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FDA Hearings on OxyContin for Children an Ego-Fest for Self InterestMarianne Skolek-Perez, Salem-News.com Investigative Reporter
Studies are being conducted on children using OxyContin and there is no outrage!
(MYRTLE BEACH, S.C.) - On September 15 and 16, I attended an FDA meeting to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients.
On September 15, the day was filled with physicians giving their "expert" opinions on neonatals and newborns being given opioids for pain -- after all they feel the pain of "needle sticks". One expert said the discussion was like "elephants in a room". I describe it as "egos in a room" and there were many of them.
I wrote about my experience during these two days for Global News Centre and Salem-News.com. Links are provided below and I encourage you to read both articles and prepare for the FDA to approve opioids for neonatals and newborns as they did when they approved OxyContin for children as young as 11 years old.
My writing on approval of OxyContin for 11 year olds reveals there was no outrage from any advocacy group or organization such as Partnership for a Drug Free Kids when the FDA was holding hearings on this life-threatening issue.
Where were you all? And, more importantly, where will you all be when neonatals and newborns receive approval by the FDA for opioid therapy?
On the second day of the hearing, the FDA held what they refer to as an "Open Public Hearing". Anyone "preapproved" by the FDA could make a statement regarding pediatric guidelines.
Strange that although they are supposed to advise prior to statements who will be testifying, they did not provide the names of individuals for the "Open Public Hearing". They did make reference to conflict of interest before the four individuals made their time monitored statements.
Without any forewarning of who was to speak, I was taken aback by Stacy Baldridge who called herself a "nurse by training" but now a clinical scientist for Purdue Pharma, maker of OxyContin. Was this considered a "public" hearing by a pharmaceutical company who will profit in the billions of dollars if neonatals and newborns receive opioids?
Ms. Baldridge, clinical scientist, did not have to worry about a conflict of interest in working for Purdue Pharma because the FDA is quick to say "The decision to publicly disclose interests and statements made to disclose such interests are at the discretion of the open public hearing speaker."
So, Ms. Baldridge skated free -- she chose not to disclose any conflict of interest. I started thinking what could she have said about conflict of interest and came up with this idea:
I posed this question in my August 17, 2015 article "FDA has Purdue Pharma conduct its own studies on children being prescribed OxyContin!":
Representatives from pharmaceutical companies paid between $20,000 and $35,000 to send one of their representative to meetings with staffers from FDA. Was this in an effort to get fast track approval of painkillers? No it can’t be. This would be almost as criminal as the FBI asking Charles Manson to consult with them on murder and home invasion cases.
So I began to think. Is this, for lack of better words, criminal activity with children’s lives at stake because of a pay-to-play involving the FDA? Is the Senate aware of this? Well, they will be and very soon.
In the meantime, I think it may benefit me to reach out to the private attorneys I have had the good fortune of working with all over the country in my 13 years of investigating this prescription opioid holocaust and ask them — "Do you feel led to becoming involved in legal action to keep our children from becoming statistics in death and addiction due to OxyContin?"
I believe they will be on board — they have consciences.
LP - Enzo and Matthew what a great year it has been as a union. For the faith, love and support to you and from you, I am so grateful.
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