To: mogo who wrote (353 ) 6/10/1998 1:00:00 PM From: Kingfisher Read Replies (2) | Respond to of 4891
Mogo, was I the impetus for your post or was your response meant for me? Too much said! As Frick would say "don't fall off your soap box". When FDA regulations changed during the 1960s requiring that all drugs show proof of efficacy, drugs that had been in use were exempt. Dr. Hirschman said [September 1966 Infectious Disease News], that due to a "change in a minor component" made at the time the new regulations took effect, Reticulose could not be included in the grandfather clause. That FDA action made it possible for all of us to capitalize greatly because ADVR would not exist if it were not for that blunder. However, this good fortune for investors and speculators has occurred at the expense of the suffering and deaths of many who could have benefited from the availability of Reticulose. [No one has to have a doctorate to realize this.] I feel that the actions the FDA took in 1962 were due to overzealous regulators who acted by the letter of the law rather than the spirit of the law. They confiscated the then available supply of Reticulose, they subsequently curtailed information on the drug and they required that ADVR provide them with the composition of the compound [active ingredients of Reticulose] even when they should have realized that the technology [science] was not available to properly determine such information. If the FDA actions do not approach harassment, they at least support Professor Henry Fraser's statement that "the FDA has not expressed much interest in this drug." This understanding about the FDA causes him to be uncertain about when Reticulose could be made available commercially in Barbados or anywhere in the world. We have recently [7 June, 60 minuets] heard where a government analyst [Pentagon] recommended that the United States not give highly technical equipment to China only to be ignored by higher authority because of political pressures. Please keep in mind that it is not out of the realm of possibility that the suspected harassment of ADVR and suppression of inexpensive Reticulose has occurred because of political pressure from a big drug company. Dr. Hirschman stated in the BioWorld interview that "They (ADVR) couldn't say what the active ingredients were, and until you establish that, you can't file for an IND. That's where I came in." Monetarily speaking, there may be a good side to this requirement. As far as I understand it, Dr. Hirschman established the Yonkers Laboratory to determine the active ingredients [and possibly the inert ingredients] of Reticulose. Therefore, I contend that Reticulose is still under development and until they (ADVR) establish how Reticulose works they cannot explain it to the FDA nor to the US Patent Office. When Dr. Hirschman finds out how Reticulose works they may be still able to apply for a patent. In addition, knowing the inert ingredients [if they exist] could allow Dr. Hirschman to alter the compound and still apply for a patent.