ASCO 2014: People in Drug Development

Reflecting on the American Society of Clinical Oncology annual meeting, I’m left thinking about the importance of people despite the vast amounts of data presented. Cancer drug development is a story whose characters are people, not molecules, not data. The ultimate goal is to help people with cancer (patients) but people are at the center of decisions about what molecules get funded, trials get run, data gets shared, treatments get paid for. So what are my “people” highlights for ASCO 2014?

Value – in the Eye of the Beholder

In a session called “Can We Find Common Ground? Stakeholder Perspectives on Value in Cancer Care,” Dr. Neal Meropol used the following definition and examples to discuss value in cancer therapy. At the time I wondered out louddo we have sufficient/the right/good enough data to define benefits of even the routine cancer treatment regimens? Costs and survival/progression benefits are more straightforward to measure than quality of life or toxicity avoided.

Value FontInc

 

Representing the patient perspective, Diane Blum used the following quote from Michael Porter:

the creation of value for patients should determine the rewards for all other actors in the system

As a patient advocate from the audience pointed out at the end of the session: Can’t make value decision w/o including pts in the discussions. There was no mention of Patient Reported Outcomes 2day (hat tip Robert Miller for capturing). There was another discussion on the topic launched by Sally Church the next morning: Presenters need to stop saying Drug X is “well tolerated” if common AEs = stomatitis, rash, diarrhea; pats feeling grotty unlikely to agree.

Value of Chemotherapy vs. Newer Therapies

On the last day, I went to a session called “Why Is Chemotherapy Here to Stay in Lung Cancer?” Dr. Mark Kris started off the session by reviewing the 25 year history of chemotherapy in lung cancer and describing chemotherapy as cell cycle targeted therapies. (Disclosure: My interest in broadly active agents is driven by being part of a team developing such a drug, although our drug doesn’t target cell cycle.) While the focus has largely shifted from chemotherapy to newer targeted and immunotherapies, Dr. Kris indicated that the majority of lung cancer patients will still receive chemotherapy at some point. In his talk, Dr. Thomas Stinchombe provided a list of the types of lung cancer patients that receive chemotherapy, while Dr. Kris provided survival curves from patients with and without EGFR mutations treated with gefintinb or chemotherapy. For the immunotherapy crowd, Dr. Kris also discussed the potential for chemotherapy to prime for treatment with these new drugs. For me, one of the striking points of the session came during questions at the end. The question from the audience: why do some cancers respond so well to chemotherapy vs. other cancers? The answer from the panel: there has been a lot of research but we don’t understand the biology. Given the number of patients receiving these drugs, is industry fully appreciating the value that chemotherapy brings to patients? And investing in ways to better select tumor types, patients, doses?

Oncology Factions: Interdisciplinary Development

In the intro paragraph, I indicated that various people are making different decisions in oncology drug development. Here I’ll mention just two players: providers (e.g. oncologists) and drug developers (e.g. pharmaceutical company employees). I was fortunate to be invited as a panelist for “The Future Is Now: Incorporating Electronic Health Records, Web-Based Decision Tools, and Social Media into Your Clinical Practice.” Dr. Michael Thompson pointed out to me that one of these things is not like the others – it isn’t that I’m the only one with a single degree or the only non-oncologist. I am the only one from industry.

Panel Table

After a scan of the program, the anecdotal analysis appears to hold true. The vast majority of speakers at ASCO are from academia, which is likely driven by commercial nature of the historical (and ongoing!) relationship between providers and developers. Much has been written about financial conflicts of interest between physicians and industry* but there are more subtle features of these relationships that can’t be separated out. During development, companies want the “best” doctors (Key Opinion Leaders or KOLs) to design and run their trials and the “best” sites (good enrollment and quality data). Oncologists are rewarded for working on the “best” drugs (publications generally for positive results, AKA drugs that work).

But treating patients with cancer has become a collaborative endeavor. Deciding on treatment options requires good quality samples for genomic testing. Complicated treatment paradigms in certain tumor types require sequencing of multiple available therapies. Phase I trials have expanded from dose escalation (~30 patients) to signal seeking (100+ patients). These changes and others are still underway. The session I participated in was an education session where I had no commercial stake in the topic. Perhaps a similar approach makes sense to increase cross-pollination with industry at primarily academic conferences.

 

While our professional objectives aren’t necessarily aligned, personally we all want to improve patient outcomes as patients are really our families, our friends, our neighbors.

 

*Here is a recent general article on conflict of interest with authors from four academic institutions (Brigham and Women’s Hospital, Harvard Medical School, Davidson College and Carolinas Medical Center) After 20 years, industry critics bury skeptics, despite empirical vacuum.

In addition, the Journal of Clinical Oncology has a few recent references on conflict of interest in oncology:

ASCO proposed changes to their policy in 2013 and recently provided rationale for why they will collect the information prior to actual implementation of some of those changes.  The Changing Landscape of Conflict of Interest Supports Further Study of American Society of Clinical Oncology Authorship Restrictions for Research Studies

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: