FDA fails to protect children from dangerous drugs

drugged-childrenFDA allows drug manufacturers to expand their market into the lives of children.

Marianne Skolek-Perez Global News Centre

(MYRTLE BEACH)  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 is shown below in its entirety — 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 I sat through, 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 suppose 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 back by a 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 “legitimate 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.


My article in Global News Centre regarding FDA approval of OxyContin for children as young as 11 years old — and there was no outrage!

August 17, 2015

FDA has Purdue Pharma conduct its own studies on children being prescribed OxyContin!

Photo: narconon.org

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

Marianne Skolek Global News Centre

(MYRTLE BEACH) 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.

The FDA 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.  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 - 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.




The FDA press release on buprenorphine implant in its entirety:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503719.htm

LP - Because you are, I am. Make sense? Only to me because of the love and peace you have given me.


skolek-new-photo-700Global News Centre’s Marianne Skolek, is an Investigative Reporter who focuses on the Prescription Opioid/Heroin Epidemic in the U.S. and Canada. In particular, Marianne has covered the criminal marketing of OxyContin going back to 1999 and continuing to the present.

In 2002, Marianne lost her daughter, Jill to prescribed OxyContin which her physician referred to as “mobility in a bottle.” It was, in fact, death in a bottle. After doing extensive research on the maker of OxyContin, Purdue Pharma, Marianne began working with the Department of Justice in Virginia in their criminal investigation into Purdue Pharma and in July 2007 was asked by the U.S. Attorney John Brownlee prosecuting the case to testify against the three CEO’s of Purdue Pharma, Michael Friedman, Paul Goldenheim, MD and Howard Udell, Chief Counsel. The CEO’s pleaded guilty to misleading the medical profession about the dangers of OxyContin. Marianne also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007.

In addition, a dangerous and highly addictive opioid named Zohydro has been approved by the FDA against their Advisory Committee’s advice and Marianne continues to alert Attorneys General, Senators and Congressmen as to the FDA’s irresponsibility in the out of control prescription opioid/heroin epidemic killing and addicting in the tens of thousands each year. Zohydro has been referred to as “heroin in a capsule” and its lowest dosage (10mg) contains twice as much hydrocodone as found in a Vicodin pill. The highest single dose of Zohydro contains as much hydrocodone as 5 to 10 tablets of Vicodin or Lortab. Zohydro mixed with alcohol can be fatal and has no abuse deterrent built in which will make it easy to crush and deliver a fatal dose of the opioid.

Currently Marianne has been instrumental in calling for the termination of Margaret Hamburg, MD, Commissioner of the FDA as well as Bob A. Rappaport, MD and Douglas Throckmorton, MD for their lack of commitment to safeguarding the American public against the prescription opioid/heroin epidemic. Marianne’s research, writing and contact with government agencies and attorneys has also exposed the heavily funded pain foundations set up by the pharmaceutical industry and their paid physician spokespersons who convinced the medical boards in 50 states and Canada that dangerous opioids such as OxyContin were less likely to be addictive. These physicians — in particular Scott Fishman, MD, J. David Haddox, DDS, MD, Perry Fine, MD, Lynn R. Webster, MD, Russell Portenoy, MD also downplayed the risks of addictive opioids in books as authors. These books are still available for sale and promoted to the medical profession.

Here are links to Marianne’s involvement in exposing the national conspiracy of the prescription opioid/heroin epidemic, the FDA, the pharmaceutical industry, their pain foundations and paid physician spokespersons.




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