Population healthiness INDEX℠ (PHI, Φ)

For regulators, public health & Advocates


A Game Changer In Healthcare


Transform Public Health - Regulator Scenario

Situation


Joan as the head of a recently formed task force to recommend regulatory reforms at a major federal agency has a very difficult task in front of her.  There are multiple pressures that led to the formation of this task force:


  • Congress, advocacy groups and general public are pressuring the agency to expedite approval of drugs and therapies to benefit patients and save lives.
  • While the drug approval process has improved lately but it has its limits given the narrow data sets to measure and review the stated outcomes and assessing short and long term impacts of the therapy.
  • Escalating cost of approved drugs and therapies is front and center in the national conversation.  While having no direct bearing, still the agency is implicitly criticized for encouraging the pursuit of expensive, block-buster drugs with fewer successful launches versus more precise drugs that could be launched faster with greater efficacies at lower costs.
  • Recent retrospective studies of some well known drugs have shown that adverse effects were not fully studied or reported, thus pressuring the agency to study impacts far beyond the narrowly stated end points, effecting both time and scope of the approval process.


Joan realizes that in order to simplify and expedite the regulatory review process, a higher level measure that is holistic and gives more consistent view of the patient is critical.  She wishes there was a solution to this challenge.

Insight

Joan’s instincts are right. PHI (​Φ) as a SINGLE measure of health and vitality for the Whole Person representing multiple factors and dimensions offers regulators an opportunity to measure the impact of a drug, therapy or a delivery system on the overall health and vitality of the patient rather than some narrowly defined outcomes for approval.

This would help simplify, and expedite the approval process, reduce potential for adverse effects of the therapies post launch, and with precision medicine, improve the health, vitality and productivity of the targeted populations and of the nation as a whole – the core mission of her agency.

 PHI (​Φ) Difference

Adaption of the PHI (​Φ) based measurement of the Whole Person would dramatically effect research and development, testing, measurement, and approval of drugs, therapies and delivery systems for a vital, healthier and more productive nation with a less expensive healthcare system.

 Expand outcome measures


  • Narrow outcomes measures or end points in clinical trials focus on the immediate results on a condition or disease but do not measure the overall impact on the health, vitality  and productivity of the patient.


 Reduce adverse and negative outcomes


  • PHI (​Φ) based end points consisting of the Whole Person view with multiple clinical and non-clinical dimensions influencing health, vitality and productivity would drive broader studies and help pre-empt some of the factors that cause adverse situations but go unstudied today.


Make regulatory system transparent, visible, and measurable


  • PHI (​Φ) based end points would make regulatory compliance more visible and transparent with consistency in the desired outcomes across the entire regulatory approval system.


Deliver effective and sustainable results

PHI (​Φ) linked outcomes would provide more effective and sustainable therapies, drugs or devices for the Whole Person.

Promote Precision Medicine

Combining genetic markers with the PHI (​Φ) model consisting of multiple dimensions and factors influencing the health, vitality and productivity of the Whole Person would deliver unprecedented insights and help develop precise solutions for the targeted populations.

Transform the regulatory regime

PHI (​Φ) would help transform the way the effectiveness is measured, reviewed and approved toward a better, safer, and consistent consumer focused regulatory regime that promotes overall health, vitality, and productivity across the nation and the world.

 


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