FDA: TELL U.S. WOMEN THE TRUTH ABOUT MAMMOGRAMS AND WHY SWITZERLAND IS ABOLISHING THEM

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“Mammography is a suboptimal test…we need a better test.” 

— former chief medical officer, American Cancer Society

 

We, the undersigned, hereby acknowledge that while mammograms save some lives and are vital to some women’s peace of mind, all the harms caused by breast cancer screening have not been conveyed to women.

 

As a result, some of these harms convinced the U.S. Preventative Services Task Force in 2009 to recommend changes to the mammography guidelines, including a decrease from annual screening to every other year for most women (1):

 

“Biennial screening starting at age 50 reduced risk of radiation-induced cancers 5-fold. (6)

 

***We ask that the U.S. Food and Drug Administration (FDA) — through its current open Federal Register Docket No. FDA-2013-N-0134 for “Mammography Quality Standards Act; Amendments to Part 900 Regulations” — include all of the following changes to its mammography regulations, and disseminate the information within six months of the notice’s closure.

[NOTE: THE FDA “PROPOSED RULE” COMMENT PERIOD CLOSES JUNE 26, 2019; PLEASE SIGN NOW AND SHARE]

Further, we ask that the Congress, the U.S. Department of Health and Human Services (HHS), and all state Attorneys General do what they can in their power to immediately disseminate the following breast cancer screening information, all of which is supported by the medical literature cited below.

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1) “INFORMED CONSENT” IS FUNDAMENTAL TO ANY MEDICAL TREATMENT:


Switzerland is abolishing mammography due to many of the harms listed herein (2)(3), including over-diagnosis/treatment and harm from radiation

 

Women have been told the benefits of mammography but not of its many limitations and harms, yet:

 

The American Cancer Society supports informing women about the limitations of mammography so they will have reasonable expectations about its accuracy and usefulness.” (4)

 

Women need complete and factual information in order to determine, if they choose to screen, which breast cancer screening test is appropriate for them based on effectiveness and risk

 

Mammography is not ‘low-dose’ radiation.” — Manfred Doepp, MD; Doctor of Nuclear Medicine

 

When a patient isn’t told the complete truth about a medical test prior to the procedure — most importantly the harms — it is no longer “Informed Consent” and most likely breaks Consumer Protection Laws (source: a former state Attorney General)

 

# ACTION: WE WANT COMPLETE INFORMATION ON THE LIMITATIONS OF AND HARMS CAUSED BY MAMMOGRAMS SO THAT WE CAN MAKE INFORMED DECISIONS

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2)  WOMEN MUST BE TOLD ABOUT RADIATION-INDUCED CANCER:

MYTH: Mammograms don’t cause cancer

TRUTH: “Theoretically, annual mammograms in women aged 40 to 80 years may cause up to one breast cancer per 1,000 women.” — National Cancer Institute (5)

 

This number is even higher in women with large breasts (6)

Large and Dense Breasts:Women with large breasts frequently undergo more mammographic x-rays and as a result receive increased radiation (7); radiation-induced breast cancer is more than doubled for large-breasted women (6)

Women with dense breasts receive a higher delivery of absorbed radiation from a mammographic screening (7)

“Dense breast tissue absorbs significantly more radiation during mammography compared with fatty breast tissue.” (8)

 

# ACTION: WE WANT TO BE TOLD THE TRUTH ABOUT THE RADIATION AMOUNT ABSORBED BY THE BREAST FROM MAMMOGRAMS AND THE HARM IT MAY CAUSE

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3)  WOMEN MUST BE TOLD THE TRUTH ABOUT THE NEW “3D” MAMMOGRAMS:

MYTH: The new 3D Mammograms are lower radiation than today’s 2D mammograms

TRUTH: Most of the new 3D mammograms have more radiation than today’s 2D mammograms (9)(10)(11)(22) (and former chief medical officer, American Cancer Society)

 

“Most U.S. practices offering screening [3D] tomosynthesis combine it with [2D] digital mammography, which at least doubles doses and the risk for radiation-induced breast cancer.”  (6)

3D screening is being offered to women — yet it hasn’t been adequately studied (11) — American Cancer Society

 

# ACTION: WE WANT 3D MAMMOGRAPHY PULLED FROM USE UNTIL FURTHER SAFETY AND EFFICACY STUDIES ARE UNDERTAKEN

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4)  WOMEN MUST BE INFORMED ABOUT THE OVER-TREATMENT OF BREAST CANCER BECAUSE OF MAMMOGRAPHY’S USE, PARTICULARLY “STAGE 0” DCIS:


Thankfully, mammograms do save some lives.  However, research has found that there is massive unnecessary treatment of some women with non-invasive cancers (cancers that haven’t spread) and pre-cancerous conditions that may or may not spread. (12)(13)  Over-treating these breast cancers may lead to early or induced death. (15)

Over a 30 year period (1976-2008), mammograms led to 1.3 million U.S. women being over-diagnosed and thus treated needlessly for non-invasive breast cancer (14) 

Because of induced and/or early deaths from the needless treatment of otherwise non-invasive and/or harmless breast cancers found during screening, some evidence suggests there are no lives saved overall from screening (15)

Estimates of the overdiagnosis of screen-detected tumors range from 15% up to 54% (16):

 

“Acknowledging the existence of breast cancer overdiagnosis challenges the value of screening: it means that the benefits of breast screening have been overstated, and that some women who have been ‘cured’ [e.g. never had cancer to begin with] were harmed because they received unnecessary treatment”. —  Otis W. Brawley, MD, then Chief Medical Officer of the American Cancer Society (16)


— A CASE STUDY: Ductal Carcinoma in Situ (DCIS):

“DCIS now accounts for about 20%–25% of all newly diagnosed cases of breast cancer” in the U.S. (17a)

DCIS is controversial as it is “a pre-cancerous or non-invasive cancerous lesion of the breast” and is classified as “Stage 0” (17b)

DCIS patients do not necessarily require treatment (18) and are thus being over-treated

 

“As many as 44 percent of patients with DCIS may not require any further treatment, and can rely instead on surveillance.” (18)

“Because doctors cannot easily distinguish cancers and cases of DCIS that need to be treated from those that do not, they are all treated.”  — National Cancer Institute (website)

 

You can only see DCIS’ micro-calcifications on mammograms (19), which has led to the over-diagnosis and unnecessary treatment of non-invasive cancers or pre-cancerous conditions (12)(13)

For every 2000 women screened over 10 years, 1 woman will be saved but 10 will be treated needlessly due to mammographic screening (Cochrane Collaboration Review) (20a)

 

Overdiagnosis of breast cancer is the main harm of mammography screening. Based on recent estimates from the United States, the relative amount of overdiagnosis (including [DCIS] and invasive cancer) is 31%.” (20b)

 

# ACTION: WE WANT THE TRUTH ABOUT THE OVER-DIAGNOSIS AND OVER-TREATMENT OF BREAST CANCER DUE TO SCREENING

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5)  WOMEN MUST BE INFORMED ABOUT MAMMOGRAPHY’S ACCURACY, WHICH IS AFFECTED BY BREAST DENSITY:

MYTH: Mammograms are over 80% accurate

TRUTH: In women with extremely dense breasts, mammograms miss up to 50% of cancers:

 

“Mammographic [accuracy] declined significantly with increasing breast density…(48% for the densest breasts)” (21)

Breast density affects the accuracy of the mammogram results and thus the detection of some cancers (21)

90% of women have some degree of dense breasts, with 10% of women having “extremely dense” breasts (22); for these women, mammograms accuracy is diminished significantly (21)(23)(24)


# ACTION: WE WANT WOMEN TO BE TOLD THE AMOUNT OF DENSE TISSUE IN THEIR BREASTS AND HOW THIS STATISTICALLY AFFECTS THE ACCURACY OF THEIR MAMMOGRAM RESULTS

 

***ACTION: RE: FDA’s “PROPOSED § 900.12(c)(1)(vi)” AND EXTREMELY DENSE BREASTS, WE WANT FDA TO INCLUDE AFTER “…LOWERS THE SENSITIVITY OF MAMMOGRAPHY”, THE WORD “SIGNIFICANTLY”

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6)  THE ULTRASOUND vs. MAMMOGRAM CONUNDRUM:

Mammograms and ultrasounds are both screening and diagnostic tools (Source: FDA)

However, the current medical Standard of Care only allows for mammography to be used as the primary stand-alone screening tool for breast cancer (Source: FDA)

Ultrasound’s accuracy is comparable to mammography as a screening device on the average, (25) yet it is not being used as a primary stand-alone screening tool

For women with dense breasts, ultrasound is a far superior screening tool to mammography (26)

 

However, ultrasound is not covered by insurance as a stand-alone screening tool because FDA has “cleared” some devices but not “approved” them as a primary stand-alone screening tool. One device (ABUS, or automated whole breast ultrasound) is approved for screening but only as an adjunctive to mammography (source: FDA)

 

Therefore, unless a screening mammogram is performed first, ultrasound will normally not be covered by insurance for screening purposes


# ACTION: WE WANT WOMEN WITH ANY DEGREE OF DENSE BREAST TISSUE TO HAVE A CHOICE OF SCREENING TESTS USING EITHER MAMMOGRAPHY OR ULTRASOUND; BOTH TESTS SHOULD BE APPROVED AND USED FOR SCREENING AND COVERED BY INSURANCE AS SUCH

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7)  WOMEN WANT EARLIER DETECTION:

MYTH: Mammography is an early detection tool and therefore a test of prevention

TRUTH: By the time breast cancer is detected by mammography, most cancers are well underway

 

A breast cancer lump is only felt after approximately 2-5 years of tumor growth (27)

Thankfully, mammograms find some breast cancers before a lump can be felt. However, earlier detection is needed for all breast cancers


# ACTION: FDA, PLEASE “APPROVE” MORE ACCURATE, PAINLESS, RADIATION-FREE BREAST CANCER SCREENING TESTS THAT PROVIDE EARLIER DETECTION

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8)  “WE NEED A BETTER TEST”:  A SAFER, RADIATION-FREE, EARLIER DETECTION SCREENING PROTOCOL:

 

THERMOGRAPHY:

— Thermography, a test of physiology, is an FDA-approved adjunctive screening test to mammography. International studies show an accuracy rate of over a 90% using thermography alone. (28)(29)(30)


Thermography reveals inflammation that may lead to developing cancer up to 10 years later (31)

Lifestyle changes after detection may reverse inflammation, thereby possibly preventing tumor formation (32)

 

ULTRASOUND:

— Ultrasound is a test of anatomy, as are mammograms and MRI


Used together, thermography and ultrasound (physiological and anatomical tests, respectively) have the potential to almost double the accuracy of mammograms when screening women with extremely dense breasts (mammography’s accuracy is 48% for these women (21))

— Most importantly, thermography and ultrasound are both non-invasive, painless, radiation-free tests

 

“Because the greatest harm of overdiagnosis is overtreatment, the key goal should not be less diagnosis but better treatment decision tools. (33)

 

# ACTION: WE WANT THE US GOVERNMENT TO CONDUCT A LARGE POPULATION STUDY ON THERMOGRAPHY USED IN CONJUNCTION WITH ULTRASOUND AS A POTENTIAL NEW STANDARD OF CARE BREAST CANCER SCREENING PROTOCOL FOR WOMEN

 

# ACTION: WE WANT TO HAVE THE OPTION OF WHICH SCREENING TEST TO USE BASED ON WOMEN’S BREAST DENSITY, OTHER CONSIDERATIONS SUCH AS GENETICS, AND ADVICE FROM OUR PHYSICIANS 

 

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****Please sign and share this petition calling on the FDA to change its regulations and inform women of the above information [COMMENT PERIOD ENDS June 26, 2019].

 


(Background: I’m a documentary filmmaker and science journalist of 12 years who stumbled onto this information, which I in turn felt women had the right to know. Using my M.S. degree, I searched the medical literature and spoke with medical doctors, which uncovered the above information)

(Personal note: My husband passed of cancer 10 years ago.  Three of my dear friends died in as many years because their treated “early” stage breast cancers metastasized 10+ years later. We need to catch cancer before it’s even Stage 1)

 


Follow this issue on FaceBook: https://www.facebook.com/boobsthewaronwomensbreasts/

 

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FOOTNOTES:

(1) https://jamanetwork.com/journals/jama/fullarticle/2679928:
“Recognizing additional evidence about the harms of mammography, in 2009, the United States Preventive Services Task Force (USPSTF) revised its previous recommendation of annual mammograms for all women beginning at age 40 years and instead recommended biennial mammograms for women aged 50 to 74 years.”

(2) https://www.nejm.org/doi/full/10.1056/NEJMp1401875

(3) http://theweeklyobserver.com/switzerland-decided-abolish-mammography-reason-will-shock/26779/

(4) [https://www.cancer.org/cancer/breast-cancer/frequently-asked-questions-about-the-american-cancer-society-new-breast-cancer-screening-guideline.html

(5) https://www.ncbi.nlm.nih.gov/books/NBK65906/

(6) “Radiation-Induced Breast Cancer Incidence and Mortality from Digital Mammography Screening: A Modeling Study” (Annals of Internal Med. 8/16/16) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878445/

(7) https://wjso.biomedcentral.com/articles/10.1186/s12957-017-1107-6

(8) https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Management-of-Women-With-Dense-Breasts-Diagnosed-by-Mammography

(9) https://pubs.rsna.org/doi/full/10.1148/radiol.10100570

(10) “…because [3D] is generally performed at the same time as standard two-dimensional (2-D) digital mammography, the radiation dose is higher than that of standard mammography.” — National Cancer Institute (website)

(11) “Why are there no recommendations for 3D mammography (tomosynthesis)?…there was too little data on [3D] to include comparisons to 2D mammography.” — American Cancer Society (website)

(12) https://www.nejm.org/doi/full/10.1056/NEJMp1401875

(13) http://theweeklyobserver.com/switzerland-decided-abolish-mammography-reason-will-shock/26779/

(14) “Effect of Three Decades of Screening Mammography on Breast-Cancer Incidence” (NEJM 11/22/12):

https://www.nejm.org/doi/full/10.1056/NEJMoa1206809

(15) “The trials with adequate randomisation [e.g., medical research trials] did not find an effect of screening on total cancer mortality, including breast cancer, after 10 years…” (Cochrane Review 6/4/13)

 https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD001877.pub5/full

(16) https://annals.org/aim/article-abstract/2597574/accepting-existence-breast-cancer-overdiagnosis

(17a) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5161058/

(17b) https://en.wikipedia.org/wiki/Ductal_carcinoma_in_situ

(18) https://www.ucsf.edu/news/2010/04/4401/breakthrough-method-predicts-risk-invasive-breast-cancer

(19) https://www.ncbi.nlm.nih.gov/pubmed/7831529

(20a) www.cochrane.org/CD001877/BREASTCA_screening-for-breast-cancer-with-mammography

(20b) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4415291/

(21) https://pubs.rsna.org/doi/abs/10.1148/radiol.2251011667

(22) Mayo Clinic: https://www.mayoclinic.org/tests-procedures/mammogram/in-depth/dense-breast-tissue/art-20123968

(23) www.ncbi.nlm.nih.gov/pubmed/19485945

(24) https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Management-of-Women-With-Dense-Breasts-Diagnosed-by-Mammography?IsMobileSet=false#table1

(25) https://academic.oup.com/jnci/article/108/4/djv408/2412596

(26) www.ncbi.nlm.nih.gov/pubmed/19485945

(27) https://oregon.providence.org/forms-and-information/a/ask-an-expert-breast-cancer-growth-rate/

(28) https://content.sciendo.com/view/journals/abm/8/1/article-p11.xml

(29) https://www.ncbi.nlm.nih.gov/pubmed/27767959

(30) https://www.ajronline.org/doi/10.2214/ajr.180.1.1800263

(31) https://www.pdfdrive.com/the-biomedical-engineering-handbook-third-edition-e33540972.html (“Medical Devices and Systems”) 

(32) interview with Ben Johnson, MD, DO, Los Angeles, CA (2016)

(33) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4589101/#B15