Following Linnea’s biopsy on June 9 (you can see the report in Slack) and start on her new clinical trial June 10, we held our weekly update call yesterday (June 11) and discussed:
How Linnea should prioritize the use of her biopsy tissue – which tests to send it out for. Jess Lin has prioritized Foundation Medicine, Caris, and mProbe (proteomics). If there is enough tissue, she will add other tests.
An article on “the issue of tissue” – highlighting the challenges a patient faces in making sure that tissue is used for guiding her treatment (vs. research uses). Sophia Cornew of Ciitizen (and Ciitizen’s PR agency) and Gail Thornton are leading this effort.
I have summarized the meeting conversation and some subsequent emails in more detail in the notes below, and you can see and hear the recording of the conversation (1/2 hour) below as well.
As always, please review the ongoing conversation and leave a comment at our online forum (on Slack). And check out the “poster” below of the Linnea Olson hackathon.
Linnea was unable to join the meeting due to a conflict with a meeting to resolve one of the many crises she has been dealing with coming out of her biopsy and treatment this week.
1. Prioritizing tissue allocation to tests
Kimary Kulig: Are they saving any tissue?
Brad: We included the request to save 1/3 in the instructions (courtesy of Grace).
Kimary: Did the clinical trial request any tissue? Was it a request or part of the inclusion criteria? (If it was a request, it could be declined to save the tissue.)
Brad: We’ll ask Linnea.
Kimary: I noticed on the report that Linnea shared that the pathologists who signed were not thoracic experts. I was surprised by that. I assume that in a final report that thoracic pathologists will weigh in. It also seemed that there weren’t any IHC tests performed. I presume that’s probably in the works there. And while I’m not a pathologist, the “acinar and micropapillary patterns, and mucin production” findings from the biopsy indicate that it might not be an ALK positive tumor.
Rene Roach: Why is Linnea having tissue sent to both Foundation and Caris? Aren’t they pretty much the same tests? Is there something different?
Kimary: I wouldn’t do that either. I put that instruction at the top of the list to avoid redundant tests.
Brad: Is there value (if you have enough tissue) in sending to multiple labs to confirm results?
Kimary: That would be true if it were a non-validated test that doesn’t have FDA approval. These tests have had to show their reliability. If it were my tissue, I would get Caris or Foundation, and choose the one that gives me more results from the tissue.
Rene: I agree. I would save the tissue. You’re only going to find some variants of unknown significance that aren’t driving her cancer anyway.
Kimary: A clinician will be curious to see how the tests are different and feel it’s more valid if two tests come up with the same answer. I hope we are empowering Linnea to say, “I don’t want that redundant testing.” Has the tissue already been sent?
Brad: I don’t think so. I know that Jamie Holloway at Caris is still working on the requisition paperwork.
Kimary: If Linnea is up for it, I would ask the question, or at least stagger the tests. If the quality of the tissue is bad, you might have two failed tests, but if you hold the second, you could do something different with it.
Linnea (via email after the meeting in response to a question from Brad summarizing the above discussion about Caris and Foundation being redundant): Wasn’t one RNA and the other DNA? Dr. Lin felt they covered different bases.
Kimary (via email in response on June 12): Foundation One CDx uses DNA and covers a gene panel. Info is here. Foundation Medicine does offer the HEME panel as a CLIA lab test. It does both DNA and RNA. Someone would have to compare the Caris and FM gene lists side-by-side to see any differences. By its name, the HEME panel may be more targeted towards hematologic malignancies, but it says it can be used for solid tumors as well. Jamie Holloway from Caris also told me she’d be sure Dr. Lin gets their more comprehensive “research report” from your test results. This would include non-clinically actionable findings. We should be sure Foundation could do the same if that test is chosen. The Caris test does both DNA and RNA and those details are here and Jamie Holloway is on standby and already in communication with Dr. Lin. Dr. Lin is not releasing your insurance information to Caris/Jamie without your permission. Thus, Jamie cannot put in the tissue requisition without the insurance info. Any company with an FDA-approved product cannot technically NOT BILL for their test. This would be considered an “inducement” to the physician to use their test preferentially over any other and is highly non-compliant and could get the company in trouble. However, Jamie has assured me that Caris doesn’t go after patients for co-pay and said their patient navigator can help with all of this. I am a blunt person, so I will just go out on a limb here and say…I would save tissue and not do both tests. I would do the more comprehensive of the two and that seems to be Caris. Caris will also return any unused tissue if you ask them to do so. (I’m sure Foundation would as well, but I was told this by Jamie). Information that would be important for the Hackathon to know is how many core needle biopsy blocks were collected in total (i.e., how many slides might you have in total)? I would not let MGH use them all!!! Apologies for my stern, direct language, but… time is of essence as these tests take a couple of weeks and you need these results ASAP.
Linnea (via email on June 12): I shall bring this up with Dr. Lin and inquire about the health insurance as well. I may have misunderstood–so I shall ask for clarification. I do know that there is a well established relationship with Foundation and that could be part of it.
2. An article on “The issue of tissue”
Brad: Gail Thornton has been proposing that we work on an article or letter to the editor on the issues that Linnea has been having with her tissue. And Ciitizen has been very strong in advocating for patient access to their data and tissue, and Sophia Cornew has been speaking with their PR agency about helping draft something.
Sophia Cornew: I’ve had conversations with our internal team and PR agency about slotting this in. I will have another conversation on Monday. Deven McGraw [Chief Regulatory Officer] and I believe this is a wonderful story of patient control over their data that needs to be told. Patient stories have had tremendous success for us. For example, we have a CBS interview with one of our clinical trial matching patients. The reporters want patient stories. The hackathon and the issue of tissue need to get out there. The agency will figure out what’s the best approach — video interview, letter to the editor — to pursue.
Gail Thornton: I’ve spoken to a few reporters on the hackathon, what it means for treatment and a new way of thinking, different options. I’ll be writing that pitch this week. I would like to know more about Linnea’s personal story.
Brad: Linnea is quite public with her blog, articles, and interviews. If you do a Google search, you’re sure to find previous articles that will give you some color.
Kimary: Following the discussion we just had on the patient prioritizing tissue uses, we wouldn’t want any physician to shy away from this kind of effort and feel like their decisions are being challenged.
Brad: It’s a fundamental tension that is underlying this whole effort and getting second opinions. For example, in the Kasey Altman hackathon, Dr. Lenny Wexler, her oncologist at MSK was brave to host the discussion of Kasey’s medical history, and take questions, some of which might be seen as second-guessing his decisions. It was very brave of him to expose himself in the way he did. And on the other side, the patients hesitate to get a second opinion for fear of being rude to their oncologist. We’re all trying to get the best answers for the patient. Collegiality and openness need to be the philosophy.
Gail: Kasey’s physician was very open, yet Linnea’s physician might ask, “Why are you questioning me? Why are you stirring up the pot? You should trust me and my judgment and years of experience and expertise.” You have to be ginger when you write this up.
Brad: With the Bryce Olson hackathon, Rana McKay of UCSD said, “You’re going to bring a crowd to this? Great! I’ll learn something.” In my consulting I have had clients who were learners and clients who were defensive. They are pre-wired that way. You hope you get people who want to learn because for them, this couldn’t be better.
Sophia: This is a line we walk every day. We are building a technology platform that challenges the status quo and puts patients in a position of power over their health data. That itself is an aggressive move in the eyes of some oncologists, and there is some pushback. It’s part of the broader move to give patients access to their notes and other changes. There might be six stories here. What are the benefits of patients having a say, or of crowdsourcing? This is happening. Get on board, or not.