Tag: mastectomy

Bioethics Blogs

Insurance coverage for fertility preservation for cancer patients

As I have discussed in previous blogs, fertility preservation for cancer patients can be quite expensive and insurance companies do not cover it. Fertility preservation for cancer patients is excluded even insurance companies cover infertility treatment because cancer patients are generally not currently infertile, but instead they have anticipated infertility due to their cancer treatment. I have argued that insurance companies should cover fertility preservation because it is not ethically different from other treatments for iatrogenic conditions currently covered for cancer patients. For example, insurance covers other quality of life treatments such as wigs for alopecia and breast reconstructive surgery following mastectomy. Like these treatments, fertility preservation is not lifesaving, but can significantly improve quality of life, as infertility can lead to depression, anxiety, and distress. Since much of medicine today focuses on improving quality of life for people with non-life threatening conditions (e.g. poor vision, back pain, seasonal allergies, sexual dysfunction, etc.), it does not make sense to exclude fertility preservation on the basis that it is not life saving.  

However, some question whether fertility preservation for cancer patients is a just use of finite health care resources based on economic reasons. One cycle of IVF is on average $12,400 and estimates for ovarian tissue cryopreservation range from $5,000-$30,000. Furthermore, annual storage fees for frozen gametes and embryos can run up to hundreds of dollars a year While ART are very expensive on the individual level, they are not on the broader social level: in fact, they account for only 0.06% of the total health care expenditure in the United States.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Reconsidering Cancer Screening Programs October 22, 2015 Screening saves lives, but not ever…

October 22, 2015

by Sean Philpott-Jones, Director of the Bioethics Program

In a public commentary that aired a little over a year ago, I caused quite a stir when I discussed the case of Amy Robach, the then-40-year-old ABC News correspondent who was diagnosed with breast cancer after receiving an on-air mammogram conducted as part of a Good Morning America story about cancer screening programs. Ms. Robach underwent a double mastectomy shortly after her diagnosis and is currently cancer free.

In that commentary, I raised concerns about the message that story presented to the American public about the utility of breast cancer screening programs. Specifically, I worried about the idea, promoted by organizations like the American Cancer Society and Susan G. Komen for the Cure, that all women should undergo screening as early as age 40. Best safe than sorry, right?

But not everyone recommends routine mammography for women starting at the age of 40 — including women like Amy Robach — unless they have a familial history of breast cancer. Those are the cancer guidelines issued in 2009 by the US Preventative Services Task Force, an independent and non-partisan group of healthcare experts. The Preventative Services Task Force concluded that most women should not undergo regular mammography until they are at least 50 years old.

This recommendation may seem counterintuitive. After all, breast cancer is a very serious public health issue. There are few families that it hasn’t touched, including mine. My aunt Kathryn recently passed after battling breast cancer for nearly two decades.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

From Self-Interest to Morality: How Moral Progress Might Be Possible

One of the most stunning successes I have personally seen in my life is the emergence of the Effective Altruism movement. I remember when Will Crouch (now MacAskill) first presented 80 000 hours to our Graduate Discussion Group and Toby Ord was still a grad student. From their ideas a whole movement has emerged of brilliant young people galvanised into doing good. We are getting the brightest, best people of the current generation coming to Oxford to engage with the Centre for Effective Altruism. Almost every grad student I come across has some connection. Well done Will and Toby, and all those others who have contributed to establishing this movement

So I guess I should not have been surprised when during my visit to Harvard this week, a student contacted me from EA to give an ad hoc talk. I discovered there were cells all over the world and the movement had spread way beyond Oxford.

Anyway, I gave an impromptu talk and predictably there were many questions I could not answer satisfactorily. One the issues I covered was the need to create a new basic (or minimal) secular morality. This is necessary not only to decide what the goals of moral bioenhancement should be (my favourite current pet topic), but indeed how education should be revised and society ordered. Every society has a set of normative commitments. Ours are outdated, archaic and unfit for the challenges of a globalised, interconnected and technologically advanced world.

Since we were talking about Altruism, I said one part of a minimal morality which could be justified on either utilitarian or contractualist grounds is:

Duty of Easy Rescue: when the cost to you of some action is minimal, and the benefit (or prevention of harm) to another is great, you should perform that action.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Alberto Prunetti’s “Amianto. Una storia operaia” by Cinzia Greco

Amianto. Una storia operaia

by Alberto Prunetti

Edizioni Alegre, 2014, 192 pages.

Amianto. Una storia operaia (Asbestos. A Working-Class Story) is written by Alberto Prunetti, an Italian writer who has published fiction and non-fiction since 2003. The book was originally published in 2012[i] and narrates the life of a factory worker, Renato Prunetti, the author’s father. Renato’s life is reconstructed from the 1960s when he started to work in his first factory, until his death, at 59, caused by an asbestos-related carcinoma in 2004. The second edition of the book integrates a debate (“Il Triello”) between the author Wu Ming 1 and the writer Girolamo De Michele, which further explores some themes of the main text. Wu Ming 1 is part of the writing collective Wu Ming, one of the major authorial voices in Italy today. De Michele, as the Wu Ming collective, has also worked both in fiction and non-fiction, and, as Prunetti, the two other participants also write in the online literary review Carmilla and come from working-class families and from environmentally problematic areas.

Amianto is a hybrid text. Matteo Giancotti, in a review of the book published in La Lettura, described Amianto as not a novel, nor reportage, nor a biography in its classic sense. By combining the salient aspects of the three genres, Prunetti writes a working-class story that, following the movements of the travelling factory worker Renato, retraces part of the history of the working class in Italy, from the 1970s to the end of the 1990s.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Putting Ourselves in Harm’s Way

“Get out of the way.” So said the European colonists as they pushed indigenous Africans, Americans, Aborigines, and Maoris off their own lands to make way for Christianity, urbanization, Western medicine, industry, capitalism, railroads, and global warming. And so says Dr. Pinker on behalf of biomedicine, stating what, in his view, should be the “primary moral goal” for bioethics.

“Biomedical research,” he writes, “promises vast increases in life, health, and flourishing.” To him, ethics is but a horsefly dogging the progress of the potent, muscular thoroughbred of biomedicine—an annoying obstacle bogging down life-saving research in “red tape, moratoria, or threats of prosecution based on nebulous but sweeping principles such as ‘dignity,’ ‘sacredness,’ or ‘social justice.'” If he and other scientific cheerleaders had their way, not only regulation of medical research but even serious discussion weighing potential harms and benefits would vanish, so that the researchers could get on with their task of saving the world.

Pinker’s Panglossian paean notwithstanding, biomedicine, like industrialization, has a mixed legacy. Industrialization has brought improvements in public health and quality of life, reduction of death and suffering, and profound creativity and culture. But it has also led to the destruction of cultures and ecosystems, pollution, and climate change. Further, it has increased some forms of suffering—through, for example, sweatshops, child labor, and occupational disease and injury. Industrialists, too, like to cry “Get out of the way!” to regulators who think beyond the short term.

In support of his argument Pinker invokes nebulous but sweeping principles such as health, flourishing, suffering, disability, harm, and effective treatment—all terms with real but complex meanings that shift with time, context, and geography.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Hereditary Breast and Ovarian Cancers: Moving Toward More Precise Prevention

Caption: “Homologous Hope” sculpture at University of Pennsylvania depicting the part of the BRCA2 gene involved in DNA repair.
Credit: Dan Burke Photography/Penn Medicine

Inherited mutations in the BRCA1 gene and closely related BRCA2 gene account for about 5 to 10 percent of all breast cancers and 15 percent of ovarian cancers [1]. For any given individual, the likelihood that one of these mutations is responsible goes up significantly in the presence of  a strong family history of developing such cancers at a relatively early age. Recently, actress Angelina Jolie revealed that she’d had her ovaries removed to reduce her risk of ovarian cancer—news that follows her courageous disclosure a couple of years ago that she’d undergone a prophylactic double mastectomy after learning she’d inherited a mutated version of BRCA1.

As life-saving as genetic testing and preventive surgery may be for certain individuals, it remains unclear exactly which women with BRCA1/2 mutations stand to benefit from these drastic measures. For example, it’s been estimated that about 65 percent of women born with a BRCA1 mutation will develop invasive breast cancer over the course of their lives—which means approximately 35 percent will not. How can women in this situation be provided with more precise, individualized guidance on cancer prevention? An international team, led by NIH-funded researchers at the University of Pennsylvania, recently took an important first step towards answering that complex question.

In a study published in the journal JAMA, the researchers analyzed genetic data and health information from more than 31,000 women with mutations in BRCA1/2.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Angelina Jolie Pitt: Diary of a Surgery

(New York Times) – TWO years ago I wrote about my choice to have a preventive double mastectomy. A simple blood test had revealed that I carried a mutation in the BRCA1 gene. It gave me an estimated 87 percent risk of breast cancer and a 50 percent risk of ovarian cancer. I lost my mother, grandmother and aunt to cancer. I wanted other women at risk to know about the options.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Ethics of Penile Transplants

by Craig Klugman, Ph.D.

This weekend, doctors in South Africa announced a new first—a successful penis transplant. The 9-hour operation took place in December 2014. After three months of recovery, the recipient is able to urinate, achieve an erection and a sexual response. As of yet, the recipient does not have full sensation in the organ.

The recipient was 18 years old when he underwent a ritual circumcision that went wrong and left him with 1cm of the original penis. Estimates are that dozens to hundreds of men are maimed each year as a result of these rituals.

This was not the first attempted transplant. That honor goes to China in 2006. The patient had the penis removed after he and his wife described psychological distress and strange swelling.

A BBC report said that the South African surgeons spent time asking whether this operation was ethical. After all, the recipient will be on anti-rejection drugs for the rest of his life and a penis may be psychologically and reproductively important, but it is not life supporting in the way that a heart or liver would be. Using needle aspiration and in vitro fertilization, these men could father children. Alternative methods can be fashioned to allow the elimination of urine. Sexual function though, is clearly compromised.

A 2010 article in the Asian Journal of Andrology discussed the ethical issues of penile transplant. These included surgical risks, informed consent, body image, and privacy. For the donor family, the authors identified concerns with assessing the suitability of a donor, privacy, and the consent process.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Weighing Surgical Options for Breast Cancer

Women in pink

Stock image

An increasing number of women with cancer in one breast are choosing to have both breasts surgically removed in hopes of reducing the chance of developing cancer in the unaffected breast. But does this approach—called bilateral, or double, mastectomy—really improve the odds of survival? A new NIH-funded study indicates that, for the vast majority of women, it does not [1].

A research team led by Allison Kurian, an oncologist at Stanford University School of Medicine, and Scarlett Gomez, an epidemiologist at the Cancer Prevention Institute of California in Fremont, used the California Cancer Registry to study the 10-year survival outcomes of patients diagnosed with early-stage cancer (stages 0–III) in one breast, between 1998 and 2011.

In this observational study, the researchers compared the outcomes of almost 190,000 women who chose one of three treatment options. The first is a lumpectomy, in which the surgeon removes the cancerous tumor and surrounding tissue, but preserves the rest of the breast. This is followed by radiation treatments. The second option is a unilateral, or single, mastectomy, in which the entire breast is removed. The third approach is bilateral, or double, mastectomy, which removes both affected and unaffected breasts.

The researchers documented that among women with early-stage breast cancer in this study, the rate of bilateral mastectomy jumped from 2 percent in 1998 to 12.3 percent in 2011. Among breast cancer patients age 40 and younger, that trend was even more dramatic, soaring from 3.6 percent in 1998 to 33 percent in 2011. The women most likely to choose double mastectomy were non-Hispanic whites of higher socioeconomic status with private health insurance.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

FDA Proposal for Regulating Laboratory Diagnostics Could Improve Patient Care

Wendy Chung’s commentary last month about the FDA’s proposed draft guidance for the regulation of laboratory-developed tests (LDTs) is heavily critical of the agency’s plans. Professor Chung argues that the FDA’s involvement in this space will have two primary negative consequences: it will stifle innovation and it will harm patient care.  

But the FDA’s proposal seems designed to address precisely these two consequences. The proposal could improve patient care by collecting, for the first time, clinical validity data on tens of thousands of LDTs in current use. And by using an extensive system of carve-outs, the FDA is seeking to minimize potential harms for diagnostic innovation. Understanding these key portions of the FDA’s disclosure to Congress is critical to a full policy discussion of the situation.  

The Importance of Clinical Validity Data for Patient Care

Imagine that you are a woman with an extensive familial history of breast cancer. You worry that you may have inherited a genetic mutation in one of your BRCA genes, and you would like to obtain a genetic test to determine that fact. The only commercial provider of such tests advertises a test for 10 possible mutations in those genes. You can be sure that the test accurately detects the presence or absence of those 10 mutations. This is because (as Professor Chung notes) all laboratory testing in the United States is currently regulated by the Clinical Laboratory Improvement Amendments (CLIA), under the auspices of the Center for Medicare and Medicaid Services (CMS).

But here’s the problem: because CLIA only tests for analytical validity, you can’t be sure that the test has any clinical validity at all.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.