Plastic and Reconstructive Surgery. 2011 Sep;128(3):629-39.
  6. Aladily TN, Medeiros JL, Amin, MB, Haideri N, et al. Anaplastic Large Cell Lymphoma Associated with Breast Implants: A Report of 13 Cases. Am J Surg Pathol. 2012 June 36(6).
  7. end Miranda, et al. Breast Implant–Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients. J Clin Oncol. 9 December 2013.
  8. FDA Update on the Safety of Gel-Filled Breast Implants.” June 2011. Center for Devices and Radiological Health. U.S. Food and Drug Administration. Web. June 25, 2012, http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf target=”_blank”>http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf>
  9. Edwards, Jim. “Breast Implant Maker Challenges FDA on Cancer Link.” CBS Money Watch. 27 January 2011. Web. 25 June http://www.cbsnews.com/8301-505123_162-42847224/breast-implant-maker-challenges-fda-on-cancer-link/ target=”_blank”>http://www.cbsnews.com/8301-505123_162-42847224/breast-implant-maker-challenges-fda-on-cancer-link/
  10. Cooper, Mary Ann, MD. “Medical Aspects of Lightning.” National Weather Service. Web. 25 June 2012.http://www.lightningsafety.noaa.gov/medical.htm
  11. Mazzucco, Anna, Ph.D and Zuckerman, Diana, Ph.D. “ALCL and Breast Implants: 2017 Update.” Breast Implant Information. Web. March 14, 2017. <http://www.breastimplantinfo.org/implantalcl/>

NCHR Comments on CPSC Agenda and Priorities for FY2018-2019

Testimony & Briefings
Diana Zuckerman, PhD, National Center for Health Research: July 26, 2017

 

Diana Zuckerman, PhD, President of National Center for Health Research 
Comments on the U.S. Consumer Product Safety Commission 
Agenda and Priorities for FY2018/2019

The National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and health experts who analyze and review research on a range of health issues. Thank you for the opportunity to share our views concerning the Consumer Product Safety Commission’s (CPSC) priorities for fiscal year 2018 and 2019. We respect the essential role of the CPSC, as well as the challenges you face in selecting the most important priorities.

Two priorities that are clearly consistent with CPSC priorities are the safety of children’s products. We are very concerned about exposures to phthalates in children’s toys and other products as well as endocrine-disrupting chemicals and other safety concerns related to recycled tire crumb rubber and other artificial turf (including “poured in place” surfaces).

The CPSC has been a champion for children with its careful analysis of phthalates in toys and products for children under 3 years of age. As you know, products specifically for children under 3 are not the only ones that pose risks: we need to also be concerned about phthalates in many products used by pregnant women and children. Through dust and other means, phthalates migrate from many products into our environment and bodies. Phthalate metabolites are detectable in nearly all people in this room and in the U.S.[1] Many phthalates are endocrine disruptors that can have long-term effects on our health and children’s development, including their ability to learn.

Our Center was instrumental in shaping the law resulting in permanent and temporary bans on six phthalates in children’s toys and child care articles.[2] However, these bans need to be expanded. Over 2 years ago, CPSC proposed the rule “Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates” following the Chronic Hazard Advisory Panel (CHAP).[3][4] This rule is absolutely essential in providing additional protections for children.

We support the permanent bans on four additional phthalates (DIBP, DPENP, DHEXP, and DCHP) and making permanent the interim ban on DINP.[3] However, the CHAP report also recommended an interim ban on DIOP, which should also be included in the rule. We strongly disagree with the proposal to lift the interim bans on DNOP and DIDP. While they may not affect male hormones, they are associated with organ toxicity and altered development.

The CHAP report also recommended additional studies on three other phthalates (DMP, DPHP, and DEP) and six phthalate alternatives.[4] The final rule should include a timeline for the completion of these studies that reflects the potential damage these phthalates can cause.

It is also important for CPSC to expand its work on phthalates to include products that can cause prenatal exposures as well as those that can harm older children and other vulnerable adults. Phthalate exposure has been found to increase risk for early puberty and problems with reproduction.[5][6][7] This is especially important because a new meta-analysis of 185 studies shows that male sperm counts are less than half what they were just a generation ago.[8]  Phthalate exposure also affects pregnant and breastfeeding women and thus their children, which can affect brain and reproductive system.[4][9] Phthalates in household dust can be extremely harmful regardless of what products it comes from.

Artificial turf made with recycled tire crumb rubber and other products raises similar issues because it is widely used and can release chemicals that affect the health of children of all ages, pregnant women, and other adults. Artificial turf is currently used on more than 12,000 athletic fields and numerous playgrounds in the U.S. and most parents are unaware of the risks it poses.[10]

Scientific evidence suggests that crumb rubber, “poured in place” (PIP) rubber and other artificial turf pose potential safety hazards when used on playground and playing field surfaces. Rubber from recycled tires and even from “virgin tires” and “virgin rubber products” is not comprised only of rubber from a rubber plant.  Instead it includes phthalates, polycyclic aromatic hydrocarbons (PAHs), volatile organic compounds (VOCs), heavy metals, and other chemicals known or suspected to harm human health.[11][12][13][14] In addition to disrupting hormones, some PAHs may increase a person’s chance of developing cancer.[15][16] While one time or sporadic exposures are unlikely to cause long-term harm, repeated exposures over years, especially during critical developmental periods clearly raise the likelihood of harm.

Artificial turf made with crumb rubber and poured rubber products can also cause short-term harms. For example, crumb rubber generates dust which may exacerbate asthma for children.[17][18] These products heat up much more than ambient temperature, which can cause heat stress and burns.[19][20][21]
In addition, some studies have indicated increased risk for joint injuries and mild traumatic brain injury.[22][23] In other words, we can conclude that grass is a relatively safe alternative. We can’t say that of artificial turf, whether crumb rubber or other products.

As is often the case when researchers are paid by those with conflicts of interest, some studies suggest that the risk is minimal. However, the studies that are more reassuring do not comprehensively evaluate health risks from exposure to recycled tire crumb material. In addition, many studies of air quality pertaining to crumb rubber and similar products use stationary measures, while particulate matter becomes airborne during activity, so these measurements may not accurately reflect exposures during play activities.[24] Our conclusion from the research is that definitive studies of the harm caused by crumb rubber and other rubber products are difficult to conduct, but there are clear reasons to be concerned about children being harmed by them.

We are encouraged that the CPSC is working with other federal agencies to investigate the safety of crumb rubber on playgrounds and playing fields.[8][25][26]

However, we strongly urge you to broaden your investigation to include other synthetic rubber products and to provide warnings to families and athletes as soon as possible. The public has limited access to information about the chemicals that make up these products, which can affect our health and that of our children. All Americans rely on the CPSC to protect us and our children from unsafe products.

In summary, we strongly urge the CPSC to consider our views as it finalizes the proposed rule on phthalates in children’s toys and child care articles, and consider how these rules could be expanded to cover other products that expose children and adults to harmful substances.

References

  1. National Health and Nutrition Examination Survey (NHANES). (2016) Phthalates and Plasticizers Metabolites – Urine (PHTHTE_H); years of content 2013-2014. https://wwwn.cdc.gov/Nchs/Nhanes/2013-2014/PHTHTE_H.htm
  2. Federal Register. (2014) Consumer Product Safety Commission. Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates. Docket No. CPSC-2014-0033. http://www.gpo.gov/fdsys/pkg/FR-2014-12-30/pdf/2014-29967.pdf
  3. Federal Register. (2014) Consumer Product Safety Commission. Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates. Docket No. CPSC-2014-0033. http://www.gpo.gov/fdsys/pkg/FR-2014-12-30/pdf/2014-29967.pdf
  4. Consumer Product Safety Commission. (2014) Chronic Hazard Advisory Panel On Phthalates and Phthalate Alternatives.https://www.cpsc.gov/PageFiles/169876/CHAP-REPORT-FINAL.pdf
  5. Bourguignon JP, Juul A, Franssen D, Fudvoye J, Pinson A, Parent AS. (2016) Contribution of the Endocrine Perspective in the Evaluation of Endocrine Disrupting Chemical Effects: The Case Study of Pubertal Timing. Hormone Research in Paediatrics. 86(4):221-232.
  6. Wang YX, Zeng Q, Sun Y, Yang P, Wang P, Li J, Huang Z, You L, Huang YH, Wang C, Li YF, Lu WQ. (2016) Semen phthalate metabolites, semen quality parameters and serum reproductive hormones: A cross-sectional study in China. Environmental Pollution. 211:173-82.
  7. Hannon PR, Flaws JA. (2015) The effects of phthalates on the ovary. Frontiers in Endocrinology. 6:8.
  8. Levine H, Jøgensen N, Martino-Andrade A, Mediola J, Weksler-Derri D, Mindlis I, Pinotti R, Swan SH. (2017) Temporal trends in sperm count: a systematic review and meta-regression analysis. Human Reproduction Update. 1-14.
  9. Ejar Ejaredar M, Nyanza EC, Ten Eycke K, Dewey D. (2015) Phthalate exposure and childrens neurodevelopment: A systematic review. Environmental Research. 142:51-60.
  10. Synthetic Turf Council. About synthetic turf. https://syntheticturfcouncil.site-ym.com/page/About_Synthetic_Turf
  11. Llompart M, Sanchez-Prado L, Lamas JP, Garcia-Jares C, Roca E, Dagnac T. (2013) Hazardous organic chemicals in rubber recycled tire playgrounds and pavers. Chemosphere. 90(2):423-431.
  12. Marsili L, Coppola D, Bianchi N, Maltese S, Bianchi M, Fossi MC. (2014) Release of polycyclic aromatic hydrocarbons and heavy metals from rubber crumb in synthetic turf fields: Preliminary hazard assessment for athletes. Journal of Environmental and Analytical Toxicology. 5:(2).
  13. California Office of Environmental Health Hazard Assessment (OEHHA). (2007) Evaluation of health effects of recycled waste wires in playground and track products. Prepared for the California Integrated Waste Management Board.http://www.calrecycle.ca.gov/publications/Detail.aspx?PublicationID=1206
  14. Kim S, Yang J-Y, Kim H-H, Yeo I-Y, Shin D-C, Lim Y-W. (2012) health risk assessment of lead ingestion exposure by particle sizes in crumb rubber on artificial turf considering bioavailability. Environmental Health and Toxicology. 27, e2012005.http://doi.org/10.5620/eht.2012.27.e2012005
  15. U.S. National Library of Medicine, National Institutes of Health. (2017) Tox Town (Environmental health concerns and toxic chemicals where you live, work, and play): Polycyclic aromatic hydrocarbons (PAHs). https://toxtown.nlm.nih.gov/text_version/chemicals.php?id=80
  16. Armstrong B, Hutchinson E, Unwin J, Fletcher T. (2004) Lung cancer risk after exposure to polycyclic aromatic hydrocarbons: a review and meta-analysis. Environmental Health Perspectives, 112(9), 970.
  17. Shalat SL. (2011) An evaluation of potential exposures to lead and other metals as the result of aerosolized particulate matter from artificial turf playing fields. Submitted to the New Jersey Department of Environmental Protection. http://www.nj.gov/dep/dsr/publications/artificial-turf-report.pdf
  18. Mount Sinai Children’s Environmental Health Center. (2017) Artificial turf: A health-based consumer guide. http://icahn.mssm.edu/files/ISMMS/Assets/Departments/Environmental%20Medicine%20and%20Public%20Health/CEHC%20Consumer%20Guide%20to%20Artificial%20Turf%20May%202017.pdf
  19. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. (2014) Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 72:895-900.
  20. Penn State’s Center for Sports Surface Research. (2012) Synthetic turf heat evaluation- progress report. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  21. Serensits TJ, McNitt AS, Petrunak DM. (2011) Human health issues on synthetic turf in the USA. Proceedings of the Institution of Mechanical Engineers, Part P: Journal of Sports Engineering and Technology, 225(3), 139-146.
  22. Balazs GC, Pavey GJ, Brelin AM, Pickett A, Keblish DJ, Rue JP. (2015) Risk of anterior cruciate ligament injury in athletes on synthetic playing surfaces: A systematic review. American Journal of Sports Medicine. 43(7):1798-804.
  23. Theobald P, Whitelegg L, Nokes LD, Jones MD. (2010) The predicted risk of head injury from fall-related impacts on to third-generation artificial turf and grass soccer surfaces: a comparative biomechanical analysis. Sports Biomechanics. 9(1):29-37.
  24. U.S. Environmental Protection Agency. (2017) Federal research on recycled tire crumb used on playing fields. https://www.epa.gov/chemical-research/federal-research-recycled-tire-crumb-used-playing-fields
  25. U.S. Consumer Product Safety Commission. Crumb rubber information center.https://www.cpsc.gov/Safety-Education/Safety-Education-Centers/Crumb-Rubber-Safety-Information-Center
  26. U.S. Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry (ATSDR). (2016) Federal research action plan on recycled tire crumb used on playing fields and playgrounds. https://www.atsdr.cdc.gov/frap/index.html

When Should Women Start Regular Mammograms? 40? 50? and How Often Is “Regular”?

Breast Cancer
Diana Zuckerman, PhD and Anna E. Mazzucco, PhD, Cancer Prevention and Treatment Fund

In recent years, there has been a growing concern that annual mammography screening for breast cancer starting at age 40 may do more harm than good for many women. Mammogram screening recommendations mainly give advice for women of average risk. Average risk means that there is no personal history of breast cancer and no genetic mutation that is associated with increased risk of breast cancer. As you read this article, keep in mind that screening guidelines vary depending on different levels of risk.

The U.S. Preventive Services Task Force (USPSTF) is an expert group that reviews the latest research findings and is widely used as a gold standard for determining medical treatment and screening. Prior to 2016, their guidelines recommended annual mammography screening starting at age 40. However, the guidelines for most women, updated in 2016, now recommend mammography screening once every two years starting at age 50.[1] These USPSTF recommendations are the same as those suggested by the American College of Physicians. Women of average risk who are ages 75 or older, as well as women with a life expectancy of 10 years or less, should consider discontinuing breast cancer screening if they have no symptoms and no previous history of breast cancer.[2]

For many years, the American Cancer Society (ACS) recommended annual mammograms starting at age 40, but in October 2015, they issued new recommendations that moved in the direction of those of the medical experts. Since 2015 they have recommended that women at average risk of breast cancer start mammography at 45, that they undergo annual mammograms from 45 – 54, and continue to undergo mammography every other year after that, indefinitely, as long as they are in good health and expected to live at least 10 more years.  Those guidelines are still in place in 2022.[1]

In contrast to these other experts, the National Comprehensive Cancer Network® published new guidelines in July 2022, urging that all women of average risk start annual mammography at age 40.[3] NCCN is an alliance of cancer centers with clear expertise; however, research has indicated that NCCN guidelines are developed by many physicians with financial conflicts of interest that could result in bias.[4]

Some experts continue to emphasize that screening mammograms usually do more harm than good, because there is no evidence that they save lives or result in less radical surgery.[5] Experts do not recommend MRIs for screening women of average risk, but clinical studies are being done to determine whether they should be.

As guidelines change and vary from different experts, it may seem challenging to know what you should do. The goal of this article is to help you understand what recommendations are likely to be best for you.

What Is Best for You?

A key reminder: These recommendations are for screening mammograms, not diagnostic mammograms. Screening mammograms are scheduled to detect breast cancer whether or not you have a lump or other  symptom. Diagnostic mammograms are scheduled after finding some possible evidence of breast cancer, such as a lump or abnormal findings from a screening mammogram. Mammograms are recommended at almost any age if a lump is found. The mammography recommendations also do not apply to all women, but are meant for women with average risk of breast cancer. Experts agree that women at especially high risk of breast cancer, such as those with mothers or sisters who had breast cancer, may want to start mammograms between the ages of 40 and 50 or in rare cases, even earlier.

The bottom line is that mammograms have the potential to help detect breast cancer earlier. However, like most medical procedures, there are risks as well as benefits. Whether to start at age 50, age 40, or earlier or later or never depends on several different factors.

For most women who are not at especially high risk of breast cancer, regular mammograms do not need to start before age 50. Or, to be cautious, a woman can get one mammogram earlier (around age 45), and then if it is normal, wait until she is 50 for her next mammogram. This is the advice that the National Center for Health Research and their Cancer Prevention and Treatment Fund have been giving since 2007.

Women at higher risk of breast cancer should not wait until they are 50 to have regular mammograms. Please remember that the age of 50 is only a guideline (not a strict rule), and only for women with no symptoms and who are not at high risk of breast cancer. If a woman finds a lump on her breast, a mammogram is still very important, regardless of her age. For a woman at high risk of breast cancer because of her family history or environmental exposures, regular screening before age 50, or even before age 40, may be a very good idea.

Who Is At Higher Risk?

One study from 2011 examined mammography for women at different ages and with different risk factors. The study’s authors concluded that each woman’s decision about mammography screening should be based on the following risk factors: age, breast density, history of breast biopsy, family history of breast cancer, and personal beliefs about the benefits and harms of screening. This study supports the USPSTF guidelines that women at an average risk of breast cancer can start screening once every two years at age 50, and that women at a higher breast cancer risk should consider screening before age 50.[6]

Women who are carriers of the BRCA genetic mutation were previously recommended to begin yearly mammograms between ages 25-30, since this mutation puts them at much higher risk of getting breast cancer. Newer studies have found that starting yearly mammograms before age 35 has no benefit and may instead be harmful. Women end up with higher exposure to radiation from mammograms over their lifetime, which increases their chance of getting radiation-induced breast cancer that they may not have gotten otherwise.[7]

Most women who have a mother, sister, or grandmother who had breast cancer at the age of 50 or older, or who are at high risk of breast cancer because of obesity or other reasons, may want to have regular mammograms (every two years) starting between ages 40 and 50. If their close relatives had breast cancer before age 40, women may consider mammograms even before age 40. Unfortunately, younger women tend to have denser breasts, which often look white on a mammogram. Since cancer also shows up as white, mammograms are less accurate for younger women (and other women with dense breasts). For those women, a breast MRI is likely to be more accurate than a mammogram, and they are safer than mammograms.

Breast MRIs are more expensive than mammograms, costing an average of $2,000 (compared to about $100 for a mammogram). The USPSTF says there isn’t enough information to recommend for or against MRIs. For that reason, insurance may not cover the cost. If you want insurance to pay for an MRI, you probably need to be recommended by your doctor due to being high risk. Women with dense breasts are at higher risk, especially women with mothers or sisters who had breast cancer at a young age. It is logical that they could potentially benefit from regular breast MRIs, but research is lacking to draw conclusions.

The Big Debate: Do Mammograms Save Lives?

Between 1975 and 2000, dramatic improvements in treatments for breast cancer became available. Surgery options were improved, important chemotherapy agents were discovered, and tamoxifen, a hormonal treatment for estrogen-sensitive breast cancer, came into widespread use. At the same time, mammography became more popular. In 2000, about 70% of women 40 and over reported that they had a mammogram within the previous two years. Despite changes in guidelines increasing the recommended age to 50, in 2018, about 67% of women aged 40 and over reported that they had a mammogram within the previous two years.[8]

The result of these important advances, as well as a decrease in the use of hormone therapy for menopause, has been a dramatic decrease in the number of breast cancer deaths, even while more cases of breast cancer were being diagnosed. The five-year survival rate for breast cancer increased from 75% between 1974 and 1976, to 91% between 2005 and 2011.[9] Death rates, on average, have been falling by 1.4% a year from 2009 to 2018.[10] Have the survival rates improved because of mammography or because of better treatments?

This question became a full-fledged medical controversy in recent years. Two issues were at the root of the debate: 1) Was mammography simply uncovering more tiny, slow-growing abnormalities or cancers that would never have developed into a health threat even if they had never been discovered? and 2) Were we doing more harm than good by subjecting so many women to cancer treatment without knowing whether some of these breast abnormalities or very early cancers would really become dangerous? Since 2009, researchers have debated whether some tiny cancers disappear on their own without treatment. More importantly, experts agree that most ductal carcinoma in situ (DCIS) will never become an invasive breast cancer, even without treatment.

Regular screening mammography can possibly help diagnose cancer earlier, but the latest research suggests it may not have as much benefit for earlier diagnosis as expected. In March 2017, the Annals of Internal Medicine published a Danish study that examined whether regularly scheduled screening mammography can prevent the number of bigger, more advanced cancers that are difficult to treat.[11] Dr. Karsten Juhl Jørgensen and colleagues looked at 30 years of data and compared women living in areas covered by screening programs to those in areas without the programs. Overall, mammography was not associated with fewer advanced cancers. However, in the areas with screening programs, diagnoses of non-advanced cancers increased. It is estimated that up to one third of the diagnosed breast cancer cases would never have caused noticeable health problems or death.

In 2021, a Swedish study published in the medical journal Cancer looked at data from 549,091 women, searching for breast cancers that were fatal within 10 years of being diagnosed, as well as advanced breast cancers. Data were collected on the type of breast cancer diagnosis, as well as the cause and date of death for each breast cancer case. The results showed that women who had participated in regular mammography (usually every 18-24 months) screening had a 41% reduction in their risk of dying from breast cancer within 10 years of diagnosis. When accounting for potential lead time (where an early diagnosis falsely makes it look like a patient’s surviving longer) and self-selection biases (when patients decide for themselves whether to participate in a research study), the estimate drops to a more conservative, but still statistically significant, 34% reduction in risk of dying within 10 years of diagnosis. The researchers compared women who received the same treatment, so the differences in survival are not related to any potential differences in treatment.[12] However, keep in mind that even if women are less likely to die of breast cancer, they may die of other causes and therefore do not necessarily live longer than women who did not undergo screening mammography.

Other research indicates mammography may not save lives, except possibly for the women who have the highest risk of developing breast cancer. Researchers estimate that for 1,000 40-year-old women who have annual mammograms, two fewer women will die of breast cancer.[13] During that time, approximately 600 of these 1000 women will have false alarms, and approximately 5 to 10 will have unnecessary surgical treatment that could be harmful to them. However, this research did not consider the benefits compared to the risks of regular mammography (every two years) after age 50. It is possible that starting less frequent mammography at 50 (and for women at high risk between the ages 40 and 50) could provide benefits that may outweigh the risks for most women. Although about 90% of worrisome findings from mammograms turn out to be false alarms — not cancer — many experts continue to believe that the overall benefits have been established for women over 50.

Having fewer women die of breast cancer does not, however, mean that fewer women die.  None of the studies that evaluate the impact of mammography do so in terms of lives saved. Instead, they evaluate the number of women who die of breast cancer specifically.

What about breast self-exams? The USPSTF recommends against teaching women to do breast self-exams, because evidence suggests the risks outweigh the benefits.[14] Breast self-exams have low accuracy, leading to women experiencing “false alarms” and increased anxiety. In the cases that breast self-exams are accurate and positive, the cancer is large enough to be obvious. The USPSTF and the American Cancer Society no longer recommend that doctors do breast exams on their patients for the same reason. Nevertheless, women should be familiar with how their breasts normally look and feel and report any changes to a doctor right away.

The Bottom Line: How Often Should You Get Mammograms?

Remember that mammograms expose women to radiation, which can increase the risk of breast cancer. Increasing the age of mammograms to age 50 for most women, and reducing the frequency to every two years could save lives because it would drastically reduce radiation exposure. Experts believe that less frequent mammograms also means a lower false alarm rate, and that means fewer unnecessary tests, anxiety, and possibly fewer unnecessary surgeries.[15][16] To summarize, women of average risk, aged 50 to 74, should get a mammography screening every two years. However, as stated earlier, for women who have higher risks of breast cancer, these recommendations do not apply, and more frequent screenings may be beneficial. For women 75 or older, the benefits of mammography screening are not clear.

For more information:

 U.S. Preventive Services Task Force, Breast Cancer Screening Final Recommendations, http://screeningforbreastcancer.org 

For information about insurance coverage for free mammograms: http://www.hhs.gov/blog/2016/01/11/bottom-line-mammograms-are-still-covered.html

 Related Content:

Should I “upgrade” to digital or 3D? A mammography guide

Breast implants and mammography: what we know and what we don’t know

DCIS: Mostly good news

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

References:

    1. Breast Cancer: Screening (2016). U.S. Preventative Services Task Force. https://uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening#:~:text=The%20USPSTF%20recommends%20biennial%20screening,aged%2050%20to%2074%20years.&text=The%20decision%20to%20start%20screening,should%20be%20an%20individual%20one.
    2. 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.
    3. Darwin, R. (2022). NCCN Publishes New Patient Guidelines for Breast Cancer Screening and Diagnosis Emphasizing Annual Mammograms for All Average- Risk Women Over 40. News Comprehensive Cancer Network (NCCN). https://www.nccn.org/home/news/newsdetails?NewsId=337
    4. Desai, A., Chengappa, M., Go, R., & Poonacha, T. (2020). Financial conflicts of interest among National Comprehensive Cancer Network clinical practice guideline panelists in 2019. National Library of Medicine. https://pubmed.ncbi.nlm.nih.gov/32497271/
    5. BMJ 2016;352:h6080
    6. Schousboe JT, Kerlikowske K, Loh A, and Cummings SR. (2011). Personalizing Mammography by Breast Density and Other Risk Factors for Breast Cancer: Analysis of Health Benefits and Cost-Effectiveness. Annals of Internal Medicine, 155:10-20.
    7. Berrington de Gonzalez A, Berg CD, Visvanathan K, and Robson M. (2009). Estimated Risk of Radiation-Induced Breast Cancer From Mammographic Screening for Young BRCA Mutation Carriers. Journal of the National Cancer Institute, 101(3): 205-209. doi:10.1093/jnci/djn440
    8. Centers for Disease Control and Prevention. FastStats – Mammography. CDC.gov. https://www.cdc.gov/nchs/fastats/mammography.htm. Updated March 26, 2021.
    9. Siegel, RL, Miller, KD, & Jemal, A (2016). Cancer statistics, 2016. CA: A Cancer Journal for Clinicians, 66(1), 7-30. doi:10.3322/caac.21332
    10. National Cancer Institute. Cancer Stat Facts: Female Breast Cancer. Cancer.gov. https://seer.cancer.gov/statfacts/html/breast.html. Updated January 27, 2021.
    11. Jørgensen KJ, Gøtzsche PC, Kalager M, Zahl PH. Breast Cancer Screening in Denmark: A Cohort Study of Tumor Size and Overdiagnosis. Ann Intern Med. 2017;166(5):313-323. doi:10.7326/M16-0270
    12. Duffy SW, Tabár L, Yen AM, et al. Mammography screening reduces rates of advanced and fatal breast cancers: Results in 549,091 women. Cancer. 2020;126(13):2971-2979. doi:10.1002/cncr.32859
    13. Welch G, et al. (2013). Quantifying the benefits and harms of screening mammography. JAMA Internal Medicine.
    14. Siu AL; U.S. Preventive Services Task Force. Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement [published correction appears in Ann Intern Med. 2016 Mar 15;164(6):448]. Ann Intern Med. 2016;164(4):279-296. doi:10.7326/M15-2886
    15. Hubbard RA, et al. (2011). Cumulative probability of false-positive recall or biopsy recommendation after 10 years of screening mammography: a cohort study. Annals of Internal Medicine, 155(8):481-92.
    16. Braithwaite D, et al. (2013). Screening Outcomes in Older US Women Undergoing Multiple Mammograms in Community Practice: Does Interval, Age or Comorbidity Score Affect Tumor Characteristics or False Positive Rates? Journal of the National Cancer Institute,105(5):334-341.

Third-hand smoke

Diet, Habits, & Other Behaviors, Environmental Exposures, Lung Cancer
Noy Birger and Celeste Chen, Cancer Prevention & Treatment Fund

You know that smoking and being exposed to other people’s cigarette smoke (second-hand smoke) is dangerous, but did you know that residue from cigarette smoke, which remains on just about every surface exposed to that smoke, is also harmful? This is called third-hand smoke.

Third-hand smoke or smoke residue clings to hair and fabrics, including clothing, carpets, drapes, and furniture upholstery.[1]  The residue reacts with other chemicals and materials in the air, combining to form substances that cause cancer.[2] This toxic mix is then breathed in or absorbed through the skin.

One particular chemical found in third-hand smoke, NNA, has been scrutinized because it can directly interact with and damage DNA, possibly paving the way for cancer to grow. Researchers believe that NNA behaves similarly to a byproduct of nicotine called NNK, which has long been known to cause cancer.

In a 2014 study, researchers confirmed that NNA not only breaks up DNA just like NNK does, but also attaches itself to DNA. By breaking up and attaching to DNA, NNA is able to produce cells that grow when they shouldn’t, creating tumors and causing damaging genetic mutations.[3]

Third-Hand Smoke Is Sneaky

Many public buildings ban indoor smoking, and the majority of people who smoke are aware of the health risks–to them and everyone around them–and therefore confine their smoking to outdoors, away from children and non-smokers. But even after the cigarette has been put out, you can carry dangerous nicotine residue back inside on your hair and clothes, and consequently put others at risk of developing cancer.[1]

Children are particularly vulnerable. Like adults, they can absorb the tar and nicotine leftovers through their skin. The effect on children is greater because they are smaller and still developing. Also, children are more likely to put their residue-covered hands on their nose or in their mouth.[4] Chemicals such as NNA that are produced when smoke residue mixes with chemicals in the air can cause developmental delays in children.[1] Parents should know that if they smoke in the car, their children can absorb the cancer-causing chemicals from the car upholstery, even if the children weren’t inside the car when the parent was smoking

Third-hand smoke is a new health concern.  While we know that the residue combines with the air and other pollutants, like car exhaust fumes, to make a cancer-causing substance, we don’t yet know for certain that it causes cancer in humans and if so, how much exposure is dangerous.[5] Figuring out the answer will be challenging, because most people exposed to third-hand smoke are also exposed to second-hand smoke. We know that non-smokers develop lung cancer, for example, but we usually don’t know if a non-smoker developed cancer because he or she was exposed to third-hand smoke, or for other reasons unrelated to smoking.

Bottom Line

Smokers with children or who live with non-smokers should never smoke inside the home or in their car, and clothing worn while smoking should be washed as soon as possible. If you smell cigarette smoke in a place or on someone, it means you are being exposed to third-hand smoke. An expert on helping people quit smoking recommends that after quitting, people should thoroughly clean their homes, wash or dry clean clothing, and vacuum their cars to remove the dangerous smoke leftovers.[2] Ideally, it would be best to replace furnishings that may have absorbed the chemicals from third-hand smoke, such as sofas, and re-carpet floors, re-seal and re-paint walls, and replace contaminated wallboard. Even if a smoker hasn’t quit yet, it’s a good idea to vacuum and wash clothes, curtains and bedding regularly to reduce their and their loved ones’ exposure to the dangerous chemicals that form when smoke residue mixes with the air.[3]

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

References

  1. “The dangers of thirdhand smoke.” Mayo Clinic. Mayo Foundation for Medical Education and Research, 13 July 2017. http://www.mayoclinic.org/healthy-lifestyle/adult-health/expert-answers/third-hand-smoke/faq-20057791.
  2. Sleiman M, Gundel LA, Pankow JF, Peyton J, Singer BC, Destaillats H. Formation of carcinogens indoors by surface-mediated reactions of nicotine with nitrous acid, leading to potential thirdhand smoke hazards. Proceedings of the National Academy of Sciences. January 6, 2010 www.pnas.org/cgi/doi/10.1073/pnas.0912820107.
  3. American Chemical Society (ACS). “Major ‘third-hand smoke’ compound causes DNA damage and potentially cancer.” ScienceDaily. ScienceDaily, 16 March 2014. www.sciencedaily.com/releases/2014/03/140316203156.htm.
  4. Winickoff JP, Friebely J, Tanski SE, Sherrod C, Matt GE, Hovell MF, et. al. Beliefs About the Health Effects of “Thirdhand” Smoke and Home Smoking Bans. Pediatrics. (123.1)74-79.
  5. Ballantyne C, What is third-hand smoke? Is it hazardous? Scientific American. January 6, 2009. http://www.scientificamerican.com/article.cfm?id=what-is-third-hand-smoke.

Libertarians Score Big Victory In ‘Right-To-Try’ Drug Bill

news-you-can-use
Sarah Karlin-Smith, Politico: August 3, 2017

The Senate unanimously approved a bill Thursday that would allow people facing life-threatening diseases access to unapproved experimental drugs, providing a victory for libertarian advocates who see government regulators thwarting patients’ rights.

The bill, S. 204 (115), passed swiftly and easily in a Senate bitterly divided over health care. The powerful pharmaceutical lobby, which had quietly opposed an earlier version, kept an unusually low profile. The industry has been focused on fighting off any efforts to go after drug pricing, which President Donald Trump has said he would tackle. […]

The legislation would allow patients with serious diseases — anything from a late-stage cancer to multiple sclerosis — to request access to experimental drugs directly from drug companies without having to go through the FDA, which has its own compassionate use program that approves 99 percent of requests.

But the right-to-try bill doesn’t require drugmakers to make the experimental treatments available. In the 37 states that have similar laws on the books, Goldwater can point to only one doctor who says he has utilized a state right-to-try law for a patient — and that medicine was being made available to certain patients by the FDA anyway.

That’s led some critics to call it “right-to-ask” — and it may give desperately ill people false hopes. […]

And if the experimental drugs do become widely used outside the standard clinical trial system, it could undermine some of the rigorous science needed to know whether medicines are safe and effective. Many drugs that start the clinical trial process flop. Some are harmful.

“You have a situation where patients think they want to take a risk and don’t necessarily understand what risk they are taking,” said Diana Zuckerman, president of the National Center for Health Research, which lobbied against the bill.

And while the revised bill would require annual reports on whether the drugs used by these patients helped — or potentially harmed — them, patient safety experts are concerned it may not be enough. […]

 

Read the original article here.

Cigarette Maker Stocks Plunge on FDA Announcement, But Health Experts Are Skeptical

News Stories & Editorials
Emma Court, Marketwatch: July 28, 2017

A Food and Drug Administration announcement Friday that included a proposal to lower nicotine levels in cigarettes to non-addictive levels sent cigarette maker shares plunging. […]

Health experts said that the Friday announcement focused on important public health priorities, including examining the effect flavors, such as menthol, have in attracting young people to tobacco products and approaching any changes so as to avoid a spike in black market activity.

But they also expressed skepticism about the real-world effects of Friday’s news, and concern about its pushback of reviews for products like cigars and hookah tobacco until 2021 and things like e-cigarettes until 2022. The aforementioned products are already on the market but have come more recently under FDA regulation. […]

And the announcement’s intent matters less than “not just what they ask for, but what they require,” said Diana Zuckerman, president of the National Center for Health Research.

Extending the product review timeline keeps harmful products on the market longer, Dobbins said.

For its part, the FDA said that extending the review deadlines will give the regulator more time along with giving companies “additional time to develop higher quality, more complete applications informed by additional guidance from the agency.” […]

Though the Friday announcement appeared to be a negative for cigarette makers, it could be “an opportunity over the long term for reduced-risk products,” said Wells Fargo Securities analyst Bonnie Herzog, such as Altria and Philip Morris’ smokeless iQOS devices. “We see this as an opportune entry point for long-term investors and would recommend building positions on today’s broad weakness.” […]

Read the original article here.

FDA Deal Would Relax Rules on Reporting Medical Device Problems

News Stories & Editorials
Sheila Kaplan, The New York Times: July 11, 2017

WASHINGTON — Makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress.

Device makers will still have to quickly report any injuries or deaths related to their products. They would have more time, though, to file reports on devices that may not be working properly, and have the potential for injury.

The deal is part of a pact between the F.D.A. and the $148 billion device industry. Renegotiated every five years, the agreement includes the fees that device makers must pay for the agency to review their products. It is scheduled for a vote in the House of Representatives on Wednesday. […]

But consumer advocates point to recent problems where initial reports of device malfunctions did not involve any injuries, but later evidence — sometimes additional devices showing flaws or reports indicating patients were harmed — began to surface. They pointed to cardiac defibrillators that ran out of batteries; the power morcellator, designed for laparoscopic surgery to remove uterine fibroids, which spread cancer through patients’ bodies; a type of breast implant that is linked to a rare cancer; and the superbug-bearing duodenoscope, whose design flaws made it virtually impossible to disinfect. […]

Textured breast implants have been linked to a rare form of cancer.Critics of relaxing the rules say this is not the right time to ease oversight when so much already goes undetected.

“It often takes months or even years for the F.D.A. to detect patterns of failure,” said Jack Mitchell, director of health policy for the National Center for Health Research in Washington. “Post-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices.” […]

 Read the original article here.

FDA Eases Notice Requirement on More Than 1,000 Medical Devices

News Stories & Editorials
Mike Stankiewicz, Bloomberg BNA: July 10, 2017

More than one thousand medical devices, including umbilical clamps, menstrual cups, and dentures, will be exempt from an FDA clearance process.The Food and Drug Administration removed 510(k) notification requirements for some moderate-risk devices under steps established by the 21st Century Cures Act ( Pub. L. No. 114-255), a 2016 law intended to speed new drugs and devices to the market and reduce regulatory burdens. The newly exempt devices include commonly used items like dentures, menstrual cups and scented menstrual pads, umbilical clamps, and certain hearing aids. […]

The 21st Century Cures Act requires the FDA to determine which class II devices no longer require the premarket clearance.The FDA said the exemption will help industry by eliminating costs and time required to comply with regulations. […]

Industry, Consumer Reactions

The Advanced Medical Technology Association, a medical device industry group, praised the FDA’s move.

“This action supports a risk-based review process for identifying lower-risk, well-established products for exemption and allows FDA to better focus its review resources to support the public health,” Janet Trunzo, senior executive vice president of technology and regulatory affairs at AdvaMed, told Bloomberg BNA July 10.

But Diana Zuckerman, president of the National Center for Health Research, a Washington-based nonprofit, said the FDA is going in the wrong direction because patients could be hurt by the moderate-risk devices.

“In addition to risks to patients, these FDA actions mean even less information about the devices that will be available to doctors and their patients,” she told Bloomberg BNA July 10. “How can doctors and patients make informed medical decisions without any any public information about these products? And how can medical care in the U.S. be made more affordable without requiring scientific evidence about safety or effectiveness for treatments that physicians are choosing for their patients?” […]

Read the original article here.

Special Report: Many Expensive New Cancer Drugs Are Useless (or Worse)

News Stories & Editorials
Bottom Line Inc., July 3, 2017

First comes the shock of a cancer diagnosis. Then comes the flurry of questions: Is there a cure? Is there a treatment? What drug do I take? Will it work?

Sometimes the answers are easy to find. People with chronic myeloid leukemia, for example, can take imatinib (Gleevec) and have an 80% chance of surviving for 10 years. 

But other cancer patients aren’t so lucky. They may be given an option of taking a chemotherapy medication that won’t help them live longer—and that will make their lives more miserable in the bargain. […]

We asked Diana Zuckerman, PhD, president of the National Center for Health Research, a nonprofit organization in Washington, DC, to explain why many new cancer medications have so few benefits…and what you or your loved ones can do to get the treatment you need and deserve—at a reasonable cost.

Rushing Cancer Drugs to Market

One big reason these drugs aren’t very effective is a sped-up approval schedule that puts many new cancer drugs in the hands of patients before they’ve been thoroughly vetted. 

Consider this: From 2002 to 2014, the Food and Drug Administration (FDA) approved 71 drugs for a variety of types of cancer—but fewer than half of these drugs have been shown to extend patients’ lives by at least two-and-a-half months, the minimum standard. Many of them came with hefty price tags of more than $10,000 a month. For some of these chemo drugs, the story is even worse—they didn’t improve survival at all. As if that weren’t bad enough, some of these new drugs have side effects that are as dangerous as the cancer they are supposed to treat.

How did this happen? In the quest to get potentially lifesaving medications to people who desperately need them, the FDA approves drugs before the information about their real benefits has been determined. […]

While stopping tumor growth or reversing it is a promising sign, physicians know that it can be temporary and sometimes followed by rapid tumor growth. […]

If you have cancer, you’re probably more interested in living longer than in simply avoiding death from cancer. For example, if the drug you take causes liver toxicity or a stroke that can kill you before the cancer would, it’s not doing you any good.

Not All Drugs Get Follow-Up Studies

When drugs are approved only on the basis of the way cancerous tumors respond, the FDA usually requires follow-up studies to prove that the drugs are truly beneficial, such as helping patients live longer or improving their quality of life for the weeks, months or years that they have left.

That process makes sense—as long as the FDA enforces it. […]

Yet all these drugs are still on the market. One reason is that postapproval studies that could result in removing a drug from the marketplace are very difficult to conduct. Example: It is difficult to conclusively prove whether these cancer drugs are effective because patients are less willing to participate in further clinical trials on a drug that’s already been approved.

The problem may get worse. The FDA is currently evaluating ways to overhaul its processes and speed up approval of all types of drugs, including cancer treatments, in its effort to get life-saving drugs on the market faster.

Little Consideration for Quality of Life

A drug that increases a cancer patient’s well-being and comfort is also considered worthy of FDA approval even in cases where living longer is not likely. But a recent study published in JAMA Internal Medicine looked closely at 18 drugs that had no survival benefit to see what effect they had on patients’ quality of life. The majority of the drugs either contributed to a worse quality of life—for example, patients suffered from diarrhea, fatigue, sleep disturbances or memory loss—or the evidence was mixed (which means the research was inconclusive, with some studies suggesting that treatment was helpful and other studies suggesting it was harmful). […]

Making the Right Treatment Choices

A cancer diagnosis is stressful under any circumstances, but if your cancer doesn’t respond to standard treatments, the choices get tougher. The choice is always the patient’s—for some people, living another two months is worth possible side effects. But there is no excuse for chemotherapy that won’t help extend life and makes you more miserable in the final days.

Unfortunately, you can’t always count on your doctor to help you sort through the options. Many doctors will list all the drugs out there because they want you to have a say in your own care. They also assume that FDA approval means that the advantages outweigh the dangers and may not realize that the studies are inconclusive.

To make an informed decision, though, you need to know the benefits and risks of the medications that are being offered. Here’s how…

Ask your doctor specific questions. Will this drug help me live longer, or will it just cause the tumor to shrink? What are the side effects and how dangerous or unpleasant are they? If you don’t get answers, ask your health-care provider to do some research and give you a summary of the results. Then do some digging on your own.

Use reputable sources for your research. Google searches can send you straight to a misleading advertisement for a drug as well as other misinformation from a variety of sources. Go to Drugs.com instead, where you’ll find the proven risks and benefits of each medication. Look for the sections on risks, side effects, adverse events and contraindications to find out what the problems might be. Check what the drug has been approved to treat. For example, some treatments used for prostate cancer are FDA approved to treat prostate “problems” or “health” but are not proven to treat prostate cancer.

You might also search on Google Scholar or PubMed to find journal articles written by scientists and medical experts who have studied the treatment you are considering. Again, read carefully to see whether there is any evidence that the drug improves “overall survival.”  If the drug improves “progression-free survival,” that doesn’t mean patients live longer.

Get impartial help. The Cancer Prevention and Treatment Fund, the primary project of the National Center for Health Research (where I work), offers a no-cost cancer help hotline to help patients sift through their choices. This organization doesn’t accept any funds from companies that make any medical treatments. Send an email to info@stopcancerfund.org with the type of cancer treatment you’re considering, and someone will reply with relevant and meaningful information that can help you make a smart decision.

Source: Diana Zuckerman, PhD, president, National Center for Health Research and the Cancer Prevention and Treatment Fund, Washington, DC. Date: July 3, 2017 Publication: Bottom Line Health

 

Read the original article here.