Dear Representative Eschoo,

 

Thank you so much for taking our call yesterday and for your past and future support of CDMRP and NIH/NCI funding.

 

As I mentioned, I am a constituent with a rare, terminal, untreated (but luckily indolent) cancer.

Untreated means there are no good medicines, rare means that few study it and terminal means I have to work with urgency.

 

For me, FDA Commissioner Dr. Janet Woodcock’s words describe Medical research best: “It’s not working”. 

So, I created rarekidneycancer.org and am collaborating with researchtothepeople.org to create an alternative patient centered approach to research. 

In particular, we held a “hackathon” in 2018 at Salesforce where 81 researchers formed 17 teams to find “genes of interest” that might help me better diagnose and treat my disease.  We held a followup hackathon in 2020.  Taken together, the two efforts have pointed me in the direction of both a better diagnosis and a treatment.

 

All participants were volunteers, so total cost to me was $0.00.  Most were cancer researchers, bioinformaticians and data analysts just wanting a clear shot at bypassing all the BS that stood between them and the patient.  

 

How did I aid in that?  By signing away my HIPAA objections (I’m terminal, what does HIPAA do for me besides get in the way?), releasing all my medical records and asking labs to create research grade medical data from my blood and tumor, which I also released to hackathon participants.  These participants were attracted by the opportunity to work on a body of such rare and valuable data.

 

You may ask “why is such data so valuable”?  Because medical institutions and their doctors can enrich themselves removing our data from our control (“Henrietta Lacks”), charging us for it and giving us nothing in return, despite the fact that it is illegal (FDAAA 2007 - which requires researchers to report their results if they take government money).

It does not bother me that people can enrich themselves using my data.  I just  want to access the results of their government funded research.

 

So.  My “ask”. 

A) Fix FDAAA 2007 - Please let the enforcer-in-chief know that the law is being broken without consequence. 

B) Fix HIPAA - Please make it effortless for patients to grant access to their imprisoned data and to direct it to whomever they want.

 

On a related topic, I understand that your primary role in the "granting process" is to ask questions about it.  Based on my experience as a patient reviewer of government grants, here are questions I would ask.

1. How much has the research accomplished as measured by patient metrics e.g. Age Adjusted mortality? (Azra Raza says the metric hasn't increased since 1920)
2. How can the "application" to "published results" process be sped up?
3. How effective is reviewer feedback?  
   • E.g. Do grant submitters resubmit applications reflecting the (e.g. patient) reviewer’s input?
4. How much are minds changed during the internal review? 
   • Note that the Review’s “Preliminary/Revised” structure enables easy measurement of this using a T-test.
5. How much of the funded work has reported results? (See “A” in my “ask” above)

If anyone in your acquaintance wants to hear more about our research approach, please let them know I'm happy to give them the relevant links at any time.

Thanks again for listening.  Few do.

Best,

Bill Paseman

408 768 7879