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Aug-20-2015 12:12printcomments

FDA Allows Creator of OxyContin to Conduct Its Own Studies on Childhood Uses

If you have ever wondered if the FDA is corrupt, this should leave you thinking long and hard...well, are they?

Sharon Hertz MD
Sharon Hertz, M.D., Director, Division of Anesthesia, Analgesia, and Addiction Products, Office of New Drugs, Center for Drug Evaluation and Research, FDA. Photo: FDA.gov

(MYRTLE BEACH, SC) - The FDA has approved OxyContin for use in children to manage their chronic and extreme pain. If you are wondering what could the FDA possibly have been thinking in approving a drug for children that has been responsible for tens of thousands of deaths and addictions throughout the U.S since its release in the late 1990's -- there was no thought.

Don't even try to imagine how the FDA could have conducted studies with their research people and physicians under the watchful eyes of the heads of the agency because they did not.

Did their advisory committee -- the last step in approving a dangerous drug determine children could "safely" take OxyContin?

After all the FDA has come under close scrutiny for their financial ties to the pharmaceutical industry and certainly did not need anymore blood on their hands -- especially with the risk of children becoming addicted and dying from OxyContin.

No. There was no advisory committee review.

Here's where it becomes criminal. The FDA asked Purdue Pharma to perform their own studies on the safety of OxyContin being given to children. An internal study, with no oversight from any other body.

Remember, this is the same Purdue Pharma that was charged in federal court with misleading the medical profession about the dangers of OxyContin. This happened in 2007 and Purdue Pharma pleaded "guilty".

Do I understand this correctly? The FDA made a deal with convicted felons -- with our children the prize?

Sharon Hertz, FDA's Director of the Division of Anesthesia, Analgesia, and Addiction Products issued this press release regarding their approval of OxyContin for children.

In her press release, Dr. Hertz made an outrageous statement as shown here:

"The major difference is that all pediatric patients that are considered for pain management with OxyContin should already have been treated with an opioid pain medicine. This way, their health care providers know that these pediatric patients can be treated safely with OxyContin."

Pediatric patients safely treated with OxyContin? Where has Dr. Hertz been while OxyContin nicknamed "hillbilly heroin" has destroyed countless lives every day?

Well I'll tell you where Hertz has been. She serves on an Executive/Steering Committee for an organization called ACTTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks), a public-private partnership with the FDA to identify, prioritize, sponsor, coordinate, and promote innovative activities — with a special interest in optimizing clinical trials expediting the discovery and development of improved analgesic, anesthetic, and addiction treatments for the benefit of the public health.

Here's where it becomes very interesting.

Also serving on the ACTTION Executive/Steering Committee is J. David Haddox, MD, VP of Health Policy for Purdue Pharma, maker of OxyContin.

ACTTION has come under U.S. Senate investigation for what is referred to as a "pay to play". Something like 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 - "so far" and beyond. Love you every minute of every day!

Note: I recently wrote an article for Global News Centre regarding the FDA's approval of Purdue Pharma's blockbuster drug, OxyContin for children in pain. Here is the link to that article: http://www.globalnewscentre.com/#sthash.TRmZJbFX.dpbs.

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Lynn Swanson Locascio August 23, 2015 4:34 am (Pacific time)

As always..... well written and well said! Thank you for all you do!


Belvia August 21, 2015 12:21 pm (Pacific time)

No offense but where are you going with this? You are fighting a corporation. Obviously they still continue to keep their addictive medication on the market. This needs way more voices, like thousands. People in the activist moment to stop prescription pill addiction and drug overdose could learn a lot from the LGBT community on how to force change. It has to be way more than Facebook advocacy groups just bringing awareness. It is way bigger than us


N. Norris August 21, 2015 10:11 am (Pacific time)

The pediatric trials meant Purdue Pharma could get a deal from FDA to extend their patent. The NY Times exposed this July 2012 (http://www.nytimes.com/2012/07/07/health/oxycontins-effect-on-children-in-testing-by-purdue-pharma.html?_r=1) You will be amazed at the Children's Hospitals across the US that are involved in these trials on babies 0-6yrs! Children's Hospital Boston was named as a participant in at least one trial. (https://clinicaltrials.gov/ct2/show/NCT02044497?term=oxycodone%2C+pediatric&rank=1) The NIH reasoning for the trial for age 0-6yrs includes this troubling statement: "We would like to find out more about how this drug is absorbed, metabolized and excreted in children." Does that sound like a trial or an experiment? The NIH site shows US and worldwide trials for this drug.

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