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The FDA Model Is Broken
Posted: Mon Jul 07, 2014 8:31 pm
by MSimon
What is clear from these presentations is that FDA model of approving drugs is simply unfit to manage the science that is coming. The conventional concept of one drug targeting one receptor is all that model can approve.
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This is where personalized medicine comes in and attempts to tailor this information for a given individual. We are witnessing a great convergence in technology that puts more power in the hands of the people. This presentation demonstrates the use of iPhone based ECGs and personalized genome sequencing guided cannabinoid selection for treating Atrial Fibrillation. In many ways this spontaneously ordered itself because we were most vested in finding a solution. We are not experts at making ECG, nor do have a clue how the iPhone operates. We understand a small slice of the genome and how to read it but in a highly networked world the
i Pencil storyis getting more and more powerful.
This would have cost over $1B and 10 years if done with the
central planner model of FDA approval. Granted our story isn’t complete and ready for blind one size fits all application to a population. We hope this aids in underscoring the need for a creative destruction in how we apply drugs to individuals. The intersections of these vectors of convergence will create rapid wealth and tremendous health. Jeff Berwick likes to reference the “3 killer B’s” radically altering the economy as being Bullion, Bitcoin, and Buds. I agree with him but believe bullion to be redundant to bitcoin and the 3rd B is really Big Biology manifested in personalized medicine. The paper I gave provides an early glimpse of this.
https://genomefreedom.liberty.me/2014/0 ... id-system/
Re: The FDA Model Is Broken
Posted: Mon Jul 07, 2014 9:01 pm
by JaMorg
It is worse than that...
Had a medical device distribution company, the FDA rules regarding what can and can't be said are insane at times. If something works for a condition off label and intended use you can't even whisper about it. Not only that but to be used in an actual doctor's office here are the other hurdles that have to be cleared:
1) FDA Approval: without clinical trials this will cost you somewhere in the neighborhood of 50,000+. Your facility and paperwork must be 501(K) FDA approved with an audit performed by an FDA approved audit company that you pay for their travel, lodging, and expenses while looking at what amounts to a glorified ISO 9001. With clinical trials or if they require documentation the cost of this jumps up to a minimum of a 1,000,000. This isn't even for experimental medical devices. This is for non-invasive devices like Knee braces etc.
2) Medicaid/Medicare: Diagnostic codes and CPT codes. If Medicare/Medicaid won't cover it then an insurance company won't cover it. If an Insurance company won't cover it no doctor's office will touch it regardless of how effective it is. Doctor's prescribe narcotic painkillers because Medicare/Medicaid took the reimbursement for non-narcotic pain relief from TENS, Ultrasound, and IR therapy to 5$ per treatment or non-covered.
3) Final hurdle is the doctor's office itself. Any treatment regime then gets compared to what is reimbursed for the highest dollar amount. Rather than use TENS or Ultrasound a doctor will put in an implant for back pain because it is the difference of tens of thousands of dollars between the two treatment options.
Re: The FDA Model Is Broken
Posted: Tue Jul 08, 2014 10:58 pm
by GIThruster
Although I am pro-GMO's, I admit there has been a huge amount of collusion concerning them and the trials have been wholly inadequate. FDA really is a mess and has always been.