The committee to start the early access clinical trials for drugs and treatments for men with advanced prostate cancer has been very hard at work. Based on the leadership and tenacity of Jan Manarite of the Prostate Cancer Research Institute (PCRI) we have managed to encourage, beg and cajole a number of pharmaceutical (pharma) companies to work with the FDA to provide their investigational treatment to men in serious need of them prior to receiving FDA approval.
This is done under the auspices of gathering additional data, especially safety data for the consideration of the FDA. Since it is a clinical trial and the trial uses unapproved treatments the pharmaceutical is not able to charge for the treatment or its administration.
So, why should a pharma be willing to give away for no enumeration their drug?
First, as I mentioned they will be able to gather additional data on both safety and efficacy. Secondly, they will be able to create good will among the patient and doctor communities. The third reason is that it will broaden the communities knowledge of the treatment so that the second they receive FDA approval they will already have a market penetration. Additionally, all the companies claim that they are concerned about the patients who need their tre