Evil Process-FDA’s Broken Approval Process

Last night I watched a great movie, Living Proof, which documented a true story about a doctor struggling to get a promising breast cancer treatment drug approved. In one of the scenes the doctor has just completed a Phase I clinical trial and has to explain to one of the patients why she won’t be allowed to move on to the next phase. Essentially, the reason is FDA rules. For all practical purposes the woman is sentenced to death. She had responded favorably to the experimental drug, but not favorably enough to move to the next phase.

Ok, you might say. But surely she could be given the drug outside of the clinical trial, right? Wrong. She is denied access to the only medicine that could possibly save her, presumably in the name of safety.

This isn’t an isolated case. Because I’ve rented similar movies in the past Netflix recommends a host of other movies about people fighting heroic battles to get potential cures through the FDA’s approval process. In the article, Whose Life is it Anyway? former FDA commissioner Scott Gottlieb is quoted as saying that the FDA is failing to use its authority to strike a balance on this issue. Gottlieb suggests a number of process improvements. Too bad his suggestions probably won’t be taken seriously.

I’m one of the lucky ones. When I turned 50 I was diagnosed with severe Barrett’s esophagus. The standard of care is what could be termed “watchful waiting.” It involves periodic endoscopies and drug treatment. In my case, the drugs did no good and my condition got steadily worse. My checkups went from every two years, to every year, to every six months. The biopsies looked more and more like cancer, putting me and my family through periodic nightmares as we awaited the biopsy results. Eventually, I was sure, my condition would progress to esophageal cancer. Like most cancer treatments, the treatments for esophageal cancer are expensive, gruesome and ineffective.

Finally, after eight years of this, I spent my own money to buy 30 minutes of time with a physician at Mayo clinic in Scottsdale. As luck would have it, he had a clinical trial starting. I qualified, received the treatment, and am now completely free of Barrett’s esophagus. While I was blessed, my nephew’s father-in-law was less fortunate. His Barrett’s degenerated into cancer and he died during my clinical trail. It will probably be several years before the treatment is approved and made available to the public. In the meantime, more people will die.

The FDA’s drug approval process is over 50 years old. It takes years and costs hundreds of millions of dollars. Thousands die while the FDA slogs along. It doesn’t take Six Sigma or Lean training to see that this process is screaming for improvement. It just takes a heart.

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Author: Thomas Pyzdek

Consultant, author, owner of The Pyzdek Institute

1 thought on “Evil Process-FDA’s Broken Approval Process”

  1. Wow, that sounds like a good case study for Six Sigma training… a good broken process, lots of readily-available data, easy process mapping and VA/VE/NVA steps (OK, more NVA steps than VA)…

    I may have to use that in a class…

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