The Decentralized FDA is meant to act as a regulatory template or platonic ideal based on crowdsourced best practices for food and drug regulation and compliance. It is meant to be forked, modified where needed, and implemented in various micro-nations, network states, or special economic zones.
Additionally, the dFDA is NOT a single entity. It is a protocol or blueprint for an incentivization ecosystem that facilitates innovation by the countless individuals and organizations needed to realize the precise and personalized medicine of the future.
- Given a clear and optimized mandate, the crowd wisdom of a large body of medical experts can produce policies that are more effective at extending healthy human lifespan than the current regulatory framework.
- It is possible to implement such a regulatory body in a micro-state or economic zone such as Prospera, a semi-autonomous jurisdiction in Honduras.
- Evidence of the success of this model will make it possible to promote adoption by other micro-nations.
- Evidence of the success of this model will make it possible to promote adoption by increasingly larger states.
- Elevate the most promising yet little known/researched treatments
- Issue certifications for the Decentralized Science web-of-trust
- Provide an API for building trustworthy alternatives to conventional health markets
The ideal framework for crowdsourcing drug approvals aims to harness the collective intelligence of a diverse and knowledgeable crowd, ensuring rigorous, transparent, and inclusive decision-making processes. Below is a detailed description of the components and mechanisms that constitute this ideal framework.
¶ 1. Diverse and Informed Participant Pool
- Medical Experts: Doctors, researchers, and healthcare professionals.
- Patients: Individuals who have experienced the condition being treated.
- Caregivers: Family members or professionals who provide care to patients.
- Advocacy Groups: Organizations representing the interests of patients and their families.
- Industry Professionals: Representatives from pharmaceutical and biotech companies.
¶ 1.2 Verification and Credentialing
- Identity Verification: Ensure that participants are who they claim to be.
- Credential Verification: Validate the expertise and qualifications of medical professionals.
- Stakeholder Representation: Ensure a balanced representation of various stakeholder groups.
¶ 2. Comprehensive Data Collection and Management
- Clinical Trial Data: Results from pre-approval clinical trials.
- Real-World Evidence: Data from patient registries, electronic health records, and other real-world sources.
- Patient-Reported Outcomes: Direct input from patients regarding their experiences and outcomes.
¶ 2.2 Data Integrity and Security
- Blockchain Integration: Use blockchain technology to ensure data integrity and traceability.
- Data Anonymization: Protect participant privacy by anonymizing sensitive information.
- Secure Access Controls: Implement robust access controls to safeguard data.
¶ 3. Transparent and Collaborative Decision-Making
- Facilitated Discussions: Create platforms for open and constructive discussions among participants.
- Moderation: Employ moderators to ensure discussions remain respectful and focused.
- Voting Systems: Implement voting mechanisms to gauge the collective opinion of the crowd.
- Delphi Method: Use iterative rounds of discussion and voting to converge towards consensus.
¶ 4. Aggregation and Analysis of Crowdsourced Input
- Weighted Averaging: Consider the expertise and stakeholder group of participants when aggregating opinions.
- Bias Detection: Implement algorithms to detect and mitigate potential biases.
- QALY Estimates: Use Quality Adjusted Life Year estimates as a key metric for decision-making.
- Risk-Benefit Analysis: Conduct comprehensive risk-benefit analyses based on crowdsourced input.
¶ 5. Continuous Learning and Improvement
- Post-Approval Surveillance: Monitor the real-world performance of approved drugs and update decisions as necessary.
- Lesson Sharing: Share lessons learned from each decision-making process to inform future efforts.
- Flexibility: Ensure the framework can adapt to new information, technologies, and methodologies.
- Continuous Improvement: Regularly assess and update the framework to enhance its effectiveness.
¶ 6. Transparency and Accountability
- Clear Rationale: Document the rationale behind each decision, including the key data and opinions considered.
- Accessible Records: Make decision records publicly accessible while protecting sensitive information.
- Third-Party Audits: Allow for independent audits of the decision-making process to ensure integrity and accountability.
QALY stands for Quality Adjusted Life Year. The QALY is commonly used in health economic evaluations as a means of quantifying the health effect of a medical intervention.
The QALY can be calculated using the following formula which assumes a utility value (quality of life) between
- 1 = perfect health and
- 0 = dead as a doornail
QALYs = Years of Life x Utility Value
If a person lives in perfect health for one year, that person will have 1 QALY.
(1 Year of Life × 1 Utility Value = 1 QALY)
If a person lives in perfect health but only for half a year, that person will have 0.5 QALYs.
(0.5 Years of Life x 1 Utility Value = 0.5 QALYs)
Conversely, if a person lives for 1 year in a situation with 0.5 utility (half of perfect health), that person will also have 0.5 QALYs.
(1 Year of Life x 0.5 Utility Value = 0.5 QALYs)
The QALY is used to quantify the effectiveness of a new medicine versus the current one. In other words, the current standard of care is taken as the baseline, and the QALYs gained from the new (improved) intervention are counted in addition.
Numerous studies have illustrated the ability of the combined estimates of a large number of minds to produce more accurate predictions than even the greatest experts in the group. However, there are five components necessary to produce optimal results:
- Independence - Opinions of people are not determined by the people around them.
- Decentralization - People can draw on domestic knowledge and specialize in it.
- Opinion Diversity - Everyone must have private information, even eccentric explanations of famous facts.
- Trust - Every person trusts that a group can make a fair decision.
- Aggregation - To turn private judgments into a mutual decision, you have to follow a mechanism.
By applying these elements to a futures market that estimates the change in utility value and average lifespan, it's possible to acheive a far more accurate cost-benefit analysis of interventions than is currently possible with small centralized regulatory bodies.
Medical experts will receive soul-bound non-transferable deFDA Credential NFTs (FDA-CRED) will be issued to all members of the American Medical Association (AMA) and other international bodies which verify medical credentialing.
One deFDA fungible Reputation Token (FDA-REP) will be airdropped to holder of FDA-NFTs for each intervention that is proposed for a specified population.
Medical experts can stake their token in one of three pools based on their belief for the experimental population relative to a control group not exposed to the intervention:
- "Uncertain Pool" - they are uncertain of the outcome of the reform
- "Harmful Pool" - reform will result in a relative net average DECREASE in healthspan
- "Helpful Pool" - reform will result in a relative net average INCREASE in healthspan
If they do nothing, it will be assumed that they did not review the proposal.
If the "Helpful Pool" is the majority, the proposal will be approved and implemented. Post-marketing pharmacovigilance data will be collected from the participants and used to determine the relative change in healthspan between affected and unaffected populations.
The ideal framework for crowdsourcing drug approvals leverages the collective intelligence of a diverse and knowledgeable crowd, ensuring a rigorous, transparent, and inclusive process. By incorporating comprehensive data management, transparent decision-making, and continuous learning mechanisms, this framework aims to enhance the efficiency and effectiveness of drug approvals, ultimately contributing to better health outcomes and trust in the approval process.
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