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Innovation breakdown : How the FDA and Wall Street cripple medical advances

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Innovation breakdown : How the FDA and Wall Street cripple medical advances

4.85 76,206 ratings · 4,334 reviews
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Overview: Winner of Maverick of The Year Award and Ernst & Young Entrepreneur of the Year Finalist, and featured by WSJ, Fortune and Bloomberg TV for his battle to defeat unlawful actions by the FDA, Dr. Gulfo provides a first-hand riveting account of an against-all odds fight that demonstrates what it takes to advance breakthrough medical products that truly benefit patients. Having been responsible for the development and FDA approval of three innovative cancer products, he provides the reader with ringside seats to the struggles that entrepreneurs of biotech and medtech companies must fight to successfully bring ideas to marketed innovative products that truly advance the lives of patients.As exclaimed by one real-life witness to a high profile public battle recounted in the book, It was like watching Gladiator! The only difference is that this really happened. Sometimes life is more dramatic and unbelievable than fiction; the courtroom-like trial in front of FDA s medical Advisory Panel is certainly one of those times. A second was the declaration of war filing a Citizen Petition against the FDA demanding that it follow its own laws and acts transparently in honoring its binding agreements. A third was a Congressional Hearing at which the FDA subsequently admitted that a mistake was made. The book contains public record facts woven together in a series of compelling stories complete with unique characters and deeply personal insights. Unrelenting focus, even to the level of personal destruction, and leadership through crises are other major themes.Part One describes how medical innovation occurs in small companies and details the challenges in moving those start-ups along a course that is anything but straightforward. It addresses issues such as the psychology of inventors and founders versus investors, the challenges of attracting and retaining talent, and the vagaries of early phase product development.Part Two takes a deep dive into the unlawful actions and cover-ups by the U.S. FDA that had to be overcome in our effort to obtain approval of a non-invasive product that saves lives. It is a brutal blow-by-blow account of a public slugfest that forever damaged the company.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. It details how with a Scarlet Letter on its back and an albatross around its neck, Wall Street s short sellers and dark pool traders hamstrung the course toward widespread use and adoption.The book concludes with The Innovation Manifesto, an actionable list of changes to help fix this horribly broken system, including reform to the legal system to reduce meritless shareholder lawsuits; securities reform to stop manipulative trading, analysis, and predatory shorting of small companies; and FDA reform that will bring in leadership that is committed to, and unafraid of, promoting health by proactively advancing the development and approval of innovative products, rather than simply blocking drugs and devices that are not deemed to be safe. The FDA needs to get back to its first principles and to stop the propaganda - the author knows how to make that happen.In medical school and residency, the author was taught to see one, do one, and teach one as the means to master a procedure and to complete the circle of education. With respect to biotech and medtech companies that have been severely compromised by an untenable system, having seen one, done one, and taught one he now seeks to prevent a hundred similar unfortunate examples. Continued advancement of our national health depends on it. "

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Published June 10, 2014
ISBN 22272721
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Joseph V. Gulfo
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Joseph V. Gulfo
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Joseph V. Gulfo is a writer and avid reader based in the Pacific Northwest. Before pursuing writing full-time, they spent over a decade working in education. When not working on their next book, Joseph V. Gulfo can usually be found hiking with their dog or trying out new coffee shops in their neighborhood.

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Rebecca Ramirez
Rebecca Ramirez August 08, 2025
Honestly one of the most premium reading experiences lately. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. Worth every moment spent reading.
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I was completely blown away. I became deeply invested in the protagonist's journey. A masterclass in storytelling. I am now a lifelong fan of this author.
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Joshua Campbell May 15, 2025
Such a rich narrative. The prose is exquisite. It’s accessible yet undeniably sophisticated. An absolute must-read for connoisseurs of the genre.
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Nicholas Ramirez September 07, 2024
Masterpiece from start to finish. The pacing was impeccable and the characters felt incredibly authentic. I was completely immersed. An effortless 5 stars.
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Karen Scott December 31, 2024
Exceeded all my expectations. The pacing was impeccable and the characters felt incredibly authentic. I was completely immersed. Worth every moment spent reading.
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I thoroughly enjoyed the elegance of it. It held my rapt attention, even when certain twists were telegraphed. A solid 4 stars from me.
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Masterpiece from start to finish. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. I will undoubtedly revisit this masterpiece.
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Exceeded all my expectations. I adored how the story unfolded. It kept me captivated without sacrificing elegance. I am now a lifelong fan of this author.
Laura Jones
Laura Jones June 02, 2024
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Daniel Perez
Daniel Perez July 22, 2024
An acceptable diversion. It verged on repetitive in the second act. A more concise edit would have served it well. Unlikely to reread, but a reasonable expenditure of time.
Richard Adams
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Absolutely brilliant. I adored how the story unfolded. It kept me captivated without sacrificing elegance. An absolute must-read for connoisseurs of the genre.
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A profoundly satisfying read. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. An absolute must-read for connoisseurs of the genre.
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Exceeded all my expectations. The author orchestrated a breathtaking finale. Truly a work of art. I will undoubtedly revisit this masterpiece.
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I was completely blown away. The author orchestrated a breathtaking finale. Truly a work of art. An absolute must-read for connoisseurs of the genre.
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A decent, if standard, experience. The tempo was somewhat languid, and I found my mind wandering. Not poor, simply average. Suitable if your reading queue is empty.
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Exceeded all my expectations. I became deeply invested in the protagonist's journey. A masterclass in storytelling. A true literary gem.
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Honestly one of the most premium reading experiences lately. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. A true literary gem.
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Such a rich narrative. I became deeply invested in the protagonist's journey. A masterclass in storytelling. I will undoubtedly revisit this masterpiece.
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I was completely blown away. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. An absolute must-read for connoisseurs of the genre.
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Honestly one of the most premium reading experiences lately. The author orchestrated a breathtaking finale. Truly a work of art. A true literary gem.
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A profoundly satisfying read. I adored how the story unfolded. It kept me captivated without sacrificing elegance. I am now a lifelong fan of this author.
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A profoundly satisfying read. The author orchestrated a breathtaking finale. Truly a work of art. An absolute must-read for connoisseurs of the genre.
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Exceeded all my expectations. The prose is exquisite. It’s accessible yet undeniably sophisticated. Worth every moment spent reading.
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Such a rich narrative. I became deeply invested in the protagonist's journey. A masterclass in storytelling. I am now a lifelong fan of this author.
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A profoundly satisfying read. I became deeply invested in the protagonist's journey. A masterclass in storytelling. An absolute must-read for connoisseurs of the genre.
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A profoundly satisfying read. I became deeply invested in the protagonist's journey. A masterclass in storytelling. A true literary gem.
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A very strong entry. The protagonist was compelling, though some subplots felt slightly overshadowed. A wonderful companion for a quiet weekend.
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A profoundly satisfying read. I became deeply invested in the protagonist's journey. A masterclass in storytelling. Worth every moment spent reading.
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Absolutely brilliant. I adored how the story unfolded. It kept me captivated without sacrificing elegance. An effortless 5 stars.
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Exceeded all my expectations. I became deeply invested in the protagonist's journey. A masterclass in storytelling. An absolute must-read for connoisseurs of the genre.
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Honestly one of the most premium reading experiences lately. The author orchestrated a breathtaking finale. Truly a work of art. An effortless 5 stars.
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Absolutely brilliant. The prose is exquisite. It’s accessible yet undeniably sophisticated. An effortless 5 stars.
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I was completely blown away. The author orchestrated a breathtaking finale. Truly a work of art. I am now a lifelong fan of this author.
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Took a moment to build, but the payoff was spectacular. It held my rapt attention, even when certain twists were telegraphed. I would highly recommend this to discerning readers.
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Such a rich narrative. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. A true literary gem.
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Excellent, though slightly flawed. A brilliant concept executed with flair. Just a few pacing choices I would change. Quite impressive overall.
Matthew  Davis
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Honestly one of the most premium reading experiences lately. The author orchestrated a breathtaking finale. Truly a work of art. I will undoubtedly revisit this masterpiece.
Jacob Scott
Jacob Scott March 03, 2025
Honestly one of the most premium reading experiences lately. I adored how the story unfolded. It kept me captivated without sacrificing elegance. An absolute must-read for connoisseurs of the genre.
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Dorothy Walker November 02, 2025
I was completely blown away. I became deeply invested in the protagonist's journey. A masterclass in storytelling. I am now a lifelong fan of this author.
Betty King
Betty King February 04, 2025
Such a rich narrative. The prose is exquisite. It’s accessible yet undeniably sophisticated. Worth every moment spent reading.
Robert Walker
Robert Walker April 28, 2025
A highly sophisticated read. The middle had a deliberate pace, but the climax was phenomenal. I would highly recommend this to discerning readers.
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Donna Rivera January 30, 2024
Such a rich narrative. I adored how the story unfolded. It kept me captivated without sacrificing elegance. I will undoubtedly revisit this masterpiece.
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Charles Thomas November 16, 2025
Such a rich narrative. The author orchestrated a breathtaking finale. Truly a work of art. An absolute must-read for connoisseurs of the genre.
Carol Collins
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Absolutely brilliant. I became deeply invested in the protagonist's journey. A masterclass in storytelling. I am now a lifelong fan of this author.
Andrew Baker
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Masterpiece from start to finish. The prose is exquisite. It’s accessible yet undeniably sophisticated. Worth every moment spent reading.
Dorothy Torres
Dorothy Torres February 12, 2024
A very strong entry. A brilliant concept executed with flair. Just a few pacing choices I would change. A very distinguished novel.
Jacob Adams
Jacob Adams January 17, 2025
Absolutely brilliant. The prose is exquisite. It’s accessible yet undeniably sophisticated. An effortless 5 stars.
Christopher Mitchell
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Excellent, though slightly flawed. Beautiful writing, though I craved slightly more depth in the lore. Still, undeniably engaging. A very distinguished novel.
Nicholas Diaz
Nicholas Diaz June 25, 2024
An acceptable diversion. It possessed moments of brilliance, but the narrative felt slightly disjointed ultimately. Perhaps more aligned with a different audience's tastes.
Steven Gonzalez
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I find myself somewhat conflicted. It verged on repetitive in the second act. A more concise edit would have served it well. Perfectly average.
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Linda Turner June 12, 2025
I was completely blown away. The pacing was impeccable and the characters felt incredibly authentic. I was completely immersed. Worth every moment spent reading.
Amanda Phillips
Amanda Phillips March 25, 2024
Took a moment to build, but the payoff was spectacular. The middle had a deliberate pace, but the climax was phenomenal. I would highly recommend this to discerning readers.
David Johnson
David Johnson December 30, 2024
A very strong entry. Beautiful writing, though I craved slightly more depth in the lore. Still, undeniably engaging. A solid 4 stars from me.
Mary Sanchez
Mary Sanchez September 27, 2025
Exceeded all my expectations. I adored how the story unfolded. It kept me captivated without sacrificing elegance. A true literary gem.
Dorothy Wright
Dorothy Wright November 23, 2024
I was completely blown away. The author orchestrated a breathtaking finale. Truly a work of art. I will undoubtedly revisit this masterpiece.
Laura Gonzalez
Laura Gonzalez October 26, 2025
Honestly one of the most premium reading experiences lately. I adored how the story unfolded. It kept me captivated without sacrificing elegance. I am now a lifelong fan of this author.
Elizabeth Hernandez
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Took a moment to build, but the payoff was spectacular. A brilliant concept executed with flair. Just a few pacing choices I would change. Quite impressive overall.
Paul Torres
Paul Torres July 05, 2024
A profoundly satisfying read. The author orchestrated a breathtaking finale. Truly a work of art. A true literary gem.
Cynthia Roberts
Cynthia Roberts January 13, 2024
I was completely blown away. The prose is exquisite. It’s accessible yet undeniably sophisticated. An effortless 5 stars.
Mary Collins
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Such a rich narrative. The author orchestrated a breathtaking finale. Truly a work of art. I am now a lifelong fan of this author.
Eric Moore
Eric Moore April 29, 2024
A very strong entry. Beautiful writing, though I craved slightly more depth in the lore. Still, undeniably engaging. I would highly recommend this to discerning readers.
Mark Young
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Honestly one of the most premium reading experiences lately. The author orchestrated a breathtaking finale. Truly a work of art. A true literary gem.
Dorothy Nelson
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Masterpiece from start to finish. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. Worth every moment spent reading.
Michelle Moore
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A very strong entry. Beautiful writing, though I craved slightly more depth in the lore. Still, undeniably engaging. I would highly recommend this to discerning readers.
Robert Martin
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Not entirely to my refined tastes. It possessed moments of brilliance, but the narrative felt slightly disjointed ultimately. Perhaps more aligned with a different audience's tastes.
Eric Clark
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Excellent, though slightly flawed. The middle had a deliberate pace, but the climax was phenomenal. Quite impressive overall.
Paul  Davis
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I was completely blown away. The pacing was impeccable and the characters felt incredibly authentic. I was completely immersed. A true literary gem.
George Cruz
George Cruz April 13, 2024
I was completely blown away. The author orchestrated a breathtaking finale. Truly a work of art. An effortless 5 stars.
James White
James White August 24, 2024
Took a moment to build, but the payoff was spectacular. It held my rapt attention, even when certain twists were telegraphed. A wonderful companion for a quiet weekend.
Sandra Martin
Sandra Martin February 29, 2024
Took a moment to build, but the payoff was spectacular. The protagonist was compelling, though some subplots felt slightly overshadowed. A solid 4 stars from me.
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A highly sophisticated read. The protagonist was compelling, though some subplots felt slightly overshadowed. A solid 4 stars from me.
Daniel Perez
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Excellent, though slightly flawed. It held my rapt attention, even when certain twists were telegraphed. A wonderful companion for a quiet weekend.
Joshua Taylor
Joshua Taylor April 29, 2024
Exceeded all my expectations. I became deeply invested in the protagonist's journey. A masterclass in storytelling. I will undoubtedly revisit this masterpiece.
Gary Gomez
Gary Gomez July 10, 2024
Honestly one of the most premium reading experiences lately. I became deeply invested in the protagonist's journey. A masterclass in storytelling. A true literary gem.
Thomas Robinson
Thomas Robinson May 05, 2024
Exceeded all my expectations. The prose is exquisite. It’s accessible yet undeniably sophisticated. Worth every moment spent reading.
Mark Anderson
Mark Anderson April 15, 2025
Masterpiece from start to finish. The prose is exquisite. It’s accessible yet undeniably sophisticated. I am now a lifelong fan of this author.
Jessica Young
Jessica Young May 29, 2024
Such a rich narrative. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. I will undoubtedly revisit this masterpiece.
Kevin Jones
Kevin Jones January 03, 2024
Honestly one of the most premium reading experiences lately. The author orchestrated a breathtaking finale. Truly a work of art. I will undoubtedly revisit this masterpiece.
Sarah Johnson
Sarah Johnson December 30, 2024
A profoundly satisfying read. I adored how the story unfolded. It kept me captivated without sacrificing elegance. An effortless 5 stars.
George Johnson
George Johnson October 01, 2024
I was completely blown away. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. Worth every moment spent reading.
Gary Gomez
Gary Gomez January 07, 2025
An acceptable diversion. The tempo was somewhat languid, and I found my mind wandering. Not poor, simply average. Perfectly average.
Richard  Parker
Richard Parker December 20, 2025
Such a rich narrative. I adored how the story unfolded. It kept me captivated without sacrificing elegance. A true literary gem.
Lisa Harris
Lisa Harris September 11, 2025
A profoundly satisfying read. I became deeply invested in the protagonist's journey. A masterclass in storytelling. An absolute must-read for connoisseurs of the genre.
Dorothy Walker
Dorothy Walker January 28, 2024
Absolutely brilliant. I became deeply invested in the protagonist's journey. A masterclass in storytelling. I will undoubtedly revisit this masterpiece.
Karen Wright
Karen Wright October 03, 2025
A decent, if standard, experience. The prose was competent, yet the characters lacked the depth I usually seek. Unlikely to reread, but a reasonable expenditure of time.
Laura Adams
Laura Adams September 03, 2025
Masterpiece from start to finish. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. I will undoubtedly revisit this masterpiece.
Ashley Rivera
Ashley Rivera January 12, 2025
A decent, if standard, experience. Certain acts were fascinating, while others felt like a slight endeavor to complete. Perfectly average.
Deborah Smith
Deborah Smith April 09, 2024
A very strong entry. The protagonist was compelling, though some subplots felt slightly overshadowed. A very distinguished novel.
Richard Hill
Richard Hill July 03, 2025
A highly sophisticated read. It held my rapt attention, even when certain twists were telegraphed. Quite impressive overall.
Cynthia Roberts
Cynthia Roberts April 11, 2024
I was completely blown away. The author orchestrated a breathtaking finale. Truly a work of art. An effortless 5 stars.
Matthew Martinez
Matthew Martinez September 29, 2024
Masterpiece from start to finish. I adored how the story unfolded. It kept me captivated without sacrificing elegance. An effortless 5 stars.
Joshua Miller
Joshua Miller January 30, 2024
Masterpiece from start to finish. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. An absolute must-read for connoisseurs of the genre.
Kimberly Baker
Kimberly Baker September 15, 2024
Exceeded all my expectations. I adored how the story unfolded. It kept me captivated without sacrificing elegance. An effortless 5 stars.
Matthew Roberts
Matthew Roberts November 07, 2024
Exceeded all my expectations. The author orchestrated a breathtaking finale. Truly a work of art. Worth every moment spent reading.
Joseph Martin
Joseph Martin July 29, 2025
I find myself somewhat conflicted. It verged on repetitive in the second act. A more concise edit would have served it well. Perhaps more aligned with a different audience's tastes.
Andrew Campbell
Andrew Campbell October 17, 2024
Absolutely brilliant. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. I will undoubtedly revisit this masterpiece.
Michael Lee
Michael Lee October 18, 2025
A very strong entry. It held my rapt attention, even when certain twists were telegraphed. A wonderful companion for a quiet weekend.
James Phillips
James Phillips February 23, 2024
A very strong entry. Beautiful writing, though I craved slightly more depth in the lore. Still, undeniably engaging. Quite impressive overall.
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