Proposed FDA “Conditional Approval”- More Details

A Q&A with Al Musella, DPM, President, Musella Foundation For Brain Tumor Research & Information, Inc., Hewlett, NY. Marty Tenenbaum, PhD, Founder and Chair, Cancer Commons, Los Altos, CA

Originally published May 10, 2017

Q: Your April 5, 2017 blog post that proposed a new “Conditional” category for FDA drug approval elicited a number of positive and negative responses. Please explain the proposal in more detail to enable better reader understanding.

A: In Response to “Conditional Approval: Right Solution for the Wrong Problem” by
Shannon Brownlee:

We appreciate Ms. Brownlee’s comments on our recent blog post, but think she missed our key points—perhaps we weren’t clear enough: Continue reading…


Conditional Approval: Right Solution for the Wrong Problem

A Q&A with Shannon Brownlee, MS, Senior Vice President of the Lown Institute, a think tank in Boston. She is also co-founder of the Right Care Alliance, a social movement for transforming health care.

Originally published April 26, 2017

Q: Musella and Tenenbaum recently proposed a new way, called conditional approval, for the American FDA to move potentially useful drugs to a patient market. They wrote that safety would be covered and efficacy assessed by a registry. What do you think of that idea?

A: Imagine if there were a way to speed up the discovery and testing of drugs for cancer. Al Musella and Marty Tenenbaum, founders of two cancer patient advocacy organizations, think they have just such a plan. Continue reading…


A Proposed New FDA Drug Approval Pathway: “Conditional”

A Q&A with Al Musella, DPM, President, Musella Foundation For Brain Tumor Research & Information, Inc., Hewlett, NY. Marty Tenenbaum, PhD, Founder and Chair, Cancer Commons, Los Altos, CA

Originally published April 5, 2017

Q: The delay time from discovery/observation, through validation to approval and distribution/use of new cancer treatments remains excessive. With promising experimental treatments, advanced computer technology and biostatistics, creative alternatives to traditional randomized clinical trials, and a government seeking efficiencies, might it now be time for the FDA to issue: “Conditional Approvals”?

A: The first advances in oncology occurred at a time when there were no regulations. Doctors had ideas, and put them to work immediately. They adjusted and combined treatments as needed until they were optimized and became standard treatments. Many types of cancer were cured by this work. Continue reading…


How to Tell a Patient Their Cancer Has Spread

A Q&A with crisis communication expert Lisa Dinhofer, MA, CT

Q. As a counselor and communicator, you are expert and experienced in managing serious situational difficulties up to and including coping with sudden unexpected death. How would you think it best to approach a person with cancer who is being told, “your cancer has spread”?

A: I’ll answer this question by posing another—how did you discuss the diagnosis initially? Did you jointly establish expectations for addressing this illness going forward?

How a diagnosis is delivered plays a critical role in future conversations around how the illness is responding—or not—to treatment. This initial conversation is the foundation for many more that could go in various directions dependent on disease progression, regression, and patient tolerance. Continue reading…


How I Survive Cancer

A Q&A with Erin Maloney: Intrepid explorer, Amateur photographer, Aspiring leader; Toronto, ON

Email: erinLmaloney@gmail.com

Originally published Nov. 1, 2017

 

Q: You have recently disclosed that you have had a diagnosis of cancer and described your experience in some detail on Medium. What does it mean to you to be a “Cancer Survivor”?

A: Calling myself a survivor sometimes feels like an exaggeration. In 2016, I was diagnosed with Stage 1A2 squamous cell carcinoma of the cervix. It began with a routine pap smear and led to a robotic laparoscopic radical trachelectomy seven months later. Every procedure was challenging, and surgery was particularly arduous. However, I did not have to endure radiation, brachytherapy, or chemotherapy. I got to keep my hair, didn’t have to cope with nausea or worry about the lifelong maintenance required after radiation. So, in many ways, calling myself a survivor feels fraudulent. I have it too easy. Continue reading…