Latest posts by Bartley J. Madden (see all)
- Better Drugs Sooner at Lower Cost - March 8, 2018
- In Defense of Free to Choose Medicine - September 21, 2017
- Trump’s FDA Pick Should Let Patients Be Free to Choose Medicine - March 18, 2017
The winners of this November’s election will have a unique opportunity to improve American healthcare. Neither higher taxes nor increased ObamaCare big government is the answer.
For guidance, look to the one area of health care where quality has improved and costs (inflation adjusted) have declined – cosmetic surgery. Why? Unlike the rest of the healthcare industry, cosmetic surgery typically is not reimbursed by insurance.
Consequently, patients choose carefully among alternative providers and weigh their out-of-pocket costs compared to risks and likely benefits. This is a free-market environment in which consumer choice and competition work to deliver high value to customers.
The operative word is freedom.
Freedom of choice involves access to new drugs that have passed FDA safety trials and shown positive results in initial clinical trials, but which have not yet been approved by the FDA. The world has been changing in ways that favor early access. This includes accelerating medical innovations, big data analytics, personalized medicine with drugs tailored to your genetic makeup, and patients’ enthusiasm for sharing data and participating in medical advancements.
Recently, the world changed in a significant way with Right To Try state legislation which permits patients fighting a terminal illness to get access to not-yet-FDA-approved drugs. Freedom is a powerful rallying call and 31 states have now passed Right To Try legislation with sky-high approval ratings by citizens.
Problems with Right To Try
Implementation of Right To Try would encounter big problems. But these very problems may set the stage for political support for freedom to make your own decisions about not-yet-approved drugs for a wide scope of illnesses.
Assuming there won’t be any federal Right To Try legislation signed into law, the states do not have the legal authority to circumvent the FDA. Moreover, drug developers have a major disincentive to participate because, to survive, drug developers need to secure FDA approvals for their new drugs. And circumventing the FDA by providing not-yet-approved drugs to terminally-ill patients could easily slow or prevent FDA approvals.
The Better Option
A better solution is Free To Choose Medicine (FTCM). It would solve the dilemma facing politicians who are pulled in one direction by citizens’ demands for more freedom and in the opposite direction by FDA proponents with demands for a highly-controlled process. A clear, brief explanation of FTCM is available on the Internet in the PowerPoint presentation, “Free To Choose Medicine and Right To Try.” It explains how we will all benefit from more freedom of choice.
FTCM has three components that greatly improve upon Right To Try.
First, the Free To Choose track (separate from the FDA’s conventional clinical testing track) enables patients and their doctors to make informed decisions about the use of FDA-approved drugs or not-yet-FDA-approved drugs. Patients, under the guidance of their doctors, would learn about initial safety results and up-to-date treatment results of FTCM drugs. FTCM drugs for a wide range of illnesses (not just terminal illnesses addressed by Right To Try) would be available up to seven years before conventional FDA approval.
Second, FTCM legislation would provide for government oversight of an open-access, Internet-accessible database. It provides up-to-date information for patients and doctors about a FTCM’s drug’s potential benefits and risks before they choose to use it. This is a self-adjusting system wherein more patients use FTCM drugs that work well and vice versa.
The open-access database would contain treatment results of FTCM patients including their genetic makeup and relevant biomarkers. This database (not part of Right To Try legislation) would reveal subpopulations of patients who do extremely well or poorly with the new drug. Pinpointing such groups of patients is a huge benefit to, not only patients, but to biopharmaceutical researchers working on new breakthroughs in medicine.
Third, FTCM federal legislation needs to provide a new type of drug approval – Observational Approval – based on treatment results for real-world patients who receive the FTCM drugs. This would motivate drug developers to participate as well as expedite insurance reimbursement for patients.
Now that more than 60 percent of states have enacted Right To Try legislation with overwhelming public support, we will inevitably see a clash between politicians who support the heavy hand of the FDA regulatory process, and those who favor freedom of choice.
[First published at FEE. Go there to see Madden’s PDF presentation.]