Skip Navigation LinksHome > March 25, 2012 - Volume 34 - Issue 6 > View from the Other Side of the Stethoscope: FDA—Friend or...
Oncology Times:
doi: 10.1097/01.COT.0000413572.35217.57
Opinion

View from the Other Side of the Stethoscope: FDA—Friend or Foe?

Harpham, Wendy S. MD

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Key words keep tripping my news alerts, with the pop-up boxes interrupting my train of thought. So I stop writing to see what the fuss is about.

WENDY S. HARPHAM, MD...
WENDY S. HARPHAM, MD...
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Players on all sides of survivorship are reacting to the FDA's revocation of approval of Avastin for treatment of breast cancer. To help me decide if the topic is blogworthy, I begin reading editorials published in major media and scrolling through patients' comments on social media.

The facts of the case are not in dispute. In 2008 the FDA granted accelerated approval to Avastin (bevacizumab) for the treatment of metastatic breast cancer.

Unlike the FDA's earlier approval for use in metastatic colorectal cancer and subsequently a few other cancers, the situation with breast cancer is special because the FDA based its decision on one small, non-blinded study that measured progression-free survival. The approval was conditional pending well-executed, double-blinded studies to validate the risk-benefit ratio for patients.

In July 2010, the advisory committee to the FDA concluded that the results of the first rigorous studies were disappointing: Avastin failed to extend life; did not slow tumor growth to the degree seen in the original study; and caused serious, life-threatening side effects.

More than another year later, the FDA handed down the decision prompting this media blitz.

My thoughts? The FDA can't win. If it denies or revokes approval, patients protest, “The FDA is too rigid.” If after approval a treatment causes serious problems, patients fume, “The FDA is too lax.”

That the FDA wrangled for more than a year before responding to the recommendations of the advisory committee with a lengthy, 69-page ruling can mean only one thing: “These are difficult decisions.”

However true, this provides little comfort to patients who are doing well on Avastin and feel the FDA just pulled the plug on their life support. The notion that the risks outweigh the benefits may seem irrelevant if they assume their risk is lower than that of patients who haven't started treatment. Such talk falls on deaf ears if patients fear that stopping Avastin will unleash their cancer, a terrifying possibility that trumps any risk of side effects.

While I've never had any of my treatments revoked, I know what it's like to have the FDA interfere with my cancer care. My early recurrences plotted a trajectory aligned with the textbooks' prophecy of ever-shorter remissions until death. In 1995, my lymphoma kept progressing while the PI of a coveted retreatment trial kept responding to FDA concerns that held up patient enrollment. The delay forced me to undergo more myelotoxic chemo instead of receiving a third round of the investigational antibody therapy that had kept my disease in check for two and a half years with negligible toxicity. To help me cope, I blocked out what happened with the FDA.

But not completely. That experience influenced my belief that problems with today's FDA stem from having a one-size-fits-all trial system bogged down in bureaucratic layers and conflicts of interest.

As both a physician and a patient, I'm frustrated and disappointed that the FDA considers input from professional lobbyists, marketing executives, politicians, and impassioned patients who recovered on treatment, but whose recoveries were perhaps not due to treatment. And while my reading of the literature suggests studies to date have not identified super-responders to bevacizumab, this is not to say they don't exist. We have an obligation to institute better ways to proceed in situations like these.

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Healing Messages

My thoughts regarding the care of patients with metastatic breast cancer are to avoid casting the FDA as friend or foe. Rather, I'd leverage the three beliefs that have helped me deal with limited treatment choices and the accompanying uncertainty:

1. Science-based data paves the way to the “best” treatments;

2. Science-based hope is stronger than that born of anecdote or wishful thinking;

3. The best we can do is the best we can do.

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Politics and Treatment

Try to redirect your patients' focus: “Let's not confuse political issues with treatment decisions. For today, let's look at things as they are, and not the way we think they should be or want them to be. Our overriding goal in your care remains the same as on Day 1: moving forward with the best available treatments in a timely manner.”

If you believe the best regimen for your patients includes bevacizumab, encourage them to explore clinical trials. If this doesn't pan out, help them work with patient advocate services. Encourage and support whatever legal channels they want to pursue to obtain the drug.

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Science and Hope

When caring for patients who unwittingly overestimate the potential benefits of bevacizumab, acknowledging and accepting the limits of current knowledge can be healing. But sharing a proper perspective without extinguishing hope can be challenging.

You can try mentioning a specific example from recent history, a cautionary tale of a promising theory or treatment that didn't hold up under scrutiny of scientific proof. “With what we know now, we simply can't say whether bevacizumab is likely to help or hurt you.”

To counter patients' disappointment and fend off despair, you can invoke the hopes of research and uncertainty: “Researchers are working feverishly toward answers that we will use as soon as they become available. Meanwhile, your unique story is still being written. We still can hope for the best.”

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A Healthy Response

There is no “right” way to respond to the news. Some patients find meaning—and joy—in testifying before Congress or raising awareness of the problems with FDA approval. Others do best to avoid the politics and, instead, pursue meaning and joy in everyday living.

Medicine is an art based in science. When study results are disappointing, healing words can help patients draw strength and nourish hope from both the science and the mystery of healing.

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Blog Posts

Dr. Harpham wrote a series of posts about the FDA revocation on her On Healthy Survivorship blog, which can be found at tinyurl.com/HS112811.

© 2012 Lippincott Williams & Wilkins, Inc.

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