I have another book my shelf: Grit by Angela Duckworth, speaking about her experience that students who exhibit GRIT, not intelligence, not luck, who ultimately succeed in life. One day I’ll get to it.
In my career at UCHealth, I’ve been fortunate enough to work with thoughtful, team-focused clinicians and leaders. I’ve also carefully cultivated an attitude of not taking “no” for an answer if I believe that it is the right thing to do.
I think it was the first President Bush, who spoke of “1000 points of light.” In our organization, we have a similar metaphor of “10,000 points of veto.” Anyone who has a clever idea, NOT ONLY has to figure out how to state the idea in a clever, attention-getting way, BUT ALSO to build a team of allies to champion the idea, AND THEN to present the idea to leadership in a way that will gain (gradual) acceptance, AND THEN figure out how to get it funded (maybe do it for free?) AND THEN overcome the “10,000 points of veto” as everyone weighs in on “why your idea is never going to work, and all the committees that will have to approve this idea.”
Well, here we are. Our idea: Build a BioBank at UCHealth, to draw an extra tube of blood during routine care of patients (with their consent), to store in our genomics research facility, do extensive testing and research on this BioBank of samples to discover new treatments, BUT ALSO to quickly scan these banks of samples for known mutations, and when we find potentially important results, communicate back to the patient to improve their care.
Here’s the catch: when we consented our first 100,000 patients, we only included a RESEARCH consent “please let us draw your blood for our massive research project.” But, we promised to send a second notice/consent if/when we found useful results, before communicating any results.
We NOW have 30,000 results on a straightforward Pharmaco-genomic test: Clopidogrel (Plavix) slow metabolizers. In brief, we know from the literature that at least 1% (1 of 100) patients has a gene mutation that means that Plavix is not a good medicine for them, and that it won’t “thin” their blood the way it is intended, and that an alternate medication would be a better choice in their healthcare. So, of 30,000 patients, we expect that 300 of them (or more) have this mutation. Problem is, we DON’T HAVE PERMISSION to send this result to their chart, or set up an automated alert for physicians caring for them, because of a lack of a “secondary clinical consent”. I begin to tear out my hair.
When we discuss this in committee, we begin listing all the points of veto:
- We didn’t get a second consent. Lets send out this consent “hey, do you mind if we send you some results from our genetic testing?” electronically and see how many people sign it. The wording is very generic, and I’m not surprised that patients don’t really know what this means. So far, of 100 patients we tried with, we have about twenty sign the consent. This means 80% of patients would not receive the result if we expand this process.
- Doctors won’t know what this alert means because they’ve not yet dealt with genetic mutations as it relates to drug-prescribing; “we must get out an education campaign to our 6000 doctors; that will take months or years.”
- The ethics committee should weigh in, because this is a brand new field and we should find out what others are doing (turns out, very little; they’re working very slowly; we have grown to be among the top 3 organizations with a large BioBank dedicated to returning clinical results to patients!)
- Our patient and family advisory council (PFAC) should weigh in, because they can tell us whether they WANT to see results like this; and how can we explain it clearly enough for them to get it?
- Our legal team should weigh in, because what about a lawsuit for wrongful sharing of information?
- Our Electronic Health Records clinical advisory team should weigh in, because maybe we need to write new guidelines on this new area of work.
- Our marketing team should help decide how we send messages and what words to use to be as clear as possible to patients.
- Our genetics counselors and genetics team should weigh in; what if patients get confused between Pharmaco-genomics (genes affecting drug prescribing) and other Genomics (Breast cancer risk? Family Risk for deadly genetic diseases?) We should set up a brand new “Genetics Advice clinic” that could take a few years to hire the right people and set up the physical infrastructure BEFORE we can release any results.
Whew! Fortunately, I have tasted such “early defeat” before, and have found that gathering a leadership team, setting a clear vision, not getting disheartened, knocking down one veto at a time, (and sometimes, outlasting a colleague who ends up retiring), can lead to ultimate success. (see: APSO notes, Open Notes, etc).
My metaphor for Pharmaco-genomics (abbreviated PGx), the “easy” part of Genomic medicine is that this is analogous to Drug-Allergy. Why would anyone object to knowing that I have an allergy to penicillin? Similarly, I have a “poor reaction to Plavix.”
Today, I began with knocking down one veto/domino. Our PFAC agreed unanimously: “Pharmaco-genomics” with the example of “Plavix slow metabolizer” is a result that ALL PFAC patients would want in their chart to alert their doctor to use an alternate med. I’m going to take this strong recommendation back to our Genomics leadership group, anticipate a slow but steady struggle to get this approve, and pave the way for future PGx. One way to do this is as an “Opt-Out” notification. I will suggest we send a notice to ALL our online patents enrolled in BioBank that:
Congratulations! Because of your early involvement in UCHealth’s Biobank, we are ready to show our first round of genetic results, called Pharmaco-genomics. Unless you tell us otherwise, our Patient Advisory Council recommended that we turn on Drug-Gene alerts that we find from BioBank, so that your treating physician can use the best medicine possible in your care. If you DON’T want such BioBank information in your chart, please let us know and we can remove it. In brief, this means that IF your doctor were to consider prescribing Plavix (a blood thinning medicine used in cardiology clinics), and IF you had a gene mutation (from our Biobank results) that would not work well with Plavix, THEN we would warn your doctor to consider a different medicine. We may find other Drug-Gene interactions and put them in your chart.
We will continue to consider separately the larger issues of Disease Risk mutations (eg Breast Cancer) and Family Trait mutations (Tay sachs or other inherited diseases), but we want to speed up the delivery of immediately valuable results.
CMIO’s take? This will not be easy, but it is, strategically, the right thing for patients and their healthcare, and for information transparency. And it will take Grit and persistence to succeed. Let me know if this resonates with you.