Guest guest Posted April 30, 2008 Report Share Posted April 30, 2008 Gang I am thinking about supporting this reintroduced bill and wanted to hear what you guys had to say. There is an attached PDF with details on the bill. This will really help folks with cancer and other illnesses. As you probably remember, congress shut down the previous attempt to pass this: A DC judge ruled for them, but then congress shut it down http://www.washingtonpost.com/wp-dyn/content/article/2006/05/02/AR2006050201470.html Background of the case here: http://en.wikipedia.org/wiki/Abigail_Alliance_v._von_Eschenbach Access ActMr. Vergel, Attached is a draft of the Access Act we are considering. There are two changes to the language just made that aren’t reflected in the attached version: p.13, line 25 to p. 14 line 2 is revised to read “manner as a drug described in regulations relating to accelerated approval promulgated pursuant to and upon enactment of this Act and any such successor regulations.†p. 26, lines 17-23 has been replaced with: (e) REPORT. -- Within 90 days after the last day of the 5-year period of the demonstration project under this section, the Secretary shall issue a report describing the rates of utilization by Medicare beneficiaries of drugs, biological products and devices approved for Compassionate Investigational Access and the total cost of payments made under the Medicare program resulting from the demonstration project. The report shall describe recommendations for such legislation or administrative action as the Secretary deems appropriate. (f) TERMINATION.-- The Secretary shall terminate payments under this Section on the day after the last day of the 5-year period of the demonstration project under this section. Thank you for your time and consideration! Scaturro Counsel Senate Judiciary Committee 152 Dirksen Building Washington, DC 20510 Need a new ride? Check out the largest site for U.S. used car listings at AOL Autos. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 1, 2008 Report Share Posted May 1, 2008 "I am thinking about supporting this reintroduced bill and wanted to hear what you guys had to say. There is an attached PDF with details on the bill. This will really help folks with cancer and other illnesses. As you probably remember, congress shut down the previous attempt to pass this"As much as we all would like to help access for the dying, I'm not certain that this will help anyone. HIV patients have kind of a skewed view, I feel, because our relatively simple disease has seen a kind of success that is truly unique. The basis of that success is that the pathogenisis of HIV disease is isolated to a single infectious agent, that is by now pretty well, if imperfectly understood. The same condition does not apply for those with the myriad forms of cancer.I've worked with chemo protocols for years, and like it or not, they are usually about slow progress, never about miracles. By the time these patients are desperately seeking a new medication, they are probably past "deep salvage," and unlikely to benefit from anything experimental.Phase one testing does not establish any clinical benefit, just that the medication, in the doses delivered has an "acceptable" risk profile to allow further development. It is very unlikely that many phase 1 compounds are going to prove helpful, and they may do harm.More significantly, some of these compounds are not available in large quantities, the chemistry may be worked out, but the methods of reliable, safe production in the quantities needed for patient use might not exist. I would want to be certain that requiring access would not force companies to divert resources to production of compounds of questionable usefulness.I think you're talking about perhaps giving a bit of hope to the desperate, but if that hope is false, expensive, and highly toxic, I'm not sure that it is a gift that should be offered.JB Quote Link to comment Share on other sites More sharing options...
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