Even as Trump changes the rules under COVID, the fight to strengthen the FDA is not new to the Breast Cancer Community

By Zoë Christopher

Headshot of Zoe ChristopherAs Breast Cancer Action’s Resource Liaison, Zoë connects those seeking information and assistance with the resources they’re looking for regarding detection, treatment, and prevention of breast cancer. Zoë holds a Masters degree in psychology and spent 20 years working in the trenches of crisis intervention and support.

Breast Cancer Action has a unique relationship with the Food and Drug Administration (FDA). We are critical of missteps taken by the agency, but that criticism is not due to malice or contempt. Our watchdog role is to work to ensure the agency is operating with the highest integrity, and with consumer and breast cancer patient interests at heart. When we call out the FDA, we do so with the intention of strengthening the agency, defending the scientists who want to protect public health, and encouraging the agency to shake off external pressures from profit-seeking industry and opportunistic politicians.

I first came to Breast Cancer Action 13 years ago during our strategic planning process. Our first programmatic priority was putting patients first: advocating for more effective, less toxic, and more affordable treatment. These three tenets have been guiding principles in how we evaluate the work of the FDA, throughout myriad breast cancer drugs and devices we’ve seen them review.

Our work on breast implants has gone on as long as we’ve been in existence. Beginning in the early nineties, we catalogued the problems women experienced with their breast implants, and advocated for better education and greater transparency regarding risks. As a social justice and feminist organization, throughout this time we have grappled with the paternalism of the medical industrial complex, as well as the misogyny and over-sexualization of women’s bodies that is at the core of the pressure to reconstruct with breast implants following mastectomy.

Calling on the FDA to implement the highest standards of safety and efficacy, for both drugs and medical devices including breast implants, is not new for us. What is new is the never-before-seen pressure on the FDA from the Trump administration.

Today, the FDA is under extreme pressure to rush approvals to market for COVID-19 treatments. The deleterious part of this process is issuing Emergency Use Authorizations (EUAs) which allow for treatments based on less supportive data than standard drug approvals require. Despite being widely criticized by both scientists and legal scholars, the Trump administration’s unrealistic push to get COVID-19 vaccines to market as soon as possible has undermined the integrity of the already abbreviated Emergency Use process, allowing under-studied treatments to be rushed to market. 

The FDA and BCAction – Drug Approvals

Breast cancer advocates and activists are all too familiar with the consequences of rushed approval processes.

In 2007, shortly after I came to BCAction, the drug Avastin® was a metastatic breast cancer treatment approved through the FDA’s accelerated approval program. We were the only breast cancer organization to actively oppose it, which was a controversial stance. We believe a drug should improve a patient’s quality of life, improve overall survival, and/or cost less than already-available treatment and Avastin was not that drug.

At first, it was hard for me to understand why we would push back on a treatment for women with metastatic breast cancer, or MBC. Like many people, I felt that any potential chance of treating MBC was better than none, and that these women should have access to any drug that might help. But I also became aware of the power held by pharmaceutical companies, and I understood the importance of protecting women from drugs that had the potential to produce devastating side effects.

Sure enough, on December 16, 2011 the headlines read: “The FDA recommends that Avastin not be used to treat breast cancer.” I remember being at the San Antonio Breast Cancer Symposium when it was announced that approval had finally been revoked, because it did not improve quality of life or lengthen survival. There was such a sense of relief in the room, among both doctors and patients; I felt like we’d fought the good fight and won on behalf of those we serve.

We’ve continued to take similar positions:

  • In 2008, we called for the FDA to prohibit the use of erythropoletin stimulating agents (ESAs) in breast cancer patients until more research was conducted into whether or not the drugs stimulate cancer growth.
  • In 2015, we spoke up about the FDA granting accelerated approval for Ibrance® (palbocicilib) without data to show that women live longer.
  • And in 2017, we called out the FDA for granting accelerated approval for Neratinib®, which was supposed to slightly reduce the risk of recurrence. However, there was no evidence of improving survival or reducing side effects.

We want to see new effective, less toxic treatment for breast cancer, but we don’t want patients to be guinea pigs. Treatment decisions that follow a breast cancer diagnosis are so personal, and we want those decisions to be informed. Some women base their decisions on wanting to see their children graduate or marry: they want as much time that they can have regardless of how they feel physically. There are women who chose quality of life over everything else. And there are women who refuse to accept the slash/burn/poison approach to treatment and want nothing to do with the standard of care. We will continue to demand high standards of safety and efficacy, even when it might appear that we are pushing back on breast cancer therapies.

The FDA and BCAction – Breast Implants

Breast Cancer Action has been pushing for post-market surveillance and studies of breast implants since before I came to the organization. In the early 1980s, the FDA began to review the safety and effectiveness of silicone breast implants, and urged manufacturers to conduct long-term controlled clinical trials. But unfortunately, the manufacturers and the American Society of Plastic Surgeons responded by funding public relations campaigns to put pressure on the FDA and to counteract negative publicity surrounding the product. Whatever research that had been published was by and large weak and characterized by conflict of interest. BCAction has persevered, and we’ve been pushing for required black box warnings and transparent risk assessments, including improved informed consent processes throughout this time. 

While we work to evaluate the safety of breast implants, at the same time we have to reckon with the misogyny and patriarchal beauty standards that are inextricable from the pressure to get breast implants following mastectomy.

One would hope that in the case of a mastectomy, a person’s health would be put before the pressure to uphold artificial standards of femininity. But that is not the case, and we work with breast cancer advocates who have been told they cannot have mastectomies without breast implants. Women are consistently pressured to reconstruct with devices that aren’t proven to be safe, and contrived aesthetics are put before our health concerns in a male-dominated field of physicians and plastic surgeons.

As early as the 1970s, women were reporting a range of harms and health issues related to breast implants, including what is now called Breast Implant Illness (BII), disfigurement, disability, and other health problems. Despite how common these reported symptoms are, women are often still told it’s “all in their heads.” To this day, Breast Implant Illness is seen as “controversial,” and there are no medical codes assigned for diagnosing, treating, and billing for the illness.

On September 28, 2020, the FDA finalized their labeling guidance for breast implants, which does include a black box warning and patient informed consent checklist. Breast Cancer Action members can take pride in knowing the pressure they put on the FDA likely helped ensure these steps were taken.

But, the new breast implant labeling guidance is simply recommended to manufacturers by the FDA, not required. Because adherence to these guidelines remains voluntary, manufacturers and surgeons will still be able to minimize the risks of breast implantsBy allowing this to continue, the FDA is not doing enough to protect consumers, people considering breast implants, and people undergoing breast cancer treatment.

The Administration and How to Move Forward

I can’t remember a time in my life when distrust of federal agencies has been so pervasive. And with ongoing deregulation, public health and safety are imperiled. We need strong leadership that we can trust, leaders that listen to our nation’s top scientists and who instill trust in the safety and efficacy of all drug and device approvals, from the newest COVID-19 vaccine to breast implants that have been on the market for decades.

Leadership in the administration and at the FDA makes a big difference in the reach and the priorities of the agency. The FDA isn’t perfect but “streamlining” the agency by the current administration has meant there has been an unnecessary hiring freeze and drastic cuts to funding, and safety standards have been relaxed to the detriment of consumers.

At Breast Cancer Action, we believe the FDA should be updating and improving regulations that will protect vulnerable populations, and that regulations that weaken FDA authority can have a dangerous and far-reaching impact.

We Can’t Be Pink’d

Right now, you can help push the FDA to protect patients and consumers, including people with breast implants, by signing our We Can’t Be Pink’d petition. It outlines our two demands most pertinent to the current moment: any effort to streamline regulations and approvals, including the approval of a COVID-19 vaccine, must also uphold the strongest safety standards and not compromise patient safety. And the breast implant labeling guidance must be strengthened and made mandatory.

This year’s Think Before You Pink® campaign demands long-overdue changes that will raise the bar in favor of public health, and demand these agencies fulfill their mission to protect and serve the public good. It’s not just about halting the breakdown of these regulatory processes; it’s about improving what’s in place and developing transparency of and trust in agency leadership.

Until we have fully prevented breast cancer, I want women to have treatment choices, and the hardest stories for me to hold, as BCAction’s Resource Liaison, are those of women who don’t have choice. I’m proud that BCAction is the watchdog that continues to push for corporate transparency and accountability. Join us as we work to address and end the breast cancer epidemic, by calling on the FDA to do better.

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