The EARLY act - issues and controversies

On March 26, 2009, Representative Debbie Wasserman-Schultz (D-FL) introduced a bill with a stated objective to increase awareness of the risks of breast cancer in young women and provide support for young women diagnosed with breast cancer. The bill (H.R. 1740) was referred to as the Breast Cancer Education and Awareness Requires Learning Young Act of 2009 or EARLY act.

According to a press release from Congressman Schultz, The EARLY act "directs the Centers for Disease Control to develop and implement a national education campaign to increase awareness of the threats posed by breast cancer in young women of all ethnic and cultural backgrounds, and the particular heightened risks faced by certain groups. The campaign will help young women and providers identify the specific threats and warning signs of breast cancer that lead to early diagnoses, and prevention efforts women can undertake to reduce their risks."

One would think that this legislative effort would have been applauded by most groups who are concerned with the care of women with breast cancer. In fact, there are many within the medical community who have voiced concerns about the legislation. The National Breast Cancer Coalition (NCCN) suggests that the bill is based on several false premises, contains incorrect information, and will not achieve these goals. The full text of their analysis is available here - http://www.stopbreastcancer.org//index.php?option=com_content&task=view&id=944&Itemid=179. The NCCN memo questions several premises in the bill (the comments that follow each point are outlined from the NCCN analysis):

1. That breast cancer in women under 40, an admittedly rare occurrence, necessitates a broad public health campaign and education in secondary schools and universities

The EARLY act is directed at women under 40. The NCCN suggests that this may be an inappropriate population to target with a large public health campaign. According to the American Cancer Society, during 2000-2004, only 5% of new cases and 3% of breast cancer deaths occurred in women under 40 years of age. For women aged 20-24, there were 1.4 cases per 100,00 women

2. That we know what women should do to prevent or lower their risk of breast cancer

There is very little known about what puts a woman at avoidable risk of breast cancer at any age. We do not know how to prevent breast cancer. Evidence for an association between dietary factors and breast cancer has been largely inconsistent and modest at best

3. That breast self examination and clinical breast examination are effective in saving lives in this age group

According to information on the National Cancer Institute website, breast self-exams cannot replace regular screening mammograms and clinical breast exams. Studies have not shown that breast self-exams alone reduce the number of deaths from breast cancer (http://www.cancer.gov/cancertopics/wyntk/breast/page5).

4. That ethnicity is sufficient to trigger genetic counseling and testing

The bill is based on the belief that women “including, but not limited to the African-American and Ashkenazi Jewish populations under 40 years of age” should contemplate genetic counseling and testing. Despite the association between mutations in these genes and breast cancer, only 5-10% of all breast cancer patients have BRCA1 or BRCA2 mutations. Scientists believe there may be other unknown genes that are strongly associated with breast cancer risk. However, the large majority of breast cancer cases are "sporadic" cancers; in other words, the individual has no known inherited predisposition to breast cancer

5. That there are significant differences in what we know and what we should tell women under 40 years old versus over 40 years old

The messaging about what to do about breast cancer raises exceedingly complex questions, many of which we do not yet have answers to. What this bill contemplates is a nationwide public health campaign that will reach out to millions of women with a message that may be misleading in some instances and pertinent to a tiny percentage. The important nuances of the issues will not be captured in this type of campaign, and will result in more harm than good.

In my assessment, there is value in this public spending proposal, notwithstanding the valid points discussed above. While young patients make up the minority of breast cancer patients, the economic and social impact of an illness in a young person has clear reverberating effects. The economic impact of days lost from work and the impact of illness on a spouse and children is devastating. Moreover, educating younger women may lead to discussion regarding breast cancer screening in their parents or extended family, leading to earlier diagnosis and lower treatment costs overall. I imagine that a 40 year old woman conversing with her mother or aunt regarding the importance of screening for breast cancer has real impact. These are the analyses that I'd like to see studied under the Obama administration's emphasis on comparative effectiveness.

Update from the 25th Annual Atlanta Breast Symposium....

I am excited to be attending the 25th annual Atlanta Breast Surgery Symposium.  This is the premier meeting dealing with advances in Plastic Surgery of the breast.  It is organized by many of my former colleagues from Emory University, where I spent 2 years in Plastic Surgery residency training from 1994-1996.  It is a forum for observation of live surgical procedures, exchange of ideas among international panel of plastic surgeons, and always a source of topical information that is directly pertinent to my daily practice.

Two interesting topics were discussed during the meeting.  Firstly, the role of nipple sparing or areolar sparing mastectomy for the treatment of breast cancer or for prophylactic mastectomy was reviewed.  While nipple and areolar reconstructive procedures have advanced significantly, it is still difficult to consistently reconstruct the nipple areolar complex to mimic the natural form in all cases.  The traditional oncologic surgical model considered removal of the nipple areolar complex vital for performance of a curative mastectomy in therapeutic cases, and necessary for complete risk reduction in prophylactic cases.  For several years, researchers have looked at the possibility of leaving the nipple areolar complex and studying the impact on local recurrence of cancer.  With certain criteria (involving tumors that are remote from the nipple areolar complex or less than a certain size, ) data is beginning to suggest that preserving the nipple areolar complex (or at least the areola) may not compromise the curative goals and can definitely improve the aesthetic outcome.  This is especially compelling since the role of prophylactic mastectomy has increased in the setting of BRCA genetic mutations, or during treatment of one breast, to reduce the chance of a new cancer developing in the untreated breast.  As I have observed in my own practice, and as many at the meeting have confirmed, bilateral mastectomy (where one breast is removed to cure the cancer and the other is removed so as to prevent cancer from developing in the other breast) is becoming much more common.  While this demands further study, women should definitely ask the breast and plastic surgeons about the role of nipple areolar sparing approaches in their particular case during initial surgical decision making.

The second topic of interest was the role of fat transfer or grafting in both cosmetic and reconstructive breast surgery.  It has been controversial to remove fat from one part of the body and add it to the breast solely from cosmetic enhancement of the breast size.  It was thought that the postoperative changes that could result from fat transfer might affect the ability to accurately interpret mammograms, and produce cysts or scarring in the breasts that would be confused with suspicious changes.  Fat transfer techniques have improved over the last decade, especially when used in facial rejuvenation.  If we can more reliably transfer living fat cells from one part of the body to the face, perhaps fat transfer could be re-examined for its role in the breast.  For several years, fat grafting to improve the results of breast reconstruction (such as adding fat to the tissues above an implant to soften the transition from the upper chest to the breast or to smooth the contours after flap surgery from breast reconstruction) have been done.  In fact, these are procedures that I do often for ultimate refinement in many of my breast reconstruction cases.

The main concern with fat grafting, especially for breast augmentation, is the possibility that the stem cells that are harvested in the fat, may release substances into the breast with unknown effect.  Might the transferred fat stimulate cancerous changes in breast cells in the future?  What about using fat transfer after mastectomy where the breast has been removed? Clearly, further study is needed, and board certified plastic surgeons are positioned to answer this question through further research.  I am optimistic about an increased role for fat transfer to the breast in the future.

Some Hidden Choices in Breast Reconstruction

The New York Times published an interesting article on breast reconstruction ( www.nytimes.com/2008/12/23/health/23beauty.html?em).  The premise of the article was that some plastic surgeons do not offer their patients all of the available options for breast reconstruction because they are not proficient with all of the techniques.  The was some suggestion that some complex surgical options are not discussed by plastic surgeons at all because the insurance reimbursement is disproportionately low, which deters some plastic surgeons from performing those procedures at all.

I have discussed making decision for surgical treatment in earlier posts.  This article highlights that some women are making reconstructive choices based on only limited information.  Amy Alderman, MD is quoted in the article, and she highlights a larger problem that many women who have breast cancer are not even made aware that reconstruction is available to them, and that limits the decision making process one step before a patient may even see a plastic surgeon.  

Remember that these issues may even affect the initial surgical decision options.  How many breasts surgeons discuss breast conservation therapy using oncoplastic techniques, where a plastic surgeon may be able to reshape the remaining breast tissue at the time of  extensive lumpectomy to prevent a breast deformity?  How many breast surgeons discuss skin sparing or nipple sparing approaches in prophylactic breasts surgery?  If a breast surgeon is being reimbursed disproportionately high to place a MammoSite catheter in the breast in their office, is there a disincentive to discuss mastectomy and the fact that reconstructive surgery is available?  How many breast surgeon discuss the Women's Health and Cancer Rights Act at the time of initial surgical decision making?

What I strive to do in a preliminary consultation is to offer patients a general overview of all of the available surgical options from implant based techniques to autologous techniques, using a patients own tissues.  I hope to outline the different surgical approaches including microsurgical techniques.  What is even more important, however, is realizing that the shared decision model demands a customized risk factor analysis to take be performed which allows patient to make more informed choices.  

While some patients find the option of using their own tissues for breast reconstruction attractive because of the possibility of improved body contour if abdominal tissue is used, they may be at higher risk of complications related to comorbidities like hypertension and diabetes, or patient risk factors like high BMI (body mass index), previous abdominal incisions, or smoking history.  While some find options of using breast implants for breast reconstruction more attractive, they may be at higher risk of complications if they have had previous radiation therapy to the breast or may require post-mastectomy radiation.  There is also a higher inherent risk of re-operation related to scar formation around the implants and implant rupture.  There are also aesthetic limitations that may be inevitable when implants are used for breast reconstruction, especially if an implant is used to reconstruct one side only.

A shared decision model relying on providing the complete range of options to patients and performing a customized risk factor analysis for possible complications of each option in each patient is the current model that I prefer.  Patients need to be informed of their rights under the Women's Health and Cancer Right Act at the time of initial diagnosis of breast cancer, that may precede their initial surgical evaluation by several days or weeks.  

There are several excellent books that women should consider reviewing at the time of their initial breast cancer diagnosis that will allow them to ask better questions and make more informed choices for regarding breast reconstruction - A Woman's Decision: Breast Care, Treatment & Reconstruction and The Breast Reconstruction Guidebook.

Back into the blogging mode...

I was reminded by a patient that blogging actually involves updating my posts with some kind of regularity!  Well, I do appreciate that advice and I am back to continue what I started back in the spring.  I think that I was looking at each post as a chapter in a textbook rather than as a running discussion of topics of interest to me and those involved in treatment of breast cancer.  I would appreciate any comments from readers regarding topics that I can blog about and I will try to get back in the habit of posting more regularly.

This month I have several breast reconstructions scheduled.  Interestingly, all of the cases are bilateral reconstructions, and in 3 cases, the cancer is only in one breast and the mastectomy is being done prophylactically, and in 1 case, the patient has tested positive for a BRCA gene mutation and is electing to have prophylactic bilateral mastectomy.

I recently read a book by Jessica Queller called Pretty Is What Changes: Impossible Choices, The Breast Cancer Gene, and How I Defied My Destiny. She is a television writer in her mid 30s who is tested for the BRCA gene mutation after her mother dies of ovarian cancer, after surviving breast cancer.  It is a frank account of her emotions upon learning the results and how she dealt with the choices she had, ultimately choosing bilateral mastectomy and reconstruction with tissue expanders and implants.  She did seem to suggest that a female plastic surgeon was somehow more "qualified" to understand her ordeal, though I would suggest this as a generalization.  In any case, I thought it was a timely book, considering that the BRCA gene mutation testing is inevitably going to become more common, and prophylactic mastectomy seems to be a choice that many more patients will be considering.  

I am aware that women often choose to have a mastectomy of the normal breast at the time of mastectomy to treat the breast with cancer (prophylactic on the normal side, therapeutic on the side with cancer).  What I hear from women who make this choice is that the uncertainty of knowing what the future holds if the normal breast is not removed, the need for constant mammographic screening, the question of why they got breast cancer in the first place, which by itself serves as a risk factor for the development of breast cancer in the future, leads many women to consider bilateral mastectomy.  With reconstruction outcomes improving, I think that women see a bilateral mastectomy with reconstruction as an empowering choice.

As always, I look forward to hearing from readers especially for suggestions regarding future blog posts.

More on decision making in breast cancer treatment...

It has been a few weeks since my last post. It is amazing how life sometimes gets in the way of sitting down and thoughtfully posting a blog entry. I am excited about some recent things that have happened and I hope they allow me to continue to improve on how I and others provide care for women with breast cancer.

A few weeks ago, I was invited to Ethicon Inc., a subsidiary of Johnson & Johnson, to give an educational lecture about breast cancer reconstruction. Ethicon is a medical device company with a plastic surgery product division. Most of their products are sutures and equipment related to wound closure, especially in the bariatric and post-bariatric body contouring market, but they are marketing a product that they hope will be useful in reconstructive plastic surgery. I hope to talk more about the product in the future, but briefly, it is an allograft - human tissue harvested from cadavers and processed so that when implanted in a patient it is not recognized as foreign tissue and rejected. It serves as a scaffold for wound healing and regeneration, and has an expanding role in certain techniques in breast reconstruction. It is marketed under the name Flex-HD. I am hoping to work with Ethicon in developing educational tools for patients and clinicians dealing with issues in reconstructive breast surgery.

I was also recently appointed as Chief of the Division of Plastic Surgery at Good Samaritan Hospital in West Islip, NY. I am looking forward to interfacing with the Breast Health Center at Good Samaritan and working to create a local and regional Specialty Center for Breast Restoration for immediate breast reconstruction after mastectomy and for the prevention and treatment of deformities associated with breast conservation surgery. As a surgical attending on the staff at Good Samaritan for the last several years, I have been privileged to develop a busy clinical practice in breast reconstruction. I would like to work with others at the hospital formalize the working relationships among all the specialties caring for women with breast cancer - those involved with diagnosis, support, and treatment.

Anyway, in my last post, I was discussing some issues regarding decision making in surgical treatment. There are some interesting research reports that shed some light on this process as it pertains to making decisions for surgical treatment of breast cancer. Does what the breast surgeon discuss at the initial consultation affect women's choices for treatment? Are their decision aids that can be used to improve communication and enable women to make choices more effectively? Should the decisions for initial surgical treatment be made by the physician, the patient, or shared? The list of questions seems almost endless! Imagine the challenges that women who are recently diagnosed with breast cancer face when they need to make surgical choices to begin their treatment.

Amy Alderman, MD and her colleagues continue to do pertinent research in this area. They surveyed patients and surgeons (in a defined group of breast cancer patients in Detroit and Los Angeles) asking whether patients reported having a discussion regarding breast reconstruction with the breast or general surgeon, whether the discussion had an impact on their willingness to be treated with mastectomy, and whether the patients, in fact, had received mastectomy as primary treatment of their breast cancer. This study is reported in the journal Cancer in 2008. What Alderman and her colleagues found was quite informative. In their study, only 33% of surgeons discussed breast reconstruction during the decision making process. The discussions were more often with younger women who were more educated, and who had larger tumors. Knowing about the reconstructive options significantly affected patients willingness to undergo a mastectomy. In fact, patients who discussed reconstruction at the initial consult were 4 times more likely to undergo mastectomy than those who did not.

I will discuss decision aids and the idea of "shared" decision making in the next post. I am finding that each blog entry can branch off in so many different directions. I am looking forward to read the comments to see if readers have questions in a particular area.

Making decisions for surgical treatment

I have always been curious about the process by which patients make decisions about their care.  I remember being in fellowship training in Hand & Microsurgery at the Massachusetts General Hospital.  I supervised 2 chief residents in plastic surgery, 2 junior residents in plastic surgery, and whichever general surgery residents were rotating on the Plastic Surgery Service that particular month.  One of the most frequently performed procedures we did on call was replantation of amputated fingers.  As a matter of course, most of these cases were done late into the night.  Sometimes I felt that we were the only replantation center for the whole city of Boston considering the volume of work we did.

Obviously, most patients WANTED everything done to save the amputated part.  But we (the community of replantation surgeons) knew from more than 2 decades of accumulated experience that just because a finger COULD be replanted, did not mean it SHOULD be replanted.  In other words, a single digit amputation through zone II (from the mid palm past the middle knuckle of the finger - where the 2 flexor tendons run through a delicate sheath where scarring can significantly effect function) may survive, but may be more of a functional hindrance than a help.  But who wants to walk around with a stump for a finger?  But if you are a manual laborer who supports their family, and return to work will be significantly prolonged with replantation and rehabilitation of a single amputated finger, and functionally one could perform their job capably without the finger replanted - what is the right choice?  In these cases, recommendations by the surgeon play a major role in the decisions ultimately made by patients.  Maybe there is a "better" choice to be made based on the available information.

Women who are diagnosed with breast cancer face several initial choices for surgical treatment - breast conservation versus mastectomy.  These treatments have been shown to lead to equivalent survival rates.  What influences what choices are made?  Shouldn't patient preference be a major part of the decision making process because of the equivalent survival rates?  I will describe some interesting findings about decision making in early stage breast cancer in my next post, but I wanted to try a reader poll about the subject.  I am sure there is nothing too scientific about the poll I have posted on the sidebar, but I am interested more in the readers' commentary than the answers per se.

Referrals for breast reconstruction

As a board certified plastic surgeon, I deal with issues surrounding breast reconstruction on a daily basis. But as I speak to most patients at their initial consultation once they have been newly diagnosed with breast cancer, it is clear that most people are unaware of most of the surgical options for treating and hopefully curing breast cancer, let alone the options for reconstruction after mastectomy. The standard primary treatments available to women with breast cancer are either lumpectomy with radiation therapy to the remaining breast (also know as breast conservation therapy) or mastectomy. Studies have shown that survival rates after either treatment are similar.

Interestingly (or sadly as I see it), only a small percentage of women who undergo mastectomy have reconstruction. The 2 studies that I reviewed (one by Monica Morrow, MD and her colleagues published in 2001 in the Journal of the American College of Surgeons, and another by Amy Alderman, MD and her colleagues published in 2007 in the journal Cancer) suggest that in the last 2 decades the rate of postmastectomy reconstruction has increased from about 3.4% in the mid 1980s to about 16% in this decade. Why is the referral rate for breast reconstruction so low?

Unfortunately, misinformation and old attitudes persist. In the early "modern period" of breast reconstruction (1980s), some were concerned that breast reconstruction would limit the ability to detect local recurrences of cancer, or that compromises in the surgical removal of the breast cancer would have to occur to ensure a better reconstructive result. Both of these misconceptions have been disproved.

What these studies revealed is that some surgeons are reluctant to refer women who are "older" for reconstruction (over 50!). I think that this attitude still persists among some general surgeons. I have performed breast reconstruction on many women in their 60s and 70s when they are medically fit and motivated to have reconstruction. There is also a lower tendency for women of lower socioeconomic status to undergo reconstruction. Alderman's study suggested that low referral surgeons cite cost of reconstruction, availability of plastic surgeons, low patient knowledge, and low patient priority for reconstruction as reasons to justify the lower referral rate. Despite the 1998 Women’s Health and Cancer Rights Act (WHCRA), a federal law establishing that insurance companies covering mastectomy must also pay for breast reconstruction, the number of reconstructions done in the USA remains low. I hope to cover the WHCRA in more detail in later posts.

There were some suggestions that high referral surgeons were more often women, with breast surgery making up a higher proportion of their practice, and often associate with a cancer center. My own experiences suggest that this may be a generalization. Most of the surgeons who refer to me are male, but I think the reason they refer as frequently as they do is that I made an effort to educate them and their staff about the surgical options for breast reconstruction after mastectomy. My staff works well with the staff in their office to coordinate surgical schedules so the patient and all physicians are accommodated promptly. Patient education is where it's at - I'll try to cover some strategies for improving decision making for patients in later posts.

I am excited about where this blog is heading....I am anxious to see comments from any one who wishes to share them!