I do not claim to be a political expert, but I do know what I am - a passionate patient advocate who has seen how systems can work for and against patients, and someone willing to put thought into action, to create a plan to make healthcare safer for a population that has long been ignored and at high risk.

As we prepared to take 30 patient advocates to Capitol Hill to discuss matters of importance to the community, we monitored the activities inside Washington DC. The floor kept shifting under us week after week as we attempted to prepare a cohesive message attached to policy that had a good chance of both being bipartisan and moving forward. Please go back and look at your news headlines between the beginning of February and the end of March - it was chaotic, and it sometimes appeared schizophrenic. But we had to keep searching for areas in which we could find some base definition of what it means to be a citizen or resident within the United States. 

There is a slow, simmering issue that has had my attention since approximately 2007,  something that reaches beyond the borders of cardiac disease but gets to the very core of our shared humanity. We will all certainly need a medication, a supplement, or a food additive to ingest into our bodies at some point in time. In the late 2000s, Dr. Harry Lever of the Cleveland Clinic brought something to my attention - an observation about generic drugs not functioning in a predictable manner. To say we've talked about this hundreds of times would be a gross understatement,  it's more like thousands of times over nearly two decades. You see, Harry Lever is a really unique mix of old school cardiologist and Detective Columbo, always searching for clues to the puzzle to unravel and find the bad guy. 

Harry and I shared observations about patients with HCM who had previously appeared stable, with no comorbidities, no lifestyle changes, no recent domestic or workplace stressors  - things seemed really normal for these people, yet their symptoms vastly changed nearly overnight in some cases.

Over the years other drug quality problems had come to my attention, including deaths related to a heart transplant medication I take, called tacrolimus. Eventually Harry put me in contact with other individuals who also were sharing our observations. There was a radio show producer named Joe Graedon, a researcher in Utah, named Erin R. Fox, and  a pharmacist by the name of David Light. David and I had spoken a number of times and he shared with me some of his scientific findings which were quite alarming.

I learned of the process of “dissolution” and how different molecules responded differently to the dissolution process and thereby would absorb differently within your body. This impacts the mechanism of action which, in my case, was to keep my heart protected from my body attacking it as a foreign entity. I learned of the problems with generic drug manufacturers through the writings of Katherine Eban (Bottle of Lies, Harper Collins ecco, 2019 ), and Rosemary Gibson, (China RX, Prometheus, 2018) an advocate on behalf of patient safety on multiple planes within the ecosystem. This small band of advocates is trying to sound an alarm throughout the country. Now it is time for the productive and equitable deployment of the shared efforts to keep every one of us safe and healthy. That is what we went to Capitol Hill to talk about.

There is a mechanism within the National Defense Authorization Act, a piece of legislation that is voted on each year to provide funding for our national defense. It is a type of legislation that typically moves unopposed through the process as we all seek to have a strong national defense. Within this act we are advocating the Department of Defense to support the NDAA amendment “Transparency and Quality in Pharmaceuticals Act,” to support the proposed ARPA-H project “Create and Deliver Actionable Transparency to Drug Quality.” We encouraged the VA to join with the DoD project and drug procurement reform efforts. 2025 VA Appropriations language already present in House section “Prescription Drug Quality” and Senate section “Drug Quality Scoring,” and the FDA to use DoD drug quality data to further inspect “red” rated manufacturers and reward “green,” to set a “zero toxins goal” in medicines similar to EPA’s goals for water and air, and to work collaboratively with independent testing efforts similar to Europe’s approach. Lastly, we encouraged the NIH to research drug quality to better identify issues, their public health impact, and strategies to best address them.

So, as we walked around Capitol Hill inviting legislators to come join us at a briefing to learn more about these initiatives. We had meaningful discussions with various members of each office’s internal administration. We spoke to legislative assistants, healthcare advisors, defense advisors, Legislative Directors, Deputy Chief of Staffs, and Health Policy Advisors. In total we met with 24 offices. This and the briefing offered them a deep appreciation for the community we are and the problem we seek to solve  - primarily the quality of generic drugs in the United States. 

Secondarily, we spoke of step therapy and prior authorization and the meaningless waste of time, effort, money and life quality by delays costing 1.3 billion dollars a year in waste fraud and abuse. The waste and fraud is being perpetrated upon healthcare systems, physicians and patients as we waste our time and precious resources playing a game that serves no one and costs, time, money and frankly the reputation of the health insurance systems themselves. It's time for us all to be reasonable adults; to fix the problems that we know are fixable and stop fighting about the differences in how to do it. Let's start negotiating how we all can benefit from better health systems and better access to safe high-quality low- cost generic drugs. If there is anybody who has an argument as to why anything I have said about these issues is not good for all Americans,  I welcome the conversation. Let's talk it out and understand how we can see the world with such different philosophies.