From the Breast Diaries:

First, Do No Harm: The Spectacular Failure of a Government Panel

As a veteran of World War II, my grandfather was a GI Bill success story, the first man to go to college from his impoverished neighborhood in Jersey City thanks to government at its finest.   A card-carrying member of the state teachers’ union, and a politically active Democrat for most of his life, it came as something of a shock to me when, after a few decades of observing big government debacles, my grandfather became one of Ronald Reagan’s most ardent fans.  I still remember his delight over the classic Reaganism, “The nine most terrifying words in the English language are, ‘I’m from the government, and I’m here to help.’”  To paraphrase the Gipper, Here we go again.

The United States Preventive Services Task Force (USPSTF), a panel appointed during the George W. Bush Administration and supported by the federal Agency for Healthcare Research and Quality, a branch of the U.S. Department of Health and Human Services, issued recommendations regarding breast cancer screening in 2009.  This panel consisted of physicians in primary care (internists, pediatricians, Ob/Gyns), nurses, epidemiologists, biostatisticians, and public policy officials.  Not one single breast cancer expert (breast surgeon, oncologist, radiologist, radiation oncologist) was included at the table, and there was neither invitation nor opportunity for breast cancer experts to address the panel before the recommendations were handed down.  The panel recommended screening mammograms every other year, beginning at age 50; this was a significant departure from the 2002 USPSTF recommendations, which called for annual screening commencing at age 40.  Incredibly, the panel also recommended that women should not be taught or encouraged to do breast self-examination, and that physicians should not perform clinical breast exams on their patients to check for cancer. Instead of being applauded as one of the few interventions in the healthcare system that actually saves people, with a 30% reduction in breast cancer mortality in the U.S. since 1991, breast cancer screening was under attack.

To support its proclamations, the panel used a computer model to create new, non-peer-reviewed data extrapolated from previously published studies on mammography screening. (At least Colin Powell wasn’t tapped to bring in the poster boards this time.  The man is still my hero, despite all of that.)  Some of these papers were decades old.  The USPSTF used the lowest estimate of mortality reduction attributed to mammography (15%) among the various numbers that exist in the literature (as high as 54%).  Even with their selective use of a low mortality reduction figure to create their new numbers, the USPSTF’s own “data” confirmed that significantly more women would survive if mammography screening began at age 40.   But they ignored their own data, and they claimed that the supposed “harms” of screening (discomfort, anxiety, being called back for additional pictures, potentially having a needle biopsy that turns out to be benign, the risk of diagnosing cancers that wouldn’t necessarily kill the woman— though no one can tell us which cancers those are at the current time) outweigh the benefit of lives being saved.  This was clearly not an objective, impartial scientific judgment; this was a value judgment, made with the over-arching goal of creating cost-saving public-policy recommendations for a broken healthcare system.

In practice, we are beginning to see the fallout from that judgment.  The infamous “death panels” have already landed, folks.  But contrary to expectations, it’s not grandma’s plug that’s being pulled; it’s women in their 40’s who are being hung out to dry.

The yellow circle in the mammogram image below denotes a 0.7cm invasive ductal carcinoma in a woman in her 40’s who decided not to follow the USPSTF guidelines, and to continue annual screening.  This patient’s cancer was detected at stage I, with an estimated 5-year survival rate of 95%, an excellent prognosis.  Her treatment consisted of a lumpectomy (breast conserving surgery) and radiation therapy.  Chemotherapy was not required:

7 cm Invasive Ductal Carcinoma breast

 

The mammogram image below is from a woman in her 40’s who had not yet had a baseline mammogram, and decided to put off screening until she turned 50 after she’d heard the USPSTF recommendations.  One day she felt a lump in her breast, and her doctor sent her for a diagnostic mammogram.  The yellow arrow in the image points to a 2.7cm invasive ductal carcinoma, at the site of her palpable lump.  Unfortunately, this patient’s cancer had metastasized by the time it was diagnosed; her cancer is stage IV, with an estimated 5-year survival of 20%.  Because her tumor is large compared to the size of her breast, a modified radical mastectomy (full breast removal) was recommended; the patient will also require many rounds of chemotherapy, and the best she can hope for is remission:

2.7cm invasive ductal carcinoma

It has been estimated that if the USPSTF recommendations are followed as clinical guidelines, 20% of breast cancer deaths will occur in women who could have been saved.  We have excellent data on mortality reduction as a result of screening women in their 40’s from numerous sources, including Dr. Laszlo Tabar’s group, Dr. Hendrick and Helvie’s study, and research presented from the Elizabeth Wende Breast Center in November 2011, to support the assertion that the USPSTF guidelines should be revised. In addition, this month’s edition of the journal Radiology published important original research concluding that mammography screening for 40- to 49-year-old women significantly decreases mortality.

The authors of this most recent study also found that cancers in women in their 40’s that were detected by mammograms required less invasive surgery (more lumpectomies rather than mastectomies; less lymph nodes removed), and these patients needed chemotherapy less frequently. These considerations were not even given a passing nod or mention by the USPSTF.  These important additional benefits for women in their 40’s, when many people’s lives are impacted if these women become sick, include:

  • Higher likelihood of being a candidate for breast-conserving surgery, with a better cosmetic outcome.  Don’t let anyone shame you into thinking that you are shallow and vain if you believe this is an important consideration.
  • Less likely need for chemotherapy—i.e. no hair loss, vomiting, fatigue, premature menopause, and a myriad of other side effects both temporary and permanent; less time missed from work and family obligations; less psychological trauma for yourself, your spouse and your children; less career disruption and the potential for discrimination due to your illness.
  • Less expensive treatment.  In a world where even patients with “good insurance” end up spending a great deal of their own money out-of-pocket when they have cancer, sometimes putting themselves and their families into debt to cover the costs, this consideration matters a great deal.  Estimated cost to treat early stage breast cancer:  $14,000.  Estimated cost to treat advanced breast cancer:  $140,000. 
  • Less likely need for complete removal of lymph nodes under the arm (axillary dissection), avoiding the potential lifelong misery of a chronically swollen and painful arm (lymphedema).

Any useful discussion regarding the value of screening for breast cancer must consider morbidity as well as mortality.  It is severely unfair to women if these factors are left out of the debate, as they invariably have been until now.

I am not suggesting that screening mammography, even when started annually at age 40, is a panacea.  If a woman has dense breast tissue, as half of women under 50 and 1/3 over 50 do, mammography is limited in sensitivity, many early cancers will not be seen on the mammogram, and a woman needs to discuss with her physician the possible need for an additional test in order to be effectively screened.  Even for women who do not have dense breasts, mammography can be imperfect, which is why self-examination and clinical breast exam by your doctor are so important.  In addition, women at high risk for breast cancer should develop an individualized, proactive screening plan with their doctor in order to protect themselves.

Breast cancer is the single most common cause of death in women age 35 to 50.  If there’s any time to screen for it, it’s then.  Don’t take one for the team on this.  Cost savings for the system should not be attained by sacrificing women in our 40’s.  An enlightened government should refrain from messing with what works, and should support efforts to make screening for breast cancer even more effective.

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  • Jessica

    Dear Dr. Vitiello,

    This is a wonderful site. I wish I had discovered it earlier. I did all the right things, but yet I wound up with Stage 2 B breast cancer at age 51. On the subject of regular mammograms, I had two back to back per year for a decade. I had dense breasts which I was not told about and was called back 1 week following the screening mammo every time for “more views.” Ironically, this cost me an xtra $300/ yr out of pocket because insurance would only pay for 1/yr. In 2005 I had a stereotactic biopsy from the wrong spot that came back benign, so all subsequent “growing and spreading calcifications were deemed “benign appearing or probably benign” with a BIRADS rating of 2. In 2009, the mammo rept to my ob-gyn read that probably benign calcifications were now covering the entire lateral side of my right breast and to come back in 6 months. My obyn gave me a script to go back in 6 mos and said that “repeat mammos will be less of an issue once I’ve finished menopause.” 6mos later (Jan 2010), the radiologist said I needed another stereo biopsy (5 years after the 1st stereo) because of a suspicious finding. Stereo again from the wrong spot diagnosed DCIS. Referred to breast surgeon who referred me for MRI. The calcifications and margins exceeded 8 cm. There was a clumped enhancement which “coalesced into a masslike appearance” and a probable pericardial or mediastinal cyst roughly 1 cm in size. The radiologists findings were that the MRI readings were “consistent with biopsy proven extensive DCIS.” On the other breast parenchmal enhancement and probably benign calcifications required that I come back in 6 months. I had Bilateral Mastectomy (required on right breast, requested on left.) Sentinel node biopsy revealed an 8 mm metatasis, leading to an AND -12 nodes total- and path discovered 2.5 cm invasive ductal carcinoma tumor with 1/12 nodes positive for cancer. Referred to oncologist.

    Oncologist assumed I was postmenopausal because I had a hysterectomy. I requested blood test and I was in fact pre-menopausal. That onc proposed clinical trial 6 cycles of TC. I sought a second opinion and 2nd onc prescribed dose dense AC followed by T chemo. I demanded oncotype test and it showed that chemo would only reduce my risk 2% plus or minus 5%.(The oncs told me chemo would reduce risk 15 to 20%) Took a pass on chemo. Dictated my own care, and I had my ovaries removed and am taking Arimidex. (which my onc says after the fact –was a good decision). Two years out I have discovered nodules in both breasts. Had surgical biopsies last week because I have implant reconstruction, and the path report came back “distorted breast tissue” with no metastasis seen. I shouldn’t have breast tissue since I had mastectomies and the biopsy showing breast tissue is from a spot very close to the original cancer. Now, I don’t know if there’s nothing seen because of distortion or because there’s no cancer.

    Needle biopsies are a needle in a haystack and surgical biopsies destroy the tissue sample. I am 2 years post bilateral mastectomy, oophorectomy and taking a drug that makes me feel miserable. The worst part about this though is my complete distrust of the medical profession and the constant fear that this disease is going to kill me, and my doctors could care less. I didn’t participate in their clinical trials so I am treated as a statistic. By the way I receive my “care” from INOVA Fairfax–the same place where Dick Cheney had heart transplant surgery–these are not uneducated or unskilled Drs. The area is very affluent, and the hospital has grants for breast cancer in the hundreds of millions of dollars. These are careless and dismissive doctors who non challantly have made erroneous assumption after erroneous assumption at my expense. The only reason they haven’t been sued for malpractice is because of Virginia Torte reform’s statute of limitations and a $1.5 million cap on awards–meaning that once the lawyers and insurance companies take their cut first, there’s nothing left for the victim—and that’s assuming you win. If you don’t there’s a $100,000 bill to pay for fees and “expert witness” testimony.

    Survival statistics presented in terms of 5 years is another disservice to women. ER positive breast cancer is slow growing. The odds are it will take 5 years for the cancer to grow back. There are plenty of women diagnosed with Stage 1 breast cancer that die of the disease–just not necessarily in 5 years.

    What’s the answer? I don’t know, but I’m sick and tired of all the lies about mammos, early detection, improved treatment and “decreased mortality rate.” There’s been no change is detection, treatment (unless you’re Her2 positive) or number of fatalities/yr in 40 years. The rate is lower because more women are being diagnosed with DCIS–a pre-cancerous condition now called cancer to improve the death rate statistics.

    • seewhy

      you said it. i am so sorry for what happened to you.

      fyi: the author totally misstates the likelihood of the need for chemo based on early detection. Not so. Research has proved that chemo only works for certain tumor types and has little to do with tumor size or even staging. So early cancers could need chemo.

      Ladies–do your homework before submitting your body to this highly toxic chemical. The latest research indicates that only 15% of women benefit from chemo. Source: NCCN National Comprehensive Cancer Network (nccn.org) My doc denied this – said every breast cancer patient must have chemo – until i printed it out and showed her. Then she looked right at me and lied and said she hadn’t said it! (and this at sloan kettering no less). We desperately need docs we can trust to cure us but not over treat us in the process.

  • JaneW

    I think you’re missing the point:

    Mammograms don’t work properly in women in their 40s. False negatives abound, as do false positives, since the breasts of premenopausal women are so dense.

    And breast cancer as the major cause of death for women aged 35-50? Sorry, lung cancer has it beat. But accidental injuries still top out both of them. (Source: National Vital Statistics report, 2009.)