It is time for Dr. Andrew von Eschenbach, Commissioner of the FDA, to make a comment and start the dialogue to change the misinformation and easy distribution of the drug reportedly killing thousands and addicting thousands more
Tampa, FL (PRWEB) December 2, 2008
"It is time for Dr. Andrew von Eschenbach, Commissioner of the FDA, to make a comment and start the dialogue to change the misinformation and easy distribution of the drug reportedly killing thousands and addicting thousands more," according to Larry Golbom, registered pharmacist and host of The Prescription Addiction Radio Show. (hhtp://http://www.prescriptionaddictionradio.com) Golbom asks, "How much longer is Congress going to remain silent on the epidemic that is killing only slightly fewer people than motor vehicle accidents? And this at a time when the Florida Medical Examiners report, the most comprehensive Medical Examiners report in the country, has linked oxycodone, the active drug in OxyContin, with thousands of deaths in Florida alone."
Before December 10th, the FDA will be announcing a decision that will, as Golbom puts it, "define the direction our country will be taking in combating the dramatic increases in deaths and addictions that started with the release and subsequent marketing of OxyContin in late 1995. Under the guise of 'abuse resistant', REMOXY, the drug being reviewed, claims to be a product that is a safer alternative, but is really just more of the same."
Larry Golbom reminds his audience, "REMOXY has the exact same active ingredient of oxycodone as OxyContin, the same exact dosage as OxyContin and we are to believe it is a safer alternative." Since a starting ingredient in the manufacture of REMOXY includes sucrose, common table sugar, Golbom, attending the November 13th FDA meeting asked if "simple heating studies to separate out pure oxycodone have been done on REMOXY?" The abuse resistant studies were suspect enough for an Advisory Committee panel member to ask "that before the product is approved, the FDA should require it to be studied in a group of drug abusers to see if the product really did deter abuse", according to Dow Jones Newswire. At the same meeting, an FDA senior clinical pharmacologist said "REMOXY'S extended release mechanism was compromised when the product was chewed or allowed to absorb in the mouth".
On November 14th, the Associated Press reported, "On Thursday, an FDA panel took an unofficial 11 to eight vote in favor of approving the drug REMOXY". Since Golbom was in attendance at the meeting, he asserts that this vote never took place for approval and he has not seen the FDA comment on the mistake the Associated Press published.
Last May, the FDA elicited and received immediate input from the FDA Advisory Committee panel concerning the also "abuse resistant" OxyContin formulation that was later not approved. "A majority of FDA panel members, in May, said that including information about the drug's resistance to abuse on a label would likely lead to more overdoses and deaths." (http://www.easybourse.com/bourse-actualite/marches/-rd-update-panel-has-deep-concerns-about-new-oxycontin-447473) On November 13th, the FDA did not ask for a vote of approval or denial from almost the same group of people who repeatedly voiced their concerns about the new REMOXY formulation.
The radio show will be asking before the December 10th announcement concerning REMOXY why there was no public vote by the FDA Advisory Committee panel concerning the approval of REMOXY before the Division of Anesthesia, Analgesia, and Rheumatology Products. The Prescription Addiction Radio Show - Breaking the Silence this Sunday night will be asking if it is time for the press and Congress to ask Dr. Von Eschenbach some questions. The radio show asks why the FDA is not more proactive in stopping the indiscriminate distribution of a drug reportedly affecting tens of thousands of families and individuals.
About The Prescription Addiction Radio Show ++ Breaking the Silence:
Hosted by Larry Golbom, a registered pharmacist for over 30 years, The Prescription Addiction Radio Show, sponsored by Novus Medical Detox Center (http://www.novusdetox.com), takes a cultural look at our prescription drug use in America and is dedicated to the thousands of families who are being or have been affected by the misuse of prescription drugs.
The Prescription Addiction Radio Show is dedicated to exploring some of the challenges we face in trying to turn around the explosion in the misuse of prescription drugs.
The Prescription Addiction Radio Show believes that addiction is a predisposed disease, whether created by poor personal choices or created from following the advice of your doctor. No individual wishes it upon themselves.