In your excellent research @Portsmouth on the integrity of our newest partner I thought you, and others, would be interested in a recent article appearing in March in the prestigious British Journal of Medicine.
Titled “The Illusion of Evidence Based Medicine” it is particularly relevant to ResApp at the moment. It describes briefly the deficiencies and distortions in the regulatory process, where regulatory bodies are funded by large pharmaceutical companies. In particular it refers to issues of integrity when pharmaceutical companies become involved in the commercialisation of university-derived research. Some extracts are below:
The pharmaceutical industry’s responsibility to its shareholders means that priority must be given to their hierarchical power structures, product loyalty, and public relations propaganda over scientific integrity.
Regulators receive funding from industry and use industry funded and performed trials to approve drugs, without in most cases seeing the raw data. What confidence do we have in a system in which drug companies are permitted to “mark their own homework” rather than having their products tested by independent experts as part of a public regulatory system?
Patients die because of the adverse impact of commercial interests on the research agenda, universities, and regulators.
Our proposals for reforms include: liberation of regulators from drug company funding …
Professor John Campbell, a British nurse educator, has provided an excellent summary of the issues involved in a 30-minute video. He refers indirectly to our newest partner as one example of poor behaviour.
RAP currently is in the process of seeking or awaiting FDA approvals for its ResApp-Dx and SleepCheck-Dx devices. The goals of its project with Pfizer also are the regulatory approval then commercialisation of a Covid-19 diagnostic.
As the relevant cough signature already has been developed and tested by RAP it is difficult to see what unique technical expertise Pfizer might add to the R&D project. Apart from funding the clinical trial its main contribution may be what could be thought of euphemistically as ‘regulatory influence’.
In the March 4C discussions on FDA approval for ResApp-Dx are simply described as ongoing. For SleepCheck-Dx a response to the FDA’s request for information in January is expected to be submitted in June. Consequent approvals therefore should not complicate discussions of the 11.5c offer price at the Scheme EGM next month.
RAP Price at posting:
11.0¢ Sentiment: Buy Disclosure: Held
