Safety: Safety is typically the purview of the FDA and medical specialty associations or boards, however, the presumption of safety is of interest to everyone.
Purity: Any drug or device must contain only those ingredients that are approved and clearly labeled, including active ingredients and excipients (inactive ingredients), clean and without micro-organisms, spores, or contaminants.
Reliability: The product (drug or device) or service (surgery, procedure or diagnostic) must perform consistently, from one lot or batch to another, without defect, using Good Manufacturing Practices.
Effectiveness: While related to safety, as part of the typical purview of the approval process, the treatment must effectively render a desired outcome.
Affordability: The price charged for any treatment or service must be affordable at the level of the patient, whether or not it is paid under a third-party benefit program or, possibly, out of pocket. The principle will vary based on the therapy but should not bankrupt the person or the health program.
Domestic Manufacturing: Because of the need for redundant supply chains, accountability of company officials, and practical oversight of the manufacturing process, wherever possible, manufacturing operations should be readily inspectable by local authorities.
Individualized: Any treatment should be customized to and agreeable with the individual patient and family members. Reliance on published algorithms or treatment protocols should be readily overridden based upon the desire of the patient.
Transparency: With the exception of the sacred privacy of patient identifiable information (see HIPAA), data used to drive decisions in clinical trials, post-marketing surveillance, or related to financial and other incentives between parties —particularly executives or decision makers— should be publicly available or available upon request or audit.
Statistical Validity & Honesty: if data is invalid or the statistics have been presented in a distorted way, the conclusions drawn may be gravely errant. The honesty of the presenters and statisticians can only be edified when the data is freely available for independent scrutiny. Because health care has been so often subject to fraud and distortion, whistleblowers should be protected and the “no man is above the law” standard should be applied to Executives, Board Members, Scientists and staff at all levels of each company, including Health Plans, Providers (including Doctors) and Manufacturers alike.
Observation of the Scientific Method: Science allows itself to be questioned and the scientific method provides accuracy when the same experiment, performed multiple times produces the same result. This standard must be honored again. Research should involve data that is accurate, objective, and open to debate. Moreover, just because science CAN do something does not mean it SHOULD. The Nuremburg code and laws against using humans as “guinea pigs” should be enforced.
Oligopolies are not helpful: Like other services or products, when there are only a handful of companies serving a health or drug market, product prices are high, and there may be supply chain problems resulting in little access to necessary drugs (think insulin), causing death or despair AND higher prices. Maximum Allowable Cost pricing practices have driven most generic manufacturers out of the US where the production cost is lower —and manufacturing standards harder to inspect for quality. Markets only flourish with competition which keeps quality high and costs as low as possible. At the same time, companies have a right to do business at a price above the cost of production. Because of perverse incentives, much of health care is driven by oligopolies where pricing deals are hidden and to the detriment of the end customers.
No grifters. We need to eliminate the fraudsters and corruption out of every level of the health care system. Jail time AND fines. Mandatory.
…And If We Can’t Agree on Common Values, Then Perhaps We Need More Than One Health Care System!
