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FDA Advisory Committee Meeting on Reformulation of OxyContin ChallengedMarianne Skolek-Perez Salem-News.com Investigative Reporter
Dispelling the falsehoods regarding the decade plus reformulation of OxyContin was a man named Edwin R. Thompson, President of Pharmaceutical Manufacturing Research Services, Inc.
(MYRTLE BEACH, SC) - On September 10 and 11, the FDA Advisory Committee held a meeting regarding Purdue Pharma, maker of the blockbuster opioid OxyContin to determine if the revamped killer drug reformulated a decade ago cut down on abuse via snorting and injecting.
Purdue Pharma, now a disgraced multi-billion dollar pharmaceutical company has filed bankruptcy, but not before the deaths and addictions of hundreds of thousands of people to addiction and death.
Purdue Pharma reps were quick to defend their reformulated OxyContin on the market for far too long with the FDA's endorsement in allowing the surge of life destruction under their watch.
Although Purdue Pharma lauded that multiple studies indicated the reformulated tablets are harder to crush and dissolve, making them harder to snort or inject, the FDA Advisory Committee thought otherwise.
They ruled that Purdue Pharma's data and data from other researchers did not conclude the reformulation curbed abuse or led to few overdoses.
One of the presenters at the Advisory Committee meeting to dispel the falsehoods regarding the decade plus reformulation of OxyContin was a man named Edwin R. Thompson, President of Pharmaceutical Manufacturing Research Services, Inc. (PMRS) a manufacturer of pharmaceuticals in PA.
Mr. Thompson was featured on CBS 60 Minutes where he exposed the FDA for their complicity in allowing the opioid epidemic to rage out of control and opening the floodgates to long-term use of dangerous opioids for chronic pain.
This was accomplished by the FDA working in concert with pharmaceutical companies such as Purdue Pharma.
Here is a link to his segment on the broadcast: www.cbsnews.com/news/opioid-epidemic-did-the-fda-ignite-the-crisis-60-minutes
Here is an abridged testimony from Ed Thompson to the FDA Advisory Committee on September 11 (see slides below):
Slide 2 - Simply put reformulated OxyContin does not have physiochemical properties that deter abuse. Absent these properties, reformulated OxyContin is precluded (prevented) from having meaningful abuse-deterrent properties.
No amount, or interpretation of epidemiology studies can cure the absence of physiochemical properties required for abuse-deterrence. The FDA did not have the required data to label reformulated OxyContin in 2013 and they do not have it today.
You are going to be asked to fix this by adding a disclaimer rather than curing the original sin. OxyContin is not the only abuse deterrent product. The FDA approved 10 abuse deterrent products. Seven (7) voluntarily withdrew from the market or did not even launch their products.
These companies spent 100’s of millions of dollars to have their drugs approved and labeled for abuse deterrence. Their drugs were approved, but they still withdrew them from the market. Their drugs were labeled for abuse deterrence but they still withdrew.
So what happened? It was about pricing and profit. The FDA exclusively gave OxyContin price protection and when the other seven (7) companies were not given price protection -- they withdrew. It was never about abuse deterrence. Yesterday one advisory committee member asked about price. That question is the most important question of this meeting.
In 2016, we notified the FDA that a simple method existed in which an untrained, unskilled person can extract Oxycodone from reformulated OxyContin into a 9 - 16 mg per ml non-viscous solution in minutes.
Multiple times we provided the FDA with the 9 minute film demonstrating the process. We asked the FDA to show the Advisory Committee the film so you would have full disclosure before you vote today. If they showed you the film, we would not be here today.
(In two instances, I was at Ed Thompson's facility in Pennsylvania to witness the above process and view the 9 minute film along with people having an interest in the FDA's stonewalling information that could have saved tens if not hundreds of thousands of lives to addiction and death. I am not a scientific person, but I was stunned by what I witnessed in the extraction of Oxycodone from reformulated OxyContin -- as well as the film that was nothing short of exposure of an unbelievable partnership between pharma and the FDA).
Slide 3 - Let's look at the evidence. If you can cut it with any sharp instrument or scissors, or you have access to water and a syringe, you can IV16 mg per ml of reformulated OxyContin.
Slide 4 - This is a commercially available 80 mg reformulated OxyContin tablet. This is a cut tablet. It is a requirement to test the tablet.
Slide 5 - Cover the tablet with hot water, or water.
Slide 6 - The viscosity of the solution is 2. For reference, water is 1 and milk is 3.
Slide 7 - We have an extracted Oxycodone solution of 9 to 16 mg per ml with a viscosity of 2 that can be syringed and injected. It is impossible for this to produce abuse deterrent labeling.
Slide 8 - So how did we get here? Dr. Bob Rappaport, the now retired FDA Division Director of the Division of Anesthesia, Addiction Medicine and Pain Medicine reviewed and wrote "These features also render the product almost impossible to dissolve, syringe and inject."
Doubling down, Dr. Douglas Throckmorton, Deputy Director of the Center for Drug Evaluation Research (CDER) wrote to Dr. Janet Woodcock, Director of the Center for Drug Evaluation Research (CDER) "OCR gradually forms a viscous hydrogel (i.e. gelatinous mass) that resists passage through a needle.
The in vitro testing was sufficient to demonstrate that OCR prevents Oxycodone from being drawn into a syringe to any meaningful extent." Nothing could be further from the truth.
(It should be noted that before Dr. Rappaport retired from his prestigious position as Division Director of the Division of Anesthesia, Addiction Medicine and Pain Medicine, he had formed his own company violating FDA employee protocol.
The company name was ANALGESIC CONCEPTS LLC
Even though Rappaport did not file his company as an LLC until a month following his retirement from the FDA, Analgesic Concepts LLC was in existence for one year and seven months -- while he was employed by the FDA, being paid by the FDA and approving dangerous opioids for the FDA.
In addition, Dr. Sharon Hertz, former Division Director of Division of Anesthesia, Addiction Medicine and Pain Medicine (replacing Rappaport) and involved with approval of opioids along with Dr. Ellen Fields, both left the FDA within the last year after a long employment record to form their own consulting company to assist companies expedite approval of their drugs with the FDA).
Slide 9 - This process precludes reformulated OxyContin from having meaningful IV abuse deterrent properties. Dr. Dasgupta told you there is a product centric and people centric part of the data. The product centric data falls on its face and disqualifies the people centric data.
Slide 10 - Reformulated OxyContin has no impact on intranasal abuse. Intranasal abuse of Oxycodone in any formulation is less effective, less dangerous route of abuse than oral.
Slide 11 - C-Max slide. People abuse Oxycodone to get increased blood levels. Any formulation, IR Roxicodone, oral beats nasal. You get a higher C-max and lower T-max with oral. If true, intranasal should decline and stop and oral abuse should increase. Isn't that what happened?
Slide 12 - Oxycodone's physiochemical properties prevent reformulated OxyContin from having meaningful intranasal abuse deterrent properties.
Slide 13 - Epidemiological data cannot reverse the enormous increases in consumption of reformulated OxyContin.
Slide 14 - APQ for background this is the government prospectively approved volume of Oxycodone for consumption by year. The pre-reformulation volume of Oxycodone does not return for 8 years. It is not even imaginable that if OxyContin was not reformulated, we would have something worse than this. This slide is an indictment for the opioid epidemic. This is an iatrogenic epidemic sanctioned by the federal government.
Slide 15 - Reformulated OxyContin did not shift misuse, abuse and deaths to heroin. Dr. Compton published in the New England Journal of Medicine in 2016 -- "Moreover, a separate study showed no significant differences between the prevalence of heroin before the introduction of the reformulation and the prevalence after the reformulated drug was available." Slide 16 - Reformulated OxyContin does not have, cannot have meaningful intranasal or IV abuse deterrent properties.
Ed Thompson presented a concise and scientific rebuttal to the FDA's unscientific approach to the fallacy in the reformulation of OxyContin. Purdue Pharma is now in bankruptcy court. Will the FDA allow the OxyContin epidemic to continue devastating lives with their eyes wide shut as Purdue Pharma reorganizes under a new name -- continuing to push their blockbuster opioid, OxyContin?
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