A first-hand account of an against-all odds fight that demonstrates what it takes to advance breakthrough medical products.

Innovation Breakdown—How the FDA & Wall Street Cripple Medical Advances highlights lessons that I have learned over my 25+ years, focusing particularly on the incredible and unprecedented behavior by the U.S. Food and Drug Administration (FDA) as well as the utterly destructive influence of Wall Street’s fast money hedge funds on a promising little company. The victim of that treachery and destruction? MELA Sciences, a small medical device manufacturer that has spent 17 years endeavoring to mitigate the debilitating effects of
melanoma, the most aggressive form of skin cancer known to man.

  • Part One lays out, quite clearly, the devastation caused by skin cancer, and makes clear the need for something that can better help us detect it when it is curable.
  • Part Two takes a deep dive into the unlawful actions and coverups by the U.S. FDA that had to be overcome in our effort to bring MelaFind to market.
  • Part Three explains how the unnecessary and very public battle with the FDA left an indelible mark on the company, a taint that was exploited by nefarious Wall Street actors who then preyed on the company for their own benefit.
  • Part Four offers a cure for the broken system that nearly ruined the company, and in doing so has arguably killed countless patients by delaying, if not ultimately preventing, widespread adoption of this product.

Innovation Breakdown is much bigger than one product or one person; it is a case study in the insurmountable obstacles that threaten true medical innovation. The story of MelaFind, in other words, is simply the prism through which I hope to advance some broader truths and reveal the pervasive dysfunctions of a system that is supposed to help advance the cause of our collective heath but is actually hindering it.

WALL STREET JOURNAL BOOK REVIEW

Yo is a smartphone app. MelaFind is a medical device. Yo sends one meaningless message: “Yo!” MelaFind tells you: “biopsy this and don’t biopsy that.” MelaFind saves lives. Yo does not. Guess which firm found it easier to put their product in consumers hands? Oy.

In “Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances,” Joseph Gulfo tells the tumultuous history of MELA Sciences, the company that invented MelaFind. When Dr. Gulfo joined the firm as president and CEO in 2004, the company’s brilliant team of scientists had spent many years and tens of millions of dollars to develop MelaFind, a “camera with a brain”—optical technology that would scan potential melanomas in multiple spectra and then, using sophisticated algorithms and large datasets, diagnose which were most likely to be cancerous.

The company’s scientists had done successful research for the Department of Defense, but they had little experience in navigating the FDA, running a clinical trial or bringing a product to market. Dr. Gulfo, an MD with an MBA and a history of successful FDA-approved products to his name, had all the right skills to lead the company. And MelaFind had a lot going for it. It was noninvasive technology, the first of its kind. It promised a crucial opportunity for earlier detection: If left untreated, melanoma often spreads and kills, but it is highly curable when caught early. Read Full Book Review

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PRAISE FOR INNOVATION BREAKDOWN

“I have no shortage of criticisms of the Food and Drug Administration. Where I fall short, I’m always embarrassed to admit, is solutions….Despite all this, Gulfo still believes in the need for a strong FDA; Taborrak says he’s wrong, wrong, wrong.”
Elizabeth Nolan Brown, The Dish
“…Joseph Gulfo tells the tumultuous history of MELA Sciences, the company that invented MelaFind…a ‘camera with a brain’ – optical technology that would scan potential melanomas…The climax to this medical thriller comes when, in ‘the greatest 15 minutes of [his] life,’ Dr. Gulfo delivers an impassioned speech a la “Twelve Angry Men,” to the FDA’s advisory committee…the FDA approved MelaFind in September 2011.”

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