Response to a reader’s comment on subsequent post FDA “Right to Try,” Control:
Thank you for reading the post. You are so correct, as you recognize the primary difference between routine and exception. You have experience in the oncology environment and have seen I’m sure your share of the upstream resistance associated with the incentives and controls of this arena. Simply, many great people of great intention get fired if they don’t follow the rules because they observe the necessity of advocating change for the patient.
Personalized medicine, as it continues to emerge, must not, and simply, cannot be bonded into this current conventional medical schema. There is a posturing of control in attempting to put a lid on it. Personalized medicine doesn’t have resistance associated with it. It is a complete downstream movement not subject to the same laws, nor governed by the same institutions or the same rules.
In other words, the FDA doesn’t know what the hell to do with it. The best place to advocate and dictate what we want! What has become routine is what is expected and allowed to occur and this vibration needs to shift to allow for the best in healthcare options.
Patients need to be offered personalized medicine as a primary choice. We need to advocate primary choice in this “Right to Try.” You know, as well as I, that availability of a single treatment existing as the routine and in continuous use is a payor-based decision model. It’s the payor’s “Right to Deny.”
Oncologists or specialists rely on this convenience and will not balk when they continue to receive revenue share that requires their adherence to some pretty controlling guidelines, otherwise, such failure to adhere they would be pounding the pavement looking for a different job.
It’s not a Lobbyist solve either we do not need manipulation to manipulate to get what we want! We simply need to get what we want by allowing it in the space. Refuse to follow the rules.
Dr. Stan Burzynski since following these rules is now restricted. He and I had conversation recently and he stated he was able to help so many more patients when he didn’t have the constraints. Now he is bound to these constraints and the only way for greater freedom is outside of the US.
One good pitch of a baseball and one solid crack of the bat on the “sweet spot,” drives the ball greater than 400 feet into the stands. That is the solid crack we need! Balls will continue to be thrown we just need to hit them solidly.
Personalized medicine must dominate as the biggest “pain in the regulatory ass” of medicine as possible without concessions. It must continue to not fall within the rules. Defying the “regulatory boobs” that want to box it in. Such regulatory bureaucracy has made it very convenient for a drug to remain on the market if it is a top multi-billion dollar performer despite its evident serious risk to patients!
All these top performing drugs receive continuous endorsement through marketing campaigns. Pleasant looking people, with catchy phrases, catchy music and visuals demonstrating ordinary patients, but patients that need to use the extraordinary fashionable hopeful drug, while they calmly state all the death risks associated with its use on the commercial campaign on public television and social media.
Personalized medicine needs no campaign, it simply will win the space by choice. “Right to Try,” advocated by the Goldwater Institute, came about by the pushback of patients against the conventional offerings. Patients are already seeing the limitations of “Right to Try.” It must be “Right to Try” as primary choice not choosing after the standard of care fails.
This is the long answer, we must change the standard of care by simply choosing the standard we want and deserve. If we all advocate the same, we will receive it as a primary offering.