We Can’t Be Pink’d: The FDA

THINK BEFORE YOU PINK® – 2020 CAMPAIGN

See full details and action steps on our Breast Cancer Action site at bcaction.org/we-cant-be-pinkd/fda

During the second week, launching Monday, October 12, we are calling out the FDA for not doing enough to protect patients and consumers with a petition you can sign right now.

The FDA approves treatment protocols and drugs to treat breast cancer[1] and is supposed to warn patients about risks and potential harms. However, approval doesn’t guarantee safety, and patients often don’t’ have complete and balanced information to make informed decisions. This has been a decades-long problem with drug treatments, exacerbated by the current pressure to approve drugs for COVID, and with their recently released industry weakened guidance on breast implants.

In this year’s Think Before You Pink® campaign, we are letting the administration know that  “We Can’t Be Pink’d: Say NO to Pink Policies.” Since 2002, Breast Cancer Action has led this campaign each October in response to “Breast Cancer Awareness Month.”

From the President down to agency leaders, we’re taking on the lack of leadership in addressing the breast cancer epidemic. Each week in October we’ll address one of these four agencies that needs to do better: the Environmental Protection Agency (EPA) the Food and Drug Administration (FDA), the National Cancer Institute (NCI), and the Department of Justice (DOJ).

The problem:

The breast cancer community is far too familiar with the consequences of the FDA not doing enough to protect patient health. The FDA has allowed companies to rake in profits by exposing patients to expensive, toxic treatments that don’t improve survival. And the agency generally lacks transparency in the approval and regulatory processes. This leaves patients and consumers uninformed and misinformed, putting them at risk for other health complications that can be debilitating, costly to treat, and even life threatening.

This needs to stop.

Accelerated approvals and breast cancer

The FDA has a long history of using inadequate standards to approve drugs and medical devices[2]. Over the last decade, there has been a decline in these standards.  The number of drugs that have been approved by the FDA has increased while the amount of time the FDA has taken to review drugs has decreased.[3]

One study showed the FDA granted more new drug approvals for breast cancer treatment than for any other type of solid tumor. This may sound like a victory, but a majority of cancer drugs have been approved based on narrow criteria of shrinking tumor size. The FDA fails to consider the treatment’s impact on women’s quality of life or long-term survival.

Classic examples:

  • In 2008, Avastin was approved for metastatic breast cancer under the accelerated approval program,[4] and three years later approval was revoked by the FDA due to dangerous side effects and failure to extend life.
  • In 2015, the FDA granted accelerated approval for Ibrance (palbocicilib) without data to show that women live longer.
  • And in 2017, the FDA granted accelerated approval for neratinib for its ability to slightly reduce the risk of recurrence. However, there was no evidence of improving survival or reducing side effects.

Approving experimental drugs and treatments that have not been shown to extend life or reduce side effects gives license to pharmaceutical companies to make billions of dollars on a drug before it’s proven to benefit patients.

Currently the FDA is under extreme pressure from the administration[5] to rush approvals for Covid-19 treatments to market. In these challenging times, issuing emergency use authorizations (EUA) is an important option to make promising Covid-19 treatments available. These EUAs allow the use of treatments with less data than a normal drug approval, but they still have meaningful standards that must be met. The current administration has been widely criticized by both scientists and legal scholars for undermining the integrity of the already abbreviated EUA process, allowing under-studied treatments to be rushed to market.

Breast cancer activists have seen the consequences of a rushed approval process and we’re calling on the FDA to stop repeating their mistakes. Their new approach to approvals could further lower their already low standards used to assess safety and efficacy of future breast cancer drugs, treatments, and devices.

Timely access to drugs and treatments are important, but not at the expense of compromising strong safety standards. The FDA needs a full scientific assessment of the impacts and value of the drugs being approved.

Lack of transparency and breast implants

Breast implants have been on the market for more than fifty years. As early as the 1970s women were reporting a range of harms and health issues, including what is now called Breast Implant Illness (BII), disfigurement, disability, and other health problems. These problems persist to this day.

In 2011 the FDA acknowledged the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare but serious cancer of the immune system. In 2019, the FDA finally issued a Class 1 recall of one company’s textured implant products because of the increased risk of BIA-ALC.[6]

Recently, on September 28, the agency finalized their guidance for breast implants, but adherence to these guidlines remains voluntary, allowing manufacturers and surgeons to minimize the risks of breast implants[7]. It’s the FDA’s responsibility to ensure anyone considering breast implants be fully informed to make the best decision. The agency can improve transparency of potential health risks by making mandatory an explicit boxed warning. Easy-to-understand Patient Informed Consent Checklists must also be required for breast implants.

Priotizing patient and consumer safety

Inadequate safety standards for pharmaceuticals, treatments and medical devices are systemic problems at the FDA. The examples of breast cancer treatments, and breast implants that cause more harm than good, are just some examples of the weaknesses in FDA approval processes, and the rushed approvals for Covid-19 treatment threaten to weaken the approval process further. Tell the FDA that patient safety must come first!

The accelerated approvals and lack of transparency around breast implants are pink policies because, while the FDA’s mission is to protect patients and consumers, these policies fail to protect people living with breast cancer, in the case of accelerated approvals, and they increase cancer risk, in the case of breast implants.  

Join us in saying NO to pink policies. Sign our petition to tell the FDA to protect patients and consumers

 

[1] https://www.fda.gov/drugs/development-approval-process-drugs

[3] https://jamanetwork.com/journals/jama/article-abstract/2758605?guestAccessKey=6c172781-0a0e-4e36-8c5c-a51962ecc2f7&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=011420

[4] https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/avastin-bevacizumab-information#:~:text=Avastin%20was%20approved%20for%20metastatic,needed%20to%20confirm%20the%20data.

[5]  https://thehill.com/policy/healthcare/513443-trump-turns-up-pressure-on-fda

[6] https://www.nytimes.com/2019/07/24/health/breast-implants-cancer-recall.html?fbclid=IwAR2FOCUv7GvTanZwtF8d18KRVDH-xNs6U42Ca3-l_b7AQsKmiX4RXu58d8g

[7] https://www.fda.gov/media/131885/download

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