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Oct-19-2016 11:55printcomments

FDA Hearings on OxyContin for Children an Ego-Fest for Self Interest

Studies are being conducted on children using OxyContin and there is no outrage!

crying baby
Image: Medical Daily

(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:

My name is Stacy Baldridge and I work for Purdue Pharma, maker of OxyContin. The same pharmaceutical company that pleaded guilty in 2007 to misleading the medical profession about the addictive qualities of OxyContin.

Our three CEO's Michael Friedman, Paul Goldenheim, MD and Howard Udell, Chief Counsel were fined and sentenced to community service for their parts in the epidemic of deaths and addictions due to their lies. Our CEO's avoided prison terms because Purdue Pharma had the legal expertise of one Rudy Giuliani, former mayor of NYC as their lead attorney.

Purdue Pharma also had a physician named J. David Haddox, MD who pioneered the word "pseudo-addiction" which meant if patients exhibited addiction to OxyContin, it was not addiction, it was pseudo-addiction. Haddox further instructed physicians to increase the dose of OxyContin. In this way, addiction would not be exhibited by the patient and they would become more and more addicted as their dosage was increased.

Purdue Pharma also had the foresight to recruit physicians as their spokespeople to convince the medical profession to liberally prescribe OxyContin. Some of these very well paid physicians were Nathaniel Katz, MD, Russell Portenoy, MD, Scott Fishman, MD, Perry Fine, MD and Lynn Webster, MD. They were heads of pain foundations and traveled the country pushing opioids and in particular OxyContin for chronic pain patients -- long term.

Our strategy worked and we now have a nation of chronic pain patients addicted to opioids as well as an out of control heroin problem. Physicians realizing their patients were, in fact, addicted to OxyContin contrary to what they were led to believe, cut the patients off from their prescribed opioid and street drugs became the only option for what we referred to as the "legitimat
e pain patient."

Purdue Pharma will in all probability be calling upon the physicians I name in my conflict of interest statement as experts to give testimony in the safety of neonatals and newborns being given opioids.

My employer, Purdue Pharma is grateful to the FDA for the opportunity to make even more in billions of dollars with the most vulnerable being victims. We are holding out hope there will be no outrage from the non-profit advocacy groups or Partnership for a Drug Free Kids because they certainly did not show outrage when 11 year olds were given approval for OxyContin.

I personally would like to thank the FDA for all their efforts in making the owners of Purdue Pharma, the Sackler Family one of the ten richest families in the U.S. -- without any concern for human life.

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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