Archive | May, 2014

Tuesday’s Briefing and Wednesday’s Hearing

7 May

On Sunday afternoon, I received an e-mail from Jeff Allen, the Executive Director of Friends of Cancer Research, the organization that hosted the Breakthrough Therapies Designation Briefing held in the Senate today, asking if Chip or I would be interested in serving on the panel to discuss our personal experience on LDK 378, now known as Zykadia, since this drug was designated as a breakthrough therapy drug by the FDA last week. I was happy to do it if being on tap for two days in a row was going to be too much for him, but Chip didn’t hesitate for a second. He happily agreed to serve on the panel. As a panelist, Chip testified about his participation in the trial and what it meant to him and our family to have had a solid 7 1/2 month stretch of “health” and normal living.


Prior to today’s briefing, the panelists and moderator had an opportunity to meet with Senator Bennet (D-CO) who, along with Senator Hatch (R-UT) and Senator Burr (R-NC), introduced the “Advancing Breakthrough Therapies for Patients Act” in the Senate last spring.

What does Breakthrough Therapy Designation mean? In total laymen’s terms, after animal testing is done, drugs go through three different phases:

  • Phase 1–A small group of qualifying candidates (the criteria and protocol for each clinical trial is unique) receive the drug to determine proper dosage levels, how long it takes your body to metabolize the drug and any side effects are recorded. The number of subjects typically ranges from 20 to 80.
  • Phase 2–Barring unacceptable toxicity levels and once the proper dosage is determined, the drug then moves into the expansion phase. Chip entered the LDK378 trial in Phase 2. The pharmaceutical company wants to get the drug to as many qualifying candidates as possible to determine if the drug is indeed effective in treating the targeted disease, and any short-term side effects are further documented. Only a couple of hospitals or cancer centers will execute a particular clinical trial at any given time, hence patients quite often having to travel for treatment, because there are thousands of clinical trials for all diseases being conducted across the nation at once, so not all hospitals can conduct all trials. Typically, the number of subjects in Phase 2 studies ranges from a few dozen to about 300. If there is substantial evidence the drug is having an effect on the disease, and more specifically over other comparable or existing treatments, the drug moves ahead to Phase 3.
  • Phase 3–More information is gathered regarding the safety and effectiveness of the drug, they study different populations and dosages and study the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people.

Breakthrough Therapies allows a drug, if designated by the FDA, to skip Phase 3 and move directly to the market, so now every ALK+ patient across the U.S. has access to this drug. Both of us being from small, rural towns, it has never been lost on either Chip or me how fortunate we are to now live where we do and to have access to such great medical centers like Johns Hopkins in Baltimore and Fox Chase Cancer Center in Philadelphia that are conducting these clinical trials.

View the Breakthrough Facts Handout for more information.

The FDA approved LDK378 to “break through” to the market by skipping Phase 3, because unfortunately, those with non-small cell lung cancer who are ALK+, are being treated for longevity and quality of life, so they just need this drug. They aren’t worried about potential long-term side effects of the drug or how it interacts with Lipitor, for example. Or in some instances, it may be a drug treating an older population or children that can’t withstand the side effects of traditional chemo, aren’t of child-bearing age, etc., so there is no need for a drug that has proven to be effective in treating their type of disease, to go through all of this additional testing. To think that a potential ALK+ NSCLC patient from Marks, MS, or Conway, NH, could now receive this drug in part to the clinical trial Chip was one of 164 to participate in is really amazing.

It truly meant much to both of us to be able to say thank you to so many in the Senate, the FDA, healthcare providers, pharmaceutical companies and various cancer organizations today for all of the work they have been doing that we are directly benefiting from; likewise, I think it was equally as rewarding for them to attach a name and face to a real person who is a husband and father just trying to live a quality-filled life. We repeatedly heard the message today that they were doing it all for us. For real people like US. Wow.

Tomorrow’s hearing in the Senate Special Committee on Aging regarding The Fight Against Cancer: Challenges, Progress, and Promise in which Chip is testifying, begins at 2:15 PM EST and will be streamed live from the Committee’s website. Riveting television, I know, but many of you have asked how to watch, so if you are indeed interested, click on for your viewing pleasure. The Committee typically leaves a recording of their hearings up on their website, too, so you can watch it later, as well. It is recommended you use Chrome or Firefox as your browser instead of Internet Explorer.

Wish us luck!

– Sheila



And this is also happening…

2 May

hopeThe LUNGevity Foundation is hosting their annual HOPE Summit in Arlington this weekend (see more on the LUNGevity website), so Chip and I are going to do a sophisticated dance, i.e., juggle with the kids and various commitments this weekend so Chip can attend as much of this as possible. Please don’t judge me if I place Crosby on one of those child leashes you see on kids at Tysons I, not II obviously, at tee ball in the morning, because Crosby is convinced she is a four-year-old little boy who has every much of a right to the field as her big brother.

Sunday, May 4, 2014
Immunology 101 and Clinical Trials

On Sunday morning, our oncologist at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Dr. Julie Brahmer, is presenting on the immunotherapy trial Chip is currently enrolled in, so he is specifically looking forward to learning more about that and other advances being made in lung cancer research.

A big, big thanks to Andrea Ferris, President and Chairman of LUNGevity, for her vision, her determination and all of the support she has provided to Chip over the last six months.

– Sheila

So…THIS is happening!

1 May

… and was officially just noticed in the Senate:


Bill Nelson, Chairman
Susan M. Collins, Ranking Member


The Fight Against Cancer: Challenges, Progress, and Promise

May 7, 2014

2:15 PM

Dirksen Room 562

  • Harold E. Varmus, MD, Director, National Cancer Institute, National Institutes of Health
  • Valerie Harper, Actress and Cancer Survivor
  • Thomas Sellers, PhD, MPH, Director, H. Lee Moffitt Cancer Center and Research Institute
  • Mary Dempsey, Assistant Director and Co-Founder, The Patrick Dempsey Center for Cancer Hope and Healing
  • Chip Kennett, Advocate and Cancer Survivor

Most cancer diagnoses occur in those aged 65 and older, and this portion of the population is rapidly growing. In addition, because of advances in research, a huge number of diagnosed individuals now “live with cancer.” New treatments for diseases that were once fatal means someone diagnosed at a young age, for instance, now will “age” with cancer, either living with cancer for a period of many years or fighting cancer and surviving earlier in life and aging with the impact of those treatments. Still another subset of those are fighting cancers that are still as-yet incurable and rely on the absolute latest of clinical trials to prolong their lives until a cure can be found. Clearly, both the advances and the demographics of those with cancer has changed since even the last Senate hearing on cancer six years ago.

This hearing will highlight each one of these factors and why innovations in cancer research are so important to confronting this trend, while also illustrating the progress that has been made against cancer because of the dedicated work of researchers, clinicians, patients, and advocates. In addition to stressing the importance of federal funding through the National Institutes of Health and the National Cancer Institute, witnesses will also cover the specific areas of treatment and survivorship.


1) Dr. Harold Varmus, Director, The National Cancer Institute (NCI). Dr. Varmus will provide an update on the Federal government’s work to get the latest advances to patients.

2) Thomas A. Sellers, PhD, MPH: Executive Vice-President and Director, Moffitt Comprehensive Cancer Center, Tampa, FL. Dr. Sellers will present research progress and challenges from the ground.

3) Mary Dempsey, Director, The Patrick Dempsey Cancer Center for Hope and Healing in Lewiston, Maine. Ms. Dempsey will talk about the services and supports needed today by cancer patients outside of medical treatment including help with finances, caregiver support, emotional and nutrition counseling, etc…and the trends she sees most often today from her vantage point and where we could improve.

4) Valerie Harper, a celebrity and survivor with Leptomeningeal carcinomatosis (LC), a rare complication of cancer in the brain. Ms. Harper has survived nearly a year after her prognosis.

5) Bayard W. Kennett (Chip). Chip is an advocate, survivor and former Collins/Congressional staffer battling Stage IV terminal ALK+ non-small cell lung cancer. Chip will speak about his diagnosis and living with an extremely recalcitrant form of an already difficult to treat stage IV lung cancer.

Gulp!! I mean, Chip and I actually know better than to agree to do something like this, but when one of our good friends and former colleague of mine, Rachel Pryor, shot me an e-mail about a month ago wanting to know if she could pick my brain on a hearing she wanted to do in the Committee, I enthusiastically said yes. She and I met for coffee at Peregrine (my new fave!!) one morning and spent a solid three hours crying, laughing, discussing life and of course, this hearing. One thing led to another, and the next thing we knew, Senators Susan Collins and Bill Nelson invited Chip to testify.

Anybody who has ever worked on the Hill usually adds to NEVER testify before a House or Senate Committee to their bucket list, but as Chip said, being invited is way better than being subpoenaed to testify. Four years ago, Chip was writing hearing questions for Senator Collins and staffing her at hearings, and on Wednesday, he will find himself on the opposite side of the dais answering questions from the Senator and other members of the Senate Aging Committee.

I am super proud of Chip for wanting to do this. As I’ve told a few people, he is on the panel with some really big names like Harold Varmus and Valerie Harper…you know, Mary Tyler Moore! Chip kindly informed me that Mary Tyler Moore was actually Mary Tyler Moore, and Valerie Harper was Rhoda on The Mary Tyler Moore Show to which I rolled my eyes and mockingly threw up some air quotes while mouthing “details…”

– Sheila