New PD Study
Check out the link below. This study, with NIH support, will apparently include a wide variety of products and drug compounds. Let's hope this gets a lot of backing and it's as big as they say. Maybe now some of these small biotechs that have potentially important products will have another avenue to get their products out. This is a great idea. As long as a product is reasonably considered safe, there should be a way for new, innovative products to get to the people that need them faster. The process now is absurdly long and outrageously expensive. Products are released in Europe much sooner than in the U.S.
WHY? If someone has an answer to that, I'd like to hear it.
If a new product has solid science behind it with a potential for becoming an innovative therapy of a chronic disease, then these products must be supported in the early stages of development. Leaving it up to the big pharmaceutical companies could mean that a potentially important product gets tossed aside......
One example........October 2000 I saw my MDS at highly regarded PD center. Two of them tell me about Amgen-474 study. They were blown away by early clinical results and strongly urge me to enter study. I could not due to obvious need to adjust my meds at the time.
Oddly, the study is for only six months and it's a brand new drug. Well, phase II ends this past summer and the drug is considered very safe, but only shows positive results on small percentage of the study group. Not being a home run, Amgen tosses it aside and Guilford is left to pick up the ball. Those that took the drug, and believe it helped them are left in Limbo. Does Guilford have enough money to carry out a big expensive PIII study. I don't think so.
Well....I saw my MDS last tuesday and ask her about the PII study. She felt pretty strongly that it wasn't long enough. She said, "We're talking about re-growth here. That may take 8 months or maybe a year. We don't know." The sad part is that this drug may still be very important, but unless the money is there we may never know. Oh, she also said a patient of hers in the study that showed improvement, regressed back after coming off the drug.
I've got to stop drinking coffee at night. Here's the link: [url="http://www.biocompare.com/news.asp?id=3609"]www.biocompare.com/news.asp?id=3609[/url]
Bernie812
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