[Rolepaul]

One of the actions that is reported is to use multi-variate testing. This means that side by side testing of only two drugs is going be less, to be replaced exploring the interactions of multiple drugs. This is definitely a shift in how testing is done. To give you an idea on how long it takes for drug development, I worked on the precursors to TDM-1 in the mid-1980s. Now drugs are going from concept, through animal models, and into initial human trials in four to six years. Testing on patients is typically two to three years more. Once a drug is approved, a further indication is another two or three years. The FDA treats a drug for Stage IV Herceptin the same as for a blood pressure medication for 20% of the population. That has got to change! I am a person who benefited from knowing the system better than most, with Nina having Clinical Trial Associate certification and me having 27 years of experience in the pharmaceutical manufacturing system. This is very unique and it should not be necessary to have similar credentials to get treatment. I hope that the medical community and the pharmaceutical industry can get earlier and more effective treatments to patients on this site. I still cannot get acceptance for IT Herceptin after demonstrating with Nina and a few other patients the effectiveness of this dose and method of introduction. But I will not give up.