Hundreds of thousands of undocumented therapies occur in clinics world-wide each year under the label of ‘medical tourism’. Even if physicians in these clinics wanted to follow their patients, there has been no method of doing so. Until now. Regenetek Research recognizes that there is a high need for a method and a study design that provides proof of both safety and efficacy for new treatment interventions such as autologous stem cell therapies or unsanctioned vascular surgeries. These types of medical interventions present viable choices for patients beyond conventional drug therapies that only treat symptoms.
The cost to an MS patient is between $60,000 in the US and $70,000 per year in Canada…and Biogen claims it’s effective for inhibiting MS symptoms…but they don’t quite know how it works…by their own admission (the medical research equivalent of throwing crap at the wall to see what sticks). Formerly it was only prescribed for symptoms of psoriasis. So how did dimethyl fumarate qualify to become the leading candidate for the treatment of MS?
With self-imposed funding caps for research, drug companies are performing big data searches on thousands of old clinical trials to look for unintended side-effects of molecules that can be interpreted to mean ‘efficacy’ for different diseases. Biogen found dimethylfumaric acid (BG-12), which demonstrated inhibition of immune cells by stimulating the expression of anti-inflammatory cytokines within the central nervous system, in previous trials. Theoretically, this old finding made it effective for the treatment of MS, and expensive-looking but short duration trials of only two years were performed to re-purpose and dress up a drug they already knew they were going to release for the treatment of Relapsing/Remitting MS. But where is Biogen’s conclusive proof that this relatively short period of clinical experimentation justifies the use of this method of disease treatment, and how solid is their data?